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MANAGEMENT PLAN OF ACTION
12 Months Ended
Dec. 31, 2012
MANAGEMENT PLAN OF ACTION  
MANAGEMENT PLAN OF ACTION

16. MANAGEMENT PLAN OF ACTION

        The accompanying consolidated financial statements have been prepared in conformity with generally accepted accounting principles, which contemplate continuation of the Company as a going concern. However, the Company has sustained substantial operating losses in recent years and expects to continue to have operating losses in 2013. In addition, the Company has used and expects to continue to use substantial amounts of working capital to fund research and development costs. In view of these matters, realization of a major portion of the assets in the accompanying consolidated balance sheet is dependent upon the Company's ability to increase its liquidity and capital resources.

        Management has developed plans and taken steps that it believes will enable the Company to continue its operations and meet operating and financing requirements. These plans include:

  • The Company has a multi-part financing plan to raise additional equity and debt financing to fund its research and development costs which are expected to be substantial. It is currently in negotiations for additional financing including equity and debt financing.

    The Company is seeking partners for the development of its drug portfolio outside the U.S. and for other indications for SFP within the U.S.
  • The Company plans to continue development of its dialysis concentrate and product supply business which generates positive cash flow based on earnings before interest, taxes, depreciation, amortization, research and development and non-cash charges for equity compensation.

    In order to accelerate the development and national penetration of its concentrate business, the Company is seeking to partner its dialysis concentrate business in the United States with interested parties which may include joint ventures, partnerships or other arrangements to increase the value of its concentrate business operations.

    The Company plans to begin selling Calcitriol, an intravenous vitamin D analogue targeted to the dialysis market, following FDA regulatory approval of a change in manufacturing location for the drug. Calcitriol is anticipated to provide substantial additional revenue and higher margins than the Company's current product lines.