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Munich – Formycon AG has completed a capital increase against cash contributions from its approved capital, and under exclusion of subscription rights, in the amount of 435,920 shares. With the successful completion of this transaction, the company’s registered capital rises from EUR 8,626,683.00 to EUR 9,062,603.00, an increase of EUR 435,920.00. The newly issued shares have been privately placed to selected institutional investors and family offices, notably including a U.S. healthcare fund, at a price of EUR 25.50 per share. Proceeds from the share placement in the gross amount of EUR 11,115,960.00 will flow entirely to the company and are to be used to advance and expand the company’s biosimilar development programs in accordance with its plans, thus further strengthening the market position which Formycon has already achieved. With this capital transaction, the company’s total holdings in cash and marketable securities will rise to approx. EUR 21.3 million. The entry of a major U.S. fund into the Formycon investor base underscores the high level of interest among international investors in the rapidly developing market for biosimilar drugs, as well as the strategic importance to the company of the North American market. First Berlin Securities Brokerage GmbH served as advisor to Formycon for this transaction.

Munich – Formycon AG has reported its preliminary consolidated financial results for fiscal year 2014, with sales revenue and other income totaling EUR 12.67 million (prior year: EUR 0.41 million). Operating expenses rose from EUR 1.25 million in the prior year to EUR 5.91 million due to ongoing product development activities at its Munich headquarters. EBITDA for the year was EUR 1.94 million (prior year: – EUR 6.64 million), while net income came in at EUR 0.86 million (prior year: – EUR 7.74 million). With these strong results, the company has delivered its first full-year profit in 2014, significantly ahead of its own earlier forecasts.

As of December 31, 2014, Formycon Group held a total of EUR 9.22 million in cash and marketable securities. Equity capital ended the year at EUR 13.11 million (prior year: EUR 12.25 million), leaving the company’s equity capital ratio (equity as percentage of total assets) almost unchanged from the prior-year level at 77.5 percent.

Because of the significant investments into building its drug development pipeline in 2013, Formycon had posted a loss of EUR 7.7 million for the prior fiscal year, as anticipated. These investments have now started paying out for the long term as the company successfully develops its own biosimilar products. Since December 2013, Formycon has already been earning significant income from the out-licensing of its first product to Santo Holding. As the licensed partner for this drug, Santo Holding is now financing the further clinical development, regulatory approval process and market launch of this first bioisimilar drug, towards the aim of global distribution.

Through its intensive R&D activities, Formycon has since managed to achieve a number of further milestones in the development of its three biosimilar candidates. As already announced, the company was able in December 2014 to moves its first biosimilar (FYB201) directly into the critically important phase III clinical trials on the basis of preliminary guidance received from the European Medicines Agency (EMA). Formycon is likewise now seeking scientific advice from the U.S. Food and Drug Administration (FDA). Development of the company’s two other biosimilar candidates (FYB 202 and FYB 203) continues to move forward according to plan.

Munich – Formycon AG, the biosimilar drug development company, has completed a successful GMP (Good Manufacturing Practices) inspection of its site in Munich-Martinsried by the Government of Upper Bavaria. The German GMP certificate confirms that Formycon conducts analytical testing in compliance with EU GMP regulations and underlines Formycon’s position as integrated biosimilar development company. This achievement is another important step in Formycon’s preparation of the pivotal phase III study of clinical testing for its first biosimilar candidate (FYB201) which already has been licensed out to Santo Holding GmbH back in December 2013.

Furthermore, the company has received final advice in December 2014 from the European Medicines Agency (EMA) in London for the non-clinical and clinical development of FYB201. EMA’s scientific experts are in consensus with Formycon’s approach to move FYB201 directly into phase III clinical testing, which puts Formycon almost one year ahead.

Formycon has now submitted the clinical study protocol and other documents to the U.S. Food and Drug Administration (FDA) to obtain also FDA’s expert advice before starting the pivotal global phase III study.

Background: What are biosimilars?
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of diseases such as cancer, diabetes, rheumatoid arthritis and multiple sclerosis. In the coming years, many of the patents for these biotech drugs will expire – and by the year 2020, medications with revenues of more than USD 100 billion will lose their patent protection. In this way, it will become possible to launch new competing drugs, known as “biosimilars”. While the global market for these new-generation drugs is currently some USD 2.5 billion, industry experts expect this figure to grow tenfold by the year 2020. In contrast to traditional generic drugs, the development and production of biosimilars is highly complex and requires specialized expertise.

Munich – Formycon AG, the biosimilar drug development company, is planning to begin the pivotal phase III study of clinical testing for its first biosimilar product (FYB201) already in the third quarter of 2015. The company has brought its schedule forward on the basis of preliminary guidance received from the European Medicines Agency (EMA) in London, with which Formycon is working closely to define the regulatory approval pathway and design of phase III clinical studies for FYB201. The company expects to receive the EMA’s final position as to its scientific advice in December. This is a service through which the EMA provides consultation and recommendations to drug developers on study design and clinical trials reflecting the consensus of the EMA’s scientific experts, in order to facilitate subsequent regulatory approval.

For Formycon AG, the favorable response to its proposed plan for clinical studies means a significant shortening of its development and approval schedule. “This puts us almost exactly one year ahead. The opportunity to jump directly to phase III serves as further confirmation of the high quality of our work,” says Dr. Carsten Brockmeyer, CEO of Formycon AG.

Following the company’s successful capital raising and its partnership deal for its first biosimilar drug signed with Santo Holding in 2013, this marks yet another key milestone for Formycon. Marketing launch for FYB201 in the USA and European Union is planned starting in 2020 – and in certain selected countries should be possible starting already in 2018. The two other biosimilar drugs currently in Formycon’s development pipeline continue to move forward according to plan and remain the subject of discussions with various pharmaceutical and generic companies.

Munich – Formycon AG, the German biosimilars company which in December 2013 licensed out its first product candidate to Santo Holding GmbH, has reported positive financial results in line with expectations. For the first nine months of 2014, the company posted revenues of EUR 8.98 million (2013: EUR 0.33 million). Its operating profitability likewise improved markedly, with EBITDA of EUR 2.64 million for the period from January through the end of September. In the same period last year, the company had posted an EBITDA loss of EUR 4.33 million.

In terms of net income, the company earned EUR 1.81 million for the first nine months. During the same period in 2013, the company had reported a loss of EUR 5.16 million. Formycon has, moreover, confirmed its expectation for ending the fiscal year with positive EBITDA. The company’s total liquidity (including credit balances with banks, cash, checks and marketable securities) as of the end of September was EUR 10.44 million, compared to EUR 3.11 million at the same time last year.

Operational work continues as planned on the company’s three currently pending biosimilar projects, with each project advancing in line with its respective development schedule. As a developer of biosimilar drugs, Formycon is benefiting from the explosion of interest from the pharmaceutical industry in the so-called “third wave” of biosimilars, biotech drugs which replicate existing biopharmaceuticals, and is thus in discussions with a number of pharmaceutical corporations and generic drug producers about further development projects.

Background: What are biosimilars?
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of diseases such as cancer, diabetes, rheumatoid arthritis and multiple sclerosis. In the coming years, many of the patents for these biotech drugs will expire – and by the year 2020, medications with revenues of more than USD 100 billion will lose their patent protection. In this way, it will become possible to launch new competing drugs, known as “biosimilars”. While the global market for these new-generation drugs is currently some USD 2.5 billion, industry experts expect this figure to grow tenfold by the year 2020. In contrast to traditional generic drugs, the development and production of biosimilars is highly complex and requires specialized expertise.

Munich – The first half of 2014 has been marked by the expansion of the company’s research and development activities. The company has started with the development of a third product, which, like the two previous products, is intended to mimic a biopharmaceutical active ingredient of the third wave of biosimilars. The company has also already licensed a biosimilar candidate out to Santo Holding GmbH and is currently in discussions with national and international pharmaceutical and generics companies about licensing out further product candidates.

In the first half of 2014, Formycon AG recorded a turnover of 7.4 million euros (2013: 0.2 million euros). This increase is substantially due to the high revenues achieved as a result of the above mentioned licence agreement and the resulting development alliance. The company’s EBITDA amounted to 3.2 million euros in the first half of 2014 (first half of 2013: -3.0 million euros). Overall, the company expects to achieve positive EBITDA for the business year 2014. The company’s liquid assets, comprising cash on hand, bank credit balances and financial securities, amounted to 11.2 million euros at the end of June 2014.

Munich – Formycon, the independent biosimilar development company, today announced that the development of its third product has now commenced, which like its first two products aims to replicate an established biopharmaceutical drug. These products will be part of the so-called “third wave” of biosimilars, referring to the major, multi-billion-dollar blockbuster drugs created through biotechnology for indications in the areas of ophthalmology, autoimmune disease, and metabolic and blood clotting disorders for which patent protection will expire beginning in 2020. According to information from FirstWord Pharma, a respected provider of industry information, many of the biosimilar development teams within the major pharmaceutical groups are still concentrating their efforts on the first and second waves of biosimilars, where there is strong competition. Formycon, in contrast, has been able to position itself as the clear global leader within the highly lucrative market for biosimilar drugs for patents expiring starting in 2020.

Formycon sees a strong validation of its positioning, in particular, through recent remarks made by Teva, the world’s largest generics producer, whose top management has, in speaking to analysts, expressed its strong interest in this third wave of biosimilars. In the view of FirstWord Pharma, the remarks point to a shift in paradigm affecting the entire industry, as the firm writes in a recent report: “Teva is one of the first companies to openly discuss biosimilar opportunities beyond 2020, but due to limited opportunity within the current crop of biosimilar targets, it certainly won’t be the last.” There is, according to the report, broad agreement among all of the surveyed experts that it is, in view of the development lead times, far too late for investments into the second wave of biosimilars, and that companies need to focusing on biopharmaceuticals for which patents will be expiring in the year 2020 or beyond.

“The development of biosimilar drugs, and the building of a product portfolio therefrom, for the period starting in 2020 is precisely the business model of Formycon. We are gratified to hear that the market leader in generics has likewise put this ‘Agenda 2020’ for biosimilars on its radar. It demonstrates that the work we are doing is very closely aligned to market needs, and it validates the strategic direction that we put into place already one and a half years ago. Since the start of 2013, we have been working on the most significant biosimilar products of the third wave, enabling us to gain a significant head start. We see further confirmation of this in the strong interest in our product developments,” explains Dr. Carsten Brockmeyer, CEO of Formycon AG.

Formycon AG has already licensed out the first of the third-wave biosimilar candidates which it has developed to Santo Holding GmbH (Bioeq GmbH) and is currently in discussions for the out-licensing of further product candidates.

Munich – Formycon reports solid performance in fiscal year 2013 and a strong start in first quarter of 2014. For the first quarter of this year, Formycon AG has reported strong top-line and bottom-line growth, with revenue of EUR 5.832.904 compared to EUR 7.886 in the prior-year period. Earnings before interest, tax, depreciation and amortization (EBITDA) for the period were EUR 4.246 million, a dramatic gain from the EBITDA loss of EUR 1.558 million reported in the first quarter of 2013. Net income after tax for the first three months of this year was EUR 3.972 million, compared to a net loss of EUR 1.837 million in the prior-year quarter. On 31 March 2014, cash and securities amounted to approximately EUR 14 million.

The strong financial performance for the first quarter was mainly attributable to a downpayment from the successful out-licensing of its first biosimilar drug product, which Formycon will develop to enter clinical trials in the middle of 2015, as well as other development work for clients on a service-provider basis. The first biosimilar product will be developed by Formycon up to registration whereby the licensee, Santo Holding GmbH, will bear the full costs for the development and will be responsible for marketing and commercialization. The development of the company’s second biosimilar drug candidate is likewise proceeding according to plan. Originally planned for out-licensing in 2015, this product could be partnered already as early as the second half of 2014. Formycon is currently working to further expand the development pipeline of its biosimilar products.

Fiscal year 2013, which ended in line with plan, was marked by steady progress in the development of the company’s first two biosimilar drugs. The expenditures for these significantly exceeded revenues, leading to a tentative loss before tax of EUR 7.766 million and a net loss of EUR 7.767 million, compared to a loss of EUR 2.395 million in the previous fiscal year. The full-year loss per share for 2013 was thus EUR 0.90, compared to a per-share loss of EUR 0.47 in the previous fiscal year. Following its successful capital-raising measures in 2013, Formycon ended the year with equity capital of EUR 13.928 million, a significant increase for the year, and equal to approximately 80 percent of total assets. Formycon AG expects to end the current fiscal year 2014 with positive full-year EBITDA.

Munich – Formycon AG announces the involvement of a further partner for the first out-licensed biosimilar development project. Polpharma, a leading East European pharmaceutical manufacturer, is with immediate effect a 50 per cent licence partner in this first Formycon development project alongside Santo Holding GmbH (Andreas and Thomas Strüngmann).

Already in December 2013 and ahead of schedule, Formycon was able to successfully out-license the first biosimilar development project to Santo.

Polpharma and Santo have now entered into a joint venture for the joint development and marketing of biosimilars. The Formycon biosimilar FYB201 is being integrated into this joint venture.

“We welcome the new partner, through whom it will be possible to considerably increase the turnover potential and the market penetration of our biosimilar”, says Dr. Nicolas Combé, Chairman (CFO) of Formycon AG.

Polpharma, strong in terms of sales and marketing, is a leading manufacturer in Poland with a high profile in other East European countries. Santo Holding is well positioned in Germany, Western Europe and in the South American countries. As a result, the two groups complement each other from both a strategic and geographical point of view.

Munich – Formycon AG has expanded its Advisory Board. With Dr. Bernhard Hampl, a top pharmaceuticals manager from the US has been acquired for the advisory body.

Over the past 20 years, Dr. Bernhard Hampl was a successful CEO in large American generics companies such as EON LABS Inc. and later Sandoz US, which after fusion of the two companies became America’s second-largest manufacturer of generics. Dr. Hampl, who started his career at the German subsidiary of American Cyanamid / Lederle in Wolfratshausen near Munich, has been living in Connecticut/USA for the past 20 years and brings wide-ranging international experience to Formycon. Today, he advises companies from the field of pharmaceuticals and biotechnology as well as investment companies. For Formycon AG, which has now progressed into the advanced phases of preclinical development with its first projects and is striving for international cooperations – above all in the USA – the expertise provided by Dr. Hampl, who has a doctorate in the field of pharmaceutical chemistry, represents a very valuable addition to the competences of the Advisory Boards.

Dr. Carsten Brockmeyer, CEO of Formycon AG, said. “I’m very pleased that we were able to enlist Dr. Bernhard Hampl, a recognised expert who knows his way around the US pharmaceuticals market and who successfully built up and managed several pharmaceutical companies in the USA. His competence will be highly regarded in the Advisory Board.”