DGAP-News: Formycon AG: Formycon With Successful 2017 Financial Year

Press Release // May 7, 2018

Formycon With Successful 2017 Financial Year

- Group sales growth stronger than forecast

- Development of biosimilar projects advances significantly

- Key milestones expected in 2018

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(R)* (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(R)** (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(R)***, 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(R) is a registered trademark of Genentech Inc.
** Stelara(R) is registered trademark of Johnson & Johnson
*** Eylea(R) is a registered trademark of Regeneron Pharmaceuticals Inc.

About Formycon:
Formycon is a leading, independent developer of high-quality follow-on products for biopharmaceutical medicines known as biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval. With its biosimilars, Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Formycon currently has four biosimilars in development.

About Biosimilars:
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection - and by 2020, medications with revenues of more than USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. While the global market for biosimilars is currently more than USD 3.0 billion, industry experts expect this figure to grow tenfold by the year 2025.

Contact:
Thorsten Schüller
Corporate Communications and Investor Relations
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried/Germany
phone +49 (0) 89 - 86 46 67 150
fax + 49 (0) 89 - 86 46 67 110
Thorsten.schueller@formycon.com // www.formycon.com

Disclaimer:
This press release may contain forward-looking statements and information which are based on our current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here.
Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful.
Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated.
This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended.
This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.