DGAP-News: Formycon publishes preliminary figures for the first half of 2022

Press Release // September 6, 2022

Formycon publishes preliminary figures for the first half of 2022

• Reporting at Group level for the first time under IFRS (International Financial Reporting Standards)
• Preliminary figures overall in line with forecast: Preliminary Group turnover of Euro 17.6 million (H1/2021 IFRS: Euro 20.3 million) and preliminary EBITDA of Euro -7.6 million (H1/2021 IFRS: Euro -9.7 million)
• Preliminary operating result (EBIT) of Euro -8.5 million reflects planned investments in fully-owned projects FYB202, FYB206 and FYB207 as well as pipeline expansion with biosimilar projects FYB208 and FYB209
• Preliminary half-year result prior to purchase price allocation from ATHOS transaction of Euro 80.0 million (H1/2021 IFRS: Euro -10.6 million) dominated by transaction-related and non-cash extraordinary effect
• Publication of the half-year report on October 28, 2022

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced its preliminary and unaudited financial figures for the first half of 2022. Reporting at Group level is performed for the first time in accordance with IFRS (International Financial Reporting Standards).

The preliminary figures do not yet include purchase price allocation effects from the ATHOS transaction 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. The publication of the final figures respectively the half-year report is scheduled for October 28, 2022.

On the day of reporting, June 30, 2022, the preliminary key 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). For the full year of 2022, Formycon continues to forecast revenues above last year's level for the entire Group (2021 IFRS: Euro 37 million).

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

The preliminary result for the period was dominated by an extraordinary effect, which had no impact on earnings or liquidity and resulted from the sale of the minority stake (24.9%) in FYB 202 GmbH & Co. KG to Aristo Pharma GmbH, following which 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.

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.

Currently, Formycon Group is focusing on research and development activities for its fully-owned and out-licensed biosimilar projects, as well as its fully-owned COVID-19 drug (FYB207). The current revenues also result from the development services for the out-licensed or partnered projects. Following the approval of these products, Formycon will also take a share of subsequent commercialization revenues. With the market launch of FYB201 in the United Kingdom (UK) and the briefly upcoming market launch in the United States of America and - following the recently announced approval by the European Commission in late August - in the EU through the respective commercialization partners, Formycon expects first revenues and earnings contributions from the commercialization revenues in the second half of 2022.

As in the previous year, the preliminary operating key figures (EBITDA and EBIT) continue to be mainly attributable to investments in the company's own pipeline. In the FYB202 project, the extended scope pharmacokinetics Phase I study is currently ongoing, following the completion of which the regulatory submission in Europe and the US is planned for the third quarter of 2023. In project FYB203, a biosimilar candidate for Eylea®³, which has been out-licensed to Klinge Biopharma GmbH (an ATHOS company), recruitment for the ongoing Phase III clinical trial was successfully completed in April 2022. Data on the primary efficacy endpoint are expected by the end of this year.

The FYB206 biosimilar project continues to progress according to plan. Scientific advice meetings with EMA and FDA and scale-up of the manufacturing process to commercial scale are planned for the second half of the year. In the innovative development project FYB207, a promising antiviral drug candidate against SARS-CoV-2 and its variants, preclinical studies are expected to be completed in 2022, the manufacturing process will be adapted to the optimized molecule, and the production of test material for stability studies and clinical trials will be carried out. Entry into clinical trials is planned for 2023. In addition, the development pipeline was expanded by the two new biosimilar projects FYB208 and FYB209.

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 approximately Euro 12.5 million in the first half of 2022 (H1/2021 HGB: Euro 12.4 million). The preliminary 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.

Dr. Stefan Glombitza, CEO of Formycon AG, comments on the preliminary half-year results as follows: "We are extremely satisfied with the performance in the first half of 2022. The successfully realized transaction with ATHOS KG and the first market approval of FYB201 were certainly outstanding events. We also made very pleasing progress in all other development projects and also initiated two new biosimilar projects with FYB208 and FYB209. The international launch of FYB201, which has already started in the UK and will soon continue in US and EU, marks another important milestone for our company. Based on the expected cash flows in combination with a broad and valuable pipeline as well as a strong development organization, we believe we are very well positioned for the continued consistent execution of our growth strategy."
 

¹⁾ Stelara® is a registered trademark of Johnson & Johnson
²⁾ Lucentis® is a registered trademark of Genentech Inc.
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 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. 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
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.