Annual Report • Apr 16, 2020
Annual Report
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As a biopharmaceutical company, Marinomed is firmly established in the global pharmaceutical and biotechnology market environment.
Global pharmaceuticals are a growth market which, according to data provider IQVIA, was estimated to be worth a volume of around USD 1.3 trillion in 2019 and is expected to grow at an annual rate of 3-6%. The impact of the COVID-19 pandemic on the pharmaceutical market is currently unclear. However, it can be assumed that the pharmaceutical industry will be less affected by a global economic crisis than other parts of the economy. What will remain is the pressure on prices exerted on the industry by those who fund healthcare systems, a pressure that has been slowing growth in the sector in Europe for some time now. Nevertheless, the rising standard of living in Asia and other growth regions means that the growth prospects for the industry are positive.
Budesolv, the first product on the Marinosolv® platform, targets the market for allergic rhinitis, which was forecast to generate sales of USD 13 billion in 2019 (Visiongain Allergic Rhinitis Report 2018). The market in nasal steroids is posting stronger growth than that of the market as a whole. Accounting for 38% of the overall market, this area has been the most important segment since 2018. These increases are partly due to the trend towards non-prescription, over-the-counter (OTC) products.
Based on the universal applicability of the Marinosolv® platform, Marinomed has initiated further product developments. Tacrosolv is the most advanced of these, with the start of the Phase II study imminent. This product is targeting the ophthalmology market, with a focus on the sub-segments of allergic conjunctivitis and dry
eye syndrome. Both markets are currently undersupplied, which means that new and innovative drugs have the chance to reach a large group of patients. The market potential of the dry eye segment was demonstrated in May 2019 when Novartis acquired the Xiidra prescription treatment from Takeda in a deal worth a total of USD 5.3 billion. In 2018 Xiidra had sales of about USD 400 million (source: Novartis).
Marinomed's Carragelose® products are freely available to buy on an OTC basis. As things stand it is not possible to forecast the long-term consequences of the global COVID-19 pandemic on this segment. For 2020 and in the short term, we expect a sharp increase in sales across all markets. Marinomed expects the pandemic to cause a sustained change in awareness of the dangers posed to society by viral infections of the respiratory tract.
The OTC market environment is characterised by intense competition, strict regulations and fragmented distribution networks. Above and beyond product development and brands, it is therefore essential to be able to bring innovations to the market. With an innovative, patent-protected and anti-viral focused product portfolio, Marinomed enables its highly specialist distribution partners to be ideally prepared for this challenge in the various countries and regions.
At around 7% p.a., the global biotechnology industry is growing significantly faster than the global economy and the pharmaceutical industry as a whole (source: GlobalData). The reason for this trend is the high level of innovation and the risk appetite of biotechnology companies to invest in research and development and then to launch successful outcomes on the market in partnership
with large pharmaceutical companies. Growing spending on research and development and the potential of young biotech companies to mobilise significant volumes of venture capital also point to sustainable growth in the industry. However, budgetary issues and political uncertainty, especially in the United States, could lead to growth disruptions at any time.
Despite Marinomed's products, which are marketed and distributed by partners, having only a small market share, the Company profits from global growth. A positive global economic climate and in particular growing life sciences markets not only allow Marinomed to grow with the market, but additionally support current and prospective partners' willingness to invest in future products and markets.
The pharmaceutical and biotechnology industries also play a significant role in the Austrian economy. More than 1,000 companies are involved in the life sciences sector in Austria, with 150 companies employing 18,000 staff in the pharmaceutical industry investing millions in research and development and generating 2.8% of the country's gross domestic product. Recent years have seen some companies achieving great success including successful market approvals for drugs (sources: Pharmig, Vienna Life Science Report 2018/19, LISA Vienna).
In line with the two technology platforms, Marinomed reports separately for the Marinosolv® and Carragelose® operating segments. Business performance is characterised by different factors in the two segments. It is essential that these are taken into account in any analysis of the earnings situation.
No distribution licensing rights or other intellectual property rights have been licensed to third parties for products of the Marinosolv® technology platform to date. As a result, the exceptionally positive trend at the research and development level has not yet been reflected in revenues or income. This operating segment is characterised by high spending on research and development, which will only generate revenues in subsequent years.
In the 2019 financial year, Marinomed achieved one of the most important development milestones for Budesolv, its flagship Marinosolv® product. In April 2019, the company published the top-line results, marking the successful completion of the pivotal Phase III study. Later in the year, Marinomed published detailed data from the study, which confirmed that with a dose that was 85% lower Budesolv achieved an equivalent effect to that produced by the market product after one week of treatment. More importantly, it was shown that a significant effect had been achieved within three hours of the first dose being administered, while this effect was not observed in the case of the market product.
The successful completion of the study not only constituted an important prerequisite in respect of the application for approval of Budesolv, it also clinically validated Marinosolv® as a technology platform: products solubilised with Marinosolv® achieve a higher bioavailability and thereby faster onset of action compared to current treatments formulated as suspensions. In 2020, Marinomed is aiming to complete preparations for the regulatory filing of Budesolv and to conclude initial contracts with partners to market the product. But, in the current environment which is impacted by the pandemic, delays cannot be excluded.
The Carragelose® platform for treating cold-related illnesses generated a more dynamic performance than in the previous year. This operating segment encompasses sales and distribution of the existing Carragelose® products alongside ongoing research and development. Product sales climbed to EUR 4.88 million (2018: EUR 4.42 million), while the gross margin also increased. Sales therefore surpassed the record posted in 2017. This was largely due a to a strong market launch by the Scandinavian partner.
In the 2019 financial year, Marinomed succeeded in increasing its revenues — which were generated almost exclusively in the Carragelose® segment — by 31% to EUR 6.14 million (2018: EUR 4.67 million). Revenues included an extraordinary effect of EUR 0.90 million relating to the

return of a sales region by a European partner. Other income largely comprised the research premium, and at EUR 0.67 million in 2019 remained largely on a par with the prior year (2018: EUR 0.68 million, conversion of FFG loans into non-repayable grants and research premium). Other gains and losses mostly related to foreign exchange gains and losses and remained at a similarly low level in 2019 to that of the 2018 financial year.
Due to a significant increase in sales of goods, expenses for materials increased from EUR 3.31 million to EUR 3.58 million in 2019. The gross margin rose from 26 to 29%. As a result of higher investments, in particular for clinical development projects, expenses for services climbed from EUR 1.52 million in 2018 to EUR 3.08 million in 2019. Personnel costs reflected the increase in staff, the expansion of the management team as well as expenses for the employee stock option programme and, at EUR 4.22 million, came in higher than the prior-year figure of EUR 2.52 million. The decrease in other expenses from EUR 2.91 million in 2019 to EUR 1.83 million in 2018 was largely attributable to the fact that advisory services and other costs in connection with the preparations for the company's IPO were already recognised in 2018.
The high level of investment in Marinomed's future trajectory was reflected in the company's earnings performance. In 2019, expenditure on research and development climbed substantially to EUR 4.78 million, from EUR 2.93 million in 2018. Accordingly, the operating result (EBIT) of EUR -6.21 million was down on the prior-year figure of EUR -5.14 million. In 2018, the financial result was adversely impacted by a one-off, noncash valuation result of EUR -5.67 million relating to the convertible bond issued in 2017, and this item therefore improved to EUR -1.00 million in 2019 (2018: EUR -6.95 million). The loss for 2019 therefore came in at EUR -7.22 million, from EUR -12.10 million in 2018.
These expenses contrasted with positive IPO issue proceeds of EUR 22.43 million in February 2019. This provided the company with sufficient funds to enable it to press ahead with its planned growth trajectory. In addition, 99.7% of the convertible bond holders converted their bonds into shares, significantly reducing Marinomed's debt burden. The company repurchased the outstanding 0.3% of the convertible bond issue in February 2019. The convertible bond was then delisted from the Third Market of the Vienna Stock Exchange. Furthermore, Marinomed was able to secure the commitment to a venture loan for research and

development of up to EUR 15 million from the European Investment Bank (EIB).
The assets and financial situation largely reflects the negative trend in earnings, which is to be expected for a biopharmaceutical firm during the development stage. The funding measures in the 2015 to 2019 financial years should ensure longterm investment in research and development.
Total assets increased from EUR 5.26 million as at December 31, 2018 to EUR 19.50 million as at the 2019 reporting date. Non-current assets increased to EUR 4.16 million compared to EUR 1.54 million on the cut-off date in the prior year, while current assets rose from EUR 3.72 million to EUR 15.34 million. This performance reflects the substantial improvement in the company's liquidity situation after the IPO in February 2019 and the proceeds from the first tranche of the EIB loan in 2019.
As at the 2019 balance sheet date, equity capital stood at EUR 10.87 million compared to EUR -16.27 million as at end-December 2018. This increase was primarily due to the IPO, the conversion of the bond and the contrary effect of the loss for the year 2019.
Non-current liabilities decreased, primarily on account of the conversion of the convertible bond, to EUR 4.61 million compared to EUR 13.89 million as at the 2018 reporting date. Current liabilities fell from EUR 7.64 million to EUR 4.03 million as at December 31, 2019, which was mainly due to the repayment of loans from the Austrian Research Promotion Agency (FFG) and shareholders.
Thanks to the successful IPO, cash and cash equivalents increased from EUR 1.72 million as at end 2018 to EUR 12.02 million on the balance sheet date 2019. Besides the IPO proceeds, the cash flow is largely characterised by investments into research and development as well as the clean-up of the balance sheet.
In full year 2020, Marinomed expects another positive performance in terms of orders and sales. The expansion of distribution partnerships will now also include the Marinosolv® segment for the first time, even though product sales are not expected yet. In the Carragelose® segment, clinical trials to extend the indication areas as well as other product launches should have a positive impact.
The elevated demand for Carragelose® products as a result of the SARS-CoV-2 pandemic is also expected to have a positive effect. However, at present it is difficult to gauge the overall impact including factors such as delays to clinical studies - of the pandemic on the healthcare sector.
In view of the high level of research and development expenditure, Marinomed expects operating losses to continue in 2020 and the subsequent years.
Marinomed's Marinosolv® technology platform serves a billion-dollar market with strong growth prospects. The platform's flagship product is the anti-allergy drug Budesolv. In the second quarter 2019, the pivotal Phase III study was successfully completed. The detailed results of the study were then published at the prestigious annual meeting of the American College of Allergy, Asthma &
Immunology (ACAAI) in Houston, USA. These results confirm that Budesolv is the first steroid nasal spray to have a clinically relevant effect within a few hours of the first dose being administered, while achieving approximately 50% of the maximum efficacy.
The successful completion of the Budesolv study represented more than just a key milestone on the road towards applying for regulatory approval. Budesolv could also be an attractive product in terms of acquiring marketing partners. In addition, the whole Marinosolv® platform was clinically validated. Accordingly, 2020 will see Marinomed focus on preparing the approval and commercial exploitation of Budesolv.
Furthermore, Marinomed is already researching further developments based on the Marinosolv® technology platform. The platform can be applied to various other compounds, amongst others immunosuppressants like tacrolimus. Marinomed is developing the Tacrosolv product for the treatment of inflammatory ocular disorders, with clinical development scheduled for 2020.
Marinomed's strategy consists of further expanding the company's intellectual property and utilising this to optimum effect. The broad applicability of the Marinosolv® technology platform opens up a multitude of options such as offering services to other pharma companies.
Marinomed sees further substantial growth potential in the pharmaceutical market for OTC products against a backdrop of what remains intense competitive pressure. Out of the ten largest regional OTC markets, the company has so far only achieved noteworthy sales in the UK and Germany. To make better use of this potential, Marinomed is constantly optimising its portfolio of products and partnerships. The goal is to acquire new partners in specific regions as well as to support new product launches with clinical data.
Against this backdrop, Marinomed expects a further long-term rise in revenues from its Carragelose® products. In the near term, the company plans to leverage the growth potential of products that have already been marketed via enhanced market penetration by, for example, boosting product recognition. Marinomed also plans to generate increased revenues via product launches in new markets and by launching additional products in existing markets.
The United States of America is a special case. There are barriers to market entry in the US in the form of regulatory provisions and licensing criteria that differ from those in the rest of the world and render authorisation in the next few years unlikely. Nevertheless, Marinomed is endeavouring to access this especially attractive market.
In the foreseeable future, further investment in research and development will be required to leverage the potential of the two platforms. Depending on the scale of this investment and the commercial success realised, there may be a need for additional capital. Marinomed is involved in ongoing discussions regarding additional project financing.
Marinomed is a research and development company that supplies its products to pharmaceutical firms and distribution partners on all continents. As such, Marinomed is exposed to various risks. The risks described below are continuously monitored so that action can be taken quickly and countermeasures adopted if necessary.
As an internationally active company, Marinomed is embedded into the world economy. Although it is not possible to predict the long-term effects the pandemic will have on the global economy, there is an increased risk that the global economic climate will deteriorate and that the downturn will continue across all continents. While the life sciences sector is less sensitive to changes of this nature, it may become more difficult to maintain a continuous supply chain and the slowdown in economic growth may lead to lower customer demand.
The main financial risks include default, liquidity and interest rate risks. There are also exchangerate risks as some sales are generated in GBP. As receivables in GBP do not generally exceed EUR 250,000, the effect on the income statement of a fluctuation of +/- 10% would be less than EUR 25,000. As a research and development company, Marinomed continues to report a negative operating result (EBIT), which means that it has no access to conventional credit instruments. Accordingly, there is a risk that the capital requirement will not be met in future, or
only on unfavourable conditions. This is a typical risk for a biotech firm.
Further, Marinomed is to a usual extent exposed to interest risks based on the development of international interest levels. Specific interest rate risks result from the AWS Seed loan (2% plus 3M-EURIBOR) and from the revenue-related royalties to be paid in connection with the EIB loan.
The company does not have any derivative financial instruments.
The risk for Marinomed is that long-term potential will not be utilised or will be misjudged. The partnerships it has entered into or may establish in future for both technology platforms could prove disadvantageous. The current assessment of the products' potential on the global markets may be overly optimistic. Accordingly, there is a risk that the revenue targets will not be met. A further risk is that competitors may develop better or cheaper products, which would erode the profitability of Marinomed's portfolio.
Government authorities are endeavouring to rein in health care costs by encouraging greater competition among providers and permanently reducing the reimbursement limits for drugs in nearly all regional markets. The rapidly growing OTC market is less vulnerable to these influences, but competition is fierce and there are larger providers that have far more financial and business options available to them than Marinomed or its partners in the respective countries.
Marinomed is dependent on partners on both the supplier and marketing sides. Despite equitable contracts, there is a risk that one or more partners may be unable to resolve financial or technical problems through no fault of Marinomed, resulting in losses for the company. Partners may fail to achieve their own revenue targets, while other issues may relate to supply delays, payment difficulties or other risks typical of the sector.
With more than 90% of sales billed in euros, the company considers its currency risk to be low. However, in non-eurozone countries (excluding the United Kingdom), appreciation of the euro against local currencies could make the company's products more expensive for distributors and end consumers, resulting in reduced sales of the company's products.
Liquidity risk arises from the potential inability to raise the requisite funds for servicing obligations relating to financial instruments. To date, the company has primarily financed its operating business via equity investments and shareholder loans, income from licensing and distribution contracts, product sales, atypical silent partnerships, the issue of a convertible bond, new shares under the IPO, as well as via subsidies, subsidised loans and other government assistance.
The management board expects the company's research and development spending and operating losses to remain substantial over the coming years at least. Management forecasts that existing cash reserves as well as the financing raised via the IPO and from the EIB will be sufficient to fund the company's operating costs and investments over the coming years. This estimate is based on assumptions that could prove to be wrong, and the company could exhaust its capital resources more quickly than it currently expects.
Marinomed always strives to maintain financial flexibility, for example via raising additional capital in more favourable market conditions or based on strategic considerations. The company currently believes that it has sufficient funds for its current or future operating plans.
Marinomed believes that the company could forego certain expenditures to reduce its cash requirements. If Marinomed becomes unable to raise capital when needed, this may result in delays, cutbacks or termination of research and development programmes as well as future commercialisation efforts.
Marinomed is a sub-lessee of the University of Veterinary Medicine in Vienna, which is also currently a shareholder of the company. The rental agreement has a fixed term until the end of June 2020. Marinomed is therefore currently constructing a new headquarters in Korneuburg. If the new premises are not ready for occupancy in time, Marinomed could be reliant on the University of Veterinary Medicine extending the rental agreement. Due to the current coronavirus crisis (SARS-CoV-2), delays are anticipated on all building sites.
The Carragelose® technology is protected by several patents worldwide. The patents of the Marinosolv® technology are currently in the nationalisation phase. Nonetheless, it is possible that patents will be contested or current unique selling points will be undermined by new technologies or products.
Marinomed's success largely depends upon the degree to which its research and development initiatives achieve the expected results. The research activities of Marinomed are designed to increase knowledge for the benefit of humanity while protecting the environment at the same time. Its internal and external researchers act in accordance with statutory rules and ethical principles. A responsible approach to research primarily involves the following measures in the event of research that is at risk of abuse: identifying and minimising research risks, carefully managing publications, documenting risks and, implementing educational and training measures.
Nonetheless, it is possible that the results of the research and clinical trials will not reach the expected primary or secondary endpoints or will not be significantly better than existing or new rival products. This could materially erode the value of Marinomed's research projects. In extreme cases, individual projects could become worthless and the envisaged income impossible to realise.
Due to the small number of personnel, there is a risk that any deficit of key staff members will lead to a loss of essential expertise, with their replacement causing delays in meeting targets.
Marinomed carries out research and development activities for drugs and medical devices. Utilising opportunities and avoiding risks is therefore important for the company's success. Consequently, Marinomed pursues a systematic approach to the early recognition of opportunities and risks. The areas outlined in the "Risk report" are repeatedly scrutinised through company-wide planning and control processes. Overall responsibility for Marinomed's internal control and risk management lies with the management board.
The risk management system focuses on the areas set out in the preceding section on risk. Operational risks are in particular addressed via close internal and also external communication. Regular contact with all external suppliers and partners and the documentation of discussions and meetings enable constant tracking of planning and implementation. Marinomed succeeded in securing investors for the IPO and also in obtaining a venture loan from the EIB. These two funding elements have, firstly, helped to improve the company's capital structure while also enabling the firm to step up implementation of its research and development activities. They have thus reduced the level of dependency on the general economic situation, financing conditions and successful receivables management.
Marinomed's internal control system has the specific task of ensuring the reliability of financial reporting, compliance with statutory and internal company guidelines, and also identifying risks including risks not related to financial reporting.
The principle of dual control is observed for all relevant transactions.
The internal control system comprises elements of both structural and procedural organisation. The structural organisation is characterised by flat hierarchies and a clear allocation of responsibility. There is organisational separation of operational and financial responsibility including accounting, which comprises bookkeeping, controlling and reporting.
The procedural organisation is shaped by a clear set of rules which provide an appropriate basis for an efficient control system based on approvals and authorities. Internal reporting to the management board is particularly important in this context in order to ensure that risks can be identified at an early stage and countermeasures taken. This takes the form of regular meetings on key thematic areas, notably research and development, supply chain and finance. Depending on their significance, these meetings are held weekly or monthly.
At the meetings, the relevant departmental managers provide the management board with structured reports containing the necessary information. The aim is to reduce risks which could result in incomplete or incorrect financial reporting.
Internal reporting is designed to enable the management board to conduct regular reviews on the plausibility of key processes and their financial impact and to compare with planning, in order to be able to decide on and adopt suitable measures in the event of deviations. The necessary planning for clinical studies, external service providers and sales is approved by the management board in advance.
In addition, the company prepares rolling liquidity planning, which is continuously monitored and aligned with the company's own criteria.
Accounting regularity is ensured through an accounting-based internal control system. This aims to ensure compliance with legal norms, generally accepted accounting principles, and the accounting rules of the Austrian Commercial Code (UGB) as well as the accounting rules of the International Financial Reporting Standards (IFRS).
Since the start of the 2019 financial year, accounting has no longer been conducted by an external tax advisor and instead has been carried out internally using the BMD software. In addition, the company has invested in financial planning software that provides an interface to BMD and allows the reporting of differences between planned and actual figures.
The accounts are audited by the international auditing firm BDO Austria GmbH Wirtschaftsprüfungs- und Steuerberatungsgesellschaft. In addition, Deloitte Tax Wirtschaftsprüfungs GmbH assists with the preparation of reporting pursuant to IFRS, especially with regard to valuation and presentation matters.
Marinomed complies with the provisions of the Austrian Code of Corporate Governance (ACCG) and prepares a corresponding public corporate governance report as part of its annual report. The Company has appointed a compliance officer to advise the management board and monitor the functioning of the internal control system from the 2019 financial year onwards.
Marinomed has a research and development facility on its premises, including state-of-the-art laboratories to facilitate research in the fields of pharmacy, biology, molecular biology, cell biology and in vivo pharmacology. Its research and development activities focus on the two platforms, Marinosolv® and Carragelose®. Spending on research and development climbed to EUR 4.78 million in the 2019 financial year, up from EUR 2.93 million in 2018.
The flagship product of the Marinosolv® technology platform is Budesolv, a new medicine to treat allergic rhinitis. Marinomed has devised a method for fully dissolving the hardly soluble compound budesonide. The successful completion of the pivotal clinical study in April 2019 as well as the detailed data presented at the annual meeting of the American College of Allergy, Asthma & Immunology (ACAAI) in Houston, Texas prove that Budesolv can achieve better and faster results in treating allergies than the market product while using a lower dose of the compound. This marks the first innovation in allergy treatment using budesonide for many years. Due to necessary regulatory steps, initial approval for the medicine is expected in 2021 at the earliest. In the meantime, Marinomed has generated promising pre-clinical data for additional products including fluticasone, mometasone, fluorometholone and pergolide. A further compound is at a more advanced stage of development: Tacrosolv is scheduled to enter clinical development in 2020.
The Carragelose® platform is set to be extended with additional products in the future. The first newly developed medical device on a physical basis received certification in 2018. In 2020, Marinomed expects to apply for marketing approval of Carravin, a combination of Carragelose® and the decongestant compound xylometazoline based on a bibliographical approval process. The company expects approval to be obtained in 2021 at the earliest.
Marinomed employed an average of 31 staff members in the 2019 financial year (FTEs, 2018: 30), 31 of whom were active (2018: 28, due to two employees on maternity leave) including 15 in research and development. 68% of employees were female, rising to as much as 75% in R&D. Female staff held 40% of management positions. The majority of the company's personnel have academic qualifications. The average fluctuation over the past 5 years has been around 10%, and there were no resignations in the past financial year.
The management board of Marinomed Biotech AG comprises a minimum of two and a maximum of five members in accordance with the Articles of
Association. The members are appointed by the supervisory board for up to five years and can be reappointed. Marinomed's management board consisted of three members at the end of the 2019 financial year.
In accordance with the Articles of Association, the supervisory board of Marinomed Biotech AG comprises a minimum of three and a maximum of six members, who are elected at the AGM for a period of five years. If a works council is established in future, it can delegate three staff representatives to the supervisory board. The supervisory board consisted of five members at the end of the 2019 financial year. The members appointed in 2017 were all members of the company's advisory council before the change of legal form to a limited stock corporation.
| Management board Name and function |
Year of birth | Initial appointment |
End of function period |
|
|---|---|---|---|---|
| Andreas Grassauer | ||||
| Chairman | 1969 | 20061) | 2022 | |
| Eva Prieschl-Grassauer | ||||
| Vice Chairwoman | 1968 | 20061) | 2022 | |
| Pascal Schmidt | ||||
| Chief Financial Officer | 1972 | 2018 | 2022 | |
| Supervisory board Name and function |
||||
| Simon Nebel | ||||
| Chairman | 1966 | 2017 | 2023 | |
| Ute Lassnig | ||||
| Vice Chairwoman | 1970 | 2017 | 2023 | |
| Karl Lankmayr | ||||
| Member | 1978 | 2017 | 2023 | |
| Gernot Hofer | ||||
| Member | 1980 | 2017 | 2023 | |
| Brigitte Ederer | ||||
| Member | 1956 | 2018 | 2023 |
1) since 2006 ‒ management; following change of legal form to a limited stock corporation in 2017 ‒ management board
Financial statements
| Year ended December 31 all amounts in kEUR |
Note | 2019 | 2018 |
|---|---|---|---|
| Profit or Loss | |||
| Revenues | 5 | 6,144.6 | 4,666.3 |
| Other income | 6 | 671.8 | 675.7 |
| Other gains (losses), net | 7 | 9.9 | 10.2 |
| Expenses for materials | 8 | –3,575.2 | –3,313.9 |
| Expenses for services | 8 | –3,081.7 | –1,517.9 |
| Personnel expenses | 9 | –4,219.4 | –2,516.5 |
| Depreciation and amortisation | 10 | –327.2 | –236.8 |
| Other expenses | 11 | –1,833.2 | –2,908.0 |
| Operating result (EBIT) | –6,210.4 | –5,140.8 | |
| Financial income | 13 | 0.3 | 210.8 |
| Financial expenses | 13 | –1,002.0 | –7,163.3 |
| Financial result | –1,001.6 | –6,952.5 | |
| Loss before taxes | –7,212.1 | –12,093.4 | |
| Taxes on income | 14 | –4.4 | –3.5 |
| Loss for the year | –7,216.5 | –12,096.9 | |
| Other comprehensive income (loss) for the year | 0.0 | 0.0 | |
| Total comprehensive loss for the year | –7,216.5 | –12,096.9 |
All results are attributable to shareholders of the Company.
| Year ended December 31 all amounts in EUR |
Note | 2019 | 2018 |
|---|---|---|---|
| Earnings per share | |||
| Basic (EUR per share) | 15 | –5.1 | –12.1 |
| Diluted (EUR per share) | 15 | –5.1 | –12.1 |
The notes are an integral part of these financial statements.
| Year ended December 31 all amounts in kEUR |
Note | 2019 | 2018 |
|---|---|---|---|
| ASSETS | |||
| Non-current assets | |||
| Intangible assets | 18 | 1,625.4 | 1,331.7 |
| Property, plant and equipment | 17 | 2,491.0 | 195.4 |
| Shares in affiliated companies | 31 | 35.0 | - |
| Deposits and other non-current receivables | 21 | 12.5 | 12.8 |
| 4,163.9 | 1,540.0 | ||
| Current assets | |||
| Inventories | 19 | 97.5 | 115.7 |
| Trade and other receivables | 21 | 3,220.4 | 1,892.2 |
| Current tax receivables | 14 | 0.0 | 0.0 |
| Cash and cash equivalents | 22 | 12,019.6 | 1,715.5 |
| 15,337.5 | 3,723.4 | ||
| Total assets | 19,501.5 | 5,263.4 |
| Year ended December 31 all amounts in kEUR |
Note | 2019 | 2018 |
|---|---|---|---|
| Equity and liabilities | |||
| Capital and reserves | |||
| Share capital | 23 | 1,469.8 | 1,000.0 |
| Capital reserves | 23 | 40,848.1 | 6,968.3 |
| Retained losses | –31,451.9 | –24,235.4 | |
| 10,866.0 | –16,267.1 | ||
| Non-current liabilities | |||
| Borrowings | 25 | 4,505.4 | 1,173.5 |
| Silent partnerships | 24 | - | - |
| Convertible bond | 26 | - | 5,583.1 |
| Other financial liabilities | 27 | - | 7,132.0 |
| Other non-current liabilities | 29 | 104.1 | - |
| 4,609.5 | 13,888.6 | ||
| Current liabilities | |||
| Borrowings | 25 | 135.2 | 3,715.6 |
| Trade payables | 28 | 1,002.4 | 2,014.5 |
| Convertible bond | 26 | - | 131.2 |
| Current contract liabilities and other current liabilities | 29 | 1,615.4 | 960.5 |
| Provisions | 30 | 1,273.0 | 820.0 |
| 4,026.0 | 7,641.8 | ||
| Total equity and liabilities | 19,501.5 | 5,263.4 |
The notes are an integral part of these financial statements.
| Year ended December 31 all amounts in kEUR |
Note | 2019 | 2018 |
|---|---|---|---|
| CASH FLOW FROM OPERATING ACTIVITIES | |||
| Loss for the year | –7,216.5 | –12,096.9 | |
| Adjustments for: | |||
| Taxes on income recognised in profit or loss | 4.4 | 3.5 | |
| Financial income recognised in profit or loss | –0.3 | –210.8 | |
| Financial expense recognised in profit or loss | 1,002.0 | 7,163.3 | |
| Depreciation and amortisation expense | 327.2 | 236.8 | |
| Net book value of disposals of assets | 0.0 | 0.0 | |
| (Gain)/Loss on disposal of assets | –0.0 | –0.2 | |
| Non-cash-income from grant due to debt relief | - | –350.5 | |
| Other non-cash income/expense | 356.4 | –10.8 | |
| Changes in deposits and other non-current receivables | 0.3 | –9.9 | |
| Changes in inventories | 18.2 | 62.0 | |
| Changes in trade and other receivables | –1,328.2 | –248.3 | |
| Changes in provisions | 453.0 | 57.0 | |
| Other changes in trade liabilities, contract liabilities and other liabilities | –870.7 | 1,650.8 | |
| Interest paid | –382.2 | –558.3 | |
| Interest received | 0.2 | 0.1 | |
| Taxes paid | –4.4 | –3.5 | |
| Cash flow utilised by operating activities | 16 | –7,640.7 | –4,315.7 |
| Purchase of plant and equipment and intangible assets | –2,340.9 | –229.1 | |
| Proceeds from sale of property, plant and equipment | - | 0.2 | |
| Investments in financial assets | –35.0 | - | |
| Cash flow utilised by investing activities | 16 | –2,375.9 | –228.9 |
| Year ended December 31 all amounts in kEUR |
Note | 2019 | 2018 |
|---|---|---|---|
| Proceeds from shareholders | 22,425.0 | 867.6 | |
| Convertible bond repayments | –24.8 | - | |
| Proceeds from EIB loan | 4,000.0 | - | |
| Repayments of shareholders' loans | –2,262.7 | –89.3 | |
| Repayments of long-term borrowings | –1,891.1 | –530.0 | |
| Lease payments | –98.4 | –17.0 | |
| Equity transaction costs | –1,779.5 | –1.7 | |
| EIB loan transaction costs | –47.9 | - | |
| Cash flow generated from financing activities | 16 | 20,320.7 | 229.7 |
| Net cash flow | 10,304.1 | –4,314.9 | |
| Cash & cash equivalents at beginning of period | 22 | 1,715.5 | 6,030.4 |
| Cash & cash equivalents at end of period | 22 | 12,019.6 | 1,715.5 |
| Of which effect of exchange rate changes on the balance of cash and cash equivalents held in foreign currencies |
8.6 | 1.8 |
The notes are an integral part of these financial statements.
| all amounts in kEUR | Nominal capital/ share |
Capital Reserves |
|---|---|---|
| January 1, 2018 | 132.4 | 6,979.3 |
| Loss for the year | - | - |
| Total comprehensive income (loss) for the year | - | - |
| Paid in capital, net of transaction cost | 867.6 | –11.0 |
| December 31, 2018 | 1,000.0 | 6,968.3 |
| Loss for the year | - | - |
| Total comprehensive income (loss) for the year | - | - |
| ESOP 2019 | - | 426.5 |
| Paid in capital, net of transaction cost | 299.0 | 20,336.3 |
| Conversion of convertible bond | 170.8 | 13,117.0 |
| December 31, 2019 | 1,469.8 | 40,848.1 |
The notes are an integral part of these financial statements.
| Total | Retained losses |
|---|---|
| –5,026.9 | –12,138.6 |
| –12,096.9 | –12,096.9 |
| –12,096.9 | –12,096.9 |
| 856.6 | - |
| –16,267.1 | –24,235.4 |
| –7,216.5 | –7,216.5 |
| –7,216.5 | –7,216.5 |
| 426.5 | - |
| 20,635.3 | - |
| 13,287.8 | - |
| 10,866.0 | –31,451.9 |
The notes are an integral part of these financial statements.
Marinomed Biotech AG ("Marinomed" or the "Company") is a biopharmaceutical company focusing on the development of innovative products in the field of antiviral and immunological diseases based on its intellectual property (IP) protected technology platforms. The Company develops therapies against respiratory diseases using its innovative antiviral respiratory technology platform, Carragelose®. In addition, Marinomed invented a technology that allows the solubilisation of otherwise hardly soluble compounds resulting in their faster and higher efficacy. This technology platform is named Marinosolv®. The Company was incorporated in March 2006 as a spinoff from the Veterinary University of Vienna. The Company's headquarters are located at Veterinärplatz 1, 1210 Vienna, Austria.
The management board approved the financial statements for issuance on April 15, 2020.
The principal accounting policies applied in the preparation of these financial statements are set out below. These policies have been consistently applied to all the years presented, unless otherwise noted. The tables in this report may contain rounding differences.
The financial statements of the Company have been prepared in accordance with the International Financial Reporting Standards (IFRS) issued by the International Accounting Standards Board (IASB), London, and the Interpretations of the IFRS Interpretations Committee (IFRS IC), as adopted by the European Union (EU).
The preparation of financial statements in conformity with IFRS as adopted by the EU requires the use of certain critical accounting estimates. It requires management to exercise its judgement in the process of applying the Company's accounting policies. The areas involving a higher degree of judgement or complexity, or areas where assumptions and estimates are significant to the financial statements are discussed at the respective balance sheet/P&L position.
Since inception, the Company has incurred significant losses from its operations. As the Company is a biotech company and engaged in intense research activity, the losses are not unexpected, but according to plan. The business model of the Company foresees a phase of research and development over several years before gaining its own relevant income. The research and development risk as well as the financing and liquidity risk are covered primarily by equity financing from shareholders as well as use of support programmes by the Austrian Research Promotion Agency (Österreichische Forschungsförderungsgesellschaft, or FFG), the research premium from the Austrian government and external research assignments.
After placement of a convertible bond on the Third Market (MTF) of the Vienna Stock Exchange in the amount of kEUR 7,000 in 2017, the Company prepared for going public in financial year 2018. In the course of a successful Initial Public Offering (IPO) on February 1, 2019 and the fully exercised greenshoe option on February 28, 2019, total gross proceeds of kEUR 22,425 were recorded from the issuance of new shares.
As of February 25, 2019, the Company was granted a loan by the European Investment Bank (EIB) in the amount of up to kEUR 15,000, which is covered by a guarantee of the European Fund for Strategic Investments (EFSI). This venture debt loan bears interest at customary market rates. It is expected to be transferred to Marinomed Biotech AG in three tranches subject to the achievement of certain milestones between 2019-2022, and will be settled in financial years 2024-2027. In October 2019, Marinomed called the first tranche in the amount of kEUR 4,000.
The Company´s ability to generate profits depends on further revenues from licensing and milestone payments from existing contracts and contracts currently under negotiation for the commercialisation of existing and future products and technologies.
However, based on the cashflows from the IPO, the EIB loan as well as from the future sale of goods, management expects liquidity to be most probably ensured until the end of 2021.
These financial statements have therefore been prepared on a going concern basis that contemplates that the Company will continue in operation for the foreseeable future and will be able to realise its assets and discharge its liabilities in the normal course of operations.
In the current year, the Company has applied the following new and revised standards and interpretations issued by the IASB that are mandatorily effective for an accounting period that begins on or after January 1, 2019:
IFRS 16 Leases (applicable to financial years beginning on or after January 1, 2019; EU endorsement: October 31, 2017): IFRS 16 specifies how an IFRS reporter will recognise, measure, present and disclose leases. The standard provides a single lessee accounting model, requiring lessees to recognise assets (the right to use the leased item) and financial liabilities for all leases unless the lease term is 12 months or less or the underlying asset has a low value. Lessees will be required to separately recognise the interest expense on the lease liability and the depreciation expense on the right-of-use asset.
Lessees will be also required to remeasure the lease liability upon the occurrence of certain events (e.g. a change in the lease term, a change in future lease payments resulting from a change in an index or rate used to determine those payments). The lessee will generally recognise the amount of the remeasurement of the lease liability as an adjustment to the right-of-use asset.
Lessors continue to classify leases as operating or finance, with IFRS 16's approach to lessor accounting substantially unchanged from its predecessor, IAS 17.
The Company applied the standard from its mandatory adoption date of January 1, 2019. The Company applied the simplified transition approach and did not restate comparative amounts for the year prior to first adoption. All right-of-use assets are measured at the amount of the lease liability on adoption (adjusted for any prepaid or accrued lease expenses). For leases that were classified as finance leases under IAS 17, the balances of lease assets and lease liabilities previously recognized were carried forward in 2019.
As at the reporting date, the Company has one operating lease commitment with the Veterinary University of Vienna for the use of business and research premises. The Company recognised a right-of-use asset of about kEUR 119 and a corresponding lease liability in respect of this lease agreement as of January 1, 2019. In the fiscal year 2019 the impact on profit or loss was to decrease other expenses by kEUR 90, to increase depreciation by kEUR 82 and to increase interest expense by kEUR 11.
The following table reconciles the operating lease commitments (without operating costs) as of December 31, 2018 to the amount of lease liabilities recognised on January 1, 2019:
| Lease liabilities recognised at January 1, 2019 | 199.8 |
|---|---|
| Finance lease liabilities at December 31, 2018 | 81.2 |
| Less: effect of discounting using the incremental borrowing rate as at the date of the initial application | –12.1 |
| Minimum operating lease commitment at December 31, 2018 | 130.7 |
| all amounts in kEUR |
Several other amendments and interpretations apply for the first time in 2019 or later, but do not have an impact on the yearly financial statements of the Company:
| Amendment | Date of Publication |
Date of Endorsement |
Effective Date (EU) |
|---|---|---|---|
| IFRIC 23 Uncertainty over Income Tax Treatments | 07.06.2017 | 23.10.2017 | 01.01.2019 |
| Amendments to IFRS 9: Prepayment Features with Negative Compensation |
12.10.2017 | 22.03.2018 | 01.01.2019 |
| Amendments to IAS 28: Long-term Interests in Associates and Joint Ventures |
12.10.2017 | 08.02.2019 | 01.01.2019 |
| Amendments to IAS 19: Plan Amendment, Curtailment or Settlement |
07.02.2018 | 13.03.2019 | 01.01.2019 |
| Annual Improvements to IFRS Standards ‒ 2015–2017 Cycle |
12.12.2017 | 14.03.2019 | 01.01.2019 |
New and amended standards that will be effective in future periods:
| Standard / Amendment | Date of Publication |
Date of Endorsement |
Effective Date (EU) |
|---|---|---|---|
| Amendments to IAS 1 and IAS 8: Definition of Material |
31.10.2018 | 29.11.2019 | 01.01.2020 |
| Amendments to Reference to the Conceptual Framework in IFRS Standards |
29.03.2018 | 29.11.2019 | 01.01.2020 |
| IBOR-Reform: Amendments to IFRS 9, IAS 39 and IFRS 7 |
26.09.2019 | 15.01.2020 | 01.01.2020 |
| Standard / Amendment (Pending Adoption into EU Law) |
Date of Publication |
Effective Date (IASB) |
|---|---|---|
| IFRS 17 Insurance Contracts | 18.05.2017 | 01.01.2021 |
| Amendment to IFRS 3 Business Combinations: Definition of a Business Operation |
22.10.2018 | 01.01.2020 |
In 2019, the Company reports the two operating segments, Carragelose and Marinosolv, based on the Company's platforms. Carragelose combines activities from products which are already distributed, as well as Research & Development of new products based on the active ingredient Carragelose®. At the moment Marinosolv generates only minor revenues, but is expected to make further contributions in the future. Residual operating activities which cannot be attributed to Carragelose or Marinosolv are reported as "Corporate".
The Carragelose® product line with unique anti-viral properties targets viral infections of the respiratory tract of more than 200 different virus strains. Marinomed has achieved market validation with its anti-viral nasal spray for the common cold, initially launched in 2008. IP protection lasts until 2036 for particular products (decongestant medical device). The Company managed to conclude licence and distribution agreements for various Carragelose® products with OTC (over the counter, or non-prescription drug) partners in countries almost all over the world.
Marinosolv® is an innovative technology platform that increases the bioavailability of hardly soluble compounds for the treatment of sensitive tissues such as nose and eyes. Stable aqueous formulations of hardly soluble compounds such as corticosteroids and immunosuppressants allow a faster onset of action, high local activity, an increased bioavailability and aseptic production. Currently, two products are in development targeting inflammatory diseases of nose (Budesolv) and eyes (Tacrosolv). A patent application was filed in 2015, which is currently in the nationalisation phase subsequent to the patent cooperation treaty (PCT) phase. Depending on the active (pharmaceutical) ingredient and the region, the products may be classified either as OTC (over-the-counter) or Rx (prescription drug).
General information on revenues from the Carragelose segment is provided in the section entitled "Break-down of revenues by categories and geographical Area."
The reporting format was derived from the Company's internal reporting. IFRS segment information is provided to the management.
The following is an analysis of the Company's revenues and operating result (EBIT) by reportable segment.
| Year ended December 31, 2018 all amounts in kEUR |
Carragelose | Marinosolv | Corporate | Total |
|---|---|---|---|---|
| Total revenues | 4,666.3 | - | - | 4,666.3 |
| Of which sale of goods | 4,416.4 | - | - | 4,416.4 |
| Austria | 74.8 | - | - | 74.8 |
| Other European countries | 2,082.8 | - | - | 2,082.8 |
| Non-European countries | 2,258.7 | - | - | 2,258.7 |
| Of which other revenues | 249.9 | - | - | 249.9 |
| Austria | 85.4 | - | - | 85.4 |
| Other European countries | 62.1 | - | - | 62.1 |
| Non-European countries | 102.4 | - | - | 102.4 |
| Cost of goods sold | –3,285.4 | - | - | –3,285.4 |
| Contract research | –168.9 | –759.1 | - | –928.0 |
| Personnel expenses | –693.8 | –792.3 | –1,030.4 | –2,516.5 |
| Other miscellaneous income/(expense) | –604.4 | –122.4 | –597.8 | –1,324.6 |
| Depreciation and amortisation | –138.8 | –27.3 | –70.7 | –236.8 |
| Non-recurring items | - | - | –1,515.8 | –1,515.8 |
| Operating result (EBIT) | –225.0 | –1,701.1 | –3,214.8 | –5,140.8 |
| Year ended December 31, 2019 all amounts in kEUR |
Carragelose | Marinosolv | Corporate | Total |
|---|---|---|---|---|
| Total revenues | 6,129.6 | 15.0 | - | 6,144.6 |
| Of which sale of goods | 4,879.4 | - | - | 4,879.4 |
| Austria | - | - | - | - |
| Other European countries | 3,020.6 | - | - | 3,020.6 |
| Non-European countries | 1,858.8 | - | - | 1,858.8 |
| Of which other revenues | 1,250.2 | 15.0 | - | 1,265.2 |
| Austria | 86.8 | 15.0 | - | 101.8 |
| Other European countries | 969.0 | - | - | 969.0 |
| Non-European countries | 194.4 | - | - | 194.4 |
| Cost of goods sold | –3,481.6 | - | - | –3,481.6 |
| Contract research | –526.7 | –1,935.6 | - | –2,462.3 |
| Personnel expenses | –719.0 | –1,275.1 | –2,225.3 | –4,219.4 |
| Other miscellaneous income/(expense) | –411.7 | 179.4 | –955.1 | –1,187.3 |
| Depreciation and amortisation | –161.2 | –76.9 | –89.0 | –327.2 |
| Non-recurring items | - | - | –677.2 | –677.2 |
| Operating result (EBIT) | 829.4 | –3,093.2 | –3,946.6 | –6,210.4 |
In 2019 "Other revenues" include kEUR 900 related to the waiver of commercialisation rights by a European licensing partner.
In both reporting periods "Cost of goods sold" include expenses for merchandise and regular batch release charges (excluding exceptional charges) related to "Sales of goods" and form part of, but do not equal the sum of the P&L items "Expenses for materials" and "Expenses for services".
In both reporting periods "Non-recurring items" include IPO-related expenses (especially for legal and other consultancy services) that were not directly deducted from equity.
In 2019 the recognition of a provision related to the relocation in the amount of kEUR 250 is also presented as "Non-recurring items".
As of December 31, 2018 this position additionally includes income from the conversion of loans to non-repayable grants in the amount of kEUR 350.5.
Revenues from the sale of goods include nasal and throat products based on the Carragelose® technology. Other revenues relate to income from licences and royalties as well as miscellaneous other services. The geographical breakdown is based on distribution markets. Between 20% and 30% of total revenues were generated in the Scandinavian market (including Denmark) in 2019, compared to less than 10% in the previous year. Between 20% and 30% of total revenues were generated in the German market in 2019 (including other revenues mentioned above amounting to kEUR 900), while Germany contributed 10-20 % in the previous year. Australia and Iran accounted for 10-20% of total revenues each in 2018, but represented less than 10% each in 2019.
Long-term assets are fully attributable to Austria where the Company´s premises are located in 2019 and 2018.
Customers exceeding 10% of total revenues are considered major customers for the following schedule.
| Year ended December 31, 2018 all amounts in kEUR |
Total revenues | % | Segment |
|---|---|---|---|
| Top 1 | 1,653.3 | 35% | Carragelose |
| Top 2 | 765.7 | 16% | Carragelose |
| Top 3 | 491.8 | 11% | Carragelose |
| Total | 2,910.8 | 62% | |
| Year ended December 31, 2019 | |||
| Top 1 | 1,558.5 | 25% | Carragelose |
| Top 2 | 1,554.9 | 25% | Carragelose |
| Top 3 | 909.7 | 15% | Carragelose |
| Total | 4,023.1 | 65% |
Items included in the financial statements of the Company are measured using the currency of the primary economic environment in which it operates (the functional currency). The financial statements are presented in Euro, which is the Company's functional and presentation currency.
In preparing the financial statements of the Company, transactions in currencies other than the entity's functional currency (foreign currencies) are recognised at the exchange rates prevailing at the dates of the transactions. Foreign currency exchange gains and losses resulting from the settlement of such transactions and from the translation at year-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognised in the statement of profit or loss and other comprehensive income (loss) (see also Note 7).
These financial statements are prepared on the basis of historical cost of acquisition with the exception of certain items such as financial assets at fair value through profit or loss ("FVTPL") and financial assets at fair value through other comprehensive income ("FVTOCI") which are shown at fair value. The statement of profit or loss and other comprehensive income (loss) is presented using the nature-of-expense method. In the statement of profit or loss and other comprehensive income (loss) and statement of financial position certain items are combined for the sake of clarity or immateriality. As required by IAS 1, assets and liabilities are classified by maturity. They are classified as current if they mature within one year, and otherwise as non-current.
To date the Company has not paid dividends. Dividend distribution to the Company's shareholders shall be recognised as a liability in the Company's financial statements in the period in which the dividends are approved by the Company's shareholders.
Assets that are subject to depreciation/amortisation are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. An impairment loss is recognised for the amount by which the asset's carrying amount exceeds its recoverable amount. The recoverable amount is the higher of an asset's fair value less costs to sell and value in use. For the purpose of assessing impairment, assets are grouped at the lowest levels for which there are separately identifiable cash flows (cash-generating units). Non-financial assets that have suffered impairment are reviewed for possible reversal of the impairment at each reporting date. During the reporting period, no events have been identified that materially reduced the value of any asset and thus no impairment is deemed necessary.
Debt and equity instruments issued by the Company are classified as either financial liabilities or as equity in accordance with the substance of the contractual arrangements and the definitions of a financial liability and an equity instrument.
An equity instrument is any contract that evidences a residual interest in the assets of an entity after deducting all of its liabilities. Equity instruments issued by the Company are recognised at the proceeds received, net of direct issue costs (transaction costs).
Compound instruments have both a liability and an equity component from the issuer's perspective. The component parts of compound instruments issued by the Company are classified separately as financial liabilities and equity according to their substance based on the definitions of liability and equity. The split is made at issuance and not revised for subsequent changes in market interest rates, share prices or other events.
In 2015, certain shareholders provided the Company with shareholders' loans (see Note 25). The shareholders' loans attract interest at a below-market rate. They shall be repaid in cash at the end of the period. However, the Company is entitled to request conversion of the loans into non-repayable shareholders' contributions upon fulfillment of certain criteria and agreement in the general meeting of shareholders by at least 80% of the votes cast.
The Company has an unavoidable obligation to make yearly interest payments on the outstanding amount. Further, there is an obligation to repay the loan at maturity. Whilst the loan may be converted into a shareholders' contribution, this is not at the Company's sole discretion. Accordingly the shareholders' loans represent a financial liability, which is initially recognised at fair value and subsequently measured at amortised cost.
Due to the fact that the interest rate in the loan agreements was below market rate, the market rate (estimated with 15.0% p.a. in 2015 and following years, see Note 25) has been taken into account to calculate the fair value of the loans at inception. The difference between the fair value and the amounts received is recognised directly in equity. This is because, in essence, the shareholders have provided the Company the benefit of finance at an advantageous rate of interest.
Transaction costs that relate to the issue of the shareholders' loans are allocated to the liability and equity components in proportion to the allocation of the gross proceeds. Transaction costs relating to the equity component are recognised directly in equity. Transaction costs relating to the liability component are deducted from the carrying amount of the liability component and are amortised over the lives of the shareholders' loans using the effective interest method.
As per the resolution of the supervisory board on April 11, 2019, the shareholder loans in the amount of kEUR 2,305 were repaid ahead of maturity in June 2019.
The Company's activities expose it to a variety of financial risks: market risk (including currency risk, fair value interest rate risk, cash flow interest rate risk and price risk), credit risk and liquidity risk. The Company's overall risk management program focuses on the unpredictability of financial markets and seeks to minimise potential adverse effects on the Company's financial performance. The Company has not used derivatives or other hedging instruments to mitigate these risk factors.
Currency risk is the risk that the value of a financial instrument will fluctuate due to changes in foreign exchange rates. The Company operates internationally and is exposed to foreign exchange risk arising from various currency exposures, primarily with respect to the British pound (GBP). Foreign exchange risk arises when future commercial transactions or recognised assets or liabilities are denominated in a currency that is not the entity's functional currency.
| As of December 31 all amounts in kEUR |
2019 GBP |
2018 GBP |
|---|---|---|
| Trade receivables | 227.3 | 133.4 |
| Cash and cash equivalents | 1.0 | 0.7 |
| Trade payables | –0.1 | –0.1 |
| Total | 228.2 | 134.0 |
Foreign currency denominated receivables and payables are short term in nature (generally 30 days to max. 75 days after the last day of the month following the issuance of the invoice). As a result, foreign exchange rate movements during the year had no material effect on the financial statements.
As stated in the table above, the Company is primarily exposed to changes in GBP/EUR exchange rates. The Company's sensitivity to a 10% increase/decrease in EUR against the GBP amounts to kEUR (22.8)/22.8 (2018: kEUR (13.4)/13.4). The sensitivity analysis includes only outstanding GBP denominated monetary items and adjusts their translation at the period end for a 10% change in foreign currency rates. Due to the seasonality in revenues receivables in GBP are above average at year-end.
Interest rate risk is the risk that the fair value or future cash flows of a financial instrument will fluctuate because of changes in market interest rates. The Company's exposure to the risk of changes in market interest rates relates primarily to the Company's long-term borrowings with variable interest rates.
The Company manages its interest rate risk by having a balanced portfolio of fixed and variable rate loans and borrowings. Although the Company has no specific requirements on the exact proportion of interest that should be fixed or floating, the position is reviewed regularly by management.
Long-term borrowings with variable rates only comprise lease contracts in 2019 (see Note 25). The majority of interest-bearing financial liabilities carry fixed interest rates. Further, the Company's operating cash flows are substantially independent of changes in market interest rates. Cash flow interest rate risk is therefore immaterial.
The Company's fixed rate borrowings are carried at amortised cost. They are therefore not subject to interest rate risk as defined in IFRS 7, since neither the carrying amount nor the future cash flows will fluctuate because of a change in market interest rates.
Price risk is the risk that the value of a financial instrument will fluctuate due to changes in the market price.
The Company is currently not exposed to equity or debt securities price risk from investments held by the Company and classified in the statement of financial position as FVTOCI or FVTPL. The Company is not particularly exposed to commodity price risk and has mostly the contractual right to pass on significant price increases.
Credit risk is the risk that one party to a financial instrument will fail to discharge an obligation and cause the other party to incur a financial loss. The Company is exposed to credit risk from its operating activities (primarily for trade receivables) and from its financing activities, including deposits with banks and financial institutions, foreign exchange transactions and other financial instruments.
Outstanding customer receivables are regularly monitored and collection measures set as required. To reduce the credit risk, advance payments are mandatory for specific customers. The customer's creditworthiness is checked regularly and impairments for expected losses are recorded in accordance with IFRS 9 based on historical experience and days past due. With regards to the favorable market environment in the pharmaceutical industry (for further details see management report and analysis) there is no indication of a future decline in creditworthiness of the Company's customers. The maximum exposure to credit risk at the reporting date is the carrying value of each class of receivable (see Note 21).
The credit risk on liquid funds (bank accounts, cash balances and securities) is limited because the counterparties are banks with high credit ratings from international credit rating agencies.
Liquidity risk (funding risk) is the risk that an enterprise will encounter difficulty in raising funds to meet commitments associated with financial instruments. Prudent liquidity risk management involves maintaining sufficient cash, ensuring the availability of adequate funding in the form of committed credit facilities and being able to close out market positions. The Company manages liquidity risk by maintaining adequate reserves, continuously monitoring forecast and actual cash flows and by matching the maturity profiles of financial assets and liabilities.
The table below shows the residual maturities of non-derivative financial liabilities and receivables at the end of the reporting period. The amounts disclosed are the contractual undiscounted cash flow values.
| As of December 31, 2018 all amounts in kEUR |
Less than 1 year |
Between 1 and 5 years |
Over 5 years |
|---|---|---|---|
| Borrowings | –4,163.9 | –1,270.0 | - |
| Convertible bond | –280.0 | –13,160.0 | - |
| Trade payables | –2,014.5 | - | - |
| Trade receivables | 622.3 | - | - |
| Total | –5,836.1 | –14,430.0 | - |
| Total | 294.6 | –7,876.7 | –6,498.5 |
|---|---|---|---|
| Trade receivables | 1,484.7 | - | - |
| Trade payables | –1,002.4 | - | - |
| Convertible bond | - | - | - |
| Borrowings | –187.7 | –7,876.7 | –6,498.5 |
| As of December 31, 2019 |
For borrowings with variable interest rates, the cash flows have been estimated using the interest rate applicable to the contract at the end of the reporting period. In 2019 borrowings include royalty payments related to the EIB venture loan (for further details ses Note 25).
The contractual undiscounted cash flows resulting from the convertible bond stated in the table above represent the maximum amount of possible payments including contingently payable licence/trade sale premiums to the highest possible extent (max. licence premium: kEUR 2,800; max. trade sale premium: kEUR 2,800). In 2019, kEUR 6,980 were converted into equity and the remaining kEUR 20 were bought back by the company for an amount of kEUR 25.
The main objectives of the Company's capital management are to ensure the Company's ability to continue as a going concern in order to provide returns for shareholders, benefits for other stakeholders and to maintain an optimal capital structure to reduce the cost of capital.
In order to maintain or adjust the capital structure, the Company may issue new shares or sell assets to reduce debt.
The Company has set a strong focus on liquidity planning in order to meet its financial commitments. In this regard, the total amount of assets in relation to borrowings and financial liabilities as recorded on the statement of financial position is used by the Company to monitor capital.
The preparation of financial statements requires management to make estimates and other judgments that affect the reported amounts of assets and liabilities, as well as the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results may differ from those estimates. Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognised in the period in which the estimate is revised and in any future periods affected. Judgements made by management in the application of IFRS that have a significant effect on the financial statements and estimates with a significant risk of material adjustment in the next year are discussed at the respective balance sheet/P&L position.
The Company derives the following types of revenues:
| Year ended December 31 | 2019 | 2018 |
|---|---|---|
| all amounts in kEUR | ||
| Sale of goods | 4,879.3 | 4,416.4 |
| Licence revenues | 998.9 | 114.7 |
| Other revenues | 266.4 | 135.2 |
| Total revenue from contracts with customers | 6,144.6 | 4,666.3 |
Marinomed's revenues are mostly based on the sale of goods. Customers of Marinomed act as distributors in the respective geographical regions. Depending on the stage of a product in the respective country, revenues may fluctuate year over year, e.g. in the case of product launches in new and existing markets, customers tend to build up significant stock. Accordingly, in subsequent years, demand from such customers decreases. In some countries, customers place TV advertisements for quick market penetration, while in other countries, they may focus on the education of physicians and pharmacists.
Today, Marinomed distributes its products via 13 partners in more than 40 countries. This enables regional fluctuations to be balanced and an increase in revenues from sale of goods of some 10% was achieved.
In 2019 "Licence revenues" include kEUR 900 related to the waiver of commercialisation rights by a European licensing partner. For more information on revenues according to geographical areas and segments, please refer to Note 2.3.
Revenue from contracts with customers is recognised when control of the goods or services is transferred to the customer at an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. Revenue is shown net of value added tax and is reduced for estimated customer returns, rebates and other similar allowances.
Revenue from the sale of goods is recognised at the point in time when control of the goods is transferred to the customer.
Some contracts for the sale of goods provide customers with a cash discount for early payment, volume rebates or other rebates/discounts. Under IFRS 15 such discounts and rebates give rise to variable consideration. The variable consideration is estimated at contract inception and maintained until the associated uncertainty is subsequently resolved. Accumulated experience is used to estimate and provide for the discounts, using the expected value method, and revenue is only recognised to the extent that it is highly probable that a significant reversal will not occur. A refund liability (included in line item "Current contract liabilities and other liabilities") is recognised for expected volume rebates payable to customers in relation to sales made until the end of the reporting period. No element of financing is deemed present as the sales are regularly made with a credit term of 30 to max. 75 days after the last day of the month following the issuance of the invoice.
A trade receivable is recognised when the goods are delivered as this is the point in time that the consideration is unconditional because only the passage of time is required before the payment is due.
A contract liability is the obligation to transfer goods or services to a customer for which the Company has received consideration (or an amount of consideration is due) from the customer. If a customer pays consideration before the Company transfers goods or services to the customer, a contract liability is recognised when the payment is made or the payment is due (whichever is earlier). Contract liabilities are recognised as revenue when the Company performs under the contract.
For revenue from licensing of intellectual property IFRS 15 provides specific guidance, which differs from the recognition model for other promised goods and services. According to this a licence will either provide a right to access the entity's intellectual property throughout the licence period, which results in revenue being recognised over time, or a right to use the entity's intellectual property as it exists at the point in time at which the licence is granted, which results in revenue being recognised at a point in time. The Company's licence contracts in place provide right-to-use licences. Thus, revenue is recognised when the licence is granted to the customer in accordance with the substance of the relevant agreement. For milestone payments agreed in licensing agreements please refer to the section below.
The Company applies the exception for sales-based or usage-based royalties received in exchange for licences of intellectual property. Accordingly, revenue is recognised only when (or as) the later of the following events occurs: a) the subsequent sale or usage occurs; and b) the performance obligation to which some or all of the sales-based or usage-based royalty has been allocated has been satisfied (or partially satisfied). Consequently royalties are not included in the transaction price until the customer makes sales, regardless of whether or not the Company has predictive experience with similar arrangements.
Milestone payments resulting from one-off revenues agreed in licensing and distributor agreements give rise to variable consideration under IFRS 15, which is estimated at contract inception and maintained until the associated uncertainty is subsequently resolved. Revenue from milestone payments is therefore only recognised to the extent that it is highly probable that a significant reversal will not occur; this is basically the fact when all contractual obligations are fulfilled by the Company and the amounts are non-refundable.
Milestone payments relating to "sales milestones" might arise when an (annual) sales threshold is met by the customer. The Company concludes that such milestones are, in substance, sales-based royalties, since they are receivable only when underlying sales are made. As such, revenue for these milestones is recognised if and when the annual sales threshold is met in accordance with the exception for royalties.
Other income consists of the following items:
| Other income | 70.4 | 10.8 |
|---|---|---|
| Grant income Research premium |
- 601.3 |
350.5 314.4 |
| Year ended December 31 all amounts in kEUR |
2019 | 2018 |
Grants were received from FFG and WAW. These grants are non-refundable, except in the case of non-compliance with the agencies' rules and regulations or in the case of misuse of the funds.
In 2018 three loans from FFG amounting to kEUR 351 have been converted into non-repayable grants.
In recent years the Company was granted several R&D support loans from FFG and aws (see Note 25). According to IAS 20.10A (and IFRS 1.B10), the differences between the nominal interest rates of the R&D support loans granted after the date of transition and the market rate of interest, estimated at 15.0% (see Note 25), are treated as a government grant and recognised over the term of the corresponding financial liabilities. In 2019 this interest advantage amounted to kEUR 70 (2018: kEUR 11) and is shown in the line item "Other Income".
Grants were provided to support specific research projects and are recognised according to the progress of the respective project. Futhermore, grant income may result from conversion of loans into non-repayable grants. The research premium, which is paid out in cash by the Austrian fiscal authorities, is calculated as 14.0% (2018: 14.0%) of a specified research and development cost base. It is recognised to the extent the research and development expenses have been incurred. All grants are non-refundable as long as the conditions of the grant are met.
According to IAS 20.10A the benefit of a government loan at a below-market rate of interest is treated as a government grant. The benefit due to the difference between the market rate of interest and the rate of interest charged by the governmental organisation is measured as the difference between the initial carrying value of the loan determined in accordance with IFRS 9 (previously IAS 39) and the proceeds received. This benefit is deferred (recorded in the line item "other liabilities" (see Note 29)), and recognised through profit or loss over the term of the corresponding financial liabilities in accordance with IAS 20.10A. For further information on the market interest rate and the nominal interest rates of the government loans please refer to Note 25. The loan is recognised and measured in accordance with IFRS 9.
Other gains and losses consist of the following items:
| Year ended December 31 all amounts in kEUR |
2019 | 2018 |
|---|---|---|
| Net gain/(loss) on disposal of property, plant and equipment | 0.0 | 0.2 |
| Net foreign exchange gains | 17.1 | 5.9 |
| Net foreign exchange losses | –6.0 | –4.0 |
| Other items | –1.2 | 8.2 |
| Total | 9.9 | 10.2 |
The Company operates internationally and is exposed to foreign exchange risk arising from various currency exposures, primarily with respect to the British pound (please refer to Note 3.1 for further details).
Expenses for materials include expenses for sale of goods (cost of goods sold) and expenses for laboratory consumables. For further details see Note 19.
The expenses for services relate primarily to third-party R&D services as well as to expenses for patent applications. For further details see Note 12.
Personnel expenses include the following items:
| Year ended December 31 | 2019 | 2018 |
|---|---|---|
| all amounts in kEUR | ||
| Salaries | –3,111.6 | –1,999.8 |
| Expenses for social security and payroll related taxes | –665.3 | –509.0 |
| Expenses for the employee stock option plan (ESOP 2019) | –426.5 | - |
| Other employee benefit expenses | –15.9 | –7.7 |
| Total | –4,219.4 | –2,516.5 |
Personnel expenses were kEUR 4,219 in 2019, an increase of kEUR 1,703. This is on the one hand related to complementing of management functions that did not affect the full fiscal year 2018 as well as additional staff. On the other hand, personnel expenses in 2019 include an additional bonus for the sucessful IPO. An additional element is related to the implementation of the employee participation program in the context of the IPO.
The Company is legally required to make monthly contributions to a state plan classified as a defined contribution plan. These contributions are recognised under expenses for social security and payroll related taxes.
On February 1, 2019, Marinomed established ESOP 2019 for the members of the management board as well as all other employees of the Company. The total number of options that may be granted under ESOP 2019 is 43,694 and each option entitles the option holder to subscribe for one voting share.
At the end of April 2019 21,847 stock options were issued to the 3 board members as well as 19,660 stock options to 28 employees from all hierarchy levels. In case of exercise, the Company can settle via shares (equity-settled) or in cash (cash-settled). This decision is taken at the sole discretion of the Company. Management plans to settle via shares. Granted options cannot be exercised immediately, but after vesting, i.e. 25% after 12 months starting with the first trading day (February 1, 2019), then another 6.25% every three months. The exercise price equals the IPO issue price (= EUR 75.00). The exercise period is limited to 10 trading days starting with the 6th trading day after the release of financial statements (annual reports, quarterly financial statements). Furthermore, a hurdle rate of 2.5% per quarter starting with the first trading day applies (without compound interest). The options expire without further compensation on January 31, 2025 or after termination of employment.
In July 2019, 780 additional options were granted to employees. In 2019, 780 options expired. Therefore, as of December 31, 2019 the total amount of granted options amounts to 41,507.
As at the grant date the Company estimated the fair value of one issued share option at EUR 20.75 (EUR 28.94 for the options granted in July 2019). The fair value of the options has been measured using a Monte Carlo simulation. Due to the lack of a long enough price history for the Marinomed share, expected volatility was derived from historical data of a representative peer group. Additionally estimates on future dividends, fluctuations and exercise dates were taken into account. Furthermore, the inputs used in the measurement were as follows (valid also for the options granted in July 2019):
The statement of profit or loss and other comprehensive income (loss) includes depreciation and amortisation expenses as follows:
| Year ended December 31 all amounts in kEUR |
2019 | 2018 |
|---|---|---|
| Amortisation of intangible assets | –165.1 | –149.2 |
| Depreciation of property, plant and equipment | –162.1 | –87.5 |
| Total | –327.2 | –236.8 |
For further details on amortisation and depreciation see also Notes 17 and 18.
Other expenses include the following items (nature of expenses):
| Year ended December 31 | 2019 | 2018 |
|---|---|---|
| all amounts in kEUR | ||
| Fees | –63.3 | –22.8 |
| Maintenance expenses | –73.4 | –81.4 |
| Operating costs | –45.1 | –42.0 |
| Insurance | –25.7 | –126.2 |
| Freight | –6.2 | –12.4 |
| Travel expenses | –64.1 | –99.3 |
| Car expenses | –6.6 | –6.1 |
| Telecommunication expenses | –13.8 | –16.8 |
| Rental expenses | –4.6 | –90.1 |
| Education expenses | –23.0 | –26.4 |
| Office and administrative expenses | –17.2 | –34.4 |
| Marketing/PR expenses | –174.6 | –95.2 |
| Consulting expenses | –1,116.6 | –2,085.9 |
| Other expenses | –199.1 | –169.0 |
| Total | –1,833.2 | –2,908.0 |
Consulting expenses include expenses for legal advice and other consulting services, mainly for consulting and legal fees in connection with the IPO.
The Company has incurred research and development expenses which are included in the following positions in the statement of profit or loss and other comprehensive income (loss):
| Year ended December 31 | 2019 | 2018 |
|---|---|---|
| all amounts in kEUR | ||
| Personnel expenses | –1,359.0 | –1,118.8 |
| Expenses for services | –2,564.3 | –1,121.6 |
| Expenses for materials | –134.9 | –76.6 |
| Other expenses | –109.3 | –193.7 |
| Depreciation and amortisation | –231.2 | –166.1 |
| Financial expenses | –376.9 | –258.0 |
| Total | –4,775.7 | –2,934.8 |
For purposes of calculating research and development expenses, personnel expenses do not include one-time IPO bonus payments for R&D personnel. In 2019 as well as in the prior year, research and development expenses were primarily attributable to clinical studies. In 2018 and the first half of 2019, the focus was on the study for the product Budesolv to treat allergic rhinitis. Mostly in the second half of 2019, the preparation of the study for Tacrosolv (allergic conjunctivitis and dry eye disease) as well as studies for new and existing products within the Carragelose segment were added.
| Year ended December 31 all amounts in kEUR |
2019 | 2018 |
|---|---|---|
| Interest income | ||
| Bank deposits | 0.3 | 0.1 |
| Total | 0.3 | 0.1 |
| Interest and similar expenses | ||
| Subsidised loans | –96.7 | –135.7 |
| Shareholders' loans | –307.6 | –436.4 |
| Convertible bond | –130.2 | –921.2 |
| Leasing | –13.3 | –2.4 |
| EIB loan | –117.6 | - |
| Other interest expenses | - | –0.0 |
| Total | –665.4 | –1,495.7 |
| Other financial income/(expenses) | ||
| Valuation equity conversion right | –336.6 | –5,667.6 |
| Adjustment of carrying amount of shareholders' loans (according to IFRS 9:B5.4.6) |
- | 193.4 |
| Adjustment of carrying amount of AWS Profit Share | - | 17.3 |
| Total | –336.6 | –5,456.9 |
| Total financial result | –1,001.6 | –6,952.5 |
| Of which financial income | 0.3 | 210.8 |
| Of which financial expenses | –1,002.0 | –7,163.3 |
Interest income arises on cash and cash equivalents. Interest expenses consist of interest on borrowings of all kinds (e.g. shareholder and other loans) as well as the convertible bond and are expensed as incurred.
As required by IFRS 7.20, interest on financial instruments is classified as follows:
| all amounts in kEUR | Financial assets at amortized cost |
Financial liabilities at amortized cost |
FVTPL (held for trading) |
Total |
|---|---|---|---|---|
| Financial result as per statement of profit or loss and other comprehensive income (loss) | ||||
| Year ended December 31, 2018 | ||||
| Financial income | 0.1 | 210.7 | - | 210.8 |
| Financial expenses | - | –1,495.7 | –5,667.6 | –7,163.3 |
| Total | 0.1 | –1,284.9 | –5,667.6 | –6,952.5 - |
| all amounts in kEUR | Financial assets at amortized cost |
Financial liabilities at amortized cost |
FVTPL (held for trading) |
Total |
| Financial result as per statement of profit or loss and other comprehensive income (loss) | ||||
| Year ended December 31, 2019 | ||||
| Financial income | 0.3 | - | - | 0.3 |
| Financial expenses | - | –665.4 | –336.6 | –1,002.0 |
| Total | 0.3 | –665.4 | –336.6 | –1,001.6 |
| Year ended December 31 all amounts in kEUR |
2019 | 2018 |
|---|---|---|
| Current tax | –4.4 | –3.5 |
| Total | –4.4 | –3.5 |
Taxes on income are calculated using the current corporate income tax rate of 25%. As the Company currently generates losses and is a stock company, the minimum corporate income tax applies, which is kEUR 3.5 per year. In 2019, a difference in the minimum tax relating to 2017 was retroactively recorded.
The total charge for the year can be reconciled to the accounting profit as follows:
| Year ended December 31 all amounts in kEUR |
2019 | 2018 |
|---|---|---|
| Profit (Loss) before taxes | –7,212.1 | –12,093.4 |
| Tax income (expense) at 25% | 1,803.0 | 3,023.3 |
| Expenses not deductible for tax purposes | –132.1 | –18.8 |
| Income not subject to tax | 186.6 | 81.8 |
| Effect of silent partnership | –567.3 | - |
| Effect of convertible bond conversion | –1,297.8 | - |
| Effect of deferred tax asset not recognised | 7.6 | –3,086.4 |
| Minimum corporate income tax | –4.4 | –3.5 |
| Tax expense (before loss carry-forwards) | –4.4 | –3.5 |
| Other tax adjustments | - | - |
| Total income tax expense | –4.4 | –3.5 |
Temporary differences resulting in deferred tax liabilities in the amount of kEUR 402.7 (2018: kEUR 711.8) are offset against deferred tax assets resulting mainly from tax loss carry-forwards showing the same amount and timing with the same fiscal authority. Further to this, no deferred tax assets have been capitalised in the statement of financial position or effects shown in the statement of profit or loss and other comprehensive income.
| Year ended December 31 | 2019 | 2018 |
|---|---|---|
| all amounts in kEUR Deferred tax asset from |
||
| Tax losses carried forward | 7,698.5 | 5,249.2 |
| Current receivables | 0.5 | - |
| Investment from silent partnership | - | 567.3 |
| Borrowings | 29.6 | 7.6 |
| Conversion right | - | 1,783.0 |
| Other liabilities | 9.2 | - |
| Non-recognition of deferred tax assets | –7,335.1 | –6,895.3 |
| Total deferred tax assets | 402.7 | 711.8 |
| Year ended December 31 | 2019 | 2018 |
|---|---|---|
| all amounts in kEUR | ||
| Deferred tax liability from | ||
| Intangible assets – software | –1.6 | –1.3 |
| Intangible assets - development costs | –380.1 | –306.6 |
| Property, plant and equipment | –20.6 | –11.5 |
| Receivables | –0.4 | –84.9 |
| Borrowings | - | –48.4 |
| Convertible bond | - | –259.1 |
| Trade payables | - | –0.0 |
| Total deferred tax liability | –402.7 | –711.8 |
| Deferred tax, net | - | - |
As of December 31, 2019 the Company has unrecognised deferred tax assets of kEUR 7,335.1 (2018: kEUR 6,895.3) mainly resulting from cumulative tax loss carry-forwards in respect of losses of kEUR 30,793.9 (2018: kEUR 20,996.9). Since the Company is in a loss-making position and has a history of losses, no deferred tax asset has been recognised. The tax loss carry-forwards will not expire.
The income tax expense (or credit) for the period is the tax payable on the current period's taxable income based on the applicable income tax rate (adjusted by changes in deferred tax assets and liabilities attributable to temporary differences and to unused tax losses, if any ‒ see below).
Deferred income tax (income or expenses) results from temporary differences between the carrying amount of an asset or a liability in the statement of financial position and its tax base. In accordance with IAS 12 (Income Taxes), the deferred tax assets/liabilities reflect all temporary valuation and accounting differences between financial statements prepared for tax purposes and IFRS financial statements.
Deferred income tax is provided in full using the liability method on temporary differences. Tax losses carried forward are taken into account in calculating deferred tax assets. Deferred income tax assets have not been recognised up to the end of the reporting period, as it is not foreseeable when future taxable profits will be available against which the temporary differences can be utilised.
A deferred tax asset is recognised for an unused tax loss carry-forward or unused tax credit if, and only if, it is considered probable that there will be sufficient future taxable profits against which the loss or credit carry-forward can be utilised.
The Company is in a loss-making position and has a history of recent losses. Therefore, the Company can recognise a deferred tax asset arising from unused tax losses or tax credits only to the extent that the Company has sufficient taxable temporary differences, or where there is convincing other evidence that sufficient taxable profit will be available against which the unused tax losses or unused tax credits can be utilised.
Significant management judgement is required to determine whether such deferred tax assets can be recognised and, if so, the amount to be recognised, based upon the likely timing and the level of future taxable profits, together with future tax planning strategies. On this basis, the Company has determined that it cannot recognise deferred tax assets on the tax losses carried forward further than to the extent that can be offset with deferred tax liabilities, as there is currently not enough convincing evidence of when future taxable profits will be available.
If the Company was able to recognise all unrecognised deferred tax assets, profit and equity would have increased by kEUR 7,335.1 (2018: kEUR 6,895.3).
Basic earnings/losses per share are calculated by dividing the net earnings/loss attributable to shareholders by the weighted average number of shares outstanding during the year.
| Year ended December 31 | 2019 | 2018 |
|---|---|---|
| Earnings (loss) for the year (in kEUR) | –7,216.5 | –12,096.9 |
| Weighted average number of shares outstanding | 1,418,099.1 | 1,000,000.0 |
| Basic earnings (loss) per share (in EUR) | –5.1 | –12.1 |
In the general meeting of May 12, 2017 the conversion of the Company into a stock company was decided with effect from December 31, 2016 (please refer to Note 23 for further details). Prior to the conversion the Company's share capital was not divided into a specific number of shares, but shareholders had a proportionate interest in the Company corresponding to their amount of nominal capital paid in. On September 17, 2018, the extraordinary general meeting approved the increase of shares from 132,360 shares by 867,640 shares to 1,000,000 shares. All shareholders subscribed to the nominal capital increase on a prorata basis. For calculating earnings (loss) per share in 2018, it was assumed that the number of shares was 1,000,000.
The amount of shares outstanding increased on February 1, 2019 by 260,000 in the course of the IPO, on February 20, 2019 by 170,772 after the conversion of the convertible bond and on February 28, 2019 due to the exercise of the greenshoe by another 39,000. Taking these capital measures into account the weighted average number of shares outstanding in 2019 amounts to 1,418,099.1.
Basic and diluted earnings per share are the same in 2018 because convertible bonds in the nominal amount of EUR 7 million (potentially 173,122 dilutive shares), which could not be exercised as at Dezember 31, 2018, were not included in the calculation of potentially dilutive shares, as they were anti-dilutive for the 2018 financial year. Basic and diluted earnings per share are the same in 2019, because 41,507 non-vested stock options as at December 31, 2019 were not included in the calculation of potentially dilutive shares, as they were anti-dilutive for the 2019 financial year. These shares may potentially have a dilutive effect in the future.
The statement of cash flows shows the changes in cash and cash equivalents resulting from the inflow and outflow of funds during the reporting period and differentiates between cash flows from operating activities, investing activities and financing activities. The funds included in the statement of cash flows are cash and cash equivalents.
The cash flow from operating activities shows the flows of funds arising from the provision and receipt of goods and services during the reporting period and includes changes in working capital.
The cash flow from investing activities consists mainly of outflows of funds for the acquisition of tangible and intangible assets.
The table below shows changes in the Company's liabilities arising from financing activities, including both cash and non-cash changes. Liabilities arising from financing activities are those for which cash flows were, or future cash flows will be, classified in the Company's statement of cash flows as cash flow from financing activities.
| all amounts in kEUR | Convertible bond |
Equity conver sion right |
Finance leases | FFG Loans |
|---|---|---|---|---|
| Carrying amount as of January 1, 2018 | 5,073.1 | 1,464.4 | 37.8 | 2,247.6 |
| Financing cash flows | - | - | –17.0 | –530.0 |
| Separation (recognition) of finance leases |
- | - | 60.3 | - |
| Non-cash income from debt relief | - | - | - | –350.5 |
| Fair value adjustments | - | 5,667.6 | - | - |
| Reclassification of grant – below market rate |
- | - | - | 13.2 |
| Effective interest accrued | 921.2 | - | 2.4 | 46.9 |
| Interest paid | –280.0 | - | –2.4 | –36.1 |
| Carrying amount as of December 31, 2018 |
5,714.3 | 7,132.0 | 81.2 | 1,391.1 |
| all amounts in kEUR | Shareholders' loans |
Silent partnerships |
AWS profit share |
AWS Seed loan |
|---|---|---|---|---|
| Carrying amount as of January 1, 2018 | 2,389.9 | - | 17.3 | 1,023.0 |
| Financing cash flows | –89.3 | - | - | - |
| Separation (recognition) of finance leases |
- | - | - | - |
| Non-cash income from debt relief |
- | - | - | - |
| Adjustment of carrying amount | –193.4 | - | –17.3 | - |
| Effective interest accrued | 436.4 | - | - | 88.8 |
| Interest paid | –238.5 | - | - | - |
| Carrying amount as of December 31, 2018 |
2,305.1 | - | - | 1,111.8 |
| all amounts in kEUR | Convertible bond |
Equity conver sion right |
Leasing | FFG Loans |
|---|---|---|---|---|
| Carrying amount as of January 1, 2019 |
5,714.3 | 7,132.0 | 199.8 | 1,391.1 |
| Financing cash flows | - | - | –98.4 | –1,391.1 |
| Conversion of convertible bond | –5,819.2 | –7,468.6 | - | - |
| Valuation adjustment right-of-use asset |
- | - | 4.8 | - |
| Repurchase | –24.8 | |||
| Fair value adjustments | - | 336.6 | - | - |
| Effective interest accrued | 130.2 | - | 13.3 | 2.9 |
| Interest paid | –0.5 | - | –13.3 | –2.9 |
| Carrying amount as of December 31, 2019 |
- | - | 106.2 | - |
| all amounts in kEUR | Shareholders' loans |
EIB Loan | AWS profit share |
AWS Seed loan |
|---|---|---|---|---|
| Carrying amount as of January 1, 2019 |
2,305.1 | - | - | 1,111.8 |
| Financing cash flows | –2,262.7 | 3,952.1 | - | –500.0 |
| Reclassification of grant – below market rate |
- | - | - | –225.5 |
| Adjustment of carrying amount | - | - | - | - |
| Effective interest accrued | 307.6 | 117.6 | - | 93.8 |
| Interest paid | –350.1 | - | - | –15.5 |
| Carrying amount as of December 31, 2019 |
- | 4,069.7 | - | 464.7 |
The movement on property, plant and equipment was as follows:
| all amounts in kEUR | IT equip ment |
Laboratory equipment |
Other plant and office equipment |
Right-of use asset |
Land Prepayments and buildings under construction |
Total | |
|---|---|---|---|---|---|---|---|
| As of January 1, 2018 | |||||||
| Cost | 95.3 | 373.6 | 110.0 | - | - | - | 578.8 |
| Accumulated depreciation |
–44.4 | –332.6 | –38.9 | - | - | - | –415.8 |
| Carrying amount | 50.9 | 41.0 | 71.1 | - | - | - | 163.0 |
| Year ended December 31, 2018 |
|||||||
| Beginning carrying amount |
50.9 | 41.0 | 71.1 | - | - | - | 163.0 |
| Additions | 43.3 | 75.3 | 1.4 | - | - | - | 120.0 |
| Disposals | –0.0 | - | - | - | - | - | –0.0 |
| Depreciation | –45.3 | –28.4 | –13.8 | - | - | - | –87.5 |
| Carrying amount | 48.8 | 87.9 | 58.7 | - | 195.4 | ||
| As of January 1, 2019 | |||||||
| Cost | 97.5 | 448.9 | 110.1 | 118.6 | - | - | 775.1 |
| Accumulated depreciation |
–48.7 | –361.0 | –51.4 | - | - | - | –461.1 |
| Carrying amount | 48.8 | 87.9 | 58.7 | 118.6 | - | - | 314.0 |
| Year ended December 31, 2019 |
|||||||
| Beginning carrying amount |
48.8 | 87.9 | 58.7 | 118.6 | - | - | 314.0 |
| Additions | 27.5 | 121.7 | 0.8 | 4.8 | 358.9 | 1,825.5 | 2,339.1 |
| Disposals | –0.0 | –0.0 | - | - | - | –0.0 | |
| Depreciation | –34.6 | –33.1 | –12.6 | –81.8 | - | –162.1 | |
| Carrying amount | 41.7 | 176.5 | 46.8 | 41.6 | 358.9 | 1,825.5 | 2,491.0 |
| As of December 31, 2019 |
|||||||
| Cost | 109.1 | 544.7 | 110.9 | 123.4 | 358.9 | 1,825.5 | 3,072.5 |
| Accumulated depreciation |
–67.4 | –368.2 | –64.1 | –81.8 | - | –581.5 | |
| Carrying amount | 41.7 | 176.5 | 46.8 | 41.6 | 358.9 | 1,825.5 | 2,491.0 |
As of December 31, 2019 fully depreciated property, plant and equipment with acquisition costs of kEUR 323.8 (2018: kEUR 340.1) is still in use.
The Company has entered into a number of agreements entailing financial commitments for the future relating to the construction of the new headquarters in Korneuburg. The remaining payments to be made under these agreements amount to kEUR 3,918 (2018: kEUR 0). These are entirely due within one year (see also Note 33).
Prepayments and buildings under construction relate to the new premises in Korneuburg. At September 6, 2019, Marinomed acquired real estate close to the border of Vienna. On this land, the new headquarters of the company will be built by refurbishing an existing building. During the fiscal year 2019, Marinomed invested in total kEUR 2,184 into the new headquarters.
Laboratory equipment includes the following amounts where Marinomed is a lessee (refer to Note 25 for further details). In 2019 depreciation amounted to kEUR 12 (2018: kEUR 9).
| Year ended December 31 all amounts in kEUR |
2019 | 2018 |
|---|---|---|
| Leasehold laboratory equipment | ||
| Cost | 132.3 | 132.3 |
| Accumulated depreciation | –93.1 | –81.0 |
| Net Book Value | 39.2 | 51.2 |
Other plant and office equipment includes the following amounts where the Company is a lessee under a lease of a vehicle (refer to Note 25 for further details). In 2019 depreciation amounted to kEUR 8 (2018: kEUR 8).
| Year ended December 31 all amounts in kEUR |
2019 | 2018 |
|---|---|---|
| Other plant and office equipment | ||
| Cost | 65.0 | 65.0 |
| Accumulated depreciation | –33.2 | –25.1 |
| Net Book Value | 31.8 | 39.9 |
Property, plant and equipment are stated at historical costs less accumulated depreciation and amortisation. Historical costs include the acquisition price, ancillary costs and subsequent acquisition costs less any discounts received on the acquisition price.
Subsequent costs are included in the asset's carrying amount or recognised as a separate asset where appropriate, but only when it is probable that future economic benefits associated with the item will accrue to the Company and the cost of the item can be measured reliably. The carrying amount of the replaced part is derecognised. All other repair and maintenance costs are charged to the statement of profit or loss and other comprehensive income (loss) during the financial period in which they are incurred.
Depreciation on assets is calculated using the straightline method over the estimated useful lives of the assets. In calculating the estimated useful life, the economic and technical life expectancy has been taken into consideration. In 2018 and 2019, the estimated useful lives of property, plant and equipment are as follows: 2-5 years for IT equipment, 2-8 years for laboratory equipment and 4-10 years for other plant and office equipment. The assets' residual values and useful lives are reviewed, and adjusted if appropriate, at each reporting date. When assets are sold, closed down or scrapped, the difference between the net proceeds and the net carrying amount of the asset is recognised in other gains (losses).
The following table shows the movement in intangible assets:
| As of January 1, 2018 all amounts in kEUR |
Development costs |
Software | Total |
|---|---|---|---|
| Cost | 2,040.0 | 70.6 | 2,110.6 |
| Accumulated depreciation | –762.2 | –36.8 | –799.0 |
| Carrying amount | 1,277.9 | 33.7 | 1,311.6 |
| Year ended December 31, 2018 | |||
| Beginning carrying amount | 1,277.9 | 33.7 | 1,311.6 |
| Additions – acquisitions | - | 91.0 | 91.0 |
| Additions – development | 78.3 | - | 78.3 |
| Disposals | - | –0.0 | –0.0 |
| Amortisation | –129.6 | –19.6 | –149.2 |
| Carrying amount | 1,226.5 | 105.2 | 1,331.7 |
| As of January 1, 2019 all amounts in kEUR |
Development costs |
Software | Total |
| Cost | 2,118.3 | 160.3 | 2,278.6 |
| Accumulated amorisation | –891.8 | –55.1 | –946.9 |
| Carrying amount | 1,226.5 | 105.2 | 1,331.7 |
| Year ended December 31, 2019 | |||
| Beginning carrying amount | 1,226.5 | 105.2 | 1,331.7 |
| Additions – acquisitions | - | 33.3 | 33.3 |
| Additions – development | 425.5 | - | 425.5 |
| Disposals | - | –0.0 | –0.0 |
| Amortisation | –131.5 | –33.5 | –165.1 |
| Carrying amount | 1,520.5 | 104.9 | 1,625.4 |
| As of December 31, 2019 | |||
| Cost | 2,543.8 | 167.1 | 2,710.9 |
| Accumulated amortisation | –1,023.3 | –62.2 | –1,085.6 |
| Carrying amount | 1,520.5 | 104.9 | 1,625.4 |
Additions to intangible assets are primarily related to external development costs, in particular the preparation for the application for market approval of the lead product of the Marinosolv® platform, Budesolv.
The Company has entered into a number of agreements entailing financial commitments for the future and relating to services provided by third parties in connection with the conduct of clinical trials and other research and development activities, which will be recognised as development costs. The remaining payments to be made under these agreements amount to kEUR 78 (2018: kEUR 0). These are entirely due within one year (see also Note 33).
Acquired computer software licences are capitalised on the basis of the costs incurred to acquire the software and bring it into use. These costs are amortised on a straight-line basis over their estimated useful lives (3-5 years in 2018 and 2019).
Research and development expenses (IAS 38) are defined as costs incurred for current or planned activities undertaken with the prospect of gaining new scientific or technical knowledge and understanding. Development expenses are defined as costs incurred for the application of research findings or specialist knowledge to production, production methods, services or goods prior to the commencement of commercial production or use.
All research costs are expensed as incurred. Development expenditures on an individual project are recognised as an intangible asset when the Company can demonstrate the following:
The amount initially recognised for internally-generated intangible assets is the sum of directly attributable costs incurred from the date when the intangible asset first meets the recognition criteria listed above. Where no internally-generated intangible assets can be recognised, development expenditure is recognised in profit or loss in the period in which it is incurred.
Subsequent to initial recognition, internally-generated intangible assets are reported at cost less accumulated amortisation and accumulated impairment losses, on the same basis as intangible assets that are acquired separately. Amortisation of the asset begins when development is complete and the asset is available for use. It is amortised on a straightline basis over the period of expected future benefit.
Development costs are capitalised in accordance with the accounting policy above. Initial capitalisation of costs is based on management's judgement that technical and economic feasibility is confirmed. In line with industry practice, the date of approval by the notified body is deemed to be the point at which the development costs fulfill all the conditions listed above. Starting with the commercialisation of the product no further development costs are capitalised.
Development costs incurred after that date that are directly attributable to the development activities have been recognised as an intangible asset. Directly attributable costs include employee costs, material costs, contract research as well as an appropriate portion of relevant overheads. Capitalised development costs are recorded as an intangible asset which is amortised over its expected useful life. The expected useful economic life has been estimated on the basis of the duration of the corresponding patent, i.e. the period over which the Company expects to generate economic benefit, which is 16.5 years starting from July 1, 2011 for development costs where the amortisation period has already started.
Management constantly monitors the recoverability of capitalised internal development costs as well as the amortisation period. Adjustments will be made if future market activity indicates that such adjustments are appropriate.
Inventories include the following items:
| Year ended December 31 all amounts in kEUR |
2019 | 2018 |
|---|---|---|
| Goods for sale | 97.5 | 115.7 |
| Of which nasal sprays | 97.5 | 115.7 |
| Total | 97.5 | 115.7 |
Inventories recognised as an expense during the year ended December 31, 2019 amounted to kEUR 3,439.5 (2018: kEUR 3,236.4). These were included under the line item "Expenses for materials" in the statement of profit or loss and other comprehensive income.
Inventories are stated at the lower of cost and net realisable value. Costs of purchased inventories (merchandise) are assigned by specific identification and include the cost of acquisition after deducting rebates and discounts. Net realisable value represents the estimated selling price in the ordinary course of business, less estimated costs of completion and the estimated costs to sell.
In accordance with IAS 39 and IFRS 7, financial instruments are classified as follows:
| As of December 31, 2018 | Financial assets | Total |
|---|---|---|
| all amounts in kEUR | at amortized cost | |
| Assets as per statement of financial position | ||
| Non-current receivables | 3.0 | 3.0 |
| Trade receivables | 622.3 | 622.3 |
| Cash and cash equivalents | 1,715.5 | 1,715.5 |
| Total | 2,340.8 | 2,340.8 |
| all amounts in kEUR | Financial liabilities at amortized cost |
FVTPL | Total |
|---|---|---|---|
| Liabilities as per statement of financial position | |||
| Borrowings | 4,889.2 | - | 4,889.2 |
| Silent partnerships | - | - | - |
| Convertible bond | 5,714.3 | - | 5,714.3 |
| Other financial liabilities | - | 7,132.0 | 7,132.0 |
| Current contract liabilities | 7.7 | - | 7.7 |
| Trade payables | 2,014.5 | - | 2,014.5 |
| Total | 12,625.7 | 7,132.0 | 19,757.7 |
| As of December 31, 2019 | Financial assets | Total |
|---|---|---|
| all amounts in kEUR | at amortized cost | |
| Assets as per statement of financial position | ||
| Non-current receivables | 3.2 | 3.2 |
| Trade receivables | 1,484.7 | 1,484.7 |
| Cash and cash equivalents | 12,019.6 | 12,019.6 |
| Total | 13,507.5 | 13,507.5 |
| all amounts in kEUR | Financial liabilities at amortized cost |
FVTPL | Total |
|---|---|---|---|
| Liabilities as per statement of financial position | |||
| Borrowings | 4,640.6 | - | 4,640.6 |
| Silent partnerships | - | - | - |
| Convertible bond | - | - | - |
| Other non-current liabilities | 104.1 | - | 104.1 |
| Current contract liabilities and other current liabilities | 1,615.4 | - | 1,615.4 |
| Trade payables | 1,002.4 | - | 1,002.4 |
| Total | 7,362.5 | - | 7,362.5 |
The Company did not hold any financial assets classified as at FVTPL or at FVTOCI as of December 31, 2019. Financial liabilities classified as at FVTPL include liabilities that meet the definition of held for trading in IFRS 9. In 2018 and 2019 the Company did not hold any financial liabilities designated as FVTPL upon initial recognition or subsequently in accordance with paragraph 6.7.1 of IFRS 9.
Trade receivables are stated under trade and other receivables in the statement of financial position (see also Note 21).
The carrying amount of current borrowings is a reasonable approximation of their fair value, as the impact of discounting is not significant. The carrying amounts for current receivables and trade payables are assumed to approximate their fair value due to their relatively short maturity. For non-current liabilities (borrowings and convertible bond) refer to Note 25 and to Note 26.
The following table presents the financial instruments measured at fair value and classified by level of the following fair value measurement hierarchy:
The following table does not include fair value information for financial assets and liabilities not measured at fair value where the carrying amount is a reasonable approximation of the fair value.
| As of December 31, 2018 | Level 1 | Level 2 | Level 3 | Total |
|---|---|---|---|---|
| all amounts in kEUR | ||||
| Liabilities as per statement of financial position |
||||
| Other financial liabilities (equity conversion right) |
- | - | 7,132.0 | 7,132.0 |
| Total Liabilities | - | - | 7,132.0 | 7,132.0 |
| As of December 31, 2019 | Level 1 | Level 2 | Level 3 | Total |
| all amounts in kEUR | ||||
| Liabilities as per statement of financial position |
||||
| Other financial liabilities (equity conversion right) |
- | - | - | - |
| Total Liabilities | - | - | - | - |
According to a separate call option agreement dated November 15, 2018, as amended by an amendment agreement dated December 30, 2018, the silent partners granted the Company a call option to acquire the shares received for the contribution in kind and incorporation. The effectiveness of the option agreement was subject to the condition precedent of a successful IPO and further gross proceeds from the IPO of at least EUR 30 million. As gross proceeds came out below the EUR 30 million, the condition precedent was not met and the option did not become effective.
There were no transfers between Level 1 and 2 in the period.
Financial instruments are recognised when the company becomes a party to the contractual provisions of the instrument.
Financial instruments are initially measured at fair value. Transaction costs that are directly attributable to the acquisition or issue of the financial instrument (other than financial assets and financial liabilities at fair value through profit or loss) are added to or deducted from the fair value of the financial instrument, as appropriate, on initial recognition. Transaction costs directly attributable to the acquisition of the financial assets or financial liabilities at FVTPL are recognised immediately in profit or loss as financial income or financial expense.
Financial assets are classified, at initial recognition, as subsequently measured at (a) amortised cost, (b) FVTOCI or (c) FVTPL. The classification depends on the company's business model for managing the financial assets and the contractual terms of the cash flows.
In order for a financial asset to be classified and measured at amortised cost or FVTOCI, it needs to give rise to cash flows that are 'solely payments of principal and interest (SPPI)' on the principal amount outstanding. This assessment is referred to as the SPPI test and is performed at an instrument level.
The company's business model for managing financial assets refers to how it manages its financial assets in order to generate cash flows. The business model determines whether cash flows will result from primarily collecting contractual cash flows, selling the financial assets, or both.
Purchases or sales of financial assets that require delivery of assets within a time frame established by regulation or convention in the market place (regular way trades) are recognised on the trade date, i.e., the date that the company commits to purchase or sell the asset.
Financial assets at amortised cost are currently the only relevant category to the company and include financial assets that are held for collection of contractual cash flows where those cash flows represent solely payments of principal and interest. The company's financial assets at amortised cost include trade and other receivables. They are included in current assets, except for items with maturities greater than 12 months after the end of the reporting period, which are classified as non-current assets.
Financial assets at amortised cost are subsequently measured using the effective interest method and are subject to impairment. Gains and losses are recognised in profit or loss when the asset is derecognised, modified or impaired.
The company currently does not have any financial assets at FVTOCI nor at FVTPL.
Financial liabilities are classified, at initial recognition, as subsequently measured at either (a) amortised cost or FVTPL and include the convertible bond, borrowings, silent partnerships, trade payables and other financial liabilities as described in more detail below.
Financial liabilities are classified as at FVTPL when the financial liability is (i) contingent consideration of an acquirer in a business combination, (ii) held for trading or (iii) it is designated as at FVTPL.
Financial liabilities are classified as held for trading if they are incurred for the purpose of repurchasing in the near term. This category also includes derivative financial instruments entered into by the company that are not designated as hedging instruments in hedge relationships as defined by IFRS 9. Separated embedded derivatives are also classified as held for trading unless they are designated as effective hedging instruments.
Gains or losses on liabilities held for trading are recognised in the statement of profit or loss.
The equity conversion feature from the convertible bond (see Note 27), which is shown under other financial liabilities in the statement of financial position, is classified as embedded derivative to the respective bond and is separated from the main contract (held-for-trading derivatives according to IFRS 9 Appendix A/previously IAS 39.9). The fair value of optional derivative instrument was calculated as the difference between the fair value of the hybrid (combined) instrument and the fair value of the host contract in line with IAS 39.13 in 2017. As of December 31, 2018 the fair value of the equity conversion right has been determined individually in line with IFRS 9.4.3.3.
Financial liabilities designated upon initial recognition at FVTPL are designated at the initial date of recognition, and only if the criteria in IFRS 9 are satisfied. The company has currently not designated any financial liability as at FVTPL.
Financial liabilities that are not (i) contingent consideration of an acquirer in a business combination, (ii) held‑for‑trading, or (iii) designated as at FVTPL, are measured subsequently at amortised cost using the effective interest method.
The effective interest method is a method of calculating the amortised cost of a financial liability and of allocating interest expense over the relevant period. The effective interest rate is the rate that exactly discounts estimated future cash payments (including all fees and points paid or received that form an integral part of the effective interest rate, transaction costs and other premiums or discounts) through the expected life of the financial liability, or (where appropriate) a shorter period, to the amortised cost of a financial liability.
This category generally applies to interest-bearing loans and borrowings as well as trade and other payables.
The Company has obtained loans from various governmental agencies for certain research and development projects, which are stated under borrowings in the statement of financial position. These loans bear an interest rate below the market interest rate. The difference between fair value and the notional amount at inception is treated as a grant in accordance with IAS 20.10A (please refer to Note 6 for further details). The loans are recognised and measured in accordance with IFRS 9.
Trade payables are obligations to pay for goods or services that have been acquired in the ordinary course of business from suppliers. Trade payables are classified as current liabilities if payment is due within one year or less. If not, they are presented as non-current liabilities. Trade payables are recognised initially at fair value and subsequently measured at amortised cost.
As described above, the Company uses valuation techniques that include inputs that are not based on observable market data to estimate the fair value of certain financial instruments, specifically with regard to the equity conversion right included under other financial liabilities.
As described in Note 26 the conversion right has to be accounted for at fair value at inception and in subsequent periods with changes in fair value being recognised as profit or loss in the financial result section of the statement of profit or loss. According to IAS 39.13 (now IFRS 9.4.3.7), if an entity is unable to measure reliably the fair value of an embedded derivative on the basis of its terms and conditions (for example, because the embedded derivative is based on an equity instrument that does not have a quoted price in an active market for an identical instrument, i.e. a Level 1 input), the fair value of the embedded derivative is the difference between the fair value of the hybrid (combined) instrument and the fair value of the host contract.
At inception the fair value of the combined instrument equals the funds raised, i.e. EUR 7 million. For subsequent measurement, the fair value of the combined instrument was measured in accordance with IFRS 13.37 in 2017, under which an entity should measure the fair value of a liability by reference to the quoted price of an identical item that is held by another party as an asset, if a quoted price for the transfer of an identical or a similar liability is not available. Accordingly the fair value of the liability is measured from the perspective of a market participant that holds the identical item as an asset at the measurement date. This requirement could be relevant, as it is the case for the Company, when measuring the fair value of corporate bonds (IFRS 13.35). Under these circumstances the appropriate bases for measuring the fair value of the liability are listed in IFRS 13.38, in descending order of preference:
Accordingly the quoted market price of the bond according to the notation on the Vienna Stock Exchange was taken as fair value of the combined instrument in 2017.
The fair value of the host contract (loan) was estimated by discounting the expected future cash flows using the prevailing market interest rate (estimated at 15.0% p.a. based on an offer received by an external financial institution at the time of the fair value calculation). The fair value of the embedded derivative (equity conversion right) then resulted as the difference between the fair value of the hybrid (combined) instrument and the fair value of the host contract (both calculated as described above).
As of December 31, 2018 the fair value of the equity conversion right was determined individually in line with IFRS 9.4.3.3. The fair value was estimated based on the lower end of the price range for the shares offered in the course of the planned IPO as published in the respective prospectus dated November 16, 2018, i.e. EUR 75.00 per share. This amount also equals the share price finally accomplished in the course of the IPO in February 2019. The fair value adjustment based on the share price just before conversion recognised in 2019 amounted to kEUR 336.6 (2018: kEUR 5,667.6) and is included under financial expenses in the statement of profit or loss and other comprehensive income (see also Note 13 and Note 27).
| Year ended December 31 | 2019 | 2018 |
|---|---|---|
| all amounts in kEUR | ||
| Deposits | 3.2 | 3.0 |
| Prepaid expenses | 9.3 | 9.8 |
| Total long term receivables | 12.5 | 12.8 |
| Trade receivables | 1,484.7 | 622.3 |
| Prepaid expenses | 53.4 | 359.3 |
| Other receivables | 1,682.3 | 910.5 |
| Total current receivables | 3,220.4 | 1,892.2 |
Current receivables were all due within one year. None of them was either past due or impaired. Other receivables mainly include receivables vis-à-vis tax authorities resulting from the research premium and credits from VAT returns.
The following table shows the cash and cash equivalents:
| Year ended December 31 all amounts in kEUR |
2019 | 2018 |
|---|---|---|
| Cash on hand | 0.6 | 0.4 |
| Cash at bank | 12,019.0 | 1,715.1 |
| Total cash and cash equivalents | 12,019.6 | 1,715.5 |
Cash and cash equivalents are classified as cash on hand and deposits held on call with banks and may include other short-term highly liquid investments with original maturities of three months or less. They are recorded at their principal amount.
Cash which is not available for the Company's immediate and general use is not included in cash and cash equivalents, but recorded as a separate asset (restricted cash) in the statement of financial position.
On January 29, 2019 Marinomed announced the closing of its IPO of 260,000 new bearer shares. In the course of an over-allotment option (greenshoe option) a further 39,000 shares were sold in February 2019. The total number of shares sold by the Company in its IPO therefore amounts to 299,000 shares. The shares were sold at the IPO price of EUR 75.00 per share, resulting in total gross proceeds of EUR 22.4 million.
The settlement date and first trading day was February 1, 2019. From this date the Marinomed shares have been traded under the symbol "MARI" on the official market (prime market segment) of the Vienna Stock Exchange. In accordance with IAS 32.37 transaction costs of an equity transaction are accounted for as a deduction from equity to the extent that they are incremental costs directly attributable to the equity transaction that otherwise would have been avoided. Therefore transaction costs directly attributable to the IPO amounting to kEUR 1,790 were recognised as a deduction from equity.
As the transaction met the requirements of a qualified public offer in accordance with the terms and conditions of the convertible bonds issued in 2017, convertible bondholders were entitled to convert their bonds into new shares of the Company. By the end of the conversion period on February 14, 2019, conversion notices for the nominal value of EUR 6.98 million of the convertible bond were submitted for conversion into new shares. The remaining bonds with a nominal value of kEUR 20 were bought back by the Company in March 2019. These transactions increased the number of shares outstanding by 170,772. Subsequently, Marinomed cancelled the listing of the convertible bond on the Third Market of Vienna Stock Exchange on March 20, 2019.
As of December 31, 2019 the number of shares outstanding amounts to 1,469,772, the authorised capital to 500,000 shares and the conditional capital to 100,000 (thereof 43,694 to serve ESOP 2019). All shares have a nominal value of EUR 1 and are fully paid-in. Capital reserves are primarily used to finance research and development.
In accordance with IFRS 2.7 expenses from ESOP 2019 amounting to kEUR 427 were accounted for in capital reserves.
Under partnership agreements dated December 30, 2011, June 22, 2012 and June 25, 2013 respectively, the Company established silent partnerships, according to which the silent partners participate in the Company's fair value and in profit or loss according to the agreed participation rate.
The development of the silent partnerships was as follows:
| Year ended December 31 | 2019 | 2018 |
|---|---|---|
| all amounts in kEUR | ||
| Amortised cost as of January 1 | - | - |
| Contributions | - | - |
| Adjustments to amortised costs | - | - |
| De-recognition/Settlement by issued equity instruments | - | - |
| Amortised cost as of December 31 | - | - |
Amortised cost of the silent partnerships consists of the following:
| Year ended December 31 all amounts in kEUR |
2019 | 2018 |
|---|---|---|
| Contributions | - | 1,205.0 |
| Attributable losses | - | –1,205.0 |
| Amortised cost | - | - |
The Company has entered into three silent partnership agreements over recent years, which entitle the silent partners to a proportionate share in the fair value of the Company, similar to a shareholder, including a share in profit or loss, according to an agreed participation rate.
Upon termination of the silent partnership agreements, the Company has to settle its obligation vis-à-vis the silent partner in cash. Accordingly, the Company does not have the ability to avoid a cash payment to settle the liability, but has a contractual obligation to pay the silent partners (i.e. not at the discretion of the Company). Therefore, the silent partnership agreements are classified as a financial liability according to IAS 32.11. According to IAS 39 (now IFRS 9) contributions of the silent partner have been initially measured at fair value and subsequently at amortised cost. Amortised cost in this sense is taken as the original paid in amount plus cumulative profit allocations less cumulative loss allocations and dividend payments made. As the silent partners do not have an additional funding obligation, amortised costs cannot go below EUR 0 after loss allocations. The amount payable on demand as of December 31, 2018 amounted to EUR 0.
Based on a contribution in kind and incorporation agreement dated November 15, 2018 as well as a deed of variation dated December 30, 2018, the investment from silent partnerships was contributed to the Company against transfer of existing shares to the silent partners by the existing shareholders subject to the condition precedent of a successful IPO of Marinomed Biotech AG, which was fulfilled on February 1, 2019. The Company did not have to settle any amount in cash to the silent partners at any time.
According to a separate call option agreement dated November 30, 2018, as amended by an amendment agreement dated December 30, 2018, the silent partners granted the Company a call option to acquire the shares received for the contribution in kind and incorporation. The effectiveness of the option agreement was subject to the condition precedent of a successful IPO and further gross proceeds from the IPO of at least EUR 30 million. As gross proceeds came out below the EUR 30 million, the condition precedent was not met and the option did not become effective.
Borrowings consist of the following items:
| Year ended December 31 | 2019 | 2018 |
|---|---|---|
| all amounts in kEUR | ||
| Non-current borrowings | ||
| EIB loan | 4,062.1 | - |
| AWS Seed loan | 415.8 | 1,111.8 |
| Lease obligations | 27.5 | 61.7 |
| Total non-current borrowings | 4,505.4 | 1,173.5 |
| Current borrowings | ||
| EIB loan | 7.6 | - |
| AWS Seed loan | 48.8 | - |
| FFG loans | - | 1,391.1 |
| Shareholders' loans | - | 2,305.1 |
| Lease obligations | 78.7 | 19.5 |
| Total current borrowings | 135.2 | 3,715.6 |
| Total borrowings | 4,640.6 | 4,889.2 |
The maturity of borrowings is as follows:
| Total borrowings | 4,640.6 | 4,889.2 |
|---|---|---|
| Later than 5 years | - | - |
| Later than 1 year and no later than 5 years | 4,505.4 | 1,173.5 |
| No later than 1 year | 135.2 | 3,715.6 |
| Year ended December 31 all amounts in kEUR |
2019 | 2018 |
Borrowings were restructured during the 2019 financial year. Using the proceeds from the public offering, the FFG loans in the amount of kEUR 1,391, the shareholder's loans in the amount of kEUR 2,305 as well as the face value of the AWS Seed loan amounting to kEUR 500 were repaid. The accrued and unpaid interest relating to the AWS Seed loan now has a lower interest rate and will be repaid over the coming years. On the other hand, the European Investment Bank (EIB) committed to a EUR 15 million Venture Loan. The first tranche of the loan in the amount of kEUR 4,000 was drawn down at October 14, 2019, which increased the borrowings.
The nominal and carrying amounts, maturity dates and interest rates on borrowings were as follows (all amounts in kEUR):
| Lender | Nominal amount |
Carrying amount as of December 31, 2019 |
Maturity date |
Weighted nominal interest rate |
Weighted average effective interest rate |
|---|---|---|---|---|---|
| EIB loan | 4,000.0 | 4,069.7 | 14.10.2024 | 7.50% | 14.71% |
| AWS Seed loan | 619.9 | 464.7 | undefined | 2.00% | 2.00% |
| Leasing | 61.7 | 61.7 | 03.11.2020 - 31.03.2023 |
2.92% | 2.92% |
Further details and explanations of the table above are given below for each class of borrowings.
The following table shows a comparison by class of the carrying amounts and fair values of the Company's borrowings, other than those with carrying amounts that are reasonable approximations of fair values:
| Year ended December 31 all amounts in kEUR |
2019 | 2018 |
|---|---|---|
| Carrying amount | ||
| FFG loan | - | 1,391.1 |
| AWS Seed loan | 464.7 | 1,111.8 |
| EIB loan | 4,069.7 | - |
| Total | 4,534.4 | 2,502.9 |
| Fair Value | ||
| FFG loan | - | 1,269.2 |
| AWS Seed loan | 464.7 | 803.9 |
| EIB loan | 4,069.7 | - |
| Total | 4,534.4 | 2,073.2 |
The fair values of non-current borrowings stated above are based on discounted cash flows using an interest rate of 15.0%, which was considered to be the best estimate for a market interest rate for the Company based on an offer received by an external financial institution at the time of the fair value calculation. They are classified as level 3 fair values in the fair value hierarchy (see Note 20) due to the use of unobservable inputs, including an estimation of the timing of repayment of the aws Seed loan based on the Company's forecast.
For other borrowings, the fair values are not materially different to their carrying amounts, since the interest payable on those borrowings is either close to current market rates or the borrowings are of a short-term nature.
Following the IPO in February 2019, the FFG loan in the amount of kEUR 1,391 was repaid to Österreichische Forschungsförderungsgesellschaft mbH as contractually required. As of December 31, 2019 the Company therefore showed a FFG loan with a nominal amount of kEUR 0 (2018: kEUR 1,391). The loan carried a fixed interest rate of 2.00% p.a. According to IAS 20.10A, the differences between the nominal interest rates of these loans and the market rate of interest, estimated at 15.0% (see above), are treated as a government grant and recognised over the term of the corresponding financial liabilities. As the Company has applied IAS 20 prospectively to government loans existing at the date of transition to IFRS according to IFRS 1.B10, the benefit of a government loan at a below-market rate of interest has only been recognised for government loans that became effective or for which tranches have been paid out after the date of transition to IFRS.
In 2018 a further three loans from FFG amounting to kEUR 351 were converted into non-repayable grants.
In 2006 the Company took out a loan from aws ("aws Seed loan") in the total nominal amount of kEUR 500. The aws Seed loan is generally granted for supporting start-up companies. In case of the Company, aws granted the loan for the purpose of supporting the development of the Company's antiviral medical devices.
The aws Seed loan has a term of 10 years including a grace period of 5 years starting on July 1, 2007 (date on which the last tranche was received from aws) and a fixed interest rate of 8.50% p.a. Yearly repayments are to be based on annual profits made by the Company. In case of a profit generated by the Company, 30% of the profit before tax (adjusted for certain items) has to be used to repay the loan. If the Company does not make any profits in any given year, no repayments shall be made in that year. The loan period is extended indefinitely until the outstanding amount is paid off. As of December 31, 2018 and 2019 the management of the Company expected the loan to be repaid within the next five years; accordingly the carrying amount of the aws Seed loan has been included in the line "later than 1 year and no later than 5 years" in the table on maturities of borrowings stated above.
Due to an improved liquidity position after the IPO in February 2019 it was possible to repay the principal of the aws Seed loan amounting to kEUR 500 in June 2019. Regarding the repayment of the accrued interest, which accumulated since 2006, a favourable agreement was reached. Starting on February 1, 2019 the interest was retrospectively reduced from a fixed rate of 8.5% to 2% plus 3M-EURIBOR (maximum interest rate according to SME grants law). Furthermore it was agreed to settle kEUR 100 yearly in the event of a loss. In the event of a profit, 30% of the profit before tax (adjusted for certain items, at least kEUR 100) has to be used to repay the loan. The first repayment date will be June 30, 2020.
In 2015 a number of shareholders provided the Company with shareholders' loans with a nominal amount of kEUR 1,075.
In 2016 a new investor and exisiting shareholders provided the Company with shareholders' loans with a nominal amount of kEUR 1,277.
In 2018 a partial repayment of the shareholders' loan with an amount of kEUR 89.3 was made.
The loans are provided to support the Company's R&D activities and working capital requirements. The term of the loans was extended for one year and ended on December 31, 2019. The loans carry fixed interest of 10% p.a., which has to be paid annually until 5 working days after the end of each calender year. The nominal amount has to be repaid in full at the end of the loan term. However, the Company was entitled to request conversion of the loans into non-repayable shareholders' contributions upon fulfillment of certain conditions which were not be fulfilled until due date.
Due to the fact that the interest rate in the loan agreements was below the market rate, the market rate of interest (estimated at 15.0% p.a. in 2017) has been taken into account to calculate the fair value of the loans at inception. The difference between the fair value and the amounts received was recognised directly in equity.
As per the resolution of the supervisory board on April 11, 2019, the shareholder loans in the amount of kEUR 2,305 were repaid ahead of maturity in June 2019 in order to save interest expenses until year end.
Accordingly, the development of shareholders' loans was as follows:
| all amounts in kEUR | 2019 | 2018 |
|---|---|---|
| Carrying amount as of January 1 | 2,305.1 | 2,389.9 |
| Repayment of shareholders' loan | –2,262.7 | –89.3 |
| Adjustment of carrying amount (according to IFRS 9:B5.4.6) | - | –193.4 |
| Effective interest accrued | 307.6 | 436.4 |
| Interest paid | –350.1 | –238.5 |
| Carrying amount as of December 31 | - | 2,305.1 |
In February 2019 Marinomed was granted a loan commitment of up to EUR 15 million by the European Investment Bank. The payout of 3 tranches in total is set to take place from 2019 to 2022 and is subject to the achievement of certain contractually defined milestones. The maturity of all tranches is 5 years. Apart from interest payments, Marinomed also has to pay royalties based on revenues.
In October 2019, Marinomed called the first tranche of the loan in the amount of EUR 4 million.
The Company leases laboratory equipment, office premises and a vehicle.
Under the terms of the laboratory equipment and office premises leases, there is no residual value guaranteed.
Under the terms of the vehicle lease, a residual value with an amount of kEUR 14.9 is guaranteed.
| Year ended December 31 all amounts in kEUR |
2019 | 2018 |
|---|---|---|
| Commitments in relation to leases are payable as follows: | ||
| Within one year | 66.6 | 21.5 |
| Later than one year but not later than five years | 28.1 | 48.9 |
| Later than five years | - | - |
| Minimum lease payments | 94.7 | 70.5 |
| Guaranteed residual value | 14.9 | 14.9 |
| Future finance charges | –3.4 | –4.2 |
| Recognised lease liabilities | 106.2 | 81.2 |
| The present value of lease liabilities is as follows: | ||
| Within one year | 78.7 | 19.5 |
| Later than one year but not later than five years | 27.5 | 61.7 |
| Later than five year | - | - |
| Total lease liabilities | 106.2 | 81.2 |
On July 14, 2017 the Company placed a PRE-IPO 4% bond with a conditional equity conversion right listed on the Vienna Stock Exchange under ISIN AT0000A1WD52. The bond has a nominal amount of EUR 7 million and a maturity of 4 years, i.e. repayable until July 14, 2021. The bondholders have the right to convert their entire claim into ordinary shares of the Company conditional upon the execution of a QPO (Refer to Note 27 for more details on the conversion right).
The bond bears interest at a rate of 4% p.a. as from the interest commencement date, i.e. July 14, 2017. Interest is payable annually in arrears at the end of each one-year period, i.e. on July 14 of each calendar year. In case of a Trade Sale or Licence Payment (both as defined in the Terms and Conditions of the Bond) the Company is obliged to pay a Trade Sales Premium/Licence Payment Premium together with the redemption amount on the Maturity Date.
As the IPO in February 2019 met the requirements of a qualified public offer in accordance with the terms and conditions of the convertible bonds issued in 2017, convertible bondholders were entitled to convert their bonds into new shares of the Company. By the end of the conversion period on February 14, 2019, conversion notices for a nominal value of kEUR 6,980 of the convertible bond were submitted for conversion into new shares. The remaining bonds with a nominal value of kEUR 20 were bought back by the Company in March 2019. Subsequently, Marinomed cancelled the listing of the convertible bond on the Third Market of Vienna Stock Exchange on March 20, 2019.
The development of the convertible bond was as follows:
| all amounts in kEUR | 2019 | 2018 |
|---|---|---|
| Carrying amount as of January 1 | 5,714.3 | 5,073.1 |
| Conversion | –5,819.2 | - |
| Repurchase | –24.8 | - |
| Effective interest accrued | 130.2 | 921.2 |
| Interest paid | –0.5 | –280.0 |
| Carrying amount as of December 31 | - | 5,714.3 |
| Thereof | ||
| Current | - | 131.2 |
| Non-current | - | 5,583.1 |
The fair value of the convertible bond (excluding the equity conversion rights) amounted to kEUR 6,228 as of December 31, 2018 and is based on discounted cash flows using an interest rate of 15.0%, which was considered to be the best estimate for a market interest rate for the Company. It is classified as level 3 fair values in the fair value hierarchy (see Note 20) due to the use of unobservable inputs.
The convertible bond represents two financial instruments: an interest bearing loan and an option in the form of an equity conversion right for the holders of these instruments. The loan feature of the contract represents a host debt contract that is accounted for at fair value at inception, net of transaction costs incurred, in line with IFRS 9.5.1.1 (previously IAS 39.43) and subsequently at amortised cost following the effective interest method.
The loan feature also includes the contingent payment of a Trade Sales Premium and/or Licence Payment Premium, which represents a financial liability containing a contingent settlement provision. Any adjustments to the underlying cash flow projections and probabilities of such premiums are taken into consideration, with any fluctuations being recognised in line with IFRS 9 B5.4.6 (previously IAS 39 AG 8) in the line items finance income or finance expense. Due to the fact that the conversion price is not fixed but dependent on future developments, the equity conversion right is considered a financial liability in accordance with IAS 32. The conversion right represents an embedded derivative, which is separated from the host contract and accounted for at fair value at inception and in subsequent periods with changes in fair value being recognised as profit or loss in the financial result line item in the statement of profit or loss and other comprehensive income (loss).
Upon initial recognition the fair value of the host contract (loan) was estimated using a market interest rate of 15.0% p.a. The fair value of the embedded derivative (equity conversion right) resulted from the difference between the fair value of the hybrid (combined) instrument and the fair value of the host contract in line with IAS 39.13 in 2017. As of December 31, 2018 the fair value of the equity conversion right was estimated based on the lower end of the price range for the shares offered in the course of the planned IPO as published in the respective prospectus dated November 16, 2018, i.e. EUR 75.00 per share, in line with IFRS 9.4.3.3. This amount also equals the share price finally accomplished in the course of the IPO in February 2019.
Other financial liabilities include the following items:
| all amounts in kEUR Equity conversion right |
- | 7,132.0 |
|---|---|---|
| Total other financial liabilities | - | 7,132.0 |
The equity conversion rights from the convertible bond represent embedded derivatives that are not closely related to the host debt and consequently accounted for separately at fair value through profit or loss (see Note 20). The development of the fair value of the conversion rights was as follows:
| Year ended December 31 all amounts in kEUR |
2019 | 2018 |
|---|---|---|
| Fair value as of January 1 | 7,132.0 | 1,464.4 |
| Fair value adjustment | 336.6 | - |
| Conversion | –7,468.6 | 5,667.6 |
| Fair value as of December 31 | - | 7,132.0 |
Refer to Note 26 for more details on the conversion and the fair value changes.
| all amounts in kEUR Trade payables |
1,002.4 | 2,014.5 |
|---|---|---|
| Total trade payables | 1,002.4 | 2,014.5 |
Trade payables were all due within one year. Trade payables are unsecured and are usually paid within 30 days of recognition.
Current contract liabilities and other liabilities include the following items:
| Year ended December 31 all amounts in kEUR |
2019 | 2018 |
|---|---|---|
| Other non-current liabilities | ||
| Grant – below market rate | 104.1 | - |
| Total other non-current liabilities | 104.1 | - |
| Current contract liabilities and other current liabilities | ||
| Clinical studies | 583.4 | - |
| Employee bonuses | 435.2 | - |
| Grant – below market rate | 51.2 | - |
| Social security and payroll related taxes | 109.0 | 118.0 |
| Accounting, tax and audit services | 43.6 | 92.7 |
| Unconsumed vacation | 203.2 | 173.5 |
| Overtime | 16.8 | 21.6 |
| Contract liability | - | 7.7 |
| Others | 173.0 | 547.0 |
| Total current contract liabilities and other current liabilities | 1,615.4 | 960.5 |
| Total contract liabilities and other liabilities | 1,719.5 | 960.5 |
The increase in current contract liabilities and other current liabilities primarily relates to two positions. In 2019, Marinomed prepared for a number of clinical studies together with external service partners. Contractually, payments to these partners for the studies do not fall due before the fulfilment of certain milestones. The company records the respective liability based on the degree of completion of work packages. In addition, Marinomed granted its employees bonus payments for the fiscal year 2019 in December, which will be paid out in 2020.
Provisions include the following items:
| all amounts in kEUR | Warranty provision | Other provisions |
|---|---|---|
| Carrying amount at January 1, 2018 | 750.0 | 13.0 |
| Use/Release | - | - |
| Additions | - | 57.0 |
| Carrying amount at December 31, 2018 | 750.0 | 70.0 |
| Use/Release | - | –57.0 |
| Additions | - | 510.0 |
| Carrying amount at December 31, 2019 | 750.0 | 523.0 |
In 2013 the Company granted the exclusive rights for the antiviral product line of the Company to an international pharmaceutical company for several territories. The amount that this Company requires to be paid back after the return of the exclusive rights has been considered as a warranty provision.
Other provisions include expected contractual payments in connection with the relocation of the company headquarters (kEUR 510).
Provisions are recognised when the Company has a present obligation (legal or constructive) as a result of a past event, it is probable that the Company will be required to settle the obligation and a reliable estimate can be made of the amount of the obligation. Provisions are measured at the present value of management's best estimate of the expenditure required to settle the present obligation at the end of the reporting period. The expense relating to a provision is presented in the statement of profit or loss and other comprehensive income (loss).
Shares in affiliated companies relate to Marino Immo GmbH, a wholly owned subsidiary of Marinomed Biotech AG based in Vienna, which was incorporated on August 3, 2019. At the moment the company does not conduct any operating activity. The 2019 financial statements have not yet been published.
Shares in affiliated companies are measured at amortised cost.
The Company has no contingent liabilities in respect of legal claims arising in the ordinary course of business.
The Company has entered into a number of agreements which also entail financial commitments for the future and mainly relate to commitments associated with the construction of the new headquarters in Korneuburg (see also Note 17), to services provided by third parties in connection with the conduct of clinical trials and other research and development activities (see also Note 18). The remaining payments to be made under these agreements, if all milestones and other conditions are met, are estimated as follows:
| Total | 6,224.3 | 1,501.3 |
|---|---|---|
| Later than 5 years | 0.0 | 0.0 |
| Later than 1 year and no later than 5 years | 71.5 | 62.2 |
| No later than 1 year | 6,152.8 | 1,439.1 |
| Year ended December 31 all amounts in kEUR |
2019 | 2018 |
In 2019 the members of the management board of the Company were:
In 2019 expenses for salaries and short-term employee benefits of members of the management board amounted to kEUR 1,458 (2018: kEUR 472). In 2019 these amounts included expenses for the Employee Stock Option Plan amounting to kEUR 223. No long-term employee benefits or termination benefits were paid in 2018 and 2019.
The Company has had a statutory supervisory board since 2017. The supervisory board ("Aufsichtsrat"), which supports management in commercial and scientific matters, consisted of the following members in 2019:
The aggregate compensation of the members of the supervisory board amounted to kEUR 186 (2018: kEUR 137).
Simon Nebel (chair of supervisory board) and Laureo Corporate Finance GmbH (100% owned by Ute Lassnig, deputy chair of the supervisory board) participated in the convertible bond issued in 2017 in the aggregate amount of kEUR 70 until conversion. For further details regarding the conversion of the convertible bond in February 2019 and contractual agreements, please refer to Note 26.
In the reporting period the Company entered into a consultancy contract with the chairman of the supervisory board in relation to certain business development activities. In the fiscal year 2019 expenses related to this contract amounted to kEUR 35.
In 2015 the Company entered into shareholders' loans (see Note 25) with some of its shareholders with an aggregate principle amount of kEUR 1,075 as of December 31, 2015. In 2017, a new shareholders' loan was provided and the existing loans were increased with a total aggregate principle amount of kEUR 2,352 as of December 31, 2017.
In 2018, a partial repayment in the amount of kEUR 89 was made. The following shareholders participated in these loans:
As per the resolution of the supervisory board on April 11, 2019, the shareholder loans in the amount of kEUR 2,305 were repaid ahead of maturity in June 2019 in order to save interest expenses until year end.
For further details and contractual agreements, please refer to Note 25.
All transactions with related parties are carried out at arms-length principle.
The auditors of the statutory accounts BDO Austria GmbH Wirtschaftsprüfungs- und Steuerberatungsgesellschaft have performed the following services for the Company:
| Year ended December 31 all amounts in kEUR |
2019 | 2018 | |
|---|---|---|---|
| Audit fees financial statements | 40.0 | 40.0 | |
| Other assurance services | 15.0 | 136.8 | |
| Tax advisory services | 4.8 | 26.4 | |
| Other advisory services | 221.9 | 61.4 | |
| Total | 281.7 | 264.6 |
Other advisory services amounting to kEUR 221.9 include cash expenses for a comfort letter insurance amounting to kEUR 166.5.
The Covid-19 crisis at the end of 2019 has so far developed into a global pandemic. Due to the exponential spread of the virus, the numerous deaths and the associated strain on the health systems worldwide, numerous countries have placed massive restrictions on liberty rights and economic activity. These include, in particular, the closure of shops in entire sectors (essentially all areas apart from those for basic services such as food, pharmaceuticals, etc.), sometimes rigid curfews, street and event bans, border controls as well as the introduction of minimum spaces with direct impact also on office operations. Starting from its origins in Asia and after the European Union, the United States are currently the worst affected by the Covid-19 pandemic. However, the virus has already reached all continents and serious consequences are still to be feared, especially in developing countries with poorer medical care.
As an internationally active company, Marinomed is embedded into the world economy. Although it is not possible to predict the long-term effects the pandemic will have on the global economy, there is an increased risk that the global economic climate will deteriorate and that the downturn will continue across all continents. While the life sciences sector is less sensitive to changes of this nature, it may become more difficult to maintain a continuous supply chain and the slowdown in economic growth may lead to lower customer demand. There will be delays in conducting the planned clinical studies for both platforms, because in particular allergy studies are prevented by the current official restrictions.
On the other hand, Carragelose® based products have clinically proven to be active against respiratory viruses. On that basis, it becomes evident that the seasonally weaker first half of the year will not show the typical decline in revenues in 2020. It is currently not possible to reliably predict whether this trend is sustainable. This is because the SARS-CoV-2 virus is originally not a human virus and there is no clinical data available on the effectiveness of Carragelose® against the new virus. Clearly and with high priority, Marinomed puts a lot of effort in producing corresponding results from clinical studies. But there remains the risk that these trials will not yield the desired results. Funds for conducting the studies are available through the Company's financial resources and should be complemented by national and international governmental programs.
The Company's financial statements were approved by the Managing Board for submission to the Supervisory Board on April 15, 2020.
The Supervisory Board is responsible for reviewing and acknowledging the Company's financial statements.
................................................. ................................................. .................................................
Vienna, 15.04.2020 Vienna, 15.04.2020 Vienna, 15.04.2020 Andreas Grassauer Eva Prieschl-Grassauer Pascal Schmidt
We have audited the financial statements of Marinomed Biotech AG, Vienna. These financial statements comprise the statement of financial position as of December 31, 2019, the income statement for the fiscal year then ended and the notes.
Based on our audit the accompanying financial statements were prepared in accordance with the legal regulations and present fairly, in all material respects, the assets and the financial position of the Company as of December 31, 2019 and its financial performance for the year then ended in accordance with International Financial Reporting Standards (IFRS), as adopted by the EU.
We conducted our audit in accordance with Austrian Standards on Auditing. Those standards require that we comply with International Standards on Auditing (ISA). Our responsibilities under those regulations and standards are further described in the "Auditor's Responsibilities for the Audit of the Financial Statements" section of our report. We are independent of the Company in accordance with the Austrian General Accepted Accounting Principles and professional requirements and we have fulfilled our other ethical responsibilities in accordance with these requirements. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinion.
Our responsibility and liability as auditor is guided by Section 275 par. 2 Austrian Company Code UGB (liability regulations for the audit of small and medium-sized companies) and is limited to a total of 2 million Euros towards the Company and towards third parties.
Key audit matters are those matters that, in our professional judgment, were of most significance in our audit of the financial statements of the fiscal year. These matters were addressed in the context of our audit of the financial state-ments as a whole, and in forming our opinion thereon, and we do not provide a separate opinion on these matters.
We considered the following matter as a key audit matter and present further information on the following page. • Accounting for the employee stock option program (ESOP)
On February 1, 2019 Marinomed Biotech AG established an employee stock option program (ESOP) for members of the management board and for all employees of the Company. The number of options granted during the fiscal year 2019 as part of the ESOP amounts to 42,287.
The general conditions of the stock option program provide for a remuneration commitment in several instalments. The exercise of these options is based on various conditions (ie market conditions). These conditions are described in the notes to the financial statements. The method of valuation needs to consider the characteristics of the stock option program.
The requirements of IFRS 2 have been observed when accounting for the ESOP. The accounting of the ESOP bears a material risk of material misstatement in the financial statements due to the high complexity. Furthermore, a material risk is the uncertainty of estimation of the underlying judgments.
A Monte Carlo simulation was chosen as valuation method. The valuation of the options at grant date is subject to significant estimates and judgements, especially in connection with the input factors of the Monte Carlo simulation, especially concerning the parameters of the Monte Carlo simulation. In this regard we refer to the information in the notes.
Further information can be found in chapter 9. of the notes to the financial statements.
We studied the structure and general conditions of the stock option program and assessed whether the accounting principles of IFRS 2 were used appropriately.
We assessed the appropriateness of the option valuation model selection and the valuation parameters which were applied in this context. The significant parameters of the Monte Carlo simulation were examined and were subject to a plausibility check performed with market data. The valuation was checked for arithmetical accuracy and for correct integration of the underlying parameters.
On a sample basis we verified with the corresponding supporting documents (resolutions, grant letters, ESOP framework conditions) that the options have been granted.
As part of our examination of the notes to the financial statements, we paid attention to the correct fulfillment of disclosure obligations related to the ESOP.
Management is responsible for the preparation of the financial statements in accordance with International Financial Reporting Standards (IFRS), as adopted by the EU, for them to present a true and fair view of the assets, the financial position and the financial performance of the Company and for such internal controls as management determines are necessary to enable the preparation of financial statements that are free from material misstatement, whether due to fraud or error.
In preparing the financial statements, management is responsible for assessing the Company's ability to continue as a going concern, disclosing, as applicable, matters related to going concern and using the going concern basis of accounting unless management either intends to liquidate the Company or to cease operations, or has no realistic alternative but to do so.
The audit committee is responsible for overseeing the Company's financial reporting process.
Our objectives are to obtain reasonable assurance about whether the financial statements as a whole are free from material misstatement, whether due to fraud or error, and to issue an auditor's report that includes our opinion. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with International Standards on Auditing will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these financial statements.
As part of an audit in accordance with Austrian Standards on Auditing, which require the application of ISA, we exercise professional judgment and maintain professional scepticism throughout the audit.
We also:
Management is responsible for the other information. The other information comprises the information included in the annual report, but does not include the financial statements, the management report and the auditor's report thereon. The annual report is estimated to be provided to us after the date of the auditor's report. Our opinion on the financial statements does not cover the other information and we do not express any form of assurance conclusion thereon.
In connection with our audit of the financial statements, our responsibility is to read the other information, as soon as it is available, and, in doing so, to consider whether — based on our knowledge obtained in the audit — the other information is materially inconsistent with the financial statements or otherwise appears to be materially misstated.
Vienna, April 15, 2020
BDO Austria GmbH Wirtschaftsprüfungs- und Steuerberatungsgesellschaft
Mag. (FH) Georg Steinkellner Mag. Klemens Eiter Certified Public Accountant Certified Public Accountant

Die Firma Marinomed Biotech AG wurde im März 2006 als Spin-off der Veterinärmedizinischen Universität Wien als Marinomed Biotechnologie GmbH gegründet und hat eine nicht-operative und nichtkonsolidierte Tochtergesellschaft. Das Unternehmen verfügt über angemietete Büro- und Forschungslaborräumlichkeiten am Campus der Veterinärmedizinischen Universität und betreibt sonst keine weiteren Standorte.
In der ordentlichen Generalversammlung vom 12. Mai 2017 wurde die Umwandlung der Gesellschaft in eine Aktiengesellschaft mit Wirkung zum Ablauf des 31. Dezember 2016 beschlossen. Das Grundkapital war zum 31.12.2017 in 132.360 auf Namen lautende nennwertlose Stückaktien zerlegt.
Mit außerordentlichem Hauptversammlungsbeschluss vom 17. September 2018 wurde das Grundkapital der Gesellschaft durch Ausgabe von 867.640 auf Namen lautenden Stückaktien gegen Bareinzahlung von € 867.640,00 auf € 1.000.000,00 erhöht.
In der außerordentlichen Hauptversammlung vom 15. November 2018 wurde die Umwandlung der Namensaktien in auf Inhaber lautende Aktien beschlossen. Darüber hinaus wurde der Vorstand ermächtigt, das Grundkapital mit Zustimmung des Aufsichtsrats gemäß § 169 AktG unter teilweisem Bezugsrechtsausschluss sowie teilweiser Ermächtigung zum Bezugsrechtsausschluss um bis zu € 500.000,00 im Einvernehmen mit dem Aufsichtsrat sowie um bis zu € 480.000,00 zur Ausgabe in Verbindung mit dem geplanten Börsengang zu erhöhen. Weiters wurde einer bedingten Kapitalerhöhung von bis zu € 173.122,00 durch Ausgabe von Inhaberaktien für den Umtausch von Wandelschuldverschreibungen zugestimmt.
Im Zuge des Börsegangs der Marinomed am 1. Februar 2019 wurden insgesamt 299.000 neue Inhaberaktien zum Preis von € 75,00 je Aktie bei Investoren platziert (davon 260.000 Aktien aus dem Basisangebot und 39.000 Aktien aus Mehrzuteilungen). Dies führte im ersten Quartal 2019 zu einer Grundkapitalerhöhung von insgesamt € 299.000,00. Für den Umtausch von Wandelschuldverschreibungen in Aktien wurden weitere 170.772 Aktien ausgegeben. In Summe ergibt sich somit ein Grundkapital von € 1.469.772,00, das in 1.469.772 stimmberechtigte Aktien eingeteilt ist. Dies entspricht dem zum 31. Dezember 2019 ausgewiesenen Grundkapital der Gesellschaft.
Zum Zeitpunkt der Abschlusserstellung stand Marinomed zu rund 27% im Eigentum der Gründer bzw. des Managements (davon 2% innerhalb des Streubesitzes) und zu rund 16,6% im Eigentum eines strategischen Altinvestors. Der börserechtliche Streubesitz betrug 58,3%.

Der Fokus der Unternehmenstätigkeit liegt auf der Entwicklung innovativer Therapien auf der Grundlage patentgeschützter, proprietärer Technologieplattformen.
Die Carragelose®-Plattform führte kurz nach der Gründung von Marinomed zur Entdeckung eines, von Marinomed als Carragelose® marken- und patentgeschützten, Polymers aus Rotalgen mit außergewöhnlicher Wirksamkeit bei viralen Infekten der Atemwege. Marinomed konnte die klinisch nachgewiesene Wirksamkeit in einer Reihe von Produkten gegen respiratorische Viren nutzen, die heute von Partnern auf allen Kontinenten vertrieben werden. Die Produktpalette besteht aus 4 Nasensprays, einem Rachenspray und Lutschpastillen. Auf Basis der Plattform entwickelt das Unternehmen weitere Produkte, so ist geplant, dass für das abschwellende Kombinationsprodukt mit Carragelose® und Xylometazolin im Geschäftsjahr 2020 der Antrag auf Zulassung eingereicht wird.
Im Zuge der Forschungs- und Entwicklungsarbeiten zur Erweiterung ihres Produktangebots mit Kombinationspräparaten, gelang es den Forscherinnen und Forschern bei Marinomed die zweite Technologie – die patentgeschützte Plattform Marinosolv® – zu entwickeln, die die Basis für neue Produkte im Bereich Allergie und Autoimmunerkrankungen darstellt.
Im Geschäftsjahr 2019 konnte Marinomed mit dem Marinosolv®-Leitprodukt Budesolv einen der wichtigsten Meilensteine der Entwicklung erreichen. Nach den Top Line-Ergebnissen im April 2019 wurde mit den später veröffentlichten Detaildaten gezeigt, dass mit 85% weniger Dosis nach einer Woche Behandlung die gleiche Wirkung wie mit dem Marktprodukt erzielt wurde. Noch entscheidender war der Nachweis, dass bereits innerhalb von 3 Stunden nach erstmaliger Anwendung ein signifikanter Effekt erzielt wurde. Das Marktprodukt konnte diesen Effekt nicht zeigen.
Mit dem erfolgreichen Studienabschluss konnte nicht nur eine wichtige Voraussetzung für die Anmeldung zur Zulassung von Budesolv geschaffen, sondern auch Marinosolv® als Technologieplattform klinisch validiert werden: Produkte, die mit Marinosolv® in Lösung gebracht wurden, haben eine höhere Bioverfügbarkeit und damit einen schnelleren Wirkeintritt verglichen mit heutigen Behandlungen, die auf Suspensionen basieren.
Als Forschungs- und Entwicklungsunternehmen hat Marinomed große Teile der Wertschöpfungskette an Partner ausgelagert. Der Vertrieb der Produkte erfolgt über Vertriebspartner, die jeweils für ihr geographisches Gebiet von Marinomed eine Vertriebslizenz erhalten haben. Mit Ausnahme einiger weniger Länder wo es Lizenzpartnerschaften gibt, agiert Marinomed als Großhändler. Dadurch ist es möglich mit limitiertem Ressourceneinsatz 14 B2B Kunden mit Vertrieb in über 40 Ländern zu betreuen und zu organisieren.
Seit der Finanz- und Wirtschaftskrise 2008/2009 hat der Internationale Währungsfonds mit Ausnahme von 2015 jedes Jahr ein Wachstum der globalen Wirtschaft ausgewiesen, im Durchschnitt von 3,7% pro Jahr (Website des Internationalen Währungsfonds: https://www.imf.org/). Damit verbunden ist auch ein steigendes verfügbares Einkommen und davon profitiert insbesondere der Gesundheitssektor und damit auch Marinomed. Als biopharmazeutisches Unternehmen ist Marinomed in das Umfeld der globalen pharmazeutischen und Biotechnologie-Märkte eingebettet.
Der globale pharmazeutische Markt ist ein Wachstumsmarkt, der laut dem Datenanbieter IQVIA für 2019 auf ein Volumen von rund USD 1 300 Mrd. geschätzt wird und mit einer Rate von 3-6% pro Jahr wachsen soll. Welchen Einfluss die COVID-19 Pandemie auf den pharmazeutischen Markt haben wird ist derzeit unklar. Es kann aber davon ausgegangen werden, dass die pharmazeutische Industrie von einer globalen konjunkturellen Krise weniger betroffen sein wird als andere Teile der Wirtschaft. Bleiben wird der Preisdruck der Finanzierer der Gesundheitssysteme auf die Industrie, der in Europa als Wachstumsdämpfer für die Branche schon seit längerer Zeit wirkt. Der zunehmende Lebensstandard in Asien und anderen Wachstumsregionen führt aber dennoch zu positiven Wachstumsaussichten der Branche.
Die globale Biotechnologie-Industrie wächst mit rund 7 % p.a. deutlich rascher als die Weltwirtschaft und die pharmazeutische Industrie (Quelle: Globaldata). Der Grund für diesen Trend ist die hohe Innovationsfreudigkeit und Risikobereitschaft der biotechnologischen Unternehmen in Forschung und Entwicklung zu investieren und dann erfolgreiche Ergebnisse gemeinsam mit großen Pharmaunternehmen auf den Markt zu bringen. Die steigenden Ausgaben für Forschung und Entwicklung sowie das Potenzial junger Biotech-Unternehmen bedeutende Volumina an Risikokapital zu mobilisieren, signalisieren ebenfalls nachhaltiges Wachstum der Branche. Budgetäre Themen und die politische Unsicherheit, vor allem in den USA könnten aber zu Störungen des Wachstums führen.
Auch wenn Marinomed mit seinen Produkten, die über Partner in den Ländern vermarktet werden, nur einen kleinen Marktanteil innehat, profitiert das Unternehmen vom globalen Wachstum. Ein positives gesamtwirtschaftliches Klima und insbesondere wachsende Gesundheitsmärkte ermöglichen Marinomed nicht nur mit dem Markt zu wachsen, sondern führen auch dazu, dass bestehende und zukünftige Partner die Bereitschaft haben, in zukünftige Produkte und Märkte zu investieren.
Das erste Produkt der Marinosolv®-Plattform Budesolv zielt auf den Markt für allergische Rhinitis ab, dem im Jahr 2019 Umsätze in Höhe von USD 13 Mrd. prognostiziert werden (Visiongain Allergic Rhinitis Report 2018). Der Markt für nasale Steroide wächst dabei stärker als der Gesamtmarkt und ist damit seit 2018 mit einem Anteil von 38 % das größte Segment in diesem Markt. Diese Steigerungen sind zum Teil auf den Trend zurückzuführen, dass verschreibungspflichtige Medikamente in den nicht verschreibungspflichtigen Over-the-Counter (OTC)-Markt transferiert werden.
Auf Basis der universellen Anwendbarkeit der Marinosolv®-Plattform hat Marinomed weitere Produktentwicklungen angestoßen und das Entwicklungsprodukt Tacrosolv steht unmittelbar vor dem Beginn einer Phase II Studie. Dieses Produkt zielt auf den Markt für Ophthalmologie ab. Teilsegmente sind hier der Markt für allergische Konjunktivitis und für Dry Eye Syndrom. Beide Märkte sind derzeit unterversorgt und neue innovative Medikamente haben die Chance eine große Gruppe von Patienten zu versorgen. Das Marktpotential des Dry Eye Segments hat sich im Mai 2019 gezeigt. Novartis hat mit einem Gesamttransaktionsvolumen von USD 5,3 Mrd. das Präparat Xiidra von Takeda übernommen. Xiidra hatte bis zu diesem Zeitpunkt Umsätze von knapp USD 400Mio (Quelle: Novartis).
Die Carragelose® Produkte von Marinomed sind frei verkäuflich, werden also OTC vertrieben. Die längerfristigen Auswirkungen der sich im Moment global ausbreitenden COVID-19 Pandemie auf dieses Segment sind noch nicht abschätzbar. Kurzfristig ist für 2020 mit einem starken Anstieg des Absatzes in allen Märkten zu rechnen. Marinomed geht davon aus, dass sich das Bewusstsein für die Gefährlichkeit von viralen Infektionen der Atemwege durch die COVID-19 Pandemie nachhaltig in der Bevölkerung verankern wird.
Das Marktumfeld im OTC-Bereich ist von intensivem Wettbewerb, strengen Regularien und fragmentierten Distributionsnetzwerken geprägt. Über die Produktentwicklung und Marken hinausgehend ist daher die Fähigkeit essenziell, Innovationen im Markt platzieren zu können. Mit einem innovativen, patentgeschützten und auf den anti-viralen Bereich fokussierten Produktportfolio ermöglicht Marinomed seinen hochspezialisierten Vertriebspartnern in den jeweiligen Ländern bzw. Regionen diese Herausforderung anzunehmen.
Auch in Österreich stellen die pharmazeutische und die Biotechnologie-Industrie wichtige Wirtschaftsfaktoren dar. Mehr als 1.000 Unternehmen sind in Österreich im Life Science-Sektor tätig, wobei im pharmazeutischen Bereich 150 Unternehmen mit 18.000 Mitarbeitern Investitionen in Millionenhöhe in Forschung und Entwicklung tätigen und einen Anteil von 2,8 % am gesamten Bruttoinlandsprodukt erwirtschaften (Quelle: Pharmig). Mit dem Börsegang 2019 ist Marinomed nun das einzige in Österreich notierte Life Science Unternehmen und hat sich als solches zu einem Leitbetrieb des Sektors entwickelt.
Der Geschäftsbereich mit Produkten der Carragelose® Plattform zur Behandlung von Erkältungskrankheiten hat sich 2019 positiv entwickelt. Nach einem stabilen Verlauf im Vorjahr, konnte mit einem Anstieg von € 4,7Mio. auf € 6,2Mio. der Umsatz deutlich gesteigert werden. Auch ohne den Sondereffekt von € 0,9Mio., der durch die Rückgabe eines Vertriebsgebiets durch einen europäischen Partner entstand, lag der Anstieg gegenüber Vorjahr bei rund 12%. Gleichzeitig konnte die Bruttomarge aus Umsatzerlösen aus dem Verkauf von Handelsware abzüglich Wareneinsatz (Handelswareneinsatz sowie regelmäßige lieferbezogene Kosten, exkl. Sonderbelastungen) von ca. 26% auf ca. 29% erhöht werden. Aufwandsseitig ist die Entwicklung stark vom Fokus auf Forschung und Entwicklung geprägt. Dies zeigt sich insbesondere im Anstieg der Aufwendungen für bezogene Leistungen von € 1,6Mio. auf € 3,6Mio. aber auch in Teilen im Anstieg des Personalaufwands von € 2,5Mio. auf € 4,2Mio. Entsprechend lag das Betriebsergebnis mit € -8,1Mio. unter dem Vergleichswert des Vorjahres von € -5,5Mio.
Marinomed sieht auf dem pharmazeutischen Markt für OTC-Produkte weiterhin großes Wachstumspotenzial bei unverändert hohem Wettbewerbsdruck. Mit dem Ausbruch der COVID-19 Pandemie ergibt sich eine unerwartete Änderung des Marktes. Sollte sich herausstellen, dass die Produkte von Marinomed gegen Sars-CoV-2 wirksam sind, dann wäre ein deutlich stärkeres Wachstum als zuletzt möglich (siehe auch Anhang "Wesentliche Ereignisse nach dem Bilanzstichtag"). Marinomed geht für diesen Fall auch davon aus, dass es dann einfacher sein würde neue Partner für bestimmte Regionen zu gewinnen. Investitionen in zusätzliche klinischen Daten wären allerdings notwendig. Seit der Rückgabe einer Vertriebsregion durch einen europäischen Partner stehen attraktive Märkte wieder offen, die Marinomed mit neuen engagierten Partnern adressieren will.
Für Produkte der neu entwickelten Marinosolv® Plattform wurden aus strategischen Gründen bis jetzt noch keine Vertriebslizenzrechte oder sonstige IP-Rechte an Dritte vergeben. Erwartungsgemäß schlägt sich die außerordentlich positive Entwicklung auf der Forschungs- und Entwicklungsebene noch nicht einnahmenseitig nieder. Das Leitprodukt Budesolv hat im Jahr 2019 mit dem erfolgreichen Abschluss der pivotalen klinischen Phase III Studie einen wichtigen Entwicklungsschritt genommen. Auf der Basis werden nun die Vorbereitungen für die regulatorische Anmeldung abgeschlossen sowie die Suche nach Partnern für die Vermarktung begonnen. Marinomed hat es darüber hinaus geschafft, auf Basis der Marinosolv®-Technologie weitere Wirkstoffe in Lösung zu bringen, darunter unter anderem auch das schwer lösliche Pergolid, mit dem die University of Utah eine präklinische Studie erfolgreich abschloss. Erste geringe Umsätze wurden auf Basis der Technologieplattform im Geschäftsjahr 2019 realisiert. Marinomed geht davon aus, dass eine entsprechend weitergehende kommerzielle Verwertung dieser Entwicklungen mit hoher Wahrscheinlichkeit zu weiterem Umsatzwachstum führen wird.
Marinomed verfolgt weiterhin das Ziel gemeinsam mit seinen Partnern mittelfristig mit seinen Carragelose®-Produkten insgesamt 1% des Umsatzes des globalen CCA-Marktes zu erreichen mit einem langfristigen Steigerungsziel auf 2%. Das Umsatzpotenzial für die Produktpalette liegt damit bei mehreren hundert Millionen Euro, von dem ein signifikanter Anteil auf Marinomed entfällt. Aufgrund der Komplexität des Marktes, der regulatorischen Hürden und der Notwendigkeit intensiv Marketing zu betreiben, ist dieses Ziel nur durch Partnerschaften erreichbar. Marinomed hat für die meisten Märkte Partnerschaften mit namhaften pharmazeutischen Firmen abgeschlossen, die in den jeweiligen Ländern für die Zulassung und Vermarktung der Produkte verantwortlich sind.
Marinomed plant das Vertriebsmodell fortzusetzen und auch die Produkte aus der Marinosolv® Plattform mit Partnern zu vermarkten. Die drei wesentlichen Umsatzquellen bleiben damit weiterhin der Verkauf von Produkten an die Vertriebspartner, Lizenzerlöse aus lizenzierten, patentierten Produkten sowie Meilensteinzahlungen basierend auf dem Erreichen bestimmter mit Partnern festgelegter Ziele.
Die Gesellschaft verfügt über keine Zweigniederlassungen. Zum Abschlussstichtag hält Marinomed 100% der Anteile an der Marino Immo GmbH. Ein Konzernabschluss wird im Sinne des § 249 (2) UGB nicht erstellt. Es bestehen keine Geschäftsbeziehungen oder sonstigen Verträge zwischen Marinomed Biotech AG und Marino Immo GmbH.
Zum Verständnis der finanziellen Leistungsindikatoren der Gesellschaft ist es wesentlich, die Spezifika der unterschiedlichen Segmente darzustellen.
Das Produktportfolio der antiviralen Carragelose® Technologie, bestehend aus vier bereits am Markt befindlichen Nasensprays und zwei Rachenprodukten, wies im Geschäftsjahr 2019 eine signifikante Umsatzsteigerung von € 1,5Mio bzw. +31,4% auf. Das Wachstum wurde einerseits durch die Markteinführung von Produkten in neuen Märkten (vor allem im skandinavischen Raum) generiert. Zum anderen gab es Erlöse aus einem Lizenzvertrag mit einem europäischen Partner, der eine Vertriebsregion zurückgegeben hatte. Die Rückgabe der Vertriebsregion bietet nun die Chance, mit neuen Partnern den Umsatz in diesen Gebieten wieder deutlich zu steigern.
Durch das wachsende Produktportfolio in inzwischen über 40 Ländern gleichen sich Schwankungen in einzelnen Ländern immer mehr aus. Insofern kann für das bestehende Basisgeschäft mit den Carragelose®-Produkten von einem stabilen Wachstum ausgegangen werden. Durch Produkteinführungen in weiteren Ländern, sowie die Marktdurchdringung der neuen Nasensprays (der abschwellende Nasenspray wird bereits in 3 Ländern vertrieben), geht das Unternehmen mit hoher Wahrscheinlichkeit von weiteren Umsatzsteigerungen in den kommenden Jahren aus.
Die Marinosolv® Technologie befindet sich noch im Entwicklungsstadium, es wurden noch keine Vertriebslizenzrechte oder sonstigen IP-Rechte an Dritte vergeben. Dadurch werden auch noch keine Produkte vermarktet. Dieses Segment ist von hohen Ausgaben für Forschung und Entwicklung geprägt, die erst in Folgejahren Umsätze generieren könnten. Die pivotale klinische Phase III Studie für das Leitprodukt Budesolv wurde in 2018 initiiert und hat im April 2019 erste Daten geliefert. Nach der statistischen Auswertung wurden später detailliertere Ergebnisse der Studie im Rahmen der renommierten Jahrestagung des American College of Allergy, Asthma & Immunology (ACAAI) in Houston, Texas, vorgestellt. Marinomed konzentriert in diesem Bereich nun die Anstrengungen auf die weiteren regulatorisch notwendigen Vorbereitungen für eine Marktzulassung sowie auf Gespräche mit potenziellen Vermarktungspartnern in den Regionen. Aufgrund regulatorischer Vorgaben und der Zeit, die von den Behörden für die Evaluierung in Anspruch genommen wird, kann mit einer Zulassung erst in 2021 gerechnet werden.
Das Jahr 2019 ergab ein Ergebnis vor Steuern in Höhe von € -9,3Mio (2018 € -6,1Mio). Das Betriebsergebnis 2019 betrug somit € -8,1Mio (2018 € -5,5Mio) und das Finanzergebnis € -1,2Mio (2018 € -0,6Mio). Das Unternehmen zeigt einen Jahresfehlbetrag in Höhe von € -9,3Mio (2018 € -6,1Mio) und einen Bilanzverlust in der Höhe von € -29,7Mio (2018 € -20,4Mio). Die wesentlichen Treiber für die deutlich höheren Verluste 2019 liegen in den Kosten der klinischen Studie, den Kosten für die Vorbereitung und Durchführung des IPOs sowie die korrigierte Erfassung der Wandelanleihe. Weitere Erläuterungen zur Entwicklung der Gewinn- und Verlustrechnung sind im Anhang dargestellt.
Die Vermögenslage des Unternehmens ist insbesondere durch Zugänge für den neuen Firmenstandort (€ 2,2Mio) sowie durch die Effekte des Börsegangs im ersten Quartal 2019 geprägt. Am Bilanzstichtag betragen die liquiden Mittel € 12,0Mio (2018 € 1,7Mio) und das Unternehmen zeigt ein positives Eigenkapital von € 9,4Mio nach einem negativen Eigenkapital im Vorjahr von € -12,3Mio. Die Anleiheverbindlichkeit (2018 € 7Mio) wurde gewandelt und das Mezzanindarlehen (2018 € 0,5Mio) sowie Darlehen gegenüber Gesellschaftern (2018 € 2,5Mio) und der Österreichischen Forschungsförderungsgesellschaft (2018 € 1,4Mio) wurden zur Gänze getilgt. Die sonstigen Rückstellungen betragen € 2,7Mio (2018 € 2,3Mio) und enthalten Vorsorgen für potenzielle Zahlungen in Zusammenhang mit der Verlegung des Firmenstandorts in Höhe von € 0,5Mio. Für weitere Details zur Entwicklung der Vermögenslage sowie zu Laufzeiten und Verzinsung des Fremdkapitals wird auf die Erläuterungen im Anhang verwiesen.
Das Unternehmen wies Ende 2019 liquide Mittel von € 12,0Mio (2018 € 1,7Mio) aus. Die Veränderung wird in der folgenden Geldflussrechnung dargestellt:
| 2019 | 2018 | |
|---|---|---|
| Mio EUR | Mio EUR | |
| Geldfluss aus dem Ergebnis | -7,8 | -6,0 |
| Netto-Geldfluss aus laufender Geschäftstätigkeit vor Steuern | -9,7 | -4,4 |
| Netto-Geldfluss aus laufender Geschäftstätigkeit | -9,7 | -4,4 |
| Netto-Geldfluss aus der Investitionstätigkeit | -2,2 | -0,2 |
| Netto-Geldfluss aus der Finanzierungstätigkeit | 22,2 | 0,2 |
| zahlungswirksame Veränderung des Finanzmittelbestands | 10,3 | -4,3 |
| Finanzmittelbestand am Beginn der Periode | 1,7 | 6,0 |
| Finanzmittelbestand am Ende der Periode | 12,0 | 1,7 |
Die Vermögens- und Finanzlage spiegelt primär die negative Ertragslage wider, die für ein biotechnologisches Unternehmen im Entwicklungsstadium zu erwarten ist. Weitere Finanzmittelabflüsse betreffen insbesondere die Tilgung der Mezzanin-, Gesellschafter- und sonstigen Darlehen sowie Investitionen in den neuen Firmenstandort (siehe bereits oben). Durch Finanzierungsmaßnahmen in den Geschäftsjahren 2015 (€ 3,5Mio), 2016 (€ 1,5Mio), 2017 (€ 7,0Mio.) und 2019 (€ 22,4Mio. Gesamtkapitalzufluss aus dem Börsegang) sollen langfristige Investitionen in Forschung und Entwicklung sichergestellt werden.
Das Unternehmen konnte zudem eine Darlehenszusage von der Europäischen Investitionsbank in Höhe von bis zu € 15,0Mio verhandeln. Das Darlehen der EIB wird in 3 Tranchen in Abhängigkeit vom Erreichen bestimmter Meilensteine ausbezahlt. Die erste Tranche in Höhe von € 4,0Mio wurde im Oktober 2019 gezogen. Dadurch ist nach Einschätzung des Unternehmens die Unternehmensfortführung überwiegend wahrscheinlich. Darüber hinaus wird auf die entsprechenden Ausführungen im Abschnitt "Wesentliche Risiken und Ungewissheiten" verwiesen.
Trotz des insgesamt nur langsam wachsenden Pharma-Markts für OTC Produkte und dem damit verbundenen Verdrängungswettbewerb, geht Marinomed von einem Umsatzwachstum des Geschäfts mit Carragelose®-Produkten aus. Die Wachstumserwartung in den kommenden Jahren basiert zum einen auf den bereits am Markt befindlichen Produkten zum anderen auf neu einzuführenden Produkten der Plattform.
Der Umstand, dass die Carragelose® die erste ursächlich wirkende und patentierte Therapie gegen Husten-, Schnupfen- und mit Grippe assoziierten Viren ist, stellt ein wichtiges Alleinstellungsmerkmal dar. Es ist anzunehmen, dass sich die COVID-19 Krise positiv auf die Nachfrage nach Carragelose® Produkten auswirken wird. Nachdem wichtige Märkte bis vor kurzem durch die Partnerschaft mit einem großen europäischen Pharmaunternehmen vertraglich blockiert waren, könnte die COVID-19 Krise den Marinomed Produkten in den noch fehlenden oder weniger gut erschlossenen großen OTC Märkten den erhofften Schwung geben.
Die USA und Japan stellen einen Sonderfall dar, wobei auch hier, eine Wirkung der Carragelose® auf Sars-CoV-2 vorausgesetzt, eine schnellere Zulassung möglich wäre. Dennoch gibt es bedingt durch regulatorische Auflagen und vom Rest der Welt abweichenden Zulassungskriterien Eintrittsbarrieren, die eine Zulassung erschweren. Marinomed unternimmt nun noch vermehrte Anstrengungen, auch diese besonders attraktiven Märkte zu erreichen.
Während das Leitprodukt im Marinosolv® Segment, das antiallergische Medikament Budesolv, seit dem April 2019 mit dem Abschluss der pivotalen Phase III Studie einen der wichtigsten Meilensteine der Entwicklung genommen hat, forscht Marinomed bereits an weiteren Produkten basierend auf der Plattform. Dadurch wird sichergestellt, dass die IP genutzt wird, um auch in der Zukunft werthaltige Produkte anbieten zu können.
Zur Ausschöpfung des Potentials der beiden Plattformen sind auf absehbare Zeit weitere Investitionen in Forschung und Entwicklung erforderlich. Insbesondere durch Ausweitung der Marinosolv® Plattform und klinische Studien für größere Indikationen wird erwartet, dass das Investitionsvolumen in Forschung und Entwicklung in den kommenden Jahren deutlich steigt. Abhängig vom Umfang dieser Investitionen und dem wirtschaftlichen Erfolg bei der Verwertung kann es zu zusätzlichem Kapitalbedarf kommen.
Marinomed ist ein auf globale Märkte zielendes Unternehmen, das pharmazeutische Unternehmen als Kunden auf allen Kontinenten beliefert. Als solches ist Marinomed einer Reihe von Risiken ausgesetzt. Diese betreffen im Wesentlichen operative und finanzielle Risiken.
Die nachfolgend beschriebenen Risiken werden laufend überwacht. Das Unternehmen ist bemüht darauf zu reagieren und entgegenzusteuern.
Marinomed ist als international tätiges Unternehmen in die Weltwirtschaft eingebunden. Auch wenn noch nicht absehbar ist, welche Auswirkungen die Pandemie langfristig auf die globale Wirtschaft hat, besteht ein erhöhtes Risiko, dass sich das Weltwirtschaftsklima weiter verschlechtert und sich die Abwärtsbewegungen auf allen Kontinenten weiter fortsetzen. Zwar reagiert der Gesundheitssektor, in dem das Unternehmen tätig ist, weniger sensibel auf derartige Veränderungen als andere Bereiche der Wirtschaft, jedoch könnte die Aufrechterhaltung einer durchgängigen Wertschöpfungskette erschwert werden sowie eine Abschwächung des Wirtschaftswachstums zu einer geringeren Kundennachfrage führen.
Zu den wesentlichen finanziellen Risiken zählen Ausfallsrisiken und Liquiditätsrisiken. Darüber hinaus werden Umsätze in GBP getätigt, so dass auch Risiken aus Wechselkursschwankungen entstehen. Da Forderungen in GBP in der Regel einen Betrag von € 250.000,00 nicht übersteigen, würde sich eine Schwankung von +/- 10% mit weniger als € 25.000 auf die Gewinn- und Verlustrechnung auswirken. Als F&E Unternehmen weist Marinomed nach wie vor einen bilanziellen Verlust aus und daher sind klassische Kreditinstrumente für Marinomed nicht zugänglich. Das Unternehmen hat daher das Risiko, dass der Kapitalbedarf in Zukunft nicht, oder nur zu nachteiligen Konditionen gedeckt werden kann. Es handelt sich dabei um ein für Life Science Unternehmen typisches Risiko. Marinomed ist zudem in üblichem Maß einem Zinsrisiko auf Basis der Entwicklung internationaler Zinsen ausgesetzt. Spezifische Zinsrisiken ergeben sich aus dem aws-Seedfinancing (2 % plus 3M-EURIBOR) sowie aus den zu leistenden umsatzabhängigen Tantiemen in Zusammenhang mit dem EIB Darlehen.
Das Unternehmen verfügt über keine derivativen Finanzinstrumente.
Für Marinomed besteht das Risiko, dass langfristige Potenziale nicht ausgenutzt oder falsch eingeschätzt werden. Bei beiden Technologieplattformen können sich die eingegangenen oder noch zu etablierenden Partnerschaften als nicht vorteilhaft erweisen. Die heutige Einschätzung des Potenzials der Produkte auf den globalen Märkten kann sich als zu optimistisch herausstellen. Es besteht daher das Risiko, dass die Umsatzziele nicht erreicht werden. Weiters besteht das Risiko, dass Mitbewerber bessere oder günstigere Produkte entwickeln und dadurch das Marinomed-Portfolio weniger ertragreich ist.
Staatliche Behörden versuchen in praktisch allen regionalen Märkten, die Kosten im Gesundheitswesen durch verstärkten Wettbewerb der Anbieter und permanente Absenkung der Erstattungsgrenzen für Pharmaka zu beschränken. Der rasch wachsende OTC-Markt ist diesen Einflüssen weniger ausgesetzt, jedoch gibt es starke Konkurrenz von größeren Anbietern, die über deutlich mehr finanzielle und unternehmerische Möglichkeiten verfügen als Marinomed bzw. ihre Partner in den jeweiligen Ländern.
Marinomed ist sowohl auf der Lieferanten-, als auch auf der Vermarktungsseite auf Partner angewiesen. Trotz aufrechter Verträge besteht das Risiko, dass ein oder mehrere Partner ohne Verschulden von Marinomed wirtschaftliche oder technische Schwierigkeiten nicht zu lösen vermögen und in der Folge für Marinomed ein Schaden entsteht. Dabei kann der Partner seine eigenen Umsatzziele verfehlen, es kann sich aber auch um Lieferverzögerungen, Zahlungsschwierigkeiten oder andere branchentypische Risiken handeln.
Auch wenn über 90 % der Umsätze in Euro fakturiert werden, könnte in Ländern außerhalb der Eurozone (mit Ausnahme des Vereinigten Königreichs) eine Aufwertung des Euro gegenüber den lokalen Währungen die Produkte des Unternehmens für Händler und Endverbraucher verteuern. Dies könnte zu einem Umsatzrückgang bei den Produkten des Unternehmens führen.
Das Liquiditätsrisiko besteht darin, dass Finanzmittel, die zur Begleichung von im Zusammenhang mit Finanzinstrumenten eingegangenen Verpflichtungen erforderlich sind, möglicherweise nicht beschafft werden können. Bisher hat das Unternehmen das operative Geschäft vor allem durch Beteiligung von Investoren am Eigenkapital und über Gesellschafterdarlehen, Einnahmen aus Lizenz- und Distributionsverträgen, den Verkauf von Handelswaren, atypisch stillen Beteiligungen, durch die Ausgabe einer Wandelanleihe, neuer Aktien beim Börsegang sowie durch Zuschüsse, geförderte Darlehen und sonstige staatliche Förderungen finanziert.
Der Vorstand geht davon aus, dass zumindest in den nächsten Jahren weiterhin erhebliche Ausgaben für Forschung und Entwicklung und operative Verluste anfallen werden. Der Vorstand rechnet damit, dass die vorhandenen liquiden Mittel sowie die in 2019 eingeworbenen Mittel aus dem Börsegang und von der EIB ausreichen werden, um die operativen Aufwendungen und Investitionen für die nächsten Jahre finanzieren zu können. Diese Schätzung basiert auf Annahmen, die sich als falsch erweisen können, und das Unternehmen könnte seine Kapitalressourcen früher ausschöpfen als derzeit erwartet.
Marinomed wird immer versuchen, sich finanzielle Flexibilität zu erhalten, z.B. durch Aufnahme zusätzlichen Kapitals zu günstigeren Marktbedingungen oder aufgrund strategischer Überlegungen. Aktuell glaubt das Unternehmen über genügend Mittel für die aktuellen oder zukünftigen betrieblichen Pläne zu verfügen.
Marinomed ist der Auffassung, dass das Unternehmen auf bestimmte Ausgaben verzichten könnte, um damit seine Bargelderfordernisse zu reduzieren. Sollte es Marinomed nicht möglich sein, im Bedarfsfall Kapital aufbringen zu können, könnte es dadurch zu Verzögerungen oder Reduzierungen bzw. zur Beendigung von Forschungs- und Entwicklungsprogrammen sowie zukünftiger Kommerzialisierungsbemühungen kommen.
Marinomed ist Untermieter an der Veterinärmedizinischen Universität Wien, die derzeit auch Aktionär des Unternehmens ist. Der Mietvertrag ist bis Ende Juni 2020 befristet. Daher plant Marinomed derzeit die Verlegung des Standortes. Im September 2019 hat das Unternehmen einen Standort in Korneuburg unmittelbar vor der Stadtgrenze Wiens erworben. Wenngleich auf der neuen Liegenschaft ein Bestandsgebäude vorhanden ist, das gerade auf die Bedarfe adaptiert wird, bedeutet eine Übersiedlung zusätzliche Kosten sowie zusätzlichen Finanzierungsbedarf und könnte möglicherweise mit einem Produktivitätsrückgang verbunden sein. Sollte der neue Standort nicht rechtzeitig bezugsfertig sein, könnte Marinomed auf die Verlängerung des Mietvertrags durch die Veterinärmedizinische Universität Wien angewiesen sein.
Die Carragelose®-Technologie ist durch mehrere Patente weltweit geschützt. Die Patente der Marinosolv®-Technologie befinden sich derzeit in der Nationalisierungsphase. Dennoch kann nicht ausgeschlossen werden, dass Patente angefochten werden oder derzeitige Alleinstellungsmerkmale durch neue Technologien oder Produkte verloren gehen.
Der Erfolg von Marinomed hängt zu einem großen Teil davon ab, inwieweit die Forschungs- und Entwicklungsinitiativen die antizipierten Ergebnisse erreichen. Die Forschungsaktivitäten von Marinomed dienen der Wissensvermehrung und sind dem Wohl der Menschheit und dem Schutz der Umwelt verpflichtet. Die internen und externen Forscher halten die rechtlichen Vorschriften ein und beachten darüber hinaus auch ethische Grundsätze. Ein verantwortungsbewusster Umgang mit Forschung umfasst im Falle missbrauchsgefährdeter Forschung insbesondere die nachfolgend angesprochenen Maßnahmen: das Erkennen und Minimieren von Forschungsrisiken, den sorgfältigen Umgang mit Veröffentlichungen, die Dokumentation von Risiken sowie Aufklärungs- und Schulungsmaßnahmen.
Dennoch kann nicht ausgeschlossen werden, dass die Ergebnisse der Forschung und von klinischen Studien nicht die erwarteten primären oder sekundären Endpunkte erreichen bzw. nicht signifikant besser sind als bestehende oder neue Konkurrenzprodukte. Das könnte den Wert der Forschungsprojekte von Marinomed deutlich reduzieren. Im Extremfall könnten einzelne Projekte wertlos und geplante Einnahmen nicht zu lukrieren sein.
Aufgrund der geringen Mitarbeiteranzahl besteht bei einem Ausfall von Schlüsselarbeitskräften das Risiko, dass essenzielles Know-how verloren geht und die Nachbesetzung von vakanten Stellen zu Verzögerungen bei der Zielerreichung führt.
Die Gesellschaft unterhält am Standort Wien eine Forschungs- und Entwicklungseinrichtung mit modern ausgerüsteten Labors, die Forschungen im Bereich Pharmazie, Biologie, Molekularbiologie, Zellbiologie und in-vivo Pharmakologie ermöglichen.
Die F&E Aktivitäten fokussieren sich auf die beiden Plattformen Carragelose® und Marinosolv®. Die Carragelose® Plattform soll um Produkte mit einer zusätzlichen abschwellenden Wirkung erweitert werden. Dabei wurde 2019 die Entwicklung eines Medizinproduktes auf Basis einer physikalischen Wirkung erfolgreich umgesetzt, die Zertifizierung erreicht und das Produkt in Österreich, Schweiz und Griechenland erfolgreich eingeführt. In weiterer Folge wurde die Entwicklung eines Arzneimittels mit einem abschwellenden Wirkstoff vorangetrieben. Die Einreichung zur Zulassung soll nun im Jahr 2020 erfolgen und erste Markteinführungen könnten im Jahr 2021 stattfinden.
Darüber hinaus hat Marinomed mit Marinosolv® eine innovative Technologieplattform entwickelt, welche die Bioverfügbarkeit schwerlöslicher Wirkstoffe für die Behandlung empfindlicher Gewebe wie Nase und Augen erhöht. Stabile wässrige Formulierungen schwerlöslicher Wirkstoffe wie Kortikosteroide und Immunsuppressiva ermöglichen einen schnelleren Wirkungseintritt, hohe lokale Aktivität, erhöhte lokale Bioverfügbarkeit und eine aseptische Herstellung. Derzeit befinden sich zwei Produkte in der Entwicklung, die auf entzündliche Erkrankungen der Nase (Budesolv) und der Augen (Tacrosolv) abzielen. Im Jahr 2015 wurde eine Patentanmeldung eingereicht, die sich in der Nationalisierungsphase nach der Beendigung der internationalen Phase gemäß Patent Cooperation Treaty ("PCT") befindet. Je nach Wirkstoff können die Produkte entweder OTC (rezeptfrei oder nicht verschreibungspflichtig) oder Rx (verschreibungspflichtig) sein. Im Falle des Kortikosteroid-Nasensprays Budesolv werden je nach Gebiet OTC- und Rx-Zulassungen erwartet, während für immunsuppressive Augentropfen eine Zulassung nur als verschreibungspflichtiges Medikament erwartet wird.
Die Gesellschaft bewahrt sich ein schlankes Geschäftsmodell durch Fokussierung auf Forschung und Entwicklung sowie Auslagerung aller anderen kostenintensiven Teile der Wertschöpfungskette. Marinomed generiert ihren Umsatz entweder durch Lizenz-Vertriebsverträge oder Tantiemen aus Lizenzverträgen mit ihren Partnern. Für die rezeptfrei vermarkteten Produkte ist die Gesellschaft als Großhändler für ihre Partner weltweit tätig.
Das Unternehmen hält zum Stichtag 31. Dezember 2019 keine eigenen Anteile. Ebenso wurden während des Geschäftsjahrs 2019 keine eigenen Anteile erworben oder veräußert.
Marinomed betreibt Forschung und Entwicklung von Arzneimitteln und Medizinprodukten. Das Nutzen von Chancen und Vermeiden von Risiken ist daher wichtig für den Erfolg des Unternehmens. Entsprechend verfolgt Marinomed einen systematischen Ansatz zur Früherkennung von Chancen und Risiken. Die im Abschnitt "Risikobericht" benannten Bereiche werden wiederkehrend über unternehmensweite Planungs- und Kontrollprozesse hinterfragt. Die Gesamtverantwortung für die interne Kontrolle sowie das Risikomanagement der Marinomed liegen beim Vorstand.
Das Risikomanagementsystem fokussiert auf die im vorangehenden Risikoabschnitt genannten Bereiche. Dabei werden die operativen Risiken vor allem durch eine enge interne wie auch externe Kommunikation adressiert. Der regelmäßige Kontakt mit allen externen Zulieferern und Partnern sowie die Dokumentation der Gespräche und Treffen erlauben ein stetes Nachhalten von Planung und Durchführung. Marinomed hat sowohl Investoren für den IPO als auch die EIB für ein Venture Loan gewinnen können. Diese beiden Finanzierungselemente haben einerseits zu einer Verbesserung der Kapitalstruktur geführt, und andererseits erlauben sie dem Unternehmen, seine Forschungs- und Entwicklungsaktivitäten beschleunigt umzusetzen. Abhängigkeiten von der allgemeinen Wirtschaftslage, dem Finanzierungsumfeld oder einem erfolgreichen Debitorenmanagement sind dadurch reduziert.
Das interne Kontrollsystem der Marinomed hat insbesondere die Aufgabe, die Zuverlässigkeit der Finanzberichterstattung, die Einhaltung gesetzlicher und unternehmensinterner Richtlinien sowie das Erkennen von Risiken auch außerhalb der Finanzberichterstattung zu sichern. Bei sämtlichen relevanten Geschäftsfällen wird das Vieraugenprinzip eingehalten.
Das interne Kontrollsystem gliedert sich in die Aufbau- und die Ablauforganisation. Die Aufbauorganisation ist durch flache Hierarchien und eindeutige Zuweisung der Verantwortlichkeit gekennzeichnet. Es besteht eine organisatorische Trennung aus operativer und finanzieller Verantwortung sowie für das Rechnungswesen aus Buchhaltung, Controlling und Berichterstattung.
Die Ablauforganisation ist durch ein klares Regelwerk gekennzeichnet, das eine angemessene Basis für ein effizientes Kontrollsystem aus Freigaben und Kompetenzen darstellt. Das interne Berichtswesen an den Vorstand besitzt dabei besonders hohe Bedeutung, um Risiken frühzeitig erkennen und Gegenmaßnahmen ergreifen zu können. Dies erfolgt durch regelmäßige Meetings zu den wesentlichen Themenbereichen, allen voran Forschung und Entwicklung, Supply Chain und Finanzen. Diese Besprechungen finden je nach Bedeutung wöchentlich bzw. monatlich statt.
Dabei wird strukturiert über die notwendigen Informationen von den jeweiligen Bereichsleitern an den Vorstand berichtet. Dadurch sollen jene Risiken vermieden werden, die zu einer unvollständigen oder fehlerhaften Finanzberichterstattung führen können.
Das interne Berichtswesen ist darauf angelegt, dem Vorstand in regelmäßigen Abständen zu ermöglichen, wichtige Prozesse und deren finanzielle Auswirkung auf Plausibilität zu prüfen und mit Planungen zu vergleichen, um bei Abweichungen geeignete Maßnahmen beschließen und ergreifen zu können. Die hierfür notwendigen Planungen, beispielsweise für klinische Studien, externe Dienstleister und Umsätze werden vom Vorstand vorab genehmigt.
Darüber hinaus erstellt die Gesellschaft eine rollierende Liquiditätsplanung, die laufend überwacht und mit den eigenen Vorgaben abgestimmt wird.
Die Ordnungsmäßigkeit des Rechnungswesens basiert auf einem rechnungslegungsbezogenen internen Kontrollsystem. Ziele sind die Einhaltung der gesetzlichen Normen, die Grundsätze ordnungsgemäßer Buchführung sowie die Rechnungslegungsvorschriften des österreichischen Unternehmensgesetzbuches (UGB) und die Rechnungslegungsvorschriften der Internationalen Financial Reporting Standards (IFRS).
Mit Beginn des Geschäftsjahres 2019 wird das Rechnungswesen nicht mehr durch eine externe Steuerberatungskanzlei, sondern mittels BMD in der Gesellschaft geführt. Ebenso wurde in eine Software für die Finanzplanung investiert, die über eine Schnittstelle den Abgleich mit den in BMD erfassten Istdaten ermöglicht.
Das Rechnungswesen wird durch die internationale Prüfungsgesellschaft BDO Austria GmbH Wirtschaftsprüfungs- und Steuerberatungsgesellschaft geprüft. Die Erstellung der Berichterstattung nach IFRS wird zudem durch Deloitte Tax Wirtschaftsprüfungs GmbH insbesondere zu Bewertungsund Ausweisfragen unterstützt.
Das Grundkapital teilt sich wie folgt auf:
| Betrag des | Nennbetrag/ | Stückzahl der | |
|---|---|---|---|
| Aktiengattung | Grundkapitals | Aktie | Aktien |
| Inhaberaktien | 1.469.772,00 | 1,00 | 1.469.772 |
Mit außerordentlichem Hauptversammlungsbeschluss vom 17. September 2018 wurde das Grundkapital der Gesellschaft durch Ausgabe von 867.640 auf Namen lautenden Stückaktien gegen Bareinzahlung von € 867.640,00 auf € 1.000.000,00 erhöht.
Im Zuge des Börsegangs der Marinomed Biotech AG im ersten Quartal 2019 wurden insgesamt 299.000 neue Inhaberaktien zum Preis von € 75,00 je Aktie bei Investoren platziert (davon 260.000 Stk. aus dem Basisangebot und 39.000 Stk. aus Mehrzuteilungen). Dies führte zu einem Gesamtkapitalzufluss von € 22.425.000,00, davon Grundkapitalerhöhung € 299.000,00.
Für den Umtausch von Wandelschuldverschreibungen in Aktien wurden weitere 170.772 Aktien ausgegeben. Zum Abschlussstichtag beläuft sich das Grundkapital somit auf € 1.469.772,00, eingeteilt in 1 469.772 stimmberechtigte Aktien.
Die Aktien der Marinomed Biotech AG werden im Prime Segment der Wiener Börse gehandelt. Besondere Kontrollrechte für einzelne Aktien bestehen nicht. Die Altgesellschafter haben sich mit dem IPO zu einer 12-monatigen Lock-up Periode verpflichtet, die zum Abschlussstichtag noch bestand. Durch Verkäufe von einigen Investoren in einem Accelerated Bookbuilding Verfahren haben sich die Lock-up Zeiträume für die restlichen Aktien teilweise verlängert. Der Vorstand hat sich zu einer 36 monatigen Lock-up Periode verpflichtet.
Die Eigentumsverhältnisse sind in Kapitel 1.1 dargestellt.
Die an der Gesellschaft beteiligten Mitarbeiter üben ihr Stimmrecht unmittelbar aus.
Es bestehen keine Entschädigungsvereinbarungen zwischen der Gesellschaft und ihren Vorstands- und Aufsichtsratsmitgliedern oder Arbeitnehmern für den Fall eines öffentlichen Übernahmeangebots. Wird ein Vorstandsmitglied aus einem Grund entlassen, der nicht in den Geltungsbereich von §27 des österreichischen Angestelltengesetzes fällt, sieht die jeweilige Managementvereinbarung eine Abfindung in Höhe von bis zu zwei Jahresgehältern vor.
Mit außerordentlichem Hauptversammlungsbeschluss vom 15. November 2018 wurde der Vorstand ermächtigt, gemäß §169 AktG mit Zustimmung des Aufsichtsrats innerhalb von 5 Jahren nach Eintragung der Satzungsänderung in das Firmenbuch, das Grundkapital der Gesellschaft um bis zu € 500.000,00, unter teilweisem Bezugsrechtsausschluss sowie teilweiser Ermächtigung zum Bezugsrechtsausschluss, allenfalls in mehreren Tranchen, gegen Bareinzahlung und/oder Sacheinlage durch Ausgabe von bis zu 500.000 neuen Stammaktien zum Mindestausgabepreis von EUR 1,00 je Aktie zu erhöhen und den Ausgabekurs sowie die Ausgabebedingungen im Einvernehmen mit dem Aufsichtsrat festzusetzen.
Am 1. Februar 2019 etablierte Marinomed ein Mitarbeiteraktienoptionsprogramm für den Vorstand und für alle weiteren Mitarbeiter des Unternehmens. Die Gesamtzahl an im Rahmen des ESOP 2019 auszugebenden Aktienoptionen beträgt 43.694, wobei jede Option den Besitzer berechtigt eine Stammaktie zu zeichnen. Im Ausgabezeitpunkt schätzte die Gesellschaft den beizulegenden Zeitwert einer ausgegebenen Aktienoption auf EUR 20,75. Zum Abschlussstichtag wird eine Optionsrücklage in Höhe von € 426.538,12 (2018: € 0k) ausgewiesen.
Mit Vertrag vom 2. August 2006 wurde durch die Austria Wirtschaftsservice GmbH ein Mezzanindarlehen mit gewinnabhängiger Verzinsung und Tilgung über € 500.000,00 gewährt. Die Zuzählung des Darlehens erfolgte im Jahr 2007. Die Laufzeit betrug ursprünglich 10 Jahre bis zum 30. Juni 2017.
Im Juni 2019 wurde das Nominale des Mezzanindarlehens in Höhe von € 500.000,00 zurückbezahlt. Bezüglich der Zinsen, die seit 2006 aufgelaufen sind, konnte eine vorteilhafte Einigung erzielt werden. Der Zinssatz wurde rückwirkend ab dem 1. Februar 2019 von 8,5 % fix auf 2,0 % plus 3M-EURIBOR (Höchstzinssatz gemäß KMU Förderungsgesetz) reduziert. Weiters wurde vereinbart, dass 30 % des (bereinigten) Gewinns vor Steuern, mindestens jedoch € 100.000,00 pro Jahr (auch im Verlustfall) zur Rückzahlung des Darlehens verwendet werden. Die erste Tilgung ist am 30. Juni 2020 zu leisten.
Mit den Zusammenschlussverträgen vom 30. Dezember 2011, 22. Juni 2012 und 25. Juni 2013 haben sich drei atypisch stille Gesellschafter mit einer Einlage von insgesamt € 1.205.000,00 am Unternehmen beteiligt. Die Einlagen der atypisch stillen Gesellschafter, sowie die Verlustzuweisungen bis zur Höhe der Einlage werden als Sonderposten ausgewiesen.
Mit Sacheinlage- und Einbringungsvertrag vom 15. November 2018 sowie Abänderungsvereinbarung vom 30. Dezember 2018 wurde die Einbringung der stillen Gesellschaft unter der aufschiebenden Bedingung des Börsegangs der Marinomed Biotech AG festgelegt. Als Gegenleistung wurde die Übertragung von insgesamt 43.694 Aktien, auf die jeweils ein anteiliger Betrag am Grundkapital von € 1,00 entfällt, von Altaktionären festgelegt. Die aufschiebende Bedingung wurde mit dem Börsegang der Marinomed Biotech AG am 1. Februar 2019 erfüllt, die Aktien wurden übertragen und die Gesellschaft hat keinerlei Verpflichtungen mehr gegenüber den stillen Gesellschaftern.
Im Geschäftsjahr 2019 waren durchschnittlich 31 Mitarbeiter (2018: 30) bei Marinomed beschäftigt, davon 31 aktive (2018: 28, auf Grund von 2 karenzierten Mitarbeiterinnen). Die durchschnittlichen Mitarbeiter werden dabei als FTE (Full Time Equivalent) auf Basis von 38,5 Wochenstunden als Durchschnitt der 12 Monatswerte des jeweiligen letzten Tages eines Monats gerechnet. Im Bereich Forschung und Entwicklung lag die durchschnittliche Anzahl bei 15 Mitarbeitern (2018: 15). 68% der Mitarbeiter im Unternehmen sind Frauen, im Bereich Forschung und Entwicklung liegt der Anteil sogar bei 75% und in Führungspositionen bei 40%. Der Großteil der Mitarbeiter verfügt über eine akademische Ausbildung. Im Durchschnitt über die letzten 5 Jahre lag die Fluktuation bei ca. 10%, dabei wurde im abgelaufenen Geschäftsjahr kein Austritt verzeichnet. Für die Berechnung der Fluktuation wird die Anzahl der Austritte durch die Anzahl der durchschnittlichen FTE gerechnet und schließt vom Unternehmen ausgesprochene Kündigungen, bzw. vorgeschlagene Aufhebungsvereinbarungen mit ein.
Marinomed vertreibt im Geschäftsjahr seine Produkte mit 14 Partnern, das ist ein Partner weniger als in 2018, da der Partner in Dänemark vom skandinavischen Partner in einer M&A Transaktion übernommen wurde. Das Unternehmen ist aktuell mit 6 Produkten auf dem Markt und hat zum Jahresende 3 weitere Produkte in der Entwicklungspipeline, über die berichtet wird. Das entspricht dem Wert im vorangegangenen Geschäftsjahr.
Marinomed folgt den Vorschriften des österreichischen Corporate Governance Kodex (ÖCGK) und erstellt im Rahmen des Geschäftsberichtes einen entsprechenden öffentlichen Corporate Governance Bericht. Die Gesellschaft hat einen Compliance Officer benannt, der ab dem Geschäftsjahr 2019 den Vorstand berät und das Funktionieren des internen Kontrollsystems überwacht.
Wien, am 15. April 2020
.......................................................
Andreas Grassauer
……………………………………….
Eva Prieschl-Grassauer
………………………………………. Pascal Schmidt
Financial statements (UGB)
.
Marinomed Biotech AG zum 31.12.2019
Passiva 31.12.2018
I. eingefordertes Grundkapital 1.469.772,00 1.000.000,00 übernommenes Grundkapital 1.469.772,00 1.000.000,00 einbezahltes Grundkapital 1.469.772,00 1.000.000,00
gebundene 30.051.961,03 0,00 2. nicht gebundene 7.086.764,00 7.086.764,00
Optionsrücklage 426.538,12 0,00 IV. Bilanzverlust -29.682.792,86 -20.400.912,87 davon Verlustvortrag -20.400.912,87 -14.294.245,71
B. Mezzaninfinanzierung 0,00 500.000,00
C. atypisch stille Beteiligung 0,00 0,00
sonstige Rückstellungen 2.713.188,09 2.261.288,41
Anleihen 0,00 7.000.000,00 davon konvertibel 0,00 7.000.000,00 davon mit einer Restlaufzeit von mehr als einem Jahr 0,00 7.000.000,00 2. Verbindlichkeiten gegenüber Kreditinstituten 4.000.000,00 9,48 davon mit einer Restlaufzeit von bis zu einem Jahr 0,00 9,48 davon mit einer Restlaufzeit von mehr als einem Jahr 4.000.000,00 0,00 3. erhaltene Anzahlungen auf Bestellungen 0,00 7.695,00 davon mit einer Restlaufzeit von bis zu einem Jahr 0,00 7.695,00 4. Verbindlichkeiten aus Lieferungen und Leistungen 1.002.432,99 2.014.536,87 davon mit einer Restlaufzeit von bis zu einem Jahr 1.002.432,99 2.014.536,87 5. sonstige Verbindlichkeiten 873.515,66 4.195.739,67 davon aus Steuern 53.527,20 59.293,34 davon im Rahmen der sozialen Sicherheit 55.464,81 58.708,45 davon mit einer Restlaufzeit von bis zu einem Jahr 270.488,43 4.156.458,60 davon mit einer Restlaufzeit von mehr als einem Jahr 603.027,23 39.281,07
davon mit einer Restlaufzeit von bis zu einem Jahr 1.272.921,42 6.178.699,95 davon mit einer Restlaufzeit von mehr als einem Jahr 4.603.027,23 7.039.281,07 Summe Passiva 17.941.379,03 3.665.120,56
A. Eigenkapital, Negatives Eigenkapital
II. Kapitalrücklagen
III. Optionsrücklagen
D. Rückstellungen
E. Verbindlichkeiten
Bilanz
EUR
EUR 31.12.2019
37.138.725,03 7.086.764,00
9.352.242,29 -12.314.148,87
5.875.948,65 13.217.981,02
| Bilanz |
|---|
| zum 31.12.2019 |
| Aktiva | 31.12.2019 EUR |
31.12.2018 EUR |
|
|---|---|---|---|
| A. | Anlagevermögen | ||
| I. Immaterielle Vermögensgegenstände | |||
| 1. Lizenzen | 98.653,54 | 99.999,49 | |
| II. Sachanlagen | |||
| 1. Grundstücke davon Grundwert |
358.925,00 358.925,00 |
0,00 0,00 |
|
| 2. Maschinen | 85.438,25 | 892,92 | |
| 3. Betriebs- und Geschäftsausstattung | 135.773,24 | 145.524,80 | |
| 4. geleistete Anzahlungen und Anlagen in Bau | 1.825.454,60 | 0,00 | |
| 2.405.591,09 | 146.417,72 | ||
| III. Finanzanlagen | |||
| 1. Anteile an verbundenen Unternehmen | 35.000,00 | 0,00 | |
| 2.539.244,63 | 246.417,21 | ||
| B. | Umlaufvermögen | ||
| I. Vorräte | |||
| 1. Handelswaren | 97.503,32 | 115.708,78 | |
| II. Forderungen und sonstige Vermögensgegenstände | |||
| 1. Forderungen aus Lieferungen und Leistungen | 1.509.069,14 | 623.081,67 | |
| 2. sonstige Forderungen und Vermögensgegenstände | 1.711.170,25 | 934.821,99 | |
| davon mit einer Restlaufzeit von mehr als einem Jahr | 28.836,98 | 24.281,98 | |
| 3.220.239,39 | 1.557.903,66 | ||
| III. Kassenbestand, Guthaben bei Kreditinstituten | 12.019.617,38 | 1.715.480,58 | |
| 15.337.360,09 | 3.389.093,02 | ||
| C. | Rechnungsabgrenzungsposten | 64.774,31 | 29.610,33 |
| Summe Aktiva | 17.941.379,03 | 3.665.120,56 |
.
.
| Bilanz |
|---|
| zum 31.12.2019 |
| Passiva | 31.12.2019 EUR |
31.12.2018 EUR |
|
|---|---|---|---|
| A. | Eigenkapital, Negatives Eigenkapital | ||
| I. eingefordertes Grundkapital übernommenes Grundkapital einbezahltes Grundkapital |
1.469.772,00 1.469.772,00 1.469.772,00 |
1.000.000,00 1.000.000,00 1.000.000,00 |
|
| II. Kapitalrücklagen | |||
| 1. gebundene | 30.051.961,03 | 0,00 | |
| 2. nicht gebundene | 7.086.764,00 | 7.086.764,00 | |
| 37.138.725,03 | 7.086.764,00 | ||
| III. Optionsrücklagen | |||
| 1. Optionsrücklage | 426.538,12 | 0,00 | |
| IV. Bilanzverlust | -29.682.792,86 | -20.400.912,87 | |
| davon Verlustvortrag | -20.400.912,87 | -14.294.245,71 | |
| 9.352.242,29 | -12.314.148,87 | ||
| B. | Mezzaninfinanzierung | 0,00 | 500.000,00 |
| C. | atypisch stille Beteiligung | 0,00 | 0,00 |
| D. | Rückstellungen | ||
| 1. sonstige Rückstellungen | 2.713.188,09 | 2.261.288,41 | |
| E. | Verbindlichkeiten | ||
| 1. Anleihen davon konvertibel davon mit einer Restlaufzeit von mehr als einem Jahr |
0,00 0,00 0,00 |
7.000.000,00 7.000.000,00 7.000.000,00 |
|
| 2. Verbindlichkeiten gegenüber Kreditinstituten davon mit einer Restlaufzeit von bis zu einem Jahr davon mit einer Restlaufzeit von mehr als einem Jahr |
4.000.000,00 0,00 4.000.000,00 |
9,48 9,48 0,00 |
|
| 3. erhaltene Anzahlungen auf Bestellungen davon mit einer Restlaufzeit von bis zu einem Jahr |
0,00 0,00 |
7.695,00 7.695,00 |
|
| 4. Verbindlichkeiten aus Lieferungen und Leistungen davon mit einer Restlaufzeit von bis zu einem Jahr |
1.002.432,99 1.002.432,99 |
2.014.536,87 2.014.536,87 |
|
| 5. sonstige Verbindlichkeiten davon aus Steuern davon im Rahmen der sozialen Sicherheit davon mit einer Restlaufzeit von bis zu einem Jahr davon mit einer Restlaufzeit von mehr als einem Jahr |
873.515,66 53.527,20 55.464,81 270.488,43 603.027,23 |
4.195.739,67 59.293,34 58.708,45 4.156.458,60 39.281,07 |
|
| davon mit einer Restlaufzeit von bis zu einem Jahr | 5.875.948,65 1.272.921,42 |
13.217.981,02 6.178.699,95 |
|
| davon mit einer Restlaufzeit von mehr als einem Jahr | 4.603.027,23 | 7.039.281,07 | |
| Summe Passiva | 17.941.379,03 | 3.665.120,56 |
| z | |
|---|---|
| s v v |
|
| s z |
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Der Jahresabschluss wurde nach den Vorschriften der §§ 189 ff des Unternehmensgesetzbuchs (UGB) unter Beachtung der Grundsätze ordnungsmäßiger Buchführung, sowie unter Beachtung der Generalnorm, ein möglichst getreues Bild der Vermögens-, Finanz- und Ertragslage des Unternehmens zu vermitteln, aufgestellt.
Bei der Erstellung des Jahresabschlusses wurde der Grundsatz der Vollständigkeit entsprechend den gesetzlichen Regelungen eingehalten.
Bei der Bewertung der einzelnen Vermögensgegenstände und Schulden wurde der Grundsatz der Einzelbewertung beachtet und eine Fortführung des Unternehmens unterstellt.
Dem Vorsichtsprinzip wurde dadurch Rechnung getragen, dass nur die am Abschlussstichtag verwirklichten Gewinne ausgewiesen wurden. Alle erkennbaren Risiken und drohenden Verluste wurden - soweit gesetzlich geboten - berücksichtigt.
Die Gliederung und der Ausweis der einzelnen Posten des Jahresabschlusses wurden nach den allgemeinen Bestimmungen der §§ 196 bis 200 UGB unter Berücksichtigung der ergänzenden Vorschriften für Kapitalgesellschaften (§§ 221 bis 235 UGB) vorgenommen.
Die Bewertung der einzelnen Posten der Bilanz erfolgte entsprechend den §§ 201 bis 211 UGB und unter Berücksichtigung der Sondervorschriften für Kapitalgesellschaften (§§ 221 bis 235 UGB).
Erworbene immaterielle Anlagewerte wurden zu Anschaffungskosten angesetzt und, sofern sie der Abnutzung unterliegen, um planmäßige Abschreibungen vermindert.
Die planmäßige Abschreibung wird linear vorgenommen. Dabei wird folgende Nutzungsdauer zugrunde gelegt:
Nutzungsdauer in Jahren
EDV-Software 3 - 5
1
Anhang
Marinomed Biotech AG
Das Sachanlagevermögen wurde zu Anschaffungs- oder Herstellungskosten angesetzt und, soweit abnutzbar, um planmäßige Abschreibungen vermindert.
Die planmäßige Abschreibung wird linear vorgenommen, wobei für die einzelnen Anlagengruppen folgende Nutzungsdauer zugrunde gelegt wird:
| Nutzungsdauer in Jahren |
||
|---|---|---|
| Technische Anlagen und Maschinen | 4 - 8 |
|
| Betriebs- und Geschäftsausstattung | 2 - 10 |
Für Zugänge in der ersten Jahreshälfte wird die volle Jahresabschreibung, für Zugänge in der zweiten Jahreshälfte die halbe Jahresabschreibung verrechnet.
Geringwertige Vermögensgegenstände des Geschäftsjahres wurden im Jahr der Anschaffung sofort voll abgeschrieben.
Das Finanzanlagevermögen wurde zu Anschaffungskosten bewertet. Wertminderungen werden berücksichtigt, wenn der beizulegende Wert am Abschlussstichtag niedriger ist und die Wertminderung voraussichtlich von Dauer ist.
Vorräte/Handelswaren wurden mit den Einkaufspreisen angesetzt, das Identitätspreisverfahren wurde angewendet. Bei der Bewertung wurde das strenge Niederstwertprinzip beachtet.
Die Forderungen und sonstigen Vermögensgegenstände wurden mit dem Nennwert angesetzt.
Im Falle erkennbarer Einzelrisiken wurde der niedrigere beizulegende Wert angesetzt.
Fremdwährungsforderungen wurden mit ihrem Entstehungskurs oder mit dem niedrigeren Devisenbriefkurs zum Bilanzstichtag, erforderlichenfalls mit dem beizulegenden Wert am Abschlussstichtag, bewertet.
In den sonstigen Rückstellungen wurden unter Beachtung des Vorsichtsprinzips alle im Zeitpunkt der Bilanzerstellung erkennbaren Risiken und der Höhe oder dem Grunde nach ungewissen Verbindlichkeiten mit den Beträgen berücksichtigt, die nach bestmöglicher Schätzung zur Erfüllung der Verpflichtung aufgewendet werden müssen. Sämtliche Rückstellungen haben eine Laufzeit von weniger als einem Jahr.
Marinomed Biotech AG
Verbindlichkeiten wurden mit ihrem Erfüllungsbetrag angesetzt.
Die Fristigkeit der Verbindlichkeiten ist aus der Bilanz ersichtlich. Die Gesellschaft weist zum Bilanzstichtag keine Verbindlichkeiten mit einer Restlaufzeit von mehr als 5 Jahren aus. Es wird auf die Erläuterungen in Kapitel B Mezzaninfinanzierung verwiesen.
Fremdwährungsverbindlichkeiten wurden mit ihrem Entstehungskurs oder mit dem höheren Devisenbriefkurs zum Bilanzstichtag bewertet.
Hinsichtlich der Erfassung des Zinsvorteils aus der Wandelanleihe wird auf die Erläuterungen im Abschnitt C verwiesen.
Die Entwicklung der einzelnen Posten des Anlagevermögens und die Aufgliederung der Jahresabschreibung nach einzelnen Posten sind in folgendem Anlagenspiegel dargestellt:
| Anschaffungs-/Herstellungskosten Abschreibungen kumuliert 01.01.2019 Zugänge 01.01.2019 Abschreibungen Abgänge 31.12.2019 Abgänge 31.12.2019 Zuschreibungen EUR EUR EUR EUR EUR |
Buchwert 01.01.2019 31.12.2019 EUR |
|---|---|
| Anlagevermögen Immaterielle |
|
| Vermögensgegenstände | |
| Lizenzen 160.250,22 33.275,15 60.250,73 34.621,00 26.406,38 |
99.999,49 |
| 167.118,89 26.406,48 68.465,35 0,00 |
98.653,54 |
| Sachanlagen | |
| Grundstücke 0,00 358.925,00 0,00 0,00 0,00 |
0,00 |
| 358.925,00 0,00 0,00 0,00 |
358.925,00 |
| davon Grundwert 0,00 358.925,00 0,00 0,00 0,00 |
0,00 |
| 358.925,00 0,00 0,00 0,00 |
358.925,00 |
| Maschinen 42.133,70 85.084,00 41.240,78 538,67 0,00 |
892,92 |
| 127.217,70 0,00 41.779,45 0,00 |
85.438,25 |
| Betriebs- und | |
| Geschäftsausstattung 478.612,63 64.832,61 333.087,83 74.584,14 41.688,65 |
145.524,80 |
| 501.756,56 41.688,68 365.983,32 0,00 |
135.773,24 |
| geleistete Anzahlungen und | |
| Anlagen in Bau 0,00 1.825.454,60 0,00 0,00 0,00 |
0,00 |
| 1.825.454,60 0,00 0,00 0,00 |
1.825.454,60 |
| 520.746,33 2.334.296,21 374.328,61 75.122,81 41.688,65 |
146.417,72 |
| 2.813.353,86 41.688,68 407.762,77 0,00 |
2.405.591,09 |
| Finanzanlagen Anteile an verbundenen |
|
| Unternehmen 0,00 35.000,00 0,00 0,00 0,00 |
0,00 |
| 35.000,00 0,00 0,00 0,00 |
35.000,00 |
| Summe Anlagenspiegel 680.996,55 2.402.571,36 434.579,34 109.743,81 68.095,03 |
246.417,21 |
| 3.015.472,75 68.095,16 476.228,12 0,00 |
2.539.244,63 |
Die Zugänge im Sachanlagevermögen betreffen überwiegend den Erwerb eines bebauten Grundstücks (davon Grundwert € 358.925,00). Das Bestandsgebäude befindet sich zum Bilanzstichtag in Umbau, weiters wird ein Zubau, der Labor- und Büroräumlichkeiten umfasst, errichtet. Die Fertigstellung des Firmenstandorts ist für das erste Halbjahr 2021 geplant. Das zum Bilanzstichtag in Umbau befindliche Gebäude sowie die an
3
Anhang
Anhang
4
den Bauunternehmer geleisteten Teilzahlungen werden in der Bilanzposition "geleistete Anzahlungen und Anlagen in Bau" ausgewiesen.
| Firmenname | Firmensitz | Eigenkapital | Anteil in % | Letztes Ergebnis | Bilanzstichtag |
|---|---|---|---|---|---|
| Marino Immo GmbH | 1210 Wien | 35.000,00 | 100,0 | n.v. | 31.12.2019 |
Anteile an verbundenen Unternehmen betreffen die Marino Immo GmbH, eine hundertprozentige Tochtergesellschaft der Marinomed Biotech AG, die am 3. August 2019 gegründet wurde. Das Stammkapital in Höhe von € 35.000,00 wurde zur Gänze bar eingezahlt. Der Jahresabschluss der Gesellschaft wurde noch nicht veröffentlicht.
Die Forderungen aus Lieferungen und Leistungen weisen an beiden Bilanzstichtagen eine Restlaufzeit von bis zu einem Jahr auf und betreffen überwiegend Warenlieferungen sowie Lizenz- und sonstige Umsatzerlöse.
Die sonstigen Forderungen beinhalten neben Guthaben bei Finanzämtern ein jederzeit kündbares Darlehen (€ 250.000,00; 2018: k€ 0), welches durch eine Bankgarantie zugunsten Marinomed besichert ist. Weiters werden Forderungen aus der erwarteten Forschungsprämie in Höhe von € 997.759,23 (2018: k€ 484) ausgewiesen. Die sonstigen Forderungen beinhalten im Jahr 2019 realisierte Erträge in Höhe von € 670.577,12 (2018: k€ 327), welche erst nach dem Bilanzstichtag zahlungswirksam werden.
Die nicht aktivierten latenten Steuern aus Unterschiedsbeträgen zwischen den unternehmensrechtlichen und steuerrechtlichen Wertansätzen betragen zum Bilanzstichtag € 21.503,17 (2018: k€ 663) und setzen sich wie folgt zusammen:
| aktive latente Steuern | 2019 | 2018 |
|---|---|---|
| EUR | EUR | |
| Geldbeschaffungskosten | 11.465,04 | 95.113,18 |
| Aktivposten PKW | 799,91 | 740,39 |
| Urlaubsrückstellung | 9.238,22 | 0,00 |
| atypisch stille Beteiligung | 0,00 | 567.312,50 |
| 21.503,17 | 663.166,06 |
Aktive latente Steuern aus steuerlichen Verlustvorträgen belaufen sich am Bilanzstichtag auf € 7.698.487,26 (2018: k€ 5.249), welche im Sinne des § 198 UGB nicht in der Bilanz angesetzt werden.
Marinomed Biotech AG
Marinomed Biotech AG
Das Grundkapital teilt sich wie folgt auf:
| Betrag des | Nennbetrag/ | Stückzahl der | |
|---|---|---|---|
| Aktiengattung | Grundkapitals | Aktie | Aktien |
| Inhaberaktien | 1.469.772,00 | 1,00 | 1.469.772 |
Mit außerordentlichem Hauptversammlungsbeschluss vom 17. September 2018 wurde das Grundkapital der Gesellschaft durch Ausgabe von 867.640 auf Namen lautenden Stückaktien gegen Bareinzahlung von € 867.640,00 auf € 1.000.000,00 erhöht.
In der außerordentlichen Hauptversammlung vom 15. November 2018 wurde die Umwandlung der Namensaktien in auf Inhaber lautende Aktien beschlossen. Darüber hinaus wurde der Vorstand ermächtigt, das Grundkapital mit Zustimmung des Aufsichtsrats gemäß § 169 AktG unter teilweisem Bezugsrechtsausschluss sowie teilweiser Ermächtigung zum Bezugsrechtsausschluss um bis zu € 500.000,00 (genehmigtes Kapital) im Einvernehmen mit dem Aufsichtsrat sowie um bis zu € 480.000,00 zur Ausgabe in Verbindung mit dem geplanten Börsengang zu erhöhen. Weiters wurde einer bedingten Kapitalerhöhung von bis zu € 173.122,00 durch Ausgabe von Inhaberaktien für den Umtausch von Wandelschuldverschreibungen zugestimmt.
Im Zuge des Börsegangs der Marinomed Biotech AG im ersten Quartal 2019 wurden insgesamt 299.000 neue Inhaberaktien zum Preis von € 75,00 je Aktie bei Investoren platziert (davon 260.000 Stk. aus dem Basisangebot und 39.000 Stk. aus Mehrzuteilungen). Dies führte zu einem Gesamtkapitalzufluss von € 22.425.000,00, davon Grundkapitalerhöhung € 299.000,00.
Für den Umtausch von Wandelschuldverschreibungen in Aktien wurden weitere 170.772 Aktien ausgegeben. Zum Bilanzstichtag beläuft sich das Grundkapital somit auf € 1.469.772,00, eingeteilt in 1.469.772 stimmberechtigte Inhaberaktien.
Das bedingte Kapital beläuft sich auf 100.000 Aktien (davon 43.694 zur Bedienung des Aktienoptionsprogramms).
Im Zuge des Börsegangs der Marinomed Biotech AG wurden € 22.126.000,00 durch Ausgabe von 299.000 neuen Inhaberaktien in die Kapitalrücklage eingestellt, weitere € 7.925.961,03 betreffen die Wandelanleihe (siehe auch Anmerkung zur Wandelanleihe im Zinsaufwand).
Am 1. Februar 2019 etablierte Marinomed ein Mitarbeiteraktienoptionsprogramm für den Vorstand und für alle weiteren Mitarbeiter des Unternehmens. Die Gesamtzahl an im Rahmen des "ESOP 2019" auszugebenden Aktienoptionen beträgt 43.694, wobei jede Option den Besitzer berechtigt eine Stammaktie zu zeichnen. Im Ausgabezeitpunkt schätzte die Gesellschaft den beizulegenden Zeitwert einer ausgegebenen Aktienoption auf EUR 20,75. Zum Abschlussstichtag wird eine Optionsrücklage in Höhe von € 426.538,12 (2018: € 0k) ausgewiesen. Für weitere Details wird auf Kapitel D Sonstige Angaben - Angaben zu Aktienoptionen verwiesen.
5
Anhang
Anhang
6
Marinomed Biotech AG
Mit Vertrag vom 2. August 2006 wurde durch die Austria Wirtschaftsservice GmbH ein Mezzanindarlehen mit gewinnabhängiger Verzinsung und Tilgung über € 500.000,00 gewährt. Die Zuzählung des Darlehens erfolgte im Jahr 2007. Die Laufzeit betrug ursprünglich 10 Jahre bis zum 30. Juni 2017.
Im Juni 2019 wurde das Nominale des aws-Seedfinancing in Höhe von EUR 500.000,00 zurückbezahlt. Bezüglich der Zinsen, die seit 2006 aufgelaufen sind, konnte eine vorteilhafte Einigung erzielt werden. Der Zinssatz wurde rückwirkend ab dem 1. Februar 2019 von 8,5 % fix auf 2 % plus 3M-EURIBOR (Höchstzinssatz gemäß KMU Förderungsgesetz) reduziert. Weiters wurde vereinbart, dass im Falle eines Verlustes jährlich € 100.000,00 zu tilgen sind. Sofern das Unternehmen einen Gewinn erwirtschaftet, müssen 30 % des Gewinns vor Steuern (bereinigt um bestimmte Posten, mindestens € 100.000,00) zur Rückzahlung des Darlehens verwendet werden. Die erste Tilgung ist am 30. Juni 2020 zu leisten. Die kumulierten Zinsen in Höhe von € 619.945,97 sind in den sonstigen Verbindlichkeiten ausgewiesen, davon € 100.000,00 mit einer Restlaufzeit von bis zu 1 Jahr und € 519.945,97 mit einer Restlaufzeit von bis zu 5 Jahren.
Mit den Zusammenschlussverträgen vom 30. Dezember 2011, 22. Juni 2012 und 25. Juni 2013 haben sich drei atypisch stille Gesellschafter mit einer Einlage von insgesamt € 1.205.000,00 am Unternehmen beteiligt. Die Einlagen der atypisch stillen Gesellschafter, sowie die Verlustzuweisungen bis zur Höhe der Einlage werden als Sonderposten ausgewiesen.
Mit Sacheinlage- und Einbringungsvertrag vom 15. November 2018 sowie Abänderungsvereinbarung vom 30. Dezember 2018 wurde die Einbringung der stillen Gesellschaft unter der aufschiebenden Bedingung des Börsegangs der Marinomed Biotech AG festgelegt. Als Gegenleistung wurde die Übertragung von insgesamt 43.694 Aktien, auf die jeweils ein anteiliger Betrag am Grundkapital von € 1,00 entfällt, von Altaktionären festgelegt. Die aufschiebende Bedingung wurde mit dem Börsegang der Marinomed Biotech AG erfüllt.
Im Geschäftsjahr 2013 wurden einem großen internationalen Pharmakonzern die exklusiven Rechte an der antiviralen Produktlinie der Marinomed für mehrere Territorien gewährt. Die vertraglich vereinbarte Gutschrift bei Rückgabe der exklusiven Rechte wurde in Vorperioden (2013 € 500.000,00 und 2014 € 750.000,00) zu 100 % rückgestellt. 2016 wurden die Vermarktungsrechte für ein Territorium zurückgegeben, ohne dass dadurch die Gutschrift schlagend wurde. Dadurch konnte die dafür gebildete Rückstellung in der Höhe von € 500.000,00 im Geschäftsjahr 2016 ertragswirksam aufgelöst werden. Die vertraglich vereinbarte Gutschrift bei Rückgabe der exklusiven Rechte für das verbleibende Territorium in der Höhe von € 750.000,00 besteht am Bilanzstichtag unverändert.
Der Anstieg der sonstigen Rückstellungen gegenüber dem Vorjahr betrifft überwiegend Vorsorgen für potenzielle Zahlungen in Zusammenhang mit der Verlegung des Firmenstandorts (€ 510.000,00) sowie Mitarbeiterprämien (€ 435.190,22). Weiters sind in den sonstigen Rückstellungen Abgrenzungen für noch nicht abgerechnete Leistungen und Ansprüche in Höhe von € 797.931,59 enthalten (2018: k€ 652).
Die kumulierten Zinsen aus der Mezzaninfinanzierung in Höhe von € 619.945,97 werden nach erfolgter Vertragsanpassung in den sonstigen Verbindlichkeiten ausgewiesen, während diese im Geschäftsjahr 2018 (k€ 612) in den sonstigen Rückstellungen auszuweisen waren.
Am 18. Juli 2017 emittierte Marinomed eine Wandelanleihe am dritten Markt (MTF) der Wiener Börse über € 7.000.000,00 (Zinssatz 4 % p.a., Fälligkeitstermin 14. Juli 2021). Für den Fall eines Börsengangs wurde den Investoren ein Wandlungsrecht in Aktien eingeräumt. Zum Ende der Angebotsfrist am 14. Februar 2019 wurden Wandlungserklärungen für Nominale in Höhe von € 6,98 Mio. (entspricht rund 99,7 % des Marinomed Biotech AG
ausstehenden Volumens der Wandelschuldverschreibungen), zwecks Wandlung in neue Aktien der Marinomed Biotech AG eingeliefert. Die nicht innerhalb der Frist gewandelten Anleihen wurden von der Gesellschaft zurückgekauft und anschließend getilgt. Mit Wirkung vom 20. März 2019 wurde die Anleihe von der Einbeziehung in den Dritten Markt der Wiener Börse gelöscht.
Die Verbindlichkeiten gegenüber Kreditinstituten enthalten ein Darlehen der Europäischen Investitionsbank in Höhe von € 4.000.000,00, welches der Gesellschaft im Oktober 2019 zugeflossen ist. Die Verzinsung erfolgt mit einem Fixzinssatz von 7,5%, ab dem Jahr 2020 ist zusätzlich eine umsatzabhängige Vergütung zu leisten. Das Darlehen weist eine Laufzeit von 5 Jahren ab Zuzählung auf.
Die Verbindlichkeiten aus Lieferungen und Leistungen (€ 1.002.432,99) betreffen überwiegend Warenlieferungen. Zum 31. Dezember 2018 war der Stand dieser Verbindlichkeiten infolge des laufenden IPO-Projekts erhöht (k€ 2.015).
Die sonstigen Verbindlichkeiten betreffen mit € 214.288,63 Aufwendungen des laufenden Geschäftsjahres, die erst in Folgejahren zahlungswirksam werden (2018: k€ 491).
Im Geschäftsjahr 2019 wurden die Gesellschafterdarlehen sowie das FFG-Darlehen zur Gänze getilgt.
| sonstige Verbindlichkeiten | 31.12.2019 EUR |
31.12.2018 EUR |
|---|---|---|
| Zinsabgrenzungen | 684.112,64 | 131.178,08 |
| Steuern und soziale Sicherheit | 108.992,01 | 118.001,79 |
| Leasingverbindlichkeiten | 39.281,06 | 50.854,04 |
| Übrige sonstige Verbindlichkeiten | 41.129,95 | 6.076,08 |
| Gesellschafterdarlehen und Zinsen | 0,00 | 2.498.547,68 |
| FFG Darlehen | 0,00 | 1.391.082,00 |
| 873.515,66 | 4.195.739,67 |
Zur Fristigkeit der Verbindlichkeit aus der Zinsabgrenzung Mezzaninkapital wird auf Kapitel B Mezzaninfinanzierung verwiesen.
Die Darstellung der Erträge und Aufwendungen erfolgt nach dem Gesamtkostenverfahren.
Die Umsatzerlöse setzen sich im Geschäftsjahr 2019 aus Erlösen aus Handelswarenverkäufen, aus Erlösen aus Lizenzverträgen und sonstigen Erlösen zusammen.
| Umsatzerlöse | 2019 | 2018 |
|---|---|---|
| EUR | EUR | |
| Verkauf von Waren | 4.919.757,80 | 4.448.516,69 |
| Erlöse aus Lizenzverträgen | 998.919,27 | 114.704,13 |
| Sonstige Erlöse | 266.317,66 | 135.195,07 |
| 6.184.994,73 | 4.698.415,89 |
7
Anhang
Die Umsatzerlöse wurden auf folgenden Märkten erzielt:
| 2018 | |
|---|---|
| k€ | |
| 160 | |
| 2.177 | |
| 2.361 | |
| 6.185 | 4.698 |
| 2019 k€ 102 4.030 2.053 |
*) Darin k€ 900 anlässlich der Rückgabe von Vermarktungsrechten durch einen europäischen Lizenzpartner.
Die sonstigen betrieblichen Erträge setzen sich wie folgt zusammen:
| sonstige betriebliche Erträge | 2019 | 2018 |
|---|---|---|
| EUR | EUR | |
| Forschungsprämie | 670.577,12 | 327.182,11 |
| Auflösung von Rückstellungen | 113.189,79 | 8.279,03 |
| Übrige betriebliche Erträge | 24.320,38 | 22.272,66 |
| Nicht rückzahlbare Förderungen | 0,00 | 350.512,00 |
| 808.087,29 | 708.245,80 |
Die Erträge aus der Auflösung von Rückstellungen betreffen insbesondere die Auflösung von Rückstellungen für drohende Verluste aus schwebenden Abnahmegeschäften (k€ 57) und den Börsegang (k€ 44).
Die höheren Erträge aus der Forschungsprämie resultieren aus dem Anstieg der forschungsbezogenen Aufwendungen in der Bemessungsgrundlage.
Die nicht rückzahlbaren Förderungen enthielten im Vorjahr Erträge aus der Umwandlung von FFG-Darlehen in Zuschüsse (k€ 351). Vergleichbare Erträge fielen im Jahr 2019 nicht an.
Die Aufwendungen für bezogene Leistungen enthalten überwiegend forschungsbezogene Dienstleistungen Dritter (k€ 2.960, 2018: k€ 1.019), welche gegenüber dem Vorjahr deutlich angestiegen sind.
Der Personalaufwand enthält zum 31.12.2019 Aufwendungen aus dem Mitarbeiteraktienoptionsprogramm in Höhe von k€ 427 (2018: k€ 0). Darüber hinaus haben Einmalprämien im Zuge des Börsegangs sowie Abgrenzungen für auf das Geschäftsjahr 2019 entfallende Mitarbeiterboni den Personalaufwand erhöht.
Im sonstigen betrieblichen Aufwand sind Rechts- und sonstige Beratungsaufwendungen sowie Prüfungs-, Versicherungs-, Marketing- und Reiseaufwendungen in Zusammenhang mit der Vorbereitung und Durchführung des Börsegangs in Höhe von € 1,9 Mio. enthalten. Im Vorjahr fielen in diesem Zusammenhang € 2,2 Mio an.
Der Zinsaufwand betrifft mit € 946.918,23 die Erfassung des Zinsvorteils aus der Wandelanleihe im Geschäftsjahr 2019. Die Österreichische Prüfstelle für Rechnungslegung (OePR) hat den Jahresabschluss und Lagebericht zum 31. Dezember 2018 und den Halbjahresfinanzbericht des vergangenen Geschäftsjahres sowie des laufenden Geschäftsjahres einer Prüfung unterzogen. Im Zuge der Prüfung haben die OePR und Marinomed unter anderem ihre unterschiedlichen Positionen zur Behandlung der Wandelanleihe zum Ausgabezeitpunkt diskutiert. Nach Auffassung der OePR hat Marinomed den §229 (2) 2. UGB nicht angewendet, bzw. unrichtig interpretiert. Das Gesetz sieht vor, dass der Betrag, der bei der Ausgabe von Schuldverschreibungen für Wandlungsrechte und Optionsrechte zum Erwerb von Anteilen erzielt wird, in der Kapitalrücklage zu erfassen ist. Nach dieser Regelung hätte Marinomed bei Begebung der Wandelanleihe in 2017 einen aktiven Rechnungsabgrenzungsposten sowie eine gebundene Kapitalrücklage in Höhe von € 946.918,23 bilden müssen. Der aktive Rechnungsabgrenzungsposten wäre in der Folge über
8
Marinomed Biotech AG
die Laufzeit gegen Zinsaufwand abzubauen gewesen (davon € 300.889,91 im Jahr 2017 und € 646.028,32 im Jahr 2018). In 2017 war das Unternehmen noch der Auffassung, dass eine höhere Darstellung des Eigenkapitals der Situation nicht angemessen wäre. Marinomed folgt nun aber der Auffassung der OePR und korrigiert die fehlerhafte Erfassung der Wandelanleihe im Rahmen der Ausgabe in 2017 in laufender Rechnung mit dem Jahresabschluss für das Geschäftsjahr 2019. Die Berichtigung führt zu einer Erhöhung des Zinsaufwands um € 946.918,23, der in 2017 ex-ante ermittelt worden wäre sowie einer Erhöhung der gebundenen Kapitalrücklage in gleicher Höhe.
Der Rückgang der übrigen Zinsaufwendungen resultiert aus der Tilgung von Gesellschafter- und sonstigen Darlehen sowie der Umwandlung der Anleiheverbindlichkeit im Jahr 2019.
Marinomed Biotech AG
Die Verpflichtungen aus Miet- und Leasingzahlungen für das Folgejahr und die folgenden fünf Jahre betragen € 75.924,84 (2018: € 138k für das Folgejahr und € 210k für die folgenden fünf Jahre).
Die Gesellschaft hat eine Reihe von Vereinbarungen geschlossen, die auch finanzielle Verpflichtungen für die Zukunft beinhalten, die sich auf bezogene Leistungen von Dritten in Verbindung mit der Durchführung von klinischen Studien und anderen F&E-Aktivitäten beziehen, diese betragen zum Bilanzstichtag k€ 2.306 (2018: k€ 1.501).
Die finanziellen Verpflichtungen aus der Errichtung des neuen Firmenstandorts, welche nicht in der Bilanz auszuweisen sind, betragen zum Bilanzstichtag k€ 3.918 (2018: k€ 0).
Der Vorstand schlägt vor, den Bilanzverlust zum 31.12.2019 in Höhe von € -29.682.792,86 auf neue Rechnung vorzutragen.
Die durchschnittliche Zahl der Arbeitnehmer während des Geschäftsjahrs betrug:
| 2019 | 2018 | |
|---|---|---|
| Vorstand | 3 | 2 |
| Sonstige Angestellte | 31 | 30 |
| Gesamt | 34 | 32 |
| Vorstände: | Name | Geschäftsführung | Vorstand seit |
|---|---|---|---|
| seit | |||
| Vorsitzender | Andreas Grassauer | 11.04.2006 | 02.06.2017 |
| Stellvertretende Vorsitzende | Eva Prieschl-Grassauer | 04.09.2007 | 02.06.2017 |
| Mitglied | Pascal Schmidt | 17.09.2018 |
9
Anhang
Marinomed Biotech AG
| Aufsichtsräte: | Name | Aufsichtsrat seit |
|---|---|---|
| Vorsitzender | Simon Nebel | 02.06.2017 |
| Stellvertretende Vorsitzende Ute Lassnig | 02.06.2017 | |
| Mitglied | Karl Lankmayr | 02.06.2017 |
| Mitglied | Gernot Hofer | 02.06.2017 |
| Mitglied | Brigitte Ederer | 21.11.2018 |
| Name | beziehbare Aktien |
|---|---|
| Andreas Grassauer | 6.816 |
| Eva Prieschl-Grassauer | 6.816 |
| Pascal Schmidt | 8.215 |
| Leitende Angestellte | 4.500 |
| Sonstige Arbeitnehmer | 15.160 |
Am 1. Februar 2019 etablierte Marinomed ein Mitarbeiteraktienoptionsprogramm für den Vorstand und für alle weiteren Mitarbeiter des Unternehmens. Die Gesamtzahl an im Rahmen des ESOP 2019 auszugebenden Aktienoptionen beträgt 43.694, wobei jede Option den Besitzer berechtigt eine Stammaktie zu zeichnen.
Ende April 2019 wurden 21.847 Aktienoptionen an die 3 Vorstandsmitglieder der Gesellschaft sowie 19.660 Aktienoptionen an 28 Mitarbeiter aller Hierarchiestufen ausgegeben. Bis zum Jahresende wurden weitere 780 Optionen ausgegeben, 780 Optionen verfielen. Bei Ausübung der Optionen kann die Gesellschaft den Anspruchsberechtigten in Aktien (equity-settled) oder in bar (cash-settled) auszahlen. Diese Entscheidung liegt im alleinigen Ermessen der Gesellschaft. Das Management plant die Anspruchsberechtigten in Aktien auszuzahlen. Die Bedienung der Optionen erfolgt in diesem Fall über das bedingte Kapital. Zugeteilte Optionen sind nicht sofort auszuüben, sondern können erst nach "Anwachsen" (vesting) ausgeübt werden, d.h. 25 % nach Ablauf von 12 Monaten ab dem ersten Börsehandelstag (1. Februar 2019), dann jeweils 6,25 % nach je 3 Monaten. Der Ausübungspreis entspricht dem Angebotspreis zum Zeitpunkt des Börsegangs (= EUR 75,00). Der Ausübungszeitraum beschränkt sich jeweils auf 10 Börsehandelstage ab dem 6. Börsehandelstag nach der Veröffentlichung von Finanzberichten (Jahresfinanzbericht, Quartalsberichte). Weiters ist eine Kurshürde von 2,5 % pro Quartal ab dem ersten Börsehandelstag vorgesehen (ohne Zinseszinsrechnung). Nicht ausgeübte Optionen verfallen entschädigungslos am 31. Januar 2025 oder nach wirksamer Beendigung des Beschäftigungsverhältnisses. Die Aktienoptionen sind nicht übertragbar oder belastbar, gehen jedoch im Falle des Todes eines Bezugsberechtigten auf seine Rechtsnachfolger von Todes wegen über.
Der Schätzwert der ausgegebenen Aktienoptionen zum Bilanzstichtag beträgt € 1.330.440,00.
Die Aufwendungen aus dem Aktienoptionsprogramm betragen im Abschlussjahr € 426.538,12 (2018: k€ 0).
Die Aufwendungen für Abfertigungen betreffen ausschließlich Beiträge an die Mitarbeitervorsorgekasse und verteilen sich wie folgt:
| 2019 | 2018 |
|---|---|
| € | € |
| 5.768,36 | |
| 5.197,46 | 3.629,43 |
| 24.321,21 | 19.616,62 |
| 41.615,41 | 29.014,41 |
| 12.096,74 |
Marinomed Biotech AG
Die für die Prüfung des Jahresabschlusses zuständige BDO Austria GmbH hat folgende Leistungen für das Unternehmen erbracht:
| 2019 | 2018 | |
|---|---|---|
| € | € | |
| Prüfung des Jahresabschlusses | 40.000,00 | 40.000,00 |
| Sonstige Bestätigungsleistungen | 15.000,00 | 136.810,00 |
| Steuerberatungsleistungen | 4.800,00 | 26.410,00 |
| Sonstige Leistungen | 221.918,75 | 61.361,56 |
| 281.718,75 | 264.581,56 |
In den sonstigen Leistungen in Höhe von k€ 221,9 sind Barauslagen für die Comfort Letter Versicherung im Zusammenhang mit dem IPO in Höhe von k€ 166,5 enthalten.
Die Gesellschaft hält zum Abschlussstichtag 100% der Anteile an der Marino Immo GmbH und macht von der Befreiung des § 249 (2) UGB Gebrauch. Es bestehen keine Geschäftsbeziehungen oder sonstigen Verträge zwischen Marinomed Biotech AG und Marino Immo GmbH.
Im Geschäftsjahr 2019 betrugen die Bezüge des Vorstands inkl. ausgezahlten und abgegrenzten Prämien sowie Aufwendungen aus dem Mitarbeiteraktienoptionsprogramm insgesamt € 1.458.260,46 (2018: € 472.032,77), davon aus dem Mitarbeiteraktienoptionsprogramm € 222.895,17 (2018: € 0,00).
Es wurden keine Vorschüsse oder Kredite an Mitglieder des Vorstands gewährt.
Die Bezüge des Aufsichtsrats (Fixvergütungen, Sitzungsgelder und Spesen) betrugen im Jahr 2019 € 185.679,24. Mit der Viopas Venture Consulting GmbH des Aufsichtsratsvorsitzenden wurde darüber hinaus ein Beratungsvertrag abgeschlossen, der eine Vergütung in Höhe von € 2.250,00 pro Beratertag vorsieht. Daraus resultierten im Jahr 2019 sonstige Aufwendungen in Höhe von € 35.393,34. Im Jahr 2018 betrugen die Gesamtvergütungen an den Aufsichtsrat € 136.869,25.
Es wurden keine Vorschüsse oder Kredite an Mitglieder des Aufsichtsrats gewährt.
Im Jahr 2015 hat das Unternehmen mit einigen seiner Gesellschafter Vereinbarungen über Gesellschafterdarlehen mit einem Gesamtbetrag von € 1.075.000,00 und einer jährlichen Verzinsung von 10% zum 31. Dezember 2015 geschlossen. Im Jahr 2017 wurde ein neues Gesellschafterdarlehen gewährt und die bestehenden Darlehen wurden zum 31. Dezember 2017 auf einen Gesamtbetrag von € 2.352.000,00 erhöht. Im Jahr 2018 erfolgte eine teilweise Rückzahlung in Höhe von € 89.314,00. Folgende Aktionäre beteiligten sich an diesen Darlehen:
Anhang
12
Marinomed Biotech AG
Im Geschäftsjahr 2019 wurden die offenen Gesellschafterdarlehen in Höhe von € 2.262.686,00 samt kumulierter Zinsen in Höhe von € 350.053,35 zur Gänze getilgt.
Die Ende des Jahres 2019 ausgebrochene Covid-19-Krise hat sich bis heute zu einer globalen Pandemie entwickelt. Aufgrund der exponentiellen Ausbreitung des Virus, der zahlreichen Todesfälle und der damit verbundenen Belastung der Gesundheitssysteme weltweit, haben zahlreiche Staaten massive Einschränkungen im Hinblick auf die Freiheitsrechte und die wirtschaftliche Aktivität gesetzt. Dazu zählen insbesondere Schließung von Geschäften ganzer Sektoren (im Wesentlichen alle Bereiche abgesehen jener der Grundversorgung wie Lebensmittel, Pharmazeutika, etc.), teilweise rigide Ausgangssperren, Platz- und Veranstaltungsverbote, Grenzkontrollen sowie Einführung von Mindestabständen, mit direktem Einfluss auch auf Büroabläufe. Ausgehend vom Ursprung in Asien ist nach der Europäischen Union gegenwärtig die USA am stärksten von der Covid-19-Pandemie betroffen. Das Virus hat aber bereits alle Kontinente erreicht und insbesondere in den Entwicklungsländern mit einer schwächeren medizinischen Versorgung werden noch gravierende Folgen zu befürchten sein.
Marinomed ist als international tätiges Unternehmen in die Weltwirtschaft eingebunden. Auch wenn noch nicht absehbar ist, welche Auswirkungen die Pandemie langfristig auf die globale Wirtschaft hat, besteht ein erhöhtes Risiko, dass sich das Weltwirtschaftsklima weiter verschlechtert und sich die Abwärtsbewegungen auf allen Kontinenten fortsetzen. Zwar reagiert der Gesundheitssektor, in dem das Unternehmen tätig ist, weniger sensibel auf derartige Veränderungen als andere Bereiche der Wirtschaft, jedoch könnte sowohl die Aufrechterhaltung einer durchgängigen Wertschöpfungskette erschwert werden als auch eine Abschwächung des Wirtschaftswachstums zu einer geringeren Kundennachfrage führen. Für geplante klinische Studien in beiden Plattformen werden sich Verzögerungen ergeben, da die aktuellen Auflagen die Durchführung insbesondere von Allergiestudien unterbinden.
Dem entgegen steht, dass die Carragelose® basierten Produkte klinisch gezeigt haben, dass sie gegen respiratorische Viren aktiv sind. Es zeichnet sich aktuell ab, dass das saisonbedingt schwächere erste Halbjahr in 2020 den üblichen Rückgang der Umsatzerlöse nicht aufweist. Ob dieser Trend nachhaltig ist, kann aktuell nicht seriös prognostiziert werden. Insbesondere, da das SARS-CoV-2 Virus nicht humanen Ursprungs ist und es keine klinischen Daten zur Wirksamkeit der Carragelose® auf das neue Virus gibt. Natürlich unternimmt Marinomed mit hoher Priorität alle Anstrengungen, entsprechende Ergebnisse aus klinischen Studien zu erhalten. Es besteht aber das Risiko, dass die Versuche nicht die erhoffte Wirkung zeigen. Die Mittel für die Durchführung können aus bestehenden Ressourcen bereitgestellt werden und sollen durch nationale und internationale staatliche Programme ergänzt werden.
Wien, am 15. April 2020
Marinomed Biotech AG
.................................................................................
Andreas Grassauer
................................................................................. Eva Prieschl-Grassauer
................................................................................. Pascal Schmidt





10
Die Veröffentlichung oder Weitergabe des Jahresabschlusses mit unserem Bestätigungsvermerk darf nur in der von uns bestätigten Fassung erfolgen. Dieser Bestätigungsvermerk bezieht sich ausschließlich auf den deutschsprachigen und vollständigen Jahresabschluss samt Lagebericht. Für abweichende Fassungen sind die Vorschriften des § 281 Abs. 2 UGB zu beachten.
Die Veröffentlichung oder Weitergabe des Jahresabschlusses mit unserem Bestätigungsvermerk darf nur in der von uns bestätigten Fassung erfolgen. Dieser Bestätigungsvermerk bezieht sich ausschließlich auf den deutschsprachigen und vollständigen Jahresabschluss samt Lagebericht. Für abweichende Fassungen sind die Vorschriften des § 281 Abs. 2 UGB zu beachten.
We confirm to the best of our knowledge that the financial statements of Marinomed Biotech AG for the year ended December 31, 2019 voluntarily prepared in accordance with the International Financial Reporting Standards (IFRS) give a true and fair view of the assets, liabilities, financial position, and profit or loss of Marinomed Biotech AG and that the management discussion and analysis for the year ended December 31, 2019 give a true and fair view of the development and performance of the business and the position of Marinomed Biotech AG, together with a description of the principal risks and uncertainties Marinomed Biotech AG faces.
We confirm to the best of our knowledge that the financial statements of Marinomed Biotech AG for the year ended December 31, 2019 prepared in accordance with the Austrian Commercial Code (UGB) give a true and fair view of the assets, liabilities, financial position, and profit or loss of Marinomed Biotech AG and that the management report for the year ended December 31, 2019 gives a true and fair view of the development and performance of the business and the position of Marinomed Biotech AG, together with a description of the principal risks and uncertainties Marinomed Biotech AG faces.
Vienna, April 15, 2020
The Management Board of Marinomed Biotech AG
Veterinärplatz 1 1210 Vienna Austria www.marinomed.com
Pascal Schmidt, Chief Financial Officer Phone +43 1 250 77-4470 [email protected]
Metrum Communications
Tina Feiertag
Produced in-house in collaboration with ns.publish
Due to the financial rounding of individual items and percentages in this report, it may contain minor calculation differences.
This report contains forward-looking statements that were prepared on the basis of all the information available at the time. Various factors mean that actual performance may differ from the expectations set out here. Marinomed Biotech AG will not update these forward-looking statements, either on account of changes in actual circumstances or due to changes in assumptions or expectations. This report does not constitute a recommendation or solicitation to buy or sell securities of Marinomed Biotech AG.
Misprints and typographical errors excepted. Published in April 2020.

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