Initial sales of Unifill syringes will begin at the end of June, and a drug master file, which enables clients to reference the device in their own regulatory submissions, should reach the FDA in the September quarter. Early shipments of Unifill syringes will permit stability studies, clinical trials, and market evaluations. In 2012, we expect drug companies to build inventory in anticipation of product launches in mid-2013. With an innovative safety technology, well conceived marketing plan, and a sound balance sheet, Unilife merits a BUY recommendation and a 12 month price target of $10.50 per share.
Q1 ?11 Complete initial production of the Unifill prefilled syringe in the qualified clean rooms of Unilife?s facility in York, PA. Q2 ?11 Complete validation of the Unifill prefilled syringe and its production process, as required by regulatory agencies. Q2/Q3 ?11 Commence initial sales of validated Unifill syringes to sanofi-aventis and other pharmaceutical companies. H2 ?11 Sign agreements for the Unifill syringe and other pipeline products with pharmaceutical and biotech companies. 2011 Secure regulatory approvals and expand sales of Unitract syringes via business development partners in India, Taiwan, Japan, and China. 2011 Enter into collaboration discussions with pharmaceutical, healthcare and medical device companies for pipeline products including the Unifill Select and Unitract Clinical Range syringes, thereby setting the stage for investments in their production lines.
UNS Price at posting:
78.0¢ Sentiment: LT Buy Disclosure: Held