Calypte Announces Second Quarter Financial Results; Company to Accelerate U.S. Studies of Rapid HIV Test.Business Editors & Health/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.--(BW HealthWire)--July 24, 2002 Calypte 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 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, today announced financial results for the second quarter and six months ended June 30, 2002. The net loss attributable to common stockholders for the quarter was $4.96 million, or $0.08 per common share, compared to a net loss of $2.84 million, or $0.10 per common share for the three months ended June 30, 2001. Revenues for the quarter totaled $1.2 million, versus revenues of $1.61 million for the same quarter last year. The loss from operations declined to $2.45 million from $2.62 million for the same quarter in 2001. For the six months ended June 30, 2002 the net loss attributable to common stockholders was $5.64 million, or $0.11 per common share, compared to a net loss of $6.4 million, or $0.23 per common share for the six months ended June 30, 2001. Revenues for the period totaled $2.36 million, versus revenues of $3.01 million for the same period last year. The loss from operations declined to $4.38 million from $5.66 million for the same period in 2001. Commenting on the second quarter results, Anthony Cataldo, Calypte's Executive Chairman, stated, "All things considered All Things Considered (ATC) is a news radio program in the United States, broadcast on the National Public Radio network. It was the first news program on the network, and is broadcast live worldwide through several outlets. , the results generated during the quarter are quite remarkable, especially when you take into consideration that mid-way through the quarter the company announced that it was winding down operations, laying off most of its workforce and contemplating bankruptcy bankruptcy, in law, settlement of the liabilities of a person or organization wholly or partially unable to meet financial obligations. The purposes are to distribute, through a court-appointed receiver, the bankrupt's assets equitably among creditors and, in most ." Company to Accelerate Development of Rapid Test Based upon the extremely positive reaction to the company's presentation of its research on the development of a new rapid urine-screening test for HIV-1 at the recently concluded AIDS 2002 Conference in Barcelona, Calypte will commence U.S. studies, along with international trials, in order to accelerate the approval process for this new test in the U.S. In one of our initial studies, results for this new test yielded 100 percent sensitivity and 100 percent specificity (no false positives and no false negatives). 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, "Without a doubt the Barcelona AIDS Conference was a huge success for the company. Not only was our research presentation on our rapid HIV test HIV test Various tests have been used to detect HIV and production of antibodies thereto; some HTs shown below are no longer actively used, but are listed for completeness and context. See HIV, Immunoblot. extremely well received, but we also had a constant flow of important visitors to our booth, most of whom expressed tremendous interest in our FDA-approved urine screening test. The conference provided us with global exposure for urine testing that would have taken us years to achieve even if we had an unlimited advertising budget. We have now definitely arrived on the world scene and intend to build upon what was accomplished at that conference." Highlights for the quarter include: -- Resumed production of its urine EIA Screening and urine and serum Western Blot supplemental confirmation tests and began shipping these products to customers. -- Signed a worldwide non-exclusive distribution agreement with Adaltis Inc. of Montreal, Canada for the distribution of Calypte's serum HIV-1 Western Blot test. -- Strengthened financial condition with $3 million in new funds. -- Executed an agreement with Marukin Diagnostics, Inc. of Berkeley, California for the distribution of Marukin's urinary bile acid sulfate (UBAS) assay. -- Appointed Dr. Luc Montagnier, co-discoverer of HIV-1 and HIV-2 and president of the World Foundation for AIDS Research and Prevention, as a consultant to the company and to assist Calypte in continuing to obtain approvals worldwide for its HIV-1 urine screening test and newly developed rapid urine based screening test. All references to "earnings per share" set forth in this press release are diluted earnings per share diluted earnings per share An earnings measure calculated by dividing net income less preferred stock dividends for a period by the average number of shares of common stock that would be outstanding if all convertible securities were converted into shares of as defined within the Statement of Financial Accounting Standards No. 128. 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, and painlessly pain·less adj. Free from complication or pain: a painless operation. pain  less·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 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, 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 Six Months Ended
June 30, June 30,
----------------- -----------------
2002 2001 2002 2001
----------------- -----------------
Revenues:
Product sales $ 1,209 $ 1,612 $ 2,368 $ 3,014
--------- --------- -------- --------
Cost of product sales 1,397 1,743 3,027 3,732
--------- --------- -------- --------
Gross Margin (Loss) on
product sales (188) (131) (659) (718)
Other operating expenses:
Research and development costs 180 354 421 851
Selling, general and
administrative costs 2,087 2,138 3,302 4,094
--------- --------- -------- --------
Total other operating expenses 2,267 2,492 3,723 4,945
--------- --------- -------- --------
Loss from operations (2,455) (2,623) (4,382) (5,663)
Interest income 1 1 2 7
Interest expense (46) (8) (67) (33)
Non-cash interest expense (2,446) (830) (2,472) (1,318)
Other income (expense) 14 501 22 524
--------- --------- -------- --------
Loss before income taxes (4,932) (2,959) (6,897) (6,483)
Income taxes -- -- (2) (2)
--------- --------- -------- --------
Net loss before
extraordinary item (4,932) (2,959) (6,899) (6,485)
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 -- 145
--------- --------- -------- --------
Net loss (4,932) (2,814) (5,580) (6,340)
Less dividends on mandatorily
redeemable Series A preferred
stock (30) (30) (60) (60)
--------- --------- -------- --------
Net loss attributable to common
stockholders $(4,962) $(2,844) $(5,640) $(6,400)
========= ========= ======== ========
Net loss per share attributable
to common stockholders
(basic and diluted) $ (0.08) $ (0.10) $ (0.11) $ (0.23)
========= ========= ======== ========
Weighted average shares used to
compute net loss per share
attributable to common
stockholders (basic and diluted) 58,434 29,070 49,564 27,451
========= ========= ======== ========
CALYPTE BIOMEDICAL CORPORATION AND SUBSIDIARY
CONSOLIDATED BALANCE SHEET DATA
(in thousands)
Unaudited
June 30, December 31,
2002 2001
Cash, cash equivalents, and restricted cash $ 395 $ 287
Working capital (3,376) (4,289)
Total Assets 3,036 4,262
Current notes payable, net of discount 505 411
Long-term portion of capital lease obligations 18 22
Non-current convertible notes and debentures,
net of discount of $2,366 at June 30, 2002 184 --
Mandatorily redeemable Series A preferred stock 2,516 2,456
Total stockholders' equity (7,514) (5,500)
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