Formycon reports successful financial year 2025 with important operational progress, growing market presence and strategic partnerships
- Operational milestones achieved across development pipeline and further progress in expanding global market access
- “FYB4Growth” strategy combines four strategic pillars into a scalable, sustainable and value‑creating business model
- Group revenue of €44.5 million below forecast (€55.0 million € to €65.0 million)
- Group EBITDA of €‑3.6 million and adjusted EBITDA of €‑2.3 million, both significantly exceeding expectations (€‑10.0 million to €‑20.0 million)
- Financial position significantly strengthened by the successful placement of a €70.0 million corporate bond
- Outlook for 2026: revenue growth and positive EBITDA expected
- Invitation to today’s conference call at 3:00 p.m. (CEST)
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.
| 2025 | 2024 | |
|---|---|---|
| Group revenues | € 44.5 million | € 69.7 million |
| Group EBITDA | € -3.6 million | € -13.7 million |
| Group Adjusted EBITDA | € -2.3 million | € -1.6 million |
| Group Working Capital | € 70.1 million | € 55.1 million |
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.
| Outlook for Fiscal Year 2026 – Financial Forecast | |
|---|---|
| Group revenues | € 60.0 million – € 70.0 million |
| Group EBITDA | € 0.0 million – € 10.0 million |
| Group Adjusted EBITDA | € 5.0 million – € 15.0 million |
| Group Working Capital | € 20.0 million – € 30.0 million |
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/
1) CIMERLI® is a registered trademark of Coherus BioSciences, Inc.
2) Nufymco® is a registered trademark of Formycon AG
3) Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA
4) https://www.iqvia.com/-/media/iqvia/pdfs/germany/publications/fokus-biosmilars/newsletter-fokus-biosimilars-ausgabe-10.pdf
5) Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
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.
Formycon invites to Conference Call on the Results of the Financial Year 2025 and announces Participation in international Investor Conferences in the 2nd Quarter of 2026
Planegg-Martinsried, Germany – Formycon AG (FSB: FYB, Prime Standard, „Formycon“) plans to publish its results of the financial year 2025 on April 22, 2026. The Management Board will discuss the company’s development, key financial figures, and provide an outlook for the 2026 fiscal year. The conference call, which will be broadcast live on the internet, will take place on Wednesday, April 22, 2026, at 3:00 PM (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/
Formycon in Dialogue
Representatives of the Management Board will attend the following events and investor conferences
in the second quarter of 2026:
May 11–12, 2026
Equity Forum Spring Conference
Enno Spillner (CFO)
Frankfurt, Germany
May 28, 2026
Publication of the Results for the first Quarter of 2026
Dr. Stefan Glombitza (CEO), Enno Spillner (CFO),
Nicola Mikulcik (CBO), Dr. Andreas Seidl (CSO)
Conference Call and Webcast
June 2–4, 2026
Jefferies Global Healthcare Conference
Enno Spillner (CFO)
New York City, U.S.
June 8, 2026
mwb research Roundtable
Dr. Stefan Glombitza (CEO), Enno Spillner (CFO)
Nicola Mikulcik (CBO), Dr. Andreas Seidl (CSO)
Webcast
June 10, 2026
Annual General Meeting
Dr. Stefan Glombitza (CEO), Enno Spillner (CFO),
Nicola Mikulcik (CBO), Dr. Andreas Seidl (CSO)
Haus der Bayerischen Wirtschaft, Munich, Germany
June 18, 2026
UBS Life Sciences Conference
Enno Spillner (CFO)
London, UK
Please find our current events at:
https://www.formycon.com/en/investors/financial-calendar/
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.
Formycon AG announces improved preliminary figures for the 2025 fiscal year and sets date for the publication of the annual financial statements
Disclosure of inside information according to Article 17 of the Regulation (EU) No 596/2014
- Group EBITDA of approx. € -4 million (vs. € -12 million) and adjusted EBITDA of approx. € -2 million (vs. € -7 million), better than previously communicated
- Group revenue unchanged at approx. € 45 million
- Group working capital of approx. € 70 million (vs. € 73 million) slightly below preliminary estimates but above the forecast
Planegg-Martinsried, Germany, April 15, 2026 – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) (“Company” or “Formycon“) announces that, as part of the final preparation of the annual financial statements for the 2025 fiscal year, changes have occurred in the key performance indicators Group EBITDA and Group adjusted EBITDA, as well as in working capital, compared to the preliminary figures published on March 4, 2026.
Based on the information currently available, the Company expects significantly better Group’s earnings before interest, taxes, depreciation and amortization (Group EBITDA) as well as clearly higher adjusted consolidated earnings before depreciation and amortization (Group adjusted EBITDA) than previously communicated. The improvements in Group EBITDA from the originally reported € -12 million to approximately € -4 million and in Group adjusted EBITDA from the originally reported € -7 million to approximately € -2 million result primarily from an adjustment to the accounting approach of development investments.
These adjustments also have an impact on the working capital, which now amounts to approximately € 70 million, slightly below the previous preliminary estimate (approximately € 73 million) but significantly above the forecast (€ 55 million to € 65 million).
Preliminary Group revenues remain unchanged at approx. € 45 million. Likewise, there have been no changes to the previously communicated impairment test for FYB202.
The final financial figures and further information on the 2025 financial year as well as the outlook for 2026 will be published on April 22, 2026 with the annual report for the 2025 financial year on the website under Publications – Formycon AG
Formycon secures license date for aflibercept 2 mg biosimilar FYB203 in Europe and further territories following settlement with Regeneron and Bayer
- Settlement and licensing agreement for FYB203 (AHZANTIVE® and Baiama®) concluded with Regeneron and Bayer; all pending patent litigations fully resolved
- Agreement covers Europe as well as key markets in Latin America and the Asia-Pacific region
- Market launches by commercialization partners across Europe to start in May 2026
Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) and its license partner Klinge Biopharma GmbH (“Klinge”) announce a settlement and license agreement (“Agreement”) with Regeneron Pharmaceuticals, Inc. (“Regeneron”) and Bayer Healthcare LLC (“Bayer”), resolving all patent disputes related to the EU-approved Eylea®1 2 mg biosimilars AHZANTIVE®2 and Baiama®3. Under the terms of the agreement, both products may be launched in Europe and further territories including key markets in Latin America and Asia-Pacific from May 2026. In October 2025, Formycon had already secured the U.S. license date for FYB203 in Q4 2026 as part of an agreement with Regeneron.
“The agreement for Europe and further territories is a significant milestone, as it secures timely market access for our commercialization partners. With our differentiated and regionally focused partnering strategy, we are sure that we have set the course for sustainable success of FYB203 across the European markets and beyond. For ophthalmologists and patients with severe retinal diseases, our biosimilars represent a highly effective and cost-efficient treatment option,” says Nicola Mikulcik, Chief Business Officer of Formycon AG.
AHZANTIVE® and Baiama® are approved by the European Medicines Agency (“EMA”) for the treatment of neovascular age-related macular degeneration (“nAMD”) and other serious retinal diseases. The active ingredient aflibercept inhibits vascular endothelial growth factor (“VEGF”), which is responsible for the excessive formation of blood vessels in the retina, causing severe visual impairment.
1 Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
2 AHZANTIVE® is a registered trademark of Klinge Biopharma GmbH
3 Baiama® is a registered trademark of Klinge Biopharma GmbH
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.
Formycon AG postpones the publication of its audited annual and consolidated financial statements for 2025
Disclosure of inside information according to Article 17 of the Regulation (EU) No 596/2014
Planegg-Martinsried, Germany, March 18, 2026 – Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) (the “Company”) announces that the publication of the audited 2025 annual and consolidated financial statements, originally scheduled for March 26, 2026, will be postponed.
A key reason is the change to a new internal financial planning system, which was rolled out companywide during the reporting period. Furthermore, in the course of closing process, additional reconciliation and validation work have arisen, requiring more time and documentation than originally anticipated. Against this background, not all documents have been finalized yet, and the required audit measures could not yet be completed.
The publication of the audited annual and consolidated financial statements for the 2025 fiscal year is scheduled for April 2026 and will therefore continue to comply with statutory and stock exchange deadlines. The company will announce the exact date in due course.
Formycon AG publishes preliminary figures for the 2025 fiscal year
Disclosure of inside information according to Article 17 of the Regulation (EU) No 596/2014
- Strong increase in Group revenues in the fourth quarter, but full-year revenues still expected to remain below guidance
- Group EBITDA expected to be at the upper end of the expected range
- Adjusted EBITDA as well as working capital expected to be improved versus guidance
Planegg-Martinsried, Germany, March 4, 2026 – Based on preliminary and unaudited figures, Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) (“Company” or “Formycon“) expects Group revenues for the 2025 fiscal year to amount to approximately € 45 million. Despite a strong increase in the fourth quarter, total revenues are below the previously communicated forecast range of € 55 million to € 65 million. This is partly due to longer negotiations to conclude further commercialization and development partnerships, for example for the Keytruda®1 biosimilar candidate FYB206, in order to optimize their financial terms. In addition, recognition of milestone events anticipated for Q4 shifted to the first quarter of 2026. Furthermore, while revenue contributions from FYB202 increased significantly in Q4, the product is still in the early phase of commercialization and did not ramp up as quickly as expected.
In this context, based on the results of the impairment test available to date, the company expects that the valuation model and balance sheet measurement for FYB202 will need to be reviewed and adjusted to reflect this slower ramp up. According to Formycon’s commercialization partners, market uptake of FYB202 is developing positively. However, despite encouraging political signals, the pharmacy benefit market (PBM) in the U.S. is still opening only gradually. Based on preliminary calculations, the company expects an extraordinary, non-cash and non-EBITDA-relevant impairment requirement in the low to mid double-digit million range.
The Group’s earnings before interest, taxes, depreciation and amortization (Group EBITDA) for the 2025 fiscal year is expected to amount to approximately € -12 million, at the upper end of the forecast range of € -20 million to € -10 million. Adjusted consolidated earnings before depreciation and amortization (Group adjusted EBITDA), which also shows the total income of the FYB201 ranibizumab biosimilar, is expected to be approximately € -7 million, which is above the most recently communicated forecast range of € -20 million to € -10 million. The significantly better-than-expected at-equity result (approx. € 5 million) from the 50% stake in Bioeq AG mainly benefited from the upfront payment from the partnership of FYB201/Nufymco®2.
The Company expects a further improvement in working capital to approximately € 73 million, which is significantly above guidance. Due to the € 70 million corporate bond placed in July 2025, Formycon had already raised its forecast for this key figure from the original € 25 million to € 35 million to € 55 million to € 65 million upon publication of its half-year results for 2025. Significant upfront payments in connection with initial partnerships for the Keytruda® biosimilar candidate FYB206 in 2025, strict cost management and efficiency improvements contributed to a further increase.
The final financial figures and further information on the 2025 financial year as well as the outlook for 2026 will be published on 26 March 2026 with the annual report for the 2025 financial year on the website.
1) Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA
2) Nufymco® is a registered trademark of Formycon AG
Formycon announces positive clinical data for Keytruda® biosimilar candidate FYB206 (pembrolizumab)
- Dahlia PK study demonstrates pharmacokinetic equivalence of FYB206 (pembrolizumab) with the reference drug Keytruda®
- Positive clinical data from the pivotal study underline Formycon’s strong position among the leading developers of a pembrolizumab biosimilar
- Focus on completing development and preparing the regulatory dossiers
Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, „Formycon“) announces that the pivotal Dahlia pharmacokinetic study (PK study) has successfully met its primary study objective. The randomized, double-blind, multicenter clinical PK study demonstrated pharmacokinetic equivalence (bioequivalence) of FYB206 (pembrolizumab) with the oncology blockbuster drug Keytruda®1.
Dr. Andreas Seidl, Chief Scientific Officer of Formycon AG, comments: “Reaching this important milestone in our clinical development program in such a short time reflects our exceptional scientific expertise as well as our strong capabilities in efficiently conducting clinical trials. The positive results of the Dahlia PK study for our biosimilar candidate FYB206 underline our position as one of the leading biosimilar developers for this important biologic drug. They confirm the strategy of our streamlined clinical development program as well as the high quality of our study design and management. We are now one step closer to making FYB206 available worldwide as quickly as possible and improving access to this essential therapy.”
At the beginning of 2025, Formycon and the US Food and Drug Administration (FDA) had agreed on a streamlined clinical strategy that aims to sufficiently demonstrate the therapeutic comparability of FYB206 with the reference drug Keytruda®, based on comprehensive analytical data and data from the Dahlia PK study. Having achieved the primary study objective, Formycon is now focusing on completing all development activities to finalize the documents for regulatory approval. The company is working closely with the regulatory authorities to make FYB206 available as soon as possible after the exclusivity of the reference drug expires. In the meantime, patients from the Dahlia study will continue to be treated to ensure optimum clinical care.
Pembrolizumab is a humanized monoclonal antibody that belongs to the class of immune checkpoint inhibitors and is used to treat various types of cancer. Due to this broad range of indications in oncology, global sales of Keytruda® in 2025 increased by 7% year-on-year to US$ 31.7 billion.2 Keytruda® thus maintains its top position among the world’s best-selling drugs.
1 Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA.
2 https://www.merck.com/news/merck-highlights-progress-advancing-broad-diverse-pipeline/
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.
Lotus Pharmaceutical becomes commercialization partner for Formycon’s Keytruda® biosimilar candidate FYB206 across major parts of the Asia-Pacific Region
Planegg-Martinsried, Germany and Taipei, Taiwan – Formycon AG (FSE: FYB, “Formycon”) and Lotus Pharmaceutical (“Lotus”) today announced the conclusion of an exclusive license agreement for Formycon’s Keytruda®1 biosimilar candidate FYB206 (Pembrolizumab). Lotus, a multinational pharmaceutical company with a strong presence in Asia and a diverse portfolio of novel, generic and biosimilar medicines will commercialize FYB206 across major parts of the Asia-Pacific (“APAC”) Region.
Upon signature of the agreement, Formycon will receive an upfront payment and will be eligible for further payments contingent on the achievement of certain development and regulatory milestones. In addition, Formycon will receive a share of the gross profits upon market launch in the region and will be responsible for the manufacturing and supply of the finished product.
“The addition of this important oncology therapeutic to our existing partnership with Lotus underscores our well-established and trusted collaboration and marks another important step in Formycon’s global commercialization strategy. Lotus has a unique footprint in the APAC region. Together we aim to broaden patient access to effective and cost‑efficient treatment options for serious diseases while creating sustainable long-term value”, said Nicola Mikulcik, CBO of Formycon AG.
Petar Vazharov, CEO of Lotus Pharmaceutical, commented: “We are pleased to expand our collaboration with Formycon through this agreement for FYB206, a highly important biosimilar candidate in oncology. Biosimilars represent a key growth pillar for Lotus, and pembrolizumab is among the most clinically impactful and widely used biologics globally. By combining Formycon’s development expertise with Lotus’ strong commercial platform across Asia-Pacific, we aim to improve patient access to high-quality, cost-effective biologic therapies while further strengthening our specialty oncology portfolio in the region.”
FYB206 is approaching the end of its clinical development phase, with primary endpoint data expected in the first quarter of 2026. Following completion of the data package, Formycon and Lotus will closely align to prepare the regulatory submissions in the APAC countries according to the local requirements.
Pembrolizumab is a humanized monoclonal antibody that belongs to the group of immune checkpoint inhibitors and is used to treat a variety of tumors. With its broad range of indications in oncology and global sales of US$ 31.7 billion in 20252, Keytruda® is currently one of the world’s best-selling drugs, underscoring the substantial oncology demand and market potential across the world. According to market research estimates, sales in the Asia-Pacific region could amount to approximately $7.0 billion in 20253.
1 Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA.
2 https://www.merck.com/news/merck-highlights-progress-advancing-broad-diverse-pipeline/
3 https://www.grandviewresearch.com/horizon/outlook/keytruda-market/asia-pacific
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, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX selection index. Further information can be found at: https://www.formycon.com/
About Lotus
Founded in 1966, Lotus (1795: TT) is a global pharmaceutical company focused on novel and generic drugs, providing better, safer, and more accessible medicines. With a top-tier R&D and manufacturing platform in Asia, Lotus has partnerships in major markets including the U.S., Europe, Japan, China, and Brazil. The company manages over 100 strategic projects in Asia and the US, with a portfolio exceeding 250 commercial products. Lotus invests in a diverse portfolio of high-barrier oncology treatments, complex generics, 505(b)(2), and NCE drugs through internal R&D and licensing. It also strengthens its competitiveness with biosimilars, supported by strategic partners. Its infrastructure is certified by leading regulatory authorities, including the US FDA, EU EMA, Japan PMDA, China FDA, and Brazil ANVISA. Further information can be found at https://www.lotuspharm.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.
FDA approves another interchangeable Ranibizumab Biosimilar, Nufymco® – Strengthening US Presence with Zydus as Commercialization Partner
- FDA approves Biologics License Application (BLA) for additional ranibizumab biosimilar under the trade name Nufymco®
- Zydus becomes commercialization partner for Nufymco® in the US
- Targeted strategy to maximize market penetration for ranibizumab biosimilars by building further on existing partnerships
Planegg-Martinsried, Germany – Formycon AG (FWB: FYB, Prime Standard, “Formycon”) and Bioeq AG (“Bioeq”) announce that the U.S. Food and Drug Administration (FDA) has approved Nufymco®1 (ranibizumab-leyk), an interchangeable biosimilar to Lucentis®2. With its second FDA-approved ranibizumab biosimilar in the US, the companies are further underscoring their pioneering position in high-quality biosimilar development.
Zydus Lifesciences Limited (including its subsidiaries and affiliates; “Zydus”) has been secured as another strong commercialization partner for the US market. The company has proven expertise with medically administered drugs (known as Medical Part B), a category that includes Nufymco®. Recently, Zydus also obtained exclusive rights to Formycon’s Keytruda®3 biosimilar FYB206 for the US and Canada – a strong testament to the attractiveness of and confidence in Formycon’s development platform.
Nufymco® is an interchangeable biosimilar to Lucentis®, developed by Formycon, and will be available in the US for all approved indications, expanding access to essential retinal therapies by offering a more affordable treatment option for patients.
“Our FDA approval for Nufymco® marks an important milestone for Formycon and reaffirms our role as an innovative leader in biosimilar development. With two strong and internationally established partners, we are ideally positioned to expand access to high-quality and affordable ranibizumab biosimilars for ophthalmic patients in the US. This expanded market coverage opens new growth opportunities by enabling a differentiated approach within the complex US healthcare and reimbursement landscape, supporting sustainable market penetration,” comments Dr. Stefan Glombitza, CEO of Formycon AG.
Nufymco® is FDA approved for the treatment of patients with age-related neovascular (wet) macular degeneration (AMD) and other serious eye diseases such as diabetic macular edema (DME), diabetic retinopathy (DR), macular edema due to retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV).
1) Nufymco® is a registered trademark of Formycon AG
2) Lucentis® is a registered trademark of Genentech, Inc.
3) Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, (NYSE: MRK) Rahway, NJ/USA.
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, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX selection index. Further information can be found at: https://www.formycon.com/
About Bioeq:
Bioeq is a Swiss biopharmaceutical joint venture between the Polpharma Biologics Group and Formycon AG. Bioeq develops, licenses, and markets biosimilars. www.bioeq.ch
About Zydus Lifesciences Limited:
Zydus Lifesciences Limited is an innovation-led life-sciences company with leadership positions across pharmaceuticals and consumer wellness, supported by an emerging MedTech franchise and a global footprint across the United States, India and other international markets. As of September 30, 2025, the group employs 27,000 people worldwide, including 1,500 scientists engaged in R&D, and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. The group aspires to transform lives through path-breaking discoveries. For more details visit www.zyduslife.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.
Formycon and Zydus partner for exclusive licensing and supply agreement of FYB206, a biosimilar to Keytruda® (Pembrolizumab), in the U.S. and Canada
- Licensing partner Zydus brings extensive commercial experience, marketing more than 225 FDA-approved medicines, providing a strong foundation for a successful launch of FYB206
- Strong early partnering interest underscores industry confidence in Formycon’s biosimilar expertise and development excellence
- Agreement structure includes in total mid-teens-million-euro upfront and 2025 milestone payments, alongside additional development and regulatory milestones and a mid-double-digit-gross-profit-share upon launch
- Clinical development phase of FYB206 nearly completed; primary endpoint data expected in the first quarter of 2026
Planegg-Martinsried, Germany; Ahmedabad, India – Formycon AG (FSE: FYB, “Formycon”) and Zydus Lifesciences Limited (including its subsidiaries and affiliates, “Zydus”), today jointly announced that they have entered into a strategic partnership for the exclusive licensing and supply of checkpoint inhibitor FYB206, a biosimilar of Keytruda®1 (Pembrolizumab), in the U.S. and Canada.
Under the terms of this agreement, Formycon AG will finalize development, prepare and file the regulatory dossier, and supply the product, while Zydus will be responsible for the commercialization of FYB206 in the U.S. and Canada. Meanwhile, FYB206 is approaching the end of its clinical development phase, with primary endpoint data expected in the first quarter of 2026. Following completion of the data package, Formycon will prepare the dossier and submit the biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) in due course.
Dr. Stefan Glombitza, CEO of Formycon, commented: “Partnering with Zydus for the U.S. and Canada marks an important milestone for us. Zydus is an established, high-revenue player with a compelling and forward-looking oncology strategy. It has a strong commercial footprint in the U.S., where it generates nearly half of its global revenue and maintains a robust, scalable presence across key commercial channels. By commercializing over 225 FDA-approved products, including injectables and hospital-use medicines, Zydus has shown solid execution strength in complex launches, supporting the high-quality implementation of FYB206. With a streamlined clinical development program, Formycon has secured a leading role among the developers of a pembrolizumab biosimilar and Zydus´ decision to join forces with us underscores their strong confidence in our expertise in developing complex biosimilar medicines for highly regulated countries. Continuing our indicated partnering approach, we are teaming up with strong local partners at attractive commercial terms as we work together to deliver meaningful value for patients and healthcare systems.”
Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited, stated: “We are happy to collaborate with Formycon to develop and commercialize a biosimilar of Keytruda® across U.S. and Canada. This venture marks Zydus’ entry into the North American biosimilar market, debuting with an immunotherapy product. This collaboration also complements Zydus’ recent proposed acquisition of Agenus Inc.’s California, USA based manufacturing facilities, which we plan to integrate and leverage for manufacturing in the future. By combining our expertise and resources, we aim to drive significant organizational growth and deliver maximum value to patients through expanded access to affordable oncology care.”
Upon signature of the agreement, Formycon will be eligible to receive mid-teens-million-euro upfront and milestone payments in 2025. In addition, Formycon will be eligible for further payments linked to the achievement of defined development and regulatory milestones, which in total are expected to amount to a mid–double-digit-million-euro range. Upon market launch, Formycon will obtain a mid–double-digit-share of the gross profits generated in the territory.
Pembrolizumab is a humanized monoclonal antibody that belongs to the group of immune checkpoint inhibitors and is used to treat a variety of tumors. With its broad range of indications in oncology and global sales of US$ 29.5 billion in 20242, Keytruda® is currently one of the world’s best-selling drugs, underscoring the substantial oncology demand and market potential across the world.
1) Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, (NYSE: MRK) Rahway, NJ/USA.
2) https://www.merck.com/news/merck-announces-fourth-quarter-and-full-year-2024-financial-results/ Merck Announces Fourth-Quarter and Full-Year 2024 Financial Results – Merck.com
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, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX selection index. Further information can be found at: https://www.formycon.com/
About Zydus Lifesciences Limited:
Zydus Lifesciences Limited is an innovation-led life-sciences company with leadership positions across pharmaceuticals and consumer wellness, supported by an emerging MedTech franchise and a global footprint across the United States, India and other international markets. As of September 30, 2025, the group employs 27,000 people worldwide, including 1,500 scientists engaged in R&D, and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. The group aspires to transform lives through path-breaking discoveries. For more details visit www.zyduslife.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.
