911216--9/13/2006--PALATIN_TECHNOLOGIES

related topics

{product, candidate, development}

{stock, price, share}

{product, liability, claim}

{property, intellectual, protect}

{cost, regulation, environmental}

{provision, law, control}

{investment, property, distribution}

{control, financial, internal}

{personnel, key, retain}

{acquisition, growth, future}

We expect to continue to incur substantial losses over the next few years and we may never become profitable. We have a limited operating history upon which to base an investment decision. If any approved product does not achieve market acceptance, our business will suffer. Development and commercialization of our proposed products involves a lengthy, complex and costly process and we may never successfully develop or commercialize any product. The regulatory approval process is lengthy, expensive and uncertain, and may prevent us from obtaining the approvals we require. We may not be able to obtain regulatory approval to reintroduce NeutroSpec to the market, or may be required to conduct extensive clinical trials prior to regulatory approval. We rely on third parties to conduct clinical trials for our product candidates and their failure to timely perform their obligations could significantly harm our product development. The results of our clinical trials may not support our product claims. Production and supply of bremelanotide and NeutroSpec depend on contract manufacturers over whom we have no control. We are subject to extensive regulation in connection with the laboratory practices and the hazardous materials we use. Contamination or injury from hazardous materials used in the development of our products could result in a liability exceeding our financial resources. We have limited or no experience in marketing, distributing and selling products and will substantially rely on our marketing partners to provide these capabilities. Competing products and technologies may make our proposed products noncompetitive. Our ability to achieve significant revenues from the sale of our future products will depend, in part, on the ability of healthcare providers to obtain adequate reimbursement from Medicare, Medicaid, private insurers and other healthcare payers. We could lose our rights to NeutroSpec, which could adversely affect our potential revenues. If we fail to adequately protect or enforce our intellectual property rights or secure rights to patents of others, the value of our intellectual property rights would diminish. If we are unable to keep our trade secrets confidential, our technologies and other proprietary information may be used by others to compete against us. Our collaboration agreements may fail or be terminated unexpectedly, which could result in significant delays and substantial increases in the cost of our research, development and the commercialization of our potential products. We may incur substantial liabilities and may be required to limit commercialization of our products in response to product liability lawsuits. We are highly dependent on our management team and senior research professionals. If we acquire other products, technologies or operations, we will incur a variety of risks that could adversely affect our current business operations. Shareholders may experience dilution from the exercise of outstanding options and warrants. Our management and principal stockholders together control approximately 20% of our voting securities and such concentration of ownership could delay or prevent a change in control. Anti-takeover provisions of Delaware law and our charter documents may make potential acquisitions more difficult and could result in the entrenchment of management. Our stock price is, and we expect it to remain, volatile, which could limit investors ability to sell stock at a profit. We expect to sell additional equity securities, which will cause dilution. We do not intend to pay cash dividends in the foreseeable future. We have broad discretion over the use of available cash and may not realize an adequate return.

Full 10-K form ▸

911216--9/13/2006--PALATIN_TECHNOLOGIES_INC