352747--3/16/2006--UNIGENE_LABORATORIES

related topics

{product, candidate, development}

{stock, price, share}

{property, intellectual, protect}

{cost, contract, operation}

{personnel, key, retain}

{provision, law, control}

{acquisition, growth, future}

{investment, property, distribution}

{control, financial, internal}

{debt, indebtedness, cash}

{regulation, change, law}

{product, liability, claim}

Unigene s operations for 2006 and future years are highly dependent on the successful marketing of Fortical. We have significant historical losses and may continue to incur losses in the future. We may require additional funding to sustain our operations and our ability to secure additional financing is uncertain. Some of our officers have made loans to us, some of which are in default, and they are entitled to remedies available to a secured creditor, which gives them a priority over the holders of our common stock. Most of our products are in early stages of development and we may not be successful in our efforts to develop a calcitonin, PTH or other peptide product that will produce revenues sufficient to sustain our operations. We may not be successful in our efforts to gain regulatory approval for our products other than Fortical and, if approved, the approval may not be on a timely basis. We may not be successful in efficiently developing, manufacturing or commercializing our products. We have made a substantial investment in our production facility which we may need to upgrade or expand in order to manufacture some of our products in commercial quantities required by our corporate partners. Our success is dependent on our ability to establish and maintain commercial partnerships and currently we have only three significant license agreements. Because we are a biopharmaceutical company, our operations are subject to extensive government regulation. Fortical currently faces competition from large pharmaceutical companies and if our other products receive regulatory approval, these other products would also face competition from large pharmaceutical companies with superior resources. Our success depends upon our ability to protect our intellectual property rights. Our technology or products could give rise to product liability claims. We have financial obligations under our current and former joint venture agreements in China. We may be unable to retain key employees or recruit additional qualified personnel. The market price of our common stock is volatile. Our common stock is classified as a penny stock under SEC rules, which may make it more difficult for our stockholders to resell our common stock. The sale of the shares of common stock acquired by Fusion could cause the price of our common stock to decline. The exercise of warrants and options, as well as other issuances of shares, will likely have a dilutive effect on our stock price. If provisions in our stockholder rights plan or Delaware law delay or prevent a change in control of Unigene, we may be unable to consummate a transaction that our stockholders consider favorable.

Full 10-K form ▸

352747--3/16/2006--UNIGENE_LABORATORIES_INC