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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.

Munich – Formycon AG today has announced details on the second biosimilar product which is jointly developed with Santo Holding GmbH. FYB203 is a biosimilar candidate for Eylea® (aflibercept). This comprises the common development pipeline with the two most important and best-selling medications in the field of ophthalmology, FYB201 (biosimilar candidate for Lucentis®**) and FYB203.

Eylea® and Lucentis® are used for the treatment of neovascular age-related macular degeneration (neovascular AMD) and other serious eye conditions. Lucentis® generated revenues of approximately USD 3.5 billion in 2015, while Eylea® achieved an estimated market volume of more than USD 4 billion. Together, both products represent almost the entire global market volume for intraocular anti-VEGF treatments, one of the fastest growing therapeutic areas on the pharmaceutical market.

Formycon out-licensed FYB203 exclusively to Santo Holding GmbH in Holzkirchen in May 2015. Bioeq GmbH, a subsidiary of Santo Holding GmbH, will be responsible for the clinical development, the approval and the global marketing and licensing of FYB203. Both development programs will be developed in close coordination with the US Food and Drug Administration (FDA), as well as the European Medicines Agency (EMA), and are striving towards approval in both regions.

Dr. Carsten Brockmeyer, CEO of Formycon AG: “The development of biosimilars for Lucentis® and Eylea® has made us pioneers in the area of opthalmology biosimilars with the two most important products in this field. We believe we are the only company with a Lucentis® biosimilar already in the pivotal Phase III clinical study. Our strong position is also underlined by the number of formulation and application patents we have already filed which gives us a further competitive advantage. It is our goal to launch our biosimilars on the market at day one after the patent on the reference product expires.”

“The anticipated significant market growth in ophthalmology means that the provision of safe and high quality medications in this area poses a significant challenge for the global health care systems. Through our biosimilars, we are striving to make a considerable contribution to the supply of as many patients as possible worldwide with these important pharmaceutical products”, added Dr. Nicolas Combé, CFO of Formycon AG.

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

Munich – Formycon AG, Munich, and bioeq GmbH, Holzkirchen, today announced that they have enrolled the first patient in their clinical Phase III study involving FYB201, Formycon’s biosimilar version of Lucentis®. The objective of the study is to demonstrate the comparability of FYB201 and Lucentis® in terms of safety, effectiveness, and immunogenicity in patients with neovascular age-related macular degeneration (nAMD). This condition, known as wet AMD, is one of the primary causes of loss of vision in people over the age of 60 in developed countries. It is estimated that as many as 7.5 million people worldwide suffer from wet AMD. Germany alone has around 450,000 patients with the condition.

Lucentis® is a leading drug for the treatment of neovascular age-related macular degeneration. It inhibits the vascular endothelial growth factor (VEGF) responsible for the excessive formation of blood vessels in the retina, which leads to a progressive loss of vision. The total market volume for intraocular anti-VEGF treatments in 2015 was around US$ 7.5 billion, and is growing rapidly.

Dr. Björn Capsius, Director Clinical Development at Formycon, said: “We are delighted that, after intensive preparations, our study has now started to enroll its first patient. It is a major step forward in the development of our biosimilar and we will gain important data supporting the regulatory approval in the EU and US.”

Dr. Joachim Kiefer, Head of Clinical Development at bioeq, added: “The active ingredient ranibizumab is an effective and proven therapy for the treatment of age-related macular degeneration. By developing a high-quality and cost-effective biosimilar, we want to give as many patients as possible the opportunity to access this treatment option. This not only helps improve patient care, but also helps to reduce healthcare costs.”

At the end of 2013, Formycon licensed FYB201 exclusively to Santo Holding GmbH, Holzkirchen. bioeq GmbH, a subsidiary of Santo Holding GmbH, is the sponsor of the Phase III study and is also responsible for the global marketing and licensing of FYB201.

* Lucentis is a registered trademark of Genentech Inc.

Munich – Formycon, the biosimilars company, has announced a significant increase in its revenue for the first nine months of this year, thus continuing on its path of profitable growth. With the signing of its second out-licensing deal in May of this year with Santo Holding GmbH, financing is now fully in place to proceed with the development of its first two biosimilar product candidates, FYB201 and FYB203, all the way through to regulatory approval and market launch. In close partnership with bioeq GmbH, Formycon recently initiated a phase III clinical trial, pivotal for gaining market approval in Europe and the U.S., for FYB201, a biosimilar version of Lucentis®*. The first patient is to be accepted into the testing program over the coming weeks. Furthermore, Formycon is planning to begin development work on three additional biosimilar candidates from next year on, thereby further expanding its existing product pipeline and setting the foundations for continued growth.

Total consolidated revenue and other income for the period was EUR 14.71 million, an increase of EUR 5.73 million compared to the prior-year period (8.98m). EBITDA for the period from January to September was EUR 2.22 million (2.64m), while nine-month net income was EUR 1.51 million (1.81m). As of the end of September, the company’s holdings of cash, cash equivalents and marketable securities were EUR 17.12 million. Including also short-term receivables in the amount of EUR 5.7 million, Formycon thus has liquid assets of well over EUR 20 million at its disposal, roughly the twice the level at the end of the prior nine-month period (EUR 10,44 million).

Total revenue and other income for parent company Formycon AG alone, on an unconsolidated basis, was EUR 11.45 million, with nine-month net income of EUR 1.28 million. Dr. Nicolas Combé, CEO of Formycon, had this to say on the nine-month results: “We are putting our growth strategy into action deliberately and consistently, underscoring our company’s commitment as a leading independent developer of biosimilar drugs. Moreover, we see enormous demand on the market for these products, and thus we are now planning to expand our pipeline by three additional molecules. With these actions, we are putting the foundations into place to generate significant further value for our company and its shareholders. This path of profitable growth is a testimony to the superb work by our team, with which we are extremely satisfied.”

Formycon continues to anticipate a full-year profit, thereby confirming its existing guidance.

* Lucentis is a registered trademark of Genentech Inc.

Munich – Formycon AG, Munich, Germany, and bioeq GmbH, Holzkirchen, Germany, today announced the initiation of a pivotal Phase III clinical trial with FYB201, an investigational biosimilar ranibizumab (Lucentis®). The global clinical trial is designed to confirm biosimilarity with regard to safety, efficacy and immunogenicity of FYB201 versus Lucentis® in patients with neovascular age-related macular degeneration (nAMD). The study design was developed in consultation with the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) and is expected to support the registration in both regions.

Top selling eye drug Lucentis® is the leading treatment for nAMD and other eye diseases and had estimated sales of $4.1 billion in 2014. It inhibits vascular endothelial growth factor (VEGF) which is responsible for the excessive formation of blood vessels in the retina leading to progressive loss of vision. The current total market size for intraocular anti-VEGF therapy is about $6.9 billion.

Formycon had licensed FYB201 exclusively to Santo Holding GmbH, Holzkirchen, Germany end of 2013. bioeq GmbH, an affiliate of Santo Holding GmbH, acts as the sponsor of the Phase III study and will also be responsible for the global commercialization and licensing of FYB201.

Carsten Brockmeyer, Ph.D., CEO Formycon AG: “We believe that we are the first company initiating a pivotal phase III study for a biosimilar version of ranibizumab. This underlines our mission to provide high quality biologics to patients across the world. I am glad that Formycon and bioeq will jointly drive the clinical development, regulatory filings and commercialization of FYB201, which will help us to become a significant player in the field of ophthalmological diseases, one of the most rapidly growing therapeutic areas. We continue to advance our pipeline with two other biosimilar candidates already in preclinical phase.”

“Intraocular anti-VEGF agents are a cornerstone in the treatment of age related macular degeneration and other eye diseases. A high quality and clinically proven biosimilar version of Lucentis® could play an important role in broadening the access to these essential medicines and generating much needed savings” said Professor Dr. O. Findl, Chair of the Department of Ophthalmology at Hanusch Hospital, Vienna.

“The costs associated with the treatment of eye diseases have become a tremendous emerging challenge for global health care systems. I am confident that, together with our partner Formycon, we can build a strong global presence in ophthalmology. Biosimilars like FYB201 will address the need for affordable access to essential high-quality treatments for payors, prescribers and patients. We continue to expand our biosimilar portfolio in ophthalmology but also in other indications” said Nicola Mikulcik, CEO of bioeq GmbH.

* Lucentis is a registered trademark of Genentech Inc

Munich – Formycon, the biosimilars company, has closed the first half of its fiscal year 2015 with very successful financial results. Consolidated revenue for the period ending June 30, 2015, was EUR 9.8 million, an increase of EUR 2.24 million over the prior-year period. Net income for the six-month period was EUR 1.53 million, with the decrease of almost EUR 1 million from the prior-year period due largely to increased material and staff expenses related to investments in projects to develop new biosimilar drugs. As of the period closing date, Formycon Group held more than EUR 20.56 million in consolidated cash and marketable securities. The company’s equity capital ratio rose from 83.4 percent to 89.8 percent.

Formycon AG, the parent and primary operating entity, as well as the entity conducting core R&D activities, reported unconsolidated revenue of EUR 7.1 million (prior-year period: 7.4 million) and unconsolidated after-tax earnings of EUR 1.65 million (2.41 million). The company continues to anticipate a full-year profit for both the consolidated group and the unconsolidated parent entity.

“We are very satisfied with these half-year results,” said Dr. Nicolas Combé, CFO of Formycon. “Because we are investing significant amounts into the development of our biosimilar candidates and are, moreover, in a growth phase, our expense levels have increased according to plan. These are investments which are serving to build our company’s long-term future.”

With out-licensing deals now signed with Santo Holding GmbH for two of the three product candidates currently in development, Formycon has a strong partner at its side. “This has put a solid foundation into place for our product candidates and their future market launch,” explained Combé. “Furthermore, this partnership gives us the financial flexibility to proceed deliberately and confidently with our own biosimilar development efforts, as we expand our R&D pipeline step by step.”

Under the terms of the licensing agreement signed in May 2015 for FYB203, the company’s second biosimilar drug, Formycon received a multi-million-euro up-front payment from Santo. Formycon will, moreover, receiving payments for further product development all the way through to regulatory approval. Since December 2013, when the company signed its out-licensing deal with Santo Holding for FYB201, its first product candidate, Formycon has been receiving ongoing payments. Its third project under development, FYB202, is currently in pre-clinical testing.

Munich – Formycon AG, a leading independent developer of biosimilar drugs, has received a scientific advice letter from the U.S. Food and Drug Administration (FDA) regarding the preclinical and clinical development program for FYB201, the first biosimilar product candidate to emerge from its development pipeline, following the receipt of similarly favorable scientific advice from the European Medicines Agency (EMA) in December 2014. In its letter, the FDA, like the EMA, expresses its support for the company’s proposed approach to proceed with FYB201 directly to the pivotal phase III clinical trial. Based upon the scientific advices received from the EMA and FDA, Formycon and its license partner Bioeq GmbH are now in a position to carry forward with a clinical study design for a global phase III trial which will enable them to apply simultaneously for regulatory approval in both the U.S. and European Union. All preclinical activities and the preparations for the phase III trial for FYB201 are moving forward according to plan.

The market launch of FYB201 in the highly regulated markets, particularly the U.S. and European Union, is planned to begin starting from 2020.

Munich – Formycon AG has announced its financial results for the first quarter of 2015, reflecting the continued advances of its biosimilar development projects in line with plan. The group’s revenue for the period was largely attributable to its licensing and development agreement with Santo Holding GmbH for FYB201, the first of its biosimilar drug projects. Expenses consisted mainly of research and development costs for its three pending biosimilar projects. Subsequent to the end of the quarter, an important operational milestone was reached with the signing of an out-licensing agreement for FYB203, which will provide a further boost to the company’s financial flexibility. As to FYB201, the farthest advanced of its development projects, preparations and consultations with U.S. and European regulatory authorities for the commencement of phase III clinical trials essential for final regulatory approval are proceeding according to plan.

In the first quarter of 2015, Formycon reported consolidated revenues of EUR 3.0 million (1Q 2014: EUR 5.8 million). The decline was due to the fact that the prior-year period included a one-time payment following the signing of the above-mentioned licensing agreement. Consolidated EBITDA for the period was negative EUR 0.3 million (1Q 2014: EUR 4.2 million), with the decline likewise attribute to the one-time payment in the prior-year period. Based upon the recently announced successful signing of a partnership deal for FYB203, the company has raised its full-year forecast for fiscal year 2015, which it now expects to end with positive EBITDA.