Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today announced its results for the first nine month of the 2021 fiscal year.
The key financial figures of the Formycon Group also developed as expected at the end of the third quarter. Turnover within the Group which, alongside the joint-stock company also includes two fully consolidated subsidiaries Formycon Project 201 GmbH and Formycon Project 203 GmbH, as well as the shareholding in FYB 202 GmbH & Co. KG which is not consolidated, stood at a total of Euro 29.1 million in the first nine months of 2021 (same period last year: Euro 23.5 million). For the full year of 2021, Formycon now expects revenues of approximately Euro 40.0 million for the entire Group (2020: Euro 34.2 million).
During the company's current phase, the Formycon Group is focusing on research and development activities for the biosimilar projects, as well as for the COVID-19 drug (FYB207). The current revenues result from the development services for the out-licensed or partnered projects. Following the successful approval of these products, Formycon will also take a share of subsequent commercialization revenues.
The Group's earnings before interest, tax, depreciation and amortization (EBITDA) stood at Euro -10.0 million (same period of the previous year: Euro -2.0 million), the operating result (EBIT) and the consolidated net profit for the period were around Euro -10.6 million and Euro -10.7 million as of September 30, 2021, compared with Euro -2.7 million in the previous year period.
The changes compared to the previous year period continue to be mainly due to investments in the pipeline. Significant progress was made in the development of the pre-clinical biosimilar candidate FYB206 and the development of the innovative SARS-CoV-2 drug FYB207 was advanced at a fast pace. The key figures include income of Euro 1.5 million from the approved grant of up to Euro 12.7 million from the Free State of Bavaria for the SARS-CoV-2 blocker FYB207 as part of the Bavarian Therapeutic Strategy to combat the COVID-19 pandemic.
The Formycon Group's stocks of liquid assets, which comprise cash, checks, bank deposits and securities, remained solid at Euro 26.3 million as of September 30, 2021. Including short-term receivables from deliveries and services, as well as other assets worth around Euro 7.4 million, the Formycon Group held liquid assets totaling Euro 33.7 million on the day of reporting (same period last year: Euro 23.5 million).
In the first nine months of the year, Formycon AG, as the company's actual operational unit, achieved a turnover of Euro 20.4 million (same period last year: Euro 18.0 million). The company's nine-month result was Euro -10.7 million compared to Euro -2.8 million last year.
"We are very satisfied with the course of the fiscal year so far. Important milestones were achieved on all development projects and major operational progress was made. A special highlight in the past quarter was the submission of the biologics license application for our Lucentis(R)1 biosimilar candidate FYB201 to the U.S. Food and Drug Administration (FDA) and the submission of the marketing authorization application to the European Medicines Agency (EMA), by our licensee. This was a key step in the transformation to a company that generates cash flows from product commercialization in addition to revenues from development activities. With the scheduled investments in the pipeline projects, particularly in FYB206, we are systematically implementing our growth strategy and are convinced that this will create sustainable value for our company. We will continue on this path", comments Chief Financial Officer Dr Nicolas Combé.
1) Lucentis(R) is a registered trademark of Genentech Inc.
Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval. With its biosimilars, Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Formycon currently has four biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of an innovative COVID-19 drug FYB207.
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection – and by 2020, medications with revenues of approximately USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. Global sales of biosimilars are estimated to exceed $15 billion by 2020. By 2030, analysts estimate that this figure could rise to over $60 billion.