Calypte Reports First Quarter 2001 Results.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.--(BUSINESS WIRE)--April 26, 2001 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 first quarter financial results for the period ending March 31, 2001. Revenues for the three months ended March 31, 2001 increased 27% to a record $1.4 million as compared to $1.1 million for the three months ended March 31, 2000. The net loss attributable to common stockholders for the first quarter was $3.6 million, or a net loss attributable to common stockholders of $0.14 per share, compared with a net loss attributable to common stockholders of $2.2 million, or a net loss attributable to common stockholders of $0.11 per share, for the first quarter of 2000. Calypte's increase in revenue during the first quarter was due primarily to an increase in sales of Calypte's HIV-1 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. serum assay. On a sequential basis, Calypte's first quarter 2001 loss of $3.6 million, or $0.14 per share, decreased slightly from a fourth quarter 2000 loss of $3.8 million, or $0.15 per share. On a sequential basis, Calypte's first quarter 2001 revenues exceeded fourth quarter 2000 reported revenues of $577,000 by 142%. Revenues from the sale of the Company's HIV-1 urine screening test and its supplemental Western Blot serum and urine tests all increased as compared to the prior quarter. During the first quarter, Calypte continued to build upon the solid foundation of international and domestic customer relationships it had established in 2000. On the domestic front, in February Calypte, operating under a Memorandum of Understanding A Memorandum of Understanding (MoU) is a legal document describing a bilateral or multilateral agreement between parties. It expresses a convergence of will between the parties, indicating an intended common line of action and may not imply a legal commitment. , began to manufacture HIV-1 Western Blot serum assay tests for sales to Organon or·ga·non or or·ga·num n. pl. or·ga·nons or or·ga·nums or or·ga·na 1. An organ. 2. A set of principles for use in scientific investigation. organon pl. organa [Gr.] organ. Teknika Corporation. The arrangement with Organon Teknika calls for significant volume going forward. In addition, Calypte announced in January that it had received final 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. approval to begin manufacturing at its Alameda facility, which led to the closing of its Berkeley facility at the end of February resulting in a substantial reduction in future overhead costs overhead costs see fixed costs. . Calypte also made significant progress in expanding its presence within international markets. Early in the quarter, the Company announced that its HIV-1 antibody urine test had been approved for distribution by the Ministry of Health in Malaysia. Calypte also announced that it had signed an agreement with Uni-Health Services Sdn., Bhd., to be the exclusive importer and distributor of Calypte's HIV-1 urine test within Malaysia. Uni-Health has indicated that it expects to commence product shipments from Calypte in the second quarter. Calypte is currently working to obtain regulatory approvals for distribution of its products in Brazil, Mexico, France, the Philippines and Korea. Of these countries, distributors have already been appointed in Brazil and South Korea, and most recently, in the second quarter, the Philippines. 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 Calypte enhanced its potential to extend its product reach to Europe when it announced late in the quarter that its Alameda, CA facility had received ISO 9001, EN 46001, and ISO 13485 certification. The awarding of ISO certification is a necessary predicate In programming, a statement that evaluates an expression and provides a true or false answer based on the condition of the data. to the marketing and distribution of Calypte's products throughout Europe. Termination of Wampole Agreement As of March 31, 2001, Calypte terminated its distribution agreement with Wampole Laboratories, a division of Carter-Wallace. The agreement had given Wampole the exclusive U.S. sales and marketing rights for Calypte's urine-based 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. products outside of the insurance market. Early in 2001, Calypte hired additional sales professionals to support its domestic sales and marketing efforts, bringing its current dedicated sales staff to eight. This sales staff is currently marketing to all domestic markets, including public health, clinics and laboratories, corrections agencies and advocacy groups, as well as to insurance companies and reference laboratories. The Company hopes that this experienced internal sales staff will help to accelerate Calypte's domestic sales. Calypte also believes that having its own U.S. sales force for the clinical market will result in improved market penetration Noun 1. market penetration - the extent to which a product is recognized and bought by customers in a particular market penetration - the act of entering into or through something; "the penetration of upper management by women" by giving it a higher degree of focus and control than is possible with a distributor. During the first quarter, several new insurance companies began to use urine HIV testing 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. as part of their underwriting Underwriting 1. The process by which investment bankers raise investment capital from investors on behalf of corporations and governments that are issuing securities (both equity and debt). 2. The process of issuing insurance policies. programs. New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of Life, one of the largest life insurance companies in the world, initiated urine testing during the quarter, as disclosed previously by Calypte. Financing Update Calypte continues to work to secure funding arrangements that will allow it to execute on its growth plans and fund the manufacturing of its products and new product development. As previously announced, the Company's cash on-hand as of March 31, 2001 was $89,000 and it does not believe that its currently-available financing will be adequate to sustain operations at current levels through the second quarter of 2001. Due to the decline in the market price of its shares, the Company's ability to draw down funds under its previously announced equity line of financing has been severely limited, and the Company does not believe that this line of financing will be sufficient to fulfill ful·fill also ful·fil tr.v. ful·filled, ful·fill·ing, ful·fills also ful·fils 1. To bring into actuality; effect: fulfilled their promises. 2. its short-term financing requirements. Early in the second quarter, the Company announced that it had sold its minority interest in Pepgen for $500,000. The Company is actively searching for strategic opportunities, including investment in the Company, a merger or other comparable transaction, or a financial restructuring restructuring - The transformation from one representation form to another at the same relative abstraction level, while preserving the subject system's external behaviour (functionality and semantics). , to sustain its operations. The Company does not currently have any agreements in place with respect to any such opportunity, and there can be no assurance that additional capital will be available to the Company on acceptable terms, or at all. Dr. Urnovitz Resignation Effective March 31, 2001, Howard B. Urnovitz, Ph.D., resigned as Chief Science Officer and as a member of the Board of Directors of Calypte to pursue research related to the role of the genome genome: see genetics. genome all the genetic content contained within an organism. An organism's genome is made up of molecules of deoxyribonucleic acid (DNA) that form long strands that are tightly wound into chromosomes, which are found in the in chronic diseases with Chronix Biomedical, a company in which he is a principal. Nancy Katz, President, Chief Executive Officer and Chief Financial Officer of Calypte, said, "I am very pleased with the progress Calypte made during the first quarter to increase sales and capitalize To regard the cost of an improvement or other purchase as a capital asset for purposes of determining Income Tax liability. To calculate the net worth upon which an investment is based. To issue company stocks or bonds to finance an investment. upon new market opportunities. We successfully completed our first shipment to China, and expect to send additional shipments during the second quarter. With our recently secured distribution agreements in place in Malaysia and the Philippines, and distribution agreements in over 40 other countries throughout the world, Calypte is well-positioned to generate revenue in the international markets. "In the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , our agreement to provide our serum Western Blot to Organon Teknika calls for minimum monthly shipments and positions Calypte as one of the largest HIV-1 supplemental blood test manufacturers in the nation. Now that we have a dedicated and experienced sales force actively marketing and selling Calypte's products in the U.S., we believe we are better-positioned to ramp-up domestic sales. "As we announced early in the second quarter, however, our enthusiasm over our record revenue achievement must be tempered by our financing difficulties and ongoing discussions with the Nasdaq Stock Market Nasdaq stock market The first electronic stock market listing over 5000 companies. The Nasdaq stock market comprises two separate markets, namely the Nasdaq National Market, which trades large, active securities and the Nasdaq Smallcap Market that trades emerging growth companies. regarding our ability to comply with certain Nasdaq listing requirements Listing requirements Requirements, including minimum shares outstanding, market value, and income, that are laid down by an exchange for any stock to be listed for trading. . Our ability to drawdown Drawdown The peak to trough decline during a specific record period of an investment or fund. It is usually quoted as the percentage between the peak to the trough. Notes: on funds available through our equity line has been severely hampered by the decline in our stock price, and our currently available cash resources are insufficient to cover our expenses. While we are actively engaged in discussions with potential investors or lenders, and with potential acquirors, and while early second quarter indicators suggest that sales will remain strong during the quarter, we will need to obtain additional financing in order to sustain operations at current levels through the second quarter." Ms. Katz continued, "We continue to work on new products and product improvements. Development efforts, for example, have demonstrated proof of concept for a rapid urine test for 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 . We believe that the ability to marry the benefits of non-instrumented rapid testing with all of the benefits inherent in urine testing can make a tremendous contribution to HIV testing initiatives here in the U.S. and around the world." "During the first quarter we made progress in achieving all five strategic goals for Calypte which we had outlined last quarter as our key focus areas for 2001," said Ms. Katz. "These goals include revenue growth, new product development, international expansion, reducing our cost of goods, and compliance with the standards set by the FDA and other government regulatory agencies regulatory agency Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. here in the U.S., and regulatory bodies abroad. If we are able to secure the additional financing needed to continue operating, we expect to remain on course to reach our goal of growing revenue substantially this year." 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 (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. The company believes that accurate, non-invasive 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. pain  less·ly adv. . Calypte
markets 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 agreement 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 registration statement filed on Form S-3 on April 13, 2001. Calypte Biomedical has scheduled a conference call to discuss financial results for the first quarter at 11:00 AM (EDT EDT abbr. Eastern Daylight Time EDT Eastern Daylight Time EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York EDT ) on Friday, April 27, 2001. All interested parties are invited to listen to this call. To listen to the call from the US, please dial 1-888-209-3754 and ask to be connected to the Calypte conference call. International callers please dial 212-271-4737. 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 (EDT) on Friday, April 27, 2001 until Thursday, May 3, 2001 at 1:00 PM (EDT). To access the rebroadcast domestically, please dial: 1-800-633-8284, reservation #: 18657109. 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
March 31,
--------------------
2001 2000
--------- ---------
Revenues:
Product sales $ 1,402 $ 1,098
--------- ---------
Operating expenses:
Product costs 1,989 1,417
Research and development costs 497 544
Selling, general and administrative costs 1,956 1,309
--------- ---------
Total expenses 4,442 3,270
--------- ---------
Loss from operations (3,040) (2,172)
Interest income 6 42
Interest expense (513) (36)
Other income (expense) 23 (9)
--------- ---------
Loss before income taxes (3,524) (2,175)
Income taxes (2) (2)
--------- ---------
Net loss (3,526) (2,177)
Less dividends on mandatorily
redeemable Series A preferred stock (30) (30)
--------- ---------
Net loss attributable to common stockholders $ (3,556) $ (2,207)
========= =========
Net loss per share attributable to
common stockholders
(basic and diluted) $ (0.14) $ (0.11)
========= =========
Weighted average shares used to compute net
loss per share attributable to
common stockholders
(basic and diluted) 25,814 20,580
========= =========
CALYPTE BIOMEDICAL CORPORATION AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
Unaudited
March 31, December 31,
2001 2000
---------- ----------
Cash, cash equivalents, and restricted cash $ 89 $ 1,203
Working capital (2,421) (875)
Total Assets 4,906 5,006
Current portion of notes payable - 471
Debentures payable, net of original
issue discount and other expenses 640 -
Long-term portion of capital lease obligations 85 78
Mandatorily redeemable Series A preferred stock 2,366 2,336
Total stockholders' equity (3,177) (1,531)
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