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.


Formycon and Scientists from TUM publish new Data on broadly effective SARS-CoV-2 antiviral Drug FYB207



  • Joint study describes optimized ACE2-IgG4-Fc fusion proteins
  • Picomolar Neutralization of the SARS-CoV-2 variants of concern
  • Neutralizing effect of SARS-CoV-2 delta variant confirmed
  • High efficacy against omicron expected



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.


Formycon Reports its Nine-Month Figures for 2021



  • Strong topline growth to Euro 29.1 million compared to previous year
  • Forecast for full-year revenues concretized and raised to around Euro 40 million
  • EBITDA of Euro -10.0 million and net result for the period of Euro -10.7 million in line with plans
  • Result due to investments in projects FYB206 and FYB207



Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today announced its results for the first nine month of the 2021 fiscal year.

The key financial figures of the Formycon Group also developed as expected at the end of the third quarter. Turnover within the Group which, alongside the joint-stock company also includes two fully consolidated subsidiaries Formycon Project 201 GmbH and Formycon Project 203 GmbH, as well as the shareholding in FYB 202 GmbH & Co. KG which is not consolidated, stood at a total of Euro 29.1 million in the first nine months of 2021 (same period last year: Euro 23.5 million). For the full year of 2021, Formycon now expects revenues of approximately Euro 40.0 million for the entire Group (2020: Euro 34.2 million).

During the company's current phase, the Formycon Group is focusing on research and development activities for the biosimilar projects, as well as for the COVID-19 drug (FYB207). The current revenues result from the development services for the out-licensed or partnered projects. Following the successful approval of these products, Formycon will also take a share of subsequent commercialization revenues.

The Group's earnings before interest, tax, depreciation and amortization (EBITDA) stood at Euro -10.0 million (same period of the previous year: Euro -2.0 million), the operating result (EBIT) and the consolidated net profit for the period were around Euro -10.6 million and Euro -10.7 million as of September 30, 2021, compared with Euro -2.7 million in the previous year period.

The changes compared to the previous year period continue to be mainly due to investments in the pipeline. Significant progress was made in the development of the pre-clinical biosimilar candidate FYB206 and the development of the innovative SARS-CoV-2 drug FYB207 was advanced at a fast pace. The key figures include income of Euro 1.5 million from the approved grant of up to Euro 12.7 million from the Free State of Bavaria for the SARS-CoV-2 blocker FYB207 as part of the Bavarian Therapeutic Strategy to combat the COVID-19 pandemic.

The Formycon Group's stocks of liquid assets, which comprise cash, checks, bank deposits and securities, remained solid at Euro 26.3 million as of September 30, 2021. Including short-term receivables from deliveries and services, as well as other assets worth around Euro 7.4 million, the Formycon Group held liquid assets totaling Euro 33.7 million on the day of reporting (same period last year: Euro 23.5 million).

In the first nine months of the year, Formycon AG, as the company's actual operational unit, achieved a turnover of Euro 20.4 million (same period last year: Euro 18.0 million). The company's nine-month result was Euro -10.7 million compared to Euro -2.8 million last year.

"We are very satisfied with the course of the fiscal year so far. Important milestones were achieved on all development projects and major operational progress was made. A special highlight in the past quarter was the submission of the biologics license application for our Lucentis(R)1 biosimilar candidate FYB201 to the U.S. Food and Drug Administration (FDA) and the submission of the marketing authorization application to the European Medicines Agency (EMA), by our licensee. This was a key step in the transformation to a company that generates cash flows from product commercialization in addition to revenues from development activities. With the scheduled investments in the pipeline projects, particularly in FYB206, we are systematically implementing our growth strategy and are convinced that this will create sustainable value for our company. We will continue on this path", comments Chief Financial Officer Dr Nicolas Combé.

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


Formycon and SCG Cell Therapy Announce Collaboration and License Agreement for Formycon’s COVID-19 Drug FYB207



  • Agreement aims to accelerate development and commercialization of FYB207 in the Asia-Pacific region
  • SCG Cell Therapy receives exclusive license to develop, manufacture and commercialize FYB207 in the Asia-Pacific region (except Japan)
  • Formycon is eligible to receive up to € 63.5 million in development, regulatory and sales-related milestone payments as well as low double-digit percentage range royalties on net sales



Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and SCG Cell Therapy Pte Ltd (“SCG”) announced that they have entered into a collaboration and license agreement for the development and commercialization of Formycon’s proprietary COVID-19 drug FYB207. Under the terms of the agreement, SCG has access to Formycon’s ACE2 fusion protein technology and has acquired an exclusive license to develop, manufacture and commercialize FYB207 in the Asia-Pacific (APAC) region (except Japan). Formycon is eligible to receive potential development, regulatory and sales-related milestone payments of up to € 63.5 million as well as royalties on net sales in the low double-digit percentage range. The APAC region is home to about 60% of the world’s population and is the world’s second largest healthcare market.

“We are very glad about the collaboration with SCG which allows us to accelerate the development and commercialization of our COVID-19 drug FYB207 in the most populated region of the world”, says Dr. Carsten Brockmeyer, CEO of Formycon, and continues: “We believe SCG with its outstanding scientific base and network in Singapore, China and Germany is an excellent partner. SCG will be responsible for the development and manufacturing of FYB207 in Asia, and if approved, bring this innovative COVID-19 drug to patients and healthcare providers in the Asia-Pacific region.”

“FYB207 is a promising antiviral drug candidate for COVID-19, and it retains its full antiviral potential even against the rapidly spreading SARS-CoV-2 variants-of-concern”, says Prof. Dr. Ulrike Protzer, Director of the Institute of Virology of the Technical University of Munich and the Helmholtz Center Munich, and Scientific Founder of SCG. “We are excited with the encouraging results from FYB207 and we are pleased to collaborate with Formycon to accelerate the development of this promising antiviral to bring it to patients in need in the Asia-Pacific region and combat COVID-19”, says Frank Wang, CEO of SCG, and adds further: “Formycon focuses on developing high-quality biopharmaceutical medicines and we look forward to combining our presence in Asia with Formycon to provide effective and affordable treatment options to patients.”


Formycon Concludes Collaboration and License Agreement with SCG Cell Therapy for its COVID-19 Drug FYB207 for the Asia Pacific Region

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and SCG Cell Therapy Pte Ltd ("SCG") today announced that they have entered into a collaboration and license agreement for the development and commercialization of Formycon's proprietary COVID-19 drug FYB207. Under the terms of the agreement, SCG, a biotechnology company established and headquartered in Singapore with a strong footprint and scientific network in Singapore, China and Germany, has access to Formycon's ACE2 fusion protein technology and has acquired an exclusive license to develop, manufacture and commercialize FYB207 in the Asia-Pacific (APAC) region (except Japan). Formycon is eligible to receive potential development, regulatory and sales-related milestone payments of up to € 63.5 million as well as royalties on net sales in the low double-digit percentage range. The APAC region is home to about 60% of the world's population and is the world's second largest healthcare market.