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Planegg-Martinsried, Germany / Montevideo, Uruguay – Formycon AG (FSE: FYB, Prime Standard, “Formycon“) and Biocelys S.A. (“Biocelys”), a company of the ATHOS Group, today announced the launch of a collaboration to develop the biosimilar candidate FYB286. The partnership combines Formycon’s proven expertise in biosimilar development with Biocelys’ state-of-the-art manufacturing infrastructure. The project is being financed upfront by Santo Biosimilar GmbH (“Santo”), an affiliated company of ATHOS KG (“ATHOS”). ATHOS is Formycon’s largest anchor shareholder and indirectly controls both Santo Biosimilar GmbH and Biocelys S.A.

Under the agreement with Santo, Formycon will receive arm’s-length compensation for its development services and will participate in future revenues of Santo with a low double-digit percentage share. The technologically demanding development program targets a niche indication with attractive growth potential, making FYB286 a strategically compelling addition to Formycon’s value-focused biosimilar portfolio.

Dr. Stefan Glombitza, CEO of Formycon AG, commented: “Biosimilars for niche-busters¹ combine two key elements: they meet the strong demand for high-quality biologic therapies for relatively rare conditions while creating an attractive market opportunity. For FYB286, we expect demand to increase substantially, particularly in emerging markets. Together with Biocelys, we can achieve both objectives: help patients with rare diseases and tap into a new market. Biocelys and Formycon complement each other perfectly by combining state-of-the-art manufacturing capabilities with our extensive expertise and operational excellence in biosimilar development. With Biocelys as part of our network of strategic manufacturing partners, we are strengthening our supply capabilities well beyond the FYB286 project and setting another important cornerstone in our FYB4Growth strategy.”

With FYB4Growth, Formycon is pursuing a growth strategy based on four strategic pillars focused on sustainable value creation: An intelligent portfolio strategy, geographic diversification of target markets, outstanding scientific excellence, and consistent cost efficiency form the foundation of Formycon’s robust and growth-oriented business model.

“In line with our vision to produce high-quality pharmaceuticals from Latin America for patients around the world, our collaboration with Formycon on the FYB286 project marks an important milestone. Our Montevideo site not only features state-of-the-art manufacturing facilities but also the expertise required to manufacture complex biologic molecules. Together with Formycon as our project partner, we will improve access to a much-needed therapy, particularly in regions where patient needs remain largely unmet,” said Adive Carrasco, Managing Director of Biocelys S.A.

“As long-term investors, we support FYB286 as a collaboration model that brings together the complementary strengths of our portfolio companies. The combination of scientific development excellence and modern biopharmaceutical manufacturing provides a solid foundation for executing projects of this kind efficiently and with clear focus on value creation. By providing the upfront financing, we are creating the framework that enables Formycon and Biocelys to implement the project independently and in partnership,” added ATHOS KG.

About Formycon:
Formycon AG is a listed, independent developer of biosimilars based in Planegg-Martinsried, one of the leading life science locations in Europe, just outside Munich, Germany. Its 200 employees from 27 countries cover the entire development chain, from laboratory analysis through manufacturing and clinical testing to the documents for approval. Three Formycon biosimilars are approved in ophthalmology and immunology and are marketed worldwide through commercialization partners. Four further candidates are in development, among them biosimilars to two of the best-selling biologic medicines in the world. With its products, Formycon makes highly effective therapies affordable for more people.

Formycon AG is 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/en/

About #FYB4Growth:
With FYB4Growth, Formycon is pursuing a growth strategy based on four strategic pillars aimed at creating 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. Find out more at: https://www.fyb4growth.com

About Biocelys:
Biocelys S.A. (“Biocelys”), based at Parque de las Ciencias in Canelones, Uruguay, is a biopharmaceutical company for the development and manufacture of biotechnological drug substances. Its focus is on monoclonal antibodies and related recombinant proteins from mammalian cell culture, covering the process from cell bank through cell culture and purification to the released drug substance. The facility is newly built to current technical standards and designed for manufacturing in line with international GMP standards.

Biocelys is a company of the ATHOS Group. The company pursues the vision of making high-quality biopharmaceuticals available from Latin America to patients worldwide. Alongside its own process development, Biocelys performs technology transfers for partners and supports projects from process transfer through validation to commercial supply. Adive Carrasco is Managing Director of Biocelys S.A.

About Biosimilars:
Biosimilars are successor products to biologic medicines. They are not copies; each one is developed from the ground up and must demonstrate to the health authorities that it has no clinically meaningful differences from the reference product in terms of safety and efficacy. According to the IQVIA Institute, 118 biologic medicines with sales of USD 232 billion will lose their exclusivity in the US alone by 2034, and for only twelve of them is a biosimilar in development. In Europe, biosimilars have saved EUR 75 billion and made more than seven billion days of treatment possible.

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.

Planegg-Martinsried, Germany; Ahmedabad, India; October 13, 2026 – Formycon AG (FSE: FYB, Prime Standard, “Formycon”), an independent developer of biosimilars, and Zydus Lifesciences Limited (Zydus), an innovation-led global life-sciences company, jointly announce that the US Food and Drug Administration (“FDA”) has accepted for review the Biologics License Application (“BLA”) for FYB206, a proposed biosimilar to Keytruda^®1 (pembrolizumab). To the best of the companies’ knowledge, this is the first publicly announced acceptance by the FDA of an application for a Keytruda^® biosimilar. The BLA was submitted in the third quarter of 2026. Under the Biosimilar User Fee Amendments (BsUFA), the FDA aims to complete its review within 12 months of submission, comprising up to 60 days for the filing review and 10 months for the substantive review. Based on this timeline, a decision could be expected in the third quarter of 2027. The regulatory dossier for FYB206 has also been submitted to Health Canada.

Dr. Stefan Glombitza, CEO of Formycon AG, said: “With the FDA’s acceptance of the FYB206 application for review, we are among the very first companies to advance a biosimilar to the world’s best-selling biologic medicine to this stage. We developed FYB206 on a path agreed with the FDA, without conducting a comparative Phase III efficacy trial. This enabled us to accelerate the program and substantially reduce development investment while maintaining the rigorous scientific standards required for biosimilar approval. With Zydus, we have a partner with strong commercial capabilities and a clear oncology strategy in the US and Canada. Together, we aim to make this important cancer therapy accessible to more patients.”

Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited, said: “Acceptance of the application marks a significant step toward expanding access to affordable pembrolizumab therapy in the US and Canada. As demand for high-quality, accessible oncology treatments continues to rise, FYB206 has the potential to improve patient access and outcomes while strengthening our oncology biosimilars portfolio. Leveraging the biologics expertise of Formycon and our established oncology platform in North America, we remain focused on delivering meaningful value to patients.”

In February 2025, Formycon agreed with the FDA that FYB206 does not require a comparative Phase III efficacy trial. Such a trial had long been standard for biosimilars of monoclonal antibodies; it typically takes one to three years and involves hundreds of patients. In its draft guidance of October 2025, the FDA proposed that comparative efficacy trials will generally no longer be required for therapeutic proteins. Development of FYB206 continued on the basis of a comprehensive analytical and functional comparability package and the pivotal Dahlia pharmacokinetic study, which met its primary objective in February 2026 and demonstrated pharmacokinetic equivalence between FYB206 and the reference product. Clinical development was completed in July 2026. Forgoing the Phase III trial is a key reason why FYB206 has reached FDA review this quickly, and it is expected to save investments in the high double-digit million euro range. This kind of lean development is one of the four pillars of the Formycon growth strategy #FYB4GROWTH.

In December 2025, Formycon and Zydus entered into an exclusive licensing and supply agreement for FYB206 in the United States and Canada. Formycon is responsible for completing development, preparing and filing the regulatory dossiers, and supplying the product. With the FDA’s acceptance of the BLA for review, Formycon has reached a regulatory milestone under the agreement that entitles it to a milestone payment from Zydus. Zydus will commercialize FYB206 in both markets, subject to regulatory approval and resolution of any intellectual property issues. Formycon holds the global rights to FYB206 and will participate in the gross profits of its commercialization partners. Beyond the US and Canada, Formycon has partnered FYB206 with MS Pharma for the MENA region and with Lotus for parts of Asia-Pacific. For all other regions, including Europe and Latin America, discussions with potential partners are ongoing.

Pembrolizumab is an immune checkpoint inhibitor that binds to and blocks the PD-1 receptor and is used to treat numerous types of cancer. In 2025, worldwide sales of Keytruda^®, including the subcutaneous formulation Keytruda Qlex™, reached USD 31.7 billion.² In the first half of 2026, combined sales of Keytruda^® and Keytruda Qlex™ totaled USD 16.4 billion.³ Keytruda^® remains the world’s best-selling biologic medicine.

About Formycon:
Formycon AG is a listed, independent developer of biosimilars based in Martinsried, one of the leading life science locations in Europe, just outside Munich, Germany. Its 200 employees from 27 countries cover the entire development chain, from laboratory analysis through manufacturing and clinical testing to the documents for approval. Three Formycon biosimilars are approved in ophthalmology and immunology and are marketed worldwide through commercialization partners. Four further candidates are in development, among them biosimilars to two of the best-selling biologic medicines in the world. With its products, Formycon makes highly effective therapies affordable for more people.

Formycon AG is listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: 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. The group employs 30,000 people worldwide, including 1,500 scientists engaged in research and development. Zydus is driven by its mission to unlock new possibilities in life sciences through quality healthcare solutions that improve lives. Further information is available at www.zyduslife.com.

About Biosimilars:
Biosimilars are successor products to biologic medicines. They are not copies; each one is developed from the ground up and must demonstrate to the health authorities that it has no clinically meaningful differences from the reference product in terms of safety and efficacy. According to the IQVIA Institute, 118 biologic medicines with sales of USD 232 billion will lose their exclusivity in the US alone by 2034, and for only twelve of them is a biosimilar in development. In Europe, biosimilars have saved EUR 75 billion and made more than seven billion days of treatment possible.

Contact:
Thorsten Ladda, Corporate Communications, +49 89 864667‑150
Elena Strassner, Investor Relations, +49 89 864667‑485
Joerg Allgaeuer, Investor Relations & Corporate Communications, +49 89 864667‑107
Email: ir@formycon.com
Formycon AG, Fraunhoferstrasse 15, 82152 Planegg-Martinsried, Germany

Sujatha Rajesh, Corporate Communications, +91-9974051180, Sujatha.Rajesh@zyduslife.com
Arvind Bothra, Investor Relations, +91-7045656895, Arvind.Bothra@zyduslife.com

Disclaimer:
FYB206 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.

Certain statements contained in this release may constitute “forward-looking statements” that involve a number of risks and uncertainties. Forward-looking statements can generally be identified by the use of the words “may,” “will,” “should,” “plan,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” “project,” or “aim,” or the negative of these words or other variations of these words or comparable terminology. Forward-looking statements are based on assumptions, forecasts, estimates, projections, opinions or plans that, by their nature, are subject to significant risks and uncertainties and contingencies that are subject to change.

Formycon does not and will not give any assurance that any forward-looking statement will be achieved or prove to be accurate. Actual future business, financial condition, results of operations and prospects may differ materially from those projected or anticipated in the forward-looking statements. Subject to applicable legal requirements, neither Formycon nor any other person intends to update, review or revise any forward-looking statements in this release to reflect actual events or developments, whether as a result of new information becoming available, new developments occurring in the future or otherwise, nor does it undertake any such obligation.

Planegg-Martinsried, Germany, October 6, 2026 – Formycon AG (FSE: FYB, Prime Standard; “Formycon”) is enhancing the efficiency and scalability of its biosimilar development activities through the focused use of digital technologies. In line with its FYB4GROWTH strategy, the company is integrating artificial intelligence (AI) and other innovative digital solutions into key development processes to further optimize operational workflows and support sustainable value creation.

One specific example is the introduction of PhlexTMF Enterprise, an electronic trial master file (eTMF) solution with AI-assisted capabilities from Phlexglobal. Trial Master Files are essential to clinical development: They document the design, conduct, and monitoring of clinical trials across several thousand pages and must meet the highest regulatory standards. Formycon is introducing PhlexTMF as the central platform for current and future clinical development activities, while simultaneously migrating existing Trial Master Files from legacy systems to the new environment.

Dr. Andreas Seidl, Chief Scientific Officer of Formycon AG, commented: “Lean Development is a key driver of our FYB4GROWTH strategy: We combine scientific excellence and innovation with financial discipline to increase the efficiency and competitiveness of our development programs. PhlexTMF demonstrates how we leverage new technologies to optimize processes and advance operational workflows. Based on our internal assessment, we expect the implementation of the new system to contribute to efficiency improvements of approximately 20 percent. At the same time, the system supports our processes for maintaining high standards for quality, data integrity, and regulatory compliance. This creates additional scope for value creation and sustainable growth.”

Separately from its implementation of PhlexTMF, Formycon has also identified lean development opportunities in technical and regulatory development. In addition to tailored database systems and the use of flexible apps to manage and evaluate data, the use of artificial intelligence can significantly accelerate time-consuming processes in these domains as well. Specifically, the company has introduced AI-powered software for analyzing manufacturing process data, which is designed to optimize and accelerate collaboration with contract manufacturers and to provide structural predictions that support the evaluation of critical quality attributes.

About Formycon:
Formycon AG is a listed, independent developer of biosimilars based in Martinsried, one of the leading life science locations in Europe, just outside Munich, Germany. Around 200 employees from 27 countries cover the entire development chain, from laboratory analysis through manufacturing and clinical testing to the documents for approval. Three Formycon biosimilars are approved in ophthalmology and immunology and are marketed worldwide through commercialization partners. Four further candidates are in development, among them biosimilars to two of the best-selling biologic medicines in the world. With its products, Formycon makes highly effective therapies affordable for more people.

Formycon shares are listed in the Prime Standard of the Frankfurt Stock Exchange (ticker FYB, ISIN DE000A1EWVY8, WKN A1EWVY). Further information at https://www.formycon.com/en/.

About #FYB4GROWTH:
With FYB4GROWTH, Formycon is pursuing a growth strategy based on four strategic pillars aimed at creating sustainable value. First, geographic diversification: in addition to Europe and the US, 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 the competitiveness of Formycon over the long term. Find out more at: https://www.fyb4growth.com

About Biosimilars:
Biosimilars are successor products to biologic medicines. They are not copies; each one is developed from the ground up and has to prove to the health authorities that it matches the reference product in safety and efficacy. According to the IQVIA Institute, 118 biologic medicines with sales of USD 232 billion will lose their exclusivity in the US alone by 2034, and for only twelve of them is a biosimilar in development. In Europe, biosimilars have saved around EUR 75 billion and made more than seven billion days of treatment possible.

About Phlexglobal:

Phlexglobal is a Trial Master File specialist service provider, helping life sciences organizations improve quality, reduce risk, and achieve continuous inspection readiness through expert services, purpose-built technology, and AI-powered innovation. Phlexglobal combines deep TMF expertise with Trusted Clinical Intelligence to help organizations operate more efficiently and confidently across the clinical trial lifecycle.

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.

Planegg-Martinsried, Germany, September 22, 2026 – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) announces the publication of the scientific article “From Reflection to Implementation – Tailored Clinical Development of a Pembrolizumab Biosimilar Candidate” in the peer-reviewed journal BioDrugs. The article describes the scientific and regulatory principles of a modern, evidence-based developmental approach for biosimilars using the example of the pembrolizumab biosimilar candidate FYB206 to illustrate how a PK-focused clinical development program can be successfully implemented. This publication reflects the current shift in regulatory science: International health authorities such as the European Medicines Agency (EMA), the U.S. FDA, and other leading regulatory agencies are recognizing that modern analytical methods, sensitive functional assays, and comparative PK studies can provide greater insight for well-characterizable biologics than traditional comparative efficacy studies. Using FYB206 as an example, the article illustrates how this science-based approach can be implemented in practice without compromising quality, safety, or efficacy.

Dr. Andreas Seidl, Chief Scientific Officer of Formycon AG, said: “In line with our FYB4Growth strategy, FYB206 demonstrates the successful implementation of a science-driven and forward-looking clinical development strategy. We believe that PK-focused clinical approaches have the potential to reshape biosimilar development in a lasting way. Formycon recognized the potential of this strategy at an early stage and is today among the companies helping to drive its practical implementation. This pioneering role is further underscored by the publication of these findings in the peer-reviewed journal BioDrugs.”

Building on the scientific understanding that modern analytical characterization methods, functional comparability studies, and sensitive PK studies can provide robust evidence of biosimilarity for most biologics, the article describes this optimized clinical strategy using Formycon’s pembrolizumab biosimilar candidate FYB206 as an example. Pembrolizumab is a humanized monoclonal antibody blocking the PD-1 signaling pathway and commonly used for the treatment of various tumor diseases. Due to its well-studied mode of action and its comprehensive analytical characterization, this compound is particularly suited for an optimized development approach.

The publication follows the successful completion of the pivotal DAHLIA study, in which FYB206 demonstrated pharmacokinetic equivalence to the reference drug Keytruda^®. This study highlights the significant potential of PK-focused development programs for future biosimilar development. For suitable biologics, such strategies can help reduce the clinical burden without compromising scientific validity. Thus, Formycon is making an important contribution to the current scientific and regulatory discussion on the further development of efficient biosimilar development programs.

The publication is available at https://doi.org/10.1007/s40259-026-00803-y.

About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company covers the entire value chain, from the selection of a promising biosimilar candidate through the various stages of development to the delivery of the approved and market-ready product. In addition, Formycon also has extensive expertise in the planning, management, and monitoring of the supply chain as well as international product logistics. For the commercialization of its biosimilars, Formycon relies on strong, trusted and long-term partnerships worldwide. With FYB201/ranibizumab, FYB202/ustekinumab and FYB203/aflibercept, Formycon already has three biosimilars on the market. Four pipeline candidates – including FYB206/pembrolizumab and 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 #FYB4Growth
With FYB4Growth, Formycon is pursuing a growth strategy based on four strategic pillars aimed at creating 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. Find out more at: https://www.fyb4growth.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.

Planegg-Martinsried, Germany – Formycon AG (FSB: FYB, Prime Standard, “Formycon“) today reports on the positive business performance and the Group’s financial results for the first half of the 2026 financial year.

Dr. Stefan Glombitza, CEO of Formycon AG, said: “Formycon achieved important operational progress in the first half of 2026 and took key strategic steps to prepare for the next phase of growth. With the successful completion of clinical development for FYB206, we further strengthened our position among the leading developers of pembrolizumab biosimilars. Our focus is now clearly on completing the next steps towards regulatory submission as a top priority. FYB4Growth is our strategic compass, which we are consistently implementing to drive sustainable value creation. The continued development of our portfolio and the successful expansion of our partner network during the first half of the year represent important progress along this strategic path.”

Enno Spillner, CFO of Formycon AG, commented: “Business performance in the first half of the year confirms our growth trajectory for the 2026 financial year, with significant revenue growth across several products and a substantial improvement in earnings. For the remainder of the year, development milestone payments related to FYB206 and royalty income from the commercialization of FYB202 are expected to be the key revenue contributors and support the achievement of our goals. Continued market penetration of FYB202 will be a key factor in this regard. We continuously monitor the commercial performance of our products and maintain regular dialogue with our commercialization partners. At the same time, we are consistently advancing our development programs and partnerships. Against this backdrop, we confirm the financial guidance for 2026 issued in April and maintain our goals for the full 2026 financial year.”

Key milestones across the development and commercialization pipeline support the implementation of the FYB4Growth strategy

The clinical Dahlia pharmacokinetic study of the pembrolizumab biosimilar candidate FYB206 met its primary endpoint and demonstrated pharmacokinetic equivalence to the reference product Keytruda^®¹. After the reporting period, clinical development of FYB206 was successfully completed, and Formycon is now working as a top priority on finalizing the regulatory submissions. In addition, the exclusive licensing agreement with Lotus Pharmaceutical covering large parts of the Asia-Pacific region further strengthened the global commercialization strategy for FYB206, following the North American partnership with Zydus Lifesciences.

With the European commercial launch of its Eylea^®² biosimilar FYB203, Formycon reached another important milestone in establishing its commercial portfolio. The Aflibercept 2 mg biosimilars Ahzantive^®³ and Baiama^®⁴ have been available in the European Union since 15 May 2026 and are being introduced progressively in key European markets through several commercialization partners. This expands Formycon’s market presence to three in-house developed biosimilars.

For FYB202, Formycon’s Stelara^®⁵ biosimilar, European approval of the autoinjector as an additional dosage form further strengthens the product’s commercial positioning. In addition, a semi-exclusive supply agreement for FYB202 covering several Latin American countries was concluded with local specialist Everex Pharmaceuticals.

For the ranibizumab biosimilar FYB201, the focus during the first half of the year was on the resumption of U.S. commercialization of FYB201/Cimerli^®⁶ by Sandoz. In addition, Zydus Lifesciences is progressively launching Formycon’s FYB201/Nufymco^®⁷ in the United States through various distribution channels during the second half of the year.

Furthermore, Formycon entered into a strategic partnership with OneSource Specialty Pharma. The collaboration supports the continued implementation of the FYB4Growth strategy with a focus on scalability, cost efficiency and security of supply for global biosimilar programs.

Financial performance in the first half of 2026

The Formycon Group significantly increased revenue in the first half of 2026 to EUR 25.8 million, compared with EUR 9.0 million in the prior-year period. The key drivers were milestone payments from commercialization and development partnerships for FYB206, higher royalty income from marketed biosimilars, as well as revenue from recharges and supply management.

Revenue from FYB201 amounted to EUR 1.7 million in the first half of the year following its re-entry into the U.S. market (prior-year period: EUR 2.4 million). This included royalties based on global product sales as well as revenue from recharges of development costs. The share of profit/loss of Bioeq AG was also allocated to this FYB201-segment and is reflected in adjusted EBITDA (see below).

Commercialization of FYB202 continued to develop in a challenging and price-sensitive market environment during the reporting period. In addition to royalty income from Otulfi^®⁸ and milestone payments relating to the Otulfi^® autoinjector, further revenue was generated from the second commercialization partner in Germany, the MENA region and sales of material. As a result, total FYB202 revenue increased significantly to EUR 8.3 million, compared to EUR 2.6 million in the prior-year period. For the second half of the year, revenue is expected to be driven by royalty income from the various commercialization regions.

Since mid-May, FYB203 has been Formycon’s third commercial product available in Europe. During the reporting period, revenue of EUR 4.4 million (prior-year period: EUR 4.0 million) was generated from recharges of development services and supply management for FYB203 on behalf of various partners. Royalties did not yet make a material contribution in the first half of 2026.

FYB206 generated revenue of EUR 11.3 million during the reporting period (prior-year period: EUR 0 million), resulting from deferred milestone payments. Further significant milestone payments and upfront payments are also expected in the second half of 2026 in connection with existing and targeted new licensing partnerships. FYB206 is therefore expected to be the key revenue driver in the current financial year.

Group earnings before interest, taxes, depreciation and amortization (EBITDA) improved significantly to EUR -3.4 million in the first six months of 2026 (prior-year period: EUR -17.9 million). The improvement was primarily attributable to significantly higher revenue as well as lower research and development expenses resulting from project progress and the capitalization of development costs for FYB206 and FYB208.

Group adjusted EBITDA amounted to EUR -6.9 million in the first six months of 2026 (prior-year period: EUR -19.2 million). This includes the share of profit/loss from the at-equity valuation of Bioeq AG of EUR -3.5 million (prior-year period: EUR -1.2 million). The weaker performance of Bioeq AG was primarily attributable to the ongoing relaunch activities for FYB201 in the United States.

The Formycon Group’s working capital amounted to EUR 51.2 million as of June 30, 2026 (December 31, 2025: EUR 70.1 million; June 30, 2025: EUR 17.0 million). The decrease was primarily attributable to cash outflows from ongoing business and development activities as well as interest and principal payments.

Formycon confirms the guidance for the 2026 financial year issued in April. The Group expects revenues of between EUR 60.0 million and EUR 70.0 million, Group EBITDA of between EUR 0.0 million and EUR 10.0 million, Group adjusted EBITDA of between EUR 5.0 million and EUR 15.0 million and working capital of between EUR 20.0 million and EUR 30.0 million.

The Management Board of Formycon AG will discuss the Company’s development and key financial performance indicators during a conference call. The earnings call, which will be broadcast live online, will take place in English on Wednesday, August 12, 2026, at 3:00 p.m. CEST.

To participate in the conference call, please register via:
https://webcast.meetyoo.de/register/Pmqy6uuLtDjm

Following registration, participants will receive a confirmation email containing their individual dial-in details.

The presentation and live audio webcast will be available via:
https://www.webcast-eqs.com/formycon-2026-h1

Following a brief presentation, the Management Board will be available to answer questions from analysts. The conference call will be recorded and subsequently made available on the Formycon website:
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 covers the entire value chain, from the selection of a promising biosimilar candidate through the various stages of development to the delivery of the approved and market-ready product. In addition, Formycon also has extensive expertise in the planning, management, and monitoring of the supply chain as well as international product logistics. For the commercialization of its biosimilars, Formycon relies on strong, trusted and long-term partnerships worldwide. With FYB201/ranibizumab, FYB202/ustekinumab and FYB203/aflibercept, Formycon already has three biosimilars on the market. Four pipeline candidates – including FYB206/pembrolizumab and 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 #FYB4Growth:
With FYB4Growth, Formycon is pursuing a growth strategy based on four strategic pillars aimed at creating 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.

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.

Planegg-Martinsried, Germany – Formycon AG (FSB: FYB, Prime Standard, „Formycon“) plans to publish its results for the first half of the 2026 fiscal year on August 12, 2026. The Management Board will discuss the company’s development, key financial figures, and provide an outlook for the course of 2026. The conference call, which will be broadcast live on the internet, will take place on Wednesday, August 12, 2026, at 3:00 PM (CEST) in English.

To participate in the conference call, please register at:
https://webcast.meetyoo.de/register/Pmqy6uuLtDjm

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-2026-h1

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 investor conferences in the coming months:

September 14 – 16, 2026
H.C. Wainwright 28th Annual Global Investment Conference
Enno Spillner (CFO)
New York City

September 16, 2026
Jefferies Fireside Chat
Enno Spillner (CFO)
virtual

September 21 – 23, 2026
Berenberg and Goldman Sachs German Corporate Conference
Dr. Stefan Glombitza (CEO), Enno Spillner (CFO)
Munich

October 6 – 7, 2026
SME Conference
Enno Spillner (CFO)
Paris

November 16 – 19, 2026
Jefferies London Healthcare Conference
Enno Spillner (CFO)
London

November 23 – 25, 2026
Deutsche Börse Equity Forum
Enno Spillner (CFO)
Frankfurt

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.

Munich, Germany / Bangalore, India, July 14, 2026 – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) and OneSource Specialty Pharma Limited (BSE: 544292, NSE: ONESOURCE, “OneSource”), a multi-modality specialty pharma CDMO, today announced a strategic manufacturing partnership for biosimilars.

Under the partnership, OneSource will serve as a strategic manufacturing partner for Formycon and provide integrated Drug Substance (DS) and Drug Product (DP) manufacturing capabilities from its state-of-the-art biologics’ facility in Bangalore, India. The collaboration brings together Formycon’s biosimilar development excellence with OneSource’s end-to-end biologics manufacturing expertise to support Formycon’s biosimilar programs for global markets.

Dr. Stefan Glombitza, Chief Executive Officer of Formycon AG, said: “Reliable, scalable and cost-efficient manufacturing is a cornerstone of our FYB4Growth strategy. By adding OneSource to our network of strategic manufacturing partners, we are further strengthening our supply capabilities with a partner that meets our unwavering commitment to high standards of quality, operational excellence and cost-efficiency. Together, we aim to broaden sustainable global access to life-changing biosimilar therapies.”

Neeraj Sharma, Managing Director & CEO, OneSource Specialty Pharma, said: “We are delighted to partner with Formycon, one of the world’s leading biosimilar developers with a proven track record of bringing high-quality biosimilars to global markets. This partnership brings together Formycon’s development expertise and OneSource’s integrated manufacturing capabilities to expand access to high-quality, affordable biologics for patients worldwide. It also reinforces our belief that India is uniquely positioned to serve as a global hub for the development and manufacturing of world-class biologics.”

The partnership reflects the shared commitment of both companies to advancing global access to biosimilars through reliable, high-quality, and scalable manufacturing. Achieving this requires not only scientific excellence but also a sustainable, cost-effective manufacturing model – one that OneSource is specifically positioned to deliver.

Formycon brings a strong track record in biosimilar development and commercialization, supported by an established portfolio and a robust pipeline. OneSource complements this with an integrated biologics platform spanning cell line development through commercial fill-finish, five manufacturing facilities approved by leading global regulatory authorities, including the US FDA and EMA, and extensive expertise across biologics, sterile injectables, and drug-device combinations.

About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company covers the entire value chain, from the selection of a promising biosimilar candidate through the various stages of development to the delivery of the approved and market-ready product. In addition, Formycon also has extensive expertise in the planning, management, and monitoring of the supply chain as well as international product logistics. For the commercialization of its biosimilars, Formycon relies on strong, trusted and long-term partnerships worldwide. With FYB201/ranibizumab, FYB202/ustekinumab and FYB203/aflibercept, Formycon already has three biosimilars on the market. Four pipeline candidates – including FYB206/pembrolizumab and 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 #FYB4Growth
With FYB4Growth, Formycon is pursuing a growth strategy based on four strategic pillars aimed at creating 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. Find out more at: https://www.fyb4growth.com

About OneSource
OneSource Specialty Pharma Limited (BSE: 544292, NSE: ONESOURCE) is a pure-play global CDMO. The company focuses on the development and manufacturing of complex pharmaceutical products including biologics, drug-device combinations, sterile injectables, and oral technologies (soft gelatine capsules). It has five state-of-the-art manufacturing facilities approved by global regulatory authorities and a dedicated team of over 1,600 professionals. OneSource with its development capabilities, industry leading manufacturing capacities, and strong compliance track record, has won trust of global pharmaceutical companies seeking efficient, end-to-end solutions. For more information, please visit www.onesourcecdmo.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.

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) today held its Annual General Meeting (AGM) as an in-person event in Munich. During its presentation, the Management Board provided shareholders with a comprehensive update on the Company’s development and answered all questions raised during the general debate.

In its report to the Annual General Meeting, the Management Board outlined the Company’s operational progress during fiscal year 2025 and beginning of 2026, and presented its strategic priorities for the coming month. Formycon achieved important advances across its biosimilar pipeline, expanded its commercial footprint further, and continued strengthening its financial foundation for the next phase of growth.

Through its “FYB4Growth” program, Formycon is pursuing a clearly defined growth strategy that combines geographic diversification, a smart portfolio approach, technological and regulatory excellence, as well as a strong focus on cost efficiency. The Management Board reaffirmed its objective of further developing Formycon into a sustainably profitable biosimilar company.

The shareholders represented at the AGM followed the recommendations of the Management Board and Supervisory Board and approved all proposed resolutions by large majorities. This included the approval of a profit and loss transfer agreement between Formycon AG and FYB202 Project GmbH. By entering into the profit transfer agreement, Formycon is laying the groundwork for a tax consolidation arrangement between Formycon AG and FYB202 Project GmbH. The goal is to make more efficient use of tax benefits within the Group and to further optimize the Group’s structure and financing arrangements.

Votes were cast for 62.34% of the Company’s share capital. Detailed voting results and further information regarding the 2026 Annual General Meeting are available on the Formycon website at: https://www.formycon.com/en/investor-relations/annual-general-meeting-2026/

About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company covers the entire value chain, from the selection of a promising biosimilar candidate through the various stages of development to the delivery of the approved and market-ready product. In addition, Formycon also has extensive expertise in the planning, management, and monitoring of the supply chain as well as international product logistics. For the commercialization of its biosimilars, Formycon relies on strong, trusted and long-term partnerships worldwide. With FYB201/ranibizumab, FYB202/ustekinumab and FYB203/aflibercept, Formycon already has three biosimilars on the market. Four pipeline candidates – including FYB206/pembrolizumab and 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 #FYB4Growth:
With FYB4Growth, Formycon is pursuing a growth strategy based on four strategic pillars aimed at creating 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.

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.