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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.

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.

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.”