Formycon Reports its Nine-month Figures for 2022

EQS-News: Formycon AG / Key word(s): 9 Month figures/Forecast
Formycon Reports its Nine-month Figures for 2022
25.11.2022 / 07:30 CET/CEST
The issuer is solely responsible for the content of this announcement.

 Press Release // November 25, 2022

 Formycon Reports its Nine-month Figures for 2022

• Group turnover and other operating income totals Euro 28.2 million
• Group full-year sales forecast to be about Euro 40 million
• EBITDA of Euro -10.9 million and EBIT of Euro -12.1 million correspond to plans due to investments in the Group’s own projects
• Nine-month result of Euro 61.1 million continues to be affected by one-off and extraordinary effects on the financial result. These effects are transaction-related and do not have an effect on liquidity

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today announced its results for the first nine months of the 2022 fiscal year. On the Group level, reporting is performed in accordance with IFRS (International Financial Reporting Standards).

At the end of the third quarter, the Formycon Group’s financial figures were expected as forecast. The turnover of the Group, which, alongside Formycon AG, comprises the fully consolidated subsidiary companies Formycon Project 201 GmbH, FYB202 Project GmbH, Formycon Project 203 GmbH, Bioeq GmbH as well as a 50% stake in Bioeq AG, which is consolidated at equity, totaled Euro 28.2 million in the first nine months of the year 2022 (prior-year period IFRS: Euro 27.4 million). Formycon is forecasting revenues at Group level of around Euro 40 million for the whole year.

The Formycon Group focuses on research and development for its own, or out-licensed biosimilars projects as well as its own COVID-19 drug (FYB207). A large part of the revenue results from the development services for the out-licensed (FYB203) and partnered project (FYB201).

In July 2022 the commercialization of FYB201 in Great Britain started, through the distribution partner Teva Pharmaceutical Industries Ltd. (“Teva”) and in October, in the US, through Coherus BioSciences Inc. Additionally, in November, FYB201 was introduced onto the market in Germany by Teva. The nine-month figures included the first commercialization revenues from Great Britain since the introduction of FYB201 onto the market at the start of July. For the full year 2022, sales and earnings contributions from the marketing revenues in the additional territories are expected.

The Group’s earnings before interest, tax, depreciation and amortization (EBITDA) stood at Euro -10.9 million (prior-year period IFRS: Euro -10.0 million), the operating result (EBIT) was Euro -12.1 million as of September 30, 2022, compared with -10.9 million in the prior-year period. The Group net period result amounted to Euro 61.1 million (prior-year period IFRS: Euro -11.1 million).

The period result is further affected by a one-off effect that influenced the result but not the liquidity. This resulted from the sale of the minority stake (24.9%) in FYB 202 in the course of the transaction with ATHOS KG (“ATHOS”). In the course of this, Formycon AG withdrew as a partner of FYB 202 GmbH & Co. KG. In parallel with this, the acquisition of 100% of the shares of FYB202 Project GmbH, in which the global assets and commercialization rights to FYB202 are located, took place.

After the acquisition of FYB202, as part of the transaction with ATHOS, the 50% stake ATHOS held in FYB201, a biosimilar for Lucentis®¹, was also taken over, among others. For both financial assets (FYB201 and FYB202) there is a conditional liability (conditional purchase price components) towards ATHOS, the amount of which depends on the project-specific and actual realization of proceeds. The compounding of this liability, which must be adapted periodically, also influences the result but not liquidity and runs counter to the previously described effect.

The Formycon Group's stocks of liquid assets, which comprise cash, checks, bank deposits and securities, remained solid at Euro 12.1 million as of September 30, 2022. Including short-term receivables from deliveries and services, as well as other assets, the Formycon Group held liquid assets totaling Euro 22.6 million on the day of reporting (prior year: Euro 33.7 million).

In the first nine months of the year, Formycon AG, as the Group’s central development and operational unit, continues to report according to the regulations of the Handelsgesetzbuch (HGB - German Commercial Code) and achieved a turnover of Euro 21.8 million (prior-year period: Euro 20.4 million). The company's nine-month result was Euro 73.7 million compared to Euro -10.7 million last year.

“The nine-month result reflects our expectations. The global introduction onto the market of FYB201 under the trade name Ongavia®² (UK) or Ranivisio®³ (EU) and Cimerli^TM4 (US) by our partners and the revenues anticipated due to this are an important milestone in our transformation to a commercial-stage company. At the same time, we continue our growth strategy with planned investments into our pipeline, in order to create sustainable value," explains Dr. Stefan Glombitza, CEO of Formycon AG.

1. Lucentis® is a registered trademark of Genentech Inc.
2. Ongavia® is a registered trademark of Teva Pharmaceutical Industries Ltd.
3. Ranivisio® is a registered trademark of Bioeq AG
4. Cimerli^TM is a trademark of Coherus BioSciences, 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
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.

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