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16.11.2016 07:50:01
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DGAP-News: Formycon AG
DGAP-News: Formycon AG: Formycon Makes Good Progress in First Nine Months of 2016
- Economic results in line with expectations
- Euro 20 million sales target for whole of 2016
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(R), 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.
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 four biosimilars under development, of which two have been licensed out.
About biosimilars: 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 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 3.0 billion, industry experts expect this figure to grow tenfold by the year 2025. 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, patent litigation, contractual risks and dependencies from third parties. 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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16.11.2016 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. Archive at 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, Tradegate Exchange; Open Market (Entry Standard) in Frankfurt End of News DGAP News Service ---------------------------------------------------------------------------
521071 16.11.2016
DGAP-News: Formycon AG / Key word(s): 9-month figures/Forecast
Formycon AG: Formycon Makes Good Progress in First Nine Months of 2016
16.11.2016 / 07:50
The issuer is solely responsible for the content of this announcement.
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Press Release // November 16, 2016
Formycon Makes Good Progress in First Nine Months of 2016
- Advancing expansion and development of valuable pipeline
- Economic results in line with expectations
- Euro 20 million sales target for whole of 2016
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(R), 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.
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 four biosimilars under development, of which two have been licensed out.
About biosimilars: 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 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 3.0 billion, industry experts expect this figure to grow tenfold by the year 2025. 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, patent litigation, contractual risks and dependencies from third parties. 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.
---------------------------------------------------------------------------
16.11.2016 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. Archive at www.dgap.de
---------------------------------------------------------------------------
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, Tradegate Exchange; Open Market (Entry Standard) in Frankfurt End of News DGAP News Service ---------------------------------------------------------------------------
521071 16.11.2016
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