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SYNTARA LIMITED AGM Information 2018

Nov 21, 2018

65830_rns_2018-11-21_fd137a16-3638-41cc-88fb-ad6a6f6a8d6a.pdf

AGM Information

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Pharmaxis 2018 AGM

Agenda

1. Welcome and opening of meeting

2. Chairman’s Address

  1. Presentation by CEO and CFO

4. Shareholder questions

5. Formal business:

  • i. Financial Report, Directors’ Report and the Auditor’s Report

ii. Adoption of the Remuneration Report

iii. Re-election of Mr Malcolm McComas as a Non-Executive Director

iv. Grant of Performance Rights to Mr Gary Phillips

  • v. Renewal of Proportional Takeover Provision in the Constitution of the Company

  • Meeting close

7. Refreshments

Chairman’s Address Malcolm McComas

Presentation by Chief Executive Officer Gary Phillips

Forward looking statement

This document contains forward-looking statements, including statements concerning Pharmaxis’ future financial position, plans, and the potential of its products and product candidates, which are based on information and assumptions available to Pharmaxis as of the date of this document. Actual results, performance or achievements could be significantly different from those expressed in, or implied by, these forward-looking statements. All statements, other than statements of historical facts, are forward-looking statements. These forward-looking statements are not guarantees or predictions of future results, levels of performance, and involve known and unknown risks, uncertainties and other factors, many of which are beyond our control, and which may cause actual results to differ materially from those expressed in the statements contained in this document. For example, despite our efforts there is no certainty that we will be successful in partnering our LOXL2 program or any of the other products in our pipeline on commercially acceptable terms, in a timely fashion or at all. Except as required by law we undertake no obligation to update these forward-looking statements as a result of new information, future events or otherwise.

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Pharmaxis has a successful track record of research, development and commercialisation of human healthcare products for the treatment and management of fibrotic and inflammatory diseases

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•Utilise global experience and
extensive clinical networks to
execute value adding Phase 1
and 2 clinical trials
Clinical
Trials
Drug
Discovery
Engine
•Leverage small molecule expertise
and in house chemistry platform
•Efficiencies from global academic &
CRO networks Value Generation
•Target high value diseases with
validated targets
•Extensive Big Pharma network
•Seek to partner after phase 1 or 2
to realise value and mitigate
program and corporate risk
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Senior management

Significant experience in drug development, commercialisation and partnering

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Gary Phillips – CEO

  • more than 30 years of operational management experience in the pharmaceutical and healthcare industry in Europe, Asia and Australia

  • joined Pharmaxis in 2003 and was appointed Chief Executive Officer in March 2013 at which time he was Chief Operating Officer

  • previously held country and regional management roles at Novartis – Hungary, Asia Pacific and Australia

David McGarvey – CFO

  • more than 30 years’ experience building Australian based companies from inception to globally successful enterprises

 joined Pharmaxis as Chief Financial Officer and Company Secretary in December 2002

  • previously Chief Financial Officer of the Filtration and Separations Division of US Filter (1998-2002), and Memtec Limited (1985-1998)

  • commenced career at PriceWaterhouseCoopers

Brett Charlton - Medical

 more than 25 years experience in clinical trial design and management

  • author of more than 80 scientific papers

  • founding Medical Director of the National Health Sciences Centre

  • previously held various positions with the Australian National University, Stanford University, the Baxter Centre for Medical Research, Royal Melbourne Hospital, and the Walter and Eliza Hall Institute

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Wolfgang Jarolimek – Drug Discovery

  • more than 20 years’ experience in pharmaceutical drug discovery and published more than 30 peer reviewed articles.

  • previously Director of Assay Development and Compound Profiling at the GlaxoSmithKline Centre of Excellence in Drug Discovery in Verona, Italy

  • spent 8 years as post-doc at the Max-Plank Institute in Munich, Germany; Baylor College of Medicine, Houston, Texas; Rammelkamp Centre, Cleveland Ohio; and University of Heidelberg, Germany

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Kristen Morgan – Alliance

Management

  • responsibility for alliance management and medical and regulatory affairs

more than 20 years’ experience in the pharmaceutical industry having previously held a senior role in medical affairs at Sanofi-Aventis, and a commercial sales role at GlaxoSmithKline.

Non Executive Directors

  • Will Delaat

  • Malcolm McComasChair

  • former CEO of Merck Australia

  • former investment banker at Grant Samuel

     - former chair of Medicines Australia
    
    • Simon Buckingham
  • Kathleen Metters

  • former head of worldwide basic – former President Global Corporate and research at Merck Business Development at Actelion

  • former CEO of biopharmaceutical  Edward Rayner

  • company Lycera Corp. over 20 years’ experience in global capital markets

Read more on the Pharmaxis website

Pharmaxis ortfolio p

Indication Discovery Lead Optimisation Lead Optimisation Pre
Clinical
Pre
Clinical
Pre
Clinical
Phase I Phase II Phase II Phase II Phase III Phase III Marketed Marketed Marketed
Commercial
Bronchitol® US Cystic fibrosis Phase 3 trial met primary endpoint in 2017. Chiesi planning to file with FDA Q4 2018. Subject to FDA
approval, US partner Chiesi will launch commercially in the US.
Bronchitol RoW Cystic fibrosis Bronchitol is currently sold in the UK, Germany and Italy by Chiesi; certain other European countries and Russia
by specialist distributors and by PXS in Australia and smaller countries
Direct & Dist
Aridol® Asthma
diagnosis
Aridol is approved and sold in Australia, South Korea and a number of European countries. Re-entering US
market Q4 2018 with specialist distributor. Filed for Canadian approval - response expected mid 2019.
Direct & Dist
In the clinic
SSAO (PXS-4728A) NASH Sold to Boehringer Ingelheim in May 2015. Phase 2a trial commenced August 20
PXS received payments of A$68m to date.
17.
SSAO (PXS-4728A) Diabetic
retinopathy
Boehringer commenced dosing a Phase 2a trial in January 2018. PXS received A$15m
to date.
LOXL-2 NASH, fibrosis -
liver, lung,
kidney, heart
Phase 1 trials in 2 compounds complete. Commercial partnering process
commence Q4 2018.
Preclinical
LOX-oral Cancer
Anti-fibrotic. Phase 1 ready.
Progress in last 12 months
SSAO/MPO Inflammation Dual inhibitor anti-inflammatory. Commenced
clinical tox Q4 2017.
pre-
LOX – topical Scarring Anti-fibrotic. Effective in scarring m odels.

Key catalysts targeted for 2018/2019

Pharmaxis value driving events

1. LOXL2 anti fibrotic program

  • Phase 2 enabling toxicity studies: 2 completed, 2 to report Q4 2018

  • Partnering process to commence - Q4 2018.

2. Boehringer Ingelheim acquired SSAO inhibitor (BI 1467335) to report clinical proof of concept in two major diseases as Phase 2 trials report in H1 2019 and H1 2020

3. Two additional programs to enter the clinic

  • LOX (oral) for pancreatic cancer and myelofibrosis to start clinical studies H1 2019

  • SSAO/MPO combo scheduled to complete pre-clinical development in H1 2019

4. Others

  • Bronchitol FDA re-submission by Chiesi in Q4 2018

  • Other internal programs developing additional compounds to take into preclinical development

  • Evaluating opportunities for in-license or acquisition of new programs in fibrosis and inflammation that leverage PXS research and commercialisation capabilities

LOXL2 inhibition program

for NASH, IPF & other high value fibrotic diseases

 Potential indications / market size:

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Excessive production and linking of
collagen fibres results in fibrosis
Fibroblast cells in
Fibroblast cells in
human tissue
human tissue
LOXL2
(from fibroblasts)
Collagen fibres Excessive ‘cross-linking’ of
collagen fibres, stiffens tissue,
causing fibrosis
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  • NASH / Liver Fibrosis; $35b[1]

Significant market opportunity

  • Pulmonary fibrosis (IPF); $3.5b[2]

  • Kidney fibrosis

  • Cardiac fibrosis

 LOXL2 and fibrosis:

  • LOX family of enzymes are the final step in the fibrotic disease process

  • Clear association of increased levels of LOXL2 (and LOXL3) with disease progression in IPF, NASH and cardiac fibrosis

 Competitive profile:

  • Novel target and mechanism of action

  • Once daily oral drug

  • Best in class drug with high level inhibition of LOXL2 enzyme for 24 hours from one dose

  • Only known drug in clinical development to inhibit LOXL3

  • Place of LOXL2 at the end of the fibrotic cascade provides opportunity to use in combination with other Pharma pipeline drugs

LOXL2 inhibitor program

approaches “deal ready” status

Feature What Pharma values PXS program status
Disease target Independent validation Multiple peer reviewed publications
Pre clinical proof of
concept
2 or more different
supportive animal models
Multiple supportive models across 5 different diseases.
Further studies in progress
Dosing regimen Ease of use Oral once a day tablet or capsule
Patent Composition of matter
As long as possible
Composition of matter
2016 filing date; 100% PXS owned
Cost of Goods Low Small molecule with easy synthesis
# Compounds 1 plus backups 2 compounds in clinical development plus back ups
Toxicity Wide therapeutic window
As long as possible
28 day tox studies complete
13 week studies (2 species): 2 successfully completed; 2
in progress – report Q4 ‘18
Clinical phase Phase 1 with target
engagement
Phase 2 ready
Both compounds successfully completed Phase 1 clinical
trials
Target engagement Drug inhibits target Very high levels of inhibition for 24 hours from a single
daily dose over 14 days – achieved with both compounds

LOXL2 inhibitor program – partnering process

Positive engagement with pharma companies

  • Pharma company interest driven by search for:

  • Inhibitor to LOXL2 and LOXL3 enzymes,

  • Effective anti-fibrotic drug, and/or

  • Drugs to complement existing disease portfolio – lung, liver, kidney, heart, etc.

  • Pharmaxis engagement with multiple potential partners on planning and progress of the LOXL2 program for over 2 years

  • Pharmaxis data packaging will complete in Q4, including:

  • Full analysis of second stage of phase 1 trials for both compounds

  • 13 week tox studies (2 species) for both compounds

  • Additional disease models

  • Data room has been available (under CDA) since Q4 2017

  • Commercial partnering discussions expected to commence Q4 2018

SSAO (Boehringer Ingelheim): Pharmaxis poised to be a major player in diseases caused by complications of diabetes

Two diseases with high unmet need and large patient populations in Phase 2 studies

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NASH
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  • Expected to become leading cause of liver transplant by 2020

  • No approved treatments

Diabetic Retinopathy

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  • Affects ~95 million people worldwide

  • No approved treatments for early stage disease

SSAO: Phase 2 trials to show clinical proof of concept in H1 2019

Boehringer Ingelheim responsible for clinical development and commercialisation

NASH

Diabetic Retinopathy

  • Phase 2a trial expected to report H1 2019 – proof of efficacy in patients with moderate – severe disease

  • Deutsche Bank estimate market size of US$35b by 2025

  • First in class anti inflammatory SSAO inhibitor for NASH with peak sales potential of ~US$2b [Analyst’s estimate]

  • Phase 2a SSAO diabetic retinopathy expected to report H1 2019 – proof of efficacy in patients with early stage disease

  • Affects one third of diabetic patients world wide

  • No approved treatments for early stage disease

  • First in class anti inflammatory SSAO inhibitor for DR with peak sales potential of ~US$800m [Analyst’s estimate]

SSAO: Boehringer Ingelheim deal

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Deal structure illustrates value generating potential of Pharmaxis business model

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PLUS earn-out payments
First indication (NASH)
on annual net sales
• Tiered percentages
increasing from high
Commencement of Commencement of Filing, regulatory &
single digits
phase 2 phase 3 pricing approvals
• Plus sales milestones
€18m €37m €140m
Total Potential
Upfront
Milestones
(2015)
€419
€29m Second indication (diabetic retinopathy)
(~A$625m)
Commencement of Commencement of Filing, regulatory &
phase 2 phase 3 pricing approvals
€10m €25m €160m
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PLUS earn-out payments on annual net sales

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€57m (A$83m) already received

No further investment required from Pharmaxis
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More programs approaching the clinic

Opportunities to fast track both programs into patient proof of clinical efficacy studies

Program LOX (oral) LOX (Topical)
Indication Severe fibrotic indications:
pancreatic cancer
myelofibrosis
Scarring
Commercialisation Partner after phase 2 Partner after phase 2
Status Phase 1 ready
Effective in reducing fibrosis in
animal models of pancreatic
cancer and myelofibrosis
Completed 28 day tox studies
Lead candidate selected
Initial stability of topical
formulation
Ongoing evaluation in various
disease models of scarring
Next steps
2018/2019
Additional animal models of
pancreatic cancer and
myelofibrosis
Conduct 3 month tox studies
Commence phase 1a (H1 2019)
Evaluate phase 1c/2 study
design in pancreatic cancer
patients
Commence full preclinical
development

Bronchitol for cystic fibrosis

Overview

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Cystic fibrosis Bronchitol Business model - RoW

Cystic fibrosis Bronchitol Business model - RoW Business model - US
Patients Active ingredient Distributors responsible Phase 3 trial (CF303)
– US: 30,000; mannitol delivered as an for promotion & support reported June 2017
– Europe: 37,000; inhalable dry powder – Chiesi in UK, Chiesi responsible for
– Russia: ~10,0001
– Australia: 3,500
Restores airway surface
liquid
Mucus clearance
Germany, Italy &
Ireland
– Other distributors in
regulatory filing &
commercialisation –
preparing for launch
– Total world: ~100,000 enhanced Russia, Eastern File updated NDA - Q4
Disease characterised by
poorly hydrated,
tenacious, thick mucus
Inexorable decline in
lung function
Improves lung function
Reduces incidence of
lung infections
Europe, Middle East
– PXS revenue share
~50%
– Russian
reimbursement
2018
~A$13m milestone
payment on launch
PXS supplies US market
from Sydney factory
Frequent infections decision H2 2018 PXS receives high mid
PXS direct in Australia teens % of in-market
1.
Estimates vary from 7,000 to 30,000
and smaller markets sales plus cost of goods

Summary

Pharmaxis is a global leader in drug development for fibrosis & inflammation

  • Pharmaxis have built a successful platform of small molecule drugs targeting high value fibrotic and inflammatory indications

  • Development pipeline across various stages - one drug in two phase 2 trials, one drug program (two compounds) in phase 1 trials, two compounds in pre-clinical development approaching the clinic, additional drug candidates in discovery.

  • Proven track record of early stage partnering and taking products through to commercialisation

  • Potential to receive total up front and milestone payments of A$625m plus further sales based payments from first deal (SSAO) – A$83m already received

  • Next drug completed phase 1 trials and long term toxicity studies: partnering negotiations planned Q4 2018

  • Strong balance sheet - $47m cash balance (30 September 2018)

  • Numerous catalysts over the next 18 months

Financial Overview David McGarvey CFO

Financials – highlights

30 June 2018

A$'000 2018 2017 2016 2015
Income Statements
Sales revenue 6,094 4,823 6,135 5,999
Other revenue 44,739 13,178 12,885 53,248
Total revenue 50,833 18,001 19,020 59,247
Expenses (44,413) (36,437) (35,476) (40,739)
Netprofit(loss)before tax 6,420 (18,436) (16,456) 18,508
Netprofit(loss)after tax 6,428 (18,346) (16,463) 18,466
Segment results - adjusted EBITDA
Bronchitol & Aridol (3,786) (7,100) (8,228) (10,045)
New drugdevelopment 28,771 (4,114) (2,625) 35,068
Corporate (13,466) (4,017) (3,988) (3,532)
(11,519) (15,231) (14,841) **21,491 **
Cash flow
Operations 12,206 (15,262) (11,989) 21,780
Investingactivities (884) (723) (1,381) (264)
Financingactivities (1,753) (1,721) (1,714) (1,791)
9,569 (17,706) (15,084) 19,725
Cash at bank 31,073 **21,504 **
39,209
54,138

Highlights of 2018

  • Increased product sales

  • Two milestone payments from Boehringer Ingelheim totaling $42m

  • Profit of $6.4m

  • Bronchitol & Aridol loss continued to reduce

  • Increased investment in new drug development

  • Corporate investment to increase revenue share of LOXL2 partnering

  • Cash flow investing activities focused on drug discovery capability and manufacturing upgrades

  • Cash flow financing activities – predominantly finance lease over facility at Frenchs Forest

  • Closing cash of $31m increased by $24m placement completed September 2018.

Refer to June and September 2018 Quarterly Shareholder Updates and 2018 Financial Statements for additional financial information

New Drug Development

Drug development and clinical trial expenditure by pipeline project

New Drug Development Expenses - Annual

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16,000
14,000
12,000
10,000
8,000
6,000
4,000
2,000
-
2016 2017 2018
Employee costs Other core costs LOXL2 LOX SSAO/MPO Other programs
$’000
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New Drug Development Expenditure - Quarters

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4,000
3,500
3,000
2,500
2,000
1,500
1,000
500
-
Sep 16 Dec 16 Mar 17 Jun 17 Sep 17 Dec 17 Mar 18 Jun 18 Sep 18
Employee costs Other core LOXL2 LOX oral LOX topical SSAO/MPO Other
A$,000
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Current status/planned expenditure

  • LOXL2:

  • 2 compounds in phase 1 – completed Q4 2018

  • 13 week tox for both compounds – to complete Q4 2018

  • Other preclinical studies to report Q4 2018

  • LOX (oral) in preclinical

  • Disease models continue – cancer

  • GLP tox – 1 month (complete) & 3 month (2019)

  • GMP material – for phase 1a/2a clinical trials

  • Plan to start phase 1 CY 2019

  • LOX (topical)

  • Ongoing stability studies

  • Commence formal preclinical

  • SSAO/MPO in preclinical

  • Ongoing disease models

  • Reviewing GLP tox (1 month)

Bronchitol & Aridol

Segment profitability

Bronchitol & Aridol EBITDA

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2015 2016 2017 2018
20,000
10,000
-
-10,000
-20,000
-30,000
Sales Other revenue Expenses
Clinical EBITDA
$’000
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Path to profitability: increase revenue to leverage cost base

  • Core cost base relatively fixed vs sales volume

  • Reimbursement of Bronchitol in Russia key to rate of overall sales growth - decision Q3 2018

  • US approval – Subject to FDA approval (~Q3 2019), launch Q4 2019 (US$10m milestone)

  • Aridol planned to re-launch in US Q4 2018 with specialist distributor. FDA inspection of factory Q3 2018

  • Other Bronchitol sales growth opportunities

  • Continued growth in major Bronchitol launched markets – UK, Germany & Australia

Sales

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7,000
6,000
5,000
4,000
3,000
2,000
1,000
-
-1,000 2015 2016 2017 2018
Aridol Bronchitol - EU Bronchitol - Australia
Bronchitol - RoW Bronchitol - Russia
$’000
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Revenue

  • 2015: Direct to pharmacy until June 15 (ie all sales revenue to PXS)

  • 2016: EU sales via distributors at lower margin (`50%) to PXS. Chiesi builds inventory levels

  • 2017: First sale to Russia ($640k)

  • 2018: Growth in EU (Chiesi UK & Germany) & Australia (expanded PBS coverage)

  • Other revenue in all years is predominantly reimbursement of clinical trial costs by US partner

  • Growth in other Bronchitol markets: Italy, Spain, CZ, Ireland

  • Aridol in Canada – target launch Q3 2019

Corporate

30 June 2018

Expenses

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16,000
14,000
12,000
10,000
8,000
6,000
4,000
2,000
0
2015 2016 2017 2018
Employee costs Other expenses Change in collaboration agreement
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  • Employee and other costs stable

  • One-off expense in 2018 to change collaboration agreement with Synairgen

Balance sheet – 30 September 2018

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Assets ($64m)
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PP&E $11.8
Inventory
$2.3 Other $2.2
Cash $46.8
Accounts
receivable
$0.7
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Liabilities ($37m)

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Accounts Other $2.9
payable $3.1 Finance lease
$8.0
NovaQuest
financing
$23.2
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  • Finance lease over 20 Rodborough Rd (to 2024)

  • NovaQuest financing – not repayable other than as % of Bronchitol revenue

Shareholders & trading

Financial Information
ASX Code PXS
Market Cap1 $103m
Shares on Issue 394m
Employee Options1 16m
Liquidity (turnover last 12 months)1 47m
shares
Share price1 $0.26
Analyst valuation2 $0.52
Cash Balance (30 September 18) A$47m
  1. As at 20 November 2018

  2. Bell Potter Securities Research 30 April 2018

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Institutional Ownership 30 Sep 18
BVF Partners (US) 23%
Arix Bioscience (UK) 11%
Australian Ethical 7%
Allan Gray 5%
Montoya Investments (UK) 5%
Other Institutions 8%
Total Institutional Ownership 59%

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Shareholder Questions

Formal Business

Resolution 1

Financial Report, Directors’ Report and the Auditor’s Report

No shareholder vote is required

Resolution 2

Adoption of the Remuneration Report

Ordinary resolution:

“That the remuneration report of the Company for the year ended 30 June 2018 be adopted.”

Resolution 2

Adoption of the Remuneration Report

The Company has received:

  • 204,074,080 proxy votes in favour of the resolution;

  • 3,156,689 proxy votes against the resolution;

  • 459,236 proxy votes abstaining from the resolution;

  • 1,620,488 proxy votes excluded from voting;

  • 569,791 proxies able to be voted by the chair/board which the chair/board intend to vote in favour of the resolution.

  • Voting exclusions apply

Resolution 3

Re-election of Mr Malcolm McComas as a Non-Executive Director

Ordinary resolution:

“That Mr Malcolm McComas, who retires and offers himself for re-election as a director of the Company, be re-elected as a non executive director of the Company.”

Resolution 3

Re-election of Mr Malcolm McComas as a Non-Executive Director

The Company has received:

  • 177,192,522 proxy votes in favour of the resolution;

  • 32,153,080 proxy votes against the resolution;

  • 327,707 proxy votes abstaining from the resolution;

  • 606,975 proxies able to be voted by the chair/board which the chair/board intend to vote in favour of the resolution.

Resolution 4

Grant of Performance Rights to Mr Gary Phillips Ordinary resolution: “That for the purposes of the ASX Listing Rules and for all other purposes, approval is given for the grant of 690,000 zero grant price and zero exercise price employee options (Performance Rights) to Mr Gary Phillips under the Company’s performance rights plan, resolved to be granted by the Board in July 2018 and, upon exercise of those Performance Rights, the acquisition of 690,000 ordinary shares underlying those Performance Rights, in accordance with the terms of the performance rights plan and the explanatory statement accompanying the notice of meeting.”

Resolution 4

Grant of Performance Rights to Mr Gary Phillips

The Company has received:

  • 197,323,111 proxy votes in favour of the resolution;

  • 10,537,073 proxy votes against the resolution;

  • 739,948 proxy votes abstaining from the resolution;

  • 710,361 proxy votes excluded from voting;

  • 569,791 proxies able to be voted by the chair/board which the chair/board intend to vote in favour of the resolution.

  • Voting exclusions apply

Resolution 5

Renewal of Proportional Takeover Provision

Special resolution:

“That approval is given for the proportional takeover provision contained in article 45 of the current constitution of the Company to be renewed for a further three years from the date of the 2018 annual general meeting, as detailed in the explanatory statement accompanying the notice of meeting.”

The Board has withdrawn Resolution 5

Thank you for your participation 2018 Annual General Meeting