Formycon reports key operational achievements in the first half of 2026 and significantly improves financial results year-on-year

Press Release // August 12, 2026
 

Formycon reports key operational achievements in the first half of 2026 and significantly improves financial results year-on-year

• First-half financial results significantly improved year-on-year, with a substantial increase in revenue – 2026 guidance confirmed
• Successful completion of FYB206 clinical development underscores Formycon’s position among the leading developers of a pembrolizumab biosimilar
• EU launch of FYB203 marks the next step in establishing the commercial portfolio
• OneSource partnership strengthens manufacturing network and competitiveness
• Operational progress and strategic initiatives under the FYB4Growth strategy further strengthen the foundation for growth
• Invitation to today’s conference call at 3:00 p.m. (CEST)

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

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

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

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

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

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

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

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

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

Financial performance in the first half of 2026

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

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

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

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

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

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

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

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

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

Overview of key financial performance indicators in € million

*As of December 31, 2025

Conference call and dial-in details

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

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

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

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

Following a brief presentation, the Management Board will be available to answer questions from analysts. The conference call will be recorded and subsequently made available on the Formycon website: https://www.formycon.com/en/investor-relations/publications

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¹ Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ/USA
² Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
³ Ahzantive® is a registered trademark of Klinge Biopharma GmbH
⁴ Baiama® is a registered trademark of Klinge Biopharma GmbH
⁵ Stelara® is a registered trademark of Johnson & Johnson
⁶ Cimerli® is a registered trademark of Sandoz, Inc.
⁷ Nufymco® is a registered trademark of Formycon AG
⁸ Otulfi® is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries

About Formycon
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company covers the entire value chain, from the selection of a promising biosimilar candidate through the various stages of development to the delivery of the approved and market-ready product. In addition, Formycon also has extensive expertise in the planning, management, and monitoring of the supply chain as well as international product logistics. For the commercialization of its biosimilars, Formycon relies on strong, trusted and long-term partnerships worldwide. With FYB201/ranibizumab, FYB202/ustekinumab and FYB203/aflibercept, Formycon already has three biosimilars on the market. Four pipeline candidates – including FYB206/pembrolizumab and FYB208/dupilumab – are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.

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

About #FYB4Growth
With FYB4Growth, Formycon is pursuing a growth strategy based on four strategic pillars aimed at creating sustainable value. First, geographic diversification: in addition to Europe and the U.S., Formycon is strategically expanding into high growth regions such as MENA, APAC and Latin America through strong regional partners. Second, a smart portfolio strategy: Formycon relies on an intelligent portfolio strategy that specifically combines blockbuster molecules with selected niche products and creates the foundation for sustainable value generation through efficient regulatory development pathways. Third, excellence and innovation: Formycon positions itself as a technological and regulatory development powerhouse, creating clear competitive differentiation through innovative product solutions and new regulatory approaches. Fourth, consistent cost efficiency: streamlined processes, optimized development structures and the increased use of digital technologies are designed to enhance the scalability of the business model and strengthen Formycon’s competitiveness over the long term. Find out more at: https://www.fyb4growth.com

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

Contact
Pamela Keck
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany

Tel.: +49 (0) 89 - 86 46 67 369
Fax: + 49 (0) 89 - 86 46 67 110
Mail: ir@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.