Calypte Reports Third Quarter 2001 Financial Results; Revenues Increase 75% Compared With Third Quarter 2000.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)--Oct. 18, 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 (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :CALY) announced today that its revenues for the third quarter ended September 30, 2001 increased 75% to $1,465,000 compared to $835,000 for the same period last year. Revenues for the nine months ended September 30, 2001 were $4,478,000, compared with $2,720,000 for the first nine months of last year, an increase of 65%. "While revenues from all products increased compared to third quarter 2000 levels, third quarter 2001 revenues from the sale of the company'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 more than doubled", said Nancy Katz, President, Chief Executive Officer, and Chief Financial Officer of Calypte. "We are very pleased with our 2001 operating results to date." "Revenues for the first nine months of 2001 already exceed those of full-year 2000 by 36%. The temporary product supply interruptions we experienced during the third quarter have been resolved and, looking forward, we expect strong performance during the fourth quarter. As blood donations “Give blood” redirects here. For other uses, see Give blood (disambiguation). Blood donation is a process by which a blood donor voluntarily has blood drawn for storage in a blood bank, generally for subsequent use in a blood transfusion. across the nation have reached unparalleled levels, we are experiencing a significant increase in demand for our serum Western Blot test Western blot test n. A serum electrophoretic analysis used to identify proteins. . Our employees are working seven days a week to meet the demands of blood banks, the military and other organizations monitoring the safety of the nation's blood supply and these organizations have our highest priority in product availability. We expect to exceed $7 million in revenues for the full year 2001," Katz said. Calypte's domestic 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. business also continues to grow. Sales to the reference labs supporting the domestic life insurance business increased by more than 40% for the first nine months of 2001 compared to the same period in 2000. The major life insurance companies continue to expand their acceptance of urine testing as a 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. standards and Calypte now counts nine of the ten "most admired" life insurance companies, as identified by Fortune magazine, as among those companies using its urine test to screen policy applicants. The company's sales force closed a number of new Sentinel Testing Service accounts during the third quarter and has a number of product evaluations in process across the country. Katz continued, "With this demonstrated base of support for urine-based testing, Calypte is developing a urine based rapid test for the detection of HIV-1 as its highest new product priority. Results of laboratory testing to this point have encouraged us to continue the development of this new product." Calypte completed its first urine HIV-1 antibody test shipment of significant size to its distributor in the People's Republic People's Republic n. A political organization founded and controlled by a national Communist party. of China earlier this week and expects another order and shipment later this quarter. These tests are destined des·tine tr.v. des·tined, des·tin·ing, des·tines 1. To determine beforehand; preordain: a foolish scheme destined to fail; a film destined to become a classic. 2. for epidemiological epidemiological emanating from or pertaining to epidemiology. epidemiological associations the associative relationships between the frequency of occurrence of a disease and its determinants, its predisposing and precipitating uses in at least 20 of the country's 28 provinces. China has recently announced the creation of a Five Year Plan against HIV/AIDS HIV/AIDS Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome and 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. epidemiological baseline screening combined with ongoing surveillance will be key elements of the plan. The company expects its products to play a key role in this effort as the Plan is implemented. During the third quarter, Calypte completed its first shipment of urine 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 to its distributor in Malaysia. That distributor is optimistic op·ti·mist n. 1. One who usually expects a favorable outcome. 2. A believer in philosophical optimism. op that additional regulatory reviews currently in process will expand the market for the company's tests to additional public and private sector entities in Malaysia. The regulatory approval process is moving forward in both the Philippines and South Korea, where, in both cases, the company expects to receive a formal request for a small clinical evaluation clinical evaluation Medtalk An evaluation of whether a Pt has symptoms of a disease, is responding to treatment, or is having adverse reactions to therapy in the near future. Calypte is also working with its distributor in Brazil to formulate the protocol for a local clinical trial that has been requested by regulatory authorities Noun 1. regulatory authority - a governmental agency that regulates businesses in the public interest regulatory agency administrative body, administrative unit - a unit with administrative responsibilities . In cooperation with its new distributors in Thailand and Taiwan, the company plans to make regulatory submissions to the appropriate authorities shortly. Although Calypte already has regulatory approval in 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. , its distributor for that territory and other countries in sub-Saharan Africa has undergone a corporate 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). that has disrupted sales efforts for the company's tests. The company is actively looking to expand its distribution channels in those territories. The company continues to actively seek product evaluations and regulatory approval in a number of other international venues, including Mexico and France. The company has reduced its burn rate significantly compared to the prior year. The net loss for the third quarter improved by $1.4 million from a year ago. The net loss attributable to common stockholders for the third quarter of 2001 was $1.7 million, or $0.05 per share, compared with a net loss attributable to common stockholders of $3.1 million, or $0.13 per share, for the same quarter of 2000. The net loss attributable to common stockholders for the first nine months of 2001 was $8.1 million, or $0.27 per share, compared with a net loss attributable to common stockholders of $8.6 million, or $0.37 per share, for the first nine months of last year. During the third quarter, Calypte continued the aggressive cost control measures implemented earlier in the year. Coupled with its increased revenues, those measures continue to generate improved margins at the company's Alameda, Calif. and Rockville, Md. manufacturing facilities. As a further cost reduction step, the company plans to reduce the size of its Rockville, Md. manufacturing facility. This change will not impact workforce size, product supply or quality from that plant, but by reducing space needs by approximately 50%, the company expects to reduce operating costs operating costs npl → gastos mpl operacionales by approximately $400,000 annually. "Based on the growth that we project both domestically and internationally, we remain on track to double revenues in 2002 compared to calendar year 2001 and to achieve profitability in the fourth quarter of 2002," Katz continued. "But, as the company's cash on-hand as of September 30, 2001 was $48,000 and with negative working capital of $4.9 million, we will require additional external financing In the theory of capital structure, External financing is the phrase used to describe funds that firms obtain from outside of the firm. It is contrasted to internal financing which consists mainly of profits retained by the firm for investment. to continue our current level of operations through the fourth quarter of 2001. The company expects to register the equity line of financing announced in September in the near future and plans to begin drawing on the line once the SEC declares the registration statement effective. At this time, however, we are unable to predict how long the SEC review process might take. Beyond the equity line, although we do not have any financing agreements Financing Agreements In the context of project financing, the documents which provide the project financing and sponsor support for the project as defined in the project contracts. in place, we are continuing to investigate funding sources that can enable the company to achieve its milestones. There can, however, be no assurance that additional capital will be available to the Company on acceptable terms, or at all," Katz concluded. Calypte Biomedical Corporation (OTC Bulletin Board OTC Bulletin Board An electronic quotation listing of the bid and asked prices of OTC stocks that do not meet the requirements to be listed on the NASDAQ stock-listing system. : 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 samples. The company also markets one of only two FDA-approved HIV-1 supplemental Western Blot tests available for testing serum 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 future financing, the ability to meet operational milestones, and shipments to and regulatory approvals in 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 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 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, 2000 and its subsequent filings with the SEC. Calypte Biomedical has scheduled a conference call to discuss financial results for the third quarter at 11:00 a.m. (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, October 19, 2001. All interested parties are invited to listen to this call. To listen to the call from the US, please dial 1-888-997-8642 and ask to be connected to the Calypte conference call. International callers please dial 973-694-6836. 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 at www.companyboardroom.com. If you are unable to participate, a rebroadcast of the call will be available beginning 2:00 p.m. (EDT) on Friday, October 19, 2001 until Friday, October 26, 2001 at 2:00 p.m. (EDT). To access the rebroadcast domestically, please dial: 1-800-428-6051, conference no.: 213772. International callers please dial: 973-709-2089. To access a rebroadcast of the webcast, please visit "Investor" at www.calypte.com or visit www.companyboardroom.com.
CALYPTE BIOMEDICAL CORPORATION AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
Unaudited
Three Months Ended Nine Months Ended
Sept. 30, June 30, Sept. 30, September 30,
2001 2001 2000 2001 2000
-------- -------- -------- -------- --------
Revenues:
Product sales $ 1,465 $ 1,612 $ 835 $ 4,478 $ 2,720
-------- -------- -------- -------- --------
Cost of product
sales 1,486 1,743 1,588 5,218 4,312
-------- -------- -------- -------- --------
Loss on product
sales (21) (131) (753) (740) (1,592)
Other operating
expenses:
Research and
development
costs 351 354 496 1,201 1,612
Selling, general and
administrative
costs 1,249 2,138 1,915 5,343 5,437
-------- -------- -------- -------- --------
Total other
operating expenses 1,600 2,492 2,411 6,544 7,049
-------- -------- -------- -------- --------
Loss from
operations (1,621) (2,623) (3,164) (7,284) (8,641)
Interest income 1 1 85 8 247
Interest expense
(non-cash expense
of $830 for the
three months ended
June 30, 2001 and
$1,318 for nine
months of 2001) (6) (838) (29) (1,357) (93)
Other income
(expense) -- 501 5 524 4
-------- -------- -------- -------- --------
Loss before
income taxes (1,626) (2,959) (3,103) (8,109) (8,483)
Income taxes -- -- -- (2) (2)
-------- -------- -------- -------- --------
Loss before
extraordinary
item (1,626) (2,959) (3,103) (8,111) (8,485)
Extraordinary gain
on repurchase of
beneficial conversion
feature, net of
tax expense -- 145 -- 145 --
-------- -------- -------- -------- --------
Net loss (1,626) (2,814) (3,103) (7,966) (8,485)
Less dividends on
mandatorily redeemable
Series A preferred
stock (30) (30) (30) (90) (90)
-------- -------- -------- -------- --------
Net loss
attributable
to common
stockholders $ (1,656) $ (2,844) $ (3,133) $ (8,056) $ (8,575)
======== ======== ======== ======== ========
Net loss per share
attributable to
common stockholders
(basic and diluted) $ (0.05) $ (0.10) $ (0.13) $ (0.27) $ (0.37)
======== ======== ======== ======== ========
Weighted average
shares used to
compute net loss
per share
attributable
to common
stockholders
(basic and diluted) 33,153 29,070 24,969 29,373 23,362
======== ======== ======== ======== ========
CALYPTE BIOMEDICAL CORPORATION AND SUBSIDIARY
CONSOLIDATED BALANCE SHEET DATA
(in thousands)
Unaudited
Sept. 30, Dec. 31,
2001 2000
-------- --------
Cash, cash equivalents, and restricted cash $ 48 $ 1,203
Working capital (4,867) (875)
Total Assets 3,524 5,006
Current portion of notes payable 400 471
Long-term portion of capital lease obligations 56 78
Mandatorily redeemable
Series A preferred stock 2,426 2,336
Total stockholders' equity (5,943) (1,531)
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