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Because people depend on us Jefferies 2014 Global Healthcare Conference November 2014

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Page 1: Jefferies 2014 Global Healthcare Conference 0920 1 BTG.pdf · Jefferies 2014 Global Healthcare Conference ... –New device technology to increase speed and reduce lytic doses –Improving

Because people depend on us

Jefferies 2014 Global Healthcare ConferenceNovember 2014

Page 2: Jefferies 2014 Global Healthcare Conference 0920 1 BTG.pdf · Jefferies 2014 Global Healthcare Conference ... –New device technology to increase speed and reduce lytic doses –Improving

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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.

BTG and the BTG roundel logo are registered trademarks of BTG International Ltd in the US, EU and certain other territories, and are trademarks of BTG International Ltd elsewhere. CroFab and

DigiFab are trademarks of BTG International Inc. Voraxaze is a trademark of Protherics Medicines Development Ltd. LC Bead, DC Bead, and Bead Block are registered trademarks of

Biocompatibles UK Ltd. TheraSphere is a trademark of Theragenics Corporation used under license by Biocompatibles UK Ltd. EKOS and EkoSonic are registered trademarks of EKOS

Corporation. Varithena and Varithena Solutions Center are trademarks of Provensis Ltd. Protherics Medicines Development Ltd, Biocompatibles UK Ltd, EKOS Corporation, and Provensis Ltd are

all BTG International group companies. Zytiga is a trademark of Johnson & Johnson; Lemtrada is a trademark of Genzyme Corporation.

Forward-looking statements

Page 3: Jefferies 2014 Global Healthcare Conference 0920 1 BTG.pdf · Jefferies 2014 Global Healthcare Conference ... –New device technology to increase speed and reduce lytic doses –Improving

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– Organic growth strategy targeting $1bn+ revenues

in Interventional Medicine through:

– Geographic expansion

– Product innovation

– Indication expansion

– Strong financial underpin from Specialty

Pharmaceuticals and Licensing business

– Successful track record of creating value

from acquisitions

Building a world leading specialist healthcare business

Not to scale

2014 2021

~$150m

~$170m

~$175m

Interventional

Medicine

Specialty

Pharmaceuticals

Licensing

Revenue

Page 4: Jefferies 2014 Global Healthcare Conference 0920 1 BTG.pdf · Jefferies 2014 Global Healthcare Conference ... –New device technology to increase speed and reduce lytic doses –Improving

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Strong growth in expanded portfolio

Interventional

Medicine

Interventional

Oncology

LC Bead®,

DC Bead®,

TheraSphere®

~ $110m Annual ~15% $300m - $400m

Interventional

Vascular

EkoSonic®

Varithena®

~ $40m Annual ~20%

Single $m year 1; 2-3x in year

2; strong growth year 3 on

$100m - $200m

$500m+

Products Current growth guidance

Specialty

Pharmaceuticals

Acute Care CroFab®,

DigiFab®,

Voraxaze®

Uridine triacetate

~ $170m Mid to high single digit

Further growth potential from pipeline and M&A

Licensing

Royalties Zytiga®, Hip

Cup, others

~ $175m Not under BTG’s control

Analysts est. $2.6bn Zytiga® peak sales potential

2021 sales potentialCurrent sales*

*12 months to 31 March 2014 (annualised for TheraSphere® and EKOS)

Page 5: Jefferies 2014 Global Healthcare Conference 0920 1 BTG.pdf · Jefferies 2014 Global Healthcare Conference ... –New device technology to increase speed and reduce lytic doses –Improving

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Highlights of recent progressStrong financial performance and execution of

growth strategy

Product Milestone achieved Strategy

Interventional

Medicine

Specialty

Pharmaceuticals

Licensing

Varithena® Launch commenced in Q2’14

First patients treated in August

Controlled launch, build

the brand

EKOS® FDA clearance to treat pulmonary

embolism

Indication expansion

DC Bead® Approved in China

Hong Kong hub openedUnlock value in Asia

TheraSphere® EU sales force established Geographic expansion

CroFab® Patent litigation settled Certainty and continuity

Zytiga® royalties

(abiraterone acetate)

Now tracking to ~$2bn worldwide Ongoing financial underpin

Lemtrada™ royalties

(alemtuzumab)

Approved in the EU (Sep. 2013)

and US (Nov. 2014)

Page 6: Jefferies 2014 Global Healthcare Conference 0920 1 BTG.pdf · Jefferies 2014 Global Healthcare Conference ... –New device technology to increase speed and reduce lytic doses –Improving

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Financial highlights25% growth in reported revenues for H1 14/15

H1 14/15(£m)

H1 13/14(£m)

% change

Revenue 191.2 153.0 25%

Contribution 80.1 66.7 20%

Operating profit

Underlying† 56.8 46.7 22%

Reported 42.8 25.0 71%

Profit before tax 37.6 32.7 15%

Basic EPS 10.8p 6.8p 59%

Closing cash 78.0 39.8 -

†Operating profit excluding acquisition adjustments and re-organisation costs of £14.0m (H1 13/14: £21.7m)

Page 7: Jefferies 2014 Global Healthcare Conference 0920 1 BTG.pdf · Jefferies 2014 Global Healthcare Conference ... –New device technology to increase speed and reduce lytic doses –Improving

Strong underlying growth across the business

7†Constant FX USD vs GBP ($1.68 vs $1.54 in prior year)

*Based on pro-forma 6 month revenues for EKOS and TheraSphere®

H1 14/15reported (£m)

H1 13/14 reported (£m)

Change(%)

Underlying change at constant FX† (%)

Interventional Medicine

Interventional Vascular

Varithena®0.4 - - -

EkoSonic®14.6 6.3 132% 28%*

Total Interventional Vascular 15.0 6.3 138% 31%*

Interventional Oncology

Beads 16.8 15.8 6% 15%

TheraSphere®20.0 7.0 186% 25%*

Total Interventional Oncology 36.8 22.8 61% 21%*

Total Interventional Medicine 51.8 29.1 78% 24%*

Specialty Pharmaceuticals

CroFab® 49.1 49.7 (1%) 8%

DigiFab® 21.9 15.3 43% 54%

Voraxaze® / Other 6.8 4.8 42% 52%

Total Spec Pharma 77.8 69.8 11% 21%Licensing

Zytiga® 50.6 41.7 21% 31%

Two-Part Hip Cup 5.8 6.3 (8%) -

Others 5.2 5.4 (4%) (2%)

Total Licensing 61.6 53.4 15% 24%

Total 191.2 152.3 26% 23%*

Non-recurring (Brachytherapy) - 0.7 - -

Total 191.2 153.0 25% 23%*

Page 8: Jefferies 2014 Global Healthcare Conference 0920 1 BTG.pdf · Jefferies 2014 Global Healthcare Conference ... –New device technology to increase speed and reduce lytic doses –Improving

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Investing for growthBuilding our commercial capability and pipeline

Investment area Detail Progress Comment

Commercial

expansion

H1 SG&A £55.2m

H2 SG&A guidance

c.£65m

Varithena® US launch;

first patients treated

Expanded EU direct

sales force

Asian hub and satellite

offices

Enhance capabilities and

capacity

24 reps established and

engaging with customers

25 reps hired for TheraSphere®;

adding Beads go-direct

Office opened in September,

enlarging internal capability

EKOS go-direct in UK, France;

widened EU distribution network

Innovation and

Development

H1 R&D £27.2m

H2 R&D guidance

c.£30m-£35m

Indication expansion –

TheraSphere®, Beads,

Varithena®, EKOS

Product innovation and

lifecycle management

Accelerating TheraSphere®

Phase 3 trials. Study into PTS

and chronic DVT for EkoSonic®

Radiopaque bead, Bioresorbable

bead

DVT = deep vein thrombosis, PTS = post thrombotic syndrome

Page 9: Jefferies 2014 Global Healthcare Conference 0920 1 BTG.pdf · Jefferies 2014 Global Healthcare Conference ... –New device technology to increase speed and reduce lytic doses –Improving

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Interventional Vascular: Varithena®

Building a $500m+ franchise

Controlled US launch creates the platform to maximise growth

opportunities in other market segments

Patient acquisition strategies to maximise potentialControlled launch

Development of US self pay market

Aesthetic Leg Vein

Other venous indications

2014 2016 2021

RoW expansion

Page 10: Jefferies 2014 Global Healthcare Conference 0920 1 BTG.pdf · Jefferies 2014 Global Healthcare Conference ... –New device technology to increase speed and reduce lytic doses –Improving

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– Reps recruited, trained and have

developed comprehensive customer

maps of their territories

– Prioritising high-volume clinicians with

strong interest in using Varithena® as a

comprehensive treatment

– Physician qualification process involves

online training, video review, patient evaluations

– First commercial treatment in August 2014

– Reimbursement support provided

– Objective is to ensure a great customer and patient experience every

time

Interventional Vascular: Varithena®

On track with launch in the US reimbursed sector

Page 11: Jefferies 2014 Global Healthcare Conference 0920 1 BTG.pdf · Jefferies 2014 Global Healthcare Conference ... –New device technology to increase speed and reduce lytic doses –Improving

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– Positive early signs

– Great feedback

Interventional Vascular: Varithena®

A compelling treatment proposition

“We achieved a flush and complete ablation of the vessel. In this particular patient, with

a history of SVT*, other interventional options were limited. I think this is a tremendous

advantage for Varithena® and a coup for the entire BTG team”— Kenneth L. Todd III, MD

Southeast Vein and Laser Center, Alabama

“Varithena® will have a significant positive impact in our practice in multiple ways.”— Tony Gasparis, MD

Stony Brook Vein Center, NY

“Varithena® will simplify the treatment of varicose veins” — Nicos Labropoulos, PhD

Stony Brook's Non-Invasive Vascular Laboratory, NY

*SVT = Supraventricular tachycardia

Page 12: Jefferies 2014 Global Healthcare Conference 0920 1 BTG.pdf · Jefferies 2014 Global Healthcare Conference ... –New device technology to increase speed and reduce lytic doses –Improving

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Controlled launch“Go slow, to go fast”

- Supporting physicians throughout the reimbursement process

- Dedicated team of reimbursement and coding experts

- Payer education and familiarisation with Varithena®

Varithena Solutions Center™

Map customer

territories

Register and

complete online

training

Complete

evaluation with x3

full GSV patients

BTG Clinical

Specialist present

Qualified

Customer

On track

for 200

physicians

by 31/3/15

Page 13: Jefferies 2014 Global Healthcare Conference 0920 1 BTG.pdf · Jefferies 2014 Global Healthcare Conference ... –New device technology to increase speed and reduce lytic doses –Improving

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Interventional Vascular: EKOSLeading product in an underpenetrated market

DVT = deep vein thrombosis, PTS = post thrombotic syndrome

Geographic expansion

– EKOS installed in less than ½ of potential US Institutions

– Europe: growing direct sales force in UK and France;

expanding distribution networks in other EU territories

Indication expansion

– Cleared for use in pulmonary embolism by the FDA in

May 2014

– Ongoing clinical trial to investigate treatment of chronic DVT

and PTS

Product innovation

– New hardware to address bilateral cases and ease of use

– New device technology to increase speed and reduce lytic

doses

– Improving power, functionality whilst reducing size

Intelligent Drug Delivery Catheter

Ultrasound Core Device

Page 14: Jefferies 2014 Global Healthcare Conference 0920 1 BTG.pdf · Jefferies 2014 Global Healthcare Conference ... –New device technology to increase speed and reduce lytic doses –Improving

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Interventional OncologyA patient-centric approach to treatment

H1 progress

US: combined Beads and TheraSphere®

sales force gaining traction and delivering

strong growth

EU: TheraSphere® sales force established;

begin selling DC Bead® from April 2015

Asia: DC Bead® approved in China in

August 2014; Taiwan direct sales force

established; developing regulatory strategy

for TheraSphere®

Future growth drivers

Geographic expansion:

– Asia growth and China strategy

Indication expansion:

– TheraSphere® Phase 3 trials

– R&D programmes guided by input from

KOLs

Product innovation:

– Radiopaque bead, bioresorbable bead

– Proprietary drug-loaded bead

2014 2021

Unique offering of both main locoregional treatment modalities creates a

compelling patient-centric franchise

Page 15: Jefferies 2014 Global Healthcare Conference 0920 1 BTG.pdf · Jefferies 2014 Global Healthcare Conference ... –New device technology to increase speed and reduce lytic doses –Improving

Ongoing delivery

– CroFab®

– Settlement of patent litigation secures leadership position

– DigiFab®

– Strong growth from geographic expansion and raising profile

– Voraxaze®

– On track for third year of double digit growth

Growth potential

– Unique sales force with in-depth knowledge of the US emergency rooms

– Uridine triacetate designated for fast track status by FDA

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Specialty PharmaceuticalsStrong performance from cash generative portfolio

Page 16: Jefferies 2014 Global Healthcare Conference 0920 1 BTG.pdf · Jefferies 2014 Global Healthcare Conference ... –New device technology to increase speed and reduce lytic doses –Improving

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Licensing Solid financial underpin from growth in Zytiga®

Zytiga® (abiraterone acetate)

– Strong growth, now tracking to ~$2bn annual sales

– Stable market position vs. competitors

– Geographical split approximately 55% RoW : 45% US sales

– Analyst estimate peak sales potential ~$2.6bn

Lemtrada™ (alemtuzumab)

– sBLA approved by US FDA November 2014

– Approved in the EU September 2013

Page 17: Jefferies 2014 Global Healthcare Conference 0920 1 BTG.pdf · Jefferies 2014 Global Healthcare Conference ... –New device technology to increase speed and reduce lytic doses –Improving

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– Strong business performance

– Executing on growth strategy:

– geographic expansion, indication expansion, product innovation

– Increasing investment across multiple platforms

– Controlled launch of Varithena® in the US reimbursed sector on track

– Expanding Interventional Oncology franchise further into Europe and Asia

– Strong performance from EKOS and TheraSphere® demonstrates successful

acquisition and integration

– FY revenue guidance now expected around upper end of £330m-£345m

range despite currency headwinds

– On track with delivering on our vision to become a leader in Interventional

Medicine with revenues >$1bn by 2021

Summary