CSL Limited (ASX:CSL)
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Shareholder Briefing

May 29, 2023

Joy Linton
CFO, CSL

Well, good morning, ladies and gentlemen. You're coming to a CSL meeting, so we always start one minute early. My name's Joy Linton, and I'm the Chief Financial Officer at CSL, and I'm delighted to be here in Brisbane with you today. This is our first one of these meetings since the pandemic, and we've had a great response, and really delighted to see you all today. Thank you for coming. Thank you for your continued interest and support in CSL. This morning I'd like to give you an update on CSL, where we're at, and more importantly, where we're investing for the future. I'm going to speak for about half an hour and then leave plenty of time for your questions. I have some colleagues with me today who will answer the tricky questions.

I'm really delighted to introduce Mark Dehring, who is our Head of Investor Relations, Bernard Ronchi, who's running the slides in Investor Relations, and down the back, Stephen McKeon and Sonia, there is from Company Secretary. Thank you also to the Computershare people who are here supporting us today. Before I begin, just a little bit about me. I joined CSL in March 2021, still in the middle of the pandemic, as CFO. I've been with CSL just a little bit over two years. Before joining CSL, I was the Group Chief Financial Officer at Bupa. Many of you will know Bupa in Australia. It is also a British company. I was the Group CFO there in London for the last five years.

Prior to Bupa, I've had a range of senior finance roles, mostly in fast-moving consumer goods. I think I bring an interesting balance between 10 years in healthcare, more on the payer and provision side, but then also on the manufacturing. There's a lot of similarities between yogurt and blood. You can talk to me or milk and blood. You can talk to me about that later. As many of you know, CSL began more than a century ago as the Commonwealth Serum Laboratories under the Australian Government. It was set up to protect Australians from a pandemic, the Spanish pandemic of 1916 to 1918.

Today, we are a global biotech company, we develop and deliver innovative medicines that help people with serious and life-threatening conditions to live full lives and to protect the health of communities around the world. We aim to have market-leading positions in our chosen sectors, as you can see on the slide here, we are either number one or number two in the major sectors that we operate in. We've achieved a lot as a public company, we currently provide life-saving products to patients in more than 100 countries and employ around 32,000 people globally. About 10% of that employment is in Australia.

Around 2,000, further 2,000 employees are scientists in our research and development team, where we spend over $1 billion each year to develop our pipeline of new and innovative products. A little bit of an overview of the CSL Group. We have three business units. The first is CSL Behring. We develop and deliver innovative therapies for people living with rare and serious diseases across a range of therapeutic areas. In order to produce many of these therapies, we rely on human plasma. At CSL Plasma, we operate one of the world's largest and most sophisticated plasma collection networks, with nearly 350 plasma collection centers, primarily in the U.S., but also in Europe and China.

As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. I hope you've all had your flu shot for the winter. Last year, we acquired what is now known as CSL Vifor, a global partner of choice for pharmaceuticals and innovative leading therapies in iron deficiency and nephrology. On this next slide, you'll see a snapshot of CSL Behring's manufacturing facilities around the world and the major products that we produce at each location. As you can see, we have an extensive network of manufacturing sites, including Bern in Switzerland, Broadmeadows here in Australia, north of Melbourne, Marburg in Germany, Kankakee in the U.S., which is just south of Chicago, and Wuhan in central China.

For Seqirus, we have three large-scale manufacturing facilities across three continents: Parkville in Australia, which uses an egg-based production and is the only manufacturer in the Southern Hemisphere; Liverpool in the U.K., which also uses egg-based production and is the U.K.'s only injectable flu vaccine facility; and Holly Springs in North Carolina in the U.S. This facility utilizes cell culture technology for production, which is really the first major advancement in flu production in over 40 years. Our Holly Springs facility is the only cell culture facility of scale globally. We have just commenced building another state-of-the-art facility at Tullamarine in Melbourne, which will use that same cell culture innovative technology to produce cell-based influenza vaccines similar to Holly Springs.

It'll also use the CSL Seqirus adjuvant technology, along with producing products such as antivenoms and Q fever vaccine for the Australian market. Eventually, this facility will replace our current operations at Parkville. On the right-hand side of the slide, you can see our new business, CSL Vifor. Vifor has been a pioneer in the development of iron-based products, and we have a production site at St. Gallen in the east of Switzerland. On this slide, you'll see our financial performance over the last 10 years. Our revenue and net profit has more than doubled, with revenue for the last financial year reaching $10.6 billion, with a net profit of $2.3 billion, a compound average growth rate of 8% and 9%.

As a growth company, this has translated into a healthy return back to you, our shareholders, primarily through the growth in our share price, along with a compound average growth rate in dividends of 10%, with last year's dividend increasing to $2.22 per share. This is a strong and consistent growth, and that's what has enabled us to continue to reinvest back into the business, and this will underpin our future growth. I'll talk more about what we're doing on that later in the presentation. On this slide, our most recent financial results were announced in February this year for the half year, which was the six months to December 2022.

Like many businesses, we have felt the impact of the pandemic. Our long-term focus gives us confidence to selectively invest through cycles so that our operations can be, and are resilient to volatility in the external environment. I think our results in the first half of the financial year for FY 2023 really demonstrates this. In CSL Behring, our immunoglobulin franchise grew very strongly, and plasma collections have recovered to record levels. CSL Seqirus continued to deliver strong sales growth, driven by our high-value differentiated products. We've also committed to further evolution of our vaccine portfolio, and we announced a licensing agreement with a company called Arcturus Therapeutics for access to their late-stage self-amplifying mRNA technology. For CSL Vifor, we have ensured a smooth transition into the CSL group, and as a result, our cost synergy objectives are on track.

On the R&D side of CSL, we are very excited to have received FDA approval for HEMGENIX in the U.S., and we have now also got approval in Europe and the U.K. This is the first gene therapy product approved for patients with hemophilia B, and it's an important new therapy that will change people's lives and potentially be a cure for many patients. That's a bit about CSL and a snapshot of our recent financial performance. For the rest of the presentation, I want to turn to the factors that have underpinned our long-term sustainable growth and will continue to guide us through the future. There's three areas I'm going to focus on: firstly, our strategy, our approach to R&D, and our commitment to sustainability.

The first part's about strategy, and that might not come as a surprise to many of you, but I think what is often an underappreciated part of strategy is disciplined execution. CSL is a company that unashamedly operates with a long-term mindset. Our strategic direction has broadly been the same over the course of our history, but every five years or so, we refresh our forward view of the next decade, revising the guardrails, ensuring that we're responding to the external realities, and then translating that into our operational plans. Our strategy in its current form was devised in 2019, and that's up on the screen now. At the heart of our organization is our people and our culture, our values, and our commitment to patients and to public health. We have five key areas of our strategy, and it really starts with focus.

In the biotech industry, it's very easy to get distracted. There is so much potential to make so much difference to people's lives, so many problems to solve, and so much science to translate. CSL has typically been very deliberate about targeting areas where we know we can have a competitive advantage. Let me give you an example. Oncology. We believe this has become a very crowded space and one that we have deliberately chosen to stay out of. Instead, the manufacturer of plasma-derived therapies, now, that's a complex process we know well. We believe we've built a sustainable edge in collecting plasma and along with discovering new therapies, making and distributing these therapies, and we're confident that there remains significant unmet needs in these markets for a long time to come.

Innovation has also been vital to our success so far. It will continue to be in the future. CSL has a large and dynamic supply chain across our different businesses. As I mentioned, regardless of whether we're producing biologics or vaccines, these processes and operations are complex. We know that to remain a top-tier company, we need to focus not only on reliability, but maximizing efficiency. This manifests through technology and continuous improvement, but also sizable capital investment program. I'll illustrate this shortly. For the sustainable growth of the enterprise, we're committed to serving our populations with the best available therapies across our strategic scientific platforms. Again, a little bit of focus, but this is our focused area for sustainable growth: plasma fractionation, recombinant protein technologies, cell and gene therapies, preventative vaccines, and iron therapy.

The fifth area there you can see is digitization, because if you're not digitizing these days, you are gonna be left behind. So we're very focused on leveraging digital technologies where that makes sense. A key factor in enabling us to deliver for patients in a safe, efficient, reliable, and innovative manner today and in the future is through reinvestment in the business. Enduring organizations have many high-value capital allocation options. Optionality is a good problem to have, and it's one that our leadership team debates regularly. Over the last five years, between 60% to 70% of our capital expenditure has been targeted on capacity or growth initiatives that will not only help us in the proceeding five years, but actually for decades to come. A couple of examples.

One was the capital investment in the completion of a $150 million expansion at Holly Springs in North Carolina. On the plasma side of the business, last year, we celebrated the opening of a new $600 million plasma fractionation facility in Broadmeadows, and this investment will result in a nine-fold increase on current capacity at that site. Now on to the second area of long-term sustainable growth, and that's targeted R&D with persistent innovation. I think R&D and innovation, these terms are often used interchangeably and can get confused, so I actually think these are very separate but interrelated concepts. The areas that we have chosen to focus on are on the slide now. They are immunology, hematology, cardiovascular and metabolic, respiratory, transplant, vaccines, and iron and nephrology.

We're also expanding our global R&D footprint. In Marburg, in Germany, we have a new seven-story R&D campus that was opened last year, and it's the new home for over 500 scientists based in Germany. This year, we also opened a new R&D facility in Waltham, Massachusetts, and that will really serve as CSL's central hub for current and future vaccine design. Most recently, only last month, we moved into our new global headquarters in Melbourne's Parkville Biomedical Precinct, and that facility holds around 800 employees, including a number of our R&D scientists, and it includes a number of leading-edge laboratories and as well as space for external collaborators, innovators, and startup companies. Up on the screen here now, you'll see our R&D portfolio.

Now, it does look like a bit of abstract art, I know, with all its variety of colors and words, so don't get too worried about that. I'll explain broadly and then pull out a couple of examples on the following slides. On the left of the screen, you will see our early-stage candidates, and then as you move to the right, you see our more advanced potential therapies. The color coding actually relates to the seven therapeutic areas that I mentioned earlier. A long-term business like CSL requires this pipeline to have a good balance at all times, and that's actually quite a tricky thing to do. It often takes 10- 15 years to move from the preclinical idea all the way through to a phase III trial, and then to commercialize the product for the benefit of the patient.

We like this balance to occur within our overall R&D budget, and which has typically been between 10% and 11% of our revenues each year. On the next slide, this sort of zooms in on that right-hand side, showing some of our near-term target launches, and I want to highlight a few of those for you today. I'll start with what's referred to as CSL112. This is a potential new plasma-derived product for cardiovascular disease. You know, I'm sure you know, cardiovascular disease is a leading cause of death globally, with an estimated 800,000 acute heart attacks occurring each year in the U.S. alone. Patients who survive an acute attack are at a high risk of experiencing a recurrent cardiovascular event, CSL112 aims to reduce these subsequent events.

The last patient was recently enrolled into our phase III trial for CSL112. This is the largest trial CSL has ever conducted. We have over 18,000 patients enrolled globally, including some in Australia, and we expect to get a readout of the top-line data early next calendar year. Another example, hereditary angioedema is another rare genetic and potentially life-threatening condition. It causes painful, debilitating, and often unpredictable episodes of swelling of the abdomen, the face, the extremities, the larynx, and among other areas of the body. In February, we announced that our phase III study had showed that our homegrown monoclonal antibody garadacimab provided patients with a significant reduction in attacks and prevention of attacks with monthly dosing.

Based on this, we're hoping to make regulatory submissions to global health authorities through the course of this calendar year for the approval of garadacimab. The third example I'd like to call out is Injectafer. This is a CSL Vifor product. It's one of our flagship iron products, and it's the leading high-dose IV iron therapy segment of the market. It was launched 15 years ago, but we talk about it internally as being 15 years young, not 15 years old, and that's because we see this market as being significantly under-penetrated. In the U.S., a supplemental new drug application for the expanded indication of Injectafer for heart failure patients is currently under review by the FDA. If approved, that label change will support our efforts to build greater awareness of Injectafer among heart failure specialists.

Overall, we have a multitude of late-stage programs, and I've just called out three there that, you know, we're quite excited about, but remain uncertain, and they are well advanced and really coming to fruition over the next few years. It's an exciting time for CSL. Our pipeline is in a very strong position, and it really does set the company up for sustained and profitable growth into the future. Finally, to our third area of long-term sustainable growth, and that is our transparent commitment to sustainability. Now, sustainability has already been mentioned a few times today, but I want to talk about it now in a slightly different context. I want to start by talking about how does CSL create value?

By far and away, the most important way we create value is by contributing to a healthier and a more productive society, and this is by saving lives and protecting public health. The second aspect is financial growth. By delivering consistent, profitable growth for our investors, it's this, our financial growth, that provides the fuel for more innovation and more research. If done successfully, it is a great continuous loop, and CSL has been able to demonstrate this over many years. The third part is about our social and economic opportunity, enabling people to benefit as we grow as an organization, be that our employees, our suppliers, our plasma donors, or our research partners.

They're the three ways we create sustainable value, but of course, we know that we need to do this in the right way, and we need to do it in an environmentally and socially responsible way. In 2021, we renewed our sustainability strategy, and that is now the guiding path for CSL and our various stakeholders around the world. The strategy itself consists of three pillars, and we've identified these pillars as material to our business and where we plan to increase our engagement and accelerate our action over the long term. Many of you will notice that we haven't followed the much-promoted ESG framework, because to us, as an ASX Top five company, good governance has and always will be a non-negotiable.

Whereas we realize that there are many elements that make up a sustainable workforce, and that that is a really vital part of a sustainable future. Our three pillars are environment, social, and then sustainable workforce. In formalizing these pillars, we're actually not introducing entirely new goals to CSL. Across all three, we have been working for some time. Under the environmental pillar, last year, we made our first public commitment to reducing our carbon emissions. We announced that by 2030, the company would reduce our overall absolute Scope 1 and Scope 2 emissions by 40%, and also ensure that our suppliers, who contribute 2/3 of our Scope 3 emissions, have also set Scope 1 and Scope 2 target reductions aligned with the Science Based Targets initiative.

Both these targets are aligned with the goal of limiting global warming to the one and a half degrees Celsius. The achievement of our Scope 1 and Scope 2 emission reductions will occur through a number of abatement levers, including increasing energy efficiency, a push to more renewable power, switching fuels to less carbon-intensive energy sources, and actually redesigning some of our manufacturing sites. You'll notice that we didn't take the popular step of committing to net zero by 2050. I think this is a deliberate and important point. We operate to our 2030 strategy, so aligning those targets to that time frame has really enabled us to better incorporate into our detailed operational plans and actually gives us a higher degree of confidence in achieving these near-term targets. When we update our group strategy, our environmental targets will be updated accordingly.

We're also very focused on ways to minimize our waste and also reduce our water usage. Before I finish up, I wanted just to talk a couple of minutes about the fundamentals of the markets that we serve, because this is what gives us confidence in our strategic plans and confidence to invest. For CSL Behring, the strong growth that we have seen in plasma collections and our immunoglobulins franchise is expected to continue. We will also soon be launching our gene therapy product, HEMGENIX, in the U.S., which will provide another option to patients with hemophilia B. Longer term, we expect demand for immunoglobulins to be robust due to significant patient needs in our core indications of primary immune deficiency, secondary immune deficiency, and CIDP.

For CSL Seqirus, we expect to deliver another profitable year. Beyond that, we anticipate strong demand across our highly differentiated high-value products, in particular FLUAD, the adjuvanted product for the elderly market. We look forward to developing the next generation of mRNA vaccines with our partners. While we've only owned CSL Vifor for a short while, we do see opportunities to grow the iron franchise with significant unmet need to drive new indications and expand into new geographies and improve access. Heart failure, for example, is a significant opportunity for the iron business. Finally, in wrapping up, I wanna tie all of these points together. CSL has demonstrated a strong track record of success over a long time, timeframe.

While there have been a lot of different factors that have contributed to this, I believe that most of them fall into three areas. Firstly, a clear and consistent strategy and the disciplined execution of that strategy. Secondly, targeted R&D, or research and development, that fits into our focus areas and a relentless passion for innovation. Thirdly, a transparent commitment to sustainability across the material parts of our business. We think we have the right strategy and the platforms to keep delivering sustainable, profitable growth well into the future.

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