Marinomed Overview November 2019
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Marinomed Overview November 2019
Disclaimer
This presentation (the “Presentation”) was prepared by Marinomed Biotech AG.
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2
Marinomed at a Glance
3
Marinomed snapshot
A lean biopharmaceutical expert in OTC and Rx therapies
Founded in 2006… …Marinomed established two platforms…
IPO and EIB
platform clinically
financing Proven ability to Proven ability of
established validated
develop revenue continued innovation
generating products and IP generation
2006 2008 2010 2012 2014 2016 2018
▪ First causal therapy for ▪ Successful Phase III for
colds and flu infections Budesolv (allergic rhinitis)
▪ Six products generating validates platform
Founded and retail sales with 14 ▪ Targeting multi-billion
first financing platform clinically partners in more than 40 Dollar markets (allergic
in 2006 established validated countries rhinitis, dry eye)
…with a lean set-up… …and a strong management team
Asset light business model
In-house Out-sourced
▪ Innovation ▪ Production
▪ Product ▪ Marketing
development
▪ Distribution
▪ Marketed products
▪ Out-licensing of
and clinical pipeline
technology
Helmut Renate Andreas Eva Prieschl- Pascal
▪ Patents and IP Baranyovszki Moser Grassauer Grassauer Schmidt
generation Operations BD & L CEO CSO CFO
4
Highlights 2019
Strong half-year allows for accelerated development going forward
€22.4m Phase III >40
Top-line results for
Financing raised in countries launched
Budesolv
Feb 1, 2019 IPO
+9.4% €15.0m
H1/19 vs. H1/18;
+20.7% Q2 vs. Q1 Venture Debt
committed by EIB
> USD 12 bn1 6+3
market for first 6 products on the
product Budesolv market, 3 in
advanced pipeline
Sources: 1. Visiongain 2018 5
Marinomed delivers new patent protected
technologies enabling innovative therapies and
unique solutions
PHASE I/II PHASE III LAUNCHED
3 Virus-blocking nasal sprays (two adult and one children formulations)
Cough, Cold, Influenza
Virus-blocking decongestant nasal spray (combination with Sorbitol)
Virus-blocking lozenges
Virus-blocking throat spray
Virus-blocking decongestant nasal spray1
Primary and secondary
Ophthalmic
Budesolv2
Allergy,
endpoints met
Tacrosolv3
PIPELINE
Notes: 1. Carregelose Xylometazoline combination, 2. Dissolved Budesonide, 3. Dissolved Tacrolimus 6
Marinosolv® explained based on Budesolv
Marinosolv® allows to provide Budesonide in solution offering a competitive edge
Suspension Solution
Rhinocort Aqua Marinosolv® enabled
Budesonide nasal spray Budesonide nasal spray
64µg per dose/spray 10µg per dose/spray
Properties USPs
Proven Solubility increase versus water shown for Increased Faster onset of action
solubility variety of compounds bioavailability Higher local, lower systemic availability
Higher specificity of compounds leads to
Increasing Dose Lower possible side effects
lower solubility → increasing number of
market reduction Lower production costs
APIs that could benefit from Marinosolv
Patent Aseptic Preservative free formulation
Patent in nationalisation phase
protected filtering Lower production costs
Marinosolv® – a technology platform with the potential to facilitate delivery of any compound with
solubility issues
7
Marinosolv® with significant milestones
Progress as promised with future untapped potential
Positive Top-line results Market approval process on track
▪ Budesolv showed a pronounced reduction of ▪ Approval process can be continued as planned
allergic nasal symptoms in less than 3 hours
▪ H2/2019 – generation of stability data
▪ Budesolv achieved non-inferiority, i.e. at least
the same effect as marketed product ▪ H1/2020 – application for market approval
(Rhinocort Aqua) on D8
▪ 280 days later (plus clock stops) – expected
▪ Budesolv has ~ 85% less of the dose of the approval
marketed product and is preservative free
▪ 2021 - launch
▪ Prominent reduction of respiratory symptoms
Addressable market with 5% growth1 Additional potential
▪ Platform validation:
7% 3% Marinosolv enables novel stable aqueous
38% 15% 47%
12% formulations of hardly soluble compounds
2019 2028
USD USD ▪ Next compound is Tacrosolv, a phase II asset
13.0bn 17.4bn in preparation for clinical development
43% 35% ▪ Additional compounds in review
corticosteroids antihistamines immunotherapy other
Source: 1. Visiongain Allergic Rhinitis 2018 8
Budesolv – redefining the market for allergic
rhinitis
Budesolv has the potential to become a blockbuster product
▪ Target market Allergic Rhinitis $12.2bn New Class
▪ Steroids in Allergic Rhinitis growing 5.4%
▪ First aqueous solution
annually from $5.0bn to $8.3bn in 2028
▪ First compound active after minutes
▪ ~85% less dose compared to originator
Rhinocort Flixonase Budesolv Clinically Proven
▪ Successful clinical phase III
▪ Equivalent effect compared to originator
Owner
▪ Fast onset of action
Huge Market Opportunity
Revenue Phase III
250 1,570
2017 ($m) completed ▪ Clinically relevant differentiation compared to
marketed products
Onset of ▪ Unsatisfied need for fast relief
1-2 weeks 4-5 days
Tacrosolv – a powerful immunmodulator
Highly potent API with Marinosolv and smart clinical approach for new eye indications
Very promising preclinical data1 Risk reduced clinical strategy
Dispersion
Allergic Conjunctivitis With successful Phase II in allergic
conjunctivitis, likely, Phase II for Dry
Phase II Eye can be skipped
Cornea
Challenge study for dose finding
Dry Eye
Phase III
Indication for market potential
Novartis acquires Xiidra (in dry eye) from Takeda in a deal
worth $3.4bn cash plus $1.9bn milestones
Retina
Dispersion Unmet medical need reflected in market figures2
Market for Allergic Conjunctivitis Market for Dry Eye
1,5 6,0 0,3
1,4 1,1 0,3
4,0
1,3
0,1
1,2 2,0 4,0
0,3
1,1 0,1
1,7
1,0 0,0
2013 2014 2015 2016 2017 2018 2016 2026
Revenues in $bn (US+EU5) US EU5 Japan China
Sources: 1. Siegl et al., Eur J Pharm Biopharm, Jan 2019; 2 GlobalData, Visiongain 2017 10Carragelose® with innovative mode of action
Carragelose® blocks viral attachment to cells via an unspecific physical mechanism
Mode of action Shortening of symptoms clinically proven
▪ Colds are caused by more than 200 different ▪ 3 Double-blind, placebo-controlled clinical trials
respiratory viruses with a total of 450 patients
▪ Carragelose® creates a protective layer that ▪ Reduction in duration of disease as well as
reduces the spreading and proliferation of the fewer relapses during 21 days of observation
common cold virus period
without symptoms (%)
Cumulative patients
Days1
▪ Significant reduction
Daily reduction of
symptoms (TSS)
of common cold
symptoms in the
2nd phase of the
▪ Trapped viruses leave the body via the natural disease (p=0,048)1.
route → The cold is either prevented or is
significantly shorter in duration
Source: 1. Ludwig et al. Respiratory Research; 2013 Note: TSS = Total Symptom Score, 11Carragelose® products continue expansion
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12Positive outlook for 2019 and beyond
Exploiting the potential of our platforms Marinosolv® and Carragelose®
Marinosolv® in the focus
▪ Targeting a 5 billion dollar market with lead product
▪ Regulatory submission of Budesolv set to take place in 2020
▪ Clinical phase II of Tacrosolv in first half 2020
▪ Further developments based on Marinosolv® technology for strong growth perspective
Carragelose® is back on growth trajectory
▪ Entry into new markets and additional product launches in existing markets
▪ Investments in clinical studies and the optimisation of production
▪ Long-term rise in revenues expected
We remain optimistic for 2019 and beyond
▪ Increasing order and sales performance expected
▪ Ramp up of R&D investments
▪ Funding provided by IPO proceeds, EIB loan commitment, subsidies and recurring
revenues
13www.marinomed.com
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