353482--9/27/2006--VIRAGEN_INC

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{product, candidate, development}
{stock, price, share}
{product, liability, claim}
{property, intellectual, protect}
{operation, international, foreign}
{loan, real, estate}
{cost, regulation, environmental}
{customer, product, revenue}
{control, financial, internal}
{provision, law, control}
{gas, price, oil}
{cost, contract, operation}
{personnel, key, retain}
{condition, economic, financial}
Risks Related to Our Financial Condition and Business We have a history of operating losses and we expect to continue to incur losses and may never be profitable. If we do not develop profitable operations, we will have to terminate our operations. As a result, investors will lose their entire investment. Our business is capital intensive, and we do not currently generate sufficient revenues to offset our debt service obligations, research and development activities and other operating expenses. If we are unable to obtain additional funding, as and when required, we may have to significantly curtail or completely terminate our operations. We will be substantially dependent on licensing fees and sales of our human alpha interferon product, Multiferon , to generate revenue for the foreseeable future. If we are unable to obtain or maintain the necessary required regulatory approvals to manufacture and sell Multiferon throughout the European Union, or if Multiferon is not widely accepted by the markets in which we manufacture and sell it, we may have to significantly curtail or cease operations and our investors may lose their entire investment. We may not be able to successfully develop and commercialize our antibody product candidates, which are in early stage development where there is a significant risk of failure. If we are unable to produce safe, efficacious, proteins in egg whites of transgenic chickens in commercially viable quantities and required quality, we may be unable to recoup our research and development expenses and we may be unable to successfully market the OVA System used to manufacture these drugs. Success in early pre-clinical studies may not be indicative of results obtained in later trials and studies and our product candidates may not commercialize and we may not recover our investment. We rely, and expect to rely in the foreseeable future, on third parties in various international territories to effectively market and distribute Multiferon and our other product candidates after receipt of regulatory approval. If these third parties are unable to effectively market Multiferon , we may be unable to achieve significant product sales. If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell product candidates, we may be unable to generate significant product revenue to support our continuing operations. Possible side effects from the use of Multiferon could adversely affect potential revenues and physician/patient acceptability of our product. Our products may not gain market acceptance among physicians, patients and the medical community, thereby limiting our potential to generate revenue. Some of the indications we are targeting represent smaller patient populations with currently unmet medical needs, which may not result in significant revenue. Our potential products may not be commercially viable if we fail to obtain an adequate level of reimbursement for those products by governments, private health coverage insurers and other organizations, our revenues from these products could be less than anticipated, which could have a negative impact on our ability to achieve profitable operations. If our competitors develop and market products faster than we do or if those products are more effective, safer or less expensive than our approved products, our commercial opportunity will be reduced or may not exist and we may be forced to suspend operations. The regulatory approval process for Multiferon and our product candidates is lengthy, and we may not be able to obtain all of the regulatory approvals required to manufacture and commercialize Multiferon and our product candidates, which could limit our revenue and, ultimately, could require us to cease operations. Our product candidates will remain subject to ongoing regulatory requirements even if they receive marketing approval, and if we fail to comply with these requirements, we could lose these approvals, and the sale of any approved commercial products could be suspended, and fines could be imposed on us. If we and our third-party suppliers do not maintain high standards of manufacturing in accordance with all applicable regulations, our development and commercialization activities could suffer significant interruptions or delays and thus prevent us from realizing revenues and may cause us to significantly curtail or cease operations. Our reliance on foreign third party manufacturers may disrupt operations, which could materially harm our business and financial condition. Our operations involve hazardous materials and are subject to environmental, health and safety controls and regulations, which can be expensive to comply with and we may be liable for damages. If third-party contract research organizations and consultants do not perform in an acceptable and timely manner, our pre-clinical studies or clinical trials could be delayed or unsuccessful. We conduct most of our operations in foreign countries and we anticipate marketing our products in foreign countries, which presents numerous challenges. If we are unable to efficiently manage these challenges, our revenue, cost of operations and ability to attain profitable operations could be materially adversely affected. Our international operations expose us to the risk of fluctuations in currency exchange rates, which could negatively impact our revenues and anticipated sales margins. If we cannot protect our intellectual property, our ability to develop and commercialize our products could be severely limited and may cause us to terminate activities on such products and never realize a return on our investments in such products. We rely on maintaining as trade secrets our competitively sensitive know-how and other information. Intentional or unintentional disclosure of this information could impair our competitive position. If we fail to comply with our obligations in the agreements under which we license development or commercialization rights to products or technology from third parties, we could lose license rights that are important to our business and incur financial obligations based on our exercise of such license rights. If third parties successfully assert that we have infringed their patents and proprietary rights, or successfully challenge the validity of our patents and proprietary rights, we may become involved in intellectual property disputes and litigation that would be costly, time consuming, and which could delay or prevent the development or commercialization of our product candidates and may cause us to seek a license to continue to develop or commercialize our product candidates, which could have a material adverse affect on our business. We may incur substantial costs as a result of litigation or other proceedings relating to patent or other intellectual property rights. Licenses to third parties may not result in revenue to us and exclusive licenses will preclude us from seeking alternative revenue streams. Our copyrightable and trademark works are assets that must be protected. If we are unable to protect these assets, our competitive position could be weakened. We may be exposed to product liability claims, and our product liability insurance may not be sufficient to cover all claims or continue to be available to us. Our reliance on third party suppliers to supply our raw materials may disrupt operations and our ability to develop and commercialize products. The production of Multiferon is highly dependent on the availability of human leukocytes, and any interruption in supply could adversely affect our ability to manufacture Multiferon . The financings that we have consummated are, and future financings may be, dilutive to stockholders and may adversely affect the market price for our shares of common stock. If we lose the services of our key management or scientific personnel, scientific collaborators or other advisors, our business and ability to attain profitable operations would suffer. Risks Related to our Common Stock We have received deficiency notices from the American Stock Exchange, or AMEX, and if we are unable to satisfy the AMEX that we will regain compliance with its continued listing criteria, our common stock may be delisted from AMEX, which could accelerate repayment of outstanding indebtedness, adversely affect investor perception and may result in institutional and other investors refraining from purchasing our common stock, units or warrants, which would adversely affect your ability to sell our common stock, units or warrants. The issuance of our shares upon the exercise or conversion of securities we have outstanding may cause significant dilution to our stockholders and may have an adverse impact on the market price of our common stock. The conversion and exercise prices of outstanding securities may be reduced, and the number of shares that we issue on conversion or exercise may be increased, in the event that we issue common stock or securities convertible into common stock in the future for consideration that is less than the conversion or exercise prices of the outstanding securities. We are engaged in the bio-pharmaceutical industry; as a result, the market for our shares of common stock may be subject to extreme volatility. We may not have sufficient surplus to redeem our Series J cumulative convertible preferred stock or for Viragen International to redeem its Series C cumulative preferred stock or Series D cumulative preferred stock. Additionally, we may not have sufficient surplus or net profits to be able to pay dividends on such preferred stock. We do not expect to pay dividends on our common stock in the foreseeable future. We could use preferred stock to fund operations or resist takeovers, and the issuance of preferred stock may cause additional dilution.

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