1123695--3/9/2009--IMARX_THERAPEUTICS

related topics

{product, candidate, development}

{property, intellectual, protect}

{stock, price, operating}

{product, liability, claim}

{stock, price, share}

{acquisition, growth, future}

{provision, law, control}

{product, market, service}

{control, financial, internal}

{regulation, change, law}

{cost, regulation, environmental}

Our competitors generally are larger than we are, have greater financial resources available to them than we do and may have a superior ability to develop and commercialize competitive products. In addition, if our competitors have products that are approved in advance of ours, marketed more effectively or demonstrated to be safer or more effective than ours, our commercial opportunity will be reduced or eliminated and our business will be harmed. If we are unable to develop, manufacture and commercialize our product candidate, we may not generate sufficient revenue to continue our business. We do not plan to manufacture any of our product candidates and will depend on commercial contract manufacturers to manufacture our products. Our product candidates may never achieve market acceptance. Technological change and innovation in our market sector may cause our products to become obsolete shortly after or even before such products reach the market. We intend to rely heavily on third parties to implement critical aspects of our business strategy, and our failure to enter into and maintain these relationships on acceptable business terms, or at all, would materially adversely affect our business. We rely on third party products, technology and intellectual property, which could negatively affect our ability to sell our MRX-801 microspheres or other products commercially or could adversely affect our ability to derive revenue from such products. We have only two full-time employees and consulting relationships with certain key consultants to provide necessary services. We may not have sufficient personnel to effectively identify or consummate an attractive strategic transaction for our clinical-stage SonoLysis program and other Company assets in a timely manner, or at all. We may be unable to manage our company s growth effectively. We depend on patents and other proprietary rights, some of which are uncertain and unproven. Further, our patent portfolio and other intellectual property rights are expensive to maintain, protect against infringement claims by third parties, and enforce against third party infringements, and are subject to potential adverse claims. Other companies may claim that we infringe their patents or trade secrets, which could subject us to substantial damages. Our rights to develop and commercialize our SonoLysis product candidate is subject to the terms and conditions of licenses or sublicenses granted to us by third parties, including other pharmaceutical companies, that contain restrictions that may limit our ability to capitalize on this product. We could be exposed to significant product liability claims, which could be time consuming and costly to defend, divert management attention and adversely impact our ability to obtain and maintain insurance coverage. The expense and potential unavailability of insurance coverage for our company or our customers could adversely affect our ability to sell our products, which would negatively impact our business. If we use hazardous or biological materials in a manner that causes injury or violates applicable law, we may be liable for damages. The FDA approval process for drugs involves substantial time, effort and financial resources, and we may not receive any new approvals for our product candidates on a timely basis, or at all. If we or our contract manufacturers fail to comply with applicable regulations, sales of our products could be delayed and our revenue could be harmed. Our products will remain subject to ongoing regulatory review even if they receive marketing approval. If we fail to comply with applicable regulations, we could lose these approvals, and the sale of our products could be suspended. Marketing and reimbursement practices and claims processing in the pharmaceutical and medical device industries are subject to significant regulation in the U.S. If we seek regulatory approvals for our products in foreign jurisdictions, we may not obtain any such approvals. Risks Related to Our Common Stock Our principal stockholders and management own a significant percentage of our stock and will be able to exercise significant influence over our affairs. If our stock price is volatile, purchasers of our common stock could incur substantial losses. We are at risk of securities class action litigation due to our stock price volatility. If there are substantial sales of common stock, our stock price could decline. The financial reporting obligations of being a public company and other laws and regulations relating to corporate governance matters place significant demands on our management and cause increased costs. Failure of our internal control over financial reporting could harm our business and financial results. If we do not achieve our projected business goals in the time frames we announce and expect, our stock price may decline. Anti-takeover defenses that we have in place could prevent or frustrate attempts to change our direction or management.

Full 10-K form ▸

1123695--3/9/2009--IMARX_THERAPEUTICS_INC