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Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) announced on March 22, 2019 the private placement of a cash capital increase from the strategic Swiss investor M&H Equity AG. With the resolution by the Management Board and Supervisory Board, the company’s share capital of currently EUR 9,422,603.00 will be increased to a total of EUR 10,000,000.00 by partially utilizing approved capital of EUR 577,397.00 to issue 577,397 new bearer shares with a computational proportion of the share capital of EUR 1.00 each in return for a cash investment.

The inward flow of funds amounts to EUR 17,264,170.30 in total and corresponds to an issue price per share of EUR 29.90. The Swiss company M&H Equity AG from Heerbrugg in the Canton of St. Gallen is a strategic investor with a long-term investment horizon. Oliver Fiechter, founder and Managing Partner of M&H Equity AG, commented on his involvement with Formycon as follows: “I’m very much looking forward to working with Formycon, and I see above-average growth potential in the company. Both the management and the business model impressed me, as did the fact that biosimilars will become increasing popular due to increasing cost pressure in global healthcare systems. When we are choosing our investments, the concept of sustainability most of all plays a very important role. The fact that Formycon AG, with its biosimilars, is keen to make access to important medicines easier for as many patients around the world as possible was an important investment criterion for us.”

The funds raised by the capital increase are primarily to be used to expand the pipeline and develop the company’s own biosimilar projects. “With Oliver Fiechter and M&H Equity AG, we have brought on board a strong strategic partner that fits very well with our company and from the support of which we will most certainly be able to benefit. We first and foremost want to advance the development of our projects with the acquired capital and, in so doing, further increase the value of the pipeline”, says Dr. Nicolas Combé, CFO of Formycon AG.

About M&H Equity AG:

The Mountains & Hills Investment Group is an international investment manager and advisor focusing on private markets and selected public holdings. The Group has its own investment approach that combines investments in value-driven companies with shareholdings in innovative technology firms. Within its group, Mountains & Hills combines its own investment fund, a VC company and a vehicle for direct investments in the healthcare market. Through its investments, Mountains & Hills creates added value by helping companies to implement the opportunities made possible by digital technologies in their day-to-day business. This allows them to achieve above-average value growth for their investors.

Munich – Today Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) published an update on development programs and key Milestones.

For FYB201, new data from the recently completed COLUMBUS-AMD phase III trial in patients with neovascular age-related macular degeneration (nAMD) are available. The last patient in the trial, in which patients were investigated for a total of 48 weeks, has completed the study on June 06, 2018. In addition to the achievement of the primary efficacy endpoint reported in May 2018, the study showed comparable results with regard to efficacy, safety and immunogenicity between the investigational medicinal product FYB201 and the reference medicinal product Lucentis®* (ranibizumab). The final study report will be available in December 2018.

Formycon’s partner Bioeq IP AG, who is responsible for the COLUMBUS-AMD study and holds the exclusive global marketing rights for the product FYB201, has filed a request for a Type IV pre-submission meeting with the US Food and Drug Administration FDA to be held in December 2018. In addition to the data package for the technical and clinical development, the implementation of the commercial supply chain will be discussed. The filing of the Biologics License Application (BLA) under the 351 (k) pathway to the FDA is planned for the first half of 2019. A respective pre-submission meeting with the European Medicines Agency EMA is planned for the first quarter 2019.

FYB202 is a biosimilar candidate for Stelara®** (ustekinumab). The drug substance process development and manufacturing scale-up are at an advanced stage. A preclinical pharmacokinetic study has concluded the in-life phase and sample analysis is ongoing. Scientific advice briefing books have been sent to the US FDA for a Type II meeting and to the EMA for a scientific advice meeting. The advices are expected for November (EMA) and early 2019 (FDA). The initiation of the clinical testing of FYB202 is planned for mid-2019.

Significant progress has also been made in the development of FYB203, which is a biosimilar candidate for Eylea®*** (aflibercept). Similar to FYB202 drug substance process development and scale-up are at an advanced level. In preclinical development the in-life phase for a pharmacokinetic study has been completed and sample analysis is ongoing. Currently scientific advice briefing books are being prepared in order to align on the future development strategy with both regulatory authorities (FDA and EMA).

FYB205, for which Formycon has so far not published any details, is an early stage biosimilar project that has been progressed up to the initial cell line screening.

In addition, Formycon is exploring other biosimilar targets with the goal of optimizing the full potential of the development pipeline.

Dr. Carsten Brockmeyer, CEO of Formycon: “We believe FYB201 is the only Lucentis® biosimilar that has successfully completed phase III testing for the global market. The positive outcome of the FYB201 phase III study and the robust progress we have made in our partnered FYB202 and FYB203 programs underlines Formycon’s pioneering role in the development of global quality biosimilars in ophthalmology and immunology. I would like to thank the Formycon team and our licensing and cooperation partners for their great commitment and cooperation.”

Dr. Stefan Glombitza, COO of Formycon, completes: “Our teams are combining strong scientific skills with tremendous passion. This is a very powerful enabler to drive such complex development programs forward and the cross-functional teams can be proud of the achievements that have been made across all programs. We have expanded our organization by further skilled talents with focus on late stage experience and this will help us thrive our programs into further advanced stages.”

* 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 – 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.