DGAP-News: Formycon AG

Press Release // September 29, 2017

Formycon Reports Financial and Operating Results for the First Half Year of 2017

- Clinical phase III study with FYB201 continues according to plan

- Half-year figures shaped by development expenses for FYB202, as expected

- Implementation of development cooperation agreement for the FYB202 project anticipated for second half of the year

Munich - The biosimilars company Formycon AG has accomplished a successful first half year in 2017. Phase III of the clinical trial involving the furthest-advanced biosimilar candidate FYB201 is continuing to progress as planned. FYB201 is a biosimilar candidate for the ophthalmic agent Lucentis* (ranibizumab) and is scheduled to be marketed in the US from mid-2020 under the responsibility of the licensing partner following successful approval and expiry of the reference product's legal protection.

The development of FYB202, a biosimilar candidate for Stelara** (ustekinumab), has also been pleasing during the first six months of 2017 and is set to continue in future as part of a development cooperation agreement. To this effect, a term sheet has since been signed for the joint development of FYB202 with Santo Holding (Deutschland) GmbH. The aim is to develop FYB202 through to market authorization. As already announced, under the terms of the co-investment agreement, Formycon will bear up to 30 percent of the development costs for FYB202 and in return will receive a share of up to 30 percent of the future global market revenues.

The development of FYB203, a biosimilar project for Eylea*** (aflibercept), which is also already being licensed out, as well as of FYB205, is progressing in accordance with the project schedule.

Formycon's economic results during the first half-year have been shaped considerably by the development expenses associated with FYB202. The group which, alongside the joint stock company also comprises the two sub-holdings Formycon Project 201 GmbH and Formycon Project 203 GmbH, therefore had a turnover of Euro 8.01 million (1st half year of 2016: 8.76 million). As in the past, the main source of income was the development of the two licensed-out biosimilar candidates FYB201 and FYB203. The group period result at the end of June 2017 stood at Euro -2.91 million compared to Euro -1.18 million during the same period last year.

The company's financial resources remain solid, regardless of the increase in expenditure on development: On the day of reporting, Formycon held liquid assets of around Euro 14.4 million. Including short-term receivables from deliveries and services worth Euro 1.33 million, Formycon's liquid assets totaled around Euro 15.7 million (20.7). The equity ratio has risen by 1.7 percentage points to 84.6 percent compared to the same period last year. The turnover forecast for the year as a whole remains unchanged at Euro 25 million.

The implementation of the term sheet for FYB202 in the intended contractual and company law structure is anticipated during the second half of the year and should make a significant contribution to improving the Formycon Group's results for the 2017 financial year. The cash inflow from the capital increase worth around Euro 6 million at the start of the third quarter is not included in the figures stated.

Formycon AG, as the company's central development and operational unit, achieved a turnover of Euro 4.80 million (previous year: 7.05 million) during the first six months, with the result from the first half-year being Euro -2.88 (-1.23) million. This change in turnover is essentially due to the shift of development activities to the respective project companies.

Dr. Nicolas Combé, Chief Financial Officer of Formycon, is satisfied with developments over the first six months: "The agreements on FYB202 will lead to an extremely valid development financing for this project too. Together with the licensing agreements for FYB201 and FYB203, development financing for our three main projects should therefore be assured. This puts us in a highly promising position for keeping the company on a healthy course for growth and being able to leverage the economic potential that will arise from our share of future product marketing revenue in particular."

Dr. Carsten Brockmeyer, CEO of Formycon, says: "In the first half year of 2017, Formycon achieved significant progress on all of its projects. The global provision to patients of safe and effective biological medicines at affordable prices is a major commitment of ours. We are well on the way to achieving this objective."

You will find the full half-year report on the Internet at http://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.

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 added value chain from technical development to the clinical phase III and 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, two of which have already been licensed out.

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. In contrast to traditional generic drugs, the development and production of biosimilars is highly complex and requires specialized expertise.

Contact:
Thorsten Schüller
Corporate Communications and Investor Relations
Formycon AG
Fraunhoferstr. 15
82152 Martinsried/Planegg/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.