Formycon Reports Half-Year Results for 2019

(PresseBox) ( Munich, )
 


Group turnover on plan at Euro 17.2 million
EBITDA of Euro -0.2 million and earnings of Euro -0.7 million as expected
Development of projects advances significantly


Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) has today announced its financial results for the first half of 2019.

On the day of reporting, June 30, 2019, the Formycon Group’s commercial figures were as forecast. During the first six months of 2019, turnover at the 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 FYB202 GmbH & Co. KG, stood at Euro 17.2 million (H1/2018 incl. a special effect of Euro 8.5 million: Euro 24.6 million).

During the company’s current phase, the Formycon Group is focusing on research and development activities for its own and licensed biosimilar projects. These development services are also the source of the current revenue returns. Following the successful approval of its products, Formycon is also involved in the various licensing partners’ subsequent marketing solutions. The company is currently focusing on three main projects for biosimilars, each targeting billion-dollar markets.

On the FYB201 project involving a biosimilar candidate to the reference drug Lucentis®1), the licensing partner Bioeq IP AG is about to submit the approval documents to the US Food and Drug Administration, the FDA. FYB202, a biosimilar candidate to the reference drug Stelara®2), is imminently due to transition to clinical trials. The start of the clinical phase III for the FYB203 project, which involves a biosimilar candidate to the reference drug Eylea®3), is planned for mid-2020.

The Group’s earnings before interest, tax, depreciation and amortization (EBITDA) stood at Euro -0.2 million (H1/2018 incl. special effect: Euro 8.63 million). The operating result (EBIT) totaled Euro 0.7 million (H1/2018 incl. special effect: Euro 8.23 million). As of June 30, 2019, the Group period result was Euro -0.7 million compared to Euro 7.59 million in the same period last year.

For the whole of 2019 Formycon anticipates revenues of around Euro 35 million at group level. As in previous years, the Group’s financial position appears to be very solid: Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled around Euro 8 million on the day of reporting. Including short-term receivables and other assets worth Euro 19.8 million, the Formycon Group held liquid assets of around Euro 27.8 million in total.

The cash capital increase carried out in the first half of 2019 increased the company's subscribed capital by Euro 577,397.00 by issuing an equal number of shares with a notional interest in the share capital of Euro 1.00 each to a total of EUR 10,000,000.00. The premium of Euro 16,686,773.30 was fully booked to the capital reserve. The Group's equity ratio therefore increased to 92 per cent on the day of reporting.

Formycon AG, as the company’s central development and operational unit, achieved a turnover of Euro 11.3 million during the first half of 2019 (H1/2018 incl. special effect: Euro 18.9 million). The earnings for this period totaled Euro -0.7 million (H1/2018 incl. special effect: Euro 7.7 million).

During the reporting period, Formycon exceeded the 100-employee threshold for the first time in the company’s history. The total number of employees within the company rose during the first half of 2019 from 95 to a total of 103.

Dr. Nicolas Combé, Formycon's CFO, was extremely satisfied with the developments of the first six months: “The half-year figures are as forecast and we have taken further key steps forward both on the development side and in the expansion of our organization. Our task continues to be developing our three key products successfully in collaboration with our partners and bringing them to approval stage so that we can then share in the future product sales. In this context, the submission of FYB201 to the FDA in the US represents an important interim goal.”

The full half-year report can be found on the Internet at
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.

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 approximately 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 5.0 billion, industry experts expect this figure to grow up to USD 30 billion by the year 2025.

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. 
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