EURX » Topics » Overview

This excerpt taken from the EURX 20-F filed Mar 31, 2009.
Overview
 
We are a specialty pharmaceutical company that develops, manufactures and commercializes enhanced pharmaceutical and biopharmaceutical products. We utilize our proprietary pharmaceutical technologies to develop novel products that we believe will have advantages over existing products or will address unmet medical needs. Through our collaboration arrangements, we have successfully applied our technologies to drug products in a diverse range of therapeutic areas, including cardiovascular, gastrointestinal, pain, nutrition and respiratory. We are simultaneously developing and commercializing our own portfolio of products to address cystic fibrosis and gastrointestinal disorders. Using our own sales and marketing team, we are currently commercializing a portfolio of products for cystic fibrosis patients in the United States. In 2009, we hope to add a proprietary pharmaceutical product EUR-1008 (Zentasetm), which is being evaluated for the treatment of exocrine pancreatic insufficiency, or EPI, to our commercialization efforts in the United States. The U.S. Food and Drug Administration, or FDA, has issued us a late second quarter 2009 Prescription Drug User Fee Act (PDUFA) date for our NDA. If approved by the FDA by the anticipated PDUFA date, we would expect to launch EUR-1008 in 2009. We currently have two late-stage proprietary product candidates, EUR-1073 (beclomethasone) and EUR-1025 (ondansetron) in development for our own portfolio, as well as a number of other products currently in development with collaboration partners, including EUR-1048 and EUR-1000, in development with GSK. In addition, the most advanced of our collaboration products include two products we developed that are being commercialized by our partners in the United States — Amrix® and Unisom® Sleepmelts. We continue to advance and develop additional products using our drug formulation technologies.
 
We are an established business with manufacturing and research facilities in the United States, Italy and France. In 2008, we had approximately €98.5 million (or $137.2 million) in revenues, primarily generated by our pharmaceutical technology business. We manufacture and supply over 40 different products for sale in many of the world’s largest pharmaceutical markets. These products generated €79.9 million (or $111.3 million) in product sales in 2008. The remainder of our revenues generally consists of royalties, milestones, and development fees.
 
We were formed in 1999 when affiliates of Warburg Pincus LLC and Gearóid Faherty, our chief executive officer and chairman, acquired the pharmaceutical technology business of American Home Products Corporation, now Wyeth. Warburg Pincus remains the majority shareholder of our ordinary shares. Since our formation, we have evolved into an integrated specialty pharmaceutical company that develops, manufactures and commercializes enhanced pharmaceutical and biopharmaceutical products. Our evolution has been marked by the acquisition a number of businesses and technologies for an aggregate amount of approximately €27.3 million, consisting of:
 
  •  In February 2000, substantially all of the assets of Vectorpharma, providing us with complementary expertise for our Biorise system, new products in the development pipeline and additional research and development capabilities.
 
  •  In June 2000, Pharmatec, which provided us with additional research and development capabilities, additional manufacturing capacity in Italy and several marketed products.
 
  •  In January 2002, certain assets of Polytech, an early-stage company specializing in polymer-based drug conjugation.
 
  •  In December 2007, SourceCF, which provided us with products marketed to the Cystic Fibrosis community. SourceCF has a sales and marketing organization with knowledge of the Cystic Fibrosis market which we expect to be an important market for EUR-1008.
 
Although the activities of SourceCF are different from those of our existing business, we manage the acquired activities as part of our existing business segment because they are comparatively small in financial terms. We will continue to monitor our activities to determine if our business should be managed in more than one segment.
 
In addition to these acquisitions, in December 2002, we entered into an agreement with Kyowa Hakko under which we have a worldwide license to practice under patents related to the AdvaTab® technology. The license is


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exclusive subject to Kyowa Hakko’s reservation of certain rights. For a further description of our arrangement with Kyowa Hakko, see “— Contractual Commitments.”
 
Traditionally, we have developed new pharmaceutical formulations and entered into agreements whereby we manufactured and supplied the resultant product and our collaboration partners or licensee commercialized the product, frequently subject to royalty and milestone obligations. Pursuant to these types of arrangements, we currently generate revenues through three primary sources: the manufacture and supply of products, development and sales of out-licensed products, and fees related to our formulation and product development work. We plan on continuing to build this business while in the process of establishing and growing our own commercialization capabilities.
 
We refer to agreements that involve new product formulation for a collaboration partner or licensee using our proprietary technologies as “co-development agreements.” In 2008, we entered into six co-development agreements with various collaboration partners and we continue to negotiate additional co-development agreements. Co-development agreements govern a wide range of arrangements from determining the feasibility of using a particular drug with a particular technology to contract services to formulate and supply a product. We believe we are not substantially dependent on any one of them individually. We have completed work on some of these co-development agreements, and, based on past experience and for a variety of reasons, it is likely that a number of our co-development agreements will not result in a commercialized product. The cash flow generated by our co-development agreements, including cash flows from product sales, provides us with financial resources to fund internally our development and commercialization programs and maintain our research and manufacturing capabilities.
 
We have successfully applied our proprietary technologies to formulate products in a diverse range of therapeutic areas, including gastrointestinal, cardiovascular, pain, nutrition, and respiratory, which represented 34%, 24%, 15%, 12% and 10% of our 2008 revenues, respectively. Our ability to meet the goals of our collaboration partners coupled with our broad technology platforms and research infrastructure has allowed us to attract many of the leading pharmaceutical and biotechnology companies as collaboration partners and licensees, including Eisai, GSK, Cephalon, Novartis, and sanofi-aventis. Since 2001, four of our partnered drug products, KCl 20mEq, Innopran XL®, Metadate CD®, and Amrix® have received FDA approval. Our collaboration partners and licensees market over 40 different products using our technologies in many of the world’s largest pharmaceutical markets, including:
 
  •  Customized release.  Innopran XL®, Amrix®, Unisom® and Ultrase®.
 
  •  Tastemasking / ODT.  Children’s Tylenol®, Cibalginadue and Rulide.
 
  •  Bioavailability enhancement.  Nimedex.
 
Our largest collaboration product, in terms of revenue, is pancreatin, a PEP which we developed and manufacture and supply to licensees in both the United States and Europe. For the years ended 2006, 2007 and 2008, revenues attributable to pancreatin accounted for 28%, 23%, 27% of our total revenues, respectively. For the year ended December 31, 2008, approximately 87% of our pancreatin revenues were generated in the United States.
 
This excerpt taken from the EURX 6-K filed May 14, 2008.
Overview
 
We are a specialty pharmaceutical company that develops, manufactures and commercializes enhanced pharmaceutical and biopharmaceutical products based on our proprietary drug formulation technologies. We utilize these technologies to develop novel products that we believe will have advantages over existing products or will address unmet medical needs. Two Phase III clinical trials have been completed for our lead product candidate, Zentasetm (formerly known as EUR-1008), for the treatment of exocrine pancreatic insufficiency (EPI). If approved by the FDA, we expect to launch Zentasetm in the US market in 2008, using our own sales and marketing organization, to target sufferers of Cystic Fibrosis, a disease which causes EPI. In addition to Zentasetm, we are also developing a pipeline of products both for our collaboration partners and for our proprietary portfolio. Currently, the most advanced of our pipeline products include two co-development products and one proprietary product candidate. We are an established business with manufacturing and research facilities in the United States, Italy and France and revenues of €84.8 million in 2007.
 
Prior to 1999, our business represented the drug delivery division of American Home Products Corporation, now Wyeth. During 1999, affiliates of Warburg Pincus LLC and Gearóid Faherty, our Chief Executive Officer, acquired from Wyeth our operating subsidiaries in a series of related transactions. The transactions were financed by sales of equity to, and loans from, Warburg Pincus and Mr. Faherty. Upon consummation of these transactions, Warburg Pincus and Mr. Faherty owned our Series A preference shares. Mr. Faherty and Warburg Pincus remain majority shareholders of our ordinary shares.
 
Since our separation from Wyeth in 1999, we acquired several businesses and technologies for an aggregate amount of €27.3 million, consisting of:
 
  •  In February 2000, substantially all of the assets of Vectorpharma, providing us with complementary expertise for our Biorise system, new products in the development pipeline and additional research and development capabilities.
 
  •  In June 2000, Pharmatec, which provided us with additional research and development capabilities, additional manufacturing capacity in Italy and several marketed products.
 
  •  In January 2002, certain assets of Polytech, an early-stage company specializing in polymer-based drug conjugation.


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  •  In December 2007, SourceCF, which provided us with products marketed to the Cystic Fibrosis community. SourceCF has a sales and marketing organization with knowledge of the Cystic Fibrosis market which is expected to be an important market for Zentasetm.
 
Although the newly acquired activities of SourceCF are different from those of our existing business, we will manage the acquired activities as part of our existing business segment because they are comparatively small in financial terms. We will continue to monitor our activities to determine if our business should be managed in more than one segment.
 
In addition to these acquisitions, in December 2002, we entered into an agreement with Kyowa Hakko under which we have a worldwide license to practice under patents related to the AdvaTab® technology. The license is exclusive subject to Kyowa Hakko’s reservation of certain rights. For a further description of our arrangement with Kyowa Hakko, see “— Contractual Commitments.”
 
We are engaged in the development of new products, both independently and in cooperation with collaboration partners, including many of the leading pharmaceutical and biotechnology companies. Currently, our licensees market over 40 different products utilizing our technologies worldwide, including in the United States, Europe, Japan and China. Pursuant to our co-development and licensing agreements, we develop and manufacture products commercialized by our collaboration partners and licensees. We generally seek to retain exclusive manufacturing rights for products that we have developed. We develop and manufacture our products in facilities in the United States, Italy and France. In 2007, we signed six new co-development agreements. See “Risk Factors — Risks Related to Our Business — The failure to maintain our existing co-development relationships on acceptable terms could adversely affect our ability to develop and commercialize our product candidates and our future growth prospects.” In the future, we will seek to market directly certain products that we develop, including our lead product candidate, Zentasetm.
 
This excerpt taken from the EURX 20-F filed Mar 31, 2008.
Overview
 
We are a specialty pharmaceutical company that develops, manufactures and commercializes enhanced pharmaceutical and biopharmaceutical products based on our proprietary drug formulation technologies. We utilize these technologies to develop novel products that we believe will have advantages over existing products or will address unmet medical needs. Two Phase III clinical trials have been completed for our lead product candidate, Zentasetm (formerly known as EUR-1008), for the treatment of exocrine pancreatic insufficiency (EPI). If approved by the FDA, we expect to launch Zentasetm in the US market in 2008, using our own sales and marketing organization, to target sufferers of Cystic Fibrosis, a disease which causes EPI. In addition to Zentasetm, we are also developing a pipeline of products both for our collaboration partners and for our proprietary portfolio. Currently, the most advanced of our pipeline products include two co-development products and one proprietary product candidate. We are an established business with manufacturing and research facilities in the United States, Italy and France and revenues of €84.8 million in 2007.
 
Prior to 1999, our business represented the drug delivery division of American Home Products Corporation, now Wyeth. During 1999, affiliates of Warburg Pincus LLC and Gearóid Faherty, our Chief Executive Officer, acquired from Wyeth our operating subsidiaries in a series of related transactions. The transactions were financed by sales of equity to, and loans from, Warburg Pincus and Mr. Faherty. Upon consummation of these transactions, Warburg Pincus and Mr. Faherty owned our Series A preference shares. Mr. Faherty and Warburg Pincus remain majority shareholders of our ordinary shares.
 
Since our separation from Wyeth in 1999, we acquired several businesses and technologies for an aggregate amount of €27.3 million, consisting of:
 
  •  In February 2000, substantially all of the assets of Vectorpharma, providing us with complementary expertise for our Biorise system, new products in the development pipeline and additional research and development capabilities.
 
  •  In June 2000, Pharmatec, which provided us with additional research and development capabilities, additional manufacturing capacity in Italy and several marketed products.
 
  •  In January 2002, certain assets of Polytech, an early-stage company specializing in polymer-based drug conjugation.


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  •  In December 2007, SourceCF, which provided us with products marketed to the Cystic Fibrosis community. SourceCF has a sales and marketing organization with knowledge of the Cystic Fibrosis market which is expected to be an important market for Zentasetm.
 
Although the newly acquired activities of SourceCF are different from those of our existing business, we will manage the acquired activities as part of our existing business segment because they are comparatively small in financial terms. We will continue to monitor our activities to determine if our business should be managed in more than one segment.
 
In addition to these acquisitions, in December 2002, we entered into an agreement with Kyowa Hakko under which we have a worldwide license to practice under patents related to the AdvaTab® technology. The license is exclusive subject to Kyowa Hakko’s reservation of certain rights. For a further description of our arrangement with Kyowa Hakko, see “— Contractual Commitments.”
 
We are engaged in the development of new products, both independently and in cooperation with collaboration partners, including many of the leading pharmaceutical and biotechnology companies. Currently, our licensees market over 40 different products utilizing our technologies worldwide, including in the United States, Europe, Japan and China. Pursuant to our co-development and licensing agreements, we develop and manufacture products commercialized by our collaboration partners and licensees. We generally seek to retain exclusive manufacturing rights for products that we have developed. We develop and manufacture our products in facilities in the United States, Italy and France. In 2007, we signed six new co-development agreements. See “Risk Factors — Risks Related to Our Business — The failure to maintain our existing co-development relationships on acceptable terms could adversely affect our ability to develop and commercialize our product candidates and our future growth prospects.” In the future, we will seek to market directly certain products that we develop, including our lead product candidate, Zentasetm.
 

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