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PROSPECTUS SUMMARY THE FOLLOWING SUMMARY HIGHLIGHTS SELECTED INFORMATION CONTAINED ELSEWHERE IN THIS PROSPECTUS OR INCORPORATED BY REFERENCE IN THIS PROSPECTUS. THIS SUMMARY DOES NOT CONTAIN ALL OF THE INFORMATION THAT YOU SHOULD CONSIDER BEFORE INVESTING IN OUR COMMON STOCK. YOU SHOULD READ THE ENTIRE PROSPECTUS CAREFULLY, ESPECIALLY THE DISCUSSION REGARDING THE RISKS OF INVESTING IN THE COMMON STOCK OF CALYPTE BIOMEDICAL CORPORATION UNDER THE SECTION ENTITLED "RISK FACTORS," BEFORE INVESTING IN CALYPTE BIOMEDICAL CORPORATION'S COMMON STOCK. REFERENCES IN THIS PROSPECTUS TO "WE," "US" AND "OUR" REFER TO CALYPTE BIOMEDICAL CORPORATION, A DELAWARE CORPORATION.
ABOUT CALYPTE BIOMEDICAL CORPORATION We develop, manufacture, and distribute in vitro diagnostic tests, primarily for the diagnosis of Human Immunodeficiency Virus ("HIV") infection. Historically, we have manufactured and marketed urine-based HIV-1 diagnostic screening tests and urine and serum-based Western Blot supplemental tests for use in laboratories, which we refer to as our "Legacy Business." Since we began marketing our urine diagnostic testing products following their approval by the FDA and through the first quarter of 2005, our revenues have been almost exclusively generated from sales of these products. The Legacy Business tests are manufactured in formats that make them most suitable for high-volume laboratory settings. Over the last two years, however, we have been broadening our historical focus to include other HIV tests, such as a blood-based incidence test and various rapid tests using other specimens. In the last quarter of 2004, we introduced our HIV-1 BED incidence EIA test (the "BED Incidence Test") that detects HIV-1 infections that have occurred within approximately the prior 6 months and that can be used by public health agencies to identify those regions and the populations within those regions where HIV transmission is occurring most recently. We are currently focusing on the development and commercialization of our new test products for the rapid detection of antibodies to HIV-1 and HIV Type 2, a second type of HIV ("HIV-2"), in blood, oral fluid and urine samples using a lateral flow dipstick design (the "HIV-1/2 Rapid Tests") and the commercialization of the BED Incidence Test on a worldwide basis. Rapid tests provide test results in less than 20 minutes and are particularly suitable for point-of-care testing, especially in lesser developed countries which lack the medical infrastructure to support laboratory based testing. We have completed field trials of our HIV-1/2 Rapid Tests that have validated our prototype products. We have recently completed clinical trials in Uganda and China and are currently engaged in clinical trials in other countries in pursuit of regulatory approvals for these tests. In an effort to reduce our cash burn rate and prolong our resources, in April 2005 we announced our plans to restructure our business (the "Plan") to consolidate our domestic operations and focus our capital resources on the global commercialization of the HIV-1/2 Rapid Tests and the BED Incidence Test. As part of the Plan, we are discontinuing the production of our Legacy Business products currently manufactured at our facility in Rockville, Maryland. Pursuant to the Plan, we will pursue various options ranging from selling the Legacy Business to discontinuing manufacturing operations at the Rockville facility pending a final determination of its disposition. In furtherance of the Plan, on April 18, 2005, we entered into a non-binding letter of intent to sell the Legacy Business to Maxim Biomedical, Inc. ("Maxim"). Effective May 1, 2005, we entered into a manufacturing services and management agreement (the "Agreement") with Maxim pursuant to which Maxim will manufacture, ship and perform quality control procedures for us in connection with the Legacy Business. Pursuant to the Agreement, Maxim has the right, but not the obligation, to purchase the assets of the Legacy Business on terms to be negotiated between the parties. We will remain liable for our Rockville facility and equipment lease obligations, however, we expect to lower our operating expenses through this arrangement. Over the next couple of months, we expect to complete either the sale of the Legacy Business to Maxim or the closure of the Rockville facility and termination of Legacy Business operations as well as the transition of our corporate headquarters to the Portland, Oregon area. We will incur severance costs for certain personnel terminated at Rockville and certain administrative personnel not transitioning to Oregon. Our restructuring activities are expected to result in severance-related charges of approximately $500,000. We also expect to incur approximately $1 million in expenses from the write-down of inventory. We may also be liable for lease costs for the California offices through July 2007 in the event we are unable to sublease that facility. Upon successful completion of a sale of the Legacy Business, we believe that we will have significantly reduced our monthly operating burn rate as compared with historical levels. If we are unable to complete such a transaction, we may incur costs to decommission the Rockville facilities; on-going facility lease costs, until and unless sub-lease opportunities are available and on-going lease or lease termination costs associated with leased equipment. We cannot currently estimate those costs, but they will increase our cash burn rate in comparison with the sale alternative. Under either scenario, the revenue stream from our Legacy Business products will have been eliminated and we will rely on revenues from the sale of our BED Incidence Test and, following regulatory approvals, from the sale of our HIV 1-2 Rapid Tests internationally. We believe that the geographic consolidation of our domestic operations and the termination of our Legacy Business resulting from this restructuring will improve our operational efficiency, decrease our cash burn and permit us to concentrate on expediting the procedures necessary to commercialize the HIV1-2 Rapid Tests and thereby begin the process of building the revenue stream necessary to support our operations and achieve our financial objective of sustained profitable operations and increased stockholder value.
THE OFFERING Total shares of common stock outstanding 171,243,303 as of May 16, 2005 Common stock offered for resale to the public 39,588,810 shares, of which 25,523,006 have been issued to selling security holders and are included in our outstanding shares and 14,065,804 shares which may be issuable upon exercise of outstanding warrants, conversion of convertible debentures or pursuant to consulting contracts. All of the shares offered by this Prospectus are being sold by the selling security holders Risk factors The shares involve a high degree of risk. Investors should carefully consider the information set forth under "RISK FACTORS" beginning on page 5. Use of proceeds We will not receive any proceeds from the sale of our common stock offered through this Prospectus by the selling security holders. All proceeds from the sale of our common stock sold under this Prospectus will go to the selling security holders. We will, however, receive an aggregate of up to $6,889,514 if the selling security holders exercise all of their warrants to purchase common stock. We would expect to use any such proceeds for general corporate purposes. Determination of offering price This Prospectus may be used from time to time by the selling security holders who offer our common stock in transactions (which may include block transactions) at prevailing market prices at the time of sale, at prices related to the prevailing market prices, or at other negotiated prices. The selling security holders will act independently in determining the offering price of each sale. Trading symbol for our common stock HIV
RISK FACTORS YOU SHOULD CAREFULLY CONSIDER THE RISKS DESCRIBED BELOW BEFORE DECIDING TO INVEST IN OUR COMMON STOCK. AN INVESTMENT IN OUR COMMON STOCK INVOLVES A HIGH DEGREE OF RISK. THE RISKS AND UNCERTAINTIES DESCRIBED BELOW ARE NOT THE ONLY ONES WE FACE. ADDITIONAL RISKS AND UNCERTAINTIES NOT PRESENTLY KNOWN TO US OR THAT WE CURRENTLY DEEM IMMATERIAL MAY ALSO IMPAIR OUR BUSINESS, FINANCIAL CONDITION AND RESULTS OF OPERATIONS. IF ANY OF THE FOLLOWING RISKS ACTUALLY OCCUR, OUR BUSINESS, FINANCIAL CONDITION AND RESULTS OF OPERATIONS COULD BE HARMED. IN THAT CASE, THE TRADING PRICE OF OUR COMMON STOCK COULD DECLINE, AND YOU COULD LOSE ALL OR PART OF YOUR INVESTMENT. IN ASSESSING THESE RISKS, YOU SHOULD ALSO REFER TO THE OTHER INFORMATION INCLUDED OR INCORPORATED BY REFERENCE IN THIS PROSPECTUS, INCLUDING OUR FINANCIAL STATEMENTS AND THE NOTES THERETO. WE DISCLAIM ANY OBLIGATION TO UPDATE ANY FORWARD-LOOKING STATEMENTS CONTAINED HEREIN AFTER THE DATE OF THIS PROSPECTUS.
Gruß
C.O
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