CSL Limited (ASX:CSL)
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Earnings Call: H2 2022

Aug 17, 2022

Operator

Thank you for standing by and welcome to the CSL Limited Full Year Financial Results conference call. All participants are in listen-only mode. There'll be a presentation followed by a question-and-answer session. If you'd like to ask a question, you'll need to press the star key followed by the number one on your telephone keypad. I'd now like to hand the conference over to Mr. Mark Dehring, Head of Investor Relations. Please go ahead.

Mark Dehring
Head of Investor Relations, CSL Ltd

Good, thank you, operator, and good morning, everyone, and welcome. I have with me here in the room Paul Perreault, CSL's Chief Executive Officer, Joy Linton, CSL's Chief Financial Officer, and Paul McKenzie, CSL's Chief Operating Officer. As with past practice, Paul will provide an overview of the results and operations, and then Joy will provide some additional details on the financials. We'll then move to Q&A. In doing that, and with a view to giving everyone an opportunity to ask a question, could you please limit your questions to two? If you do have further questions, 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. I'll now pass you over to Paul Perreault. Paul.

Paul Perreault
CEO and Managing Director, CSL Ltd

Thank you, Mark, and good morning, everyone, and thank you for joining the call today. Before I move into the results, I wanna make a few comments on a very contemporary topic, our acquisition of Vifor Pharma. Look, it's a very exciting time for us. The ink is still wet on signing the virtual check, and already we're in full swing of engaging with our new colleagues and starting the integration process. What does this mean for CSL shareholders? Early data indicates no change to our overall view of the financial contribution from the acquisition of Vifor Pharma Limited. It remains a really good deal for CSL. In fact, it's quite unusual. How often do you come across a biotech that's actually generating cash flows, as well as having an exciting future for growth opportunities?

We now have an amazing franchise encompassing renal disease and diseases of iron deficiency. All this and our balance sheet remains solid. In fact, it's in really good shape. We received strong support from both debt and equity investors in raising $11 billion, showing extreme confidence in the transaction. We've now paid for the acquisition, which incidentally, Vifor came with half a billion dollars of its own cash, and we've kept our A credit ratings. The takeout being we are now a significantly larger company, have a broader strategic horizon, and at the same time, we've retained our financial flexibility. I could go on, but we'll be talking more about the strategic merits of the deal at a dedicated CSL Vifor briefing in October, and I hope all of you can make it. Now turning to the results.

CSL has delivered a good result at the top end of our guidance in a very challenging global COVID environment. Before I get into the detail, it would probably be remiss of me not to call out our 27,000 CSL employees. Over the last few years, since the emergence of COVID, our employees have displayed enormous resilience with an unwavering commitment to deliver on our promise to patients and the protection of public health around the world. We continue to invest in the business and remain focused on executing on our 2030 strategy, and I couldn't be any prouder of the CSL team than what I am today. Moving to the performance slide.

Revenue was up 3% at constant currency, and net profit after tax came in at AUD 2.25 billion at the top end of our financial guidance provided at the half year result. In the CSL Behring business, our sales of immunoglobulin and albumin, the two major products we extract from every liter of plasma, have been constrained by the volume of plasma collected in the previous year, remembering that plasma products have a long manufacturing cycle between nine and 12 months. A constant topic since the emergence of COVID has been the growth rate of plasma collections. I'm pleased to say that plasma collections have grown strongly, up 24% over the previous year, which we anticipate will underpin strong sales growth this current financial year, and we aim to continue this momentum into the future.

Supply chain challenges, inflationary pressures, and higher plasma collection costs have all contributed to margin compression throughout fiscal 2022. Over the last few years, I've really commended CSL Seqirus on delivering a set of impressive results, and fiscal year 2022 is very much the same. We continue to execute on the innovation and strategy that we set forth for CSL Seqirus. We will continue to drive sustainable growth across the enterprise in fiscal year 2023 and beyond. R&D is a major component of that. As such, we continue to invest in programs that will deliver both mid to long-term growth. We formally, as I mentioned earlier, welcome Vifor, now CSL Vifor, to the CSL group. We are not in the position, as I said, to discuss this today.

However, CSL Vifor market briefing is scheduled for Monday, October seventeenth, when investors will have an opportunity to hear from CSL Vifor management team as well as CSL execs as we discuss CSL Vifor's growth strategy, insights into its product portfolio, and some of the key value drivers. For CSL Behring, a very strong performance from IDELVION, our market-leading hemophilia B product, which was up 20%. This does remain the standard of care in all major markets where we've launched IDELVION. Our major specialty products continue to experience growth with Kcentra up 18% and HAEGARDA up 5%. HPV royalty revenue exceeded pre-pandemic levels and was up 55% year-over-year. Our core franchise of immunoglobulins declined 3%, a reflection of the lower plasma volumes collected last financial year.

Continued investment in our plasma collection, supported by digital enhancements and marketing initiatives, and we saw plasma collections, as I just mentioned, grow. Our new plasmapheresis platform was approved during the year and is being rolled out during fiscal year 2023. Today, I'm also pleased to announce you may have seen a press release on the receipt of positive top-line data for garadacimab for the treatment of hereditary angioedema. Very exciting progress for us on that phase III trial. For CSL Seqirus, our influenza vaccines business has delivered another exceptional performance. U.S. sales exceeded $1 billion for the first time, with seasonal influenza vaccine sales up 16%. This was primarily driven by exceptional growth in Fluad, which was up 41%. CSL Seqirus distributed a record number of 135 million doses of influenza vaccine during the year.

To support this growth, we continue to invest in process innovation and our manufacturing facilities, and also with fill and finish capacity projects having been completed at both Holly Springs and Liverpool. Turning to slide 5 in CSL Behring sales by therapeutic area. Overall, the Behring revenue was up 2% at constant currency. IG, our core franchise, declined 3%. Albumin was down 1%. Hemophilia was up 8%, and specialty products were up 3%, including strong performances, as I mentioned, by Kcentra and HAEGARDA. The 37% growth in other largely reflects HPV royalties and the contribution from COVID vaccines. Of note, we have now completed the manufacture of 50 million COVID vaccine doses for the Australian government, and this contribution will not repeat in fiscal year 2023.

In terms of the geographic split of CSL Behring revenue, North America continues to be our largest market, accounting for 49% of total CSL Behring revenue, up 1%. Our next biggest market, Europe, declined 5% in revenue, and this is where we really felt the impact of IG supply tightness. Asia-Pacific was up 21%, primarily as a result of the strong albumin demand in China. Moving on to slide 6 in immunoglobulins. As I mentioned earlier, sales have been constrained by plasma collected last year. You know, and supply is the core limiting factor. We are optimistic that we are seeing improved momentum evidenced by a strong second-half performance in IG. Our product, Hizentra, remains the clear leader in the sub-Q market, with approximately 60% market share in the U.S..

Supporting Hizentra growth has been the demand for CIDP treatment following an update to the Peripheral Nerve Society treatment guidelines, as well as Medicare Part B reimbursement approval. The guidelines recommend subcutaneous for the maintenance treatment in CIDP and enhanced label dosing and long-term efficacy information from the PATH extension data update. Most importantly, Hizentra will now offer an improved patient experience with faster and easier administration option of a prefilled syringe. Patients want the convenience of home-based treatment, an offering that Hizentra has been the leader in and is able to provide. I will say COVID has presented challenges for patients. They have had limited access to treatment and diagnosis. There's also been an environment of constrained supply.

However, as the global supply recovers, we are anticipating a strong growth rebound in the IG portfolio with opportunities in core indications of primary immune deficiency, secondary immune deficiency, and CIDP. Turning to slide 7 in albumin, where sales were down 1%. Despite the increased competition in China, we have maintained our market leadership position with sales up 10%. The change in our operating model in China is paying off. The 10% growth comes from being able to extract greater effectiveness from having increased channel transparency and greater reach to hospitals and healthcare providers. Having said that, China remains a competitive market as our competitors increase their investments in China. Looking forward, we anticipate volume demand to continue to grow at mid- to high-single-digit %. However, pricing pressures may continue due to the increased supply from importers.

Outside of China, it has been a bit more challenging. Volume declined in Europe and emerging markets following increased competition from local manufacturers who have access to some local plasma sources. In the US, volume also declined as supply constraints continue due to the direct effect of the lower plasma collections in the previous financial year. More broadly, across the markets, clinicians are using albumin in preference to other colloids, as well as increased usage of albumin in sepsis and liver patients. Now to hemophilia on slide 8, where we start to talk a little bit about CSL products not impacted by plasma collections with sales up 8%. IDELVION was the standout performer, up 20%. It is the clear market leader for HemB patients with a compelling clinical profile that continues to drive patient demand and market share.

IDELVION does remain the number one factor nine prophylactic product in markets where we've launched with the highest patient shares in major European countries. We continue to explore further opportunities with IDELVION, having completed an extension study which evaluated patients for up to four years, confirming the long-term efficacy and safety profile of IDELVION. We have also gained 21-day dosing approval in EU, Switzerland, Japan, and Canada, and have seen strong uptake in France since we launched with approximately 30% patient share. AFSTYLA declined 4%, primarily driven by the continued competitive market pressures in the Hem A market. Despite the challenges, we've made some good gains in key markets. Competitive market pressures have also negatively impacted on our plasma-derived hemophilia products. This was offset to some extent by Humate-P growth in the United States.

Overall, we're seeing ongoing movements towards new generation products within the hemophilia space and expect this trend to continue going forward. Etranacogene is one such example. On to Slide 9 in specialty products, which nearly tripled over the last decade to $1.8 billion. Now our second-largest therapeutic group. HAEGARDA, our transformational therapy for treating patients with hereditary angioedema, or HAE, continues to perform strongly and up 5%. Recent launches in EU and Australia have exceeded our expectations, with Europe recording 60% growth and market share in the Australian prophylaxis segment quickly surpassing competitors to gain 70%. We continue to add new patients despite increased competition as the treatment paradigm further shifts from on-demand to long-term prophylaxis.

In the U.S., HAEGARDA continues to have the largest share of on-demand prophylaxis switches and remains the only therapy indicated for patients six years of age and older and with special populations data such as pregnancy now contained in the label. BERINERT was down 6% primarily reflecting patient shifting to HAEGARDA, and Kcentra, commonly known as the gold standard for warfarin reversal, was up 18%. In the U.S., where the bulk of the sales originate, Kcentra has grown significantly since launch, driven by both penetration within existing large hospitals and expansion into smaller regional accounts. The small volume and fast infusion profile appeals to the target market. Lastly, Alpha-1 sales were down 17% following the supply interruptions at Kankakee.

We've now resolved these issues and have provided consistent supply to the channel over the last six months, with commercial now focusing all of their efforts on regaining ZEMAIRA users. Just to comment on specialty products. You know, some years ago, we indicated a target of $800 million-$1 billion for this category, and we've now reached $1.8 billion of sales, illustrating the benefit when you have a differentiated product portfolio. Turning to Slide 10 in plasma collections. As has been well documented, COVID has presented the plasma industry with many challenges, and plasma collections is one such area of our business that has been greatly impacted by the pandemic. A return to growth just doesn't happen via one response effort. It requires a team that's in sync, driving and executing multiple innovative measures.

The CSL Plasma team has worked tirelessly and have implemented a number of targeted initiatives with a core focus on growing plasma collections. The team's resilience and dedication has been outstanding, and we have seen a volume improvement of 24% from fiscal year 2021 to fiscal year 2022. The following slide graphically illustrates this performance, but before we get there, I'd like to share some of the initiatives we've undertaken to support collections growth. We have enhanced our operating and marketing efforts to attract new donors, but also lapsed donors, both of which are an important source of future donations. For example, our revamped brand positioning and advertising via the Do the Amazing campaign has been delivering compelling brand positioning, surpassing industry benchmarks, and ultimately driving new applicant donor prospects and importantly, raising brand awareness.

The donor app-enabled digital marketing initiative has reached approximately 2 million people and is one of the key levers for the increased level of donations leading to collections now exceeding pre-pandemic weekly average run rates. Self-serve initiatives and the ability for donors to register online are other components of our digital offering, all of which are dedicated to ensuring a best-in-class donor experience. Our investment continued in opening new plasma collection centers with 27 new plasma collection centers opened last year. Not only have we invested in increasing the size of our network, but as many of you already know, we've made investments in the new plasma plasmapheresis platform being rolled out during the fiscal year 2023.

This platform will improve the donor experience by reducing average donation time by more than 30%, improve donor safety and comfort by reducing the amount of blood outside the donor body at any one time. It delivers material sustainable benefits, specifically waste management, with a significant reduction in one-time use of plastics. It improves the employee experience with ease of use and advanced diagnostics for maintenance and operation. More broadly, across the industry, as donor fees have increased, we have redesigned donor fee structures, and that has assisted us in capturing more new donors and help retain those donors. We continue to gain momentum. However, there are some industry-wide issues that remain. The pandemic is ongoing. New variants continue to emerge. Staffing centers to remain open and to operate at optimal levels is a challenge for the industry.

As you would know, there are labor shortages in many countries, including Australia. The U.S. employment environment is very competitive, and while we have introduced retention schemes to enhance compensation for staff, attracting and retaining employees remains a challenge in this space. Turning to the next slide, the donors per week graphic, which is a good proxy for liters collected. The red line is calendar year 2022, gray 2021, and black 2020. You can clearly see the improvement on prior period, which was +24% overall. As I mentioned before, the plasma team have left no stone unturned when evaluating and executing initiatives to grow plasma volumes. The growth has been extremely positive and gives us confidence about sales growth in fiscal year 2023. I'd like now to bring the key elements underlying our outlook for CSL Behring together.

Fundamentally, the business is well-positioned for growth post-COVID, with more collection capacity, more manufacturing capacity, and good demand indicators. With regards to increasing collection volumes, through the continued investment, CSL Plasma has opened 73 new centers since the beginning of the pandemic. That's more than a 30% increase. As some state and local county executive orders were rescinded in mid-2021, plasma collection centers are progressively now returning to pre-pandemic operational design. Of the 10% of beds that we temporarily removed during COVID to meet social distancing requirements, 5% of the beds are still to be returned to the center, so there is latent capacity available to have more donors in the center.

Our new plasmapheresis platform brings with it a number of benefits, including a more than 30% reduction in average donation time, and that means faster bed turns, lower staff-to-donor ratios, fewer new centers needing to be opened. With regards to manufacturing capacity, as you know, at CSL, improving IG yield has always been and is always a core focus. We continue to invest in our pursuit of yield through maximizing data analytics. Collecting plasma, albeit an important part of the process, is only one part of the jigsaw. We recently completed modules five and six at Bern, which has added 8 million liters of additional IG capacity. Investments in these types of projects are costly but absolutely necessary. Demand has and will continue to remain robust. It is the only reason why we continue to invest in our facilities.

There are some driving forces supporting this type of growth, including leading indicators of disease diagnosis that are now returning. These include bronchitis, ear infections, and respiratory infections. Many patients, even in Tier one markets, remain undiagnosed. Patient groups in the U.S. have run awareness campaigns as multiple primary immunodeficient patients are unaware that they have the disease and continue to live unnecessarily with ongoing infections. Ongoing preference for the convenience of home treatment will continue to drive demand for Hizentra, and approximately three-quarters of targeted physicians are now using Hizentra to treat CIDP patients. These patients not only come from Privigen, but also from other intravenous products. Demand for treatment of secondary immune disease continues to grow. Many new cancer treatments require suppression of the immune system prior to treatment. Patients then need to rebuild their immune system. IG is usually the only answer.

Even though incidences of diseases are similar across geographies, I want to remind you that the rates of IG consumption are not. IG in the U.S. is still consumed at almost three times the rate per head of population when compared to Europe, and we are currently seeing strong growth opportunities outside the U.S.. The world needs IG. Before I leave CSL Behring and move to CSL Seqirus, I just want to say this. At CSL Behring, we are the leading plasma collection company with capabilities and continue to innovate to be the industry's largest and most efficient. Operationally, we could not be better placed for capacity, both on a collections and manufacturing front. We are doing everything we possibly can to ensure patient demand and make sure that patient demand is satisfied with our products.

Changing gears and moving on to slide 13 and our influenza vaccines business, CSL Seqirus. As I said from the outset, CSL Seqirus has delivered another exceptional performance in fiscal year 2022. Total revenues were just short of AUD 2 billion, up 13% at constant currency, with seasonal influenza vaccines up 16%. The increase reflects an ongoing shift to CSL Seqirus' differentiated products, particularly Fluad, our adjuvanted product, which was up 41%. The Northern Hemisphere continues to be the dominant market for CSL Seqirus, with EU and U.K. delivering particularly strong growth, up 42%. Continuing with CSL Seqirus on slide 14 and some of the operational highlights, CSL Seqirus continues to achieve significant growth in seasonal influenza vaccines, which, as I mentioned earlier, saw a record volume of 135 million distributed doses globally in fiscal year 2022.

In the US, CSL Seqirus delivered vaccine revenue in excess of $1 billion for the first time. They were also awarded a new pandemic contract by the U.S. government, BARDA, for the development of two influenza A virus vaccine candidates using both our cell-based adjuvant combination technology platform and our self-amplifying mRNA technology. We've achieved pandemic ready designation from the US government for Holly Springs. In Europe and the U.K., CSL Seqirus continued to achieve heightened recognition of the benefits of our differentiated products, namely from the Joint Committee on Vaccination and Immunisation in the U.K., and we successfully launched Fluad in Ireland. We continue to work with regulatory bodies and are pleased that the CDC adopted the Advisory Committee on Immunization Practices for Fluad to be one of the preferentially recommended seasonal vaccines for adults aged over 65 in the U.S..

Exciting opportunities for CSL Seqirus going forward and a great job by the team. Moving on to R&D on slide 15. Just whilst we're here, the annual CSL R&D day is to be held virtually on November third. With that in mind, I'll only provide some high-level comments as we move through some exciting developments in the CSL pipeline of assets. Starting with immunology. We are so excited to announce the positive top-line data today for garadacimab for HAE. The study met its primary and secondary endpoints and also demonstrated safety and tolerability. These results underscore our belief that garadacimab has the potential to become a transformative first-in-class therapy for people living with HAE, a patient group that CSL has been serving for many years. CSL aims to begin filing with global health authorities by the end of this fiscal year for approval in the U.S..

In hematology, the primary endpoint was achieved for Etranacogene dezaparvovec, also known as HEMGENIX, with submissions now made to European and U.S. regulators. Notably, it has been fast-tracked in the U.S., and if approved, will be launched in 2023. Moving over to cardiovascular and metabolic. The phase III trial for CSL112 continues to progress well, with over 80% enrollment achieved and last patient in estimated to be the end of this calendar year of 2022, with primary completion date 12 months thereafter. Top-line results will be released once the study has been completed and the data has been analyzed. In respiratory, beyond garadacimab for treating HAE, we have initiated a phase II study for the treatment of idiopathic pulmonary fibrosis. Garadacimab has the potential to be another flagship molecule for CSL, and of course, it is a homegrown monoclonal antibody.

In influenza vaccines, Flucelvax, with the most notable development, was achieving six months and older age indication in the U.S. and Argentina. In Fluad Quadrivalent, adults 50- 64, the phase III study enrollment is now complete. With that, I'm now gonna hand over to Joy, who will provide some details on our financial statements and an update on our sustainability strategy. Joy?

Joy Linton
CFO, CSL Ltd

Thank you, Paul, and good morning, everyone. As Paul said at the beginning, CSL has delivered a good result in line with our expectations and at the top end of our guidance. Reported net profit after tax was AUD 2.255 billion, a decline of 5%. On a constant currency basis, net profit after tax was AUD 2.236 billion, down 6% after adjusting for a currency tailwind of AUD 19 million. The main features of the result which Paul has touched on are the lower IG sales due to the constrained plasma collections in financial year 2021, offset to some extent by the strong performance of IDELVION and CSL Seqirus. We have seen an increased cost for plasma collections and higher fixed cost absorption this year, and that has caused downward pressure on the CSL Behring gross margin as expected.

With the strong increase in plasma collections over financial year 2022, the fixed cost per unit will be absorbed over higher volumes, and this will start to have a beneficial impact on the gross margin over time. The FY 2022 result also included at the NPAT line the costs incurred to date associated with the Vifor acquisition and a contribution from the manufacturing of COVID vaccines, which will not repeat in FY 2023, and the net effect being a contribution of around AUD 70 million. Looking at the financials in more detail, our total revenue was up 3% to AUD 10.7 billion. Gross profit of AUD 5.8 billion was steady. EBIT was down 8% to AUD 2.9 billion. The main factor driving this is our increased investment in R&D, and NPAT was down 6%.

On a reported basis, EPS was down 8%, and this is due to the shares we issued as part of the capital raising for the Vifor acquisition in December 2021 and January 2022. Cash flow from operations was $2.6 billion, down 27% from the prior year. The single biggest factor driving this was the significant increase in inventory due to the higher plasma costs per liter and the improved plasma volumes we collected. Other factors impacting cash flow were the lower profit before tax and an increase in trade payables consistent with the increase in inventories, as well as timing changes relating to rebates and influenza vaccine returns.

Despite the lower net profit and the issue of shares in support of the Vifor acquisition, we have maintained our final dividend at $1.18 per share, bringing the total dividend for the financial year 2022 to $2.22 per share. For Australian shareholders, the final dividend translates to approximately AUD 1.68, up 6% and is franked to 10%. Turning to the segment results on slide 19. For CSL Behring, total revenue was up 2% at constant currency. The increase in other revenue is due to the significant increase in Gardasil royalties and the revenue we received from manufacturing the AstraZeneca COVID-19 vaccine. As Paul mentioned, that contract has now been completed.

Gross profit was down 4%, and as I've mentioned, the higher costs of collecting plasma and the fixed cost absorption underpinned the decline in CSL Behring's gross margin to 53.3%. The arrival of a new COVID variant at the beginning of the calendar year, together with challenges of attracting and retaining staff, has delayed the expected gross margin recovery. For CSL Seqirus, total revenue is up 13% and gross profit up 16%, an exceptional result reflecting the strong demand for influenza vaccines and the continued success of our product differentiation strategy and improved manufacturing efficiencies. On the next slide are the group's expenses with the changes for the period shown on a constant currency basis.

Our investment in research and development was up 17% to $1.16 billion and towards the top end of our guidance of 10%-11% of revenue. We have continued to invest in innovation and have a number of exciting programs coming to fruition as Paul has outlined. Despite an increase in our spend on Etranacogene pre-launch activity, we have managed to hold sales and marketing expenses steady compared with the prior year, and this reflects our strong focus on managing costs. General and admin expenses were also well controlled, particularly after taking into account the costs we have incurred with the Vifor acquisition. Finally, the effective tax rate for FY 2022 was down modestly to 18.9%, and we expect the tax rate to remain in the 18%-20% range for FY 2023.

Moving on to slide 21 in inventory. Here you can see the various components that make up our inventory levels split between raw materials, work in progress, and finished goods. While the graph gives the appearance of growing inventory volumes, which is accurate to some extent, it also reflects the increase in the cost per liter of plasma. By contrast, we've had to judiciously manage the tension between patient demand and supply chain needs within finished goods, and at the end of the year, we've continued to have a lower level of cover of finished goods than we need, particularly in today's supply chain environment.

As plasma volumes continue to improve, we will need to rebuild our finished goods inventory levels over the next couple of years so that we have a more comfortable level of inventory on hand, both to meet patient demand, but also to be able to better manage our supply chain costs. Turning to the next slide in our debt profile, and here you'll see the maturity profile of our debt. This has significantly and materially changed following the very successful $4 billion debt raising in the U.S. 144A market. This debt raising delivered an excellent outcome and gives us enhanced flexibility to fund future growth. We now have a diverse mix of debt with a full range of maturities out to 2062.

The average weighted tenor is just under 12 years, and the weighted average cost of debt is 3.38%. Overall, our balance sheet remains strong, and our A grade credit ratings have been maintained. Moving on to the next slide in our sustainability strategy. As you know, we communicated our sustainability strategy 12 months ago, which was focused on three key pillars of the environment, social, and sustainable workplace. As part of this strategy under our environment pillar, today we are announcing our new carbon emissions reduction targets. These will serve as a transparent roadmap to decarbonize our global operations by cutting both direct and indirect carbon emissions. By 2030, CSL is targeting a reduction of 40% of absolute Scope 1 and Scope 2 emissions against a baseline of the average annual emissions across FY 2019 to 2021.

We intend to ensure that suppliers who contribute two-thirds of scope three emissions will set scope one and scope two target reductions aligned with the Science Based Targets initiative. CSL looks forward to achieving scope one and scope two emission reductions through a range of key initiatives, including increased energy efficiency, pushing towards more renewable power, switching fuels to less carbon-intensive energy sources, and over time, redesigning our manufacturing sites. Aspects of this work are already well underway. Our facilities in Liverpool, the U.K., and in Bern, in Switzerland, today source renewable energy. Our new R&D complex in Marburg, Germany, our new headquarters in Melbourne, and our new cell culture facility, also in Melbourne, will feature state-of-the-art sustainable design features.

To achieve our Scope 3 target, we will be working with our suppliers through a range of initiatives, including revised procurement standards and award criteria, through supplier enablement, with advocacy and education, and strategic partnerships to innovate and collaborate. As a scientific and data-driven company, we are undertaking these specific measures and analysis to ensure that we continue to set and to meet the right targets for the road ahead. At the most senior levels, our corporate governance and nomination committee of the board will have oversight of these goals, and with the Executive Sustainability Committee that I chair, we are creating a culture of accountability across the CSL enterprise. With that, I will hand back to Paul, who will finish up with some comments on the outlook.

Paul Perreault
CEO and Managing Director, CSL Ltd

Well, thank you, Joy. Now on the outlook for fiscal year 2023. Let's look specifically at CSL Behring. We see a continued improvement in plasma collections, and that is expected to underpin strong future sales growth for our market leader products, IG and albumin. The higher cost of plasma is still evident and expected to prevail in fiscal year 2023, and we are looking to replenish inventory to a level that gives us more confidence on our ability to meet the patient's needs and the demand that's coming, and in a more cost-effective way. For CSL Seqirus, product differentiation will continue to drive strong demand for our influenza vaccines, particularly Flucelvax. Across the enterprise, we expect to continue to be faced with challenges in the external cost environment, whether that be inflationary pressures, staffing constraints, or the logistics and supply chain challenges.

In terms of guidance for fiscal year 2023, we expect revenue growth to be in the range of 7%-11% over the fiscal year 2022 at constant currency, with net profit after tax expected to be approximately in the range of AUD 2.4 billion-AUD 2.5 billion at constant currency. On a like for like basis, this represents a growth of between 10%-14%. This all excludes CSL Vifor earnings and costs associated with the acquisition, as well as the non-recurring COVID vaccine contribution. Guidance for the CSL group will be updated to include CSL Vifor at the first practical opportunity. Of course, our forward-looking statements are subject to the usual disclaimers, as mentioned at the start of this presentation.

I guess to close, I am absolutely certain that the fundamentals of our business are strong and the diversity of the pipeline is rich, and that we are really set up at CSL to build on our track record of sustainable growth for years to come. With that, we'll now be happy to take your questions.

Mark Dehring
Head of Investor Relations, CSL Ltd

Good. Thank you, Paul. Operator, if I could ask you to open the lines up. Our first question comes from Andrew Goodsall at MST Marquee. Andrew, go ahead, please.

Andrew Goodsall
Research Analyst, MST Marquee

Thanks very much for taking my question. Just, the result's got a lot of noise in it, obviously, with non-recurring items, Vifor acquisition, et cetera. I guess just on a ballpark level, just trying to get a sense of where you think you landed on an organic basis, whether it's at EBIT or NPAT or even just your exit rate. Just trying to get a sense of where you sort of base level trading was.

Joy Linton
CFO, CSL Ltd

Thank you, Andrew. I think what we've tried to do here and acknowledge that, you know, closing the acquisition of CSL Vifor on the ninth of August when you announce your results on the seventeenth of August is slightly tricky. We will come back to the market as soon as we are able. As you know, we need to also do the acquisition accounting work and get a good look at how we think intangibles will be valued or the fair value of the whole balance sheet really for Vifor. That's just gonna take us a little bit of time.

What we've tried to do here today, with our forward guidance of AUD 2.4 million-AUD 2.5 million at NPAT is very much the legacy company. It's the underlying performance of the business we've outlined today, being CSL Behring and CSL Seqirus. I think we've tried to be, you know, transparent on just making sure we're clear that we're, you know, the COVID vaccine contribution doesn't repeat in FY 2023. The notes of the financial accounts are very clear on what Vifor costs sit in the FY 2022 numbers that I'd point you to note two of the accounts.

We've excluded Vifor, anything to do with Vifor in that forward guidance of $2.4-$2.5, including interest costs, any contingent, any acquisition or integration costs. You know, an underlying performance sort of guidance of sort of that 10%-14% on a go-forward basis.

Andrew Goodsall
Research Analyst, MST Marquee

Okay. Oh, that's great. 10-14 is your sort of underlying business before we think about 54, if I

Joy Linton
CFO, CSL Ltd

Yeah, that's correct. Yep.

Andrew Goodsall
Research Analyst, MST Marquee

Perhaps my second question just for Paul, just in terms of the plasma business, it does look like the exit rate or second half gross margins were ahead. I think that's probably a reasonably sort of clean number just looking at Behring. Just ask you to sort of, I guess, sort of the green shoots you might be seeing, you know, across the markets that you're in and the, I guess the opportunity. You know, we know that European prices are up quite considerably. Just I guess as more volume comes on, is that an amplifier sort of effect?

Paul Perreault
CEO and Managing Director, CSL Ltd

Look, I would say, Andrew, that the exit rate in the second half is a good indicator. I mean, we're slower starting in the second half than we would have expected with Omicron, some of the massive weather issues they had in the U.S. in the wintertime, et cetera. You know, these variants continue to come up, and that affects staffing, it affects donors, it affects, you know, kinda everybody that's out in the business. Having said that, as we look at the exit rates, you know, we feel very confident that things have been improving quite well. The costs are up. We know that. We've had to retain and acquire new staff, you know, thousands of people actually. You look at the centers we opened last year, that's all staffing as well.

The cost of that staffing is high because you're not getting the throughput in those centers. They're brand new, right? We normally say it takes 1-3 years to get a center up and running. With COVID, you know, we've opened 73 centers since the start of the pandemic, and I'd say that rate of ramp-up has been closer now to 2-4 years just because it's longer during the pandemic to get them up and running. I would say that's really something where we're trying to make sure that we're, you know, in the right area.

I would say that, you know, when we look at the fiscal year for IG, and we take a look at the first half, you know, we were down about 9% on previous quarters or previous period. In the second half, we were up 6%. Overall, we ended up at -3% for the fiscal year. Pricing, I would just be cautious on, you know. I'd just say that everybody's got their eye on pharmaceutical costs, as you might be well aware. You know, we will continue to look at opportunities with tenders and other things to optimize our portfolio and the pricing that we have in a responsible way.

Mark Dehring
Head of Investor Relations, CSL Ltd

Thank you, Andrew. Our next question comes from Saul Hadassin at Barrenjoey. Go ahead, Saul.

Saul Hadassin
Vice President and Equity Analyst, Barrenjoey

Thanks, Mark. Good morning, Paul and Joy. Paul, just a question on IG in general. We've seen the first FcRn product launched with an indication myasthenia gravis. It looks like sales have done relatively well, albeit you know in early stage post that launch. The data on CIDP is due out, I think, first quarter of next calendar year. You spoke positively about the outlook for IG in general. Do your thoughts on that change at all if indeed there is a CIDP indication that is approved come say first quarter calendar year 2023?

Paul Perreault
CEO and Managing Director, CSL Ltd

Not really, Saul. I think, you know, we're still very bullish on the fact that IG is a standard of care. You know, this isn't going to be a transformative product, at least not from the interim results they showed in their trials. I would say unless they had some major change in their efficacy rates and response rates, from interim to final phase III results, you know, you have to have a product that is really completely transformational, like an IDELVION, to make a difference to penetrate a market, especially in a chronic disease where patients don't wanna get sick and IG has been the standard of care. You know, everybody wants to point to, you know, the takeover of IG, you know, with a product. It's not really going to affect PID.

It's not gonna affect SID. If it has a decent effect, and depending on the pricing and the cost and the access, you know, sure, they'll get some market share, but the likelihood that this is gonna happen overnight or change my outlook for this year, or our current strategic plan in terms of demand, we see the demand growing in a lot of areas with IG still. I think I pointed out also the fact that there's still an underutilization in terms of grams per capita per 1,000 head of IG in many countries. During the pandemic, there is still a lot of need and demand for IG outside of the U.S.. I know people have looked at some of the numbers in U.S. IG, which tends to be the flavor of the day, every result.

You know, people have satisfied a lot of that demand. Let's be frank, I mean, there has been less diagnosis during COVID of rare diseases because you can't diagnose rare disease through telemedicine. You have to have these patients face to face going through history, you know, for a long time. You have to do multiple testing to really get to the underlying condition as opposed to the symptoms that these people are exhibiting. We are seeing a return as things return to normal in terms of physician office access, hospital access, testing, coming back online. During COVID and just after, you know, COVID started to apparently subside, although we're still seemingly in different waves, you couldn't. You know, it was months and months even in the U.S. even to get an MRI done.

The specialized testing that has to get done for patients coming in takes time and access. I think, you know, I'm still very, very bullish, as you might tell, on IG and the growth that we see from a demand perspective, from a patient perspective, and an efficacy perspective. I'm very positive on it.

Saul Hadassin
Vice President and Equity Analyst, Barrenjoey

Thanks, Paul. Just to follow up on that, you know, the commentary around albumin was probably a little bit softer than what we had expected, commentary around competitive pressures, pricing, and I guess even just the underlying demand profile. Where is the confidence still there that you can maintain two core proteins per last year over the next few years?

Paul Perreault
CEO and Managing Director, CSL Ltd

Yeah. Yeah, I think the demand for albumin in China was pretty strong. The problem with Europe is they had to go to other things because it wasn't widely available. It still goes back to the plasma collection issue over the last couple of years. You know, that's really the impact. When there's more product available, I feel very confident that albumin will be there, and China still continues to be a key driver for sure. It's just that everybody also understands that, and that's why the pricing pressures, you know, just get a bit more tight in terms of the competitive nature of the beast, right? I think that's kind of what I was trying to get across.

Mark Dehring
Head of Investor Relations, CSL Ltd

Thanks, Saul. Next question comes from David Low at JP Morgan. Go ahead, David.

David Low
Research Analyst, JPMorgan

Look, just starting with the plasma collections. I mean, we see the strong growth. It's been reported by your competitors as well. Just wondering how you think we should think about that extrapolating into sales. I mean, is that 20%+ growth in volumes gonna contribute to that level of growth in volumes of immunoglobulin and albumin in 2023, FY 2023?

Paul Perreault
CEO and Managing Director, CSL Ltd

David, I think, you know, as we take a look. Remember, we don't start with 24% sitting ready to sell, right? I mean, this is a python that swallowed a goat. You know, it takes a long time for this to pass through the system. That 24% didn't come all in one month. It's been coming as we go, right? It has to go through our long production process that we've talked about. It gives us confidence in our 23 numbers for sure, but we're also been running on fumes, right? I mean, our inventory levels have been, you know, exhausted pretty much to a point where we have a safety stock for sure, 'cause we wanna take care of patients.

We've also had to limit growth in other countries because of the amount of finished goods inventory that we had going forward from the last couple of years of plasma collection. I think as you think about it, you know, think about the fact that, you know, we have to get those inventory levels back up. I mean, if I had more product to sell, you would've seen an even better, you know, growth in the second half than the 6% of IG, and that just shows the underlying demand. You can't just extrapolate that, you know, we've collected 24% more, that it's all sitting there ready to pump out IG tomorrow. It'll happen over the course of the year.

I would say that the exit rate coming out of the second half, moving into the first half is going to be strong, second half will be stronger, and it really gives me confidence moving past that. Obviously not giving guidance to 2024, but I think it's really important to understand as you do because, you know, we've all been looking at this a long time, these long lead cycles to making sure that we can get it out in the appropriate time and get it into the markets to sell. That's why.

You know, I mean it's. You do the math and you say, "Well, 24%, you'll probably get 20-22% growth on IG." It just takes a bit more effort to get it through the pipe and make that happen while we're building inventory and supplying the markets that need the supply.

David Low
Research Analyst, JPMorgan

No, that's crystal clear, but I thought it was worth clarifying. The other question I had was CapEx. I mean, Paul, you talked about all the collection centers. You talked about the Bern capacity coming on. I believe Melbourne's not so far behind as well. Is there less of a need to expand capacity now that all of that, all those collection centers and fractionation capacity is coming online?

Paul Perreault
CEO and Managing Director, CSL Ltd

Look, it helps in the near term, David, but I would say that because these facilities take, you know, 5-6 years to actually build and get validated and licensed, we're looking towards our 2030 strategy because we do look out 10 years because of the long lead times in the business. I would say that there still will be some capital that needs to go. I mean, you know, we're just finishing off some other large capital projects. We have this new R&D facility in Marburg, which will have the capacity to house 600 scientists. We have the new headquarters here in Melbourne, which also has a number of floors of lab space, plus 2 floors of incubator space to help, you know, support the biotech infrastructure here in Australia.

We have Banksia going on, which is out of Tullamarine for the cell culture facility. There's still some big projects to complete and to continue, and we're looking at when we might have to start the next project. We are obviously trying to manage that very closely and carefully. We are still concerned about return on invested capital, so we wanna make sure that whatever we invest in, it's the right time. We wanna utilize the facilities that we have built, you know, in the appropriate way. When you start them up, we're also looking at, you know, the startup times and seeing if we can do something more efficient on the startup of some of these facilities now that they're completed.

Mark Dehring
Head of Investor Relations, CSL Ltd

Thanks, David. Next question comes from Chris Cooper at Goldman Sachs. Go ahead, Chris.

Chris Cooper
Research Analyst, Goldman Sachs

Thanks, Mark. Joy, just on the Behring gross margins, you said in February you expected them to bottom out in the second half of 2022, and then continue to recover from there. I just want to confirm that was still the expectation. You did state on this call, the gross margin recovery was delayed by Omicron and staffing, but I wasn't clear whether [audio distortion]

Joy Linton
CFO, CSL Ltd

Thanks, Chris, for your question. Clearly in Feb we didn't anticipate the length of time that Omicron was going to hang around and the impacts on staffing, as Paul's articulated, the additional costs to retain our staff. Really in the northern hemisphere, there was that peak in kind of January, February with Omicron, but then again in and around Easter. April was a very sort of challenging month as well. It was really only into May where we really started to see, you know, plasma collections coming back. Those first four months of the year were pretty expensive months in terms of cost per liter. That is all still to come through in FY 2023.

Yes, there is a delay in the return on the gross margin, and we will see a little bit more downward pressure on gross margin in the first half of FY 2023.

Chris Cooper
Research Analyst, Goldman Sachs

Got it. Okay. Perhaps a more specific question on that cost dynamic into fiscal 2023. Collection costs, obviously one of your competitors very notably commented that they were reducing donor compensation by 15% in the June quarter. Are you seeing anything similar to that across your network at the moment in the U.S.?

Paul Perreault
CEO and Managing Director, CSL Ltd

We haven't really seen anything that tells us that it's wholesale across all the areas. Like most of our friends in the industry, you know, everything is kind of local, right? It's a massive country and the local environment is something that's there too. In some centers we have seen where competition might be not as pervasive, where you've seen some adjustment in donor fees. I think the new donor fees are one area to look at for maybe some relief.

You know, you're only talking about somewhere between 4%-6% of the donors coming through the door are new or lapsed donors that have to be quote, "a new donor again coming into the system." I think everyone is certainly working on their cost structures. Donor fees is only one part though, as you know, Chris. There's other areas that we're working on, and one of the things will be the new platform that we're putting in place, which, you know, is gonna reduce the time on the beds for these donors.

As we roll this out to all of our centers this year, that's gonna be a massive change for people in terms of time for money, because, you know, over a 30% decrease in time on the bed and on the machine is significant. We will look for ways to continue to be aggressive and competitive, but also make sure that we're gaining the value for the investments and innovation that we've made.

Mark Dehring
Head of Investor Relations, CSL Ltd

Good. Thanks, Chris. Next question comes from Sean Laaman at Morgan Stanley. Go ahead, Sean.

Sean Laaman
Research Analyst, Morgan Stanley

Thank you, Mark. Good morning, Paul and Joy. Hope you're both well. My question also relates to cost of plasma and gross margin. You know, thinking about some of those elements, you know, the volumes of plasma on a fixed cost base, and the fixed cost base has been expanding as you roll out centers and donor fees, the staff in the center and then what Rika could mean for the business going forward. Thinking about some of those elements, Paul, I wonder if you give us a brief comments again on each of them. If you know, some of them might actually prove to be quite positive.

I mean, if you can get some of those less efficient new centers up and running, you know, if donor fees somewhat normalize, and then Rika yields some benefit. If we look into 2024, do you think you can get sort of gross margin higher than pre-pandemic levels? Just all that, some commentary as a question would be really useful.

Paul Perreault
CEO and Managing Director, CSL Ltd

Yeah, thanks. Look, I am doing well. Thanks for asking, Sean. I would say that, you know, the complexity of this business tells us that there are 1,000 different levers that we're gonna have to push and pull to get to, you know, the benefits of all of these items. Because, you know, the first thing we have to do is, as you said, you know, get our centers up to snuff in terms of the ones we've already opened, and to actually get some of that latent capacity. I mentioned the number of beds and the percentage of beds that we had to take out during social distancing with COVID back into the centers, because we're gonna need those beds with Rika, right? So we need the amount of beds.

If we're gonna be turning the beds quicker, because the donors spend less time in the centers and on the machines, we need to make sure that we have, you know, the bays filled, and these donors really moving through the system. Time is money, you know. If you can spend, you know, 30% less time in our centers than the competition, then, you know, for a change in a dollar or so for donor fee, they're more likely to come to our center than another. The other thing is that it's a more comfortable donation actually for the donor, and we believe, you know, the amount of time and the volume of red cells that you have outside the donor at any one time will make that very comfortable.

There's also, you don't have the cycles of the machine and the, you know, the pumping that people go through with their fist to try to get the volumes moving through during those cycles. There's so many pieces of Rika that makes so much sense from a technology standpoint and a safety and a comfortable donor experience that, you know, that's why we're so excited about, you know, getting it rolled out. Now, having said that, you know, there's a lot of execution that we have to stay focused on within that business, and part of it is the staffing, right? We have to make sure that we have staff available and ready when the donors come in the door.

As the donors have started to return, we've had to increase cost in terms of the infrastructure that we have and the salaries and the hourly wage that we've paid in that retail environment. You know, you see it here in Australia. I mean, I've been here now another couple of weeks and I was here in June and February, and you see that there's a lack of, you know, people working in the areas that in the service industry that even here in Australia. It's no different in the U.S., it's just bigger scale. You know, you take a look at that across the U.S. and it's been a major issue for us. We've invested significantly in that.

Getting those centers up and running is costly because you don't have the overhead, you know, recoveries that you'd like to see, with the number of liters flowing through. But as the liters increase in each of those centers and we're doing everything we can to do that through the digital app and the digital analytics that we've involved, as well as actually contacting the donors digitally, has really paid off in terms of the marketing efforts. Like I say, you know, almost 2 million people have been reached through that new app, which is fantastic. We saw some really good metrics in terms of donors coming back to CSL.

As we take a look out, the gross margins and where they return to, you know, are a bit delayed, as Joy pointed out, with, you know, things being a little bit slower than what we had predicted at half year. It's timing. You know, it's timing. It'll start to come back. We have to get the overheads not only through the plasma centers but through the plants. As we continue to put more volume through the plants, then we'll get the overhead recovery on the COGS and, you know, we'll hopefully that'll flow back down through the margins.

You know, all of this, including, you know, whatever price we might be able to, you know, work on, which we've done, I think, a very good job over the last couple of years on pricing as we've had to allocate product in different markets and been very judicious on tenders that we participate in. All of that has helped us to make sure that, you know, we're pulling on all the levers as well as, you know, managing our expenses as it flows down through from margin into the EBIT line and hopefully to the profit line.

All in all, I'd say complex as usual, but I think we have all of the levers that we're pushing and pulling on to make sure that we get back to, you know, the expectations which are high, I know, for us. Happy to take the challenge on.

Sean Laaman
Research Analyst, Morgan Stanley

Great. Thanks, Paul. Just one quick follow-up. I just wanna check I've got the timelines right on 112 and the commentary that you provided. It's 80% completed on the recruitment front. Maybe you get to 100% by the end of the calendar year, I think you said, then 12 months to complete the trial and then maybe 12 months to do the analysis to release the headline data. Did I get that right?

Paul Perreault
CEO and Managing Director, CSL Ltd

No. I think the end of this fiscal year for the completion of the trial is what we're expecting. Of course, that's been delayed, you know, through COVID. We expected to already have it completed. But after the completion of the trial, it'll take us, you know, about 12 months to get all the top-line data and everything released. Depending on how fast we can get that data done, it might be eight months after that, it could be 10. Just depends on, you know, the data, the complexity, and the analysis it has to do. I would say before the end of calendar 2023, we should have the top-line data and the understanding as to where we are.

Mark Dehring
Head of Investor Relations, CSL Ltd

Thanks, Sean. Next question comes from Gretel Janu at Credit Suisse. Go ahead, Gretel.

Gretel Janu
Stock Analyst, Credit Suisse

Thanks, Mark. Just going back to the guidance. It does imply costs will continue to remain elevated. We've talked through gross margin in quite a bit of detail, but just wondering if you could make any explicit commentaries around guidance for SG&A costs and R&D.

Joy Linton
CFO, CSL Ltd

Thanks, Gretel, for your question. I think you'll see on SG&A, we've actually done a pretty good job of managing those costs. Notwithstanding, we are investing in Etranacogene , which we're hopeful will come to market. We're doing quite a lot of pre-launch marketing activity on that as we speak. You know, that particular cost aside, I think you can expect that our underlying SG&A will remain well controlled in the next period of time. In terms of R&D, I think you know, our guidance is 10%-11% and see no reason for that to be any different going forward. As Paul's outlined, we have a big load of programs coming to fruition, hopefully in the next period of time.

We're continuing to invest in R&D.

Gretel Janu
Stock Analyst, Credit Suisse

Just in terms of HAEGARDA, the growth is slow in second half 2022. Are you seeing significant pressure from bulk product? I guess, how do we think about this product now going into FY 2023? Is it now more of a low- to mid-single-digit growth product?

Paul Perreault
CEO and Managing Director, CSL Ltd

No, look, I think now that patients. Again, this goes back, Gretel, to you know, the COVID environment and diagnosing these diseases, people having access to the hospitals. You know, a lot of these patients that present are in emergency situations, but not always. You know, you still have to have the people diagnosing this disease and the people available. I'd say that the demand. You know, patients haven't stopped getting disease or getting sick just because COVID's been around. This demand piece is something that I wanna make sure that everybody's clear on. The demand for IG, the demand for these specialty products has not gone away just because COVID has been around. These patients are still sick, still need to be diagnosed, and this is the process with rare disease. I

You know, what the percentage of growth will be interesting to see. I would say there are competitors out there. I wouldn't say that, you know. Let me just say that you need to have a product that isn't going to give you any attacks. You know, that's not the case with all of our competitors. I would say that the data on HAEGARDA and with the data that, you know, the top-line data that, you know, we've seen with garadacimab, you know, I think we're gonna be in very good shape in the HAE community. We've been there for a long time. There has been cannibalization of BERINERT as people have moved to, you know, longer-term prophylaxis. They're going to longer-term prophylaxis with HAEGARDA because they haven't had attacks.

I think there's still a lot more growth to come with HAEGARDA, and then hopefully also with garadacimab as we move that through the pipe. Look, I would just say that specialty is a little bit of an area that I get excited about, just because I can remember the days when we talked about trying to get the franchise to $800 million, and nobody believed me then. That's fine. I think we're at $1.8 billion now. Products like Kcentra and HAEGARDA are transformational for these patients. I just think that there's some real value here because that's what we're about, is continuing to innovate. If we have to disrupt ourselves, then we will.

We wanna bring the best to the market, and HAEGARDA is much better than some of the competition, that is currently available.

Mark Dehring
Head of Investor Relations, CSL Ltd

Good. Thanks, Gretel. Next question comes from Steve Wheen at Jarden. Go ahead, Steve.

Steve Wheen
Managing Director and Head of Healthcare, Jarden

Thanks, Mark. Paul, hi. I just wanted to go back to the guidance, particularly around the top line, the 7%-11%, and you know, think about that in the context of IG growth, because I just wonder to what extent is IG growth being constrained by your efforts to rebuild inventory over the next year?

Paul Perreault
CEO and Managing Director, CSL Ltd

Yeah. Thanks, Steve. I would just say that we're going to grow as fast as we can with the appropriate caveat of building back that finished goods inventory. You know, if we continue to see, remembering that anything we're collecting starting like the next couple of weeks really goes into next fiscal year, not 2023. What's already been collected has been collected. Now it's you know, up to Paul McKenzie sitting next to me here and his group to make sure that we have all the available slots and production lines ready to go. Now having said that, you know, it does take time to get it through, fill finish, et cetera, labeling, et cetera, blah, blah.

We have the various markets in Europe that need to be replenished as well as you know making sure that patients around the globe have access. It's hard for me to give you an exact number between the finished goods inventory and the growth, but just say I've never been shy about trying to get additional growth.

Steve Wheen
Managing Director and Head of Healthcare, Jarden

Yeah. Okay. Fair enough. With regards to those new products that are coming in with garadacimab into HAE and Etranacogene into Hem B, if you could have a comment as to do you expect to see some cannibalization of your existing product? If so, is that mix change that might ensue if those products are approved? Does that mix change cause a margin benefit or accretion as a result?

Paul Perreault
CEO and Managing Director, CSL Ltd

Yeah, sure. Look, I think garadacimab, the answer would be yes. It would be cannibalization, but it would be, I would say, market share gains as well based on the product profile, right? From others outside of my own product portfolio. The main thing that drives us, as you know, Steve, is to make sure that we have the most innovative, differentiated, best product and efficacy and safety available for patients. If that's what we're delivering with garadacimab, then I would expect it to do really well and be a good earner for the company. In terms of Etranacogene, I'd say that, yes, this is a potentially transformational product for gene therapy. It'd be the first gene therapy in hemophilia and really in Hem B, a smaller market than Hemophilia A, of course.

I would say that from that perspective, it's also a gene therapy that, you know, is under a lot of scrutiny by both patients and regulators. Not saying that it's not going to get approved by any stretch, but all I would say is that, you know, people will be picking and choosing when they start that program. It's not going to be indicated for the pediatrics at first, for sure. So there's going to be, you know, a more limited start. I would say over the next couple of years, it will continue to deliver, and it will be a good earner as well because it is basically, you know, we're looking at sustainability data out, you know, for a long time with one dose.

Yes, I would say that, you know, the changeover would be quite helpful from a margin perspective.

Mark Dehring
Head of Investor Relations, CSL Ltd

Good. Thanks, Steve. Next question comes from David Bailey at Macquarie. Go ahead, David.

David Bailey
Senior Analyst, Macquarie

Yeah, thanks, Mark. Hi, Paul and Joy. Just maybe on Seqirus. The last couple of years, we've seen some good revenue growth on the back of mix shift, and that's also supported some gross margin expansion. I'm just wondering if you think that there's still room for higher growth of higher-priced products into 2023 and any quantification of benefits from the completion of the expansion at Holly Springs and Liverpool would be good too.

Paul Perreault
CEO and Managing Director, CSL Ltd

Yeah, look, David, I think there's a couple of things. The real-world effectiveness data that's also being generated with Flucelvax and Fluad has been fantastic. This will expand and continue to expand the strategy we had of innovative, differentiated, higher priced products because of the technology and the efficacy that it's shown. You know, these are the things that make a difference, as you know. You know, one of the key drivers of our growth is differentiated products and, you know, a portfolio that's high value. I think there's still a lot of room to grow. There's more people that want these products around the globe. It's hard in the northern hemisphere, which is the main markets, right, is to get it all out at the same time because everybody wants it all at the same time.

That's why we've invested in capacity, fill and finish, yield. You know, one of the things that people may not be aware of, you know, is I haven't lost my way at CSL. You know, it's yield. Yield is gold, right? So it's not only yield in IG, right? So we're working, and we have programs going on yield improvements in influenza as well. So that's the thing where, you know, we continue to drive the basics of what's gotten us to where we've gotten to today. I haven't forgotten about the things that, you know, are the key drivers for CSL. Yield, whether it's cell culture or plasma, is gold. So we'll continue to move on that. The differentiation, you look at the recommendation that we had in the U.S..

I'm sure that there are some people that also, you know, I compete with that weren't happy with the recommendation. You know, the data proves the way. You know, this is indicated for 65 years and older with FLUAD, and it is a preferential product for the elderly because it is what the elderly needs. You need the adjuvanted, you know, vaccine for those people that have immunosenescence so that the immune system can compensate. The value of this portfolio continues to expand. The ask from people continue to come, you know, we're building a new cell culture facility in Tullamarine that's not a small facility. I wouldn't be building it if I didn't think there was more to come, David. I do think there's a lot more in Seqirus.

David Bailey
Senior Analyst, Macquarie

Just maybe just interested in your thoughts around the supply and demand of plasma. I mean, the industry's added quite a few more centers over the past couple of years. Just thinking medium to longer term, you know, do you think there's a risk of or potential for oversupply, or do you think you need to have these centers to meet the demand for IG and other products? But then on the demand side, again, I'd also be interested in, you know, how material new patients are to demand for IG versus existing users as well.

Paul Perreault
CEO and Managing Director, CSL Ltd

Yeah, sure. No, look, the demand is there. I'm convinced that the medical demand is there. That you can go back to, you know, I've been around long enough to remember the early 2000s when there were real shortages of IG in the marketplace. You know, the demand was always there, and people were worried, "Oh, well, there's all this oversupply." Well, it's because people were still hoarding product because they didn't think we were coming out of the shortage. Once they finally realized they could prescribe IG with confidence, there was nothing but a straight upward line in terms of uptake. The demand was just constrained by the fact that people were constraining the supply, even though manufacturers were continuing to build that supply. Thank goodness we did, because we needed it, coming out of that era.

Here, when you look at the amount of IG that the industry is producing, you know, I mean, it is more than 10 times what it was back in those days. To oversupply, you know, would mean that somebody would have to collect, manufacture, and be holding, you know, like a year's supply just to oversupply. Because you can oversupply for a month or two, maybe, but it goes back to the question I had earlier about, you know, the 24% increase. It's in the pipeline. It takes time. If you sell it all in one month, then you're gonna be short the next month. You know, it's gonna be really hard to oversupply for any one company. The raw material is key, obviously. You can't make orange juice without oranges, right?

You have to make sure that you have that precious raw material that these wonderful donors, you know, show up and stick their arm out to provide us every single day. By the same token, you have to have an infrastructure that's of scale when you're the scaled player in the industry. I have no doubt that we've done the appropriate things. This year we will still have some new centers on the books, but not as many as last year. Because you know what? We have to focus. We have to get those centers that we've already put in place up and running. We got to get the beds back in the centers. By the way, I have to change the engines while we're flying the plane to get the new platform for plasmapheresis implemented in all the centers.

Yes, I think the demand's there. Yield helps because that limits the number of new centers you have to build if you can get some significant improvements in yield. You know, if you can get more plasma from the individual centers by having donors spend less time on the beds, that's also a benefit for us. We take all of that into consideration when we look at our projections for investment and the number of centers that we need to open.

Mark Dehring
Head of Investor Relations, CSL Ltd

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

David Stanton
Head of Australian Healthcare Research, Jefferies

Good afternoon, everyone. I hope everyone's well. Thank you for taking my questions. Just following up on David Bailey's question, actually. You know, you've got adjuvanted egg vaccines in Seqirus over 50% of revenue now. You know, what can that get to going forward, do you think? Is it gonna top out at circa 70% or stay, you know, approximately where it is now?

Paul Perreault
CEO and Managing Director, CSL Ltd

Well, look, I'd say it's in. Thanks, David. Yes, I hope you're doing well too. I think that you know, the egg adjuvanted vaccine needs to move on to cell adjuvanted, right? I mean, that's our goal, is to continue to innovate that product from egg to cell, and that's where our clinical focus you know in that area is being focused right now in the R&D portfolio, and Seqirus is in that area. I would say that where will it top out? It depends on how we expand the market, right? I think there's still not enough people getting vaccinated for flu. You know, you have to take into consideration the current vaccination rates, you know, to that percentage where we've climbed and what that percentage rate would be.

I mean, if it stayed static, but I expanded the market further, then I'm fine, right? That, that's the question, but I can just tell you that our plan is that we see a continued need for continuing to improve not only the process and the product, but also the volumes that we're producing. You saw that big increase. It just shows again, you know, our ability to compete with some very big competitors in the marketplace. I'm very proud of the team. They've done a heck of a job. You know, of course, like you all expect me, I expect that they'll continue to do better than they tell me. How's that?

David Stanton
Head of Australian Healthcare Research, Jefferies

Understood. Thank you. Perhaps a question for Joy in my second question. Could you give us the net transaction fees you paid for Vifor in 2022 and what you expect those to be in 2023, please?

Joy Linton
CFO, CSL Ltd

Yeah. Thanks, David. If I'll point you to note two of the accounts which go through it in all its glorious detail, it does come out to at an NPAT basis a little bit over AUD 60 million in the financial year. I think our guidance back at December was that it was kind of circa AUD 200 million all up, and our view on that hasn't changed.

Mark Dehring
Head of Investor Relations, CSL Ltd

Thanks, David. Next question comes from Craig Wong-Pan at Royal Bank of Canada. Go ahead, Craig.

Craig Wong-Pan
Director and Senior Equity Analyst, RBC Capital Markets

Great. Thanks. Just with the collections in our beds that were temporarily removed during COVID, there was the point made that you can put about 5% of beds back into those centers. I was wondering how much of that 5% has been put back at the end of June or what timeline you expect those beds to be put back in?

Paul Perreault
CEO and Managing Director, CSL Ltd

Yeah, thank you. We actually took out 10% of beds, and we still have about 5% to put back in. We've already put back in 5%, and it really depends on the local jurisdictions and the current, you know, social distancing that still goes on in certain counties of, you know, certain cities of certain states in the U.S.. It's all local. That's the reason that we haven't put all the beds back in yet, is that it really depends on the local requirements for COVID. And the, you know, some areas are, you know, I would say a bit tighter than others. We have about 5% left to go and, you know, hopefully through the course of this year, we can put those back in.

Craig Wong-Pan
Director and Senior Equity Analyst, RBC Capital Markets

Okay. Thanks for clarifying. Then the second question, just around donors, and you've mentioned there were a few marketing initiatives and engagement with lapsed donors that saw your increase in collections. I was wondering whether your information shows whether there's been any donors returning because of higher cost of living or economic conditions. I was wondering whether those factors have had any influence on those donors coming back.

Paul Perreault
CEO and Managing Director, CSL Ltd

Absolutely. You know, inflation's running about 9% in the U.S.. The gig economy is, you know, somewhat full. You know, there's enough Ubers around at the moment, and other things. I would just say that, people are feeling the pinch. You know, petrol prices, even though, you know, the current administration will claim that it's come down, which it has over the last, you know, couple of months, it's still higher than it was a year ago. Everybody's feeling it, and this is a time when new donors, you know, and our marketing efforts get people aware of what we actually do in these centers that they drive by every day. 'Cause unless you've been in, you don't know what goes on, right? It's really about the marketing campaigns and getting people back.

Some of them are lapsed donors, and, you know, if you've been out of our system for more than six months, you have to present again as a new donor. So we call those lapsed donors. They're familiar with donation and they lapse for certain reasons. I mean, it could be that they got a new job, they went part-time to full-time, they had children, they got to stay at home, they've left college, so they actually graduated, which, you know, that's always a good thing, if you're going to college. They then are not in the same areas where the plasma centers were located. So people move around the U.S. quite a bit. All of those are reasons that people may lapse, and then during this time, the economy does have an impact.

Mark Dehring
Head of Investor Relations, CSL Ltd

Thanks, Craig. Next question comes from John Deakin-Bell at Citigroup. Go ahead, John.

John Deakin-Bell
Director of Research, Citi

Thanks, Mark. A quick question for Joy. Apologies for getting into the detail. On that note one segment information, looking at the gross margin there, you've got segment gross profits for 2022 53.3%. If we look at the second half, it's 52.5%. That includes this COVID revenue and profit, which is very high. If I back that out, it looks like the gross margin is kind of 51-51.5%. You said the first half 2023 gross margin is going to be lower. Obviously, the COVID doesn't repeat. Can you confirm that, you know, ex COVID margin's probably 100 basis points lower, the gross margin in the first half is gonna be more like 51 or 52%?

Joy Linton
CFO, CSL Ltd

Without confirming your exact numbers, you're directionally correct, John. Yep.

John Deakin-Bell
Director of Research, Citi

Okay. Okay, thank you. Just on the outlook slide, you talked about the early data indicates no change to the contribution from Vifor. I know you're gonna talk about it in October. We need to forecast it now. Can we assume from that those EPS accretion numbers that you put out at the time of the acquisition, that they're all still valid?

Joy Linton
CFO, CSL Ltd

I think what we would say is we're not in a position to do a positive validation of them. What we can say is based on what we've seen to date, we have no reason to suggest that they're, you know, it's a bit more of a negative assurance perhaps, John, rather than a positive one. I can't sit here and validate it because I haven't actually got all the data yet. Based on what we have seen, we don't see anything yet that would suggest it's not still valid. That's correct.

John Deakin-Bell
Director of Research, Citi

Okay, thanks very much.

Joy Linton
CFO, CSL Ltd

Apologies for the nuance, but hopefully you can appreciate the position we're in on that.

Mark Dehring
Head of Investor Relations, CSL Ltd

Cool.

Joy Linton
CFO, CSL Ltd

I think what we would say is, you know, we've seen the bank account and the cash is very strong, which is very encouraging.

Mark Dehring
Head of Investor Relations, CSL Ltd

Thanks, John. Next question comes from Andrew Paine at CLSA. Go ahead, Andrew. Andrew, you're on mute? Okay, we're not hearing you, Andrew. Maybe we can circle back afterwards and have a chat. Next question comes from Lyanne Harrison at Bank of America. Go ahead, Lyanne.

Lyanne Harrison
Research Analyst, Bank of America

Yeah, good afternoon all. Can I just follow up on those questions on Seqirus? You know, as we head into the Northern Hemisphere winter, how does demand and negotiated prices compare to where you were this time last year?

Paul Perreault
CEO and Managing Director, CSL Ltd

I think we're in pretty good shape, Lyanne. It's you know, we. There's clearly, you know, a lot happening in the markets in the U.S., but I would say that we've done very well on the negotiations and on the delivery actually. We were first to market in the U.S.. We had a lot of releases in July, which is quite early. That bodes well for the rest of the season because, you know, the sooner you get out, the sooner it gets into arms and the less returns you have at the end of the year. I'm pretty confident that Seqirus is on the right track so far.

Lyanne Harrison
Research Analyst, Bank of America

Okay. Thank you. Just one final question for Joy on the inventory. Obviously, we've seen the inventory balance go up 15% as at June. Can you give us an indication of how much of that increase is volume versus cost?

Joy Linton
CFO, CSL Ltd

Thanks, Lyanne, for your question. I'm not sure I have a split between the two at hand. It's both, right? You should think about it both as higher volume coming through off the back of higher plasma collections, but clearly the cost is higher, as the year has gone on as well. It's also got Seqirus timing of Seqirus in there as well. Yeah, it's both, Lyanne. Yeah.

Lyanne Harrison
Research Analyst, Bank of America

Okay. Thank you very much.

Mark Dehring
Head of Investor Relations, CSL Ltd

Good. Thanks. Thanks, Lyanne. We'll need to draw to a close very soon, so we'll need to make the next question our last, and that's from David Nayagam at Evans & Partners. Go ahead, David.

David Nayagam
Executive Director, Evans & Partners

Well, thanks very much for taking the question. Just these are actually just a couple of high-level questions. Firstly, you know, you've noted the strong culture and employee satisfaction, which is very admirable, and recognize, you know, I think this is happening in the backdrop of, you know, global staffing challenges, which you've also mentioned that, you know, you described the Omicron wave impacting on that. And then you've also talked about your ongoing investments in pipeline R&D. Just curious, what are your strategies to continue to attract, you know, the key research, the collection staff, other key people? And what impact do you expect this will have on your OpEx and salary lines going forward?

Paul Perreault
CEO and Managing Director, CSL Ltd

Well, look, I guess it's one of those things where we continually look at our employment staff and what our ability is to retain and attract, how competitive we are in the marketplace. All of those things go into our thinking and our projections. You know, once you add people to staff, you know, then, you know, there's cost incurred, and we're looking for value as well. One of the things we try to do is to make sure that we're focused as an organization, David, to make sure that we only hire when we need people to actually do the hard yards, right? It's easy to lose your way, and R&D is one of those areas where there's a lot of, I mean, there are billions and billions of wasted money in R&D in our industry.

It's because there's a lot of pet projects, a lot of things that, you know, companies focus on that don't deliver, but everybody's afraid to stop them because, you know, everybody has their favorites. I've seen it for a very long time, and that's why Bill Mezzanotte, our head of R&D, and myself sit and review every single project in our portfolio twice a year to really make sure that we're focused on the right areas, that we've seen progress or not progress. We'll stop projects, which is not popular in the company. I still probably have some people mad at me for projects we've stopped through the years.

You know, it's because, you know, the science is good, but if it's not gonna see a benefit for patients or see a commercialization of the product, then why are we doing it, right? I mean, you have to do some basic science to get the data and move it through. You know, people wanna deliver and we need to deliver because that's the only reason we exist, is to take care of patients and protect human health. Without that, we shouldn't be in business. It's really important to me that we focus as an organization. I think when people come in sometimes from other big organizations, they see that we actually, you know, expect them to do the work.

Many people are energized by that because even though we're a big company, and, you know, there is bureaucracy because, you know, David, if you and I started a company together, we'd probably have politics with just the two of us. You know, that's the way people are at times. We have to earn the trust, and we have to earn the delivery, and we have to earn the culture and have people really living the culture. Holding people accountable for what they do in the culture is also important. When we do objectives, it's not just, did you do the job, but how did you get it done? We hold people to that. That's what you have to do if you're gonna drive a culture in the organization. Having said that, people are expensive, and it's gotten more expensive.

We do need to be competitive. We're a global organization. We have people in over thirty-eight countries. We have now with CSL Vifor 30,000 employees. It's a big business with a lot of people. We have to make sure that we're competitive. I think we're doing the right things. It's just a constant talking, collaborating, explaining, communicating with the employees in terms of our mission, our vision, and what we're trying to achieve for patients around the globe and connecting them with patients. Whether it's plasma donors, whether it's employees, we try to connect them with the patients that we're serving so that they see what we're doing. A lot of companies say that, but what I hear from people we've hired is we actually mean it.

I think that's an important piece of what we do. Long way of saying it'll cost us more to get the right talent, but that's the global environment. It's not gonna break the bank. You know, we'll continue to make sure we have the right skills. As I tell people when I interview them, because, you know, when I'm interviewing people, if a recruiter sends me somebody that doesn't have the skills, they won't be used again, right? That's your ticket to entry. I mean, they better have the skills. What I wanna know, are they good people? Are they people that can work within our culture and live the culture? That's made a difference, I think, at CSL.

Hopefully, I'm not kidding myself, but, you know, the numbers and the responses from our employees seem to be pretty positive. I think we're on the right track. Look, we're not perfect. You know, there's no organization that is, but we try hard.

David Nayagam
Executive Director, Evans & Partners

Oh, that's a great answer. Thanks, Paul. Thanks to that, of course, very happy to start a company with you anytime. If I could quickly ask my second question, with COVID, you know, bringing mRNA vaccines to the forefront, and then, of course, CSL investing in your mRNA facility and competitors doing so too, as we know it in Victoria, in particular, what are your thoughts on this change in the vaccine technology just at a high level and obviously, it seems to lead to some higher margin growth. But what about the regulatory changes that need to accompany this? How long do you see this playing out over assuming it won't be an instant change and you know, years to ramp up to peak sales with new technologies?

Just general thoughts, I guess.

Paul Perreault
CEO and Managing Director, CSL Ltd

Thanks, David. Look, I think it'll take time. You know, there is no burning platform to have an mRNA flu vaccine, right? There's plenty of vaccine available today. We're making more, we can still make it. There's no emergency use authorization that's gonna be needed just because it says mRNA in front of it, right? I think that, you know, as we go forward, you know, the mRNA technology is quite promising, I think for a number of areas, including therapeutics. There's not gonna be, you know, just because it says mRNA that everybody's gonna get it through without doing the hard yards. This is gonna take your normal process of clinical development, clinical trials, data analysis, you know, without any fast-track approvals just because of the technology platform.

You know, COVID was an impetus for quick approvals with a lot of data, so it's not done without the right data, but it was an emergency approval. The going through that process again, when you don't have that really you know spark that you need to deliver billions of doses to the world is gonna take more time. What you're looking for again is differentiation. We've seen the issue with mRNA in its current state, which is, you know, the first state of mRNA, where you have issues with dose, you have issues with stability, you have issues with distribution and cold chain, and those need to be solved.

It's gonna take a while for us to get to the next generation, which is what we're working on in the self-amplifying space, to actually reduce dosing so that you don't have to put as much antigen in. Lord knows, if you wanna do a flu vaccine and you have four antigens, not just one, you know, spike virus that you're trying to inject into people, that you wanna make sure that you're not gonna have the reactivity that you've seen, you know, in the arms of people with the current mRNA COVID vaccine because of the dose with one particular virus.

If you're gonna do a combo vaccine, you know, the FDA and other regulators around the world for the last 30 years have not been fans of combination therapies because it's very difficult to tell, and especially with COVID and flu, for instance, you know, their symptoms are very similar. How are you gonna show the efficacy? You know, you might get it approved with immunogenic response and immunogenicity, but it's gonna take some time to sort through the variants, and then is it seasonal the same way as flu? Is it at the same time? Then you have the durability of the vaccine, right? Because we're on our, what? Fifth booster now, you know, in about a year and a half. I don't think people want more than one flu shot in a year.

There's a lot of work left to go. You know, it used to be called the art of medicine, and you know, we're very, you know, smart people these days, but there's still a lot of art left in some of this that we have to work through. That would be my overall comment.

Mark Dehring
Head of Investor Relations, CSL Ltd

Good. Thank you for your questions, David. Ladies and gentlemen, more broadly, thank you for your interest in CSL. I'll now draw the meeting to a close.

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