DGAP-News: Formycon Publishes Half-Year Results for 2021

Press Release // September 21, 2021

Formycon Publishes Half-Year Results for 2021

- Group turnover above H1 half-year level at Euro 20.3 million

- EBITDA of Euro -9.7 million and half-year results of Euro -10.2 million in line with plans

- Result due to investments in the non-partnered projects FYB206 and FYB207

- Significant progress in the biosimilar projects and the COVID-19 drug

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today announced its financial results for the first half of 2021.

On the day of reporting, June 30, 2021, the Formycon Group's financial figures were as forecast. 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 20.3 million in the first six months of 2021 (H1/2020: Euro 16.5 million). For the full year of 2021, Formycon forecasts revenues above last year's level 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 its own and licensed biosimilar projects, as well as its own COVID-19 drug (FYB207). The current revenues also 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 -9.7 million (H1/2020: Euro -0.9 million), the operating result (EBIT) and the consolidated net profit for the period were around Euro -10.2 million as of June 30, 2021, compared with Euro -1.4 million in the prior-year period.

The changes compared to the prior-year period are mainly due to investments in our own 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. In collaboration with experienced European manufacturers, Formycon has accelerated the development of the production process for FYB207 and has already produced material at a pilot scale for pre-clinical in vivo studies and begun scale-up to a large GMP scale for clinical trial supply. At the same time, the entire infrastructure for conducting the pre-clinical in vivo studies and starting clinical development was established together with experienced contract companies. The key figures do not yet include income from the approved funding of up to Euro 12.7 million from the Free State of Bavaria as part of the Bavarian Therapy Strategy to combat the COVID 19 pandemic, as a first tranche of Euro 1.5 million was not disbursed until after the reporting date.

As in previous years, the Group's financial position appears to be solid: Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled around Euro 33.6 million on the day of reporting. Including short-term receivables and other assets worth around Euro 9.6 million, the Formycon Group held liquid assets of around Euro 42.2 million in total (H1/2020: Euro 26.2 million).

Formycon AG, as the company's central development and operational unit, achieved a turnover of approx. Euro 12.4 million during the first half of 2021 (H1/2020: Euro 12.0 million). The result for this period was Euro -10.1 (H1/2020: Euro -1.3 million).

Dr. Nicolas Combé, CFO of Formycon AG, gave the following statement with regard to the half-year results: "The progress of our development activities, both in biosimilar candidates and in our innovative COVID-19 drug, is reflected in the half-year figures. The submission of the marketing authorization application for our Lucentis(R)¹ biosimilar candidate FYB201 to the FDA and EMA by our licensee also paved the way towards future commercialization revenues. At the same time, we have invested heavily in our own development projects to create sustainable value and thus generate further growth."

The full half-year report can be found on the Internet at
https://www.formycon.com/en/investor-relations/financial-reports/

¹⁾Lucentis(R) is a registered trademark of Genentech Inc.

About Formycon:

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.

About Biosimilars:

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.

Contact:

Sabrina Müller

Senior Manager Corporate Communications and Investor Relations

Formycon AG

Fraunhoferstr. 15

82152 Martinsried/Planegg/Germany

phone +49 (0) 89 - 86 46 67 149

fax + 49 (0) 89 - 86 46 67 110
[email protected] // www.formycon.com

Disclaimer:

This press release may contain forward-looking statements and information which are based on our current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.