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CSL Ltd. — Investor Presentation 2020
Jan 13, 2020
17854_rns_2020-01-13_5ccdc57b-57a4-4078-a27e-39a19929f345.pdf
Investor Presentation
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For immediate release 14 January 2020
2020 JP MORGAN HEALTHCARE CONFERENCE PRESENTATION
CSL Limited (ASX:CSL; USOTC:CSLLY)
Please find attached CSL Limited’s presentation at the 2020 JP Morgan Healthcare Conference.
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Fiona Mead Company Secretary
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, please visit www.csl.com or contact:
Investors:
Media:
Mark Dehring Jemimah Brennan VP Investor Relations Head of Communications, Asia Pacific P: +61 3 9389 3407 P: +61 412 635 483 E: [email protected] E: [email protected]
Christina Hickie
Bernard Ronchi Christina Hickie Senior Manager, Investor Relations Senior Manager, Communications P: +61 3 9389 3470 P: +61 429 609 762 E: [email protected] E: [email protected]
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CSL Limited
JP Morgan Conference - January 13, 2020
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.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.
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 .
Trademarks
Except where otherwise noted, brand names designated by a ™ or ® throughout this presentation are trademarks either owned by and/or licensed to CSL.
| Driven by Our Promise[™]
2
CSL Today
5[th] Largest Global Biotech
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Global #1 in plasma therapies
- $30 billion industry
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Global #2 in influenza vaccines
- $6 billion industry
Strong Market Position
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Revenues ~$8.5bn into 100+countries
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8 major manufacturing sites in 6 countries
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• Major capacity expansion underway
Current Industry Themes
Plasma Supply Growth
Robust Ig demand Influenza Vaccine Technology Shift
- Deep R&D pipeline fueling future growth
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Solid Financial Position
-
Net debt/EBITDA 1.4x
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A3 / A- credit rating (stable / stable)
3 | Driven by Our Promise[™]
FY19 Highlights
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Strong Business Performance
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Balanced Executing to Ig Growth well Regional Plan on New Above Market Growth Launches
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Expanding Compelling Market real-world Presence effectiveness through New influenza Affiliates vaccine data
4 | Driven by Our Promise[™]
CSL Behring Portfolio
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Ig
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Coagulation
Specialty
AlbuRx [®] Albumin
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Strong underlying market growth
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Disciplined approach to market expansion
-
• Growth driven by volume and mix improvements
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Market leadership with IDELVION[®] in key markets
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• Additional launch opportunities for AFSTYLA[®] / IDELVION[®] • Life-cycle expansion (21-day dosing)
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New launches with HAEGARDA[®]
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• Continued growth of KCENTRA[®] in the US
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Disciplined approach in China
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• Volume growth in all regions
5 | Driven by Our Promise[™]
Immunoglobulin Market
Market Dynamics
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Increasing awareness and diagnosis
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Growth in PID and CIDP
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Expanding usage for SID
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Potential new indications
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Continued market supply tightness
Global IG Volume by Indication 8% Growth
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Other
21%
MG
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PID
28%
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ITP
6%
SID
16%
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Source: Data on file
6 | Driven by Our Promise[™]
HIZENTRA[®] indication for CIDP
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Experience IV-related 5x as many patients said
systemic adverse they felt fewer side effects
reactions with HIZENTRA [®]
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Seek the flexibility, freedom, 8x as many patients said
and control HIZENTRA [®] offers more
of self-infusing freedom than IVIG
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Approved March ‘18 US & EU Approved March ‘19 Japan
Interest & Awareness Remains High
Market Share Growth With Both Privigen & Hizentra Orphan Exclusivity Granted for Hizentra CIDP
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HIZENTRA [®]
Have venous
does not require
access issues
venous access
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Require more frequent HIZENTRA[®] provides infusions to manage their steady state Ig levels for disease continuous control
Source: Data represents patients reporting a preference between IVIG in the pre-randomised phase and HIZENTRA[®] in the randomised phase of the phase III study of subcutaneous immunoglobulin for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study.
7 | Driven by Our Promise[™]
CSL Behring on Track to Become Market Leader in CIDP
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40
35
30
25
20
15
10
5
0
Q1 17 Q2 17 Q3 17 Q4 17 Q1 18 Q2 18 Q3 18 Q4 18 Q1 19 Q2 19
CSL Behring Competitor A Competitor B Competitor C Competitor D
% Patient Share (US, 5EU, JP)
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Source: Data on file
8 | Driven by Our Promise[™]
IDELVION[®] Prophylaxis Market Leadership
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45%
39% 40%
38%
40%
37%
35%
35%
30% 33%
29%
25%
25%
20% 21%
17%
15%
10%
5%
0%
Q1 17 Q2 17 Q3 17 Q4 17 Q1 18 Q2 18 Q3 18 Q4 18 Q1 19 Q2 19
IdelvionDELVION [®] Competitor A Competitor B All Other
Patient Share
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Based on 5 major markets (US, Japan, Germany, Italy and UK) where IDELVION[®] is reimbursed and commercially available. Source: Data on File
9 | Driven by Our Promise[™]
KCENTRA[® ] Growth in US
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KCENTRA[®]
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KCENTRA [®] remains the first and only FDA approved 4F-PCC for reversing patients on warfarin
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KCENTRA [®] is supported by multiple clinical guidelines as the preferred reversal agent
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KCENTRA [®] growth driven by:
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Penetration within existing large hospital systems
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Expansion into new regional accounts
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250
200
150
100
50
0
FY13 FY14 FY15 FY16 FY17 FY18 FY19
Units (Millions)
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Source: Data on file
10 | Driven by Our Promise[™]
Innovation for Future Growth
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Sickle Cell Anaemia – CSL200 (lentiviral stem cell gene therapy), CSL889 (Hemopexin)
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Contact-Mediated Thrombosis – CSL312 Garadacimab (Anti-Factor XIIa)
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Respiratory Disease – CSL311 (Anti-Beta common)
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Diabetic Nephropathy – CSL346 (Anti-VEGF-B)
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Neutrophilic Dermatoses – CSL324 (Anti-GCSF)
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Systemic Lupus Erythematosus – CSL362 (Anti-IL-3Ra)
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Scleroderma – PRIVIGEN[®] and HIZENTRA[®]
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Dermatomyositis – HIZENTRA[®]
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Immunology and Haematology Cardiovascular
Neurology and Thrombosis Respiratory and Metabolic Transplant
Plasma Recombinant Cell and
Fractionation Technology Gene Therapy
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5 Therapeutic Areas
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3 Platforms
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- Hereditary Angioedema – CSL312 Garadacimab (Anti-Factor XIIa)
| Driven by Our Promise[™]
11
Transplant Strategy
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1. Reduce Complications (e.g. AMR) IVIG, C1-INH, anti-IL6
SOT
2. Improve Organ Function AAT, C1-INH
3. Organ Availability and Viability
2018 2023 2028 2033
Unmet Needs
&
Leadership
Opportunities
1. Reduce Complications (e.g. GVHD) AAT
2. Adjunct T-Cell Therapy
HSCT
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| Driven by Our Promise[™]
12
CSL112 ApoA-1 – Progressing Well
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Study enrolment is active in >45 countries and progressing well
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PMDA approval for Japan to join trial
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Independent Data Monitoring Committee – no safety concerns
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First futility analysis in 2020
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CSL112
particles
ABCA1 transporter
Intracellular
cholesterol
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17,000 AMI subjects ≥18yrs of age with Acute Coronary Syndrome
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1° Endpoint : MACE MACE Follow Up
D90 D180 D365
6g CSL112
Screening Randomisation
Placebo
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13 | Driven by Our Promise[™]
Seqirus Product Portfolio
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High-risk
Standard risk populations
Seasonal Adjuvanted
TIV / QIV seasonal
TIV / QIV
Pandemic
Egg Based Cell Based
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Influenza Science
14 | Driven by Our Promise[™]
Influenza Vaccine Market Evolving
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Global influenza vaccine market volumes between 500-600 million doses
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150 million doses distributed in US* in 2018-2019 season
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Slow future growth, largely due to ageing population
• Seasonal global market value ~US$4B
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Differentiation a key driver of growth, especially in US – doses shifting to
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Cell-based vaccines
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Enhanced vaccines in 65 years and older segment (currently US, UK, AUS, Sth EU)
- Potential for benefit in infants (6 months - 6 years)
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Variable pace in geographical uptake
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Source: https://www.cdc.gov/flu/prevent/vaccine-supply-historical.htm
15 | Driven by Our Promise[™]
Growth Catalysts
PLASMA PROTEINS
Outperformance Drivers
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Ongoing robust demand
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Commercialization of 5 global product launches
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Grow China business
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R&D pipeline
INNOVATION
- Cardiovascular disease, transplant, gene therapy
INFLUENZA
- Product differentiation – FLUCELVAX [®]
EFFICIENCY
- Sales shifting towards FLUAD [®] and QIV
EFFICIENCY & FLEXIBILITY
- Harness benefits from new technology investments
FLEXIBILITY
-
Significant manufacturing capacity expansion
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Opening 40 collection centres in FY20
16 | Driven by Our Promise[™]
CSL Limited ~~Contact~~ Mark Dehring VP Investor Relations
-
+61 3 9389 3407
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