DGAP-News: Formycon Reports First Quarter 2022 Financial Results and Announces Development Start of two New Biosimilar Candidates FYB208 and FYB209

Press Release // June 21, 2022

Formycon Reports First Quarter 2022 Financial Results and Announces Development Start of two New Biosimilar Candidates FYB208 and FYB209

- Sales and other earnings total EUR 8.2 million

- EBITDA is EUR -4.0 million as planned

- EBIT and net result in line with expectations at around EUR -4.3 million each

- Reference molecules for new biosimilar candidates FYB208 and FYB209 identified and initial development work initiated

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today presented the sales and earnings figures for the first quarter of 2022, demonstrating a start to the financial year that meets expectations.

Group turnover including other income amounted to a total of EUR 8.2 million as March 31, 2022 (same period of the previous year: Euro 9.4 million). Earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to EUR -4.0 million (Q1/previous year: EUR -1.7 million), the operating result (EBIT) amounted to EUR -4.3 million (Q1/previous year: EUR -1.9 million) and therefore was in line with expectations. The quarterly result also totaled EUR -4.3 million (Q1/previous year: Euro -2.0 million). The forecast Group sales for 2022 will be higher than in the previous year (EUR 37 million).

Reported revenues mainly result from development activities for the late-stage biosimilar projects FYB201 (biosimilar for Lucentis®1), FYB202 (biosimilar candidate for Stelara®2) and FYB203 (biosimilar candidate for Eylea®3), as Formycon continues to be remunerated by the licensing or collaboration partners for services rendered after partnering. After successful approval of the biosimilar candidates, Formycon will also participate in the marketing revenues. The transaction with ATHOS KG, which was concluded in the second quarter and significantly increased the shareholdings in the future marketing revenues of FYB201 and FYB202, had no impact on the first quarter in terms of figures. With the anticipated product launch of FYB201 in the second half of 2022, Formycon expects to generate revenue from product commercialization for the first time. These are expected to make a significant financial contribution to the implementation of the planned growth strategy.

Accordingly, Formycon will continue to invest in the development of its own pipeline in 2022. In addition to the COVID-19 drug FYB207, the unpublished biosimilar candidate FYB206 is also being advanced on the development side. In addition, two new biosimilar projects were initiated. For FYB208 and FYB209, the reference molecules have been identified and initial development activities have been started.


The liquidity ratios of the Formycon Group also developed as planned by the end of the first quarter: Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled EUR 20.1 million at the end of March. Including short-term receivables from deliveries and services, as well as other assets worth around EUR 4.4 million, the Formycon Group held liquid assets totaling EUR 24.5 million on the day of reporting (Q1/previous year: Euro 46.0 million).

In the first three months of the year, Formycon AG as the company’s actual operational unit achieved a turnover of EUR 6.5 million (Q1/previous year: Euro 5.1 million). The company's three-month result was EUR -4.4 million (Q1/previous year: Euro -2.1 million).

Commenting on the first three months, Chief Financial Officer Dr. Nicolas Combé said: "The first quarter was a special one, not least because of the transaction with ATHOS KG. With the acquisition of the 50% stake in FYB201 as well as the full integration of FYB202 into the Formycon Group and the associated increase of our share in future expected revenues, we are in a position to accelerate the expansion of the development pipeline in line with our growth strategy. The implementation of this strategy is reflected in the initiation of two new biosimilar projects. With the launch of FYB208 and FYB209, we are laying the foundation for a further increase in pipeline valuation and sustainable business growth."

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 (ISIN: DE000A1EWVY8 / WKN: A1EWVY) 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 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.