1055726--3/26/2010--INOVIO_BIOMEDICAL

related topics

{product, candidate, development}

{property, intellectual, protect}

{product, liability, claim}

{regulation, government, change}

{stock, price, operating}

{personnel, key, retain}

{stock, price, share}

{competitive, industry, competition}

{condition, economic, financial}

{provision, law, control}

{control, financial, internal}

{financial, litigation, operation}

{cost, regulation, environmental}

Risks Related to Our Business and Industry We have incurred losses since inception, expect to incur significant net losses in the foreseeable future and may never become profitable. We have limited sources of revenue and our success is dependent on our ability to develop our vaccine and other product candidates and electroporation equipment. None of our human vaccine product candidates has been approved for sale, and we may not develop commercially successful vaccine products. We will need substantial additional capital to develop our electroporation-based DNA vaccine delivery technology and vaccine and other product candidates and for our future operations. If we are unable to attract and retain key personnel and advisors, it may adversely affect our ability to obtain financing, pursue collaborations or develop or market our product candidates. We may not successfully integrate the VGX Pharmaceuticals business or realize all of the anticipated benefits of our acquisition of VGX. We face intense and increasing competition and many of our competitors have significantly greater resources and experience. If we lose or are unable to secure collaborators or partners, or if our collaborators or partners do not apply adequate resources to their relationships with us, our product development and potential for profitability will suffer. A small number of licensing partners and government contracts account for a substantial portion of our revenue. We have agreements with government agencies, which are subject to termination and uncertain future funding. Our quarterly operating results may fluctuate significantly. If we are unable to obtain FDA approval of our products, we will not be able to commercialize them in the United States. Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results. Delays in the commencement or completion of clinical testing could result in increased costs to us and delay or limit our ability to generate revenues. We and our collaborators rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we and our collaborators may not be able to obtain regulatory approval for or commercialize our product candidates. Even if our products receive regulatory approval, they may still face future development and regulatory difficulties. Even if our products receive regulatory approval in the United States, we may never receive approval or commercialize our products outside of the United States. We face potential product liability exposure and, if successful claims are brought against us, we may incur substantial liability. We currently have no marketing and sales organization and have no experience in marketing products. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our products, we may not be able to generate product revenues. If any of our products for which we receive regulatory approval does not achieve broad market acceptance, the revenues that we generate from their sales will be limited. We are subject to uncertainty relating to reimbursement policies which, if not favorable to our product candidates, could hinder or prevent our products' commercial success. Healthcare reform measures could hinder or prevent our products' commercial success. If we fail to comply with applicable healthcare regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected. If we and the contract manufacturers upon whom we rely fail to produce our systems and product candidates in the volumes that we require on a timely basis, or fail to comply with stringent regulations, we may face delays in the development and commercialization of our electroporation equipment and product candidates. Our failure to successfully acquire, develop and market additional product candidates or approved products would impair our ability to grow. Our business involves the use of hazardous materials and we and our third-party manufacturers must comply with environmental laws and regulations, which can be expensive and restrict how we do business. We may be subject to stockholder litigation, which would harm our business and financial condition. Our results of operations and liquidity needs could be materially affected by market fluctuations and general economic conditions. Risks Related to Our Intellectual Property It is difficult and costly to protect our intellectual property and our proprietary technologies, and we may not be able to ensure their protection. If we are sued for infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in that litigation would have a material adverse effect on our business. Risks Related to Our Common Stock The price of our common stock is expected to be volatile and an investment in our common stock could decline substantially in value. Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control which could limit the market price of our common stock. We have never paid cash dividends on our common stock and we do not anticipate paying dividends in the foreseeable future.

Full 10-K form ▸

1055726--3/26/2010--INOVIO_BIOMEDICAL_CORP