CSL Limited

Good morning everyone and welcome to CSL's Financial Year 2024 results presentation. I'm Joy Linton, CSL's Chief Financial Officer, and before we begin the formalities today, I would like to say a few words about Mark Daring, who has opened these calls over the past 21 years. As many of you know, Mark Daring has decided to retire as the head of CSL's Investor Relations function. over his extensive time with us. He's been a trusted advisor to our leadership group and a respected spokesperson with the investment community. In the time I've been at CSL, I've very much valued Mark's wisdom, guidance and insights. So thank you, Mark. Also with us today, having moved into Mark's role, is Chris Cooper, who joined CSL earlier this year. Many of you will know Chris from his successful career as a healthcare analyst, and we are delighted to have him on our side of the fence. So Chris, welcome to your first CSL results announcement, and over to you.

Thank you, Joy, and good morning, everyone. It's a pleasure to be here. I also want to personally thank Mark for his help and support while I've been at CSL, and particularly for all those years previously. I've met or spoken with many of you before, and I'm looking forward to doing so again in the days and weeks ahead. I'm pleased to be joined this morning by three of CSL's leadership team. With me are Dr. Paul McKenzie, CSL's Chief Executive Officer, Joy Linton, CSL's Chief Financial Officer, and Ken Lim, CSL's Chief Strategy Officer. As with past practice, Paul will provide an overview of the results, then Joy will provide some additional detail on the financials. We'll then 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. Please note this briefing is being webcast. And lastly, before we start, I draw your attention to the forward statement disclaimer contained in the slide deck. I now hand over to CSL's Chief Executive Officer, Dr. Paul McKenzie.

Thank you, Chris, and good morning, everyone. Thank you for joining today's CSL full-year result call for 2024. I'd also like to extend my thanks to Mark for his support since I joined CSL. We have spent a lot of time together, be it in airports, meetings, or planning sessions for our results. He always brought wise counsel. Oh, all right, not always, but some of the time. And even a bit of humor when it was needed. Thanks, Mark, and all the best to you and your family for the future. Before we jump into the fiscal year results and the outlook for fiscal year 25, I'd like to make a few remarks about the progress we've made on several key strategic priorities. So let's get started and move to slide four. From the day I joined CSL, I clearly saw that we are well-placed to deliver sustainable, profitable growth well into the future. At our Capital Markets Day last October, CSL's leadership team took the opportunity to spell out this value proposition. At a high level, CSL Bearing is a unique and resilient business, with our IG franchise continuing to drive growth. In our CSL Securus business, the value of our differentiated vaccine portfolio delivers ongoing value to public health systems, and has outperformed the market again in fiscal year 24. CSL V4 has now been fully transitioned into the CSL Group with over $100 million of synergies realized. The business is well placed in iron and has attractive growth opportunities in nephrology. We shared with the market the priorities and plans that would underpin double digit earnings growth over the medium term. I am pleased to report that we have made excellent progress across all fronts in fiscal year 2024. Some highlights include the RECA rollout is ahead of plan with deployment in 84 centers as of the end of fiscal year 24. Terumo's individualized nomogram received clearance from the FDA and has been released to the CSL Plasma team for validation at our centers. Another topic that I know is of interest to a lot of our investors is the progression on our yield initiatives. I am pleased to say that both Horizon 1 and Horizon 2 are progressing to plan. Joy will talk to the CSL bearing gross margin in greater detail later. However, what I will say is that we have delivered on what we said we would do, 120 basis point increase in gross margin at constant currency from fiscal year 23. This is a tremendous effort from the team. However, there is much more to be done. We continue to expand our geographic footprint with the EU launches of Hemgenix and Tavernos, as well as the Ferenjek launch in China. Developing innovative products is at the very core of why we exist, so we are committed to advancing our R&D pipeline. In CSL bearing, Garidacimab provides a great example of this as we aim to build our ongoing strength in HAE. We continue to reinforce our leadership position in IG as we execute studies to expand indications that benefit more patients. We are progressing development of Hycentra in DM, for which we are currently in phase three trials. For CSL Securus, product innovation remains a core focus, with phase three clinical work progressing well for our ATIVC product in seasonal influenza. At CSL v4, the European Commission granted conditional marketing authorization for Felspare, providing us with the exciting new treatment in the IGAN market. We continue to deliver on our key priorities that will enable future growth. We are driving operating efficiencies within our enabling functions, increasing capacity to support SALs, building new capabilities and driving yield to support production of our new products and building new plasma centers. All of these have been a core focus of the business over the last five to 10 years. Increasingly, we are viewing the world differently from an engineering perspective. We intend to further leverage contract manufacturing organizations, particularly for fill finish capabilities and capacities. These initiatives are aimed at making our overall capital spend more efficient and have largely contributed to a significant reduction in our overall capex spend. We believe this can continue and see further opportunities to optimize this in the near term. As you can see, we've made significant progress on the strategic priorities outlined at Capital Markets Day. This is a true testament to the hard work of all of our people but everyone is aware there remains much more to be done. We hope this progress to date demonstrates our ability to execute to plan, and we believe with these foundations well established, CSL is in a strong position to continue to deliver annualized double-digit earnings growth over the medium term. Now let's move on to slide five, where I dive into the results of the CSL group. I'm pleased to report that CSL has delivered an excellent result for fiscal year 24, which has been driven by the strong performance of the CSL-bearing business. First, the headline numbers. Revenue was $14.8 billion, up 11% at constant currency. NPAT-A was $3 billion, up 15%. Net profit after tax, was $2.6 billion, up 25%. In terms of the major highlights for the year, the CSL Bearing business delivered strong growth across the portfolio, primarily driven by the IG franchise, which grew very strongly, up 20%. On the following slide, I will talk to these in more detail. However, Agarda, albumin and adelveon continue to deliver for the CSL bearing portfolio, with each contributing double-digit growth for the fiscal year. There are several plasma initiatives ongoing, some of which have had an immediate impact on the gross margin for fiscal year 24 and positively contributed to the 120 basis point expansion. The RECA rollout has progressed well and we remain on track for full U.S. deployment by the end of fiscal year 25. FDA clearance was obtained for the iNomagram. This is an important milestone for both CSL and Tarumo, and we anticipate the rollout to complete in line with the full deployment of Rika. We are excited about the prospect of bringing Garidacimab to market. building on our strength in HAE with a product that expands the opportunity for patients through differentiated and class-leading efficacy, safety, and convenience. Regulatory filings for Garidacimab have now been submitted in the US, Europe, and Japan. Moving over to CSL Securits, which delivered solid sales growth, outperforming the market in a challenging season, Growth was primarily driven by our adjuvanted Fluad product, which grew 14%. In partnership with Meiji, regulatory approval was received for the world's first ever self-amplifying mRNA vaccine, CoStave, for the prevention of COVID-19 in adults. We expect sales from the Japan launch in this coming fiscal year. The Phase III clinical trial for ATIVC completed enrollment earlier this calendar year, while the Phase I self-amplifying mRNA for seasonal influenza is in progress. As our pipeline illustrates, CSL Securus continues to expand its differentiated portfolio, and we are passionate about bringing these innovations to the market over the next few years. CSLV4 continues to grow volumes despite the impact of generic competition on Ferenject. There has been strong patient conversion to Mesera, our long-acting ESA, and that continued through the year. The strength in nephrology has been supported by Tavanos, and we expect this momentum will be maintained with multiple ongoing and upcoming EU country launches in fiscal year 25. we remain confident in our plan to drive long-term value from the business. Focusing now on CSL Bearing, where revenue was up 14% at constant currency, as I mentioned, growth in our IG franchise remains strong. Sales were up 20%, with strong growth recorded across all geographies. Our intravenous IG products, Privagen and Intergam, were up 21% in total, and our subcutaneous product, Hycentra, was up 19%. Underlying demand for IG continues to be robust across all the core indications of PID, SID, and CIDP. Hycentra maintains its leadership position And earlier this calendar year, we launched the 50-ml pre-filled syringe in the U.S. and the EU. The albumin portfolio grew by 12%, with solid growth in China, U.S., and Europe. Over to hemophilia, up 10%, where once again the standout performer was Adelvion, which was also up 10%. Adelvion continues to be the leading brand and standard of care in all markets where we have launched, maintaining leadership positions in the U.S. and several key markets in the EU and Japan. We also had our first patient enrolled in a Phase III clinical trial in China. Hemgenics, the disruptive addition to CSL Behring's bleeding disorders portfolio, administered infusions in both the U.S., While the transition from referrals to administrations has been slower than we anticipated, largely due to the fragmented U.S. healthcare system, we continue to experience an increasing rate of referrals. These will result in new administrations in fiscal year 25. Specialty products were up 6%, led by Haygarda, which grew 12%. Despite the increased competition in the HAE space, we continue to add new patients and maintain our patient base, with strong growth in EU and Japan. Kcentra remains the gold standard for warfarin reversal, and that grew 5% year over year. With the emergence of competition, there has been some volume impact. However, we remain confident that Kcentra will continue to lead the market. Moving to plasma highlights for CSL Bearing on slide seven. The underlying fundamentals of plasma collection remain strong, with continued momentum in donation growth. While we remain at the early stage of our gross margin recovery timeframe, we are making good progress. Cost per liter continues to reduce, and we have several initiatives in train to manage this down further. We continue to expand the geographic footprint of our network, having opened three centers in Puerto Rico. We have also made significant progress on our digital transformation, and there is an increased focus on center efficiencies, both of which contribute to the overall reduction in CPL and improvement of gross margin. We continue to drive productivity through the centers via a standardized framework for labor staffing, which ultimately leads to maximizing center level output and improving cost absorption at the center level. Focusing now on the Ricca plasma donation system and the iNomagram, the increase in donation yield is expected to be approximately 10% on average per procedure versus current baseline. This allows us to achieve annual leader targets with fewer procedures. Horizon 1 and 2 yield initiatives are both progressing to the plan that we outlined 12 months ago. The recovery of CSL bearing gross margin is on track, and I've spoken to this slide. It gives us confidence on the pathway ahead for continued progress. We are under no illusions. There is still much more to do, but we are encouraged by the progress to date and will be working hard to continue this momentum. Now moving on to CSL Securus, which in fiscal year 24 outperformed the market with revenue growth of 4% at constant currency. This clearly reflects the strength of CSL Securus's differentiated portfolio. Fluad was the standout contributor, growing 14%, achieving $1 billion of annual sales for the first time. This was the first season following U.S. ACIP preferred recommendation for the over 65 age group for Fluad. Pandemic revenue increased 9% as we are the sole awardee for the UK Advanced Purchase Agreement, which was included in other income for fiscal year 24. We also have some milestone payments attributable to Coast Day vaccine launch, which will occur in fiscal year 25. Some operational highlights for CSL Securus. Flu-Celvax six-month age extension approved in the EU, UK, Australia, and New Zealand. And for Fluad, 50-year-plus age extension approved in the EU, in addition to receiving preferential recommendation in Canada for the 65 and over population. In relation to product innovation, we commenced the phase three trial in the Northern Hemisphere for ATIVC. This brings the best of our technologies together, cell culture, high dose, and our adjuvant. Our next generation self-amplifying mRNA COVID vaccine, COSTAVE, recently received regulatory approval in Japan, the first self-amplifying mRNA vaccine approved anywhere in the world. There has also been some very positive immune response duration data that was published in the Lancet earlier this calendar year. We also progressed a phase one trial for self-amplifying mRNA for seasonal and pandemic influenza. On the pandemic side of the business, we were selected by BARDA and HERA to deliver H5N8 vaccine for preparedness against potential avian flu outbreak in humans. Lastly, and this is very recent news, we attained the certificate of occupancy for our new telemarine facility. Turning to CSLV4 on slide 10, where revenue was just over $2 billion. Similar to the prior reporting periods, we have not provided growth numbers since the prior comparable period only included 11 months following the acquisition of V4 Pharma in August 2022. Starting with iron, in an evolving iron market, we have continued to see robust volume growth. As noted at the beginning of the presentation, Ferrinjectin China was included in the national reimbursement drug list with the launch as per our expectation. U.S. step edits remained during fiscal year 24, which placed pressure on our high-dose iron product, Injectifer, albeit with an offsetting positive impact on Venifer, CSLV4's low-dose iron product. The impact of these step edits has begun to stabilize. Moving on to nephrology. Strong ESA performance in the U.S. followed continued patient conversion to Macera, reaching the highest number of patients treated since launch. Strong performance of Capruvia in launch countries, especially Germany, France, and Austria. Valforo's performance in the U.S. was impacted by reduced inventory target levels as requested by our customers, but in China was included on the national drug reimbursement list. Tavanos continues to perform well, having recorded strong sales growth across all launch markets. And finally, Veltasa recorded growth in the U.S. and EU, while also receiving approvals for pediatric indications in these same markets. And just a quick word on R&D. I have summarized some of the updates while describing the performance within the respective business units. As is customary, Bill Mezzanotti and his team will be hosting a full R&D day in October, and we look forward to providing further detail on our portfolio progression at that meeting. So with that, I will hand over to Joy, who will talk you through the financials.

Thank you, Paul. As Paul indicated, CSL has delivered a strong result for the 2024 fiscal year. On a reported basis, NPAT-A was $2.907 billion, up 11%. On a constant currency basis, NPAD A was $3.008 billion, up 15%, after adjusting for a currency headwind of $101 million. As a reminder, references to NPAD A are attributable to CSL equity holders only, and for the first time, this result includes the full 12-month contribution from CSL v4. On this slide, we have again provided a bridge between NPAT A down to NPAT at constant currency. Let me run through these numbers. So starting with NPAT A, the following adjustments in total are included. $298 million attributable to the amortisation of acquired intellectual property. The increase from the prior year was due to the 12 months versus 11 months of amortisation for CSLV4, plus an amount relating to hemigenics, now that we are booking sales revenue. There were some remaining one-off acquisition costs of $83 million. This consists of continuing integration costs relating to the acquisition of CSL V4 of $53 million and the final month of unwinding the inventory fair value uplift recognised on acquisition a non-cash item of $30 million. And as expected, these items will not continue beyond FY24. After adjusting for tax and non-controlling interests, NPAT attributable to CSL shareholders was $2.745 billion, which was up 25%. You will notice at the back of this presentation on slide 21, we have provided guidance for FY25 amortisation costs and the associated non-controlling interest. Turning to the next slide, our largest business unit, CSL Bearing, which as Paul has already mentioned was the main driver of our strong result. This table shows the gross profit of CSL Bearing, less sales and marketing costs to give the operating result. You will recall that R&D and G&A expenses are no longer allocated to individual segments as this reflects the way we now manage the business units. A key highlight to focus on here is the gross margin for CSL bearing, which improved 120 basis points from 49.1% to 50.3% at constant currency. This is largely in line with what we anticipated and was driven by a reduction in CPL, price increases for IG and efficiencies across our plasma collections and manufacturing network. On the right side of the slide is a reminder of the pathway back to our pre-COVID margins and the main contributors to that recovery, as we have previously outlined. Some of these factors have been materially de-risked. In particular, the approval of the individualised nomogram is a significant milestone. the Horizon 1 yield improvements are being realised and we are delivering manufacturing efficiencies as volumes have increased. Other levers are still a work in progress but are progressing well, such as the rollout of RECA, the plan for the rollout of the ionomogram, plasma centre efficiencies that we've been implementing will see further CPL benefits the mix shift which we expect to see over time and momentum from new products. It is still early days but we remain confident of getting back to pre-COVID margins as we outlined at our Capital Markets Day in October last year. On the next slide is our other two business units, CSL Securus and CSL V4. While both businesses have experienced some near-term challenges, it is pleasing that both have managed to maintain our operating margins at very healthy rates, which is testament to CSL's focus on commercial execution and efficiency initiatives. As Paul touched on, CSL Securus grew its revenue by a modest 4%, which is below where we would have liked it to have been. However, we are pleased that we continue to gain market share in a challenging environment, and we believe that our strategy puts us in a strong position when market demand recovers. For CSL V4, the impact of the follow-on competition for iron in Europe has been within our expected range. The franchise has continued to grow volume, notwithstanding the inevitable price reduction that occurs as the market becomes tender-based. This continued volume growth is testament to the degree of underpenetration we see in the iron market over the long term, and it is a core part of what attracted us to V4. Bringing this all together on the next slide are the group financial highlights. As mentioned already, total revenue was up 11% to $14.8 billion. The group operating result was up 13% to $6.5 billion. Research and development costs were up 12%, largely in line with sales growth and at the low end of our guidance envelope of 10% to 11% of revenue. General and administration costs were down 6% due to the efficiencies that we have generated from our enabling functions and some reduced FX impacts relative to the prior year. Net finance costs increased 7% due to the full 12-month impact of the CSLV4 debt and the higher interest rates on our floating debt. The average maturity of our debt is 10.6 years, and the weighted average interest rate is 4.24%, slightly up from 4.11 in the prior year, with 80% of our debt fixed at a rate below 4%. Our balance sheet is in a strong position, and we continue to strongly prioritise our investment-grade credit ratings. We have been able to deliver significant deleveraging in the year with our net debt to EBITDA now at approximately 2.2 times and we will make more progress in the year ahead. As I mentioned at the start of the presentation, NPAD A attributable to CSL shareholders was up 15%. The reported effective tax rate increased to 19.2% largely within our guidance range. The increase was due to the geographic profit mix and also an increase in the corporate tax rate in the UK. Return on invested capital was lower at 10.5% as we foreshadowed and this was due to the full year impact of the CSL V4 acquisition. To reiterate our statements from Capital Markets Day, this is the low point and ROIC is expected to improve over the medium term, driven by our annual double-digit profit growth expectations. Cash flow from operations increased by 6% to $2.8 billion, reflecting the growth in sales, partly offset by an increase in working capital, including the cash impact of one-off acquisition and integration costs recognised in the profit statement in the prior year. NPAT A EPS was up 11% and NPAT EPS up 20%. Total dividend was up 12% to US$2.64 a share. This translates to approximately $4 Australian, up 10% on the prior year. Turning now to capital expenditure on the next slide. Those of you who have followed CSL closely will know that we've been through a significant capacity expansion program over the last several years to meet the increasing demand for our products. and many of you have had the opportunity to see these investments firsthand. While there will always be the need to invest in future capacity, we are currently well placed to meet the strong demand growth that we expect to see through the medium term. As most of you know, we're excited by the opportunities that we see to improve our collection and manufacturing yields. And this will allow us to continue to expand supply over the medium term without needing to deploy the same level of capital. As a result, our capex in FY24 reduced by 31% to $849 million and for FY25 is anticipated to be in the range of $700 to $800 million. Turning to the next slide, this shows our cash conversion cycle over the past 10 years. The main point to note here is that since the pandemic-driven peak, our cash conversion has steadily improved as the business has grown in size, and despite some of the macro headwinds, particularly inflationary pressures that persisted longer than first anticipated. We saw an uptick in the days in FY24, and this largely reflects some timing differences in trade receivables. Cash flow efficiency is a strategic priority for us, and we expect to see a return to an improving trend in FY25 and beyond. And with that, I'll hand back to Paul.

Thank you, Joy. I'd now like to make a few comments on our outlook for fiscal year 25. Looking by business unit and starting at CSL Bearing, we continue to expect strong demand for IG across core indications. With various positive global reimbursement decisions now in place, we look forward to increasing Hingenex patient uptake in fiscal year 25. We are preparing for regulatory approval for Garidacimab, which, if achieved, will make this the next CSL product to come to market. We will progress the full deployment of the Rika technology, including the individualized nomogram. Horizon 1 and 2 yield initiatives will continue to advance. All these factors will drive the expansion of CSL Bearing's gross margin. For CSL Securus, we expect continued market outperformance driven by its differentiated portfolio, albeit within some tough operating conditions in the market. Commercialization of CoastAve in Japan while continuing to progress registration for the EU and US markets. We remain prepared to deliver H5N8 vaccine against potential avian flu outbreak in humans. For CSLV4, we are operating with an evolving iron market. And while there are challenges for near-term revenue growth, we continue to be the largest and most significant player in the EU iron market. with further geographic expansion planned. We will maintain growth momentum within the nephrology franchise, capitalizing on the recent launch success of Tabinos and Capruvia and the imminent launch of Filspare. We remain focused on identifying and unlocking value by leveraging capabilities across the entire CSL group. In collaboration with CSL Bearing, CSLv4 will continue to advance the significant public health need in patient blood management. For CSL at the group level, I am pleased to provide financial guidance for fiscal year 25. Revenue growth is expected to be approximately 5 to 7 percent at constant currency. With NPAD-A expected to be in the range of approximately 3.2 to 3.3 billion at constant currency. growth of between 10% and 13%. Importantly, I reaffirm our annual double-digit earnings growth outlook over the medium term. And of course, being forward-looking statements, these are subject to the usual disclaimers mentioned at the start of this presentation. With that, we will now move to your questions.

Thanks, Paul. Just a reminder to please limit your questions to two. Okay, first up, Leanne Harrison from Bank of America.

Good morning, all. And I might start with guidance but more focused on V4. I'm sure there's a lot of questions on guidance. But with V4, acknowledge that you're forecasting 5% to 7% revenue growth for the overall business. what do we expect in terms of V4 revenue growth? And then also the second part to that, you know, looking at V4 gross margins going into 25, you know, given the step edit challenges and also the launches, also note that in the second half, gross margin for V4 seemed to improve. Do we expect to see further gross margin expansion for V4 in 25 as well?

Great. Thanks, Leanne. Thanks for the question, and I'll share this off with Julie as well. But from the revenue viewpoint, look, we're being very realistic on our overall revenue. The bearing is back. We'll be high single digits. We expect secures to be above market, but probably in the flattish area, given the dynamic of the marketplace itself. And V4, to your question, will be flattish. And I'll ask Joy to comment on the gross margin for V4.

Yeah, thanks, Paul. And hi, Leanne. So on V4 gross margin, we expect that to be broadly stable in FY25. You referenced the US step edits, which... have certainly been a headwind in the year that it's gone. I think we're starting to see the impact of some of that stabilised, like getting a full sort of year-on-year view. So I think that will... We're hopeful that the V4 margin will broadly stabilise in the next 12 months.

OK, thank you. And just a quick follow-up on V4. You know, noticing that year-on-year gross margins declined, obviously due to those step edits and the like. But operating segment margins stayed relatively flat because of cost out, I guess, in sales and marketing. Can we expect similar cost out in V4 sales and marketing in 25 or is that largely done now?

Thanks. So we've done a lot of work on the cost side of V4 and you can clearly see that in the numbers. There is more to do. Some of it's V4, some of it is more broadly across the enterprise as we continue to drive cost efficiency and that's a big focus for us. So yeah, there's probably some more to come.

Thanks, Leanne. The next question is from Saul Hadassin at Baron Joey.

Thanks very much, Chris. Joy, if I could just ask you about your gross margin comments as it relates to bearing. I know last year you gave some colour around the magnitude of that gross margin increase for fiscal 24. Can you talk to the magnitude of uplift and what guidance is factoring in, just the amount of gross margin expansion you expect for bearing in FY25?

Yeah, thanks, Saul. So consistent with what we said at Capital Markets Day in October, And I think we said 100 basis points in 24, which we've delivered slightly up on that. And we said, you know, what did I say, 100 and a bit in 25, over and above 24, we would hold to that guidance.

Thanks, Joanne. Just one more, just on cash conversion cycle and days, just noting that 24 fiscal stepped up in those days, but you do talk to better working capital efficiency going forwards. I guess from a days perspective into 25, do you expect much to change as it relates to that conversion cycle?

We don't expect it to be worse. I'd like to think that we get some improvement, both from an inventory perspective and a receivables perspective.

Thank you.

Cheers. Thanks, all. The next question is from Gretel Janu at Evans & Partners.

Thanks, Chris, and good morning, everyone. So just want to go to Rika to start with. So in the census where you have rolled Rika out, are you seeing higher throughput that was expected given the lower collection times? Or has there been anything that you can talk to about what you've experienced? And just one confirmation just around the individualised nomogram. Is it correct that you're not currently rolling out? You have it, but not in the census as yet. Thanks.

Great. Thanks, Greta. Let me start with your last question first. So, yes, we received FDA clearance to room O for the individualized nomogram, but there's a second part of the validation of that when you put it into beneficial use in the centers. So we've received it, and we're now working through the validation process across all the centers. In terms of RECA, we are in the centers we've rolled out seeing the benefits of RECA, right, in terms of the reduction of time on the bed, 30% on average. We're also seeing across those centers enhanced center efficiency for lots of reasons, not just RECA. Right? Rica is one part of the overall story of our journey. The donor app, we're now at 4 million downloads of the donor app, and we continue to see more and more people use that to do things like their health questionnaire outside the center. We continue to see efficiencies as we've rolled out an operations efficiency program across all the centers from labor that I mentioned in the speaking notes, but as well as donor experience and donor flow. So RECA is living up to its commitments tied to with all the other work that we're doing on overall center efficiency.

The growth continues to be very strong there. Your peers have also seen very strong growth. So has the HAE market just been growing at a faster rate? I guess with the potential upcoming approval of Garidacimab, how should we think about the opportunity of Haygada in the next few years? And are you worried about cannibalisation there? Thanks.

Look, the HAE market continues to do well. For instance, in Hagarda itself, it's continued to expand and maintain its patient base as well as get new patients on. We find, as we've commented on the past, people end up, they try another product and then switch back to Hagarda because it's a very reliable product in that space. With that said, Garidacimab will be the standard of care in HAE. efficacy, extremely highly efficacious, very early onset of that efficacy, really favorable safety profile, and a great patient convenience with monthly injections. So we'll see how the market plays out in the dynamic, but we have two of the leading products in a market that's expanding, and we will do very well in that space.

Next question from Steve Ween at Jordan.

Yeah, thanks, Chris. Joy, I was wondering if you could just talk to the Horizon 2 pilot study, stability study that's undergoing or underway for that manufacturing process. If you just give some timeline and even any sort of indication as to what the experience has been thus far.

Steve, I'll take that question if you don't mind. Horizon 2 is going well. It's a development project, as we shared before. So what we have done is we completed the laboratory work. We ordered the pilot plan equipment. made pilot plant batches. We now have them up on what is stability studies as well as comparability work. So you do the analytical work to show comparability to the other products made in a different process. So that work's all continuing. The stability clock is the stability clock. You need to let time happen to show that stability. We have had a good set of sessions with the FDA. They were all according to plan. And our launch facility concept that we have in mind, if you remember, I wanted to approach this as a modular add-on to the existing IG modules so that we can run the IG modules either with or without Horizon 2 as we transition regulatory filings. That design is complete. and we have begun to order the equipment that we need to bring this to use in the initial launch. So it's continuing to plan, and we're quite confident in the technology, and we're continuing to engage with regulators.

And so, sorry, as part of that, do you think there will be a requirement to do a clinical trial to support the data, or... Based on what you've seen thus far, you probably would, based on what you've seen, would you conclude that that's unlikely to be required?

Like any development project, Steve, it depends on the data. So as we see the data for stability and comparability, we'll be able to make that judgment and give a recommendation to the regulatory agencies.

Okay. Thanks. Next question from Andrew Goodsall at MST Marquis. Thanks, Chris, and thanks very much for taking my questions.

If I could ask you just to give us a little bit of colour on collections, I guess, firstly, where you're stabilising, or sorry, if you're back stabilising at a more normal cadence now, and then just thinking about FY24 versus FY25, where you are on that sort of curve of lower CPL?

Yeah, well, first off, I think our collections, we're at record levels for our collections, right? And we continue, team continues to do a great job bringing everything together, the donor experience, the donor fees, the cost at the centers, the efficiency at the centers. So we continue, the cost overall CPL at the second half of the year kind of stabilized, but we've de-risked significant opportunities, the RICA rollout, the iNomagram. So we continue see a continued decrease in the CPL while we continue to bring in the appropriate donors as needed for our demand.

Okay. And would you say it's more weighted to FY25 in terms of that CPL flowing down?

Yeah, I think that's a fair statement, Andrew.

Step down. My follow-up question, just a bit more color on avian flu, sort of where you are on the sort of opportunity set that's sort of come from some of those recent outbreaks.

So I have Ken here, so maybe I'll ask Ken to answer on AVM. Sure.

Thanks for the question. So as you're probably aware, our Securus business has contracts with about three dozen countries around the world where we stand ready to provide a vaccine in the event of an influenza pandemic. Some of those countries, for example, the UK and the US, have taken steps to explore with us and other manufacturers the potential to supply vaccine in this period now where the risk of human-to-human transmission is causing some concern. Those processes still have some way to play out and so we're engaged in those discussions and when we have more to report, we will do so.

Thanks, Andrew. Next question from David Lowe at JPMorgan.

Thanks very much, Joy. If we could just start just with the gross margin guidance for bearing. And there's a 60 basis point FX headwind there. We're very used to FX headwinds with CSL. But just thinking through the return to pre-COVID margins, how much adjustment should we be thinking about with FX?

Thanks, David, for your question. Yeah, FX hasn't been our friend in the last year or two. Our guidance remains unchanged, though, compared with what we said or consistent with what we said at Capital Markets Day. So gross margin recovery, you know, in 26 to 28 with the midpoint of 27.

Okay, so no adjustment necessary for FX. Look, my other question just related to album sales in China. Can I get you to talk a little bit about what you're seeing there and the growth rates that we saw in 24 and what you're to be expecting in the near term, please?

Thank you for the question, David. Albumen has done very well. It grew 12% year-on-year, which was a great result, and that growth was across all markets, U.S., EU, and China. In China, we continue to see high single-digit growth, which is great. The demand is very strong, and we believe it will continue over the midterm.

Thanks, David. Thank you very much. Next question from Craig Wong Pan at RBC.

Great, thank you. My question is on the increased use of contract manufacturing. Just could you elaborate on what you've done there, the impact that would have on earnings by business unit and sort of the impact on CapEx as well going forward?

Right. So one of our goals was to make sure that we access the right capabilities and capacities when we need them. And so using contract manufacturers, particularly for areas that weren't where we have expertise, like in plasma, fill finish is a great opportunity. There's a lot of changes going on in the regulations, Annex I in particular in Europe, which requires an upgrading of lots of our facilities. By using our contract manufacturing network, we're able to really dial in on where we want to do upgrades and where we want to outsource it. In terms of any margin impact, it's all factored into our guidance. But in general, we're working with providers that as we provide them more opportunity across our portfolio, we obviously can do better in terms of the overall competitive pricing. This is a very select area because of a lot of the regulation change and the need for upgrades across that space. So it makes our capital more efficient.

And does that mean that the capex can stay sort of at these low levels, sort of past FY25?

Well, our goal is always to continue to manage how we spend our dollars and spend it most efficiently. We think that we, in the medium term, this range looks right. But obviously, as we continue to see demand, we'll have to respond appropriately. But we're trying to pull all levers, right? Engineering excellence, partner utilization, and really making sure our operation efficiency. As we brought on these new facilities, they're highly automated. How do we use machine learning and other things to continue to make them even more efficient as we move forward?

And sorry, just my second question then. Just on China, Farah Injek, could you talk about just how that launch has gone and whether this could be a meaningful contributor in FY25?

The launch has gone very well, and to have approval and to end up on the reimbursement list within a short time period is a good sign for our opportunity in China. We don't give forecasts for individual products. It's all included in the guidance. But I would say the launch is off to a good start.

Thanks, Greg. Next question from David Stanton at Jefferies.

Thanks very much, team, and thanks for taking my questions. Firstly, on Garidacimab, can you give us some kind of timing on Garidacimab reimbursement approval, particularly in the United States, please?

I'd have to come back to you on that because the team's been working. Obviously, you work across so many insurance agencies. Let me circle back with you on that, David. I don't want to give you a generic number because there's so many agencies that we need to work with.

No problem. If that means I can sneak in another question because I didn't get that one answered, that'd be great. Not a good answer. There you go. And then can you give us some kind of guidance or perhaps color on how many hemigenics patients in total you expect for 25, please?

Yeah, we're going to not forecast that for 25. We had 12 and 24, a handful or so in July, and we need to continue to work across this U.S. fragmented system. What we are very happy to see is that our reimbursement contract negotiations in Europe have progressed well and will continue to work to change from referrals to administration. Our referrals are going quite well. We've been able to increase the referrals quite significantly. But again, the U.S. healthcare system is quite fragmented and it's taken us longer than we had planned to penetrate that.

Understood. And my last question, if that's okay, perhaps one for Joy. Can you give us some kind of color around expected tax rate for 25, please, Joy?

Hi, David. So I think we would just hold our guidance of 18% to 20%.

Thank you. Thanks, David. Next question from Laura Sutcliffe at UBS.

Hello. Thank you for taking my questions. Just going back to the IV iron piece in China, I think I appreciate we're not going to get product by product guidance, but I think V4 as a standalone business focused heavily on the patient blood management piece in China, given high incidence of hepatitis C in that region. Is that still the right way to think about the China opportunity for you now?

Well, I think there's lots of opportunity in China beyond just patient blood management, right? There's lots of other areas relative to women's health. You know, pregnancy, for instance, is a huge area. So patient blood management is part of the overall China story, but not the only part of that China story. We see it as a significant unmet need across cancer, women's health, and the like.

All right, thanks. And then just back on hemigenics, can you tell us what percentage of referrals are being converted to administrations at the moment in the U.S.?

No, we would have included everything in the forecast. I don't want to go to that level of granularity because it may confuse how things move forward. All right, thank you.

Thanks, Laura. Next question from Matthew Chevrier at Citi.

Good morning. Thanks for taking my question. Just on the IG growth, which was very strong, could you help us unwrap the contribution from a volume mix in pricing and what are you assuming in F25 in terms of impact from the launch of FGARC from Argenix?

Great. Well, thanks for the question, Matthew. As typical, we're always looking to grow volume more than price. So the growth was about 70, 80% volume and the rest price. And in terms of our GenX, you know, obviously they're in their launch, but when we look at the data, We see in CIDP, IG is the standard of care and we think that will continue to be the standard of care in that space. FCRNs in general only compete with a small percentage of our overall business and given the clinical data, we don't see a significant advantage for FCRNs in that space. So we feel strongly that IG will remain the standard of care and we expect to see good growth across CIDP in fiscal year 25.

Got it. And then just on the RECA, how should we interpret the safety reports on RECA from the various FDA databases?

Can you clarify your question?

Yeah, there's some, you know, safety reports from a database called MOD. an AUD in the U.S. where people can report adverse events from the use of various medical devices. I was just wondering if there's anything here to flag or to signal that may slow down the use of the device or it's just part of normal course of using a new device.

No, no more than we would have typically expected in our normal use of plasmapheresis machines across the industry.

Got it. Thank you.

Thanks, Matthew. We have one more question in the queue and after that we'll draw the meeting to a close. So that question is David Bailey at Macquarie.

Yeah, thanks, Chris. Morning all. Just looking at V4 on a 12-month annualised basis for 23, it's gone backwards 5% at the top line and 8% in the gross profit line. Just clarifying that for 25, your expectation is stabilisation around top line and the gross margin versus 24.

Yeah, that's correct, David.

Yep. And Joy, you sort of reiterated that three to five year time horizon around the recovery to 57% for the bearing gross margins. Based on your run rates to date, is there any ability or can you sort of talk to any potential for tightening of that range either towards the earlier end or other factors that might drive it to be towards the later end of that three to five year time horizon?

Not at this stage, David. I think we've been quite clear that 24 and 25 would be, you know, 100 bps and a bit. And then once some of these other initiatives that we've been talking about today, RECA, iNormagram, the YIELD initiatives, product mix, new products. Once all of those sort of things start to get some more momentum is when we'll start to see some further improvement and FY26 should be the first part of that. But I think what we've tried to do today is outlay where some areas have been de-risked but there's a lot that is still very much a work in progress and so our guidance remains unchanged.

Thanks, David. We have no further questions in the queue, so I'd like to thank you for your interest in CSL, and I'll now draw the meeting to a close. Thanks and goodbye.