Calypte Reports Third Quarter 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)--Nov. 2, 2000 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 (Nasdaq: CALY) announced today its third quarter results for the period ending September 30, 2000. Revenues for the three months ended September 30, 2000 were $1,077,000, flat as compared to revenue of $1,077,000 for the three months ended September 30, 1999. Revenues for the nine months ended September 30, 2000 were $2,962,000 compared to $2,825,000 for the nine months ended September 30, 1999, an increase of 5%. The net loss attributable to common stockholders for the third quarter of 2000 was $3.0 million, or a net loss attributable to common stockholders of $0.12 per share, compared with a net loss attributable to common stockholders of $2.3 million, or a net loss attributable to common stockholders of $0.12 per share for the third quarter of 1999. The net loss attributable to common stockholders for the nine months ended September 30, 2000 was $8.5 million or $0.36 per share, compared with a net loss attributable to common stockholders for the nine months ended September 30, 1999 of $7.6 million or $0.40 per share. Although revenues were unchanged as compared to the third quarter of 1999, the Company noted that its product mix had changed considerably, making comparisons with the third quarter in 1999 difficult. Overall, as compared to the results of 1999, sales of Calypte's 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 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. tests increased significantly, reflecting an increase in domestic and international demand for EIA screening tests. Revenues from Calypte's urine HIV-1 EIA screening test increased nearly three-fold, or 181%, as compared to the third quarter 1999, including the impact of revenues from the first orders from the Company's Sub-Saharan African distributor, American Edge Medical Company. Similarly, sales of the urine HIV-1 EIA screening test increased 62% in 2000 as compared to the first nine months of 1999. Additionally, third quarter 2000 sales of Calypte's EIA screening test to domestic reference labs servicing the life insurance industry doubled as compared to third quarter 1999 levels. Revenues from the sale of supplemental tests and related products slowed as compared to supplemental test sales in 1999. Supplemental test sales were reduced to half of the level achieved in the third quarter 1999. Calypte believes the decrease is due primarily to a change in the timing of an annual customer purchase. Supplemental test sales decreased by 16% for the first three quarters of 2000 as compared to revenues for the same period in 1999. The shift in product mix reflects the Company's increasing focus on penetrating penetrating breaching the tissues of the body. key regions in the international marketplace as well as the change in order timing. Traditionally, sales of supplemental tests have been largely attributable to demand from domestic insurance companies, as opposed to international distributors who have largely favored the Company's urine HIV-1 EIA test. As Calypte continues to shift its sales focus toward international markets, Calypte believes demand for its urine HIV-1 EIA product will continue to trend upward. 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, "I am very pleased with our overall performance for the quarter. We achieved important milestones this quarter, as we began shipping to 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. and also announced the expansion of interest in our innovative mobile HIV-1 antibody urine-testing program from South Africa to 41 countries in sub-Saharan Africa. In August, we received approval for our urine-based HIV-1 antibody test for use in the PRC, making it the only urine-based HIV-1 test approved for distribution in China. We expect to realize revenues from sales to China beginning in the fourth quarter. Currently, a 180 person sales force is completing its training, and our product will be officially launched in the PRC during the fourth quarter. "To keep up with increased sales volume and facilitate our shift to the international market, direct costs associated with higher product sales and the allocation The apportionment or designation of an item for a specific purpose or to a particular place. In the law of trusts, the allocation of cash dividends earned by a stock that makes up the principal of a trust for a beneficiary usually means that the dividends will be treated as of additional resources to improve our sales and marketing effort overseas resulted in an increase in selling, general and administrative expenses and product costs. Additionally, while we await AWAIT, crim. law. Seems to signify what is now understood by lying in wait, or way-laying. final approval from the 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. to ship commercial products from our Alameda facility, we continue to incur To become subject to and liable for; to have liabilities imposed by act or operation of law. Expenses are incurred, for example, when the legal obligation to pay them arises. An individual incurs a liability when a money judgment is rendered against him or her by a court. redundant costs to operate and validate To prove something to be sound or logical. Also to certify conformance to a standard. Contrast with "verify," which means to prove something to be correct. For example, data entry validity checking determines whether the data make sense (numbers fall within a range, numeric data processes there." Ms. Katz added, "We have made progress in ramping up sales to insurance companies this quarter as new insurance companies agreed to begin using our urine products and existing customers increased the volume of their orders. We expect that some of our large insurance customers will expand the use of urine testing 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. within the next few quarters, which could provide some upside Upside The potential dollar amount by which the market or a stock could rise. Notes: This is basically an educated guess on how high a stock could go in the near future. See also: Bull, Downside revenue potential. We recognize that the sales and marketing efforts for the Sentinel testing service have been disappointing and are currently exploring new approaches to market and sell the Sentinel testing service." New Products During the quarter, management began work on securing agreements to expand the company's urine-based product offerings. Today Calypte announced the signing of an agreement with Marukin Diagnostics Inc., marking the first step toward Calypte becoming the exclusive distributor of Marukin's Urinary urinary /uri·nary/ (u´ri-nar?e) pertaining to, containing, or secreting urine. u·ri·nar·y adj. 1. Relating to urine and its production, function, or excretion. 2. Total 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. Sulfate sulfate, chemical compound containing the sulfate (SO4) radical. Sulfates are salts or esters of sulfuric acid, H2SO4, formed by replacing one or both of the hydrogens with a metal (e.g., sodium) or a radical (e.g., ammonium or ethyl). (UBAS UBAS Urea Based Ammonia System UBAS Under Bonnet Alarm Switch ) Assay in the U.S. and Canadian insurance markets. In the insurance sector, Marukin's UBAS assay would be a natural complement to Calypte's HIV-1 Antibody urine test. The availability of the Marukin test will make urine a more broad-based testing application, making it possible to use a single urine specimen SPECIMEN. A sample; a part of something by which the other may be known. 2. The act of congress of July 4, 1836, section 6, requires the inventor or discoverer of an invention or discovery to accompany his petition and specification for a patent with specimens to test for HIV-1 antibody, cotinine cotinine (kō´tinēn), n a substance that remains in body fluids after nicotine has been used. Presence of this chemical in body fluids is considered proof of recent nicotine use. , illegal drugs and now liver function, faster, easier and more cost-effectively than ever before. Calypte also announced today that it will collaborate with the Osborn Scientific Group to develop two urine-based rapid HIV antibody HIV antibody A self antibody specifically directed against one or more proteins or antigens on the surface of HIV, which may be minimally protective against HIV tests. Once the assays are completed and have received regulatory clearance, Calypte and Osborn expect the products to be the first urine-based rapid HIV antibody tests on the market. In addition to the Marukin and Osborn Tests, Calypte is currently exploring the development of an over-the-counter product for the domestic market, and negotiations are also underway for the development of several other new products, including a second EIA which will be targeted towards the international marketplace. Fundraising
As mentioned previously, to continue to execute on its aggressive growth plans and fund new product development, Calypte is currently engaged in negotiations to raise additional capital, which it expects to be completed by the end of the fourth quarter of 2000. "During the third quarter we continued to focus on growing the top line of our business and were successful in achieving many of the milestones we had articulated ar·tic·u·la·ted adj. Characterized by or having articulations; jointed. earlier in the year. I expect continued progress in meeting our goals during the remainder of 2000. With the commencement of sales to South Africa and the launch of our products in China, we expect an increase in our international sales in the fourth quarter. We believe that today's announcements of the Marukin Total Bile Acid Sulfate Assay and the Osborn rapid tests underscore The underscore character (_) is often used to make file, field and variable names more readable when blank spaces are not allowed. For example, NOVEL_1A.DOC, FIRST_NAME and Start_Routine. (character) underscore - _, ASCII 95. our potential for making significant headway head·way n. 1. Forward movement or the rate of forward movement, especially of a ship. 2. Progress toward a goal. 3. The clear vertical space beneath a ceiling or archway; clearance. 4. in the development of new products for both the international and domestic markets. We are pleased with the success of the Needlestick Prevention Bill and AIDS funding legislation, which can potentially generate additional market opportunities for Calypte in the domestic healthcare market. As we move into the fourth quarter and look ahead into 2001, I believe that we will see an acceleration in Calypte's top line growth as a result of the important milestones we have achieved in 2000," Ms. Katz concluded. 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 chronic illnesses. Calypte's tests include the screening EIA and supplemental Western Blot tests Western blot test n. A serum electrophoretic analysis used to identify proteins. , the only two FDA-licensed HIV-1 antibody tests that can be used on urine samples. The company believes that accurate, non-invasive urine-based testing methods for HIV and other chronic 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
sells its products in over 40 countries worldwide through international
distributors and strategic partners.Calypte Biomedical has scheduled a conference call to discuss financial results for the third quarter of 2000 at 11:00 AM (EST EST electroshock therapy. EST abbr. electroshock therapy ) on Friday, November 3, 2000. All interested parties are invited to listen to this call. To listen to the call from the US, please dial 1-800-530-8983 and ask to be connected to the Calypte conference call. International callers please dial 212-346-0300. This conference call will also be webcast on the Internet. 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 Friday, November 3, 2000 until Friday, November 10, 2000 at 1:00 PM (EST). To access the rebroadcast domestically, please dial: 800-633-8284, reservation #: 16658498. 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. 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 the development, regulatory approval and market adoption of the Marukin Total Bile Acid Sulfate Assay and the Osborn rapid tests and our urine HIV-1 EIA screening and supplemental tests, our expectations for sales overseas including but not limited to Sub-Saharan Africa and China, the effect of the Needlestick Prevention Bill and AIDS funding legislation on our markets, the success of our fundraising efforts and the timing and effect of FDA inspections of our facilities. 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, Calypte's ability, directly or through third parties, to successfully manufacture and market the HIV-1 urine testing products and to develop and gain regulatory approval for our new products, the development of the infrastructure necessary to support our marketing and sales efforts in overseas markets and the ability of the Company to continue to finance its operations and to enter into distribution and marketing arrangements. 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.
CALYPTE BIOMEDICAL CORPORATION AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(Unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
---------------------------------------------
2000 1999 2000 1999
---------------------------------------------
Revenues:
Product sales $1,077 $1,077 $2,962 $2,825
------ ------ ------ ------
Operating expenses:
Product costs 1,771 1,266 4,495 3,382
Research and
development costs 481 864 1,597 3,437
Selling, general and
administrative
costs 1,915 1,317 5,437 3,663
------ ------ ------ ------
Total expenses 4,167 3,447 11,529 10,482
------ ------ ------ ------
Loss from
operations (3,090) (2,370) (8,567) (7,657)
Interest income, interest
expense, and other income 61 45 158 143
------ ------ ------ ------
Loss before
income taxes (3,029) (2,325) (8,409) (7,514)
Income taxes - - (2) (2)
------ ------ ------ ------
Net loss (3,029) (2,325) (8,411) (7,516)
Less dividends on mandatorily
redeemable Series A
preferred stock (30) (30) (90) (90)
Net loss attributable to
common stockholders $(3,059) $(2,355) $(8,501) $(7,606)
====== ====== ====== ======
Net loss per share attributable
to common stockholders
(basic and
diluted) $ (0.12) $ (0.12) $ (0.36) $ (0.40)
====== ====== ====== ======
Weighted average shares used
to compute net
loss per share attributable
to common stockholders
(basic and
diluted) 24,969 20,399 23,362 18,966
====== ====== ====== ======
CALYPTE BIOMEDICAL CORPORATION AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(Unaudited)
September 30, December 31,
2000 1999
------------------------------
Cash, cash equivalents, and
restricted cash $3,945 $2,652
Securities available for sale - 503
Working capital 2,722 1,860
Total Assets 7,836 7,821
Current portion of notes payable 648 844
Long-term portion of note payable - -
Long-term portion of capital lease
obligations 104 50
Mandatorily redeemable Series A
preferred stock 2,306 2,216
Total stockholders' equity 2,041 1,330
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