EQS-News: Formycon reports on a successful financial year 2024 with strong operational progress and continuous strengthening of its market position

 Press Release // March 27, 2025
 

Formycon reports on a successful financial year 2024 with strong operational progress and continuous strengthening of its market position

• Group revenue exceeds forecast with €69.7 million (guidance: €55.0 million to €65.0 million)
   
• Group EBITDA at €-13.7 million also better than expected (guidance: €-25.0 million to €-15.0 million)
   
• Adjusted EBITDA totaled €-1.6 million and was in line with the expected range (€-5.0 million to €5.0 million)
   
• Commercial challenges in the U.S. and an adjusted outlook for FYB201 and FYB202 lead to significant balance sheet adjustments
   
• All key operational milestones for 2024 achieved, including FDA and EMA approvals of FYB202 (Stelara^®1 biosimilar) and FYB203 (Eylea^®2 biosimilar) as well as the successful start of clinical development for FYB206 (Keytruda^®3 biosimilar candidate)
   
• Cash inflow of €82.8 million from capital increase with a strategic partner; cash position of €41.8 million as of year-end 2024
   
• Successful uplisting to the Prime Standard of Deutsche Börse and inclusion in the SDAX
   
• 2025 guidance at around the same level as 2024 - despite the current challenging market environment in the U.S.
   
• Invitation to today’s conference call at 3:00 p.m. (CET)
   

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
 

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

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

About Biosimilars:

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

Contact:

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

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

Disclaimer:

This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.