EQS-News: Formycon AG
/ Key word(s): Half Year Results/Half Year Report
Formycon reports successful first half of 2023
30.08.2023 / 07:30 CET/CEST
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Press Release // August 30, 2023
Formycon reports successful first half of 2023
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today published the financial results and the corporate development of Formycon Group for the first half of 2023.
Strong development of Biosimilar pipeline and good market establishment of FYB201 drive corporate success in the first half of 2023
The successful progress in the development of the biosimilar candidates forms the basis for Formycons long-term and sustainable growth. The late-stage biosimilar projects FYB202 (ustekinumab) and FYB203 (aflibercept) have successfully concluded the clinical development phase in the first half of the year.
The submission of the Biologics License Application for FYB203 (Eylea®1 biosimilar candidate) to the U.S. Food and Drug Administration (“FDA”) and the subsequent acceptance of the application (“File Acceptance”) has already been reported. FYB203 submission to the European Medicines Agency (“EMA”) is also planned in the course of this year. The same applies for FYB202 (Stelara®2 biosimilar candidate), which is scheduled to be submitted to both authorities during 2023. Together with its global commercialization partner Fresenius Kabi, Formycon also secured a settlement agreement (after the end of the reporting period) with Johnson & Johnson for the launch of FYB202 following approval in the U.S. no later than April 15, 2025.
Keytruda®3 biosimilar candidate FYB206 is in an advanced preclinical development stage and is expected to enter clinical development during 2024. In addition, Formycon is continuously investing in the further expansion of the biosimilar pipeline and significantly enriched its product portfolio last year with the development start of two new biosimilar candidates (FYB208 & FYB209).
“We look back on a successful first half-year with many positive events. The conclusion of the global commercialization partnership with Fresenius Kabi, the successfully completed clinical trials of our biosimilar candidates FYB202 and FYB203 as well as their submissions to the respective regulatory authorities, some of which have already been completed and some of which are still planned for this year, are important milestones in the Company’s development,“ comments Dr. Stefan Glombitza, CEO of Formycon AG.
With FYB201, a Lucentis®4 biosimilar was successfully launched on the market, reaching a market share of roughly 17%[i] in the U.S. by the end of the first half of 2023, with a further upward trend. The development of the market share achieved by Formycon’ s commercialization partner Teva in the UK as part of a national tender is also extremely satisfying. Due to the highly fragmented EU market, country-level product launches of FYB201 will take place sequentially through the end of 2023, with further launches in countries such as Brazil, Canada and Saudi Arabia planned in 2024.
With launches in additional territories by the end of 2023 as well as in 2024, Formycon expects further increasing revenue and net-earnings contributions from product commercialization by the respective commercialization partners.
COVID-19: Changed situation of FYB207 project – Focus on biosimilar pipeline
The lifting of the global health emergency by World Health Organization (“WHO”) has changed the framework for the innovative COVID-19 drug FYB207. Based on economic as well as strategic factors, the project was re-evaluated with the result that the development of the innovative FYB207 drug will initially be pursued only in focused areas and in a very resource-sparing way. Formycon remains confident in this platform and remains committed to moving FYB207 into a strategic development partnership. Scientific advice meetings and patent applications will be continued and further funding opportunities will be evaluated to ensure a quick move into the clinical phase if needed.
Key financial figures underline progressive development
The Group’s key financial figures developed very positive as of June 30, 2023: Group revenues increased to a total of € 43.8 million in the first half of 2023, more than doubling (+148%) compared to the same period last year (H1/2022: € 17.6 million).
A significant part of the revenue resulted from the success payments under the commercialization partnership with Fresenius Kabi from the FYB202 project. As a result of the permanent reimbursement code (Q-code) issued in the U.S. since April 01 and the associated simplification of the reimbursement process, the U.S. distribution partner Coherus BioSciences, Inc. was able to more than quadruple net sales of CIMERLI™5 in the second quarter to US$ 26.7 million[ii] compared to the first quarter (Q1/2023: US$ 6.2 million)[iii]. As a result, direct licensing revenues for Formycon also increased to a total of € 1.2 million in the first half of the year (Q1/2023: € 0.3 million).
EBITDA and EBIT clearly positive in H1 due to milestone payments
Consolidated earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to € 7.3 million (H1/2022: € -7.6 million), while operating profit (EBIT) were around € 6.4 million as of June 30, 2023, compared with € -8.5 million in the same period of the previous year, and were mainly driven by the significant increase in revenues.
Net result continues to show effects from at-equity consolidation and from contingent liability to ATHOS KG
The Group’s net result 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 € -6.2 million, as well as the fair value valuation of the contingent purchase price component to ATHOS KG for the acquired assets (FYB201 and FYB202) in the amount of € 8.5 million, the consolidated net result for the first half of the year 2023 stood at € 1.8 million (H1/2022: € 80.0 million). In addition, a deferred tax expense of around € 7.3 million was recognized in the reporting period (H1/2022: € 0 million).
The Group’s financial position at the reporting date of June 30, 2023 remained solid: Cash and cash equivalents totaled around € 36.9 million compared to € 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 € 70.1 million (gross proceeds). After an initial repayment of the shareholder loans in the amount of € 20.0 million, € 20.0 million remain drawn as of June 30, 2023.
„We can be very satisfied with the key figures and the business performance in the first half of the year. We are striving to build Formycon into a globally operating company with a focus on biosimilars, while maintaining our high-quality performance. In order to achieve this, we will continue to invest significantly in expanding our pipeline and capacity. We were able to further concretize and slightly increase our guidance for the full year 2023, so that we can expect the highest revenue in the company’s history so far,” comments Enno Spillner, CFO of Formycon AG.
Formycon Group Forecast for 2023 concretized
For 2023, the Formycon Group expects revenues between € 75.0 million and € 85.0 million, which will predominantly result from marketing revenues of the Lucentis® biosimilar (FYB201) Ranivisio®6/ Ongavia®7 /CIMERLI™ and success payments for the FYB202 project as well as development services for the out-licensed (FYB203) and the partnered project (FYB201).
As the Company remains in investment and development mode, EBITDA is forecast to be between
The full Half-Year-Report can be found at Financial Reports – Formycon AG
Formycon‘s Executive Board will introduce the company’s development and key financial figures for the first half year 2023 in a conference call.
The conference call, streamed live on the internet, will be held in English on August 30, 2023 at 3:00 p.m. (CEST).
To join via phone, please register at:
You will then receive a confirmation email with the telephone number, access code and PIN to access the call.
The presentation and audio can be accessed via the following link:
Following a short presentation, the Executive Board will be available for direct questions. A recording of the conference call can subsequently be accessed via the Formycon website at:
1) Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
2) Stelara® is a registered trademark of Johnson & Johnson
3) Keytruda® is a registered trademark of Merck Sharp & Dohme LLC
4) Lucentis® is a registered trademark of Genentech Inc.
5) CIMERLITM is a trademark of Coherus BioSciences, Inc.
6) Ranivisio® is a registered trademark of Bioeq AG
7) Ongavia® is a registered trademark of Teva Pharmaceutical Industries Ltd.
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