Investor Update. Jefferies Global Healthcare Conference June Because people depend on us

Transcription

1 Investor Update Jefferies Global Healthcare Conference June 2014 Because people depend on us

2 Forward-looking statement 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. 2

3 BTG s business has been built for the new healthcare environment Clinically proven, differentiated products that address underserved patient populations: BTG s focus and capability Clinical Data No longer the preserve of pharma Meeting clinician and patient needs Customer Experience Innovation Investment Payer Trends Need to see value and clinical benefit 3

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 *Annualised for TheraSphere and EKOS DigiFab is a registered trademark of BTG International Inc. Voraxaze is a registered trademark of Protherics Medicines Development Ltd, a BTG International group company. Zytiga is a trademark of Johnson & Johnson.. 4

5 Significant pipeline potential Disease Product FY13/14 FY20/21 Interventional Medicine: Vascular Varicose veins Varicose veins Venous indication Aesthetic leg vein Varithena Varithena PEM PEM First ex-us approvals Phase 4 Study Phase 3 PRO development Phase 3b Thrombus EkoSonic DVT EkoSonic Pulmonary embolism EkoSonic Product innovation Chronic disease treatment Product innovation Interventional Medicine: Oncology HCC TheraSphere HCC TheraSphere mcrc TheraSphere Embolisation LC Bead /DC Bead Embolisation LC Bead /DC Bead HCC BTG US PMA Phase 3 study (STOP-HCC) Registration study EU/US Phase 3/4 (YES-P) Supportive Label extension for mcrc Phase 3 global 2nd line (EPOCH) Registration study Proprietary new product development Proprietary new product development Proprietary drug bead combination BPH BTG New bead product Post approval clinical Leiomyoma BTG New bead product Post approval clinical Specialty Pharmaceuticals Envenomation CroFab 5FU overdose Xuriden Copperhead Phase 4 potential label expansion Uridine triacetate NDA submission EkoSonic is a registered trademark of EKOS Corporation. LC Bead and DC Bead are registered trademarks of Biocompatibles UK Ltd. EKOS Corporation and Biocompatibles UK Ltd are BTG International group companies. CroFab is a trademark of BTG International Inc. Xuriden is a trademark of Wellstat Therapeutics Corporation. 5

6 Financial highlights 2013/14 ( m) 2012/13 ( m) Revenue % Underlying % Acquisitions Non-recurring Operating profit % Underlying % Acquisitions Non-recurring (2.2) 21.4 Profit before tax % Basic EPS % Closing cash Operating profit excluding acquisition adjustments and reorganisation costs 6

7 20% growth in underlying revenues 2013/14 ( m) 2012/13 ( m) Change (%) CroFab Specialty Pharmaceuticals Interventional Medicine DigiFab Voraxaze /other Total Embolic beads Total Licensing Zytiga Two-Part Hip Cup Others Total Total Total underlying revenues Acquisitions TheraSphere EKOS Non-recurring (Brachytherapy, BeneFIX, AZD9773) Total BeneFIX is a trademark of Genetics Institute, LLC. 7

8 A leader in Interventional Medicine 8

9 Investing to deliver $1bn+ vision in Interventional Medicine $1bn+ Growth drivers: Geographic expansion Indication expansion Product innovation Varithena $500m+ EKOS $100m - $200m ~$150m Beads + TheraSphere $300m - $400m 2013/ /21 9

10 US commercial expansion for IM Increased coverage and team-selling opportunities Location Physicians BTG sales force Team-selling opportunity Emergency room Cath lab Vein clinic Acute care specialists Interventional radiologists Phlebologists Vascular surgeons Interventional radiologists SP 530 hospitals IO 600 hospitals EKOS 600 hospitals Varithena 1,000 vein specialists EKOS 50% of blood clots present in ER Varithena vein treatments often conducted in hospitals EKOS vein specialists in hospitals also use EKOS products Opportunities to team-sell within Interventional Medicine and to leverage Specialty Pharmaceuticals sales force capabilities 10

11 Interventional Vascular Varithena : US market overview 1.4m people visited a vein clinic in m people symptomatic hence likely to be eligible for reimbursement 0.5m people treated Reasons for dropping out include not liking treatment options, vein anatomy, not wanting to underwrite treatment cost Half had only one leg treated, i.e. 0.75m legs treated Significant opportunity for a patientcentric treatment option US prevalence 30m US incidence 2.5m Prevalence: ~30m Prevalence: ~30m Incidence: ~2.5m Visited vein clinic: ~1.4m Incidence: BTG 2013 ~2.5m sales ~$90m GSV Treated: Procedures ~0.5m 2012: ~0.75m GSV procedures in m Potential procedures annually Potential including US selfpay, aesthetic and ex-us markets ~5.0m $500m+ 11

12 Executing our controlled US launch strategy Phase I: Build a solid base Establish clinical utility for treating symptoms in all veins affected by GSVI Focus initially on high-volume, earlyadopting physicians Ensure clinical use is reflected in the intermediate drug and procedure codes Ensure a total quality experience for doctors and patients Invest in Phase 4 differentiation and additional pharmacoeconomic studies Marketing activities focusing on comprehensive nature of Varithena Reps mapping territories, focusing on well-established clinicians Outreach to local and national payers; interim codes established Educational and training programmes, reimbursement support in place Studies being progressed Phased launch strategy: single $m year 1 sales, 2-3 x in year 2, strong growth from year 3 12

13 Compelling value proposition FDA-approved, comprehensive treatment for GSV system incompetence Treats wide range of vein diameters/anatomies No tumescent anesthesia Novel efficacy endpoints in clinical trials including patient symptoms and appearance Evaluated in 1,333 patients in 12 clinical trials Multi-treatment product provides flexibility to tailor dose (to max 15ml) Indicative revenue per leg to BTG of $500 - $1,000; 80% margin at volume Support to help clinicians integrate Varithena into their clinical practice Varithena Solutions Center Qualification process involves online training and BTG medical support Commercial sales targeted to begin Q

14 Building a $500m+ franchise Multiple near and medium term growth drivers Other venous indications Aesthetic Leg Vein and RoW expansion Establishment of permanent J-code Development of US self pay market Controlled launch Patient acquisition strategies to maximise potential Controlled US launch creates the platform to maximise growth opportunities in under-served market segments 14

15 Interventional Vascular: EKOS Advancing the treatment of severe blood clots 1,000,000 annual occurrences of DVT, PE and PAO in the US* 675,000 candidates for interventional treatment Total US market potential ~$1bn 70,000 current interventional treatments 2012 Total US interventional device sales ~$95m Continued growth of interventional procedures US continued growth, significant EU expansion Indication expansion Supportive positive pulmonary embolism data *DVT = deep vein thrombosis, PE = pulmonary embolism, PAO = peripheral arterial occlusion 15

16 Interventional Oncology Beads and TheraSphere sales forces integrated and selling both products Innovation and Development programmes prioritised Guided by input from KOLs in locoregional treatment of liver cancer Patient-centric approach well received Now accelerating investment of three key growth drivers in parallel Indication expansion Geographic expansion Product innovation 16

17 Interventional Oncology Geographic expansion US: Increased coverage: combined TheraSphere /Beads sales force 147k available patients: Potential $1.3bn global market EU: Direct sales force in EU5 Initial focus on TheraSphere expansion Asia: BTG target 2020/21: $300m - $400m BTG sales 2013: ~$110m DC Bead launched in Japan Hong Kong: hub established for regulatory and medical Global market opportunity in 2021 Satellite offices: Taiwan established China: develop regulatory strategy for TheraSphere ; progress Beads regulatory strategy dependent on outcome of current review $560m $540m $175m $1.3bn 17

18 Interventional Oncology Near-medium term growth drivers US commercial expansion Phase 3 trial results / indication expansion Initial Asia growth (Japan, Taiwan, other) Product innovation - imageable Bead and bioresorbable Bead China expansion Product innovation exploring proprietary drug loaded Bead EU go-direct impact for TheraSphere Interventional Oncology a key driver of 2021 vision to create a $1bn+ Interventional Medicine business 18

19 Growth opportunities in Specialty Pharmaceuticals Ongoing delivery CroFab Copperhead study progressing New educational website ITC action in the US to support our intellectual property DigiFab approved in Australia 1 st EU named-patients sales of uridine triacetate Wellstat aim to submit uridine triacetate US NDA by end 2014 Growth platform Current franchise provides significant leverage opportunity Highly cash generative business US salesforce with in depth knowledge of US emergency rooms Active programme for M&A and R&D growth opportunities 19

20 Financial underpin from Licensing Zytiga (abiraterone acetate) growth potential 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 Other Licensing Lemtrada approved in the EU sbla re-submitted and accepted for review; FDA action expected Q

21 Summary Strong results reinforce consistent delivery of financial objectives BTG is now a leader and disruptive player in high-growth areas of Interventional Medicine, with a vision to build a $1bn+ business Differentiated products that meet patient, physician and payer needs Controlled US launch of Varithena building long-term value Significant pipeline of innovation and development programmes Actively seeking M&A opportunities to leverage Interventional Medicine and Specialty Pharmaceuticals platforms Scalable platforms providing multiple investment opportunities BTG is fit for purpose for today s healthcare environment to sustain high growth over the long term 21