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 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.
Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially 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. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of an innovative COVID-19 drug FYB207.
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. Global sales of biosimilars are estimated to exceed $15 billion by 2020. By 2030, analysts estimate that this figure could rise to over $60 billion.