881890--6/14/2007--ABAXIS

related topics

{product, liability, claim}

{product, candidate, development}

{cost, regulation, environmental}

{customer, product, revenue}

{personnel, key, retain}

{product, market, service}

{regulation, change, law}

{regulation, government, change}

{operation, international, foreign}

{control, financial, internal}

{stock, price, share}

{operation, natural, condition}

{property, intellectual, protect}

{acquisition, growth, future}

{tax, income, asset}

We could fail to achieve anticipated revenue if the market does not accept our products. We rely on patents and other proprietary information, the loss of any would negatively affect our business. We must continue to develop our marketing and distribution experience in the human diagnostic market or our business will not grow. We have only recently become profitable on a consistent basis and we must increase sales of our Piccolo and VetScan products or we may not be able to maintain profitability. We may inadvertently produce defective products, which may subject us to significant warranty liabilities or product liability claims and we may have insufficient product liability insurance to pay material uninsured claims. Many of our sales force have been employed by us for less than one year and we must effectively train and integrate our sales team in order to achieve our anticipated revenue or expand our business. We need to successfully manufacture and market additional reagent discs for the human diagnostic market if we are to compete in that market. We rely on distributors to sell our products and we rely on sole distributor arrangements in a number of countries. Our failure to successfully maintain these relationships could adversely affect our ability to achieve our anticipated revenue or expand our business. We depend on sole suppliers for several key components in our products, many of whom we have not entered into contractual relationships with and failure of our suppliers to provide the materials to us could harm our business. We are dependent upon our profitability, and if we cannot remain profitable we may need additional funding in the future and these funds may not be available to us. We may not be able to compete effectively with larger, better established entities or their products, or with future organizations or future products, which could cause our sales to decline. Changes in third-party payor reimbursement regulations can negatively affect our business. We are subject to numerous governmental regulations and any regulatory changes are difficult to predict and may be damaging to our business. Need for FDA Certification for Our Medical Device Products Need to Comply with Manufacturing Regulations Effects of the Clinical Laboratory Improvement Amendments on Our Products We are Subject to Various Federal, State, Local, and International Regulations We depend on key members of our management and scientific staff, and we must retain and recruit qualified individuals if we are to be competitive or our ability to execute our business strategy and generate sales could be harmed. Standards for compliance with Section 404 of the Sarbanes-Oxley Act of 2002 are complex, and if we are unable to maintain effective internal control over our financial reporting, our business could be harmed and our stock price could decline. Our operating results could be materially affected by unanticipated changes in our tax provisions or exposure to additional income tax liabilities. We must comply with strict and potentially costly environmental regulations or we could pay significant fines. Our facilities and manufacturing operations are vulnerable to natural disasters and other unexpected losses; system failures or delays may harm our business. Fluctuations in foreign exchange rates and the possible lack of financial stability in foreign countries could prevent overseas sales growth. Our stock price is highly volatile and investing in our stock involves a high degree of risk, which could result in substantial losses for investors.

Full 10-K form ▸

881890--6/14/2007--ABAXIS_INC