• Approval and commercial launch of FYB201 as well as ATHOS transaction mark transformative fiscal year
  • Group revenues increase to Euro 42.5 million (2021 IFRS: Euro 36.6 million) and include first earning contributions from commercialization of FYB201
  • EBITDA of Euro -15.9 million (2021 IFRS: Euro -12.6 million) and operating result (EBIT) of Euro -17.7 million (2021 IFRS: Euro -14.0 million) reflect investments in maturing product pipeline
  • Net result after purchase price allocation from ATHOS transaction of Euro 36.0 million (2021 IFRS: Euro -13.3 million) impacted by transaction-related and non-cash positive extraordinary effect

Munich/Martinsried – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today published its financial results and business development for the fiscal year 2022. The annual report at Group level is published for the first time in accordance with IFRS (International Financial Reporting Standards).

Strong corporate development due to progressing product pipeline, ATHOS transaction as well as market approvals and commercial launches of the first biosimilar FYB201

Formycon reflects on a transformative and successful financial year, which, in addition to significant progress in the development projects, was primarily driven by the transaction with ATHOS KG (“ATHOS“) in spring 2022 as well as by the approvals and market launches of the first biosimilar in the second half of the year.

The successful progress of the development projects forms the basis for Formycon’s long-term and sustainable growth. The late-stage biosimilar candidates FYB202 (ustekinumab) and FYB203 (aflibercept) have meanwhile successfully completed the clinical development phases and FYB206 (pembrolizumab) is in an advanced preclinical development stage. Formycon will continue to invest in the expansion of its biosimilar pipeline and has started the development of two new biosimilar candidates (FYB208 & FYB209) in the past fiscal year, substantially expanding the product portfolio. The final construct with a significantly longer half-life and improved efficacy was selected for the innovative COVID-19 drug FYB207 and GMP production has been started. Furthermore, a toxicity study has been initiated, which results are a prerequisite for entering the clinical development phase.

As part of the ATHOS transaction, 50% of the formerly out-licensed Lucentis®1 biosimilar FYB201 and 100% of the Stelara®2 biosimilar candidate FYB202, previously developed in a joint venture, were reacquired. The step-up in ownership of both projects has significantly increased the share in the initial and future commercialization revenues of the two products. The acquisition and integration of the long-standing partner Bioeq GmbH complemented and sustainably strengthened the development organization with extensive competencies.

Following approvals of FYB201 in the United Kingdom, the United States of America and Europe of FYB201 and market launches by the respective commercialization partners in the second half of 2022, Formycon expects significant revenue contributions from product commercialization starting in 2023.

Financial figures underline advancing development

On December 31, 2022, the Formycon Group’s financial figures had developed as follows: Group revenues, which in addition to Formycon AG also include the fully consolidated subsidiaries Formycon Project 201 GmbH, FYB202 Project GmbH, Formycon Project 203 GmbH, Bioeq GmbH and the 50% stake in Bioeq AG increased to a total of Euro 42.5 million (2021 IFRS: Euro 36.6 million) in the fiscal year 2022.

Consolidated earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to Euro -15.9 million (2021 IFRS: Euro -12.6 million), while the operating result (EBIT) was around Euro -17.7 million as of December 31, 2022, compared to Euro -14.0 million in the prior-year, primarily reflecting investments in the company’s own pipeline projects.

The net result for the period amounted to approximately Euro 36.0 million (2021 IFRS: Euro -13.3 million) and was mainly driven by a one-off effect affecting earnings but not liquidity in the amount of approximately Euro 89.7 million, which resulted from the ATHOS transaction. In addition, a non-cash financial expense of approximately Euro 22.8 million from the fair value valuation of the contingent purchase price payments associated with the transaction and the pro rata loss of Bioeq AG of Euro 12.8 million were included in the financial result.

The Group’s financial position remained stable as of the reporting date: Liquidity totaled around Euro 9.8 million on the reporting date, compared to Euro 25.0 million in the previous year. In addition, as part of the ATHOS transaction, the company was provided with an on-demand credit-line amounting to Euro 68.0 million, of which Euro 40.0 million had been drawn down as of the reporting date.

At the beginning of 2023 (after period end), 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.

The net proceeds from the capital increase will primarily be used to accelerate the ongoing development projects (FYB202, FYB206, FYB208, FYB209) towards regulatory approval, as well as to expand the biosimilar pipeline and support the organic growth strategy. In addition, Formycon is considering integrating further assets along the value chain into the Company in order to accelerate its development into a highly specialized and globally active company in the biosimilars market segment. The capital measure also serves to strengthen the balance sheet, including the repayment of the drawn amount under the loan facility granted by ATHOS and Active Ownership as part of the ATHOS transaction.

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 / German GAAP). Formycon AG achieved revenues (HGB) of Euro 28.3 million in the financial year 2022 (2021 HGB: Euro 26.5 million). The result (HGB) for this period amounted to Euro 65.8 million (2021 HGB: Euro -13.3 million) which is also caused by the extraordinary effect described above.

“We look back to a successful financial year with many positive events. The approvals and launches of our first biosimilar FYB201 as well as the ATHOS transaction have provided important growth impulses for our company. It is a great source of pride for us and the entire team that we were able to make an initial contribution to providing patients worldwide with expanded access to modern therapeutic options in ophthalmology. We will continue to invest in our development pipeline and focus on the successful advancement of our biosimilar candidates to sustainably increase the value creation of our company,” said Dr. Stefan Glombitza, CEO of Formycon AG.

 Formycon Group outlook for 2023

In 2023, Formycon Group expects a significant increase of revenues compared to fiscal 2022, resulting from revenue and earnings contributions from the commercialization of the Lucentis® biosimilar (FYB201) Ranivisio®3/ Ongavia®4 /CIMERLI™5 as well as anticipated milestone payments for the FYB202 project.

Due to the Group still continuing in a growth phase committing to intensive investment and product development, EBITDA is expected to remain at roughly prior-year level. No significant change is likewise expected to consolidated net result excluding the non-recurring gain from Formycon’s former investment participation in the FYB 202 GmbH & Co. KG partnership.

From a development perspective, regulatory submissions for Stelara® biosimilar candidate FYB202 and Eylea®6 biosimilar candidate FYB203 to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are expected in 2023.

The full Annual Report can be found at Financial Reports – Formycon AG

1) Stelara® is a registered Trademark of Johnson & Johnson 

2) Lucentis® is a registered Trademark of Genentech Inc.

3) Ranivisio® is a registered Trademark of Bioeq AG

4) Ongavia® is a registered Trademark of Teva Pharmaceutical Industries Ltd.

5) CIMERLITM is a Trademark of Coherus BioSciences, Inc.

6) Eylea ® is a registered Trademark of Regeneron Pharmaceuticals Inc.