1123695--3/31/2008--IMARX_THERAPEUTICS

related topics

{product, candidate, development}

{property, intellectual, protect}

{product, liability, claim}

{stock, price, operating}

{stock, price, share}

{personnel, key, retain}

{product, market, service}

{control, financial, internal}

{competitive, industry, competition}

{interest, director, officer}

{regulation, change, law}

{cost, regulation, environmental}

{acquisition, growth, future}

We incurred significant indebtedness in connection with our acquisition of urokinase assets from Abbott Laboratories. We anticipate that we will not be able to satisfy this obligation by its March 31, 2008 due date, in which case Abbott Laboratories will have a right to reclaim our remaining inventory of urokinase, along with a portion of the cash we have received from our sales of urokinase. Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern. The manufacturing facilities of our suppliers must comply with applicable regulatory requirements. If these manufacturing facilities do not maintain or receive regulatory approval, our business and our results of operations would be harmed. We rely on a third party to manufacture our urokinase product. The loss of this manufacturer relationship could prevent us from obtaining additional urokinase inventory to sell. Even if Microbix Biosystems is able to develop a manufacturing facility and we obtain regulatory approval to manufacture additional urokinase, we will need to develop an infrastructure, or contract with a third party, capable of successfully marketing and selling our products. The Kinlytic brand name for our urokinase product is unfamiliar to our market. We have limited sales and marketing capabilities and depend on drug wholesalers to distribute our Kinlytic product. We will need substantial additional capital to fund our operations. If we are unable to raise capital when needed, we may be forced to delay, reduce or eliminate our research and development programs or commercialization efforts, and we may be unable to timely pay our debts or may be forced to sell or license assets or otherwise terminate further development of one or more of our programs. 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 and 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 microbubbles or other products commercially or could adversely affect our ability to derive revenue from such products. We may be unable to attract and retain management and other personnel we need to succeed. 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. We have limited patent protection for Kinlytic, and third parties likely could develop urokinase without a license from us, which could decrease the market opportunity for Kinlytic. 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.

Full 10-K form ▸

1123695--3/31/2008--IMARX_THERAPEUTICS_INC