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CSL Ltd. Investor Presentation 2018

Dec 4, 2018

17854_rns_2018-12-04_69b71344-0924-419d-a06b-95fc56c5dd97.pdf

Investor Presentation

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5 December 2018

Annual Research & Development Investor Briefing

Please find attached the presentation and an accompanying media release ahead of the Company’s Annual Research & Development Investor Briefing being held today commencing at 9am ADST.

The briefing will be webcast and can be accessed in the ‘Investor” section of the website – www.csl.com.au .

For further information, please contact:

Investors: Media: Mark Dehring Jemimah Brennan VP Investor Relations Head of Communications, Asia Pacific CSL Limited CSL Limited Telephone: +613 9389 3407 Mobile +61 412 635 483 Email: [email protected] Email: [email protected]

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R&D Investor Briefing December 05, 2018 1 | Driven by Our Promise[™]

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.

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[™]

Agenda

  • Welcome

  • Introduction and Highlights

  • Seqirus

  • Research & Early Development

  • Commercial Market Overview, Ig & Haemophilia

Mark Dehring Andrew Cuthbertson Gregg Sylvester Andrew Nash Bill Campbell

  • Q&A

  • Break –

  • Clinical Development Overview

  • Commercial Overview Specialty, Transplant, CSL112

  • Summary

Bill Mezzanotte Bill Campbell Bill Mezzanotte

  • Q&A

3 | Driven by Our Promise[™]

Introduction and Highlights

Professor Andrew Cuthbertson AO Chief Scientific Officer

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4 | Driven by Our Promise[™]

Commitment to Research and Development

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New Product Development
activities focus on innovative new therapies for life-
threatening diseases
Market Development
strategies seek to bring therapies to new markets
and new indications
Life Cycle Management
ensures continuous improvement of existing
products
Includes R&D for CSL Behring and Seqirus.
m = US$millions
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  • R&D investment ~10-11% global revenue

5 | Driven by Our Promise[™]

Key Past Launches from R&D Portfolio

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2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
PRIVIGEN [®] HIZENTRA [®] PRIVIGEN [®] CIDP (US)
HIZENTRA [®]
PRIVIGEN [®] CIDP (EU) Ig IsoLo [®]
CIDP
BERINERT [® ] (US) KCENTRA [® ] (US) RESPREEZA [® ] (EU)
RIASTAP [®] CORIFACT [®] HAEGARDA [® ] (US)
VONCENTO [® ] (EU)
IDELVION [®]
AFSTYLA [®]
AFLURIA [® ] QIV FLUAD [® ] UK
AFLURIA [®]
FLUCELVAX [®] FLUCELVAX [® ]
H1N1
QIV US
FLUAD [® ] US
Ig
Specialty
Haem
Vaccines
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6 | Driven by Our Promise[™]

Leveraging Global Capabilities

Integration via project management processes

7 | Driven by Our Promise[™]

R&D Portfolio - December 2017

RESEARCH PRE-CLINICAL PHASE I PHASE II PHASE III REGISTRATION COMMERCIAL /
PHASE IV
Life Cycle
Management /
Market
Development
Clinical
Applications
C1-INH New
Indications
PRIVIGEN® Japan HIZENTRA® CIDP PRIVIGEN®
CIDPUS
Fibrinogen New
Formulations
HIZENTRA® IIM KCENTRA®
Japan
Haptoglobin/
Hemopexin
CSL964 AAT
GvHD Prevention
CSL830
C1-INHSubcut EU
HAEGARDA®
US
CSL640
rIX-FPsubct
PRIVIGEN® CIDP
Japan
AFLURIA® QIV
5-17 AUS
FLUAD® TIV
65+ US, UK
CSL842 C1-INH
AMR
FLUCELAX® QIV
4+US
AFLURIA® QIV
5-17US
New Product
Development
Emerging
Technologies
CSL730
rFc Multimer
clazakizumab
Transplant*
IDELVION®
Novel Strategies CSL626 D’D3
LA rVIII
CSL312
Anti-FXIIa

Mavri GM-CSFR-
AZ*
pdFVIII Ruide AFSTYLA®
Discovery Projects CSL334 IL-13R
ASLAN*
CSL324
Anti-G-CSF
Clinical
Applications
CSL311
Anti-BC

CSL346
Anti-VEGF-B
CSL112
apo-AI
P. gingivalis/POD
OH-CRC*

Core Capabilities: Immunoglobulins | Haemophilia | Specialty Products | Breakthrough Medicines | Vaccines & IP | Transplant

*Partnered Projects

8 | Driven by Our Promise[™]

Progress Through Stage Gates in 2018

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New Product
Phase I Registration & Post
Product Research Development & Phase II Phase III
(FIH) Launch Registration
Opportunity GLP Toxicology
1 2 3 4 5 6 7
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1 2 3 4
5
6
7 7
Ent
Rese
er
arch
Enter
Dev.
T
Product
& GLP
ox.
Enter P
hase I
Enter
Phase II
Enter
I
Phase
II
E
Reg
& La
nter
ister
unch
Ente
Regis
r Post
tration
Emerging
Technologies
CSL787
Nebulised Ig
CSL730
rFC Multimer
CSL312 Anti-FXIIa PRIVIGEN®
CIDP Japan
HIZENTRA®
CIDP US
Novel Strategies HIZENTRA®
CIDP Japan
PRIVIGEN®
CIDP US
Clinical
Applications
HIZENTRA®
CIDP EU
Clinical
Applications
CSL889 Hemopexin
in SCD
CSL830
C1-INH Subcut EU
Discovery
Projects
CSL200
(CAL-H) SCD
CSL346
Anti-VEGF-B PhIb
AFLURIA® QIV
6m+ US
CSL626 D’D3
LA rVIII
CSL324
Anti-GCSF PhIb
CSL112
Apo-AI
AFLURIA® QIV
6m-4 yr AUS
FLUCELAX® QIV
4+ yr US
CSL334 IL-13R
ASLAN*
Pre-Pandemic
Vaccine (aH5N1c)
FLUAD® QIV 65+yr
US
FLUAD® aTIV
65+ yr US, UK, AUS

Core Capabilities: Immunoglobulins | Haemophilia | Specialty Products | Breakthrough Medicines | Transplant | Vaccines & IP

9 | Driven by Our Promise[™]

R&D Portfolio - December 2018

RESEARCH PRE-CLINICAL PHASE I PHASE II PHASE III REGISTRATION COMMERCIAL /
PHASE IV
New Product
Development
Emerging
Technologies
CSL787
Nebulised Ig
CSL730
rFc Multimer
CSL312 Anti-FXIIa
in HAE
Clazakizumab
Transplant*
IDELVION®
Novel Strategies CSL311
Anti-BC

CSL324
Anti-G-CSF
Mavri GM-CSFR* pdFVIII Ruide AFSTYLA®
Discovery Projects CSL200 (CAL-H)
SCD
CSL346
Anti-VEGF-B
CSL112
Apo-AI
FLUAD® aTIV
65+ yr US, UK, AUS
Haptoglobin CSL889 Hemopexin
in SCD
CSL334 IL-13R
ASLAN*
FLUAD QIV 65+ yr FLUCELAX® QIV
4+ yr US
Clinical
Applications
P. gingivalis/POD
OH-CRC*
Pre-Pandemic
Vaccine (aH5N1c)
CSL830
C1-INH Subcut EU
Life Cycle
Management
/ Market
Development
Clinical
Applications
C1-INH New
Indications
PRIVIGEN® ID Japan PRIVIGEN® CIDP US
Fibrinogen New
Formulations
HIZENTRA® IIM AFLURIA® QIV
6m-4 yr AUS
HIZENTRA® CIDP
CSL842 C1-INH
AMR
PRIVIGEN® CIDP
Japan
KCENTRA® Japan
CSL964 AAT
GvHD Prevention
HIZENTRA® CIDP
Japan
HAEGARDA® US
AFLURIA® QIV
6m+ US

Core Capabilities: Immunoglobulins | Haemophilia | Specialty Products | Breakthrough Medicines | Transplant | Vaccines & IP

*Partnered Projects

10 | Driven by Our Promise[™]

Seqirus R&D Dr Gregg Sylvester Vice President Medical Affairs

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11 | Driven by Our Promise[™]

Seqirus Influenza Vaccines

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At-risk
Standard risk populations
seasonal Adjuvanted
TIV / QIV seasonal
TIV / QIV
Pandemic
Cell Based Egg Based
Influenza Science
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12 | Driven by Our Promise[™]

Influenza Viruses Mutate in Various Ways

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Circulating virus
Yearly seasonal vaccine
Environmental shift Immunological drift
• Environmental 4 strains

Manufacturing 2 x “A” – H3N2, H1N1
2 x “B” – B/Victoria, B/Yamagata
New virus Strain altered
Usually vary season to season
→ pandemic → seasonal

Southern Hemisphere vs Northern
Hemisphere
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13 | Driven by Our Promise[™]

Seqirus Technologies aim to Enhance Influenza Vaccines

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Cell Seed Egg Seed
Circulating strain MF59
Adjuvant
Antigenic distance
Antigenic distance
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14 | Driven by Our Promise[™]

Milestones in 2018

  • AFLURIA QIV

  • US approval for 6M-4yrs

  • FLUCELVAX QIV

  • US approval of major process improvement (“FCC3.0”)

  • European positive opinion

  • Positive effectiveness data compared with egg-based vaccines in US 2017-18 season

  • FLUAD

  • Completion of US registration QIV trial for 65yrs+

  • Positive TIV effectiveness data compared with non-adjuvanted vaccines

  • Pre-Pandemic vaccine (MF59-adjuvanted H5N1 cell = aH5N1c)

  • Clinical program completed

15 | Driven by Our Promise[™]

Successful completion of AFLURIA QIV program

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6 to 35 months age group 36 to 59 months age group
NHF0405
USF0629
USF0736
AFLURIA TIV
Pooled
Fluzone
USF0736
Fluzone
AFLURIA
0 5 10 15 20 25 30 35 40 45 50 5 10 15 20 25 30 35 40 45 50
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Percentage of subjects with fever above 38[º] C

16 | Driven by Our Promise[™]

Improvements in FLUCELVAX manufacturing output

Number of doses of FLUCELVAX manufactured by calendar year

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30
FCC3.0 dossier
filing
• MDV launch
25 • FCC3.0 PPQ
20
15
FCC3.0
Licensed for 2 lines • QIV PFS approval
• TIV PFS • Latex free
10 • 18yr+ indication • 4yr+ indication
Licensed for 1 line
• TIV PFS
5 • 18yr+ indication
0
CY14 CY15 CY16 CY17 CY18
Trivalent (TIV) Quadrivalent (QIV)
million doses
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17 | Driven by Our Promise[™]

Vaccine Seed Adapts to Grow in Eggs

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Adaptation Required in Generation of Egg Seed
Seasonal strain
\
Selection based on
• seasonal HA and NA

high growth properties
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High growth donor strain
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No Adaptation Required in Generation of Cell Seed

Seasonal strain

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High yielding viruses
selected as cell seed
(grown in MDCK)
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18 | Driven by Our Promise[™]

Science describes specific adaptation required for virus to grow in eggs, especially (but not only) H3N2

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HEMAGGLUTININ
Receptor Dominant
binding Antigenic
site Region
HA1
HA2
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19 | Driven by Our Promise[™]

H3N2-dominant seasons occur often and can be associated with a substantial health burden

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Deaths 37,000 12,000 43,000 38,000 51,000 25,000 51,000
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Source: US data from CDC , available at www.cdc.gov/flu/about/disease/2015-16.htm

20 | Driven by Our Promise[™]

US 2017-18 Season was Severe and Dominated by H3N2

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First season a cell-based
seed was included in
FLUCELVAX
→ H3N2 chosen
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Source: Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases (NCIRD); https://www.cdc.gov/flu/weekly/index.htm#OISmap

21 | Driven by Our Promise[™]

Big Data to Assess Real World Health Impact of a Vaccine

  • Randomised clinical trials provide an estimate of efficacy in a controlled setting in a welldefined population

  • Real world vaccine effectiveness (VE) evaluation addresses the health impact of a vaccine in the general population

  • Relative VE – versus another vaccine

  • Absolute VE – versus no vaccine

  • We conducted a retrospective cohort study of relative VE assessment of FLUCELVAX™ QUADRIVALENT with H3N2 cell seed versus egg-based vaccines during the 2017/18 season in the USA using Electronic Medical Records (ALLSCRIPTS)

Note: FLUCELVAX[®] Quadrivalent was approved by FDA based upon demonstrated non-inferiority relative to FLUCELVAX[®] trivalent influenza vaccine. There have been no RCT demonstrating clinical superiority compared with egg-based or other influenza vaccines. Real World VE data not for US promotional use.

22 | Driven by Our Promise[™]

Relative VE of cell- vs egg-based vaccines in 2017-18 US Season

  • Seqirus data (ALLSCRIPTS)*

  • → 36% (95% CI 26.1, 44.9) reduction in ‟influenza-like illness”

  • FDA data (Centers for Medicare & Medicaid Services)^

  • → 11% (95% CI 7.5, 13.7) reduction in hospital/ER “encounters”

  • Nth CA Kaiser Permanente[#]

  • 8% (NS) reduction in influenza A by lab test (PCR)

  • 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

  • ^ Lu et al, Relative effectiveness of cell-cultured versus egg-based influenza vaccines, 2017-18. Advisory Committee on Immunization Practices June 2018. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2018-06/flu-03-Lu-508.pdf. Accessed 28 October 2018

  • Klein et al, Vaccine Effectiveness of Flucelvax Relative to IIV During the 2017-18 Influenza Season in Northern CA. IDWeek October 2018, San Francisco, CA (Late Breaker 15).

23 | Driven by Our Promise[™]

Francis Crick Institute (WHO) 15 year data Cell- vs egg-based “reference virus” similarity to wild-type H3N2

Virus collection date

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100

Cell-propagated virus; n = < 50 Cell-propagated virus; n = 50 – 99 Cell-propagated virus; n = ≥ 100

80

Egg-propagated virus; n = < 50 Egg-propagated virus; n = 50 – 99 Egg-propagated virus; n = ≥ 100

60

Average № isolates: Cell = 90; Egg = 96 * Two vaccine strains in one season † Data values undetermined

Oseltamivir use (20 nM) 40 20 0 † † † † † † †

Antigenically similar if sera demonstrate no more than a 4-fold lower HI reactivity against wild-type compared with reference virus

24 | Driven by Our Promise[™]

MF59 Adjuvant

  • Oil-in-water adjuvant

  • Seasonal vaccine (FLUAD) – increased and broader immunogenicity, focussed on people 65yrs and older

  • Pandemic vaccine – dose sparing

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Span 85
Tween 80
Squalene
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  • aH5N1c dose 1/12 of that required without adjuvant

  • >130 million doses administered – excellent clinical safety

25 | Driven by Our Promise[™]

FLUAD is Gaining Wider Usage for People 65yrs and Older

  • Approved in Europe 1997, USA 2015

  • Preferential recommendation for population 65years and older in UK & AUS

  • Meta-analysis* of published studies (real world data) describes effectiveness of FLUAD in prevention of lab-confirmed influenza and hospitalisation in people 65 years and older

*Domnich et al, Vaccine 35:513-520, 2017

26 | Driven by Our Promise[™]

Real World Data to Investigate the Potential Benefits of FLUAD

  • FDA/CMS (insurance claims) data 2017/18 season

  • FLUAD showed 3% reduction in hospital/ER encounters in mismatch season*

  • Cluster Randomised Trial in Nursing Homes during 2016/17 season (interim analysis)

  • FLUAD showed 6% reduction in all-cause hospitalisation in mismatch season^

  • Previous study of similar design by same investigators with Fluzone HD – 6.7% reduction in all-cause hospitalisation in matched season[#]

* Lu et al, Relative effectiveness of cell-cultured versus egg-based influenza vaccines, 2017-18. Advisory Committee on Immunization Practices June 2018. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2018-06/flu-03-Lu-508.pdf. Accessed 28 October 2018

^ Gravenstein et al. A cluster-randomized trial of adjuvanted trivalent influenza vaccine vs. standard dose in U.S. nursing homes. IDWeek October 2018, San Francisco, CA (Poster 996)

# Gravenstein et al. Comparative effectiveness of high-dose versus standard-dose influenza vaccination on numbers of US nursing home residents admitted to hospital: a cluster-randomised trial. Lancet Respir Med 2017 Sep;5(9):738-746.

27 | Driven by Our Promise[™]

Seqirus Technologies aim to Enhance Influenza Vaccines

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

Cell Seed Egg Seed
Circulating strain MF59
Adjuvant
Antigenic distance
Antigenic distance
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28 | Driven by Our Promise[™]

Anticipated Milestones in 2019

  • AFLURIA QIV

  • AUS approval for 6M-4yrs

  • FLUCELVAX QIV

  • European approval for 9yrs+

  • AUS submission

• FLUAD QIV

  • US approval for 65yrs+

  • EU/UK and AUS submissions

  • PrePandemic aH5N1c

  • US submission

29 | Driven by Our Promise[™]

CSL Behring Research and Early Development Portfolios Dr Andrew Nash Senior Vice President, Research

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30 | Driven by Our Promise[™]

Research Organisation and Portfolio

  • Coordinated global project portfolio

Specialty Breakthrough Products Medicines

Immunoglobulins Haemophilia

  • Bio21(Parkville), Bern and Marburg

  • Bio21 expansion completed

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  • Research capabilities: plasma and recombinant proteins, gene and cell-based therapies

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Transplant

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Bio21 expansion

31 | Driven by Our Promise[™]

Research Organisation and Portfolio

  • Relocation of CSL Research Bern

Swiss Institute of Translational and Entrepreneurial Medicine (SITEM)

  • Bern University and Hospital Campus

  • Translational medicine, Phase I Unit

  • Cell and Gene Therapy

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Bern relocation / expansion – completed by H1 2019

32 | Driven by Our Promise[™]

Early Development Portfolio

• Portfolio of preclinical and early-mid stage clinical opportunities consistent with CSL commercial objectives

• Delivery of high quality candidates for clinical development

Research Product Dev / Tox Phase I Phase II

CSL312 (anti-FXIIa) CSL324 (anti-G-CSF) CSL346 (anti-VEGF-B) CSL730 (rFC multimer) CSL311 (anti-βc) CSL200 (γ-globin gene therapy) CSL787 (nebulised Ig) CSL889 Haemopexin CSL334/ASLAN004* (anti-IL-13Rα1)

  • partnered, CSL retains significant stake

More detail about our pipeline projects can be found here https://www.csl.com/research-and-development/product-pipeline

33 | Driven by Our Promise[™]

Immunoglobulin Therapy

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

Ig Fab region
• Immune deficiencies
• Autoimmune conditions
recombinant Fc multimer – CSL730
FcRn
Ig Fc region targeting
Potentially reproduces all
• Autoimmune conditions
Fc mediated Ig activity
FcγR
targeting
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From Lunemann et al ., Nat Rev Immunol 2015

34 | Driven by Our Promise[™]

Immunoglobulin Therapy

Targeting FcRn – IG vs. anti-FcRn agents

  • IV & SC IG therapy in autoimmune disease

  • Increase in total circulating IgG

  • Pathogenic auto-antibody IgG out-competed for access to FcRn

  • Long term safety established

Anti-FcRn therapy

  • Relevant for auto-antibody mediated disease only

  • Blocks access of all IgG to FcRn

  • Total circulating IgG reduced by up to 80%

  • Long term safety implications unclear

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

IVIG therapy
FcRn recycling controls
circulating levels of IgG
Ab mediated auto-immunity
Anti-FcRn therapy
= pathogenic auto-antibody
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35 | Driven by Our Promise[™]

Immunoglobulin Therapy

Mechanism of action summary

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

Pathogen Reduction of Complement FcγR Expression Immune Cells Cytokine
Neutralisation Pathologic Ig Scavenging Modulation Modulation Modulation
Ig Therapy
IgG Fc
Multimers
FcRn Binding Agents
No Activity Possible Activity Activity
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36 | Driven by Our Promise[™]

CSL730 – Recombinant Fc Multimer

CSL730 is effective in a mouse model of ITP CSL730 dose

  • Non-clinical safety toxicity data supports commencement of FIH studies

  • Phase I study (healthy volunteers) commenced Q1 2018

37 | Driven by Our Promise[™]

Immunoglobulin Therapy – Expanding Benefit

Nebulised Ig – respiratory tract infections

  • Concept: Prevention of viral and bacterial infections of the respiratory tract by inhaling polyclonal immunoglobulins

  • Technical feasibility demonstrated

Potential indications for NebIg:

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  • Prevention of infections in PID patients

  • Prevention of infection-related exacerbations in COPD and Bronchiectasis patients

38 | Driven by Our Promise[™]

Immunoglobulin Therapy – Expanding Benefit

Inhaled IgG prevents bacterial and viral infection

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Mouse model of S. pneumoniae infection
100
50
Vehicle
IgG
0
0 5 10 15 20 25
Days
Intranasal IgG prevents S. pneumonia
bacterial infection in mouse model
Percent survival
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----- Start of picture text -----

In vitro model of influenza virus infection
Tissue integrity Mucociliary clearance
infected infected
IgG preserves tissue integrity and mucociliary clearance of
primary human bronchial cells after influenza virus infection
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  • GLP Toxicology studies in progress

  • First-in-human trial planned for 2019

39 | Driven by Our Promise[™]

CSL312 – HAE and Thrombosis

• Targeting FXIIa represents a novel approach to the treatment of HAE & contact activated thrombosis

  • Efficacy in multiple animal models and translational studies

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

Auto-activation
FXIIa -
FXI → FXIa PK → KAL βFXIIa
→ thrombin HK → BK→ BR2 C1qr,s → C1qr,s
Vasodilation, Complement
Haemostasis
vascular permeability activation
Thrombosis HAE Transplant
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40 | Driven by Our Promise[™]

CSL312 – HAE and Thrombosis

First in Human (healthy volunteers) Phase I study

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

Pharmacokinetics (SAD)

Phase II study in HAE
patients in progress

Study in contact activated
thrombosis to commence
in 2019
Time (h)
CSL312 serum conc.(mg/ml)
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  • Safe and well tolerated

  • Linear pharmacokinetics with expected pharmacodynamic effects

  • Inhibits FXIIa mediated activity in a dose dependent manner

41 | Driven by Our Promise[™]

CSL324 – Neutrophil Mediated Inflammation

G-CSF / Neutrophils / Inflammation

  • Neutrophils – contribute to protective mechanism against infections

  • Neutrophil numbers and activity under control of Granulocyte Colony Stimulating Factor (G-CSF)

  • Excessive activated neutrophils can cause chronic severe inflammatory diseases

  • Targeting G-CSF represents a novel approach to the treatment of inflammatory diseases

  • Efficacy in multiple animal models and translational studies

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COPD exacerbations
CF exacerbations
ARDS
Reperfusion injury /
Delayed graft function
Rheumatoid
arthritis
G-CSF
Vasculitis
Neutrophilic
dermatoses
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42 | Driven by Our Promise[™]

CSL324 – Neutrophil Mediated Inflammation

First in Human (healthy volunteers) Phase I study

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

Pharmacokinetics (SAD)
10
0.8 mg/kg
1.0
0.3 mg/kg
0.1 mg/kg
0.1
Nominal time
CSL334 serum conc.(mg/ml)
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  • Safe and well tolerated

  • Linear PK with target saturation and expected pharmacodynamic effects

  • ex vivo STAT 3 and in vivo G-CSF challenge

43 | Driven by Our Promise[™]

CSL324 – Neutrophil Mediated Inflammation

Phase Ib study in neutrophilic dermatoses commencing Q2 2019

Hidradenitis Suppurativa (Acne Inversa)

Palmoplantar pustulosis

  • Chronic, inflammatory, recurrent, debilitating skin disease of the hair follicle

  • Characterised by a chronic eruption of sterile pustules on palms and soles – filled with neutrophils

  • Lesions are painful, unsightly, odorous, with devastating effect on the patients QOL

  • Prevalence 1-4% of the general population

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  • Unmet need – Adalimumab is not effective in all patients, and does not always have a durable response

  • The lesions are usually painful and decrease patients QOL

  • Prevalence data limited – very rare

  • Unmet need – SoC topical steroids, phototherapy and systemic Methotrexate, cyclosporine

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44 | Driven by Our Promise[™]

CSL324 – Neutrophil Mediated Inflammation

Kidney graft reperfusion injury

  • G-CSFR blockade protects against renal Ischemia Reperfusion Injury (IRI) in a mouse model

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

G-CSFR blockade prevents neutrophil infiltration
Control Ab (500 ug) VR81 (100 ug)
Left renal
ischemia (22 min)
20 µm
Reperfusion
for 24 hours
VR81 = surrogate anti-mG-CSFR
Ly-6G
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45 | Driven by Our Promise[™]

CSL324 – Neutrophil Mediated Inflammation

Kidney graft reperfusion injury

  • G-CSFR blockade protects against renal IRI in a mouse model

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

G-CSFR blockade preserves kidney function
VR81 = surrogate anti-mG-CSFR
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Opportunity for CSL324 in solid organ transplantation

46 | Driven by Our Promise[™]

Research and Early Development

  • Expanding capacity and capability across global Research sites

  • New projects leveraging Calimmune gene and cell therapy technologies

  • Continuing to innovate in areas of business strength

Specialty Immunoglobulins Haemophilia Products

  • Developing new opportunities in areas of unmet need

Breakthrough Medicines

Transplant

  • Creating and progressing a sustainable portfolio of early stage opportunities

47 | Driven by Our Promise[™]

Commercial Market Overview

Mr Bill Campbell Executive Vice President & Chief Commercial Officer

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48 | Driven by Our Promise[™]

Targeted Protein Therapeutic Market

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

Albumin
$4.1B
Immunoglobulin
$11.1B
Total Global
Market Value:
~$30.5B
Haemophilia
$11.4B
Specialty
$3.6B
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Source: Adivo, Global Market Research, Analyst Reports, Company Annual Reports, Haemophilia mkt includes Inhibitor mkt

49 | Driven by Our Promise[™]

CSL Portfolio

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

Albumin Immunoglobulin
Haemophilia
Specialty
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CSL Total FY18 $6,678M $3,145M +11% $1,490M +24% $1,113M +5% $921M +7% Growth at constant currency

50 | Driven by Our Promise[™]

New Product Launches

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CIDP CIDP
March ‘16 May ‘16 June ‘17 Feb. ’18 March ‘18
(US only)
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Launch date denotes first country to launch globally

5 major launches in 24 months Some of the most successful launches in the industry Significant contribution to the business now…in future

R&D Productivity

Commercial Excellence

51 | Driven by Our Promise[™]

Immunoglobulin Market

Global IG volume by indication 9% Growth

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

PID
28%
Other
21%
MG
4%
ITP
6%
CIDP
24%
SID
17%
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Growth Drivers

  • Enhanced diagnosis in PID, CIDP

  • Immunotherapy driving SID growth

  • Increasing per capita use in emerging markets

  • • Continued market supply tightness

Source: Data on file

52 | Driven by Our Promise[™]

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CSL Portfolio: Immunoglobulin

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

Immunoglobulin
Albumin
Haemophilia
Specialty
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FY18 $3,145M +11%

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Above market volume growth
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  • Expansion in PID, SID, CIDP

  • Balanced growth across all regions

  • Continued life-cycle investments Disciplined execution

53 | Driven by Our Promise[™]

Immunoglobulins: Category Leadership

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GROW

the current business

EXPAND

our presence in neurology

INNOVATE

and protect the franchise

  • Maximise PID / SID opportunity

  • Leverage broad portfolio

• Enhance product offerings

  • Replicate our approach to build market leading segments

  • Build on PRIVIGEN[®] experience in CIDP

  • Launch HIZENTRA[®] in CIDP

  • Novel delivery devices

  • New indications e.g. IIM, SSc

  • rFc multimer

54 | Driven by Our Promise[™]

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

Privigen is a ready-to-use Proven effective and well
10% IVIG approved in tolerated with
80+ countries 10+ years
worldwide [1] of patient experience
Approved for use in Used in Proven efficacy and
tolerability profile since
6 >100,000 patients
indications 2010
with chronic disease in the last year [2]
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More than
100,000
patient-years of & 6 million
experience [3] exposures worldwide [3]
57 countries
HIZENTRA [®] is a 20% SCIG that is
approved in 57 countries worldwide [4]
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References: 1. Data on file. Available from CSL Behring as PRI-10015; 2. Data on file. Available from CSL Behring as DOF-PRI-10016; 3. Data on file. Available from CSL Behring as DOF-HIZ-005; 4. Data on file. Available from CSL Behring as DOF-HIZ-004

*PID,SID, adults with CIDP, chronic ITP, Guillain-Barre syndrome and Kawasaki disease All Indications are not approved in all markets

55 | Driven by Our Promise[™]

: Innovator, Market Leader

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

Patients on SCIG Therapy: US 1
16,000
14,000
12,000
10,000
8,000
6,000
4,000
2,000
0
Q1'16 Q2'16 Q3'16 Q4'16 Q1'17 Q2'17 Q3'17 Q4'17 Q1'18 Q2'18
Cuvitru Competitor 1 HIZENTRA® HyQvia Competitor 2
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----- Start of picture text -----

Patients on SCIG Therapy: 7 Major Markets 1
25,000
20,000
15,000
10,000
5,000
0
Q1'16 Q2'16 Q3'16 Q4'16 Q1'17 Q2'17 Q3'17 Q4'17 Q1'18 Q2'18
Cuvitru Competitor 1 HIZENTRA® HyQvia Competitor 2
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Source: Adivo Q2 2018 Tracking Data Major Markets include: US, Germany, France, Spain, Italy, UK, Japan 1 Not all products shown

56 | Driven by Our Promise[™]

addresses unmet needs in CIDP therapy

CIDP Update

  • Early in launch cycle

  • Leading indicators are positive

  • Market share growth with both PRIVIGEN[®] and HIZENTRA[®]

Significant opportunity for leadership with HIZENTRA[®]

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

5x as many patients
Experience IV- said they felt fewer Have venous HIZENTRA [®]
related systemic side effects with access issues does not require
adverse reactions venous access
HIZENTRA [®]
8x as many patients HIZENTRA [®] provides
Seek the flexibility, Require more
said HIZENTRA [®] steady state Ig levels
freedom, and control frequent infusions to
offers more freedom for continuous
of self-infusing manage their disease
than IVIG control
----- End of picture text -----

Source: Data represents patients reporting a preference between IVIG in the prerandomized phase and Hizentra in the randomized phase of the phase III study of subcutaneous immunoglobulin for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study

57 | Driven by Our Promise[™]

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  • Positioned for continued growth

  • Expanding market presence

  • Diverse disease opportunities

  • Balanced geographic footprint

  • Continued life cycle investment

  • Plasma collections running ahead of the market

  • Early days…but very positive in CIDP

Market Leading Therapies

58 | Driven by Our Promise[™]

Haemophilia Market

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

Inhibitor
20%
VWD
4%
Total value
$11.4B
Hem B Hem A
14% 62%
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  • Highly competitive Haem A segment

  • Rapid transition of Haem B to long acting products

  • 75% of patients with bleeding disorders are under or untreated

  • New technologies / advancements hold great promise…

59 | Driven by Our Promise[™]

CSL Portfolio: Haemophilia

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

Albumin
Immunoglobulin
Haemophilia
Specialty
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FY18 $1,113M +5%

Haem A

  • AFSYTLA[®]

    • Launched in 12 countries
  • Plasma-derived portfolio

  • Haem B

  • IDELVION[®]

    • Transformational Product

    • Strong growth

    • Market leadership

von Willebrand Disease

  • HUMATE-P[®] , VONCENTO[®]

  • Strong contributors to portfolio

60 | Driven by Our Promise[™]

Positioning in a Competitive Market

Higher binding
affinity to vWF
• Unique single-chain molecular structure provides increased binding
• Enhanced binding affinity protects AFSTYLA® from degradation, extending time in circulation
2x weekly dosing • FDA-approved for 2x or 3x weekly dosing
• Factor trough levels above 1.9% with 2x weekly dosing
Excellent bleed
protection
• ZERO bleeds (median AsBR*) in all patients, regardless of age and dosing frequency
Low annual
consumption
• AFSTYLA® delivers the benefits of an EHL† with the lowest annual consumption
  • AsBR: Annualized spontaneous bleeding rate.

  • EHL: Extended half life

61 | Driven by Our Promise[™]

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Clinical Profile is Uniquely Differentiated

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  • 0 • Zero median annualized spontaneous

  • Median AsBR bleeding rate (AsBR) in prophylaxis

  • Up to 14 day dosing • Greater freedom from infusions 21% Factor IX* • High and sustained factor levels at

  • steady state trough levels[†] steady-state with prophylactic use • IDELVION is the most switched

  • #1 Factor Choice[1] to Factor IX when changing therapy

  • In appropriate patients 12 years and older.

  • Average FIX levels with 7-day dosing over 92 weeks in clinical trials Reference: 1. Data on file. Available from CSL Behring as DOF IDL-002.

62 | Driven by Our Promise[™]

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Performance in Key Markets

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

Switzerland
100%
80%
58%
60%
40%
20%
0%
Q3 16 Q4 16 Q1 17 Q2 17 Q3 17 Q4 17 Q1 18 Q2 18
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----- Start of picture text -----

Germany
100%
80%
58%
60%
40%
20%
0%
Q1 16 Q2 16 Q3 16 Q4 16 Q1 17 Q2 17 Q3 17 Q4 17 Q1 18 Q2 18
----- End of picture text -----

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

Japan
60%
50%
40% 37%
30%
20%
10%
0%
Q1 16 Q2 16 Q3 16 Q4 16 Q1 17 Q2 17 Q3 17 Q4 17 Q1 18 Q2 18
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----- Start of picture text -----

US
50%
40%
30%
30%
20%
10%
0%
Q1 16 Q2 16 Q3 16 Q4 16 Q1 17 Q2 17 Q3 17 Q4 17 Q1 18 Q2 18
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Source: Adivo Q2 2018 Tracking Data Patient share of recombinant prophylaxis in launch markets

IDELVION[®] ALPROLIXCompetitor 1[®]

Competitor 2BeneFIX[®] All Other

63 | Driven by Our Promise[™]

Q&A

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64 | Driven by Our Promise[™]

Clinical Development Dr Bill Mezzanotte EVP & Head R&D

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65 | Driven by Our Promise[™]

Immunoglobulins

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

Breakthrough
Transplant
Medicines
Specialty
Immunoglobulins
Products
Haemophilia
Products
----- End of picture text -----

  • Maintaining leadership position through focus on:

  • New Indications

  • Geographic expansion

  • Delivery options

  • Key Focus:

  • HIZENTRA[®]

  • PRIVIGEN[®]

66 | Driven by Our Promise[™]

Milestones in Ig Development for CIDP

PRIMA study shows PATH study confirms efficacy of PRIVIGEN[®] efficacy of PRIVIGEN[®] for CIDP for CIDP

HIZENTRA[®] and PRIVIGEN[® ] for CIDP PMDA Approval 2019

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

PRIVIGEN [®] for CIDP PRIVIGEN [®] for CIDP:
approved in EU FDA approval Sept 13
2012 2013 2014 2015 2016 2017 2018 2019
----- End of picture text -----

PATH study confirms HIZENTRA[®] for efficacy of HIZENTRA[®] CIDP FDA & EU for CIDP Approval March 2018

67 | Driven by Our Promise[™]

Impact of Ig (IV & SC) in Rare Diseases

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

Primary
Immuno-
deficiency
Secondary
Additional
Immuno-
Diseases
deficiency
Ig
Immune &
Chronic Inflammatory
Inflammatory Myositis IIM and SSc CIDP
Demyelinating Polyneuropathy
and Systemic Sclerosis
----- End of picture text -----

  • Health Authority (FDA, EMEA, PMDA) interactions – 2018

  • • Trials start 2019

| Driven by Our Promise[™]

68

Haemophilia Products

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

Breakthrough
Transplant
Medicines
Specialty
Immunoglobulins
Products
Haemophilia
Products
----- End of picture text -----

  • Supporting and enhancing plasma products and developing novel recombinant portfolio with focus on:

  • Scientific and product innovation

  • Patient benefit

  • Key Focus:

  • IDELVION[®] (rIX-FP)

  • AFSTYLA[®] (rVIII-Single Chain)

69 | Driven by Our Promise[™]

IDELVION[®] Delivering in the Real World

Annualised Bleed Rates in switched patients

FIX product All FIX rFIX-Fc IDELVION
Prophylaxis-to-
prophylaxis patients
mean ± SD
7.4 ± 9.1
(n=34)
8.9 ± 9.6
(n=12)
1.5 ± 4.5
(n=34)
# with zero bleed (%) 6 (17.6) 2 (16.7) 23 (67.6)
  • Further increased dosing flexibility anticipated

  • 21-day dosing submission planned 3Q 19

Escobar et al, ISTH July 2018

  • 85% of All-FIX therapies were administered every 7 days or more frequently

  • 45% of IDELVION administration was every 14 days

70 | Driven by Our Promise[™]

Specialty Products

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

Breakthrough
Transplant
Medicines
Specialty
Immunoglobulins
Products
Haemophilia
Products
----- End of picture text -----

  • Leveraging high quality broad product portfolio through:

  • New markets

  • Novel indications

  • Novel modes of administration

  • Key Focus:

  • HAEGARDA[®] /BERINERT[®]

  • KCENTRA[®] /BERIPLEX[®]

  • ZEMAIRA[®] /RESPREEZA[®]

71 | Driven by Our Promise[™]

Hereditary Angioedema (HAE)

  • Hereditary angioedema (HAE) is a disorder that results in recurrent attacks of severe swelling

  • All body sites are associated with impairment and patients are impacted during and between attacks

  • Most severe are laryngeal attacks which can require emergency interventions to protect the airway

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72 | Driven by Our Promise[™]

Demonstrating Unique Benefit of HAEGARDA[®]

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

BASELINE Median Attack Rate Reduction: 95%
4
Mean Age 39.6 ± 14.9
3
Female % 67
2
Mean # HAE attacks 3 prior months 9.8 ± 6.6
1
% use of HAE Prophylaxis 3 prior
months 42% 0 Placebo 60 IU/kg
HAE attack/month (median)
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Longhurst et al NEJM March 2017

73 | Driven by Our Promise[™]

Demonstrating Unique Benefit of HAEGARDA[®]

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

CSL830 Reduces Severity of Attacks
100
8.9
75 28.9
Severe
68.9
Moderate
17.8
50
Mild
4.4
Unknown severity
25 No attack
40.0 22.2
2.2
6.7
0
60 IU/kg CSL830 Low-volume Placebo
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----- Start of picture text -----

Persistent Efficacy of 60 IU/Kg
100
90
80
70
60
50 Attack-Free
40 No Rescue Use
30
20
10
0
Months 1-6 Months 13-18 Months 25-30
% of Study Patients
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Longhurst et al NEJM March 2017

74 | Driven by Our Promise[™]

CSL312 Anti-FXIIa in HAE

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

Placebo
Run-in
Low dose
Patients
with HAE
Medium dose
High dose

Phase II study
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  • Phase II study initiated in October

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Extension
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75 | Driven by Our Promise[™]

Transplant

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

Breakthrough
Transplant
Medicines
Specialty
Immunoglobulins
Products
Haemophilia
Products
----- End of picture text -----

  • Developing CSL and other novel therapies with potential to improve transplant outcomes:

  • Significant unmet need

  • Key Focus:

  • C1 inhibitor (C1-INH)

  • Alpha1 anti-trypsin (AAT)

  • Anti-IL-6 / clazakizumab*

76 | Driven by Our Promise[™]

Solid Organ Transplant (SOT): Unmet Medical Need

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

Before Transplantation
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During Transplantation After Transplantation

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

Patient & Donor Donor Organs Patient Patient
Organ Availability and Organ Viability and Ischemia-Reperfusion Transplant
Patient-Donor Matching Donor Management Injury and Consequences Rejection
Reducing IR-related injury and its
Donor-specific antibody
Decreasing organ discard consequences – e.g. Primary Graft Improving Treatment of
reduction; increased access
and reduce ischemic injury Dysfunction (PGD) & Delayed Antibody Mediated Rejection
to transplantation
Graft Function (DGF)
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More Patients/Organs Viable

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

Graft Survival
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77 | Driven by Our Promise[™]

Improving Graft Survival in Kidney Transplantation

Ischemia-Reperfusion Injury and Consequences

Delayed Graft Function (DGF)

  • Delayed graft function (DGF - any use of HD within 7 days of KTx or slow graft function (SGF) occurs in 20-30% of cases

  • More common with deceased donors

  • Patients who develop DGF have:

  • ~40% increased risk of graft loss and acute rejection

  • Higher health care costs

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

Transplants by Organ Type
(US - 2015) Transplant Rejection
Other
3%
Antibody Mediated Rejection
Lungs
7%
Heart
9%

AMR occurs in up to 5-10% of
transplants acutely and up to
30% chronically
Liver Kidney • AMR is marked by declining renal
58%
23% function and is associated with
lower graft survival

Patients with donor-specific
antibodies are denied transplant
due to the risk for AMR
----- End of picture text -----

78 | Driven by Our Promise[™]

Donor-specific Antibodies (DSAs) underpin Antibody Mediated Rejection in Kidney Transplantation

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Complement-binding DSAs

  • Associated with more severe inflammation and graft injury

  • C1-INH offers therapeutic option

Non-complement-binding DSAs

  • Antibody-mediated cellular toxicity

  • Direct endothelial activation & proliferation

  • Anti IL-6 offers therapeutic option

Loupy A, Lefaucheur C, et al. N Engl J Med . 2013;369(13):1215-1226

79 | Driven by Our Promise[™]

Long Term C1 INH Administration Stabilises Graft Function in AMR Patients Unresponsive to Standard of Care

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Renal Function at the time of initial AMR Dx. Renal Function at the end of first-line AMR SOC.

Renal Function at the end of 6 mos. C1inh Tx.

In a pilot study 6 patients with AMR, unresponsive to standard of care, were treated with C1 INH and had improved renal function (estimated Glomerular Filtration Rate, eGFR) at 6 months

Viglietti et al., Am J of Transplantation 2016

80 | Driven by Our Promise[™]

CSL842 Phase III Randomised, Placebo-controlled Withdrawal

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

Part 1: 12 Weeks Part 2: 26 Weeks 3.5 Years
C1 INH
IVIg + C1 INH
open label
Placebo
Responders Randomised 1° endpoint 2° endpoint
Study actively recruiting and on track
Loss of Response Graft Survival
----- End of picture text -----**

**occurrence of any of the following Decline in renal function (eGFR) Allograft failure Subject death

81 | Driven by Our Promise[™]

Vitaeris and CSL Strategic Collaboration in AMR

  • Clazakizumab (anti-IL6) in clinical development

  • Successful FDA Type C meeting

  • Anticipated dosing in chronic AMR patients in 2019

  • IL-6 may play a role in

  • DSA production and DSA mediated allograft injury

  • Cell-mediated rejection

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  • Chronic allograft vasculopathy

  • Pilot study demonstrated blocking IL-6 stabilises renal function and prolongs graft survival*

*Choi et al Am J Transplantation 2017

82 | Driven by Our Promise[™]

Beyond Solid Organ Transplant: Hematopoietic Stem Cell Transplant (HSCT) and Graft versus Host Disease

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

Annual HSCTs in the US
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GvHD is a common cause of morbidity and mortality in HSCT

  • ~50-60% of Allogeneic HSCT develop acute Graft versus Host Disease (GvHD[) ]

  • Survival is 30% for Grade III and 10% for Grade IV

  • Therapies are often ineffective or cause severe immunosuppression

83 | Driven by Our Promise[™]

Potential Immunomodulation of Alpha-1 Antitrypsin (AAT) in Acute GVHD

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

AAT
Cyclosporine or
Tacrolimus + MTX
DAMPs
Activation and
proliferation of
Teff cells
Naïve T cell
PAMPs APC
TNF-α, IL-1β
Acute GVHD
AAT IL-6, IL-32 Teff End-organ damage:
Skin, liver, gut
AAT
Promotion
AAT
Inhibition Treg
Blazar, B. R., et al. (2012). Nat Rev Immunol 12(6): 443-458.
3 : 274 Neutrophil
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Blazar, B. R., et al. (2012). Nat Rev Immunol 12(6): 443-458. Schmidt, S. V., et al. (2012) Front Immunol 3 : 274

84 | Driven by Our Promise[™]

Treatment of Steroid-Refractory GvHD with AAT

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Mangenau et al Blood 2018
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Alpha-1 Antitrypsin (AAT)

  • 40 Patients with Steroid refractory aGVHD

CSL964 AAT GvHD Prevention

  - Planned evaluations in prophylaxis of GvHD with AAT

  - Study start up activities commenced
  • Open label AAT - 60mg/kg twice weekly x 4 weeks

  • Day 28 overall response rate (ORR) - 65%

  • 35% Complete Response

  • Sustained responses - 73% at Day 60

  • Well tolerated with low rates of infection

85 | Driven by Our Promise[™]

Breakthrough Medicines

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Breakthrough
Transplant
Medicines
Specialty
Immunoglobulins
Products
Haemophilia
Products
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  • Leveraging clinical and technical insight in developing novel proteinbased therapies:

  • Significant unmet need

  • Multiple indications

Key Focus:

  • CSL112 (ApoA-I)

  • CSL312 (anti-FXIIa mAb)

  • CSL324 (anti-G-CSFR mAb)

  • CSL346 (anti-VEGF-B mAb)

  • CSL311 (anti-BC mAb)

86 | Driven by Our Promise[™]

CSL112 Hypothesis

CSL112 will

  • be safe and well tolerated

  • enhance cholesterol efflux capacity (CEC)

  • acutely stabilise atherosclerotic plaques and prevent subsequent major adverse cardiovascular events (MACE) in the early, highest risk period (unique treatment period)

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CSL112
particles
ABCA1 transporter
Intracellular
cholesterol
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87 | Driven by Our Promise[™]

CSL112 Phase III Study Design

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1° Endpoint: MACE MACE Follow Up
D90 D180 D365
17400 AMI subjects ≥ 18
Placebo (n=8700)
years of age, With Acute Screening Randomisation
6g CSL112 (n=8700)
Coronary Syndrome
1000 Centers - >40 Countries
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  • Enriched Study Population: Multi-vessel coronary artery disease and at least one of the following:

  • Age >65

  • History of MI

  • Diabetes mellitus

  • Peripheral artery disease (PAD)

  • Registry data confirms enriched AEGIS-II population is associated with high early recurrent event rate and supports our trial assumptions

88 | Driven by Our Promise[™]

CSL112 Program Timeline

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2016 2017 2018 2019 2020 2021 2022 2023
CSL112 CMC - Supply
AEGIS-I
Phase III (AEGIS II) Outcomes Study
BLA
MOD RI Phase II
Futility #1
Mar ‘20
Futility #2 MAA
Oct ‘20
Interim Efficacy
Apr‘21
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  • Actively recruiting and on track

  • To date, patient activity at sites supports the Registry data

| Driven by Our Promise[™]

89

Commercial Overview Specialty, Transplant, CSL112 Mr Bill Campbell Executive Vice President & Chief Commercial Officer

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90 | Driven by Our Promise[™]

CSL Portfolio: Specialty

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Albumin
Immunoglobulin
Haemophilia
Specialty
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FY18 1,490M +24%

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91 | Driven by Our Promise[™]

Continued Growth Opportunity for

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Anticoagulation Market US [1]
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Other , 3%
Xarelto, 24%
Warfarin,
39%
Eliquis, 34%
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Warfarin Market US[1]

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KCENTRA®,
40%
FFP &
Others, 60%
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US clinical practice guidelines recommend KCENTRA[®] over FFP to reverse the effects of Warfarin*

Source: 1. IQVIA NPA Market Dynamics Anti-Coagulant Patients Q3 2018

*Neurocritical Care Society, Society of Critical Care Medicine, American College of Cardiology, American College of Chest Physicians, American Society of Gastrointestinal Endoscopy, American College of Surgeons

92 | Driven by Our Promise[™]

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Growth Since Launch

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End User Demand (IU)
250
200
150
100
50
0
FY 13/14 FY 14/15 FY 15/16 FY 16/17 FY 17/18
Millions
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93 | Driven by Our Promise[™]

Specialty Products –

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  • Transformational HAE therapy

  • New patients weekly

  • Strong patient, physician and prescriber engagement

  • Natural C1 replacement

  • #1 prescribed therapy in the US for prevention of HAE attacks

94 | Driven by Our Promise[™]

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Established efficacy

  • 95% reduction in HAE attacks

  • Rescue medication reduced by >99%

  • HAEGARDA[®] studied in patients with 3.8 attacks per month

C-INH for C1-INH deficiency

  • HAEGARDA[®] replaces missing or dysfunctional C1-INH, regulating the normal production of bradykinin

  • C1-INH has been used in HAE for over 35 years

  • WAO Guidelines

  • 2017 WAO Treatment Guidelines recommend the use of C1-INH for first line, long-term prophylaxis therapy

95 | Driven by Our Promise[™]

Why

Key KOL Quote

“With efficacy it is as good as it gets with HAEGARDA[®] . However if Lanadelumab can prove the same level of efficacy, HAEGARDA[®] can still clearly differentiate by its MOA, replacing the missing protein of CI-INH”

Additional HCP Quotes

“From our collective experience, we gave efficacy 5. I have some Cinryze patients that still have breakthrough attacks but haven’t had any with HAEGARDA[®] .”

— HAE HCP

— Leading KOL

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Additional Patient Testimonials

“I never realized how much HAE limited me until it stopped being a big part of my life.”

— Shari, HAEGARDA[®] patient

“When I started HAEGARDA[®] , I went longer without an attack than I had in over 18 years.”

— Stephanie, HAEGARDA[®] patient

“For 40 years I lived with so many limitations, until HAEGARDA[®] . I’m still getting used to a new way of life.” — Melissa, HAEGARDA[®] patient

“She started HAEGARDA[®] …and literally her life changed. She said she owed it all to HAEGARDA[®] . I cried with this woman. And she didn’t have any attacks. She started HAEGARDA[®] and was attack free.”

— HAE HCP, MD

“Maybe the most important part of the guidelines is the emphasize of C1 inhibitors as first line. No matter how you feel about guidelines, its still number one.”

— HAE HCP, MD

“C1-INH has been around for 35 years. It is a trusted product.” — HAE HCP, MD

96 | Driven by Our Promise[™]

Cardiovascular Disease (CVD) High Unmet Medical Need

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  • CVD remains leading cause of death globally

  • In the US & Europe, 2 million MI’s occur each year

  • Survivors remain at high risk for early recurrent CV events

  • Among high-risk populations:

  • 14% recurrence in year one

  • of these ~70% within first 90 days

  • Reducing the risk of early recurrent events represents a significant unmet need

97 | Driven by Our Promise[™]

CSL112 – Our Vision and Strategy

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Vision

Establish CSL112 as a leading hospital initiated solution to prevent early recurrent CV events in post-AMI pathway of care

Strategy

  • Define the unmet need within the 90d period • Establish the role of Apo A-I and Cholesterol Efflux • Position CSL112 in the post AMI pathway of care • Define the clinical and economic value of CSL112

98 | Driven by Our Promise[™]

CSL112 – Our Journey

  • Expanding patient focus to heart disease, the leading cause of death W/W

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  • Refining high-risk AMI target population and validating with real world data

  • Developing insights relative to the post-MI pathway of care

  • Engaging with hospitals and payors to define value proposition and pricing

  • Building insight and partnerships through Advisory Boards and Scientific exchange

  • Developing a global Disease Awareness educational program

  • Partnering with hospitals, payers and patients to prepare the market

99 | Driven by Our Promise[™]

Transplant Opportunity

  • Two fundamental types of transplant:

  • Solid organ transplant (SOT)

  • Hematopoietic stem cell transplant (HSCT)

  • Transplant is amongst the most transformative and curative therapies in all of medicine

  • Utility is currently restricted due to

  • Treatment-related toxicities

  • Demand outstrips availability of healthy compatible donors

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  • Reducing complications could significantly increase utilisation

100 | Driven by Our Promise[™]

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[™]

101

Transplant Fit for CSL

  • Significant unmet patient needs

  • Multiple opportunities with current assets with proof-of-concept evidence

  • Limited competition and concentrated call points

  • Building on our strong foundation of plasma assets

  • Potential to expand use of Hematopoietic Stem Cell Transplant

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102 | Driven by Our Promise[™]

Summary

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103 | Driven by Our Promise[™]

R&D Portfolio - December 2018

RESEARCH PRE-CLINICAL PHASE I PHASE II PHASE III REGISTRATION COMMERCIAL /
PHASE IV
New Product
Development
Emerging
Technologies
CSL787
Nebulised Ig
CSL730
rFc Multimer
CSL312 Anti-FXIIa
in HAE
Clazakizumab
Transplant*
IDELVION®
Novel Strategies CSL311
Anti-BC

CSL324
Anti-G-CSF
Mavri GM-CSFR-AZ* pdFVIII Ruide AFSTYLA®
Discovery Projects CSL200 (CAL-H)
SCD
CSL346
Anti-VEGF-B
CSL112
Apo-AI
FLUAD® aTIV
65+ yr US, UK, AUS
Haptoglobin CSL889 Hemopexin
in SCD
CSL334 IL-13R
ASLAN*
FLUAD QIV 65+ yr FLUCELAX® QIV
4+ yr US
Clinical
Applications
P. gingivalis/POD
OH-CRC*
Pre-Pandemic
Vaccine (aH5N1c)
CSL830
C1-INH Subcut EU
Life Cycle
Management
/ Market
Development
Clinical
Applications
C1-INH New
Indications
PRIVIGEN® ID Japan PRIVIGEN® CIDP US
Fibrinogen New
Formulations
HIZENTRA® IIM AFLURIA® QIV
6m-4 yr AUS
HIZENTRA® CIDP
CSL842 C1-INH
AMR
PRIVIGEN® CIDP
Japan
KCENTRA® Japan
CSL964 AAT
GvHD Prevention
HIZENTRA® CIDP
Japan
HAEGARDA® US
AFLURIA® QIV
6m+ US

Core Capabilities: Immunoglobulins | Haemophilia | Specialty Products | Breakthrough Medicines | Transplant | Vaccines & IP

*Partnered Projects

104 | Driven by Our Promise[™]

Current CSL Behring Therapeutics Platform

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Breakthrough
Medicines Transplant
Immunoglobulins
Specialty
Products
Haemophilia
Products
Plasma Recombinant
Fractionation Technology
Gene Therapy
Protein Science
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105 | Driven by Our Promise[™]

Future CSL Behring Therapeutic Area Framework

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Immunology and Neurology
Haematology and Thrombosis
Transplant
Respiratory
Cardiovascular and Metabolic
Plasma Recombinant Gene and Cell
Fractionation Technology Therapy
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106 | Driven by Our Promise[™]

R&D Portfolio - December 2018

RESEARCH PRE-CLINICAL PHASE I PHASE II PHASE III REGISTRATION COMMERCIAL /
PHASE IV
New Product
Development
Discovery Projects CSL787
Nebulised Ig
CSL730
rFc Multimer
CSL312 Anti-FXIIa
in HAE
Clazakizumab
Transplant*
IDELVION®
Discovery Projects CSL311
Anti-BC

CSL324
Anti-G-CSFR
Mavri GM-CSFR* pdFVIII Ruide AFSTYLA®
Discovery Projects CSL200 (CAL-H)
SCD
CSL346
Anti-VEGF-B
CSL112
Apo-AI
FLUAD® aTIV
65+ yr
Discovery Projects CSL889 Hemopexin
in SCD
CSL334 IL-13R
ASLAN*
FLUAD QIV 65+ yr FLUCELVAX® QIV
4+ yr US
Discovery Projects P. gingivalis/POD
OH-CRC*
Pre-Pandemic
Vaccine (aH5N1c)
CSL830
C1-INH Subcut EU
Life Cycle
Management
/ Market
Development
Clinical
Applications
PRIVIGEN® PID
Japan
FLUCELVAX® QIV
9+ yr EU
PRIVIGEN® CIDP US
Clinical
Applications
HIZENTRA® IIM AFLURIA® QIV
6m-4 yr AUS
HIZENTRA® CIDP
Clinical
Applications
CSL842 C1-INH
AMR
PRIVIGEN® CIDP
Japan
KCENTRA® Japan
Clinical
Applications
CSL964 AAT
GvHD Prevention
HIZENTRA® CIDP
Japan
HAEGARDA® US
Clinical
Applications
AFLURIA® QIV
6m+ US

Therapeutic Areas: Immunology & Neurology | Haematology & Thrombosis | Respiratory | CV & Metabolic | Transplant | Vaccines & IP

*Partnered Projects

| Driven by Our Promise[™]

107

Expected Progress in Next 12 Months

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New Product Product Dev. & Registration Post
Research Phase I (FIH) Phase II Phase III
Opportunity GLP Toxicology & Launch Registration
1 2 3 4 5 6 7
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1
2
3
4
5
6
7 7
En
Rese
ter
arch
Enter P
Dev. & G
roduct
LP Tox.
Enter
Phase I
Enter P
hase II
Enter P
hase III
Enter R
& La
egister
unch
Enter
Regist
Post
ration
Clin Applications &
Discovery
CSL889
Hemopexin in SCD
PRIVIGEN
SSc
HIZENTRA
IIM
PRIVIGEN ID
Japan
HIZENTRA®
CIDP Japan
Clin Applications &
Discovery
CSL200 (CAL-H) SCD CSL312 (Anti-FXIIa)
in Thrombosis
HIZENTRA
SSc
IDELVION®
21 Day Dosing
PRIVIGEN®
CIDP Japan
Clin Applications &
Discovery
CSL311
Anti-Beta Common
CSL324
Anti-G-CSFR Ph1b
AFLURIA QIV
6m-4 yr AUS
CSL830
C1-INH Subcut EU
Clin Applications &
Discovery
CSL787
Nebulised Ig
CSL346
Anti-VEGF-B Ph1b

CSL964AAT
GvHD Prevention
FLUCELVAX QIV
9+ yr EU
Clin Applications &
Discovery
CSL200 (CAL-H) SCD CSL819 C1-INH
Kidney DGF
FLUAD QIV
65+ yr
Pre-Pandemic
aH5N1c US

Therapeutic Areas: Immunology & Neurology | Haematology & Thrombosis | Respiratory | CV & Metabolic | Transplant | Vaccines & IP

108 | Driven by Our Promise[™]

Significant Target Launch Dates

2018 2019 2020 2021-2024
HIZENTRA® CIDP US/EU HIZENTRA® CIDP Japan PRIVIGEN® PID Japan CSL312 (Anti-FXIIa) HAE
PRIVIGEN® CIDP US PRIVIGEN® CIDP Japan IDELVION® 21 Day Dosing Hizentra® IIM
CSL830 C1-INH Subcut EU Improved Fibrinogen
Kcentra Japan CSL112 ApoA-I
Clazakizumab* Transplant
IVIg Kidney AMR
AFLURIA® QIV 6m+ US CSL842 C1-INH AMR
AFLURIA® QIV 5-17yr AUS AFLURIA® QIV 6m to 5yr AUS FLUCELVAX® QIV 4+ yr AUS
FLUAD® aTIV 65+ yr UK, AUS FLUCELVAX® QIV 9+ yr EU FLUAD® aQIV 65+ yr US FLUAD® aQIV 65+ yr EU

Therapeutic Areas: Immunology & Neurology | Haematology & Thrombosis | Respiratory | CV & Metabolic | Transplant | Vaccines & IP

109 | Driven by Our Promise[™]

2018 Highlights

Immunology &
Neurology
Haematology &
Thrombosis
Transplant
Cardiovascular &
Metabolic
Respiratory
Licensing & Vaccine
• Completion of CSL324 (anti-G-CSF) Phase I study
• Initiation of CSL312 (anti-FXIIa) HAE Phase II study
• Initiation of CSL730 (rec FC multimer) Phase I study
• PRIVIGEN® CIDP and HIZENTRA® CIDP approved in the US
• Ongoing IDELVION® dosage extension study supports 21 day regimen
• Initiation of CSL200 (CAL-H) in SCD GTP Toxicology studies
• CSL842 C1-INH AMR Phase III actively recruiting and on track
• Successful FDA Type C meeting regarding Clazakizumab (anti-IL6) study
• Initiation of CSL112 (Apo A-1) Phase III study (AEGIS-II)
• Completion of CSL346 (Anti-VEGF-B) Phase 1 study
• Initiation of CSL787 Nebulised Ig GLP Toxicology studies
• AFLURIA® QIV registered in US for 6M-4years
• FLUAD® aTIV registered in UK and Australia
• FLUCELVAX® QIV positive effectiveness data compared with egg-based vaccines in US 2017-18 season
• Initiation of CSL334 IL-13R Phase I study by ASLAN
s*

110 | Driven by Our Promise[™]

Q&A

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111 | Driven by Our Promise[™]

For immediate release 5 December 2018

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Next Generation Cell-based Influenza Vaccine Shows Significantly Greater Effectiveness Compared to Standard Egg-based Options in the 2017-18 US Influenza Season

CSL spotlights developments in cell-based vaccine technology at Australian Research and Development briefing

CSL Limited (ASX:CSL; USOTC:CSLLY) subsidiary Seqirus, today presented new real‐world data showing that its cell‐based quadrivalent influenza vaccine (QIVc) was 36.2 percent more effective than standard* egg‐based quadrivalent vaccines (QIVe) in preventing influenza‐like illnesses during the 2017/18 influenza season in the United States. This is likely due to the predominance of the H3N2 virus and its propensity for mutation when it is adapted for influenza vaccine production in chicken eggs. These observational data were presented today at the Canadian Immunisation Conference and also shared at CSL’s annual Research and Development briefing in Sydney.

The finding is based on an analysis of over one million (1,353,862) medical records for patients aged four years and above who received either a four‐strain egg‐based influenza vaccine or a four‐strain cell‐based influenza vaccine in a primary care setting during the 2017/18 influenza season in the United States. Analysing real‐world data from electronic medical records is a new and important approach to understanding the effectiveness of influenza vaccines and their impact on health outcomes. These types of analyses are different from traditional randomised clinical trials which study clinical efficacy.

According to the US Centers for Disease Control[1] the 2017/18 influenza season in the US was the worst in recent years with the H3N2 virus being associated with the majority of influenza infections. Research has shown that H3N2 viruses often undergo changes when they are grown in eggs[2] . When produced completely outside of the egg‐based process, cell‐based influenza vaccines avoid egg‐adapted changes, which means they may offer a closer match and potentially improved protection compared to standard egg‐based options in some seasons.[3, 4, ] 5, 6, 72,3,4,5,6,7

QIVc was first licensed in the US in 2016 based on a study showing non‐inferiority immune response to a three‐strain cell‐based influenza vaccine. Both cell‐based products used in this study were produced using egg‐based starting viruses.[8] The 2017/18 season was the first in which QIVc was manufactured using a cell‐derived H3N2 starting virus, making this component of the vaccine exclusively cell‐based. Seqirus is incorporating other cell‐derived starting viruses into the production process for QIVc and has plans to conduct real‐world studies over future seasons to help determine the full potential of the cell‐based technology in preventing influenza.

*standard QIVe is non‐adjuvanted with standard dose of antigen.

For more information about CSL Limited, visit www.csl.com.au Page 1 of 4

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“The real‐world data, along with other emerging evidence, indicates that cell‐based influenza vaccines may result in better influenza‐related outcomes compared to standard egg‐based vaccine options in some seasons, particularly those seasons characterised by egg‐adapted changes,” said Gregg Sylvester, VP Medical Affairs, Seqirus. “We are greatly encouraged by the data and with increasing availability of our vaccine look forward to working with partners to generate additional data in future seasons.”

Developing new and better influenza vaccine technologies is a strategic priority for Seqirus, including further advancing current cell‐based technology as well as adjuvants – or ‘immune boosters’ – to enhance the immune response of those particularly vulnerable to influenza such as children and the elderly.

While QIVc is currently only licensed in the US, the European regulatory agency (EMA) recently issued a positive recommendation for the vaccine, indicating formal approval in Europe by the end of 2018. Expansion into other markets is planned after that, including the submission of an application to the TGA in Australia in 2019.

Seqirus’ QIVc is manufactured in the company’s Holly Springs facility in North Carolina. The capacity of the plant to meet anticipated future demand for the vaccine has been greatly enhanced with approval by the FDA earlier in 2018 for important process improvements to the manufacturing process, and by the recently announced US$140 million plant expansion.

"The burden of influenza is a global healthcare concern, and Seqirus is committed to developing new and potentially better vaccines that help reduce the hundreds of thousands of deaths and severe illness caused every year by influenza. Since we acquired the cell‐based technology just three years ago, we have increased vaccine production five‐fold and introduced cell‐derived starting viruses (rather than viruses that have been optimised to grow in eggs). These innovations together with other major investments into the Holly Springs facility will assist us to meet further global demand for the vaccine," said CSL’s Chief Scientific Officer Professor Andrew Cuthbertson.

Influenza is a common, highly contagious infectious disease that can cause severe illness and life‐threatening complications in many people. In Australia, the impacts of the 2017 season included high levels of absenteeism and a substantial burden on primary care and hospitals.[9]

“Vaccination is the best line of defence in reducing deaths and severe illness caused by influenza. Every flu season is different and it’s important that we stay one step ahead of influenza viruses through the development of more effective vaccines, better matched to the strains in circulation. This real‐world data on cell‐based vaccines is encouraging and will bring another welcome influenza vaccine option to Australia,” said Professor Terry Nolan AO, Head, Melbourne School of Population and Global Health. ‐ ends ‐

Media Contact

Christina Hickie CSL Limited Phone: +61 9389 3425/ 0429 609 762

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

Page 2 of 4

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About the Study: Data from a large U.S. electronic medical record (EMR) provider for primary care practices were obtained between August 1, 2017 and March 31, 2018. This was a retrospective cohort study with the objective of determining the relative vaccine effectiveness ( rVE ) of cell‐based quadrivalent, inactive influenza vaccine (QIVc) compared to that of egg‐ based, quadrivalent, inactive influenza vaccine (QIVe). The endpoint assessed was influenza‐ like illness (ILI), as defined by CDC, which is a widely used set of symptoms that serves as an indicator for people who have influenza infection and reflects exposure and outcome experiences during routine clinical practice.

The analysis included data from people 4 years and older in primary care setting, 92,192 who received QIVc and 1,255,983 who received a QIVe. Exposures were derived from recorded immunizations in individual patients EMRs.

The rVE estimated from the study’s primary analysis indicated that QIVc was more effective than standard egg‐based QIVs in preventing ILI (rVE of 36.2%, 95% CI (26.1,44.9; P<0.001)). Potential study limitations were minimised using stringent quality control of the data set, cross‐referencing the exposure classification step, evaluating two different outcomes code sets for ILI, adjusting for key variables and conducting multiple sensitivity analyses.[10] There are currently no head to head clinical trials comparing the efficacy QIVc to QIVe.

Quadrivalent cell‐culture influenza vaccine is not approved in Australia.

About Seasonal Influenza: Influenza is a common, highly contagious infectious disease that can cause severe illness and life‐threatening complications in many people. To reduce the risk of more serious outcomes, such as hospitalization and death, resulting from influenza, the CDC encourages annual vaccination for all individuals aged 6 months and older.[11] Because transmission to others may occur one day before symptoms develop and up to 5 to 7 days after becoming sick, the disease can be easily transmitted to others.[12] Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases death. The CDC estimates that 959,000 people in the United States were hospitalized due to influenza‐related complications during the 2017/18 influenza season. Since it takes about 2 weeks after vaccination for antibodies to develop in the body that protect against influenza virus infection, it is best that people get vaccinated to help protect them before influenza begins spreading in their community.[9]

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 60 countries and employs 22,000 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.

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For immediate release 5 December 2018

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REFERENCES:

1 Centers for Disease Control and Prevention (CDC). (2018). Estimated influenza illnesses, medical visits, hospitalizations, and deaths in the United States — 2017–2018 influenza season. Retrieved from: https://www.cdc.gov/flu/about/burden/estimates.htm Accessed November 2018. 2 CDC. (2018). Advisory Committee on Immunization Practices (ACIP) Presentation Slides: June 2018 Meeting. Retrieved from https://www.cdc.gov/vaccines/acip/meetings/slides‐2018‐06.html Accessed November 2018.

3 Rajaram S., Van Boxmeer J., Leav B., et al . (2018). Retrospective evaluation of mismatch from egg‐ based isolation of influenza strains compared to cell‐based isolation and the possible implications for vaccine effectiveness. Presented at IDWeek 2018, October 2018.

4 Zost S.J., Parkhouse K., Gumina M.E., et al. (2017). Contemporary H3N2 influenza viruses have a glycosylation site that alters binding of antibodies elicited by egg‐adapted vaccine strains. PNAS , 114(47)12578‐12583. doi:10.1073/pnas.1712377114.

5 Wu N.C., Zost S.J., Thompson A.J., et al. (2017). A structural explanation for the low effectiveness of the seasonal influenza H3N2 vaccine. PLOS Pathogens , 13(10): e1006682. doi:10.1371/journal.ppat.1006682.

6 The Francis Crick Institute. (2018). Worldwide Influenza Centre: Annual and Interim Reports – February 2018 interim report. Retrieved from https://www.crick.ac.uk/research/worldwide‐influenza‐ centre/annual‐and‐interim‐reports/ Accessed November 2018.

7 ‐ CDC. (2018). Cell‐Based Flu Vaccines. Retrieved from: https://www.cdc.gov/flu/protect/vaccine/cell based.htm Accessed November 2018.

8 Flucelvax Quadrivalent – Seqirus Inc. 07/2018 (revision 2) Highlights of Prescribing Information: https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM619588.pdf 9 Australian Government Department of Health. 2017 Influenza Season in Australia – A summary from the National Influenza Surveillance Committee, Information Brief 22 Nov, 2017: http://www.health.gov.au/internet/main/publishing.nsf/Content/097F15A91C05FBE7CA2581E20017F0 9E/$File/2017‐season‐summary‐22112017.pdf

10 Armed Forces Health Surveillance Center (AFHSC): Influenza‐Like Illness (ILI). (2015). Retrieved from https://www.health.mil/Reference‐Center/Publications/2015/10/01/Influenza‐Like‐Illness Accessed November 2018.

11 CDC. (2018). Key facts about seasonal flu vaccine. Retrieved from: http://www.cdc.gov/flu/protect/keyfacts.htm Accessed November 2018.

12 CDC. (2018). How flu spreads. Retrieved from: https://www.cdc.gov/flu/about/disease/spread.htm Accessed November 2018

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