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Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) today announced details of one of its previously undisclosed development projects: FYB208 is a biosimilar candidate for the immunological blockbuster drug Dupixent^®1 (INN: dupilumab). With successful demonstration of the Technical Proof of Similarity (TPoS), FYB208 shows high analytical comparability to the reference drug.

Dupilumab is used to treat certain patients with chronic obstructive pulmonary disease (COPD), asthma, atopic dermatitis (neurodermatitis), and other chronic inflammatory diseases. The active ingredient inhibits the signaling pathways of interleukin-4 (IL-4) and IL-13, which are responsible for type 2 inflammatory reactions. Due to its wide range of therapeutic opportunities with approvals for additional indications, the active ingredient has been recording high growth rates for years. In 2024, global sales reached US$14.1 bn, an increase of 22% compared to the previous year.² In 2025, growth continued at a similar rate: Dupixent^® generated revenues of around US$8 bn in the first six months.³ Forecasts underscore the sustainably high potential of dupilumab: sales are expected to rise to more than US$ 20 bn⁴ by 2030.

Dr. Andreas Seidl, CSO of Formycon AG, commented: “With the achieved Technical Proof of Similarity, we successfully completed the preclinical development of our dupilumab biosimilar candidate. The convincing data on its comparability with the reference drug highlights our strong expertise in development of biosimilars, especially in chronic inflammatory diseases and marks another important milestone in our growth strategy. Based on this excellent data set, we are highly confident that we will be able to meet all requirements for approval of FYB208 without a comparative efficacy study (Phase III study). This allows us to advance development with an optimized timeline, in order to improve access to a much-needed treatment option for the many patients suffering from chronic inflammatory diseases. This is supported by the high productivity of the developed cell line, which enables competitive manufacturing.”

Full project and commercialization rights for FYB208 are held by Formycon. The company is currently developing the study design for the planned clinical pharmacokinetic (PK) study in close alignment with the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). Study planning is performed on the background that, following the publication of the Reflection Paper⁵ by EMA, the U.S. FDA has also recently published a draft guideline for the streamlined development of biosimilars⁶. The next development phase, including GMP manufacturing, has already been initiated following the successful achievement of the TPoS milestone.

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

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

About 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, “Formycon”) today reports on the Group’s business development and financial results for the first nine months of fiscal year 2025. During the reporting period, the company successfully expanded its operational activities and consistently pursued its strategic priorities in the areas of development, financing, partnerships, and competitiveness. Based on these positive developments, Formycon confirms its existing guidance for the 2025 fiscal year.

Enno Spillner, CFO of Formycon, commented: “Operational development and financial performance in the third quarter were in line with expectations. In addition, we confidently anticipate a dynamic fourth quarter and expect significant sales momentum from the ongoing market penetration of our Stelara® biosimilar FYB202 in the US and Europe. In particular, the exclusive US distribution agreement concluded by Fresenius Kabi with CivicaScript promises a significant increase in sales in the fourth quarter. In addition, we expect further positive momentum from the advanced commercialization discussions for our Keytruda®2 biosimilar candidate FYB206 in selected regions. Our rigorous, streamlined development program without a Phase III study has enabled us to advance the clinical development of FYB206 significantly faster and more cost-efficiently. The successful completion of patient recruitment once again underscores our pioneering role in global biosimilar development and at the same time strengthens our appeal for future partnerships. With strict cost control and the solid financing structure from our first corporate bond in the summer, we are well positioned to achieve our annual targets.”

Group revenues and earnings development on track – guidance for 2025 confirmed

In the first nine months of 2025, the Formycon Group generated revenues of approximately €19.5 million (9M/2024: €41.1 million). While the previous years’ figures included one-time payments from license and milestone agreements for FYB202, current revenues increasingly derive from recurring proceeds from the marketing of approved biosimilars, from development services for out-licensed or jointly developed projects, and from service payments for supply chain coordination.
Revenues from the ranibizumab biosimilar FYB201 from direct participation in commercialization proceeds amounted to €1.5 million (9M/2024: €6.0 million). As previously reported, Sandoz temporarily paused commercialization in the US from the second quarter of 2025 for tactical market reasons; based on current information, resumption is planned for the first quarter of 2026. In the remaining 24 markets outside the US – including Europe and the MENA region – FYB201 continued to be marketed, and development proceeded as expected. After the end of the reporting period, FYB201 was launched as the first ready-to-use syringe of a ranibizumab biosimilar in the first European countries. The syringe system sets new standards in quality and innovation and increases the marketing potential of the ranibizumab biosimilar FYB201 in Europe.

The Stelara® biosimilar FYB202 (Otulfi®3/Fymskina®4) developed according to plan during the reporting period. Following the market launch by our partner Fresenius Kabi in March, market development is progressing steadily. In the US, FYB202 is primarily distributed through the pharmacy benefit channel. An exclusive distribution agreement with CivicaScript and other contracts have now been concluded. In Europe, FYB202 has already been launched in 18 countries. In Germany, our distribution partner Ratiopharm has additionally been handling sales for FYB202/Fymskina® since this summer. Revenues from direct participation in the commercialization of FYB202 amounted to €3.2 million (9M/2024: €0). Milestone payments of €0.5 million were also realized for approvals in additional regions. Based on the contracts concluded and the expected order volumes, Formycon anticipates a significant increase in revenue contributions from FYB202 in the final quarter of 2025.
The Group’s earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to
€-21.4 million in the reporting period (9M/2024: €-17.7 million) and were thus in line with planning. This development mainly reflects the temporary decline in sales revenues resulting from the transition phase between one-time license payments and the increasing share of sales from commercialized products. Adjusted EBITDA amounted to €-21.7 million (9M/2024: €2.9 million) and includes the earnings contribution from the 50% stake in Bioeq AG.
The at-equity result of Bioeq AG for the first nine months was €-0.3 million (9M/2024: €20.6 million), reflecting the temporary marketing pause for FYB201 in the US. The forecast for EBITDA and adjusted EBITDA in the range of €-20 million to €-10 million for the full year remains unchanged.

The current positive developments in easing regulatory requirements, such as the waiver of Phase III clinical trials as a standard requirement, are paving the way for shorter and less expensive development cycles and allowing Formycon to focus its structures on greater efficiency. Based on the successful development and approval of three biosimilar products, the company is leveraging the experience it has gained to pool capacities in a targeted manner, further optimize the use of resources, and significantly reduce costs. The growing use of digital technologies and artificial intelligence is increasingly helping to make development processes focused, lean, and thus competitive. Formycon is aiming for EBITDA-profitable corporate development in the medium term and expects that a positive EBITDA result can ideally be achieved in 2026, but no later than in the 2027 fiscal year.

In the second quarter of 2025, Formycon AG successfully placed its first corporate bond 2025/2029 (ISIN NO0013586024 / WKN A4DFJH) in Nordic Bond format with a total volume of €70 million on the capital market. The four-year, floating-rate bond (maturity: July 2029) bears interest based on the 3-month Euribor plus a margin of 7.00% p.a.; interest payments are made quarterly. Investor feedback during the roadshow and after the placement confirms confidence in Formycon’s promising growth strategy and business model.
In connection with the successful placement of a €70 million corporate bond, the working capital forecast was already raised in the first half of the year. Working capital amounted to €83.2 million in the first nine months (9M/2024: €65.8 million), securing the financing of ongoing development activities and operating business in the medium and long term.

Operational development on track – strategic progress and settlement and license agreement confirm outlook for the full year

Dr. Stefan Glombitza, CEO of Formycon AG, said: “In fiscal year 2025, we further refined our strategy in the areas of development, partnerships, and competitiveness and achieved important milestones. With the introduction of the innovative FYB201 prefilled syringe, we are setting new standards in ophthalmic care and creating additional differentiation in the European market. The settlement of the patent dispute with Regeneron regarding FYB203 also marks a decisive step forward in the US market entry of our Eylea®5 biosimilar and strengthens our position in one of the largest biosimilar markets worldwide. The latest initiative by the US health authority to simplify the approval process for biosimilars marks a significant regulatory advance with immediate relevance for our industry. The planned facilitations can significantly shorten development times and at the same time make them more cost-effective. We anticipated this change early on and aligned our clinical strategy for our Keytruda® biosimilar candidate FYB206 accordingly in consultation with the FDA. The streamlined design of our clinical program already shows that scientific excellence can be successfully combined with economic efficiency. These developments confirm our approach and create additional opportunities to develop and bring biosimilars to market faster, more cost-effectively, and with high quality.”

In the third quarter of 2025, Formycon advanced the development of key biosimilar projects as planned and achieved significant operational progress. This includes, in particular, further progress with the pembrolizumab biosimilar candidate FYB206. Following positive regulatory feedback, a Phase III study was not required as therapeutic comparability can be demonstrated by comprehensive analytical data and the ongoing Phase I Pharmacokinetic (PK) study. Patient recruitment for this ongoing Phase I PK study was already completed in July. Formycon expects results for the primary endpoint in the first quarter of 2026.

Further important steps toward market expansion and portfolio differentiation were taken after the end of the reporting period: One focus was on the launch of the pre-filled syringe version of the ranibizumab biosimilar FYB201 (Ranivisio®6) in Europe by our partner Teva. At the beginning of October, a settlement and license agreement for FYB203 was concluded with Regeneron, which resolves all the patent disputes in connection with the aflibercept biosimilar FYB203/Ahzantive®7 in the US. From today’s perspective, this means that the biosimilar, which has already been approved by the FDA, could enter the market in the fourth quarter of 2026. Exclusive commercialization in the United States and Canada will be carried out by the distribution partner Valorum Biologics based on the license agreement concluded at the end of June 2025.

In addition, exclusive commercialization agreements for FYB203 were signed with Actor Pharmaceuticals for Australia and with Megalabs for Latin America. A co-marketing partnership was agreed with Horus Pharma for selected European countries. These partnerships will expand FYB203’s future geographic market coverage and penetration and strengthen Formycon’s competitive position. At the same time, development activities for early-stage projects continued as planned.

Conference call and dial-in details

The Executive Board will discuss the company’s performance and key financial figures and provide an outlook for the remainder of fiscal year 2025. The conference call, which will be broadcast live on the Internet, will take place on Thursday, November 13, 2025, at 3:00 p.m. (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 their individual dial-in details.

The presentation and audio webcast can be accessed via the following link:
https://www.webcast-eqs.com/formycon-2025-q3

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/.

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.

Contact:
Sabrina Müller,
Director Investor Relations & Corporate Communications,
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany

Tel.: +49 (0) 89 – 86 46 67 149
Fax: + 49 (0) 89 – 86 46 67 110
Sabrina.Mueller@formycon.com

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, “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.

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.

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.

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

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/.

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/

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.

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.