Investors Presentation, April 2018 Disclaimer: Forward-looking - - PowerPoint PPT Presentation
Investors Presentation, April 2018 Disclaimer: Forward-looking - - PowerPoint PPT Presentation
Investors Presentation, April 2018 Disclaimer: Forward-looking statements This document contains certain statements that are not historical facts The Company is an emerging clinical-stage healthcare company and may be forward-looking
2
Disclaimer: Forward-looking statements
This document contains certain statements that are not historical facts and may be forward-looking statements that are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statement made by SynDermix (“the Company”). These factors include (but are not limited to): ------------------ i. The Company's and/or the Company's partners’ ability to successfully complete product research and development ii. The Company's and/or the Company's partners’ ability to obtain required governmental approvals (including product and patent approvals; the impact of industry and government regulation; the difficulty of predicting regulatory authority approvals; the regulatory environment and changes in the health policies and structures of various countries)
- iii. The acceptance and demand for new products and technologies,
and the Company's ability to attract and/or maintain manufacturing, sales, distribution and marketing partners
- iv. The Company's and/or the Company's partners’ ability to develop
and commercialise products before its competitors and the impact
- f competitive products and pricing; the availability and pricing of
ingredients used in the manufacturing
- f
products and uncertainties regarding market acceptance of innovative products, be they newly launched, currently being sold or in development. In addition, significant fluctuations in financial results may occur as a result of the timing of milestone payments and the timing of costs and expenses related to the Company's research and development programme The Company is an emerging clinical-stage healthcare company with higher investment risk and higher potential compared to larger
- r more established companies. If one or more of these risks or
uncertainties materialises,
- r
if underlying assumptions prove incorrect, the Company's actual results may vary materially from those expected, estimated or projected. Given these risks and uncertainties, potential investors should not place any reliance
- n forward-looking statements
Without limiting the generality of the foregoing, no assurance is given as to when the Company’s products will be launched or licensed or whether that launch or licensing will be commercially successful, and words such as "may", "will", "to", "expect", "plan", "believe", "anticipate", "intend", "could", "would", "estimate"
- r
"continue" or the negative or other variations thereof or comparable terminology is intended to identify forward-looking statements Neither the Company nor its directors undertake any obligation to update forward-looking statements or risk factors other than as required by applicable law, whether as a result of new information, future events or otherwise
3
CONTENTS
THE COMPANY
- p. 4
THE PRODUCT PORTFOLIO
- p. 10
THE WAY FORWARD
- p. 14
4
1
THE COMPANY
5
About SynDermix
We value innovation, creativity, integrity, dedication and fairness; we believe that success is achieved by people with a diverse range of talents and through partnerships; we maintain a commitment to sustainability in
- ur
development ethics and collaborations; we are driven by passion and professionalism Our vision is to become a global leading-edge developer of unparalleled products that will be continuously relevant to improving peoples’ health and well-being SynDermix is a Swiss clinical-stage biotech company funded by private investors
6
Business model and operations
SynDermix identifies and acquires the rights to innovative products, which it develops until a robust demonstration of their clinical value and a strengthening of their innovation value (IP); the Company then enters into corporate partnerships for market access Our focus is on products of natural origin that satisfy unmet healthcare needs and wellcare demands; this strategy enables us to benefit from accelerated timelines to market access — through Orphan Drug Designation, registration as a medical device or as a cosmetic product We operate a lean structure, which leverages the complementary expertise of a seasoned executive team and a broad network of selected service providers and key opinion leaders; the creation of a formal Scientific Advisory Board is in progress
7
SynDermix in the biopharma industry
Early-stage biotech Big Pharma
High risk Emphasis on research, drug discovery and securing IP Emphasis on drug refinement, sales & marketing New IP protection Products of natural origin Single product (usually) Multiple platforms & pipelines Lean structure & adaptability Risk mitigation Investments Leading-edge products Accelerated timelines Value chain Asset heavy enterprise model Chemically- synthesised drugs & biologics Initial investments difficult to secure
SynDermix
Emphasis
- n demonstration
- f clinical value &
strengthening
- f IP
8
Management team
Dieter Hemmer — Chief Executive Officer
15 years’ senior executive experience at Nestlé as Head of the Strategic Business Unit (Nestlé Professional Food Services) and Chairman of the Pro Gastronomia Nestlé Foundation. Prior to Nestlé, he spent 22 years in a number of senior executive positions with Lufthansa, including Head of Global Inflight Service and Managing Director for Lufthansa Service (LSG) Asia. BSc in Economics from FHS Heidelberg and management education at INSEAD, London Business School and IMD
Anthony Lockett, MD, PhD, MBA — Research & Manufacturing
Over 25 years’ experience in the pharmaceutical and medical devices
- industry. For the last 13 years he has been part of a team of consultants
advising clients on the regulatory and clinical strategy for product development and has acted as a CMO for an AIM listed company. He is also a Professor at King’s College, London
Angel Benito, LL.M — Executive Vice President
An entrepreneur with over 20 years’ experience in banking and asset management. Served as a manager for Credit Suisse, Bank Sarasin and Hyposwiss. In 2010 he formed his independent asset management company and subsequently several
- ther
companies
Rolf Küng, MBA — Finance & Controlling
A Swiss Certified Accountant and co-founder of the Institute For Innovative Trading (IFIT) in 1998. 17 years’ experience in auditing (Touché Ross, Deloitte Haskins & Sells, Grant Thornton and others). Has been a director and CEO of several companies within the IFIT Group with a focus on business projects in Europe and overseas, and is currently a consultant to ARIA Capital Management with
- ffices in the UK, UAE, Greece and Switzerland
Carlos Camozzi, MD, PhD, MBA — Clinical & Regulatory
Over 25 years’ international senior management experience in the biopharmaceutical industry (Roche, American Cyanamid, Mepha AG, Orphan Europe, UniQure, Orphazyme). Successfully led several regulatory achievements with both the EMA and the FDA. He is a permanent expert in the European Commission for Eureka and H2020 grant frames, and an expert in rare diseases and orphan drugs
Konstantinos Efthymiopoulos, PharmD, PhD, MBA — Medical Marketing & Business Development
Over 25 years’ international experience in big pharma, biotech and VC-backed companies (Farmitalia-Carlo Erba, Glaxo/GlaxoWelcome, Serono, Eurand, Funxional Therapeutics, Index Ventures) at increasingly senior levels that culminated in CSO, CEO and board
- positions. He is currently the Chairman of the Board of Synaffix BV and
Biopôle SA
9
Board of Directors
Alexander Ospelt, LL.M, PhD — Chairman of the Board
Founder of the law firm Ospelt & Partners Attorneys at Law Ltd. in 1997. Has been active in politics and numerous associations; is currently the President of the Foundation for crisis intervention, Liechtenstein (KIT) and member of the Scientific Advisory Board
- f the Private University Liechtenstein, and was a member of the
Board of the European Advocates’ Association (DACH) and Chairman of the Board of Liechtenstein Life Assurance Ltd. Dr. Ospelt has published several academic studies
Dimitri Dimitriou, MSc — Vice Chairman
25 years’ experience in the pharmaceutical and biotech industry. He is the CEO of ImmuPharma plc, a pharmaceutical company listed on AIM of the London Stock Exchange. Past roles include senior positions in business development with GlaxoSmithKline and Bristol- Myers Squibb and earlier appointments with Procter & Gamble and Novartis (Sandoz). Mr Dimitriou is also President of Dragon Finance AG, a Swiss company providing business development and management services
Dieter Hemmer — Delegate of the Board
(See Management Team on previous page)
Laura Piccinini — Director
25 years’ experience in the medical device industry, including roles as President with full P&L responsibility across the international markets for several American multinational companies such as Mallinckrodt, Tyco, Covidien and Acelity. Currently she works for Nobel Biocare, a Danaher Company, in an executive role. Ms Piccinini is a member of the Global Summit of Women, Medical Device Industry. She has been awarded many honours, including, the Mallinckrodt Chairman's Award for best performance worldwide in 2005, and the Tyco CEO Award for best performance worldwide in 2007 and 2008
10
2
THE PRODUCT PORTFOLIO
11
Our current portfolio is based on three proprietary technology
platforms: ▸Plant lectins ▸Nitric oxide ▸Vibration therapies
These platforms provide a broad range of medical and wellcare
products with indications that include oral mucositis, gastrointestinal mucositis, diabetic foot ulcers, chronic rhinosinusitis, acne, atopic dermatitis, as well as skin ageing and mouth hygiene
Our most advanced medical product is entering into Phase III
development for the treatment
- f
- ral
mucositis (an
- rphan
indication), while
- ur
wellcare product against skin ageing is expected to enter the market by the end of 2018
The potential value of our current product portfolio has been
estimated to be well above CHF 1,000 million
Portfolio overview
12
Knowledge Bank
Among the most valuable assets of SynDermix is its Knowledge Bank; this consists of 80 boxes of scientific data on plant lectins acquired in 2009 from Alizyme plc (the data was generated by Alizyme between 1997 and 2008 at a cost of 20 million GBP) The digitisation of the Knowledge Bank was completed in March 2018; with the formatting of the data to eCTD standards in progress, in Q2 2018 SynDermix will hold a regulatory master file whose value is estimated to be 4 times greater than in 2009 The SynDermix Knowledge Bank is a dynamic repository that is continuously enriched with new data from the manufacturing activities of the Company, pre-clinical studies and clinical trials
13
Strategic segments: Health & Wellcare
Health (Prescription & medical devices) Wellcare (Cosmetics & OTC)
Plant lectins Nitric oxide Vibration therapies Plant lectins Nitric oxide
▸ Oral mucositis ▸ Inflammatory bowel diseases ▸ Wound-healing ▸ GI ulceration ▸ Pulmonary diseases ▸ Skin diseases ▸ Eye disorders ▸ Cancer ▸ Cardiometabolic ▸ Radiodermatitis ▸ Wound-cleansing ▸ Chronic rhinosinusitis ▸ Migraine ▸ Bone density ▸ Anti-ageing ▸ Skincare ▸ Mouthwash ▸ Mouth ulcers ▸ Acne ▸ Gingivitis ▸Anti-aging ▸Skincare
Strategic segments Platforms Target indications
(unmet medical needs & wellcare demands)
14
3
THE WAY FORWARD
15
Next steps
/
Plant lectins
- First wellcare product manufactured and tested to be partnered
- Orphan Drug Designation and Phase III clinical trial in oral mucositis
- Proof of principle across a wide spectrum of diseases
Nitric oxide
- Proof of principle in radiodermatitis
Vibration therapies
- Phase II/III clinical trial in chronic rhinosinusitis
Intellectual property
- Expansion and strengthening of patent portfolio in all three platforms
Investors
- Investment activities as a bridge to Swiss stock exchange listing
16
Health: Orphan Drug Designation (ODD)
SynDermix is committed to seeking Orphan Drug Designation (ODD) in Europe and the United States for all relevant health indications that apply to the Company’s product portfolio An
- estimated 75-82 million patients suffer from rare diseases/disorders in the US and Europe, and
these conditions present major unmet medical needs Products
- with ODD benefit from accelerated development timelines and review schemes, as well as
from early sales access programmes The
- achievement of ODD provides high asset protection, with market exclusivity for 7 years in the US
and 10 years in Europe
17
Plant lectins pipeline according to indication
R&D Pre-Clinical Phase I Phase II Phase III Approval
Oral mucositis Inflammatory bowel diseases Gastrointestinal ulceration Pulmonary diseases (e.g. cystic fibrosis) Skin diseases Eye disorders Cancer Wound healing (e.g. diabetic foot ulcers) Cardiometabolic
SDX-1301 SDX-13 SDX-13 SDX-13/14 SDX-13/14 SDX-1403 SDX-13/14 SDX-1402 SDX-13/14 Orphan indication Non-orphan indication
18
Vibration therapies, nitric oxide & wellcare pipelines
R&D Pre-Clinical Phase I Phase II Phase III Approval
Chronic rhinosinusitis Migraine Bone density Radiodermatitis Wound-cleansing Wellcare
SDX-3101 SDX-3103 SDX-3102 SDX-2101 SDX-2102 Énielle Vibration therapies Nitric oxide Wellcare product
19
Our collaborators
IP, regulatory & legal CMOs & CROs Others
20
Registered offices SynDermix AG Buochserstrasse 2 CH-6370 Stans Operating offices SynDermix Management AG Voltastrasse 61 CH-8044 Zurich Contact us Tel +41 44 366 40 16 info@syndermix.ch www.syndermix.ch
A member of the Swiss Biotech Association