AutoGenomics, Inc designs, develops, manufactures and markets a fully integrated molecular diagnostics platform called the INFINITI system that includes their highly automated bench-top INFINITI Analyzer, which has the versatility to run a large menu of genetic tests. By eliminating the need for multiple specialized instruments and automating many of the discrete processes of genetic testing, they believe their system can significantly improve laboratory productivity, workflow and cost per reportable result over many existing technologies and methods. They intend to establish a large installed base of INFINITI Analyzers which in turn should generate significant recurring demand for our high margin testing consumables, including our test-specific BioFilmChips and Intellipac Reagent Management Modules. As of March 31, 2010, they had an installed base of 151 INFINITI Analyzers in reference laboratories, hospital laboratories and specialty clinics in North America, Europe, Asia, the Middle East and South America.
They have received U.S. Food and Drug Administration, or FDA, clearance for the INFINITI Analyzer and their Warfarin, FII, FV and FII-FV Panel tests, and they intend to seek clearance or approval, as necessary, for their other tests. For the year ended December 31, 2009, sales of their RUO tests represented 86% of their revenue from the sale of consumables.
The company is offering shares of common stock and they estimate that the net proceeds from this offering, will be used to repay the principal and interest under the $19.1 million of aggregate principal amount of outstanding subordinated promissory notes, to fund research and development activities and clinical studies and clinical trials of their tests, including a clinical trial to support a PMA for their HPV-HR Quad test, to fund the expansion of their sales and marketing operations and to fund the expansion of their manufacturing capacity, including purchasing equipment. There are 7,748,931 shares of common stock outstanding as of December 31, 2009.
The company has not been profitable since inception. They have incurred substantial costs to develop their technology. As of December 31, 2009, they had an accumulated deficit of $63.7 million. Revenue for the year ended December 31, 2009 was $5.9 million compared to $5.0 million for the year ended December 31, 2008.
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