Formycon confirms full-year guidance following business development in line with plan – working capital raised

  • Half-year results in line with expectations – full-year 2025 guidance confirmed
  • Outlook for working capital raised following successful placement of oversubscribed €70 million corporate bond
  • Strong second half expected: increasing market penetration of FYB202 and partnering of FYB206 as key value drivers for fiscal year 2025
  • FYB206: patient enrollment in Phase I trial successfully completed – streamlined clinical development program underscores leading position in the global race for a Keytruda®1 biosimilar
  • Invitation to today’s conference call at 3:00 p.m. (CEST)

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) today reported on the Group’s business development and financial results for the first half of 2025. The Company has continued its operational activities in a targeted manner and achieved significant progress across its biosimilar projects. The first half of the year was characterized by many positive operational milestones, progressive regulatory optimizations, new product launches, the further expansion of international commercialization partnerships, and the successful placement of a corporate bond.

Enno Spillner, CFO of Formycon AG, commented: “Our half-year figures are in line with our expectations and reflect structural effects that were already taken into account when preparing our annual forecast. The positive developments of recent weeks and months strengthen our expectations for a strong and highly dynamic second half of the year – in particular through the further market penetration of FYB202 and potential partnerships for FYB206. Both programs are excellently positioned to make a significant contribution to achieving our targets in both the remainder of the year and, in particular, in the fourth quarter. Our guidance for 2025 therefore remains largely unchanged. With the clearly oversubscribed issuance of our first corporate bond, we have strengthened our financial flexibility and are raising our working capital forecast accordingly. This puts us in a solid operational and strategic position for sustainable corporate growth.”

Group revenue and earnings performance in line with plan – 2025 guidance confirmed and working capital forecast raised

In the first half of 2025, the Formycon Group generated revenues of around €9.0 million (H1/2024: €26.9 million). The anticipated decline compared to the previous year primarily reflects a project-related transition phase and a changed revenue structure: While substantial milestone payments from the FYB202 partnership were recognized in the same period of the previous year, there were no comparable one-off revenues in the reporting period. Similarly, reimbursements for billable development services for FYB201 and FYB203 declined as forecast due to the advanced project status. New revenue from profit sharing for FYB202 was not yet sufficient to compensate for this decline. However, Formycon expects a strong and highly dynamic second half of the year, driven by the conclusion of targeted license partnerships for FYB206 and the further market penetration of FYB202. This applies in particular to Q4/2025.

The Stelara®2 biosimilar FYB202/Otulfi®3 was launched commercially by Formycon’s partner Fresenius Kabi at the end of the first quarter. In the U.S., the product is mainly distributed through the pharmacy benefit channel. Market development is still in its early stages and will be built up gradually through further contract signings, which will then generate additional market momentum. In Europe, FYB202 was launched in several countries in March. Since the third quarter, the product has also been marketed semi-exclusively in Germany by Ratiopharm under the trade name Fymskina®4. Revenue from the direct share in the commercialization of FYB202 amounted to €1.7 million (H1/2024: €0). In line with advancing market penetration, Formycon expects FYB202 to make a significant contribution to revenue.

In the case of the ranibizumab biosimilar FYB201, marketing partner Sandoz decided in the first quarter to temporarily suspend marketing in the U.S. Market-related adjustments to the pricing structure also had a dampening effect on earnings contributions. These structural changes had already been considered in the annual forecast, meaning that business development in the first half of the year was in line with expectations. Revenue from direct involvement in the marketing of FYB201 amounted to €0.8 million (H1/2024: €3.8 million). FYB201 continued to be successfully marketed across 21 markets outside the U.S., including Europe and the MENA region. Additional market momentum is expected in the second half of the year, particularly from the launch of the prefilled syringe in several European countries. This is intended to expand the product offering and specifically strengthen market penetration. The resumption of marketing in the U.S. is planned for the first half of 2026.

Overall, Formycon continues to expect full-year sales of €55.0 to 65.0 million, based on the assumption that sales from the profit share for FYB202 will increase significantly in the second half of the year, particularly in Q4. In addition, licensing activities for FYB206 are expected to play a significant role in revenues in the second half of the year.

The Group’s earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to €-17.9 million in the first half of 2025 (H1/2024: €-16.9 million). Performance was in line with financial planning and primarily reflects the decline in revenues. At the same time, following the successful approval of FYB202 in the fourth quarter of the previous year, the scheduled amortization of the capitalized intangible asset began, resulting in additional non-EBITDA-relevant costs of sales of approximately €12.5 million. As development costs incurred for FYB206 are capitalized, these investments are not recognized in the income statement.

Based on the expected increase in revenues in the second half of the year, Formycon continues to forecast EBITDA for the full year 2025 in the range of €-20.0 million to €-10.0 million.

Adjusted EBITDA amounted to €-19.2 million (H1/2024: €-2.1 million) and includes the earnings contribution from the 50% stake in Bioeq AG. The equity-accounted result of Bioeq AG amounted to €-1.2 million in the reporting period (H1/2024: €14.8 million) and reflects the temporary marketing pause for FYB201 in the U.S. as well as market-driven pricing adjustments. The forecast for adjusted EBITDA of between €-20.0 million and €-10.0 million remains unchanged.

The Formycon Group’s net working capital amounted to approximately €17.0 million as of June 30, 2025 (December 31, 2024: €55.1 million). The decline compared to the prior-year figure is mainly attributable to the capital increase of €83 million realized in February 2024 and project-related payment deferrals. In addition, the cash inflow from the €70.0 million corporate bond successfully placed in July 2025 occurred after the reporting date and is therefore not yet reflected in the balance sheet figures as of June 30. As a result, Formycon is raising its working capital outlook for 2025 from the original range of €25.0 million to €35.0 million to a range of €55.0 million to €65.0 million.

With the completion of the transaction and the associated cash inflow, the financing of ongoing development activities for the existing portfolio and operating business is secured. Formycon is pursuing sustainable and medium-term EBITDA-profitable corporate development and expects to achieve a positive EBITDA result ideally as early as 2026, but no later than fiscal year 2027.

Solid operational start to the year with significant regulatory milestones

Dr. Stefan Glombitza, CEO of Formycon AG, said: “We made strong progress on our growth strategy and reached key milestones in the first half of the year. With FYB202, our second biosimilar has entered international commercialization; the market rollout in the U.S. and Europe remains in its early stages but continues to make steady progress. The development of FYB206 is progressing very well: the successful completion of patient enrollment in the Phase I study confirms the effectiveness of our innovative, streamlined study design and will help us develop our biosimilar projects faster and more cost-efficiently.

Diversification is the key to sustainable success and stability in a dynamic market environment. In recent months, we have intensified our efforts in this direction. Through targeted expansion into high-growth emerging markets, a broad network of regional commercialization specialists, and a strategically balanced, maturing portfolio, we are laying the foundation for tomorrow. Building on our extensive biosimilar experience, combined with AI-driven development and increasingly improved regulatory frameworks, we optimize resources and processes, positioning ourselves lean and efficient to seize the numerous opportunities in the growing biosimilars segment.”

Right at the beginning of the year, the Eylea®5 biosimilar FYB203 received EU approval under the brand names AHZANTIVE®6 and Baiama®7, followed by authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA). Klinge Biopharma, holding the global marketing rights, established commercialization partnerships with Teva (Europe), Lotus Pharmaceutical (Asia-Pacific), and Valorum Biologics (USA/Canada). Within this framework, Formycon will be responsible for coordinating the supply chain and market supply.

The Stelara® biosimilar FYB202 received approvals in Canada and the United Kingdom at the beginning of the year. Commercialization partner Fresenius Kabi launched the product in the U.S. at the end of February, followed by market launches in several European countries. In April, the U.S. Food and Drug Administration granted interchangeability status, which facilitates substitution in pharmacies. This was followed in May by the launch in Canada and the assignment of a permanent billing code in the U.S. to ensure reimbursement eligibility. In June, Formycon also signed an agreement with Teva subsidiary Ratiopharm for secondary commercialization in Germany.

Based on positive feedback from the FDA, Formycon decided in February 2025 to discontinue the Phase III trial for its Keytruda® biosimilar candidate FYB206, as therapeutic comparability can be demonstrated by comprehensive analytical data and an ongoing Phase I PK study. This adjustment significantly accelerates development and reduces the expected investment by over €75 million. Patient recruitment for the study was completed in July, and the first participants have already completed all 17 treatment cycles. Results for the primary endpoint are expected in the first quarter of 2026.

FYB201 (Lucentis®8 biosimilar) is now approved in 21 countries. In the first half of 2025, FYB201’s global presence was expanded with additional approvals, including Brazil, South America’s largest market. Launch by regional partner Biomm is planned for the fourth quarter. Further approvals were granted in Peru, El Salvador, Honduras, and the Dominican Republic. In addition, an exclusive marketing agreement for Sub-Saharan Africa was signed with Bio Usawa. The launch of a pre-filled syringe in Europe in the second half of the year is expected to further increase market penetration in the region.

In addition to its advanced biosimilar programs, Formycon is also continuing to advance its younger product pipeline. The candidates FYB208, FYB209, and FYB210 are in early stages of development. FYB208 is scheduled to enter clinical development this year.

Successful debt financing underscores attractiveness of the biosimilars business

To finance its growth strategy and expand its investor base, Formycon issued its first corporate bond in June 2025, which was increased from €50.0 million to €70.0 million due to high demand. The four-year, floating-rate bond was placed with institutional and private investors in Germany and abroad. The net proceeds will be used primarily to further develop the biosimilar pipeline and scale up commercial activities.

Key financial performance indicators at a glance in € million

 

Results H1 2024Results H1 2025Guidance 2025 old
Guidance 2025 newChange
Revenue26.99.055.0 to 65.055.0 to 65.0unchanged
EBITDA-16.9-17.9-20.0 to -10.0-20.0 to -10.0unchanged
Adjusted EBITDA-2.1-19.2-20.0 to -10.0-20.0 to -10.0unchanged
Working Capital63.017.025.0 to 35.055.0 to 65.0raised

The complete 2025 half-year report can be found here. 

Conference call and dial-in details

The Executive Board of Formycon AG will discuss the Company’s development and key financial figures in a conference call. The earnings call, which will be broadcast live on the Internet, will take place on August 13, 2025 at 3:00 p.m. CEST and will be held in English.

To participate in the conference call, please register at:

https://webcast.meetyoo.de/reg/F0udEyLuS7H5

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

The presentation and audio webcast can be accessed via the following link:

https://www.webcast-eqs.com/formycon-2025-h1

Following a brief presentation, the Executive Board will be available to answer questions from analysts. The conference call will be recorded and subsequently available on the Formycon website at: https://www.formycon.com/en/investors/publications/.


1) Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, einer Tochtergesellschaft von Merck & Co, Inc, Rahway, NJ/USA
2) Stelara is a registered trademark of Johnson & Johnson
3) Otulfi® is a registered trademark of Fresenius Kabi Deutschland GmbH in ausgewählten Ländern
4) Fymskina® is a registered trademark of Formycon AG
5) Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
6) AHZANTIVE® is a registered trademark of Klinge Biopharma GmbH
7) Baiama® is a registered trademark of Klinge Biopharma GmbH
8) Lucentis® is a registered trademark of Genentech Inc.


Formycon invites to conference call on 2025 half-year results and announces participation in international investor conferences in the 3rd quarter of 2025

Planegg-Martinsried, Germany – Formycon AG (FSB: FYB, Prime Standard, „Formycon“) plans to publish its results of the first half of the 2025 fiscal year on August 13, 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 Wednesday, August 13, 2025, at 3:00 PM (CEST) in English.

To participate in the conference call, please register at:
https://webcast.meetyoo.de/reg/F0udEyLuS7H5

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-h1

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

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

September 03 – 05, 2025
2025 Wells Fargo Healthcare Conference
Enno Spillner (CFO)
Everett / Boston

September 08 – 10, 2025
H.C. Wainwright 27th Annual Global Investment Conference
Enno Spillner (CFO)
New York City

September 23, 2025
Berenberg & Goldman Sachs German Corporate Conference
Dr. Stefan Glombitza (CEO), Enno Spillner (CFO)
Munich

Additionally scheduled conference participations in 2025:

November 17 – 20, 2025
Jefferies Global Healthcare Conference
Enno Spillner (CFO)
London

November 24 – 26, 2025
Deutsche Börse Equity Forum
Enno Spillner (CFO)
Frankfurt

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


Formycon successfully completes patient enrollment for the clinical development of its Keytruda® biosimilar candidate FYB206

  • Streamlined clinical development program, which no longer requires a Phase III trial, is already in a far advanced stage
  • Last patient enrolled in Dahlia pharmacokinetic (PK) study (Last Patient-In)
  • First patients have completed all 17 treatment cycles of the Dahlia study
  • Results on the primary endpoint of the study expected in the first quarter of 2026

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) announced today that the patient enrollment for the clinical PK study Dahlia1 has been successfully completed with a total of 96 participants (Last Patient-In). The Dahlia study, which was launched in June 2024 in selected Southeastern and Eastern European study centers, compares the pharmacokinetics, safety and tolerability of FYB206 with the immuno-oncology blockbuster drug Keytruda®2.

At the end of 2024, Formycon submitted a streamlined clinical strategy to the U.S. Food and Drug Administration (FDA) with the intention to demonstrate the therapeutic comparability of FYB206 with the reference drug Keytruda® based on comprehensive analytical data and data from the PK study (Dahlia). Following a positive response from the FDA, the company decided in February 2025 to discontinue recruitment for the already-started Phase III trial. This decision accelerates the development of the biosimilar and at the same time significantly reduces the related investments over the coming years. The treatment of patients already enrolled in the Phase III trial has subsequently been continued with the locally available Keytruda® outside the trial.

„With our streamlined clinical development program for FYB206, we have secured a leading role among the developers of a pembrolizumab biosimilar. This is further underlined by the efficient and reliable execution of the Dahlia PK study. The fact that we can now announce the completion of patient enrollement with the ‘last patient in’ is further proof of Formycon’s professional study management and the strong recruitment performance in the study centers“, says Dr. Andreas Seidl, Chief Scientific Officer of Formycon AG and adds: „The first patients in the Dahlia trial have already completed all 17 treatment cycles. We therefore currently expect to receive the results of the study endpoint in the first quarter of 2026.

As a reminder: based on our stringent Dahlia study design, our sound scientific rationale and the comprehensive analytical data showing high structural and functional comparability with the reference drug, we have aligned with the FDA on a streamlined clinical development program that allows us to skip the Phase III trial. This approach accelerates development without compromising on quality, safety and efficacy. Furthermore – the streamlined clinical program supports our strategy to provide the pembrolizumab biosimilar FYB206 to patients worldwide as soon as possible and thus improve access to this essential drug.“

Pembrolizumab is an immune checkpoint inhibitor that is used in cancer therapies to treat various tumor diseases. With this broad range of indications and sales of around US$ 29.5 billion in 20243, Keytruda® is currently the world’s best-selling drug. Sales could rise even further in the coming years according to forecasts to over US$ 50 billion in 20324. The number of cancer diagnoses is also continuing to rise estimates by the International Agency for Research on Cancer (IARC) predict an increase of 77% by 2050.5

Following the successful completion of clinical development and approval by the regulatory authorities, Formycon currently expects the earliest market entry of its biosimilar candidate FYB206 after the expiry of the market exclusivity of the reference product in 2029 for the USA and after 2030 for the EU.


1   The Dahlia-PK study treats patients who have had malignant melanoma (black skin cancer) surgically removed. This so-called adjuvant therapy over 17 treatment cycles aims to minimize the risk of relapse in these patients.
2   Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA.
3   Source: https://www.merck.com/news/merck-announces-fourth-quarter-and-full-year-2024-financial-results/
4   Source: https://www.custommarketinsights.com/report/keytruda-market/
5   Source: https://www.who.int/news/item/01-02-2024-global-cancer-burden-growing–amidst-mounting-need-for-services


Bio Usawa becomes partner for the commercialization of FYB201/BioUcenta™ (ranibizumab) across Sub-Saharan Africa

  • Partnership marks a landmark step towards global availability of FYB201
  • Bio Usawa gets exclusive rights to register and commercialize FYB201/BioUcenta™1 in Sub-Saharan Africa
  • Product launch expected in Q1/2026 in the first countries
  • Partnership will provide access to ophthalmic treatment for millions of people facing preventable blindness from diabetes complication

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


Formycon increases bond volume following oversubscription – Bond 2025/2029 with a volume of EUR 70 million successfully and entirely placed

  • Due to strong demand, the offering period for the public offering has been shortened and target volume was increased from initially EUR 50 million to EUR 70 million
  • Interest rate fixed at the lower end of the marketing range at EURIBOR plus a margin of 7.00% p.a.
  • Inclusion to trading on the Quotation Board of the Frankfurt Stock Exchange scheduled for June 30, 2025; issue and value date on July 9, 2025

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.


Formycon successfully places an EUR 70 million senior unsecured floating rate bond

Disclosure of inside information according to Article 17 of the Regulation (EU) No 596/2014


NOT FOR DISTRIBUTION, PUBLICATION OR TRANSMISSION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA, CANADA, AUSTRALIA, JAPAN OR ANY OTHER JURISDICTION IN WHICH SUCH DISTRIBUTION OR PUBLICATION MAY BE UNLAWFUL. FURTHER RESTRICTIONS APPLY. PLEASE REFER TO THE IMPORTANT NOTICE AT THE END OF THIS ANNOUNCEMENT.

 

Planegg-Martinsried, Germany, June 27, 2025. The management board of Formycon AG (ISIN: DE000A1EWVY8) (“Company“) today successfully placed a senior unsecured floating rate bond in a total volume of EUR 70 million (ISIN: NO0013586024 / WKN: A4DFJH) (“Bond“). The Bond has a maturity of four years and bears interest at a rate equal to EURIBOR (three months) plus a margin of 7.0% p.a.

Due to very strong demand, the offering period for the public offering of the bond has been shortened. On the back of an oversubscribed book, the volume has been increased from initially EUR 50 million to a total of EUR 70 million.

The Bond was placed with both private investors and institutional investors in Germany and abroad. All subscription orders submitted during the public offering via the subscription functionality of Deutsche Börse (DirectPlace) and the Company’s website were fully allocated up to a volume of EUR 2,000 per order and 40% for orders above, rounded to whole bonds, with each order being allocated a maximum of EUR 20,000.

The issue and value date of the Bond is July 9, 2025 (“Issue Date“). Trading of the Bond on the Regulated Unofficial Market (Freiverkehr) of the Frankfurt Stock Exchange is scheduled to commence on June 30, 2025 (trading per appearance). The Company will also apply for the inclusion of the Bond in trading on the Euronext ABM, a self-regulated marketplace organised and operated by the Oslo Stock Exchange (Oslo Børs), within six (6) months after the Issue Date.

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.

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


Teva becomes secondary commercialization partner for Formycon's Stelara® biosimilar FYB202 (ustekinumab) under the brand name Fymskina® in Germany

  • Teva’s subsidiary Ratiopharm is going to commercialize Fymskina® as a second Formycon ustekinumab biosimilar on a semi-exclusive basis in Germany
  • Market launch of Fymskina® is planned for Q3 2025
  • Formycon is responsible for the manufacturing and supply of the finished product

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.


1) Stelara® is a registered trademark of Johnson & Johnson
2) Fymskina® is a registered trademark of Formycon AG
3) Otulfi® is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries
4) Lucentis® is a registered trademark of Genentech Inc.
5) Ranivisio® is a registered trademark of Bioeq AG


U.S. biosimilar specialist Valorum Biologics LLC becomes commercialization partner for Formycon’s Eylea® biosimilar FYB203/AHZANTIVE® (aflibercept-mrbb) in the United States and Canada

  • Valorum Biologics, an expert for ophthalmology and oncology biosimilars in the U.S. market, will exclusively commercialize FYB203/AHZANTIVE® in the United States and Canada
  • Formycon’s major shareholder ATHOS KG directly supports the commercialization of FYB203/AHZANTIVE® by leading the Series A financing of Valorum

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.


1AHZANTIVE® is a registered trademark of Klinge Biopharma GmbH
2Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
3Through its subsidiary Santo Holding (Deutschland) GmbH, ATHOS KG represents an indirect shareholder of Formycon AG


Strong demand for Formycon 2025/2029 Bond leads to early closing of subscription period

  • High demand by institutional investors enables early termination of public offering period
  • Subscription period via the Formycon website is now scheduled to end on 26 June 2025, at 11:59 p.m. CEST
  • Subscription via Deutsche Börse’s DirectPlace still possible until 27 June 2025, at 12:00 p.m. CEST
  • Inclusion to trading on the Frankfurt Stock Exchange in the Quotation Board segment is still scheduled for 9 July 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

IssuerFormycon AG, Planegg-Martinsried, Germany
Issuer Volume (Target)EUR 50,000,000
ISIN / WKNNO0013586024 / A4DFJH
Interest Rate Range3-months EURIBOR plus 7.0 % to 7.5 % p.a.
Issue Price100 %
DenominationEUR 1,000
Interest PaymentQuarterly, first payment on October 9, 2025
TermFour years, July 9, 2025 to July 9, 2029
Redemption DateDue on July 9, 2029
StatusSenior unsecured
CovenantsIncludes restrictions on distributions, liquidity maintenance, and quarterly financial reporting
Stock Exchange SegmentOpen Market (Freiverkehr) of the Frankfurt Stock Exchange, Quotation Board; admission to Euronext ABM (Oslo Børs) planned within six months
Issue / Value DateJuly 9, 2025
Joint Lead ManagerIKB Deutsche Industriebank AG, Pareto Securities AS, Frankfurt Branch


Early end of the offer period for the bond due to high demand

Disclosure of inside information according to Article 17 of the Regulation (EU) No 596/2014


NOT FOR DISTRIBUTION, PUBLICATION OR TRANSMISSION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA, CANADA, AUSTRALIA, JAPAN OR ANY OTHER JURISDICTION IN WHICH SUCH DISTRIBUTION OR PUBLICATION MAY BE UNLAWFUL. FURTHER RESTRICTIONS APPLY. PLEASE REFER TO THE IMPORTANT NOTICE AT THE END OF THIS ANNOUNCEMENT.

 

Planegg-Martinsried, Germany, 24 June 2025 – The announced corporate bond (ISIN NO0013586024 / WKN A4DFJH) (“Bond“) of Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) (“Company“) has met with great interest, particularly among institutional investors.

Due to the strong demand, the offer period of the public offer of the Bond will be shortened. Interested investors can still submit their binding offers to purchase bonds via the Company’s website (https://www.formycon.com/en/investor-relations/bond-2025/) until 26 June 2025, 23:59 CEST, and via the subscription functionality DirectPlace of Deutsche Börse until 27 June 2025, 12:00 CEST.

Inclusion to trading on the Frankfurt Stock Exchange in the Quotation Board segment (Open Market) is still scheduled for Wednesday, 9 July 2025. The company reserves the right to enable trading upon publication in advance.

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/).