Munich – In the first nine months of the 2016 financial year, the biosimilars company Formycon has further advanced the development of its drug candidates. Revenue from sales has primarily been generated through the development of the two partnered biosimilar product candidates FYB201 and FYB203. At the same time, Formycon has also invested heavily in both of its own development programs – FYB202 and FYB205 – thereby continuing its successful economic path as planned.
With a turnover of Euro 11.66 million, the Formycon Group achieved an overall performance of Euro 11.82 million after consideration of other operating income worth Euro 0.16 million. The nine-month earnings before interest, taxes, depreciation and amortizations (EBITDA) stood at Euro -2.06 million, with the operating result (EBIT) amounting to Euro -2.58 million. The result for the period totaled Euro -2.57 million.
As of September 30, 2016, the Formycon Group held liquid assets worth Euro 16 million. Including short-term receivables from deliveries and services worth around Euro 3 million, Formycon had liquid assets of around Euro 19 million at its disposal. As a result, the company continues to maintain a solid financial buffer which will enable it to advance the development of its biosimilar candidates.
For the full year, Formycon continues to anticipate group revenues in the range of Euro 20 million.
In the first three quarters of 2016, Formycon AG as the actual operational unit achieved sales of Euro 8.72 million, while the overall performance amounted to Euro 8.87 million. The EBITDA stood at Euro -2.30 million, the EBIT at Euro -2.82 million and earnings at Euro -2.81 million. On the day of review, Formycon employed 68 people.
Dr. Nicolas Combé, Director and CFO of Formycon, believes these results confirm that the company remains on the right path: “With the planned investments in our biosimilar projects, we are building up a valuable pipeline and positioning ourselves as a leading independent developer for biosimilars. Together with our licensing partners Santo Holding and Bioeq IP AG, our goal is to be the first to offer high-quality follow-on drugs after the expiry of patents on reference products. The progress this year shows us that we are on the right track.”
Formycon currently has four biosimilar projects in clinical and pre-clinical development. The furthest-advanced is FYB201, a biosimilar candidate of the ophthalmic drug Lucentis®* (ranibizumab), for which patients have been enrolling in a global clinical phase III since the start of 2016 in collaboration with Bioeq IP AG. FYB201 is therefore the world’s only Lucentis® biosimilar to be in the phase III licensing study, the final stage of clinical development to gain marketing approval.
FYB203, which has been licensed out to Santo Holding (Deutschland) GmbH, is a biosimilar candidate for Eylea®** (aflibercept) which, like Lucentis®, is used to treat neovascular, age-related macular degeneration (nAMD) and other serious eye conditions. Details of the FYB202 and FYB205 projects, which have not yet been partnered and the rights to which are still fully owned by Formycon, have so far not been published.
* Lucentis is a registered trademark of Genentech Inc.
** 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.