EQS-News: Formycon maintains 2026 guidance for revenue, EBITDA and working capital, revises adjusted EBITDA and reassesses FYB201 and FYB202

Press Release // November 05, 2026

Formycon maintains 2026 guidance for revenue, EBITDA and working capital, revises adjusted EBITDA and reassesses FYB201 and FYB202

• 2026 guidance: revenue of EUR 60 to 70 million, EBITDA of EUR 0 to 10 million and working capital of EUR 20 to 30 million unchanged, revenue and EBITDA each at the lower end of the ranges; adjusted EBITDA revised to EUR -15 million to EUR -5 million due to the Bioeq result (previously EUR 5 to 15 million)
• FYB201 (ranibizumab) and FYB202 (ustekinumab): commercialization partners expect lower revenues due to the competitive market environment, with additional competitors and rising price pressure
• Impairments on both products, with no cash outflow: net EUR 82 million for FYB202 and EUR 39 million for FYB201, charged to consolidated net income for 2026
• Next product generation not affected: FYB206 (pembrolizumab) under FDA review, decision expected in the third quarter of 2027; FYB208 (dupilumab) in development; FYB286 funded in advance by a partner
• Nine-month results and conference call on November 12, 2026, as planned

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”), an independent developer of biosimilars, is adjusting the valuation of its first two products to current market developments. Additional competitors have entered the markets for ranibizumab and ustekinumab, further increasing price pressure. The commercialization partners for FYB201 (ranibizumab) and FYB202 (ustekinumab) therefore expect lower revenues. As announced today in an ad hoc release, Formycon has incorporated these updated expectations into its planning as part of the regular quarter-end impairment test and is recognizing non-cash impairments on both products. Three of the four guidance metrics for 2026 remain unchanged: revenue, EBITDA and working capital. For revenue and EBITDA, Formycon expects to be at the lower end of the ranges. For adjusted EBITDA, which also includes the result from the investment in Bioeq, Formycon now expects EUR -15 million to EUR -5 million. The other revenue streams are developing in line with plan. The next product generation, led by FYB206, the biosimilar candidate to Keytruda®, is not affected by the adjustment.

Dr. Stefan Glombitza, CEO of Formycon AG, said: “FYB201 and FYB202 have made Formycon what it is today: a company that develops biosimilars with high quality and reliability, takes them through approval and currently markets them with 14 partners worldwide. Both markets have now changed significantly. Today we are taking this into account, in our planning and on our balance sheet. The next generation of our portfolio is built on these experiences: diversified markets, smart development approaches and manufacturing costs that hold up even as price discounts increase. With FYB206, our biosimilar candidate to Keytruda®, we are in the leading group of the field. FYB208 targets the fastest-growing market we have ever addressed, and we are developing FYB286 together with a strategically important manufacturer and a partner that is funding the development in advance. Today’s adjustment does not change our conviction that Formycon is one of the world’s leading biosimilar developers.”

The markets for FYB201 and FYB202

The markets for ranibizumab and ustekinumab have changed considerably. Prices are falling, and additional competitors have entered the market with steep discounts. For healthcare systems, that is the purpose of biosimilars. For these two molecules, therapy alternatives are also gaining share. In the US, sales of ustekinumab also depend on access to the formularies of pharmacy benefit managers, which remains difficult. The commercialization partners have therefore lowered their revenue expectations for both products. Formycon has incorporated them into its planning and is adjusting the carrying amounts. Both products remain on the market and continue to generate revenue for Formycon.

What changes on the balance sheet

In 2022, Formycon acquired the rights to FYB201 and FYB202 from Athos and paid for them with new shares and a share for Athos in future revenues from both products (contingent purchase price obligations). The rights are carried in the consolidated balance sheet at their amortized carrying amount. If expected revenues decline, this carrying amount declines and Formycon recognizes impairments. In the consolidated figures as of September 30, 2026, this affects FYB202 and FYB201, and for FYB201 the investment in the joint venture Bioeq. At the same time, the contingent purchase price obligations decline, because they too depend on expected revenues. On a net basis, the impairments reduce consolidated net income for 2026 by EUR 82 million for FYB202 and EUR 39 million for FYB201. The impairments do not affect EBITDA for 2026. There is no cash outflow, and the agreements with the partners remain unchanged.

2026 guidance

For fiscal year 2026, the Management Board continues to expect revenue of EUR 60 to 70 million and EBITDA of EUR 0 to 10 million, each at the lower end of the previously communicated ranges, as well as working capital at year-end of EUR 20 to 30 million. The Management Board now expects adjusted EBITDA of EUR -15 million to EUR -5 million (previously EUR 5 to 15 million). The reason is the result from the investment in Bioeq, which is included in adjusted EBITDA and declines with the revenue expectations for FYB201. The guidance is based on the plans of the commercialization partners, which are responsible for selling the products and in whose revenues Formycon participates. Their plans for the fourth quarter are reflected in the ranges.

Enno Spillner, CFO of Formycon AG, said: “Our planning is based on the plans and input of our commercialization partners. Now that they have lowered their expectations for FYB201 and FYB202, we are reflecting this on our balance sheet. The impairments involve no cash outflow. For revenue, EBITDA and working capital, we are within our previous guidance. For revenue and EBITDA, we expect the lower end, in a challenging environment. Only for adjusted EBITDA will we not reach the range, because the result of our investment in Bioeq declines with the revenue expectations for FYB201.”

The next product generation

The adjustment concerns the first two products that Formycon has brought to market. The next generation of the portfolio is designed for today’s conditions: diversified markets, optimized development and manufacturing costs that hold up even as prices fall. FYB206, the biosimilar candidate to Keytruda®, the world’s best-selling biologic medicine, was accepted for review by the FDA in October 2026. A decision is expected in the third quarter of 2027. Formycon was the first company worldwide to publicly announce the FDA’s acceptance of a pembrolizumab biosimilar for review. The optimized clinical development without a comparative Phase III study saves development costs in the high double-digit millions of euros. Unlike ustekinumab, pembrolizumab is not distributed in the US through the formularies of pharmacy benefit managers but is purchased and billed directly by physicians and hospitals (buy-and-bill). Pricing dynamics there are different. Commercialization partners are Zydus Lifesciences for the US and Canada, MS Pharma for the Middle East and North Africa, and Lotus Pharmaceutical for parts of the Asia-Pacific region. FYB208 (dupilumab) is in technical development; with revenue growth of 26 percent in 2025, its reference product Dupixent® is the fastest-growing market in the portfolio. Formycon is developing FYB286 together with its strategic manufacturing partner Biocelys for Santo Biosimilar, which is funding the development in advance. In 2025, the reference products of FYB206 and FYB208 generated combined sales of almost USD 50 billion, more than three times as much as the reference products of the three products Formycon currently markets.

Conference call

The Management Board will explain the impairments and the guidance in the conference call on the nine-month results on November 12, 2026, at 3:00 p.m. CET, held in English with a webcast. Registration at https://webcast.meetyoo.de/register/6P6Ir00BfxpL is required to participate; participants will then receive a confirmation email with their individual dial-in details. The presentation and audio can be accessed via the webcast at https://www.webcast-eqs.com/formycon-2026-9m. A recording will subsequently be available at www.formycon.com in the Investor Relations section.
 

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Keytruda^® is a registered trademark of Merck Sharp & Dohme, a subsidiary of Merck & Co.
Lucentis^® is a registered trademark of Genentech. 
Stelara^® is a registered trademark of Johnson & Johnson.
Dupixent^® is a registered trademark of Sanofi Biotechnology.

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

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

About FYB4Growth:
With FYB4Growth, Formycon is pursuing a growth strategy along four strategic pillars aimed at sustainable value creation. First, geographic diversification: in addition to Europe and the US, Formycon is specifically opening up high-growth regions such as MENA, APAC and Latin America through strong regional partners. Second, Formycon relies on a smart portfolio strategy that combines blockbuster molecules with selected niche products and, through efficient regulatory development pathways, lays the foundation for sustainable value creation. Third, Formycon is positioning itself as a technological and regulatory development powerhouse that achieves strong competitive differentiation through innovative product solutions and new regulatory approaches. Fourth, Formycon is committed to consistent cost efficiency through lean processes, optimized development structures and the increased use of digital technologies, in order to sustainably strengthen the scalability of its business model and its competitiveness. Learn more at: www.fyb4growth.de

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

Disclaimer:
This release neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG in any jurisdiction, including the United States of America, Canada, Australia and Japan. No public offering of securities of Formycon AG will be made, or is intended, in connection with this release.

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

This release may contain forward-looking statements and information, which are based on the current expectations, estimates and assumptions of the management of Formycon AG. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of Formycon AG, development of the products and the estimates given here.

Such known and unknown risks and uncertainties include, among others, risks relating to 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, tariffs and trade policy, product quality, patient safety, the conclusion and performance of commercialization partnerships, market acceptance, pricing and competition, manufacturing and supply, including by third-party manufacturers, financing, including compliance with the covenants of the bond of Formycon AG, and the patents and exclusivities protecting reference products, including related litigation. With respect to pipeline products, Formycon AG does not make any representation, give any warranty or provide any other guarantee that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. Forward-looking statements should not be relied upon as predictions of future events. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated, except as required by law.