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Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) today published its audited consolidated financial statements for the 2024 financial year and provided an outlook for fiscal year 2025 as well as an assessment of the company’s medium-term development.

Dr. Stefan Glombitza, CEO of Formycon AG, said: “2024 was a year marked by significant milestones for Formycon and substantial progress in our product pipeline. We achieved important regulatory and operational successes, including the approvals of FYB202 and FYB203 in key markets. The successful completion of these procedures has paved the way for the commercialization of two additional products from our portfolio, further solidifying our position as one of the leading independent biosimilar developers. Another important milestone was the start of the clinical program for FYB206, our first oncological biosimilar, in mid-2024. Following clear scientific advice from the FDA in early 2025, we were encouraged to continue the clinical development of FYB206 without a Phase III study. With this forward-looking strategy, Formycon is playing a pioneering role among Keytruda^® biosimilar developers.

FYB201, our first commercial product, performed strongly in key markets, particularly in the first three quarters of 2024. At the same time, however, recent market developments in the U.S. require us and our partner to adjust the marketing approach. This will also have an impact on commercial expectations for the U.S. product in 2025. Our entire pipeline continues to address highly attractive therapeutic areas. With the launch of FYB202 in the U.S. and Europe, we are now also entering the immunology market segment. We believe that Formycon is on track for success and has set the stage to harness the potential of the rapidly growing biosimilar market across multiple indications and to help ensure that patients with serious diseases gain access to highly effective and affordable biologics.”

Enno Spillner, CFO of Formycon AG, added: “Formycon remains in a phase of targeted investment and transformation into a commercial-stage company. With more than €40 million in cash at year-end 2024 – supported by the successful capital increase with our strategic partner Gedeon Richter, the successful uplisting to the Prime Standard, and our inclusion in the SDAX – we are well positioned to advance our pipeline and further strengthen our market position. Despite temporary commercial challenges in the U.S., we expect revenue and EBITDA in 2025 to be at the 2024 level. Our long-term financial strategy continues to focus on enabling sustainable growth and leading Formycon to profitability in the medium term – ideally as early as 2026.”

Key regulatory and operational milestones underscore development expertise

FYB201 (Lucentis^®4 biosimilar)

FYB201 (ranibizumab biosimilar) was successfully launched in additional markets in 2024, including Canada, Saudi Arabia, and several countries in the MENA region. Thus, FYB201 is now available in 20 countries worldwide and has successfully establish its position in the competitive market. Overall, FYB201’s revenue contribution in financial year 2024 was broadly in line with expectations. While license income from global product sales increased year-over-year, the equity result from Bioeq AG declined significantly in the fourth quarter due to ongoing price erosion in the U.S. The current price development has prompted our commercialization partner Sandoz to temporarily suspend marketing activities and reposition FYB201 in the U.S. after one year. This temporary marketing pause leads to a non-recurring impairment requirement of €27.3 million, which will be recognized as an impairment loss.

FYB202 (Stelara^® biosimilar)

FYB202 (ustekinumab biosimilar) received marketing authorization from the FDA and the European Commission at the end of September 2024 for the treatment of severe inflammatory diseases. An agreement with patent holder Johnson & Johnson regulated the market entry of FYB202, allowing Formycon’s marketing partner Fresenius Kabi to launch FYB202 in the U.S. at the end of February instead of mid-April 2025. Adjusted estimates of volume and price forecasts in the immediate run-up to the U.S. market launch by Fresenius Kabi led to an unscheduled adjustment of the valuation model and the balance sheet approach for FYB202 in the amount of €106.7 million in fiscal year 2024.

The product was launched in Europe almost at the same time beginning of March 2025. In the meantime, FYB202 has also successfully received approvals for the United Kingdom and Canada. In addition, Formycon secured a commercialization partnership with MS Pharma for the MENA region to expand its global market presence and international marketing potential.

FYB203 (Eylea^® biosimilar)

Another key success was the FDA approval of FYB203 (aflibercept biosimilar) and the positive CHMP opinion from the EMA, which led to approval by the European Commission in January 2025. In addition, Formycon was able to conclude commercialization partnerships with MS Pharma (MENA region) and, at the beginning of 2025, with Teva Pharmaceuticals (Europe, Israel) and Lotus Pharmaceutical (Asia-Pacific).

FYB206 (Keytruda^® biosimilar candidate)

The clinical development program for FYB206 started with the inclusion of the first patient in June 2024. This puts Formycon among the first companies to have a pembrolizumab biosimilar in clinical testing. In addition to a phase I study which investigates pharmacokinetics, safety and tolerability, a parallel phase III study was launched in July 2024 to compare the safety and efficacy of FYB206 with the reference drug Keytruda^®. In the second half of the year, scientific discussions with the FDA on the clinical development program continued and resulted in a Scientific Advice from the agency in 2025. According to this, the therapeutic comparability of FYB206 with the reference drug Keytruda^® can be sufficiently demonstrated based on the comprehensive analytical data and the data from the ongoing phase I study. Thus a continuation of the phase III study for the development and approval of FYB206 in the U.S. is no longer considered necessary.

Key personnel appointment and capital increase, as well as uplisting to a higher stock market segment, confirm strategic direction

Formycon has a highly experienced management team with longstanding industry expertise. To ensure continuity and quality in the management of the company, the contract of CEO Dr. Stefan Glombitza was extended to 31 December 2027 in November 2024.

The entry of the strategic investor, the specialty pharmaceutical company Gedeon Richter Plc. (Gedeon Richter), and the associated cash capital increase at the beginning of 2024, allowed Formycon to raise €82.84 million for the further development of its existing biosimilar pipeline. In return, new company shares amounting to 9.08% were issued. This transaction opens-up the possibility of working together with Gedeon Richter on long-term strategic opportunities in the areas of development, manufacturing and commercialization.

On 12 November 2024, Formycon successfully uplisted to the Prime Standard, the highest transparency segment of Deutsche Börse. This step marks a significant milestone in the company’s capital market strategy. As a result, the company was included in the SDAX on 23 December 2024 and in the TecDAX on 13 January 2025 – after the end of the reporting period. This strengthens the company’s visibility and transparency in the global capital markets and supports its future growth strategy.

Solid business development and market performance in fiscal year 2024

Group revenues in financial year 2024 amounted to €69.7 million, which is above the communicated forecast (€55.0 million to €65.0 million). Compared to the previous year, this represents an anticipated decrease of 10.3% (previous year: €77.7 million). The change is mainly due to the decline in deferred milestone revenues for the FYB202 project from the partnership with Fresenius Kabi. These amounted to €23.1 million in the financial year (previous year: €37.7 million). In addition, revenues from the reimbursement of development activities for FYB201 and FYB203 decreased as expected. On the opposite, one-time proceeds from the sale of excess inventory from the FYB202 development, realized in the amount of €9.5 million, had a positive effect.

Group EBITDA for 2024 amounted to €-13.7m (previous year: €1.52m) and was thus also slightly above expectations (€-25.0m to €-15.0m) and below the previous year’s result. This development is mainly due to the aforementioned revenue developments with almost stable cost of sales. At the same time, research and development costs increased due to the continued progress of the early-stage pipeline projects as well as administrative costs, particularly due to the expansion of the workforce, consultancy expenses in connection with strategic and financial projects and the uplisting to the Prime Standard.

Adjusted EBITDA amounted to €-1.6 million (previous year: €13.3 million) and is thus in line with the forecast (€-5.0 million to €5.0 million). The earnings contribution from FYB201 (Lucentis^® biosimilar) via Bioeq AG (at-equity result) was roughly on a par with the previous year at €12.1 million (previous year: €11.8 million). A strong first half of the year largely offset the noticeable price decline for FYB201 in the U.S. that began in the fourth quarter.

After the approval of FYB202 at the end of September 2024, the scheduled amortization of the intangible asset started. At the same time, adjusted revenue and price forecasts, particularly for the U.S., led to an impairment of the cash-generating unit FYB202 in the amount of €106.7 million. This includes, among other things, the full write-off of the goodwill of FYB202 in the amount of €44.5 million resulting from the acquisition in May 2022. In addition, the intangible asset was reduced by €84.2 million, whereas deferred tax liabilities were reduced by €22.6 million. The fair value of the earn-out decreased by 16.0 million in the opposite direction to the impairment.

In addition, the fair value of the shareholding in Bioeq was reduced by €27.3 million based on the FYB201 performance. Positive effects from the revaluation of the conditional purchase price for ATHOS reduced liabilities by €5.1 million.

The net result in the financial year 2024 was strongly impacted by the impairment losses and, at € -125.7 million, was significantly lower than in the previous year (€75.8 million).

Working capital developed positively and increased to €55.1 million (previous year: €38.7 million), which was mainly due to the cash milestone payment for the earlier than expected approval of FYB202 in Europe and the capital measure at the beginning of 2024. The strong financial position enables Formycon to continue investing into continuous development of its biosimilar pipeline.

As of 31 December 2024, the Formycon Group held cash and cash equivalents of €41.8 million (previous year: €27.0 million), creating a stable financial basis for future business development. This balance was strengthened in particular by the successful capital increase carried out in February 2024, which generated gross proceeds of €82.8 million. At the same time, liabilities in the amount of €41.3 million, in particular shareholder loans and contingent purchase price obligations, were repaid in fiscal year 2024. In addition, payments were received from the loan issued to Bioeq AG in the amount of €27.3 million.

Outlook for biosimilar projects 2025

The development of biosimilars remains the strategic focus of Formycon AG and forms the basis for long-term growth. All forecasts by renowned institutes predict further dynamic growth in the global biosimilar market. While biosimilars are already well established in Europe, market conditions are particularly challenging in the U.S. Overdue fundamental policy reforms are necessary to lead to open competition and greater market penetration by biosimilars, especially in the pharmacy benefit segment.

FYB201 (Lucentis^® biosimilar) – Adjustment of U.S. marketing strategy

Facing price decline, Formycon’s marketing partner Sandoz AG is adjusting the marketing strategy for FYB201/Cimerli^®5 and plans to temporarily pause U.S. marketing for approximately one year. The aim is to commercially realign the product and to tap into new customer segments after reintroduction. However, a decline in sales is expected in 2025 and early 2026 due to the suspension of marketing activities in the U.S. In other regions, including Europe and the MENA region, the product will remain available and will be marketed by local partners Teva and MS Pharma, respectively. With the planned introduction of the pre-filled syringe, further market penetration is expected in 2025, particularly in Europe. Further markets, such as Latin America, are also going to be entered.

FYB202 (Stelara^® biosimilar)

FYB202 was launched in the U.S. at the end of February and in Europe at the beginning of March this year. Initial market analyses show that the introduction of biosimilars in the U.S. pharmacy benefit market continues to develop positively, albeit at a significantly slower pace than originally anticipated. Formycon is monitoring the market penetration of FYB202 and analyzing the regulatory and economic conditions to optimally position the product in the market together with its partner Fresenius Kabi. Several further approvals and launches in key markets are planned over the course of the year.

FYB203 (Eylea^® biosimilar)

Following the successful approvals in the U.S. and Europe, no agreement has yet been reached with the patent holder of the reference product, Regeneron Pharmaceuticals Inc., regarding a potential market launch date for FYB203. An agreement to this effect is being sought. At present, Formycon expects a market launch to take place in the course of 2026 at the earliest. Formycon is working closely with its commercialization partners Teva Pharmaceuticals (Europe & Israel), MS Pharma (MENA region) and Lotus Pharmaceutical (Asia-Pacific) to ensure a coordinated market launch. Formycon will, for the first time, be responsible for the entire supply chain and market supply with the finished product. In addition, the announcement of a marketing partner for the U.S. is expected by mid-2025. Corresponding negotiations are being conducted by the license holder Klinge Biopharma.

FYB206 (Keytruda^® biosimilar candidate)

Based on the scientific advice received from the FDA, the Formycon management board decided in February 2025 to discontinue the phase III study. The ongoing phase I study in the indication malignant melanoma will continue as planned. This decision will significantly accelerate the development of the biosimilar and reduce the associated costs. With this pioneering development strategy, Formycon is underpinning its leading role in the competition for a biosimilar of this blockbuster drug.

Pipeline development – new projects in focus

In addition to the advanced biosimilar programs, Formycon is pressing ahead with the development of its new pipeline projects. The biosimilar candidates FYB208, FYB209 and the FYB210 project initiated in 2024 are in early stages of development. FYB208 is supposed to enter the clinical development phase in 2025, once the Technical Proof of Similarity (TPoS) milestone is achieved.

Financial forecast 2025

Despite challenging market conditions in the U.S. and the planned repositioning of FYB201, Formycon expects a comparable development of the key financial figures in 2025 at the previous year’s level. While the market launch of FYB202 is expected to provide new revenue momentum, the expected declines in other areas are within the planned range.

For fiscal year 2025, the Formycon Group expects revenues between €55.0 million and €65.0 million, roughly at the same level as 2024.

The temporary decline in revenue contributions from the marketing of FYB201 is the result of the planned strategic adjustment in the U.S. commercialization of the product by partner Sandoz AG which will be paused prospectively for one year starting in the second quarter of 2025. The reintroduction with improved market opportunities is expected in the first half of 2026. Commercialization in Europe and other international markets remains unaffected.

For FYB202/Otulfi^®6, initial substantial contributions to revenue are expected with the market launches in the first quarter of 2025 in the U.S. and in key European markets. The market environment in the U.S. is highly competitive and, given the current conditions of the American healthcare system, the speed of biosimilar market penetration and the economic conditions are difficult to predict. Nevertheless, Formycon expects FYB202 to be the group’s largest revenue generator in 2025.

Following completion of the development of the pre-filled syringe for the ophthalmic biosimilars FYB201 and FYB203, revenues from development activities will continue to decline, as expected during the project. At the same time, the market launch of the pre-filled syringe for FYB201 in various European regions, planned for 2025, is expected to be followed by an increase in market penetration.

The major progress in the phase I clinical trial of FYB206, combined with the positive feedback from the FDA regarding the waiver of the phase III trial, is a significant milestone for Formycon. This decision not only significantly reduces the remaining development time, but also results in estimated investment savings of more than €75 million over the next four years. Based on this good starting position, Formycon plans to conclude the first license agreements with future marketing partners as early as 2025. This could result in the first commercial revenues from FYB206 already this year.

FYB206 is a key and valuable component of the company’s strategic development. The biosimilar candidates FYB208, FYB209 and project FYB210 form the basis for a stable future pipeline beyond the market launch of FYB206.

Formycon will therefore continue to operate in an intensive investment phase and expects EBITDA for the 2025 financial year to be in the range of € -10.0 million to € -20.0 million. This reflects the expected revenue at the previous year’s level and the continued investments in the advancing biosimilar pipeline, with FYB206 having a neutral effect on the EBITDA due to the capitalization of the costs incurred.

Sales revenues from FYB201 are mainly reported in the at-equity result of the joint venture Bioeq AG, which is not consolidated within Formycon’s operating segment. To better reflect the company’s operational performance, EBITDA is adapted in the adjusted EBITDA. Due to the planned temporary pause in U.S. marketing by Sandoz, an at-equity result of €0 is anticipated for Bioeq AG in 2025. For 2025, Formycon therefore anticipates adjusted EBITDA in the range of €-10.0 million to €-20.0 million, being in the same range as EBITDA.

For 2025, net working capital is expected to be between €25.0 million and €35.0 million, largely influenced by investments in the FYB206 project.

Mid-term outlook

Formycon continues to pursue the goal of sustainable and EBITDA-profitable corporate development. Management currently expects that a positive EBITDA can ideally be achieved as early as 2026, but no later than 2027.

Four key factors are expected to contribute significantly to achieving this goal:

FYB201: Resumption of marketing in the U.S. after the planned pause, increasing market penetration in regions already developed through the introduction of the pre-filled syringe as well as expansion into further markets, including Latin America.

FYB202: Gaining share in key markets such as the U.S., Europe, Canada and other international territories.

FYB203: Clarification of the patent situation and/or an agreement with the patent holder of the reference drug to enable the medium-term market launch together with commercialization partners.

FYB206: Concluding regional or global commercialization partnerships with potential upfront and milestone payments.

Overview of the most important financial performance indicators in million euros

The full Annual Report 2024 can be found on the Formycon website at
https://www.formycon.com/en/investor-relations/publications/

Conference call and webcast

The Executive Management Board of Formycon AG will discuss the company’s development and key financial figures during a conference call. The earnings call, which will be webcast live, will take place on 27 March 2025 at 3:00 p.m. (CET) in English.

To participate in the conference call, please register at: https://webcast.meetyoo.de/reg/9TZk1xrmZhA6

After registering, participants will receive a confirmation email with individual dial-in details and the date.

The presentation and audio broadcast can be accessed via the following webcast link: https://www.webcast-eqs.com/formycon-2024-fy

Following a short presentation, the Executive Board will be available to answer analysts’ questions. The webcast will be recorded and will be available to view afterwards on the Formycon website at https://www.formycon.com/en/investor-relations/publications/

1) Stelara^® is a registered trademark of Johnson & Johnson
2) Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.
3) Keytruda^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA
4) Lucentis^® is a registered trademark of Genentech Inc.
5) CIMERLI^® is a registered trademark of Coherus BioSciences, Inc.
6) Otulfi^® is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) today announced details of the conference call for the release of the fiscal year 2024 results on March 27, 2025. The Management Board will discuss the company’s development, key financial figures, and provide an outlook for the 2025 fiscal year. The conference call, which will be broadcast live on the internet, will take place on March 27, 2025, at 3:00 PM (CET) in English.

To participate in the conference call, please register at:
https://webcast.meetyoo.de/reg/9TZk1xrmZhA6

After registration, participants will receive a confirmation email with individual dial-in data.

The presentation and audio broadcast can be accessed via the following webcast link:
https://www.webcast-eqs.com/formycon-2024-fy

After a brief presentation, the Management Board will be available for analysts’ questions. The conference call will be recorded and can subsequently be accessed via the Formycon website at: https://www.formycon.com/en/investor-relations/publications/

Formycon in Dialogue

Additionally, representatives of the Management Board will participate in the following international investor conferences in the coming weeks:

April 3, 2025
Metzler Small Cap Days 2025
Enno Spillner (CFO)
Frankfurt

April 8, 2025
mwb research German Select Conference
Dr. Stefan Glombitza (CEO), Enno Spillner (CFO)
Virtual

May 12 – May 14, 2025
Equity Forum Spring Conference
Enno Spillner (CFO)
Frankfurt

May 14 – May 16, 2025
Hauck & Aufhäuser Stockpicker Summit
Enno Spillner (CFO)
Hamburg

May 21 – May 22, 2025
Berenberg European Conference
Enno Spillner (CFO)
New York

June 11, 2025
UBS Life Science Conference 2025
Enno Spillner (CFO)
London

June 12, 2025
Warburg Highlights Conference
Enno Spillner (CFO)
Hamburg

Please find our current events at:
https://www.formycon.com/en/investors/financial-calendar/

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) and its commercialization partner Fresenius announce the commercial availability of Otulfi^®1, a biosimilar to Stelara^®2 in the United States (U.S.) and the European Union (EU).

In the U.S., Otulfi^® is indicated for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. The FDA has provisionally determined that Otulfi^® will be interchangeable with the reference drug Stelara^®, following the expiration of a competitor’s interchangeability exclusivity. In the EU, Otulfi^® has been launched to treat moderately to severely active Crohn’s disease, moderate to severe plaque psoriasis and active psoriatic arthritis.

In February 2023, Formycon and Fresenius had entered into a global license agreement providing Fresenius Kabi with commercialization rights of FYB202/Otulfi^® in key global markets, including the U.S. and the EU.

Dr. Stefan Glombitza, CEO of Formycon AG, said: “With the launch of Otulfi^® in these key global markets, patients, healthcare professionals and payors will have access to a biosimilar with the same efficacy and safety as Stelara^® but at a lower cost. For many patients worldwide suffering from chronic inflammatory diseases, biologic therapies are inaccessible, and many patients experience significant delays before they can benefit from this highly effective treatment. The launch of Otulfi ^® will provide enhanced treatment access and choice.”

Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Kabi Management Board, said: “The U.S. availability of Otulfi^® demonstrates our commitment to serving patients and clinicians and through the expansion of our biopharma portfolio, we are able to do this globally and, in the U.S. In addition to approving Otulfi^® for all indications matching the reference product Stelara^®, the FDA also granted a provisional determination of interchangeability for Otulfi^®.”

Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play an important role in inflammatory and immune responses. Otulfi^® was approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in September 2024, having successfully met the agency’s standards for biosimilarity to the reference product, including equivalent efficacy, safety and pharmacokinetics.

Otulfi^® will be available in the U.S. and in the European Union in the following presentations: a 45 mg/0.5 mL and 90 mg/mL single-dose prefilled syringe for injection and a 130 mg/26 mL (5 mg/mL) single dose vial for IV infusion.

Otulfi^® in a 45 mg/0.5 mL single-dose vial for subcutaneous injection is expected to receive FDA and EMA approval in the first half of 2025.

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¹⁾ Otulfi^® is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries
²⁾ Stelara^® is a registered trademark of Johnson & Johnson

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) and its licensing partner Klinge Biopharma GmbH (Klinge) jointly announce that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved FYB203 (aflibercept), a biosimilar to Eylea^®1, under the brand name AHZANTIVE^®2. The approval covers the treatment of Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal conditions, including Diabetic Macular Edema (DME), visual impairment due to Myopic Choroidal Neovascularisation (CNV) and Macular Edema following Retinal Vein Occlusion (RVO).

“With the approval of FYB203, our second ophthalmic biosimilar in the UK, we take yet another significant step in making essential ophthalmic therapies more widely available,” said Dr. Stefan Glombitza, CEO of Formycon AG. “In addition to Ongavia^®3, our successful ranibizumab biosimilar in the UK, ­­AHZANTIVE^® will provide a new, cost-efficient treatment option for patients with severe retinal diseases, through our strong commercial partner Teva.”

The U.S. Food and Drug Administration (FDA) had already granted marketing authorization for FYB203 in June 2024, followed by European Commission`s approval in January 2025.

Recently, Formycon and Teva Pharmaceuticals International GmbH (Teva) announced a partnership for the semi-exclusive commercialization of FYB203 across major parts of Europe, including the United Kingdom, and Israel. Concurrently, Formycon had concluded an agreement with Teva for product supply. Teva is already marketing Formycon’s FYB201 ranibizumab Biosimilar (Ongavia^®) in the UK and can synergistically leverage an existing commercial infrastructure and well-established distribution channels in the ophthalmology field.

Aflibercept is an inhibitor of the vascular endothelial growth factor (VEGF), which plays a key role in the abnormal formation of blood vessels in the retina, leading to vision impairment.

¹⁾ Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.
²⁾ AHZANTIVE^® is a registered trademark of Klinge Biopharma GmbH
³⁾ Ongavia^® is a registered trademark of Teva Pharmaceuticals Limited

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) will present an overview of the comparative data of the ustekinumab biosimilar FYB202 at this year’s Congress of the European Crohn’s and Colitis Organisation (ECCO), taking place in Berlin, Germany, from February 19 to 22, 2025. The poster presentation summarizes the clinical phase I and phase III study results and is complemented by advanced analytical laboratory data demonstrating the comparability of FYB202 with the reference product Stelara^®1.

Using a comprehensive set of analytical methods, the relevant quality characteristics of FYB202 were first examined and its functional comparability with the reference product was assessed in terms of the main mechanism of action using IL-12 and IL-23 binding tests and bioassays. FYB202 was found to be analytically comparable to the reference ustekinumab with respect to physicochemical and biological properties, including structure, function, purity and potency.

The therapeutic equivalence of FYB202 was demonstrated in a Phase I pharmacokinetics (PK) study in 491 healthy volunteers and in a Phase III efficacy study in 392 patients with moderate to severe plaque psoriasis. Based on a totality of evidence approach, these results allow for extrapolation to other approved indications of the reference drug and confirm that FYB202 has a comparable clinical performance to Stelara^® in all indications, making it a safe and highly effective alternative for patients treated with ustekinumab.

Presentation details:

• Session: Guided poster session, February 21, 2025, 12:40 pm – 1:40 pm CET
• Poster-ID: P0879
• Title: The Totality of Evidence for FYB202 – an EU-approved and US-licensed Biosimilar to Reference Ustekinumab
• Room: Poster Exhibition Area
• Date: February 19-22, 2025

FYB202 is an interleukin inhibitor that can be used in dermatology to treat psoriasis and in gastroenterology to treat chronic inflammatory bowel disease. The biosimilar received marketing authorization from the EMA and the FDA in September 2024, and from Health Canada and the UK’s MHRA in January 2025.

1) Stelara^® is a registered trademark of Johnson & Johnson

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard) (“Formycon” or “the Company”) today provided an update on key developments across various biosimilar projects and invites participants to an extraordinary conference call on February 17, 2025, at 5:00 p.m. CET to share further details regarding these recent events.

FYB206 – biosimilar to Keytruda^®3 (pembrolizumab)

Based on intensive scientific dialogue with the U.S. Food and Drug Administration (FDA) regarding the clinical development programme, the Executive Board of Formycon has today decided to terminate the phase III trial (“Lotus”) for the biosimilar candidate FYB206 ahead of schedule. After careful consideration, the Executive Board has concluded that the continuation of the trial is no longer necessary for the development and approval of FYB206 in the U.S. The therapeutic comparability of FYB206 with the reference drug Keytruda^® can be sufficiently demonstrated based on the comprehensive analytical data and the data from the parallel phase I trial (“Dahlia”) in patients with malignant melanoma (black skin cancer). Formycon is thus taking a pioneering role among pembrolizumab biosimilar developers, once again highlighting its expertise in the development of biosimilars. Patients with non-small cell lung cancer (NSCLC) who have been treated in the phase III trial so far will continue to be given the reference drug Keytruda^®.

As a result of the early termination of the extensive phase III trial, the company expects probable investment savings in the high double-digit millions over the next few years. As the development costs for FYB206 have been capitalised on the balance sheet since 2022, future savings will not affect the income statement but will have a direct positive impact on liquidity. Accordingly, the company expects significantly positive effects in the high double-digit million range for the cash flow statement and working capital.

FYB202/Otulfi^TM – biosimilar to Stelara^®4 (ustekinumab)

In consultation with its commercialization partner Fresenius Kabi AG in the context of the imminent market launch of FYB202/Otulfi^TM in the U.S., Formycon assumes that the valuation model and the balance sheet measurement for FYB202 will need to be reviewed and adjusted accordingly due to an emerging, significantly higher-than-expected price discount for biosimilars in the U.S. In 2022, FYB202 was acquired by the Company through a contribution in kind as part of the Athos transaction and approved in 2024 in the U.S. and Europe in various immunological indications. According to preliminary calculations, Formycon currently expects a non-cash impairment in the high double-digit to almost low triple-digit million range. The exact figures are currently being calculated and audited by the company as part of the year-end financial audit.

FYB201/CIMERLI^® – biosimilar to Lucentis^®5 (ranibizumab)

Due to the increasing price discount offered by ranibizumab providers in the US, Bioeq AG, the exclusive license holder of FYB201/CIMERLI^®, is currently in discussions with its commercialization partner Sandoz AG regarding the further commercialization strategy for FYB201/CIMERLI^® in the U.S. Based on the status of these discussions, the company currently assumes that the commercialization of FYB201/CIMERLI^® will likely be temporarily paused. As a result, this is expected to lead to an extraordinary adjustment of the valuation model and the balance sheet measurement for FYB201 as well as the stake in Bioeq AG, amounting to a high single-digit to low double-digit million figure for the 2024 financial year. In this context, Bioeq AG is evaluating alternative commercialization strategies for the ophthalmic biosimilar in the U.S. Formycon will provide updates on further developments in due course.

The Company currently assumes that the key financial performance indicators (Group revenue and EBITDA, adjusted Group EBITDA and working capital) for the 2024 financial year should not be affected by these adjustments. However, the company’s net result could be negatively affected by the impairment.

Dr Stefan Glombitza, CEO of Formycon AG, commented: “The latest developments in our projects underscore both the dynamics and the opportunities of the market environment. For biosimilars in the so-called Pharma Benefit market segment in the US, it is becoming apparent that the market opening for biosimilars is still progressing slower and requires greater price discounts than previously anticipated. This will also affect our product FYB202/Otulfi^TM, which is marketed by our partner Fresenius Kabi. In the case of FYB201/CIMERLI^®, our partner Sandoz is observing increasing price discounts in the U.S. and has informed us of planned adjustments to the marketing strategy. Bioeq AG is therefore examining options for alternative commercialization strategies for the U.S. that combine economic success with long-term market presence. Biosimilars have already amply demonstrated that they can achieve a sustainable market position in the long term and are based on a profitable business model. Our strategy remains focused on working with our partners to achieve a leading position in this dynamic environment.

At the same time, regulatory developments in the U.S. indicate that the framework conditions for biosimilars continue to improve. The FDA has confirmed that extensive analytical data, together with the ongoing phase I trial, will be sufficient to demonstrate the therapeutic comparability of our biosimilar candidate FYB206 with Keytruda^®. This eliminates the need for a phase III trial for FYB206 – an important step that will not only shorten the development time but also significantly reduce investment. This also highlights the importance of the quality of our analytical and preclinical data. Formycon is thus taking on a pioneering and leading role among Keytruda^® biosimilar developers.”

Enno Spillner, CFO of Formycon AG, added: “We expect the financial adjustments in our three projects to have differing effects. The consideration of the price discounts for FYB202 will require a review of our assumptions and financial models. This could lead to significant valuation adjustments for FYB202. In addition, the temporally pause in the marketing of FYB201 would require an adjustment to our short-term planning. Therefore, we are currently analyzing the potential impact and the specific impairment requirements. Meanwhile, the decision on FYB206, based on feedback from the FDA, brings us significant financial benefits. By ending the phase III trial early, we expect savings in the high double-digit million range over the next few years. This strengthens our working capital, creates additional financial flexibility for the further development of our pipeline and could partially compensate for lower cash flows from FYB201 and FYB202. We will provide guidance for the 2025 financial year when publishing the 2024 annual financial statements. In general, our goal of achieving profitability and positive operating cash flow in the medium term remains unchanged.”

Conference call and webcast

The Executive Board of Formycon AG will discuss and provide context for the company’s latest developments in a conference call. The conference call, which will be webcast live, will be held in English on February 17, 2025, at 5:00 p.m. (CET).

To participate in the conference call, please register at: https://webcast.meetyoo.de/reg/X9bNqTxsvSRH

After registration, participants will receive a confirmation email with individual dial-in details and the date.

The presentation and audio broadcast can be accessed via the following webcast link: https://www.webcast-eqs.com/formycon-2025-02

After a short presentation, the Executive Board will be available to answer analysts’ questions. The webcast will be recorded and will be available for viewing afterwards on the Formycon website at: https://www.formycon.com/news-media/blog/.

1) Otulfi^TM is a trademark of Fresenius Kabi Deutschland GmbH in selected countries
2) CIMERLI^® is a registered trademark of Coherus BioSciences, Inc.
3) Keytruda^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA
4) Stelara^® is a registered trademark of Johnson & Johnson
5) Lucentis® is a registered trademark of Genentech, Inc.

Planegg-Martinsried, Germany – Klinge Biopharma GmbH (“Klinge”), the exclusive owner of the global commercialization rights of FYB203/AHZANTIVE^®1 (aflibercept), Formycon’s biosimilar to Eylea^®2, informed Formycon AG (FSE: FYB), that it has concluded an exclusive license agreement with Lotus Pharmaceutical (“Lotus”), a multinational pharmaceutical company, for the commercialization of FYB203/AHZANTIVE^® in Asia-Pacific (“APAC”) countries: Indonesia, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam as well as the Special Administrative Region Hong Kong. In parallel, Formycon has signed an agreement with Lotus under which Formycon will supply the finished product.

Lotus is a global pharmaceutical company with a strong presence in Asia and a diverse portfolio of novel, generic and biosimilar medicines. Upon signature of the agreement, Klinge will receive upfront payments and is eligible to receive milestone payments on launch and sales. Additionally, Klinge will receive royalties on Lotus’ net sales. Formycon will participate in all Klinge income in the mid-single to low-double-digit percentage range.

“We are extremely pleased to welcome Lotus as a strong partner with a unique presence in the APAC region. Formycon and Lotus share the ambition to improve access to affordable, high-quality medicines for patients worldwide. Together we look forward to making a relevant contribution to healthcare in the APAC region and providing AHZANTIVE^® as an effective and cost-efficient treatment option for patients affected by serious retinal diseases,” says Nicola Mikulcik, CBO of Formycon AG.

“Lotus is proud to partner with Formycon and to add AHZANTIVE^® (aflibercept), a biosimilar to Eylea^®, to our product portfolio aimed at improving access to healthcare in the Asia-Pacific region,” says Petar Vazharov, CEO of Lotus. “Leveraging our regional expertise, we look forward to working closely with Formycon to deliver this impactful and much-needed treatment to healthcare providers and patients.”

In June 2024, the U.S. Food and Drug Administration (FDA) approved the aflibercept biosimilar FYB203. Approval by the European Commission followed in January 2025. Formycon and Lotus closely align to prepare the regulatory submissions in the APAC countries according to the local requirements.

Eylea^® (Aflibercept) is used to treat neovascular age-related macular degeneration (nAMD) and other severe retinal diseases. The active ingredient inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina.

1) AHZANTIVE^® is a registered trademark of Klinge Biopharma GmbH
2) Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) and its licensing partner Klinge Biopharma GmbH (“Klinge”) today jointly announce that the European Commission has granted central marketing authorization for FYB203 (Aflibercept), a biosimilar to Eylea^®1, under the brand names AHZANTIVE^®2 and Baiama^®3. The approval encompasses the treatment of Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), visual impairment due to Myopic Choroidal Neovascularisation (CNV) and Macular Edema following Retinal Vein Occlusion (RVO). The decision of the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) from November 2024 and applies to all countries in the European Economic Area (EEA), including the 27 member states of the European Union (EU) as well as Iceland, Liechtenstein, and Norway.

Dr. Stefan Glombitza, CEO of Formycon AG, commented: “The EU approval of FYB203, our biosimilar for Eylea^®, marks another milestone for Formycon and is based on the expertise and dedication of our entire team. As our second ophthalmic biosimilar, FYB203 significantly expands therapeutic options for patients with severe retinal diseases. With AHZANTIVE^® and Baiama^®, we are improving access to high-quality and affordable therapies that contribute sustainably to enhancing patients’ quality of life.”

Aflibercept inhibits the vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina, thereby impairing vision. In 2023, the reference product Eylea^® achieved global sales of approximately USD 9 billion⁴, highlighting the significance and necessity of a cost-effective alternative like FYB203.

In mid-January 2025, Formycon and Teva Pharmaceuticals International GmbH (Teva) signed a licensing agreement for the semi-exclusive commercialization of FYB203 across major parts of Europe and Israel. Concurrently, Formycon has concluded an agreement with Teva for product supply. FYB203 was already approved by the U.S. Food and Drug Administration (FDA) in June 2024.

¹⁾ Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.
²⁾ AHZANTIVE^® is a registered trademark of Klinge Biopharma GmbH
³⁾ Baiama^® is a registered trademark of Klinge Biopharma GmbH
⁴⁾ Source: https://investor.regeneron.com/news-releases/news-release-details/regeneron-reports-fourth-quarter-and-full-year-2023-financial/

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) and its commercialization partner Fresenius Kabi announce that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved FYB202/Otulfi^®1 (ustekinumab), a biosimilar to Stelara^®2, for the treatment of moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. The U.S. Food and Drug Administration (FDA) as well as the European Commission had already granted marketing authorization for FYB202 in September 2024, followed by Health Canada’s approval end of December 2024.

Dr. Stefan Glombitza, CEO of Formycon AG, said: “For millions of people around the world, chronic inflammatory diseases have a massive impact on the quality of life. There is a clear demand to help those patients, who are suffering severely from the symptoms of their disease. Each approval is important and brings us a step ahead in our mission to offer a highly effective and cost-efficient treatment option to as many patients as possible across multiple geographies.”

In February 2023, Formycon and Fresenius Kabi had entered into a global license agreement providing Fresenius Kabi with commercialization rights of FYB202 in key global markets, including the UK.

Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play an important role in inflammatory and immune responses. The approval is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB202 demonstrated comparable efficacy, safety and pharmacokinetics to the reference drug Stelara^® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).

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¹⁾ Otulfi^® is a trademark of Fresenius Kabi Deutschland GmbH in selected countries
²⁾ Stelara^® is a registered trademark of Johnson & Johnson