3116--3/30/2009--AKORN

related topics

{product, candidate, development}

{product, liability, claim}

{stock, price, share}

{personnel, key, retain}

{customer, product, revenue}

{interest, director, officer}

{stock, price, operating}

{loss, insurance, financial}

{financial, litigation, operation}

{loan, real, estate}

{property, intellectual, protect}

{condition, economic, financial}

{product, market, service}

{acquisition, growth, future}

{cost, regulation, environmental}

{regulation, change, law}

{debt, indebtedness, cash}

There is substantial doubt as to our ability to continue as a going concern. Risks relating to our Credit Agreement Inadequate liquidity could materially adversely affect our business operations. Our lack of liquidity has caused us to be unable to make payments when due under our Exclusive Distribution Agreement with Massachusetts Biologic Laboratories. We must obtain additional capital to continue our operations. Unstable market and economic conditions may have serious adverse consequences on our business. We have invested significant resources in the development of lyophilization manufacturing capability, and we may not realize the benefit of these efforts and expenditures We depend on a small number of distributors, the loss of any of which could have a material adverse effect. Our growth depends on our ability to timely develop additional pharmaceutical products and manufacturing capabilities. We have entered into several strategic business alliances which may not result in marketable products. Our growth and profitability is dependent on our ability to successfully market and distribute new products, including vaccine products, through various distribution channels. We have accumulated substantial Td vaccine inventory which may be difficult to sell. Our success depends on the development of generic and off-patent pharmaceutical products which are particularly susceptible to competition, substitution policies and reimbursement policies. We can be subject to legal proceedings against us, which may prove costly and time-consuming even if meritless. Our revenues depend on sale of products manufactured by third parties, which we cannot control. Certain of our directors are subject to conflicts of interest. Dependence on key executive officers. Through stock ownership, his position on our board of directors, and his loans to us, Dr. John Kapoor has substantial influence over our business strategies and policies. Recent changes in our senior management may cause uncertainty in, or be disruptive to, our business. We must continue to attract and retain key personnel to be able to compete successfully. We are subject to extensive government regulations that increase our costs and could subject us to fines, prevent us from selling our products or prevent us from operating our facilities. We may implement product recalls and could be exposed to significant product liability claims; we may have to pay significant amounts to those harmed and may suffer from adverse publicity as a result. The FDA may authorize sales of some prescription pharmaceuticals on a non-prescription basis, which would reduce the profitability of our prescription products. Our industry is very competitive. Additionally, changes in technology could render our products obsolete. Many of the raw materials and components used in our products come from a single source. Our patents and proprietary rights may not adequately protect our products and processes. Concentrated ownership of our common stock and our registration of shares for public sale creates a risk of sudden changes in our share price. Exercise of warrants and options may have a substantial dilutive effect on our common stock. We may issue preferred stock and the terms of such preferred stock may reduce the value of our common stock.

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3116--3/30/2009--AKORN_INC