815838--3/15/2006--NOVEN_PHARMACEUTICALS

related topics

{product, candidate, development}

{product, liability, claim}

{property, intellectual, protect}

{customer, product, revenue}

{regulation, government, change}

{stock, price, operating}

{control, financial, internal}

{loss, insurance, financial}

{cost, regulation, environmental}

{system, service, information}

{personnel, key, retain}

{tax, income, asset}

{provision, law, control}

{acquisition, growth, future}

{operation, natural, condition}

{debt, indebtedness, cash}

{stock, price, share}

Publication of negative results of studies or clinical trials may adversely impact our products. If we cannot develop, license or acquire new products and commercialize them on a timely basis our financial position and results of operations could be adversely affected and the price of our common stock could decline. If we undertake an acquisition of technology, we will incur a variety of costs, and we may never realize the anticipated benefits of the acquisition. We depend on partners to obtain regulatory approval for, and to market and sell, certain of our products. Our marketing partners sell products that compete with our products. We do not control Novogyne and we may face additional risks because Novartis, our joint venture partner, has significantly greater resources than we do. We depend on Novartis to perform all financial, accounting, regulatory, compliance, inventory, sales deductions and other functions for Novogyne. We may be unable to obtain marketing approval for our new products, including Daytrana , on a timely basis or at all. Our approved products may not achieve the expected level of market acceptance. Failure to comply with our supply agreements or otherwise adequately supply our products to our licensees could negatively affect our financial position and results of operations. Our products may be recalled. Failure to comply with applicable regulations may result in product recalls and/or penalties. We face scale-up risks in the manufacture of new products in commercial quantities. We rely on a single supplier or a limited number of suppliers for certain raw materials and compounds used in our products. We face significant competition, which may result in others discovering, developing or commercializing products before, or more successfully, than we do. Competitors may use legal, regulatory and legislative strategies to prevent or delay our launch of generic products. The European market for our products may be limited due to pricing pressures and other matters. Our quarterly operating results are subject to significant fluctuations. Our results of operations will be adversely affected if we or Novogyne fail to realize the full value of our intangible assets. We cannot be certain of the protection or confidentiality of our patents and proprietary rights. Third parties may claim that we infringe their proprietary rights, forcing us to expend substantial resources in resulting litigation, the outcome of which is uncertain. Any unfavorable outcome could negatively affect our financial position and results of operations. We may experience reductions in the levels of reimbursement for our products by governmental authorities, private health insurers and managed care organizations. Health care reform or other changes in government regulation could harm our business. We may be exposed to product liability claims and there can be no assurance of adequate insurance. All of our products are manufactured at one location. An interruption of production at this facility could negatively affect our business, financial position and results of operations. We use hazardous chemicals in our business. Potential claims relating to improper handling, storage or disposal of these chemicals could be time consuming and costly. Our operations could be disrupted if our information systems fail or if we are unsuccessful in implementing necessary upgrades. Our insurance coverage may not be adequate and rising insurance premiums could negatively affect our profitability. Our financial position and results of operations could be harmed if we are required to perform under existing or future contractual indemnification provisions. Our success depends on attracting and retaining our key employees. Our stockholders rights plan, our charter documents, Delaware law and our joint venture with Novartis may have an anti-takeover effect. The market price for our common stock is volatile.

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815838--3/15/2006--NOVEN_PHARMACEUTICALS_INC