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Calypte Reports Fourth Quarter and Year-End 2000 Results.


Business Editors

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)--March 2, 2001

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 (Nasdaq: CALY) announced today its fourth quarter and year-end year-end also year·end
n.
The end of a year.

adj.
Occurring or done at the end of the year: a year-end audit.

Noun 1.
 financial results for the period ending December December: see month.  31, 2000. Revenues for the three months ended December 31, 2000 were $576,000, as compared to $903,000 for the three months ended December 31, 1999. The net loss attributable to common stockholders for the fourth quarter was $3.8 million, or a net loss attributable to common stockholders of $0.15 per share, compared with a net loss attributable to common stockholders of $2.5 million, or a net loss attributable to common stockholders of $0.12 per share for the fourth quarter of 1999.

Revenues for the year ended December 31, 2000 were $3.3 million, as compared to $3.7 million for 1999. The net loss attributable to common stockholders for the year ended December 31, 2000 was $12.2 million and the net loss per share attributable to common stockholders for 2000 was $0.52, compared to a loss of $10.1 million and $0.52 per share for 1999. Cash balances on December 31, 2000 totaled $1.2 million. Overall, Calypte ended the year with $0.5 million in product backorders, bringing revenues essentially in line with revenues at year-end 1999.

Sales of Calypte's HIV-1 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.  screening test were essentially unchanged between 1999 and 2000. International sales of the Company's screening test were insignificant in 2000, but the Company expects such sales to constitute an increasing proportion of revenues in 2001 and thereafter now that it has received regulatory approval of its HIV-1 EIA product in countries such as the Republic of South Africa South Africa, Afrikaans Suid-Afrika, officially Republic of South Africa, republic (2005 est. pop. 44,344,000), 471,442 sq mi (1,221,037 sq km), S Africa. , the People's Republic People's Republic
n.
A political organization founded and controlled by a national Communist party.
 of China, and Malaysia Malaysia (məlā`zhə), independent federation (2005 est. pop. 23,953,000), 128,430 sq mi (332,633 sq km), Southeast Asia. The official capital and by far the largest city is Kuala Lumpur; Putrajaya is the adminstrative capital. . The Company is actively pursuing product approval in several other countries.

The impact of so-called so-called
adj.
1. Commonly called: "new buildings ... in so-called modern style" Graham Greene.

2.
 "Triple X" legislation, which essentially eliminated the availability of 30-year life insurance policies after 1999, caused noticeable increases in fourth quarter 1999 revenues as testing associated with final applications for 30-year policies was completed, making comparisons with the fourth quarter 1999 difficult. Sales of the Company's 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 tests declined in 2000 versus 1999, consistent with the trend Calypte has experienced for the past few years. The Company expects revenues from supplemental tests to increase in 2001, however, as a result of its recently signed agreement to supply Organon-Teknika with HIV-1 serum Western Blot tests Western blot test
n.
A serum electrophoretic analysis used to identify proteins.
.

Accomplishments for 2000

Nancy Katz Katz , Bernard 1911-2003.

German-born British physiologist. He shared a 1970 Nobel Prize for the study of nerve impulse transmission.
, President, Chief Executive Officer and Chief Financial Officer of Calypte, said, "Although I am disappointed with the financial results for the year, I believe that the strategic and operational milestones position us to realize our goals for 2001. Among many significant accomplishments, we achieved the following:
- We secured agreements in key countries - specifically China, Brazil and 40
countries throughout Sub-Saharan Africa, including South Africa, and most
recently Malaysia - and we're shipping product to South Africa and China, where
a 180-person sales force is marketing our product.

- We have secured export certificates from the FDA for our products from all
facilities and early in 2001 received final approval to begin manufacturing in
our Alameda facility. We closed our Berkeley facility at the end of February
2001.

- We were extremely active on the advocacy front and secured relationships with
Planned Parenthood, Whitman Walker Clinic and a variety of influential
community leaders and organizations, outreach that we believe enhanced our
visibility within important constituencies for Calypte. We also supported
legislation recently passed by Congress that requires Congress to update
existing standards to account for advances in safety technology, such as
Calypte's needleless HIV-1 urine screening test, that will help prevent
needlestick injuries to health care workers.

- In 2000, we made significant inroads with the domestic insurance marketplace.
We added major insurance companies to our customer list, including New York
Life, Cigna and Unum Provident.

- We secured a Memorandum of Understanding with Marukin Diagnostics Inc.,
positioning Calypte to become the exclusive distributor of Marukin's Urinary
Total Bile Acid Sulfate (UBAS) Assay in the insurance markets of the United
States and Canada. The Marukin test will make urine a more broad-based testing
application, so that a single urine specimen can be used to test for HIV-1
antibody, cotinine, illegal drugs and now liver function.

- On the new product front, in addition to the Marukin test, we also entered
into a collaboration with the Osborn Scientific Group to develop two
urine-based rapid HIV antibody tests, which are in the early stages of
development. We are also exploring additional new tests to identify other
infectious diseases that will be applicable to the domestic and international
markets."


Adjustment to Third Quarter Revenues

During the quarter ended September 30, 2000, the Company recognized $242,000 in product sales revenues which related to transactions with two customers. Upon further review of the transactions, it was determined that one transaction in the amount of $86,000 should be recognized in the Company's December 31, 2000 quarter and a second transaction in the amount of $156,000 should be recognized in the first quarter of 2001.

Accordingly, Calypte's previously reported results for the third quarter of fiscal 2000 have been restated. Third quarter revenues were revised from $1,077,000 to $835,000. The revision increased the net loss for the third quarter from $3,029,000 to $3,103,000 and increased the net loss per share from $0.12 to $0.13.

Goals for 2001

Ms. Katz continued, "Our accomplishments in 2000 put us in a position to achieve our primary objective for 2001: to grow revenue to between $7 million and $8 million. The first two months of 2001 have been strong for Calypte, giving us reason to be optimistic op·ti·mist  
n.
1. One who usually expects a favorable outcome.

2. A believer in philosophical optimism.



op
 about the prospects for growth throughout the year. We believe that the groundwork we established in 2000 will enable us to reach our revenue target, including the following:

- We began the year with backorders of $0.5 million and are capable

of meeting our orders with the expansion of our manufacturing

capacity in Alameda.

- We closed the Berkeley facility in February, which will provide

$500,000 in annual cost savings.

- In addition to existing contracts with insurance companies and

reference labs, we're contractually obligated ob·li·gate  
tr.v. ob·li·gat·ed, ob·li·gat·ing, ob·li·gates
1. To bind, compel, or constrain by a social, legal, or moral tie. See Synonyms at force.

2. To cause to be grateful or indebted; oblige.
 to ship one million

tests to China in 2001 and to provide Organon-Teknika's customers

with our product.

- Calypte is targeting opportunities in new international markets,

including Brazil, Mexico, Hungary, Thailand, France, the

Philippines and Korea. We are investigating a plan to begin

limited manufacturing operations Manufacturing operations concern the operation of a facility, as opposed to maintenance, supply and distribution, health, and safety, emergency response, human resources, security, information technology and other infrastructural support organizations.  in China.

- We are optimistic about achieving ISO (1) See ISO speed.

(2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI.
 Certification, which would

enable us to ship our products to Europe.

- We have also added six new sales professionals to support our

efforts in selling to the domestic market, bringing our sales

staff to nine.

- On the new product front, we expect to demonstrate the feasibility

and conduct clinical trials for an 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.  rapid test and other urine-

and serum-based diagnostic tests. We also expect to launch the

sale of bile acid bile acid /bile ac·id/ (bil as´id) any of the steroid acids derived from cholesterol; classified as primary, those synthesized in the liver, e.g.  salts assay in the U.S. in conjunction with

Marukin and hope to introduce additional new products by the end

of the year.

"The difference between achieving $7 million in revenue and $8 million in revenue by year-end will be a function of the milestones we accomplish, as I have just described. As we have stated in the past, we expect to achieve profitability by the end of 2002. I look forward to realizing the goals I have established for Calypte in 2001."

Calypte Biomedical Corporation (NASDAQ: CALY) 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 and supplemental Western Blot tests, the only two FDA-approved HIV-1 antibody 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. 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 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, and painlessly pain·less  
adj.
Free from complication or pain: a painless operation.



painless·ly adv.
. Calypte sells its products in over 40 countries worldwide through international distributors and strategic partners.

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.
, including statements regarding future revenues and sales projections, plans for new product developments, product development expenditures and shipments to international markets. 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 that will allow us to continue our current and future operations, our ability to draw down funds under our existing equity line of credit and debenture debenture (dəbĕn`chər), document acknowledging indebtedness. In Great Britain a debenture is practically the same as a bond, and debenture stock is similar to preferred stock.  agreements and whether demand for our product in domestic and international markets will continue to 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, including the periodic report on Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 for the year ended December 31, 2000.

Calypte Biomedical has scheduled a conference call to discuss financial results for the fourth quarter and year-end 2000 at 11:00 AM (EST EST electroshock therapy.

EST
abbr.
electroshock therapy
) on Monday, March 5, 2001. All interested parties are invited to listen to this call. To listen to the call from the US, please dial 1-800-252-8302 and ask to be connected to the Calypte conference call. International callers please dial 212-896-6112. This conference call will also be webcast on the Internet Internet

Publicly accessible computer network connecting many smaller networks from around the world. It grew out of a U.S. Defense Department program called ARPANET (Advanced Research Projects Agency Network), established in 1969 with connections between computers at the
. A link to a live broadcast of the call on the Internet can be found at "Investor" at www.calypte.com or the call can be accessed through Vcall's web site at www.vcall.com.

If you are unable to participate, a rebroadcast of the call will be available beginning 1:00 PM (EST) on Monday, March 5, 2001 until Monday, March 12, 2001 at 1:00 PM (EST). To access the rebroadcast domestically, please dial: 1- 800-633-8284, reservation #: 18174797. International callers please dial: 858-812-6440. To access a rebroadcast of the webcast, please visit "Investor" at www.calypte.com or visit www.vcall.com.


             CALYPTE BIOMEDICAL CORPORATION AND SUBSIDIARY

            CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
                 (in thousands, except per share data)
                              (Unaudited)

                           Three Months Ended          Year Ended
                               December 31,           December 31,
                        ---------------------   ---------------------
                            2000        1999        2000        1999
                        ---------   ---------   ---------   ---------
Revenues:
 Product sales          $     576   $     903   $   3,296   $   3,728
                        ---------   ---------   ---------   ---------
Operating expenses:
 Product costs              1,579       1,339       5,891       4,721
 Research and
  development costs           642         686       2,254       4,123
 Selling, general and
  administrative costs      2,131       1,418       7,568       5,081
                        ---------   ---------   ---------   ---------

  Total expenses            4,352       3,443      15,713      13,925
                        ---------   ---------   ---------   ---------

   Loss from operations    (3,776)     (2,540)    (12,417)    (10,197)

Interest income,
 interest expense,
 and other income              17          30         175         173
                        ---------   ---------   ---------   ---------

   Loss before
    income taxes           (3,759)     (2,510)    (12,242)    (10,024)

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

   Net loss                (3,759)     (2,510)    (12,244)    (10,026)

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

Net loss attributable
 to common stockholders $  (3,789)  $  (2,540)  $ (12,364)  $ (10,146)
                        =========   =========   =========   =========

Net loss per share
 attributable to
 common stockholders
 (basic and diluted)    $   (0.15)  $   (0.12)  $   (0.52)  $   (0.52)
                        =========   =========   =========   =========

Weighted average
 shares used to
 compute net loss per
 share attributable to
 common stockholders
 (basic and diluted)       25,341      20,422      23,859      19,333
                        =========   =========   =========   =========


            CALYPTE BIOMEDICAL CORPORATION AND SUBSIDIARY

              CONDENSED CONSOLIDATED BALANCE SHEET DATA
                           (in thousands)
                             (Unaudited)

                                             December 31, December 31,
                                                    2000         1999
                                             ------------ ------------
Cash, cash equivalents, and restricted cash       $ 1,203      $ 2,652
Securities available for sale                           -          503
Working capital (deficit)                            (875)       1,860
Total Assets                                        5,006        7,821
Current portion of notes payable                      471          844
Long-term portion of capital lease obligations         78           50
Mandatorily redeemable Series A preferred stock     2,336        2,216
Total stockholders' equity (deficit)               (1,531)       1,330
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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