Futura Medical Plc · LSE:FUM
Futura Medical — FY2018 Earnings Presentation
29 slides from Futura Medical's earnings presentation, April 2019
Slide 1: Preliminary Results and R&D Summary, Year Ending 31st December 2018
Preliminary Results and R&D Summary Year Ending 31st December 2018 April 2019 1 CONFIDENTIAL
Slide 2: Disclaimer
Disclaimer This presentation has been prepared by and is the sole responsibility of the Directors of Futura Medical plc (the “Company”). This presentation does not constitute or form part of any offer or invitation to sell or issue, or any solicitation of any offer to purchase or subscribe for any s
Slide 3: Contents
Contents • FUTURA MEDICAL CORPORATE OVERVIEW • YEAR ENDING 31 DECEMBER 2018 HIGHLIGHTS • MED2005 – AN INNOVATION IN THE TREATMENT OF ED • MED2005 – CLINICAL DEVELOPMENT PROGRAM • COMMERCIAL OPPORTUNITY & INTELLECTUAL PROPERTY • TOPICAL PAIN RELIEF • FINANCIAL RESULTS & OUTLOOK 3
Slide 4: Futura Medical – a corporate overview
Futura Medical – a corporate overview 4
Slide 5: About Futura – a corporate overview
About Futura – a corporate overview Fundamentals Futura listed on AIM market and located at the Research Park, Guildford ‘Virtual’ organisation with 15 staff and low overheads Significant outsourced infrastructure with over 30 consultants DermaSys® Clinically proven transdermal science Drug de
Slide 6: Year End Highlights – Products, Organisation & Financial
Year End Highlights – Products, Organisation & Financial Strategic decision to focus resources on maximising R&D pipeline value Priorities are MED2005 Phase 3 trial completion and further realisation of value from pain portfolio Increased awareness of MED2005 within scientific and pharmaceutical com
Slide 7: MED2005 – An Innovation in the Treatment of ED
MED2005 – AN INNOVATION IN THE TREATMENT OF ED 7 LEAD PRODUCT
Slide 8: Erectile Dysfunction – Quality of Life & size of the problem
Erectile Dysfunction – Quality of Life & size of the problem The number of men with ED will increase from 152 1 Sexual activity is beneficial1 million men in 1995 to 322 million men by 2025 2 Low self esteem and confidence Asia North America Europe 3 Partner concerns – affair, less attractive ↑ 9.1
Slide 9: ED market size and treatment options
ED market size and treatment options PDE5 inhibitors Erectile Dysfunction Viagra US$ 1.8 billion1 prescription (Rx) market worth Levitra over US$ 5.6 billion in 20161 US$ 0.3 billion1 Cialis US$ 2.5 billion1 But no real innovation for 10+ years Caverject® Muse® Vitaros® 9 1 - Market size with sales
Slide 10: MED2005 & the DermaSys transdermal technology
MED2005 & the DermaSys® transdermal technology MED2005 uses unique DermaSys® technology, which enables targeted and rapid delivery of GTN through the tissue to achieve and maintain an erection 1. 2. 3. Application of gel Seconds later Minutes later with active GTN Volatile solvents evaporate, GTN pe
Slide 11: MED2005 – First topical gel to treat ED with key differentiators
MED2005 – First topical gel to treat ED with key differentiators MED2005 is a topical gel containing from 0.2% up to 0.6% w/w of glyceryl trinitrate (GTN) Utilises Futura’s proprietary drug delivery technology DermaSys® Is applied directly to the exterior of the glans penis by the male or sexu
Slide 12: MED2005 value proposition
MED2005 value proposition MED2005’s unique proposition could become a preferred treatment option for many men with ED and their partners. It will also present a new treatment option for those for whom PDE5is are unsatisfactory or unsuitable Alternative first line treatment Unable to use PDE5is Dissa
Slide 13: MED2005 represents a potential US$1 billion opportunity
MED2005 represents a potential US$1 billion opportunity1 ED prescription (Rx) market worth over US$5.6 billion in 20162 (up 6% vs. 2015) 01 Research by Cello suggests a > 20% patient share for MED2005 (Branded Eroxon®) $560 million potential prescription peak sales at $5 per dose 02 Research by Cell
Slide 14: MED2005 – Clinical Development Program
MED2005 – CLINICAL DEVELOPMENT PROGRAM 14 LEAD PRODUCT
Slide 15: Clinical study programme
Clinical study programme Study Number of Study Study Phase Test Article Code Subjects status 0.025%, 0.033% , 0.083% & 0.166% MED2003, FM33 Phase I – PK. 16 0.25% MED2004 and 0.4% MED2005 Complete 0.0033% , 0.025% & 0.083% MED2003 and 0.2% FM35 Phase I – PD. 15 MED2005 Complete Phase 2a – headli
Slide 16: FM53 (Phase 2a efficacy study) – completed Sep 2016
FM53 (Phase 2a efficacy study) – completed Sep 2016 A randomized double blind, placebo-controlled, home use, cross-over clinical trial of topically- FM53 applied glyceryl trinitrate, MED2005, 0.2% for the treatment of erectile dysfunction in 231 patients Primary endpoint: Evaluate efficacy of MED200
Slide 17: Phase I PK study (FM58) – successfully completed April 2018
Phase I PK study (FM58) – successfully completed April 2018 (Part 1 30 Subjects; Part 2 10 Subjects) Dose-related absorption 7500 Cmax achieved with MED2005 GTN doses of 0.4%, 0.6% MED2005 Plasma Concentration pg/ml and 0.8% was approximately 170%, 260% and 320% 7000 MED2005 - 0.2% respectively of
Slide 18: Phase 3 studies – risk mitigation
Phase 3 studies – risk mitigation Strong evidence of efficacy from Phase 2a study (FM53) 01 Regulators acknowledged ‘Minimally effective dose’ probably established Broad regulatory consensus1 on remaining clinical program (Phase 3) 02 Regulatory recommendations included into Phase 3 study de
Slide 19: Phase 3 study design - FM57
Phase 3 study design - FM57 A Phase 3, dose-ranging, multi-centre, randomized, double-blind, placebo-controlled, home use, parallel group FM57 clinical trial of topically applied GTN for the treatment of ED Primary objective: • To demonstrate the efficacy of MED2005 versus placebo in male subjects s
Slide 20: MED2005 indicative development path timelines
MED2005 indicative development path timelines 2018 2019 2020 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 ✔ PHARMACOKINETIC SAFETY STUDY (4 doses + Nitrostat®) ✔ PHASE 3 EUROPEAN EFFICACY STUDY PHASE 3 EUROPEAN EFFICACY STUDY – OPEN LABEL EXTENSION PHASE 3 SECOND EFFICACY STUDY1 ✔ ONGOING MED2005 STABILITY E
Slide 21: MED2005 – Commercial Opportunity & Intellectual Property
MED2005 – COMMERCIAL OPPORTUNITY & INTELLECTUAL PROPERTY 21 LEAD PRODUCT
Slide 22: Commercial opportunity
Commercial opportunity 1 Futura has a proven track record in delivery of Research & Development (‘R&D’) First Phase 3 (FM57) Fully Funded 2 First patient enrolled October 2018 – Headline data expected by end of December 2019 Futura monetises its assets via 3rd parties. Strong interest from a number
Slide 23: Robust IP protection
Robust IP protection Patent protection EU Data exclusivity Generic regulatory protection protection • Patents are formulation specific EU rules grant 10-year protection • GTN has narrow therapeutic • Current US regulations for range for ED • 8-year exclusivity period generic topical Data generated b
Slide 24: Topical Pain Relief
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Slide 25: Futura's DermaSys transdermal technology
Futura’s DermaSys® transdermal technology TPR100 uses unique DermaSys® technology, which enables targeted and rapid delivery of Diclofenac through the skin to achieve rapid pain relief TPR100 Applying Futura’s advanced transdermal science to diclofenac Increased permeation of active compound throu
Slide 26: Topical Pain Relief
Topical Pain Relief Global sales of topical over the counter non steroidal anti-inflammatory US market - $1 billion 2 01 drugs (“NSAIDs”) > US$2.9 billion1 FLECTOR PATCH 13% Demand for safe, effective and long lasting topical pain relief PENNSAID 02 DermaSys® provides faster drug permeation, a key p
Slide 27: Topical Pain Relief
Topical Pain Relief 2017 agreement with Thornton & Ross (part of STADA) for UK rights to TPR100 01 UK regulatory submission filed in July 2018 – 1st round of questions received from MHRA in March 2019 Commercial discussions ongoing with other potential distributors 02 TPR100 - USA will require furth
Slide 28: Financial Results & Outlook
FINANCIAL RESULTS & OUTLOOK 28
Slide 29: Year End Highlights – Organisation & Financials
Year End Highlights – Organisation & Financials Net loss of £5.89 million in period (2017: net loss of £3.90 million) Cash resources of £9.16 million (at 31 December 2018) Plus tax credit of £1.36 million expected Q2-3 2019 (At 31 December 2018: cash resources excluding potential tax credit du