Futura Medical Plc · LSE:FUM
Futura Medical — FY2020 Earnings Presentation
28 slides from Futura Medical's earnings presentation, Apr 14, 2021
Slide 1: Preliminary Results 12 months to 31 December 2020
PRELIMINARY RESULTS 12 months to 31 December 2020 14 April 2021
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® ▪ DermaSys® i
Slide 5: Strategic Outlook
STRATEGIC OUTLOOK Exploiting the potential of our transdermal technology DermaSys® and enhancing 1 the Company’s position as an innovative research and development company Prioritising resource on our potential US$1 billion sales asset: MED3000, a fast 2 acting topical gel to treat erectile dysfunct
Slide 6: Year End Highlights – Products, Organisation & Financial
YEAR END HIGHLIGHTS – PRODUCTS, ORGANISATION & FINANCIAL ▪ Strategic decision to focus on maximising R&D pipeline value by de-risking assets through to approval ▪ Priorities of completing supplementary MED3000 study (FM71) to enable US approval ▪ In parallel to focus on several country launches for
Slide 7: MED3000 – Topical Treatment for ED
MED3000 – TOPICAL TREATMENT FOR ED UNIQUE 1 ✓ The only rub-on gel clinically proven to treat erectile dysfunction (ED) ✓ The only clinically proven ED treatment available for OTC1 sales throughout Europe BREAKTHROUGH 2 ✓ Superior technology helping men get an erection within 10 minutes: faster than
Slide 8: MED3000 Research & Development
MED3000 Research & Development CONFIDENTIAL 88
Slide 9: MED3000 Mode of Action
MED3000 MODE OF ACTION Projected temperature change when gel is MED3000 Endothelial cells Novel evaporative action applied to glans penis stimulates nerve sensors in NANC the highly innervated glans Natural NO penis through temperature, 30.5 production neurons touch and pressure NO 28.5 GMP GTP 26.5
Slide 10: Exterior Over-the-Counter Labeling – Illustrative Only
EXTERIOR OVER-THE-COUNTER LABELING – ILLUSTRATIVE ONLY Eroxon® Gel is a clinically proven treatment for erectile dysfunction in adult men aged 18 years and over Helps you get and keep an erection hard enough for sex Directions for use: Massage the contents of one tube onto the head of the penis for
Slide 11: MED3000 EU Regulatory Milestones – Class 2B medical device
MED3000 EU Regulatory Milestones – Class 2B medical device EU Notified1 Body Selection and commission of Feb Selection EU Notified Body 2020 QMS2 Updating of Futura’s QMS for Mar Update MED3000 2020 Application Submission of MED3000 Jul Submission Technical Dossier 2020 Expedited Medical Devic
Slide 12: MED3000 US Regulatory Milestones – De Novo medical device
MED3000 US Regulatory Milestones – De Novo medical device 1st Pre-Submission De Novo classification Discuss Feb meeting existing FM57 clinical data 2020 2nd Pre-Submission FDA – New clinical required Jul meeting Discuss route to OTC 2020 3rd Pre-Submission Agree supplementary study design Oct “E
Slide 13: FM71 Design
FM71 DESIGN A multi-centre, randomised, open label, home use, parallel group, clinical investigation of topically FM71 applied MED3000 gel and oral Tadalafil (5mg) tablets for treatment of erectile dysfunction (ED) over Subjects pre-screening a 24 week period 4 week Run-in run-in period to establish
Slide 14: FM71 – FDA Agreement Reached Feb 2021 After Four Q-Sub Meetings
FM71 – FDA AGREEMENT REACHED FEB, 2021 AFTER FOUR Q-SUB MEETINGS Phase 3, multi-centre, comparative, randomized, open-label, home-use, parallel group study of MED3000 and tadalafil 5mg in 100 subjects FDA concern that efficacy may tail off after 12 weeks – not our experience with FM57 24 week durati
Slide 15: FM71 – FDA Agreement Reached Feb 2021 (cont)
FM71 – FDA Agreement reached Feb, 2021 after four Q-sub meetings (cont) Phase 3, multi-centre, comparative, randomized, open-label, home-use, parallel group study of MED3000 and tadalafil 5mg in 100 subjects Primary endpoint; clinical MED3000 exceeded minimal clinically important difference of 4 uni
Slide 16: MED3000 Commercial Opportunity
MED3000 Commercial Opportunity CONFIDENTIAL 16
Slide 17: OTC Availability Opens Up Large Untapped Market
OTC AVAILABILITY OPENS UP LARGE UNTAPPED MARKET TRADITIONAL SEGMENTS NEWER SEGMENTS PDE5i USERS DIAGNOSED, UNDIAGNOSED, YOUNG MEN PARTNERS (SATISFIED AND DISSATISFIED) NOT TREATING SUSPECTED Drivers of switch to MED3000 ▪ ~ 20% of ED patients are ▪ Embarrassment of speaking to ▪ The prevalence of ED
Slide 18: Significant Commercial Potential
SIGNIFICANT COMMERCIAL POTENTIAL Global ED prescription market worth over US$5.6 billion 1 in 20181 Potential 1st worldwide OTC product clinically proven to 2 treat ED 3 US$660 million potential ‘Over the Counter’ sales2 4 Specialist corporate advisors appointed Q3 2020 Out-licensing discussions wit
Slide 19: China & SE Asia – JV Arrangement
CHINA & SE ASIA – JV ARRANGEMENT Joint collaboration with Atlantis Group1 EU approval may facilitate approval in most Asian countries aside China Chinese Pivotal study required but all additional R&D costs met by partner 50/50 share of profits for region2 ✓ Local expertise and knowledge ✓ All furthe
Slide 20: MED3000 – Ongoing Commercial Discussions
MED3000 – ONGOING COMMERCIAL DISCUSSIONS Specialist corporate advisers retained and running process for other 1 countries (i.e. non-China region) Imminent EU certificate strengthens Futura’s creditability and clarity 2 around product claims Objective of building long term sustainable value 3 Initial
Slide 21: MED3000 Patent Strategy
MED3000 PATENT STRATEGY Patent protection Data exclusivity / trademarks ▪ Patents are formulation specific ▪ Special controls under discussion with FDA ▪ First generation patents covers all previous MED formulations ▪ Exclusivity on one key excipient for sexual healthcare ▪ New patent filed in Decem
Slide 22: MED3000 – A Breakthrough Clinically Proven Treatment for ED
MED3000 – A BREAKTHROUGH CLINICALLY PROVEN TREATMENT FOR ED First OTC gel to treat ED, clinically proven with a rapid speed ✓ of onset imminent approval throughout EU1 ✓ 1 ✓ Clear regulatory pathway with small confirmatory study for likely OTC approval in USA ✓ 1 50/50 joint collaboration signed for
Slide 23: Pain Relief
Pain Relief CONFIDENTIAL 23
Slide 24: Topical Cannabidiol with DermaSys – CBD100
TOPICAL CANNABIDIOL WITH DERMASYS®- CBD100 Joint venture signed with CBDerma Technology to fund development of DermaSys® based cannabidiol formulation Providing a near term opportunity under cosmetic regulations as a superior product in respect of absorption Longer term CBD100 could be supported wit
Slide 25: Topical Pain Relief – TPR100
TOPICAL PAIN RELIEF – TPR100 1 Global sales of over the counter topical analgesics US$ 4.9 billion1 GSK’s Voltaren Arthritis Pain Gel now over the counter in USA market creating potential opportunity for TPR100 Demand for safe, effective and long lasting topical pain relief 2 DermaSys® provides fast
Slide 26: Financial Results & Outlook
FINANCIAL RESULTS & OUTLOOK CONFIDENTIAL 26
Slide 27: Year End Highlights – Financials
YEAR END HIGHLIGHTS – FINANCIALS ▪ Net loss of £2.41 million in period of which £1.93 million was related to R&D (2019: Net loss £8.92 million) ▪ Cash resources of £1.02 million; with a further £2 million received post-period end: ▪ £2.0 million investment completed March and April 2021 ▪ £0.5 milli
Slide 28: Outlook
OUTLOOK MED3000 CE Mark expected by end of May to enable potential launch in EU and facilitate ‘fast track’ 1 regulatory approval through many countries world-wide other than US & China Agreement reached with FDA over supplementary study to enable US approval 2 JV reached with Atlantis for Asia incl