Archives Press Releases

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) today announces that Klinge Biopharma GmbH (Klinge), the exclusive owner of the global commercialization rights of FYB203/AHZANTIVE^®1 (aflibercept-mrbb), Formycon’s biosimilar to Eylea^®2, concluded an exclusive license agreement with U.S. biosimilars specialist Valorum Biologics LLC (“Valorum”) for the commercialization of FYB203/AHZANTIVE^® in the United States and Canada.

Upon signature of the agreement, Klinge is eligible to receive upfront payments and milestone payments, plus royalties on net sales. Formycon will participate in the mid-single-digit to low-double-digit percentage range in all payment streams to Klinge resulting from this agreement. Furthermore, Formycon will act as authorized designee to organize the supply chain for FYB203/AHZANTIVE^® and will receive additional service payments and a volume-based profit component for organizing the commercial market supply on behalf of Klinge.

Valorum is a biosimilar commercialization specialist established by experienced industry leaders including past presidents of AmerisourceBergen, Cardinal Health and General Manager of McKesson, respectively. The company is focused on best-in-class commercialization of biosimilars in the U.S. to improve access, reach and cost savings for the healthcare system. Valorum has built a team with unparalleled experience and established networks across the U.S. pharmaceutical market and will be well positioned to maximize the commercial potential of FYB203/AHZANTIVE^®. The team has collectively launched several multi-billion-dollar pharmaceutical products within large pharmaceutical organizations such as Johnson & Johnson, Merck and Roche in the past.

ATHOS KG³, a major indirect shareholder of Formycon, leading the Series A financing of Valorum underlines its confidence in this U.S. commercialization partner, their strategy and the potential of FYB203/AHZANTIVE^®.

“Partnering with Valorum as a dedicated market specialist builds a key success component for the commercialization of FYB203/AHZANTIVE^® in the U.S. and Canada. The highly experienced management team with profound knowledge of U.S. market dynamics along with a strong customer network makes Valorum a powerful choice to drive the commercialization of our second ophthalmic biosimilar product. We are delighted to join forces with this highly committed partner to maximize the – market potential of AHZANTIVE^® and further strengthen our strategic position as biosimilar player,” says Dr. Stefan Glombitza, CEO of Formycon AG.

Par Hyare, CEO of Valorum Biologics, added: “We are pleased to introduce AHZANTIVE^® in the U.S. and Canada, recognizing its strong potential as a biosimilar to Eylea^®. With our team’s proven expertise in specialty markets and established track record of commercial excellence, we are committed to driving broad market adoption, reinforcing our industry leadership, and helping reduce financial burdens for patients and providers alike.”

Wolfgang Essler, chief representative (Generalbevollmächtigter) of ATHOS KG and Chairman of the Supervisory Board of Formycon AG, commented: “Biosimilars will become even more a game-changer in the U.S. healthcare system. As the industry moves toward more sustainable healthcare models, biosimilars provide a unique opportunity to improve patient access to life-saving treatments while reducing the overall burden on the healthcare system. We believe in the great potential of Formycon’s high-quality biosimilar products and are convinced that the partnership with Valorum will set the course for additional commercial success.”

FYB203/AHZANTIVE^® obtained FDA approval for the treatment of patients with Age-related neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), Diabetic Retinopathy (DR) and Macular Edema following Retinal Vein Occlusion (RVO) in June 2024. The active ingredient inhibits the vascular endothelial growth factor (“VEGF”), which is responsible for the excessive formation of blood vessels in the retina. Launch timing for FYB203/AHZANTIVE^® in the U.S. depends on several factors, like the progress and outcome of pending or potential future related litigations or any potential settlements. Approval of FYB203 by the Canadian regulatory authority Health Canada is expected by the end of this year.

FYB203 also received approval from the European Medicines Agency (EMA) in January and the UK Medicines and Healthcare products Regulatory Agency (MHRA) in February 2025.

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) today announced that strong demand, particularly from institutional investors, for its 2025/2029 corporate bond (ISIN: NO0013586024 / WKN: A4DFJH) has led to the public offering period ending ahead of schedule.

Interested investors may submit their binding subscription offers until 26 June 2025, 11:59 p.m. CEST via the company’s website (https://www.formycon.com/en/investor-relations/bond-2025/) and until 27 June 2025, 12:00 p.m. CEST via Deutsche Börse’s subscription functionality ‘DirectPlace”.

“The strong demand for our inaugural bond issuance is a clear sign of Formycon’s capital markets maturity and the trust in our sustainable business model,” said Enno Spillner, CFO of Formycon AG. “The significant interest, particularly from institutional investors, validates our strategic direction and financial strength. The bond will enhance our financial flexibility and represents an important milestone in the long-term diversification of our capital structure and investor base.”

The bond carries a variable interest rate consisting of the three-month EURIBOR plus a margin ranging from 7.0% to 7.5% per annum. The final margin will be determined on 27 June 2025, based on all submitted subscription offers. Listing on the Quotation Board (Open Market) of the Frankfurt Stock Exchange is still scheduled for 9 July 2025, but the company reserves the right to allow trading upon publication in advance. Formycon plans 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 the issuance.

The supplement to the securities prospectus approved by the Luxembourg Commission de Surveillance du Secteur Financier (CSSF), Luxembourg, and to be notified to the Federal Financial Supervisory Authority (Bundesanstalt für Finanzdiensteistungsaufsicht – BaFin), Germany, and the Austrian Financial Market Authority (Österreichische Finanzmarktaufsichtsbehörde – FMA) will be published on the website of the Luxembourg Stock Exchange (www.luxse.com) and the Company (https://www.formycon.com/en/investor-relations/bond-2025/).

Key Terms of the Formycon Corporate Bond 2025/2029

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) announces that investors can now subscribe to the 2025/29 corporate bond (ISIN: NO0013586024 / WKN: A4DFJH) via Deutsche Börse’s ‘DirectPlace’ subscription service. This service allows interested investors to place purchase orders directly with their house bank or custodian bank on the Frankfurt Stock Exchange during the subscription period. Since June 17, 2025, it is also possible to subscribe to the bond directly via the company website at (https://www.formycon.com/en/investor-relations/bond-2025/). 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.

“With this bond, we are opening ourselves up to a broader investor base and are utilizing the bond market as a strategic capital market instrument for the first time. This gives us the flexibility to further develop our pipeline and strengthen our position as a growth-oriented company with an increasing commercial focus,” explains Enno Spillner, CFO of Formycon AG.

The bond governed by Norwegian law, 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.

The transaction is being led by IKB Deutsche Industriebank AG and Pareto Securities AS as Joint Lead Managers. The bonds are being issued as part of a public offering in Luxembourg, Germany and Austria. The offering is based on a securities prospectus approved by CSSF, which has been notified to the German Federal Financial Supervisory Authority (BaFin) and the Austrian Financial Market Authority (FMA). The prospectus is available on the websites of the Luxembourg Stock Exchange (www.luxse.com) and Formycon AG (https://www.formycon.com/en/investor-relations/bond-2025/).

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.

Key Terms of the Formycon Corporate Bond 2025/2029

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) announces that the securities prospectus for the newly issued corporate bond 2025/2029 (ISIN NO0013586024 / WKN A4DFJH) has been approved by the Luxembourg financial supervisory authority (CSSF) on June 17, 2025, and that investors can now subscribe to the bond via the company’s website. The newly issued four-year unsecured senior bond has a target volume of EUR 50 million and carries a variable interest rate.

The Management and Supervisory Boards of Formycon AG approved the new bond issuance on June 17, 2025. The proceeds will be used to advance Formycon’s growth strategy – in particular for the consequent development and expansion of the Company’s biosimilar product portfolio. The bond has a minimum subscription amount of EUR 1,000, is governed by Norwegian law and carries a variable interest rate consisting of three-month EURIBOR plus a margin between 7.0% and 7.5% p.a. The final margin is expected to be determined and announced on June 30, 2025, based on submitted subscription offers.

Interested investors can submit binding subscription offers during the subscription period either via the company’s website (www.formycon.com; subscription period: June 18 to June 27, 2025, 11:59 p.m. CEST) or via Deutsche Börse’s “DirectPlace” subscription functionality (subscription period: June 20 to June 30, 2025, 12:00 noon CEST), subject to early closing. Using DirectPlace, investors can place buy orders through their custodian bank during the subscription period at the Frankfurt Stock Exchange; alternatively, subscription via the company’s website is available.

The Bond, governed by Norwegian law, 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.

The transaction is being led by IKB Deutsche Industriebank AG and Pareto Securities AS as Joint Lead Managers. The bond was issued as part of a public offering in Luxembourg, Germany, and Austria. The offering is based on a securities prospectus approved by CSSF, which has been notified to the German Federal Financial Supervisory Authority (BaFin) and the Austrian Financial Market Authority (FMA). The prospectus is available 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.

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, 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