Creating innovative therapies for allergy, respiratory and eye diseases - Marinomed
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Creating innovative therapies for
allergy, respiratory and eye diseases
Results for half-year 2019
Investor Presentation
Vienna, 30 August 2019
Disclaimer
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2
Highlights Half-Year 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
On track 99.6%
for go-to-market
Budesolv and Conversion of
Phase II Tacrosolv convertible bond
• Sources: 1. Visiongain 2018, 2.OTC yearbook 2018 by N. Hall 3
Marinosolv® with significant milestones
Progress as promised with future untapped potential
Positive Top-line results Market approval process on track
Budesolv achieved non-inferiority, i.e. at least Approval process can be continued as planned
the same effect as marketed product
(Rhinocort Aqua) on D8 H2/2019 – generation of stability data
Budesolv has < 1/6th of the dose of marketed H1/2020 – application for market approval
product and is preservative free
280 days later (plus clock stops) – expected
Budesolv showed a pronounced reduction of approval
allergic nasal symptoms in less than 4 hours
2021 - launch
Prominent reduction of respiratory symptoms
Addressable market with 5% growth Additional potential
Prove of platform: Marinosolv enables novel
7% 3% stable aqueous formulations of hardly soluble
38% 15% 47%
12% 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 4
Tacrosolv – a powerful immunmodulator
Highly potent API with Marinosolv and smart clinical approach
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
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
1 Siegl et al., Eur J Pharm Biopharm, Jan 2019
2 GlobalData, Visiongain 2017 5
Carragelose® products continue expansion
Multiple additional launches and line extensions planned in the coming years
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6
Statement of profit or loss (IFRS)
€m H1 2019 H1 2018 1 Revenue €m H1 2019 H1 2018
Revenues 1 1.7 1.5 Sale of goods 1.5 1.4
Other income 0.3 0.5 License revenues 0.0 0.1
Other net gains/losses 0.0 0.0 Other revenues 0.2 0.0
Materials and services expenses 2 (2.7) (1.9) Total revenue 1.7 1.5
Personnel expenses (2.0) (1.1)
2 Margin H1 2019 H1 2018
Depreciation and amortisation (0.2) (0.1)
Sale of goods 1.5 1.4
Other expenses 3 (1.1) (0.7)
Cost of goods sold (1.0) (1.1)
Operating result (4.1) (1.8)
Gross result 4.7 4.8
Financial income 0.0 0.5
Gross margin 28.7% 23.1%
Financial expenses 4 (0.8) (0.7)
Therein contract research in the amount of €1.3m
Financial result (0.8) (0.3) (H1 2018: €0.4m)
3 Therein “non-recurring” expenses in the context of
Profit/loss before taxes (4.9) (2.1)
the preparation of the IPO in the amount of €0.4m
Taxes on income (0.0) (0.0) Therein valuation of equity conversion right and
4
interest relating to the convertible bond of €0.5m
Profit/loss for the period (4.9) (2.1) and interest on shareholder loans of €0.3m
7Statement of financial position (IFRS)
Assets
€m H1 2019 YE 2018 1 Therein Austrian Research Premium in the amount of
€0.6m (YE 2018: €0.5m)
Assets
Intangible assets 1.3 1.3
2 Not yet taking into account any disbursement from
Property, plant and equipment 0.3 0.2 EIB; total available commitment from EIB is €15.0m
Deposits and other non-current
0.0 0.0
receivables
Total non-current assets 1.6 1.5
Inventories 0.0 0.1
Trade and other receivables 1 1.4 1.9
Current tax receivables 0.0 0.0
Cash and cash equivalents 2 12.6 1.7
Total current assets 14.0 3.7
Total assets 15.6 5.3
8Statement of financial position (IFRS)
Equity and liabilities
€m H1 2019 YE 2018 1 Therein IPO related paid-in capital of €20.3m (net
of transaction costs) and conversion of the
Equity and liabilities
convertible bond in the amount of €13.1m
Share capital 1.5 1.0
Capital reserves 1 40.6 7.0 2 Primarily related to AWS Seed loan, where the
nominal has been repaid and the accumulated
Accumulated deficit (29.1) (24.2) interest remains at €0.4m
Total capital and reserves 12.9 (16.3) Also including IFRS 16 changes
Borrowings 2 0.5 1.2 3 IPO related expenses have been paid in 2019
Silent partnerships - -
4 Primarily related to a credit note to be granted to an
Convertible bond - 5.6
international pharmaceutical company in case of the
Other financial liabilities - 7.1 return of the exclusivity
Other non-current liabilities 0.1 0.0
Total non-current liabilities 0.6 13.9
Borrowings 2 0.2 3.7
Trade payables 3 0.3 2.0
Convertible bond - 0.1
Current contract liabilities and other
0.8 1.0
current liabilities
Provisions 4 0.8 0.8
Total current liabilities 2.1 7.6
Total equity and liabilities 15.6 5.3
9Statement of cash flows (IFRS)
Cash flow characterised by IPO proceeds as well as R&D and IPO spending
Reversal Net
Cash at of net change in Net D&A Cash at
beginning Loss for financial working interest and Investing Financing end of
of period the period result capital paid other cash flow cash flow period
10Positive outlook for 2019
Exploiting the potential of our platforms Marinosolv® and Carragelose®
Marinosolv® in the focus
Targeting a 5 billion dollar market with strong growth perspective
Regulatory submission of Budesolv set to take place in 2020
Start of the clinical phase II of Tacrosolv in the next 6 months
Further developments based on Marinosolv® technology
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
Increasing order and sales performance expected
Operating result will remain negative based on continuous high R&D expenses and
one-time expenses related to IPO
Funding provided by IPO proceeds, EIB loan commitment, subsidies and recurring
revenues
11www.marinomed.com
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