Formycon Doubles Nine-Month Revenue and Consistently Advances Implementation of its FYB4Growth Strategy

Press Release // November 12, 2026

Formycon Doubles Nine-Month Revenue and Consistently Advances Implementation of its FYB4Growth Strategy
 

• Consolidated revenue rises to €40.0 million in the first nine months of 2026 (prior-year period: € 19.5 million)
• EBITDA and adjusted EBITDA improved significantly year-on-year to €-8.9 million (prior-year period: €-21.4 million) and €-14.9 million (prior-year period: €-21.7 million), respectively.
• FYB206 achieves regulatory milestone: FDA accepts the Biologics License Application (BLA) for the pembrolizumab biosimilar for review; this marks the first publicly announced acceptance of an application for a proposed biosimilar candidate to Keytruda^®1 in the U.S.
• FYB4Growth strategy gains momentum: New partner-funded development program FYB286 expands portfolio and establishes new strategic manufacturing partnership
• Market environment for FYB201 and FYB202 result in non-cash impairment charges as announced on November 5; next-generation pipeline remains unaffected
• Guidance for revenue, EBITDA, and working capital in 2026 unchanged; outlook for adjusted EBITDA revised to €-15 million to €-5 million (previously €5 million to €15 million) on November 5
• Invitation to today’s conference call at 3:00 p.m. (CET)

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”), a specialized developer of biosimilar, doubled its consolidated revenue in the first nine months of the 2026 financial year, compared to the prior-year period, whilst making significant progress in the implementation of its FYB4Growth strategy. Key operational milestones include the acceptance of the U.S. BLA for the pembrolizumab biosimilar candidate FYB206 for review by the FDA, start of the market launch of FYB203 in Europe, and the expansion of the development pipeline with the partner-funded project FYB286.

Dr. Stefan Glombitza, CEO of Formycon AG, said: “This year, we have taken important steps to lay the foundation for the next generation of our biosimilar portfolio. With FYB206, we have achieved a significant milestone, reinforcing our position among the leading biosimilar developers. At the same time, we have sharpened our strategic priorities through our FYB4Growth strategy. With FYB286, we have already initiated our next project, with more to follow. Our focus remains firmly on the next generation of biosimilars and their long-term value creation.”

Consolidated Revenue and Earnings Performance

Group revenue doubled to €40.0 million in the first nine months of 2026 (prior-year period: €19.5 million). The main drivers were revenue recognition from deferred milestone payments related to FYB206, as well as increasing royalty and commercialization revenues from the existing product portfolio. Of the total, €20.7 million was attributable to milestone revenues (prior-year period: €3.7 million), €9.7 million to royalties (prior-year period: €4.4 million), €7.6 million to the recharge of development services (prior-year period: €11.4 million), and €2.0 million to supply management services. No material revenue contributions from supply management services were recorded in the corresponding period of 2025.

Revenue was primarily generated by the four product programs FYB201, FYB202, FYB203 and FYB206.² The three approved biosimilars FYB201, FYB202 and FYB203 continued to make a significant contribution to Group revenue, accounting for approximately €22.4 million, or about 56% of the total.² Together with its commercialization partners, Formycon remains firmly focused on expanding the market presence and revenue potential of its existing portfolio, thereby strengthening the financial foundation for its next phase of growth.

Direct revenue from FYB201 (ranibizumab), a biosimilar to Lucentis^®3, amounted to €2.6 million (prior-year period: €4.4 million). The product continues to be commercialized in 25 countries, although increasing competition and emerging therapeutic alternatives, particularly in the United States, continue to weigh on revenue development.

FYB202 (ustekinumab), a biosimilar to Stelara^®⁴ marketed under the brand name Otulfi^®5 in most countries, significantly increased its revenue contribution to €13.4 million (prior-year period: €5.6 million). This growth was primarily driven by commercialization, supply management and milestone revenues related to the Otulfi^® autoinjector. Despite progress in securing market access, the market environment remains challenging, particularly in the United States, due to intense price competition and complex reimbursement mechanisms.

FYB203 (aflibercept), a biosimilar to Eylea^®⁶, generated revenue of €6.1 million (prior-year period: €9.3 million), primarily from development and supply management services. FYB203 has been commercially available in Europe since mid-May 2026. Together with its partners, Formycon is working to further expand commercialization activities and enter additional markets, including the United States, where a launch is planned still for later this year.

FYB206 (pembrolizumab) generated revenue of €17.7 million (prior-year period: €0 million), resulting from deferred milestone payments. FYB206 is therefore a key revenue and value driver in the current financial year and is gaining further strategic importance as the regulatory approval processes in the U.S. and Canada advance.

Group EBITDA improved to €-8.9 million (prior-year period: €-21.4 million). Adjusted Group EBITDA, which includes the share of profit or loss from the investment in Bioeq AG, improved to €-14.9 million (prior-year period: €-21.7 million). The improvement in earnings was primarily supported by higher revenue and lower research and development expenses recognized in the income statement.

Cost of sales increased in line with revenue, as expected, to €47.9 million (prior-year period: €37.3 million) and included scheduled amortization of €15.8 million related to the rights to FYB202. Research and development expenses amounted to €3.8 million (prior-year period: €9.5 million). During the same period, development costs of €16.2 million (prior-year period: €31.9 million) were capitalized for FYB206 and FYB208.

As of September 30, 2026, Formycon had cash and cash equivalents of €42.5 million (December 31, 2025: €68.8 million). Net working capital amounted to approximately €40.6 million (December 31, 2025: €70.1 million).

As announced on November 5, 2026, Formycon significantly adjusted the carrying values of FYB201 and FYB202 due to reduced revenue expectations. The product rights re-acquired from Athos in 2022 were paid for through the issuance of new shares and revenue-linked contingent purchase price obligations, which were recognized accordingly on the balance sheet. Updated revenue forecasts from commercialization partners resulted in impairments of the capitalized product rights for FYB202 and Formycon’s investment in the Bioeq AG joint venture for FYB201. Conversely, the revenue-linked contingent purchase price obligations decreased, particularly for FYB201. Taking these offsetting effects into account, the non-cash valuation adjustments will have a net negative impact of approximately €121 million on the Group’s 2026 net result, comprising €82 million for FYB202 and €39 million for FYB201. Neither liquidity nor reported EBITDA is affected. No other development programs are affected by impairments.

Enno Spillner, CFO of Formycon AG, said: “The nine-month results demonstrate a significant improvement in revenue and operating earnings compared to the previous year. At the same time, we have consequently considered the changing market environment for FYB201 and FYB202 in our valuations and revenue expectations. The impairments have no cash impact and do not affect our next generation of products. Through disciplined liquidity management and the targeted allocation of resources to development programs with attractive long-term potential, we are setting clear financial priorities. Our commercialized product portfolio continues to be an important pillar for the next phase of growth. Together with our operational progress, this provides the foundation to further implement FYB4Growth and shape our next phase of development and growth.”

FYB206 and FYB4Growth: progress in implementing our growth strategy

With FYB206, a biosimilar candidate for Keytruda^®1 (pembrolizumab), Formycon has achieved a significant regulatory milestone. On October 13, 2026, the U.S. Food and Drug Administration (FDA) accepted the BLA for review - the first publicly announced acceptance of an application for a pembrolizumab biosimilar candidate in the U.S. A decision on market approval could be expected in the third quarter of 2027.

FYB206 underscores Formycon’s scientific and regulatory expertise: Based on an innovative development approach, the FDA agreed that a comparative Phase III efficacy study could be omitted. This significantly accelerated development and resulted in cost savings in the high double-digit million-euro range. The FDA’s acceptance of the application for review also triggered a regulatory milestone payment from our North American commercialization partner, Zydus Lifesciences.

These advances underscore the consistent implementation of the FYB4Growth strategy, which is based on a smart product portfolio, geographic diversification, scientific excellence and innovation as well as lean development models with cost-effective production.

The new FYB286 development program combines these strategic pillars and drives the expansion of the next generation of products. Additional pipeline projects are in the works. The targeted use of digital and AI-powered technologies, together with the expansion of our network of strategic manufacturing partners, is expected to optimize development and cost efficiency. These initiatives are aimed at strengthening the long-term competitiveness of Formycon.

2026 Outlook

For the 2026 financial year, Formycon continues to expect revenue of €60 million to €70 million and EBITDA of €0 million to €10 million, with both figures anticipated at the lower end of their respective ranges amid a persistently challenging market environment. For the end of the year, the company still expects a working capital of €20 million to €30 million. Formycon now expects adjusted EBITDA to total between €-15 million and €-5 million (previously: €5 million to €15 million), as announced on November 5, 2026. Additionally, it considers the earnings from its stake in Bioeq AG, which are declining in line with the lower revenue expectations for FYB201.

The guidance considers the latest sales and revenue forecasts provided by the commercialization partners, including their expectations for the fourth quarter.

For the fourth quarter, Formycon anticipates further contributions from existing partnerships, particularly in connection with FYB206, as well as from the ongoing marketing and development of the product portfolio.
 

Key Financial Metrics at a Glance

Condensed Consolidated Balance Sheet (IFRS)

Condensed Consolidated Statement of Comprehensive Income

Condensed Consolidated Statement of Cash Flows

Conference Call and Webcast

The Management Board will discuss business performance and key financial figures and provide an outlook for the remainder of fiscal year 2026. The conference call will take place today, Thursday, November 12, 2026, at 3:00 p.m. (CET) in English and will be webcast live.

To participate in the conference call, please register at: https://webcast.meetyoo.de/register/6P6Ir00BfxpL

After registering, participants will receive a confirmation email containing their individual dial-in information.

The presentation and audio webcast will be available via

https://www.webcast-eqs.com/formycon-2026-9m

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 An additional €0.2 million in revenue is attributable to other segments and is therefore not included in the reported product revenues.
³ Lucentis^® is a registered trademark of Genentech, Inc.
⁴ Stelara^® is a registered trademark of Johnson & Johnson.
⁵ Otulfi^® is a registered trademark of Fresenius Kabi Deutschland GmbH in select countries
⁶ Eylea^® is a registered trademark of Regeneron Pharmaceuticals, Inc.

About Formycon:
Formycon AG is a publicly traded, independent developer of biosimilars headquartered in Martinsried, one of Europe’s leading life sciences hubs, near Munich. Its 200 employees from 27 countries cover the entire development chain, from laboratory analyses through manufacturing and clinical trials to regulatory submissions. Three of Formycon’s biosimilars are approved for use in ophthalmology and immunology and are distributed worldwide through marketing partners. Five additional candidates are in development, including biosimilars for two of the world’s top-selling biologic drugs. With its products, Formycon makes highly effective therapies affordable for more people.

Formycon AG is listed on the Prime Standard segment of the Frankfurt Stock Exchange: Ticker symbol: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. For more information, visit: www.formycon.com/en/

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

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

Disclaimer:
FYB206 and Formycon’s other biosimilar candidates are in development and have not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.

This press release may contain forward-looking statements and information based on the current expectations, estimates, and assumptions of the Executive Board of Formycon AG. Various known and unknown risks, uncertainties, and other factors could cause the actual future results, financial position, and business development of Formycon AG, as well as the development of its products, to differ materially from the estimates provided herein.

These risks and uncertainties include, among other things, risks related to research and development, the regulatory approval process, the timing of actions by regulatory and other authorities, clinical results, changes in laws and regulations, tariffs and trade policy, product quality, patient safety, the conclusion and implementation of marketing partnerships, market acceptance, pricing and competition, manufacturing and delivery (including by third-party manufacturers), financing (including compliance with the covenants of Formycon AG’s bond), as well as the patents and exclusivity rights protecting reference products, including related legal disputes. Formycon AG makes no representation, warranty, or other guarantee regarding products under development that they will obtain the necessary regulatory approvals or be commercially successful. Forward-looking statements should not be construed as predictions of future events. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in the event of developments other than those expected, unless required by law.

This announcement does not constitute an offer to sell or 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 Formycon AG securities is taking place in connection with this announcement, nor is one intended.

This announcement contains alternative performance metrics, such as adjusted EBITDA, which are not defined in accordance with the IFRS® Accounting Standards as applicable in the EU (“IFRS Accounting Standards”) or other generally accepted accounting principles. They should not be considered in isolation or as a substitute for metrics in accordance with the IFRS Accounting Standards. Their current definitions can be found in Formycon AG’s most recent financial reports. Due to rounding, discrepancies may occur in the totals.