Formycon informs about the modified BLA-Submission Strategy for its Lucentis(R)* Biosimilar-Candidate FYB201

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its licensing partner Bioeq AG ("Bioeq") announced today that the Biologics License Application (BLA) resubmission strategy for FYB201 has been adjusted.

The approval for FYB201 will be requested directly for a large commercial scale. Formycon and Bioeq are in close coordination with the U.S. Food and Drug Administration (FDA). Through the revised submission strategy, Formycon and Bioeq expect a simplification of the approval procedure. The modified submission dossier is expected to be filed with the FDA in the first half of 2021. The adjustment of the regulatory strategy in the course of optimizing the commercial supply chain is not expected to have any impact on the timing of the anticipated launch of FYB201 in the US and European Union countries.

* Lucentis(R) is a registered Trademark of Genentech Inc.

End of Ad Hoc Announcement


Formycon Announces Virtual Annual General Meeting for December 10, 2020

Munich - Against the background of the COVID-19 pandemic, which is set to continue for the foreseeable future, the rules of conduct adopted by the Free State of Bavaria which are still in force, and the objective of avoiding health risks, the Management Board of Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has, with the approval of the company's Supervisory Board on the basis of Article 2 of the law intended to mitigate the consequences of the COVID-19 pandemic in civil, insolvency and criminal proceedings of March 27, 2020, and for the benefit of the health of shareholders, decided to hold the Annual General Meeting (AGM) in a virtual format. The AGM will be broadcast in sound and vision over the Internet, via the company's AGM portal, for formally registered shareholders of Formycon AG and their proxies.

The notice convening the AGM was published today in the electronic Federal Gazette (Bundesanzeiger) in accordance with normal statutory deadlines. All further information regarding the company's virtual AGM can be found on the website at https://www.formycon.com/en/investor-relations/annual-general-meeting/.


Formycon Receives Funding for COVID-19 Drug Research from the Bavarian Research Foundation

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has received a grant from the Bavarian Research Foundation for the project "Characterization of ACE2-lgG constructs" amounting to Euro 290,000.

SARS-CoV-2 requires the binding of the virus spike protein to the membrane angiotensin converting enzyme 2 (ACE2) for entry into the human host cell. The aim of the project is to develop therapeutic fusion proteins that interrupt this bond. Through sequence model development, the fusion proteins will be characterized structurally and functionally in order to identify the characteristics that are important for a therapeutic application. Formycon's project partners are Prof. Dr. Ulrike Protzer, Chair of Virology, Technical University Munich and Prof. Dr. Johannes Buchner, Chair of Biotechnology, Technical University Munich.

"We are very pleased about the positive assessment of our project by the Bavarian Research Foundation, which took place in an overly competitive environment. The funding by the Bavarian Research Foundation and the very good cooperation with top researchers at the Technical University of Munich make us confident to achieve our goal to contribute significantly to the solution of the worldwide COVID-19 pandemic with a highly effective and safe drug", commented Dr. Carsten Brockmeyer, CEO of Formycon AG.


Strategic Investor Active Ownership Group Subscribes for Cash Capital Increase of EUR 25.75 million



  • Increase of the share capital by 1,000,000 shares at an issue price of EUR 25.75 per share
  • Use of cash inflow mainly for expansion and further development of own pipeline projects
  • Capital measure supports consistent implementation of the company’s growth strategy

Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced the subscription of a cash capital increase by the Active Ownership Group in a private placement. Based on the resolutions of the Management Board and the Supervisory Board, the Company's share capital will be increased by partially utilizing the approved capital from currently EUR 10,000,000.00 by EUR 1,000,000.00 to a total of EUR 11,000,000.00 by issuing 1,000,000 new no-par value bearer shares, each with a notional value of EUR 1.00 of the share capital, against cash contribution.

The total inflow of funds amounts to EUR 25,750,000.00 and corresponds to an issue price per share of EUR 25.75. The Active Ownership Group (AOC) is an independent, owner-managed investment company that acquires significant shares in medium-sized, listed companies in the DACH region and Scandinavia. As a committed co-owner, AOC is actively committed to increasing shareholder value by implementing operational, strategic and structural improvements. Together with the management, AOC defines value-creating strategies and measures for this purpose. AOC supports the implementation of these strategies and measures by serving on supervisory and advisory boards as well as by providing new growth capital. The company was founded in 2015 by Florian Schuhbauer and Klaus Roehrig. In its category, the Active Ownership Fund 2019 was awarded by the analysis house Preqin as the best fund with a European focus in the period 2017-2019.

The funds raised from the capital increase will be used primarily for the expansion and further development of the Company's own product pipeline. Strategically, the development of biosimilars remains the company's focus. The additional liquidity provides Formycon with the opportunity to develop the projects into late stages of development and thus tap significant value creation potential. With FYB206, the company has a promising preclinical biosimilar project in which important milestones have already been reached and value-generating intellectual property (IP) has been built up. In addition, Formycon is pursuing a promising approach in the development of novel antibody-based COVID-19 medicines. The transfer of this project into clinical trials is planned for next year.

Klaus Roehrig, founding partner of AOC, comments on the entry as follows: "We see significant potential in Formycon and have great confidence in the management team. By subscribing to the capital increase and the associated provision of growth capital, we are expressing this. Formycon is on its way to becoming a key global player in the rapidly growing, multi-billion dollar global biosimilar market. The upcoming launch of FYB201 (biosimilar candidate for ranibizumab), combined with the advanced development of biosimilars for ustekinumab (FYB202) and aflibercept (FYB203), underscores the current value of the company. At the same time, the existing pipeline of late-stage projects demonstrates the company's ability to select the right reference products and successfully advance their development all the way to market approval. Formycon thus fits perfectly with our investment focus on well-positioned and future-oriented companies. We look forward to supporting the company's growth strategy over the long term."

Dr. Nicolas Combé, CFO of Formycon AG adds: "We are very pleased about the entry of the Active Ownership Group and their long-term commitment to support the consistent implementation of our growth strategy. We will invest the capital provided in the further development of our pipeline. The FYB206 project is extremely promising and with the additional liquidity we are able to move this and other projects into later development phases while retaining exclusive rights for as long as possible. This is the core of our growth strategy and we are confident that it will further optimize the commercialization potential of our projects. In addition to the development and expansion of our biosimilar pipeline, we want to advance our project in the field of COVID-19 therapies and see considerable opportunities here as well. Formycon is a strong development company with exceptional growth potential and together with AOC, it is our goal to successfully continue on the path we have taken so far. We are looking forward to a long-term and trusting cooperation."


Formycon places Cash Capital Increase of 25.75 Million Euros with Strategic Investor

Munich - The Management Board of Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) resolved yesterday, with the approval of the Supervisory Board, to increase the company's capital against cash contributions by partially utilizing the approved capital. The Company's share capital of currently EUR 10,000,000.00 will be increased by EUR 1,000,000.00 to a total of EUR 11,000,000.00 by issuing 1,000,000 new no-par value bearer shares with a notional value of EUR 1.00 each in the share capital against cash contribution.

The issue price of the new shares was set at EUR 25.75 per share, resulting in gross issue proceeds of EUR 25,750,000.00. Shareholders' subscription rights for the new shares were excluded in accordance with § 4 (3) of the Articles of Association. The subscription was made in a private placement by the Active Ownership Group, an independent, owner-managed investment company that acquires significant shares in medium-sized, listed companies in the DACH region and Scandinavia.

The funds raised from the capital increase will be used primarily for the expansion and further development of the Company's own product pipeline. Strategically, the development of biosimilars remains the company's focus. The additional liquidity provides Formycon with the opportunity to develop the projects into late stages of development and thus tap significant value creation potential. With FYB206, the company has a promising preclinical biosimilar project in which important milestones have already been reached and value-generating intellectual property (IP) has been built up. In addition, Formycon is pursuing a promising approach in the development of novel antibody-based COVID-19 medicines. The transfer of this project into clinical trials is planned for next year.

The new shares will shortly be approved for trading in the "Scale" segment of OTC trading at the Frankfurt Stock Exchange and will be entitled to a share of profits from the start of the financial year, for which the Annual General Meeting had not yet passed a resolution regarding the use of the balance sheet profits at the time that the shares were issued.

End of Ad Hoc Announcement


Formycon Announces Half-Year Results for 2020



  • Group turnover of Euro 16.5 million corresponds to forecasts
  • EBITDA of Euro -0.9 million and half-year result of Euro -1.35 million in line with expectations
  • Significant progress in late-stage projects, the expansion and further development of the company’s own pipeline and in organizational development



Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today announced its financial results for the first half of 2020.

On the day of reporting, June 30, 2020, the Formycon Group's commercial figures developed as forecasted. The Group's turnover which, in addition to the joint-stock company also includes the 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, totaled Euro 16.5 million in the first six month of 2020 (H1/2019: Euro 17.2 million).

During the company's current phase, the Formycon Group continues to focus on research and development activities for its own and out-licensed biosimilar projects as well as its own COVID-19 project. The development services for the out-licensed or partnered projects are also the source of the current revenue returns. Following the successful approval of these products, Formycon also participates in the subsequent marketing revenues.

Consolidated earnings before interest, tax, depreciation and amortization (EBITDA) amounted to Euro-0.9 million (H1/2019: Euro -0.2 million), the operating result (EBIT) totaled around Euro -1.4 million (H1/2019: Euro -0.7 million). As of June 30, 2020, the Group period result was Euro -1.4 million compared to Euro -0.7 million in the same period last year.

For the full year 2020, Formycon expects revenues at the group level to be between EUR 35 and 40 million. As in previous years, the Group's financial position is solid: Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled around Euro 20.2 million on the day of reporting. Including short-term receivables and other assets worth Euro 6.0 million, the Formycon Group held liquid assets of around Euro 26.2 million in total.

Formycon AG, as the company's central development and operational unit, achieved a turnover of Euro 12.0 million during the first half of 2020 (H1/2019: Euro 11.3 million). The earnings for this period totaled Euro -1.3 million (H1/2019: Euro -0.7 million).

"The half-year figures are in line with our expectations. We have made good progress in the out-licensed and partnered projects. At the same time, we are working intensively on building and developing our own pipeline and are convinced that we will create sustainable value. In addition, we are investing in organizational development, which includes expanding our capacities as well as extensive measures to further digitalize our processes," comments Dr. Nicolas Combé, CFO of Formycon AG.

The full half-year report can be found on the Internet at https://www.formycon.com/en/investor-relations/financial-reports/


Formycon and Bioeq Enroll First Patient in Phase III Study with Aflibercept Biosimilar (FYB203)

  • The MAGELLAN-AMD study investigates the comparable efficacy, safety and immunogenicity of Formycon’s aflibercept biosimilar candidate FYB203 and the reference product Eylea®1 in patients with neovascular age-related macular degeneration (nAMD)
  • Global development program highlights leading position of Formycon and Bioeq in the field of ophthalmologic biosimilars

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and Bioeq GmbH have today announced the launch of the randomized, double-blind, multi-center phase III study for FYB203, a biosimilar candidate to Eylea®. The aim of the clinical study is to demonstrate the comparability of FYB203 and the reference product Eylea® in terms of efficacy, safety and immunogenicity in patients with neovascular age-related macular degeneration (nAMD). Also known as wet AMD, this is one of the main causes of loss of vision in people over the age of 50 in developed countries. The study design was developed in agreement with the US drug authority (FDA), the European regulatory authority (EMA) and the Japanese regulatory authority (PMDA) and is intended to support the approval process in these regions. Bioeq GmbH, a company of the ATHOS Group, is the sponsor of the phase III study.

The active ingredient aflibercept (Eylea®) inhibits the vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina, which leads to a progressive loss of vision. Eylea® is the highest-selling drug in the field of age-related eye disease and in 2019 achieved revenues of around US$ 7.5 billion. In 2015, Formycon AG concluded an exclusive global licensing agreement for FYB203 with Santo Holding (Deutschland) GmbH.

Formycon’s COO, Dr. Stefan Glombitza, sees the company’s leading position in ophthalmologic biosimilar development being confirmed: “We are delighted that our second project in the field of ophthalmology is now starting the phase III study. Given the extensive experience from the FYB201 project and the successful cooperation with Bioeq GmbH, we are confident that we will also be able to develop a high-quality and cost-effective biosimilar with FYB203. The active ingredient, aflibercept, is an extremely effective and proven treatment for wet macular degeneration and we want to play our part in ensuring that as many patients as possible gain access to this treatment option.”

1 Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.


Formycon Reports Financial Results for the First Quarter of 2020



  • Sales and other earnings total EUR 7.2 million
  • EBITDA is EUR 0.4 million
  • EBIT and net earnings also positive at EUR 0.2 million each
  • Revenue forecast at group level for 2020 between EUR 35 and 40 million



Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today presented the sales and earnings figures for the first quarter of 2020, demonstrating a positive start to the financial year. By responding early and implementing appropriate measures to protect employees in the context of the COVID-19 pandemic, Formycon was able to adapt well to the prevailing situation, so that the company's operational development activities were largely in line with planning. This is also reflected in a solid quarterly result.

Group turnover including other income amounted to EUR 7.2 million as of March 31, 2020 (same period of the previous year: EUR 9.5 million). Earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to EUR 0.4 million (previous year: EUR 0.5 million). The operating result (EBIT) as well as the quarterly result totaled around EUR 0.2 million (previous year EUR 0.2 million). The reported sales revenues result from reimbursements for development work in the licensed-out projects or projects developed in partnership. For the full year, the Formycon Group expects revenues of EUR 35 to 40 million.

The liquidity ratios of the Formycon Group developed as planned by the end of the first quarter: Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled EUR 21.1 million at the end of March. Including short-term receivables from deliveries and services, as well as other assets worth around EUR 4.7 million, Formycon Group held liquid assets totaling EUR 25.8 million on the day of reporting.

In the first three months of the year, Formycon AG as the company's actual operational unit achieved a turnover of EUR 5.3 million (first quarter of 2019: EUR 6.4 million). The company's quarterly result stood at EUR 0.1 million, as in the previous year. As expected, the number of employees rose from 97 to 114 compared with the same period last year and is expected to increase moderately over the course of the year.

Dr. Nicolas Combé, Chief Financial Officer, is very satisfied with progress during the first quarter: "We are pleased about the good start to the new financial year. Despite the ongoing COVID-19 pandemic and the associated uncertainties, we were able to guide the company well through the crisis by taking appropriate measures early on. It is also thanks to our stable cooperations that the development activities in our projects were largely continued as planned. In addition, we were able to use our expertise in protein chemistry, analytics and immunology to also initiate an innovative project in the field of antibody-based drug development against COVID-19. Our solid financial KPIs and the consolidated liquidity base give us a certain amount of room for maneuver to be able to react flexibly even in the event of unforeseeable situations, such as the global COVID-19 pandemic."


Formycon Publishes Annual Financial Statements for the 2019 Financial Year



  • Group turnover and other operating income as planned at Euro 33.9 million
  • Liquidity very solid at Euro 27.7 million
  • Equity ratio above average at 90 percent



Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today published its financial performance indicators for 2019 and has recorded a solid financial year.

On the day of reporting, December 31, 2019, the Formycon Group's commercial figures had developed as forecast. Consolidated group sales, which in addition to the AG include the two subsidiaries Formycon Project 201 GmbH and Formycon Project 203 GmbH as well as the 24.9 percent share in the FYB 202 GmbH & Co. KG joint venture, amounted to a total of Euro 33.2 million (overall performance 2019: Euro 33.9 million; sales revenue previous year: Euro 43.0 million including a special effect of Euro 8.5 million). The Formycon Group is currently focusing on research and development activities for both its own and out-licensed biosimilar projects, which are the source of its current revenues. After successful approval of the biosimilar candidates, Formycon will also participate in the subsequent marketing revenues.

Group earnings before interest, taxes and depreciation on fixed assets and intangible assets (EBITDA) amounted to Euro -1.4 million (previous year: Euro 8.0 million). The operating result (EBIT) as well as the annual result amounted to a rounded Euro -2.3 million (previous year Euro 7.1 million) and were thus in line with the forecast.

Current assets consist largely of liquidity and near-liquid assets. As in previous years, the Formycon Group has a very solid capital base, which, with approximately Euro 22.4 million (prior year: Euro 12.3 million) in cash and cash equivalents (cash on hand, checks, bank balances and securities), allows for flexibility. Including short-term receivables and other assets worth Euro 5.3 million, the Formycon Group holds liquid assets of Euro 27.7 million in total (previous year Euro 17.5 million).

The Group's balance sheet total rose by 35% to around Euro 53.6 million (previous year: Euro 39.6 million) with a simultaneous increase in the equity ratio to 90.0 percent (previous year 83.9 percent). This was mainly due to the cash capital increase of around Euro 17.3 million carried out in the second quarter of 2019. The company has no financial liabilities.

Formycon AG, as the Group's actual operational unit, achieved a turnover of Euro 21.0 million (previous year: Euro 29.6 million including a special effect) and recorded an EBITDA of Euro -1.3 million (previous: Euro 8.2 million). Accordingly, this resulted in an EBIT as well as an annual result of a rounded Euro - 2.2 million (previous year: Euro 7.3 million).

Formycon continued to recruit qualified professionals in 2019 according to the needs of the development projects. The number of employees at the end of the reporting period was 113 (+19%).

Dr. Nicolas Combé, CFO of Formycon AG, draws the following conclusion: "We have ended the 2019 financial year in line with our forecasts and made key operational and strategic progress. The good liquidity base allows us to operate from a stable position. Eventful months lie ahead of us and we are confident that we will reach the milestones we have set. This applies both to our late-phase projects, which are being developed within the framework of development partnerships, and to our early pipeline projects. For the current financial year, we anticipate a turnover volume that will be above the level of last year."

The full 2019 annual financial statements / annual report can be found on our website at https://www.formycon.com/en/investor-relations/financial-reports/.


Formycon Announces Update on Biosimilar Programs



  • Early preventions regarding COVID-19 ensure operating schedule
  • Liquidity situation not affected and still solid
  • FDA-Resubmission of FYB201 planned for the second half of the year
  • FYB202 and FYB203: Clinical trial strategy unchanged
  • Pipeline candidate FYB206 in preclinical phase



Munich - In consideration of the current developments of the corona pandemic, Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announces news on its development portfolio.

An early reaction and the implementation of appropriate organizational decentralization measures enabled Formycon to adapt well to the current situation, so that the impact of the pandemic on the company's operational development activities has been minimal so far. This also applies to the company's liquidity situation, which is unaffected and remains very solid.

Formycon continues to work with license partner Bioeq AG and its manufacturing partner on the resubmission of the Biologics License Application (BLA) for the FYB201 project, a biosimilar candidate for Lucentis(R)* (Ranibizumab), despite the situation regarding COVID-19. Together, Formycon and its partners are interacting with the U.S. Food and Drug Administration (FDA) and are currently focused on supporting the effort to generate the additional manufacturing data requested by the FDA for resubmission. Based on the manufacturing dates, completion of these efforts, and certain regulatory interactions for FYB201, a resubmission of the BLA is expected in the course of the second half of 2020 by license partner Bioeq AG.

The development project FYB202, a biosimilar candidate for Stelara(R)** (Ustekinumab), has been in phase I clinical trial since October 2019, which is at an advanced stage. Preparations for the start of the phase III clinical trial, which is scheduled for the third quarter of 2020, are continuing as planned. FYB202 is being developed in a joint venture by Aristo Pharma GmbH and Formycon AG in which Aristo Pharma GmbH holds 75.1% and Formycon AG 24.9%. Bioeq GmbH is the sponsor of the clinical trials and is also responsible for the study design and clinical operations.

Initiating work on the planned phase III clinical trial with FYB203, Formycon's biosimilar candidate for Eylea(R)*** (Aflibercept), is also proceeding as expected. The first regulatory approvals have been granted for the randomized, double-blind, multicenter phase III study comparing the efficacy and safety of Aflibercept FYB203 biosimilar with the reference drug Eylea(R) in patients with neovascular age-related macular degeneration. The start of the phase III clinical trial is planned for mid-2020. The worldwide marketing rights for FYB203 have since been transferred from Santo Holding (Deutschland) GmbH within the Santo Group to Klinge Biopharma GmbH.

In addition, Formycon continues to expand its biosimilar pipeline. The development of the biosimilar candidate FYB206, for example, is currently in the preclinical phase and relevant intellectual property (IP) has already been established by filing a corresponding patent application. There have been no details on the other pipeline candidates (FYB20x) announced yet. The rights to these projects are held by Formycon.

"Formycon took early extensive measures to protect employees from infection during the corona pandemic, while at the same time ensuring the operating schedule. In addition, we are in close contact with our external partners, which have also taken intensive arrangements within the framework of the current situation to minimize the effects as far as possible," explains Dr. Stefan Glombitza, COO of Formycon.

CEO Dr. Carsten Brockmeyer adds: "The current crisis will also impact the healthcare systems financially. The access to affordable high-quality medicines will become even more important and the need towards the use of biosimilar medicinal products is therefore expected to increase in the future."

* Lucentis(R) is a registered trademark of Genentech Inc.** Stelara(R) is a registered trademark Johnson & Johnson*** Eylea(R) is a registered trademark of Regeneron Pharmaceuticals Inc.