|
19.05.2016 07:30:01
|
DGAP-News: Formycon AG
DGAP-News: Formycon AG: Formycon Publishes Figures for the First Quarter of 2016
- Expansion of the product pipeline with fourth biosimilar candidate
- Growth in sales and quarterly results as forecasted
Munich - The first quarter of 2016 has been successful for the biosimilars company Formycon both in operational and financial terms. On the furthest- progressed development project FYB201, a biosimilar candidate for Lucentis(R)*, the first patient was enrolled in February of this year in the phase III study which is intended to support market approval in Europe and the USA. The study is being financed by and carried out under the responsibility of Formycon's licensing partner Santo Holding/bioeq, as is all of the further development and subsequent marketing. Work has also begun on the development of a further biosimilar candidate. The program has now been given an official project status with the code FYB205.
At group level, sales revenues and other earnings totaled Euro 6.34 million, which represents an increase of Euro 3.34 million (previous year: Euro 3.0 million). From January to March, the EBITDA was Euro -0.02 million (Euro -0.3 million) based on a quarterly result of Euro -0.19 million (Euro -0.57 million). Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled Euro 15.29 million at the end of March. Including short-term receivables from deliveries and services worth Euro 7.48 million, Formycon held liquid assets of Euro 22.76 million on the day of reporting.
Revenues from sales and other earnings at Formycon AG totaled Euro 4.99 million. The quarterly result stood at Euro -0.33 million. Chief Financial Officer Dr. Nicolas Combé commented on the quarterly figures with these words: "We are very happy with how the first quarter has progressed and we have achieved further important milestones on our various projects. The financial results lay entirely within our forecasts. As already communicated, we anticipate a growth in sales to over Euro 20 million for the whole year at group level. The annual result will depend greatly on the time at which we partner our FYB202 project. We are already in negotiations with potential partners for this, however there is still a possibility that we will continue to manage the project on our own for a certain period."
* Lucentis is a registered trademark of Genentech 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.
---------------------------------------------------------------------------
19.05.2016 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
---------------------------------------------------------------------------
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 ---------------------------------------------------------------------------
464437 19.05.2016
DGAP-News: Formycon AG / Key word(s): Monthly Figures/Quarter Results
Formycon AG: Formycon Publishes Figures for the First Quarter of 2016
19.05.2016 / 07:30
The issuer is solely responsible for the content of this announcement.
---------------------------------------------------------------------------
Press Release // May 19, 2016
Formycon Publishes Figures for the First Quarter of 2016
- First patient enrolled in phase III registration study for FYB201
(ranibizumab)
- Expansion of the product pipeline with fourth biosimilar candidate
- Growth in sales and quarterly results as forecasted
Munich - The first quarter of 2016 has been successful for the biosimilars company Formycon both in operational and financial terms. On the furthest- progressed development project FYB201, a biosimilar candidate for Lucentis(R)*, the first patient was enrolled in February of this year in the phase III study which is intended to support market approval in Europe and the USA. The study is being financed by and carried out under the responsibility of Formycon's licensing partner Santo Holding/bioeq, as is all of the further development and subsequent marketing. Work has also begun on the development of a further biosimilar candidate. The program has now been given an official project status with the code FYB205.
At group level, sales revenues and other earnings totaled Euro 6.34 million, which represents an increase of Euro 3.34 million (previous year: Euro 3.0 million). From January to March, the EBITDA was Euro -0.02 million (Euro -0.3 million) based on a quarterly result of Euro -0.19 million (Euro -0.57 million). Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled Euro 15.29 million at the end of March. Including short-term receivables from deliveries and services worth Euro 7.48 million, Formycon held liquid assets of Euro 22.76 million on the day of reporting.
Revenues from sales and other earnings at Formycon AG totaled Euro 4.99 million. The quarterly result stood at Euro -0.33 million. Chief Financial Officer Dr. Nicolas Combé commented on the quarterly figures with these words: "We are very happy with how the first quarter has progressed and we have achieved further important milestones on our various projects. The financial results lay entirely within our forecasts. As already communicated, we anticipate a growth in sales to over Euro 20 million for the whole year at group level. The annual result will depend greatly on the time at which we partner our FYB202 project. We are already in negotiations with potential partners for this, however there is still a possibility that we will continue to manage the project on our own for a certain period."
* Lucentis is a registered trademark of Genentech 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.
---------------------------------------------------------------------------
19.05.2016 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
---------------------------------------------------------------------------
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 ---------------------------------------------------------------------------
464437 19.05.2016
Der finanzen.at Ratgeber für Aktien!
Wenn Sie mehr über das Thema Aktien erfahren wollen, finden Sie in unserem Ratgeber viele interessante Artikel dazu!
Jetzt informieren!
Nachrichten zu Formycon AGmehr Nachrichten
Analysen zu Formycon AGmehr Analysen
| 10.12.24 | Formycon Outperform | RBC Capital Markets |
ETF-Sparplan
Oskar ist der einfache und intelligente ETF-Sparplan. Er übernimmt die ETF-Auswahl, ist steuersmart, transparent und kostengünstig.