899426--3/31/2008--CALYPTE_BIOMEDICAL

related topics

{stock, price, share}

{product, candidate, development}

{customer, product, revenue}

{product, liability, claim}

{operation, natural, condition}

{property, intellectual, protect}

{product, market, service}

{regulation, change, law}

{acquisition, growth, future}

{provision, law, control}

{control, financial, internal}

{tax, income, asset}

{personnel, key, retain}

{condition, economic, financial}

Risks Related to Our Financial Condition We Will Require Additional Financing to Sustain Our Operations and Without It, We May Have to Significantly Curtail the Scope of Our Operations and Alter Our Business Model. Our Financial Condition has Adversely Affected Our Ability to Pay Suppliers, Service Providers and Licensors on a Timely Basis Which May Jeopardize Our Ability to Continue Our Operations and to Maintain License Rights Necessary to Continue Shipments and Sales of Our Products. We Have an Operating History of Significant Losses and Expect Losses to Continue for the Near Future. We Have Federal and State Net Operating Losses and Research and Development Credits Which May Expire Before We Can Utilize Them. Risks Related to the Market for Our Common Stock The Sale of Our Common Stock to Fusion Capital May Cause Dilution to Our Current Stockholders and Fusion Capital s Sale of Common Stock May Cause the Price of Our Common Stock to Decline. The Significant Amount of Securities Issued in Recent Financings May Have a Negative Effect on the Market Price of Our Common Stock. We May Need our Stockholders to Authorize Additional Shares of Common Stock or a Reverse Split of Our Common Stock in the Near Future. Our Issuance of Warrants, Options and Stock Grants to Consultants for Services and the Granting of Registration Rights for the Underlying Shares of Common Stock May Have a Negative Effect on the Market Price of Our Common Stock. The Market Price of Our Common Stock Is Highly Volatile. Our Charter Documents May Inhibit a Takeover. We Have a Stockholder Rights Plan That Has Certain Anti-takeover Effects. Our Board has Certain Discretionary Rights With Respect to Our Preferred Stock That May Adversely Affect the Rights of our Common Stockholders. Our Common Stock is Subject to the Penny Stock Rules of the SEC and the Trading Market In Our Securities is Limited, Which Makes Transactions in Our Stock Cumbersome and May Reduce the Value of an Investment in Our Stock. Risks Related to Our Business A Viable Market for Our Products May Not Develop or We May Not Be Able to Successfully Develop and Market New Products That We Plan to Introduce. We are Dependent Upon Patents, Licenses and Other Proprietary Rights From Third Parties. Our Success Depends on Our Ability to Protect Our Proprietary Technologies. We May Need to Establish Additional Collaborative Agreements, and this Could Have a Negative Effect on Our Freedom to Operate Our Business or Profit Fully from Sales of Our Products. The Time Needed to Obtain Regulatory Approvals and Respond to Changes in Regulatory Requirements Could Adversely Affect Our Business. Failure to Comply With SFDA, FDA or Similar International Regulatory Bodies or Other Requirements May Require Us to Suspend Production of Our Products Which Could Result in a Loss of Revenues. We Engage Contract Manufacturers and Plan to Conduct International Manufacturing Operations to Produce Some of Our Products, Including Our Rapid Tests Currently Being Commercialized. We Rely on Sole Source Suppliers that We Cannot Quickly Replace for Certain Components Critical to the Manufacture of Our Products. We May Not Be Able to Retain and/or Attract Key Executives and Other Personnel. Our Research, Development and Commercialization Efforts May Not Succeed or Our Competitors May Develop and Commercialize More Effective or Successful Diagnostic Products. We Face Intense Competition in the Medical Diagnostic Products Market and Rapid Technological Advances by Competitors. Our Quarterly Results May Fluctuate Due to Certain Regulatory, Marketing and Competitive Factors Over Which We Have Little or No Control. The Success of Our Plans to Enter International Markets May Be Limited or Disrupted Due to Risks Related to International Trade and Marketing and the Capabilities of Our Distributors, Manufacturers and Joint Venture Partners. The Chinese Government Could Change Its Policies Toward Private Enterprises or Even Nationalize or Expropriate Them, Which Could Result in the Total Loss of Business in That Country. An Economic Downturn, Terrorist Attacks or Other Conditions Beyond Our Control May Adversely Affect Our Business or Our Customers May Not Be Able to Satisfy Their Contractual Obligations and We May Not Be Able to Deliver Our Products as a Result of the Impact of Conditions Such as Certain World Events or Natural Disasters. As a Small Manufacturer of Medical Diagnostic Products, We Are Exposed to Product Liability and Recall Risks For Which Insurance Coverage is Expensive, Limited and Potentially Inadequate.

Full 10-K form ▸

899426--3/31/2008--CALYPTE_BIOMEDICAL_CORP