1030839--2/13/2007--Synovics

related topics

{product, candidate, development}

{stock, price, share}

{acquisition, growth, future}

{property, intellectual, protect}

{personnel, key, retain}

{product, liability, claim}

{interest, director, officer}

{regulation, change, law}

{control, financial, internal}

{debt, indebtedness, cash}

{customer, product, revenue}

{provision, law, control}

{cost, regulation, environmental}

{competitive, industry, competition}

{operation, international, foreign}

{loss, insurance, financial}

AN ADVERSE DETERMINATION OF OUR DISPUTE WITH NOSTRUM WILL HAVE A MATERIAL ADVERSE EFFECT ON THE COMPANY AND POSSIBLY ITS FINANCIAL CONDITION. WE HAVE SUBSTANTIAL INDEBTEDNESS OUTSTANDING AND ARE LATE IN THE PAYMENT OF CERTAIN OUTSTANDING NOTES. WE ARE CONTINUING TO ACCRUE PENALTIES FOR FAILURE OF A REGISTRATION STATEMENT TO BE DECLARED EFFECTIVE. A FAILURE TO LOCATE AND HIRE A SUITABLE CHIEF SCIENTIFIC OFFICER IN REPLACEMENT OF DR. MULYE COULD HAVE A MATERIAL ADVERSE EFFECT ON THE COMPANY'S OPERATIONS AND FINANCIAL RESULTS. SYNOVICS HAS A LIMITED OPERATING HISTORY UPON WHICH AN INVESTOR CAN EVALUATE ITS POTENTIAL FOR FUTURE SUCCESS. INCLUDING COSTS ASSOCIATED WITH CLINICAL TRIALS AND REGULATORY COMPLIANCE. THE COMPANY WILL REQUIRE ADDITIONAL CAPITAL, AND IF ADDITIONAL CAPITAL IS NOT AVAILABLE, THE COMPANY MAY HAVE TO CURTAIL OR CEASE OPERATIONS. MANY OF THE PRODUCTS MANUFACTURED BY KIRK CONTAIN CONTROLLED SUBSTANCES, THE SUPPLY OF WHICH IS REGULATED. THE COMPANY'S FAILURE TO COMPETE EFFECTIVELY MAY LIMIT ITS ABILITY TO ACHIEVE PROFITABILITY. THE COMPANY MAY FAIL TO ESTABLISH OR CULTIVATE STRATEGIC PARTNERSHIPS TO EXPAND ITS BUSINESS. THE COMPANY'S ABILITY TO MARKET ITS PRODUCTS IS SUBJECT TO THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES. IF SYNOVICS IS UNABLE TO FILE FOR APPROVAL UNDER SECTION 505(B)(2) OF THE FDCA OR IF IT IS REQUIRED TO GENERATE ADDITIONAL DATA RELATED TO SAFETY AND EFFICACY IN ORDER TO OBTAIN APPROVAL UNDER SECTION 505(B)(2), IT MAY BE UNABLE TO MEET ITS ANTICIPATED DEVELOPMENT AND COMMERCIALIZATION TIMELINES. WHICH COULD INCREASE THE COSTS OR CAUSE THE COMPANY TO REVISE CERTAIN PRODUCT CLAIMS. THE COMPANY HAS A LIMITED HISTORY OF RESEARCH AND DEVELOPMENT OR COMMERCIALIZATION OF DRUG PRODUCTS. THE COMPANY FACES PRODUCT LIABILITY RISKS AND MAY NOT BE ABLE TO OBTAIN ADEQUATE INSURANCE TO PROTECT IT AGAINST LOSSES. BECAUSE OF THE SPECIALIZED NATURE OF THE COMPANY'S BUSINESS, THE TERMINATION OF RELATIONSHIPS WITH ITS KEY MANAGEMENT AND SCIENTIFIC PERSONNEL OR ITS INABILITY TO RECRUIT AND RETAIN ADDITIONAL PERSONNEL COULD PREVENT THE COMPANY FROM DEVELOPING ITS TECHNOLOGIES AND OBTAINING FINANCING. IF THE SUPPLIERS AND MANUFACTURERS OF THE COMPANY'S INGREDIENTS ENCOUNTER DIFFICULTIES, THE COMPANY COULD EXPERIENCE PRODUCTION PROBLEMS. THE COMPANY MAY EXPERIENCE DIFFICULTY IN ENTERING INTERNATIONAL MARKETS. THE COMPANY RELIES ON PATENTS, LICENSES AND INTELLECTUAL PROPERTY RIGHTS TO PROTECT ITS PROPRIETARY INTERESTS. THE COMPANY'S STOCK IS THINLY TRADED AND MAY EXPERIENCE PRICE VOLATILITY, WHICH COULD AFFECT A STOCKHOLDER'S ABILITY TO SELL THE COMPANY'S STOCK OR THE PRICE FOR WHICH IT CAN BE SOLD. RIGHTS TO ACQUIRE SHARES OF THE COMPANY'S COMMON STOCK WILL RESULT IN DILUTION TO OTHER HOLDERS OF ITS COMMON STOCK. EVEN IF THE ACQUISITION OF CONTROL WOULD BE IN THE BEST INTERESTS OF ITS STOCKHOLDERS. THE BY-LAWS OF THE COMPANY HAVE BEEN RECENTLY AMENDED TO RESTRICT THE ABILITY OF STOCKHOLDERS TO PARTICIPATE IN THE ELECTION OF DIRECTORS AND THE PRESENTATION OF MATTERS AT STOCKHOLDER MEETINGS. FORWARD-LOOKING STATEMENTS SHOULD NOT BE RELIED ON BECAUSE THEY ARE INHERENTLY UNCERTAIN.

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1030839--2/13/2007--Synovics_Pharmaceuticals