Futura Medical Plc · LSE:FUM
Futura Medical — H1 2019 Earnings Presentation
26 slides from Futura Medical's earnings presentation, Sep 11, 2019
Slide 1: Interim Results: Six months to 30 June 2019
INTERIM RESULTS Six months to 30 June 2019 11 September 2019 Strictly Private and 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 a recommendation regarding the shares of the Company nor a representation that any dealing in those shares is appropriate. Th
Slide 3: A Corporate Overview
A CORPORATE OVERVIEW CONFIDENTIAL 3
Slide 4: About Futura - A Corporate Overview
ABOUT FUTURA - A CORPORATE OVERVIEW Futura is listed on AIM and located at the Research Park, Guildford FUNDAMENTALS ‘Virtual’ organisation with 15 staff and low overheads Significant outsourced infrastructure with over 30 consultants Clinically proven transdermal science DERMASYS® Drug delivery thr
Slide 5: Six Month Highlights – Products, Organisation & Financial
SIX MONTH HIGHLIGHTS – PRODUCTS, ORGANISATION & FINANCIAL Strategic decision to focus on maximising R&D pipeline value by de-risking assets Priorities are MED2005 Phase 3 trial completion and further realisation of value from pain portfolio Increased awareness of MED2005 within scientific and pharma
Slide 6: MED2005 – An Innovation in the Treatment of ED
MED2005 – AN INNOVATION IN THE TREATMENT OF ED LEAD PRODUCT CONFIDENTIAL 66
Slide 7: 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 million men in 1995 to 322 million men by 20252 1 Sexual activity is beneficial1 2 Low self esteem and confidence North America Europe Asia 9.1 million 11.9 million 113 million 3 Partner con
Slide 8: ED Market Size and Treatment Options
ED MARKET SIZE AND TREATMENT OPTIONS PDE5 inhibitors Erectile Dysfunction Viagra US$ 0.9 billion12 prescription (Rx) market worth over US$ 5 billion Levitra US$ 0.2 billion1 in 20181 Cialis But no real innovation for 10+ US$ 1.95 billion1 years Caverject® Muse® Vitaros® 1 Market size with sales base
Slide 9: MED2005 & the DermaSys Transdermal Technology
MED2005 & THE DERMASYS® TRANSDERMAL TECHNOLOGY Application of gel with active GTN Glans Penis Combination of solvents, including volatile solvents Corpus Spongiosum Seconds later Volatile solvents evaporate, MED2005 uses unique DermaSys® leaving the remaining solvent technology, which enables target
Slide 10: 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% of glyceryl trinitrate (GTN) Utilises Futura’s proprietary drug delivery technology DermaSys® Is applied directly to the exterior of the head (glans) of the penis by the male or
Slide 11: 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 Unable to use Dissatisfied line treatmen
Slide 12: 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 20182 1 Research by Cello suggests a > 20% patient share for MED2005 (Branded Eroxon®) PDE5i now generic ED prescription (Rx) market worth US$5.6 billion in 20182 2 Rx US$ sales down by
Slide 13: MED2005 – Clinical Development Programme
MED2005 – CLINICAL DEVELOPMENT PROGRAMME LEAD PRODUCT CONFIDENTIAL 13
Slide 14: Clinical Study Programme
CLINICAL STUDY PROGRAMME Study Number of Study Phase Test Article Study status Code Subjects 0.025%, 0.033% , 0.083% & 0.166% MED2003, 0.25% MED2004 and 0.4% FM33 Phase 1 – PK. 16 MED2005 Complete FM35 Phase 1– PD. 15 0.0033% , 0.025% & 0.083% MED2003 and 0.2% MED2005 Complete Phase 2a – headlin
Slide 15: 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 16: FM57 – Phase 3 Study Design
FM57 – PHASE 3 STUDY DESIGN A Phase 3, dose-ranging, multi-centre, randomized, double-blind, placebo-controlled, home use, parallel group clinical trial of topically applied GTN for FM57 the treatment of ED in 1,000 male subjects with ED & their female partners Primary objective: To demonstrate the
Slide 17: FM57 – Risk Mitigation
FM57 – RISK MITIGATION Strong evidence of efficacy from 232 patient Phase 2a study (FM53) especially for men with mild and mild to moderate 1 erectile dysfunction Broad regulatory consensus1 on remaining clinical programme (Phase 3) 2 Regulatory recommendations included into Phase 3 study design and
Slide 18: FM57 – Risk Profile and Possible Outcome Scenarios
FM57 – RISK PROFILE AND POSSIBLE OUTCOME SCENARIOS FM57 has been designed to study a number of scenarios – Outcome is not binary 3 different doses (0.2%, 0.4% & 0.6%) trialed in 3 types of ED (mild, moderate & severe) Possible Highly successful clinical result is where at least one dose meets all pr
Slide 19: 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 CONFIRMATORY EFFICACY STUDY1 ✔ ONGOING ME
Slide 20: Topical Pain Relief
TOPICAL PAIN RELIEF CONFIDENTIAL 20
Slide 21: Topical Pain Relief: TPR100 Market and Permeation Data
TOPICAL PAIN RELIEF FLECTOR Global sales of topical over the counter non steroidal anti-inflammatory drugs PATCH 13% 1 (“NSAIDs”) > US$ 2.9 billion1 US NSAID PENNSAID Demand for safe, effective and long lasting topical pain relief 2 DermaSys® provides faster drug permeation, a key point of differenc
Slide 22: Topical Pain Relief
TOPICAL PAIN RELIEF Agreement signed with Thornton & Ross (part of STADA) for UK rights in 2017 1 UK regulatory submission first responses received in Q2 2019 Futura assisting Thorton & Ross preparing responses by Q1 2020 Commercial discussions ongoing with other potential distributors 2 TPR100 - US
Slide 23: CBD100 – Topical Cannabidiol Gel Using the Power of DermaSys
CBD100 – TOPICAL CANNABIDIOL GEL USING THE POWER OF DERMASYS® Early development programme underway Exploiting Futura’s DermaSys® transdermal technology Targeting Cannabidiol – one of 113 Cannabinoids found in Cannabis Joint venture signed with CBDerma Technology 1 15 months initial development progr
Slide 24: Financial Results & Outlook
FINANCIAL RESULTS & OUTLOOK CONFIDENTIAL 24 24
Slide 25: Interim Highlights – Organisation & Financials
INTERIM HIGHLIGHTS – ORGANISATION & FINANCIALS Net loss of £4.46 million in period (30 June 2018: net loss of £1.95 million) Cash resources of £5.63 million at 30 June 2019 (30 June 2018: £6.03 million) Plus Tax Credit of £1.36 million received in August 2019 Funding Current cash sufficient to compl
Slide 26: Outlook
OUTLOOK Headline data of first Phase 3 for MED2005 by end of December 2019 1 Start up activities commencing H2 2019 and last patient last visit expected by end of 2020 Increasing awareness of MED2005 through scientific advisory meetings involving high profile US and EU 2 key opinion leaders (‘KOLs’)