727510--3/12/2010--ENZON_PHARMACEUTICALS

related topics

{product, candidate, development}

{stock, price, share}

{property, intellectual, protect}

{product, liability, claim}

{customer, product, revenue}

{product, market, service}

{cost, regulation, environmental}

{debt, indebtedness, cash}

{personnel, key, retain}

{provision, law, control}

{control, financial, internal}

{acquisition, growth, future}

Risks Relating to Our Business We expect to incur losses over the next several years and may never achieve or sustain profitability. Development of any successful product candidates is highly uncertain due to the extended testing and regulatory review process required before marketing clearance can be obtained and failure to develop, obtain regulatory approval and commercialize our product candidates could materially harm our business. Our financial results are heavily dependent on the continued sales of PEGINTRON on which we receive royalties; if revenues from these royalties materially decline, our results of operations and financial position could be materially harmed. We may require additional financing to meet our future capital needs and failure to obtain such funding could have a material and adverse effect on our business, financial condition and operations. We depend on our collaborative partners; if we lose our collaborative partners or they do not apply adequate resources to our collaborations, our product development and financial performance may suffer. We purchase some of the compounds utilized in our product candidates from a single source or a limited group of suppliers, and the partial or complete loss of one of these suppliers could cause production delays and a substantial loss of revenues. Our product candidates must undergo extensive clinical testing, the results of which are highly uncertain and could substantially delay or prevent us from obtaining regulatory approval. We depend on third parties to conduct the clinical trials for our product candidates and any failure of those parties to fulfill their obligations could harm our development and commercialization plans. We depend on patents and proprietary rights, which may offer only limited protection against potential infringement and the development of competing products. Blocking patents or claims of infringement may stop or delay the development of our proprietary products. We may have to develop or license alternative technologies if we are unable to obtain key technology from third parties or maintain our rights to technology we license from third parties. The patents upon which our original PEGylation technology was based have expired and, as a result, the scope of our patent protection is narrower. The manufacture of our product candidates is a complex and highly-regulated process and we rely on third-party manufacturers to manufacture materials for us. If any of them fails to meet regulatory requirements, our business could suffer. We may be subject to a variety of types of product liability or other claims based on allegations that the use of our product candidates by participants in our clinical trials has resulted in adverse effects, and our insurance may not cover all product liability or other claims. We depend on key personnel and may not be able to retain these employees or recruit additional qualified personnel, which would harm our business; our chief executive officer recently resigned and we currently do not have a chief executive officer. Risks Relating to Our Industry Significant competition for our technology platforms and product candidates could make our technologies or product candidates obsolete or uncompetitive, which would negatively impact our business, results of operations and financial condition. The regulatory approval process is highly uncertain and we will not be allowed to market products if regulatory approval has not been obtained. Even if we are granted regulatory approval in one jurisdiction, we may not receive regulatory approval in another jurisdiction. Once approved, our products may not be accepted in the marketplace. Our operations are subject to extensive environmental laws and regulations. The successful commercialization of our product candidates will depend on obtaining health insurance coverage and reimbursement for use of these products from third-party payors and these payors may not agree to cover or reimburse for use of our products. Risks Related to Our Common Stock and our Convertible Notes The price of our common stock has been, and may continue to be, volatile, which also may significantly affect the trading price of our convertible notes. Events with respect to our share capital could cause the shares of our common stock outstanding to increase. Anti-takeover provisions in our charter documents and under Delaware law may make it more difficult to acquire us, even though such acquisitions may be beneficial to our stockholders. The issuance of preferred stock may adversely affect rights of common stockholders. The market for unrated debt is subject to disruptions that could have an adverse effect on the market price of the 2013 convertible notes, or a market for our notes may fail to develop or be sustained. We may not have sufficient funds available to pay amounts due under our 2013 convertible notes.

Full 10-K form ▸

727510--3/12/2010--ENZON_PHARMACEUTICALS_INC