Varithena 3 rd February 2015

Transcription

1 Varithena 3 rd February 2015

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. 2

3 Introductions Paul McCubbin Head of Interventional Vascular Greg Walsh General Manager Varithena Phill Keefe Product development and LCM Director Varithena is a registered trademark of Provensis Ltd, a BTG International group company BTG and the BTG roundel logo are registered trademarks of BTG International Ltd 3

4 What are varicose veins? Veins in the legs that are Superficial and raised Dilated, tortuous, elongated Different than spider veins Caused by Failed valves in the vein (GSV) High hydrostatic pressure Time and age They are Symptomatic (aching, throbbing, itching, swelling, disabling) Unsightly Progressive Can cause Itching, pain, eczema Skin damage, ulcers 4

5 CEAP Classification of Chronic Venous Disease of the Leg C 1 telangiectasia C 2-4 varicose veins C 4 lipodermatosclerosis C 6 venous ulceration C 1 : Telangiectasia C 2 : Varicose veins C 4 : Lipodermatosclerosis or hyperpigmentation C 6 : Active ulcer CEAP Classification C 0 : No venous disease C 3 : Edema C 5 : Healed ulcer CEAP = clinical, etiology, anatomy, pathophysiology classification of venous disorders. Bergan et al. N Engl J Med. 2006;355:488. 5

6 Varicose Veins (Superficial Venous Incompetence) are not just a cosmetic condition My legs ache. They just throb and they ache the only relief I get is to hang them straight up in the air Not that I want to show you my ankle right now but it will swell to like three times its regular size because everything just collects there I ve scaled back on exercising because they do feel heavy and tired. And then this one leg has the worse veins in it, throbbing and the pain Well for me it s the itching. that hot, itchy kind of bugs under the skin kind of feeling 6

7 Varicose Veins US Market data* 1.4m people saw a vein specialist in m people symptomatic hence likely to be eligible for reimbursement 0.5m people had treatment, representing approximately 750k GSV procedures Reasons for dropping out include not liking treatment options, vein anatomy and out-of-pocket cost is too high Significant opportunity for a patientcentric treatment option Prevalence: ~30m US incidence 2.5m Incidence: ~2.5m Visited vein Incidence: clinic: BTG 2013 ~1.4m ~2.5 m sales ~$90m Treated: Estimated growth rate ~8% Estimated GSV procedures 2021 ~0.5m GSV Procedures 2012: ~0.75 m Peak sales potential US reimbursed sector Potential including indication expansion and ex-us markets 1.25m $250m $500m+ *BTG estimates based on available reports and proprietary market research 7

8 Treatment of Varicose Veins Visible varicosities 1,2 (GSV tributaries) Ambulatory phlebectomy Liquid/PCF sclerotherapy Varithena Above knee 1,2 (Proximal GSV) Stripping and ligation Endovenous thermal ablation Varithena Below knee 1,2 (Distal GSV) PCF sclerotherapy Some endovenous thermal ablation Varithena Primary cause of symptoms GSV = great saphenous vein; PCF = physician-compounded foam. 1. Draft Prescribing Information. 01/2013; 2. Gloviczki et al J Vasc Surg. 2011;53(suppl 5):2S. 8

9 9

10 The Compelling Varithena Story We are Telling FDA-approved, comprehensive treatment for GSV system incompetence Treats a wide range of vein diameters and anatomies No tumescent anesthesia Cohesive, low-nitrogen foam for consistent performance Novel efficacy endpoints in clinical trials including patient symptoms and appearance Safety evaluated in 1,333 patients in 12 clinical trials Support provided by BTG to help clinicians integrate Varithena into their clinical practice Varithena Solutions Center Varithena Solutions Center is a trademark of Provensis Ltd, a BTG International group company 10

11 So how are we going to be successful? A fully integrated customer centric approach fully supporting our customers We have made conscious choices and investments to ensure the right customer experience 11

12 Embracing the customer KPI s No disappointed legs Go slow to go fast PRO Clinical End points and studies Field team configuration CRM systems & account planning (Left hand right hand) Customer Market access & medical Physician training Payer advocacy SD and SP distribution Varithena Solutions Center HEOR data 12

13 Executing our controlled Varithena US launch Sales Force commenced selling in August and have qualified 1k accounts Prioritising high-volume clinicians with strong interest in using Varithena as a comprehensive treatment Physician qualification process involves online training, video review, patient evaluations Reimbursement support provided Objective is to ensure a great physician and patient experience every time 13

14 Is it working? First patients treated. 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 14

15 Varithena US reimbursement Drug reimbursed through a interim J code: Launched as a multi-treatment canister at $3,195 for 45ml usable foam per label i.e. $71 per ml Reimbursed to the physician at upwards of ASP plus 6% Procedure reimbursed under interim CPT code: Work effort and practise expense are near equivalent to Endothermal Ablation (ETA). This is reflected in claims payment successes where reimbursement has been substantially equivalent. Physician Revenue detail GSV ~10mls Comprehensive Leg ~15mls J-code - Drug ~(ASP + 6%) $753 $1,129 CPT code Procedure Comparable to ETA (via crosswalk) Comparable to ETA (via crosswalk) 15

16 Varithena indication and geographic expansion Additional indications US aesthetic market, potential 2017 launch Other venous indications in development RoW markets Leveraging NDA approval Planning a sequenced rollout based on market readiness First approvals potential 2015/16 16

17 Thank you 17