Formycon reports successful financial year 2025 with important operational progress, growing market presence and strategic partnerships

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard) today published its audited consolidated financial statements for the 2025 financial year and provided a forecast for the 2026 financial year.

Dr. Stefan Glombitza, CEO of Formycon AG, said: “The financial year 2025 was a year of strong operational execution and disciplined financial management for Formycon. In a dynamically growing and challenging market environment, we clearly exceeded our guidance for EBITDA, adjusted EBITDA and working capital, underscoring the robustness and quality of our business model, even though certain revenue components were deferred into the new financial year. In line with our tailored FYB4Growth strategy, we are consistently advancing sustainable value creation across our pipeline, supported by strategic partnerships, a diversified portfolio and efficient development approaches. Against this backdrop, our 2026 guidance reflects both the value potential of our pipeline and Formycon’s solid foundation for sustainable, profitable growth.”

Enno Spillner, CFO of Formycon AG, added: “From a financial perspective, 2025 was a year of important strategic decisions. Improved regulatory frameworks, our proven experience from three approved biosimilar developments and the increased use of digital technologies enable streamlined and more cost‑efficient development processes. With the successful placement of a corporate bond, effective resource allocation and a solid financing structure, we have further strengthened the Group’s financial position. Looking ahead, we expect to benefit from the relaunch and an additional partner for FYB201 in the U.S., continued revenue growth from FYB202, further market entries and a growing number of commercialized products. The ongoing commercialization of our biosimilars and the expansion of international partnerships are intended to support our objective of achieving positive EBITDA from 2026 onwards and sustaining this development over time.”

Solid Business Performance and Market Development in the Financial Year 2025
Formycon achieved significant operational milestones across its biosimilar pipeline, further demonstrating its development expertise and partnering capabilities. FYB201 strengthened its international market position through additional country launches, the introduction of an innovative ophthalmic pre‑filled syringe, and an additional regulatory approval in the U.S. FYB202 was launched in the U.S., Europe and Canada; however, market penetration to date has progressed only gradually and, despite continued growth, remained below expectations. For FYB203, key patent-related hurdles were resolved, enabling market entry in Europe and the U.S. in 2026. With FYB206, Formycon achieved decisive clinical progress and further strengthened its development position, supported by an optimized study design and disciplined execution. This led to the successful conclusion of initial licensing partnerships, including corresponding upfront and milestone payments, and positive study results reported in February 2026. In addition, the pipeline continued to mature with the achievement of Technical Proof of Similarity (TPoS) for FYB208, while the successful placement of a corporate bond strengthened the Company’s financial foundation for the next phase of growth.

Group revenue for the financial year 2025 amounted to €44.5 million (previous year: €69.7 million). The year‑on‑year decline was primarily attributable to the expected reduction in payments for development compensations related to FYB201 and FYB203 due to their advanced project status. In addition, the Group recorded lower revenue contributions from licensing income, partly reflecting the temporary pause of U.S. commercialization of FYB201/Cimerli^®1. In contrast, milestone revenues developed positively, driven in particular by the conclusion of regional commercialization partnerships for FYB206 and FYB202.

The lower revenue level compared to the forecast range of €55.0 million to €65.0 million was primarily the result of prolonged negotiations related to the conclusion of additional partnerships, including for FYB206, which required additional time due to the optimization of economic terms. Furthermore, milestone payments originally expected in the fourth quarter of 2025 were deferred into the first quarter of 2026. In addition, despite a strong fourth quarter, revenues from the commercialization of FYB202 developed less dynamically than anticipated overall and also contributed to the deviation.

Group EBITDA for the financial year 2025 amounted to €‑3.6 million (previous year: €‑13.7 million) and thus significantly exceeded the expected range of €‑20.0 million to €‑10.0 million. This improvement was primarily driven by strict cost management, higher‑than‑anticipated capitalized development investments, and a timing shift in development costs.

Group Adjusted EBITDA amounted to €‑2.3 million (previous year: €‑1.6 million) and was therefore significantly above the forecast range (€‑20.0 million to €‑10.0 million). In addition to the EBITDA effects described above, this was mainly attributable to the upfront payment received in connection with the partnership for FYB201/Nufymco^®2. The earnings contribution from FYB201 via the joint venture Bioeq AG (equity income from the at-equity valuation) amounted to €1.2 million (previous year: €12.1 million) and was below the prior‑year level, primarily due to the significant decline in revenues following the temporary pause of U.S. commercialization of FYB201/Cimerli^®. The product was reintroduced to the U.S. market in January 2026.

Due to market and price developments, particularly in the U.S., the planning assumptions for the FYB201 and FYB202 projects were reviewed and adjusted accordingly during the fiscal year, as in the previous year. As part of the impairment test performed for FYB202, the fair value of intangible assets was reduced by around €60 million. This resulted in a decrease in the related deferred tax liabilities of approximately €14 million and a reduction in the fair value of the earn‑out of approximately €5 million, leading to a net impact of around €41 million on net income. In addition, the fair value of the investment in Bioeq AG was reduced by approximately €18 million. Positive effects resulted from the fair value of the earn-out related to ATHOS, which reduced contingent purchase price liabilities by approximately €12 million, leading to net earnings effect of around €-6 million.

Working capital developed positively and increased to €70.1 million (previous year: €55.1 million), thereby exceeding the forecast range of €55 million to €65 million. This development was primarily driven by the successful placement of a €70 million corporate bond in July 2025, as well as significant upfront payments received in 2025 in connection with initial licensing partnerships for the Keytruda^®3 biosimilar candidate FYB206. In addition, consistent cost management and efficiency improvements contributed to the increase in working capital. As of December 31, 2025, the Formycon Group reported cash and cash equivalents of €68.8 million (previous year: €41.8 million), providing a solid financial basis for future business development and the further advancement of the existing biosimilar product portfolio in line with the Group’s growth strategy.

Due to technical adjustments as well as extended review and reconciliation processes, the publication of the audited consolidated financial statements for fiscal year 2025 took place later than originally planned.

Outlook for the Financial Year 2026 – FYB4Growth
The development of biosimilars remains Formycon’s core strategic focus and the foundation for long‑term, sustainable growth. According to IQVIA, the global biosimilars market is expected to grow to approximately USD 74 billion by 2030.⁴ At the same time, market conditions – particularly in the U.S. – remain challenging for Formycon’s outlook, driven by slower-than-expected access to certain market segments and higher price discounts than originally anticipated. Recent project developments reflect this volatility, while at the same time highlighting the opportunities arising from a dynamic and evolving market environment.

With “FYB4Growth”, Formycon is pursuing a clearly defined growth strategy based on four strategic pillars aimed to create sustainable value. First, geographic diversification: in addition to Europe and the U.S., Formycon is strategically expanding into high‑growth regions such as MENA, APAC and Latin America through strong regional partners. Second, a smart portfolio strategy: Formycon relies on an intelligent portfolio strategy that specifically combines blockbuster molecules with selected niche products and creates the foundation for sustainable value generation through efficient regulatory development pathways. Third, excellence and innovation: Formycon positions itself as a technological and regulatory development powerhouse, creating clear competitive differentiation through innovative product solutions and new regulatory approaches. Fourth, consistent cost efficiency: streamlined processes, optimized development structures and the increased use of digital technologies are designed to enhance the scalability of the business model and strengthen Formycon’s competitiveness over the long term.

Formycon expects to achieve further key operational milestones in the financial year 2026, which will lay the foundation for its continued transformation from a successful development company into a sustainable, commercially focused, and profitable biosimilar company.

For the financial year 2026, the Formycon Group expects revenue to increase to a range of €60.0 million and €70.0 million.

Following the reintroduction of FYB201/Cimerli^® in the U.S. in early 2026, as well as the planned commercialization by an additional U.S. partner under the secondary brand Nufymco^® starting in the second half of the year, Formycon expects increasing sales contributions for FYB201 in 2026.

According to the commercialization partners, the market rollout of FYB202 is expected to continue to develop positively, even though the US pharmacy benefit manager (PBM) market is opening only gradually. At the same time, political signals in the U.S. indicate potential structural changes that could create a more favorable environment for biosimilars in the long term. Formycon therefore expects a significantly greater revenue contribution from FYB202, generated across various regions worldwide, and anticipated to assume a leading role within the overall Group’s revenue structure.

For the Eylea^®5 biosimilar FYB203, licensing agreements have been concluded enabling market entry in Europe from May 2026 and in the U.S. in the fourth quarter of 2026. In this context, Formycon expects initial moderate licensing revenues.

With respect to the Keytruda^® biosimilar FYB206, an important operational milestone was already achieved in the first quarter of 2026 with the successful completion of the pharmacokinetic (PK) study. On this basis, preparations for the regulatory submissions are being further advanced, particularly in the U.S. and the EU. Together with initial licensing partnerships, this creates potential for revenues from clearly defined development milestones, while further regional partnerships are being pursued to enable additional upfront and milestone payments. Overall, FYB206 is thus expected to contribute meaningfully to revenues in 2026, primarily through milestone-based income, despite not yet being approved.

The biosimilar candidates FYB208 through FYB210 are at different stages of development. FYB208 has advanced into clinical development, following the achievement of Technical Proof of Similarity (TPoS), with preparations underway for clinical studies and commercial‑scale manufacturing.

The foundation of value creation is Formycon’s diversified product pipeline. Accordingly, the Company will continue to invest significantly in its development portfolio and also aims to initiate the development of additional biosimilar candidates over the course of 2026.

For the financial year 2026, Formycon expects EBITDA in a range between €0 million and €10 million, reflecting both increasing revenues and continued investments in the biosimilar pipeline. EBITDA is expected to improve further on a sustainable basis in subsequent years.

Revenues generated from the commercialization of FYB201 are primarily reported within the at equity result of the joint venture Bioeq AG, which is not consolidated in Formycon’s operating result. To better reflect the Group’s operating performance, EBITDA is therefore adjusted accordingly. For 2026, Formycon expects adjusted EBITDA in a range between €5.0 million and €15.0 million.

For financial year 2026, working capital is expected to amount to between €20.0 million and €30.0 million, mainly driven by ongoing investments in the FYB206 and FYB208 projects.

The full 2025 Annual Report is available on the Formycon website at https://www.formycon.com/en/investor-relations/publications/

Conference Call and Webcast

The Management Board of Formycon AG will discuss the company’s performance and key financial figures during a conference call. The earnings call, which will be broadcast live online, will take place on April 22, 2026, at 3:00 p.m. (CEST) in English.

To participate in the conference call, please register at:
https://webcast.meetyoo.de/reg/lNibT8TVWubG

After registration, participants will receive a confirmation email with individual dial-in data.

The presentation and audio broadcast can be accessed via the following webcast link:
https://www.webcast-eqs.com/formycon-2025-fy

After a brief presentation, the Management Board will be available for analysts’ questions. The conference call will be recorded and can subsequently be accessed via the Formycon website at: https://www.formycon.com/en/investor-relations/publications/

About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab and FYB202/ustekinumab, Formycon already has two biosimilars on the market. Another biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA. Four pipeline candidates – including FYB208/dupilumab – are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.

Formycon AG is headquartered in Munich and listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.com/

About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.

Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s 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.