Thank you for standing by, and welcome to the CSL Vifor briefing. All participants are in listen-only mode. There will be a presentation followed by a question-and-answer session. If you wish to ask a question, you will need to press the star key followed by the number one on your telephone keypad. I would now like to hand the conference over to Mr. Mark Hill, VP, Investor Relations. Please go ahead. Thanks, Kelly. Very good morning, everybody, and welcome to this morning's CSL Vifor Investor briefing. I'm joined here with Paul Perreault and a number of CSL senior executives. I'm sure everybody know Paul is our Chief Executive Officer. As Kelly mentioned, we will be having a briefing, but we have put aside a generous amount of time for Q&A. With that in mind, I do ask that during Q&A, to give everybody an opportunity to ask a question, as with past practice, 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. Lastly, before we start, I draw your attention to the forward-looking statement disclaimer contained in the slide deck. With that, I'll pass you over to Paul Perreault. Paul. Thanks, Mark, and good morning, everyone. Thank you for joining our CSL Vifor briefing today. I'm gonna start off with a strategic overview of how CSL Vifor fits into the CSL strategy. Then Paul McKenzie, our Chief Operating Officer, will highlight some of the market opportunities we see for CSL Vifor. After Paul, I'll be pleased to introduce you to Hervé Gisserot, who has been appointed to lead the CSL Vifor business as General Manager. Hervé joined Vifor Pharma in January 2022 as the Chief Commercial Officer and has vast experience in the pharmaceutical industry globally, including 13 years at GSK, and prior to that, held leadership roles at Sanofi and Fournier Pharma. Hervé will go through the CSL Vifor portfolio in more detail and outline the key priorities and the growth drivers for CSL Vifor. Following Hervé will be Dr. Bill Mezzanotte, our Head of R&D and Chief Medical Officer. Bill will cover the R&D pipeline and really provide more detail on the opportunities across both CSL and CSL Vifor. Then our CFO, Joy Linton, will provide an update on the financials, including the new segment reporting and our updated guidance for fiscal year 2023, including CSL Vifor for the very first time. There's plenty to like in my view with CSL Vifor, and I think that many in the audience will agree that CSL is not a habitual acquirer of companies. We take our time. We look at companies where there are capabilities, competencies, and adjacencies to what we do. Companies with well-established market positions are especially attractive to us. EPS accretion, or at least a path to EPS accretion, goes without saying. We are instinctively cautious so as not to stretch the balance sheet too far. I think we've achieved all of these objectives with the acquisition of Vifor Pharma, along with a few other things. CSL Vifor, in my view, is a unique company. It adds tremendous value and strength to CSL. It helps to accelerate our growth strategy and brings increased innovation, capability, and scale. It's a durable business that will continue to provide us with profitable, sustainable growth. It helps really because CSL Vifor brings a like-minded business with a similar culture and values to CSL, which is quite important as a 2030 strategy is underpinned by our people, as you see on this slide. CSL Vifor also contributes to our diverse product portfolio and our deep R&D pipeline and advances the health of those that face a range of serious medical conditions because patients and public health really do also underlie the strategy. Good starts with both the rare diseases, the area of need, and the culture fitting together to underpin the strategy at CSL. We are now significantly a larger company, have a broader strategic horizon, and at the same time, we've retained our financial flexibility. At the announcement back in December last year, we said that the acquisition would be low to mid-teens NPAT A per share accretive, and today I can reaffirm that outlook. This acquisition is quite unusual. It's not often you come across a biotech company that is actually generating cash, has an exciting future for growth opportunities, and will continue for years to come. We now have a world-leading franchise encompassing renal disease and diseases of iron deficiency. This brings me back to the slide on the screen. It's that strategic fit. We already had a great strategy before our. Announcing our intentions to acquire Vifor Pharma. Did we have to do the deal? I'd say probably not, but it's a great opportunity. You can see here on the slide how well CSL Vifor fits into CSL's 2030 strategy. Diseases of iron deficiency adds neatly to our strategy of achieving sustainable growth. Nephrology fits neatly into our areas of focus. As you know, we already have clinical programs within transplant and nephrology. Elsewhere in our 2030 strategy, we have added partnerships under the efficiency and reliable supply pillar. CSL Vifor's iron business is the jewel of the business, yet people have been asking me, "What about things like cliffs with intellectual property or loss of exclusivity?" There's a lot more to this business than just viewing it as an earnings erosion story following a loss of exclusivity. FMC gives us access to the nephrologist and patients, a critical element when you're developing products. Interestingly, we are already taking calls from small biotechs who have assets in this area. They are looking for a preferred partner to help them to take their products forward, and we are just that, a preferred partner for innovation. The combination of CSL and Vifor Pharma is greater than simply the sum of the parts. We will be stronger together. CSL Vifor have strong expertise in developing these partnerships with a constant cadence of deals. CSL can learn from this, but whilst we have been we haven't been an acquirer of assets, we will bring continued focus and opportunities to what CSL Vifor has already established. CSL Vifor does R&D, but not quite the same way we do R&D at CSL. In the past, Vifor Pharma has often outsourced their R&D. Now, I'm sure many of you who have attended our annual R&D briefing and will have seen the approach CSL has to R&D. Bill Mezzanotte and the team will bring capabilities and experience to their R&D at CSL Vifor, but also expanding the new broader CSL group opportunities. Some may recall when I came into the CEO seat here at CSL a decade ago, at that time, CSL was ripe for a step forward. When Brian and I made the transition, we talked about the need to globalize and commercialize the focus and the strategy, really making it and taking it a leap forward. CSL Vifor is in that same vein as CSL was 10 years ago. It's a relatively smaller business, doing well, generating cash, but it needs the boost. It's now time to really commercialize the strategy at CSL Vifor. Moving forward, CSL Vifor is about expansion of its commercial opportunities, leveraging the broader group of R&D opportunities. You know, I sometimes reflect on the doubt that's been expressed at times about our acquisition of the Novartis asset from Seqirus. While in hindsight it's convenient to talk up a success story, my thinking is somewhat different here. You know, perfect companies typically aren't for sale. In fact, I'd say that no company that you would acquire will be perfect. Certainly, a lot of the companies aren't at a valuation that we would entertain. The right strategic fit, the right people, the right focus, will inevitably deliver sustainable, profitable growth and value for CSL and for our CSL shareholders. It is about that long-term sustainable growth. I'd like now to hand over to Paul McKenzie, who will talk a little bit more about the growth opportunities for CSL Vifor. Paul? Thank you, Paul, and good morning, everyone. As Paul highlighted, CSL Vifor strengthens CSL's 2030 strategy by adding a durable and growing business that adds complementary and adjacent franchises to CSL's portfolio. CSL Vifor has leadership positions in diseases of iron deficiency, dialysis, and nephrology. Our strategic goal is to unlock the full potential of CSL Vifor by building on these leadership positions and continuing to grow the product portfolio. CSL Vifor's largest franchise is its iron franchise. They have been the pioneer in the development of iron-based products and are the global leader in the treatment of iron deficiency. Iron deficiency and iron deficiency anemia affect many people around the world, with more than 3 billion people having iron deficiency and around 1.2 billion having iron deficiency anemia. Despite the high prevalence and potentially serious consequences, iron deficiency and iron deficiency anemia remain underdiagnosed and undertreated. There is a high unmet medical need in this area and a significant untapped potential for CSL Vifor to continue to grow its iron franchise, and Hervé will cover our strategic priorities with the iron franchise in his presentation. The other large and growing opportunity for CSL Vifor is in renal disease. Chronic kidney disease is a leading cause of mortality and morbidity globally. In the U.S. alone, approximately 15% of all adults suffer from chronic kidney disease. It is estimated that the market size for renal disease will grow from $13 billion- $25 billion by 2026, representing a compound annual growth rate in the low double digits, driven by an aging population and increased prevalence of chronic kidney disease arising from risk factors such as diabetes and heart disease. CSL Vifor gives us the opportunity to build a significant renal franchise and become the partner of choice in this important and growing market. Chronic kidney disease is a complex and debilitating condition that affects millions of people around the world. People living with chronic kidney disease face a long and difficult journey associated with multiple and varying conditions and complications that severely impact their daily quality of life and life expectancy. Building a significant renal franchise involves supporting patients with chronic kidney disease and caring for them as they progress along their journey so that they can get the best possible treatment and maximize the quality of their lives. CSL Vifor has a strong presence in nephrology, and we are committed to growing the range of therapies to address the full spectrum of kidney disease, with a focus on non-dialysis, dialysis, and rare disease to improve the lives of patients. CSL also has existing products and products in both commercial development and clinical development, which complement and extend CSL Vifor's portfolio. My colleague, Bill Mezzanotte, will be talking to this later in his presentation. I am now pleased to hand over to Hervé Gisserot, who will take you through the CSL Vifor portfolio in more detail. Hervé. Thank you, Paul, and good morning, ladies and gentlemen. It's a great pleasure to be talking to you today. It has only been a short time since we joined the CSL family, but we have been very warmly welcomed. It's an exciting time for CSL Vifor to become part of the wider CSL group, and we are looking forward to working with our CSL colleagues to drive sustainable growth. As Paul Perreault said at the outset, one of the common values that we share is our focus on patients. Patients are the center of everything we do at CSL Vifor, and we are committed to supporting and improving the lives of patients in underserved therapeutic areas with significant unmet medical needs. As Paul McKenzie outlined, CSL Vifor has leadership positions in iron, dialysis, and nephrology. We have a very attractive portfolio with a combination of established products such as Injectafer, Ferinject in our iron franchise, recently launched products like Korsuva in dialysis and TAVNEOS in nephrology rare diseases, and a pipeline of exciting new prospects and opportunities across all three of our therapy areas, which Bill Mezzanotte will go into more detail later on. Starting with our iron franchise. Ferinject or Injectafer is our flagship iron product and is leading the high-dose IV iron therapy segment of the market. It was launched 15 years ago. For us, it's 15 years young for reasons I will explain in a minute, and has achieved global in-market sales on annual basis of over CHF 1 billion since 2019. As Paul McKenzie mentioned, there's a large prevalence of iron deficiency and iron deficiency anemia among the world's population. The majority of iron deficiency and iron deficiency anemia patients are yet to be diagnosed and treated, with only a small portion of eligible patients currently receiving intravenous iron, as exemplified on the graph for the EU5 countries. Of those that are treated, Ferinject has a market share of 50% of the high-dose intravenous iron segment and 29% market share of the overall iron market. More than 90 million patient years of experience has helped to establish Ferinject, Injectafer as trusted brands with clinical benefits demonstrated by its efficacy and safety data. Despite being 15 years on the market, we still see a tremendous opportunity to really grow our iron franchise, and I will talk about some of the ways we intend to do this on the next slide. Our key strategic priorities for the iron franchise to leverage the untapped potential are first to maximize the penetration of Ferinject ex U.S. We will do this by expanding the market further in Europe and our geographic footprints into markets such as China, where we expect NDA approval shortly, Japan, where we launched during the pandemic, and Canada, where a regulatory dossier will be filed by the end of the year. We will also continue a strong focus on patient blood management and look at the potential revenue synergies in this area with CSL Behring. Patient blood management or PBM is designed to improve surgical and medical patient outcomes by preserving patient's own blood and minimizing the requirement for blood transfusions in the surgical setting. One of the three pillars of PBM is detection and management of iron deficiency and iron deficiency anemia prior to surgery. It has been proven that implementing PBM, including IV iron therapy, leads to better clinical outcomes. Specifically, there is evidence showing clinical and health benefits of Ferinject when used in the perioperative setting. Today, PBM is already a significant contributor to worldwide Ferinject revenues in Europe and the rest of the world. However, there remains a significant unmet medical need acknowledged by the World Health Organization's call on ministries of health and policymakers to foster rapid PBM implementation. Several global leading medical societies also emphasize the importance of PBM in their updated clinical practice guidelines. We intend to improve PBM share voice in targeted hospitals through best-in-class scientific engagement and key account management capabilities. We also support various policy initiatives in that space. Second, and very importantly, we also want to maximize the penetration of Injectafer in the U.S. in close collaboration with our partner, American Regent, a Daiichi Sankyo company. A great opportunity to do so is the expected U.S. label change, including heart failure. Heart failure is already a significant driver of revenue for Ferinject in Europe in particular, but there also remains a significant increased commercial potential. Close to one in every two chronic heart failure patients has iron deficiency, with a significant number of heart failure patients either not diagnosed or inadequately treated for iron deficiency. Iron deficiency is a strong, independent, modifiable predictor of heart failure outcomes. A large body of evidence has demonstrated in heart failure patients that Ferinject treatment not only significantly improved function, reduced symptoms, and improved quality of life, but was also associated with reduced hospitalizations. The value of treating iron deficiency in heart failure patients was clearly recognized by guideline committees all over the world who implemented recommendations to screen patients regularly for iron deficiency and to consider treatment to improve their health status. The European Society of Cardiology's heart failure guidelines implemented the strongest recommendations in 2021, in that they even recommend considering ferric carboxymaltose to reduce the risk of heart failure hospitalization in patients who were recently hospitalized. In other words, the open guidelines recognize that the data has been collected for Ferinject, and hence, Ferinject remains the only IV iron specifically mentioned. In addition, it is clearly stated that oral iron is not recommended for patients with iron deficiency and heart failure in the ESC guidelines. This gives us significant opportunities to strengthen iron deficiency diagnosis and for increased treatment with IV iron. We want to drive the same patient success story in the U.S., supported by upcoming heart failure label updates. Currently, the approved label for Injectafer is specifically for the treatment of iron deficiency anemia. It does not allow for the promotion of iron deficiency without anemia. In the near term, following an sNDA submission by our U.S. partner, we aim for label updates, including the improvement in quality of life, exercise capacity, as well as reduction in hospitalizations in heart failure adult patients with reduced ejection fraction and iron deficiency with or without anemia. We anticipate an FDA decision in February 2023. If approved, this new indication will allow us to engage with heart failure specialists and highlight the important role of iron deficiency in heart failure and Injectafer as a valuable treatment option for their patients. Another key upcoming event is the completion and readout of an important phase III registration study led by American Regent, the HEART-FID trial. The primary objective of this morbidity and mortality study is to determine the efficacy and safety of iron repletion using IV ferric carboxymaltose relative to placebo in the treatment of heart failure adult patients with reduced ejection fraction and iron deficiency with or without anemia. The HEART-FID outcome study is expected to be completed in January 2023, with a readout in the first half of the same year. Should this study be successful, it will allow our partner to submit another sNDA, helping to raise awareness of the benefits of high-dose IV iron treatment in this patient population and improve patient access. Finally, we intend to explore other avenues for IV iron differentiation based on Ferinject specifics as a nanomedicine, which include advocacy and education on nanomedicines across all stakeholders. As you can see, we remain confident on the ability of CSL Vifor as part of the CSL family to drive growth in the iron franchise, even though the exclusivity expires in the next few years. Our IV iron products are defined by their consistent and firmly controlled manufacturing process based on decades of experience. With the enhanced reach of CSL's geographic footprint and market access, we are confident of the longer-term growth potential of these products. CSL Vifor's other leading franchises in dialysis and nephrology are competitively positioned and empowered by our partnership with Fresenius Medical Care in the form of a joint company, which is called Vifor Fresenius Medical Care Renal Pharma. CSL Vifor owns 65% of the stake in the joint company. This partnership was forged in 2010 and has achieved global leadership in the treatment of nephrology care. The joint company harnesses the combined expertise and know-how of CSL Vifor's strong pharmaceutical expertise with FMC's leading kidney care capabilities, even beyond dialysis. It's a unique business model that comes with a strong and loyal patient population. The joint company treats approximately 350,000 patients in FMC's global network of over 4,200 dialysis clinics and is the world's leading provider of products for people with chronic kidney failure. Notwithstanding the additional dialysis patients morbidity experienced during the COVID-19 pandemic, we are starting to see growth returning and remain confident in the long-term growth potential of the joint company. The unique combination is a natural funnel for high-quality assets, making CSL Vifor the partner of choice in nephrology. Through our close collaboration and the sharing of ideas on a global scale, through access to patient data as well as improved clinical trial design coming from real-world data which allows a faster clinical trial execution. Through the implementation of treatment algorithms based on medical evidence, which can accelerate changes in medical practices and improve patient outcomes, and through our commitment to bring more innovation to patients. Turning to the next slide, here you can see the products from our dialysis and nephrology franchises that are sold through the joint company. Noting that the joint company has rights for nephrology only for iron products globally. On the left-hand side of the slide is the percentage of sales for each therapy group that was generated via the joint company in full year 2022 for Vifor Pharma. For dialysis, it was 75%, nephrology 15%, and iron 20%. In total, the percentage of Vifor Pharma sales generated through the joint company in full year 2020 was about 40%. On the next slide, I would like to talk about an exciting product that we have launched this year in the dialysis market, which is Korsuva. Korsuva, which was developed by our partner Cara Therapeutics, is the first and only approved therapy for the treatment of moderate to severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. CKD-associated pruritus is an itching condition that impacts up to 40% of this patient population around the world. It is associated with poor quality of life, reduced social interactions, and depression. I've had the opportunity to listen to patients suffering from CKD-associated itching. Some said it's like having their body on fire. They feel like they are a human torch, that their itching is inside their body and cannot be reached. In other words, it makes their already very challenging quality of life as CKD patients even more miserable, with also an impact on the family caregivers. With Korsuva, we bring an approved solution to their condition for the first time. Korsuva was approved in the U.S. in 2021 and launched in April of this year. Korsuva was also granted separate funding with Transitional Drug Add-On Payment Adjustment, the so-called TDAPA, for a period of two years, which supports the timely patient access. We have a strong focus to delivering this innovative treatment to the patients in need and maximize its uptake. To this end, we have signed agreements to supply major dialysis players, including Fresenius Kidney Care and DaVita. We are also in the process of actively pursuing policy initiatives focused on improving the future access for Korsuva to secure long-term patients and CSL value for this innovative medicine. So far, we are hearing very encouraging patient testimonials of the clinical benefit of Korsuva. In Europe, Korsuva is marketed as Kapruvia and was approved in April 2022. Launches are underway in Europe, starting with Germany and Austria. We expect a few more countries to launch Kapruvia this year, with the majority of countries launching in 2023. Turning to nephrology, which is a large and expanding market, we are building out our capability, which gives us significant growth opportunity. Firstly, sparsentan. This is first-in-class treatment indicated for two major types of ANCA-associated vasculitis, or AAV. AAV is a rare systemic disease in which overactivation of the complement pathway activates neutrophils. Leading to inflammation and destruction of blood vessels. Many patients with AAV face an unbearable burden of problems brought on by the disease itself or the consequences of the disease. We are very confident that TAVNEOS will become part of the new standard of care, allowing patients to achieve remission while reducing exposure to glucocorticoids. This will support better outcomes for patients and a better quality of life by reducing the challenging side effects of glucocorticoids. We just launched TAVNEOS in Germany and Austria earlier this year, and more recently in Great Britain and Japan, with many more launches planned over the next 12 months-24 months, as you can see on the slide. Moving on to the next product, Veltassa. Veltassa is indicated for the treatment of hyperkalemia or elevated levels of potassium in the blood in chronic kidney disease and chronic heart failure patients. In patients with acute hyperkalemia, Veltassa can be used to manage potassium after emergency treatment for life-threatening hyperkalemia. Beyond the acute setting, Veltassa can be used to manage chronic hyperkalemia, permitting them to stay on optimal doses of life-saving RAAS medication. Performance in the U.S. has been challenging in a competitive market landscape. However, U.S. payer coverage is continuously improving, with nearly 70 million patients gained through new year payer contract, new payer contract since the beginning of the year. In addition, we have secured an agreement with Humana recently. Veltassa will be the only product on the Humana formularies starting January 2023. We are confident on future growth, driven by better access to new patients in the U.S. In addition, we are planning to launch Veltassa in France in 2023. France is a promising market for hyperkalemia treatment, as it represents 25% of global potassium binder use. The third product on this slide is sparsentan, which is in phase III development for the treatment of IgA nephropathy or IgAN and focal segmental glomerulosclerosis, FSGS, two rare kidney disorders where no effective or approved therapy exists. While our partner, Travere, has just announced that they expect a three-month extension of their PDUFA target action date for IgAN following interaction with the U.S. FDA, our confidence in this product remains unchanged. If approved in the two indications, we will be targeting European launches in 2024. In summary, at CSL Vifor, we are very, very excited about the future sales growth potential in our portfolio. We expect greater than 10% revenue growth for CSL Vifor into the medium term. The key drivers of this growth are in iron. If approved, the new heart failure indication for Injectafer in the U.S., which is expected to boost sales from 2023. We will look to maximize the full potential of Ferinject in Europe and the rest of the world, leveraging the capabilities and the geographic footprints of the broader CSL group. For dialysis, we believe Korsuva will be a key driver of growth, and we'll be focusing on the commercial uptake in both the U.S. and Europe. For erythropoiesis-stimulating agents or ESA products, we expect increasing U.S. share following a recent agreement signed with DaVita, which will be effective by year-end. We also expect a normalization in the mortality rate of dialysis patients that we have seen in recent times due to COVID-19. Last but not least, for nephrology, we expect Veltassa growth to accelerate, driven by better access in the U.S. market and the upcoming launch in France. For TAVNEOS, we expect a solid uptake as we launch in multiple countries over the coming 12 months-24 months before bringing sparsentan, our second rare disease medicine, to patients. I am confident the commercial opportunities we see will be greater now that we are part of the CSL family, and I'm excited to be leading this business. I would like now to hand over to Bill Mezzanotte. Thank you, Hervé, and may I offer you a public welcome to CSL. I'm looking forward to working closely with you to maximize the value of CSL Vifor, just as I do with Steve Marlow of CSL Seqirus and Bill Campbell of CSL Behring. In the next two slides, I would like to take a portfolio perspective of the ideas previously presented by Paul McKenzie and Hervé. I also want to expand on Paul Perreault's earlier comments about blending the capabilities, experience, focus, and opportunities across the legacy organizations to build an even stronger CSL portfolio. While I will touch on these points as well as some of the products today, I invite all of you to join me in early November for our annual R&D day, where the R&D team will have an opportunity to delve more deeply into many of these assets. Next slide. Hervé presented this slide earlier and touched on many of the end market products supporting CSL Vifor's three target therapy areas. I'd like to add some color regarding CSL Vifor's pipeline, as well as how CSL Behring's interest and capabilities dovetail into these areas. Let me start with the iron axis. As Hervé mentioned, a large body of evidence has been generated in patients with heart failure, showing that Ferinject treatment not only reduces symptoms and improves quality of life, but is also associated with reduced hospitalization. These data have led the European Society of Cardiology's heart failure guidelines to recommend considering ferric carboxymaltose to reduce the risk of recurrent hospitalizations for heart failure. However, more and more health authorities and payers are looking for clinical outcome studies to prove benefit. The ongoing heart failure with iron deficiency trial, or HEART-FID trial, is an important additional outcome study that aims to further cement the clinical benefit that patients with heart failure and iron deficiency derive from Ferinject. Data readout from this important trial are due in the first half of 2023, with a filing in the U.S. and other parts of the world to follow. Beyond this exciting trial, we plan to bring the full capabilities of CSL to help accelerate or maximize the other opportunities in iron that Hervé has described. In the middle of this slide, patients who are dialysis-dependent. Let me make two key points. First, these patients have a five-year survival of only about 50%, which is substantially worse than many cancers. For me, no statement more aptly explains why the acquisition of Vifor blends so nicely into our core purpose to improve the lives of patients with rare and serious diseases. One of the major causes of morbidity and mortality in dialysis-dependent patients are cardiovascular complications. Very soon, CSL will be initiating a phase II trial looking to reduce major adverse cardiovascular events, or MACE, in dialysis-dependent patients utilizing our anti-IL-6 compound clazakizumab. Importantly, we plan to employ a number of dialysis centers in the Fresenius network in the execution of this clinical trial. A rare cause of morbidity and mortality in dialysis-dependent patients is a condition called calciphylaxis, where small blood vessels throughout the skin and fat are seeded with calcium, leading to excruciating pain, diffuse non-healing skin ulcers, and septic complications. This rare condition is associated with an approximate 50% one-year mortality. SNF 472 blocks hydroxyapatite crystals, blocking this systemic calcification. Phase II data were very positive, and we expect phase III data in the early part of 2023. In the nephrology axis, Hervé has already mentioned the dual endothelin and angiotensin II antagonist sparsentan for IgA nephropathy and FSGS that we are very excited about. INS-3001 is a subcutaneous calcification inhibitor, similar to SNF 472, but can be used in patients with CKD not on dialysis. In addition, CSL Behring has ongoing programs using CSL 346 to slow the progression of diabetic kidney disease. We are also exploring the safety and efficacy of clazakizumab to prevent antibody-mediated rejections in patients who have received a kidney transplantation. Next slide. Paul McKenzie showed this slide depicting the journey patients with kidney disease might undergo. Now I add the in-market and pipeline therapies that the CSL enterprise has to help practitioners manage the complications and improve the outcomes in these patients. Focusing on the pipeline, the combined CSL portfolio already targets some of the morbidities and opportunities present along this disease continuum. Those assets outlined in blue are products from CSL Vifor, while those outlined in red are CSL Behring assets. Starting with prevention or slowing of kidney damage, we have sparsentan in phase III, CSL 346 completing phase II, and a number of earlier stage immunology products with the benefit of combating diseases that also impact the kidney. In the chronic kidney disease space, I already mentioned INS-3001 that is currently in phase I. We in CSL, and myself in particular, have spoken many times over the past few years about our 18,000+ patient phase III study evaluating the efficacy of CSL 112 in patients who have recently suffered a heart attack. That study is progressing well, but what may not be well appreciated is that approximately 25% of the patients enrolled in that study have evidence of chronic kidney disease. For dialysis patients, SNF 472 for calcification is completing phase III, and we anticipate results early in 2023. The study of CSL 300, clazakizumab, in patients on dialysis, as I mentioned, is starting phase II. Finally, CSL 300 is also being evaluated in phase III for the treatment of antibody-mediated rejection in patients who have received a kidney transplantation. This is a great start, but only a start. We look forward to future opportunities where we either discover ourselves or leverage through partnerships, new therapies. This will include utilizing the expertise of Fresenius Medical Care, all in the service of expanding treatment opportunities for patients suffering with renal disease, diseases that affect the kidney, and for patients who have the hope of cure through renal transplantation. Now it's my pleasure to turn the mic over to Joy Linton. Joy. Thank you, Bill, and good morning, everyone. Now we come to the financials. Since our results presentation in mid-August, having just completed the acquisition of Vifor Pharma, we've made a great deal of progress with our purchase price accounting activities. This work is required by the business combinations accounting standard AASB 3, and seeks to assign a fair value to all of the assets and liabilities of the acquired entity. The primary focus of the work over the past two months has been on fair valuing items that may impact FY 2023 net profit after tax. The work is subject to audit and finalization over the course of this financial year. There remains some work to be done, such as liabilities and the determination and allocation of goodwill, and we're working to have this completed by our first half results announcement in February. Today, we can share with you our view on the combined group outlook for FY 2023. Firstly, however, I would like to take you through how we will be reporting our group results, including those of CSL Vifor going forward. Turning to slide 22. Our new segment reporting reflects the way the chief executive officer, who's also the chief operating decision-maker, monitors and assesses business performance in order to make decisions about resource allocation in accordance with the accounting standards, specifically AASB 8. This new segment note, restated for the years ending 30 June 2021 and 30 June 2022, is included as an appendix to this presentation for your information. We have rebranded our business divisions into CSL Behring, CSL Seqirus, and CSL Vifor. The segment operating results shows gross profit, less sales and marketing expenses as managed by the business unit. We have also centralized the management and reporting of research and development, reflecting the portfolio approach we are now taking to our R&D investments. General and admin costs following the work over the past few years to bring together our enabling functions in a single global structure. R&D and G&A expenses are therefore no longer allocated to individual segments. A new line has been introduced, NPAT A, which is the statutory net profit after tax before impairment and amortization of acquired intellectual property, as well as one-off business acquisition and integration costs and other acquisition accounting-related adjustments. The segment note also shows the statutory NPAT and NPAT A attributable to CSL equity holders and that attributable to the non-controlling interest. As you know, part of CSL Vifor's business includes the majority-owned joint company, Vifor Fresenius Medical Care Renal Pharma. CSL Vifor controls the joint company, 100% of the result is consolidated into the financials. The earnings are then attributed according to the ownership structure of the joint company's earnings. 55% in favor of CSL Vifor and 45% in favor of the non-controlling interest. Both earnings per share by NPAT and NPAT A are provided in this manner. Going forward, we intend to use NPAT A attributable to CSL shareholders to provide financial guidance for the CSL group. We believe that adjusting for the amortization of acquired intellectual property is a better measure of the underlying growth of the company. Finally, you will notice the absence of Vifor financials in the segment note. Given the deal did not close until the ninth of August this year, they will not appear in the historical numbers when we first report in this format at the interim results announcement in February next year. However, I do recognize investors may want to model CSL with the inclusion of Vifor numbers realigned to the CSL financial year-end. To that end, I've provided the key historical Vifor numbers separately, which we'll discuss on the next slide. On slide 23, we see the key CSL Vifor historical pro forma unaudited financial realigned to CSL's financial year-end, including the three main revenue segments of iron, dialysis, and nephrology, followed by gross profit, sales marketing, and the segment results, all in our new reporting format. The split of revenue by region is quite similar to that of the CSL group, with 53% of revenue derived in the US and 34% in the UK and Europe. I'd like to take a few moments to walk you through the P&L items between CSL Vifor's segment results and CSL Vifor's net profit after tax. Going forward, of course, we will only be reporting CSL Vifor to the segment result line, but I felt it was important that investors have a clear understanding of the reconciling items between the two numbers. For fiscal 2023, investors should consider: firstly, we have revenue and earnings for 11 months rather than a full year. Just like to reiterate that point. This is 11 months, not the full year. We then take amortization of acquired intellectual property. As you know, CSL expenses R&D as it's incurred, but when IP is acquired, as it is in this case, we simply expense the cost of this intangible asset over the projected life of the asset. Both commercial and pipeline IP have been assessed, and we have determined that all of the assets of CSL Vifor have a finite life ranging from 10 years-40 years. Indicatively, in FY 2023, this is expected to be around AUD 140 million-AUD 170 million post-tax. In terms of R&D, group guidance remains unchanged at 10%-11% of revenue, noting that between the segments, this may vary year-to-year depending on the programs underway. For G&A, CSL Vifor's spend on G&A is comparable to the broader group at about 7%-8% of revenue. Lastly, CSL Vifor's effective tax for FY 2023 is expected to be circa 15%. This brings us to net profit after tax. Adjusting for the 45% attributable to the non-controlling interest, the FY 2023 net profit after tax for CSL Vifor is expected to be approximately AUD 300 million-AUD 330 million for the eleven months. This is represented on the next slide 24. Starting at the top, our previous guidance for the company, that is CSL Behring and CSL Seqirus, was for a net profit after tax of AUD 2.4 billion-AUD 2.5 billion at constant currency for FY 2023. This component of the guidance remains unchanged. Who knows what will happen to exchange rates, but I do note that if the FX rates as at the end of September held for the balance of the financial year, all else being equal, we would have a circa AUD 200 million headwind at NPAT, primarily reflecting the non-US dollar denominated revenue in our CSL Behring business. The next line being our expectation for CSL Vifor of between AUD 300 million-330 million for the 11 months as discussed on the previous slide, from which we then deduct the net incremental cost of debt attributable to the acquisition. In broad terms, this debt is made up of $4 billion raised earlier in the year through the 144A process in the US at an average rate of 4.14%. An additional 2.5 billion of bank loans was drawn down on completion of the acquisition, currently at a floating rate of circa 4%, up from about 2.5% assumed when we first announced the acquisition. Now with the focus on NPAT A, we then adjust for the amortization of acquired intellectual property. This brings us to an NPAT A outlook for FY 2023 of approximately AUD 2.7 billion-AUD 2.8 billion, representing a growth on FY 2022 NPAT A of between 13% and 18%. I note the above guidance excludes the one-off acquisition costs related to the non-cash revaluation of acquired inventory, as well as the one-off transaction and integration costs, which remain consistent with our prior expectations of about AUD 200 million in total. I'm also pleased to reaffirm commentary we made almost a year ago when we first announced our intention to acquire Vifor Pharma. We remain on track to deliver circa $75 million of cost synergies over three years. We also foreshadowed a low to mid-teens NPAT A per share accretion in the first full year of CSL ownership, including the full run rate of cost synergies. Notwithstanding the recent increase in the cost of debt, we expect this statement to be true for FY 2023. With that, I'll now hand back to Paul Perreault for some concluding comments. Well, thank you, Joy. Boy, that was pretty comprehensive over the last hour or so, I have to say. Let me just make a few comments to try to bring back some of the key items. Before I get to the key value catalyst on this slide, just a couple of other comments that I'd like to make. I talked about the fact that, you know, it's hard to find a business that's perfect if you're doing an acquisition. I have to say, I think Vifor Pharma is the perfect fit for CSL. When we take a look at the various areas of the company that you've just heard about, it fits really nicely with the strategy that we've put into place. You know, I think there are enormous opportunities to really grow the iron franchise, as you heard from Hervé, to drive new indications, expand into new geographies, and improve access. He talked about heart failure, which is a significant opportunity for the iron business. On the commercial front, you know, CSL Vifor is only in about 20 countries, and they haven't launched every product in 20 countries, just like CSL Behring is in 102 countries, and we don't have all products there. There's plenty of room for growth and expansion to service patients in many countries around the globe. I talked about the fact that, you know, that everybody wants to hang on the loss of exclusivity and, you know, we will be involved in this therapy for a long time to come. You know, I thought plasma manufacturing was hard, and people ask me, "Well, how does this fit with kind of the plasma business?" Clearly, operationally, there's a lot of complexity to what Vifor Pharma does. Iron is actually harder. When I say hard, it's hard as a rock. Many of you know iron ore in this country, and it does start with iron ore when we manufacture iron. I've been to St. Gallen. It is a very difficult process starting with iron ore and powder, cranes that take the iron powder, put it in, and you start with purification and hydrochloric acid. It's not that other people can't make it, but it is complicated. As Hervé pointed out, this nanomedicine, this unique mixture of the different areas of iron that are controlled in Ferinject and Injectafer are just unbelievable. We feel we have some really great opportunities to look at this complex compound and continue to sell iron for many years to come, across the globe. You know, I think today, certainly, iron is today's jewel in the crown. For tomorrow, we're adding a new jewel, and that's really in nephrology. That's tomorrow's jewel that will be added onto, you know, the crown jewels of the company. The sheer incidence of the disease and the opportunities available are huge, really big opportunities for us to have an impact in a positive way on patients. You know, nephrology encompasses a whole range of diseases and therapies needed to treat them. I think both Hervé and Dr. Bill talked about that during their presentations. The fact that a patient doesn't typically start with dialysis, there's a progression of disease. 15%, I think Paul had on his slide, of the U.S. population, and I'm talking about the older population. If you take the 40 years and older population in the U.S., you're talking about a potential market need of almost 25 million people in the U.S. alone. There's a lot to do and a lot to like about the durability of this business in terms of where we can help patients. All in all, I'd say that, you know, the dialysis space is interesting. Not many pharmaceuticals or companies are in this space. The joint company that we have with FMC gives us that access to the nephrologists, the patients, which is really a critical element when you're developing products. That's just a few general comments to kind of wrap up some of the key items. Let me talk about some of these key value catalysts that we have in the business. In the near term, we expect that Injectafer change in label to reflect that heart failure to come. We have a program of launches in dialysis and nephrology that includes Korsuva and Kapruvia, TAVNEOS and sparsentan, and the phase III readout of SNF472 in CUA. In the midterm, we have another readout of our expected SNF472, this time for peripheral arterial disease in end-stage kidney disease patients, and we will maximize Ferinject ex-US. We're really looking forward to the FDA decision on Injectafer in the US for heart failure based on the HEART-FID trial outcome. We will be leveraging our relationships with the joint company to accelerate changes in medical practice. Over the long term, we'll be focused on leveraging both the joint company and the CSL relationships to bring innovative products into the pipeline. Overlaid on these catalysts are the strengths that CSL bring to CSL Vifor, our scale, our focus, and the discipline that we bring, not only every day to the company, but especially when we do an acquisition. In the near term, business continuity remains our top priority. As we work through the integration process, we will focus on implementing our cost synergies, which we're on track for and that we flagged when we announced the acquisition. Remember, this isn't a synergy deal, actually. I mean, you know, $75 million in synergies over three years is not what you would expect most pharma companies to be talking about when they do a $12 billion acquisition. This is about the future focus of the company that we're really excited about. We will get those synergies, and we are on track. We will also be focused on leveraging CSL's extensive distribution network to launch CSL Vifor products into new geographies and indications, as well as expand CSL Vifor's commercial opportunities over the near to midterm. Over the longer term, a key strategic priority will be to maximize the value of the existing partnerships, such as the joint company with Fresenius Medical Care, and leveraging CSL's R&D capabilities to continue to deliver innovative medicines to meet patients' needs. On the last slide, let me just finish by reiterating what I said at the beginning. CSL Vifor accelerates our strategy to create value, deepens our patient focus, and the ability to protect the health of patients through an expanded portfolio of medicines and a broader pipeline. Today, CSL Vifor has leadership positions in iron, dialysis, nephrology, and we see tremendous opportunity to maximize the value of these franchises and drive profitable, sustainable growth, and we expect to deliver greater than 10% revenue growth over the midterm. Finally, for CSL Group guidance for fiscal year 2023, including CSL Vifor, we expect revenue growth to be in the range of 28%-30% at constant currency, with NPAT A expected to be approximately in the range of AUD 2.7 billion-AUD 2.8 billion at constant currency, and as Joy said, is a growth of between 13%-18%. With this change to NPAT A, we will also be aligning management incentives with NPAT A going forward. Lastly, CSL Vifor is expected to provide low to mid-teens NPAT A per share accretion in fiscal year 2023 and into the midterm. With that, I thank you for your interest and your attention, and we'll be happy now to take some questions. Mark? Terrific. Thank you, Paul. Ladies and gents, as we move to questions, I just remind you, take two questions and then, feel welcome to rejoin the queue. Our first question comes from Andrew Goodsall at MST Marquee. Go ahead, Andrew. Oh, thanks very much. Terrific briefing. Thank you. You did talk to the 10% top line, but you haven't talked to margin, and I know previous Vifor management had a long-term margin expansion target of greater than 1,500 basis points. Just wondering if you could talk to where you think margins can go? Thanks, Andrew, for your question. When we talk margins going forward, we will be talking at the segment level for CSL Vifor. Clearly, the margins on the Ferinject product, you know, being the owned product, are fairly strong. I hope you've heard today that we see good growth in that business. We would expect some margin expansion from that. I think we're a little bit thoughtful just to see how each of the various, you know, products play out over time. You know, we're not gonna come out and predict a big margin expansion over time, but that's certainly the general direction. Okay. A follow-up could be for Paul McKenzie, just talking about the doubling of the renal disease opportunity. Just wondering how you reconcile that with the medical capacity, whether there's actually the capacity to expand that aggressively. I appreciate that some of that growth is gonna be outside of the dialysis setting. Just gonna leave that one with you, if you could talk to it. Great. Thanks, Andrew, for the question, and I'll also ask Hervé to weigh in. As you said, there is definitely space in that market for growth. As you said, there will be both additions in the dialysis space as well as in other avenues of healthcare for the patients to be satisfied. I'd ask Hervé to add a few comments in any particular markets that he'd wanna highlight. Yes, we. Sorry, can you repeat, Hervé, I missed a bit the question. I missed the beginning of the question. Looking for the opportunity of the marketplace for this increase and the need for dialysis and iron and the treatment in the nephrology area, both in dialysis and outside of dialysis. We obviously see with the aging population and you know, lifestyle issues like diabetes or heart failure, a growing need you know to support CKD patients along the journey. It will indeed in the end translate into more patients receiving dialysis after the slight dip we have experienced through COVID. We expect the number of dialysis patients to return to normal and gradually start you know growing again, let's say low single digit in the years to come. We believe that in the US, but also across the rest of the world, we can leverage really our joint company to really best support this pool of patients, make sure they get best care and receive, you know, the innovative medicines CSL Vifor has in the current portfolio or plan to brings going forward. In addition to maximizing iron, we really believe that this renal/dialysis franchise will be a major growth engine for us in the many years to come. I think, Andrew, the capacity to treat these patients is certainly there. I think there's plenty of opportunity for the healthcare system to absorb. By the way, there's a lot of innovation looked at in this space. Even FMC and others, they're looking at home dialysis treatments. Yeah. Looking at, you know, ways to get better access to dialysis for patients outside of the dialysis centers themselves. That new way of caring for patients is something that certainly those that are in the dialysis space right now are looking at how can they participate and help to optimize in the area. Because everybody's looking to move out of some of these centers and try to do it more conveniently, but also more individually. Bill, I don't know if you have any comments on the treatment, because I think what Andrew was asking is the capacity to treat the new growth in this area. Yeah. I would just say, you know, no nephrologist only focuses on dialysis. They look both ways, either earlier to prevent kidney disease or manage CKD or later to take care of patients who've had transplantation. I think there's plenty of capacity. What we don't have is enough good medicines. Got it. That makes sense. Thank you. Comes from Sean Laaman at Morgan Stanley. Go ahead, Sean. Thank you, Mark, and good morning, Paul and team. Thanks for your time today. I'd like to ask about Veltassa and you know, its performance. You know, clearly over the last few years, or at least the last little while, you know, Lokelma's been doing better, but research suggests there could be quite a competitive advantage when you're talking to cardiologists with Veltassa in your pocket. Insofar as it you know, sucks up the potassium ion and spits out calcium versus Lokelma doing sodium. I'm wondering if that is a meaningful advantage. As you create more into the cardiology space as opposed to talking to nephrologists, that's one area where you could drive market share. Is that gonna be synergistic with revenues, particularly if you get Injectafer approved in heart failure? Thanks, this question is very close to my heart since I joined Vifor earlier in the year. I really looked at Veltassa in the U.S. in particular where, to be completely transparent, the performance has not been completely in line with our expectations in recent years. After really understanding the root cause, we have really implemented a corrective action plan, and we have made excellent progress since the beginning of the year. In particular, in terms of gaining more access both commercial lives and Medicare in the U.S. We were able to gain 70 million additional lives. As I said during my remarks, we just signed an agreement with Humana, which will give us really exclusive position on their formulary from January 2023 onwards. It will be all about pulling through now, leveraging really the competitive profile of Veltassa versus Lokelma. We have very strong data, as you said, based on the DIAMOND study, suggesting that for chronic use, Veltassa is extremely well positioned to ensure that patients receive optimal RAASi-enabling treatment. Veltassa is also sodium free, which is clearly another competitive advantage. After unlocking access, we are focusing now on really the commercial fundamentals, the quality of our scientific engagement, to make sure that we accelerate the growth of Veltassa, which is really very significant. I really believe that CSL brings with this cardiorenal portfolio, really also a fantastic opportunity going forward. We can really synergize in that regard. That's for the U.S. Ex-U.S., we have been quite successful in many European markets, where we continue this head-to-head competition with Lokelma. There are also many more established products still being widely used, representing a potential for further growth. We are launching in France, one of the largest potassium binder market in the world. We are in phase III in Japan with an expected launch in the 2025 timeframe. I think the Veltassa has a bright future with a lot of potential for further growth, and it will certainly be at the heart of our strategy in this cardiorenal space. Maybe I'll just add a couple of things, Hervé, to your answer. It's an excellent mechanistic question that I think deserves a little bit more of a scientific story. We'll be interrogating the DIAMOND results to look for things, but it also begs for real-world evidence kind of approach. We may need a little more time to get those approaches and the type of evidence that you're suggesting mechanistically. We'll look. Great. Thank you. I have one more follow-up just on the reported results to date. The iron franchise has grown really strongly in fiscal 2022 and hasn't followed the trend we've observed in dialysis, which was expected according to our primary research. Is this suggesting that the iron franchise is growing out of the dialysis space and you're seeing better uptake in areas such as patient blood management? I mean, we see many opportunities to maximize the iron franchise going forward. If we talk specifically about Injectafer, Ferinject, the main focus because, you know, there are so many opportunities that we have to be extremely focused and disciplined in the way we try to look at this entire potential. The top priority is patient blood management, heart failure, where we want to continue to maximize this opportunity in Europe. We want to launch heart failure in the U.S. early 2023. Geographic expansion is a critical priority, especially in China, where we expect the approval at some point in time very soon now, probably in the coming days or weeks. We are in close conversation with our colleagues from CSL Behring to see what we can do together, especially in countries like China or to support indications like patient blood management. There are many other opportunities like women's health, including the fatigue segment, which could represent a fantastic driver of growth, especially in emerging markets in the many years to come. We really believe, as Paul said, that we can continue to grow this iron franchise with Ferinject Injectafer at the heart of it for the many years to come. Even if we face follow-on competition at some point, we really believe that the market potential is so high that we can continue to deliver growth. If you talk about the patient blood management section, you know, we're kind of used to trying to convince skeptical or critical health authorities, payers, and governments of the value of our medications. Here, blood transfusion is not necessarily a benign occurrence. We're actually working with the tailwind there of what governments and the health authorities would like to see. I think when we generate the data, there'll be a very receptive audience to what the data we do generate. Good. Thanks, Sean. Next question comes from Chris Cooper at Goldman Sachs. Go ahead, Chris. Thanks, Mark. Hi, everyone. Just maybe a follow-up to one of Sean's questions there. The sort of segmental disclosure on slide 23, so it's when we look at the different franchises. Now, clearly 2021 and 2022 are not gonna be representative years on any level, but the only one that sort of got close to the overall sort of divisional sales guidance of 10%+ was iron. Can I just confirm, is it the expectation that the dialysis, nephrology and the other segment, they move towards or above that 10% level over the medium term? Is it that the sort of positivity you have around the additional upside of the iron franchise, it's gonna be that does the heavy lifting, and the other segments are gonna be perhaps tracking below that 10% level? Can you just clarify that? Thanks, Chris, for your question. Now we see this 10%+ growth across all three of the therapy areas. You've got to remember Korsuva is a new product. In 2022 we're seeing some nice growth from Korsuva which wasn't there previously. Yeah, no, we're across all three areas, we see that sort of growth. Okay. Thank you. Just if I sort of think back to December when you first announced the deal, you had the slide there with the pre-commercial opportunities which, you know, many of which you talked about today, of course, but I just wanted to get a sort of update. First of all, I mean, vadadustat, no mention about it at all today. Can I just confirm that that is now, that that's no longer gonna be moving forward after the CRL you received in February? Or do you need to wait and see what happens with the Glaxo drug before you make a final decision there? Just on Korsuva and TAVNEOS, it sounds like everything's in line with expectations. Are you in a position to sort of reconfirm the sales targets that Vifor themselves have put out for those two drugs? Yeah. Let me touch on vadadustat, and then I'll turn it over to Hervé for TAVNEOS and Korsuva sales. Right now we're awaiting some further response from Akebia, and we haven't written it off completely yet. Obviously GSK has another product in that area, and we're watching with interest their approach. The data in the dialysis segment was even stronger for vadadustat than it was in the non-dialysis space, so there may still be a path forward for that product, but we have to wait and see a little bit. Maybe commenting on TAVNEOS and Korsuva. For TAVNEOS, we are off to a great start in the countries where we have launched, Germany and Japan in particular, in Japan with our partner, Kissei. In fact, if you look at our performance per million inhabitants, we are tracking ahead of the TAVNEOS launch in the U.S. from ChemoCentryx. That's very encouraging and we have a very large wave of launch countries down the line as I highlighted in my remarks. TAVNEOS really addressed an unmet medical need and the initial trajectory is very promising in that regard. Korsuva is, I'm very passionate about Korsuva. I really believe that we can change the life of CKD patients on hemodialysis with this product because itching really makes their life absolutely miserable. The dynamic of this market segment is very interesting, in particular in the U.S., in the sense that it's not the traditional pharma market where you promote and then you see a relatively linear ramp up here. You know, you have to partner very closely with the providers, and many things are also driven top-down based on medical and financial considerations. That's what makes our partnership with Fresenius Medical Care so powerful because we have the ability together to gather real world evidence on an ongoing basis, adjust algorithms and make sure we can drive the change in medical practices. The problem with CKD-associated pruritus is that there was no treatment, and as a consequence, there was underdiagnosis and under treatment. Now we have this major task of convincing doctors and nurses to systematically screen and make sure that the appropriate patients, probably about 35% of the total pool of patients, get Korsuva for their severe to moderate itching. We see now for a few weeks a major acceleration of the Korsuva ramp up in the US. We believe it will have. It's primarily in the Fresenius clinic, but also across other providers. We believe that it will have a very positive halo effect and we will see this acceleration. In parallel, we have just launched in Germany. Where the initial feedback, qualitative, at this point in time because the product was launched early October, is extremely encouraging in line with the patient testimonials we have received from the US. This is a major growth driver, because we do address a very clear unmet medical need with Korsuva and Kapruvia. Good. Thanks, Chris. Next question comes from Lyanne Harrison at Bank of America. Go ahead, Lyanne. Yeah. Good morning, all. I might start with bigger picture and talk about or ask about the in-licensing arrangements. Obviously a few therapies there under that sort of arrangement. Can you talk about what CSL Vifor strategy under CSL ownership with respect to in-licensing in the longer term, and can we expect Vifor to move away more heavily and develop a fuller portfolio in-house using R&D capabilities from CSL? Thanks, Lyanne. Thanks for the question. Look, as I said, you know, CSL Vifor has in the past, when it was Vifor Pharma, done a lot of licensing and acquisitions to try to build a portfolio of business. As usual, what I wanna do is focus. I want to make sure that the strategy is a focus strategy, that we understand deeply all of the relationships, the arrangements that are in place, and that we optimize what we can in all of those and add value. Because I think there is value we can add with the CSL portfolio, with the joint company, with Fresenius, as well as, you know, some of the other relationships that we have, the development line that Dr. Bill talked about. You know, we have opportunities here to really change some of the R&D focus that we see in the portfolio, working with partners and separately with our own assets that we have currently in the CSL portfolio to bring to the CSL Vifor group. We've done the same, by the way, with, you know, other things, right? When you think about the work that we did to manufacture the AstraZeneca vaccine for COVID here in Australia, we utilized CSL resources, CSL Behring resources with CSL Seqirus to actually utilize the best knowledge that we had in cell culture development and cell-based therapies to actually get that product, you know, delivered to the Australian and South Asian population. There's been this idea here that we've been moving to, which Bill has done this year, which we combined the whole portfolio from an R&D perspective underneath Bill, so that he and I both have visibility over the assets of CSL. It's the enterprise that really will drive our future. Being part of that enterprise-wide strategy, we won't be running it as a separate company per se. It's a division of the business for sure, that's focused in a completely unique area, especially the iron and nephrology space, but it's all part of the CSL family, and that really is part of how we're going to approach the opportunities. Will we do more licensing? Probably. It has to be the right thing as usual for CSL. It's not a take-all-comer strategy. We will evaluate where it fits into that continuum of care for patients that are undergoing CKD, so chronic kidney disease, and where in that life cycle we can impact, hopefully, and slow down or prevent some of the diseases that could occur later. We'll be open to opportunities as we always are, because there's always. You know, we don't have our head in the sand. By the same token, you won't see us wavering from our strategy too much. It is, as I mentioned at the very beginning, about competencies, capabilities and adjacencies to what we do. You know, we try not to get entertained with things outside of that. I wouldn't say we'll be on the same cadence and metrics that Vifor Pharma had, which, you know, they had a cadence and some metrics around the number of deals each year they were trying to get done. That's not how we run the business here. It doesn't mean we won't do something else, you know, as time moves through. Okay. Thank you. Just one other question. Again, a bigger picture question. CSL Behring and CSL Seqirus have been, you know, very successful at growing fast to the market. Can we expect, you know, similar for CSL Vifor, particularly in the nephrology market? I know that, you know, broadly you're talking about greater than 10% over the medium term. Obviously a great opportunity there in nephrology. Look, I think so, Lyanne. When I look at our portfolio and what we have, we are the company that's really has the broadest portfolio within that space. There aren't a lot of players in this space which, you know, it's been a bit unloved and underserved, and that's one of the things I loved about the business because we like areas that people don't find as attractive. You know, when you're in a big market like oncology or immuno-oncology, you know, there's a lot of rabbits, but there's a lot of hunters, right? You know, we just have to make sure that we're in the right spot at the right time here, and I think we're exactly there. As I said, this is the commercialization of this, of the Vifor Pharma strategy underneath CSL's focus and determination to make sure that we deliver for shareholders like we've done in our previous acquisitions. That's what we're here to do. Faster than the market, music to my ears because that's what we try to do. We try to be the leaders in anything that we do, and we've been fairly successful, but we can't, you know, just sit on that. You all will have to watch us and hopefully you'll see the same thing you've seen in the other acquisitions that we've done. Thank you very much. Good. Thanks, Lyanne. Next question comes from David Stanton at Jefferies. Go ahead, Dave. Good morning, team, and thanks very much for taking my questions. I guess, to follow up on a previous question, you know, you've got these new products that you've outlined today. Would it be fair to say that those new products are higher percentage margin compared to base business products? Or should we expect sort of percentage margin increase in CSL Vifor as those new products come to prominence, please? Yeah, that's correct, David. Yep, good assumption. Okay. Thank you very much. Despite the fact that it might cause some aggravation, I am gonna ask about the potential new generic entrants for Injectafer. I've never really understood. I understand that they're coming in FY 2027, but we see lots of different models of authorized generics. Could you give us some color as to what authorized generics or genericization of this market might mean for CSL? I mean, are you working with the new players or are you just agreeing not to disagree anymore? Thanks, David. That. Aggravation? What do you mean aggravation? No aggravation here. Look, I think, as I said, these are not products to be manufactured for the faint of heart, so that's fine. It doesn't mean that they can't make them, but they'd have to make sure that the components and the actual inner workings of the product are right there, and that's what Hervé was referring to with nanomedicines. You know, there's a complexity of the way this molecule is put together that is really difficult to duplicate. So yeah, I mean, some of these other generics, we're not moving quickly to talk about four years from now or three or four years from now, but I'm sure discussions will continue to be had. Think about, you know, there's different curves in terms of how people look at LOEs, and this is not a small molecule LOE, where you see a, you know, a big cliff and a drop off because this is a complex market. We're gonna continue, first of all, to expand this business and maximize the iron business in the next few years. We'll be starting from a higher base. Think of it more in a harder biosimilar erosion curve than a small molecule curve. There's a long tail to this franchise. This goes out many, you know, decades actually, I think, in terms of our ability to continue to gain value, launch in new markets, expand the indications, patient blood management, heart failure as was mentioned. There's a lot to do here, and people that have been suffering from diseases of anemia or fatigue as Hervé pointed out. Look, we're very, very bullish on this market. We think it's here for quite a while. We're not immune nor are we ignoring, you know, those that may wanna come into this market, and we'll deal with that as time gets a bit closer. Right now I'd say we're all understanding where we are. Thanks, David. Next question comes from Gretel Janu at Credit Suisse. Go ahead, Gretel. Thanks, Mark, and good morning all. Just wanted to go back to the anemia franchise and vadadustat. I do understand there's an element of wait and see here, but how do you see the risk to Mircera if the FDA was to give a positive opinion on GSK's daprodustat here? With vadadustat, we are obviously working very closely with our partner, Akebia. I cannot comment more. Specifically, there is an ongoing discussion with the FDA. At the same time, considering the importance of HIF-PHIs, if HIF-PHIs reaches the market for our portfolio, we keep monitoring the market, we keep monitoring the situation. We do believe, however, that near term, mid term, we still have a bright future with our ESA portfolio. As I mentioned during my remarks, we were able to sign this agreement with DaVita, so we expect our ESA business to grow significantly in the coming months and years based on this new agreement. As you know, DaVita has roughly a 36%-37% market share of the dialysis market segment in the U.S. It's a very significant step change or step forward for ESA business. We keep focusing on ESA, we keep working closely with Akebia, and we keep monitoring the situation regarding HIF-PHIs as it is a potential innovation in the future. I just would add that, you know, HIF-PHIs are a promising therapy, but there's always therapeutic inertia. Once there's some safety concerns raised in a class, the therapeutic inertia sometimes goes up. You know, we'll see what happens with the whole landscape of the class. ESAs generally work and so I think there will always be a strong place for them in the future. Great. Thanks. Gretel, did you have another question? Yes, just one other question on Ferinject and Injectafer. You've talked about the opportunity from a rest of world perspective with Ferinject, but on the U.S. side of things with Injectafer, I guess how much are you actually impacted or restricted by really maximizing the potential of this product with the distributor agreement you have with American Regent? And I guess what are the benefits of this partnership? Thanks. I mean, we have a long-standing relationship with American Regent, in fact, for 25 years. I've been in very close contact with American Regent and Daiichi Sankyo management in the US. I feel that there's an extremely high level of commitment for Injectafer. We are working, as we speak, very closely to see if we can join forces to maximize the heart failure opportunity. We have a field force in the US, CSL Vifor US pharma. We have a field force focusing on nephrologists. American Regent and DSI or Daiichi Sankyo will have to call on heart failure specialists in the context of the heart failure launch. We are assessing, as we speak, really the opportunity to join forces to maximize this opportunity for patients and for CSL. One thing in summary, super high level of commitment, opportunities to do more together, maybe compared to what we have achieved so far. I really feel that our partner is very open-minded in that regard. Good. Thanks, Gretel. Next question comes from Saul Hadassin at Barrenjoey. Go ahead, Saul. Thanks, Mark. Good morning, everyone. Yeah, just following up on that question about the opportunity for Injectafer. Patient blood management is a large area outside of heart failure. I guess in terms of driving some of those other indications in critical care or critical bleeding, perioperative and also obstetrics, are those indications? First of all, would you have to do clinical trials in all of those indications to get labeling? Based on the commentary before, is that something that you will drive, or does it have to be driven through American Regent, or will it be part of that combined entity as you alluded to? Thanks. I'll start. You know, not sure that we have to do a study in all of those areas to gain some area or foothold. As you saw in heart failure, there was some work done in symptoms. Some of that is actually real world evidence, some of it's clinical trials. I would imagine that patient blood management would be more similar to that and need real world evidence, which may be available. Some of the other areas, we may need clinical trials, but we'll just see. We haven't done a deep dive from the CSL standpoint to really look at that. We'll be, that's what I mentioned earlier when I'll say we'll take our capabilities and look closely. Maybe I can add a couple of words here. In fact, the main difference is really versus iron deficiency anemia versus iron deficiency. When our label, which is the case in Europe, is iron deficiency, gives us the opportunity to really tap into the very broad use of IV iron therapy. The label in the U.S. in that regard is more restrictive, which is the reason why we have submitted this sNDA to expand the labeling in iron deficiency for heart failure patients. We're also reassessing what we can do in the PBM space with Injectafer in the U.S. It is being considered as off-label promotion, so therefore it is not being promoted, even if we see use of Injectafer in PBM, because of you know, the guidelines from the WHO and many other medical societies. We are in the process of reassessing what we can do, either by improving, enhancing, the labeling, or any other option. If we can promote iron deficiency, we can really leverage the full spectrum of the various Ferinject and Injectafer indications. Go ahead. Thanks. Good, thanks. Next question comes from Steve Wheen, Jarden. Go ahead, Steve. Thanks, Mark. Good morning, everyone. A quick question as well on Injectafer. At the time you were able to extend the patent to expire 1 July, 2026. It indicated at that time that you'd gone into a licensing agreement with Mylan and Sandoz. I just wonder if you could talk to what that licensing agreement looks like. And is that, you know, at its base that you'll be manufacturing, you know, an Injectafer sort of style product for them? I mean, we do not provide more specific details about this kind of agreements. We have indeed granted a license to Mylan and Sandoz from July 2026 onward, and I don't believe we can share more specific details. Yeah, as I said earlier, I think it's really a matter of, you know, we're gonna be working with them, you know, as time moves on, and, you know, we'll see where we end up on the generic side. But, again, we're focused on the near term, so more will come, you know, in the next few years. Okay, thanks. Just more of a macro question around dialysis, just the opportunity that home dialysis represents, and does that change any of the economics of any of your licensing arrangements with the various providers of in-clinic dialysis, such as with Fresenius and DaVita? No, I don't view it that way, Steve. I think this is part of the innovation in medicine that, you know, we just need to keep up with, and I know they will too, because it's their core franchise. I don't see any major risk there at all, either to the portfolio, because you're gonna need the products, whether it's at home, you know, dialysis or whether it's in a clinic. It's really about keeping abreast of the innovation because as I've said before, you know, if you're not innovating in our business, then you should get out. We're gonna keep up. We're gonna look to see if we can accelerate some of these innovations as well, because again, that will help secure our spot in the dialysis and nephrology space. It's like the oversight of dialysis will be extended to the home. It's just that like telehealth, many hospital systems now, they're still the same patients in the same system. The point of care just happens to happen at home rather than in the hospital. I think you can think about it that way, and that Fresenius will still be involved in those same patients. Good. Thanks, Steve. Next question comes from Andrew Paine at CLSA. Go ahead, Andrew. Yeah. Hi, thanks for taking my question. Just thinking about some of the recent studies looking at the iron replacement therapies, and it seems to show a higher incidence of hypophosphatemia in Injectafer versus other drugs. It'd be good to get your thoughts on how you think that may impact your current market share and potentially approval and launch of Injectafer for use in heart failure. Yeah. The short answer is that we don't think so. There is indeed a known risk of hypophosphatemia with Ferinject and this risk has been addressed in the SmPC. We you know no medicine is perfect. As long as we provide to healthcare professionals a fair balance when we promote the product, then I think this kind of adverse event is relatively easily manageable. Once again, this is part of the product profile, well known and perfectly managed with full transparency in terms of communication to healthcare professionals. While we'll obviously see the data when the data come out, there's no mechanistic reason to think that the effect will be exaggerated in patients with heart failure. Okay, sure. Thanks. Just thinking about Ferinject, the growth opportunity in rest of world markets. Vifor's previously said you have market authorization in 84 countries at the end of 2021. It sounds like the product hasn't been launched in that many countries. Just thinking how quickly you think you can ramp up sales in these markets and, you know, what can the CSL business add to help drive this growth? The product has been launched in most of these countries, but not through historically Vifor affiliates, but with a very comprehensive network of partners. The product is available through our partner network pretty much around the globe, where the product has been approved. Now, I think the key question for us going forward is that can we leverage the CSL geographic footprint to either accelerate this course or in some cases launch Ferinject or pipeline products on our own, which is something we are currently assessing for some of our pipeline products in particular. Product available through partners, but we can do more with our own in-house resources going forward, certainly now that we are part of the CSL family. Andrew, I think that's part of, you know, again, part of the things that people may be thinking about, and clearly we haven't expanded on tremendously at this point. But it's absolutely what happened, you know, over 10 years ago when we were commercializing the strategy here at CSL. We increased the number of affiliates. We were able to work closely with our distribution network to look for opportunities to transition products back to CSL because we expanded and grew the business and our infrastructure. We do have a large infrastructure in many countries around the globe. You know, we also continue on the CSL side to work on affiliates that we want to open to get back the product to ourselves as we continue to grow the organization. I think the Vifor Pharma group, now part of CSL, to Hervé's point, really can benefit from the relationships that we've had, the relationships we do have, and also some of the expanded affiliate offices that we've put in over the last few years. We'll work together on that and make sure. You know, there will be a clear focus though, right? I mean, we have to maintain our focus that we have as an organization, not distract the Behring business completely from what they're doing because they have a lot to deliver on with our numbers. It's still the beast of the business that continues to drive value and certainly the amount of revenue in the organization. It's the leading division. We have to stay focused. We can't get distracted. We do have some relationships already set up. We've got some cross-functional knowledge that's been shared and will be on the CSL Vifor leadership. Dirk As-sauer, who is running the CSL Behring Germany group, is now heading up kind of rest-of-world commercial outside of U.S., reporting to Hervé. We're making sure that we get the right thinking, the right infusion, the right people to make sure that we can commercialize the strategy that Vifor Pharma had in a more expedited and focused way under CSL. That's what we're gonna do. Thanks, Andrew. Next question comes from David Bailey at Morgan Stanley. Go ahead, David. Yeah, thanks, Mark. You sort of talked to that, the EPS guidance being reaffirmed. I'm just curious to see your thoughts around the return profile for the group post Vifor, if you think it'll get back to pre-acquisition levels, and if so, over what timeframe? Thanks, David. Yes, again, I think we would say something very similar to what we said in December, which is we do see our return on investor capital, you know, returning back to, you know, that sort of FY 2021 type number, but you know, towards the end of the decade. I think that's what we said in December, and we see no reason why that is still not the case. Got it. Just maybe can you expand a little bit more on CSL112? You know, what you've seen or learnt that could mean this is a new opportunity, and then maybe just reference some of the exclusion criteria as part of the phase III AEGIS-II trial. Well, I'd like to, David, but this is the Vifor briefing. You know in about a month our Bill will be doing the R&D update, and I think we'll get some more information at that particular point. All I can say is, look, we've been running this clinical trial and you know 50-plus sites around the globe with you know tens of thousands of patients, and we've learned a lot. We hope to bring that to bear with some of the opportunities that we've seen here with the iron franchise and the HEART-FID. Sorry, I can't expand more today. No worries. Good. Thanks, David. Next question comes from Mathieu Chevrier from Citi. Go ahead, Mathieu. Hi, good morning, and thanks for taking my questions. Just to go back on the 10% growth that you're expecting going forward, at least your target, could you maybe give us a sense of what the split is between the volume and the pricing that we can expect? I think you'll find, like, a lot with CSL, we are very volume driven, and we want to reach more patients, and so very focused on driving volume growth. We're not gonna, I'm not gonna split out the more than 10% today, but you should assume that a chunk of that is volume growth rather than. It's a volume strategy rather than a pricing strategy, shall we put it that way? Yeah, I think as usual, and you've probably heard me, Mathieu, before talk about the fact we've never been the price leader because, you know, you live by price, you die by price, and in today's environment, we don't want to make sure that we're doing the appropriate things for patients. Many of these areas, especially in nephrology, you know, and dialysis particularly, you have caps in terms of utilization. If you get outside of that, then all of a sudden you're above the cap, and you won't get reimbursed, and then you won't get access. You know, it's a different business in some respects than some of the areas within the Behring portfolio, which limits some of the price growth you can have. By the same token, as we move into new countries and new areas, we'll look to make sure that, you know, we're doing the right things both from a volume and price perspective. It is, as Joy said, it's a volume game. You know, we're here to expand these products and access across the globe and volume will win the day. Understood. Just looking at the payer mix and how does that compare to CSL Vifor versus Barrenjoey, and how does that change, you know, how does that change your strategy? I'm not really able to compare with CSL Behring because of my limited knowledge of his business at this point in time. For CSL Vifor, I mean, the payer mix is a very traditional mix. With of course, the exception of the dialysis market where, as you know, in the U.S., we have the so-called CMS bundle, which is a very important parameter. And by the way, we are very much engaged to try to further improve this CMS bundle policy to ensure midterm, long-term value for innovative medicines in the U.S. landscape. The comparison with Behring, I cannot really comment. It's similar because we do have, you know, Medicare as well in terms of the infusion products and such, both with the hemophilia portfolio as well as with the IG portfolio and specialty products. It's very much the same. Different than the Seqirus business, you know, which is more of an individual vaccine dose, which, you know, it's how that works. The payers themselves are pretty homogeneous across both Behring and Vifor for the most part. It's just when you have the DRGs, like you have within the dialysis space, you have to deal with that, but that's more of the Medicare caps that you see in this population. You know, if you see changes in governmental payments, then that's there, but this is already kind of a price managed area for the Vifor business. The rest of the payer community is pretty similar. Thank you, Mathieu. Next question comes from Sean Laaman. Go ahead, Sean. Thanks, Mark. Yeah, a couple of follow-ups if I may. Just to clarify on Veltassa. It says on slide 14 in reference to the FMC JV that there's global rights excluding U.S. and Japan. So does that mean that the Veltassa sales in the U.S. are outside of the JV, and we should ascribe 100% of revenue to Vifor? Was the first question. That's correct. That's correct? Yep. Yep, great. Great. Thank you. Then just a quick follow-up. This is a Vifor question, but you know, we've clearly seen the impact of the pandemic on plasma collection. It follows suit that we've seen a similar impact on whole blood donations. Given in the medical literature, we've observed you know, the benefits of treating iron deficiency anemia has on reducing the requirement for transfused blood. You know, coming out of the pandemic, you know, has this sort of cemented a more broader discussion you know, with hospital managers on you know, the benefits of using injectable? Or is it a bit of a tailwind when our hospital managers are thinking about managing whole blood? Yeah, thanks. That's what I was trying to allude to earlier, that normally we're used to needing to convince hospitals and convince health systems of the benefit of our therapies, and that's what we do, right? That's why we generate evidence. We're still generating evidence and collecting evidence on patient blood management. As you put it, there's a lot of tailwind here to be accepting of it once we present proper data or arguments. I do think there's a helping effect here. Great. Thank you. Thank you. Thank you, Sean. We have a further question from Chris Cooper at Goldman Sachs. Go ahead, Chris. Thanks for taking the follow-up. Just on Korsuva. You mentioned the TDAPA pathway earlier. Can I just confirm what your expectations are beyond that two-year period? By extension, whether you have any ambition of securing the rights to the oral as and when that comes? That's a very fundamental question obviously for Korsuva. As I briefly alluded to, we have reacted to the CMS draft policy guidance for 2023. CMS has asked for comments, which is a sign that CMS is aware of the potential health inequality created by the current policy. We strongly believe that the current system does not support sufficiently funding for innovation. We have submitted our comments and we hope that these comments will be taken into account as CMS issue the final guidance. We would like CMS to ensure additional funding for innovative medicines like Korsuva, and we would like, as much as possible, this funding to follow the patient to make sure that it really supports innovation. There is an ongoing discussion. We feel that there is an open mind with the acknowledgement that the policy has to be improved for the benefit of patients. Look, I think post-DAPA, you know, we're looking for extensions. We're looking at ways to craft the right argument for CMS because these patients are suffering. As Hervé talked about it is underdiagnosed and not treated at all in many cases. It's tough. I mean, these patients really are. We've met with a number of them, and they really have been in pain, and they are so thankful for a product like Korsuva. This is life-changing for them. We need to make sure that that stays reimbursed and done. We're gonna utilize like we have on the Vifor side. You utilize the medical community, the patient organizations, you know, ourselves as industry and then moving forward. I can't comment on your other question yet, Chris, on the oral. Okay. Thank you. Thanks, Chris. Putting it all together. A further follow-up question from Lyanne Harrison at Bank of America. Go ahead, Lyanne. Hi. Just one more follow-up. If I think about the 10% growth that you're expecting in the medium term, how should I think about that for the dialysis franchise? Obviously, that's been hard hit by COVID. What sort of, I guess, recovery are you expecting over that medium-term period? I would think about it like we thought about plasma, right? It takes a while to turn the ship because there were patients unfortunately that passed away during COVID. Prior to COVID, dialysis patients were growing about 3%-5% a year. We expect that that's gonna continue. As I said, just in the over-40 population in the US, if you do the calcs on 15% of the population on CKD that eventually could end up on dialysis, that's about 25 million people. We think that there's plenty of opportunity for continued growth, but they don't all come back at once because this is a continuum disease. Patients continue on this pathway until they end up unfortunately on dialysis. I think there's a good growth pathway coming forward, and we've already seen turnaround there. We've seen patients starting to return because it's not only, you know, the patients have passed away, but the access. They suffered in the dialysis centers, not unlike plasma in terms of staffing, right? They had to turn patients away because they didn't have the nursing staff in these centers as well. There are a lot of corollaries to what we experienced on the plasma collection side here within the dialysis center. We understand it. We know what the levers are. We've worked and talked with FMC. They've done a lot of work and invested a lot of money to restaff their centers and move the nursing back in. I think, you know, we're all on the same page here that these patients are coming back. They will come back, but it won't be overnight to return to the same levels until, you know, the patients start presenting. Maybe building on Paul's comment. You know, part of our dialysis portfolio is established, and I don't want to repeat what Paul said because that's, you know, there's nothing to be added here. The growth will be also very much driven, as I highlighted, one, by the fact that for our ESA business, we signed an agreement with DaVita for Mircera, which will start early next year. Two, the launch of Korsuva and Kapruvia will be a major driver of our growth in the dialysis segment. If you put all these components into account, I think you should come to the conclusion that we can not only achieve but exceed with this 10% growth for this specific segment. Okay. Thank you very much. Good. Thank you. Thank you, Leanne. Ladies and gentlemen, there are no further questions in the queue, so I will draw the meeting to a close. Thank you very much for your interest in CSL, and good afternoon.