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Page 1: 36th JP Morgan Annual Healthcare Conference - BTG plc · PDF file4 Sustained value creation through leadership in Interventional Medicine therapies Building leadership positions in

January 2018

36th JP Morgan Annual Healthcare Conference

Page 2: 36th JP Morgan Annual Healthcare Conference - BTG plc · PDF file4 Sustained value creation through leadership in Interventional Medicine therapies Building leadership positions in

2Not all products and/or indications are available in all territories. For prescribing information, safety information, and/or product information, go to: btg-im.com | crofab.com | digifab.us | ekoscorp.com | galilmedical.com |

lemtrada.com | pneumrx.com | therasphere.com | varithena.com | vistogard.com | voraxaze.com | zytiga.com

Forward-looking statements

This presentation and information communicated verbally to you may contain certain projections and other

forward-looking statements with respect to the financial condition, results of operations, businesses and prospects

of BTG plc (“BTG”). These statements are based on current expectations and involve risk and uncertainty because

they relate to events and depend upon circumstances that may or may not occur in the future. There are a number

of factors which could cause actual results or developments to differ materially from those expressed or implied by

these forward-looking statements. Any of the assumptions underlying these forward-looking statements could

prove inaccurate or incorrect and therefore any results contemplated in the forward-looking statements may not

actually be achieved. Nothing contained in this presentation or communicated verbally should be construed as a

profit forecast or profit estimate. Investors or other recipients are cautioned not to place undue reliance on any

forward-looking statements contained herein. BTG undertakes no obligation to update or revise (publicly or

otherwise) any forward-looking statement, whether as a result of new information, future events or other

circumstances. Neither this presentation nor any verbal communication shall constitute an invitation or

inducement to any person to subscribe for or otherwise acquire securities in BTG.© 2017 BTG International Ltd. All rights reserved. “See More, Reach Further, Treat Smarter” and “Imagine where we can go.” are trademarks of BTG International Ltd. BTG and the BTG roundel logo are trademarks

and/or registered trademarks of BTG International Ltd. Bead Block, DC Bead, DC BeadM1, DC Bead LUMI, LC Bead, LC BeadM1, LC Bead LUMI, LUMI and Simplicit90Y are trademarks and/or registered trademarks

of Biocompatibles UK Ltd. EKOS is a trademark and/or registered trademark of EKOS Corporation. GALIL is a trademark and/or registered trademark of Galil Medical Ltd. PneumRx is a trademark and/or registered

trademark of PneumRx, Inc. TheraSphere is a trademark and/or registered trademark of Theragenics Corporation used under license by Biocompatibles UK Ltd. Varithena is a trademark and/or registered trademark of

Provensis Ltd. CroFab and DigiFab are trademarks and/or registered trademarks of BTG International Inc. Vistogard is a trademark and/or registered trademark of Wellstat Therapeutics Corporation. Voraxaze is a

trademark and/or registered trademark of Protherics Medicines Development Ltd. SnakeBite911 is a trademark and/or registered trademark of Protherics UK Ltd. Lemtrada is a trademark and/or registered trademark

of Genzyme Corporation. Zytiga is a trademark and/or registered trademark of Johnson & Johnson. Biocompatibles UK Ltd, EKOS Corporation, Galil Medical Ltd, PneumRx, Inc., Protherics Medicines Development

Ltd, Protherics UK Ltd and Provensis Ltd are all BTG International group companies

Page 3: 36th JP Morgan Annual Healthcare Conference - BTG plc · PDF file4 Sustained value creation through leadership in Interventional Medicine therapies Building leadership positions in

3 1 At 2 January 2018 using £1:$1.36

BTG is building leadership positions in specialist areas of medicine. Our differentiated Interventional

Medicine products are used in the treatment of cancer, severe emphysema and vascular disorders, and

our Pharmaceutical products help patients who are overexposed to certain medications or toxins.

BTG overview

Profile

• FTSE 250 company

(LSE: BTG)

• Market cap ~$3.9bn1

• Employees ~1,500

• Global business

Diversified portfolio

• Leading-edge oncology,

vascular, pulmonology

therapies

• Investing ~$130m

annually in R&D

Strong financials

• +32% 5 year product

sales CAGR

• +12% 5 year adjusted

EPS CAGR

• ~$300m cash at 9/30/17,

no debt

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Sustained value creation through leadership in Interventional Medicine therapies

Building leadership

positions in attractive

markets

• Changing healthcare landscape favors IM therapies

• Focusing on underpenetrated markets with unmet needs

• Building our business on customer understanding

Investing to deliver sustained

value creation

Scalable business

delivering a strong

financial performance

• Built a strong portfolio, capabilities and infrastructure

• Targeting sustained double-digit product sales growth

• Strong free cash flow available for investment

Investing for sustained

shareholder value

creation

• Expanding pipeline through organic development and acquisitions

• Providing data and services to increase procedures, patient flow

• Extending sales into key global markets

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Investing to deliver sustained growth and shareholder value

$Strong

free

cash

flow

Double-digit product

sales growth

Investments across multiple

drivers of growth

Innovation &

Development

Commercial

M&A

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Differentiated therapies in underpenetrated markets

Therapy Indications Annual patients* Current number of

procedures p.a.*

Liver and

kidney tumours

Severe

blood clots

Severe

emphysema

Symptomatic

varicose veins

c. 25,000 with

BTG products

c. 150,000

c. 900 with

PneumRx® Coils

c. 700k

below the

knee

*Company estimates†US only

Ea

rly S

tag

eH

igh

Gro

wthc. 325,000

c. 2-3m

> 4m

c. 2.5m†

c. 800k

GSV

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Interventional Medicine is an expanding field

Pulmonology

Neurology

Cardiology

Oncology

Peripheral/

Vascular

“At Memorial Sloan-Kettering in the past decade the number

of IRs has gone from approximately 8 to 20, we now have 13

dedicated IR suites compared with 4. We are adding an

additional 3 rooms in 2019 and will probably be at 22

faculty. Our volume has increased to over 15,000 annual

cases.”Stephen Solomon, MD

Minimally invasive therapies enable you to deliver more

quality care, less invasively, so you can:

i. Reduce the per capita cost of care

ii. Minimise risk to patient

iii. Improve health outcomes

iv. Improve the patient care experience

Royal College of Radiologists

SIR membership +60% since 2008/9, with >360% growth in

member-in-training categories

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The benefits of minimally invasive therapies are evident

vs.

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Interventional Radiologists (IRs):

• Apply technology to give better patient

outcomes

• Are hungry for more procedures

• Need data to drive adoption of our offering

– Products

– Procedures

– Patients

Building our business on customer understanding

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A portfolio of leading-edge therapies

Schematic. Not to scale.

An

nu

al sa

les

Interventional Medicine

Early

StageHigh

GrowthEstablished

Varithena®

Injectable

microfoam

clinically proven

to reduce the

symptoms and

improve the

appearance of

varicose veins

PneumRx®

Coils

Shape-memory

metal coils

clinically proven

to improve

quality of life,

lung function and

exercise capacity

of patients with

severe

emphysema

Interventional

Vascular

Ultrasonic catheter

drug delivery device

used in the

treatment of severe

blood clots

Anchoring catheters

and microcatheters

offering options for

physicians in the

crossing of complex

lesions and arterial

blockages

Interventional

Oncology

Embolic, drug-

eluting beads and

radioactive

microspheres to

treat tumours in the

liver

Cryoablation

needles to treat

tumours in the

kidney

Pharmaceuticals

Acute care antidote

products offering

medication for

patients with little or

no other treatment

options

Licensing

Royalties relating to

products subject to

BTG intellectual

property and

licence agreements

Establishing new therapies Sustainable businesses Cash generation

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A differentiated, multi-modality customer offering in Interventional Oncology

Open surgery

“remove it”

Systemic Interventional

Controlled destruction of tumour

while sparing healthy tissue

External Beam

Radiation

“irradiate it”

Targeted local delivery of

radiation

Ability to tailor dose to individual

tumour

Chemotherapy

“poison it”

Dual action embolisation and

targeted drug delivery

Ability to see precise location of

beads

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• Insoluble radioactive glass microspheres for the treatment of liver tumors

• Microspheres deliver a high-dose of radiation using yttrium-90 via the hepatic artery into the

tumor

• Microspheres are trapped in the tumour capillaries where they emit beta radiation

• Very high concentration of radioactivity per sphere

(50x greater than direct competitor)

• Differentiated product:

– Simplicit90Y™ dosimetry software cleared

– βETA™ Radiation Safety Programme launched

– Flexible 90Y product with a range of doses that can be tailored

to each patient

TheraSphere®

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Indication Trial description Detail End-points Timing (CY)

Hepatocellular Carcinoma Patients randomised (1:1) to

TheraSphere® followed by

sorafenib vs. sorafenib

Global Phase III trial; 520 Patients

Multicentre (up to 100 sites in N.

America, EU and Asia)

ClinicalTrials.gov ref: NCT01556490

Primary: Overall Survival (OS)

Secondary: TTP, TTUP, TTSP,

Tumor Response, QoL, Safety

2019

Metastatic Colorectal Carcinoma Patients randomised (1:1) to

TheraSphere® + 2nd line

chemo vs. 2nd line chemo

Global Phase III trial; 420 (actual 280)

Multicentre (up to 100 sites in US,

Canada, EU, Asia)

ClinicalTrials.gov ref: NCT01483027

Primary: PFS & HPFS

Secondary: OS, TTSP,

Disease Control Rate, QoL,

Safety

2019

Dosimetry in HCC

Retrospective evaluation of

dosimetry in TheraSphere®

using Simplicit90Y™ software

Global trial; up to 300 Patients

Multicentre in N. America, EU and Asia

Primary: correlation between

dose and adverse events

Secondary: Tumor absorbed

dose, safety, OR, OS

2019

Expanding the label for TheraSphere®

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Pre-treatment imaging

The injection of Contrast Media makes the tumor

appear brighter than the normal liver

Treatment with radiopaque bead LUMI™

24-hour post-treatment imaging

The radiopaque beads indicate the proper deposition

of the device in the tumor

Case from Dr. Dominic Yee - Presbyterian St. Lukes - Denver, Colorado

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• Market leader in cryoablation of kidney cancer

• Ongoing studies in lung and bone metastases

• Investing to accelerate product innovation

– Ablation centre of excellence for BTG

– Several new products in the pipeline

• Systems and needle improvements

• Other ablation modalities

Going outside the liver: Galil Medical

=

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Significant clinical development to expand use of cryoablation

Indication Trial description Detail End-points Timing (CY)

Bone metastases Single arm study to assess

efficacy of cryoablation for

palliation of painful

metastases

65 Patients; multicentre (11 sites);

ClinicalTrials.gov ref: NCT02511678

Primary: Difference in worst

pain

Secondary: Responders,

QoL, physical function,

change in analgesic use,

reduction in pain, and safety

2018

Lung metastases Single arm study to assess

safety and efficacy of

cryoablation in patients

with pulmonary metastatic

disease (tumors ≤ 3.5cm)

130 Patients/ 226 tumours, multicentre

(10 sites);

ClinicalTrials.gov ref: NCT01957787

Primary: Tumor control

Secondary: OS, TTP, QoL,

safety

2018

with 2-year

follow-up

Lung metastases Single arm study to assess

safety and efficacy of

cryoablation in patients

with pulmonary metastatic

disease (tumors ≤ 3.5cm)

Pilot Study, 40 Patients/60 tumours,

multicentre (4 sites);

ClinicalTrials.gov ref: NCT01307501

Primary: Tumor control

Secondary: OS, TTP, Safety

2018

with 5-year

follow-up

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IO2: exploring the combination of interventional oncology and immuno-oncology to fight cancer

Society of Interventional Oncology Partnership

• Funded independent research grants with 4 leading institutions to support research

evaluating immune stimulation with our LRT

• More grants to be awarded in early 2018

Investigator Initiated Study (IIS) Programme

• Exploring the immune response with radioembolisation, chemoembolisation and

cryoablation in a broad range of tumor types

• NCT03203837 – Dr. Robert Lewandowski, Northwestern, Biomarker Analyses in

Hepatocellular Carcinoma Patients Treated with TheraSphere®

• NCT03035331 – Dr. Yi Lin, Mayo Clinic, Cryosurgery, cell therapy and pembrolizumab in

treating patients with Non-Hodgkins Lymphoma

Collaborative Research Partnerships

• Conducting basic research to optimise use of LRT in combination with immunotherapy

• Forging strategic alliances with companies to offer BTG IM expertise and be at the

forefront of therapeutic breakthrough

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A unique method of action: EKOS® Acoustic Pulse Thrombolysis™

Features• 5.4 Fr catheter

• 106 and 135 cm

working length• 6, 12, 18, 24, 30,

40 and 50 cm treatment zones

Intelligent Drug Delivery

Catheter

Ultrasound Core Device

Fibrin withoutUltrasound

Fibrin With Ultrasound

Acoustic Streaming Drives Lytic into clot

Page 19: 36th JP Morgan Annual Healthcare Conference - BTG plc · PDF file4 Sustained value creation through leadership in Interventional Medicine therapies Building leadership positions in

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Indication Trial description Detail End-points Timing (CY)

Pulmonary Embolism Retrospective and prospective

international EKOS® registry of

the treatment and clinical

outcomes of patients with PE

Multicentre in N. America (up to 75

sites), EMEA (25 sites), Asia (3sites)

1000 retrospective; 500 prospective

Primary: to understand the APT treatment

protocol used as standard-of-care and

document changes in practice

following the OPTALYSE PE results;

to describe the effects of varied APT

protocols on long-term

patient outcomes

Initial data:

Retrospective

2018

Prospective

2020

Chronic DVT / Post-thrombotic

Syndrome

Evaluate the safety and efficacy of

endovascular recanalisation,

including Acoustic Pulse

Thrombolysis®

In patients with chronic DVT

suffering from PTS

Multicentre in N. America (22 sites)

73 patients / 77 limbs

ClinicalTrials.gov ref: NCT02159521

Primary: reduction in Villalta score at 30

days: 35.5% reduction

Secondary: major bleeds within 72 hours:

1 bleed

Initial data 2017

2 year follow-up

Pulmonary Embolism To determine the optimum

duration and dose of r-tPA using

EKOS thrombolysis; patients

randomixed to 4 treatment arms

Multicentre in N. America (16 sites)

100 patients

ClinicalTrials.gov ref: NCT02396758

Primary: improvement in RV/LV ration

over 48 hours: 23%-26%

Secondary: major bleeds within 72 hours:

3 bleeds across 2 arms, 0 in 2 arms

Initial data 2017

2 year follow-up

Pulmonary Embolism Prospective single-arm study

evaluating ultrasound-facilitated,

low-dose fibrinolysis for acute

massive and submassive PE

Multicentre in N. America (22 sites)

150 patients

ClinicalTrials.gov ref: NCT01513759

Primary: improvement in RV/LV ratio

ours: 25% reduction

Secondary: frequency of major bleeds

within 72 hours: no intracranial

hemorrhages

2014

KNOCOUT

Investing in data to drive more patients & procedures

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Roxwood complements the existing EKOS business

Primary strategy

Wire Escalation

$100-$200 / wire

Existing secondary strategy

CTO Crossing Device

$2,000-$3,000 / device + capital

costs to power each device

$1,200

Bridging the gap between two existing treatment

options for occlusion crossing, enabling our

customers to do more procedures

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Reduces air trapping and hyperinflation in the

lungs of advanced emphysema patients

The PneumRx® Coil improves:

• Shortness of Breath

• Lung Function

• Quality of Life

The PneumRx® Coil is the only minimally invasive, non-surgical option for all severe emphysema patients

Fig. x-ray after bilateral Coil implantation

Page 22: 36th JP Morgan Annual Healthcare Conference - BTG plc · PDF file4 Sustained value creation through leadership in Interventional Medicine therapies Building leadership positions in

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PneumRx® CoilProgress and Growth Drivers

• US PMA review progressing

– Targeting 2018 approval and

launch

• EU medical education

programme established

• Initiating ELEVATE study

– Prospective study to confirm

patient responder profile

Recent progress

• Potential US approval and launch

• EU reimbursement progress

• Adoption of patient selection

criteria

• Quantitative CT service roll-out to

support treatment planning

• ELEVATE study outcome will

support therapy adoption and

reimbursement

Growth drivers

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Varithena®: a patient-centric treatment for symptomatic varicose veinsDedicated reimbursement codes from January 2018

% of US procedures by segmentPayment

Levels

Varithena®:

Microfoam Ablation$1,660.66*

Sclerotherapy: PCF $106.53

Stab phlebectomy $730.97*

Mechanical Ablation $1,524.55

Radiofrequency Ablation $1,523.83

Laser Ablation $1,220.07

Glue $2,138.18

Commercial impact of new codes is expected to be clearer by the end of 2018

* Average of single and multiple vein payment

Below The Knee / Tributaries

47% approx. 700k

PCF, Stab phlebectomy

GSV / Truncal

53% approx. 800k

Ablation, Glue

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Multiple investment opportunities in Interventional Medicine therapies

Smart access

Local delivery

Enhanced safety

Value for money

Precision medicine

Patient friendly

Radiation

Embolisation

Ablation

Coil and foam technology

Enhanced drug delivery

Liver

Kidney

Lung

Bone

Neuro

Vascular

Prostate

Pain

BTG

Interventional

Medicine

Themes

Existing and

potential therapy

area targets

Technology

platforms

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Pipeline building: R&D pipeline accelerators

Novel IV products

Immuno-oncologyExplore how BTG products synergise in combination with I-O agents

Forge strategic alliances with companies to offer BTG IM expertise

Beads /

TheraSphere®

Expanding our product range; explore indications beyond HCC and mCRC

Integrated offerings to simplify procedures and improve outcomes

AblationIndication expansion to lung and bone metastases

Product development for surgical specialties

New therapy area:

Bone

Explore opportunities to develop to an integrated bone solution

Build on data in bone metastases with spinal data and pain endpoints

Roxwood Medical acquisition to provide specialty catheters

Move towards tougher obstructions and smaller vessels

Product development in the COPD space

Long term oncology and vascular adjacencies identified

Expanding lung

expertise

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PharmaceuticalsLife-saving therapies delivering sustained cash flows

Acute Care • SnakeBite911™ app continues to drive greater physician and patient

interactions with >7,500 downloads

• Copperhead study published in the Annals of Emergency Medicine

Oncology • Voraxaze® included in the 2017 Expert Consensus Guidelines

contained within the Annals of Emergency Medicine

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Delivering a strong financial performance

1 2012/13 excludes non-recurring product revenue2 Adjusted EPS is not prepared in accordance with IFRS. Further detail on the adjustments to IFRS financial measures is included in the interim results announcement published on 14 November 2017.

0

60

120

180

240

300

360

420

2012/13 2013/14 2014/15 2015/16 2016/17

(£m

)

Product sales: 32% CAGR1

0

5

10

15

20

25

2012/13 2013/14 2014/15 2015/16 2016/17

(GB

p)

Adjusted EPS2: 12% CAGR

Targeting sustainable double-digit product sales growth

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Sustained value creation through leadership in Interventional Medicine therapies

Delivering strong financial performance

Scalable platform delivering growth

Excellent strategic position

Well placed to achieve additional growth through investment in organic development

and M&A

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Appendix

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Double-digit product sales and adjusted operating profit growth

1 Constant exchange rate (“CER”) growth is computed by restating 2017/18 results using 2016/17 foreign exchange rates for the relevant period.2 Further detail on the adjustments to IFRS financial measures is included in the interim results announcement. 30

H1 17/18 (£m) H1 16/17 (£m) Growth Growth at

CER1

Product Sales 239.7 193.2 +24% +17%

Licensing 101.6 92.2 +10% +4%

Revenues 341.3 285.4 +20% +13%

Adjusted Operating Profit2 99.1 78.8 +26% +15%

Adjusted Operating Profit Margin 29% 28% +1ppts

Adjusted Basic EPS2 21.0p 13.9p +51%

Free Cash Flow2 75.2 55.7 +35%

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Strong product sales growth driven by IO, IV and Pharmaceuticals

31

H1 17/18

(£m)

Growth at CER Drivers of H1 17/18 performance

High Growth

Interventional Oncology (IO) 76.6 +15%Strong TheraSphere® performance and expansion of GALIL™

cryotherapy

Interventional Vascular (IV) 35.4 +18% Continued US penetration of EKOS® products

Early Stage

PneumRx® Coils 4.0 (23%) Fewer procedures in Germany

Varithena® 2.8 +57% Continued progress ahead of finalised CPT codes

Total IM 118.8 +15%

Pharmaceuticals 120.9 +20%High bite season for CroFab®, with good DigiFab® growth and

increased oncology sales

Product Sales 239.7 +17%

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Licensing royalties benefit from good Zytiga® performance and Lemtrada™ back-royalties

32

H1 17/18

(£m)

H1 16/17

(£m)

Growth Growth

at CER

Zytiga® 71.0 65.8 +8% +3%

Lemtrada™ 21.6 17.0 +27% +17%

Other royalties 9.0 9.4 (4%) (10%)

Licensing 101.6 92.2 +10% +4%

• Lemtrada™ royalties ceased in H1 17/18 due to licence expiration, with final back-royalties

of £11m included in the half

• Continued good contribution from Zytiga®, with a strong last quarter

– No generic entrant expected in the US before October 2018

– No generic entrant expected in Europe before September 2021

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• Investment in IM commercial capabilities ahead of anticipated growth

• Spec Pharma continues to provide strong financial underpin

• Contribution from Licensing to gradually decline as royalties drop off

Revenue mix reflected in H1 margins

33

All £m Interventional

Medicine

Pharmaceuticals Licensing Total

Revenues 118.8 120.9 101.6 341.3

Adjusted gross profit1 83.9 106.4 46.9 237.2

Gross margin 71% 88% 46% 69%

Adjusted SG&A1 63.2 16.9 13.1 93.2

Contribution1 20.7 89.5 33.8 144.0

Contribution margin 17% 74% 33% 42%

R&D 46.1

Adjusted operating profit1,2 99.1

Operating margin 29%

1 Further detail on the adjustments to IFRS financial measures is included in the interim results announcement.2 Includes £1.2m from FX and other operating income.

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Adjusted to IFRS earnings H1 17/18

34

+72%

Growth

>100%

Growth

Adjusted

EPS

21.0p

IFRS

EPS

13.8p(3.7)(8.5) (0.9) 6.9 (1.0)-