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Munich – Today Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) announced its financial result for the first nine months of the fiscal year 2018.

The turnover of the Formycon group, which, aside from the AG consists of both subsidiaries Formycon Project 201 GmbH and Formycon Project 203 GmbH, increased significantly compared with the first nine months of 2017. Thus revenues recorded an increase of 17.30 million euros to a total of 32.42 million euros (previous year: 15.12 million euros). This sales performance was driven by credit for the investments in the FYB202 project between 2013 and 2016. Taking these investments in the amount of 8.47 million euros into account for Formycon’s financing obligations for the joint venture FYB 202 GmbH & Co. KG led to a one-time effect on turnover and earnings to the same amount, however not on liquidity.

Formycon holds a 24.9 percent share in the joint venture with Aristo Pharma GmbH and on completion of a pilot stage, bears this amount of previous project investments and further development costs. On condition of a further successful development and approval Formycon will benefit at the same ratio from any potential future licensing and marketing revenues.

Total turnover, adjusted by this one-off effect, increased in the third quarter of 2018 by 8.83 million euros to a total of 23.95 million euros (previous year: 15.12 million euros). This means the Formycon group also records a clear growth in sales due to further development of both biosimilar candidates FYB201 and FYB203.

On the reporting date, earnings before interest, taxes and depreciation on fixed assets and intangible assets (EBITDA) amounted to 9.34 million euros (previous year: minus 4.25 million euros). Operational results (EBIT) amounted to 8.70 million euros (previous year: minus 4.84 million euros), net results totaled 8.06 million euros (previous year: minus 4.89 million euros).

For the whole of 2018 Formycon now anticipates a turnover of slightly over 40 million euros at group level. In addition, consolidated net earnings of 7.00 million euros are expected for the total year. On September 30 2018, stocks of liquid assets, which comprise cash, bank deposits and securities, totaled 12.01 million euros. Including short-term receivables from deliveries and services worth 6.24 million euros, liquid assets totaled around 18.25 million euros at the end of the third quarter.

In the first three quarters of 2018, Formycon AG as the actual operational unit, achieved a turnover of 23.72 million euros (previous year: 7.41 million euros). The EBITDA amounted to 9.08 million euros (previous year: minus 4.48 million euros), the operating result to 8.44 million euros (previous year: minus 5.07 million euros) and net earnings to 7.80 million euros (previous year: minus 5.11 million euros).

As planned, the number of employees at Formycon AG also increased. On the day of reporting in September the number was 93 (previous year: 75) and is expected to further increase slightly by the end of the year.

Dr. Nicolas Combé, member of the board and CFO of Formycon AG, gave the following statement with regard to the results: “We are pleased with the positive development of the business and are very happy with the figures of the first nine months of 2018. The key value driver for our company continues to be the development progress of our biosimilar candidates. The whole team is working very consistently towards this and we are optimistic about being able to give detailed information on the development state of our projects very soon.”

Munich – The biosimilars company Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has revealed impressive results for the first half of 2018 both in the development of its product candidates and its business figures. Key milestones were reached on project FYB201, a biosimilar candidate for Lucentis®* (ranibizumab). Following the achievement of the primary endpoint of the COLUMBUS-AMD phase III study under the licensing partner’s responsibility in the second quarter of 2018, which confirmed comparable efficacy of FYB201 and the reference product, treatment of the last patient has now also been completed. The final study results are expected during the course of the second half of 2018. Work is currently focused on the creation of a dossier for submission to the US medicines authority FDA, as well as the European agency EMA. In addition to the data package from the clinical and technical development, the implementation of the commercial supply chain represents a further key prerequisite for submission. Concepts to safeguard commercial market supplies will be implemented under the responsibility of the licensing partner.

FYB202, a biosimilar candidate for Stelara®** (ustekinumab) and FYB203, a biosimilar candidate for Eylea®*** (aflibercept), are currently at an advanced stage of preclinical development. Important development goals have been achieved on both projects over the last six months. Formycon will publish more details in due course.

Formycon’s economic performance parameters developed positively during the first half of 2018. Turnover at the Formycon 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 FYB 202 GmbH & Co. KG, grew compared to the first six months of 2017 from Euro 8.01 million to Euro 24.59 million. The earnings before interest, tax, depreciation and amortization (EBITDA) improved from Euro -2.50 million to Euro 8.63 million. The operating result (EBIT) totaled Euro 8.23 million (previous year: Euro -2.89 million). The group period result at the end of June 2018 stood at Euro 7.59 million compared to Euro -2.91 million during the same period last year.

This significant improvement in results was due primarily to the inclusion of investments in the FYB202 project from 2013 and 2016, which were charged to the company as a financial contribution for FYB 202 GmbH & Co. KG. At the end of 2017, Formycon transferred its rights in the FYB202 biosimilar project to this new company respectively to its subsidiary FYB 202 Project GmbH.

For the year as a whole, Formycon anticipates continued highly positive results, raising its turnover forecast from Euro 36 million to Euro 40 million.

The company’s financial resources remain as solid as ever, regardless of the increase in expenditure on development: Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled Euro 11.82 million on the day of reporting. Including short-term receivables from deliveries and services worth Euro 8.42 million, Formycon’s liquid assets totaled around Euro 20.23 million. The Group’s equity ratio stands at 79 percent and is higher than industry average, as in previous years.

Formycon AG, as the company’s central development and operational unit, achieved a turnover of Euro 18.91 million during the first half of 2018 (previous year: Euro 4.80 million), with the result from this period being Euro 7.7 million (-2.88). Turnover was essentially generated, as in the past, from development services for proprietary projects.
The company’s workforce rose as planned during the first half of 2018 from 83 to 91.

Dr. Nicolas Combé, Chief Financial Officer of Formycon, is satisfied with developments over the first six months: “Through our licensing agreements and the newly founded joint venture with Aristo, Formycon is in a strong position. The funding of our ongoing projects is therefore extensively secured. It remains important for us during this phase to successfully and efficiently develop our biosimilar candidates. Their potential market launches promise very exciting market opportunities for our partners, from which we will participate.”

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

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

Munich – The biosimilars company Formycon (ISIN: DE000A1EWVY8/ WKN: A1EWVY) is appointing Thomas Siklosi, a former board member of Rentschler Biopharma SE, to its Advisory Board. Siklosi is a renowned biotech manager and expert in the development and production of biologics and biosimilars with 34 years of professional experience in this field.

Thomas Siklosi studied chemistry at the Academy of Applied Sciences in Isny. He completed his thesis with distinction at the Institute of Radiochemistry at the Technical University of Munich. He gained his early professional experience in the field of biotechnology at Boehringer Mannheim in the laboratory led by Prof. Hans Ulrich Bergmeyer in Tutzing.

In 1984, he moved to the biotech pioneer Rentschler Arzneimittel in Laupheim and held various roles in the development and production of interferons, later being responsible at Rentschler Biotechnologie, a contract development and manufacturing organization (CDMO), for the provision of biopharmaceutical substances. In cooperation with a leading generic manufacturer, he was responsible as project manager for the technical development of the complex glycoprotein erythropoetin, which received approval as the first epoetin-alfa biosimilar in the EU in the fall of 2007.

In September 2012, Siklosi was appointed to the Board of Management at Rentschler Biopharma SE. As Chief Operating Officer, he was responsible for the Development, GMP Production, Technology, and Quality departments. Siklosi is a Member of the University Council of Biberach University and owns numerous patents in the field of biotechnology.

Dr. Carsten Brockmeyer, board member and CEO of Formycon, said of Siklosi’s appointment: “I’m delighted that we have been able to bring on board Thomas Siklosi, one of the world’s most experienced biotech managers. As a man who has been involved with biotechnology right from the start, he has managed numerous biotechnology drugs and biosimilars from cell line development to market maturity over the course of his career. With his many years of in-depth experience in the management of major development and production facilities, Mr. Siklosi will be advising and supporting Formycon AG on its ambitious future projects.”

Alongside Mr. Thomas Siklosi, the Advisory Board is also made up of Prof. Johannes Buchner, Dr. Bernhard Hampl and Dr. Gerhard Schaefer.

Munich – The biosimilars company Formycon from Martinsried near Munich (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has ended the 2017 financial year successfully and has once again significantly advanced the development of its product candidates. The clinical phase III study for its most developed biosimilar candidate, FYB201, a follow-on product for the ophthalmic drug Lucentis®* (ranibizumab), is in an advanced stage of progress and is expected to be completed in the first half of 2018.

With the integration of the FYB202 development project, a biosimilar candidate for Stelara®** (ustekinumab), into a newly founded joint venture operated with Aristo Pharma GmbH, the third project has already been transferred into a development cooperation. Formycon holds a 24.9 percent share in the joint venture. This means that the company bears this stake of the development costs, but also shares accordingly in any potential future marketing revenues.

FYB203, a biosimilar candidate for Eylea®***, is also making good progress and is in its pre-clinical phase. Entry into clinical trials is being prepared.

The development targets for 2017 were also reached on the FYB205 project. Various scenarios are currently being evaluated for the further development strategy.

As a function of the company’s operational progress, its financial benchmarks have also developed in a very satisfactory manner. The Group increased its turnover by a good 48 percent compared to the previous year to Euro 29.00 million (2016: 19.53 million). Originally, Formycon had anticipated sales of around Euro 25 million for 2017. The founding of the FYB202 joint venture with Aristo Pharma in particular had a positive effect, since Formycon received compensation impacting on its turnover and liquidity for contributing the project rights to the joint venture company. In addition, sales were essentially generated from ongoing remunerations from licensing partners for the FYB201 and FYB203 development programs. With the increase in turnover, the earnings before interest, tax, depreciation and amortizations (EBITDA) improved significantly compared to last year to Euro -0.75 million (2016: Euro -3.37 million). The result before interest and taxes (EBIT) totaled Euro -1.54 million (2016: Euro -4.07 million). The net loss for the year was Euro -1.58 million (2016: Euro -4.07 million).

In July 2017, Formycon acquired Euro 6 million as part of a private placement which is to be used for the further development of its biosimilar product portfolio, and in particular FYB202. The Group’s equity ratio remained unchanged at 82.9 percent and is higher than the average, as in previous years. The company has no financial liabilities. Stocks of liquid assets, including securities, totaled Euro 15.47 million on the day of reporting (2016: Euro 13.97 million). Including short-term receivables from deliveries and services worth Euro 10.52 million, Formycon held liquid assets of around Euro 26.00 million (2016: Euro 19.17 million).

Formycon AG as the Group’s actual operational unit achieved a turnover of Euro 16.39 million (2016: Euro 13.86 million) and improved its EBITDA significantly to Euro -0.67 million (2016: Euro -3.49 million) and the EBIT to Euro -1.45 million (2016: Euro -4.19 million). The net loss for the year, at Euro -1.49 million, was also significantly less than the previous year’s figure of Euro -4.18 million.

The number of employees over the past year has risen considerably, as planned, from 70 to 83 due to the growing maturity of the product pipeline and the associated personnel requirements.

Dr. Carsten Brockmeyer, Chairman and CEO of Formycon, is happy with the company’s development: “I would like to thank all of our employees and the entire Formycon team for an exceptionally successful year in 2017. We have once again taken a major step forward in the development of our biosimilar projects, and we have also taken the company forward structurally. Particular thanks go to our licensing and cooperation partners, with whom we enjoy trusting and focused collaboration.”

Dr. Stefan Glombitza, responsible on the Board of Directors as COO for product development, is proud of the development team’s achievements in 2017: “All of our departments have shown tremendous dedication to achieving our planned goals and milestones across all four programs in 2017. This is a remarkable achievement, especially since we have also been investing at the same time in a scalable, robust organization and efficient processes.”

Financial Director Dr. Nicolas Combé sees the company as being in a solid financial state, irrespective of its growth: “We have ended the 2017 financial year in an exceptionally satisfactory position, and in terms of finance we are well prepared for forthcoming development activities. For the current financial year, we anticipate a volume of sales that should be around the same level as last year. The potential market launch of FYB201 from 2020 onwards should then bring us the first product marketing revenue, which is expected to build up considerably with the step-by-step market expansion and potential launch of marketing of our other product candidates over time.”

You can find the full 2017 annual report on the Internet at www.formycon.com/investors/financial-reports. The English version will be published at the end of May.

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

May 02, 2018, Munich/Zurich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its licensee Bioeq IP AG have today published an interim result for the clinical phase III trial for the biosimilar candidate FYB201. According to this, the primary endpoint has been achieved in the COLUMBUS-AMD trial, thus confirming comparable efficacy between FYB201 and the reference medicinal product Lucentis® in patients with neovascular age-related macular degeneration (nAMD). The clinical endpoint relates to efficacy of the investigational product and measures the change in the best corrected visual acuity after eight weeks. The confidence interval lies within the pre-defined equivalence limits and the study has so far progressed without any abnormalities with regard to the safety and immunogenicity of the product FYB201.

The last patient in the trial, in which patients are treated for a total of 48 weeks, is expected to complete treatment in the second quarter of 2018. The data from the phase III study will be part of the application for marketing approval with the US Food and Drug Administration FDA and the European Medicines Agency EMA.

Formycon’s development and distribution partner Bioeq is responsible for the clinical phase III study. Bioeq also holds the exclusive global marketing rights for the product FYB201.

Dr. Thiemo Schreiber from Bioeq comments: “As the sponsor and marketer of the FYB201 program, we are pleased about this positive study result and, on the basis of this important milestone, we will continue license negotiations with interested parties. Our aim is the approval and launch of FYB201 as the first biosimilar to Lucentis® in the United States of America in 2020 and in the countries of the European Economic Area in 2022. We thus want to offer a larger number of patients more affordable access to this important and highly effective treatment.”

Dr. Carsten Brockmeyer, CEO of Formycon, considers Formycon’s leading position as a developer of biosimilars in the promising biosimilar sector to have been confirmed: “We are delighted with the result. It confirms Formycon’s pioneering role in the development of biosimilars in ophthalmology and emphasizes our ability to successfully develop high-quality biosimilars. We will consistently drive forward our development pipeline of currently four biosimilars.”

Lucentis® is used in the treatment of neovascular age-related macular degeneration (wet AMD) and other serious eye diseases. It inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina. This leads to a progressive loss of vision and is one of the major causes of age-related blindness. Globally, it is estimated that up to 7.5 million people suffer from wet AMD. There are some 450,000 patients in Germany alone. The total market volume for treatments in this field amounted to over 9.3 billion dollars in 2017, and is continuing to rise sharply.

* Lucentis is a registered trademark of Genentech Inc.

Munich – The biosimilars company Formycon has ranked 7th in the FT1000 list compiled by the highly respected business newspaper the Financial Times and data provider Statista, making it the only biotech company to appear in the top ten. The rankings, which have now been compiled for the second time, list Europe’s 1,000 strongest-growing companies that have achieved the highest percentage sales growth between the financial years of 2013 and 2016.

This placement represents a further honor in recognition of Formycon’s dynamic growth: In 2016 and 2017, Formycon was crowned growth champion in the “Chemistry and Pharmaceuticals” category by the news magazine Focus. Formycon took 1st place in this segment out of 500 companies in Germany.

Dr. Nicolas Combé, board member and CFO of Formycon, said: “We are absolutely delighted by this award and see this as confirmation of our strategic focus. At this stage in the company’s life, the financing of our development activities is of central importance. Through existing licensing agreements, a joint venture and our solid liquidity, we are excellently placed and in a very promising position for a biotech company.”

Dr. Stefan Glombitza, board member and COO of Formycon, was also thrilled by the company’s top-ten placement on the FT1000 list: “The rewarded growth reflects the continuous progress of our biosimilar programs, which we are supporting by a structured organizational development. All these activities are consistently targeting a clear goal: to provide through our biosimilar developments as many patients as possible with access to high-quality therapies and sustainably relieve the financial burden from health systems.”

The complete FT1000 list is already available to view online. A special printed edition will appear on April 30, 2018 in the Financial Times.

The overall FT1000 rankings can be found here
More information about the rankings can be found here

Munich – Over the recent months of the 2017 financial year, the biosimilars company Formycon has again progressed well with the further development of its four biosimilars, which are in various stages of development.

FYB201 is the worldwide only biosimilar candidate for the ophthalmic agent Lucentis®* (ranibizumab) in a clinical phase III trial for the regulated markets. Alongside advanced clinical testing, Formycon is working intensively and in close consultation with the respective regulatory authorities on the preparation of the filing documents. On condition of a further successful development, market launch in the USA is planned for 2020. With the development of an innovative application system underpinned by the company’s own patent applications, Formycon has created additional tools for a highly promising positioning of FYB201 on the market.

FYB203 is a biosimilar candidate for Eylea®** (aflibercept) which, like Lucentis®, is used to treat neovascular, age-related macular degeneration (nAMD) and other serious eye conditions. In this project Formycon is completing its final measures to establish a highly efficient biosimilar manufacturing process. Formycon has submitted various patent applications for the pharmaceutical formulation of this product, and therefore believes that FYB203 is also in a highly promising position for its market launch following the expiry of the reference product’s legal protection in the USA in 2023.

Project activities for FYB202, a biosimilar candidate for Stelara®*** (ustekinumab), are currently focusing on the optimization of a suitable manufacturing process. As already announced in July 2017, a term sheet was signed for the joint development of FYB202 with Santo Holding (Deutschland) GmbH. Under the terms of the agreement, Formycon will bear up to 30 percent of the development costs for FYB202 and in return will receive up to a 30 percent share of the global marketing proceeds.

On the FYB205 project, for which Formycon has so far not published any details, work has been stepped up on the development of a suitable cell line.

The business figures of the Formycon Group, which alongside the joint stock company also comprises the two sub-holdings Formycon Project 201 GmbH and Formycon Project 203 GmbH, continue to be impacted by project activities. As in the past, income resulted primarily from the development of the two licensed-out biosimilar candidates. The planned expenditure on un-licensed projects in particular has had an impact on the earnings side. As a result, turnover at the Formycon Group during the first nine months rose by just under 3.5 million to Euro 15.12 million compared to the same period last year, while earnings before interest, taxes, depreciation and amortization on tangible and intangible assets (EBITDA) was Euro -4.25 million. The operating result (EBIT) was Euro -4.84 million, while the net earnings were Euro -4.89 million.

As of September 30, 2017, the Formycon Group held liquid assets worth Euro 19.04 million. Short-term receivables from deliveries and services totaled Euro 4.67 million.

For the year as a whole and under the assumption that the planned agreement with Santo Holding on FYB202 will be implemented within 2017, Formycon continues to anticipate group turnover in the region of Euro 25 million.

In the first three quarters of 2017, Formycon AG as the actual operational unit achieved a turnover of Euro 7.41 million. The EBITDA stood at Euro -4.48 million, the operating result at Euro -5.07 million, and net earnings at Euro -5.11 million. On the day of review at the end of September, Formycon employed 75 people.

Dr. Carsten Brockmeyer, board member and CEO of Formycon AG explains: “Over the past nine months, Formycon has made significant advances. Together with our partners, we have progressed very well in the clinical testing of FYB201. We are working closely with the authorities on this. We have also pushed ahead rapidly with our other biosimilar programs. We are delighted by the interest in our biosimilars, which is also expressed in the term sheet for FYB202. We are confident that we will be able to report on more specific outcomes of our work in the near future.”

Dr. Nicolas Combé, board member and CFO of Formycon AG, comments: “The investments in our biosimilar projects mean we are continuously increasing the value of our pipeline. The company’s economic development over the first nine months of 2017 shows that we remain in a very solid financial position. With the implementation of the term sheet signed with Santo for FYB202, we also anticipate a significant improvement in our results. The potential market launch of FYB201 should then bring us the first product marketing revenue from 2020 onwards, which is expected to build up considerably with the step-by-step market expansion and potential market launch of our other product candidates over time.”

Dr. Stefan Glombitza, board member and COO of Formycon AG, adds: “To be ideally prepared for the forthcoming challenges arising from the projects, it is important to work continuously on developing our business processes and organization further. In the first nine months, in parallel to our operational project activities, we have also successfully implemented targeted measures that create the framework for an efficient and scalable organization. By the end of this year, we will have increased our workforce to 83 and we are also planning additional expansions in capacity for 2018.”

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