DGAP-News: Formycon Publishes Annual Financial Statements for the 2021 Financial Year

Press Release // May 18, 2022

Formycon Publishes Annual Financial Statements for the 2021 Financial Year

- Group turnover and other earnings total Euro 41.7 million

- Liquidity solid at a total of EUR 36.2 million

- Annual result shaped by scheduled investments in FYB202, FYB206 and FYB207

- Conversion of Group reporting to IFRS as of the 2022 half-year consolidated financial statements

Munich Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today released its financials for 2021.

The focus in 2021 was on the further development of the current biosimilar candidates as well as the COVID-19 drug (FYB207). The development activities of the late-stage biosimilar projects FYB201 (biosimilar candidate for Lucentis®1), FYB202 (biosimilar candidate for Stelara®2) and FYB203 (biosimilar candidate for Eylea®3) result in the currently reported revenues, as Formycon continues to perform remunerated development activities for the aforementioned biosimilar candidates after partnering by the licensing or collaboration partners. In the event of subsequent marketing, Formycon will receive a corresponding share of the marketing proceeds generated. With the anticipated product launch of FYB201 in 2022, Formycon is moving closer to entering a new corporate phase, whereby the expected revenues from this should open up new growth opportunities for the company. In addition, Formycon is working on the continuous expansion of its pipeline. Due to the increasingly international nature of our business activities, the consolidated financial statements will be prepared in accordance with IFRS (International Financial Reporting Standards) for the first time as of the 2022 half-year financial statements. The separate financial statements of the parent company Formycon AG continue to be prepared and published in accordance with the rules of the German Commercial Code (HGB).

On the day of reporting, December 31, 2021, the Formycon Groups commercial figures had developed as planned. Consolidated group sales which, in addition to the AG, include the two subsidiaries Formycon 201 Project GmbH and Formycon 203 Project GmbH as well as the 24.9 percent share in the FYB 202 GmbH & Co. KG joint venture, amounted, as forecast, to a total of around Euro 37 million (previous year: Euro 34.2 million).

Group earnings before interest, taxes and depreciation on fixed assets and intangible assets (EBITDA) amounted to Euro -12.4 million (previous year: Euro -4.8 million). The operating result (EBIT) totaled Euro -13.3 million (previous year: Euro -5.7 million). At Euro -13.5 million (previous year Euro -5.9 million), the result for the year was in line with expectations. Formycon had invested in the development of its own pipeline in the 2021 financial year, resulting in a higher negative annual result compared to previous years. In addition to the COVID-19 drug (FYB207), primarily the as yet unpublished biosimilar candidate FYB206 was advanced on the development side, as well as scheduled investments in FYB202. Formycon was also able to recruit further qualified specialists last year in line with the needs of the development projects and employed 171 people at the end of the reporting period (+30% compared to the previous year).

Current assets consist largely of liquidity and near-liquid assets. As of December 31, 2021, the Formycon Group had capital resources of approximately Euro 25.2 million (previous year: Euro 42.4 million) in cash and cash equivalents (cash on hand, checks, bank balances, and securities). Including short-term receivables and other assets worth a further Euro 10.9 million, the Formycon Group holds liquid assets of Euro 36.1 million in total (previous year Euro 49.2 million) and therefore has solid room for maneuver for the further development of its own projects.

The Group's balance sheet was around Euro 66.3 million (previous year: Euro 75.6 million) with an equity ratio of 85 percent (previous year: 90 percent). The company has no financial liabilities.

Formycon AG, as the Group's actual operational unit, achieved a turnover of Euro 26.5 million (previous year: Euro 25.1 million) and recorded an EBITDA of Euro -14.3 million (previous year: Euro -4.7 million). Accordingly, this resulted in an EBIT amounting to Euro -13.4 million (previous year: Euro -5.6 million) and an annual result of a rounded Euro -13.3 million (previous year: Euro -5.7 million).

With the recently announced closing of the transaction with ATHOS KG, the ownership structure in two of the three late-stage biosimilar candidates has changed: Formycon now owns 100% of the rights to FYB202 (previously 24.9%) and 50% of the rights (previously fully out-licensed with royalty interest) to FYB201, a biosimilar candidate for Lucentis® being developed with Polpharma Biologics Group in the 50/50 joint venture Bioeq AG. By acquiring the biosimilar assets, Formycon will participate in a significantly higher proportion of the future revenues from their commercialization. The company will invest the expected cash inflows mainly in the accelerated expansion of its own development pipeline. This is intended to enable future biosimilar candidates to be developed independently, thus contributing sustainably to the value creation and further growth of the company.

Dr. Nicolas Combé, CFO of Formycon AG, gave the following statement with regard to the past fiscal year: "In 2021, we achieved important milestones with the submission of FYB201 to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). With the anticipated commercialization launch of FYB201 later this year, we expect to generate the first commercialization revenues, laying the foundation for sustainable growth and accelerated execution of our growth strategy, to which of course in particular the recently announced acquisition of the biosimilar assets FYB201 at 50% and FYB202 at 100% contributes."

The full 2021 annual financial statements / annual report for 2021 can be found on our website at https://www.formycon.com/en/investor-relations/financial-reports/.

¹⁾ Lucentis® is a registered trademark of Genentech Inc.
²⁾ Stelara® is a registered trademark of Johnson & Johnson.
³⁾ Eylea is a registered trademark of Regeneron Pharmaceuticals 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 a COVID-19 drug FYB207.

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 2025 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
Tel.: +49 (0) 89 - 86 46 67 149
Fax: + 49 (0) 89 - 86 46 67 110
Sabrina.Mueller@formycon.com // 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.