I would now like to hand the conference over to Mr. Chris Cooper, Head of Investor Relations. Please go ahead.
Good morning and welcome to CSL's first half results call for fiscal 2025. It's Chris Cooper speaking, and I'm pleased to be joined here today by Dr. Paul McKenzie, CSL's Chief Executive Officer, and John Levy, CSL's Interim Chief Financial Officer. As with past practice, Paul will provide an overview of the results, and then John will provide additional detail on the financials. We'll then move to Q&A. 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'll now hand over to CSL's CEO, Dr. Paul McKenzie.
Thank you, Chris, and good morning, everyone. Thank you for joining us for CSL's first half results call for fiscal year 2025. Before I get into the results, a word on my management team. I am pleased to say that Andy Schmeltz will resume the role of Executive Vice President for CSL Behring in March, and Joy Linton, who has been filling in for Andy, will resume the role of Chief Financial Officer. I would like to thank both Joy and John for their significant contributions during this interim period. Now on to the results. CSL has delivered a solid result for the first half of fiscal year 2025, driven by the strong performance of CSL Behring business and also growth in CSL Vifor. Importantly today, we are reaffirming our guidance for fiscal year 2025 for NPATA, which is expected to grow by 10%-13%.
CSL Seqirus' performance was impacted by weak market conditions in the U.S., and I will go into more detail on this shortly. First, the headline numbers. Revenue was $8.5 billion, up 5% at constant currency. NPATA was $2.1 billion, also up 5%. Net profit after tax was $2 billion, up 7%. In terms of the major highlights for the period, the CSL Behring business delivered strong growth of 10%, driven once again by the Ig franchise, which grew 15%, and another robust performance by albumin. The gross margin for CSL Behring continues to improve and was up 170 basis points at constant currency. The rollout of the Rika plasmapheresis machines is well advanced, and we are excited to implement the iNomi technology in December. This is already delivering benefits as planned. The uptake of HEMGENIX continues to accelerate, with the four-year data reinforcing the strength of this product.
The regulatory process for garadacimab, our next-generation HAE therapy, which has been branded ANDEMBRY, is progressing well. Approvals have been received in Australia and the U.K. A positive CHMP recommendation was received in Europe, and our resubmitted filing in the U.S. was accepted by the FDA. Moving over to CSL Seqirus, as I said at the beginning, its performance has been negatively impacted by the significant decline in immunization rates in the U.S., specifically in the 18 to 64-year cohort, which drove competitive pressures in the market. While this is a disappointing outcome for public health, there are signs that vaccination rates outside the U.S. are stabilizing, which gives us some comfort on the future market outlook. During the period, CSL Seqirus secured several pandemic tenders for avian flu. The majority of this revenue will be recognized in the second half of the year.
KOSTAIVE was launched by our partner in Japan. This is the world's first self-amplifying mRNA vaccine for the prevention of COVID-19 in adults. Switching over to CSL Vifor, revenue was up 6%, driven by both iron and nephrology. Ferinject delivered volume growth of 6% in Europe. In nephrology, Tavneos performed strongly, and we successfully launched FILSPARI in Europe. Focusing now on CSL Behring, where revenue was up 10% at constant currency. As I mentioned, growth in our Ig franchise was strong. Underlying demand continues to be robust in all of our core indications, and patient diagnosis rates continue to improve. Sales were up 15%, with strong growth recorded across all geographies. Our intravenous Ig products were up 15%, and our subcutaneous product, Hizentra, was up 16%. For Hizentra, the uptake of our recently launched 50 mL prefilled syringe in both the U.S. and the EU has accelerated.
Hizentra continues to be the clear market leader in subcutaneous treatment for patients in PID and CIDP. Our albumin portfolio grew strongly by 9%, driven by exceptional performance in China. Hemophilia growth was 11%, with IDELVION up 6%. Contributing to the growth in hemophilia is our gene therapy, HEMGENIX. I am pleased to say that the uptake is accelerating as we slowly but steadily find a way through the complexities of the U.S. healthcare system to bring this transformative therapy to patients. Further, last week we announced the four-year results from the pivotal HOPE-B study. These results underscore the ability of HEMGENIX to offer long-term bleed protection with a single treatment. Plasma-derived hemophilia products grew by 6%, led by Humate and Haemate, our treatment for patients with von Willebrand disease.
Specialty products were down 5%, with the loss of a substantial contract for KCENTRA saw its sales decline by 20% in the period. Despite the loss of this contract, KCENTRA remains the clear market leader in a growing market. In HAE, HAEGARDA was up 1%, and BERINERT up 6%. We've been able to add new patients and preserve our existing patient base ahead of bringing ANDEMBRY to market in the second half of this financial year. Moving to the operating highlights for CSL Behring on slide six. The underlying fundamentals of plasma collection remain strong. Plasma donations continue to grow, and we have seen further reduction in our cost of collecting plasma as we continue to focus on introducing innovation and driving efficiencies in our plasma centers. This is helping to drive improvement in the gross margin for CSL Behring.
One of our biggest focus areas has been the rollout of the Rika platform. As I mentioned earlier, we are well advanced with this major change program, with 220 centers now operating with Rika machines. We are on track to have this completed in all U.S. centers by June this year. The other exciting component of the Rika platform is the introduction of the iNomi technology, which we implemented in December last year as planned. We are observing an increase in donor yields of around 10% on average. As a reminder, all Rika machines to be rolled out over the next half will utilize the iNomi technology immediately. Our Horizon 1 and Horizon 2 yield initiatives are both progressing, with Horizon 1 continuing to deliver tangible yield benefits as it is incorporated into our existing manufacturing processes across the network.
The other highlights for CSL Behring that we are excited about is the progress we have made on bringing our homegrown monoclonal antibody, garadacimab, to market for patients suffering with HAE. Branded as ANDEMBRY, we have recently received regulatory approvals in Australia and the U.K., a positive CHMP recommendation in the EU, and our resubmitted BLA was accepted by the FDA in December. Our phase III study evaluating RiaSTAP for the treatment of acquired fibrinogen deficiency is progressing in Europe, and we are preparing for a filing in the U.S. These are important early steps in our patient blood management strategy. Moving on to the next slide and results for CSL Seqirus. Revenue for CSL Seqirus was down 9%, and this was significantly impacted by the decline in vaccination rates for influenza in the U.S., particularly in the 18-64 cohort.
After increasing sharply during the COVID pandemic, vaccination rates have declined for various reasons, with consumer apathy and reduced access being two of the main factors. Lower vaccination rates have also led to competitive pressures in the market. This weak market backdrop has led to a disappointing result for CSL Seqirus this period. However, the incidence of influenza and hospitalization rates are up, and this poses a significant public health risk. In Europe, there are signs that vaccination rates are stabilizing, and over time, we expect to see a similar recovery in the U.S. For the full year, the negative performance of the seasonal influenza vaccines will be offset to some extent by CSL Seqirus' leadership position and pre-pandemic preparedness as we secured several tenders for avian flu. As I mentioned, the majority of this revenue will be recognized in the second half.
Finally, the first half also included revenue from the supply of KOSTAIVE to our partner in Japan. Turning to the next slide and operational highlights for CSL Seqirus. Flucelvax received a positive CHMP opinion for six-month plus age extension in the EU. It also launched in Switzerland and listed on Australia's national immunization program. Fluad. STIKO, Germany's highly influential technical advisory group, has given Fluad a preferential recommendation for the over-60s population. This recommendation underscores the effectiveness and public health value of Fluad. We expect this to be a benefit for sales in the upcoming northern hemisphere season. Fluad was also awarded central tender for key populations in Finland and Denmark, and also launched in Taiwan and South Korea. On the pandemic side of the business, we were selected by BARDA, HERA, and the U.K. Government to deliver H5 vaccines for preparedness against potential avian flu outbreak in humans.
Under product innovation for aTIVc, the initial data supports our projected profile, and we expect to have the full 12-month data set in the third quarter of this calendar year. As I mentioned, we supplied doses of KOSTAIVE to our partner in Japan, and we presented one-year data from a head-to-head study demonstrating that our self-amplifying COVID-19 vaccine provided a durable and superior response compared to the conventional mRNA vaccine. Turning to CSL Vifor on slide nine, revenue was up 6%. For iron, revenue was up 3%. We continue to maintain our leadership position in Europe, with volume growth in Ferinject up 6%. In the U.S., Injectafer sales were up 3%, with step-edit policies remaining stable. The launches of Ferinject in China and Canada are on track.
For nephrology, Mircera sales normalized in this half after a strong comparable period in which a new agreement came into effect with a large dialysis provider. After completion of this very successful rollout, Mircera is a well-established standard of care in the U.S. Vifor's performance was driven by strong demand. Tavneos saw solid sales growth in Europe with increased patient penetration. FILSPARI was successfully launched in Germany, Austria, and Switzerland. Focusing now on the operating highlights for CSL Vifor. On the commercial side, CSL Vifor continues to execute on its strategy to remain the market leader in iron. Our flagship iron product, Ferinject, is navigating the competitive landscape in the EU with volumes growing strongly. Iron deficiency remains a significant challenge around the world, and CSL Vifor is well-positioned to continue its leadership role in helping patients.
For nephrology, we have seen strong growth across the portfolio, driven by the successful launches of Tavneos, FILSPARI in Europe, and Velphoro in China. We remain on track for over 30 country launches in fiscal year 2025 and see significant long-term growth opportunities in nephrology. The R&D pipeline is progressing, with a key highlight being the phase III study for clazakizumab for end-stage kidney disease, which is actively enrolling in 32 countries. I will now hand over to John, who will take you through the financials in more detail.
Thank you, Paul, and good morning, everybody. It's been a pleasure to step in as the CFO of CSL on an interim basis, and I've enjoyed catching up with many of you on calls over the past six months.
Today, CSL has reported a solid set of financial results for the half, and I'll now provide some more detail on those results. Net profit after tax, but before amortization, was up 5% at constant currency to $ 2.109 billion. As a reminder, we have provided a bridge on slide 19 of this deck between NPATA and NPAT. The following adjustments are included in those adjustments: $ 155 million attributable to the amortization of acquired intellectual property. This is largely accountable for by amortization of the assets acquired from CSL Vifor, as well as a little for HEMGENIX, which obviously has been commercialized this year. The adjustment of $ 39 million favorable is primarily the net gain on disposal related to the sale of the group's 100% interest in the Ruide operations in China, which we announced in August last year.
After adjusting for tax and the non-controlling interest, group NPAT grew 9% to $ 2.092 billion, while NPAT attributable to CSL shareholders grew 7% to $ 2.043 billion. Now turning to the group highlights and looking at the financials in more detail. On a constant currency basis, total revenue for the group was up 5% to $ 8.470 billion. A breakdown of our major products by revenue is provided for you in appendix A and B of this presentation. Gross profit was $ 4.728 billion, also up 5%. Group operating result was up 5% to $ 3.974 billion. Research and development costs were down 4%. The first half has been slightly lower due to some programs, such as CSL 112, being finalized. However, I would like to emphasize that we still expect R&D spend to be approximately 10% of revenue for the full year. General and admin costs increased by 27% over the prior period.
This is largely related to the timing of one-off project costs. We expect this to normalize in the second half and anticipate the full year G&A expense to be around 6% of revenue. Net finance costs decreased primarily due to a reduction in our overall debt position. Our balance sheet continues to delever as planned and is in a strong position. As previously mentioned, NPATA attributable to CSL shareholders was up 5% at constant currency. The reported effective tax rate was 19.1%. Cash flow from operations increased by 18% to $1.259 billion, primarily as a result of the growth in cash earnings and ongoing working capital management initiatives. The interim dividend of $1.30 per share was up 9%. This translates to approximately AUD 2.08 in Australian dollar terms, which is up 16% on the prior year.
Turning to the next slide, CSL Behring was again a significant driver of our first half results. This table shows the gross profit of CSL Behring, less sales and marketing costs to give the operating result. A highlight to focus on here is the gross margin for CSL Behring, which improved 170 basis points from 50% to 51.7% at constant currency. This is largely in line with what we expected and was driven by a reduction in cost per liter and efficiencies across both our plasma collection and manufacturing networks. On the right-hand side of this slide is a reminder of the main contributors to the recovery in gross margin to pre-COVID levels. I don't intend to go into detail on each of these as we have discussed them previously, but they each remain a key lever relevant to that gross profit recovery. Moving to the other two business units.
As Paul mentioned, CSL Seqirus has faced a challenging environment, which is reflected in the total revenue decrease of 9%. However, the pandemic side of the business is performing well, and we anticipate the majority of revenue in relation to the avian flu contracts to be recognized in the second half. We remain confident in our strategy and continue to invest in the generation of real-world data and in our sales force to drive growth. CSL Vifor revenue was up 6%, demonstrating the resilience of the iron portfolio despite the generic competition and the uptake of key products in nephrology. With that, I'll hand back to Paul to run through the outlook for the group.
Thank you, John. I'd now like to make a few comments on the outlook for the rest of fiscal year 2025.
Looking specifically at CSL Behring, we continue to expect strong demand for Ig across all of our core indications. We expect momentum in the uptake of HEMGENIX. We are well-prepared for the global launch of ANDEMBRY across all markets. We look forward to completing the rollout of Rika and delivering the improved experience for donors in all of our U.S. plasma centers. We will continue to progress our yield initiatives, and we are confident that the gross margin for CSL Behring will continue to improve. For CSL Seqirus, the second half of fiscal year 2025 will see increased revenue for the supply of H5 avian flu vaccines to governments around the world. We will begin preparation for the launch of Fluad into Germany, and our Tullamarine facility will be proceeding to validation. For CSL Vifor, we will be focused on maintaining our leadership position in iron.
We will continue to maintain the sales momentum of our nephrology products and expand the CSL Vifor portfolio into new geographies. For CSL at the group level, I am pleased to confidently reaffirm our financial guidance for fiscal year 2025. We expect revenue growth to be approximately 5%-7% over fiscal year 2024 at constant currency, with NPATA expected to be in the range of approximately $ 3.2 billion-$ 3.3 billion at constant currency, growth of between 10% and 13%. I also reaffirm our double-digit earnings growth outlook for the medium term. With that, we will move to your questions.
Thanks. In addition to Paul and John, we are also joined for the Q&A session by several other representatives of CSL's leadership team.
In the room with us are Joy Linton, Interim Head of Behring; Dave Ross, Head of Seqirus; Hervé Gisserot, Head of Vifor; Ken Lim, CSL's Chief Strategy Officer; and Dr. Bill Mezzanotte, Head of R&D. 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. The first question comes from Lyanne Harrison at Bank of America.
Yeah, good morning, all, and thank you for taking my question. I might start with Behring gross margin, so this might be a question for Joy. Previously, you've guided that you're expecting 100 basis points plus gross margin expansion for Behring in 2025. I think what we saw in this half was materially higher than that.
Given, I guess, some of those gross margin recovery initiatives that was in the slide, it looks like a lot of that will also come through in the second half. So how should we think about gross margin for second half 2025 for Behring?
Hi, Lyanne, and thank you for your question. Behring gross margin does seem to follow me around the organization, so I will hand to John to answer. But perhaps the first comment, as you know, we don't really manage the business half on half, and so we would encourage you to think about that guidance that we've given as 100 and a bit in the full year, and we're not necessarily moving away from that, but I'll hand to John.
Sure, thank you, Joy.
Yeah, I would reiterate the comment that drawing too many conclusions from a six-month slice is difficult because there are many, many factors, as you've seen, that impact on the Behring margin outcome. We're delighted with the performance in the first half. It's very strong, but the pattern over the past few years has been for margin to be slightly lower in the second half than in the first half, and we're expecting that to recur this year. We still are going to deliver our 100 and a bit, so we're very confident about delivering that for the full year.
Okay, thank you very much.
Thanks, Lyanne. The next question comes from Davin Thillainathan at Goldman Sachs.
Thanks, Chris, and morning, Paul and team. Can I just talk to earnings guidance? Clearly reiterated on a full-year basis.
Just trying to understand when you set guidance and what's sort of happened since then. It does appear that the Seqirus business is perhaps weaker than expectations, so I'm therefore interested to understand what the offsets could be to sort of reiterate your guidance. And then just overlaying that with the comment on Behring gross margin, despite it coming ahead of the first half print, it does appear that you've reiterated your full-year expectations. So what else, other than the gross margin, perhaps, to get you to your guidance? Thank you.
Great, thanks, Davin. I appreciate the question. I'll answer and ask John to fill in if I left any blanks. In terms of the year, we're reaffirming our full-year guidance for 2025, which is the 10%-13% on NPATA. How that comes together has changed slightly based on the performance of the different businesses.
So we'll continue to see Behring delivering in that high single-digit region. And now we have, before with Vifor, we had that flattish, and we're now expecting that to be low positive single digits. And likewise, in the opposite direction with Seqirus, we had envisioned that to be flattish, but now looks to be more in the negative single-digit direction. So the sum of the parts will ensure that we deliver our guidance for fiscal year 2025.
Yeah, I would just add. I think that in Seqirus, we have an offset in the second half, which is the pandemic contracts where revenue will be recognized in the second half. So Seqirus will actually outperform its normal H2 levels, and that adds to our confidence in restating the guidance.
Okay, and my next question, pardon me, is on your Ig franchise, very strong for the first half, sort of 15% and 16% levels. And if I look at, I guess, some of your peers and the channel checks that we're doing, and also based on some results that have come through, it does appear that you're growing more than those peers. Could you give us a sense of what you think the drivers are for your business for the half? Maybe just to understand market share and also any pricing dynamics. Thank you.
Great, I'll ask Joy to address that one.
Thanks, Davin. So yeah, look, we're really pleased with the performance of our Ig franchise and really nice to see Hizentra growing ever so slightly faster than IV Ig, which is something that we've been working on for quite a while.
We have launched our prefilled syringe 50 ml, which means the entire Hizentra portfolio is now available in prefilled syringes, and that's a significant thing for our patients and has been very well received. That launch has gone well, so we think that has certainly helped. Then the second comment I would make is we have capacity, and the investments that we've been making over the last five years, which have largely, from an Ig perspective, come to its natural conclusion, we have capacity, and we are now producing through the manufacturing network quite efficiently, and we're able to meet the needs of patients in growing markets. From an Ig perspective, we're in a good spot.
For pricing, Davin, I would just assume our normal low single digit. As you know, we're not a historic price taker, and so we will continue with that journey.
Our goal is to continue to make a difference for patients and the healthcare systems through volume, and we take price where appropriately relative to the marketplaces.
Thanks. Great, thank you. Our next question comes from David Stanton at Jefferies.
Good morning, team. Thanks very much for taking my question. If I could talk to the bird flu contracts that you talked to coming through in the second half, can you give us some data or perhaps some color around what the implied bird flu contracts in terms of number of doses that you expect for the second half of FY 2025, please? First question.
Yeah, David, thanks for the question. I'll hand that off to Dave Ross, our head of Seqirus business.
Thank you for the question. Yes, so for context, what you're seeing are outbreaks of H5 that are occurring in avian and in cattle.
You have farm animals as well as in the wild flocks. And as a result of that, around the world, the governments, U.S., the EU as a central purchasing, as well as U.K., and now in the Middle East, are starting to purchase some outbreak volumes of vaccine to address the frontline responders in the event that a pandemic were declared. Those volumes are being produced now and is the reason why the revenue is going to be recognized in the second half of the year. The contracts have been signed and initiated, and the delivery of those vaccines will be made during the second half. There are still negotiations going on with other jurisdictions, so the volumes may continue to grow through the second half.
But I guess, sorry, this is just a follow-up. I guess you can't tell me what the volumes might be, though.
I'm just trying to figure that out.
They're all included in the guidance, David, so I think because every contract is slightly different, some by the actual vaccine, some by just the antigen adjuvants, I think it would probably be more misleading than beneficial on providing that guidance.
Understood, and my second question then is, you're still talking to, getting back to within CSL Behring pre-COVID gross margins in that two to four-year timeframe from here? You haven't stepped away from that at all?
Yeah, let me take that one, David. I think, yes, we haven't stepped away from that. I think the only thing that we would do is provide a little bit more clarity on the timing. As you're aware, as we've said today, the drivers are all progressing extremely well, and we remain on track.
But we have seen some headwinds over the last couple of years, and the launch of new products has been a little slower. So we remain very confident about achieving the original target, but it'll be FY 2027 or FY 2028, not FY 2026.
Yeah, the FX headwinds haven't been helpful.
No, not at all.
Thanks, David. The next question comes from David.
Thank you very much.
Next question from David Low at JP Morgan.
Thanks very much. If I could just start with KCENTRA. So you've acknowledged the loss of a contract. Could you talk a little bit about what your expectations are now and how competitive the market is, where the price is settled? How much of a drag might KCENTRA be in the second half for gross margins, please?
Yeah, sure. Thanks, David. So yeah, there was a high-volume contract that we lost in the second half of last year.
I think this one's been coming for a while. A couple of important points. The market is still growing at mid-single digits, and 35% of patients are still using fresh frozen plasma. So we continue to see market growth and opportunity. KCENTRA remains the clear market leader. And actually, we've been continuing to win many of the tenders on offer. And pleasingly, I think we've maintained some commercial discipline in being able to do that. We're working on a range of initiatives around the label, and we'll say more on that when we can. But we see growth for KCENTRA. It's a slightly different competitive environment. We'll maintain market discipline or commercial discipline, and we do see growth going forward.
Okay, thank you very much for that. And just perhaps the other one, HEMGENIX. I noticed that the numbers weren't broken out. I noticed a very positive commentary there.
Maybe if I could get Paul possibly to talk about what your expectations are now, and I'm really interested to understand where you think peak sales could get to.
Yeah, so we're very encouraged by what we're seeing by the patient journeys. If you saw the four-year data that was just published, the HOPE-B study, it's a remarkable story. And I've had the opportunity to meet personally with patients who've described their journey now with this singular treatment to help their bleeding. And it's really just outstanding. And so we're starting to see momentum as the patient word gets out there. So our marketing team has now done some recent work where we've gotten different patient testimonies now that the clinical trial is done out so that people can really experience their journey and understand it.
So we think that HEMGENIX is scientifically and clinically a tremendous product and will continue to work through the overall market penetration. We've been happy to see progress not just in the U.S., but the beginning of reimbursements in Europe, dosages occurring in Europe. And we typically won't forecast for peak sales because that will be contained in our guidance on a yea rly basis.
Understood. Thanks very much.
Thank you, David. The next question comes from Andrew Goodsall at MST Marquee.
Hi, good morning, and thanks very much for taking my questions. Just the first one, we've talked to Ig, but just asking if you could call out what you're seeing on albumin, particularly China, and secondly, whether you're sort of a beneficiary of where your competitors got some reconstruction going on.
Yes, I think is the short answer. China was clearly the source of growth in albumin.
The world is short albumin. I think we can sell every piece of albumin we can get our hands on. And so yeah, it's a positive story for us.
And then second one, just I'm presuming this is in your guidance, but obviously Medicare Part D reforms are now in place with the lower copay. Just checking if you're seeing any impact or how you're navigating through that.
No, it's a great point, Andrew. And yes, that is in our guidance. And obviously, it's a very fluid situation, and we keep on working through it with our government affairs team and the commercial business. But our scenarios are firmly in our guidance.
Thank you.
Thanks, Andrew. The next question from Sacha Krien at Evans and Partners.
Good morning. Thanks for taking my questions.
First question, I just wanted to enquire if you could provide a bit of an update or some color around Ig sales across the half. It looks like your largest competitor was particularly weak in the December quarter, particularly in the U.S. Your comments seem to suggest that maybe that's capacity related.
I'm not sure, Sacha. Thanks for your question. We're doing well in the U.S. in Ig and won a couple of tenders, and the business is performing well. It's not clear to us that there is any capacity constraint in the U.S. I think you're likely to see that in other markets first. So I'm not sure we would necessarily say that for the U.S.
Okay, great. Thanks. Second question on Seqirus, just wondering if you can break out or maybe talk a bit to the cost savings impact and how it's accounted for in the numbers.
Has it all come through as 100% margin, or are there some costs associated with that revenue?
It reflects in the numbers in a couple of different ways. You'll notice on the Seqirus slide, there's some other income, which was milestone payments associated with the ongoing development and commercialization of KOSTAIVE. The sales of product are sitting in the product sales line. And yes, there is some cost, obviously. Nothing comes for nothing, but it's a relatively modest component.
Got it. Okay, thank you.
Thank you, Sacha. Our next question from Saul Hadassin at Barrenjoey.
Yeah, thanks, Chris. A couple of questions, please. The first one maybe for Joy. Joy, just looking at the Behring divisional performance for the half and just looking at the sales and marketing growth of 10%.
Just considering the composition of revenues, just wondering why you're not able to get better operating leverage through that cost line, knowing revenues growth really predominantly coming from Ig and albumin, sort of more established products rather than new products.
Yeah, thanks, Saul, for the question. There's a bit of timing in there. We have been investing ahead of the launch of ANDEMBRY. So we haven't got the revenues yet, but there is some marketing expense in there. That's probably the main reason. Yeah.
Okay, thank you. And Joy, again, maybe just for some color or John, the FX headwind for FY 2025, I'm assuming that's going to have a significant impact on the Behring margin.
So when we get to the full year and we look at the constant currency gross margin versus reported, is the expectation that that FX headwind is going to translate to maybe sort of 50 basis points, 60 basis points like we've seen in this half?
So the FX headwind will be reflected in our actual results, not so in our constant currency results. So constant currency will eliminate that impact. Your percentage is about right in terms of the delta between constant currency and reported. The one thing I would say is pretty hard today to predict what's going to happen to currency markets over the next six months. We're seeing unprecedented volatility in markets, a lot of it coming out of 1600 Pennsylvania Avenue, but there's just a lot of uncertainty out there, and we will continue to monitor.
Yeah, no, thanks, John.
I guess in the context of currency doing what it's doing, if it was to hold here, if the U.S. dollar strength holds, the notion of getting back to pre-COVID margins, is it still the expectation that you can do that, particularly with the euro being so low?
Absolutely. Yeah, no, no, we're very confident. Currency is only one of the impacts. The other drivers, which we've talked about since Capital Markets Day on a pretty consistent basis, will override the negative impact of any currency headwinds because they are systemic improvements in margin, whereas currency bounces around from period to period. So no, we remain very confident about our ability to get back to pre-COVID levels.
Great, thanks.
Thank you, Saul. Our next question comes from Craig Wong-Pan at RBC.
Thanks.
Just wanted to understand if you could clarify if there was any impact on the Behring gross margin from the lower KCENTRA sales in this half or due to the production process. Would a lower level of KCENTRA sales impact future margins in second half 2025?
There's certainly an impact in H1. I mean, it's a profitable product, and we haven't sold as much of it. The impact on absorption of overheads in manufacturing is less significant because it's obviously one of a broad range of products that we manufacture. So I wouldn't build too much in. The main focus is simply related to sales and the cost of sales, so.
Okay, I think that's helpful.
And then the second question, just with the avian vaccine sales that are coming through in the second half, based on the agreements you've signed today, will there be any volumes that come through in FY 2026, or is this more a second half 2025 story?
Yeah, right now it's a second half 2025 story. What happens beyond that is yet to be seen. We have to continue to track the epidemiology of the virus, and depending on how that evolves or mutates, it may create other opportunities, but that's speculation at this point.
Okay, thank you.
Thanks, Craig. Our next question comes from Steve Wheen at Jarden.
Thanks, Chris. My question is about the G&A. You're guiding for it to be 6% of revenue as 5% in the first half. So obviously, that starts to step up in the second half, or step up a bit.
I'm just trying to understand what the non-recurring nature of those project costs are, and if you could sort of help us quantify it for sort of trying to understand what G&A more reasonably would look like going forward.
So I think taking the second part of the question first, we are looking to continue to improve our leverage through the P&L and to drive that percentage of G&A as a percentage of revenue down. The issues we have in the current year, there are a number of project-related costs. These are not capital projects where you get to defer the spend and match the amortization against the benefit you get. They're OpEx projects where we have no choice under the accounting standards but to take the charge as and when we incur it. So it's really a matter that's largely related to H1 this financial year.
We don't expect that to recur, which is why we're providing the guidance for the full year. But certainly, the plan long-term is to continue to leverage the scale of the business and to continue to drive down that G&A as a percentage of revenue. It's just a bit of a blip in the first half of this year.
Yeah, sorry, but as a percentage of revenue, it increases for the full year relative to what you did in the first half. So is it just a blip?
It looks like it's changing. That's just that we're measuring against prior comparative period. The pattern in last year was not that even over the two years either. I don't have the numbers in front of me, Steve, but we can deal with that when we see you later in the week and give you more background.
But it's really just timing both in last year and in this year that's driving that, what looks a little bit like an anomaly, so.
Okay. The second part of my question is just what sort of costs are you incurring that would be one-off in nature that is associated with the deployment of the Rika platform? I kind of was thinking that might have been your non-recurring project, but maybe perhaps it's elsewhere in your P&L.
Rika is a capitalized project that we're rolling out, Steve. So if you think about it, there's other projects that we're looking at, how the business overall works, how we work across the business. Procurement's a good example of an overall enterprise process that we're looking at a one-time expense to really improve our procurement engine and, to John's point, to really leverage our scale much better.
So you'd have the project, but then the benefits of that come from the procurement events after that event. So that modernization of our procurement was an important part. Our enterprise procurement was an important part of one of those costs, for instance.
Got it. Thanks a lot.
Thanks, Steve. Our next question comes from Andrew Paine at CLSA.
Yeah, morning all. Thanks for taking my question. Just looking at the HAEGARDA growth, it looks sort of slowed a bit. Just wanted to know about the market dynamics for this product and if there's any impact by the upcoming transition to garadacimab. Obviously, you haven't launched that product, but has there been any kind of consideration leading up to the launch?
Yeah, so HAEGARDA has got some modest growth. I mean, it's still doing a good job for us.
Yeah, we're hoping that ANDEMBRY comes soon and perhaps in the U.S. in particular, not quite as soon as we were expecting. So there is a bit of an impact on that. HAEGARDA is still a good product, but ANDEMBRY will be absolutely the standard of care, and it will be by far the best product there is in the market. So very much looking forward to that coming to patients.
Just remember that market; it's still a significant unmet market from an opportunity for patients, right? So there's still about 50% of the patients that are not on prophylactic treatment. So although there's been more choices entered into the market, I think there's still a population left to be served. And with ANDEMBRY coming on, HAEGARDA has kept its patient numbers.
It's grown small, modest numbers, low single digit, but ANDEMBRY opens up both clinical efficacy and convenience, right? A 15-second injection once a month, which is just outstanding.
Yeah, okay, that's great. And then just also looking at Ferinject, the volume and sales look very positive there. Just be good to talk through the market dynamics on pricing erosion versus volume gains and also where you are on the rollout of this franchise on a global basis.
Sure, I'll ask Hervé to address that.
So in Europe, we are facing generic competition, as you know. So two products have been approved from Sandoz and Teva. We are expecting a third one from Viatris to enter the market soon. As a consequence, we are facing, of course, pricing competition, and we expect this pricing competition to intensify in the coming months as we go through tenders.
But so far, we have really managed the situation, I will say, very smartly, very successfully, making the right judgment calls in terms of price and volume, which is the reason why we have been able to grow volume in Europe by 6% in a market also being quite dynamic because of the unmet medical need, the number of undiagnosed patients, and only 15% of the eligible patients receive Ferinject as we speak. So we remain confident in our ability to grow the market and grow the volume of Ferinject despite this generic competition. In the other regions, U.S., we have been able to stabilize with our partner the performance of Injectafer. No new step-edit policies, and the new indication for heart failure patients suffering from iron deficiency has been largely carved out from step-edit policies. So that's good news.
In the rest of the world, beyond the launches in China and Canada, which are on track, we see really very strong growth, double-digit growth, both in terms of volume and value. So overall, we are confident in our ability to maintain our leadership position in the iron market.
Yeah, and I'd just say, adding to Hervé's comments, it's that competitive discipline, right? As we shared before, we brought in several skill sets as we entered into this period. And that competitive discipline is very important because you don't want to necessarily win every tender, right? There's a strategy. It's like war gaming as you go into these things, as you balance what the competitors' capacities are versus ours, balance the marketplace. And so the great thing is our capabilities from a supply chain viewpoint, without a doubt, are industry-leading in iron.
And that gives us the flexibility to really execute competitive discipline to make sure that we get the right competitive price in the tendering market.
That's great. Thanks for your time.
Thank you, Andrew. Our next question comes from Laura Sutcliffe at UBS.
Hello, thank you for taking my questions. One on vaccines, please. Do you have any thoughts on the intention by one of your competitors to develop a non-mRNA winter combi vaccine? I think it's still at the stage where it's two separate shots, but there's the intention to eventually co-formulate it so you could end up with flu and COVID in one shot. Does that affect how you see the competitive landscape? And perhaps is the situation in the U.S. a sort of new normal as well?
Look, I think technologies, there's lots of technologies out there that can solve the combination vaccine need if it presents itself in the marketplace. So we, like any competitor, also look at different modalities and the best way to address that issue. So I think it's really a matter of what's fit for purpose. There's a lot of devil in the details of how you bring these compounds together in a combination offering. And I think all bets, all modalities, and that's the strength of our R&D team, is able to work in monoclonal antibodies, as you know, as well as in the self-amplifying mRNA. So I think it's really a matter of getting the best science and the best clinical profile, and what modality you need to use to do that is really the modality you'll use to do that, right? And that's what we've been looking at.
All right, thank you. And then maybe just on the FcRn class, I think J&J is expecting an approval for nipocalimab and myasthenia gravis later this year. Do you view that situation as just FcRn sort of competing with each other in that space, or is a class that potentially starts growing in size and maybe poses a bit more of a threat?
Yeah, so the first point is that the CIDP market is growing kind of low double digits. So it's a growing market. We think there is, with the introduction of the FcRn, some improved awareness of the disease and perhaps some earlier diagnosis. So that's actually good for patients. But we're also very clear that Ig works very well and is the first line of treatment and will remain the first line of treatment. And I think our Ig numbers support that.
So we've really seen minimal switching. But where Ig doesn't work for patients, it's good that there's another solution for them.
And I'd also just bring to your attention that there have been publications that have shown that if you were not intolerant to Ig and you switched to FcRns, your disease progression actually got worse. So there was a recent publication on that. So we see the patient need for those that are Ig intolerant across those areas for FcRns, but don't see FcRns as fundamentally threatening the standard of care, which is Ig.
Okay, thank you. The question was actually about myasthenia gravis. Does the answer hold for that? I think you said CIDP.
Yeah, I would say similarly on MG. I'd say you'll see competition amongst the FcRn competitors in that space.
And Ig, as we shared a while back, the number of percentage of Ig people we had on using Ig has been the same now as it was prior to FcRns being introduced. So it's more of an opportunity for them to compete in that space.
Yeah, we don't have a label on MG for Ig, as you know. Yeah.
Thank you.
Thank you, Laura. Our next question comes from Mathieu Chevrier at Citi.
Hey, good morning. Thanks for taking my questions. Just to clarify on garadacimab, when do you expect that to be approved and launched in the U.S.?
So we resubmitted the BLA filing in December, and that was accepted by the FDA. And a typical regulatory pathway for that is between four to six months. So we look for approval before the end of the fiscal year.
Right.
Just to be curious, I'm just keen to further understand what's happened in the flu market. You mentioned a number of things, including the shift in immunization settings as well as the competitive pressures. You've tended to do well over the last few years on those fronts. I'm just keen to understand what may have changed this year versus the previous years.
Yeah, thank you for the question. I think what you're seeing is just the collective weight of the change in immunization rates. If you look at the U.S. in particular, over the last four years, there's been a reduction in demand of 50 million doses in our estimation.
While we've been able to grow in the recent years through that decline, we're at a point where we've seen a dramatic reduction in the overall immunization rates, in particular in the retail setting as well as in the GP setting. In fact, in some GP settings, they've decided to stop the immunization efforts, which is reducing access points for patients. So those are the key drivers for the decline. I do want to reiterate the importance of our differentiation strategy. While we are feeling the impacts of those decreases in immunization rates, we maintain premium pricing with our enhanced vaccines of Flucelvax and Fluad versus standard egg. And the platform itself, while we talk about our differentiation strategy normally around seasonal, it's playing out very strongly on the pandemic side where, as we've mentioned already, we've secured the majority of those pandemic contracts.
Got it. Thanks very much.
Matthew, our next question comes from Shane Storey at Wilsons Advisory.
Thanks, Chris. Good morning, everyone. I'd like to just pick back into that change of setting piece with respect to vaccines. So, I mean, I heard just there that GPs have sort of stepped back from participating and more volumes going into perhaps pharmacies. Maybe you could characterize whether there's been any shift in the customer groups that you'd seek to contract with in optimizing your ability to compete and service that demand. Thanks.
Generally, the customer mix while changing, it remains relatively the same. It's a trend that we have to monitor carefully, but our sales force is positioned well across the various segments so that if there is a shift, we'll be able to address that shift. I think the question that we all are focused on is the immunization rates as the key driver here.
We believe, as Paul had said earlier, that over the medium term, we will see recovery in immunization rates, which will create a more healthy market for growth and price appreciation. What we're seeing currently is a pretty alarming situation because as you're tracking disease this year, we're seeing a very severe flu season come out of these lower immunization rates. In the U.S., in particular, we're seeing a second peak of flu, and it's trending towards a 15 to 20-year high in epidemiology and disease. We're tracking hospitalizations, and unfortunately, there's already been 50 pediatric deaths. These are really, really sobering reminders of the importance of immunization, and hopefully, that will reengage healthcare providers in the coming seasons to reengage and drive those rates back up.
Thank you. That's very helpful. My last question is back to HEMGENIX, please.
We're fully aware of the channel conflicts that you've had to very patiently work through in the last year or two. But if you've had any breakthrough this period, what do you think it's been?
Yeah, I think it's really, I would account it to two things. One, the patient voice getting out there, right? I think when you see published data like the four-year data is really important. And then second, the KOLs and their healthcare systems looking at this in a more integrated way. The challenge in the healthcare system is most of these hemophilia centers were kind of standalone on their dependency of the hospital systems that they sit in. And as HEMGENIX came in, that dependency was changed because a lot of hospital settings require gene therapies or advanced medications like that to be managed through the clinical pharmacy of the hospital.
So there were new dependencies that didn't exist for these hemophilia centers that all of a sudden came into play. But we're seeing the hospital systems work through those dependencies and figure out how they're going to divvy up the appropriate accountabilities and financial benefits amongst the hospital. So I do think that as the change was introduced, the hemophilia centers became more dependent on their hospital systems that they sit in for both infusion and pharmacy. And it's taken some time for that to work through. But now, as those hospital systems work through that, they realize they can't not have this offering for patients. It's just too transformational to have the bureaucracy, the system have that. So I think it's just a realization of the challenge of the system.
Thanks very much. That's perfect. Cheers.
Thank you, Shane. Our next question comes from Thomas Wakim at Bell Potter.
Thanks for taking my question. Just on Vifor. In light of some of the comments about intensifying competition in Europe, do you think that at a gross margin level, is it fair to say that it's probably a challenging outlook to maintain the gross margin for Vifor where it's been at in this half? Or do you think you can uphold that moving forward?
I would point you to the first half performance, which is pretty solid on the gross margin and on the operating margin for the Vifor business. Iron's part of a broad portfolio. And yes, we are losing some margin in iron, but we're actually picking up in other areas. So I think we expect that we will maintain Vifor gross margin as it stands at the moment, which is a fantastic outcome in the face of the competition.
Thanks very much.
A second question just on garadacimab. Assuming the FDA approval plays out as expected, is it fair to assume that your commercial launch could follow quite quickly thereafter, given the existing presence in HAE? Any more timing you're able to provide on that?
No, you should assume that a rapid launch post-approval in all markets, right? I mean, because it's a well-established area, in Europe, there'll be a little more time for reimbursements. But I would say you should see rapid launch both from a supply readiness viewpoint as well as market readiness viewpoint.
Thanks very much.
Thank you, Thomas. Our next question from David Bailey at Morgan Stanley.
Yeah, thanks, Chris. Hi, Paul. Just following on from that early commentary around FcRns and CIDP, just confirming your comments that there's been no volume impact to date.
Just wanted to check your view is that FcRns are going to be more relevant to people who are naive to treatment and/or those who can't tolerate IVIg. I think we just sort of saw the same study that pointed to some less than optimal results for those patients who switched across from IVIg to FcRn. I just wanted to confirm those comments and any other observations to date you can make around FcRns and CIDP.
I think, David, nice to hear your voice. Thanks for the question. I think you summarized it very well. I think we look at the FcRn current penetration for patients that are intolerant on Ig. We continue to see, as we introduce new capabilities, the 50 ml PFS, as for instance, for Hizentra CIDP area. Hizentra is the standard of care.
And we do not see that changing because of the introduction of FcRns.
Understood. And maybe just a quick follow-up for Joy. You mentioned there's a potential label extension coming through for Hizentra to be more detailed to be provided. How material could that be? Is that something that's quite fairly substantial, something that could help drive some more decent growth and penetration of that, those volumes going to FFP or elsewhere?
Well, it's part of our life cycle management work that we're doing with Hizentra. The market is growing. As I said, there's still 35% of that market is fresh frozen plasma, so there's opportunity. And yeah, we'll share more when we can. Hopefully, by Capital Markets Day in November, we'll have something more specific to share.
Thank you.
Thank you, David. We have a follow-up question from David Sta nton at Jefferies.
Yes, thanks very much.
Just two from me again, if that's okay. So would you be able to put some color around the decline that you've seen in cost per liter within Behring, maybe for the first half compared to what you saw in FY 2024? Is it down circa 10%, 2%? Any color around that would be greatly appreciated.
It's down. I think we're not going to specify exactly how much it's down. It's on a downward trend. The way in which we're managing donor fees continues to evolve, and we become more sophisticated, and that's one of the drivers of our ability to drive that cost down. As we've said, it's one of the key drivers for margin improvement. We remain on track.
Yeah, and I'd also say our operational efficiency of the centers. We've had a full-court press on that in terms of really making sure that we have the right labor models, looking at centers to make sure that they're meeting what we expect should be the donation volumes against that labor. So, I mean, there's so many levers we're pulling in addition to the manufacturing yield. But overall story of better management of cost, better systems to understand the market clearing price on donor fees in given regions, as well as just operational discipline across the whole pipe.
Understood. Thank you. And just to follow up on a question from two of my colleagues, when will garadacimab likely get reimbursement approval within calendar 2025?
Should we expect, if it's approved for the end of FY 2025, so say June 2025, that you won't be able to get widespread reimbursement approval for six months in the U.S., so say December 2025? Or should we just assume, okay, it comes on, you get reimbursement approval pretty much straight away?
Yeah, you should assume on average that it comes on straight away. We've already been having those negotiations. It's a known class, known disease area, and so you should see rapid reimbursement in the U.S.
Very clear. Thank you.
Thank you, David. We have one more question in the queue. Shane Ponraj from Morningstar.
Yeah, thanks for squeezing me in . So just on milestone payments for HEMGENIX, from memory, I think it could have been over $1.5 billion, but haven't seen much in cash outflows yet. Just what's the latest on that, please?
We pay them in accordance with the contract we signed with uniQure. There hasn't been much this year. There's a minor amount, but I don't really have any other color to add to that. A lot of that number we quoted was based; there were milestones based on sales levels as well as technical achievement and commercialization. So clearly, with the relatively slow uptake, we're not approaching those sales milestones anytime soon. We will get that. The key thing is that if we do pay them, we will have realized the value from the commercialization of the product. So there's a direct link between value to CSL and a milestone paid to uniQure.
Yeah, thanks. And just thinking about the uptake, on slide 21, if I assume HEMGENIX is in the other section of the pie chart, I think you had about $50 million in sales in the half.
Maybe confirm if that's right, please. And yeah, I heard your answer for David Low's question, but what sort of momentum do you see in the second half and beyond? Thanks.
That's about right. Yep, that's about right. And we've seen improvement quarter on quarter, and as I think Paul has eloquently outlined, slowly, steadily continuing to improve as we firstly get the patient voice out there and secondly continue to unlock the blockages that we'd had in the U.S. system. And then thirdly, as we continue to get approvals in other countries, particularly across Europe.
Great. Thanks .
Thanks, Shane. 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. Thank you and goodbye.