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20.04.2016 07:31:01
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DGAP-News: Formycon AG
DGAP-News: Formycon AG: Formycon ends 2015 fiscal year with successful results
2. Substantial sales growth; positive results
3. Good financial position safeguards development over the next few years
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 million 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.
About Formycon: Formycon is a leading independent pure play developer of biosimilars and has become a recognized innovator in this field. The company has extensive experience in the development of complex biological molecules. Formycon's specialist expertise allows the company to develop high-quality biosimilars that meet the strict regulatory requirements of highly regulated markets such as Europe and the United States. Formycon currently has three biosimilars under development, with further product candidates already identified. Two biosimilar candidates have been licensed out to Santo Holding GmbH.
About Biosimilars: Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis and multiple sclerosis. 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 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.
Contact: Thorsten Schüller Corporate Communications and Investor Relations Formycon AG Fraunhoferstr. 15 82152 Martinsried/Planegg/Germany phone +49 (0) 89 - 86 46 67 150 fax + 49 (0) 89 - 86 46 67 110 Thorsten.schueller@formycon.com // www.formycon.com
Disclaimer: This press release may contain forward-looking statements and information which are based on our current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety and patent litigation. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.
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20.04.2016 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de
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Language: English Company: Formycon AG Fraunhoferstraße 15 82152 Planegg-Martinsried Germany Phone: 089 864667 100 Fax: 089 864667 110 Internet: www.formycon.com ISIN: DE000A1EWVY8 WKN: A1EWVY Listed: Regulated Unofficial Market in Berlin; Open Market (Entry Standard) in Frankfurt End of News DGAP News Service ---------------------------------------------------------------------------
455701 20.04.2016
DGAP-News: Formycon AG / Key word(s): Final Results/Forecast
Formycon AG: Formycon ends 2015 fiscal year with successful results
20.04.2016 / 07:31
The issuer is solely responsible for the content of this announcement.
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Press Release // April 20, 2016
Formycon ends 2015 fiscal year with successful results
1. Significant advances in the development pipeline: FYB201 (ranibizumab)
in Phase III, license agreement for FYB203 (aflibercept) with Santo
Holding
2. Substantial sales growth; positive results
3. Good financial position safeguards development over the next few years
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 million 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.
About Formycon: Formycon is a leading independent pure play developer of biosimilars and has become a recognized innovator in this field. The company has extensive experience in the development of complex biological molecules. Formycon's specialist expertise allows the company to develop high-quality biosimilars that meet the strict regulatory requirements of highly regulated markets such as Europe and the United States. Formycon currently has three biosimilars under development, with further product candidates already identified. Two biosimilar candidates have been licensed out to Santo Holding GmbH.
About Biosimilars: Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis and multiple sclerosis. 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 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.
Contact: Thorsten Schüller Corporate Communications and Investor Relations Formycon AG Fraunhoferstr. 15 82152 Martinsried/Planegg/Germany phone +49 (0) 89 - 86 46 67 150 fax + 49 (0) 89 - 86 46 67 110 Thorsten.schueller@formycon.com // www.formycon.com
Disclaimer: This press release may contain forward-looking statements and information which are based on our current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety and patent litigation. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.
---------------------------------------------------------------------------
20.04.2016 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de
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Language: English Company: Formycon AG Fraunhoferstraße 15 82152 Planegg-Martinsried Germany Phone: 089 864667 100 Fax: 089 864667 110 Internet: www.formycon.com ISIN: DE000A1EWVY8 WKN: A1EWVY Listed: Regulated Unofficial Market in Berlin; Open Market (Entry Standard) in Frankfurt End of News DGAP News Service ---------------------------------------------------------------------------
455701 20.04.2016
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