CSL Ltd. - Investor Presentation 2017

December 5, 2017

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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.

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Professor Andrew Cuthbertson AO R&D Director and Chief Scientist

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Agenda

Welcome
• Introduction and Highlights
• Research
• Early Development
• Immunoglobulins, Haemophilia and Specialty Products – Clinical Development
– Commercial Opportunities
• Q&A

– Break –

Transplant and Breakthrough Medicines (CSL112) – Clinical Development
– Commercial Opportunities
• Summary
• Q&A

Mark Dehring Andrew Cuthbertson Andrew Nash Charmaine Gittleson Bill Mezzanotte Bill Campbell Bill Mezzanotte Bill Campbell Andrew Cuthbertson

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Global

Commitment to Research and Development

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Research and
645
Development Investment
614 New Product Development
(US$ Millions) activities focus on innovative new
therapies for life-threatening diseases
466 463
Market Development strategies
427
seek to bring therapies to new
markets and new indications
Life Cycle Management
ensures continuous improvement
of existing products
12-13 13-14 14-15 15-16 16-17
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• R&D investment ~10-11% global revenue

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Global

Key Past Launches from R&D Portfolio

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2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
VIVAGLOBIN [® ]
PRIVIGEN [® ] HIZENTRA [® ] PRIVIGEN [®] Ig IsoLo [® ]
RHOPHYLAC [® ]
CIDP (EU)
ZEMAIRA [® ] (US) BERINERT [® ] (US) KCENTRA [® ] (US) RESPREEZA [® ] (EU)
BERIPLEX [® ] (EU) RIASTAP [® ] CORIFACT [® ] HAEGARDA [® ] (US)
VONCENTO [® ] (EU)
IDELVION [® ]
AFSTYLA [® ]
AFLURIA [® ] QIV
AFLURIA [® ]
GARDASIL [® ] FLUCELVAX [® ]
H1N1
FLUAD [® ] US
Ig
Specialty
Haem
Vaccines
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Global Global

Leveraging Global Capabilities

PASADENA, US WUHAN, CHINA CSL Behring Seqirus

>1,500 scientists globally

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Global

R&D Portfolio – December 2016

	RESEARCH	PRE-CLINICAL	PHASE I	PHASE II	PHASE III	REGISTRATION	COMMERCIAL / PHASE IV
Life Cycle Management#							Immunoglobulins
							Haemophilia
							Specialty Products
							Influenza Vaccine
Market Development	PCC New Indications	C1-INH New Indications			HIZENTRA® CIDP	PRIVIGEN® CIDP US	VONCENTO® VWD EU
		Fibrinogen New Forms			PRIVIGEN® Japan	KCENTRA® Japan	RESPREEZA® EU/US
		Haptoglobin /Hemopexin			HIZENTRA® IIM
					CSL842 C1-INH Transplant
New Product Development	Next GenIg Formulations	CSL626 D’D3 LA rVIII	CSL689 rVIIa-FP Congen Def	CSL689 rVIIa-FP Inhibitors		AFSTYLA® Europe	IDELVION® US, EU, Japan
	Rec Coagulation Factors	CSL334 IL-13R ASLAN*	CSL640 rIX-FP subct	Mavri GM-CSFR-AZ*		AFLURIA® QIV 5-17 US, AUS	AFTSYLA® US
	P. gingivalis/POD OH- CRC	CSL346 Anti-VEGFB	CSL312 Anti-FXIIa	CSL362 IL-3R AML Janssen			AFLURIA® QIV 18+ US & AUS
	Discovery Projects		CSL324 Anti-G-CSFR	CSL112 apo-AI			FLUAD® TIV 65+ US
							FLUCELVAX® QIV 4+ US

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

*Partnered Projects
8 #LCM includes direct post marketing commitments as well as pathogen safety, capacity expansions, yield improvements, new packages and sizes for all registered products

Global

CSL Behring Protein Therapeutics Platform

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Specialty
Products
Haemophilia
Products
Plasma Recombinant
Fractionation Technology
Protein Science
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Global

Evolving Therapeutics Platform

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Breakthrough
Medicines Transplant
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Specialty
Products
Haemophilia
Products
Plasma Recombinant
Fractionation Technology
Gene Therapy
Protein Science
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Global

Progress Through Stage Gates in 2017

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New Product Product Dev. & Registration Post
Opportunity Research GLP Toxicology Phase I (FIH) Phase II Phase III & Launch Registration
1 2 3 4 5 6 7
Enter Enter Product Enter Phase I Enter Phase II Enter Phase III Enter Register Enter Post
Research Dev. & GLP Tox. & Launch Registration
Emerging CSL730 HIZENTRA [®] PRIVIGEN [®] CIDP
Technologies rFc Multimer
CIDP US US
CSL689
Novel Strategies pdFVIII Ruide AFSTYLA [®] EU
rVIIa-FP
Applications Clinical CSL640 rIX-FP subcut CSL842 C1-INH AMR AFSTYLA [®] Japan
Clinical CSL964 AAT clazakizumab HAEGARDA [®]
Applications GvHD Transplant US, CAN
CSL311 CSL112
Anti-BC CSL346 Apo-AI KCENTRA [®] Japan
Anti-VEGF-B
AFLURIA [®] QIV FLUAD [®] QIV 65+
Discovery Projects CAL-H SCD FLUAD [®] QIV 65+ 6m-4 US, AUS UK
CSL362 IL-3R AFLURIA [®] QIV AFLURIA [®] QIV
AML Janssen 5+ CAN, ARG 5-17 US
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11 *Partnered Projects

Global

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® CIDP US
		Fibrinogen New Formulations			HIZENTRA® IIM		KCENTRA® Japan
		Haptoglobin/ Hemopexin		CSL964 AAT GvHD		HAEGARDA® EU	HAEGARDA® US
		CSL640 rIX-FP subct			PRIVIGEN® CIDP Japan	AFLURIA® QIV 5-17 AUS	FLUAD® TIV 65+ US, UK
					CSL842 C1-INH AMR		FLUCELAX® QIV 4+ US
							AFLURIA® QIV 5-17 US

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-CSFR
	Clinical Applications	CSL311 Anti-BC	CSL346 Anti-VEGF-B		CSL112 apo-AI
		P. gingivalis/POD OH-CRC*

12 *Partnered Projects

Dr Andrew Nash Senior Vice President, Research

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Research Organisation & Portfolio

Coordinated global project portfolio

Specialty Immunoglobulins Haemophilia Products

Breakthrough Transplant Medicines

Hub (Bio21, Parkville) & spoke model

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Bio21 expansion to be completed Feb 2018
Research capabilities: plasma & recombinant proteins, gene and cell-based therapies

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Bio21 expansion

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Recombinant Fc Multimer – CSL730

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Fab region
• Immune deficiencies
recombinant multimerised Fc
Fc region
• Autoimmune
conditions
Improved target binding
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Recombinant Fc Multimer – CSL730

CSL / Momenta Collaboration

‐ ‐
First in class recombinant Fc multimer targeting Fcγ receptors
Exclusive Research Collaboration and License Agreement
Development and commercialisation of the Fc multimer M230/CSL730
Research & development of additional Fc multimers
Momenta has elected to co-fund development of CSL730

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Recombinant Fc Multimer – CSL730

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CSL730 therapeutic efficacy in ITP model
CSL730 dose
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Non-clinical safety toxicity data supports commencement of FIH studies
Phase I study (healthy volunteers) planned to commence Q1 2018
Phase Ib proof of mechanism study anticipated for 2019

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Calimmune Technology

Acquisition of California based biotechnology company
Performance based milestones
Gene / cell based therapy, rare genetic disorders
ex vivo Lenti virus transduction of hematopoietic stem cells (HSC’s)
Calimmune differentiating technology:

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Cytegrity Lentivirus Manufacturing

stable & scalable GMP

compliant system

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Select[+] In Vivo Selection Tool

drives engraftment with lower intensity conditioning
significantly reduced burden on patient

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Calimmune – CAL-H Program

Sickle Cell Disease

Group of disorders caused by abnormal beta-globin gene resulting in sickled red cells
Average life expectancy in the developed world is 40 – 60yrs
High unmet need
Total SCD patients: 155,000 (US + 5EU)

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Cytegrity™ Select+™
SIN-LV γ-globin construct (sGbG [M] )
lenti-backbone technology
7SK shRNA β pro LCR
HPRT shRNA γ-globin exons
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CAL-H program aims to provide sufficient functional globin gene to prevent sickling

Calimmune – CAL-H Program

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CAL-H Select+
Cytegrity
lenti vector Post cell infusion monitoring /
Patient referral / transfer 6-TG dosing (Select [+] ), outpatient
strategy
HSC
Clinical program
planned to commence
in 2019
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Range of further opportunities beyond SCD

Dr Charmaine Gittleson Chief Medical Officer

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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

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Research Product Dev / Tox Phase I Phase II CSL312 (anti-FXIIa) CSL324 (anti-G-CSFR) CSL346 (anti-VEGF-B) CSL730 (rFC multimer) CSL311 (anti-BC) CSL626 (D’D3 LA rVIII)

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CSL312 – HAE and Thrombosis

• Targeting FXIIa represents a novel approach to the treatment of hereditary angioedema and contact activated thrombosis • Efficacy in multiple animal models and translational studies

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Auto-activation
FXIIa
-
FXI → FXIa PK → KAL βFXIIa
→ thrombin HK → BK→ BR2 C1qr,s → C1qr,s
Haemostasis Vasodilation, Complement
vascular permeability activation
Thrombosis HAE Transplant
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CSL312 – HAE and Thrombosis

Phase I (dosing complete Nov 2017) Safe, well tolerated GO Normal Healthy Volunteers • Safety/PK/PD

First in Human Phase I study

Phase II (2018/19) Patients with HAE

Phase Ib (~2019) Proof of mechanism in thrombosis

Single doses administered
Confirmed CSL312 safe and well tolerated with good bioavailability

CSL324 Anti-G-CSF Receptor Antibody

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White blood cells (neutrophils) – contribute to protective mechanism against infections
• Neutrophil numbers and activity under control of Granulocyte Colony Stimulating Factor (G-CSF)
Excessive activated neutrophils, in absence of infection, cause chronic severe inflammatory diseases
Blocking G-CSF could decrease unwanted effects of excessive neutrophils, possibly ameliorate chronic inflammatory diseases

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CSL324 Anti-G-CSF Receptor Antibody

Phase I (completing Jan 2018) Normal Healthy Volunteers • Safety/PK/PD

Safe, well tolerated GO

Phase Ib (2018/19) Patients with neutrophil driven disease • Proof of mechanism

First in Human Phase I study

Single and multiple doses administered; dosing completed
Confirmed CSL324 can block receptors and lower neutrophil counts

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CSL346 Anti-VEGF-B Antibody

Free fatty acids (FFA) in diet support normal energy requirements in skeletal muscle, heart and kidney
VEGF-B controls FFA movement into tissues
Excess fatty acid uptake causes:
Reduced glucose utilisation, insulin resistance and diabetic complications
Toxic fat accumulation in vital organs (liver, kidney)
Blocking VEGF-B action may help prevent or treat effects of excess FFA

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Tissue Blood vessel wall
V EGFR
-1
NRP-1
VEGF- B
PGC-
1a
Fatty
FATP acids
3/4
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CSL346 Anti-VEGF-B Antibody

Phase I

Normal Healthy Volunteers • Safety/PK/PD
Started November 2017

Safe, well tolerated

Phase Ib Patients with metabolic disorders • Proof of mechanism
• Study anticipated for 2019

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CSL311 – Anti-Beta Common

Central receptor (Beta Common) involved in stimulating immune modulating cells
Increased activation in Auto-immunity, Allergy and Inflammation
Blocking Beta Common (CSL311) and down regulating cells may ameliorate disease
CSL311 blocks activity of GM-CSF, IL-3 and IL-5
CSL311 inhibits activity of myeloid cells from normal and diseased tissue
FIH targeted for calendar year 2019

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Dr Bill Mezzanotte Senior Vice President, Clinical Development

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Immunoglobulins

Immunoglobulins

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Breakthrough
Transplant
Medicines
Specialty
Immunoglobulins
Products
Haemophilia
Products
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Maintaining leadership position through focus on: – New Indications
– Geographic expansion
– Delivery options
Key Focus: – HIZENTRA[® ]
– PRIVIGEN[® ]

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Immunoglobulins

Impact of Ig (IV & SC) in Rare Diseases

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Primary
Immuno-
deficiency
Systemic Secondary
Sclerosis & Immuno-
other diseases? Ig deficiency
Immune & Chronic Inflammatory
IIM CIDP
Inflammatory Myositis Demyelinating Polyneuropathy
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Immunoglobulins

Impact of Ig (IV & SC) in Rare Diseases

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Immunoglobulins

PATH: SCIg (HIZENTRA[®] ) Provides Effective Prophylaxis for CIDP Patients

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PATH study the largest controlled CIDP study ever performed
Investigated multiple doses
Disease control demonstrated in patients previously treated with IVIG

van Schaik et al; Lancet Neurology – Nov 17

Immunoglobulins

IV and SC Ig are Effective Treatments for CIDP

In the PRIMA trial
61% of patients responded to PRIVIGEN[®] ; 50% after the first dose
– Almost 50% of IVIG-naïve patients responded to PRIVIGEN[® ]
In the PATH study
81% patients on high dose and 67% on low dose of HIZENTRA[®] remained relapse free (after initial PRIVIGEN[®] stabilisation)
All efficacy outcomes showed clinically relevant improvements
PRIVIGEN[®] & HIZENTRA[® ] :
Improve multiple measures of CIDP disease activity
– Are well tolerated by patients with CIDP

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Immunoglobulins

Milestones in Ig Development for CIDP

PRIMA study shows efficacy of PRIVIGEN[®] for CIDP PRIVIGEN[®] for CIDP approved in EU

PATH study confirms efficacy of PRIVIGEN[®] for CIDP

PRIVIGEN[®] for CIDP: FDA approval Sept 13 2017 2018 HIZENTRA[®] for CIDP PATH study Expected Approval confirms efficacy of FDA / EU 1H 2018 HIZENTRA[®] for CIDP Japan 2H 2018

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Immunoglobulins

Impact of Ig (IV & SC) in Rare Diseases

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Proposed Ig IIM with Unique Study Design to start 2018
Health Authority (FDA, EMEA, PMDA) interactions 1Q 2018

Specialty

Specialty Products

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Breakthrough
Transplant
Medicines
Specialty
Immunoglobulins
Products
Haemophilia
Products
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Leveraging high quality broad product portfolio through: – New markets
– Novel indications
– Novel modes of administration
Key Focus: – HAEGARDA[®] /BERINERT[® ]
– KCENTRA[®] /BERIPLEX[® ]
– ZEMAIRA[®] /RESPREEZA[® ]

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Specialty

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

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

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Specialty

Demonstrating the Unique Benefit of HAEGARDA[® ]

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Median Attack Rate Reduction: 95% CSL830 Reduces Severity of Attacks
4 100
8.9
3 75 28.9 Severe
68.9
Moderate
2 50 17.8
Mild
4.4
Unknown severity
1 25
40.0 22.2
No attack
2.2
6.7
0 0
Placebo 60 IU/kg 60 IU/kg CSL830 Low-volume Placebo
HAE attack/month (median)
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Approval in US & Canada; approval pending EU

Mr Bill Campbell Executive Vice President & Chief Commercial Officer

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Global

Targeted Protein Therapeutic Market

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Haemophilia Immunoglobulin
$10.8B $9.3B
Total Global
Market Value:
~$27.6B
Specialty
Albumin $3.6B
$3.9B
Sources: Company annual reports/financial schedules, MRB
global Coagulation Factors Concentrate Market 2016, MRB
WW Plasma Fractionation Market 2015 report, CSL Actuals
FY17.
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Global

CSL Portfolio

CSL Total FY17 $5,811M

$2,774M Immunoglobulin $1,174M Specialty $1,023M Albumin $840M Haemophilia

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Global

Commercial / R&D Partnership

• Integrated strategy teams Multiple high value product launches: • Coordinated New Product 2013 KCENTRA[®] Development / Market 2016 IDELVION[®] & AFSTYLA[®] preparation 2017 HAEGARDA[®] • Disciplined launch preparation & execution 2018 HIZENTRA[®] CIDP (pending approval)

Foundational products plus new launches will continue to fuel significant growth

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Immunoglobulins

CSL’s Global Performance

CSL FY17 Sales $2,774 M
Significant growth opportunity
Per capita use varies widely
Core areas PID / SID
Neurology
New indications
Continued acceptance, growth & patient benefits of SCIG

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IVIG
SCIG
Hyper
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Immunoglobulins

Immunoglobulins: Category Leadership

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GROW • Maximise PID / SID opportunity
• Leverage broad portfolio
the current business • Enhance product offerings
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EXPAND • Replicate our approach to build market leading segments
• Build on PRIVIGEN [®] experience in CIDP
our presence in neurology • Launch HIZENTRA [®] in CIDP
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INNOVATE • Novel delivery devices
• New indications eg IIM, SSc
and protect the franchise • rFc multimer
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Immunoglobulins

HIZENTRA[®] : Innovator, Market Leader

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7 years and 51 countries

90,000 patient-years, Convenient Individualised 4.8M exposures self-administration therapy worldwide

Most prescribed SCIG worldwide

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Immunoglobulins

CIDP – Growing Area of Focus

Global IG volume by indication

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CIDP
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Other
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PID
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~23% of all IG usage globally
Growing market segment
Many unmet needs remain

Sources: Data on File – US, 5EU, Japan.

Immunoglobulins

HIZENTRA[®] addresses unmet needs in CIDP therapy

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Unmet Needs

IVIG improves CIDP symptoms but many patients experience “wear off” with IVIG therapy

Steady state IG levels for continuous control

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IVIG therapy difficult for patients with poor venous access

Hizentra therapy does not require venous access

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Many patients on IVIG suffer from systemic effects like nausea and headache

4 fold lower systemic AE rates than IVIG

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Majority of patients receive IVIG at infusion centers

Increased independence and flexibility (time/site/frequency)

HIZENTRA[®] was preferred by 3X as many patients as IVIG

Haemophilia

Global Market

Highly competitive Haem A market space
Rapid transition of Haem B category
Major advancements in patient care
75% of patients with bleeding disorders are under/untreated

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Haem B
$1.4B
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Total Global Inhibitor Market Value: Bleed Therapy ~$10.7B $2.1B

Sources: Company annual reports/financial schedules, based on 2017 data, MRB Global Coagulation Factors Concentrate Market 2016, CSL Actuals FY17.

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Haemophilia

Coagulation Portfolio

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Haemophilia A
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Haemophilia B
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Other
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VWD

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Haemophilia

Transforming Care of Haemophilia B Patients

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#1 “Switch to” brand providing highest factor levels for the longest period of time

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1 [st] Haemophilia Long-lasting
Excellent
therapy with up protection with
efficacy
to 14-day dosing high trough levels
UP TO 14 DAYS ZERO
14-DAY ABOVE 13% BLEEDS
DOSING WITH 75 IU/KG MEDIAN AsBR
Greater freedom Ability to live a more Protection from
from infusions normal life bleeds
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Haemophilia

Product of Choice for Physicians

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“All my IDELVION[®] patients were on prophylaxis previously with BeneFIX… they were very interested in having less frequent infusions. ”

– Hematologist, HTC

“This is not something I would associate with another FIX. It’s higher than Alprolix, and, from a physician’s perspective the most important thing is that a patient not bleed. ”

– Hematologist, MD

“I mean, it’s very impressive. Once we get to 21%, you know the patient is very well-protected. Seven-day dosing – there’s nothing not to like about this. ” – HTC MD

“ About half of my Alprolix patients have switched to IDELVION[®] now. I expect more will do the same.”
Hematologist, MD

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Haemophilia

Transition to New Products in Haemophilia B

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Patient switches %

Demand exceptionally strong

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US QTR pre US 15 mths Germany 13
launch post launch mths post
launch
IDELVION Alprolix Other
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Capturing ~2/3 of patient switches
• Ongoing launch
Launched in 12 countries
First hemophilia product in Japan
France, Spain, Greece, Poland, Portugal, Israel, Canada, Australia, New Zealand and others still to come
Extension Study
Clinically meaningful efficacy using 21 day regimen

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Haemophilia

Accelerating AFSTYLA[®] Adoption

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Proven long-lasting bleed protection with a unique single-chain design

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Long-lasting
Higher binding Excellent Individualised
protection with
affinity to vWF efficacy dosing
high trough levels
3X HIGHER ABOVE 1.9% ZERO
2X WEEKLY
COMPARED TO WITH 2X/WEEK BLEEDS
AVAILABLE
OCTOCOG ALFA DOSING MEDIAN AsBR
Extended time Ability to live a more Protection from Flexible dosing –
in circulation normal life bleeds 2x or 3x weekly
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Specialty

CSL’s Global Performance

Specialty portfolio growth FY17 +20% – KCENTRA[® ] / BERIPLEX[®] +35%; BERINERT[®] +31%
• HAEGARDA[®] US launch & rapid acceptance
Often under or misdiagnosed

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Acquired
Bleeding
CSL FY17
Sales $1,174 M
Other HAE
AATD
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Specialty

Continued Growth Opportunities for Kcentra[® ]

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US Anti-Coagulation Market US Demand (IU)
PRADAXA SAVAYSA 180 170 Japan
4% 0%
160 • Launch Sep 2017
140
119 •
120 Fast formulary
XARELTO 100 94 acceptance
25% COUMADIN/
WARFARIN
46% 80 –
Over 300
60
hospitals
ELIQUIS 40
25%
20
0
2014/15 2015/16 2016/17
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Sources: IMS Health NPA data, Sept 2017; Decision Resource Group Claims data, Mar 2017; Internal data (Japan)

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Specialty

Specialty Products – HAEGARDA[® ]

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Product launched July 2017
7 year orphan exclusivity
95% reduction in HAE attacks
99% reduction in the need for rescue medication
First and only subcutaneous formulation
Strong patient, physician and provider Other
engagement

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Specialty

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“ I haven’t had a single attack since starting the HAEGARDA[®] study in 2015!”

“This is the longest period in my life having gone without a single attack since my very first one at age 13.”

“ I choose not to suffer, and ”
HAEGARDA[®] gives me that choice .
“I feel like I am finally a participant in my own life! ”
“The patient is just giddy.”
“It is, hands down, the easiest medication I’ve had to administer that ACTUALLY works. ”

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Dr Bill Mezzanotte Senior Vice President, Clinical Development

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Transplant

Transplant

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Breakthrough
Transplant
Medicines
Specialty
Immunoglobulins
Products
Haemophilia
Products
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Developing CSL and other novel therapies with potential to improve transplant outcomes:
Significant unmet need
Key Focus:
C1 inhibitor (C1-INH) / BERINERT[® ]
– Alpha1 anti-trypsin (AAT) / ZEMAIRA[®]
– Anti-IL-6 / clazakizumab*
CSL312 (anti-FXIIa mAb)
– CSL324 (anti-G-CSFR mAb)

*Partnered project

Transplant

Solid Organ Transplant (SOT): Unmet Medical Need

Before Transplantation During Transplantation After Transplantation 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 Donor-specific antibody Improving organ utilisation its consequences – e.g. Improving Treatment & reduction; increased access and reducing ischemic injury Primary Graft Dysfunction Prevention of Antibody to transplantation prior to transplant (PGD) & Delayed Graft Mediated Rejection Function (DGF) More Viable Organs Graft Survival Available

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Transplant

Solid Organ Transplant (SOT): Unmet Medical Need

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Before Transplantation During Transplantation After Transplantation
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
Donor-specific antibody Improving organ utilisation its consequences – e.g. Improving Treatment &
reduction; increased access and reducing ischemic injury Primary Graft Dysfunction Prevention of Antibody
to transplantation prior to transplant (PGD) & Delayed Graft Mediated Rejection
Function (DGF)
More Viable Organs
Graft Survival
Available
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Transplant

Antibody Mediated Rejection (AMR) in Kidney Transplantation

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J Am Soc Nephrol 2010 Aug; 21(8): 1398–1406

The kidney is the most commonly transplanted solid organ

AMR occurs in up to 5-10% of transplants acutely and up to 30% chronically
AMR is marked by declining renal function and is associated with lower graft survival
Patients with donor-specific antibodies are denied transplant due to the risk for AMR

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

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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

Renal Renal Renal Function Function Function at the at the at the time of end of end of 6 initial first-line mos. AMR Dx. AMR C1inh SOC Tx.

Viglietti et al., Am J of Transplantation 2016

Transplant

CSL842 C1-INH to prevent recurrent AMR: Randomised, Placebo-controlled Withdrawal

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

Transplant

Complement Dependent & Independent Pathways Involved in AMR

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Complement-dependent
Donor-Specific cytotoxicity
Antibodies
(DSA) &
Antibody
Mediated Complement-independent:
•
Rejection Antibody-mediated
(AMR) cellular toxicity
• Direct endothelial
activation & proliferation
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Potential Benefits of Anti-IL6 therapy in AMR:

Reducing DSA production
Reducing DSA mediated injury to allograft
Pilot study demonstrated blocking IL-6 stabilises renal function and prolongs graft survival[* ]

*Choi et al Am J Transplantation 2017

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Transplant

Vitaeris and CSL Strategic Collaboration

Vitaeris Inc.
clazakizumab (anti-IL6 mAb) in clinical development
• Successful FDA Type C Meeting

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Anticipated dosing in AMR patients in 2018
CSL – Vitaeris Strategic Collaboration
Collaboration and purchase option agreement to expedite the development of clazakizumab
Exclusive Option to acquire company at later date with data readout
CSL with Board Observer & Director seats, Member of Scientific Advisory Board

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Transplant

Unmet Medical Need in Graft versus Host Disease (GvHD)

• Incidence and mortality

Hematopoietic Stem Cell Transplant (HSCT) is a common effective therapy for many lifethreatening malignant and non-malignant diseases
Autologous – Patient’s own cells
Allogenic – Donor cells
~50-60% of Allogeneic HSCT develop acute Graft versus Host Disease (GvHD) despite prophylaxis
GvHD is a common cause of morbidity & mortality in HSCT
Therapies are often ineffective or cause severe immunosuppression
Survival is 30% for Grade III and 10% for Grade IV
Pathophysiology of GvHD in HSCT may be addressed by immunomodulatory effects of Alpha 1 Anti Trypsin (AAT)

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Transplant

Clinical Data:

Treatment of Steroid-Refractory GvHD with AAT

ZEMAIRA[®] (AAT) - Mangenau, ASBMT 2016
40 Patients with Steroid refractory aGVHD
Open label AAT - 60mg/kg twice weekly x 4 weeks
Overall response rate (ORR) - 65%
- 35% Complete Response
Sustained responses - 73% at Day 60
Well tolerated with low rates of infection

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Proposed AAT GvHD Study
Anticipated study start in 2018
Final design pending ongoing regulatory discussions

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Transplant

Transplant

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Breakthrough
Transplant
Medicines
Specialty
Immunoglobulins
Products
Haemophilia
Products
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Developing CSL and other novel therapies with potential to improve transplant outcomes:
Significant unmet need
Key Focus:
C1 inhibitor (C1-INH) / BERINERT[® ]
– Alpha1 anti-trypsin (AAT) / ZEMAIRA[®]
– Anti-IL-6 / clazakizumab*
CSL312 (anti-FXIIa mAb)
– CSL324 (anti-G-CSFR mAb)

*Partnered project

Breakthrough Medicines

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 protein-based 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)

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Breakthrough Medicines

Cardiovascular Disease (CVD) - High Unmet Medical Need

CVD remains leading cause of death globally
In the US alone, 800,000 acute MIs 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

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Breakthrough Medicines

Cholesterol Efflux With CSL112 (apolipoprotein A-I)

Apolipoprotein A-I (ApoA-I) is the primary component of HDL (“good cholesterol”) and responsible for cholesterol efflux capacity (CEC)

HDL levels & CEC are inversely correlated with atherosclerotic heart disease

CSL112:

purified ApoA-I from human plasma
• increases CEC, particularly ABCA1dependent CEC

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CSL112
particles
ABCA1 transporter
Intracellular cholesterol
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unique compound

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Breakthrough Medicines

CSL112 Hypothesis

CSL112 will be safe and well tolerated
CSL112 will enhance cholesterol efflux capacity (CEC)
CSL112 will 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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Breakthrough Medicines

CSL112: Clinical Path to Phase III – Safety & Mechanism of Action

Phase I Single Ascending Dose (SAD) Phase I Multiple Ascending Dose (MAD) • Normal Healthy Volunteers • Normal Healthy Volunteers • N=57; Single Site: AUS • N=36; Single Site: AUS STATUS: Completed 2011 STATUS: Completed 2011 Phase IIa • Stable coronary artery disease • Safety, PK, PD • N=44; Multicenter: US STATUS: Completed 2013
Phase IIb Dose-ranging (AEGIS-I) Moderate RI PK/safety (Phase I) Moderate RI safety (Phase IIa) • AMI target population • Moderate RI vs. normal renal • AMI target population • Safety, MOA, pop PK • Safety, PK, PD • Safety, pop PK, MOA • N=1,258 (PBO, 2g, 6g; weekly x 4) • N=32 (2,6g SD) • N=83 (6 g; weekly x 4) • 145 sites: NA, Europe, AUS, IS • Specialty sites (4-6 Europe) • 31 sites (US, IS, GER, HUN, NL) STATUS: Completed 2015-16 STATUS: Completed 2015-16 STATUS: Completed 2016-17

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Phase III Pivotal Trial (AEGIS-II)
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AMI target population
CV outcomes efficacy (MACE) and safety
Multicenter: ~40 countries; ~1000 sites; ~17,400 patients
STATUS: Start planned 2018

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Breakthrough Medicines

No Safety Concerns in Patients with Moderate Renal Impairment

	Number of subjects with data	Number of subjects with events, n (%) n’
Renal SAEs
CSL112 6g (N=52)	52	1 (1.9%) 1
Placebo (N=28)	28	4 (14.3%) 5
Acute Kidney Injury (AKI) Events
CSL112 6g (N=52)	50	2 ( 4.0%) 2
Placebo (N=28)	28	4 (14.3%) 4

Low incidence of renal events across CSL112 and placebo Safety data are consistent across:

Degree of renal impairment: (eGFR 30- <45 ml/min) versus (eGFR 45 - <60ml/min)
Presence or absence of antidiabetic therapy

Results support including patients with moderate renal impairment into Phase III (AEGIS II)

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Breakthrough Medicines

CSL112 raises Cholesterol Efflux to a similar extent in Patients with and without Moderate Renal Impairment

Total Cholesterol Efflux Capacity

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At the end of infusion time points, the relative increases in CEC and ABCA1 dependent CEC were similar in both studies
These efflux results are encouraging as patients with moderate renal impairment tend to experience a greater number of MACE events

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Breakthrough Medicines

Phase III (AEGIS-II): Study Design

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1° Endpoint : MACE Follow Up
MACE D90 D180 D365
6 g CSL112 (n=8700)
17400 AMI subjects ≥ 18 years of age, Screening Randomisation
With Acute Coronary Syndrome Placebo (n=8700)
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1000 Centers - >40 Countries

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

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Breakthrough Medicines

Phase III (AEGIS-II)

Designed with Health Authority Input

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Designed with International Trialists

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Breakthrough Medicines

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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Mr Bill Campbell Executive Vice President & Chief Commercial Officer

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Breakthrough Medicines

CSL112 to Address High Unmet Medical Need

CVD remains leading cause of death globally
• In the US alone, 800,000 acute MIs occur each year
Survivors remain at high risk for early recurrent CV events:
Among high-risk populations:
14% in year one
of these ~70% within first 90 days
Reducing the risk of early recurrent events represents a significant unmet need

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

apoA-I
Macrophage
ACBA1
surface
transporter
Free cholesterol
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Breakthrough Medicines

AEGIS-II Population – High Early Recurrent Event Rate

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

16% 14%
14% 12%
Statins
12% 10% Chronic PCSK9i’s
10%
8%
8%
CSL “Uncontested sub-acute
6% Sub-Acute
112 market space”
4%
2% Acute
0%
0 30 60 90 120 150 180 210 240 270 300 330 360 390
Days from AMI Admission
Patients with vascular death, MI or stroke %
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US AMI Registry/Symphony Health Claims Database N=75,758 (AEGIS-II eligible);2012-2015

Breakthrough Medicines

Significant Opportunity in Sub Acute Space

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• Acute MI Discharges per year (US & EU5)
1.2M
• High Risk Patients and other exclusion
380-520K (AEGIS II population)
• Hospital coverage & utilisation
230-320k
• CSL112 patient population
200-270k
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Breakthrough Medicines

CSL112 Strategic Commercial Activities

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

Phase III Plan Integrating clinical, regulatory and payer input
Real World Evidence Validating with customised database
Value Proposition & Pricing Engaging hospitals and payers
Education & Prelaunch Developing the market
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Professor Andrew Cuthbertson AO R&D Director and Chief Scientist

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Highlights of 2017

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• FLUAD™

Approved in UK, strong recommendation for people 65yr and older
Holly Springs approved by FDA as a MF59 manufacturing and FLUAD fill-finish site
aQIV
Submission for paediatric indication USA (end December)
AFLURIA[®] QIV
5 years+
- Approved USA
- Submitted Australia, Canada, Argentina, Sth Korea

6 months to 4 years

Pivotal trial completed – confirms improved safety profile of product
Submitted USA, AUS

• FLUCELVAX[®] QIV

FDA approval and first commercial manufacture of H3N2 using cell-based seed
Manufactured volumes more than quadrupled to 21m doses

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Planned Milestones During 2018

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Phase III Registration & Launch Post Registration Fluad™ QIV 65yrs+ Fluad™ QIV 6m-23m Fluad™ TIV 65yrs+ Safety & Immuno complete Approval USA Approval AUS Afluria[®] QIV 5yrs+ Approval AUS, CAN Afluria[®] QIV 5yrs+ Afluria[®] QIV 6m-4yrs Submitted Canada, Argentina Approval USA, AUS aH5N1c prepandemic Submitted USA

NB: plan to increase QIVc volumes by further 20%

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Global

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® CIDP US
		Fibrinogen New Formulations			HIZENTRA® IIM		KCENTRA® Japan
		Haptoglobin/ Hemopexin		CSL964 AAT GvHD		HAEGARDA® EU	HAEGARDA® US
		CSL640 rIX-FP subct			PRIVIGEN® CIDP Japan	AFLURIA® QIV 5-17 AUS	FLUAD® TIV 65+ US, UK
					CSL842 C1-INH AMR		FLUCELAX® QIV 4+ US
							AFLURIA® QIV 5-17 US

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-CSFR
	Clinical Applications	CSL311 Anti-BC	CSL346 Anti-VEGF-B		CSL112 ApoA-I
		P. gingivalis/POD OH-CRC*

32 *Partnered Projects

Expected Progress in Next 12 Months

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	1 2		3	4 5		6	7
En Rese	ter arch Enter Dev. &	Product GLP Tox. Enter	Phase I Enter P	hase II Enter P	hase III Enter R & La	egister unch Ente Regis	r Post tration
	Emerging Technologies		CSL730 rFC Multimer		HIZENTRA® IIM	HIZE CI	NTRA® DP
	Novel Strategies			CSL964 AAT GvHD	clazakizumab* Transplant	HAEG E	ARDA® U
	Clinical Applications			CSL312 Anti-FXIIa	CSL112 ApoA-I	pdFVIII Ruide
	Clinical Applications					FLUA 6m-2	D®QIV 3m US
	Discovery Projects					AFLUR 6m-4 yr	IA®QIV US, AUS

*Partnered project

Significant Target Launch Dates

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

2017 2018 2019 2020-2023
PRIVIGEN [®] CIDP US HIZENTRA [®] CIDP US/EU PRIVIGEN [®] CIDP Japan Hizentra [®] IIM
PRIVIGEN [®] PID/SID Japan
HIZENTRA [®] CIDP Japan
AFSTYLA [®] EU/Japan pdFVIII Ruide
CSL830 HAEGARDA [®] US CSL830 EU
KCENTRA [®] Japan
CSL112 ApoA-I
AFLURIA [®] QIV 5-17yr US AFLURIA [®] QIV 6m-4yr US AFLURIA [®] QIV 6m-5yr AUS
AFLURIA [®] QIV 5-17yr AUS QIV EU
FLUAD [®] QIV 6m-23m US
CSL842 C1-INH AMR
clazakizumab Transplant
----- End of picture text -----*

34 *Partnered Projects

2017 Highlights

• PRIVIGEN[®] CIDP approved in US Immunoglobulins • HIZENTRA[® ] CIDP accepted for review by US FDA and EMA • Momenta collaboration to develop CSL730 (rFC Multimer)

HAEGARDA[® ] results in 95% reduction in HAE attacks and >99% reduction in rescue mediation
Specialty Products and new standard of care for HAE • HAEGARDA[®] registered and launched in the US
IDELVION[®] dosage extension study supports 21 day regimen
Haemophilia • AFSTYLA[®] registered in EU, Japan and Australia • CSL842 (C1INH) Phase III study in kidney AMR commenced
Transplant • Strategic collaboration and option agreement with Vitaeris to develop clazakizumab (anti-IL6 MAb) as a therapeutic option for AMR
• Data supports decision to proceed to CSL112 (Apo A-1) Phase III study (AEGIS-II)
Breakthrough • CSL346 (anti-VEGF-B) Phase I study commenced Medicines • Completion of CSL312 (anti-FXIIa) HAE Phase I study • Acquisition of Calimmune platform gene therapy technology and CAL-H SCD program • AFLURIA[®] QIV registered in US in 5+ yrs; 6mnths-4yrs trial completed
Licensing & Vaccines • FLUAD[®] registered in UK, strong recommendation for people 65yr and older

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Further Information

Presentation Playback

A webcast of the presentation can be accessed in the investors section of the CSL website. Contact: [email protected]

Investor Relations:

Mark Dehring Head of Investor Relations CSL Limited Phone: +613 9389 3407 Email: [email protected]

Media:

Jemimah Pentland Head of Asia Pacific Communications CSL Limited Phone: +613 9389 3473 Mobile: +614 1263 5483 Email: [email protected]

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AI assistant

CSL Ltd. — Investor Presentation 2017

17854_rns_2017-12-04_3b079521-310a-4ce1-b0eb-98b94d6a0cea.pdf

Legal Notice

Forward looking statements

Trademarks

Agenda

– Break –

Commitment to Research and Development

• R&D investment ~10-11% global revenue

Key Past Launches from R&D Portfolio

Leveraging Global Capabilities

R&D Portfolio – December 2016

CSL Behring Protein Therapeutics Platform

Evolving Therapeutics Platform

Progress Through Stage Gates in 2017

R&D Portfolio – December 2017

Research Organisation & Portfolio

Recombinant Fc Multimer – CSL730

Recombinant Fc Multimer – CSL730

CSL / Momenta Collaboration

Recombinant Fc Multimer – CSL730

Calimmune Technology

Calimmune – CAL-H Program

Sickle Cell Disease

Calimmune – CAL-H Program

Early Development Portfolio

CSL312 – HAE and Thrombosis

CSL312 – HAE and Thrombosis

First in Human Phase I study

CSL324 Anti-G-CSF Receptor Antibody

CSL324 Anti-G-CSF Receptor Antibody

First in Human Phase I study

CSL346 Anti-VEGF-B Antibody

CSL346 Anti-VEGF-B Antibody

CSL311 – Anti-Beta Common

Immunoglobulins

Impact of Ig (IV & SC) in Rare Diseases

Impact of Ig (IV & SC) in Rare Diseases

PATH: SCIg (HIZENTRA[®] ) Provides Effective Prophylaxis for CIDP Patients

IV and SC Ig are Effective Treatments for CIDP

Milestones in Ig Development for CIDP

Impact of Ig (IV & SC) in Rare Diseases

Specialty Products

Hereditary Angioedema (HAE)

Demonstrating the Unique Benefit of HAEGARDA[® ]

Targeted Protein Therapeutic Market

CSL Portfolio

CSL Total FY17 $5,811M

Commercial / R&D Partnership

CSL’s Global Performance

Immunoglobulins: Category Leadership

HIZENTRA[®] : Innovator, Market Leader

CIDP – Growing Area of Focus

Global IG volume by indication

HIZENTRA[®] addresses unmet needs in CIDP therapy

Unmet Needs

Global Market

Coagulation Portfolio

Transforming Care of Haemophilia B Patients

#1 “Switch to” brand providing highest factor levels for the longest period of time

Product of Choice for Physicians

Transition to New Products in Haemophilia B

Patient switches %

Accelerating AFSTYLA[®] Adoption

Proven long-lasting bleed protection with a unique single-chain design

CSL’s Global Performance

Continued Growth Opportunities for Kcentra[® ]

Specialty Products – HAEGARDA[® ]

Transplant

Solid Organ Transplant (SOT): Unmet Medical Need

Solid Organ Transplant (SOT): Unmet Medical Need

Antibody Mediated Rejection (AMR) in Kidney Transplantation

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

CSL842 C1-INH to prevent recurrent AMR: Randomised, Placebo-controlled Withdrawal

Complement Dependent & Independent Pathways Involved in AMR

Vitaeris and CSL Strategic Collaboration

Unmet Medical Need in Graft versus Host Disease (GvHD)

• Incidence and mortality

Clinical Data:

CSL Ltd. Investor Presentation 2017