Marinomed Overview May 2020€¦ · Marinomed Overview May 2020. 2 Disclaimer This presentation ......

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Marinomed Overview May 2020

Transcript of Marinomed Overview May 2020€¦ · Marinomed Overview May 2020. 2 Disclaimer This presentation ......

Page 1: Marinomed Overview May 2020€¦ · Marinomed Overview May 2020. 2 Disclaimer This presentation ... 2. Visiongain Allergic Rhinitis 2018. Budesolv has the potential to become a blockbuster

Marinomed OverviewMay 2020

Page 2: Marinomed Overview May 2020€¦ · Marinomed Overview May 2020. 2 Disclaimer This presentation ... 2. Visiongain Allergic Rhinitis 2018. Budesolv has the potential to become a blockbuster

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Disclaimer

This presentation (the “Presentation”) was prepared by Marinomed Biotech AG.

The information contained in this Presentation has not been independently verified and no representation or warranty expressed or implied is made as to, and no reliance should be placed on, the fairness, accuracy, completeness or correctness of this information or opinions contained herein. Neither Marinomed Biotech AG nor any officer or employee of Marinomed Biotech AG or any person connected with them accepts any liability whatsoever for any direct, indirect or consequential damages or losses arising from any use of this Presentation or its contents or otherwise arising in connection therewith. Marinomed Biotech AG undertakes no obligation to update or correct any information contained herein or to otherwise advise as to any future changes to it.

Certain statements contained in this document may be statements of future expectations and other forward looking statements that are based on management‘s current view and assumptions and involve known and unknown risks and uncertainties that could cause actualresults, performance or events to differ materially from those expressed or implied in such statements.

Certain figures in this presentation have been rounded in accordance with commercial principles and practice. Such figures that have been rounded in various tables may not necessarily add up to the exact total given in the respective table.

This Presentation does not constitute or contain any investment advice. It is not and shall not be construed as an offer, invitation, recommendation or solicitation to sell, issue, purchase or subscribe for any securities in any jurisdiction or to enter into any transaction.

By accessing this Presentation, you represent, warrant and undertake that you have read and agree to comply with and to be bound by the contents of this disclaimer.

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In-house

▪ Innovation

▪ Product development

▪ Marketed products and clinical pipeline

▪ Patents and IP generation

Marinomed snapshot

Founded in 2006… …Marinomed established two platforms…

…with a lean set-up… …and a strong management team

2006 2008 2010 2012 2016 20182014

platform established

Founded and first financing

in 2006

platform established

clinically validated

IPO and EIB financing

clinically validated

Proven ability to develop revenue

generating products

Proven ability of continued innovation

and IP generation

▪ First causal therapy for colds and flu infections

▪ Six products generating retail sales with 13 partners in more than 40 countries

▪ Successful Phase III for Budesolv (allergic rhinitis) validates platform

▪ Targeting multi-billion Dollar markets (allergic rhinitis, dry eye)

Out-sourced

▪ Production

▪ Marketing

▪ Distribution

▪ Out-licensing of technology

Asset light business model

Helmut Baranyovszki

Operations

Renate Moser

BD & L

Andreas Grassauer

CEO

Eva Prieschl-Grassauer

CSO

Pascal Schmidt

CFO

A lean biopharmaceutical expert in OTC and Rx therapies

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Important milestones provide basis for accelerated development going forward

Record year 2019 and positive outlook 2020

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Budesolv with strong results – technology platform validated

Phase III

Financing through IPO and EIB

€37.4m

Revenues up from €4.7m to €6.1m

+31%

Increases demand for virus blockers

COVID-19

On-going double digit growth in 2020 and

strong pipeline

Strong Outlook

Shareholders placed 220,000 shares at €95 (ABB) and strong share

performance

Free Float 58%

for nose, lung, eyes and gastrointestinal

AdvancedPipeline

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Marinomed delivers new patent protected technologies enabling innovative therapies and unique solutions

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Marinosolv® allows to provide Budesonide in solution offering a competitive edge

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Marinosolv® explained based on Budesolv

SuspensionRhinocort Aqua Budesonide nasal spray64µg per dose/spray

SolutionMarinosolv® enabled

Budesonide nasal spray10µg per dose/spray

Marinosolv® – a technology platform with the potential to facilitate delivery of any compound with solubility issues

USPs

Increased bioavailability

Dose reduction

Aseptic filtering

Faster onset of actionHigher local, lower systemic availability

Lower possible side effectsLower production costs

Preservative free formulationLower production costs

Properties

Proven solubility

Increasing market

Patent protected

Solubility increase versus water shown for variety of compounds

Higher specificity of compounds leads to lower solubility → increasing number of APIs that could benefit from Marinosolv

Patent in nationalisation phase

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38%

43%

12%

7%

corticosteroids antihistamines immunotherapy other

47%

35%

15%3%

▪ Budesolv showed a pronounced reduction of allergic nasal symptoms in less than 3 hours

▪ Budesolv achieved non-inferiority, i.e. at least the same effect as marketed product (Rhinocort Aqua) on D8

▪ Budesolv has ~ 85% less of the dose of the marketed product and is preservative free

▪ Prominent reduction of respiratory symptoms

Positive Top-line results

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▪ Platform validation: Marinosolv enables novel stable aqueous formulations of hardly soluble compounds

▪ Next compound is Tacrosolv, a phase II asset in preparation for clinical development

▪ Additional compounds in review

Additional potential

Marinosolv® with significant milestones

Progress as promised with future untapped potential

2019USD

13.0bn

2028USD

17.4bn

Addressable market with 5% growth2

▪ ongoing – generation of stability data

▪ H1/2021 – application for market approval

▪ 280 days later (plus clock stops) – expected approval

▪ 2022 - launch

Market approval process1

Notes: 1. subject to current SARS-CoV-2 situation; 2. Visiongain Allergic Rhinitis 2018

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Budesolv has the potential to become a blockbuster product

8Sources: GlobalData, Visiongain 2018, OTC yearbook 2018 by N. Hall

Budesolv – redefining the market for allergic rhinitis

▪ Target market Allergic Rhinitis $13.0bn

▪ Steroids in Allergic Rhinitis growing 5.4%annually from $5.0bn to $8.3bn in 2028

Rhinocort Flixonase Budesolv

Owner

Revenue 2017 ($m)

250 1,570Phase III completed

Onset of action

1-2 weeks 4-5 days <3 hours

Potency of API

Budesolv is expected to outcompete the originator drug and to grab market share from the leaders

New Class

▪ First aqueous solution▪ First compound active after minutes▪ ~85% less dose compared to originator

Clinically Proven

▪ Successful clinical phase III▪ Equivalent effect compared to originator▪ Fast onset of action

Huge Market Opportunity

▪ Clinically relevant differentiation compared to marketed products

▪ Unsatisfied need for fast relief

Attractive Go-to-Market

▪ De-risked compound based on approved substances

▪ Market approval expected in 2022▪ Patent protected until 2036

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Very promising preclinical data1 Risk reduced clinical strategy

Tacrosolv – a powerful immunmodulator

9Sources: 1. Siegl et al., Eur J Pharm Biopharm, Jan 2019; 2 GlobalData, Visiongain 2017

Highly potent API with Marinosolv and smart clinical approach for new eye indications

Unmet medical need reflected in market figures2

1,7

4,00,1

1,1

0,3

0,3

0,1

0,3

0,0

2,0

4,0

6,0

2016 2026

Market for Dry Eye

US EU5 Japan China

Novartis acquires Xiidra (in dry eye) from Takeda in a deal worth $3.4bn cash plus $1.9bn milestones

Corn

ea

Dispersion

Retina

Allergic Conjunctivitis

Phase II

Dry Eye

Phase III

With successful Phase II in allergic conjunctivitis, likely, Phase II for Dry

Eye can be skipped

Dispersion

1,0

1,1

1,2

1,3

1,4

1,5

2013 2014 2015 2016 2017 2018

Revenues in $bn (US+EU5)

Challenge study for dose finding

Market for Allergic Conjunctivitis

Indication for market potential

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▪ Colds are caused by more than 200 different respiratory viruses

▪ Carragelose® creates a protective layer that reduces the spreading and proliferation of the common cold virus

▪ Trapped viruses leave the body via the natural route → The cold is either prevented or is significantly shorter in duration

Mode of action

▪ 3 Double-blind, placebo-controlled clinical trials with a total of 450 patients

▪ Reduction in duration of disease as well as fewer relapses during 21 days of observation period

Days1

▪ Significant reduction of common cold symptoms in the 2nd phase of the disease (p=0,048)1.

Shortening of symptoms clinically proven

Carragelose® with innovative mode of action

10Source: 1. Ludwig et al. Respiratory Research; 2013 Note: TSS = Total Symptom Score,

Carragelose® blocks viral attachment to cells via an unspecific physical mechanism

Cum

ula

tive p

atients

without

sym

pto

ms (

%)

Daily r

eduction o

fsym

pto

ms (

TSS)

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11Sources: Marinomed; Leibbrandt et al., 2010; Hebar et al., 2015; B&C Privatstiftung, Houska Preis 2016

Carragelose®: Innovative applications

Plannable growth through market entries in the coming years

Example of Carragelose® based nasal sprays

13 partners in more than 40 countries Additional growth potential

Goal: all productsavailable

everywhere

Carragelose®

basedpharmaceuticals

Anti-allergicproperty of

Carragelose®

100 countries already

partnered

Newmarkets

Existingmarkets

New products

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High demand for Carragelose® products

▪ Close contact with partner producers to increase production

▪ Supply chain management is the main challenge in 2020

Pandemic-related, short-term postponements of clinical trails

▪ Allergy challenge trials are currently not possible

▪ Planned start for the Tacrosolv phase II study in autumn

▪ Anticipated Carragelose® trials also delayed

Lockdowns temporarily effect Budesolv timeline

▪ Business development process and registration process are effected temporarily due to lockdowns and crisis management of potential partners

Short-term COVID-19 impact on Marinomed

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Increased demand for Carragelose® products and some short term delays in trails

In total: limited short-term effects but big long-term perspectives of COVID-19 pandemic on Marinomed operations

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COVID-19 boosts demand for virus blocking products

▪ Marinomed’s technology platforms are broadly and excellent positioned

▪ Marinomed is involved in extensive national and international research activities

Strong demand for Carragelose® products

▪ Carragelose® physically binds Corona viruses and reduces multiplication

▪ Further global increase in demand expected, if similar effects for Sars-CoV-2

Advanced Marinosolv® pipeline

▪ Clinical validation and strong pre-clinical trails enable rapid expansion

▪ New applications for nose, lung, eyes and gastrointestinal

Positive Outlook 2020

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Investments in Marinosolv® and commercialisation of Carragelose®

Double-digit growth in 2020 and strong pipeline

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