DGAP-News: Marinomed Biotech AG / Key word(s): Annual Results Marinomed Biotech AG Reports Financial Results for Fiscal Year 2020 and Record Sales For Virus Blocker Carragelose 2021-04-14 / 07:45 The issuer is solely responsible for the content of this announcement. =---------------------------------------------------------------------------------------------------------------------- Marinomed Biotech AG Reports Financial Results for Fiscal Year 2020 and Record Sales For Virus Blocker Carragelose Conference call to be held today, 14 April 2021; 10:00 am CEST / 9:00 am BST . Marinomed meets financial outlook for 2020 . Revenues of EUR 8.1 m, an increase of 32% (2019: EUR 6.1 m) . R&D spending of EUR 5.9 m in 2020, up 24% from EUR 4.8 m in 2019 . Reduced loss of EUR 6.0 m (2019: EUR 7.2 m) . Strong demand for Carragelose-based virus blockers due to COVID-19 pandemic . Progress in all clinical programs: Efficacy of Carragelose against SARS-CoV-2 clinically validated; treatment period in Tacrosolv phase II concluded Korneuburg, Austria, 14 April 2021 - Marinomed Biotech AG (VSE:MARI), an Austrian science-based biotech company with globally marketed therapeutics derived from innovative proprietary technology platforms, today reported strong results for the fiscal year ending 31 December 2020. The company closed the year with an 32 % increase in revenues to EUR 8.12 m (2019: EUR 6.14 m). Investments in research and development increased by almost 25 % in 2020 at EUR 5.94 m (2019: EUR 4.78 m), of which the largest part is attributable to clinical development. The operating loss (EBIT) of EUR 5.82 m improved compared to 2019 at EUR 6.21 m. The total loss for 2020 was reduced to EUR 6.01 m from EUR 7.22 m in 2019. "Due to the COVID-19 pandemic, 2020 was a challenging but very successful year for Marinomed. We were able to quickly build on our expertise in the existing research and data in coronaviruses and to initiate the necessary preclinical and clinical work to demonstrate that Carragelose is effective against SARS-CoV-2. As we are seeing from the results, Carragelose could be one building block in overcoming this pandemic," said Dr. Andreas Grassauer, Marinomed's CEO. "With our Marinosolv platform, progress was slower than we had expected due to our increased focus on the Carragelose COVID-19 program. However, we did substantially advance our Marinosolv platform. In addition to gastroenterological and allergic indications, we also plan to target asthma and ophthalmology. Marinomed soon expects results from the Tacrosolv phase II trial in ocular hay fever symptoms. We will continue to work hard to build on the excellent achievements of the year, scientifically, commercially, and financially. Both Carragelose and Marinosolv will play a major role in our future success and remain value drivers for the company." Operational highlights 2020 through April 2021: Corporate: . January 2020: Successful completion of accelerated book building with over 100.000 shares placed with institutional investors . June 2020: Moved into new Company headquarters in Korneuburg on Vienna city borders . February 2021: First rank on BCG's Gender Diversity Index Austria 2020 Carragelose: . April 2020: Research grant from the Austrian Research Promotion Agency (FFG) to investigate a Carragelose-based therapy against SARS-CoV-2 . May 2020: First license agreement to commercialize Carragelose in Italy . June 2020: Preclinical proof of Carragelose efficacy against SARS-CoV-2 . August 2020: Decongestant nasal spray filed for approval in Europe . November 2020: Clinical trial with Carragelose nasal spray initiated in Vienna to investigate prevention of COVID-19 infection in frontline healthcare staff; support for similarly designed investigator-initiated trial (IIT) in Swansea, UK . January 2021: New supporting data on the in vitro efficacy of Carragelose(R) against SARS-CoV-2 published . February 2021: Clinical validation of iota-carrageenan nasal spray for prevention of COVID-19 in Argentinian IIT . February 2021: Positive clinical data for Carragelose lozenges against respiratory viruses including SARS-CoV-2 . March 2021: First patient in clinical study of inhaled Carragelose to treat COVID-19 infections Marinosolv: . January 2020: Strong preclinical Marinosolv results in severe eye disease Neurotrophic keratopathy . February 2020: Marinosolv additional application in ophthalmology . September 2020: First development steps for medicinal product against autoimmune gastritis . December 2020: European Patent granted for Marinosolv technology . February 2021: First patients in phase II clinical trial of Tacrosolv to treat allergic rhinoconjunctivitis (hay fever) . April 2021: Last patient completes phase II clinical trial with Tacrosolv to treat ocular hay fever symptoms Impact of the COVID-19 pandemic The COVID-19 pandemic provided, and continues to exert, a strong influence on Marinomed's business activities. Accordingly, Marinomed increasingly allocated resources to the Carragelose business, yielding some very strong clinical and commercial results. In early 2021, clinical data were published, which confirmed Marinomed's previous preclinical findings that Carragelose virus blocker is effective against SARS-CoV-2. Carragelose is the first causally effective and patented therapy against common cold and flu-associated viruses, that also has demonstrated clinical efficacy against SARS-CoV-2. The year 2020 has been extremely positive for Carragelose products, as Carragelose had previously demonstrated efficacy against other coronaviruses. However, the pandemic and the re-allocation of resources resulted in delays regarding the Marinosolv platform. Partnering discussions were slowed down due to pandemic challenges and shifting priorities. Significant advances have however been reported with adding Flutisolv to the pipeline, a potential phase III asset to treat allergic rhinitis, as well as ongoing preclinical studies in the autoimmune gastritis program. Though delayed, a Tacrosolv phase II trial evaluating the eye drops in allergic rhinoconjunctivitis, i. e. hay fever affecting both the eyes and nose, is expected to report results in the second half of 2021. Pascal Schmidt, Marinomed's CFO, said: "We are very pleased to report a strong 2020. We saw a significant increase in Carragelose demand and optimized our supply chain early in the year to eliminate supply bottlenecks. This allowed us to realize record revenues. Based on this, we improved our operating results despite significantly increased spending in our R&D programs. As a science-based company, research and development is a central pillar for Marinomed's strategic development. We will also build on the promising Carragelose sales by further extending our global reach and the product line itself." 2020 Financial Results Marinomed reports Marinosolv and Carragelose as separate segments, as both platforms are in different development stages and accordingly, different factors influence the respective business developments. While the Marinosolv technology is still in the development stage and full rights lie with Marinomed, the Carragelose platform consists of six already marketed products plus several new products still in development. Commercialization rights of the available products are licensed to 15 partners, which are marketing the products in over 40 countries on five continents. Revenues in 2020 increased by 32 % to EUR 8.12 m (2019: EUR 6.14 m). Adjusted by a one-time effect in 2019 from a licensing contract, revenues in 2020 increased by 55 %. Other income increased to EUR 1.15 m (2019: EUR 0.67 m), primarily because if a SARS-CoV-2 research grant for Carragelose from the Austrian government (Emergency Grant KLIPHA-COVID19). Other gains and losses remained at a largely constant level. In expenses, investments in research and development increased by almost 25 %, totaling EUR 5.94 m in 2020 (2019: EUR 4.78 m). Material expenses went up to EUR 5.41 m (2019: EUR 3.58 m) due to the increase in Carragelose sales. Personnel expenses decreased slightly due to bonuses that had been paid in 2019 in relation to the IPO. This was partially made up in parts due to the increase in headcount. Other expenses remained mostly unchanged 2020 EUR 1.83 m (2019: EUR 1.79 m). Despite high investments, the operating loss (EBIT) of EUR 5.82 m was improved compared to 2019 (EUR 6.21 m). The total loss for 2020 was reduced to EUR 6.01 m, compared to EUR 7.22 m in 2019. Assets and balance sheet structure are largely typical for a biopharmaceutical company in the development stage. Total assets increased from EUR 19.50 m as of December 31, 2019 to EUR 23.50 m at year-end 2020. Non-current assets increased to EUR 8.11 m (31 December 2019: EUR 4.16 m) mainly from additions to fixed assets due to the new company headquarters in Korneuburg. Current assets remained almost stable at EUR 15.40 m (2019: EUR 15.34 m). The balance sheet closed with an equity of EUR 5.36 m (31 December 2019: EUR 10.87 m). Non-current liabilities increased from EUR 4.61 m to EUR 12.54 m during 2020 due to drawing down the second tranche of the European Investment Bank loan of EUR 5 m and the drawdown of the first tranche of the real estate financing (ERP loan) amounting to EUR 3 m. Current liabilities increased from EUR 4.03 m to EUR 5.61 m as of December 31, 2020. Cash and cash equivalents decreased from EUR 12.02 m (2019) to EUR 9.21 m (31 December 2020). Large positions in the cash flow were the second tranche of the EIB loan and investments in the new Company headquarters. Select financial figures for the fiscal year 2020 2019 All amounts in EUR thousand Revenues 8,124.4 6,144.6 Personnel expenses -4,097.9 -4,219.4 Operating result (EBIT) -5,816.0 -6,210.4
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April 14, 2021 01:45 ET (05:45 GMT)