The biosimilars company Formycon AG has revealed impressive results for the first half of 2018 both in the development of its product candidates and its business figures. Key milestones were reached on project FYB201, a biosimilar candidate for Lucentis* (ranibizumab). Following the achievement of the primary endpoint of the COLUMBUS-AMD phase III study under the licensing partner’s responsibility in the second quarter of 2018, which confirmed comparable efficacy of FYB201 and the reference product, treatment of the last patient has now also been completed. The final study results are expected during the course of the second half of 2018. Work is currently focused on the creation of a dossier for submission to the US medicines authority FDA, as well as the European agency EMA. In addition to the data package from the clinical and technical development, the implementation of the commercial supply chain represents a further key prerequisite for submission. Concepts to safeguard commercial market supplies will be implemented under the responsibility of the licensing partner.
FYB202, a biosimilar candidate for Stelara** (ustekinumab) and FYB203, a biosimilar candidate for Eylea*** (aflibercept), are currently at an advanced stage of preclinical development. Important development goals have been achieved on both projects over the last six months. Formycon will publish more details in due course.
Formycon’s economic performance parameters developed positively during the first half of 2018. Turnover at the Formycon 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 FYB 202 GmbH & Co. KG, grew compared to the first six months of 2017 from Euro 8.01 million to Euro 24.59 million. The earnings before interest, tax, depreciation and amortization (EBITDA) improved from Euro -2.50 million to Euro 8.63 million. The operating result (EBIT) totaled Euro 8.23 million (previous year: Euro -2.89 million). The group period result at the end of June 2018 stood at Euro 7.59 million compared to Euro -2.91 million during the same period last year.
This significant improvement in results was due primarily to the inclusion of investments in the FYB202 project from 2013 and 2016, which were charged to the company as a financial contribution for FYB 202 GmbH & Co. KG. At the end of 2017, Formycon transferred its rights in the FYB202 biosimilar project to this new company respectively to its subsidiary FYB 202 Project GmbH.
For the year as a whole, Formycon anticipates continued highly positive results, raising its turnover forecast from Euro 36 million to Euro 40 million.
The company’s financial resources remain as solid as ever, regardless of the increase in expenditure on development: Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled Euro 11.82 million on the day of reporting. Including short-term receivables from deliveries and services worth Euro 8.42 million, Formycon’s liquid assets totaled around Euro 20.23 million. The Group’s equity ratio stands at 79 percent and is higher than industry average, as in previous years.
Formycon AG, as the company’s central development and operational unit, achieved a turnover of Euro 18.91 million during the first half of 2018 (previous year: Euro 4.80 million), with the result from this period being Euro 7.7 million (-2.88). Turnover was essentially generated, as in the past, from development services for proprietary projects.
The company’s workforce rose as planned during the first half of 2018 from 83 to 91.
Dr. Nicolas Combé, Chief Financial Officer of Formycon, is satisfied with developments over the first six months: “Through our licensing agreements and the newly founded joint venture with Aristo, Formycon is in a strong position. The funding of our ongoing projects is therefore extensively secured. It remains important for us during this phase to successfully and efficiently develop our biosimilar candidates. Their potential market launches promise very exciting market opportunities for our partners, from which we will participate.”
The full half-year report can be found 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.
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.
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 5.0 billion, industry experts expect this figure to grow up to USD 30 billion by the year 2025.
SOURCE: Formycon AG