Archives Press Releases

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) today announces that Bioeq AG (“Bioeq”), licensee and exclusive holder of the worldwide commercialization rights for FYB201, Formycon’s biosimilar candidate for Lucentis®² (ranibizumab), entered into an exclusive partnership with African biotechnology company Bio Usawa Biotechnology Ltd. (“Bio Usawa”).

This partnership grants Bio Usawa exclusive rights to register and commercialize FYB201 under the brand name BioUcenta™, bringing a highly effective ophthalmic medicine within reach for millions of patients across Sub-Saharan Africa.

FYB201/ BioUcenta™ is a monoclonal antibody used to treat diabetic macular edema (DME), neovascular age-related macular degeneration (nAMD), and other retinal diseases like diabetic retinopathy, that often lead to vision loss if not treated. While this therapy has been established in higher-income countries for nearly 20 years, patients across Africa have predominantly been denied access due to prohibitive costs and limited availability.

Africa is at the front line of a growing diabetes crisis. According to the International Diabetes Federation, more than 24 million Africans were living with diabetes in 2024, with that number projected to double by 2050. Diabetic retinopathy, a leading complication, threatens the sight of up to one-third of these patients.³

“By making ranibizumab accessible in Sub-Saharan Africa, we are empowering doctors to save the vision of millions, particularly those suffering complications from diabetes—a disease that is quietly but rapidly becoming one of Africa’s greatest health threats,” said Dr. Menghis Bairu, Co-founder, President and CEO of Bio Usawa. “This collaboration is about equity,” he added. “Access to advanced biologic therapies should not be a privilege of geography or income. We are proud to work with Formycon to make this a reality for Africa — ensuring that patients, regardless of where they live, can receive the care they deserve.”

“We are very excited to collaborate with Bio Usawa, who is a strong commercial partner with in-depth knowledge of the regional market and the specific requirements of the ophthalmology sector,” says Formycon CBO Nicola Mikulcik, adding: “This partnership represents a demonstration of the fulfillment of our joint mission to democratize access to high-quality, affordable, and proven biotherapies in low and middle income countries. This initiative should create the foundation of making essential medicines developed by Formycon available to the African continent.”

Developed by Bioeq AG, a joint venture between Formycon AG and Polpharma Biologics Group BV, FYB201 is currently available in a total of 21 countries.

1. BioUcenta™ is a trademark of Bio Usawa Biotechnology Ltd.
2. Lucentis^® is a registered trademark of Genentech Inc.
3. Source: IDF_Atlas_11th_Edition_2025_AFR_Factsheet.pdf

Planegg-Martinsried, Germany –. Formycon AG (FSE: FYB, Prime Standard, “Formycon”) announces that its 2025/2029 corporate bond (ISIN: NO0013586024 / WKN: A4DFJH) was significantly oversubscribed due to high demand, leading to an increase in the initially targeted issuance volume from EUR 50 million to EUR 70 million. The senior unsecured and floating rate bond with a term of four years was successfully and entirely placed on the capital market. The margin was fixed at 7.00% p.a., at the lower end of the indicated range.

“The active dialogue with investors and the positive feedback during the roadshow were key contributors to the successful order book. The significant oversubscription and full placement confirm the attractiveness of this bond as well as the trust in our business model and the future of biosimilars. We succeeded in addressing a new investor base – internationally and in our home market, institutionally and in retail. We would like to thank all investors for their trust and commitment.

With the successful placement of the bond, we are creating the basis for a long-term diversified financing structure. The proceeds will provide us with the flexibility to continue executing our growth strategy, to optimize our biosimilar platform and to strengthen our position as a commercially focused company. We are very proud of the outcome and would like to thank the entire team for the excellent preparation and execution of this transaction,” explained Enno Spillner, CFO of Formycon AG.

The offering met with strong demand, particularly from institutional investors both in Germany and internationally. Retail investors also showed significant interest as part of the public offer and participated via Deutsche Börse’s DirectPlace platform as well as the company’s website. All subscription orders up to an amount of EUR 2,000 per order were fully allocated; higher volumes were allocated on a pro rata basis of 40%, rounded to whole bonds, with each order being allocated a maximum of EUR 20,000.

The interest rate was finally set at EURIBOR plus a margin of 7.0% p.a., placing it at the lower end of the initial marketing range of 7.0% to 7.5% p.a.

The net proceeds received by the Company will be used to finance the development and expansion of the Company’s biosimilar product portfolio as part of its corporate growth strategy.

Inclusion of the bond in trading on the Open Market of Deutsche Börse AG is scheduled for July 9, 2025 (issue and value date). Trading on a per appearance basis is expected to commence on Monday, June 30, 2025. Formycon further plans to apply for inclusion in trading on Euronext ABM of the Oslo Stock Exchange within six months following the bond’s issue date.

The transaction was led by IKB Deutsche Industriebank AG and Pareto Securities AS as Joint Lead Managers.

Planegg-Martinsried, Germany – Formycon AG (FWS: FYB, “Formycon”) announces that it has entered into a distribution agreement with ratiopharm GmbH (“Ratiopharm”), a subsidiary of the Teva Group (“Teva”), for the semi-exclusive commercialization of its Stelara^®1 biosimilar FYB202/Fymskina^®2 in Germany. Under the agreement, Formycon is responsible for the manufacturing and the supply of the finished product, while Ratiopharm is responsible for commercialization.

In February 2023, Formycon entered into a global commercialization partnership for FYB202/Otuli^®3 (ustekinumab) with Fresenius Kabi. Under this agreement, Formycon retained secondary commercialization rights for Germany, parts of Latin America, and the MENA region in order to also license these rights separately to strong regionally focused distribution partners. In this respect, a license and supply agreement with MS Pharma for numerous countries in the MENA region was successfully concluded in December 2024.

“We aim to provide as many patients as possible with access to high-quality biosimilars while expanding our market presence in Germany. That’s why we set the strategic course for semi-exclusive partnerships early on,” explains Nicola Mikulcik, Chief Business Officer of Formycon AG. She adds: “With Fresenius Kabi, we already have a strong partner that, successfully launched FYB202/Otulfi^® in the US and various European markets, including Germany in March this year. We are delighted to have gained Teva/Ratiopharm as a strong second partner for the commercialization of FYB202 in our important home market Germany. We are convinced that we can significantly increase market coverage in Germany with this second product, FYB202/Fymskina^®.”

Teva already commercializes Formycon’s Lucentis^®4 biosimilar FYB201/Ranivisio^®5 in Europe. As one of the world’s leading pharmaceutical companies, Teva is leveraging its unique expertise in the generics and biosimilars market to drive the availability of modern medicines.

Under the agreement for the commercialization of Fymskina^® in Germany, Formycon will receive milestone payments and a share of the gross margin.

FYB202/Fymskina^® (ustekinumab) is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23. These play an important role in inflammatory and immune responses. In September 2024, Fymskina^® was approved by the European Commission for the treatment of moderate to severely active Crohn’s disease, moderate to severe plaque psoriasis, and active psoriatic arthritis.

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