Futura Medical plc · LSE:FUM
Futura Medical — H1 2016 Earnings Presentation
23 slides from Futura Medical's earnings presentation, 2016
Slide 1: Results for the six months ended 30 June 2016
Results for the six months ended 30 June 2016
Slide 2: Disclaimer
Disclaimer These presentation materials (“the Presentation Materials”) are prepared by Futura Medical plc (“the Company”) and constitute a financial promotion for the purposes of section 21 of the Financial Services and Markets Act 2000 ("FSMA"). The Presentation Materials may only be issued to UK p
Slide 3: About Futura
About Futura What we do • Apply advanced transdermal science to generic compounds • Develop products with compelling commercial potential Our key strengths • Clinically proven innovation of generic compounds • Sexual health and pain relief product focus • Experienced management team • Products enter
Slide 4: 2016 Interim Results Highlights
2016 Interim Results Highlights 4
Slide 5: Interim Highlights – Products
Interim Highlights – Products MED2002 – Erectile dysfunction gel • Clinical primary endpoints achieved • Potential First line therapy – fast and safe • Projected $500+ million opportunity* CSD500 – Erectogenic condom • Approvals expected shortly on modified manufacturing process • First licensee pro
Slide 6: Interim Highlights – Financials
Interim Highlights – Financials Net loss of £1.89 million in the period (2015: net loss of £2.47 million) Cash resources of £2.90 million at 30 June 2016 (30 June 2015: £7.23 million) 6
Slide 7: Sexual Healthcare
Sexual Healthcare O Futura Medical } Advanced Transdermal Technology
Slide 8: MED2002 – Gel for Erectile Dysfunction
MED2002 – Gel for Erectile Dysfunction Sexual Healthcare Product • Topically applied gel containing 0.6mg of glyceryl trinitrate • Utilises Futura’s DermaSys® drug delivery technology Market research • Market research highlighted significant potential for MED2002 ~7.5% of men with ED are contra-ind
Slide 9: MED2002 – Clinical Development
MED2002 – Clinical Development Sexual Healthcare Pre-clinical, early stage development complete MED2002 pivotal efficacy study recently completed • Randomised, placebo controlled, double blind, home use, crossover design in a minimum of 192 ED patients Headline data 6 September, full analysis expec
Slide 10: MED2002 pivotal study – Headline Data
MED2002 pivotal study – Headline Data Sexual Healthcare Primary clinical endpoint met • Statistically significant improvement in the International Index of Erectile Function domain (IIEF-EF) between MED2002 & placebo P = < 0.0132 across all ED patients Secondary analyses of IIEF-EF in ED patients •
Slide 11: MED2002 pivotal study – Headline Data
MED2002 pivotal study – Headline Data Sexual Healthcare Mild ED patient group (IIEF-EF>/=4) • Highly statistically significant improvement in the IIEF-EF domain for MED2002 vs placebo P = < 0.0001 • Rapid speed of onset 82% of patients with onset of < 10 minutes 54% of patients with onset of < 5
Slide 12: MED2002 pivotal study
MED2002 pivotal study Sexual Healthcare “The positive data from this study provides an exciting new innovation with the potential to be a first line therapy in erectile dysfunction. “MED2002 has the required efficacy, speed of onset and safety profile consistent for an over-the-counter as well as pr
Slide 13: MED2002 – Commercial
MED2002 – Commercial Sexual Healthcare $5 billion estimated global market* • $4.3 billion PDE5 inhibitor sales ** • Contraindicated market of 7.5% estimated at over $300 million • Balance made up with intra-urethral, injection & non-invasive devices MED2002 potential opportunity of over $0.5 billion
Slide 14: CSD500 – Erectogenic Condom
CSD500 – Erectogenic Condom Sexual Healthcare Product • Lubricated condom with Zanifil® gel incorporated inside teat • Zanifil® clinically proven claims to give: Only over the Increased penile firmness counter clinically proven sexual Longer lasting sexual experience performance Improved sexual p
Slide 15: CSD500 – Out-licensing
CSD500 – Out-licensing Sexual Healthcare Global out-licensing strategy • Seven distribution agreements in place • All milestone and royalty based, for lifetime of patents • Ongoing discussions with further licensees Launch timelines • First licensee launch on track for Q4 2016 • Next order already p
Slide 16: Topical Pain Relief
Topical Pain Relief = OE utura Medical lvanced Transdermal Technology 16
Slide 17: Topical Pain Relief – The Market
Topical Pain Relief – The Market Pain Relief Demand for safe, effective, long lasting topical pain relief • Current topical pain relief is often ineffective • Significant commercial partner interest Strong permeation claims and 12 hour duration Global and US sales of topical analgesics • Global sa
Slide 18: TPR100 – Diclofenac Pain Relief
TPR100 – Diclofenac Pain Relief Product • 2% diclofenac gel for symptomatic relief of pain and inflammation • Market leaders EU – GlaxoSmithKline: Voltarol® (1% & 2% gel) US – Horizon Pharma: Pennsaid® (2%) – Rx Clinical study development • Pharmaco-kinetic and pharmaco-dynamic studies completed
Slide 19: TIB200 – Ibuprofen Pain Relief
TIB200 – Ibuprofen Pain Relief Product • 10% ibuprofen gel for relief of pain and inflammation • Market leaders UK – Nurofen® and Ibugel ® US – None approved Clinical study development • Pharmaco-kinetic and pharmaco-dynamic studies completed Superior drug delivery over market leaders Primary en
Slide 20: Topical Pain Relief – Commercial
Topical Pain Relief – Commercial Pain Relief Improved delivery with DermaSys® technology • Improved drug delivery claims give consumer point of difference • NICE1 guidance requires prescribing of topical NSAID before oral NSAID for osteoarthritis of the knee or hand • Potential to be considered “bes
Slide 21: Outlook
Outlook = OE utura Medical lvanced Transdermal Technology 21
Slide 22: News Flow and Outlook
News Flow and Outlook Expected news flow during 2016 • CSD500 – 18-month shelf life regulatory approvals • CSD500 – first distributor launch • Pain relief – at least one partner agreement • MED2002 – regulatory guidance over remaining regulatory pathway Outlook for 2017 • CSD500 – further distributo
Slide 23: Vision and Objectives
Vision and Objectives To build upon our recognised status as a transdermal innovation specialist in the pharmaceutical industry Three to five year corporate objectives • CSD500 becoming the market leading premium condom worldwide • Successful licensing and launch of pain relief products in key terri