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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

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon“) today published its consolidated financial report for the first six months of fiscal year 2024, providing an update on the company’s business performance.

“Formycon can look back on a very successful first half of the year, characterized by significant progress in its development projects. Particularly remarkable is the strong performance of our first biosimilar, FYB201, which continued to secure a significant market share against biosimilar competitors in key markets such as the USA and the UK. This success, along with the approval of FYB203 in the USA and the positive CHMP opinion for FYB202 in Europe in July, underscore the high quality of the biosimilars we develop. With the enrolment of the first patients in our clinical program for FYB206, we are well-positioned among the leading developers of Keytruda^® biosimilars. Our development expertise and operational agility lay the foundation for a successful future for Formycon AG as an independent specialist in biosimilars and the partner of choice,” says Dr. Stefan Glombitza, CEO of Formycon AG.

Enno Spillner, CFO of Formycon AG, adds: “Formycon is pursuing a clear growth strategy to become a leading and sustainably profitable biosimilar company. With the approval, market entry, and successful establishment of the two biosimilar candidates FYB202 and FYB203, Formycon aims to achieve EBITDA and operating cash flow profitability in the medium term. Until then—and even beyond—we will continue to invest heavily in our pipeline projects to ensure the swift progress of our promising development projects and to further strengthen our excellent position in the dynamic growth market of biosimilars.”

Operational milestones drive key growth momentum

Formycon achieved strong corporate development in the first half of the year, successfully meeting all targeted operational, clinical, and regulatory objectives.

FYB201 Lucentis^®[1]-biosimilar

Formycon’s FYB201 (Ranibizumab), marketed under the trade name CIMERLI^®[2] in the USA, has secured a significant share of the overall U.S. Lucentis^® market. Following the strategic realignment of commercialization partner Coherus BioSciences, Inc. (Coherus), the marketing rights for CIMERLI^®, including Coherus’ ophthalmology sales team, were transferred to Sandoz AG on March 1, 2024. According to market reports, CIMERLI^®‘s market share in the U.S. Ranibizumab market was over 45%[3]. In the United Kingdom, FYB201/ONGAVIA^®[4] holds a dominant market position with a 79% share based on indication-specific market volume[5]. Additionally, further markets, such as Canada and Saudi Arabia, were entered in the first half of the year. As of the reporting date, FYB201 is available in a total of 19 countries worldwide.

FYB202 Stelara^®[6] biosimilar candidate

For FYB202, Formycon’s Stelara^® biosimilar candidate, a settlement agreement with Johnson & Johnson was reached in the first half of 2024 regarding the commercialization of the biosimilar in Europe and Canada. It was agreed to keep the terms of the agreement confidential. A prior agreement had already been made for the U.S. market entry, which is scheduled for no later than April 15, 2025. At the end of July 2024 (after the reporting period), the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of FYB202 for the treatment of serious inflammatory diseases in the fields of gastroenterology, dermatology, and rheumatology. 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.

FYB203 Eylea^®[7] biosimilar candidate

Formycon achieved another success with the U.S. approval of FYB203, a biosimilar candidate for Eylea^®. On June 28, 2024, FYB203/AHZANTIVE^®[8] was approved by the FDA for the treatment of patients with age-related neovascular (wet) macular degeneration (nAMD) and other serious eye diseases such as diabetic macular edema (DME), diabetic retinopathy (DR), and macular edema following retinal vein occlusion (RVO). The decision on approval in Europe is expected by early 2025 at the latest.

FYB206 Keytruda^®[9] biosimilar candidate

The start of the clinical development program for FYB206, a biosimilar candidate for the immuno-oncology blockbuster drug Keytruda^®, marked another significant operational milestone. In June, the enrolment of the first patient in the Phase I study to compare the pharmacokinetics (PK), safety, and tolerability of FYB206 with the reference drug Keytruda^® (pembrolizumab) in patients with malignant melanoma (black skin cancer) was announced. At the end of July (after the reporting period), the parallel Phase III study was initiated to compare the safety and efficacy of FYB206 with the reference drug Keytruda^® in patients with non-small cell lung cancer.

FYB208 / FYB209 / (FYB210) – undisclosed biosimilar candidates

Formycon continues to invest in expanding its biosimilar platform and further strengthened its product pipeline with the addition of two early-stage biosimilar candidates, FYB208 and FYB209. Furthermore, the launch of development for FYB210, a new biosimilar candidate, is planned for the second half of the year.

With the strategic investment from Gedeon Richter Plc., a specialty pharmaceutical company, and the subsequent capital increase early in the year, Formycon successfully raised €82.84 million. In return, new company shares amounting to 9.08% were issued. This transaction opens up the opportunity to jointly leverage long-term strategic opportunities in the areas of development, manufacturing, and commercialization in the future.

Group revenue and Group EBITDA remain in line with expectations

The Formycon Group’s revenue for the first half of 2024 amounted to approximately €26.9 million (H1/2023: €43.8 million). This revenue includes earnings from the commercialization of FYB201 as well as income from development services for the collaboratively developed or out-licensed biosimilar candidates FYB201 and FYB203. Additionally, it includes partial realization of milestone payments from the commercialization partnership for FYB202 with Fresenius Kabi AG (Fresenius Kabi). The decrease in revenue compared to the previous year is primarily due to the additional revenue generated in 2023 through significant upfront and milestone payments, as well as the deferral of expected success payments that were realized for the FYB202 project under the then-new partnership with Fresenius Kabi.

The commercialization of the Ranibizumab biosimilar FYB201, which was launched in additional markets in the first half of the year and is now available in 19 countries worldwide, is developing very positively. Revenue from the direct participation in the commercialization of the Lucentis^® biosimilar FYB201 increased to approximately €3.8 million (H1/2023: €1.2 million). A significant portion of the success contribution from FYB201 was realized through the 50% at-equity investment in Bioeq AG and is therefore not reflected directly in revenue but below EBITDA (see below).

The Group’s earnings before interest, taxes, depreciation, and amortization (EBITDA) amounted to approximately €-16.9 million in the first half of the year (H1/2023: €7.3 million) and was in line with expectations. This result is primarily due to the decline in revenue and the increase in costs in the areas of administration as well as research and development, driven by the progress of FYB208 and FYB209.

Adjusted Group EBITDA reflects strong FYB201 performance

The adjusted Group EBITDA aims to present the total earnings from the FYB201 project, which are partially reported as at-equity results below EBITDA due to the existing 50% stake in Bioeq AG, as regular operating income. This adjustment allows for a clearer emphasis on the direct financial contributions of FYB201 to Formycon Group’s business success and provides better insight into the company’s actual operating performance. The adjusted Group EBITDA for the first half of 2024 amounted to €-2.1 million (H1/2023: €1.1 million). This is primarily due to the strong performance of FYB201 and the resulting significant increase in earnings contributions from Bioeq AG, amounting to €14.8 million (H1/2023: €-6.2 million).

Increased net working capital

As of June 30, 2024, the Formycon Group’s net working capital amounted to €63.0 million (December 31, 2023: €38.9 million), including cash and cash equivalents of €40.6 million (December 31, 2023: €27.0 million). The increase in cash and cash equivalents is primarily attributable to the capital increase carried out at the beginning of the year, which generated gross proceeds of €82.84 million, in addition to the positive business performance in the first half of the year. The remaining shareholder loan of €20.0 million was fully repaid by the end of the first quarter.

2024 guidance for adjusted Group EBITDA and working capital raised

The targeted development and continuous expansion of the biosimilar pipeline form the foundation for the long-term and sustainable growth of Formycon AG. For 2024, the Formycon Group continues to expect revenue between €55 million and €65 million. This forecast is based on the expectation of further increasing revenue contributions from the commercialization of FYB201. Additionally, income from development services for the collaboratively developed or out-licensed projects FYB201 and FYB203 is expected, though at a lower level compared to previous years due to the advanced stage of these projects.

The revenues from the success payments expected for FYB202 in 2024 were already partially realized in 2023 and recognized as deferred expected success payments. As a result, the expected regulatory milestone payments upon successful approval will not be fully recognized as revenue in 2024.

Given that Formycon will remain in an intensive phase of investment and transition in the second half of the year, with continued significant investments in its maturing product pipeline, management still expects a Group EBITDA between €-25 million and €-15 million for the 2024 fiscal year. This is mainly due to the planned development costs for the biosimilar projects FYB208 and FYB209, which are entering more cost-intensive project phases. Additionally, there are plans to expand Formycon’s biosimilar platform with a new project, FYB210.

FYB206 entered clinical development in the first half of the year, which will lead to significant investments in 2024 to 2026. These investments will not be reflected in the income statement and therefore not in EBITDA, but rather on the balance sheet due to the capitalization of the incurred costs.

The adjusted Group EBITDA includes not only revenue but also the at-equity result from jointly managed Bioeq AG. The result from Bioeq AG is driven by the operational success of the FYB201 product, which performed better than expected in the first half of the year. As a result, Formycon anticipates a significantly higher at-equity result for 2024 and has raised its guidance for adjusted EBITDA from the original range of €-15.0 million to €-5.0 million to now €-5.0 million to €5.0 million.

Compared to the previous guidance, a higher working capital is now expected for 2024. This is due to a milestone payment, already recognized in revenue, that is now anticipated to positively impact liquidity in 2024 (instead of Q1 2025) due to the EU approval of FYB202 that is now expected earlier than originally assumed. Additionally, better payment terms were negotiated for the clinical development costs of FYB206, leading to a deferral of significant payments to the following year. As a result, Formycon has raised its working capital guidance from the original range of €10.0 million to €20.0 million to now €35.0 million to €45.0 million.

The complete 2024 half-year report can be found on the Formycon website under Financial Reports.

The Management Board of Formycon AG will discuss the development of the company and the key financial figures for the first half of the financial year 2024 in a conference call. The conference call, which will be broadcasted live on the Internet, will take place on August 13, 2024 at 3:00 p.m. (CEST) in English.

To participate, please register at: https://webcast.meetyoo.de/reg/T7S30CRURfic

After registration, participants will receive a confirmation email with individual login details to the call.

The presentation and audio transmission can be accessed via the following link:
https://www.webcast-eqs.com/formycon-2024-h1

Following a short presentation, the Management Board will be available to answer analysts’ questions. The conference call will be recorded and will be available afterwards on the Formycon website at:
https://www.formycon.com/en/investor-relations/facts-figures/

[1] Lucentis^® is a registered trademark of Genentech Inc.

[2] CIMERLI^® is a registered trademark of Coherus BioSciences, Inc.

[3] Based on IQVIA weekly WSP data

[4] ONGAVIA^® is a registered trademark of Teva Pharmaceuticals Ltd.

[5] Based on IQVIA monthly R3M (rolling 3-month) data

[6] Stelara^® is a registered trademark of Johnson & Johnson

[7] Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.

[8] AHZANTIVE^® is a registered trademark of Klinge Biopharma GmbH

[9] Keytruda^® is a registered trademark of Merck Sharp & Dohme LLC

Planegg-Martinsried, Germany – Formycon AG (FWB: FYB) today announced details for the financial and earnings conference call for the first half of the 2024 fiscal year on August 13, 2024. The Management Board will discuss the company’s development, key financial figures, and provide an outlook for the second half of 2024. The conference call, which will be broadcast live on the internet, will take place on August 13, 2024, at 3:00 PM (CEST) in English.

To participate, please register at:
https://webcast.meetyoo.de/reg/T7S30CRURfic

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-2024-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/facts-figures/

Formycon in Dialogue

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

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

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) announced today that the first patient has been enrolled in the Phase III clinical trial “Lotus” to compare the safety and efficacy of FYB206/pembrolizumab with the immuno-oncology blockbuster drug Keytruda^® (First Patient In). The double-blind, multicenter “Lotus” study is evaluating the best overall response rate (bORR) in patients with non-small cell lung cancer (NSCLC). The comparative treatment comprises up to 17 treatment cycles within 52 weeks. Changes in tumor size will be continuously documented during this period using imaging techniques. Following the comparative treatment, the therapy will be continued for an additional 12 months.

The study design was developed in close coordination with the regulatory authorities U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The trial is being conducted in several countries in Eastern Europe and Southeast Asia and is running in parallel to the Phase I study, which started in mid-June, comparing the pharmacokinetics (PK), safety and tolerability of FYB206 with the reference drug Keytruda^® in patients with malignant melanoma (black skin cancer).

“Immuno-oncology is a relatively young field in cancer therapy and is seen as a great hope for many patients. Pembrolizumab has already demonstrated its efficacy in numerous types of cancer. Additionally, several studies are currently underway to expand the range of indications. This alone highlights the enormous potential of our pembrolizumab biosimilar candidate FYB206 – both in medical and economic terms. In fact, sales of Keytruda^®, currently the world’s best-selling drug, are also continuing to grow.

The start of the Phase III clinical trial represents an important milestone for us in order to provide an effective, safe and cost-effective treatment option for many severely ill cancer patients worldwide in the future,” comments Dr. Andreas Seidl, Chief Scientific Officer (CSO) of Formycon AG.

Non-small cell lung cancer is one of numerous cancer diseases for which the immune checkpoint inhibitor pembrolizumab is indicated. In a wide variety of cancers, cancer cells manage to inhibit the body’s own immune defenses by manipulating so-called immune checkpoints. Pembrolizumab, which targets the immune checkpoint PD-1, ensures that the body’s own T cells can again fight and kill the cancer cells.

Due to the increasing use of the active ingredient in earlier stages of cancer and the continuing high global demand, sales of Keytruda^® increased by 20% year-on-year in the first quarter of 2024.³ As a result, sales of this currently best-selling drug could rise to USD 30 billion worldwide by 2026.⁴

Following the completion of clinical development and subject to approval by the regulatory authorities, Formycon currently anticipates the earliest market entry of FYB206 after the expiry of the market exclusivity of the reference product in the USA from 2029 and in the EU from 2030. First results of the Phase I trial are expected in 2026. Preliminary results of the Phase III trial are to follow in the course of 2027.

¹ Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA

² Non-small-cell lung cancer

³ https://www.merck.com/news/merck-announces-first-quarter-2024-financial-results/

⁴ https://www.reuters.com/business/healthcare-pharmaceuticals/merck-raises-2024-profit-forecast-strong-cancer-hpv-drugs-sales-2024-04-25/