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CSL Ltd. AGM Information 2019

Oct 15, 2019

17854_rns_2019-10-15_bef7aca7-c59b-4c62-be37-fec6e22e046f.pdf

AGM Information

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For immediate release 16 October 2019

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CSL LIMITED 2019 ANNUAL GENERAL MEETING SPEECHES

CSL Limited (ASX:CSL; USOTC:CSLLY)

Please find attached the Chairman and Chief Executive Officer addresses, and the accompanying slides, to be presented at CSL Limited’s Annual General Meeting today in Sydney.

The meeting will be webcast at https://register.webcastcloud.com.au/csl/agm2019.

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Fiona Mead

Company Secretary

About CSL

CSL (ASX:CSL) is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL — including our two businesses, CSL Behring and Seqirus - provides life-saving products to more than 70 countries and employs 25,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest.

For more information about CSL Limited, visit www.csl.com

For further information, please contact:

Investors: Media: Mark Dehring Jemimah Brennan Head of Investor Relations Head of Asia Pacific Corporate Affairs Phone: +61 393 893 407 Phone: +61 412 635 483 Email: [email protected] Email: [email protected]

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Chairman Address at the 2019 CSL Annual General Meeting

Good afternoon Ladies and Gentlemen,

My name is Brian McNamee and as Chairman of CSL Limited it is a pleasure to welcome you to CSL Limited’s 2019 Annual General Meeting. I also acknowledge all of our shareholders who are accessing the meeting via webcast today. There is a quorum present and I am delighted to officially open the meeting.

For those in the room here, I want to take a moment to ensure that you are familiar with the evacuation procedures to be followed in the unlikely event of an emergency. If an evacuation alarm sounds, the venue’s fire wardens will enter the room and direct us to the emergency evacuation points. Please follow their instructions.

This is the first time that we have held our Annual General Meeting in Sydney and we are pleased to gather with a good number of over 48,000 of our shareholders who live in New South Wales. They represent around 30% of all CSL’s shareholders and for this reason we felt it was a good thing to bring the AGM to Sydney in our 25[th] year as a listed company.

To begin formalities today, the Notice convening the Meeting has been circulated to every shareholder and I now take that Notice as read. I would now like to introduce your Board of Directors and our Company Secretary:

To my left (your right);

  • Ms Fiona Mead, Company Secretary

  • Ms Marie McDonald;

  • Mr Bruce Brook;

  • Professor Andrew Cuthbertson.

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And to my right (your left):

  • Mr Paul Perreault, Managing Director

  • Dr Megan Clark

  • Mr Abbas Hussein

  • Ms Christine O’Reilly

  • Mr Tachi Yamada

You will have an opportunity to hear from the two Directors who are standing for election later in the meeting.

Having been in the Chair since the conclusion of last year’s AGM, I am delighted to address this meeting today - especially gratifying as this week we marked the occasion of the 25[th] anniversary since CSL listed on the Australian Securities Exchange.

Back in 1994, the company included a small group of very talented people and a very modest set of assets, and it was firmly underpinned by big hopes and dreams. We could never have envisaged then the company as it is today; the value it has delivered to people with rare and serious diseases, the contribution it has made to public health to many communities’ right around the world and to you, our shareholders. So I stand before you with pride, but also quite humbled. In that time, the world has changed dramatically and CSL has changed with it. Importantly there is much ahead of us and while it’s nice to reflect for a moment with nostalgia, it is vastly more interesting to have our eyes focused forward – on what is next for our Company.

Paul Perreault, our CEO and Managing Director, will shortly be sharing with you some detail on the performance of our individual business units for FY19 – and we are delighted to deliver to our shareholders another great year, including a Financial Year 19 dividend that was up 18% in $A terms. For this, I’d like to recognize and thank Paul and his Management team for their strong leadership.

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They continue to effectively cultivate our strategy and drive a culture of innovation, not only across our R&D organization, but enterprise-wide.

I’d also like to thank our Board for their guidance and commitment to excellence. At the conclusion of the meeting we will say farewell to Mr. Tachi Yamada, who has been a Director since 2016. I’ll say a few more words to acknowledge Tachi’s contribution a little later.

What I have seen in my first year as Chair is a strong company with continued potential. I have enjoyed visiting some of our sites this year, including Kankakee, Liverpool, Bern and Marburg, and I have been impressed by the scale, discipline, innovation and culture flowing through the veins of the company. CSL has a presence in almost 70 countries globally and employs more than 25,000 people. We have in our stable some of the brightest and most educated minds within the scientific and business communities alike.

This year we had a 13 percent growth in our employee base - a testament to the Promising Futures we offer our employees and jobseekers alike.

‘Company culture’ has been given much airtime in the Australian corporate governance environment in recent times, and it something that my fellow Directors and I care about deeply.

We believe that the Board has a role in building and fostering a values-based culture, and that this must flow through the organisation. We know that the bedrock of our success lies in living our five Values:

  • Patient focus.

  • Innovation.

  • Integrity.

  • Collaboration.

  • Superior Performance.

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For CSL to continue to grow, to make a difference in people’s lives through our science and be a highly desirable workplace, we ensure that Our Values remain the foundation of our culture and act as the guide for how we work.

That is one of the reasons why our Board spends two weeks of their year visiting CSL sites, talking to our people and seeking to understand the challenges, looking and listening for how well our values are translating into day to day behaviours. We know that long term sustainability cannot be founded on financial success alone. For us, patients must be kept at the forefront of decision-making - and then success in other areas will follow.

In fact, everything we do is driven by our promise to patients and protecting public health. Our strong performance last year is undoubtedly a key indicator of the shared purpose of our people and whether they are based in Parkville, Dubai, Tokyo, Bern, or King of Prussia – the needs of patients and demands of public health remain our compass.

We are also proud of the external recognition we have received in relation to our employee engagement. In the last financial year, the company received a few recognitions of note such as CSL’s inclusion on Thomson Reuters’ Top 100 Most Diverse & Inclusive Organizations Globally, Universum’s Most Attractive Employers in Switzerland, and Forbes America’s Best Large Employers.

I’d now like to turn our attention to our engagement with our broader stakeholder community, a subject of significant focus for the Board and an area in which CSL and its people remain deeply committed.

We conduct our business based on CSL’s Values and know that being a mindful contributor to the economic, social and environmental well-being of our communities is critical to the sustainability of our company.

For us, corporate responsibility is aligned with business goals and complements our unique capabilities for the benefit of a diverse set of stakeholders.

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This year, we made significant financial and in-kind contributions to the communities in which we live, work and serve. We continue to have strong and deep relationships with participants across the sector including healthcare professionals, regulators, patient and clinical groups. These ties are an important part of the social capital that adds value to our business.

We also engage with governments directly and through active membership in industry groups, and contribute to public policy through engagement with patient organisations, public health agencies, and other stakeholders at a national and global level.

We recognise the importance of participating in public policy matters that directly impact both the operations of our business, and the equitable access to non-discretionary medicines and vaccines that people around the world deserve. We strive to work with governments across more than 70 countries in order to foster healthier, global populations.

As you would be aware, we are seeing a high level of volatility in various markets around the world, and naturally this brings a level of uncertainty. As a company, we watch with interest, and where we need to, prepare to adjust and participate. For example, in anticipation of Brexit, we’ve established a new quality release laboratory in Amsterdam to allow Seqirus to seamlessly deliver vaccines across Europe.

We are optimistic that despite the fluctuations of the global trade environment, countries and their governments know that the good health of their populations leads to thriving economies, and they place priority on this.

In reflecting on my first 12 months as Chair, I am grateful for everything our teams have accomplished for patients and public health under the leadership of Paul and his team.

This reflection includes assessing how we work and knowing that we must continue to drive innovation.

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Our ability to evolve continues to be one of our core strengths, and supports sustained growth and a continued ability to deliver innovative therapies for patients.

The last 25 years have clearly shown us that while innovation can revolutionalise the way that we approach the prevention and treatment of disease, commercial success can only come from being able to effectively compete in the global marketplace in which we operate.

With this view, our focus for the longer term is on the following strategic pillars:

  1. People and culture – we continue to seek diverse skill sets and depth of knowledge, driven by a values-based culture.

  2. Growth – we want to lead commercialisation know-how, geographic expansion and depth of experience in our industry

  3. Efficiency – efficiency has always been a hallmark of CSL and will continue to be so. We strive for operational excellence at the core of what we do each day, to build capacity for today and tomorrow.

  4. Public health – we will continue to differentiate our influenza vaccine offering and further protect diverse communities across the globe.

Overseeing these strategic areas is where the Board provides support to Paul and the leadership team.

As a Board, we are also focused on ensuring that we have an appropriate mix of skills and diversity in our composition – and we do have some very fine skills on this Board. For a complex, global company such as ours, we must have a range of diverse and relevant experience that spans pharmaceutical industry, international business, finance, management and accounting, and scientific expertise.

Now for a word on recent investments made by our company. While we are a truly global company, we’re committed to maintaining our corporate

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headquarters and our global R&D hub in Australia. Australia is a good place to do business and to conduct world-leading science. We demonstrate this belief by continuing to make significant investments into the scientific community and into advanced manufacturing, and by promoting policy that allows the nation to punch above its weight on a highly competitive international stage.

We announced in August this year that we will relocate our Global Corporate Head Office into the heart of the Melbourne biomedical precinct.

When it is completed in 2024, this bespoke building will house 800 CSL employees and incorporate state-of-the-art biotech laboratories and clinical production suites.

We know that close collaborations, including physical proximity, between academia and industry better fosters the translation of brilliant scientific ideas into tangible outcomes. We’re very pleased with the progress being made across our R&D portfolio and Paul will speak to some of the particular highlights from our pipeline.

We continue to invest in our ability to meet demand for our products at many of our facilities around the world. This includes doubling the footprint of our Broadmeadows, Melbourne plant to build a new base fractionation facility. In Marburg, Bern and Kankakee we have construction projects underway to expand capacity for the production of immunoglobulin and specialty products. Further, we’re investing US$140 million to extend our Seqirus US facility in Holly Springs to meet growing demand for our influenza vaccine products. These projects are timed to come on line ahead of demand to ensure a seamless supply of product to patients.

In conclusion, I would say to you that we are well positioned to continue creating value for our shareholders in the years ahead. It’s been quite a journey, and we are looking forward to the next part of it.

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I now call on Paul to present a more detailed review of the Company’s operations, including our research and development portfolio.

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CEO and Managing Director Address at the 2019 CSL Annual General Meeting

Good afternoon and thank you for joining us today for CSL’s 2019 Annual General Meeting.

I’m pleased to be here and excited to take you through both the financial and operational highlights of what we have achieved over the 2019 financial year.

Additionally, I will take this opportunity today to cover expectations for 2020.

But first, our strong performance in FY19 is a testament to our Values-based culture and deep commitment to serving patients and protecting public health.

In our business, we cannot be complacent or rest on our success because the needs are always evolving. As Brian said, patient focus and innovation have been in the DNA of CSL from our start more than 100 years ago when we delivered access to critical medicines to the people of Australia and continues as the basis of everything we do today across the global organization.

As part of our promise to patients, we constantly ask ourselves, “How can we better serve patients? How can we better protect public health?”. When we consistently deliver on those needs and keep Our Values at the center of everything we do, sustainable growth follows.

I’m pleased to report that CSL delivered another strong year of growth.

  • Revenue was up 11% at constant currency;

  • Net Profit after Tax was up 17% at constant currency, slightly ahead of our guidance; and

  • As mentioned by the Chairman, the FY19 total dividend was up 18% in A$ terms.

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This is an excellent performance given the strong result we achieved in the previous year (FY18 NPAT was up 28% at CC). It also reflects our focus on delivering innovative medicines to patients around the world and the successful execution of our strategy.

  • Our largest franchise, immunoglobulins, performed exceptionally well with Privigen up 23% and Hizentra up 22%, which is outstanding growth;

  • We’ve also seen a return to growth of albumin with global sales up 15% led by a strong resurgence in China in the second half;

  • Demand for our specialty products remains robust with sales of Haegarda up 61% and Kcentra up 14%;

  • The successful evolution of our Haemophilia portfolio has continued with Idelvion sales up 40%; and

  • Seqirus, our influenza vaccines business, has achieved strong sales and profit growth and is well positioned to deliver on its strategy.

The growth that we achieved in 2019 comes down to our focus on delivering life-saving and life extending medicines for our patients and the successful execution of our strategy.

This wouldn’t be possible without Our Values, which our employees carry out every day.

A very important pillar of CSL’s strategy and one of Our Values is Innovation. We need to keep developing innovative therapies to meet our patient’s needs through our world class R&D capabilities.

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Highlights for 2019 include:

  • Our phase III study for CSL112, our cardiovascular disease therapy, is progressing well.

  • Our Phase II study in patients with Hereditary Angioedema, CSL312 a Factor 12a antagonist, is now fully enrolled.

  • We’ve also initiated a Phase II/III organ transplant study for the prevention of Graft versus Host disease with alpha-1 antitrypsin.

  • Hizentra and Privigen were approved for CIDP in Japan as well as Hizentra for CIDP in Australia. CIDP, or Chronic Inflammatory Demyelinating Polyneuropathy is a neurological disorder that results in slowly progressive weakness and loss of feeling in the arms and legs.

  • And lastly, we’re making good progress with our early stage portfolio.

We recognize that innovation shouldn’t be confined solely to R&D. We are committed to building a culture in which our people are empowered to innovate throughout our organization whether they work in a lab, an office or in a manufacturing site.

Our passion for patients and strong track record of developing and delivering transformational medicines compel us to evolve the way we work.

As part of our commitment to patients and protecting public health, we continue to evaluate all aspects of our operating model to ensure we not only innovate, but do so in an efficient way.

Efficiency is another hallmark of CSL. It’s something we continually focus on, giving us a competitive advantage.

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  • We continue to expand our plasma collection network by opening another 30 new plasma collection centres in the US, a rate unmatched in the industry. This provides us access to the valuable raw material we need to produce our plasma products and meet the increasing patient demand.

  • We have also made a significant investment in new Enterprise Resource Planning systems right across the group.

  • We opened a new research facility in Melbourne and have major capital projects underway at all our sites.

  • We were pleased to receive approval from the Chinese regulatory authority for marketing of AlbuRx – which is manufactured at our Kankakee facility - in China.

More recently, as Brian mentioned, we announced our future move to the Parkville biomedical precinct in Melbourne, Australia. This will facilitate closer collaboration with the biomedical and academic science community – which is extremely important to CSL.

On People and Culture, our people and culture play a critical role in carrying out our strategy. The ability to attract, develop and retain the talent CSL needs to deliver on our promise to patients and protect public health is imperative.

In the past six months alone, we’ve made two key executive appointments:

  • Paul McKenzie, Chief Operating Officer. Paul is an accomplished global leader with diverse biotech experience and he is responsible for our global end-to-end Operations; and

  • Anjana Narain, Executive Vice President and General Manager of Seqirus. Anjana is also a seasoned leader with broad

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experience in vaccines and biopharma. She has just recently taken the reins at Seqirus from Gordon Naylor, who announced his retirement earlier this year.

As Brian said, our global workforce grew by 13% to now be more than 25,000 employees strong, 57% of whom are female.

Our growth and ability to attract top talent from within the industry are testaments to the highly desirable workplace we are creating and how people want to be part of our inclusive culture.

Our employee feedback survey tells us our people continue to be actively engaged, and proud to work for the company. They believe CSL offers a rewarding place to develop and grow in their careers.

In addition to being able to offer promising careers with purpose, we also know how important our standing as a good corporate citizen is to our employees and future employees.

We are passionate about giving back to the communities where we live and do business. This includes supporting patient advocacy groups through partnerships, investing in the next generation of scientific leaders through fellowships and assisting communities in times of emergency.

Turning now to CSL Behring sales, CSL Behring recorded overall sales growth of 11% for FY19 at constant currency.

Our core products immunoglobulins and albumin grew at 16% and 15%, respectively. Specialty products delivered a growth of 6% whereas haemophilia recorded a modest decline of 3%.

In terms of the geographic split, the pie chart on the right shows the broad global reach of CSL Behring’s sales.

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We recorded solid growth in all regions around the world including our 2 major markets North America and Europe, which were up 11% and 9%. The Asia pacific market was up 10%, with the ‘rest of world’ group up 17%.

Turning our attention to Plasma Collections.

At CSL we operate one of the world’s largest and most efficient plasma collection networks.

As you have heard me say many times in the past, the supply of plasma continues to be tight due to the strong demand for our end products.

And, at the risk of stating the obvious, that is why we continue to grow our collections network. In FY19 we opened another 30 new centres in the U.S. – now totalling 221 US centers as of June 30. We also have 8 in Germany, 3 in Hungary and 5 in China.

And we won’t stop there. In FY20 we are planning on opening around 40 new centres.

As well as increasing the number of our centres we continually look at ways to do things better and more efficiently throughout our network.

To this end, we achieved efficiencies in both labour and yield this past year.

We also acquired a manufacturing facility in South Carolina that produces liquid saline and sodium citrate. This acquisition will mitigate a risk exposure, and introduce an additional level of robustness into our supply chain.

Moving on to next slide and innovation – here we have an update on some of the initiatives we are focusing on:

  • CSL112 is in our phase III cardiovascular disease trial, recruitment is well underway with now over 5,000 patients enrolled.

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  • CSL312 is a Factor XIIa antagonist which is currently in Phase 2 of development to increase our offerings for patients with Hereditary Angeioedema. We enrolled the last patient in the Phase 2 study in June and look forward to our first look at the results before the end of the calendar year.

  • We are currently enrolling patients in a Phase III study for CSL964 to evaluate the appropriate dose and respective efficacy of Alpha-1 Antitrypsin for the prevention of acute graft versus host disease (GvHD) in patients receiving hematopoietic cell transplant.

  • We have now completed Phase 1 for CSL346 with planning underway for Phase 2a Proof of Concept study in patients with diabetic nephropathy to be initiated in the first half of next year.

  • We also completed Phase 1 for CSL324 which is a monoclonal antibody that has the potential to treat multiple inflammatory diseases. Phase I trial in healthy volunteers was completed in 2018 and was safe and well tolerated.

On the slide you can see we have several programs ready to move into the clinic,

  • CSL889 – in sickle cell disease;

  • CSL 200 – in cell and gene therapy; and

  • CSL311 – targeting multiple chronic inflammatory indications.

Onto Seqirus, our influenza vaccines business.

Seqirus has delivered another impressive year with total revenue growth of 12% in FY19, underpinned by growth in the sales of seasonal influenza vaccines, which was up 19%.

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Seqirus’ portfolio of products continues to transition to the higher valued quadrivalent influenza vaccines and the sales of the adjuvanted influenza vaccine, FLUAD, more than doubled, driving the 51% growth in sales in the European market.

Pandemic reservation fees grew 18%, a function of governments wanting to secure manufacturing capacity to protect their populations against the threat of a pandemic.

Continuing with Seqirus, here are some operational highlights.

I mentioned the ongoing shift in the portfolio to differentiated products, this has really been gaining traction.

In the past year, we have seen some very positive data in relation to the real world effectiveness of Flucelvax - our cell-based vaccine that is manufactured at Holly Springs.

Real world effectiveness data published indicated that Flucelvax was 36% more effective than standard egg-based QIV in preventing influenza-like illness in the 2017/18 season in the US.

Other highlights include:

  • Fluad granted preferred recommendations for the over 65’s in the UK and Australia which underpinned its strong sales performance;

  • All the strains for Flucelvax were manufactured using cell-specific seed for the first time for the upcoming northern hemisphere season;

  • New pandemic reservation agreements were signed with the EU and Canada; and

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  • The FDA accepted our submission for the world’s first adjuvanted cellbased pandemic influenza vaccine.

Looking forward we are expanding the market for Flucelvax by launching in the EU in the 2019/20 northern hemisphere season and have submitted a dossier to the TGA in Australia. We have also made good progress on the fill and finish expansions we have underway at Liverpool and Holly Springs.

Overall, these results and initiatives show that the strategy we embarked upon for Seqirus some years ago is coming to fruition. We are well on track to reach the long range goals that we set for this business for 2020.

As I mentioned earlier, I’d now like to make a few comments on the outlook for FY20.

  • We expect strong demand for our plasma and recombinant therapies to continue;

  • As we disclosed in June this year, there will be a one-off adjustment on the way we recognise albumin sales arising from the transition to a our own distributor model in China;

  • We also expect to see a slight increase in margin arising from product mix shift; and

  • We expect Seqirus to continue to benefit from its product differentiation and process improvement and to deliver in line with prior guidance.

I can reaffirm the guidance we provided in August that CSL’s net profit after tax for FY20 is expected to be in the range of approximately $2,050 to $2,110 million at constant currency.

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This is a growth of around 7-10% after absorbing the one-off financial headwind of the China Good Supply Practice for Pharmaceutical Products or GSP.

Revenue is expected to grow by around 6% at constant currency or around 10% after adjusting for the GSP.

And of course, as I alluded to earlier, our forward-looking statements are subject to the usual disclaimers as mentioned at the start of this presentation.

Thank you for joining us here today and for your continued support of our business.

Now I’ll hand back to the Chairman to address the formal items of business.

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CSL Limited

2019 Annual General Meeting 16 October 2019

Paul Perreault, CEO and MD

LEGAL NOTICE

Forward looking statements

The materials in this presentation speak only as of the date of these materials, and include forward looking statements about CSL Limited and its related bodies corporate (CSL) financial results and estimates, business prospects and products in research, all of which involve substantial risks and uncertainties, many of which are outside the control of, and are unknown to, CSL. You can identify these forward looking statements by the fact that they use words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “target,” “may,” “assume,” and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. Factors that could cause actual results to differ materially include: the success of research and development activities, decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; competitive developments affecting our products; the ability to successfully market new and existing products; difficulties or delays in manufacturing; trade buying patterns and fluctuations in interest and currency exchange rates; legislation or regulations that affect product production, distribution, pricing, reimbursement, access or tax; acquisitions or divestitures; research collaborations; litigation or government investigations, and CSL’s ability to protect its patents and other intellectual property. The statements being made in this presentation do not constitute an offer to sell, or solicitation of an offer to buy, any securities of CSL.

After struggling for years to get an accurate diagnosis, hereditary angioedema (HAE) patient Kathrin Schoen is working to ensure the next generation of patients doesn’t have to wait so long.

No representation, warranty or assurance (express or implied) is given or made in relation to any forward looking statement by any person (including CSL). In particular, no representation, warranty or assurance (express or implied) is given in relation to any underlying assumption or that any forward looking statement will be achieved. Actual future events may vary materially from the forward looking statements and the assumptions on which the forward looking statements are based.

Subject to any continuing obligations under applicable law or any relevant listing rules of the Australian Securities Exchange, CSL disclaims any obligation or undertaking to disseminate any updates or revisions to any forward looking statements in these materials to reflect any change in expectations in relation to any forward looking statements or any change in events, conditions or circumstances on which any such statement is based. Nothing in these materials shall under any circumstances create an implication that there has been no change in the affairs of CSL since the date of these materials.

Trademarks

Except where otherwise noted, brand names designated by a ™ or ® throughout this presentation are trademarks either owned by and/or licensed to CSL.

2 | Driven by Our Promise[™]

FY19 Group Performance

A strong year for CSL with revenue up 11%1 and profit after tax up 17%1 reflecting:

  • Continued strong growth in our core immunoglobulin and albumin therapies

  • High patient demand for specialty products Haegarda and Kcentra

  • Successful evolution of our Haemophilia portfolio

  • Seqirus delivering on strategy with strong profit growth

CSL BEHRING

  • 1

  • • PRIVIGEN[® ] sales +23% 1

  • • HIZENTRA[® ] sales +22% 1

  • • ALBUMIN sales +15% 1

  • • IDELVION[®] sales +40% 1

  • • HAEGARDA[® ] sales +61% 1

  • • KCENTRA[® ] sales +14%

SEQIRUS

  • 1

  • • Influenza vaccine sales +19%

  • FLUAD[®] sales more than doubled

  • • Holly Springs – FCC 3.0 approved delivering future antigen capacity expansion

  • • Compelling real world effectiveness data for FLUCELVAX[®]

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1 Growth percentages shown at constant currency to remove the impact of exchange rate movements, facilitating comparability of operational performance.

Delivering on Strategy

  • Innovation • CSL112 phase III progressing

  • CSL312 phase II study in patients with HAE enrolled

Efficiency

  • 30 new US plasma collection centres

  • Saline facility purchased, supporting plasma collection

  • New ERP systems

  • New research facility in Melbourne

  • CSL964 phase II/III study in prevention of GvHD with AAT initiated

  • Major capital projects all sites

  • HIZENTRA[®] and PRIVIGEN[®] approved for CIDP in Japan

  • HIZENTRA[®] approved for CIDP in Australia

  • Good progress with early portfolio

People &

Culture

Key appointments

  • Paul McKenzie – Chief Operating Officer

  • Anjana Narain – Seqirus EVP & GM

  • 25,000 employees, up 13%

    • 57% female, 43% male
  • CSL named in Top 100 Global Diversity and Inclusion Index (Thomson Reuters)

4 | Driven by Our Promise[™]

CSL Behring Sales FY19

Therapy Sales
$m
Change
1
%
Immunoglobulins 3,543 16%
- IVIG 2,375 15%
- SCIG 985 22%
Albumin 1,018 15%
Haemophilia 1,051 (3%)
- Recombinants 563 7%
- Plasma 488 (12%)
Specialty 1,572 6%
- Peri-Operative Bleeding 729 8%
- Other Specialty 842 4%
Other 3
Total 7,187 11%

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----- Start of picture text -----

REGION
17%
ROW
7%
11%
North
Asia Pac
America
10% 17%
US$7.2b 48%
11%
EU 28%
9%
----- End of picture text -----

1 Growth percentages shown at constant currency to remove the impact of exchange rate movements, facilitating comparability of operational performance.

5 | Driven by Our Promise[™]

Plasma Collections

Continued growth in plasma collection network

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30 new centres opened in the US

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Total centres – 221 in the US, 8 in Germany, 3 in Hungary and 5 in China

Planning to open ~40 new centres in FY20

Achieved continued efficiencies in both labour and yield

Liquid saline & sodium citrate facility purchased in South Carolina US to support plasma collection

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6 | Driven by Our Promise[™]

Innovation Update

CSL112

  • Phase III study underway:

  • 44 countries actively enrolling

  • PMDA endorsement to join phase III

CSL312 CSL964

  • Phase II/III study in prevention of GvHD with AAT initiated

  • Factor XIIa antagonist Phase II study in patients with HAE:

  • First patient enrolled March 2019

  • Last patient enrolled June 2019

  • Results 4Q19

Early Portfolio

  • Phase I complete:

  • CSL 346 (anti VEGF-B)

  • CSL 324 (anti GCSF)

  • Phase I ready:

  • CSL 889 (Hemopexin)

  • CSL200 (cell & gene therapy)

  • CSL 311 (anti-beta common)

7 | Driven by Our Promise[™]

9%

Seqirus Revenue FY19 1 Revenue up 12%

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----- Start of picture text -----

||||||
|---|---|---|---|---|
|Sales|%|REGION|
|1|
|$m|Change|
|35%|
|QIV|430|26%|
|Seasonal|
|Influenza|
|TIV|69|(63%)|ROW|
|vaccines|4%|
|Adjuvanted|300|117%|+19%1|
|North|
|Other / In-licence|219|(2%)|America|
|4%|Asia Pac|61%|
|Total Product Sales|1,018|14%|19%|US$1,196m|
|12%|
|Pandemic|133|18%|
|Royalties & Licence|
|20|0%|
|Revenue|
|EU|
|16%|
|Other Income|24|(39%)|
|51%|
|Total Revenue|1,196|12%|

----- End of picture text -----

1 Growth percentages shown at constant currency to remove the impact of exchange rate movements, facilitating comparability of operational performance.

8 | Driven by Our Promise[™]

Seqirus Operating Highlights

Looking Forward…

  • Ongoing shift in portfolio to differentiated products

  • Real world data provides new insight into the effectiveness of cellbased influenza vaccine.

  • FLUCELVAX[®] Quadrivalent was 36% more effective than standard egg-based QIV in preventing influenza-like illness in 1,2

  • the US 2017/18 season (predominated by H3N2)

  • FLUAD[®] preferred recommendations in the UK and Australia

  • FLUCELVAX[®] market expansion:

    • NH 2019/20 launch in EU Submitted dossier to TGA in Australia – anticipate private market launch in SH 2021
  • FLUCELVAX[®] - all strains manufactured using cell-specific seed for NH 2019/20 season

  • Pandemic reservation agreements with the EU and Canada

  • FDA acceptance of aH5N1c submission – world’s first adjuvanted, cell-based pandemic influenza vaccine

  • Good progress on fill & finish expansion:

    • Liverpool operational from SH 2021

    • Holly Springs operational from NH 2022/23

  • Boikos et al, Effectiveness of the Cell Culture- and Egg-Derived, Seasonal Influenza Vaccine during the 2017-2018 Northern Hemisphere Influenza Season, US National Foundation for Infectious Disease 2018 Clinical Vaccinology Course, November 2018, (Poster), Bethesda MD

  • FLUCELVAX[®] Quadrivalent was approved by FDA based upon demonstrated non-inferiority relative to FLUCELVAX® trivalent influenza vaccine. There have been no randomized controlled trials demonstrating clinical superiority of FLUCELVAX[®] Quadrivalent compared to other influenza vaccines.

| Driven by Our Promise[™]

9

Outlook for FY201,3

- Reaffirmed -

  • Continued strong demand for plasma and recombinant products

  • One-off effect on albumin sales arising from transition to new distributor model in China

  • Slight margin growth from plasma product mix shift, recombinant products growth & conclusion of HELIXATE[®]

FY20 NPAT ~$2,050m to $2,110m @CC2 (up ~7 - 10% on FY19)

2 Revenue growth ~6% (up ~10% adj for GSP)

Includes headwinds:

  • China GSP transition

  • New Lease standard

  • Seqirus to deliver in line with prior guidance and benefiting from product differentiation and process improvement

1 For forward looking statements, refer to Legal Notice page 2

  • 2 Growth shown at Constant Currency (CC) to remove the impact of exchange rates movements and facilitate comparability

  • 3 Full year FX impact expected to be $60m unfavourable, assuming current rates remain steady for the remainder of the financial year

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CSL Limited

Contact

11 | Driven by Our Promise[™]