Futura Medical Plc · LSE:FUM
Futura Medical — FY2019 Earnings Presentation
52 slides from Futura Medical's earnings presentation, Apr 1, 2020
Slide 1: Full Year Results & MED3000 R&D Seminar
FULL YEAR RESULTS 12 months to 31 December 2019 & MED3000 -‐ RESEARCH & DEVELOPMENT SEMINAR 1 April 2020
Slide 2: Disclaimer
DISCLAIMER This presentaJon has been prepared by and is the sole responsibility of the directors of Futura Medical plc (the “Company”). This presentaJon does not consJtute a recommendaJon regarding the shares of the Company nor a representaJon that any dealing in those shares is appropriate. The Com
Slide 3: Welcome & Corporate Overview
WELCOME & CORPORATE OVERVIEW James Barder CEO 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’ organisaJon with 13 staff and low overheads § Significant outsourced infrastructure with over 30 consultants Clinically proven transdermal science DERMASYS® § DermaSys® i
Slide 5: 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 § PrioriJes are MED3000 EU and USA regulatory submissions within the next six months § Increased awareness of MED3000 within scienJfic and pharmaceuJcal co
Slide 6: Strategic Outlook
STRATEGIC OUTLOOK GAIN APPROVAL FOR MED3000 AS A CLINICALLY PROVEN TREATMENT FOR ERECTILE DYSFUNCTION WITHIN THE NEXT 12-‐18 MONTHS REALISE SHAREHOLDER VALUE FROM MED3000 THROUGH COMMERCIALISATION WITH DISTRIBUTION PARTNERS EXPAND THE POTENTIAL OF OUR TRANSDERMAL TECHNOLOGY, DERMASYS®, FRO
Slide 7: Financial Results
FINANCIAL RESULTS Angela Hildreth FD & COO 7
Slide 8: Full Year Highlights – Organisation & Financials
FULL YEAR HIGHLIGHTS – ORGANISATION & FINANCIALS § Net loss of £8.92 million in period of which £8.27m was related to R&D (2018: £6.04m) § (December 2018: net loss of £5.88 million) § Cash resources of £2.51 million § Plus £3.25 million (gross) fundraise completed January 2020 § Plus £2.20 mill
Slide 9: FM57 Results
FM57 RESULTS Ken James ExecuJve Director & Head of R&D CONFIDENTIAL 99
Slide 10: MED3000 Key Benefits
MED3000 KEY BENEFITS Strong overall efficacy across all ED paJent severiJes Rapid speed of onset Excellent safety profile PotenJal paJent use with: § Begins to work § Extremely low number of § Nitrates immediately in some AE’s; much lower than drug paJents with 60% of treatments for ED § Alpha Bloc
Slide 11: FM57 – Phase 3 Study Design
FM57 – PHASE 3 STUDY DESIGN A Phase 3, 12 week dose-‐ranging, mulJ-‐centre, randomized, Subjects pre-‐screening double-‐blind, placebo-‐controlled, home use, parallel group clinical FM57 trial of topically applied GTN for the treatment of ED in 1,000 male subjects with ED & their female partner
Slide 12: Primary Endpoints Used in FM57
PRIMARY ENDPOINTS USED IN FM57 – IIEF-‐EF DOMAIN, SEP2 AND SEP3 § InternaJonally recognized standards and fully validated § Requested by FDA in pre-‐IND meeJng § Used for recent Phase 3 ED drug trials leading to approval IIEF-‐EF Domain SEP2 1. How oven did you get an erecJon? Were you able to
Slide 13: FM57 Headline Results – 12 Weeks
FM57 HEADLINE RESULTS – 12 WEEKS Primary Endpoints MED3000 P-values MED2005 P-values MED2005 P-values MED2005 P-values 0.6mg (0.2%) 1.2mg (0.4%) 1.8mg (0.6%) Mean 21.6 - 21.5 - 21.6 - 21.7 - IIEF-EF Change from Domain Baseline LS 3.60 <0.001 3.39 <0.001 3.42 <0.001 3.66 <0.001 Mean* SEP2 Mean 86% -
Slide 14: FM57 MED3000 Efficacy Primary Endpoints vs Baseline and ED Severity
FM57 MED3000 EFFICACY PRIMARY ENDPOINTS VS BASELINE AND ED SEVERITY Means Observed Means LS P Values Change from Baseline Change from Baseline MED3000 vs Baseline Means LS IIEF-‐EF Domain Overall 5.10 3.61 P<0.001 Mild 3.15 1.51 P<0.014 Moderate 5.84 4.95 P<0.001 Severe 12.15 7.41 P<0.001 SEP2 Over
Slide 15: FM57 Headline Results – MED3000 Patient Reported Outcomes
FM57 HEADLINE RESULTS – MED3000 PATIENT REPORTED OUTCOMES Using Rosen and Araujo Criteria (InternaJonally accepted standards) Clinically Important Differences at 12 weeks – Percentage of paSents who noSced a meaningful difference Mild/Moderate/Severe ED MED3000 Overall Responders (%) Responders (%) II
Slide 16: Other MED3000 Secondary Endpoints
OTHER MED3000 SECONDARY ENDPOINTS GAQ1 vs. prior to study (No Baseline) Value p-‐Value GAQ Q1 -‐ Has the treatment improved your ErecSle FuncSon 61.9% N/A GAQ Q2 -‐ Has the treatment improved your ability to have sexual acSvity 60.6% N/A SEAR2 vs baseline Baseline value Change from baseline3 p-‐
Slide 17: MED3000 Rapid Speed of Onset and Adverse Events
MED3000 RAPID SPEED OF ONSET AND ADVERSE EVENTS DURATION OF APPLICATION AND SPEED OF ONSET SPEED OF ONSET – MED3000 MED3000 60% subjects saw a speed of onset within 10 applicaSon 1 minutes of applicaSon 8% -‐ Almost immediately 32% -‐ Under 5 minutes 2 Faster speed of onset than oral PDE5i’s 60% -
Slide 18: FM57 MED3000 Adverse Events % Patients
FM57 MED3000 ADVERSE EVENTS % PATIENTS1 ADVERSE EVENT PROFILE FOR PATIENTS & PARTNERS Adverse Events MED3000 (N=250) Headache (men) 2.8% Penile burning (men) 1.2% Vulvovaginal burning (women) 0.4% NO SERIOUS ADVERSE EVENTS REPORTED FOR MED3000 1. Approximately 3,000 intercourse events in FM57 for ME
Slide 19: Comparison of MED3000 Efficacy & Safety with Published Literature
COMPARISON OF MED3000 EFFICACY & SAFETY WITH PUBLISHED LITERATURE CONFIDENTIAL 19
Slide 20: Comparative Responder Analysis for MED3000 vs Araujo 2009
THE MANAGEMENT OF ED WITH PLACEBO – ARAUJO 2009 COMPARATIVE RESPONDER ANALYSIS FOR MED3000 VS ARAUJO 2009 (GROUP 21) 100 90 77.9 80 70 63.8 Percentage (%) 60 50 36.8 40 30 20 10 0 Responder analysis Araujo 2009 1 MED3000 unadjusted 2 MED3000 adjusted 3 1. Group 2 informed they would receive an ac8ve
Slide 21: ED Trials in Mixed Populations
ED TRIALS IN MIXED POPULATIONS Study/IntervenSon Product Baseline IIEF-‐EF Endpoint IIEF-‐EF Difference Carson et al 2002 Sildenafil 6.0 18.8 12.8 Placebo 6.0 9.9 3.9 Montorsi et al 2004 Tadalafil 12.5 17.7 5.2 Placebo 12.3 13.3 1.0 Hellstrom et al 2002 Vardenafil 12.8 21.8 9 Placebo 13.6 14.8 1.2 MED
Slide 22: Efficacy of MED3000 Observed Data vs Cialis and Vitaros
EFFICACY OF MED3000 OBSERVED DATA VS CIALIS® AND VITAROS®1 IIEF-‐EF Domain at 12 weeks % SEP22 at 12 weeks vs Baseline % SEP31,3 at 12 weeks v Baseline IIEF-‐EF Score vs Baseline 100 100 25 90 90 80 80 20 70 70 60 60 15 50 50 40 40 10 30 30 5 20 20 10 10 0 0 0 MED3000 Cialis Cialis Cialis Vitaros
Slide 23: FM57 MED3000 – IIEF-EF Efficacy & Side Effects vs Cialis
FM57 MED3000 – IIEF-‐EF EFFICACY & SIDE EFFECTS vs CIALIS® Table 1 -‐ IIEF-‐EF Comparison of MED3000 vs Cialis® – All SeveriJes Cialis® IIEF-‐EF FM57-‐ IIEF-‐EF Side Effect Profile – MED3000 versus Cialis® MED30001 Placebo 5 mg 10 mg 20 mg 1 ® Adverse MED3000 Cialis 5mg N 243 308 151 321 258 Eve
Slide 24: MED3000 Mode of Action
FT —||| a FUTURAMEDICAL - “\\7e MED3000 - " MODE OF > ‘ ACTION \ 4
Slide 25: MED3000 – Unique Evaporative Mode of Action
MED3000 – UNIQUE EVAPORATIVE MODE OF ACTION “Upon applicaJon of MED3000, the volaJle solvent components evaporates. The glans penis is very highly innervated and there are sensors which are reacJve to a range of physical sensaJons, including touch, pressure and temperature. The cooling from solvent
Slide 26: Regulatory Strategy & Timelines
REGULATORY STRATEGY & TIMELINES CONFIDENTIAL 26
Slide 27: MED3000 – Estimated Regulatory Timelines
MED3000 – ESTIMATED REGULATORY TIMELINES US – De Novo Medical Device EU – Class II Medical Device FDA MeeJng § Submit meeJng request Dec QMS EvaluaJon § Map out EU requirements Dec Request § Provide summary data 2019 P Medical device EU for company QMS 2019 P Pre-‐Submission § IniJal meeJng t
Slide 28: MED3000 – A Breakthrough Clinically Proven Treatment for ED
MED3000 – A BREAKTHROUGH CLINICALLY PROVEN TREATMENT FOR ED 1 A first in the world, easy to apply gel Highly effecJve in mild, moderate and severe ED 2 Works in 5-‐10 minutes for spontaneous sex Use as part of foreplay 3 Very low side-‐effects No drug interacJons 4 Patent protected Rx and OTC potenJa
Slide 29: Current ED Treatments & Unmet Medical Needs (Part 2 webcast)
Please go to Part 2 of the webcast for Professor David Ralph’s presentaJon CURRENT ED TREATMENTS & UNMET MEDICAL NEEDS Professor David Ralph MED3000 -‐ RESEARCH & DEVELOPMENT SEMINAR 1 April 2020
Slide 30: Current ED Treatments & Unmet Medical Needs
CURRENT ED TREATMENTS & UNMET MEDICAL NEEDS Professor David Ralph MED3000 -‐ RESEARCH & DEVELOPMENT SEMINAR 1 April 2020
Slide 31: Current ED Treatments & Unmet Medical Needs
CURRENT ED TREATMENTS & UNMET MEDICAL NEEDS Professor David Ralph CONFIDENTIAL 33
Slide 32: Is Sexual Activity Beneficial?
IS SEXUAL ACTIVITY BENEFICIAL? The Duke Longitudinal Study of Ageing (1982) 1 Frequency of intercourse a significant predictor of longevity in men Swedish Study (1981) 2 Early cessaIon of sex associated with premature death Caerphilly Cohort Study (BMJ 1997) 3 50% reducIon in cardiac death with more
Slide 33: Erectile Dysfunction and Quality of Life
ERECTILE DYSFUNCTION AND QUALITY OF LIFE 1 Low self esteem and confidence 2 Partner concerns – affair, less a[racIve 3 Loss inImacy 4 Affects work and family 5 Depression 5
Slide 34: The Scope of the Problem
THE SCOPE OF THE PROBLEM The number of men with ED will increase from 152 million men in 1995 to 322 million men by 20251 North America Asia Europe ↑ 9.1 million ↑ 113 million ↑ 11.9 million Africa South/Central ↑ 19.3 million America and Caribbean Oceania ↑ 15.6 million ↑ 0.9 million 1. Adapted fro
Slide 35: Massachusetts Male Aging Study: Key Prevalence Study of ED
MASSACHUSETTS MALE AGING STUDY: KEY PREVALENCE STUDY OF ED MassachuseFs Male Aging Study. 7 Feldman HA, et al. J Urol. 1994;151:54-‐61.
Slide 36: Prevalence of ED Increases with Age
PREVALENCE OF ED INCREASES WITH AGE 50 44% (range 26–76%) 40 32% (range 7–74%) Prevalence 30 16% 20 (range 3–50%) 6% 10 (range 1–29%) 0 40–49 50–59 60–69 70–79 Age (years) Data from 34 studies with a Prins score ≥12 and published in peer-‐reviewed literature showing median and range of 8 ED prevale
Slide 37: Recreational Use of PDE5i – Performance Anxiety
RECREATIONAL USE OF PDE5I – PERFORMANCE ANXIETY 21.5% of healthy men between 18 and 30 years old used PDE5i as a recreational drug, mostly associated with alcohol or other drugs without medical control. This could have led to misuse and a public health problem. Schnetzler G, et al., J Sex Med. 2010
Slide 38: Sexual Performance Anxiety
SEXUAL PERFORMANCE ANXIETY Robert E. Pyke, Sexual Medicine Reviews 2019 10
Slide 39: Sexual Performance Anxiety
SEXUAL PERFORMANCE ANXIETY Robert E. Pyke, Sexual Medicine Reviews 2019 11
Slide 40: Erectile Dysfunction and Diabetes
ERECTILE DYSFUNCTION AND DIABETES 1 Overall ED 3-‐4 Gmes more common in men with diabetes 2 Between 30 & 70 % of men with Diabetes mellitus will develop ED 3 20% have it at diagnosis 4 Onset commonly occurs within first 10 years in > 50% of diabeGc men 5 ED related to duraGon & severity 6 Correlates
Slide 41: Relationship of ED and Incident CVD
RELATIONSHIP OF ED (INCIDENT OR PRESENT AT BASELINE) & INCIDENT CVD Unadjusted HR for ED End Points P Value (95% CI) Angina 1.99 (1.48-‐2.67) <0.001 MI 1.86 (1.50-‐2.30) <0.001 Stroke 2.72 (1.76-‐4.20) <0.001 TIA 2.45 (1.45-‐4.12) 0.001 Thompson IM, et al. JAMA. 2005;294:2996-‐3002 13 HR = haza
Slide 42: PDE5 Inhibitors Administration Times
PDE5 INHIBITORS ADMINISTRATION TIMES PDE5-‐i AdministraTon Tmes Sildenafil 60 minutes before sexual activity1 Vardenafil 25-60 minutes before sexual activity2 Tadalafil 10mg prior to sexual activity3 Tadalafil 20 mg 30 minutes prior to sexual activity3 Avanafil 30 minutes before sexual activity4 1. Viag
Slide 43: Successful Intercourse (%)
SUCCESSFUL INTERCOURSE (%) Sildenafil Tadalafil Vardenafil 100 100 100 79.1 80 80 80 69 70 60 60 60 49 40 40 40 31 22 20 20 20 0 0 Placebo Sildenafil 0 Placebo Vardenafil 100mg Placebo Tadalafil 20mg 20mg P<0.001 P<0.001 P<0.001 Hellstrom WJG et al. Urology 2003, 61(S4A):8-‐14; Goldstein I et al. N
Slide 44: Diabetes Mellitus: SEP3 (%)
DIABETES MELLITUS: SEP3* (%) Sildenafil Tadalafil Vardenafil 100 100 100 79.1 80 80 80 69 70 60 60 60 49 40 40 40 31 22 20 20 20 0 0 Placebo Sildenafil 0 Placebo Vardenafil 100mg Placebo Tadalafil 20mg 20mg P<0.001 P<0.001 P<0.001 Goldstein I et al. Diabetes Care 2003, 26:777-‐783: Boulton AJM et a
Slide 45: Caverject / MUSE
CAVERJET® MUSE® SINGLE USE SYSTEM FOR ADMINISTERING ALPROSTADIL INTO THE URETHRA 17
Slide 46: Vitaros / Vacuum Erection Device
VITAROS® VACUUM ERECTION DEVICE Vitaros® (0.3 ml) is applied topically for a local effect § No inserIon of the applicator into the penis § Training in the applicaIon procedure recommended to achieve opImal efficacy VACUUM-‐DEVICE THERAPY: OSBON ERICAIDTM 18
Slide 47: Inflatable Penile Prosthesis, Renova, Shockwave
INFLATABLE-‐3 PENILE PROSTHESIS RENOVA® – SHOCKWAVE COLOPLAST TITAN MORE EXPERIENCE & EVIDENCE IS NEEDED 19
Slide 48: Changing Mindset for ED Treatments
CHANGING MINDSET FOR ED TREATMENTS Early surgery Pumps Implants Prescribed Oral agents Future & natural remedies injecIons treatments 1960 Mid 21st Pre-1960 + 1980 1998 century 1970 1990 Any improvements Successful ErecTon Normal Sex Life DesperaTon ExpectaTon HackeF GI. Eur Urol 2002:1;4-‐11 20
Slide 49: How Decisions Are Made in Clinical Practice
HOW DECISIONS ARE MADE IN CLINICAL PRACTICE Evidence Experience Efficacy Familiarity Safety Expertise Tolerability Reputation Duration Preferences, Values, and Rights Marital status Culture Costs Expectations McMahon CM et al. Poten]al predictors for treatment preference in men with erec]le dysfunc]
Slide 50: The Ideal ED Treatment – What Patients Want
THE IDEAL ED TREATMENT -‐ WHAT PATIENTS WANT 1 EFFECTIVE 2 RAPID 3 SAFE 4 TOLERANCE FREE 5 CHEAP 6 NO EFFECT ON DESIRE 7 DISCREET 8 SPONTANEOUS 9 LOCAL THERAPY 10 UNAFFECTED BY FOOD OR DRINKS 11 ACCEPTABLE TO PARTNER Ø The aim: Enable the couples to enjoy 12 CURE – STEM CELLS? saTsfactory sexual e
Slide 51: Conclusion
CONCLUSION James Barder CEO CONFIDENTIAL 23
Slide 52: The Ideal ED Treatment – What MED3000 Delivers
THE IDEAL ED TREATMENT -‐ WHAT MED3000 DELIVERS 1 EFFECTIVE ü Highly effecTve clinically proven treatment 2 RAPID ü Onset within 10 minutes for 60% of paTents 3 SAFE ü Excellent safety profile 4 TOLERANCE FREE ü No expected contra-‐indicaTons 5 CHEAP ü Low cost of goods 6 NO EFFECT ON DESIRE ü