737207--3/17/2008--NASTECH_PHARMACEUTICAL_CO

related topics

{product, candidate, development}

{product, liability, claim}

{property, intellectual, protect}

{stock, price, share}

{control, financial, internal}

{cost, operation, labor}

{competitive, industry, competition}

{stock, price, operating}

{provision, law, control}

{acquisition, growth, future}

{customer, product, revenue}

{cost, regulation, environmental}

{interest, director, officer}

{personnel, key, retain}

We do not generate operating income and will require additional financing in the future. If additional capital is not available, we may have to curtail or cease operations. Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern. We have not been profitable on an annual basis for ten years, and we may never become profitable. Risks Related to the Development and Regulatory Approval of our Drug Candidates Clinical trials of our product candidates are expensive and time-consuming, and the results of these trials are uncertain. We are subject to extensive government regulation, including the requirement of approval before our products may be manufactured or marketed. New legal and regulatory requirements could make it more difficult for us to obtain approvals for our product candidates and could limit or make more burdensome our ability to commercialize any approved products. If our generic calcitonin-salmon product is approved under the FDA s Abbreviated New Drug Approval Authority, our ability to commercialize it will be subject to exclusivity periods provided by law. We use hazardous chemicals and radioactive and biological materials in our business. Any disputes relating to improper use, handling, storage or disposal of these materials could be time-consuming and costly. Failure to comply with foreign regulatory requirements governing human clinical trials and marketing approval for drugs could prevent us from selling our drug candidates in foreign markets, which may adversely affect our operating results and financial condition. Risks Related to our Dependence on Third Parties We depend on a limited number of customers for a significant percentage of our revenue. These customers may be able to terminate their contracts with us on short notice, with or without cause. Accordingly, the loss of, or delay in payment from, one or a small number of customers could have a significant impact on our revenue, operating results and cash flows. We are dependent on our collaborative arrangements and feasibility study agreements with third parties for a substantial portion of our revenue, and our development and commercialization activities may be delayed or reduced if we fail to negotiate or maintain successful collaborative arrangements. Our success depends to a significant degree upon the commercial success of products manufactured by us pursuant to supply agreements or marketed by our collaboration partners. An interruption in the supply of our raw and bulk materials needed to make our products could cause our product development and commercialization to be slowed or stopped. We rely on third parties to conduct our clinical trials, and those third parties may not perform satisfactorily, including failing to meet established deadlines for the completion of such clinical trials. We have limited experience in marketing or selling our products, and we may need to rely on marketing partners or contract sales companies. Risks Related to our Intellectual Property and Other Legal Matters If we are unable to adequately protect our proprietary technology from legal challenges, infringement or alternative technologies, our competitive position may be hurt and our operating results may be negatively impacted. Because intellectual property rights are of limited duration, expiration of intellectual property rights and licenses will negatively impact our operating results. Our patent applications may be inadequate in terms of priority, scope or commercial value. We may be required to defend lawsuits or pay damages for product liability claims. Risks Related to the Commercialization of our Drug Candidates Our product development efforts may not result in commercial products. Even if we are successful in commercializing a product candidate, it is possible that the commercial opportunity for nasally-administered products will be limited. Our revenues and profits from our generic calcitonin-salmon product, if approved, and any other approved products, will decline as our competitors introduce their own generic equivalents. If we have a problem with our manufacturing facilities, we may not be able to market our products or conduct clinical trials. Risks Related to our Industry Reforms in the healthcare industry and the uncertainty associated with pharmaceutical pricing, reimbursement and related matters could adversely affect the marketing, pricing and demand for our products. Coverage and reimbursement status of newly-approved drugs is uncertain and the failure to obtain adequate reimbursement coverage could limit our ability to generate revenue. We may be unable to compete successfully against our current and future competitors. Risks Related to Employee Matters and Managing Growth If we lose our key personnel, or if we are unable to attract and retain additional personnel, then we may be unable to successfully develop our business. If we make strategic acquisitions, we will incur a variety of costs and might never realize the anticipated benefits. Failure of our internal control over financial reporting could harm our business and financial results. Risks Related to our Common Stock We cannot assure you that our stock price will not decline. We have never paid cash or stock dividends on our common stock and we do not anticipate paying cash dividends in the foreseeable future. The anti-takeover provisions of our stockholder rights plan may entrench management, may delay or prevent beneficial takeover bids by third parties and may prevent or frustrate any stockholder attempt to replace or remove the current management even if the stockholders consider it beneficial to do so. Our operating results are subject to significant fluctuations and uncertainties, and our failure to meet expectations of public market analysts or investors regarding operating results may cause our stock price to decline. A significant number of shares of our common stock are subject to options and warrants, and we expect to sell additional shares of our common stock in the future. Sales of these shares will dilute the interests of other security holders and may depress the price of our common stock.

Full 10-K form ▸

737207--3/17/2008--NASTECH_PHARMACEUTICAL_CO_INC