• Significant advances in the development pipeline: FYB201 (ranibizumab) in Phase III, license agreement for FYB203 (aflibercept) with Santo Holding
  • Substantial sales growth; positive results
  • Good financial position safeguards development over the next few years

Munich – The biosimilars company Formycon, Martinsried near Munich, has ended the 2015 financial year with both operational and financial success. In the last year, Formycon has made great strides with the initiation of the clinical Phase III study involving the biosimilar candidate FYB201 (ranibizumab) in particular. FYB201 is a follow-on drug to the successful ophthalmic agent Lucentis®*, which achieved global sales worth around 3.5 billion dollars in 2015. With the Phase III, managed by licensing partner Santo Holding, the widespread use on patients is intended to demonstrate that FYB201 is comparable with the reference product in terms of efficacy and safety.

At the same time, Formycon was able to license out a further biosimilar project – FYB203 (aflibercept) – from its pipeline to Santo Holding GmbH in 2015. FYB203 is a biosimilar candidate for Eylea®**. Consequently, Formycon’s development pipeline comprises the two most important and best-selling drugs for intraocular anti-VEGF treatments, one of the fastest-growing therapeutic sectors on the pharmaceutical market.

Operational advances have been underpinned by the company’s strong financial development. Formycon was therefore able to successfully raise capital in the spring of 2015, bringing in Euro 11.1 million for the company’s further development. As a result of the out-licensing, the company has also once again earned significant sales that were considerably higher than 2014.

The Formycon Group increased its turnover in 2015 by 34 percent compared to the previous year, from Euro 12.58 million to Euro 16.9 million. The EBITDA was Euro 1.47 million (2014: 1.94 million), while the annual net profit stood at Euro 0.57 million (2014: 0.86 million). The Group’s equity ratio had risen during the period under review from 77.6 percent to 91.5 percent, representing an above-average level. The company has no financial liabilities. Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled Euro 20.3 million on the day of reporting. Including short-term receivables from deliveries and services worth Euro 2.76 million, Formycon held liquid assets of around Euro 23.1 million (2014: 12.48 million).

Formycon AG achieved a turnover of Euro 13.6 million (2014: 10.53 million) and had an annual net profit of Euro 0.6 million (0.87 million).

The number of employees has grown from 40 at the start of the year to 53 at the end of December 2015. For 2016, Formycon is planning a further moderate increase in its workforce.

The focus of the next few years will be on the further consistent implementation of the company’s strategy, ongoing expansion of the pipeline and further out-licensings of biosimilar candidates. The aim is to continue combining business development with healthy financial results.

Dr. Nicolas Combé, Director and CFO of Formycon, also anticipates positive development in 2016: “Thanks to our two out-licensed biosimilar projects FYB201 and FYB203, we expect the 2016 financial year to bring a further increase in group turnover compared to 2015 to over Euro 20 million. The 2016 annual results will depend greatly on a potential partnership for the FYB202 project. We will also continue to invest a considerable share of our resources in the development of our biosimilars and the expansion of our pipeline in order that we can guarantee the long-term economic success of our company.”

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