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Planegg-Martinsried, Germany – Formycon AG (WKN: A1EWVY ISIN: DE000A1EWVY8) will join the SDAX of Deutsche Börse, just a few weeks after its successful uplisting to the Prime Standard. As of December 23, 2024, Formycon will officially be part of the Small-Cap Index. The decision was announced yesterday during Deutsche Börse’s regular index review. With its inclusion in the SDAX, Formycon will now rank among the 70 largest publicly listed companies in Germany below the DAX and MDAX, based on the market capitalization of freely tradable shares (free float).

“Joining the SDAX is a significant milestone for Formycon and a remarkable event in our capital market history, which further strengthens our position and visibility in the capital market. Following our inclusion in the MSCI Germany Small Cap Index last year, being listed in the SDAX is yet another testament to the success of our capital market strategy and the outstanding work of the entire Formycon team,” said Enno Spillner, CFO of Formycon AG.

The inclusion in the SDAX supports Formycon’s growth strategy and ongoing evolution as a leading biosimilar developer. From its initial listing on the Open Market in 2010 to its uplisting to the Prime Standard in November 2024, the Company has consistently aligned itself with capital market requirements, laying the foundation for its exceptionally positive business development in recent years.

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) today reported on the financial results and business performance of the Formycon Group for the first nine months of fiscal year 2024.

“We can look back on an extremely successful business performance in the first nine months of fiscal year 2024 and have met all operational, clinical and regulatory targets. In the third quarter of 2024, we were able to announce the EMA and FDA approvals for FYB202/Otulfi^®1, which followed in quick succession. This also triggered two milestone payments from our partner Fresenius Kabi. We are equally pleased about the EMA’s Committee for Medicinal Products for Human Use (CHMP) positive opinion for FYB203/AHZANTIVE^®2/Baiama^®3, which once again underscores the excellent quality of our data, processes and products. Our biosimilar FYB201, approved in 2022, was able to further expand its strong market position in the key markets USA and UK during the course of this financial year, gaining impressive market shares. At the same time, we achieved a groundbreaking development milestone with our Keytruda^®4 biosimilar candidate by including the first patients in our clinical program for FYB206, thereby consolidating our position among the leading developers for this product. Thanks to our development expertise and agility, we are ideally placed to position Formycon AG as a leading independent provider of high-quality biosimilars in the market,” says Dr. Stefan Glombitza, CEO of Formycon AG.

Enno Spillner, CFO of Formycon AG, adds: ”After a great deal of intensive preparation, we completed the final step necessary for entry into the Prime Standard in the third quarter of 2024. This uplisting to the regulated market of the Frankfurt Stock Exchange in mid-November marks a significant chapter in our capital market strategy. It gives us access to a broader range of international and institutional investors. This increases our attractiveness to the capital market and strengthens our position in international competition.”

Operational success and progress in the second half of the year underpin growth strategy

FYB201 Lucentis^®5 biosimilar

Formycon’s FYB201 (ranibizumab), available in the United States under the tradename CIMERLI^®6, has captured a significant share of the overall U.S. Lucentis^® market. Following the strategic realignment of Formycon’s distribution partner Coherus BioSciences, Inc. (Coherus), the marketing rights for CIMERLI^®, including the Coherus ophthalmology sales team, were transferred to Sandoz AG on March 1, 2024. According to market reports, CIMERLI^®‘s market share in the US ranibizumab market was over 40% in August. In the United Kingdom, FYB201/ONGAVIA^®7 has a market share of over 80% based on indication-based market volume and thus has a dominant market position. In addition, further markets such as Canada and Saudi Arabia have been tapped in the current fiscal year. FYB201 is now available in a total of 20 countries worldwide.

FYB202 Stelara^®8 biosimilar

At the end of September 2024, both the U.S. Food and Drug Administration (FDA) and the European Commission granted approval for FYB202/Otulfi^®, Formycon’s ustekinumab biosimilar, for the treatment of severe inflammatory diseases such as Crohn’s disease, moderate to severe plaque psoriasis, and active psoriatic arthritis. A settlement agreement had already been concluded between Formycon, Fresenius Kabi and Johnson & Johnson, granting Formycon’s marketing partner Fresenius Kabi the right to launch Otulfi^® in the USA no later than February 22, 2025. A further agreement governs the launch of the biosimilar in Europe and Canada, the terms of which remain confidential. The European Commission’s approval covers both subcutaneous and intravenous formulations and is valid in all countries of the European Economic Area (EEA), including the 27 EU member states, Iceland, Liechtenstein and Norway.

FYB203 Eylea^®9-Biosimilar

On November 15, 2024 (after the reporting period), the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of FYB203, a biosimilar to Eylea^® (aflibercept), under the brand names AHZANTIVE^® and Baiama^®. The recommendation includes the treatment of neovascular age-related macular degeneration (nAMD) as well as other serious eye diseases such as diabetic macular edema (DME), diabetic retinopathy (DR) and macular edema secondary to retinal vein occlusion (RVO). The final decision of the European Commission is expected in the second half of January 2025. The FDA had already approved FYB203/AHZANTIVE^® in the US for the same indications on June 28, 2024. With these advances, Formycon is on track to make FYB203 available in both the US and Europe as a cost-effective treatment alternative for patients with severe retinal diseases.

FYB206 Keytruda^® biosimilar candidate

Another important operational milestone was reached with the start of the clinical development program for FYB206, a biosimilar candidate for the immuno-oncology blockbuster drug Keytruda^®. The first patient was enrolled in the phase I study to compare the pharmacokinetics (PK), safety and tolerability of FYB206 with the reference drug Keytruda^® in patients with malignant melanoma (black skin cancer) in June 2024. The parallel phase III study comparing the safety and efficacy of FYB206 with Keytruda^® in patients with non-small cell lung cancer (NSCLC) started at the end of July 2024. The scientific basis for the ongoing clinical trials is provided, among other things, by the results of an analytical study comparing FYB206 with Keytruda^®, which were published in October 2024 in the peer-reviewed journal Drugs in R&D. The results confirmed a high degree of structural and functional similarity between FYB206 and the reference medicine. With the start of the study, Formycon is consolidating its excellent position in the leading group of developers of pembrolizumab biosimilars.

FYB208 / FYB209 – early biosimilar candidates and further development of the pipeline

Formycon is continuously investing in the expansion of its biosimilar platform and has further expanded its product pipeline with the two younger biosimilar candidates FYB208 and FYB209. For both candidates, cell lines with convincing stability, productivity and quality have been identified and transferred to manufacturing partners for further process development and scale-up.

FYB210 – a new biosimilar candidate in the pipeline in the field of immunology

Following a complex selection process, a further biosimilar candidate FYB210 was recently launched (after the reporting period). Following the official start of the development process, FYB210 is now the seventh biosimilar project in Formycon’s development pipeline and is positioned in the immunology indication area. It addresses an attractive and strongly growing therapeutic area with the aim of commercialization after the loss of exclusivity rights after 2030.

Key personnel appointment and promotion to a higher stock exchange segment confirm strategic direction

Formycon has a highly experienced management team with many years of industry expertise. To ensure continuity in the company’s successful management, the management contract of CEO Dr. Stefan Glombitza has been extended until December 2027 (after the reporting period).

In addition, on November 11 (after the reporting period), Formycon successfully completed its uplisting to the Prime Standard of the Frankfurt Stock Exchange, the segment with the highest transparency requirements on Deutsche Börse. This step marks a significant milestone in the company’s capital market strategy. The Prime Standard requires strict disclosure and reporting obligations and is an important prerequisite for investment decisions by institutional and international investors. This uplisting also lays the foundation for a potential inclusion in important indices, such as the SDax or TechDax; it strengthens the company’s visibility and transparency in the global capital markets.

Formycon Group revenue and EBITDA remain in line with planning

The Formycon Group’s revenue for the first nine months of 2024 was around €41.1 million (9M/2023: €60.2 million), in line with expectations. These revenues include both income from the marketing of FYB201 and revenues from development services for the partnered or out-licensed biosimilar candidates FYB201 and FYB203. In addition, milestone payments from the commercialization partnership for FYB202 with Fresenius Kabi AG (Fresenius Kabi) were recognized on a pro-rata basis, a portion of which had already been deferred in 2023.

The commercialization of the ranibizumab biosimilar FYB201, which was launched in further markets in the first nine months, is developing very positively in terms of sales figures. Revenues from the direct participation in the commercialization of this Lucentis^® biosimilar increased to around €6.0 million (9M/2023: €2.3 million). The significant portion of the contribution of earnings from FYB201 is realized in the context of the 50% at-equity investment in Bioeq AG and is therefore not directly reflected in revenues, but below EBITDA (see below). As of the September 30, 2024 reporting date, it amounted to a total of €20.6 million and is reflected accordingly in the adjusted EBITDA.

Consolidated earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to around €-17.7 million in the first nine months (9M/2023: €5.2 million) and are in line with planning. This result was due to lower revenues, a planned and significant increase in research and development costs due to the rapid progress of FYB208 and FYB209, but also higher administrative costs due to the preparation and execution of the uplisting.

Adjusted group EBITDA reflects strong FYB201 performance

The adjusted Group EBITDA aims to present the total income from the FYB201 project, which is partially recognized as equity-accounted income below EBITDA due to the existing 50% stake in Bioeq AG, as regular operating income. It shows the direct financial contributions of FYB201 to the business success of the Formycon Group and the actual operating performance of the company.

Adjusted consolidated EBITDA for the first nine months of 2024 amounted to €2.9 million (9M/2023: €3.5 million). This is due in particular to the good performance of FYB201 and the resulting significant increase in the earnings contribution from Bioeq AG (at equity earnings) of €20.6 million (9M/2023: € -1.7 million).

Working capital increase due to higher cash and receivables

The net working capital of the Formycon Group amounted to €65.8 million as of September 30, 2024 (September 30, 2023: €41.3 million) and includes cash and cash equivalents of €33.8 million (September 30, 2023: €35.6 million). The working capital includes two milestone payments from Fresenius Kabi, which were recognized in receivables earlier than expected due to the already granted EU approval for FYB202 but are not due for payment until the fourth quarter.

The existing shareholder loan of €48.0 million was extended. The credit line remains fully available and can be utilized flexibly until May 2026.

Forecast for the Formycon Group for the full year 2024 remains unchanged

For the fourth quarter, Formycon expects business to continue as planned. In addition to further operational progress with the biosimilar candidates, revenues are expected to be slightly higher than the average of the first three quarters. The milestone payments received from Fresenius Kabi for the approvals of FYB202 will lead to a stable cash position in the fourth quarter. The guidance for the full year 2024, which was already revised upwards for adjusted EBITDA and working capital in the context of the half-year results, is thus confirmed.

Conference Call and Webcast

The Executive Board of Formycon AG will discuss the company’s performance and key financial figures, as well as the recent uplisting to the Prime Standard of the Frankfurt Stock Exchange, in a conference call. The earnings call, which will be webcast live, will take place in English on November 28, 2024 at 3:00 p.m. (CET).

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/

1) Otulfi^® is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries
2) AHZANTIVE^® is a registered trademark of Klinge Biopharma GmbH
3) Baiama^® is a registered trademark of Klinge Biopharma GmbH
4) Keytruda^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA
5) Lucentis^® is a registered trademark of Genentech Inc.
6) CIMERLI^® is a registered trademark of Coherus BioSciences, Inc.
7) ONGAVIA^® is a registered trademark of Teva Pharmaceutical Industries
8) Stelara^® is a registered trademark of Johnson & Johnson
9) Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.

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/

—

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