Investors’ Presentation, April 2018 · 7 SynDermix in the biopharma industry Early-stage biotech...

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Investors’ Presentation, April 2018

Transcript of Investors’ Presentation, April 2018 · 7 SynDermix in the biopharma industry Early-stage biotech...

Page 1: Investors’ Presentation, April 2018 · 7 SynDermix in the biopharma industry Early-stage biotech Big Pharma High risk Emphasis on research, drug discovery and securing IP Emphasis

Investors’ Presentation, April 2018

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Disclaimer: Forward-looking statements� This document contains certain statements that are not historical factsand may be forward-looking statements that are subject to a variety ofrisks and uncertainties. There are a number of important factors thatcould cause actual results to differ materially from those projected orsuggested in any forward-looking statement made by SynDermix (“theCompany”). These factors include (but are not limited to): ------------------

i. The Company's and/or the Company's partners’ ability tosuccessfully complete product research and development

ii. The Company's and/or the Company's partners’ ability to obtainrequired governmental approvals (including product and patentapprovals; the impact of industry and government regulation; thedifficulty of predicting regulatory authority approvals; the regulatoryenvironment and changes in the health policies and structures ofvarious countries)

iii. The acceptance and demand for new products and technologies,and the Company's ability to attract and/or maintainmanufacturing, sales, distribution and marketing partners

iv. The Company's and/or the Company's partners’ ability to developand commercialise products before its competitors and the impactof competitive products and pricing; the availability and pricing ofingredients used in the manufacturing of products anduncertainties regarding market acceptance of innovative products,be they newly launched, currently being sold or in development. Inaddition, significant fluctuations in financial results may occur as aresult of the timing of milestone payments and the timing of costsand expenses related to the Company's research and developmentprogramme

� The Company is an emerging clinical-stage healthcare companywith higher investment risk and higher potential compared to largeror more established companies. If one or more of these risks oruncertainties materialises, or if underlying assumptions proveincorrect, the Company's actual results may vary materially fromthose expected, estimated or projected. Given these risks anduncertainties, potential investors should not place any relianceon forward-looking statements

� Without limiting the generality of the foregoing, no assurance isgiven as to when the Company’s products will be launched orlicensed or whether that launch or licensing will be commerciallysuccessful, and words such as "may", "will", "to", "expect", "plan","believe", "anticipate", "intend", "could", "would", "estimate" or"continue" or the negative or other variations thereof or comparableterminology is intended to identify forward-looking statements

� Neither the Company nor its directors undertake any obligation toupdate forward-looking statements or risk factors other than asrequired by applicable law, whether as a result of new information,future events or otherwise

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CONTENTSTHE COMPANY p. 4

THE PRODUCT PORTFOLIO p. 10

THE WAY FORWARD p. 14

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1THE COMPANY

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About SynDermix

We value innovation, creativity, integrity, dedication and fairness; we believe thatsuccess is achieved by people with a diverse range of talents and through partnerships;we maintain a commitment to sustainability in our development ethics andcollaborations; we are driven by passion and professionalism

Our vision is to become a global leading-edge developer of unparalleled products thatwill be continuously relevant to improving peoples’ health and well-being

SynDermix is a Swiss clinical-stage biotech company funded by private investors

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Business model and operations

SynDermix identifies and acquires the rights to innovative products, which it developsuntil a robust demonstration of their clinical value and a strengthening of their innovationvalue (IP); the Company then enters into corporate partnerships for market access

Our focus is on products of natural origin that satisfy unmet healthcare needs andwellcare demands; this strategy enables us to benefit from accelerated timelines tomarket access — through Orphan Drug Designation, registration as a medical device or as acosmetic product

We operate a lean structure, which leverages the complementary expertise of a seasonedexecutive team and a broad network of selected service providers and key opinion leaders;the creation of a formal Scientific Advisory Board is in progress

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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 on demonstration of clinical value &

strengthening of IP

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Management team

Dieter Hemmer — Chief Executive Officer15 years’ senior executive experience at Nestlé as Head of theStrategic Business Unit (Nestlé Professional Food Services) andChairman of the Pro Gastronomia Nestlé Foundation. Prior toNestlé, he spent 22 years in a number of senior executive positionswith Lufthansa, including Head of Global Inflight Service andManaging Director for Lufthansa Service (LSG) Asia. BSc inEconomics from FHS Heidelberg and management education atINSEAD, London Business School and IMD

Anthony Lockett, MD, PhD, MBA — Research & ManufacturingOver 25 years’ experience in the pharmaceutical and medical devicesindustry. For the last 13 years he has been part of a team of consultantsadvising clients on the regulatory and clinical strategy for productdevelopment and has acted as a CMO for an AIM listed company. He isalso a Professor at King’s College, London

Angel Benito, LL.M — Executive Vice PresidentAn entrepreneur with over 20 years’ experience in banking andasset management. Served as a manager for Credit Suisse, BankSarasin and Hyposwiss. In 2010 he formed his independent assetmanagement company and subsequently several othercompanies

Rolf Küng, MBA — Finance & ControllingA Swiss Certified Accountant and co-founder of the Institute ForInnovative 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 IFITGroup with a focus on business projects in Europe and overseas,and is currently a consultant to ARIA Capital Management withoffices in the UK, UAE, Greece and Switzerland

Carlos Camozzi, MD, PhD, MBA — Clinical & RegulatoryOver 25 years’ international senior management experience in thebiopharmaceutical industry (Roche, American Cyanamid, Mepha AG,Orphan Europe, UniQure, Orphazyme). Successfully led severalregulatory achievements with both the EMA and the FDA. He is apermanent expert in the European Commission for Eureka and H2020grant frames, and an expert in rare diseases and orphan drugs

Konstantinos Efthymiopoulos, PharmD, PhD, MBA — Medical Marketing & Business DevelopmentOver 25 years’ international experience in big pharma, biotech andVC-backed companies (Farmitalia-Carlo Erba, Glaxo/GlaxoWelcome,Serono, Eurand, Funxional Therapeutics, Index Ventures) atincreasingly senior levels that culminated in CSO, CEO and boardpositions. He is currently the Chairman of the Board of Synaffix BV andBiopôle SA

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Board of Directors

Alexander Ospelt, LL.M, PhD — Chairman of the BoardFounder of the law firm Ospelt & Partners Attorneys at Law Ltd.in 1997. Has been active in politics and numerous associations; iscurrently the President of the Foundation for crisis intervention,Liechtenstein (KIT) and member of the Scientific Advisory Boardof the Private University Liechtenstein, and was a member of theBoard of the European Advocates’ Association (DACH) andChairman of the Board of Liechtenstein Life Assurance Ltd. Dr.Ospelt has published several academic studies

Dimitri Dimitriou, MSc — Vice Chairman25 years’ experience in the pharmaceutical and biotech industry. Heis the CEO of ImmuPharma plc, a pharmaceutical company listed onAIM of the London Stock Exchange. Past roles include seniorpositions in business development with GlaxoSmithKline and Bristol-Myers Squibb and earlier appointments with Procter & Gamble andNovartis (Sandoz). Mr Dimitriou is also President of Dragon FinanceAG, a Swiss company providing business development andmanagement services

Dieter Hemmer — Delegate of the Board(See Management Team on previous page)

Laura Piccinini — Director25 years’ experience in the medical device industry, includingroles as President with full P&L responsibility across theinternational markets for several American multinationalcompanies such as Mallinckrodt, Tyco, Covidien and Acelity.Currently she works for Nobel Biocare, a Danaher Company, inan executive role. Ms Piccinini is a member of the GlobalSummit of Women, Medical Device Industry. She has beenawarded many honours, including, the Mallinckrodt Chairman'sAward for best performance worldwide in 2005, and the TycoCEO Award for best performance worldwide in 2007 and 2008

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2THE PRODUCT PORTFOLIO

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� 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 wellcareproducts with indications that include oral mucositis, gastrointestinalmucositis, diabetic foot ulcers, chronic rhinosinusitis, acne, atopicdermatitis, as well as skin ageing and mouth hygiene

� Our most advanced medical product is entering into Phase IIIdevelopment for the treatment of oral mucositis (an orphanindication), while our wellcare product against skin ageing isexpected to enter the market by the end of 2018

� The potential value of our current product portfolio has beenestimated to be well above CHF 1,000 million

Portfolio overview

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Knowledge Bank

Among the most valuable assets of SynDermix is its Knowledge Bank; this consists of 80boxes of scientific data on plant lectins acquired in 2009 from Alizyme plc (the data wasgenerated 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 theformatting of the data to eCTD standards in progress, in Q2 2018 SynDermix will hold aregulatory 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 enrichedwith new data from the manufacturing activities of the Company, pre-clinical studies andclinical trials

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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)

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3THE WAY FORWARD

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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

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Health: Orphan Drug Designation (ODD)

SynDermix is committed to seeking Orphan Drug Designation (ODD) in Europe and the United Statesfor 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, andthese conditions present major unmet medical needs

Products• with ODD benefit from accelerated development timelines and review schemes, as well asfrom early sales access programmes

The• achievement of ODD provides high asset protection, with market exclusivity for 7 years in the USand 10 years in Europe

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Plant lectins pipeline according to indication

R&D Pre-Clinical Phase I Phase II Phase III Approval

Oral mucositis

Inflammatorybowel diseases

Gastrointestinalulceration

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

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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

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Our collaborators

IP, regulatory & legal CMOs & CROs Others

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Registered officesSynDermix AGBuochserstrasse 2CH-6370 Stans

Operating officesSynDermix Management AGVoltastrasse 61CH-8044 Zurich

Contact usTel +41 44 366 40 [email protected] www.syndermix.ch

A member of the Swiss Biotech Association