Formycon reports results for the first quarter 2023

Press Release // May 30, 2023

Formycon reports results for the first quarter 2023

• Group revenues amount to Euro 21.5 million (Q1/2022: Euro 8.1 million) and include, in addition to a significant milestone payment for the successful global partnering of FYB202, revenue contributions from the commercialization of FYB201
• Group EBITDA of Euro 4.5 million and Group EBIT of Euro 4.1 million (Q1/2022: Euro -4.0 million and Euro -4.4 million respectively) due to milestone payment clearly positive
• Group net result of Euro -13.5 million affected by non-cash effects from the financial result
• Overall guidance for fiscal year 2023 confirmed

Munich/Martinsried – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today published the unaudited results for the first quarter of the fiscal year 2023. Reporting on Group level is published in accordance with IFRS (International Financial Reporting Standards).

Significant milestone payment from FYB202 project and revenue contributions from FYB201 commercialization reflected in revenues

Formycon Group’s revenues increased to a total of Euro 21.5. million in the first quarter of 2023 (Q1/2022: Euro 8.1 million).

A significant part of revenues resulted from a first milestone payment as part of the commercialization partnership from project FYB202 signed in Q1/2023. A further milestone payment is expected in the course of 2023. The revenue and net-earnings contributions from the commercialization of FYB201, which are partly reflected in the revenues and partly in the at-equity result [1], are around the same level as in the previous quarter (Q4/2022). With the recent granting of the permanent reimbursement code (Q-code) in the United States and the associated simplification of the reimbursement process for treating physicians and their staff, a significant increase in sales of CIMERLI™^* in the United States can be expected from the second quarter of 2023 onwards.

For 2023, Formycon continues to forecast a significant increase in revenues at Group level compared to the previous fiscal year (2022: Euro 42.5 million), resulting from revenue contributions related to Lucentis®^** Biosimilars (FYB201) Ranivisio®^***/ Ongavia®^**** /CIMERLI™, anticipated milestone payments for project FYB202 and development services for the out-licensed (FYB203) and partnered project (FYB201).

EBITDA and EBIT in Q1 clearly positive due to milestone payment

As a result of the significant milestone payment on the revenue side, both EBITDA at Euro 4.5 million (Q1/2022: Euro -4.0 million) and EBIT at Euro 4.1 million (Q1/2022: Euro -4.4 million) are clearly positive compared to the prior-year quarters. However, as Formycon continues to remain in investment and development mode, EBITDA for the year is forecasted to be approximately at the level of the previous year (2022: Euro -15.9 million).

Net result for Q1 affected by at-equity consolidation and contingent liability to ATHOS KG

The Group's net result for the period remains impacted by the following effects, which are recognized in earnings but not in cash: Due to the at-equity consolidation of the 50% share in Bioeq AG and the resulting pro-rata loss of Euro -6.5 million, as well as the fair value valuation of the contingent liability (contingent purchase price component) to ATHOS KG for the acquired assets (FYB201 and FYB202) in the amount of Euro -8.0 million, the consolidated net result for the first quarter of 2023 stood at Euro -13.5 million (Q1/2022: Euro -4.5 million). For 2023, Formycon group continues to expect a net result approximately in the amount of the previous year's net result excluding the non-recurring gain from Formycons former investment participation in the FYB 202 GmbH & Co. KG partnership (2022: Euro -54.0 million).  

The Group's financial position at the reporting date of March 31, 2023 was strengthened as follows: Cash and cash equivalents totaled around Euro 54.8 million compared to Euro 9.8 million at December 31, 2022. At the beginning of 2023 Formycon was able to place a capital increase against contributions in cash in the amount of approximately Euro 70.1 million (gross proceeds), making partial use of the authorized capital and excluding shareholders’ subscription rights. In addition, as part of the ATHOS transaction, the company was provided with an on-demand credit-line amounting up to Euro 68.0 million, of which Euro 20.0 million remained drawn as of March 31, 2023 after an initial repayment of Euro 20.0 million.

„In terms of key figures, the first quarter of 2023 was characterized by various positive special effects. In addition to the milestone payment as part of the global commercialization partnership for our FYB202 Stelara®***** biosimilar candidate, we also expect revenue and net-earnings contributions from the commercialization of FYB201 to increase significantly in the upcoming months, due to the recently issued reimbursement code in the United States. In addition, we will continue to invest significantly in the expansion of our pipeline to generate sustainable value. We continue to confirm our guidance for 2023", commented Enno Spillner, CFO of Formycon AG.

*  Cimerli^TM is a Trademark of Coherus BioSciences, Inc.
**  Lucentis® is a registered Trademark of Genentech Inc.
***  Ranivisio® is a registered Trademark of Bioeq AG
****  Ongavia® is a registered Trademark of Teva Pharmaceutical Industries Ltd.
***** Stelara® is a registered Trademark of Johnson & Johnson

About Formycon:
Formycon (ISIN: DE000A1EWVY8 / WKN: A1EWVY) is a leading 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.

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. Currently, global sales of biosimilars are estimated at more than $15 billion. By 2030, analysts estimate that this figure could rise to over $74 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.

^[1] Due to the at-equity valuation of the 50% share in Bioeq AG, Formycon realizes a negative investment result in the amount of 50% of Bioeq AG's net income for the period in addition to the direct license income from product sales.