Archives Press Releases

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, „Formycon“) invites to the conference call and webcast for the publication of the nine-month results 2024 on November 28, 2024. The Management Board will discuss the company’s development and the key financial figures as well as the recent uplisting to the Prime Standard of the Frankfurt Stock Exchange. The earnings call, which will be broadcast live on the Internet, will be held in English on November 28, 2024 at 3:00 p.m. (CET). Details and dial-in data see below.

Formycon in Dialogue

Additionally, representatives of the Management Board will participate in the following international investor conferences in the coming weeks:

November 19 – 21, 2024
Jefferies London Healthcare Conference
Dr. Stefan Glombitza (CEO), Enno Spillner (CFO)
London, UK

November 25 – 27, 2024
Deutsches Eigenkapitalforum
Enno Spillner (CFO)
Frankfurt, Germany

December 02, 2024
H.C. Wainwright virtual Fireside chat
Dr. Stefan Glombitza (CEO), Enno Spillner (CFO)
virtual

December 12, 2024
MWB Research Roundtable
Dr. Stefan Glombitza (CEO), Enno Spillner (CFO), Nicola Mikulcik (CBO), Dr. Andreas Seidl (CSO)
virtual

January 13 – 16, 2025
43^rd Annual J.P. Morgan Healthcare Conference
Dr. Stefan Glombitza (CEO), Enno Spillner (CFO), Nikola Mikulcik (CBO)
San Francisco, USA

January 21, 2025
UniCredit & Kepler Cheuvreux German Corporate Conference
Enno Spillner (CFO)
Frankfurt, Germany

For the latest schedule of Formycon’s events, please visit:
https://www.formycon.com/en/investor-relations/financial-calendar/

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

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/login/formycon-2024-q3

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/

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard) and its licensing partner Klinge Biopharma GmbH (Klinge) jointly announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the marketing authorization of FYB203, a biosimilar candidate to Eylea^®1 (aflibercept).

Dr. Stefan Glombitza, CEO of Formycon AG, commented: „We are excited about the positive CHMP opinion for FYB203, our biosimilar candidate to Eylea^®. As our second ophthalmic biosimilar therapy following the success of our Lucentis^®2 biosimilar, FYB203 represents a further advancement in treatment options for serios retinal diseases. After FDA approval in June, this milestone is a testament to the expertise, dedication and hard work of the entire Formycon team and underscores our commitment to enhancing patient care through affordable alternatives. We are now awaiting European Commission approval in the second half of January 2025 and look forward to offering patients a high-quality treatment option that can improve their quality of life.”

Under the tradenames AHZANTIVE^®3/ Baiama^®4 FYB203 has been recommended by the CHMP for approval in Europe for treating adult patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), visual impairment due to Myopic Choroidal Neovascularisation (CNV) and Macular Edema following Retinal Vein Occlusion (RVO).

Within the approval process, the CHMP’s positive opinion represents an important regulatory step towards the approval of FYB203/ AHZANTIVE^®/ Baiama^® in the European Union. The CHMP’s scientific assessment report forms the basis for the European Commission’s decision to grant a central marketing authorization valid in all European Economic Area (EEA) countries, including the 27 European Union (EU) Member States as well as in Iceland, Liechtenstein, and Norway, which is expected in the second half of January 2025.

Aflibercept inhibits the vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina. In 2023, Eylea^® reached global sales of around US$ 9 billion⁵, confirming its status as the currently best-selling drug in the field of anti-VEGF therapies.

FYB203 was approved by the U.S. Food and Drug Administration (FDA) in June 2024.

1) Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.
2) Lucentis^® is a registered trademark of Genentech Inc.
3) AHZANTIVE^® is a registered trademark of Klinge Biopharma GmbH
4) Baiama^® is a registered trademark of Klinge Biopharma GmbH
5) Source: https://investor.regeneron.com/news-releases/news-release-details/regeneron-reports-fourth-quarter-and-full-year-2023-financial/

Planegg-Martinsried, Germany – The Supervisory Board of Formycon AG (FSE: FYB; “Formycon” or “The Company”) has extended the contract of CEO Dr. Stefan Glombitza until December 31, 2027. The Board thus acknowledges Dr. Glombitza’s outstanding work as Chief Executive Officer (CEO) in recent years and is committed to the continued success of the company’s management. In addition, the shares of Formycon AG were admitted to the Prime Standard of the Frankfurt Stock Exchange today. Trading is scheduled to start on November 12, 2024.

Dr. Stefan Glombitza has been with Formycon AG since 2016 and during this time, has played a key role in the development and growth of the company. Initially responsible for operational development activities as Chief Operating Officer (COO), he was appointed as Chief Executive Officer (CEO) in July 2022. With over 25 years of experience in the international pharmaceutical industry, at Formycon he has built an excellent development platform leading a dedicated team, which has already resulted in approvals for three biosimilars. With the first product launches, he successfully guided Formycon into the commercial stage and has paved the way for further product launches.

“Dr. Glombitza has decisively shaped the strategic and operational development of Formycon in recent years and has significantly strengthened the company’s position in the biosimilar market,” explains Wolfgang Essler, Chairman of the Supervisory Board of Formycon AG. ”Thanks to his leadership, important milestones have been reached and the company has been set on a course for success.. With Dr. Glombitza at the helm, Formycon will further expand its role as one of the leading developers of biosimilars in the international market.”

“I am very pleased to be able to actively drive the growth phase that lies ahead of us, with the goal of fully realizing the tremendous potential of our company in the coming years. With three market-ready biosimilars and a strong pipeline, we have created a solid foundation for our continued growth. Today’s uplisting to the Prime Standard of the Frankfurt Stock Exchange increases our appeal to international investors and improves the tradability of our shares. I would like to thank the supervisory board and the entire Formycon team for their trust, cooperation and commitment, which are the cornerstones of our success,” said Dr. Stefan Glombitza.

As part of the uplisting, the shares of Formycon AG were admitted for trading in the Prime Standard of the Frankfurt Stock Exchange today. The Prime Standard is the segment with the highest transparency requirements in the regulated market and offers Formycon access to a broader group of investors. Inclusion in this segment isintended  to increased international awareness and higher liquidity of the stock. Trading in the Prime Standard is scheduled to start tomorrow, on November 12, 2024.

The company’s securities prospectus required for uplisting can be found at www.formycon.com/en/investor-relations/uplisting.

Further information can be found on our website at: www.formycon.com/en/investor-relations

Planegg-Martinsried, Germany – Formycon AG (“Formycon” or “The company”) announced today that it is applying to list its shares on the regulated market (Prime Standard) of the Frankfurt Stock Exchange (“uplisting”). The Prime Standard segment maintains the highest transparency standards with above average reporting requirements, specifically aimed at companies with an international investor focus. Through this uplisting, Formycon seeks to strengthen its international market position and enhance its visibility and appeal among investors by meeting the most stringent transparency and disclosure criteria.

The company expects to receive trading approval for the Prime Standard segment of the regulated market on November 11, 2024, with trading set to commence on November 12, 2024. The prospectus required for the uplisting is anticipated to earn BaFin approval on November 8, 2024, and will be made available shortly thereafter on the Formycon website at www.formycon.com/prospectus

“Over the past years, we’ve established Formycon as an internationally recognized, independent specialist for the development of biosimilars. Following FYB201 ­- which is now available in 20 countries and the leading Lucentis® biosimilar in most markets – FYB202 and FYB203 will offer attractive therapeutic options for many patients and markets. This promising operational business development underlines the development potential of our company and forms the basis for the planned uplisting to a higher stock market segment, which sends a strong signal for our presence on the capital market,” says Dr. Stefan Glombitza, CEO of Formycon AG.

“We have been preparing intensely for this step over the past months, and we are thrilled to announce this important milestone for Formycon. With a market capitalization of approximately 870 million euros, the company has reached a stage of growth and maturity that has significantly increased interest from international and institutional investors. Moving to the Prime Standard was essential to provide this investor group—and our existing shareholders—with enhanced access to Formycon’s stock. Looking ahead, this transition also opens the door to potential inclusion in one of Deutsche Börse’s select indices, which would further boost the stock’s visibility and appeal,” explained Enno Spillner, CFO of Formycon AG.

Currently, the company’s shares are traded on the Frankfurt Stock Exchange’s open market (Scale segment) under ISIN DE000A1EWVY8 (WKN A1EWVY). This listing will be discontinued once trading on the regulated market begins. The ISIN and WKN will remain the same following the uplisting.

M.M.Warburg & CO (AG & Co.) is acting as the listing agent for the uplisting.

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) announced today that the results of the comparative analytical evaluation of the proposed pembrolizumab biosimilar FYB206 and the immuno-oncology blockbuster drug Keytruda^®1 were published in Drugs in R&D, an international, peer-reviewed journal owned by Springer. The paper indicates that FYB206 is structurally and functionally highly similar to the reference product, thereby supporting the testing of the proposed pembrolizumab biosimilar in clinical trials to confirm the similarity between the two products.

To determine FYB206’s suitability to enter clinical trials, a comprehensive comparative analytical assessment was designed to demonstrate analytical similarity in clinically relevant quality attributes between the reference product and the corresponding biosimilar candidate. The analytical panel to evaluate similarity in the current study was designed on the basis of available information on pembrolizumab and knowledge gained during initial analyses of the reference product. The wide battery of qualified and fit for purpose analytical and functional tests was assigned to categories such as structural characterization, product-related variants, glycosylation, general properties, and biological function. All tested functional attributes with a potential impact on clinical performance (PD-1 binding, neutralization of PD-1, FcRn binding) of FYB206 were found to be highly similar to the reference product.

In summary, the results of the extensive data package from all assessments covering structure, purity, protein variants, binding and potency confirm the high similarity between FYB206 and Keytruda^®.

Dr. Andreas Seidl, Chief Scientific Officer (CSO) at Formycon, commented: “The remarkable results of this comparative analytical evaluation suggest that FYB206 has the characteristics to be a safe and efficacious alternative to Keytruda^®. With this solid foundation, obtained prior to the start of the pharmacokinetic equivalence and confirmatory efficacy and safety trials with FYB206 in June and July 2024, we are committed to continuously initiate new clinical centres and to work closely with the investigators to expand access for patients with high unmet medical needs.”

The full paper entitled “Comparative Analytical Evaluation of the Proposed Biosimilar FYB206 and its Reference Medicinal Product Keytruda^®” can be found here.

The active ingredient pembrolizumab is a humanized monoclonal antibody that belongs to the group of immune checkpoint inhibitors and is used to treat a variety of tumors. Pembrolizumab binds to the PD-1 receptor and specifically blocks the interaction between PD-1 and its ligand PD-L1. This helps the immune system to activate the body’s own cellular anti-tumor immune response and kill cancer cells. With its broad range of indications in oncology and the continuing high global demand, sales of this currently best-selling drug worldwide could rise to USD 30 billion by 2026.²

FYB206/pembrolizumab is currently being tested in the pharmacokinetic equivalence trial “Dahlia” to compare the pharmacokinetics (PK), safety and tolerability of FYB206 with the reference product Keytruda^® in patients receiving adjuvant treatment for malignant melanoma (black skin cancer). The parallel “Lotus” trial compares the efficacy and safety of FYB206 with Keytruda^® in combination with chemotherapy in patients with non-small cell lung cancer (NSCLC).

¹ Keytruda^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA
² https://www.reuters.com/business/healthcare-pharmaceuticals/merck-raises-2024-profit-forecast-strong-cancer-hpv-drugs-sales-2024-04-25/

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) and its commercialization partner Fresenius Kabi jointly announce that the U.S. Food and Drug Administration (FDA) has approved FYB202/Otulfi^TM1 (ustekinumab-aauz), a biosimilar to Stelara^®2, for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. FYB202/ustekinumab is the third Formycon biosimilar successfully approved by the FDA.

In February 2023, Formycon and Fresenius Kabi entered into a global license agreement providing Fresenius Kabi with commercialization rights of FYB202 in key global markets, including the U.S.

Dr. Stefan Glombitza, CEO of Formycon AG, said: “After FYB203 end of June, this marks our second FDA approval this year and we are very proud of achieving this milestone in line with our plans. Our ustekinumab biosimilar FYB202 exemplifies Formycon´s technical expertise and capabilities in developing high-quality, safe and affordable biologics. Particularly in the area of chronic inflammatory diseases, only a limited number of patients worldwide have access to biologic therapies or often have to wait for years to receive this highly effective treatment. It is important to us to improve access to biosimilars as quickly and broadly as possible.

Beyond that, FYB202 represents a key pillar of Formycon’s commercial and financial development going forward. In this context, we are very pleased with the settlement, as it allows our biosimilar to enter the market earlier than previously announced, improving our competitive positioning even further.”

Enno Spillner, CFO of Formycon AG, added: “The U.S. approval is an important step on our path to sustainable profitability, since FYB202 will contribute strongly to the financial strength of Formycon. We are pleased that with the recent approval decisions of the European Commission and the FDA, we have now successfully completed the formal approval process of FYB202 for the major markets.“

Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Kabi Management Board, said: “The FDA approval of FYB202, Fresenius Kabi’s fourth biosimilar product in the US market, is an important milestone on our pathway to consistently broadening our biopharma portfolio in the US and worldwide. In line with our Vision 2026 growth strategy, we are fully committed to becoming a significant player in the biopharma field and offering essential treatment options for patients globally.”

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. The approval is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB202 demonstrated comparable efficacy, safety and pharmacokinetics to the reference drug Stelara^® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis). With global sales of more than USD 10 billion in 2023³, Stelara^® is one of the best-selling immunological drugs. The U.S. market accounted for the largest share of these sales at around USD 6 billion.

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¹⁾ Otulfi^TM is a trademark of Fresenius Kabi Deutschland GmbH in selected countries

²⁾ Stelara^® is a registered trademark of Johnson & Johnson

³⁾ https://www.investor.jnj.com/news/news-details/2024/Johnson–Johnson-Reports-Q4-and-Full-Year-2023-Results/default.aspx

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) and its commercialization partner Fresenius Kabi jointly announce that the European Commission (EC) has issued a marketing authorization for FYB202/Otulfi^®1, a biosimilar to Stelara^®2. The centralized marketing authorization is valid in all European Economic Area (EEA) countries, including the 27 European Union (EU) Member States as well as in Iceland, Liechtenstein, and Norway.

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. The European Commission’s decision to issue a marketing authorization came after the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency’s (EMA) adopted a positive opinion in July 2024 to approve FYB202/Otulfi^® in the indications of moderately to severely active Crohn’s disease, moderate to severe plaque psoriasis and active psoriatic arthritis. The EC decision is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB202 demonstrated comparable efficacy, safety and pharmacokinetics to the reference drug Stelara^® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).

In February 2023, Formycon and Fresenius Kabi entered into a global license agreement providing Fresenius Kabi with commercialization rights for FYB202 in key global markets. Semi-exclusive commercialization rights that cover Germany, parts of the MENA region and Latin America remain with Formycon. In March 2024, Formycon and Fresenius Kabi reached a settlement agreement with Johnson & Johnson concerning the commercialization of their ustekinumab biosimilar in Europe and Canada. The terms of the agreement are confidential. Stelara^® ranks among Europe’s top-10 medicine brands by value with annual sales in Europe in excess of €2.5 billion.

Dr. Stefan Glombitza, CEO of Formycon AG, said: “FYB202/ustekinumab is our second biosimilar with market approval in Europe, and this marks another very important step on our way to a leading, profitable and sustainable pure-play biosimilar company. Chronic inflammatory diseases are globally on the rise and negatively impact the quality of life of millions of people. This especially relates to Europe, which has the highest prevalence of psoriatic diseases in the world.³ With FYB202/Otulfi^® we are – together with our partner Fresenius Kabi – committed to providing a safe, effective and cost-efficient treatment option for this large number of patients.”

Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Kabi Management Board, said: “With the approval of Otulfi^® in Europe, we expand our biosimilar portfolio with the fourth biosimilar to better support patients’ treatment experience and clinical outcomes. Our ustekinumab biosimilar is a testament to our dedication and commitment to patients across Europe, and we are proud to continue to deliver high-quality and affordable therapies for autoimmune diseases, while striving to ease the burden on local healthcare systems.”

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

²⁾ Stelara^® is a registered trademark of Johnson & Johnson

³⁾⁾ https://cms.ifpa-pso.com/tools/20072022_IFPA-FORUM_Briefing-Book_Speaking-up.pdf

Planegg-Martinsried – Formycon AG (FWB: FYB) will present clinical study data of its ustekinumab biosimilar candidate FYB202 at this year’s European Academy of Dermatology & Venerology (EADV) congress, taking place in Amsterdam from September 25 to 28, 2024. The randomized, double-blind, multicenter VESPUCCI Phase III study met the primary endpoint, demonstrating similar efficacy of FYB202 and the reference drug Stelara^® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis). The ePoster presentation shows details of the study design as well as the primary and secondary endpoints.

In addition, Formycon will present study data focusing on the pharmacokinetics of the ustekinumab biosimilar candidate FYB202 at the United European Gastroenterology (UEG) Week from October 12 to 15, 2024 in Vienna. In the Phase I pharmacokinetics study FYB202 showed bioequivalence to the reference drug for all primary endpoints.

Both posters were designed in cooperation with Fresenius Kabi, Formycon’s commercialization partner for FYB202.

Presentation details:

EADV Congress

• Session: ePoster
• Poster-ID: P0984
• Title: A randomised, double-blind trial to compare the efficacy, safety, and immunogenicity of the proposed biosimilar ustekinumab (FYB202) with reference ustekinumab in patients with moderate-to-severe plaque psoriasis
• Room: Poster Area
• Date: September 25 – 28, 2024

UEG Week

• Session: ePoster incl. audio/video presentation on demand
• Poster-ID: PP0593
• Title: Proposed ustekinumab Biosimilar FYB202: Pharmacokinetic equivalence demonstrated in a randomised, double-blind, parallel-group, single-dose trial in healthy subjects (RUSTIC)
• Speaker: Sigrid Balser, Vice President Clinical Development & Operations, Formycon AG
• Room: Poster Area
• Date: October 13 – 15, 2024

FYB202 is an interleukin inhibitor that can be used both in dermatology for the treatment of psoriasis and in gastroenterology for the treatment of chronic inflammatory bowel disease. The biosimilar candidate is currently in the final phase of the approval process for the US and the European Union. The decision of the European Commission on the approval is expected in early Q4, while the decision of the FDA is anticipated by the end of September 2024.

¹ Stelara^® is a registered trademark of Johnson & Johnson