Formycon announces successful results of Phase I clinical trial for ustekinumab biosimilar candidate FYB202 and concludes clinical development
- Positive data from extended Phase I pharmacokinetics study complete clinical development program
- Phase I and phase III clinical trial program demonstrated comparable safety and efficacy of FYB202 and the reference drug Stelara®*
- Submission for regulatory approval in Europe and the U.S. planned for the third quarter of 2023
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced the successful conclusion of the extended Phase I clinical study comparing the pharmacokinetics of FYB202 and the reference drug Stelara®.
As early as August 2022, the primary endpoint was achieved in the randomized, double-blind, multicenter Phase III study (VESPUCCI), demonstrating the comparable efficacy of FYB202 and the reference drug in patients with moderate-to-severe psoriasis vulgaris (plaque psoriasis). The positive results of the Phase I pharmacokinetics study successfully conclude the clinical development program. FYB202 was bioequivalent to the reference drug Stelara® sourced in the EU as well as in the U.S. for all primary endpoint parameters.
European and U.S. regulatory submissions are still planned for the third quarter of 2023. Provided successful approval by the respective health agencies, Fresenius Kabi will commercialize FYB202 in key global markets.
The active ingredient ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23. Since 2009, the originator medicine has been used to treat various severe inflammatory conditions such as moderate-to-severe psoriasis as well as psoriatic arthritis. Its approved indications were expanded to chronic inflammatory bowel diseases like treatment of Crohn’s disease (2016) and ulcerative colitis (2019). Stelara® achieved a global sales volume of USD 9.7 billion in 2022.[1]
Formycon CEO Dr. Stefan Glombitza comments: “The successful conclusion of the development phase of our ustekinumab biosimilar candidate marks a very important milestone for Formycon and highlights the significant progress in our biosimilar pipeline. We are confident that we will provide the authorities with a convincing data package this fall. With FYB202, we can contribute significantly to the treatment options in the growing market segment of inflammatory diseases.”
* Stelara® is a registered Trademark of Johnson & Johnson
[1] Johnson & Johnson top pharmaceutical products by sales 2022 | Statista.
Enno Spillner appointed Chief Financial Officer (CFO) of Formycon AG
Munich, Germany – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced that the Company’s Supervisory Board has appointed Mr. Enno Spillner to the Company’s Executive Board as Chief Financial Officer (CFO) effective April 1, 2023.
Mr. Spillner has more than 23 years of experience and outstanding expertise in the biotechnology industry. In his latest position he has been serving from 2016 to 2023 as CFO and member of the Management Board of Evotec SE, an international science company for the discovery, development and production of highly effective medicines.
In his role as CFO at Evotec SE, which is listed on MDAX, TecDAX as well as NASDAQ, the 52-year-old business graduate was responsible, inter alia, for the company’s successful capital market positioning and various successful financial and M&A transactions, and led the company to the US technology exchange NASDAQ in 2021. Most importantly, he helped ensure Evotec SE’s very dynamic international growth. Previously, Mr. Spillner worked for more than ten years (2005-2016) at the publicly listed 4SC AG, an innovative biopharmaceutical company, where he held the position as Chief Financial Officer and later additionally as Chief Executive Officer. Prior to that, Mr. Spillner had worked at Bioᴹ AG since 1999, initially as Head of Finance & Controlling. Later on, he gained additional responsibility for significant parts of the Bioᴹ investment business and in 2021 also took over the management of the BioM VC Fund as a partner. In this context, he held interim positions as CFO or CEO in portfolio companies.
Mr. Spillner currently holds supervisory board mandates at Nanobiotix SA, Paris and Leon-Nanodrugs GmbH, Munich.
In his role as Formycon CFO, he will be operationally responsible for the areas Finance/Controlling, Communications & Investor Relations, Human Resources, Legal/Compliance and IT and will, together with his colleagues on the Executive Board Dr. Stefan Glombitza (CEO), Nicola Mikulcik (CBO) and Dr. Andreas Seidl (CSO), drive the company’s further development into a globally operating and fully integrated pharmaceutical company with a focus on biosimilars.
Enno Spillner succeeds Dr. Nicolas Combé, whose appointment ended as scheduled on June 30, 2022. Since then, the co-founder of Formycon AG accompanied the company in an advisory capacity as interim CFO.
“I am very much looking forward to my new role of supporting Formycon with full verve in implementing its further growth strategy. The company has established a very promising position as a developer of high-quality biosimilars with a substantial portfolio. Formycon has extraordinary potential and I will work intensively with my new colleagues and the entire team to develop Formycon into one of the leading players in one of the large growth segments in the pharmaceutical industry. In particular, my wide-ranging experiences from the years at Evotec as well as my network can help to consistently implement the upcoming organizational and strategic steps. I would like to thank the Supervisory Board for the trust they have placed in me,” said Enno Spillner.
“With Enno Spillner, we are gaining an experienced and outstanding manager who has worked extremely successfully for many years as Chief Financial Officer at internationally operating listed biotechnology companies. We are convinced that he will shape the company with his expertise and help to continue Formycon’s success story.
I would like to express my special thanks to Dr. Combé, who, as founder and CFO, was jointly responsible for the establishment and development of our company for more than ten years and played a decisive role in driving it forward. On behalf of the entire Supervisory Board, we wish Nicolas all the best and are pleased that he will remain closely associated with the company,” commented Dr. Olaf Stiller, Chairman of the Supervisory Board of Formycon AG.
“Building Formycon from a start-up to a publicly listed company has been a fantastic and intense experience with many great moments. I have been very fortunate to be able to contribute to this success story, and I am very grateful for the support of so many special people over the years. In particular, I would like to thank my employees for their exceptional commitment, loyalty and willingness to perform, as well as my colleagues and the Supervisory Board for their ever-trusting cooperation and high personal appreciation. I am convinced that Enno Spillner as the new CFO is the ideal solution for Formycon and wish him and the entire Formycon family only the best for the future,” adds Dr. Nicolas Combé.
Aflibercept Biosimilar Candidate FYB203 shows comparable efficacy to the reference product Eylea®1 in Phase III Study
- MAGELLAN-AMD study demonstrates the comparable efficacy of FYB203 to the reference product Eylea® in patients with neovascular age-related macular degeneration (nAMD)
- Primary efficacy endpoint for submission to the U.S. Food and Drug Administration (FDA) achieved in global phase III study
- Second successful clinical development program in the field of ophthalmological biosimilars highlights Formycon’s strong position in this area
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today published positive preliminary efficacy and safety data from MAGELLAN-AMD Phase III clinical trial for FYB203, its proposed biosimilar to Eylea®.
The FDA-specific interim analysis of the randomized, double-blind, multi-center phase III study met the primary efficacy endpoint, demonstrating comparable efficacy between FYB203 and the reference medicine Eylea® in patients with neovascular age-related macular degeneration (nAMD).
The primary endpoint of the comparative global Phase III trial measures the change in best corrected visual acuity after eight weeks from baseline. The values obtained for FYB203 and the reference product are within the relevant equivalence limits. In addition, to date, the study was conducted without any clinically relevant differences in terms of safety and immunogenicity.
Following the approval and market launch of the ophthalmological biosimilar for Lucentis® (FYB201 marketed as Ongavia®2 (UK), Ranivisio®3 (EU), and CimerliTM4 (US)), Formycon is now announcing, with FYB203, another successful development in the field of ophthalmology, thereby highlighting its strong position in this area.
Neovascular age-related macular degeneration (nAMD) is caused by the excessive growth of blood vessels in the retina. The active ingredient aflibercept 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. In industrialized countries, AMD is the most common cause of severe visual impairment or blindness. According to estimates, up to 77 million Europeans will be affected by 2050.[i]
Eylea® is currently the top-selling drug in the field of age-related eye disease and in 2021 achieved revenues of around US$ 9 billion. Recently, Klinge Biopharma GmbH, licensee and exclusive holder of the worldwide commercialization rights of FYB203, had entered into a binding term sheet for the exclusive commercialization of FYB203 in the United States of America with Coherus BioSciences, Inc.
Formycon’s CSO, Dr. Andreas Seidl, comments on the successful phase III study as follows: “We are delighted that our second project in the field of ophthalmology was able to impress in the clinical phase III MAGELLAN-AMD study. Given the extensive experience from FYB201, we are confident that we will also be able to make a high-quality and cost-effective biosimilar available with FYB203, thereby further expanding our strong position in the field of biosimilar development.”
[i] Li JQ, Welchowski T, Schmid M, et al. Prevalence and incidence of age-related macular degeneration in Europe: a systematic review and meta-analysis British Journal of Ophthalmology 2020;104:1077-1084.: https://bjo.bmj.com/content/104/8/1077. Last accessed in January 2023.
1Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
2Ongavia® is a registered trademark of Teva Pharmaceutical Industries Ltd.
3Ranivisio® is a registered trademark of Bioeq AG
4CimerliTM is a trademark of Coherus BioSciences, Inc
Formycon and Fresenius Kabi conclude global commercialization partnership for FYB202, a biosimilar candidate to Stelara®1 (ustekinumab)
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY), as the exclusive owner of the global commercial rights to FYB202, a biosimilar candidate to Stelara® (ustekinumab), announced the conclusion of a global license agreement with Fresenius Kabi AG (“Fresenius Kabi”). Provided successful approval by the respective health agencies, Fresenius Kabi will commercialize FYB202 in key global markets.
Upon conclusion of the agreement Formycon receives an upfront payment as well as milestone payments contingent on the successful achievement of certain regulatory events which are expected to total in the mid double digit million Euro range. Post-commercialization value will be shared approximately equally by both companies. Semi-exclusive commercialization rights for Germany as well as rights for parts of the MENA2 region and Latin America remain with Formycon.
Fresenius Kabi is a global healthcare company that specializes in pharmaceuticals, medical technologies, and nutrition products for critical and chronic conditions. In the field of biosimilars, Fresenius Kabi focuses on the development and marketing of biosimilars in the area of autoimmune diseases and oncology.
In August 2022, Formycon published positive interim results for efficacy for FYB202 from the clinical phase III study VESPUCCI. The randomized, double-blind multi-centric phase III study achieved the primary endpoint, demonstrating comparable efficacy of FYB202 and the reference medicine Stelara® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).
In the extended phase I pharmacokinetics study, the recruitment of study subjects was successfully completed in October 2022. European and U.S. regulatory submissions for FYB202 are planned for the third quarter of 2023.
FYB202 is a proposed biosimilar referencing Johnson & Johnson’s Stelara®, a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin 23 for treatment of immune-mediated disorders. Stelara® is approved for treatment of moderate-to-severe plaque psoriasis, Crohn’s disease, ulcerative colitis as well as active psoriatic arthritis with a global sales volume of more than USD 9.5 billion in 2022.
“We are delighted about the conclusion of the agreement and are looking forward to a successful commercialization of our Ustekinumab biosimilar after approval. The combination of Formycon’s development expertise and Fresenius Kabi’s global commercial competence offers an excellent basis for providing access to our highly efficacious product to many patients,” says Nicola Mikulcik, Chief Business Officer at Formycon AG.
“We welcome the potential of this agreement to build on the strengths of our companies across the value chain from development to commercialization. With the commercialization of the Ustekinumab biosimilar we are expanding our product portfolio with another autoimmune disease treatment option. In line with our Vision 2026, this is yet another key milestone for Fresenius Kabi in delivering on our strategic priority of providing access to biosimilars for patients worldwide,” says Dr. Michael Schönhofen, Fresenius Kabi’s Chief Operating Officer and Member of the Fresenius Kabi Management Board.
1) Stelara® is a registered trademark of Johnson & Johnson
2) Middle East and North Africa
Formycon AG announces result of private placement and sets placement price for the new shares from the capital increase
Munich – Management Board and Supervisory Board of Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) (“Formycon” or “Company”) resolved to increase the Company’s share capital by EUR 910,000.00 from EUR 15,128,775.00 to EUR 16,038,775.00 by issuing 910,000 new shares (the “New Shares”). The 910,000 new no-par value bearer shares were placed with institutional investors by means of an accelerated bookbuilding and carry full dividend rights as of 1 January 2022.
The anchor shareholders ATHOS KG (26.4%) and Active Ownership Capital (6.6%) had agreed in advance to support the capital measure and participated in the capital increase. ATHOS KG was allocated 279,220 New Shares and Active Ownership Capital was allocated 67,532 New Shares.
On the basis of the bookbuilding procedure carried out as part of the private placement, the Management Board, with the approval of the Supervisory Board, set a placement price of EUR 77.00 per new share, resulting in gross proceeds from the offering of EUR 70,070,000.00 before commissions and costs. The shares issued correspond to approximately 6.02% of the Company’s currently issued share capital.
The New Shares were placed with selected investors in Germany and in other member states of the European Economic Area who are “Qualified Investors” within the meaning of Art. 2 lit. e) of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 and with selected investors in other selected jurisdictions. In the United States of America, the New Shares have been placed exclusively with “Qualified Institutional Buyers” as defined in Rule 144A under the Securities Act of 1933.
The New Shares are expected to be included in the existing listing on the “Scale” segment of the Frankfurt Stock Exchange on February 7, 2023 following registration of the implementation of the capital increase. Delivery of the New Shares is also scheduled for February 7, 2023.
The net proceeds from the capital increase will primarily be used to accelerate the ongoing development of Formycon’s proprietary biosimilar candidates (FYB202, FYB206, FYB208, FYB209) to regulatory approval, as well as to expand the biosimilar pipeline and support the organic growth strategy. In addition, Formycon is considering integrating further assets along the value chain into the Company in order to accelerate its development into a highly specialized and globally active company in the biosimilars market segment. The capital measure also serves to strengthen the balance sheet, including the repayment of the drawn amount under the loan facility granted by ATHOS and Active Ownership as part of the ATHOS transaction.
Formycon agreed to a lock-up obligation with market-standard exemptions for a period of six months.
Hauck Aufhäuser Lampe and Jefferies acted as joint global coordinators and First Berlin as selling agent in the private placement.
Formycon AG upsizes capital increase from authorized capital following strong demand
Munich – Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) (“Formycon” or “Company”) announces that, following strong demand, the Company has decided to upsize their previously announced capital increase from authorized capital from approx. 5% to in total approx. 6% of the outstanding share capital. The share capital of the Company will be increased from currently EUR 15,128,775.00 to now up to EUR 16,038,775.00 through issuing up to 910,000 new shares, making partial use of the Authorized Capital.
The net proceeds from the capital increase will primarily be used to accelerate the ongoing development of Formycon’s proprietary biosimilar candidates (FYB202, FYB206, FYB208, FYB209) to regulatory approval, as well as to expand its biosimilar pipeline and support its organic growth strategy. In addition, Formycon is considering integrating further assets along the value chain into the Company in order to accelerate its development into a highly specialized and globally active company in the biosimilars market segment. The capital measure also serves to strengthen the balance sheet, including the repayment of the drawn amount under the loan facility granted by ATHOS and Active Ownership Capital as part of the ATHOS transaction.
The New Shares will be offered without a prospectus by way of a private placement to selected investors in Germany and in other member states of the European Economic Area who are “Qualified Investors” within the meaning of Article 2 lit. e) of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017. In addition, the New Shares may also be offered to institutional investors in other selected jurisdictions. In the United States of America, the New Shares will only be offered for purchase to “Qualified Institutional Buyers” as defined in Rule 144A under the Securities Act of 1933.
Books have opened earlier today and may close at short notice. Following the private placement, Formycon will be subject to a lock-up obligation with market-standard exemptions for a period of six months.
Formycon AG plans capital increase of approx. 5% of the share capital by way of an accelerated bookbuilding procedure to finance further growth
Munich – Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) (“Formycon” or “Company”) intends to issue approx. 5% of the issued share capital of the Company, representing approx. 750,000 new shares (the “New Shares”). In this respect, the Management Board of the Company resolved, with the approval of the Supervisory Board of the Company, to increase the share capital of the Company against contributions in cash by partial use of the authorized capital of the Company. The Company’s existing shareholders’ subscription rights are excluded. The offering will be conducted by way of an accelerated bookbuilding procedure overnight. The New Shares will carry full dividend rights from 1 January 2022.
The anchor shareholders ATHOS KG (26.4%) and Active Ownership Capital (6.6%) have each agreed to support the capital measure and to subscribe for New Shares in the capital increase in proportion to their existing shareholding in the Company but committed to a combined minimum subscription of EUR 26.5 million.
The net proceeds from the capital increase will primarily be used to accelerate the ongoing development of Formycon’s proprietary biosimilar candidates (FYB202, FYB206, FYB208, FYB209) to regulatory approval, as well as to expand its biosimilar pipeline and support its organic growth strategy. In addition, Formycon is considering integrating further assets along the value chain into the Company in order to accelerate its development into a highly specialized and globally active company in the biosimilars market segment. The capital measure also serves to strengthen the balance sheet, including the repayment of the drawn amount under the loan facility granted by ATHOS and Active Ownership Capital as part of the ATHOS transaction.
The New Shares will be offered without a prospectus by way of a private placement to selected investors in Germany and in other member states of the European Economic Area who are “Qualified Investors” within the meaning of Article 2 lit. e) of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017. In addition, the New Shares may also be offered to institutional investors in other selected jurisdictions. In the United States of America, the New Shares will only be offered for purchase to “Qualified Institutional Buyers” as defined in Rule 144A under the Securities Act of 1933.
The accelerated bookbuilding process will commence with immediate effect and is expected to close tomorrow prior to the commencement of trading, possibly already as early as the late evening of February 1, 2023. Formycon will announce the results of the Offering, including the final number of New Shares and the Placement Price per New Share, before the start of trading on February 2, 2023. The inclusion of the New Shares in trading on the Stock Exchange and the delivery of the New Shares are scheduled for February 7, 2023.
Following the private placement, Formycon will be subject to a lock-up obligation with market-standard exemptions for a period of six months.
Hauck Aufhäuser Lampe and Jefferies are acting as joint global coordinators and First Berlin as selling agent in the private placement.
Formycon AG announces global license agreement with Fresenius Kabi for FYB202, a biosimilar candidate to Stelara®1 (ustekinumab)
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY), as the exclusive owner of the global commercial rights to FYB202, a biosimilar candidate to Stelara® (ustekinumab), today announced the conclusion of a global license agreement with Fresenius Kabi AG (“Fresenius Kabi”). Provided successful approval by the respective health agencies, Fresenius Kabi will commercialize FYB202 in key global markets.
Upon conclusion of the agreement Formycon receives an upfront payment as well as milestone payments contingent on the successful achievement of certain regulatory events which are expected to total in the mid double digit million Euro range. Post-commercialization value will be shared approximately equally by both companies. Semi-exclusive commercialization rights for Germany as well as rights for parts of the MENA2 region and Latin America remain with Formycon.
In August 2022, Formycon published positive interim results for efficacy for FYB202 from the clinical phase III study VESPUCCI. In the extended phase I pharmacokinetics study, the recruitment of study subjects was successfully completed in October 2022. European and U.S. regulatory submissions for FYB202 are planned for the third quarter of 2023.
FYB202 is a proposed biosimilar referencing Johnson & Johnson’s Stelara®, a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin 23 for treatment of immune-mediated disorders. Stelara® is approved for treatment of moderate-to-severe plaque psoriasis, Crohn’s disease, ulcerative colitis as well as active psoriatic arthritis.
1) Stelara® is a registered trademark of Johnson & Johnson
2) Middle East and North Africa
Formycon announces binding Term Sheet between Klinge Biopharma and Coherus BioSciences for the exclusive commercialization of FYB203, a biosimilar candidate to Eylea®1, in the United States
Munich – Klinge Biopharma GmbH (“Klinge”), the exclusive owner of the global commercialization rights of FYB203, Formycon’s biosimilar candidate to Eylea® (aflibercept), informed Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today, that it has entered into a binding term sheet with Coherus BioSciences, Inc. (“Coherus”) for the exclusive commercialization of FYB203 in the United States (U.S.). The parties expect to complete the transaction in Q1 2023.
FYB203 is being evaluated in a Phase III clinical trial (MAGELLAN-AMD) and topline results are expected within the next few weeks. Coherus plans to file a Biologics License Application with the U.S. Food and Drug Administration (FDA) later this year and intends to launch the product at Eylea® biosimilar market formation, currently expected in 2025, if approved.
Under the binding term sheet, Coherus will make a total upfront payment to Klinge of approximately €30 million, comprised of cash and Coherus common stock, thirty days after the execution of the definitive agreements. Coherus will also make other regulatory and launch milestone payments and share profits approximately equally with Klinge in consideration for the commercialization rights to FYB203 in the United States. Formycon is entitled to participate in all Klinge income under the agreement with Coherus in the mid-single to low-double-digit-percentage range.
Coherus is already marketing Formycon’s ophthalmic Lucentis®2 biosimilar FYB201/CIMERLITM3 in the U.S. and can therefore leverage on established sales channels and an existing commercial infrastructure in the ophthalmic space for the commercialization of FYB203.
1)Eylea® is a registered trademark of Regeneron Pharmaceuticals, Inc.
2)Lucentis® is a registered trademark of Genentech, Inc.
3)CIMERLITM is a trademark of Coherus BioSciences, Inc.
Formycon Reports its Nine-month Figures for 2022
- Group turnover and other operating income totals Euro 28.2 million
- Group full-year sales forecast to be about Euro 40 million
- EBITDA of Euro -10.9 million and EBIT of Euro -12.1 million correspond to plans due to investments in the Group’s own projects
- Nine-month result of Euro 61.1 million continues to be affected by one-off and extraordinary effects on the financial result. These effects are transaction-related and do not have an effect on liquidity
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today announced its results for the first nine months of the 2022 fiscal year. On the Group level, reporting is performed in accordance with IFRS (International Financial Reporting Standards).
At the end of the third quarter, the Formycon Group’s financial figures were as expected. The turnover of the Group, which, alongside Formycon AG, comprises the fully consolidated subsidiary companies Formycon Project 201 GmbH, FYB202 Project GmbH, Formycon Project 203 GmbH, Bioeq GmbH as well as a 50% stake in Bioeq AG, which is consolidated at equity, totaled Euro 28.2 million in the first nine months of the year 2022 (prior-year period IFRS: Euro 27.4 million). Formycon is forecasting revenues at Group level of around Euro 40 million for the whole year.
The Formycon Group focuses on research and development for its own, or out-licensed biosimilars projects as well as its own COVID-19 drug (FYB207). A large part of the revenue results from the development services for the out-licensed (FYB203) and partnered project (FYB201).
In July 2022 the commercialization of FYB201 in Great Britain started, through the distribution partner Teva Pharmaceutical Industries Ltd. (“Teva”) and in October, in the US, through Coherus BioSciences Inc. Additionally, in November, FYB201 was introduced onto the market in Germany by Teva. The nine-month figures included the first commercialization revenues from Great Britain since the introduction of FYB201 onto the market at the start of July. For the full year 2022, sales and earnings contributions from the marketing revenues in the additional territories are expected.
The Group’s earnings before interest, tax, depreciation and amortization (EBITDA) stood at Euro -10.9 million (prior-year period IFRS: Euro -10.0 million), the operating result (EBIT) was Euro -12.1 million as of September 30, 2022, compared with -10.9 million in the prior-year period. The Group net period result amounted to Euro 61.1 million (prior-year period IFRS: Euro -11.1 million).
The period result is further affected by a one-off effect that influenced the result but not the liquidity. This resulted from the sale of the minority stake (24.9%) in FYB 202 in the course of the transaction with ATHOS KG (“ATHOS”). In the course of this, Formycon AG withdrew as a partner of FYB 202 GmbH & Co. KG. In parallel with this, the acquisition of 100% of the shares of FYB202 Project GmbH, in which the global assets and commercialization rights to FYB202 are located, took place.
After the acquisition of FYB202, as part of the transaction with ATHOS, the 50% stake ATHOS held in FYB201, a biosimilar for Lucentis®1, was also taken over, among others. For both financial assets (FYB201 and FYB202) there is a conditional liability (conditional purchase price components) towards ATHOS, the amount of which depends on the project-specific and actual realization of proceeds. The compounding of this liability, which must be adapted periodically, also influences the result but not liquidity and runs counter to the previously described effect.
The Formycon Group’s stocks of liquid assets, which comprise cash, checks, bank deposits and securities, remained solid at Euro 12.1 million as of September 30, 2022. Including short-term receivables from deliveries and services, as well as other assets, the Formycon Group held liquid assets totaling Euro 22.6 million on the day of reporting (prior year: Euro 33.7 million).
In the first nine months of the year, Formycon AG, as the Group’s central development and operational unit, continues to report according to the regulations of the Handelsgesetzbuch (HGB – German Commercial Code) and achieved a turnover of Euro 21.8 million (prior-year period: Euro 20.4 million). The company’s nine-month result was Euro 73.7 million compared to Euro -10.7 million last year.
“The nine-month result reflects our expectations. The global introduction onto the market of FYB201 under the trade name Ongavia®2 (UK) or Ranivisio®3 (EU) and CimerliTM4 (US) by our partners and the revenues anticipated due to this are an important milestone in our transformation to a commercial-stage company. At the same time, we continue our growth strategy with planned investments into our pipeline, in order to create sustainable value, explains Dr. Stefan Glombitza, CEO of Formycon AG.
1Lucentis® is a registered trademark of Genentech Inc.
2Ongavia® is a registered trademark of Teva Pharmaceutical Industries Ltd.
3Ranivisio® is a registered trademark of Bioeq AG
4CimerliTM is a trademark of Coherus BioSciences, Inc.