Munich, Amsterdam, Zug – Formycon AG (“Formycon”), Polpharma Biologics Group BV (“Polpharma Biologics”) and Bioeq AG (“Bioeq”) jointly announce, that the U.S. Food and Drug Administration (“FDA”) has approved CIMERLI™ (ranibizumab-eqrn), a biosimilar product interchangeable with Lucentis® (ranibizumab injection).
FYB201 was developed by Bioeq, a Joint Venture between Formycon and Polpharma Biologics. End of the year 2019, Coherus BioSciences, Inc. (“Coherus”) entered into a license agreement for the exclusive commercialization of FYB201 under the brand name CIMERLI™ in the United States of America (“U.S.”).
CIMERLI™ obtained approval from FDA for the treatment of Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), Macular Edema following Retinal Vein Occlusion (RVO) and Myopic Choroidal Neovascularization (mCNV). CIMERLI™ is the first and only interchangeable biosimilar with an exclusivity of 12 month after market launch that is indicated for the treatment of all five Lucentis® indications and as such is a new medical option for patients with serious retinal diseases. [i]
FDA-approval and interchangeability designation are based on a totality of evidence including analytical, nonclinical, clinical and manufacturing data. Efficacy, safety, pharmacokinetics and immunogenicity of CIMERLI™ were found to be comparable to the reference drug Lucentis® in patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD). Clinical readouts from the randomized, double-masked, parallel group, multicenter phase III study (COLUMBUS AMD) have been published in the peer-reviewed journal Ophthalmology. [ii]
CIMERLI™ belongs to the anti-VEGF therapy class of biologics that have been revolutionary in helping retinal patients in maintaining or regaining vision. It inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina. The U.S. market for ophthalmic drugs in anti-VEGF therapy is around $7 billion per year and, according to analysts, will continue to grow further. The commercial launch of CIMERLI™, in both 0.3mg and 0.5mg dosages, in the U.S. by Coherus, is planned for early October.
“We are very delighted about the full label approval as it will allow to offer this highly effective treatment option to an increasing number of patients with retinal diseases. At the same time, we would like to thank our partners Bioeq and Polpharma Biologics for the excellent joint development work and are pleased that Coherus acts as commercialization partner for the U.S.,” explained Dr. Stefan Glombitza, CEO of Formycon AG.
“As the impact of serious retinal diseases continues to rise in the U.S., it is critical that treatment options are both efficacious and affordable. Advanced biosimilars to Lucentis® can change patients’ lives, while also minimizing the financial impact of the cost of treatment on healthcare systems,” said Michael Soldan, CEO of Polpharma Biologics Group. “Polpharma Biologics is proud to have collaborated with Formycon and Bioeq on the development of ranibizumab biosimilar and we are excited about our contribution to this valuable treatment option that we expect to positively impact many patients lives.”
1) CIMERLI™ is a trademark of Coherus BioSciences, Inc.
2) Lucentis® is a registered trademark of Genentech Inc.
[i] U.S. Food and Drug Administration (FDA) website. Available from: https://www.fda.gov/
[ii] Holz FG, Oleksy P, Ricci F, et al. Efficacy and Safety of Biosimilar FYB201 Compared with Ranibizumab in Neovascular Age-Related Macular Degeneration. Ophthalmology. 2022; 129 (1): 54-63
by Formycon AG
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) announces that the U.S. Food and Drug Administration (“FDA”) has approved CIMERLI™ (ranibizumab-eqrn), a biosimilar product interchangeable with Lucentis® (ranibizumab injection).
FYB201 was developed by Bioeq AG, a Joint Venture between Formycon AG and Polpharma Biologics Group BV. End of the year 2019, Coherus BioSciences, Inc. ("Coherus") entered into a license agreement for the exclusive commercialization of FYB201 under the brand name CIMERLI™ in the United States of America (“U.S.”). The commercial launch of CIMERLI™, in both 0.3mg and 0.5mg dosages, in the U.S. by Coherus, is planned for early October 2022.
CIMERLI™ obtained approval from FDA for the treatment of Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), Macular Edema following Retinal Vein Occlusion (RVO) and Myopic Choroidal Neovascularization (mCNV).
CIMERLI™ is the first and only interchangeable biosimilar with an exclusivity for 12 month after market launch, that is indicated for the treatment of all five Lucentis® indications and as such is a new medical option for patients with serious retinal diseases.
FDA-approval and interchangeability designation are based on a totality of evidence including analytical, nonclinical, clinical and manufacturing data. Efficacy, safety, pharmacokinetics and immunogenicity of CIMERLI™ were found to be comparable to the reference drug Lucentis® in patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD).
1) CIMERLI™ is a trademark of Coherus BioSciences, Inc.
2) Lucentis® is a registered trademark of Genentech Inc.
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) held its Annual General Meeting on June 30, 2022 in virtual form.
The shareholders were able to follow the virtual Annual General Meeting live in picture and sound via the company’s AGM portal. They followed the proposals of the Management Board and Supervisory Board and approved all the resolutions proposed by the management with large majorities. Both the members of the Management Board and the Supervisory Board were given a vote of confidence with majorities of more than 98 % each. The expansion of the Supervisory Board was also approved by a large majority, and Dr. Thomas Strüngmann was elected as a member of the Supervisory Board with 99.99 % of the votes represented.
In its presentation, the Management Board informed the shareholders in detail about the current biosimilar projects, the development of the COVID-19 drug as well as about the transaction with ATHOS KG and answered all the questions received in advance. In addition, Nicola Mikulcik, who has been appointed to the Management Board as Chief Business Officer (CBO) since June 01, 2022, and the future Chief Scientific Officer (CSO) Dr. Andreas Seidl, who was appointed to the Management Board by the Supervisory Board effective July 01, 2022, introduced themselves to the shareholders in person or via a video message.
Voting rights could be executed before and during the virtual Annual General Meeting by postal vote or by authorizing the Company’s proxies. A total of around 10.7 million no-par value shares were submitted to the vote, corresponding to 70.96 % of the share capital.
Detailed voting results and further information on the 2022 virtual Annual General Meeting can be found at https://www.formycon.com/en/investor-relations/annual-general-meeting/.
Munich – Based on the resolution of the Supervisory Board of Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) dated June 27, 2022, the election proposal under agenda item 9 of the agenda for the 2022 Annual General Meeting of Formycon AG published in the Federal Gazette on May 20, 2022 shall be amended. The Supervisory Board of Formycon AG now proposes Dr. Thomas Strüngmann for election as a member of the Supervisory Board.
In a statement to the Supervisory Board dated June 27, 2022, the initially proposed candidate declared that she was no longer available for the proposed election to the Supervisory Board of the Company for personal reasons.
The Supervisory Board wants to adhere to the proposed elections to the Supervisory Board in the interests of the Company. Against the background of the new fact that the originally proposed candidate is no longer available, the Supervisory Board cannot adhere to its previous proposed resolution and has therefore amended it accordingly.
The Supervisory Board is convinced of the qualification of Dr. Thomas Strüngmann as a candidate for the Supervisory Board, in particular due to his outstanding competence profile, his many years of experience in the pharmaceutical industry, and his comprehensive industry and technical knowledge. Further information on the candidate can be found at:
Based on the resolution of the Supervisory Board, the proposed resolution on agenda item 9 of the invitation to the Annual General Meeting is amended as follows:
Elections to the Supervisory Board
The expansion of the Supervisory Board to four members proposed under agenda item 8 will, under German law, take effect upon entry into the Commercial Register of the respective amendment to the Articles of Incorporation.
The Supervisory Board of Formycon AG will thereupon, under the amended sec. 6 no. 1 of the Articles of Incorporation, consist of four members, each to be elected by a general meeting of shareholders. In its election of members of the Supervisory Board, the general meeting of shareholders is not bound by nominations.
To fill this additional future Supervisory Board position, it is proposed that this Annual General Meeting elect a fourth member of the Supervisory Board. It should be noted, however, that the term of office of the newly elected member will not begin until the expansion of the Supervisory Board enters into force.
Athos KG, which indirectly holds a total of 26.6% of the shares of Formycon AG by way of Santo Holding AG (Zug, Switzerland), Klinge Biopharma GmbH and FYB 202 GmbH & Co. KG, has in its capacity as a shareholder proposed Dr. Thomas Strüngmann for election to the Supervisory Board. Following its own examination, the Supervisory Board has considered and adopted this shareholder proposal and, against this background, herewith proposes Dr. Thomas Strüngmann for election as a member of the Supervisory Board in accordance with sec. 124 para. 3 sentence 1 of the Stock Corporation Act. Dr. Thomas Strüngmann has expressed his accordance with this proposal of the Supervisory Board and declared his intention to stand for election to the Supervisory Board.
The Supervisory Board therefore proposes, subject to and beginning with the entry into force of the amendment to the Articles of Incorporation proposed under the above agenda item 8, that
Dr. Thomas Strüngmann,
residing in Bad Wiessee,
Entrepreneur, especially in the pharmaceutical industry and principal of ATHOS KG,
be elected as a member of the Company’s Supervisory Board for a term of office ending with the Annual General Meeting which decides upon the ratification of the acts of Supervisory Board members for the fourth fiscal year following the start of this term of office, whereby the fiscal year during which the term of office begins is not included.
The Supervisory Board has obtained assurance from the candidate that he will be able to devote the expected amount of time to her work on the Supervisory Board.
Further information on the proposed candidate (curriculum vitae) is available to shareholders on the Company's website prior to and during the virtual Annual General Meeting at
Munich - Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its licensing partner Bioeq AG ("Bioeq") announce that the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMA") today issued a positive opinion for FYB201, a biosimilar to Lucentis®1.
FYB201 has thus been recommended for approval in the European Union (EU) for the treatment of patients with age-related neovascular (wet) macular degeneration (AMD) and other serious ocular diseases such as diabetic macular edema (DME), proliferative diabetic retinopathy (PDR), macular edema due to retinal vein occlusion (branch RVO or central RVO) and choroidal neovascularization (CNV).
The CHMP recommendation is based on an in-depth evaluation of a comprehensive set of data for comparative analytical characterization and commercial-scale manufacturing. In a randomized, double-blind, multicenter, parallel-group Phase III study, FYB201 also demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug Lucentis® (ranibizumab) in patients with age-related neovascular (wet) macular degeneration.
Within the approval process, the CHMP's favorable opinion represents an important regulatory step towards the approval of FYB201 in the European Union. The CHMP's scientific assessment report forms the basis for the European Commission's decision to grant a central marketing authorization, which is expected at the end of August.
Teva Pharmaceutical Industries Ltd.has licensed the distribution rights under an exclusive strategic partnership from Bioeq for Europe and other territories and is currently preparing the launch of FYB201 in Europe.
1)Lucentis® is a registered trademark of Genentech Inc.
Group turnover including other income amounted to a total of EUR 8.2 million as March 31, 2022 (same period of the previous year: Euro 9.4 million). Earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to EUR -4.0 million (Q1/previous year: EUR -1.7 million), the operating result (EBIT) amounted to EUR -4.3 million (Q1/previous year: EUR -1.9 million) and therefore was in line with expectations. The quarterly result also totaled EUR -4.3 million (Q1/previous year: Euro -2.0 million). The forecast Group sales for 2022 will be higher than in the previous year (EUR 37 million).
Reported revenues mainly result from development activities for the late-stage biosimilar projects FYB201 (biosimilar for Lucentis®1), FYB202 (biosimilar candidate for Stelara®2) and FYB203 (biosimilar candidate for Eylea®3), as Formycon continues to be remunerated by the licensing or collaboration partners for services rendered after partnering. After successful approval of the biosimilar candidates, Formycon will also participate in the marketing revenues. The transaction with ATHOS KG, which was concluded in the second quarter and significantly increased the shareholdings in the future marketing revenues of FYB201 and FYB202, had no impact on the first quarter in terms of figures. With the anticipated product launch of FYB201 in the second half of 2022, Formycon expects to generate revenue from product commercialization for the first time. These are expected to make a significant financial contribution to the implementation of the planned growth strategy.
Accordingly, Formycon will continue to invest in the development of its own pipeline in 2022. In addition to the COVID-19 drug FYB207, the unpublished biosimilar candidate FYB206 is also being advanced on the development side. In addition, two new biosimilar projects were initiated. For FYB208 and FYB209, the reference molecules have been identified and initial development activities have been started.The liquidity ratios of the Formycon Group also developed as planned by the end of the first quarter: Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled EUR 20.1 million at the end of March. Including short-term receivables from deliveries and services, as well as other assets worth around EUR 4.4 million, the Formycon Group held liquid assets totaling EUR 24.5 million on the day of reporting (Q1/previous year: Euro 46.0 million).
In the first three months of the year, Formycon AG as the company’s actual operational unit achieved a turnover of EUR 6.5 million (Q1/previous year: Euro 5.1 million). The company's three-month result was EUR -4.4 million (Q1/previous year: Euro -2.1 million).
Commenting on the first three months, Chief Financial Officer Dr. Nicolas Combé said: "The first quarter was a special one, not least because of the transaction with ATHOS KG. With the acquisition of the 50% stake in FYB201 as well as the full integration of FYB202 into the Formycon Group and the associated increase of our share in future expected revenues, we are in a position to accelerate the expansion of the development pipeline in line with our growth strategy. The implementation of this strategy is reflected in the initiation of two new biosimilar projects. With the launch of FYB208 and FYB209, we are laying the foundation for a further increase in pipeline valuation and sustainable business growth."
1) Lucentis® is a registered trademark of Genentech Inc.2) Stelara® is a registered trademark of Johnson & Johnson3) Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
FYB201, Formycons biosimilar to Lucentis® (ranibizumab), was recently approved by the British Medicines Agency MHRA (Medicines and Healthcare products Regulatory Agency) in the United Kingdom. The Commercialization partner Teva Pharmaceutical Industries Ltd. („Teva“) expects to launch FYB201 under the trade name ONGAVIA® in the UK later this year. ONGAVIA® will become available to patients in the UK suffering from age-related neovascular (wet) macular degeneration and other serious eye diseases. Thereby FYB201/ONGAVIA® is expected to be the first biosimilar to Lucentis® to be marketed in Europe.
Approval processes for FYB201 with the European Medicines Agency („EMA“) and the U.S. Food and Drug Administration („FDA“) continue to proceed as planned. The opinion of the Committee for Medicinal Products for Human Use ("CHMP") of the EMA is expected shortly. The subsequent decision of the European Commission and the associated EU approval of FYB201 is expected this summer. In addition, the submission of marketing authorization applications for FYB201 in further attractive markets is planned or has already occurred.
In the U.S., a biologics license application seeking approval of FYB201 for all Lucentis® indications including neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization is under review by the FDA with a target action date of August 2, 2022. If approved by the FDA on August 2, 2022, U.S. partner Coherus BioSciences, Inc. plans to launch FYB201 under the trade name CIMERLI™3 in the second half of 2022. Earlier in 2022, the FDA’s pre-license inspections (“PLI”) in Europe for FYB201 were completed. As part of the PLI, Formycons premises in Martinsried/Planegg (Germany) were inspected by the FDA in March. The inspection went without any complaint, no form 4834 was issued.
Nicola Mikulcik, CBO of Formycon, explains: “We are delighted that FYB201 under the brand name ONGAVIA® is expected to be the first available biosimilar to Lucentis® in the United Kingdom and can be used in the treatment of age-related neovascular (wet) macular degeneration and other serious eye diseases. This will provide access to this highly effective drug to more patients."
In the FYB202 project, a biosimilar candidate for Stelara®5 (ustekinumab), the treatment of the last patient in the phase III clinical trial (VESPUCCI study) was successfully completed (last-patient-out) despite the current challenging environment for conducting clinical trials. The aim of the randomized, double-blind, multi-center phase III study is to demonstrate the similarity of FYB202 and the reference product Stelara® in terms of safety, efficacy and immunogenicity in patients with moderate to severe psoriasis vulgaris. Results on the primary efficacy endpoint are expected in July.
In parallel to the ongoing phase III trial, additional Scientific Advice Meetings were held with the FDA and the EMA to discuss the development strategy of FYB202 in detail and in which additional extensive analytical data packages for the similarity of FYB202 with the reference product Stelara® on a commercial production scale were presented. Both authorities support Formycon's similarity testing strategy. In addition, a comparative phase I pharmacokinetics study of FYB202 with the reference product Stelara® was discussed, in which the confidence interval for one of the required parameters was narrowly missed. Based on the findings, the study concept was adapted accordingly and the changes have already been coordinated with the authorities. The study start of the extended scope pharmacokinetics study is planned in the next weeks. European and U.S. regulatory submissions for FYB202 are planned for the third quarter of 2023 following the availability of these additional pharmacokinetic data.
Dr. Stefan Glombitza, COO of Formycon AG, adds: "We are confident that we will be able to provide a compelling data package for submission next year. There is strong interest in our FYB202 development and we aim to make a decision on a suitable commercialization partner in the second half of 2022."
In the development of FYB203, Formycon's biosimilar candidate for Eylea®6 (aflibercept), the last patient in the ongoing phase III clinical trial (MAGELLAN-AMD study) was enrolled in April (last-patient-in). The aim of the randomized, double-blind, multi-center phase III study is to demonstrate the similarity of FYB203 and the reference product Eylea® in terms of efficacy, safety and immunogenicity in patients with neovascular (wet) age-related macular degeneration. Data on the primary efficacy endpoint are expected by the end of this year.
The FYB206 biosimilar project continues to progress according to plan. Following convincing results from the extensive analytical characterization of the developed molecule as well as significant progress in the development of the manufacturing process, a comprehensive data package is currently being compiled in order to closely coordinate further program steps in Scientific Advice Meetings with the EMA and FDA in the second half of the year. Scaling up of the manufacturing process to commercial scale is planned for the end of 2022. Formycon plans to announce details of the reference molecule later this year.
FYB207 is a promising antiviral drug candidate against SARS-CoV-2 and its variants. This is a fusion protein of the human protein ACE2 (Angiotensin Converting Enzyme II) and the constant part of a human antibody. Since ACE2 is the entry point for cell infection, the virus cannot evade a drug based precisely on this protein. Previously published laboratory studies have shown that FYB207 retained its full antiviral potential against the SARS-CoV-2 alpha, beta and delta variants. New laboratory data demonstrate that the omicron variant now prevalent is neutralized by FYB207 with consistently high efficacy as well. In contrast, vaccines and therapeutic antibodies against SARS-CoV-2 variants have already lost efficacy.
Based on preclinical studies conducted in 2021, Formycon was able to make defined proprietary modifications to the FYB207 molecular structure that resulted in significant improvements in half-life and efficacy. The development strategy for an accelerated approval process has already been coordinated with the Paul Ehrlich Institute ("PEI") and the FDA through Scientific Advices in 2021. In a follow-on Scientific Advice in May 2022, the PEI confirmed full support for the improved drug molecule for the accelerated development program. On this basis, preclinical studies are expected to be completed, the manufacturing process will be adapted to the optimized molecule, and the production of test material for stability studies and clinical trials will be carried out in 2022. Entry into clinical trials is planned for 2023.
Formycon has extensive know-how and numerous patent applications in the field of fusion proteins against viral diseases, an increasingly important therapeutic area. Together with its academic partners Prof. Dr. Ulrike Protzer, Chair of Virology, and Prof. Dr. Johannes Buchner, Chair of Biotechnology at the Technical University of Munich ("TUM"), Formycon has built a great scientific reputation, which is reflected for FYB207, in addition to the Pharma Trend Image & Innovation Award "The Most Innovative Product®" in the category of Leap Innovations, also in the granting of extensive funding. Formycon is therefore evaluating various strategic options for fully exploiting the commercial potential of this platform technology. In this context, discussions are also underway with SCG Cell Therapy Ltd. to regain the exclusive license to develop, manufacture and commercialize FYB207 for the Asia-Pacific region (excluding Japan). Collaboration with academic partners will continue intensively as FYB207 development continues.
Dr. Carsten Brockmeyer, CEO of Formycon AG, says: "With each successful mutation, SARS-CoV-2 escapes vaccines and therapeutic antibodies a little bit more. In particular, older people, whose vaccination protection declines more rapidly than in younger ages, and people who have to take immunosuppressive drugs continue to have a high risk of becoming more severely ill or even dying from COVID-19. The threat of viral mutations is likely to increase even further in the future worldwide due to social and environmental developments. Fusion proteins such as FYB207 can potentially make an important contribution here for the prevention and treatment of COVID-19, but also aid global pandemic preparedness in general."
1) ONGAVIA® is a registered trademark of Teva Pharmaceutical Industries Ltd.2) Lucentis® is a registered trademark of Genentech Inc.3) CIMERLI™ is a trademark of Coherus BioSciences, Inc.4) Form 483 is used by FDA to document and comment on concerns, identified during the inspection.5) Stelara® is a registered trademark of Johnson & Johnson6) Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
Munich – Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) ("Formycon") today announced changes to its Executive Board, setting the stage for continued and stable leadership as the company moves towards becoming a global and fully integrated biosimilars pharmaceutical company.
Today and effective July 1, 2022, the Supervisory Board of Formycon appointed Dr. Stefan Glombitza, who has led Formycon's operational development activities as Chief Operating Officer (COO) since 2016, as Chief Executive Officer (CEO). Dr. Glombitza thus takes over the position from Dr. Carsten Brockmeyer, with whom he has worked closely in recent years to shape the strategic and organizational direction of the company.
The 57-year-old pharmacist, who holds a doctorate, can look back on more than 20 years of experience in internationally operating companies in the pharmaceutical industry and brings great expertise to this position from various global management and executive positions. In his role as CEO, he is to shape the strategic development of the company in the increasingly commercial phase and, together with his team of experts, implement the successful development of a continuously growing product portfolio.
Dr. Carsten Brockmeyer will leave the Executive Board as planned on June 30, 2022, when his appointment regularly expires. From 2012, he initially worked as a consultant for Formycon before joining the company as Chief Executive Officer (CEO) in 2013. After 9 successful years on the Executive Board, Dr. Brockmeyer will continue to support the company as a scientific advisor, in particular assisting with the development of the biosimilar candidates and the COVID-19 drug.
Dr. Stefan Glombitza says: "I am very much looking forward to the new role and the extremely motivating task of leading Formycon into the next phase of its business and realizing the enormous potential of this company. I very much appreciate the trust placed in me. For this, I would like to express my special thanks to our Supervisory Board and also to my colleagues on the Executive Board, with whom I have had the opportunity to do a great deal of work over the past 6 years. My enthusiasm for Formycon is undiminished and I will continue to do my utmost to drive the company forward with full vigor. I would like to thank Dr. Brockmeyer very much for his many years of trusting and productive cooperation. It means a lot to me to be able to continue the Formycon success story he started."
Dr. Carsten Brockmeyer adds: "Dr. Glombitza has already impressively demonstrated in recent years how to build a very efficient development organization and create the stable foundation for the commercialization of our product portfolio. When we started the strategic realignment as a biosimilar developer at Formycon in 2012, the company comprised around 30 employees. Today, we have grown to over 200 employees from 24 nations and have positioned ourselves internationally as a renowned biosimilar developer with a substantial portfolio. On our way to becoming a globally operating and fully integrated pharmaceutical company for biosimilars, I cannot imagine a more suitable CEO than Dr. Glombitza. I remain closely associated with Formycon and will be happy to continue contributing as a scientific advisor. I am very proud of what we have achieved together at Formycon and would like to thank my colleagues on the Executive Board, the Supervisory Board, the employees, the shareholders, and our business partners for their consistently trusting and constructive cooperation."
The Chairman of the Supervisory Board of Formycon, Dr. Olaf Stiller comments: "I can only endorse the words of Dr. Brockmeyer. Dr. Glombitza has done an exceptional job in the past years and has shaped Formycon into an outstanding and scalable development organization. We are convinced that we will achieve the goals we have set ourselves with him at the helm. At the same time, I would like to thank Dr. Brockmeyer on behalf of the entire Supervisory Board for his outstanding work in building up Formycon. With his expertise in biosimilars, the course was set right from the start. We are pleased that Dr. Brockmeyer continues to support us as a scientific advisor and wish him all the best for the future."
The Executive Board around CEO Dr. Glombitza will also be supplemented by two additional experienced pharmaceutical managers. Effective June 1, 2022, the Supervisory Board of Formycon has appointed Nicola Mikulcik (51) to the Executive Board in the function of Chief Business Officer (CBO) for a period of 5 years. A graduate in business administration, she has years of expertise in product development, business development and commercial affairs. During her career in the pharmaceutical industry, she passed through various management positions at Hexal AG and Sandoz International. For the past 7 years, Ms. Mikulcik has been the managing director of Bioeq GmbH, which Formycon acquired from ATHOS KG in the transaction announced at the end of March. As part of Formycon's collaboration with Bioeq, Ms. Mikulcik was largely responsible for the FYB201 commercialization partnerships with pharmaceutical companies Teva Pharmaceutical Industries Ltd. and Coherus BioSciences, Inc. In her role as CBO, she will be responsible for Business Development and Commercial Affairs.
"Due to the long-standing and constructive cooperation with Formycon, I am very pleased to now become a part of the Executive Board and to actively shape the company's development. We have exciting years ahead with global launches by our commercial partners. I would like to thank the Supervisory Board for the trust they have placed in me," comments Nicola Mikulcik.
In addition, the Supervisory Board of Formycon has appointed Dr. Andreas Seidl as a member of the Executive Board as Chief Scientific Officer (CSO) for a period of 5 years, effective July 1, 2022. The 52-year-old biochemist and experienced scientist brings more than 20 years of experience in biosimilar development and, together with Dr. Carsten Brockmeyer, was one of the pioneers in the development and approval of the first biosimilars. He was most recently responsible for the development operations of Leukocare AG as COO. Previously, he was head of Analytical Characterization & Bioanalytics at Novartis and held similar positions at Sandoz Biopharmaceuticals and Hexal AG. In his role as Chief Scientific Officer, he will ensure Formycon's strong presence and reputation in the scientific community and lead the preclinical and clinical development, bioanalytics and Scientific Affairs functions.
"Formycon is a prime example of a dynamic and research-driven company that is now on its way to becoming a globally operating and fully integrated pharmaceutical company in the growing biosimilars market. It is a great pleasure for me to support the scientific work of this outstanding team with my energy and to actively contribute to the further growth of the company," explains Dr. Andreas Seidl.
The Chairman of the Supervisory Board of Formycon, Dr. Olaf Stiller adds: "With Nicola Mikulcik and Dr. Andreas Seidl, we are adding strong people to the Executive Board of Formycon who are well-known in the pharmaceutical world and who are capable of advancing the company in the long term and strategically in their respective areas of responsibility. With this strong leadership team, we are not only creating continuity and stability, but also the foundation for agile development and further growth."
The operational management team is completed by Chief Financial Officer (CFO) Dr. Nicolas Combé, whose appointment as a member of the Executve Board will also end as planned on June 30, 2022 after a total of 12 years. Until a suitable CFO has been found and trained, Dr. Combé will continue to be available to the company as CFO and in an advisory capacity.
Munich – Today and effective July 1, 2022, the Supervisory Board of Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) ("Formycon") appointed Dr. Stefan Glombitza, who has led Formycon's operational development activities as Chief Operating Officer (COO) since 2016, as Chief Executive Officer (CEO). Dr. Glombitza thus takes over the position from Dr. Carsten Brockmeyer, who leaves the Executive Board as planned on June 30, 2022, when his appointment regularly expires. Dr. Brockmeyer will continue to support the company as a scientific advisor.
The Executive Board around CEO Dr. Glombitza will also be supplemented by two additional experienced pharmaceutical managers:
Effective June 1, 2022, the Supervisory Board of Formycon has appointed Nicola Mikulcik (51) to the Executive Board in the function of Chief Business Officer (CBO) for a period of 5 years. A graduate in business administration, she will be responsible for Business Development and Commercial Affairs.
In addition, the Supervisory Board of Formycon has appointed Dr. Andreas Seidl as a member of the Executive Board as Chief Scientific Officer (CSO) for a period of 5 years, effective July 1, 2022. The 52-year-old biochemist and scientist will lead the preclinical and clinical development, bioanalytics and Scientific Affairs functions.
The previous Chief Financial Officer (CFO), Dr. Nicolas Combé, who is also leaving the Executive Board with the regular expiry of an appointment as planned on June 30, 2022, will continue to be available to the company as CFO and beyond in an advisory capacity, until a suitable Chief Financial Officer has been found and trained.
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today released its financials for 2021.
The focus in 2021 was on the further development of the current biosimilar candidates as well as the COVID-19 drug (FYB207). The development activities of the late-stage biosimilar projects FYB201 (biosimilar candidate for Lucentis®1), FYB202 (biosimilar candidate for Stelara®2) and FYB203 (biosimilar candidate for Eylea®3) result in the currently reported revenues, as Formycon continues to perform remunerated development activities for the aforementioned biosimilar candidates after partnering by the licensing or collaboration partners. In the event of subsequent marketing, Formycon will receive a corresponding share of the marketing proceeds generated. With the anticipated product launch of FYB201 in 2022, Formycon is moving closer to entering a new corporate phase, whereby the expected revenues from this should open up new growth opportunities for the company. In addition, Formycon is working on the continuous expansion of its pipeline. Due to the increasingly international nature of our business activities, the consolidated financial statements will be prepared in accordance with IFRS (International Financial Reporting Standards) for the first time as of the 2022 half-year financial statements. The separate financial statements of the parent company Formycon AG continue to be prepared and published in accordance with the rules of the German Commercial Code (HGB).
On the day of reporting, December 31, 2021, the Formycon Group’s commercial figures had developed as planned. Consolidated group sales which, in addition to the AG, include the two subsidiaries Formycon 201 Project GmbH and Formycon 203 Project GmbH as well as the 24.9 percent share in the FYB 202 GmbH & Co. KG joint venture, amounted, as forecast, to a total of around Euro 37 million (previous year: Euro 34.2 million).
Group earnings before interest, taxes and depreciation on fixed assets and intangible assets (EBITDA) amounted to Euro -12.4 million (previous year: Euro -4.8 million). The operating result (EBIT) totaled Euro -13.3 million (previous year: Euro -5.7 million). At Euro -13.5 million (previous year Euro -5.9 million), the result for the year was in line with expectations. Formycon had invested in the development of its own pipeline in the 2021 financial year, resulting in a higher negative annual result compared to previous years. In addition to the COVID-19 drug (FYB207), primarily the as yet unpublished biosimilar candidate FYB206 was advanced on the development side, as well as scheduled investments in FYB202. Formycon was also able to recruit further qualified specialists last year in line with the needs of the development projects and employed 171 people at the end of the reporting period (+30% compared to the previous year).
Current assets consist largely of liquidity and near-liquid assets. As of December 31, 2021, the Formycon Group had capital resources of approximately Euro 25.2 million (previous year: Euro 42.4 million) in cash and cash equivalents (cash on hand, checks, bank balances, and securities). Including short-term receivables and other assets worth a further Euro 10.9 million, the Formycon Group holds liquid assets of Euro 36.1 million in total (previous year Euro 49.2 million) and therefore has solid room for maneuver for the further development of its own projects.
The Group's balance sheet was around Euro 66.3 million (previous year: Euro 75.6 million) with an equity ratio of 85 percent (previous year: 90 percent). The company has no financial liabilities.
Formycon AG, as the Group's actual operational unit, achieved a turnover of Euro 26.5 million (previous year: Euro 25.1 million) and recorded an EBITDA of Euro -14.3 million (previous year: Euro -4.7 million). Accordingly, this resulted in an EBIT amounting to Euro -13.4 million (previous year: Euro -5.6 million) and an annual result of a rounded Euro -13.3 million (previous year: Euro -5.7 million).
With the recently announced closing of the transaction with ATHOS KG, the ownership structure in two of the three late-stage biosimilar candidates has changed: Formycon now owns 100% of the rights to FYB202 (previously 24.9%) and 50% of the rights (previously fully out-licensed with royalty interest) to FYB201, a biosimilar candidate for Lucentis® being developed with Polpharma Biologics Group in the 50/50 joint venture Bioeq AG. By acquiring the biosimilar assets, Formycon will participate in a significantly higher proportion of the future revenues from their commercialization. The company will invest the expected cash inflows mainly in the accelerated expansion of its own development pipeline. This is intended to enable future biosimilar candidates to be developed independently, thus contributing sustainably to the value creation and further growth of the company.
Dr. Nicolas Combé, CFO of Formycon AG, gave the following statement with regard to the past fiscal year: "In 2021, we achieved important milestones with the submission of FYB201 to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). With the anticipated commercialization launch of FYB201 later this year, we expect to generate the first commercialization revenues, laying the foundation for sustainable growth and accelerated execution of our growth strategy, to which of course in particular the recently announced acquisition of the biosimilar assets FYB201 at 50% and FYB202 at 100% contributes."
The full 2021 annual financial statements / annual report for 2021 can be found on our website at https://www.formycon.com/en/investor-relations/financial-reports/.
1) Lucentis® is a registered trademark of Genentech Inc.2) Stelara® is a registered trademark of Johnson & Johnson.3) Eylea is a registered trademark of Regeneron Pharmaceuticals Inc.
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