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.
Formycon Publishes Half-Year Results for 2019
- Group turnover on plan at Euro 17.2 million
- EBITDA of Euro -0.2 million and earnings of Euro -0.7 million as expected
- Development of projects advances significantly
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today announced its financial results for the first half of 2019.
On the day of reporting, June 30, 2019, the Formycon Group’s commercial figures were as forecast. During the first six months of 2019, turnover at the Group which, in addition to the joint-stock company also includes the two sub-holdings Formycon Project 201 GmbH and Formycon Project 203 GmbH, as well as the shareholding in FYB202 GmbH & Co. KG, stood at Euro 17.2 million (H1/2018 incl. a special effect of Euro 8.5 million: Euro 24.6 million).
During the company’s current phase, the Formycon Group is focusing on research and development activities for its own and licensed biosimilar projects. These development services are also the source of the current revenue returns. Following the successful approval of its products, Formycon is also involved in the various licensing partners’ subsequent marketing solutions. The company is currently focusing on three main projects for biosimilars, each targeting billion-dollar markets.
On the FYB201 project involving a biosimilar candidate to the reference drug Lucentis®1), the licensing partner Bioeq IP AG is about to submit the approval documents to the US Food and Drug Administration, the FDA. FYB202, a biosimilar candidate to the reference drug Stelara®2), is imminently due to transition to clinical trials. The start of the clinical phase III for the FYB203 project, which involves a biosimilar candidate to the reference drug Eylea®3), is planned for mid-2020.
The Group’s earnings before interest, tax, depreciation and amortization (EBITDA) stood at Euro -0.2 million (H1/2018 incl. special effect: Euro 8.63 million). The operating result (EBIT) totaled Euro 0.7 million (H1/2018 incl. special effect: Euro 8.23 million). As of June 30, 2019, the Group period result was Euro -0.7 million compared to Euro 7.59 million in the same period last year.
For the whole of 2019 Formycon anticipates revenues of around Euro 35 million at group level. As in previous years, the Group’s financial position appears to be very solid: Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled around Euro 8 million on the day of reporting. Including short-term receivables and other assets worth Euro 19.8 million, the Formycon Group held liquid assets of around Euro 27.8 million in total.
The cash capital increase carried out in the first half of 2019 increased the company’s subscribed capital by Euro 577,397.00 by issuing an equal number of shares with a notional interest in the share capital of Euro 1.00 each to a total of EUR 10,000,000.00. The premium of Euro 16,686,773.30 was fully booked to the capital reserve. The Group’s equity ratio therefore increased to 92 per cent on the day of reporting.
Formycon AG, as the company’s central development and operational unit, achieved a turnover of Euro 11.3 million during the first half of 2019 (H1/2018 incl. special effect: Euro 18.9 million). The earnings for this period totaled Euro -0.7 million (H1/2018 incl. special effect: Euro 7.7 million).
During the reporting period, Formycon exceeded the 100-employee threshold for the first time in the company’s history. The total number of employees within the company rose during the first half of 2019 from 95 to a total of 103.
Dr. Nicolas Combé, Formycon’s CFO, was extremely satisfied with the developments of the first six months: “The half-year figures are as forecast and we have taken further key steps forward both on the development side and in the expansion of our organization. Our task continues to be developing our three key products successfully in collaboration with our partners and bringing them to approval stage so that we can then share in the future product sales. In this context, the submission of FYB201 to the FDA in the US represents an important interim goal.”
The full half-year report can be found on the Internet 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.
Formycon Reports on Annual General Meeting 2019
- Shareholders approve all items on the agenda
- Ratification of the actions of the Management Board and Supervisory Board by a large majority
- Hermann Vogt re-elected as member of the Supervisory Board
Munich – The biosimilars company Formycon (ISIN: DE000A1EWVY8/ WKN: A1EWVY) held its Annual General Meeting on June 27, 2019.
At the Annual General Meeting, the shareholders represented followed the proposals of the Board of Management and the Supervisory Board and approved all resolutions proposed by the management with large majorities in each case. Both the members of the Board of Management and the Supervisory Board were given a vote of confidence by a majority of more than 95 percent each. Hermann Vogt, who had already been a member of the Supervisory Board since 2013 and acted as Deputy Chairman, was elected to the Supervisory Board with a large majority and for a further full term of office. In a subsequent constituent meeting, the Supervisory Board reappointed Dr. Olaf Stiller as Chairman and Mr. Hermann Vogt as Deputy Chairman.
At the time of the vote, around 4.4 million shares were represented, corresponding to 44.0% of the share capital. Detailed voting results and further information on the 2019 Annual General Meeting can be found at https://www.formycon.com/en/investor-relations/annual-general-meeting/.
