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Munich – Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) ("Formycon") today announced changes to its Executive Board, setting the stage for continued and stable leadership as the company moves towards becoming a global and fully integrated biosimilars pharmaceutical company.

Today and effective July 1, 2022, the Supervisory Board of Formycon appointed Dr. Stefan Glombitza, who has led Formycon's operational development activities as Chief Operating Officer (COO) since 2016, as Chief Executive Officer (CEO). Dr. Glombitza thus takes over the position from Dr. Carsten Brockmeyer, with whom he has worked closely in recent years to shape the strategic and organizational direction of the company.

The 57-year-old pharmacist, who holds a doctorate, can look back on more than 20 years of experience in internationally operating companies in the pharmaceutical industry and brings great expertise to this position from various global management and executive positions. In his role as CEO, he is to shape the strategic development of the company in the increasingly commercial phase and, together with his team of experts, implement the successful development of a continuously growing product portfolio.

Dr. Carsten Brockmeyer will leave the Executive Board as planned on June 30, 2022, when his appointment regularly expires. From 2012, he initially worked as a consultant for Formycon before joining the company as Chief Executive Officer (CEO) in 2013. After 9 successful years on the Executive Board, Dr. Brockmeyer will continue to support the company as a scientific advisor, in particular assisting with the development of the biosimilar candidates and the COVID-19 drug.

Dr. Stefan Glombitza says: "I am very much looking forward to the new role and the extremely motivating task of leading Formycon into the next phase of its business and realizing the enormous potential of this company. I very much appreciate the trust placed in me. For this, I would like to express my special thanks to our Supervisory Board and also to my colleagues on the Executive Board, with whom I have had the opportunity to do a great deal of work over the past 6 years. My enthusiasm for Formycon is undiminished and I will continue to do my utmost to drive the company forward with full vigor. I would like to thank Dr. Brockmeyer very much for his many years of trusting and productive cooperation. It means a lot to me to be able to continue the Formycon success story he started."

Dr. Carsten Brockmeyer adds: "Dr. Glombitza has already impressively demonstrated in recent years how to build a very efficient development organization and create the stable foundation for the commercialization of our product portfolio. When we started the strategic realignment as a biosimilar developer at Formycon in 2012, the company comprised around 30 employees. Today, we have grown to over 200 employees from 24 nations and have positioned ourselves internationally as a renowned biosimilar developer with a substantial portfolio. On our way to becoming a globally operating and fully integrated pharmaceutical company for biosimilars, I cannot imagine a more suitable CEO than Dr. Glombitza. I remain closely associated with Formycon and will be happy to continue contributing as a scientific advisor. I am very proud of what we have achieved together at Formycon and would like to thank my colleagues on the Executive Board, the Supervisory Board, the employees, the shareholders, and our business partners for their consistently trusting and constructive cooperation."

The Chairman of the Supervisory Board of Formycon, Dr. Olaf Stiller comments: "I can only endorse the words of Dr. Brockmeyer. Dr. Glombitza has done an exceptional job in the past years and has shaped Formycon into an outstanding and scalable development organization. We are convinced that we will achieve the goals we have set ourselves with him at the helm. At the same time, I would like to thank Dr. Brockmeyer on behalf of the entire Supervisory Board for his outstanding work in building up Formycon. With his expertise in biosimilars, the course was set right from the start. We are pleased that Dr. Brockmeyer continues to support us as a scientific advisor and wish him all the best for the future."

The Executive Board around CEO Dr. Glombitza will also be supplemented by two additional experienced pharmaceutical managers. Effective June 1, 2022, the Supervisory Board of Formycon has appointed Nicola Mikulcik (51) to the Executive Board in the function of Chief Business Officer (CBO) for a period of 5 years. A graduate in business administration, she has years of expertise in product development, business development and commercial affairs. During her career in the pharmaceutical industry, she passed through various management positions at Hexal AG and Sandoz International. For the past 7 years, Ms. Mikulcik has been the managing director of Bioeq GmbH, which Formycon acquired from ATHOS KG in the transaction announced at the end of March. As part of Formycon's collaboration with Bioeq, Ms. Mikulcik was largely responsible for the FYB201 commercialization partnerships with pharmaceutical companies Teva Pharmaceutical Industries Ltd. and Coherus BioSciences, Inc. In her role as CBO, she will be responsible for Business Development and Commercial Affairs.

"Due to the long-standing and constructive cooperation with Formycon, I am very pleased to now become a part of the Executive Board and to actively shape the company's development. We have exciting years ahead with global launches by our commercial partners. I would like to thank the Supervisory Board for the trust they have placed in me," comments Nicola Mikulcik.

In addition, the Supervisory Board of Formycon has appointed Dr. Andreas Seidl as a member of the Executive Board as Chief Scientific Officer (CSO) for a period of 5 years, effective July 1, 2022. The 52-year-old biochemist and experienced scientist brings more than 20 years of experience in biosimilar development and, together with Dr. Carsten Brockmeyer, was one of the pioneers in the development and approval of the first biosimilars. He was most recently responsible for the development operations of Leukocare AG as COO. Previously, he was head of Analytical Characterization & Bioanalytics at Novartis and held similar positions at Sandoz Biopharmaceuticals and Hexal AG. In his role as Chief Scientific Officer, he will ensure Formycon's strong presence and reputation in the scientific community and lead the preclinical and clinical development, bioanalytics and Scientific Affairs functions.

"Formycon is a prime example of a dynamic and research-driven company that is now on its way to becoming a globally operating and fully integrated pharmaceutical company in the growing biosimilars market. It is a great pleasure for me to support the scientific work of this outstanding team with my energy and to actively contribute to the further growth of the company," explains Dr. Andreas Seidl.

The Chairman of the Supervisory Board of Formycon, Dr. Olaf Stiller adds: "With Nicola Mikulcik and Dr. Andreas Seidl, we are adding strong people to the Executive Board of Formycon who are well-known in the pharmaceutical world and who are capable of advancing the company in the long term and strategically in their respective areas of responsibility. With this strong leadership team, we are not only creating continuity and stability, but also the foundation for agile development and further growth."

The operational management team is completed by Chief Financial Officer (CFO) Dr. Nicolas Combé, whose appointment as a member of the Executve Board will also end as planned on June 30, 2022 after a total of 12 years. Until a suitable CFO has been found and trained, Dr. Combé will continue to be available to the company as CFO and in an advisory capacity.

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today released its financials for 2021.

The focus in 2021 was on the further development of the current biosimilar candidates as well as the COVID-19 drug (FYB207). The development activities of the late-stage biosimilar projects FYB201 (biosimilar candidate for Lucentis®1), FYB202 (biosimilar candidate for Stelara®2) and FYB203 (biosimilar candidate for Eylea®3) result in the currently reported revenues, as Formycon continues to perform remunerated development activities for the aforementioned biosimilar candidates after partnering by the licensing or collaboration partners. In the event of subsequent marketing, Formycon will receive a corresponding share of the marketing proceeds generated. With the anticipated product launch of FYB201 in 2022, Formycon is moving closer to entering a new corporate phase, whereby the expected revenues from this should open up new growth opportunities for the company. In addition, Formycon is working on the continuous expansion of its pipeline. Due to the increasingly international nature of our business activities, the consolidated financial statements will be prepared in accordance with IFRS (International Financial Reporting Standards) for the first time as of the 2022 half-year financial statements. The separate financial statements of the parent company Formycon AG continue to be prepared and published in accordance with the rules of the German Commercial Code (HGB).

On the day of reporting, December 31, 2021, the Formycon Group’s commercial figures had developed as planned. Consolidated group sales which, in addition to the AG, include the two subsidiaries Formycon 201 Project GmbH and Formycon 203 Project GmbH as well as the 24.9 percent share in the FYB 202 GmbH & Co. KG joint venture, amounted, as forecast, to a total of around Euro 37 million (previous year: Euro 34.2 million).

Group earnings before interest, taxes and depreciation on fixed assets and intangible assets (EBITDA) amounted to Euro -12.4 million (previous year: Euro -4.8 million). The operating result (EBIT) totaled Euro -13.3 million (previous year: Euro -5.7 million). At Euro -13.5 million (previous year Euro -5.9 million), the result for the year was in line with expectations. Formycon had invested in the development of its own pipeline in the 2021 financial year, resulting in a higher negative annual result compared to previous years. In addition to the COVID-19 drug (FYB207), primarily the as yet unpublished biosimilar candidate FYB206 was advanced on the development side, as well as scheduled investments in FYB202. Formycon was also able to recruit further qualified specialists last year in line with the needs of the development projects and employed 171 people at the end of the reporting period (+30% compared to the previous year).

Current assets consist largely of liquidity and near-liquid assets. As of December 31, 2021, the Formycon Group had capital resources of approximately Euro 25.2 million (previous year: Euro 42.4 million) in cash and cash equivalents (cash on hand, checks, bank balances, and securities). Including short-term receivables and other assets worth a further Euro 10.9 million, the Formycon Group holds liquid assets of Euro 36.1 million in total (previous year Euro 49.2 million) and therefore has solid room for maneuver for the further development of its own projects.

The Group's balance sheet was around Euro 66.3 million (previous year: Euro 75.6 million) with an equity ratio of 85 percent (previous year: 90 percent). The company has no financial liabilities.

Formycon AG, as the Group's actual operational unit, achieved a turnover of Euro 26.5 million (previous year: Euro 25.1 million) and recorded an EBITDA of Euro -14.3 million (previous year: Euro -4.7 million). Accordingly, this resulted in an EBIT amounting to Euro -13.4 million (previous year: Euro -5.6 million) and an annual result of a rounded Euro -13.3 million (previous year: Euro -5.7 million).

With the recently announced closing of the transaction with ATHOS KG, the ownership structure in two of the three late-stage biosimilar candidates has changed: Formycon now owns 100% of the rights to FYB202 (previously 24.9%) and 50% of the rights (previously fully out-licensed with royalty interest) to FYB201, a biosimilar candidate for Lucentis® being developed with Polpharma Biologics Group in the 50/50 joint venture Bioeq AG. By acquiring the biosimilar assets, Formycon will participate in a significantly higher proportion of the future revenues from their commercialization. The company will invest the expected cash inflows mainly in the accelerated expansion of its own development pipeline. This is intended to enable future biosimilar candidates to be developed independently, thus contributing sustainably to the value creation and further growth of the company.

Dr. Nicolas Combé, CFO of Formycon AG, gave the following statement with regard to the past fiscal year: "In 2021, we achieved important milestones with the submission of FYB201 to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). With the anticipated commercialization launch of FYB201 later this year, we expect to generate the first commercialization revenues, laying the foundation for sustainable growth and accelerated execution of our growth strategy, to which of course in particular the recently announced acquisition of the biosimilar assets FYB201 at 50% and FYB202 at 100% contributes."

The full 2021 annual financial statements / annual report for 2021 can be found on our website at https://www.formycon.com/en/investor-relations/financial-reports/.

¹⁾ Lucentis® is a registered trademark of Genentech Inc.²⁾ Stelara® is a registered trademark of Johnson & Johnson.³⁾ Eylea is a registered trademark of Regeneron Pharmaceuticals Inc.

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Bioeq AG (“Bioeq”) announce, that today the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization (MA) in the United Kingdom (“UK”) for FYB201, a biosimilar to Lucentis® (ranibizumab). Teva Pharmaceutical Industries Ltd. (“Teva”) will serve as the exclusive commercial partner and will market the biosimilar under the brand name ONGAVIA® throughout the UK.

Lucentis® is used in the treatment of age-related neovascular (wet) macular degeneration (nAMD) and other serious eye diseases like visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) and visual impairment due to choroidal neovascularization (CNV). It inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina.

The MHRA approval is based on a totality of evidence including analytical, clinical and manufacturing data. In a randomized, double-masked, parallel group, multicenter phase III study, the efficacy, safety, pharmacokinetics and immunogenicity of FYB201/ONGAVIA® was proven comparable to the reference drug Lucentis® (ranibizumab) in patients with age-related neovascular (wet) macular degeneration (nAMD).

Dr. Stefan Glombitza, COO of Formycon comments: “Retinal diseases are an increasing burden for patients worldwide. We are pleased to announce the approval of our Lucentis® biosimilar in UK, creating a treatment option for some of the most common and serious retinal diseases.”

The commercial launch of FYB201/ONGAVIA® in the UK by Teva Pharmaceutical Industries Ltd. ("Teva"), which has licensed the distribution rights from Bioeq under an exclusive strategic partnership, is expected to follow as soon as possible and targets to be the first available Biosimilar for Lucentis® in Europe.

¹⁾Lucentis® is a registered trademark of Genentech Inc.

Munich – Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) (“Formycon”) and ATHOS KG (“ATHOS”) announce the closing of the acquisition of the biosimilar assets FYB201 and FYB202 as well as Bioeq GmbH ("Bioeq") with the registration of the implementation of the non-cash capital increase in the commercial register after the occurrence of all necessary conditions and the approval of the required authorities.

Formycon has thereby acquired 100% of the rights in FYB202, a biosimilar candidate for Stelara®¹, the 50% stake of ATHOS in FYB201, a biosimilar candidate for Lucentis®², and the operational development unit Bioeq GmbH. Through the acquisition of the biosimilar assets, Formycon will have a significantly higher share in future revenues from their marketing. The company will primarily invest the cash inflows expected from this transaction into accelerated expansion of the development pipeline. This will enable future biosimilar candidates to be developed independently. The intention is for them to contribute sustainably to value added and to the ongoing growth of the company in the future. In addition, with the integration of its long-time partner Bioeq, Formycon is expanding its expertise in a number of sectors that are important for the development, approval and commercialization of biosimilars.

The value of the consideration to be paid by Formycon in the acquisitions totals approximately Euro 650 million and consists of two components:

(I) As a result of the completed capital increase, the Company's share capital of Euro 11,064,750.00 was increased via making full use of the existing authorized capital by Euro 4,000,000.00, to a total of Euro 15,064,750.00 through the issue of 4,000,000 new no-par value bearer shares, each with a notional interest in the share capital of Euro 1.00 to the seller companies in return for a non-cash contribution. Based on a jointly determined and expertly confirmed valuation of the Formycon share of Euro 83.41, the total value of the non-cash capital increase amounts to approximately Euro 334 million. With the completion of the transaction, ATHOS is now Formycon's largest shareholder with an indirect shareholding of around 26.6% in the share capital.

(II) In addition, ATHOS has received an earn-out component in the future sales of Formycon generated with FYB201 and FYB202, which is expected overall to be in the middle-triple-digit million range for ATHOS over an expected 15-year period. Formycon has the option to serve the earn-out component in full or in part in advance at any time.

Dr. Nicolas Combé, CFO of Formycon, said: “We are delighted about the closing of this transaction and would like to thank ATHOS and all involved parties for the constructive cooperation. The acquisition of the biosimilar candidates significantly increases the revenue potential for Formycon allowing a massive acceleration of the implementation of the planned growth strategy. Within the framework of a long-term strategic partnership with our anchor investors, Formycon aims to become a globally operating and fully integrated pharmaceutical company in the field of biosimilars.”

Melissa Simon of ATHOS added: “The merger of the biosimilar assets and the development competencies was an important milestone in Formycon's transformation into a highly specialized and globally active company. We see great potential in the biosimilars market segment and will actively accompany the company on its growth path.”

¹⁾ Stelara® is a registered trademark of Johnson & Johnson²⁾ Lucentis® is a registered trademark of Genentech Inc.

Munich - Bioeq AG ("Bioeq"), licensee and exclusive holder of the worldwide commercialization rights for FYB201, Formycon's biosimilar candidate for Lucentis(R) (ranibizumab), has informed Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) that it has entered into an exclusive partnership with MS Pharma for the commercialization of FYB201 in the Middle East and North Africa (MENA region).

MS Pharma is a leading pharmaceutical company in the MENA region with 2400 employees in 12 countries and specializes in the distribution of biotechnological as well as generic drugs. Under the exclusive agreement, MS Pharma will be responsible for the registration and commercialization of FYB201 in the countries covered by the agreement. The initiation of the approval procedures is expected to start immediately.

By the end of 2019, Bioeq had already entered into a licensing and development agreement with US Biosimilar Specialist Coherus BioSciences, Inc. which will exclusively distribute FYB201 in the United States of America. In August 2021, an exclusive strategic partnership for the commercialization of FYB201 in Europe and a few other markets was also entered into between Bioeq and Teva Pharmaceutical Industries Ltd. Upon successful approval of FYB201, Formycon will participate in the commercialization revenues of FYB201 in all territories.

"MS Pharma is a strong partner for the very dynamically developing Middle East and North Africa region. We are very excited about this additional commercialization partnership, which further increases the economic potential for FYB201. Our partner Bioeq is doing an excellent job in building the global commercialization structure, which also reflects our joint mission to provide access to high quality drugs like our biosimilar candidate for Lucentis(R) to as many patients worldwide as possible," said Dr. Nicolas Combé, CFO of Formycon AG.

¹⁾Lucentis(R) is a registered trademark of Genentech Inc.

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY), together with its academic partners Prof. Dr. Ulrike Protzer, Chair of Virology, and Prof. Dr. Johannes Buchner, Chair of Biotechnology, Technical University of Munich (TUM), today announced the publication of new in vitro data on the development of the COVID-19 drug FYB207 following peer review in the journal Antiviral Research.

The study, titled "Picomolar inhibition of SARS-CoV-2 variants of concern by an engineered ACE2-IgG4-Fc fusion protein" (https://doi.org/10.1016/j.antiviral.2021.105197), which builds on previously published data (BioRxiv Preprint: https://doi.org/10.1101/2020.12.06.413443), describes optimized ACE2-IgG4-Fc fusion constructs that exhibit broad neutralizing activity against SARS-CoV-2 viruses, retain ACE2 enzyme activity, and show promising pharmaceutical properties. The ACE2-IgG4-Fc fusion proteins neutralize the original SARS-CoV, the January and April 2020 SARS-CoV-2, and the rapidly spreading alpha, beta and delta variants. Importantly, the neutralizing effect is maintained even with the SARS-CoV-2 delta variant at picomolar concentrations, demonstrating that the lead candidate ACE2-IgG4-Fc (FYB207), unlike vaccines and neutralizing antibodies, retains its full antiviral potential even with the SARS-CoV-2 variants of concern currently circulating worldwide.

SARS-CoV-2 and other coronaviruses use the ACE2 protein on the surface of human cells as a portal of entry for respiratory infections. Formycon has therefore fused the human ACE2 protein to the constant part (Fc) of human immunoglobulin G (IgG4) using computational structural design, creating a very effective SARS-CoV-2 blocker that completely prevents cell infection in vitro. The fusion with the Fc moiety stabilizes ACE2 and prolongs its in vivo efficacy. ACE2 also has inherent enzymatic activity that may provide patients with additional pulmonary and cardiovascular protection. In addition, FYB207 can potentially be used with all other coronaviruses that utilize ACE2 as a portal of entry.

As part of the ongoing in vivo preclinical studies, pharmacokinetics data are being collected in two different models and efficacy data on different variants of the ACE2-Fc fusion proteins are being collected in another model to select the most appropriate candidate for clinical testing. The clinical trial is scheduled to begin in the first half of 2022.

"New variants of concern, such as the omicron variant, demonstrate once again that vaccines and antibodies alone are not sufficient in the SARS-CoV-2 pandemic. Because ACE2 is the entry point for cell infection, SARS-CoV-2 cannot escape the ACE2-Fc fusion proteins. Our ACE2-Fc fusion proteins show consistently strong neutralization in cell cultures of all SARS-CoV-2 viral variants tested to date. Testing of omicron is underway, and we expect high efficacy here as well. Thus, with FYB207, we are developing a highly potent, long-lasting COVID-19 drug directed against all variants. Our ongoing preclinical program is designed to select the best FYB207 drug candidate and thus increase the probability of success for clinical testing," states Dr. Carsten Brockmeyer, CEO of Formycon AG.

"ACE2-IgG4-Fc is a promising antiviral drug candidate for COVID-19 that retains its full antiviral potential against the rapidly spreading SARS-CoV-2 variants. Against the background of further emerging variants of concern, there is a great need for a broadly acting SARS-CoV-2 antiviral agent", says Prof. Dr. Ulrike Protzer, Director of the Institute of Virology at the Technical University of Munich and Helmholtz Center Munich and senior author of the study.

Formycon, together with its academic research partners, receives funding from the Bavarian Research Foundation for the basic research of this project. In July 2021, Formycon also received a commitment from the Bavarian State Ministry of Economic Affairs, Regional Development and Energy (StMWi) of up to €12.7 million to support further development of the COVID-19 drug FYB207.

In October 2021, Formycon and SCG Cell Therapy Pte Ltd ("SCG") entered into a collaboration and license agreement to develop and commercialize Formycon's COVID-19 drug FYB207 in the Asia Pacific (APAC) region, excluding Japan.