CSL Limited

Good morning, everyone. Thank you for joining CSL's results presentation for the first half of the 2026 financial year. I'm Mark Dearing, CSL's Head of Investor Relations. Please note, this briefing is being webcast. We've a lot to get through today, but as usual, I'd like to draw your attention to the important disclaimer on your screen. A copy of this, along with our other ASX materials, have been published on the CSL and the ASX websites. You will also have seen an announcement we made to the ASX yesterday relating to the appointment of Gordon Naylor as interim chief executive officer and managing director. We'll hear from Gordon shortly, but before we do, I'd like to introduce our other speakers today. With me here in Melbourne is Ken Lim. Ken has been our CFO since October last year. Prior to that, he was our chief strategy officer and has previously led our Securus business unit. Also here is Chief Commercial Officer Andy Schmelz. Andy joined CSL in 2023 as Executive Vice President, CSL Bearing, and last year his role was expanded to include CSL V4. And finally, we have Dave Ross, General Manager and Senior Vice President of CSL Securus since 2024. And prior to that, he was the Head of Commercial Operations in North America since 2017. I'll now hand you over to Gordon for some comments before we get into the detail of the results.

Thanks Mark and good morning everyone. My name's Gordon Naylor and following the announcements yesterday, I'm CSL's interim CEO. My main job is to run the business, giving the board the space to find and appoint a suitable successor. I'll briefly cover my background, but in that respect, I will work to be an experienced set of hands for about a year. Interim does not mean that I'll be taking a back seat. With the support of the board, I fully intend to drive the company forward. In the short run, we have an ambitious half year ahead of us, and we need to complete the strategic transformation that is now well underway and already delivering value. At the same time, we must deeply examine CSO's journey, especially over the last decade, to fully understand the opportunities for improving strategic growth and profitability. As an investor, I'm not prepared to accept that we can't do better and I see opportunities to do so. Just to briefly recap on my time with CSL, I have a deep connection to the company over my 33 years as an employee before I was invited to join the CSL board in December. Along with Brian McNamee and many others, I took CSL from an unloved part of the Australian government to global leadership in plasma therapeutics and then influenza vaccines. We had and continue to have a deep understanding of those industries and the economics that drive them. I was a key player in the globalisation of the company and was heavily involved in the major acquisitions that Brian drove to establish CSL Plasma, Bearing and Securus. I then took CSL Plasma to global leadership and at different times ran various functions including the global supply chain and IT. I was Chief Financial Officer through a period of remarkable growth. My last assignment was to build Securus into global influenza vaccine leadership. Dave and Ken were key parts of my team. I'll make a couple of early high level comments before handing over to Ken. I think that the strategic framework is sound. The challenge is whether we can do better within that framework. I'm very happy with Securus. It has used its global product leadership to drive market share gains in an extraordinarily difficult US market, a classic CSL play. The non-cash impairments around the V4 products are allowing us to move forward. The cash flow from the iron franchise and the growth opportunities in nephrology make this an attractive space. Your focus and my focus will be on bearing. It's a highly attractive growth sector and we have the right assets. This is where the greatest opportunity lies. CSO remains a strong and consistent cash generator. I'm looking forward to engaging in more depth with our shareholders over the coming weeks and months. With that, I'll hand over to Ken and the rest of the team.

Thanks, Gordon, and good morning, everyone. Before I get into the results for the first half, I'd like to remind you of our strategic framework. The results we're presenting today represent a step in a broader transformation of CSL with the objective of delivering enhanced growth, profitability, and shareholder returns. Andy will then provide an update on bearing and V4, and Dave will take you through the securest result. I'll then discuss our financials in more detail, as well as our guidance for the rest of the 2026 financial year. Many of you will be familiar with this slide from our Capital Markets Day in November. CSL's growth is underpinned by our leadership in large growing markets with high unmet medical need. We're embedding a relentless focus on cost leadership to deliver profit growth that's faster than revenue growth and generate strong cash flows that enable us to reinvest in the business. I'm confident that this strategy will underpin strong, sustainable shareholder value creation over the long run. Six months ago, we introduced a transformation program to simplify our organization and drive stronger growth. I'm pleased to say we're progressing well and are already seeing significant value creation. I'll speak to some of the key initiatives. Those in white are now complete and those shaded gray are underway. In terms of portfolio growth opportunities, we're excited about our collaboration with Varmex on a potential new coagulation treatment. And just this week, we entered into an early-stage research collaboration with Mimo Therapeutics, focusing on their recombinant polyclonal Ig technology. On the efficiency side, we've rationalised R&D sites and streamlined our corporate functions, resulting in savings that we'll see flow into the P&L this year. We've integrated Bearing and V4's commercial and medical functions, eliminating duplicated spend that has facilitated reinvestment in our US and China commercial capabilities. In plasma collection and manufacturing, we've reallocated collections to more efficient centres and are making strong progress on multiple yield enhancement projects. While we're pleased with our progress so far, there's still a lot of opportunity ahead of us. And as I said earlier, I'm confident we'll see these initiatives translate into strong, sustainable shareholder value creation over the long run. Turning now to our financial results. While we made strong progress on the transformation program, we're clearly not satisfied with our first half results and we'll be speaking to the initiatives we've implemented to drive stronger growth going forward. Our first half performance was also adversely impacted by government policy changes and one-off costs associated with our transformation program and asset impairments. I'll get into more detail shortly. We have a strong balance sheet in cash flows and today are announcing an expansion of our share buyback from $500 million to $750 million today. Looking at our high-level financials on a constant currency basis, group revenue fell by 4% and NPA declined by 7%. Reported net profit after tax was down 81% after factoring in the one-off cost that I mentioned earlier. Cash flow from operations was $1.3 billion. Looking ahead to the full year, we're maintaining guidance and have an ambitious plan for growth in the second half, driven by IG, Alberman, and our newly launched products. I'll return later in the presentation to discuss our full-year results guidance in more detail. With that, I'll hand over to Andy Schmelz to discuss the performance of the Bearing and V4 businesses.

Thanks, Ken. You see the Bearing half-year results here. Needless to say, this has been a challenging time for the business. Let me give you some context. IG sales of Privagen and Hyzentra declined relative to a strong comparable period in the first half of fiscal year 25. This performance includes the adverse impacts of IRA Medicare Part D reforms, which crimped IG sales in the U.S., and the expiration of some contracts internationally, which I've spoken about previously. However, when compared to the trailing six months through June 2025, where the comparison is like for like relative to Medicare Part D, revenue from IG increased by 3%. For albumin, the disruption from policy changes and cost controls in China, which we highlighted at our annual general meeting in October, are reflected in the numbers. That said, we've mobilized rapidly to mitigate the impact of these challenges. In fact, we've seen a positive response in the most recent three months from the expansion of our hospital field force in China and from our exclusive retail channel partnership announced in early November 2025. I'll talk more about this in a moment. The performance of Ig and albumin was partially offset by strong growth in other areas, including hemophilia, where we continue to see steady uptake of hemigenics. Sales of hemogenics grew 16% backed by positive five-year data published in the New England Journal of Medicine in December of 2025, which reinforced durable efficacy and safety for hemogenics in adults with hemophilia B. And we were very pleased with the strong launch of our new treatment for hereditary angioedema, Andembri, after it received approval in the U.S. and many international markets during fiscal year 25. Andembre can eliminate HAE attacks for the majority of patients with once-monthly dosing via pre-filled auto-injector. Today, less than a year into the launch, more than 1,000 HAE patients globally are now on therapy. With this momentum, Andembre is poised to become a leading medicine for HAE prophylaxis. Finally, perioperative bleeding, in particular case centra, continued to be impacted by competitive market dynamics. I'd now like to dive a little deeper into our IG franchise and also albumin dynamics in China. Our view is the fundamentals of the IG market remain strong with significant unmet patient need. We continue to see the market growing consistently in the mid to high single digit range over the medium term. This is underpinned by robust growth across core indications like primary and secondary immunodeficiency and CIDP. And importantly, IG market demand and supply are balanced. In the coming second half, I believe we will see stronger double-digit CSL IG portfolio growth. Now that one, we have digested the one-time adverse impacts previously mentioned, And two, we anticipate benefiting from commercial investments triggered over the past several months. Specifically, the expansion of our U.S. IG and hospital sales forces, restarting our U.S. Hyzentra direct to patient marketing campaign, and broadening our contracting efforts across targeted accounts in the U.S. and with customers and governments internationally. Early signals are promising from these investments. Our U.S. privigin business grew faster than the IVIG market over the last quarter, and our international business, excluding the U.K., is growing in high single digits. All that said, I appreciate this is a show-me story with forward results necessary. Moving to albumen sales in China. Upon seeing the market decline early in the fiscal year as government policy enforcement ramped up, we rapidly deployed mitigation efforts which should lead to a stronger performance in the second half. These included expanding our geographic footprint across more provinces, cities, and hospitals in China. We are ramping up our commercial presence across eight must-win provinces and pursuing more than 100 new hospital listings. We also entered into an exclusive partnership with local Chinese distributor, Baheel Medical, focused on the private pay retail segment. And finally, our medical team is generating fit-to-purpose real-world evidence to demonstrate albumin's important role across diseases, while our commercial team is driving on-label demand. I'm confident these measures will see albumin sales in China stabilize, recover, and grow in the second half. Turning now to V4. CSL V4 delivered a strong performance driven by nephrology. Overall revenue was up double digits at constant currency. However, the iron business fell, having been impacted by generic competition. Nephrology was the standout as sales in the dialysis segment jumped. This was driven by continued strong demand for Velforo as the full benefit of its inclusion in the Tdapa scheme was realized. Mercera also performed well and continues to be the market leader in the U.S. Our rare nephrology launch products also reflected robust demand and sales growth, driven by continued uptake of Tavneos in all markets where it's launched and Filspari, which successfully launched in several European markets. This next slide outlines why we believe nephrology will continue to be a strong contributor to overall performance. VELFORO is benefiting from TdapA designation that will continue through the end of the calendar year. And our rare nephrology launch products, Tavneos and Filspari, are well differentiated and performing well in Europe. As alluded to in the previous slide, iron growth was impacted by the launches of generics and associated price deterioration. Also, we expect to see the impact of the loss of exclusivity of injectifer in the U.S. in the 2027 financial year. Despite this, there continues to be high unmet medical need for iron, and we believe growth opportunities will come from geographic expansion, as well as via market development to grow IV iron penetration into areas such as women's health, cardio, and chronic kidney disease. I'll now hand off to Dave Ross to discuss the results for CSL Seqirus.

Thanks, Andy. As expected coming into this year, our influenza pandemic business returned to more normalized levels following a non-recurring H5 outbreak revenue in FY25. With that, our focus was placed squarely on driving our differentiation strategy in seasonal influenza, where I'm proud to say that we're the only company with year-on-year revenue growth. continuing our long-standing track record of growing market share. The breadth of real-world evidence continues to demonstrate the increased effectiveness of our cell-based vaccine, Flucelvax, and the benefits of our adjuvant vaccine, Fluad. This compelling clinical data, coupled with strong commercial execution, has allowed us to grow share in key U.S. customer segments and to continue the execution of our geo-expansion strategy, all of which is designed to drive growth while diversifying our customer base. Additionally, the opening of our cell-based telemarine facility allows us to make a full conversion to differentiated vaccines while expanding our pandemic capabilities and offering. Our performance was achieved against a backdrop of a global seasonal influenza market that we project will decline by mid to high single digits on a value basis. While immunization rates in ex-U.S. markets have essentially recovered to pre-pandemic levels, U.S. immunization rates will see a low to mid-single-digit decline this season. While lower demand in the U.S. has put downward pressure on global prices, the most significant impact has occurred in non-differentiated standard egg-based vaccines, to which we are no longer exposed with the forthcoming sunset of our Floria brand. I remain confident that the U.S. immunization rates will recover over the medium term, especially given the significant public health burden we're currently experiencing. As a reminder, last year marked a 15-year high in influenza disease and is currently trending to be an equally bad or even worse flu season this year. There are at least 20 million cases this season in the U.S., with disease activity still running high. Sadly, pediatric deaths are again on the rise, with the overwhelming majority of those deaths occurring in children who are either under or unvaccinated. With the rising burden of disease and recent U.S. policy changes, we're seeing a groundswell of stakeholder momentum building to combat vaccine hesitancy. The most notable being the American Academy of Pediatrics reaffirmation that all children six months and above in the U.S. should be immunized. As I've stated before, the science and the data will ultimately prevail. The public health consequences of influenza are just too big to ignore. So while the current market dynamics are challenging, our differentiation strategy positions us well to continue our trend of outperforming the market. And as U.S. immunization rates recover, it will act as an accelerant for our strategy and growth ambition. And with that, I'll hand it back to Ken to discuss the financial results in more detail.

Thank you, Dave. I'll start by walking you through the P&L, focusing on our reported numbers and changes in constant currency. Total revenue for the group was $8.3 billion, down 4%. Gross profit was $4.6 billion, down 3%, and group operating result was $3.8 billion, down 4%. In research and development, we made strong progress on our restructuring initiatives, and in fact are a little ahead of schedule. R&D expense in the first half was $600 million, down 8%. For the second half, we expect R&D to be a similar amount as the first half, again benefiting from our restructuring work. Importantly, we're investing where we see attractive opportunities, such as our VARMEX candidate, which is scheduled to commence phase three in the second half. General and admin costs were also down, in this case by 2%. We expect G&A costs in the second half to be similar to the first. Net interest expense was down 11% as our balance sheet continued to delever given strong cash flow. NPAT-A before restructuring and impairments was $1.9 billion, down 7%. I'll go into more detail on the restructuring and impairment costs shortly. Post these one-offs and amortisation, net profit after tax was down 81%. Our underlying effective tax rate was 21%. We expect this to be in the range of 18 to 20% for the full year. We continue to deliver strong cash flows of $1.3 billion in the half. We declared an interim dividend of $1.30 US, which is unchanged from the prior comparable period. And finally, a reminder that from fiscal 27, we'll be moving to NPAT rather than NPAT-A as our core earnings metric. Turning to the next slide, we presented the operating results for each of our business units. Andy and Dave have already spoken to the sales drivers. For CSL Bearing, revenue was down 7%, gross profit down 7%, and the operating result was down 9%. Baring's gross margin improves slightly by 10 basis points. This reflects the positive impact of efficiencies in plasma collection and manufacturing and the growth in hemigenics and endembury. It also reflects headwinds from Medicare Part D and the sales declines in albumin and case centra. Medicare Part D alone represents a roughly 100 basis point margin headwind. Securus's revenue was down 2%, which is pleasing given the challenging market backdrop Dave spoke about earlier. However, Securus's margins did come under pressure due to pricing in the US, geographic mix shift towards lower priced markets, and the non-continuation of avian flu sales recognised in fiscal 25. Sales and marketing costs for Securus were up, reflecting launches into new markets such as Germany and France. For V4, revenue was up 12%, driven by the strong performance in nephrology, and its operating result was up 22% as we continued to leverage the P&L through efficiency gains. On the next slide is an update on the financial aspects of our transformation program. As a reminder, we're targeting annual cost savings of up to $550 million by fiscal 28 with one-off restructuring costs of 700 to $770 million. Our plan in fiscal 26 is to deliver $100 million of cost savings. And I'm pleased to say at the half year, we've achieved 60% of that target. In relation to one-off restructuring costs, we're about two-thirds complete. There are two areas that account for the bulk of these costs, employee expenses as we right-size the organisation and facility closures and asset write-offs. Turning to the balance sheet on the next slide, separate to the restructuring costs that I just discussed, In fiscal year 26, we'll be booking total after-tax impairments of approximately $1.1 billion with $1.05 billion taken in the first half. The impairments principally relate to three main areas. First, a write-down relating to our agreement to license self-amplifying mRNA technology. Since entering this agreement in 2022, We've seen a decline in COVID disease burden, as well as a significantly more onerous regulatory regime in the US, particularly regarding mRNA vaccines. We're also impairing the carrying value of Venifer, our iron sucrose treatment for anemia. The impairment follows the licensure of three generic competitors in the US in the latter half of 2025, resulting in reduced future sales expectations. Reduced forecasts for Venefa have minimal impacts to the group, with Venefa contributing approximately $170 million in sales last fiscal year. Finally, our decision to accelerate investment in Horizon 2 manufacturing capacity has led to the redundancy of some plant property and equipment. In the second half of this fiscal year, we anticipate an impairment of approximately $70 million post-tax relating to VELFORO. As we previously noted, VELFORO sales have grown significantly following its inclusion in the US TDAPA framework. However, TDAPA inclusion is expected to roll off from December 2026. These impairments are almost entirely non-cash, and as I mentioned earlier, have minimal impact on the forward-looking prospects for the group. Our balance sheet remains in a strong position, with leverage of two times at December 2025 after repurchasing approximately $400 million US of shares in the first half. This has given us the opportunity to expand our existing share buyback program for this year from $500 million to $750 million. Moving to my final slide, we're maintaining guidance for the full year. We've set out here the drivers of our strong second half ambition and a bridge from our first half results. Starting with our first half group revenue that we announced today, if we simply double this, then take off an amount that allows for the expected seasonality in Securus, we get a simple annualised revenue figure for the full year. On the right of the waterfall, we've shown the growth expected in the second half. In IG, we expect double-digit second-half growth for both Privagen and Hyzentra due to our expanded field force in the US, direct-to-patient advertising, and broadened contracting. For albumin in China, as you heard earlier, we've already seen positive signs from our expanded commercial footprint across more hospitals and cities, supported by our retail partnership with Barhill Medical. And finally, we expect continued strong momentum in our recently launched products, Hemgenics and Endembri. We also acknowledge that there will be competitive pressures in other areas of our portfolio, such as Iron, Kcentra and Hagata, and have taken these into account for our full year expectations. Before handing back to Mark for Q&A, I'd like to make a few closing comments. We have significant untapped potential in this business. While our transformation program is progressing well, there is still much work and many more opportunities ahead of us to enhance growth and shareholder returns. I'm looking forward to working with Gordon to realise that full potential. With that, I'll now hand over to Mark to coordinate the Q&A.

We'll now move to Q&A. With a view to giving everyone an opportunity to ask a question, could you please limit your questions to two? If you do have a further question, you are, of course, welcome to rejoin the queue. Our first question comes from Andrew Goodsell at MST Marquis. Go ahead, Andrew.

Thanks very much for taking my question. Just to the ownership of the result, and obviously with Gordon as the incoming CEO, there's the propensity in the marketplace to see a new CEO as successful. sort of generally coming in resetting numbers. So just asking directly on that ownership, obviously Ken's gone through it in a bit of detail, but just wanted to hear from Gordon on that.

Yeah, I'm familiar with the model. So, yeah, there'd be no ambiguity. I completely own the situation the company's in at the moment and that's a bit of my job is to look for the opportunities that Ken referenced earlier and do something about it.

And then the second question, just perhaps to Andy, just on confidence around second half IG growth. And, you know, obviously we're familiar, you've won a few contracts, including the step up in your participation in the Aussie import contract. But just any more colour and detail you're sort of willing to share with us that gives you that confidence in recovery?

Thanks for the question, Andrew. Clearly, we knew that the first half was going to be a challenging period for our IG portfolio, and we faced many headwinds here in the first half and adverse impacts that are going to be predominantly behind us in the second half. The U.S. Medicare Part D reform, that's a few points of growth that were impacted. The impact of the lost contracts internationally, which we've worked a lot through. That's another few points of growth. And then there was some choppiness in trade purchases as well. So with those behind us and the investments that we've made, as I kind of articulated, in our U.S. field force, in our direct-to-patient campaign, in our broadened contracting platform, Those all have started in recent months to have some momentum. We see, you know, in the U.S., Privagen is growing faster than the IVIG market. We see Hyzentra holding share. We see our growth ex-UK internationally in the high single digits. And that will all benefit us in the second half. We think that probably a better barometer is trailing period growth, which was 3% versus the trailing period. And we think that's probably a more appropriate kind of barometer for a full year.

Thanks, Andrew. Next question comes from Saul Hadassin at Baron Joey. Go ahead, Saul.

Yeah, thanks, Mark. Just a first question, sort of cognizant of the pressures for IG and albumin in the half, but maybe one for Andy. you know, Cassandra, Idelvian, Hagarda, Berenert, effectively all delivering growth well below expectations, at least what the market was looking for. Can you talk to some of the measures that you're introducing outside of IG specifically that might see some recovery in those particular products?

Sure, Saul. Thanks for the question. Certainly, Kcentra is predominantly a U.S. story where there was an introduction of a competitor a couple years ago at a significantly lower price point than Kcentra. And so we've been competing well. We've actually decelerated the impact It's now from a volume perspective in the single digits, but there's a price impact. We've been broadening our contracting approach. We now have a U.S. hospital field force that's promoting not only Privagen but Kcentra as well, which is very helpful. You know, we're being successful with contracts, and actually our volume growth in contracted accounts is growing in mid-single digits. But that doesn't take away that the return to growth for Kcentra is going to take time, and it's going to, you know, be predicated upon broadened indications in DOAC reversal and in cardiac surgery, which are coming in the next few years. Just to comment, Idealveon is actually holding its own in hemophilia B quite nicely in the face of three new subcutaneous competitors. Haygarda also is holding its own. Lots of innovation in the hereditary angioedema space. And, you know, so that was as expected for us, especially with Andembri performing so well. I think I covered the major products that you mentioned.

Thanks. And you can ask a quick follow-up just to the outlook then for second half gross margin for bearing. Clearly, first half, not a bad outcome in terms of some degree of margin expansion. Is second half going to deliver even more margin uplift on the basis of benefits coming through from RECA and the NOMA grant?

So let's, Ken and Mike, take that question. So as you saw, margin in the first half were marginally up, and that reflects a number of positive drivers. So what we're doing in plasma collections, plasma manufacturing, and then the growth that we've seen in some of these high-margin products that Andy spoke to, particularly hemigenics and endembry, have been positive to margin. And then there's also some headwinds. So we've seen a decline in albumin, we've seen a decline in case centra, and then also the Part D impact. We will cycle through those, but they're embedded in the results for this full fiscal year. The medium-term outlook for margin is definitely continuing to trend upwards, but for fiscal 26, it'll be broadly stable, marginally up, consistent with the first half.

Good. Thanks, all. Next question comes from Steve Ween at Jardin. Go ahead, Steve.

Yeah, thanks, Mark. It's a bit of a continuation of the gross margin in bearing. I mean, there's clearly a lot of moving parts here and a lot of headwinds based on some of your high-margin products doing well. worse than less than expected I just trying to understand what is driving the ability to offset that so you've you've called out a hundred basis points from Medicare Part D but what what other sort of you know I'm ultimately just trying to quantify the upside to the margin in that half that you're getting through efficiencies and some of the other initiatives you've put in place

Sure, so I'll expand a little bit. So we have a number of operational levers that impact margins, so what we're doing internal to the company, and they're all going quite well. So CPL is trending down. We've previously spoken about the benefits that we're delivering through Horizon One, yield improvement that continues to deliver. We're taking fixed costs out across the network, including in operations which impact the gross margin. Some of that, because of supply chain lead times, take a while to manifest in the P&L. So as an example, if you recall, Riku and Inomi were only fully rolled out at the end of fiscal 25, and we don't get a full year impact of those benefits until fiscal 27. So I'd say on those internal operational levers, we feel pleased with progress. And then, of course, there's the product mix. And so that goes back to the topics that we've already discussed and a mixture of drivers there, some tailwinds and some headwinds, which I think Andy has already covered.

Yeah, thanks. Ken, can I just follow up on that? Clearly price is a major driver to margin. Could you just talk to some of the pricing dynamics that you've seen in IG in the US specifically and then maybe in albumin as you start to look into some of these, into this retail channel?

Yeah, I'll take that, Steve. Look, price for IG, particularly in the U.S., prices are relatively stable. We're able to take modest price increases. And then, of course, you know, there's a lot of contracts in the U.S., particularly for IVIG. But that being said, in this period, the Medicare Part D impact is purely on price. So you see this – negative impact on price and that's that's where we capture the the medicare part d uh but that will be behind us as we move into calendar year 26 and going forward for albumin clearly in china which is the the highest price realization for albumin globally it will continue to be so even with the cost controls but uh we are being thoughtful and modestly taking some price down in order to grow volume, because it's a volume play for albumin as we expand geographically, but modest taking price. And around the rest of the world, prices are relatively stable for albumin, but significantly lower than China and the U.S. And so our strategy for albumin is to continue to expand in China, and I think we'll see a nice turnaround in the second half.

Thanks, Steve. Next question comes from Laura Sutcliffe at Citi. Go ahead, Laura.

Hello. Thank you. Could you please explain a bit more what the phrase broadened contracting approach means?

I think that's to me, Laura. Happy to. Look, broadened contracting is our attempt to kind of encapsulate both in the U.S. and internationally a recognition, particularly with IG, There's opportunities for us to grow volume by being more robust in our contracting approach. In the U.S., there's segments in the hospital segment, in the specialty pharmacy segments, and in clinics. And we had been a little narrower in our approach historically of where we contract and where we don't, so now we're being much more purposeful. And internationally, of course, you know, 60% of the IG volume goes through tenders. And we've been very thoughtful in improving our capabilities, database analytics, modeling, game theory, so that we can be successful in the tenders that we think are appropriate and that we choose to win. And so that's kind of what the phrase broadened contracting speaks to.

Just to follow up on that, does that mean you're willing to be a bit more flexible on price? Is that what that is really getting at?

Yeah, I think we absolutely are being thoughtful and purposeful. At the end of the day, there's limited supply for IG. And so we want to allocate our limited supply in areas where we think it's appropriate and at the price points that make sense for us. But we also don't want to be predictable. And so that's part of this as well.

Thanks, Laura. Next question comes from Dave Stanton at Jefferies. Go ahead, Dave.

Thanks very much for taking my questions, team. Just a modelling question for me. Do you expect revenue growth in Albion in F26 on F25, please?

Again, I think that one goes to me, Dave. So albumin, the second half is going to be much stronger than the first half, not only because the real impact was in the first three months of the year in China, and the investments that we quickly made that I articulated are already starting to pay dividends. And so we're going to see a nice turnaround in the second half. Can we make up for the entire shortfall in the first half of the second half? I think we're going to get close, but I think modest year-over-year decline in albumin in 26 with a return to growth in 27 is probably more appropriate guidance.

Thank you. Very clear. And my follow-up, then, one for Ken. You have mentioned in F27 and F28 that you're looking for high single-digit guidance at NPAT previously. Does that still hold?

Sure, so we obviously need to get through the second half and we've been speaking a lot about that on this call in relation to the longer term outlook for 27 and 28, seeing nothing that would lead us to change that outlook. There's always the case at the moment we're working through the budgets for fiscal 27 and as is normally the case, we'll give more detail on that when we get to the full year result in August.

Thanks, Dave. Next question comes from Leanne Harrison at Bank of America. Go ahead, Leanne. Good morning, all.

Can I come back to IG? There were some comments in the prepared remarks where you talked about the IG market demand and supply are well balanced. And that's very different from previous comments where you talk about unmet demand and also your response to Laura's question saying that there's limited supply of IG. So I just wanted to understand, are you seeing different demand supply dynamics in different geographies? Can you talk about the United States versus rest of the world core countries? And then can you also speak to this expanded sales force in the United States targeting certain accounts? Is that where you're seeing more competition? And as a result, you're having to invest more in sales and marketing there?

Thanks for the question, Leanne. So let me try to clarify my comments about the IG market dynamics. First of all, the unmet need for IG is significant, and the diseases that IG is used to treat, primary and secondary immunodeficiency, CIDP, we see the diagnosis and the utilization of IG growing. High single digits, low double digits. My comments, and we think that's going to continue for the foreseeable future. That being said, my comments about supply and demand balance were that, you know, just about all companies now, the major companies, are vertically integrated and are very thoughtful in the amount of plasma that's needed to collect to deliver on, you know, looking a couple years out, the demand projections for IG. And so we're in an environment that, you know, you know, there's sufficient supply generally to meet the projected demands for IG. And so that's how I refer to a well-balanced market, but growing. I mean, absolutely growing and attractive. And in our position as a market leader, you know, we continue to expect to be a market leader. It's growing in the U.S. The demand is growing internationally. We do see the per capita usage of IG is more robust in the U.S., in Australia, and in other geographies, right? There's just not as much IG use, so we think the global growth is going to continue. To your questions about the expanded field forces, I mean, look, we've been very thoughtful but believe that there's an opportunity for Bering to grow faster than the market in IG over the midterm by ratcheting up our commercial capabilities and infrastructure. And so we created a new hospital-focused field force that's promoting Privagen and Kcentra. at the beginning of this fiscal year. And we also increased the scale of our IG immunology field force that promotes Hyzentra and also Privagen. And we think it's just to help us continue, not to stay competitive, but to be successful in growing faster than the market over the midterm.

Thank you. And just to follow up, if we could come back to Kcentra. So obviously, if we think back to the December 24 half, that's when you had a contract loss there. But since then, we've had three halves of, I guess, declining case centric revenue. So I hoped that that would cycle out this half. But you talked about, I guess, competition in that space. Can you talk about that a little bit more and what your expectations are for the second half of 26?

Sure. The Kcentra dynamic is that the competitor that entered, and, you know, Kcentra was the only four-factor PCC in the U.S., and now there's another competitor. They came in with a price point. I think the average selling price is about 30% below Kcentra. We've been very thoughtful about where to contract so that this doesn't become – you know so that it makes sense for us but it is fair to say that i mean in analog show that it takes several years to reach an equilibrium uh... when there's a market entrant with a price differential like that and so that's what we're working through we're pleased to see that we're winning contracts uh... And that with our broadened portfolio, it also gives us a leg up here to be successful in winning contracts. And in those areas where we have contracted volume, we're growing. The four-factor PCC market is growing in volume, but the revenue of the market has come down, not surprisingly, given this dynamic. And I think we're stabilizing, but I do think a return to growth is going to still be a few years out as we broaden indications.

Thanks, Leanne. Next question from David Bailey at Morgan Stanley. Go ahead, David.

Thanks, Mark. Morning, everyone. Ken, you've given some numbers there for the operating expenses. R&D and G&A have pretty much been the same in the second half. Just with the initiatives coming through on the IG side, how should we be thinking about that sales and marketing line for the second half?

So as a percentage of sales for bearing reasonably consistent with the first half, similar with V4, securest percentage of sales, not as helpful first half, second half, just given the seasonality. But hopefully that gives you a sufficient guide.

Yep, no, that's helpful. Thank you. Maybe just in terms of the perioperative bleeding segment, obviously case interest is under a bit of pressure there, but there is some things going on to potentially look at label expansions. Similarly with fibrinogen and acquired fibrinogen deficiency, just maybe talk to us a little bit about where some of those life cycle management programs are at and then when we could potentially start to think about the benefits from those label expansions coming into the top line, the gross profit line.

uh... sure david i'll take that one uh... look look uh... uh... this space we think is attractive and we have a right to win uh... with case entra we've got the cardiac surgery life cycle that's underway and we're working with if they have a path forward for delac reversal indication for case entra those will both take a few years so we're looking at twenty twenty eight fiscal year and beyond We did get feedback from the FDA on our Ryostep expanded label, where they had some questions about clinical evidence, and we're working with the FDA to get through that. So we do hope to be able to have an update and to broaden the indication for Ryostep fibrinogen. And then, of course, our Varmex partnership, which we think will be really great, that that should come online if all goes well in the future. you know, the end of the decade here, 2029, 2030. So it's going to take a little bit of time, but this is a space where CSL certainly is poised not only to compete, but to compete successfully and win over time.

Thanks, David. Next question comes from Andrew Payne at CLSA. Go ahead, Andrew.

Yeah, morning. Thanks for taking my question. Just wondering if you have any thoughts around visibility through to half 26th just in terms of breaching your MPAT-A guidance. Really just thinking about the October update where the focus is on albumin and flu and at least those market expectations to clear us out performed and albumin underperformed. Just, you know, try and understand the moving pieces here and, you know, keen to know how much clarity you have on underlying trends through to half 26th.

So incorporated within our guidance for the full year, obviously the dynamics we've seen pan out in the first half. So within that, security is probably doing a little bit better than what we thought a few months ago. I think a solid result for V4, 12% up, probably unlikely to hold that percentage growth over the full year. And then Andy has spoken to the bearing drivers. So that's all built into the numbers. Happy to elaborate if there's any other further detail you're looking for.

Yeah, I guess in terms of the visibility that you have for these numbers through the half and I guess leading into the half, it seems like there was quite a material shift in the last two months. there versus what we thought was going to happen in October. I guess what happened there and I guess what's the confidence in the second half that you're not going to see some moves like you saw in those last two months?

Sure. So we've touched on some of that, but to elaborate, obviously with the Securus business, there is some inherent uncertainty in US vaccination rates, and we've been pleased to see some stronger late-season vaccinations that have obviously then been incorporated into the Securus result. With respect to Bering, The progress through the half varied quite considerably. So if you recall, it was at the annual general meeting that we spoke about some of the headwinds that we're seeing in China. And I think the team pivoted very quickly to put countermeasures in place. And as you've heard from Andy, those countermeasures are having some really tangible positive impact. So I would say the results that we're seeing over the latter part of the half to us give us a good indicator of the trend that we expect to see as we move through the second half.

Thanks, Andrew. Next question comes from Sasha Crean at Evans & Partners. Go ahead, Sasha.

Thank you, Mark, and thanks for taking the questions. Similar vein of questions. to Andrew. I'm just wondering, it looks like the composition of your 26 guidance has changed. I'm just wondering how much of that is attributable to better performance on costs. Ken, it sounded like those numbers that you were sort of talking to in the second half are well below at least what the market was expecting. Is it just a $100 million saving from the cost out program in FY26?

So I'll talk generally about costs. So yes, the $100 million target that we have been working towards for fiscal 26, we're happy with progress against that target. We are always looking for efficiencies across the group. And so if you look at, for example, our G&A line, I think at the full year result of 25, we guided to a G&A outcome of about a billion in the full year. I think we're going to come under that. Equally in R&D, I think at the time, we guided to a full year outcome of about 1.35. I think we'll be less than that. So we're very, very focused on taking out inefficiencies and unproductive spend. But importantly, where we see opportunities to grow the business, we will do that. And so I mentioned in my opening comments on R&D, we're investing in some exciting candidates where we see the opportunity. So that's the balance that we're making. But yes, there are some nice cost benefits that are flowing into the full year.

Yeah, and just on, sorry to look at FY27 a little bit, but you sort of flagged the Tadapa falling away for Valforo. And we've heard of some regulatory issues around Tabanos. I'm just wondering what V4 looks like into 27, given those issues, what the headwinds are from the start of 2017.

So I'll touch on V4, and then I think we'll get Andy to make some comments with respect to Tavernios. So V4, very much two different businesses. So with respect to iron, you would have seen that iron declined in the first half. because of the well-known drivers there with loss of exclusivity. So we will see continuing declines in iron. Andy spoke to some of the initiatives we're doing to counteract that, but overall I think that will net out with a decline in iron. And then, of course, in fiscal 27, we have the impact of the loss of exclusivity for injectifer. With respect to the nephrology portfolio, the growth has been very strong in recent periods. A lot of that has been driven by the Orforo. And as we've articulated today, which you need to be aware that the VELFORO TDAPA reimbursement period ends at the end of fiscal 26. Sorry, it ends at the end of calendar 26. And the way reimbursement works for that channel in the US, we would expect to see a significant drop in VELFORO revenues from that point in time. So that's gonna temper the nephrology growth rates that we expect in VFORO.

And then maybe to just add to the rare nephrology portfolio with the launches, Filspare internationally is growing well. Tavneos as well. You mentioned Tavneos. And, you know, we're aware of the European Medical Authority Article 20 assessment, and we're working with the regulatory authorities following that procedure. So we just have to follow the process and allow that to play out.

Thank you, Sasha. Next question comes from Davin Thillenathan. Go ahead, Davin.

Thanks, Mark. Morning team. I guess I just want to understand a little bit more in terms of your Salesforce changes that you've put through for your IG business. I guess the question really is about having seen the market share loss you've seen across the last 12 months and the change of CEO that you have announced. Just curious to understand perhaps if there were any missteps that were made across that timeframe on the commercial execution stage. and then trying to, I guess, understand effectively if that assists you in growing your share again, if you understand the line of questions.

So let me take a stab at addressing some of your questions. Look, we are looking to grow our leadership in IG, not only growing with the market over the midterm, but growing faster than the market. And we see that there's opportunities everywhere. The way to be more successful in the U.S. is through the full range of commercial levers that we're pulling. And some of those include kind of share of voice on the ground. And so we've expanded our field force in the hospitals. We've expanded our office-based field force. And now we're actively promoting both Privagen and Hyzentra. We are in the U.S. We have a little bit lower share in IVIG with Privagen than we do internationally, and we think that there's an opportunity to expand our business. And so that's definitely part of our strategy going forward. That's something that has been well thought out over the last couple years, and we'll take time to play out. Really pleased to see Privagen for the first time in a while growing faster than the market, particularly in the important hospital segment in the U.S. recently. So I think it's just one example of our mindset to not rest on our laurels, not expect anything to be given to us, but to, you know, resource our teams appropriately to enable us to address the unmet need and to capture more patients with the CSL IG franchise.

Okay. And then just to follow up, Ben, maybe a question for Ken with the bearing gross margin, just thinking about the moving parts there. In the first half, I guess, we had a pretty big headwind with Medicare Part D, as you called out, 100 bits, and the albumin pressure. But I think through the second half of 26, then those two factors kind of fall away. Would you then expect you would have a better margin performance from an accretion perspective in the second half?

Yeah, so just go back to my earlier comments. Thanks for the question that over the full year, we guide to expect margins to be broadly flat a little bit up. And so it reflects a lot of different drivers. So I won't repeat everything else that I've said, but there's operational drivers, internal drivers that I think are going well. and then we're working through the impact of the product mix shifts on the top line. Overall, medium-term outlook remains for an upward trend, but I think we'll see a slower margin expansion in fiscal 26.

Thanks, Devin. Next question comes from Craig Wong Pan at RBC. Go ahead, Craig.

Thanks. Within IG, could you just explain the competitive dynamics you're seeing given you have been underperforming tiers like is the field force expansion in response to something your competitors have been doing?

Look, we're proud of our market-leading position in IG globally, and we're always looking for ways to accelerate growth. And we did a thoughtful review and identified opportunities resource ourselves a little bit more strongly in the U.S. And I think it's not, you know, reflective of an acute shift or a competitive approach. It's just a recognition that we're always looking for ways to allocate our resources in the most impactful way to drive the business. And so certainly that plays out. The U.S. dynamics as they are in other markets, are quite, you know, always evolving. The customers, the channels, the level of concentration versus fragmentation, and so this was a purposeful investment, and we're already seeing it pay off, and so that that will drive further investment. I mean, another example is the direct-to-patient campaign for Hyzentra, where we know that that hyzentra is the most convenient subcutaneous IG offering for patients and many who are on IVIG or diagnosed with these conditions, that hyzentra is a better total solution for them. And by going directly to the patients, which is a tried and true approach in many other disease areas, but had not been done in the IG space before, that this is an opportunity to further differentiate ourselves. And of course, for CSL, Um, there's a benefit of having, uh, expanding our leadership in Skig, um, uh, in the, in the U S so I think it's all just thoughtful and smart commercial execution.

Okay. Um, thanks. And then just moving to iron that decline, could you help us understand how much was lost volume or how much was kind of price that you had to, um, like price reduction you had to incur to, to keep the volume?

I can take that one. So I would say overall, the decline is probably about 80% volume, 20% price over the years as a rough guide.

Thanks, Craig. Next question comes from Thomas Wakeham at Bell Potter Securities. Go ahead, Thomas.

Thanks for taking my question. Just on the bearing gross margin. So expecting, I guess, a bit of a small step up in FY26, but longer term, have there been any changes to the longer term expectations around getting back to bearings kind of pre-COVID gross margin level?

No change in that longer term expectation. As you know, we're not going to put a time on it. But I think what's important is that we'll continue to deliver margin expansion over time. That's a really important metric for us and we continue to deliver against it.

Thank you. And then just a second question, please, on IG. Can you give us any update at all about the competitive dynamics within the CIDP indication? Obviously, some peers in the space have made some pretty significant sales gains with FCRN products. Have you noticed any impact at all of that on your IG products? Thank you.

The dynamics in CIDP with the introduction of FCRNs are aligned with what we represented at Capital Markets Day. We see the vast majority of the utilization being after IG in the second and third line settings. And so IG continues to be the market leading standard for first line utilization. And, in fact, we see that for a subset of patients, the benefit-risk of FCRNs kind of wanes, and we see them returning to IGUs. So, look, it's good for patients to have more options, given these are chronic diseases. But, you know, I'd say nothing has changed over, you know, the recent six-month period here.

Thanks, Thomas. Next question comes from David Stanton at Jefferies. Go ahead, David.

Yeah, so just a follow-up from me, gentlemen. With the cost savings you're planning to get over the medium term, can you give us some ideas about whether you'll reinvest those cost savings you've outlined? And if so, what percentage of the total and where potentially might you reinvest? Thank you.

Sure. So with the cost savings, what we've said before, which remains the case, is that we will balance capital allocation between reinvesting in the business to drive growth. And so in the most recent period, I spoke about the reinvestments in commercial investments. But we need to be satisfied that those reinvestments are going to drive an attractive ROI. And if not, then obviously those benefits will be released to the P&L with the objective of making sure that we can deliver adequate, attractive returns to shareholders over the near, medium and longer term. In relation to a fixed metric, when you look forward, That's not a metric that I can give you because it depends upon the quality of those reinvestment opportunities that come up at the time. So there will be a mix. We are looking to reinvest in growth, but we are also looking to drive P&L leverage. As I mentioned before, uh gross margin uh growing faster than revenue and operating margins growing faster than gross margins and uh cost saving initiatives and releasing a significant part of that to the p l is is fundamental to that okay thanks dave look there are no further questions in the queues so i'll draw the briefing to a close so thank you for your interest and goodbye