Formycon invites to Conference Call on 2025 Nine-month Results and announces Participation in Investor Conferences in the 4th Quarter of 2025
Planegg-Martinsried, Germany – Formycon AG (FSB: FYB, Prime Standard, „Formycon“) plans to publish its Nine-Month Results 2025 on November 13, 2025. The Management Board will discuss the company’s development, key financial figures, and provide an outlook for the course of 2025. The conference call, which will be broadcast live on the internet, will take place on Thursday, November 13, 2025, at 3:00 PM (CET) in English.
To participate in the conference call, please register at:
https://webcast.meetyoo.de/reg/KYTa1G3ju56X
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-q3
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 participate in the following national and international investor conferences in the fourth quarter of 2025:
October 30, 2025
ODDO BHF Autumn Round Table
Dr. Stefan Glombitza (CEO)
Frankfurt, Germany
November 17 – 20, 2025
Jefferies Global Healthcare Conference
Enno Spillner (CFO)
London, UK
November 24 – 26, 2025
Deutsche Börse Equity Forum 
Enno Spillner (CFO)
Frankfurt, Germany
December 9, 2025
mwb Research Roundtable
Dr. Stefan Glombitza (CEO), Enno Spillner (CFO),
Nicola Mikulcik (CBO), Dr. Andreas Seidl (CSO)
virtual
Preview on 2026:
January 12 – 15, 2026
J.P. Morgan 44th Annual Healthcare Conference
Dr. Stefan Glombitza (CEO), Enno Spillner (CFO), Nicola Mikulcik (CBO)
San Francisco, USA
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 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 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’s FYB201/Ranivisio® sets innovative standard as Europe’s First Ranibizumab Biosimilar available in Pre-filled Syringe
- Innovative pre-filled syringe (PFS) with high standards for intravitreal injections1 offers improved handling, high dosing accuracy and greater convenience for applicants
 - Teva Pharmaceutical Industries Ltd. to commercialize FYB201/Ranivisio®2 PFS across Europe
 - Market launch of FYB201/Ranivisio® PFS started in France in October 2025, with additional countries – including Germany – to follow in a staggered approach
 - FYB201/Ranivisio® PFS expands therapeutic options and maximizes the potential reach of the ranibizumab biosimilar FYB201 throughout Europe
 
Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”), Bioeq AG (“Bioeq”) and Teva Pharmaceutical Industries Ltd. (NYSE/TASE: TEVA, “Teva”) jointly announce the European launch of FYB201/Ranivisio® as the first Lucentis®3 biosimilar available in an EMA-approved innovative pre-filled syringe (“PFS”) presentation. The launch started in France in October 2025, with additional countries – including Germany – to follow in a staggered approach.
FYB201/Ranivisio® will be the first Lucentis® biosimilar in Europe to be offered as a pre-filled syringe, providing patients and healthcare professionals with a convenient, and efficient treatment option. Teva, Bioeq’s established commercialization partner for the vial presentation since 2022, will now also market the PFS, significantly expanding market reach and therapeutic access. This collaboration combines Teva’s deep commercial experience in biosimilars and its extensive distribution network and broad sales and marketing reach across Europe, with Formycon’s capabilities in the development of biosimilar medicines for highly regulated countries.
The innovative PFS technology has been specifically designed for intravitreal injections and is characterized by high dosing accuracy, low injection pressure, and a minimized risk of application errors – key factors in ophthalmic care. The silicon-oil free syringe-device combined with a modern sterilization technology is setting high and innovative standards.
The ready-to-use syringe reduces preparation time and supports efficient administration for patients with neovascular (wet) age-related macular degeneration (nAMD) and other serious retinal diseases.
Dr. Stefan Glombitza, CEO of Formycon, comments: “The launch of our FYB201 pre-filled syringe is another testament to Formycon’s outstanding development expertise paired with innovation power. By introducing the first ranibizumab biosimilar in this modern pre-filled syringe presentation, we are setting new standards in convenience, safety and efficiency for ophthalmic treatments and are underlining our strong commitment to advancing ophthalmic care. The pre-filled syringe not only streamlines clinical workflows by reducing preparation time and minimizing the risk of application errors, it also offers high dosing accuracy and ease of use – features that are highly valued by ophthalmologists in daily practice.
We are confident that this new presentation will enable our commercial partner Teva to reach even more healthcare professionals and patients, and ultimately improve access to FYB201/Ranivisio®”
Michał Nitka, Teva SVP Head Generics Europe & Global Head OTC, added: “We are pleased to offer healthcare professionals and patients a treatment solution, further expanding access to high-quality medicines. At Teva, we are committed to pushing boundaries to deliver the right medicines whenever they are needed. Through our partnership with Formycon, we are accelerating the availability of therapies and broadening Teva’s biosimilars portfolio, in line with our Pivot to Growth strategy, while leveraging our capabilities to serve patients with the treatments they need.”
FYB201/Ranivisio® (ranibizumab) is used to treat severe visual impairments such as wet age-related macular degeneration (nAMD) and other retinopathies. FYB201 is owned by Bioeq AG, a joint venture between Formycon AG and Polpharma Biologics Group BV. The Biosimilar product is currently available in a total of 21 countries in Europe, North America and the MENA region.
1) An intravitreal injection refers to the injection of a medication into the vitreous body of the eye.
2) Ranivisio® is a registered trademark of Bioeq AG.
3) Lucentis® is a registered trademark of Genentech 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 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 commercializes biosimilars. www.bioeq.ch
About Teva Pharmaceutical Industries Ltd.:
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.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.
Actor Pharmaceuticals and Megalabs become partners for the commercialization of Formycon’s Eylea® biosimilar FYB203 (aflibercept) for Australia and Latin America
Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) announces that Klinge Biopharma GmbH (“Klinge”), the exclusive owner of the global commercialization rights of Formycon’s Eylea®1 biosimilar FYB203 (aflibercept), concluded an exclusive license agreement with Actor Pharmaceuticals Pty. Ltd. (“Actor”) for the commercialization of FYB203 in Australia. Furthermore, for Latin America, Klinge has signed an exclusive license agreement with Megalabs S.A. (“Megalabs”).
Upon signature of the agreements, Klinge is eligible to receive upfront and milestone payments, plus royalties on net sales. Formycon will participate in the mid-single-digit to low-double-digit percentage range in all payment streams to Klinge resulting from these agreements. Furthermore, Formycon will act as authorized designee to organize the supply chain for FYB203 and will receive additional service payments and a volume-based profit component for organizing the commercial market supply on behalf of Klinge.
“Severe retinopathies are on the rise worldwide due to demographic trends and the increasing number of diabetes cases, which can lead to retinal diseases. With the partnerships for Australia and Latin America, Klinge has laid the foundation for making our Eylea® biosimilar FYB203 available as an effective and cost-efficient treatment option in further important regions of the world. With Actor and Megalabs, we have gained two strong distribution partners with excellent regional networks and a profound local market knowledge. Together, we are focused on improving the treatment options for the many patients who have been underserved in the past. At the same time, we are contributing to reduce the financial burden on healthcare systems,” says Nicola Mikulcik, Chief Business Officer (CBO) of Formycon AG.
Actor Pharmaceuticals is an established Australian pharmaceutical company specializing in the registration and commercialisation of innovative medicines and biosimilars in Australia. With a strong commitment to quality, patient access, and long-term partnerships, Actor Pharmaceuticals collaborates with global industry leaders to bring clinically proven therapies to the Australian market. The company’s expertise spans product registration, market access, and commercialization – driving growth across both prescription and over-the-counter segments.
Megalabs is a leading pharmaceutical company based in Uruguay with a strong presence and market position in the Americas. Megalabs is at the cutting edge of biotechnological innovation, with its High-Tech business unit serving as one of the main pillars of the organization’s success. The company’s various business areas also include the development, manufacturing and marketing of biosimilar products.
In June 2024, the aflibercept biosimilar FYB203 was approved by the US Food and Drug Administration (“FDA”). Approval by the European Commission followed in January 2025 and approval by the British MHRA one month later. For Australia, the regulatory application has been submitted to the Therapeutic Goods Administration (“TGA”). Formycon is also working closely with Megalabs to prepare the applications for approval in Latin American countries.2
Eylea® (aflibercept) is used to treat neovascular age-related macular degeneration (nAMD) and other severe retinal diseases. The active ingredient inhibits the vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina.
1) Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
2) The commercial launch of FYB203 in Australia and Latin America depends on several factors – firstly on approval by the respective regional regulatory authorities, and secondly on the progress and outcome of ongoing or potential future patent litigation or possible settlement agreements.
Formycon secures U.S. License Date for proposed Aflibercept Biosimilar FYB203 following settlement and license agreement with Regeneron
- Formycon and its partners entered into a settlement and license agreement with Regeneron for FYB203/AHZANTIVE® (Aflibercept-mrbb)
 - Pending litigation at the U.S. District Court for the Northern District of West Virginia fully resolved
 - Commercial launch of FDA approved FYB203 in the U.S. expected in Q4/2026 by commercialization partner Valorum Biologics
 
Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”), together with its license partner Klinge Biopharma GmbH (“Klinge”) and Valorum Biologics (“Valorum”), announces a settlement and license agreement (“Agreement”) with Regeneron Pharmaceuticals, Inc. (“Regeneron”), resolving all patent disputes related to its FDA-approved Eylea®2 biosimilar for the U.S. market. Under the terms of the agreement, Valorum may launch AHZANTIVE® in the United States in the fourth quarter of 2026, or potentially earlier under certain circumstances.
“This agreement marks a significant milestone for Formycon and our partners. It resolves all outstanding patent matters and establishes a clear timeline for the U.S. launch of FYB203/AHZANTIVE®. Together with Valorum Biologics, our exclusive commercialization partner, we are committed to ensuring that patients and healthcare providers in the United States gain access to a high-quality, affordable biosimilar option for retinal diseases. This achievement highlights our ability to navigate complex regulatory and legal frameworks and reinforces our dedication to expanding patient access in the U.S. market,” says Nicola Mikulcik, Chief Business Officer of Formycon AG.
Regeneron initiated patent infringement proceedings against Formycon in connection with AHZANTIVE® pursuant to the Biologics Price Competition and Innovation Act (BPCIA) in the US Federal District Court for the Northern District of West Virginia in November 2023. This included infringement claims under about 40 patents protecting the reference product Eylea® and expiring as late as 2040. All pending litigation has now been resolved by the parties in the agreement.
FYB203/AHZANTIVE® received FDA approval in July 2024 for the treatment of patients with neovascular (wet) age-related macular degeneration (nAMD) and other serious retinal diseases, including diabetic macular edema (DME), diabetic retinopathy (DR), and macular edema following retinal vein occlusion (RVO). The active ingredient, aflibercept, inhibits vascular endothelial growth factor (VEGF), targeting abnormal blood vessel formation in the retina.
In June 2025, Formycon announced an exclusive license agreement between Klinge and U.S. biosimilars specialist Valorum for the commercialization of FYB203/AHZANTIVE® in the United States and Canada.
1) AHZANTIVE® is a registered trademark of Klinge Biopharma GmbH
2) Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
Horus Pharma becomes additional commercialization partner for Formycon's Eylea® biosimilar FYB203 in selected European countries under the brand name Baiama®
Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) announces that Klinge Biopharma GmbH (“Klinge”), the exclusive owner of the global commercialization rights of Formycon’s Eylea®1 biosimilar FYB203 (aflibercept), concluded an additional semi-exclusive license agreement with Horus Pharma (“Horus”) for the commercialization of FYB203/Baiama®2 in selected European countries. The agreement follows the semi-exclusive partnership signed in January with Teva Pharmaceuticals International GmbH (“Teva”) for the commercialization of FYB203/AHZANTIVE®3 covering major parts of Europe and Israel.
Upon signature, Klinge is eligible to receive upfront and milestone payments, plus royalties on net sales. Formycon will participate in the mid-single-digit to low-double-digit percentage range in all payment streams to Klinge resulting from these agreements. Furthermore, Formycon will act as authorized designee to organize the supply chain for FYB203 and will receive additional service payments and a volume-based profit component for organizing the commercial market supply on behalf of Klinge.
Aflibercept is used to treat neovascular age-related macular degeneration (nAMD), the leading cause of blindness and visual disability in patients aged over 60 years in Europe and North America, as well as other severe retinal diseases.
Nicola Mikulcik, CBO of Formycon AG says: “We are very pleased that we could add Horus Pharma, a distinguished specialist in ophthalmology, to the group of our excellent commercial partners. Horus will market the brand Baiama® in selected European markets including its home market France. Baiama® will be sold as a second brand in addition to AHZANTIVE®, which will be launched by Teva across Europe. Teva is already successfully marketing our Lucentis®4 biosimilar Ranivisio®5. With our two-brand-partner strategy we are striving for the best possible therapeutic coverage to fully leverage the high market potential in Europe.”
Horus Pharma is the second largest independent ophthalmological laboratory in France and a leading player in Europe. For more than 20 years, the independent laboratory has been recognized for its know-how in developing preservative-free products in ophthalmology. Thanks to a sustained Research & Development policy, Horus Pharma is improving the daily lives of patients by developing and distributing solutions and products for all segments of eye health.
In June 2024, the aflibercept biosimilar FYB203 was approved by the US Food and Drug Administration (“FDA”). Approval by the European Commission under the brand names AHZANTIVE® and Baiama® followed in January 2025. One month later, FYB203 also received marketing authorization by the British MHRA.6
1)Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
2)Baiama® is a registered trademark of Klinge Biopharma GmbH
3)AHZANTIVE® is a registered trademark of Klinge Biopharma GmbH
4)Lucentis® is a registered trademark of Genentech Inc.
5)Ranivisio® is a registered trademark of Bioeq AG
6)The commercial launch of FYB203 in Europe depends on the progress and outcome of ongoing
or potential future patent litigation or possible settlement agreements.
Alira Health has acted as strategic advisor to Klinge and Formycon
in the transaction with Horus Pharma.
Formycon confirms full-year guidance following business development in line with plan – working capital raised
- Half-year results in line with expectations – full-year 2025 guidance confirmed
 - Outlook for working capital raised following successful placement of oversubscribed €70 million corporate bond
 - Strong second half expected: increasing market penetration of FYB202 and partnering of FYB206 as key value drivers for fiscal year 2025
 - FYB206: patient enrollment in Phase I trial successfully completed – streamlined clinical development program underscores leading position in the global race for a Keytruda®1 biosimilar
 - Invitation to today’s conference call at 3:00 p.m. (CEST)
 
Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) today reported on the Group’s business development and financial results for the first half of 2025. The Company has continued its operational activities in a targeted manner and achieved significant progress across its biosimilar projects. The first half of the year was characterized by many positive operational milestones, progressive regulatory optimizations, new product launches, the further expansion of international commercialization partnerships, and the successful placement of a corporate bond.
Enno Spillner, CFO of Formycon AG, commented: “Our half-year figures are in line with our expectations and reflect structural effects that were already taken into account when preparing our annual forecast. The positive developments of recent weeks and months strengthen our expectations for a strong and highly dynamic second half of the year – in particular through the further market penetration of FYB202 and potential partnerships for FYB206. Both programs are excellently positioned to make a significant contribution to achieving our targets in both the remainder of the year and, in particular, in the fourth quarter. Our guidance for 2025 therefore remains largely unchanged. With the clearly oversubscribed issuance of our first corporate bond, we have strengthened our financial flexibility and are raising our working capital forecast accordingly. This puts us in a solid operational and strategic position for sustainable corporate growth.”
Group revenue and earnings performance in line with plan – 2025 guidance confirmed and working capital forecast raised
In the first half of 2025, the Formycon Group generated revenues of around €9.0 million (H1/2024: €26.9 million). The anticipated decline compared to the previous year primarily reflects a project-related transition phase and a changed revenue structure: While substantial milestone payments from the FYB202 partnership were recognized in the same period of the previous year, there were no comparable one-off revenues in the reporting period. Similarly, reimbursements for billable development services for FYB201 and FYB203 declined as forecast due to the advanced project status. New revenue from profit sharing for FYB202 was not yet sufficient to compensate for this decline. However, Formycon expects a strong and highly dynamic second half of the year, driven by the conclusion of targeted license partnerships for FYB206 and the further market penetration of FYB202. This applies in particular to Q4/2025.
The Stelara®2 biosimilar FYB202/Otulfi®3 was launched commercially by Formycon’s partner Fresenius Kabi at the end of the first quarter. In the U.S., the product is mainly distributed through the pharmacy benefit channel. Market development is still in its early stages and will be built up gradually through further contract signings, which will then generate additional market momentum. In Europe, FYB202 was launched in several countries in March. Since the third quarter, the product has also been marketed semi-exclusively in Germany by Ratiopharm under the trade name Fymskina®4. Revenue from the direct share in the commercialization of FYB202 amounted to €1.7 million (H1/2024: €0). In line with advancing market penetration, Formycon expects FYB202 to make a significant contribution to revenue.
In the case of the ranibizumab biosimilar FYB201, marketing partner Sandoz decided in the first quarter to temporarily suspend marketing in the U.S. Market-related adjustments to the pricing structure also had a dampening effect on earnings contributions. These structural changes had already been considered in the annual forecast, meaning that business development in the first half of the year was in line with expectations. Revenue from direct involvement in the marketing of FYB201 amounted to €0.8 million (H1/2024: €3.8 million). FYB201 continued to be successfully marketed across 21 markets outside the U.S., including Europe and the MENA region. Additional market momentum is expected in the second half of the year, particularly from the launch of the prefilled syringe in several European countries. This is intended to expand the product offering and specifically strengthen market penetration. The resumption of marketing in the U.S. is planned for the first half of 2026.
Overall, Formycon continues to expect full-year sales of €55.0 to 65.0 million, based on the assumption that sales from the profit share for FYB202 will increase significantly in the second half of the year, particularly in Q4. In addition, licensing activities for FYB206 are expected to play a significant role in revenues in the second half of the year.
The Group’s earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to €-17.9 million in the first half of 2025 (H1/2024: €-16.9 million). Performance was in line with financial planning and primarily reflects the decline in revenues. At the same time, following the successful approval of FYB202 in the fourth quarter of the previous year, the scheduled amortization of the capitalized intangible asset began, resulting in additional non-EBITDA-relevant costs of sales of approximately €12.5 million. As development costs incurred for FYB206 are capitalized, these investments are not recognized in the income statement.
Based on the expected increase in revenues in the second half of the year, Formycon continues to forecast EBITDA for the full year 2025 in the range of €-20.0 million to €-10.0 million.
Adjusted EBITDA amounted to €-19.2 million (H1/2024: €-2.1 million) and includes the earnings contribution from the 50% stake in Bioeq AG. The equity-accounted result of Bioeq AG amounted to €-1.2 million in the reporting period (H1/2024: €14.8 million) and reflects the temporary marketing pause for FYB201 in the U.S. as well as market-driven pricing adjustments. The forecast for adjusted EBITDA of between €-20.0 million and €-10.0 million remains unchanged.
The Formycon Group’s net working capital amounted to approximately €17.0 million as of June 30, 2025 (December 31, 2024: €55.1 million). The decline compared to the prior-year figure is mainly attributable to the capital increase of €83 million realized in February 2024 and project-related payment deferrals. In addition, the cash inflow from the €70.0 million corporate bond successfully placed in July 2025 occurred after the reporting date and is therefore not yet reflected in the balance sheet figures as of June 30. As a result, Formycon is raising its working capital outlook for 2025 from the original range of €25.0 million to €35.0 million to a range of €55.0 million to €65.0 million.
With the completion of the transaction and the associated cash inflow, the financing of ongoing development activities for the existing portfolio and operating business is secured. Formycon is pursuing sustainable and medium-term EBITDA-profitable corporate development and expects to achieve a positive EBITDA result ideally as early as 2026, but no later than fiscal year 2027.
Solid operational start to the year with significant regulatory milestones
Dr. Stefan Glombitza, CEO of Formycon AG, said: “We made strong progress on our growth strategy and reached key milestones in the first half of the year. With FYB202, our second biosimilar has entered international commercialization; the market rollout in the U.S. and Europe remains in its early stages but continues to make steady progress. The development of FYB206 is progressing very well: the successful completion of patient enrollment in the Phase I study confirms the effectiveness of our innovative, streamlined study design and will help us develop our biosimilar projects faster and more cost-efficiently.
Diversification is the key to sustainable success and stability in a dynamic market environment. In recent months, we have intensified our efforts in this direction. Through targeted expansion into high-growth emerging markets, a broad network of regional commercialization specialists, and a strategically balanced, maturing portfolio, we are laying the foundation for tomorrow. Building on our extensive biosimilar experience, combined with AI-driven development and increasingly improved regulatory frameworks, we optimize resources and processes, positioning ourselves lean and efficient to seize the numerous opportunities in the growing biosimilars segment.”
Right at the beginning of the year, the Eylea®5 biosimilar FYB203 received EU approval under the brand names AHZANTIVE®6 and Baiama®7, followed by authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA). Klinge Biopharma, holding the global marketing rights, established commercialization partnerships with Teva (Europe), Lotus Pharmaceutical (Asia-Pacific), and Valorum Biologics (USA/Canada). Within this framework, Formycon will be responsible for coordinating the supply chain and market supply.
The Stelara® biosimilar FYB202 received approvals in Canada and the United Kingdom at the beginning of the year. Commercialization partner Fresenius Kabi launched the product in the U.S. at the end of February, followed by market launches in several European countries. In April, the U.S. Food and Drug Administration granted interchangeability status, which facilitates substitution in pharmacies. This was followed in May by the launch in Canada and the assignment of a permanent billing code in the U.S. to ensure reimbursement eligibility. In June, Formycon also signed an agreement with Teva subsidiary Ratiopharm for secondary commercialization in Germany.
Based on positive feedback from the FDA, Formycon decided in February 2025 to discontinue the Phase III trial for its Keytruda® biosimilar candidate FYB206, as therapeutic comparability can be demonstrated by comprehensive analytical data and an ongoing Phase I PK study. This adjustment significantly accelerates development and reduces the expected investment by over €75 million. Patient recruitment for the study was completed in July, and the first participants have already completed all 17 treatment cycles. Results for the primary endpoint are expected in the first quarter of 2026.
FYB201 (Lucentis®8 biosimilar) is now approved in 21 countries. In the first half of 2025, FYB201’s global presence was expanded with additional approvals, including Brazil, South America’s largest market. Launch by regional partner Biomm is planned for the fourth quarter. Further approvals were granted in Peru, El Salvador, Honduras, and the Dominican Republic. In addition, an exclusive marketing agreement for Sub-Saharan Africa was signed with Bio Usawa. The launch of a pre-filled syringe in Europe in the second half of the year is expected to further increase market penetration in the region.
In addition to its advanced biosimilar programs, Formycon is also continuing to advance its younger product pipeline. The candidates FYB208, FYB209, and FYB210 are in early stages of development. FYB208 is scheduled to enter clinical development this year.
Successful debt financing underscores attractiveness of the biosimilars business
To finance its growth strategy and expand its investor base, Formycon issued its first corporate bond in June 2025, which was increased from €50.0 million to €70.0 million due to high demand. The four-year, floating-rate bond was placed with institutional and private investors in Germany and abroad. The net proceeds will be used primarily to further develop the biosimilar pipeline and scale up commercial activities.
Key financial performance indicators at a glance in € million
| Results H1 2024 | Results H1 2025 | Guidance 2025 old | Guidance 2025 new | Change | |
|---|---|---|---|---|---|
| Revenue | 26.9 | 9.0 | 55.0 to 65.0 | 55.0 to 65.0 | unchanged | 
| EBITDA | -16.9 | -17.9 | -20.0 to -10.0 | -20.0 to -10.0 | unchanged | 
| Adjusted EBITDA | -2.1 | -19.2 | -20.0 to -10.0 | -20.0 to -10.0 | unchanged | 
| Working Capital | 63.0 | 17.0 | 25.0 to 35.0 | 55.0 to 65.0 | raised | 
The complete 2025 half-year report can be found here.
Conference call and dial-in details
The Executive Board of Formycon AG will discuss the Company’s development and key financial figures in a conference call. The earnings call, which will be broadcast live on the Internet, will take place on August 13, 2025 at 3:00 p.m. CEST and will be held in English.
To participate in the conference call, please register at:
https://webcast.meetyoo.de/reg/F0udEyLuS7H5
After registration, participants will receive a confirmation email with their individual dial-in details.
The presentation and audio webcast can be accessed via the following link:
https://www.webcast-eqs.com/formycon-2025-h1
Following a brief presentation, the Executive Board will be available to answer questions from analysts. The conference call will be recorded and subsequently available on the Formycon website at: https://www.formycon.com/en/investors/publications/.
1) Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, einer Tochtergesellschaft von Merck & Co, Inc, Rahway, NJ/USA
2) Stelara is a registered trademark of Johnson & Johnson
3) Otulfi® is a registered trademark of Fresenius Kabi Deutschland GmbH in ausgewählten Ländern
4) Fymskina® is a registered trademark of Formycon AG
5) Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
6) AHZANTIVE® is a registered trademark of Klinge Biopharma GmbH
7) Baiama® is a registered trademark of Klinge Biopharma GmbH
8) Lucentis® is a registered trademark of Genentech Inc.
Formycon invites to conference call on 2025 half-year results and announces participation in international investor conferences in the 3rd quarter of 2025
Planegg-Martinsried, Germany – Formycon AG (FSB: FYB, Prime Standard, „Formycon“) plans to publish its results of the first half of the 2025 fiscal year on August 13, 2025. The Management Board will discuss the company’s development, key financial figures, and provide an outlook for the course of 2025. The conference call, which will be broadcast live on the internet, will take place on Wednesday, August 13, 2025, at 3:00 PM (CEST) in English.
To participate in the conference call, please register at:
https://webcast.meetyoo.de/reg/F0udEyLuS7H5
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-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
August 28, 2025
HIT – Hamburg Investors’ Day
Enno Spillner (CFO)
Hamburg
September 03 – 05, 2025
2025 Wells Fargo Healthcare Conference
Enno Spillner (CFO)
Everett / Boston
September 08 – 10, 2025
H.C. Wainwright 27th Annual Global Investment Conference
Enno Spillner (CFO)
New York City
September 23, 2025
Berenberg & Goldman Sachs German Corporate Conference
Dr. Stefan Glombitza (CEO), Enno Spillner (CFO)
Munich
Additionally scheduled conference participations in 2025:
November 17 – 20, 2025
Jefferies Global Healthcare Conference
Enno Spillner (CFO)
London
November 24 – 26, 2025
Deutsche Börse Equity Forum
Enno Spillner (CFO)
Frankfurt
Please find our current events at:
https://www.formycon.com/en/investors/financial-calendar/
Formycon successfully completes patient enrollment for the clinical development of its Keytruda® biosimilar candidate FYB206
- Streamlined clinical development program, which no longer requires a Phase III trial, is already in a far advanced stage
 - Last patient enrolled in Dahlia pharmacokinetic (PK) study (Last Patient-In)
 - First patients have completed all 17 treatment cycles of the Dahlia study
 - Results on the primary endpoint of the study expected in the first quarter of 2026
 
Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) announced today that the patient enrollment for the clinical PK study Dahlia1 has been successfully completed with a total of 96 participants (Last Patient-In). The Dahlia study, which was launched in June 2024 in selected Southeastern and Eastern European study centers, compares the pharmacokinetics, safety and tolerability of FYB206 with the immuno-oncology blockbuster drug Keytruda®2.
At the end of 2024, Formycon submitted a streamlined clinical strategy to the U.S. Food and Drug Administration (FDA) with the intention to demonstrate the therapeutic comparability of FYB206 with the reference drug Keytruda® based on comprehensive analytical data and data from the PK study (Dahlia). Following a positive response from the FDA, the company decided in February 2025 to discontinue recruitment for the already-started Phase III trial. This decision accelerates the development of the biosimilar and at the same time significantly reduces the related investments over the coming years. The treatment of patients already enrolled in the Phase III trial has subsequently been continued with the locally available Keytruda® outside the trial.
„With our streamlined clinical development program for FYB206, we have secured a leading role among the developers of a pembrolizumab biosimilar. This is further underlined by the efficient and reliable execution of the Dahlia PK study. The fact that we can now announce the completion of patient enrollement with the ‘last patient in’ is further proof of Formycon’s professional study management and the strong recruitment performance in the study centers“, says Dr. Andreas Seidl, Chief Scientific Officer of Formycon AG and adds: „The first patients in the Dahlia trial have already completed all 17 treatment cycles. We therefore currently expect to receive the results of the study endpoint in the first quarter of 2026.
As a reminder: based on our stringent Dahlia study design, our sound scientific rationale and the comprehensive analytical data showing high structural and functional comparability with the reference drug, we have aligned with the FDA on a streamlined clinical development program that allows us to skip the Phase III trial. This approach accelerates development without compromising on quality, safety and efficacy. Furthermore – the streamlined clinical program supports our strategy to provide the pembrolizumab biosimilar FYB206 to patients worldwide as soon as possible and thus improve access to this essential drug.“
Pembrolizumab is an immune checkpoint inhibitor that is used in cancer therapies to treat various tumor diseases. With this broad range of indications and sales of around US$ 29.5 billion in 20243, Keytruda® is currently the world’s best-selling drug. Sales could rise even further in the coming years – according to forecasts to over US$ 50 billion in 20324. The number of cancer diagnoses is also continuing to rise – estimates by the International Agency for Research on Cancer (IARC) predict an increase of 77% by 2050.5
Following the successful completion of clinical development and approval by the regulatory authorities, Formycon currently expects the earliest market entry of its biosimilar candidate FYB206 after the expiry of the market exclusivity of the reference product in 2029 for the USA and after 2030 for the EU.
1   The Dahlia-PK study treats patients who have had malignant melanoma (black skin cancer) surgically removed. This so-called adjuvant therapy over 17 treatment cycles aims to minimize the risk of relapse in these patients.
2   Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA.
3   Source: https://www.merck.com/news/merck-announces-fourth-quarter-and-full-year-2024-financial-results/
4   Source: https://www.custommarketinsights.com/report/keytruda-market/
5   Source: https://www.who.int/news/item/01-02-2024-global-cancer-burden-growing–amidst-mounting-need-for-services
Bio Usawa becomes partner for the commercialization of FYB201/BioUcenta™ (ranibizumab) across Sub-Saharan Africa
- Partnership marks a landmark step towards global availability of FYB201
 - Bio Usawa gets exclusive rights to register and commercialize FYB201/BioUcenta™1 in Sub-Saharan Africa
 - Product launch expected in Q1/2026 in the first countries
 - Partnership will provide access to ophthalmic treatment for millions of people facing preventable blindness from diabetes complication
 
Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) today announces that Bioeq AG (“Bioeq”), licensee and exclusive holder of the worldwide commercialization rights for FYB201, Formycon’s biosimilar candidate for Lucentis®2 (ranibizumab), entered into an exclusive partnership with African biotechnology company Bio Usawa Biotechnology Ltd. (“Bio Usawa”).
This partnership grants Bio Usawa exclusive rights to register and commercialize FYB201 under the brand name BioUcenta™, bringing a highly effective ophthalmic medicine within reach for millions of patients across Sub-Saharan Africa.
FYB201/ BioUcenta™ is a monoclonal antibody used to treat diabetic macular edema (DME), neovascular age-related macular degeneration (nAMD), and other retinal diseases like diabetic retinopathy, that often lead to vision loss if not treated. While this therapy has been established in higher-income countries for nearly 20 years, patients across Africa have predominantly been denied access due to prohibitive costs and limited availability.
Africa is at the front line of a growing diabetes crisis. According to the International Diabetes Federation, more than 24 million Africans were living with diabetes in 2024, with that number projected to double by 2050. Diabetic retinopathy, a leading complication, threatens the sight of up to one-third of these patients.3
“By making ranibizumab accessible in Sub-Saharan Africa, we are empowering doctors to save the vision of millions, particularly those suffering complications from diabetes—a disease that is quietly but rapidly becoming one of Africa’s greatest health threats,” said Dr. Menghis Bairu, Co-founder, President and CEO of Bio Usawa. “This collaboration is about equity,” he added. “Access to advanced biologic therapies should not be a privilege of geography or income. We are proud to work with Formycon to make this a reality for Africa — ensuring that patients, regardless of where they live, can receive the care they deserve.”
“We are very excited to collaborate with Bio Usawa, who is a strong commercial partner with in-depth knowledge of the regional market and the specific requirements of the ophthalmology sector,” says Formycon CBO Nicola Mikulcik, adding: “This partnership represents a demonstration of the fulfillment of our joint mission to democratize access to high-quality, affordable, and proven biotherapies in low and middle income countries. This initiative should create the foundation of making essential medicines developed by Formycon available to the African continent.”
Developed by Bioeq AG, a joint venture between Formycon AG and Polpharma Biologics Group BV, FYB201 is currently available in a total of 21 countries.
- BioUcenta™ is a trademark of Bio Usawa Biotechnology Ltd.
 - Lucentis® is a registered trademark of Genentech Inc.
 - Source: IDF_Atlas_11th_Edition_2025_AFR_Factsheet.pdf
 
Formycon increases bond volume following oversubscription – Bond 2025/2029 with a volume of EUR 70 million successfully and entirely placed
- Due to strong demand, the offering period for the public offering has been shortened and target volume was increased from initially EUR 50 million to EUR 70 million
 - Interest rate fixed at the lower end of the marketing range at EURIBOR plus a margin of 7.00% p.a.
 - Inclusion to trading on the Quotation Board of the Frankfurt Stock Exchange scheduled for June 30, 2025; issue and value date on July 9, 2025
 
Planegg-Martinsried, Germany –. Formycon AG (FSE: FYB, Prime Standard, “Formycon”) announces that its 2025/2029 corporate bond (ISIN: NO0013586024 / WKN: A4DFJH) was significantly oversubscribed due to high demand, leading to an increase in the initially targeted issuance volume from EUR 50 million to EUR 70 million. The senior unsecured and floating rate bond with a term of four years was successfully and entirely placed on the capital market. The margin was fixed at 7.00% p.a., at the lower end of the indicated range.
“The active dialogue with investors and the positive feedback during the roadshow were key contributors to the successful order book. The significant oversubscription and full placement confirm the attractiveness of this bond as well as the trust in our business model and the future of biosimilars. We succeeded in addressing a new investor base – internationally and in our home market, institutionally and in retail. We would like to thank all investors for their trust and commitment.
With the successful placement of the bond, we are creating the basis for a long-term diversified financing structure. The proceeds will provide us with the flexibility to continue executing our growth strategy, to optimize our biosimilar platform and to strengthen our position as a commercially focused company. We are very proud of the outcome and would like to thank the entire team for the excellent preparation and execution of this transaction,” explained Enno Spillner, CFO of Formycon AG.
The offering met with strong demand, particularly from institutional investors both in Germany and internationally. Retail investors also showed significant interest as part of the public offer and participated via Deutsche Börse’s DirectPlace platform as well as the company’s website. All subscription orders up to an amount of EUR 2,000 per order were fully allocated; higher volumes were allocated on a pro rata basis of 40%, rounded to whole bonds, with each order being allocated a maximum of EUR 20,000.
The interest rate was finally set at EURIBOR plus a margin of 7.0% p.a., placing it at the lower end of the initial marketing range of 7.0% to 7.5% p.a.
The net proceeds received by the Company will be used to finance the development and expansion of the Company’s biosimilar product portfolio as part of its corporate growth strategy.
Inclusion of the bond in trading on the Open Market of Deutsche Börse AG is scheduled for July 9, 2025 (issue and value date). Trading on a per appearance basis is expected to commence on Monday, June 30, 2025. Formycon further plans to apply for inclusion in trading on Euronext ABM of the Oslo Stock Exchange within six months following the bond’s issue date.
The transaction was led by IKB Deutsche Industriebank AG and Pareto Securities AS as Joint Lead Managers.