Press Release // October 28, 2022

 Formycon reports final figures for the first half of 2022

• Consolidated reporting for the first time under IFRS (International Financial Reporting Standards)
• Group turnover of Euro 17.6 million (H1/2021 IFRS: Euro 20,1 million) as well as EBITDA of Euro -7,6 million (H1/2021 IFRS: Euro -9,7 million) and operating result (EBIT) of Euro -8,5 million (H1/2021 IFRS: Euro -10,5 million) confirmed against preliminary figures
• Operating figures reflect investments in fully-owned projects FYB202, FYB206 and FYB207 as well as in pipeline expansion with biosimilar projects FYB208 and FYB209
• Half-year result after preliminary purchase price allocation from ATHOS transaction of Euro 80.0 million (H1/2021 IFRS: Euro -10.6 million) impacted by transaction-related and non-cash extraordinary effect
• Significant balance sheet extension due to valuation of acquired intangible assets as part of the ATHOS transaction and due the purchase price recognition of the acquired companies

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today published its half-year report 2022, confirming the preliminary operating figures for the first half of 2022 already announced on September 06, 2022. In addition to this, the figures published today include purchase price allocation effects from the transaction with ATHOS KG closed in May where Formycon AG acquired 100% of the rights to FYB202, a biosimilar candidate for Stelara®¹, the 50% stake of ATHOS KG in FYB201, a biosimilar for Lucentis®², and the operational development unit Bioeq GmbH.

On the day of reporting, June 30, 2022, the financial figures of the Formycon Group were in line with Formycon’s expectations. Turnover within the Group, which alongside Formycon AG also includes the fully consolidated subsidiaries Formycon Project 201 GmbH, FYB202 Project GmbH, Formycon Project 203 GmbH, Bioeq GmbH and the 50% stake in Bioeq AG, which is consolidated at equity, totaled in Euro 17.6 million in the first six months of 2022 (H1/2021 IFRS: Euro 20.2 million). 

With the market launch of FYB201 in the United Kingdom (UK) and the United States of America, as well as the launch in the EU by the respective commercialization partners, the first revenue and earnings contributions from commercialization proceeds are expected in the second half of 2022. For the full year of 2022, Formycon continues to forecast revenues above last year's level for the entire Group (2021 IFRS: Euro 36.6 million).

Consolidated earnings before interest, taxes, depreciation and amortization (EBITDA) stood at Euro -7.6 million (H1/2021 IFRS: Euro -9.7 million), while the operating result (EBIT) was around Euro -8.5 million as of June 30, 2022, compared with Euro -10.5 million in the prior-year period. The consolidated result for the period recorded a significant increase and amounted to Euro 80.0 million (H1/2021 IFRS: Euro -10.6 million).

Due to the sale of the minority stake (24.9%) in FYB 202 GmbH & Co. KG to Aristo Pharma GmbH as part of the transaction with ATHOS KG, the result for the period was dominated by an extraordinary effect, which had no impact on earnings or liquidity. In this context Formycon AG ceased to be a shareholder of FYB 202 GmbH & Co. KG. In parallel, the acquisition of 100% of the shares in FYB202 Project GmbH, in which the global assets and commercialization rights to FYB202 are located, was realized.

Extract of the Formycon Group balance sheet (IFRS)

The increases in non-current assets, shareholders equity and non-current liabilities mainly resulted from the transaction with ATHOS KG and the subsequent purchase price allocation. Deferred tax liabilities reflect the tax effect of the intangible assets acquired and recognized. Liabilities from the conditional purchase price payment represent the component of the purchase price that is contingent on project-specific and factual revenue recognition in the acquired projects (FYB201 and FYB202). This purchase price component can assume values between 0 and the amount stated here.

The Group's financial position continues to be solid: Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled around Euro 18.2 million on the day of reporting, compared to Euro 25.0 million as of December 31, 2021. In addition, as part of the ATHOS transaction, the company was provided with an on-demand line of credit amounting to Euro 50 million, of which Euro 40.0 million have not been utilized and could still be drawn down as of the reporting date.

Formycon AG, as the Group's parent company and central development and operating unit, will continue to report in accordance with the rules of the German Commercial Code (HGB). Formycon AG achieved a turnover (HGB) of Euro 12.5 million in the first half of 2022 (H1/2021 HGB: Euro 12.4 million). The result (HGB) for this period amounted to Euro 82.6 million (H1/2021 HGB: Euro -10.0 million) which is also caused by the extraordinary effect described above.

“We look back on a successful half-year which culminated in the transaction with ATHOS KG and the first approval of FYB201. The launch of FYB201, which has now taken place in the U.K. as well as in the US and is expected in the EU shortly, is another important milestone in our transformation into a company generating income from product commercialization,“ commented Dr. Stefan Glombitza, CEO of Formycon AG.

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

¹⁾ Stelara® is a registered trademark of Johnson & Johnson 
²⁾ Lucentis® is a registered trademark of Genentech 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 six 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. Currently, global sales of biosimilars are estimated at more than $15 billion. 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.