INVESTOR PRESENTATION - 1 CONFIDENTIAL - Seeking Alpha
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INVESTOR
PRESENTATION
Preliminary Results for Year Ended
31 December 2017
1 CONFIDENTIAL
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. The Company accepts no duty of care whatsoever to the reader of this presentation in respect of its contents and the Company is not acting in any fiduciary capacity. The information contained in the presentation has not been verified, nor does this presentation purport to be all-inclusive or to contain all the information that an investor may desire to have in evaluating whether or not to make an investment in the Company. In all cases potential investors should conduct their own investigations and analysis concerning the risks associated with investing in shares in the Company, the business plans, the financial condition, assets and liabilities and business affairs of the Company, and the contents of this presentation. This presentation (including its contents) is confidential and is for distribution in the United Kingdom only, to persons who are authorised persons or exempted persons within the meaning of the Financial Services and Markets Act 2000 or any Order made thereunder, or to persons of a kind described in Articles 19 or 49 or 50 of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (as amended) and, if permitted by applicable law, for distribution outside the United Kingdom to professions or institutions whose ordinary business involves them in engaging in investment activities. It is not intended to be distributed or passed on, directly or indirectly, to any other class of persons. No offer or invitation or solicitation of any offer to acquire securities of the Company is being made now nor does this presentation constitute or form part of any invitation or inducement to engage in investment activity under section 21 of the Financial Services and Markets Act 2000. No reliance may be placed for any purpose whatsoever on the information contained in this presentation or any assumptions made as to its completeness and no warranty or representation is given by or on behalf of the Company nor its directors, employees, agents and advisors as to the accuracy or completeness of the information or opinions contained in this presentation and no liability is accepted by any of them for any such information or opinions, provided that nothing in this paragraph shall exclude liability for any representation or warranty made fraudulently. The information and opinions contained in this presentation are provided as at the date hereof. This presentation is not, and should not be construed as, a recommendation or advice by the Company or its advisers to potential investors to participate in any investment in the Company. The contents of this presentation are confidential and must not be copied, published, reproduced, distributed or passed in whole or in part to others at any time by recipients. This presentation is being provided to recipients on the basis that they keep confidential any information contained herein or otherwise made available, whether oral or in writing, in connection with the Company. This presentation may contain certain forward-looking statements. Whilst the directors believe all such statements to have been fairly made on reasonable assumptions, there can be no guarantee that any of them are accurate or that all relevant considerations have been included in the directors' assumptions; accordingly, no reliance whatsoever should be placed upon the accuracy of such statements, all of which are for illustrative purposes only, are based solely upon historic financial and other trends and information, including third party estimates, and may be subject to further verification. Neither the Company nor its directors makes any representation or warranty in respect of the accuracy, completeness or verification of the contents of the Presentation Materials. In particular, this presentation should not be distributed, published or reproduced in whole or in part or disclosed by recipients to any other person or entity and, in particular, should not be distributed to United States residents, corporations, or other entities, US persons (as defined in Regulation S promulgated under the United States Securities Act of 1933 (as amended), persons with addresses in the United States of America (or any of its territories or possessions), Canada, Japan, the Republic of Ireland, the Republic of South Africa or Australia, or to any corporation, partnership or other entity created or organised under the laws thereof, or in any other country outside the United Kingdom where such distribution may lead to a breach of any law or regulatory requirement. Notwithstanding the foregoing, the Company can distribute this document to US Persons (as defined above), persons with addresses in the United States of America (or its territories or possessions), United States residents, corporations or other entities if the Company is satisfied that an applicable exemption applies. Distribution of this document in the United States of America in the absence of such an applicable exemption may constitute a violation of United States securities law. 2
Year End Highlights – Products, Organisation & Financial
Positive meetings with USA & EU regulatory authorities
MED Clear regulatory pathway defined for MED2002 for USA & EU
2002 Headline results on PK study showing acceptable safety profile
Commercial out-licensing discussions at an advanced stage
Successful launch in Saudi Arabia with over 500,000 condoms supplied
CSD
Production of further order underway for same territory
500 Further launches planned during 2018 through other distributors
First out-licensing agreement signed for pain relief product
TPR
UK dossier submission close to completion with filing in Q2
100 Commercial discussions ongoing in other countries
Strengthened resources with Regulatory Affairs Director and Chief Operating Officer appointed
Net Loss for year ending 31 Dec 2017: £3.90 million (Net Loss 31 Dec 2016: £3.70 million)
Cash Resource at end of year: £8.36 million (with tax credit of £0.94 million expected)
3
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 entering commercial phase with strong development pipeline
DermaSys®
• Optimised drug delivery through the skin
• 8 core patent families around DermaSys®
4
DermaSys® transdermal technology
Futura’s unique DermaSys® technology enables targeted and rapid delivery of active pharmaceutical
ingredients (API) through the skin to the required site of action
1. 2. 3.
Application of gel Seconds later Minutes later
with API Volatile solvents evaporate, API penetrates
Combination of solvents, leaving the remaining solvent the skin rapidly
including volatile solvents supersaturated with API
Skin surface
Dermis
The supersaturation
powerfully drives API
through the skin
API starts Rapid
working rapidly penetration or
sustained release
Target area
(eg: smooth muscles
or soft tissues)
5
Futura’s Growth Portfolio
Sexual MED2002 Topical gel for erectile dysfunction (ED)
healthcare Strong differentiator with potential 5-minute speed of onset
Phase III programme underway
CSD500 Condom with an erectogenic gel
First distributor launch complete with a further order placed
Further launches planned during 2018
Pain relief TPR100 Topical diclofenac gel for pain relief
UK regulatory submission close to completion with filing in Q2
Further commercial discussions underway
TIB200 Topical ibuprofen gel for pain relief
Commercial discussions ongoing
6
Futura has over 120 years senior pharmaceutical experience
John Clarke James Barder Ken James Angela Hildreth Jonathan Freeman
Non-Executive Chief Executive Executive Director Finance Director and Senior Independent
Chairman and Head of R&D Chief Operating Non-Executive
Past roles: Officer Director
Past roles: Appointed Managing Director of Past roles:
President of GSK Aon Capital Markets Senior Vice President Past roles: Past roles:
Consumer Healthcare Limited and Non- of Research and Senior financial roles in Director of Beeson
in 2006, a position from Executive Director of Development for a diverse range of Gregory, Chief
which he stepped Lorega Limited. GlaxoSmithKline industries, including as Executive Officer of
down in 2011. Worldwide Consumer UK Finance Director at Syndicate Asset
Healthcare, having Shield Therapeutics Plc Management plc and
worked in the UK and a Director of Hume
the United States. Capital Securities plc.
7
MED2002 – AN
INNOVATION IN THE
TREATMENT OF ED
8
MED2002 – an innovation in the treatment of ED
MED2002 is a topical gel containing 0.2% up to 0.8% 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 sexual partner
Has a rapid onset of action within 5 minutes
Works rapidly Enables spontaneity
MED2002 has the potential to have MED2002 removes the need for planning
the fastest speed of onset for any of sex associated with some oral PDE5
erectile dysfunction treatment inhibitor medications
Efficacious
Enhances desire Well tolerated Restores intimacy
MED2002’s direct mode of MED2002 significantly improves orgasmic
application can form part of function, sexual desire, intercourse
foreplay and combined with its satisfaction and overall satisfaction
speed of onset can significantly
enhance desire
9
MED2002’s unique PK profile – Key point of difference
Comparative pharmacokinetics - MED2002 is rapidly absorbed with rapid clearance compared with
leading PDE5 inhibitors
Comparative Dual Axis Pharmacokinetic graph comparing MED2002 (0.4%)
1.8 vs Viagra (100 mg) vs Cialis (20 mg) over 6hrs 500
1.6 450
Viagra and Cialis Plasma concentration
MED2002 0.4%
MED2002 (0.4%) Plasma concentration ng/ml
Viagra 400
1.4
Cialis
350
1.2
300
1
250
0.8
200
0.6
150
0.4
ng/ml
100
0.2 50
0 0
0 1 2 3 4 5 6
Time - hrs
10 Data derived from multiple studies – Illustrative purposes onlyMED2002 – PK interim study results
FM58 – Pharmacokinetic study (1st part complete)
Safety comparison of MED2002 doses compared to Nitrostat® (US reference product)
❶ 0.2% w/w GTN (dose previously used in efficacy study)
❷ 0.4% w/w GTN
❸ 0.6% w/w GTN
❹ 0.8% w/w GTN
FM58 - Number of Related Headaches
Systemic side effects data 16
All doses safe and well tolerated compared to Nitrostat® 14
12
Levels of GTN within serum (blood plasma) 10
Cmax and AUC for 0.2 – 0.6% w/w GTN doses not greater than 8
Nitrostat® 6
AUC for 0.8% w/w GTN slightly higher than Nitrostat® 4
2
Tmax median of 10-12 minutes for all MED2002 doses 0
0.2% 0.4% 0.6% 0.8% Nitrostat*
Tmax median of 14 minutes for Nitrostat® MED2002 MED2002 MED2002 MED2002
* Average headache profile with Nitrostat® across two dosages (as per
FDA guidance on bioequivalence studies)
Cmax – maximum concentration of drug in serum Tmax – Time to Cmax AUC – reflects the actual body exposure to drug
11MED2002 – Remaining Development Path
FM58 – Pharmacokinetic study (2nd part)
Analysis of residual non-absorbed amounts of MED2002 left on penis
Regulatory pathway to Rx approval clear
Meetings and consultations with MHRA, MEB and FDA have provided guidance to enable Futura to finalise
the clinical development programme and address regulatory requirements
FM57 –Adaptive Design Phase III study
4 escalating doses of MED2002 from 0.2% w/w to 0.8% w/w GTN, placebo controlled, parallel design study
Reducing to the 2 optimal doses selected by an independent panel
FM59 – Confirmatory Phase III study
2 optimal MED2002 doses, placebo controlled, parallel design study
2017 2018 2019
INDICATIVE TIMETABLE Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
EU & USA REGULATORY MEETINGS
PHARMACOKINETIC SAFETY STUDY
PHASE III EFFICACY STUDIES
MANUFACTURING SCALE UP & STABILITY
EU & USA REGULATORY SUBMISSIONS
12Cello Physician Research – Rx Opportunity in all patient populations
200 physicians interviewed in USA, France & Germany by Cello Health Consulting (“Cello”) in 2017
Research reinforced earlier findings commissioned by Futura with Decision Resources and Ipsos Mori
Research supports MED2002 as potential alternative to oral PDE5s with estimated >20% patient share*
Rapid speed of onset key driver of physician and patient interest to try or switch to MED2002
NEW PATIENT SWITCH FROM CURRENT SWITCH SATISFIED LAPSED ON ED
USA* ED TREATMENT ED PATIENTS TREATMENT
INITIATION
27% 25% 19% 34%
NEW INITIATION SWITCH SWITCH SATISFIED PATIENTS RE-INITIATION
CELLO HEALTH CONSULTING
* Cello Health Consulting Market Research 2017; Potential patient share based on target product profile and intention to prescribe indicated by physicians;
Average patient shares have been discounted by 50% to account for the overstatement common between intention and actual prescribing practice, a
13 50% discount factor is widely used in forecasting within the pharma industry ; Conclusions are based on physician stated opinion or behaviour which may
vary from real life clinical practice.MED2002 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 MED2002
$560 million potential prescription peak sales at $5 per dose
02 Research by Cello and model provided by Decision Resources for Futura
$660 million potential ‘Over the Counter’ sales at $5 per dose with 70% incremental to prescription sales
03 Research and forecast provided by Ipsos Mori for Futura
Commercial out-licensing discussions at an advanced stage with licensing agreement targeted by
04 the end of H1 2018
CELLO HEALTHCARE RESEARCH DECISION RESOURCES RESEARCH IPSOS MORI RESEARCH
us FRANCE GERMANY Rx Sales of MED for key countries
25% 20% 16%
Ipsos scenario
800
600 Year 3 Year 5 Year 10
400
200 RSP
500 584 661
0
2020 2021 2022 2023 2024 2025 2026 2027 2028 2029
($m)
SWITCH FROM CURRENT ED TREATMENT US EU5 Japan China Australia Canada
1 - Directors’ belief based on market research conducted on behalf of Futura by Ipsos, Cello Health Consulting and
14 Decision Resources Group
2 - Manufacturers Selling Prices 2016: 15 Key ED markets, IMS HealthCSD500
ERECTOGENIC
CONDOM
15CSD500 – Novel erectogenic condom
Lubricated standard latex condom 3 Clinically proven claims
incorporating Zanifil® gel
Increased penile firmness
Only product licensed throughout EU with over
the counter clinically proven sexual Longer lasting sexual performance
performance claims
Improved sexual performance
01 Approved Class III Medical Device with ancillary medicinal substance in EU
02 Approved also in Saudi Arabia with other regulatory submissions for other regions underway
03 Two contract manufacturers to supply CSD500 in all countries with regulatory approval
16CSD500 – Commercial
Milestone and royalty based out-licencing strategy
01 Seven distributors at year-end: Discussions with additional distributors ongoing
Further distributor launches targeted for 2018
02 Further country regulatory approvals expected in 2018
Over 600,000 condoms supplied to-date
03 Further order in production
MILLWARD BROWN
RESEARCH Potential Market Share at Price Premium Futura trademarks & patents
400 UK & 400 US 25% • Zanifil® brand logo required on all licensee
interviews
24% products
20%
70% current & 30% 20%
15% 18% • Existing patents already granted in 36
lapsed condom 15% countries
users 10%
14%
6%
• Further patent filed to extend
5%
14 – 18% market protection until 2033
share at 50% price 0%
premium Average… 50%… 100%…
17TOPICAL PAIN
RELIEF
18Topical 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 point of difference
45%
TPR100 is a Diclofenac gel that utilises Futura’s DermaSys® technology
03 Improved permeation compared to market leaders at same dosage
VOLTAREN
(1%)
42%
TPR100 Human skin permeation study
Amount of Diclofenac permeated ug/cm2
45.00
40.00
35.00 TPR100 DE
30.00 Voltarol 12hr Emulgel
25.00
Pennsaid 2%
20.00
15.00 TPR100 LA
10.00
5.00
0.00
0 4 8 12 16 20 24
Hours
19 1 – 2015 IMS Health Estimate
2 – 2015 IMS Data sourceTopical Pain relief
Agreement signed with Thornton & Ross (a division of STADA) for UK rights in
01 Q1 2017
UK regulatory submission close to completion with filing in Q2
Commercial discussions ongoing with other potential distributors
02 TPR100 - USA will require further clinical data to support regulatory submission
TPR100 – USA strategy Illustrative positioning only TIB200 – 10% ibuprofen gel
• FDA Pre-IND response given • Opportunity to move from current 3-4 times
Simplified new drug application 505(b)(2) to twice a day dosing
filing route
700 patient, placebo controlled 12-week
efficacy study required • Placebo controlled efficacy study required
prior to EU regulatory filing
• Ongoing discussions with potential US
licensees • Futura require partner commitment before
Futura require partner commitment before progressing clinical expenditure
progressing clinical expenditure
20FINANCIAL
RESULTS
&
OUTLOOK
21Year End Highlights – Products
ME Positive meetings with USA & EU regulatory authorities
MED Clear regulatory pathway defined for MED2002 for USA & EU
D20
2002 Headline results on PK study showing acceptable safety profile
02 Commercial out-licensing discussions at an advanced stage
Successful launch in Saudi Arabia with over 500,000 condoms supplied
CSD
Production of further order underway for same territory
500 Further launches planned during 2018 through other distributors
First out-licensing agreement signed for pain relief product
TPR
UK dossier submission close to completion with filing in Q2
100 Commercial discussions ongoing in other countries
22Year End Highlights – Organisation & Financials
Strengthened operations appointing Regulatory Affairs Director
Angela Hildreth appointed as Finance Director & Chief Operating Officer
Net loss of £3.90 million in period
(2016: net loss of £3.70 million)
Cash resources of £8.36 million (at 31 December 2017)
Plus Tax Credit of £0.94 million expected Q2 2018
(At 31 December 2016: cash resources of £12.35 million)
OUTLOOK AND NEWS FLOW FOR 2018
MED2002 MED2002 CSD500 Pain relief
Commercial PK final study results Further country UK regulatory submission
……… launches ……..
out-licensing ………
update Start of Phase III Commercial updates
Commercial updates
efficacy studies
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