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Calypte Announces Fourth Quarter and Year-End Financial Results; Adds Planned Parenthood Golden Gate to Customer Base.


Business Editors/Medical Writers

ALAMEDA Alameda (ăləmē`də, –mā`də), city (1990 pop. 76,459), Alameda co., W central Calif., on an island just off the eastern shore of San Francisco Bay; settled 1850, inc. as a city 1884. , Calif.--(BUSINESS WIRE)--Feb. 27, 2003

Calypte Calypte is a genus of hummingbirds. It consists of two small species.

They are:
  • Anna's Hummingbird, Calypte anna
  • Costa's Hummingbird, Calypte costae
References:
"National Geographic"
 Biomedical bi·o·med·i·cal
adj.
1. Of or relating to biomedicine.

2. Of, relating to, or involving biological, medical, and physical sciences.
 Corporation (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
:CALY), the developer and marketer of the only two FDA-approved HIV-1 antibody antibody, protein produced by the immune system (see immunity) in response to the presence in the body of antigens: foreign proteins or polysaccharides such as bacteria, bacterial toxins, viruses, or other cells or proteins.  tests that can be used on urine urine, clear, amber-colored fluid formed by the kidneys that carries metabolic wastes out of the body (see urinary system). As the blood circulates it collects excretory products from the tissues and these substances are separated from the blood by the kidneys and  samples, as well as an FDA-approved serum HIV-1 antibody Western Blot Western blot
A technique developed in 1979 that is used to confirm ELISA results. HIV antigen is purified by electrophoresis and attached by blotting to a nylon or nitrocellulose filter.
 supplemental test, announces financial results for the fourth quarter and year ended December December: see month.  31, 2002.

Recent Highlights

During the second half of 2002 and in first part of 2003, Calypte's management team has moved forward with its objective to advance sales growth by increasing product distribution and gaining further acceptance in the marketplace. Recent highlights include:
-- Achieved sequential-quarterly revenue growth of 64% from $493,000 to $809,000 in the fourth quarter.

-- As announced today, added Planned Parenthood Golden Gate to the growing list of customers utilizing Calypte's urine HIV-1 tests. As one of the larger Planned Parenthood affiliates, this relationship represents an excellent opportunity to demonstrate the benefits of urine testing to other Planned Parenthood chapters and similar organizations.

-- Qualified for distribution in the state of California by PathNet Esoteric Laboratory Institute, which specializes in pathology, cytopathology and amplified esoteric sexually transmitted disease (STD) testing for numerous women's healthcare providers. Calypte and PathNet intend to work together to develop and implement outreach programs to notify PathNet's clients and other healthcare providers about the test availability.

-- Received its first and second commercial orders from its Chinese distributor for a total of over 260,000 tests. The first order for 100,000 tests was received in October and shipped in December and the second order for 160,000 tests was received in January 2003, sooner than anticipated, and will be shipped in the next several weeks.

-- Executed a Memorandum of Understanding with the Safe Blood for Africa Foundation to market and distribute Calypte's urine-based HIV-1 antibody tests and Serum Western Blot tests in sub-Saharan Africa. The tests are to be used as blood donor pre-screening tools in Safe Blood for Africa Foundation's mission to help prevent the spread of HIV/AIDS throughout 34 countries in sub-Saharan Africa.

-- Joined the Community Healthcare Network's (CHN) menu of testing services. CHN, a not-for-profit organization, oversees a network of nine health care centers and three mobile vans, which reach over 60,000 individuals and their families in New York City annually.

-- The U.S. Food and Drug Administration (FDA) eliminated the requirement for lot release testing for the Calypte HIV-1 Urine EIA, as the result of a demonstrated multi-year history of successful product manufacture. Elimination of the FDA lot release testing is expected to reduce the production-to-market time by two to eight weeks and decrease associated production costs without sacrificing any product quality. A similar elimination of FDA lot release testing for the Cambridge Biotech HIV-1 Urine Western Blot is also being sought by the company.

-- Gained recognition for Calypte's test in a study led by Johns Hopkins University that concluded urine-based HIV screening can be an effective tool for identifying and treating infected persons in high-prevalence inner city communities, and leads to increased voluntary HIV testing versus testing for HIV with blood samples. The test was published in the December 2002 JAIDS Journal of Acquired Immune Deficiency Syndromes.

-- Increased government relations expertise by hiring Dr. Richard George, a CDC and HIV veteran, to spearhead global programs to increase awareness of the importance of HIV testing, highlight the benefits of urine-based testing, develop HIV testing programs and secure capital to fund programs with public sector and government-sponsored agencies.

-- Appointed Ms. Dian Harrison, CEO of Planned Parenthood Golden Gate Chapter, to the company's Board of Directors effective February 24, 2003. The company intends to utilize Ms. Harrison's experience educating and administering care in reproductive and general health issues.


"During the last quarter of 2002, we believe that our continued progress was evidenced by the increase in sequential One after the other in some consecutive order such as by name or number.  revenue and our expanded distribution channels," stated Anthony Cataldo, executive chairman of Calypte. "We believe that in the first half of 2003, Calypte will continue to build its distribution channels and sign on new customers, to provide future growth. As these customers generally need approximately six months to ramp up Ramp Up

To increase a company's operations in anticipation of increased demand.

Notes:
A company might 'ramp up' operations if they just signed a contract creating substantially more demand for their product.
See also: Demand, Economies of Scale
 and provide a normalized revenue, we hope to benefit during the second half of the year."

Nancy Katz Katz , Bernard 1911-2003.

German-born British physiologist. He shared a 1970 Nobel Prize for the study of nerve impulse transmission.
, Calypte's president and chief executive officer, stated, "Calypte has also made important strides operationally. As Calypte already has FDA-approved manufacturing facilities, during a review of production goals for our Rapid HIV-1 Test, which is under development, we determined that we will manufacture the test internally. Thus, we plan to utilize our expertise and strict quality controls, and we expect to increase efficiencies and rate of production. As our decision to manufacture our proposed Rapid HIV-1 Test internally will require us to obtain the necessary funding to purchase equipment and materials as well as time to finalize fi·nal·ize  
tr.v. fi·nal·ized, fi·nal·iz·ing, fi·nal·iz·es
To put into final form; complete or conclude: "They have jointly agreed ...
 product design, we have delayed our IDE (1) (Integrated Development Environment) A set of programs run from a single user interface. For example, programming languages often include a text editor, compiler and debugger, which are all activated and function from a common menu.  submission. However, we believe this strategy and these initial capital investments will provide significantly greater long-term Long-term

Three or more years. In the context of accounting, more than 1 year.


long-term

1. Of or relating to a gain or loss in the value of a security that has been held over a specific length of time. Compare short-term.
 return and margins on the Rapid product once developed."

Cataldo continued, "Our long-term goal is to maximize the potential of our core urine-based testing solutions. We have built a foundation with our urine HIV-1 screening and confirmatory tests. Now, one of our highest priorities is to secure the necessary funding to complete our Rapid HIV-1 Urine Test IDE submission and to be able to meet our current manufacturing requirements for our FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 approved products. Upon filing the IDE, we intend to launch the Rapid Test internationally, which is our largest target market. At the same time, we intend to pursue FDA clearance to distribute the Rapid Test product domestically. We can begin clinical trials 30 days after our IDE submission, and from there we would anticipate receiving FDA clearance in 12-18 months, allowing 6-12 months for our trials and a maximum of 6 months for the FDA's review process. We will also simultaneously continue our research and development of tests in the areas of infectious and other diseases."

For the fourth quarter ended December 31, 2002, Calypte recorded revenues of $809,000, compared with $2.3 million in the fourth quarter of 2001. The net loss attributable attributable

emanating from or pertaining to attribute.


attributable proportion
see attributable risk (below).

attributable risk
 to common stockholders for the quarter was approximately $6.3 million, or $0.05 per common share, compared with a net loss attributable to common stockholders of $1.2 million, or $0.03 per common share, for the three months ended December 31, 2001. The net loss for the fourth quarter ended December 31, 2002 included $3.6 million in non-cash charges Non-Cash Charge

A charge off, made by a company against earnings, that does not require an initial outlay of cash.

Notes:
Non-cash charges are typically against the depreciation, amortization, and depletion accounts on a company's balance sheet.
 related the grants of common stock and fully vested vested adj. referring to having an absolute right or title, when previously the holder of the right or title only had an expectation. Examples: after 20 years of employment Larry Loyal's pension rights are now vested. (See: vest, vested remainder)  options and warrants as compensation for services that are included in selling, general and administrative expenses and non-cash interest expense. During the quarter ended December 31, 2001, there was less than $0.1 million in non-cash charges.

For the year-ended December 31, 2002, Calypte reported revenues of $3.7 million, compared with $6.8 million in 2001. The net loss attributable to common stockholders for 2002 was $13.4 million, or $0.17 per common share, compared with a net loss attributable to common stockholders of $9.2 million, or $0.30 per common share, for the year ended December 31, 2001. Calypte's 2002 operations and results were significantly impacted by the second quarter decision that resulted in an almost-complete wind down of its operations due to insufficient cash to fund continuing operations continuing operations

Parts of a business that are expected to be maintained as an ongoing segment of an overall business operation. Income and losses from continuing operations are reported separately if any segments have been discontinued during the
. This decrease also reflects lower revenues, increased non-cash-operating expenses, and an increase in non-cash interest expense related to the financings, offset by extraordinary income related to the extinguishment The destruction or cancellation of a right, a power, a contract, or an estate.

Extinguishment is sometimes confused with merger, though there is a clear distinction between them.
 of debt. The net loss for the year-ended December 31, 2002 included $5.1 million in non-cash charges related to the grants of common stock and fully vested options and warrants as compensation for services that are included in selling, general and administrative expenses and non-cash interest expense. During the year ended December 31, 2001 these non-cash charges were approximately $1.6 million.

Calypte will hold a conference call today at 11:00 a.m. (ET), 8:00 a.m. (PT). Investors can access the call from the investor section of the Calypte web site, www.calypte.com. Investors in the U.S. and Canada Canada (kăn`ədə), independent nation (2001 pop. 30,007,094), 3,851,787 sq mi (9,976,128 sq km), N North America. Canada occupies all of North America N of the United States (and E of Alaska) except for Greenland and the French islands of  interested in participating in the conference call may dial (877) 282-0743 and reference the Calypte Biomedical call. International investors may dial (703) 871-3073. Calypte recommends dialing into the call approximately 10 minutes prior to the scheduled start time. The webcast will be available until March 27, 2003. A telephone replay will be available through March 1, 2003 by calling (888) 266-2081. International callers should dial (703) 925-2533 for the replay. The replay confirmation code is 6411592.

About Calypte Biomedical

Calypte Biomedical Corporation, headquartered in Alameda, California Alameda is a city in Alameda County, California, United States. It is located on a small island of the same name next to Oakland, California in the San Francisco Bay. An additional part of the city is Bay Farm Island, which is adjacent to the Oakland International Airport. , is a public healthcare company dedicated to the development and commercialization of urine-based diagnostic products and services for Human Immunodeficiency Virus human immunodeficiency virus
n.
HIV.


Human immunodeficiency virus (HIV)
A transmissible retrovirus that causes AIDS in humans.
 Type 1 (HIV-1), sexually transmitted diseases Sexually transmitted diseases

Infections that are acquired and transmitted by sexual contact. Although virtually any infection may be transmitted during intimate contact, the term sexually transmitted disease is restricted to conditions that are largely
 and other infectious diseases infectious diseases: see communicable diseases. . Calypte's tests include the screening EIA (Electronic Industries Alliance, Arlington, VA, www.eia.org) A membership organization founded in 1924 as the Radio Manufacturing Association. It sets standards for consumer products and electronic components.  and supplemental Western Blot tests Western blot test
n.
A serum electrophoretic analysis used to identify proteins.
, the only two FDA-approved HIV-1 antibody tests that can be used on urine samples, as well as an FDA-approved serum HIV-1 antibody Western Blot test. The company believes that accurate, non-invasive Non-invasive
A procedure that does not penetrate the body.

Mentioned in: Multiple-Gated Acquisition Scan


non-invasive

1. not penetrating the skin, e.g. a non-invasive test.

2.
 urine-based testing methods for HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States.  and other infectious diseases may make important contributions to public health by helping to foster an environment in which testing may be done safely, economically ec·o·nom·i·cal  
adj.
1. Prudent and thrifty in management; not wasteful or extravagant. See Synonyms at sparing.

2. Intended to save money, as by efficient operation or elimination of unnecessary features; economic:
, and painlessly pain·less  
adj.
Free from complication or pain: a painless operation.



painless·ly adv.
. Calypte markets its products in countries worldwide through international distributors and strategic partners. Refer to current product package inserts package insert Pharmacology A synopsis of key physicochemical, pharmacologic, clinical efficacy, and clinical safety properties of a prescription drug, bundled therewith, intended to be highly readable and helpful to clinicians looking for specific  for complete information on product performance characteristics.

Statements in this press release that are not historical facts are forward-looking statements forward-looking statement

A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections.
 within the meaning of the Securities Act of 1933, as amended a·mend  
v. a·mend·ed, a·mend·ing, a·mends

v.tr.
1. To change for the better; improve: amended the earlier proposal so as to make it more comprehensive.

2.
. Those statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements reflect management's current views, are based on certain assumptions and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to, our ability to obtain additional financing and access funds from our existing financing arrangements that will allow us to continue our current and future operations and whether demand for our product and testing service in domestic and international markets will continue and expand. The Company undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances CIRCUMSTANCES, evidence. The particulars which accompany a fact.
     2. The facts proved are either possible or impossible, ordinary and probable, or extraordinary and improbable, recent or ancient; they may have happened near us, or afar off; they are public or
 that occur after the date hereof here·of  
adv.
Of this.


hereof
Adverb

Formal or law of or concerning this

Adv. 1. hereof - of or concerning this; "the twigs hereof are physic"
 or to reflect any change in the Company's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact the Company's success are more fully disclosed in the Company's most recent public filings with the U.S. Securities and Exchange Commission ("SEC"), including its annual report on Form 10-K/A (No.3) for the year ended December 31, 2001 and its subsequent filings with the SEC.


             CALYPTE BIOMEDICAL CORPORATION AND SUBSIDIARY
                 CONSOLIDATED STATEMENTS OF OPERATIONS
                 (in thousands, except per share data)
                               Unaudited

                                Three Months Ended     Year Ended
                                    December 31,       December 31,
                                 ----------------- -------------------
                                   2002     2001     2002       2001
                                 -------- -------- --------- ---------
 Revenues:
    Product sales                   $809   $2,347    $3,670    $6,826
                                 -------- -------- --------- ---------

    Cost of product sales          1,592    1,768     6,162     6,986
                                 -------- -------- --------- ---------
        Gross Margin (Loss) on
         product sales              (783)     579    (2,492)     (160)

 Other operating expenses:
    Research and development
     costs                           289      344       929     1,546
    Selling, general and
     administrative costs          4,139    1,397     9,006     6,740
                                 -------- -------- --------- ---------
        Total other operating
         expenses                  4,428    1,741     9,935     8,286
                                 -------- -------- --------- ---------
           Loss from operations   (5,211)  (1,162)  (12,427)   (8,446)

 Interest income                       -        1         3         9
 Interest expense                   (114)     (16)     (331)      (55)
 Non-cash interest expense          (880)       -    (1,875)   (1,318)
 Other income (expense)              (17)      15        16       539
                                 -------- -------- --------- ---------
           Loss before income
            taxes                 (6,222)  (1,162)  (14,614)   (9,271)

 Income taxes                          -        -        (2)       (2)
                                 -------- -------- --------- ---------

           Net loss before
            extraordinary item    (6,222)  (1,162)  (14,616)   (9,273)

 Extraordinary gain on
  extinguishment of debt, net of
  income taxes                         -        -     1,319         -
 Extraordinary gain on
  repurchase of beneficial
  conversion feature, net of
  income taxes                         -        -         -       145
                                 -------- -------- --------- ---------
           Net loss               (6,222)  (1,162)  (13,297)   (9,128)

 Less dividends on mandatorily
  redeemable Series A preferred
  stock                              (30)     (30)     (120)     (120)
                                 -------- -------- --------- ---------

 Net loss attributable to common
  stockholders                   $(6,252) $(1,192) $(13,417)  $(9,248)
                                 ======== ======== ========= =========
 Net loss per share attributable
  to common stockholders (basic
  and diluted)                    $(0.05)  $(0.03)   $(0.17)   $(0.30)
                                 ======== ======== ========= =========

 Weighted average shares used to
  compute net loss per share
  attributable to common
  stockholders (basic and
  diluted)                       121,613   35,527    77,737    30,928
                                 ======== ======== ========= =========


             CALYPTE BIOMEDICAL CORPORATION AND SUBSIDIARY
                    CONSOLIDATED BALANCE SHEET DATA
                            (in thousands)
                               Unaudited
                                             December 31, December 31,
                                                2002         2001
                                            ------------ -------------

 Cash and cash equivalents                         $147          $287
 Working capital                                 (3,887)       (4,289)
 Total Assets                                     3,297         4,262
 Current notes payable, net of
  discount                                          519           411
 Long-term portion of capital
  lease obligations                                  13            22
 Non-current convertible notes and
  debentures, net of discount of $2,638 at
  December 31, 2002                               1,662             -
 Mandatorily redeemable Series A
  preferred stock                                 2,576         2,456
 Total stockholders' equity                      (7,494)       (5,500)
COPYRIGHT 2003 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2003, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Feb 27, 2003
Words:2159
Previous Article:Arotech Corporation Posts Record Year End and Fourth Quarter 2002 Revenues with Sharp Reduction in Loss Per Share.
Next Article:Planned Parenthood Golden Gate to Offer Calypte's Urine HIV-1 Antibody Tests; Earnings Results Conference Call to be Conducted Today.
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