Munich – Over the recent months of the 2017 financial year, the biosimilars company Formycon has again progressed well with the further development of its four biosimilars, which are in various stages of development.
FYB201 is the worldwide only biosimilar candidate for the ophthalmic agent Lucentis®* (ranibizumab) in a clinical phase III trial for the regulated markets. Alongside advanced clinical testing, Formycon is working intensively and in close consultation with the respective regulatory authorities on the preparation of the filing documents. On condition of a further successful development, market launch in the USA is planned for 2020. With the development of an innovative application system underpinned by the company’s own patent applications, Formycon has created additional tools for a highly promising positioning of FYB201 on the market.
FYB203 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. In this project Formycon is completing its final measures to establish a highly efficient biosimilar manufacturing process. Formycon has submitted various patent applications for the pharmaceutical formulation of this product, and therefore believes that FYB203 is also in a highly promising position for its market launch following the expiry of the reference product’s legal protection in the USA in 2023.
Project activities for FYB202, a biosimilar candidate for Stelara®*** (ustekinumab), are currently focusing on the optimization of a suitable manufacturing process. As already announced in July 2017, a term sheet was signed for the joint development of FYB202 with Santo Holding (Deutschland) GmbH. Under the terms of the agreement, Formycon will bear up to 30 percent of the development costs for FYB202 and in return will receive up to a 30 percent share of the global marketing proceeds.
On the FYB205 project, for which Formycon has so far not published any details, work has been stepped up on the development of a suitable cell line.
The business figures of the Formycon Group, which alongside the joint stock company also comprises the two sub-holdings Formycon Project 201 GmbH and Formycon Project 203 GmbH, continue to be impacted by project activities. As in the past, income resulted primarily from the development of the two licensed-out biosimilar candidates. The planned expenditure on un-licensed projects in particular has had an impact on the earnings side. As a result, turnover at the Formycon Group during the first nine months rose by just under 3.5 million to Euro 15.12 million compared to the same period last year, while earnings before interest, taxes, depreciation and amortization on tangible and intangible assets (EBITDA) was Euro -4.25 million. The operating result (EBIT) was Euro -4.84 million, while the net earnings were Euro -4.89 million.
As of September 30, 2017, the Formycon Group held liquid assets worth Euro 19.04 million. Short-term receivables from deliveries and services totaled Euro 4.67 million.
For the year as a whole and under the assumption that the planned agreement with Santo Holding on FYB202 will be implemented within 2017, Formycon continues to anticipate group turnover in the region of Euro 25 million.
In the first three quarters of 2017, Formycon AG as the actual operational unit achieved a turnover of Euro 7.41 million. The EBITDA stood at Euro -4.48 million, the operating result at Euro -5.07 million, and net earnings at Euro -5.11 million. On the day of review at the end of September, Formycon employed 75 people.
Dr. Carsten Brockmeyer, board member and CEO of Formycon AG explains: “Over the past nine months, Formycon has made significant advances. Together with our partners, we have progressed very well in the clinical testing of FYB201. We are working closely with the authorities on this. We have also pushed ahead rapidly with our other biosimilar programs. We are delighted by the interest in our biosimilars, which is also expressed in the term sheet for FYB202. We are confident that we will be able to report on more specific outcomes of our work in the near future.”
Dr. Nicolas Combé, board member and CFO of Formycon AG, comments: “The investments in our biosimilar projects mean we are continuously increasing the value of our pipeline. The company’s economic development over the first nine months of 2017 shows that we remain in a very solid financial position. With the implementation of the term sheet signed with Santo for FYB202, we also anticipate a significant improvement in our results. The potential market launch of FYB201 should then bring us the first product marketing revenue from 2020 onwards, which is expected to build up considerably with the step-by-step market expansion and potential market launch of our other product candidates over time.”
Dr. Stefan Glombitza, board member and COO of Formycon AG, adds: “To be ideally prepared for the forthcoming challenges arising from the projects, it is important to work continuously on developing our business processes and organization further. In the first nine months, in parallel to our operational project activities, we have also successfully implemented targeted measures that create the framework for an efficient and scalable organization. By the end of this year, we will have increased our workforce to 83 and we are also planning additional expansions in capacity for 2018.”
* Lucentis is a registered trademark of Genentech Inc.
**Eylea is a registered trademark of Regeneron Pharmaceuticals Inc.
*** Stelara is registered trademark of Johnson & Johnson
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 antibody-based COVID-19 compounds.
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. In 2019, global sales of biosimilars exceeded USD12 billion. Analysts estimate that this figure could rise to around USD 69 billion by 2025.