About us

URL Pharma is a leading specialty pharmaceutical company with fully integrated technology development, product development, manufacturing, and commercialization capabilities. We leveraged over 60 years of experience, as a generic pharmaceutical R&D and manufacturing company, to successfully transition into a growing, profitable, and technology driven proprietary branded pharmaceutical business. Most of our gross profit in 2008 will come from Branded/Licensing products.

Our strategy is to develop and commercialize scientifically and medically innovative products and technologies that fulfill unmet medical needs. These advances are also accompanied by intellectual property or regulatory exclusivity.

URL Pharma primarily focuses on compounds, and technologies, where we can unlock sustainable medical value and minimize development risk. The Company currently has 4 NDAs (new drug approvals) from FDA, and over 260 ANDA (abbreviated new drug approvals), with an annual manufacturing capacity of 4 billion tablets and capsules. We have demonstrated a unique ability to use our medical and scientific expertise to guide our historically extensive skills as a generic company in overcoming the development, intellectual property, legal, and regulatory challenges associated with drug development. We have built our branded business on a generic cost structure. URL Pharma believes that our unique business model, and experienced management team, positions us exceptionally well to benefit operationally and strategically from emerging market trends.

Most of the senior management, including the President and CEO, have medical or scientific degrees with a strong commercial orientation and extensive pharmaceutical industry experience.

URL Pharma successfully commercialized its first organically developed branded product, Qualaquin®, in 2006 and currently has a substantial pipeline of additional NDA products in mid to late stages of development. In addition to these products, which are expected to launch throughout the next five years, URL Pharma has many technologies for near-term lifecycle management out-licensing. Total licensing revenues, to date, have exceeded $800MM.

URL Pharma's strategy addresses three key macro trends affecting the U.S. pharmaceutical industry:

• Heightened FDA sensitivity to safety issues—URL Pharma's primary scientific focus is to enhance the safety and efficacy profiles of currently marketed drugs and unapproved drugs, including approved and unapproved products. We expect all such efforts to result in intellectual property or regulatory exclusivities;
• Rise of therapeutic substitution by managed care payors—URL Pharma is developing products that are designed to be bio- or therapeutically equivalent to reference brands, that can be priced at a discount to existing reference brands, that benefit from intellectual property or regulatory exclusivities, and which will be market driven by managed care payors;
• Erosion of generic pharmaceutical pricing—URL Pharma is developing proprietary products and technologies which retain pricing power.

Our goal has been to create a branded pharmaceutical company on a generic SG&A. We have a strong track record of execution in creating a platform to develop and promote branded products with the low cost infrastructure of a generic company. From the years 2004 to 2007, net sales have increased at a CAGR of 24% and EBITDA has increased at a CAGR of 46%. Margins continue to increase as our revenue mix shifts towards branded products and licensed technologies. Lastly, we are also executing on first-to-file generic patent challenges which result in a period of generic exclusivity. Specific first-to-file products are identified in our press releases.