Archives Press Releases

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) today decided to issue a four-year corporate bond (ISIN NO0013586024 / WKN A4DFJH) with a target volume of EUR 50 million. The company intends to use the proceeds to advance its growth strategy – in particular for the consequent development and expansion of the Company’s biosimilar product portfolio.

“In recent years, Formycon has evolved from a biosimilar development company into a commercially focused company with a growing and maturing product portfolio while increasing revenues from global licensing and commercialization partnerships. This commercial foundation enables us to tap into another attractive source of financing with the planned bond issuance. It is our goal to transition our corporate financing towards a more long-term setup. In doing so, we are optimizing our capital structure and tapping into debt capital for the first time. The proceeds will support the continued execution of our strong growth strategy, the optimization of our biosimilar platform, and the further strengthening of our position as a commercially operating company. Having laid a solid groundwork with the necessary structures and processes over the past years, we are now ready to scale them to the next success level,” said Enno Spillner, CFO of Formycon AG.

The transaction is being led by IKB Deutsche Industriebank AG and Pareto Securities AS as Joint Lead Managers. The bonds will be issued as part of a public offering in Luxembourg, Germany, and Austria. The offering is based on a securities prospectus which is expected to be approved today by the Luxembourg financial supervisory authority (CSSF) and to be notified to the German Federal Financial Supervisory Authority (BaFin) and the Austrian Financial Market Authority (FMA). The prospectus will be published on the websites of the Luxembourg Stock Exchange (www.luxse.com) and Formycon AG (www.formycon.com, section ‘Investor Relations’).

In addition, the Joint Lead Managers plan to offer the bond to institutional investors in Germany, Luxembourg, and Austria, as well as selected other European and international markets as part of a private placement.

Interested investors may submit their binding subscription offers during the offering period either through Deutsche Börse’s subscription functionality “DirectPlace” (subscription period: June 20 to June 30, 2025, 12:00 p.m. CEST) or via the Formycon AG website (www.formycon.com; subscription period: June 18 to June 27, 2025, 11:59 p.m. CEST), subject to an early closing of the subscription period. When using DirectPlace, investors may place purchase orders through their house or custodian bank on the Frankfurt Stock Exchange during the subscription period; alternatively, the subscription is also possible via the website.

The Bond, governed by Norwegian law, will have a term of four years. The minimum investment amount is EUR 1,000. The interest rate will be based on the three-month EURIBOR plus a margin ranging from 7.0% to 7.5% per annum. The final margin and total nominal amount of the Bond are expected to be determined and announced on or around June 30, 2025, based on the subscription offers received.

The Bond is intended to be included in the Open Market (Freiverkehr) of the Frankfurt Stock Exchange. Additionally, the Company intends to apply for the Bond to be admitted to trading on Euronext ABM, a self-regulated marketplace operated by the Oslo Stock Exchange (Oslo Børs), within six (6) months following issuance.

With the placement of the bond, Formycon is utilizing this capital market instrument for the first time to further and sustainably strengthen its position as a growth-oriented company with an increasing commercial focus in a highly attractive and dynamically growing market.

Key Terms of the Formycon Corporate Bond 2025/2029

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) today announces that the Brazilian regulatory authority ANVISA has granted marketing authorization for Ranivisio^®1, a biosimilar to Lucentis^®2 (ranibizumab). Product launch by the Brazilian biopharma specialist Biomm is expected in Q4 2025, marking the beginning of a phased market rollout of FYB201/Raniviso^® across Latin America. Marketing authorizations have already been granted by the regional regulatory authorities in Peru, El Salvador, Honduras, and the Dominican Republic. Further approvals and product launches in Central and South America are planned through early 2027.

“The marketing approval of FYB201/Ranivisio^® in Brazil underlines our mission to improve access to high-quality biologic drug therapies especially in countries where the usage of high-cost biologics is quite limited today,” says Formycon CBO Nicola Mikulcik, adding: “We are extremely pleased to offer a safe, effective and affordable treatment option for the growing patient population with severe retinal diseases in Brazil. In Biomm, we have a strong commercial partner with in-depth knowledge of the local market and the specific requirements of the ophthalmology sector. Based on the country-by-country rollout in LATAM, which is planned to start in Q4 this year, we expect the region to become a good contributor to our profits mid-term.”

Biomm is a well-established pharmaceutical company with a strong presence in Brazil, the largest healthcare market in South America. The company focuses on the development, manufacturing and distribution of biopharmaceutical drugs, including biosimilars. According to Biomm, the Brazilian market for anti-VEGF therapies, including the active ingredient ranibizumab, is valued at BRL 374 million (approx. US$ 66 million) annually and has demonstrated consistent growth over the past three years.

FYB201/Ranivisio^® (ranibizumab) is used to treat severe visual impairments such as wet age-related macular degeneration (nAMD) and other retinopathies. Developed by Bioeq AG, a joint venture between Formycon AG and Polpharma Biologics Group BV, the biosimilar is currently available in a total of 21 countries in Europe, North America and the MENA region.

¹Ranivisio^® is a registered trademark of Bioeq
²Lucentis^® is a registered trademark of Genentech Inc.

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) and its commercialization partner Fresenius Kabi proudly announce the market launch of FYB202/Otulfi^™1 an ustekinumab biosimilar referencing Stelara^®2 in Canada. Following Health Canada’s Notice of Compliance (NOC) end of December 2024, Otulfi^™ is now available as a high-quality and cost-effective treatment option for adult patients with moderate to severe active Crohn’s disease, moderate to severe active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.

“Canada is a key market with a strong commitment to biosimilar adoption. We are proud that our ustekinumab biosimilar is now available to Canadian patients, contributing to broader access to high-quality biologic therapies across the North American continent,” said Dr. Stefan Glombitza, CEO of Formycon AG. “For many patients suffering from chronic inflammatory diseases, access to biologic therapies remain limited. There are often substantial delays that keep patients from benefiting from these highly effective treatments when they need them most. Biosimilars like Otulfi^™ play a crucial role in reducing healthcare expenditure while maintaining high standards in quality and safety of patient care.”

To support patients transitioning to Otulfi^™, Fresenius Kabi provides access to its KabiCare^® patient support program. KabiCare^® offers a full range of services including injection training, reimbursement assistance, a dedicated single point of contact, bloodwork coordination and lifestyle assessments. With KabiCare^®, patients receive assistance in accessing their medicine, ongoing support, education, and guidance throughout their biosimilar treatment journey.

“The high demand for biosimilars in Canada underscores the necessity for accessible and cost-effective biologics. We are very proud to be introducing a cost-effective and European manufactured alternative ustekinumab treatment for patients living with inflammatory and immune diseases,” said Abhi Bhoite, Sr. Director and Head of Commercial, Fresenius Kabi Biopharma, Canada.

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 and launched in Europe and the U.S. in March 2025.

Otulfi^™ is available in Canada in the following presentations:

• 45 mg/0.5 mL and 90 mg/mL single-dose prefilled syringe for subcutaneous injection
• 130 mg/26 mL (5 mg/mL) single dose vial for IV infusion.

¹⁾ Otulfi^™ is a 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 commercialization partner Fresenius Kabi announce today that the U.S. Food and Drug Administration (FDA) designated FYB202/Otulfi^®1 (ustekinumab-aauz) as interchangeable with the reference biologic Stelara^®2 (ustekinumab). As of April 30, 2025, Otulfi^® is interchangeable in all presentations matching the reference product.

Fresenius Kabi launched the 45 mg and 90 mg single-dose prefilled syringe for injection as well as the 130 mg single dose vial presentations for IV infusion in the U.S. beginning of March 2025. In April the Centers for Medicare and Medicaid Services (CMS) issued a permanent, product-specific billing code (Q-Code) for Otulfi^®. These codes are used by commercial insurers and government payers to standardize claims submissions and simplify reimbursements.

Dr. Stefan Glombitza, CEO of Formycon AG, commented: “The interchangeability designation for FYB202/Otulfi^® in the U.S. is a strong endorsement of the product’s excellent quality and underscores Formycon’s recognition as one of the leading biosimilar developers. Both the product-specific reimbursement code and the interchangeability designation are important drivers of improved patient access to a much-needed treatment option for severe inflammatory diseases in the U.S. This will create additional impetus for market uptake.”

Depending on state pharmacy laws in the U.S., an interchangeable biosimilar can be dispensed at the pharmacy as a substitute for the reference product without requiring direct approval from the prescribing healthcare provider. Not all biosimilars receive interchangeability status.

FYB202/Otulfi^® was approved by the U.S. Food and Drug Administration (FDA) in September 2024 for the treatment of the same conditions as Stelara^®. FDA approval and interchangeability designation are based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB202/Otulfi^® demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug in patients with moderate to severe plaque psoriasis and offers a comprehensive, alternative treatment solution for health care professionals and patients treated with ustekinumab in the U.S.

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”) today reports on the Group’s business development and financial results for the first quarter of fiscal year 2025. The reporting period was marked by operational milestones and positive regulatory trends, successful product launches, the expansion of international commercialization partnerships but also by challenging macroeconomic conditions.

Dr. Stefan Glombitza, CEO of Formycon AG, stated: “Q1 was a turbulent quarter for our industry and Formycon alike. Nevertheless, we achieved several important milestones during the reporting period. These include, in particular, the successful market launch of our Stelara^®2 biosimilar FYB202/Otulfi^® in the U.S. and Europe, as well as the approval of our Eylea^®3 biosimilar FYB203 in Europe and the United Kingdom. Just a few weeks after launch, FYB202 already generated notable revenue contributions. This encouraging start, against the backdrop of increasing biosimilar penetration, confirms the product’s international market potential. We remain firmly focused on the strategic advancement of our pipeline and are particularly well positioned with our Keytruda^®4 biosimilar FYB206 to drive further growth.”

Enno Spillner, CFO of Formycon AG, added: “With our pioneering development strategy for FYB206, we are significantly reducing development costs while reinforcing our leading role in the global competition for a biosimilar to Keytruda^®. Despite increasing economic challenges in the U.S. market, we are operating well within our communicated financial guidance. Even in light of volatile capital markets and macroeconomic uncertainties, including U.S. trade policy, Formycon remains strategically and operationally on track. We reaffirm our guidance for the current fiscal year and remain committed to achieving sustainable, EBITDA-positive growth.”

Strong start to the year marked by key operational achievements

In January 2025, FYB203 (Aflibercept), a biosimilar to Eylea^®, was approved by the European Commission under the brand names AHZANTIVE^®5 and Baiama^®6. UK approval followed in February. Teva Pharmaceuticals will market FYB203 on a semi-exclusive basis across major parts of Europe. In addition, Formycon entered into a commercialization agreement with Lotus Pharmaceutical for the Asia-Pacific region.

Formycon’s commercialization partner Fresenius Kabi initiated the U.S. launch of FYB202 (ustekinumab), a biosimilar to Stelara^®, at the end of February with an encouraging start. Shortly thereafter, the European launch followed in early March. In the meantime, FYB202 also received important marketing authorizations in the United Kingdom and Canada. To further expand its global presence and maximize commercial potential, Formycon also initiated a partnership with MS Pharma for the MENA region. After the reporting period, FYB202/Otulfi^® was assigned a permanent, product-specific reimbursement code (Q-code) in the U.S., facilitating reimbursement by private and public payers.

Based on the positive feedback from the U.S. Food and Drug Administration (FDA), Formycon decided to waive the Phase III trial with FYB206 (Pembrolizumab) in February 2025 as the therapeutic comparability of FYB206 with the reference medicine Keytruda^® can be sufficiently demonstrated based on comprehensive analytical data and data from the ongoing Phase I study. The Phase I trial in malignant melanoma continues as planned. This decision accelerates development of the biosimilar and reduces the investments over the coming years by more than €75 million. In a recently published “reflection paper”⁷, the European Medicines Agency (EMA) has also signaled its support for this approach, reinforcing Formycon’s position as a pioneer among pembrolizumab biosimilar developers.

FYB201 (ranibizumab biosimilar) is available in 20 countries worldwide and has continued to strengthen its position in various markets. Competitive discounting by ranibizumab providers in the U.S. prompted Formycon’s commercialization partner Sandoz AG to adjust its marketing strategy and to implement a temporary pause in the commercialization of FYB201/Cimerli^®8 for approximately one year, starting at the end of Q1 2025. Following the pause, the product is to be strategically repositioned to target new customer segments. The product remains available in other regions, including Europe and MENA, where it is marketed by Teva and MS Pharma, respectively. With the planned launch of the pre-filled syringe in 2025, further market penetration is expected, particularly in Europe. Further markets such as in Latin America are targeted for expansion.

Alongside its advanced biosimilar programs, Formycon continues to drive the development of new pipeline candidates. The candidates FYB208, FYB209, and FYB210 are currently in early stages of development. FYB208 is expected to enter the clinical phase later this year upon achieving Technical Proof of Similarity.

Following Formycon’s successful inclusion in the SDAX at the end of 2024, the company’s visibility as one of Germany’s key technology stocks was further enhanced at the beginning of 2025 through its admission to the TecDAX.

Group revenue and EBITDA in line with expectations – FYB202 revenue contributions reflect a successful market launch

Formycon Group generated revenues of €5.3 million in Q1 2025 (Q1/2024: €17.7 million). The year-on-year decline was anticipated and reflects the revenue mix shift. In the prior-year period, significant milestone revenues were recognized from the commercialization partnership with Fresenius Kabi related to the FYB202 project. As development of the pre-filled syringe for the two ophthalmic biosimilars FYB201 and FYB203 progressed successfully, revenues from reimbursed development services declined as expected accordingly.

Despite being on the market for only about one month in the U.S. and Europe, FYB202/Otulfi^® generated revenues of €0.74 million in the first quarter, demonstrating a positive market launch. Further increasing revenue contributions are expected over the course of the year, positioning FYB202 as a key revenue driver for the Group in 2025.

As expected, revenues from the ranibizumab biosimilar FYB201 were below the prior-year level. This was attributable to continued price pressure and the previously announced temporary pause in U.S. commercialization by partner Sandoz, which took effect on April 1, 2025. Direct revenue contributions from commercialization of the Lucentis^®9 biosimilar FYB201 amounted to €0.6 million (Q1/2024: €1.9 million). A further significant portion of revenue from FYB201 was realized through the 50% at-equity investment in Bioeq AG. The at-equity result is not included in revenue and is reported below EBITDA (see below).

Group EBITDA for the first three months amounted to €-13.2 million (Q1/2024: €-5.5 million), primarily reflecting the aforementioned decline in revenues. However, the initial revenue contribution from FYB202/Otulfi^® is viewed positively. The Stelara^® biosimilar was launched at the end of the first quarter in the U.S. and Europe and remains in the early stage of market ramp-up. Increasing research and development expenses related to early-stage biosimilar candidates also impacted Group EBITDA accordingly.

Adjusted Group EBITDA amounted to €-11.8 million (Q1/2024: €2.9 million) and was in line with expectations. The result was primarily attributable to the weaker performance of FYB201 in the U.S. and the resulting lower earnings contribution from Bioeq AG (at-equity result), which amounted to €1.4 million (Q1/2024: €4.3 million).

Working capital as of March 31, 2025, stood at €29.4 million (December 31, 2024: €55.1 million). The year-over-year change reflects initial investment savings in FYB206, where development costs are capitalized and thus cash-effective but not EBITDA-relevant. The existing shareholder loan of €48.0 million remains fully available and can be drawn flexibly.

Formycon confirms its full-year 2025 guidance and continues to pursue sustainable and EBITDA-positive development. Management still anticipates achieving positive EBITDA as early as 2026, but no later than 2027.

Key financial figures at a glance (in € million):

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 today, May 12, 2025, at 3:00 p.m. (CEST) in English.

To participate in the conference call, please register at:

https://webcast.meetyoo.de/reg/dv2D4A5Z3vhL

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-2025-q1

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⁾ Otulfi^® is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries
²⁾ Stelara^® is a registered trademark of Johnson & Johnson
³⁾ Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.
⁴⁾ Keytruda^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA
⁵⁾ AHZANTIVE^® is a registered trademark of Klinge Biopharma GmbH
⁶⁾ Baiama^® is a registered trademark of Klinge Biopharma GmbH
⁷⁾ EMA Reflection Paper  www.ema.europa.eu/en/reflection-paper-tailored-clinical-approach-biosimilar-development
⁸⁾ CIMERLI^® is a registered trademark of Coherus BioSciences, Inc.
⁹⁾ Lucentis^® is a registered trademark of Genentech Inc.

Planegg-Martinsried, Germany – Formycon AG (FSB: FYB, Prime Standard, „Formycon“) plans to publish its results for the first quarter of 2025 on May 12, 2025. The Management Board will discuss the company’s development, key financial figures, and provide an outlook for the course of 2025. The conference call, which will be broadcast live on the internet, will take place on May 12, 2025, at 3:00 PM (CEST) in English.

To participate in the conference call, please register at:
https://webcast.meetyoo.de/reg/dv2D4A5Z3vhL

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-2025-q1

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:

May 13 – May 14, 2025
Equity Forum Spring Conference
Dr. Stefan Glombitza (CEO)
Frankfurt

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

August 28, 2025
Hamburg Investors’ Days (HIT)
Enno Spillner (CFO)
Hamburg

September 8 – 10, 2025
H.C. Wainwright 27th Annual Global Investment Conference
Enno Spillner (CFO)
New York

September 22, 2025
Berenberg & Goldman Sachs German Corporate Conference
Dr. Stefan Glombitza (CEO), Enno Spillner (CFO)
Munich

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

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.

————————————————————————————-

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