Formycon publishes Update on Development Projects



  • FYB201/ONGAVIA®1 is expected to be the first biosimilar to Lucentis®2 to be commercialized in Europe
  • EMA and FDA approvals for Lucentis® biosimilar FYB201 anticipated in Q3/2022
  • FYB202: Treatment of all patients in phase III clinical trial completed (last-patient-out) primary efficacy endpoint data expected by end of July 2022
  • Additional phase I study initiated
  • FYB203: Enrollment in phase III clinical trial completed (last-patient-in) primary efficacy endpoint data expected by end of 2022
  • FYB207: Neutralization of the omicron variant proven in vitro
  • Improved molecular structure increases in vivo half-life and efficacy
  • Paul Ehrlich Institute confirms full support for accelerated development program
  • Clinical trial in preparation



Munich – Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) („Formycon“) today announced an update on their development projects.

FYB201, Formycons biosimilar to Lucentis® (ranibizumab), was recently approved by the British Medicines Agency MHRA (Medicines and Healthcare products Regulatory Agency) in the United Kingdom. The Commercialization partner Teva Pharmaceutical Industries Ltd. („Teva“) expects to launch FYB201 under the trade name ONGAVIA® in the UK later this year. ONGAVIA® will become available to patients in the UK suffering from age-related neovascular (wet) macular degeneration and other serious eye diseases. Thereby FYB201/ONGAVIA® is expected to be the first biosimilar to Lucentis® to be marketed in Europe.

Approval processes for FYB201 with the European Medicines Agency („EMA“) and the U.S. Food and Drug Administration („FDA“) continue to proceed as planned. The opinion of the Committee for Medicinal Products for Human Use ("CHMP") of the EMA is expected shortly. The subsequent decision of the European Commission and the associated EU approval of FYB201 is expected this summer. In addition, the submission of marketing authorization applications for FYB201 in further attractive markets is planned or has already occurred.

In the U.S., a biologics license application seeking approval of FYB201 for all Lucentis® indications including neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization is under review by the FDA with a target action date of August 2, 2022. If approved by the FDA on August 2, 2022, U.S. partner Coherus BioSciences, Inc. plans to launch FYB201 under the trade name CIMERLI™3 in the second half of 2022. Earlier in 2022, the FDA’s pre-license inspections (“PLI”) in Europe for FYB201 were completed. As part of the PLI, Formycons premises in Martinsried/Planegg (Germany) were inspected by the FDA in March. The inspection went without any complaint, no form 4834 was issued.

Nicola Mikulcik, CBO of Formycon, explains: “We are delighted that FYB201 under the brand name ONGAVIA® is expected to be the first available biosimilar to Lucentis® in the United Kingdom and can be used in the treatment of age-related neovascular (wet) macular degeneration and other serious eye diseases. This will provide access to this highly effective drug to more patients."

In the FYB202 project, a biosimilar candidate for Stelara®5 (ustekinumab), the treatment of the last patient in the phase III clinical trial (VESPUCCI study) was successfully completed (last-patient-out) despite the current challenging environment for conducting clinical trials. The aim of the randomized, double-blind, multi-center phase III study is to demonstrate the similarity of FYB202 and the reference product Stelara® in terms of safety, efficacy and immunogenicity in patients with moderate to severe psoriasis vulgaris. Results on the primary efficacy endpoint are expected in July.

In parallel to the ongoing phase III trial, additional Scientific Advice Meetings were held with the FDA and the EMA to discuss the development strategy of FYB202 in detail and in which additional extensive analytical data packages for the similarity of FYB202 with the reference product Stelara® on a commercial production scale were presented. Both authorities support Formycon's similarity testing strategy. In addition, a comparative phase I pharmacokinetics study of FYB202 with the reference product Stelara® was discussed, in which the confidence interval for one of the required parameters was narrowly missed. Based on the findings, the study concept was adapted accordingly and the changes have already been coordinated with the authorities. The study start of the extended scope pharmacokinetics study is planned in the next weeks. European and U.S. regulatory submissions for FYB202 are planned for the third quarter of 2023 following the availability of these additional pharmacokinetic data.

Dr. Stefan Glombitza, COO of Formycon AG, adds: "We are confident that we will be able to provide a compelling data package for submission next year. There is strong interest in our FYB202 development and we aim to make a decision on a suitable commercialization partner in the second half of 2022."

In the development of FYB203, Formycon's biosimilar candidate for Eylea®6 (aflibercept), the last patient in the ongoing phase III clinical trial (MAGELLAN-AMD study) was enrolled in April (last-patient-in). The aim of the randomized, double-blind, multi-center phase III study is to demonstrate the similarity of FYB203 and the reference product Eylea® in terms of efficacy, safety and immunogenicity in patients with neovascular (wet) age-related macular degeneration. Data on the primary efficacy endpoint are expected by the end of this year.

The FYB206 biosimilar project continues to progress according to plan. Following convincing results from the extensive analytical characterization of the developed molecule as well as significant progress in the development of the manufacturing process, a comprehensive data package is currently being compiled in order to closely coordinate further program steps in Scientific Advice Meetings with the EMA and FDA in the second half of the year. Scaling up of the manufacturing process to commercial scale is planned for the end of 2022. Formycon plans to announce details of the reference molecule later this year.

FYB207 is a promising antiviral drug candidate against SARS-CoV-2 and its variants. This is a fusion protein of the human protein ACE2 (Angiotensin Converting Enzyme II) and the constant part of a human antibody. Since ACE2 is the entry point for cell infection, the virus cannot evade a drug based precisely on this protein. Previously published laboratory studies have shown that FYB207 retained its full antiviral potential against the SARS-CoV-2 alpha, beta and delta variants. New laboratory data demonstrate that the omicron variant now prevalent is neutralized by FYB207 with consistently high efficacy as well. In contrast, vaccines and therapeutic antibodies against SARS-CoV-2 variants have already lost efficacy.

Based on preclinical studies conducted in 2021, Formycon was able to make defined proprietary modifications to the FYB207 molecular structure that resulted in significant improvements in half-life and efficacy. The development strategy for an accelerated approval process has already been coordinated with the Paul Ehrlich Institute ("PEI") and the FDA through Scientific Advices in 2021. In a follow-on Scientific Advice in May 2022, the PEI confirmed full support for the improved drug molecule for the accelerated development program. On this basis, preclinical studies are expected to be completed, the manufacturing process will be adapted to the optimized molecule, and the production of test material for stability studies and clinical trials will be carried out in 2022. Entry into clinical trials is planned for 2023.

Formycon has extensive know-how and numerous patent applications in the field of fusion proteins against viral diseases, an increasingly important therapeutic area. Together with its academic partners Prof. Dr. Ulrike Protzer, Chair of Virology, and Prof. Dr. Johannes Buchner, Chair of Biotechnology at the Technical University of Munich ("TUM"), Formycon has built a great scientific reputation, which is reflected for FYB207, in addition to the Pharma Trend Image & Innovation Award "The Most Innovative Product®" in the category of Leap Innovations, also in the granting of extensive funding. Formycon is therefore evaluating various strategic options for fully exploiting the commercial potential of this platform technology. In this context, discussions are also underway with SCG Cell Therapy Ltd. to regain the exclusive license to develop, manufacture and commercialize FYB207 for the Asia-Pacific region (excluding Japan). Collaboration with academic partners will continue intensively as FYB207 development continues.

Dr. Carsten Brockmeyer, CEO of Formycon AG, says: "With each successful mutation, SARS-CoV-2 escapes vaccines and therapeutic antibodies a little bit more. In particular, older people, whose vaccination protection declines more rapidly than in younger ages, and people who have to take immunosuppressive drugs continue to have a high risk of becoming more severely ill or even dying from COVID-19. The threat of viral mutations is likely to increase even further in the future worldwide due to social and environmental developments. Fusion proteins such as FYB207 can potentially make an important contribution here for the prevention and treatment of COVID-19, but also aid global pandemic preparedness in general."

1) ONGAVIA® is a registered trademark of Teva Pharmaceutical Industries Ltd.2) Lucentis® is a registered trademark of Genentech Inc.3) CIMERLI™ is a trademark of Coherus BioSciences, Inc.4) Form 483 is used by FDA to document and comment on concerns, identified during the inspection.5) Stelara® is a registered trademark of Johnson & Johnson6) Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.


Formycon appoints Dr. Stefan Glombitza as CEO and sets the course for the future by appointing the two experienced pharmaceutical managers Nicola Mikulcik and Dr. Andreas Seidl to the Executive Board



  • Long-standing Chief Operating Officer (COO) Dr. Stefan Glombitza takes over the position of Chief Executive Officer (CEO)
  • Previous CEO Dr. Carsten Brockmeyer leaves the Executive Board after 9 years with the regular end of contract and remains with the company as a scientific advisor
  • Nicola Mikulcik and Dr. Andreas Seidl join the Executive Board as the Chief Business Officer (CBO) and Chief Scientific Officer (CSO)
  • Enlargement and personnel alignment of the Executive Board ensures stable management of the company and sets the course for future commercial growth



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.


Formycon announces changes to its Executive Board

Munich – Today and effective July 1, 2022, the Supervisory Board of Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) ("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, who leaves the Executive Board as planned on June 30, 2022, when his appointment regularly expires. Dr. Brockmeyer will continue to support the company as a scientific advisor.

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 will be responsible for Business Development and Commercial Affairs.

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 scientist will lead the preclinical and clinical development, bioanalytics and Scientific Affairs functions.

The previous Chief Financial Officer (CFO), Dr. Nicolas Combé, who is also leaving the Executive Board with the regular expiry of an appointment as planned on June 30, 2022, will continue to be available to the company as CFO and beyond in an advisory capacity, until a suitable Chief Financial Officer has been found and trained.


Formycon Publishes Annual Financial Statements for the 2021 Financial Year



  • Group turnover and other earnings total Euro 41.7 million
  • Liquidity solid at a total of EUR 36.2 million
  • Annual result shaped by scheduled investments in FYB202, FYB206 and FYB207
  • Conversion of Group reporting to IFRS as of the 2022 half-year consolidated financial statements



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.


United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) grants Marketing Authorization for FYB201, Formycon's Biosimilar for Lucentis®¹, to be Commercialized by Teva as ONGAVIA®

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.


FYB201, Formycon's Biosimilar for Lucentis®¹, achieves Marketing Authorization in United Kingdom

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).

Lucentis® is used in the treatment of age-related neovascular (wet) macular degeneration (nAMD) and other serious eye diseases. It inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina.

The commercial launch of FYB201 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. FYB201 will be marketed in the UK under the brand name ONGAVIA® and targets to be the first available Biosimilar for Lucentis® in Europe.

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


Formycon AG and ATHOS KG announce closing of transaction to acquire biosimilar assets FYB201 and FYB202 as well as Bioeq GmbH



  • Full acquisition of biosimilar candidate FYB202 (ustekinumab) and acquisition of a 50% stake in biosimilar candidate FYB201 (ranibizumab) completed
  • Takeover of the operational development unit Bioeq GmbH concluded
  • Execution of the non-cash capital increase makes ATHOS KG largest indirect shareholder of Formycon with 26.6%



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.


Formycon is acquiring the biosimilar assets FYB201 and FYB202 and strengthening its position in the global growth market of biosimilars through long-term partnership with ATHOS KG

  • Total value of transaction volume approximately Euro 650 million
  • Complete acquisition of biosimilar candidate FYB202 (ustekinumab) and acquisition of a 50% stake in biosimilar candidate FYB201 (ranibizumab)
  • ATHOS will be the largest future shareholder of Formycon with a stake of around 26.6%
  • Significant increase of the share in the marketing revenues of FYB201 and FYB202 by integration within the Formycon Group
  • Strengthening of the development organization and accelerated pipeline expansion through acquisition of Bioeq GmbH
  • Transaction-based fair-value valuation of the Formycon share at Euro 83.41

Munich – Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) (“Formycon”) and ATHOS KG (“ATHOS”) have agreed to merge their development activities in the area of biosimilars through a long-term strategic partnership.

The structure of the transaction will involve Formycon acquiring all the rights in FYB202, a biosimilar candidate for Stelara®1 (ustekinumab), as well as a 50% share in FYB201, a biosimilar candidate for Lucentis®2 (ranibizumab). Stelara® is used to treat various serious inflammatory diseases like moderate to severe psoriasis and inflammatory bowel diseases such as Crohn’s disease and ulcerative colitis. Lucentis® is used to treat age-related neovascular (wet) macular degeneration (nAMD) and other serious eye diseases.

Furthermore, the acquisition and integration of long-time partner Bioeq GmbH (“Bioeq”) is enabling Formycon to expand its expertise in a number of areas that are important for the development, approval and commercialization of biosimilars.

For purposes of development, approval and commercialization, Formycon integrated FYB201 in 2013 and FYB202 in 2017 into the existing partnerships with Bioeq AG (since 2016, previously Santo Holding GmbH) and respectively Aristo Pharma GmbH, a company of ATHOS. The acquisition of the biosimilar candidates will give Formycon a significantly higher share in the 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 the value added and to the ongoing growth of the company.

The transaction therefore creates key enablers for further expanding Formycon’s position as a company operating on the global stage in the growth market for biosimilars. Subject to the assumption of the expected approvals and market launches or out-licensing of their biosimilar candidates, Formycon is targeting an EBITDA3 in the amount of a triple-digit million euro figure in 2025.

The value of the consideration to be paid by Formycon as part of the transactions (issuance of new shares to ATHOS and an earn-out component) amounts to approximately Euro 650 million as of the completion date. After the deal is closed, ATHOS will be the largest shareholder in Formycon with an indirect shareholding of around 26.6% in the share capital. In the context of the transactions, the Formycon share was valued at a fair value of Euro 83.41 confirmed by expert opinion.

Dr Nicolas Combé, CFO of Formycon, said: “The certified valuation reports of both parties confirm the attractiveness of this transaction for Formycon and implicitly also the potential of our share. This should be significantly further increased by these acquisitions. The measure empowers Formycon to expand its sphere of operation in the strongly growing biosimilar market. This deal demonstrates our ongoing commitment to sustainable growth through the future income of our biosimilar candidates and continuous expansion of our development pipeline.”

Dr Stefan Glombitza, COO of Formycon, explained: “This takes us into the next stage of partnership with ATHOS and consolidates our position as a highly specialized company for biosimilar development. Pooling expertise in the area of Research & Development combines the complementary capabilities and strengths of Formycon and Bioeq honed over years of collaborative partnership. This will give the expansion of our development pipeline additional dynamic impetus.”

Dr Carsten Brockmeyer, CEO of Formycon, added: “The transaction is of outstanding relevance for Formycon and creates the best enablers for further development to becoming a fully integrated pharmaceuticals company in the area of biosimilars. I would like to extend my explicit thanks to all those involved in successfully moving this transaction forward.”

Melissa Simon of ATHOS added: “Formycon is one of the few dedicated biosimilar experts worldwide. We have the common objective of providing patients better access to modern and highly effective therapies. We are confident that Formycon will be in a position to fully exploit its potential in the biosimilars’ growth market through this merger.”

Details of the transaction

The transaction will involve Formycon in acquiring (I.) the operational development unit Bioeq GmbH, (II.) all the rights in FYB202, a biosimilar candidate for Stelara®, which has so far been developed in a joint venture between ATHOS (75.1%) and Formycon (24.9%) and (III.) the 50% shareholding of ATHOS in Bioeq AG, a joint venture between ATHOS and Polpharma Biologics Group B.V, Poland, which holds the commercial rights in FYB201, a biosimilar candidate for Lucentis®:

(I) The acquisition of Bioeq enables Formycon to strengthen its own organization with experienced experts from the areas of clinical development, regulatory affairs, business development, commercial affairs, IP and project management. On the basis of many years of partnership and collaboration between the two companies in ongoing biosimilar projects, synergies should be leveraged and an efficient expansion of the development pipeline is to be driven forward. Furthermore, Bioeq has an established international network in the area of commercialization of biosimilars.

(II) Acquisition of all the rights in FYB202, a biosimilar candidate for Stelara®, which is currently in clinical phase III, involves Formycon in purchasing 75.1% of the project shares of Aristo Pharma GmbH, a fully-owned subsidiary of ATHOS. In future, Formycon will consequently own the project and commercialization rights for FYB202 and will thereby be able to benefit to a much greater extent from the potential revenues of the biosimilar candidate in a target market with an estimated volume of around nine billion US dollars.

(III) The worldwide licensing and marketing rights in FYB201, a biosimilar candidate for Lucentis®, have been held by Bioeq AG since 2016, a 50/50 joint venture between ATHOS and Polpharma Biologics Group B.V. As part of the transaction, Formycon will acquire the 50% shareholding of ATHOS in Bioeq AG. By comparison with the previous compensation structure, Formycon will increase its potential income by more than 40% as a result of the transaction. The approvals for FYB201 in the USA and Europe are expected in the third quarter of 2022.

Furthermore, Formycon continues to hold the rights in FYB206, a preclinical biosimilar candidate and in FYB207, a broad acting antiviral drug development for the treatment of COVID-19.

Valuation level and financing of the transaction

The transaction between Formycon and ATHOS was carried out at fair-value conditions that were jointly determined and confirmed by experts and on the basis of a valuation of the Formycon share at Euro 83.41. The payment of the purchase prices to ATHOS for the assets being acquired (I. – III.) in the value of approximately Euro 650 million is to be partly financed by the issue of shares from a non-cash capital increase and by making full use of the existing authorized capital (Euro 4,000,000 or shares) of Formycon. This issue of shares from a non-cash capital increase will solely include the participation of ATHOS via various subsidiaries. Furthermore, ATHOS is to receive an earn-out component in the future sales of Formycon generated with FYB201 and FYB202, which are expected overall to be in the middle triple-digit million range for ATHOS.

ATHOS will be the largest future shareholder of Formycon with a shareholding of around 26.6%. A further 15.87% of the shares will be held by Wendeln & Cie. KG including associated entities and 6.64% of the shares by Active Ownership Capital after the capital increase has been carried out. The anchor shareholders as well as the members of the Executive Board and Supervisory Board have entered into a customary lock-up agreement for a period of 10 months starting from today’s date. This agreement includes more than 50% of all total issued shares of Formycon. They want to support the company over the long term in driving forward the growth strategy to become a fully integrated company operating on the global stage in the growth segment of biosimilars.

In addition, the investor consortium made up of ATHOS and the investment company Active Ownership, which focuses on healthcare investments, will make available an on-demand line of credit amounting to up to Euro 50 million. In this way, ATHOS and Active Ownership are strengthening the liquidity base of the Formycon Group to enable further short-term investments in the pipeline. The commitment of Active Ownership as an anchor shareholder of Formycon has been characterized by enormous confidence in the management and the potential of the company since its entry in 2020. The fact that Active Ownership is now also participating with debt capital is a confirmation of this trust.

The transaction is subject to the usual conditions including specific regulatory approvals and is projected to be closed in the first half-year of 2022.

1)Stelara® is a registered trademark of Johnson & Johnson
2)Lucentis® is a registered trademark of Genentech Inc.
3)EBITDA calculated in accordance with the current accounting policies for financial reporting


Webcast for presentation of the transaction

The Executive Board of Formycon AG has presented and explained the transaction to analysts and shareholders in an audio webcast (in German) at 11.00 (CET) on March 30, 2022.

The Webcast Presentation is available for download at the following link:
Webcast-Presentation


Formycon and ATHOS KG merge development activities through the acquisition of biosimilar assets in a long-term strategic partnership


Publication of insider information in accordance to Article 17 of Regulation (EU) No. 596/2014
Ad Hoc Announcement

Munich – Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) (“Formycon”) and ATHOS KG (“ATHOS”) have agreed to merge their development activities in the area of biosimilars through a long-term strategic partnership.

This will involve Formycon in acquiring 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.

The value of the consideration to be paid by Formycon as part of the transactions amounts to a cumulative volume of approximately Euro 650 million as of the completion date and is based on mutually determined fair-value conditions confirmed by expert opinion. As part of this framework, the Formycon share is valued at Euro 83.41.

The payment of the purchase prices to ATHOS for the assets being acquired is to be partly financed by the issue of shares from a non-cash capital increase, making use of the existing fully authorized capital (Euro 4,000,000 or shares) of Formycon at a notional value of Euro 83.41 per new Formycon share. This issue of shares from a non-cash capital increase will solely include the participation of ATHOS via various subsidiaries. Furthermore, ATHOS is to receive an earn-out component in future cash flows of Formycon from the biosimilar candidates FYB201 and FYB202, which are expected to total in the middle triple-digit million range for ATHOS.

Upon completion, ATHOS will become the largest shareholder of Formycon with an indirectly held share of approximately 26.6% of the share capital. ATHOS as well as other anchor shareholders and members of the Executive Board and Supervisory Board have entered into a customary lock-up agreement for a period of 10 months starting from today's date. The agreement includes more than 50% of all total issued shares of Formycon.

By acquiring the two biosimilar candidates, 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. The acquisition and integration of the long-time partner Bioeq GmbH is enabling Formycon to expand its expertise in a number of sectors that are important for the development, approval and commercialization of biosimilars.

The transaction is subject to the usual conditions including specific regulatory approvals and is projected to be closed in the first half-year of 2022.

 

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


MS Pharma becomes Partner for the Commercialization of FYB201, Formycon's Biosimilar Candidate to Lucentis(R)1 (ranibizumab), in the MENA Region

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.