1087294--3/19/2010--CUMBERLAND_PHARMACEUTICALS

related topics

{property, intellectual, protect}

{product, candidate, development}

{product, liability, claim}

{acquisition, growth, future}

{stock, price, operating}

{regulation, government, change}

{product, market, service}

{condition, economic, financial}

{regulation, change, law}

{stock, price, share}

{operation, international, foreign}

{provision, law, control}

{personnel, key, retain}

{system, service, information}

{control, financial, internal}

If any manufacturer we rely upon fails to produce our products in the amounts we require on a timely basis, or fails to comply with stringent regulations applicable to pharmaceutical drug manufacturers, we may be unable to meet demand for our products and may lose potential revenues. We are dependent on a variety of other third parties. If these third parties fail to perform as we expect, our operations could be disrupted and our financial results could suffer. Competitive pressures could reduce our revenues and profits. The commercial launch of Caldolor is subject to many internal and external challenges and if we cannot overcome these challenges in a timely manner, our future revenues and profits could be materially and adversely impacted. Any attempt by us to expand the potential market for Caldolor is subject to limitations. Our future growth depends on our ability to identify and acquire rights to products. If we do not successfully identify and acquire rights to products and successfully integrate them into our operations, our growth opportunities may be limited. If we are unable to maintain and build an effective sales and marketing infrastructure, we will not be able to commercialize and grow our products and product candidates successfully. If governmental or third-party payors do not provide adequate reimbursement for our products, our revenue and prospects for continued profitability may be limited. Formulary practices of third-party payors could adversely affect our competitive position. Continued consolidation of distributor networks in the pharmaceutical industry as well as increases in retailer concentration may limit our ability to profitably sell our products. Our CET joint initiative may not result in our gaining access to commercially viable products. We depend on our key personnel, the loss of whom would adversely affect our operations. If we fail to attract and retain the talent required for our business, our business will be materially harmed. We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability for a product or product candidate and may have to limit its commercialization. We have never paid cash dividends on our capital stock, and we do not anticipate paying any cash dividends in the foreseeable future. RISKS RELATING TO GOVERNMENT REGULATION We are subject to stringent government regulation. All of our products face regulatory challenges. Proposed legislation may permit re-importation of drugs from other countries into the U.S., including foreign countries where the drugs are sold at lower prices than in the U.S., which could materially adversely affect our operating results and our overall financial condition. RISKS RELATING TO INTELLECTUAL PROPERTY Our strategy to secure and extend marketing exclusivity or patent rights may provide only limited protection from competition. If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could be adversely affected. We depend on our licensors for the maintenance and enforcement of our intellectual property and have limited, if any, control over the amount or timing of resources that our licensors devote on our behalf. If the use of our technology conflicts with the intellectual property rights of third parties, we may incur substantial liabilities, and we may be unable to commercialize products based on this technology in a profitable manner or at all. We may be involved in lawsuits to protect or enforce our patents or the patents of our collaborators or licensors, which could be expensive and time consuming. If we breach any of the agreements under which we license rights to our products and product candidates from others, we could lose the ability to continue commercialization of our products and development and commercialization of our product candidates. RISKS RELATED TO OUR FINANCIAL CONDITION AND RESULTS OF OPERATIONS Our operating results are likely to fluctuate from period to period. Our focus on acquisitions as a growth strategy has created a large amount of intangible assets whose amortization could negatively affect our results of operations. We may need additional funding and may be unable to raise capital when needed, which could force us to delay, reduce or eliminate our product development or commercialization and marketing efforts. RISKS RELATED TO OWNING OUR STOCK The market price of our common stock may fluctuate substantially. Unstable market conditions may have serious adverse consequences on our business. We are experiencing increased costs as a result of operating as a public company, and our management will be required to devote additional time to new compliance initiatives. Some provisions of our third amended and restated charter, bylaws, credit facility and Tennessee law may inhibit potential acquisition bids that you may consider favorable.

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1087294--3/19/2010--CUMBERLAND_PHARMACEUTICALS_INC