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
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.
Formycon is postponing the general assembly into the fourth quarter of 2020 to maintain the possibility of an event in person
- New date scheduled for December 10, 2020
- Postponement to later date should allow for an event in person
- Publication of the annual financial statements as planned on May 18, 2020
Munich - The board of management and the supervisory board of Formycon AG have decided to postpone the general assembly, which was originally scheduled for June 30, 2020 to December 10, 2020. This decision was made in light of the ongoing corona pandemic in order to protect the shareholders, employees and all service providers involved in the general assembly. Formycon is therefore following the general (large-scale) ban on events until August 31, 2020, which was declared by the federal government in mid-April 2020, and is making use of the law passed by the legislator to mitigate the consequences of the COVID-19 pandemic, which allows for the annual general assembly to be held beyond the usual eight-month period (§175 para. 1 sentence 2 Stock Corporation Act).
By postponing the general assembly to a date at the end of the year, Formycon would like to allow its shareholders the possibility of participating in the event in person if the prevailing corona pandemic situation permits by then. The announcement of the convening of the annual general assembly on the new date will be made according to the regular statutory periods. The annual financial statements for the 2019 fiscal year will be published on May 18, 2020 as planned.
Formycon Starts Antibody-Based Drug Development for COVID-19
- Longtime expertise in antibody-based therapies enables targeted development of COVID-19 drugs.
- Cooperation with renowned academic and industrial partners
- Implementation of the innovative project without impact on ongoing biosimilar programs
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced the start of development of COVID-19 drugs. The company develops biological COVID-19 drugs using its clinically validated antibody-based protein drug technology platform, leveraging computer-aided structural protein design as well as a broad panel of physicochemical, functional and biological tests to screen for SARS-CoV-2 blocking antibody-based drugs.
Antibody-based COVID-19 drugs are being designed by computer modeling to achieve the desired specific function, efficacy and safety. Large molecules have specific advantages over small molecule anti-viral drugs, such as a significant longer half-life, which could also allow prophylactic treatment.
Formycon has established collaborations with renowned academic and industrial partners in this field and could already identify eight candidates for further testing. The results of preclinical development are expected in the fourth quarter of 2020. Depending on the outcome of the preclinical phase, clinical testing could be initiated in the third quarter of 2021.
“The novel coronavirus SARS-COV-2 is an unprecedented threat to millions of people, with enormous socio-economic implications. The development of drugs for the treatment of COVID-19 must therefore be accelerated worldwide. We are pleased to be able to contribute with Formycon, because antibody-based drugs have great potential as an important treatment option for COVID-19, and the long half-life of these large molecules could ultimately also protect physicians and care givers from infection in an outbreak scenario”, comments Dr. Carsten Brockmeyer, CEO of Formycon.
Dr. Stefan Glombitza, COO of Formycon, adds: “We are excited to combine the knowledge of our experienced team with our excellent scientific and industrial network to find treatment solutions for this global pandemic. Our scientists cumulate decades of experience in protein chemistry, analytics and immunology. Formycon also has many years of experience in successfully moving antibodies and antibody-based therapies into late stage clinical development. The implementation of this innovative project will have no impact on our ongoing biosimilar programs.”
Formycon informs about the current Status of the BLA Review Process of the Lucentis®Biosimilar Candidate FYB201
Publication of insider information in accordance with Article 17 of the Regulation (EU) No 596/2014
Ad-Hoc announcement // February 4, 2020, 22:00 CET
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its licensing partner Bioeq AG (“Bioeq”) announce today, that the U.S. Food and Drug Administration (FDA) has requested additional data as part of the review process of the Biologics License Application (BLA) for the Lucentis® biosimilar candidate FYB201, submitted by Bioeq in December 2019.
Following the request of a national European health authority, the drug substance contract manufacturer has moved a piece of processing equipment to a different location within the same site after the production of the FYB201 drug substance qualification batches was completed. As a result of the move, the FDA has requested additional manufacturing data for the equipment in its new location in the context of its review of the BLA application. Formycon and Bioeq believe that it will take approximately four months to generate this additional data to comply with the FDA’s request. Therefore Bioeq has decided to withdraw its BLA application for the Lucentis® biosimilar candidate, provide the requested data and resubmit the application thereafter, which may delay the approval of the BLA. These additional requests are not related to the quality of the drug substance or other product characteristics.
* Lucentis® is a registered trademark of Genentech Inc.
Formycon Reports Its Nine-Month Figures For 2019
- Group turnover and other earnings total EUR 26.8 million
- EBITDA well-balanced
- Group revenues for 2019 remain forecast to be EUR 35.0 million
Munich – The biosimilars company Formycon (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today published its financial results for the first nine months of the 2019 fiscal year.
The company announced that group sales, including other earnings, as of September 30 of this year, amount to EUR 26.8 million (previous year, including special effect, in the amount of EUR 8.5 million: EUR 32.4 million). The earnings before interest, tax and depreciations and amortizations (EBITDA) was well-balanced (previous year, including special effect: EUR 9.3 million). The operating result (EBIT) as well as the net result totaled around EUR -0.7 million (previous year, including special effect: EUR 8.1 million) and therefore were in line with expectations.
The Formycon Group’s stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled EUR 9.6 million as of September 30, 2019. Including short-term receivables from deliveries and services as well as other assets worth approximately EUR 19.6 million, Formycon held liquid assets totaling EUR 29.2 million on the day of reporting.
The reported sales revenues result from reimbursements for development work in the licensed-out projects or projects developed in partnership. For the 2019 fiscal year, revenues in the amount of approximately EUR 35.0 million are expected at group level.
In the first nine months of the year, Formycon AG – as the company’s actual operational unit – achieved a turnover of EUR 16.2 million (same period last year, including special effect: EUR 23.7 million). The nine-month result of the joint stock company amounted to EUR -0.8 million compared to EUR 7.8 million in the same period last year (taking the special effect into consideration).
CFO Dr. Nicolas Combé commented on the results as follows: “We are happy with the financial figures from the first nine months. As a result of sales revenue generated from development services and solid liquidity, we are operating from a stable financial position. For Formycon, advances in the development of our biosimilar candidates are our key value drivers. We are therefore delighted by the positive progress of 2019 so far, and by the fact that we have already achieved important milestones in our development projects.”
Bioeq IP AG Exclusively Licenses US Marketing Rights For FYB201 To Coherus BioSciences, Inc.
Publication of insider information in accordance with Article 17 of the Regulation (EU) No 596/2014
Ad-Hoc announcement // November 6, 2019, 22:05 CET
Munich – Today Bioeq IP AG, the exclusive owner of the global commercialization rights of Formycon’s biosimilar candidate to Lucentis®1 (FYB201), informed Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) that it has signed a license and development agreement with Coherus BioSciences, Inc. The US Biosimilar-specialist, headquartered in Redwood City, California, will exclusively market and distribute FYB201 in the United States of America (US). Bioeq plans to file the Biologics License Application with the U.S. Food and Drug Administration in the fourth quarter of 2019 and Coherus plans to launch the product in the United States in 2021. Formycon very much appreciates the decision and considers Coherus as a strong and competent partner for a successful commercialization of FYB201 in the US.
1)Lucentis® is a registered trademark of Genentech Inc.
Formycon Announces Start of Phase I Clinical Trial With Ustekinumab Biosimilar Candidate FYB202
- Testing of comparable pharmacokinetics, safety, and tolerability of FYB202 with
reference drug Stelara®* - Dosing of study subjects started
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced the start of a Phase I clinical trial comparing the pharmacokinetics, safety, and tolerability of FYB202 and the reference product Stelara® (USA / EU). Dosing of study subjects started last week.
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 trial and is also responsible for the study design and clinical operation.
Provided successful completion of clinical Phase I and subsequent Phase III testing and timely regulatory approval, FYB202 can be launched after patent expiry of Stelara® (USA 09/2023; EU 07/2024).
* Stelara® is a registered trademark of Johnson & Johnson.