Jefferies 2014 Global Healthcare Conference November Because people depend on us

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

2 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 forwardlooking 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. 2

3 Building a world leading specialist healthcare business 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 Interventional Medicine Revenue ~$150m ~$170m ~$175m Specialty Pharmaceuticals Licensing Not to scale

4 Strong growth in expanded portfolio Products Current sales* Current growth guidance 2021 sales potential 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+ 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 *12 months to 31 March 2014 (annualised for TheraSphere and EKOS) 4

5 Highlights of recent progress Strong financial performance and execution of growth strategy Product Milestone achieved Strategy Varithena Launch commenced in Q2 14 First patients treated in August Controlled launch, build the brand Interventional Medicine Specialty Pharmaceuticals EKOS DC Bead FDA clearance to treat pulmonary embolism Approved in China Hong Kong hub opened Indication expansion Unlock value in Asia TheraSphere EU sales force established Geographic expansion CroFab Patent litigation settled Certainty and continuity Licensing Zytiga royalties (abiraterone acetate) Lemtrada royalties (alemtuzumab) Now tracking to ~$2bn worldwide Approved in the EU (Sep. 2013) and US (Nov. 2014) Ongoing financial underpin 5

6 Financial highlights 25% growth in reported revenues for H1 14/15 H1 14/15 ( m) H1 13/14 ( m) % change Revenue % Contribution % Operating profit Underlying % Reported % Profit before tax % Basic EPS 10.8p 6.8p 59% Closing cash Operating profit excluding acquisition adjustments and re-organisation costs of 14.0m (H1 13/14: 21.7m) 6

7 Strong underlying growth across the business H1 14/15 reported ( m) H1 13/14 reported ( m) Change (%) Underlying change at constant FX (%) Interventional Medicine Interventional Vascular Interventional Oncology Varithena EkoSonic % 28%* Total Interventional Vascular % 31%* Beads % 15% TheraSphere % 25%* Total Interventional Oncology % 21%* Total Interventional Medicine % 24%* Specialty Pharmaceuticals CroFab (1%) 8% Licensing DigiFab % 54% Voraxaze / Other % 52% Total Spec Pharma % 21% Zytiga % 31% Two-Part Hip Cup (8%) - Others (4%) (2%) Total Licensing % 24% Total % 23%* Non-recurring (Brachytherapy) Total % 23%* Constant FX USD vs GBP ($1.68 vs $1.54 in prior year) *Based on pro-forma 6 month revenues for EKOS and TheraSphere 7

8 Investing for growth Building our commercial capability and pipeline Investment area Detail Progress Comment Commercial expansion H1 SG&A 55.2m H2 SG&A guidance c. 65m Innovation and Development H1 R&D 27.2m H2 R&D guidance c. 30m- 35m Varithena US launch; first patients treated Expanded EU direct sales force Asian hub and satellite offices Enhance capabilities and capacity Indication expansion TheraSphere, Beads, Varithena, EKOS Product innovation and lifecycle management 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 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 8

9 Interventional Vascular: Varithena Building a $500m+ franchise Controlled launch Patient acquisition strategies to maximise potential Development of US self pay market Aesthetic Leg Vein RoW expansion Other venous indications Controlled US launch creates the platform to maximise growth opportunities in other market segments 9

10 Interventional Vascular: Varithena On track with launch in the US reimbursed sector 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 10

11 Interventional Vascular: Varithena A compelling treatment proposition Positive early signs Great feedback Varithena will simplify the treatment of varicose veins Nicos Labropoulos, PhD Stony Brook's Non-Invasive Vascular Laboratory, NY 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 *SVT = Supraventricular tachycardia 11

12 Controlled launch Go slow, to go fast 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 Varithena Solutions Center - Supporting physicians throughout the reimbursement process - Dedicated team of reimbursement and coding experts - Payer education and familiarisation with Varithena 12

13 Interventional Vascular: EKOS Leading product in an underpenetrated market 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 Intelligent Drug Delivery Catheter Ultrasound Core Device 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 DVT = deep vein thrombosis, PTS = post thrombotic syndrome 13

14 Interventional Oncology A 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 Unique offering of both main locoregional treatment modalities creates a compelling patient-centric franchise 14

15 Specialty Pharmaceuticals Strong performance from cash generative portfolio 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 15

16 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

17 Summary 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

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