893970--11/15/2007--INTERPHARM_HOLDINGS

related topics

{stock, price, share}

{product, liability, claim}

{product, candidate, development}

{debt, indebtedness, cash}

{customer, product, revenue}

{stock, price, operating}

{financial, litigation, operation}

{loss, insurance, financial}

{personnel, key, retain}

{tax, income, asset}

{competitive, industry, competition}

{cost, contract, operation}

Our future success is dependent on our ability to develop, manufacture and commercialize new generic drug products. Our future success is dependent upon incurring significant levels of research and development expenditures which will continue to have an adverse effect on our profitability. We face intense competition which could significantly limit our expansion and growth and materially adversely affect our business and financial results. We may not maintain adequate product liability insurance. We enter into various agreements in the normal course of our business which have indemnification provisions, the triggering of which could have a material adverse impact on our business and financial results. Our operating results are affected by a number of factors and may fluctuate significantly on a quarterly basis. Reserves for credits and pricing adjustments may be inadequate. We are presently dependent on a limited number of products for most of our revenues. We are presently dependent on a small number of major customers. Our loan agreement with Wells Fargo Business Credit imposes significant operating and financial restrictions, which may prevent us from capitalizing on business opportunities and taking certain actions. We may be liable to pay substantial damages, including liquidated damages, or be obligated to redeem such stock for cash if we do not timely perform certain obligations we have to holders of our Series B-1 and C-1 Preferred Stock. We are currently involved in legal disputes which could have a material adverse effect on our financial condition. We rely on independent third parties for some of the research and development and testing required for the regulatory approval of our products. Any failure by any of these third parties to perform this research and development or testing properly and in a timely manner may have an adverse effect upon our ability to obtain regulatory approvals. Our future success depends on our ability to attract and retain key employees and consultants. Our ability to service our debt from Wells Fargo Business Credit and make dividend payments to the holders of our Series B-1 and C-1 Preferred Stock and to meet our cash requirements depends on numerous factors, some of which are beyond our control. Litigation is common in our industry and can cause significant expense and delays. We are susceptible to product liability claims that may not be covered by insurance, which, if successful, could require us to pay substantial damages. We are subject to extensive governmental regulation, the non-compliance with which may result in fines and/or other sanctions, including product seizures, product recalls, injunctive actions and criminal prosecutions. Our raw materials are purchased primarily from foreign distributors of bulk pharmaceutical chemicals. Any significant supply interruption could have a material adverse effect on our business and financial condition and could cause a decline in the market value of our common stock. We may not be able to utilize all of the deferred tax assets recorded on our balance sheet. Our research and development expenditures may not lead to the commercialization of successful products. We have never paid cash dividends on our common stock and are not likely to do so in the foreseeable future. Six of our shareholders control us through their ownership and control of voting stock. There is only a limited trading market for our common stock. The trading of our common stock has been suspended for failure to comply with rules and regulations of the American Stock Exchange relating to timely SEC filings.

Full 10-K form ▸

893970--11/15/2007--INTERPHARM_HOLDINGS_INC