Calypte Announces Third Quarter and Nine-Month Financial Results; Management Expects Sequential Fourth Quarter Revenue Growth of at Least 50 to 75%
ALAMEDA, Calif., Oct 24, 2002 (BUSINESS WIRE) -- Calypte Biomedical Corporation (OTCBB:CALY), the developer and marketer of 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 supplemental test, today announced financial results for the third quarter and nine months ended September 30, 2002.
During the third quarter, the company achieved numerous milestones, which management believes will help position Calypte for long-term growth. Accomplishments year to date include:
-- Received funding of over $7 million after the company reversed
its shut down plans and restarted its operations.
-- Rehired 100% of top management staff following the restart of
operations.
-- Resumed business with all of Calypte's premier US insurance
companies after the restart, which includes 9 of the top 10
insurance providers. The insurance carriers have continued to
make purchases through the major laboratories.
-- Signed a new agreement with a distributor for serum Western
blot business.
-- Received first order for Burkina Faso in West Africa.
-- Sponsored visit by Dr. Luc Montagnier to Chinese health
authorities. Dr. Montagnier, World Foundation for AIDS
Research and Prevention president, co-discovered HIV-1 and
discovered HIV-2.
-- Negotiated, and in early October, signed a two-year
distribution agreement with a Chinese pharmaceutical
distributor, ZYPute, for minimum purchases totaling
approximately $3 million. Received the first commercial order
for 100,000 tests.
-- Added last of 50 states to regulatory approval list for urine
HIV-1 life insurance testing.
-- Conducted a preliminary Investigational Device Exemption
(pre-IDE) meeting with the Food and Drug Administration (FDA),
with a goal of accelerating the FDA acceptance process for the
rapid urine test. The company plans to submit the IDE
application in December 2002 and initiate US clinical studies
in February 2003.
-- Completed Phase One testing for three Calypte urine tests with
the World Health Organization (WHO).
-- Focused on developing strategic alliances and resuming
evaluations of urine HIV testing with key, influential
customers.
-- Showcased the results of the feasibility testing for the Rapid
HIV Urine Test at the United States Conference on AIDS, in
Anaheim, California.
-- Secured FDA approval for and implemented several
manufacturing-related cost-reduction/saving measures.
Anthony Cataldo, Calypte's executive chairman, stated, "Our goal for the quarter was to take a cash-constrained company with an outstanding product, and begin building a world-class marketing and distribution platform. Among our most significant milestones was the signing of a new distribution agreement in China, which includes minimum purchase order requirements, and has already brought us a new order from this large and expanding market. We also met with the FDA to accelerate the development of our Rapid Urine HIV-1 Test in the United States. In addition, our domestic distribution partners are executing on their marketing and sales programs."
Cataldo continued, "Although the third quarter results were impacted by the fact that we sold through most of our inventory in the second quarter during the shut-down phase, we expect fourth quarter results to reflect significant progress in our recovery. At this point, we anticipate sequential revenue growth of at least 50 to 75 % during the fourth quarter."
For the third quarter of 2002, Calypte recorded revenues of $493,000 compared to $1.5 million in the third quarter of 2001. The net loss attributable to common stockholders for the quarter was approximately $1.5 million, or $0.02 per common share, compared to a net loss of $1.7 million, or $0.05 per common share for the three months ended September 30, 2001.
Nancy Katz, Calypte's president and chief executive officer, stated, "Our execution during the quarter has been excellent from all perspectives. Employees are enthusiastically back at work, and both orders and production are increasing. Significant progress has been made on our business plan both domestically and internationally. We have gained new visibility in the capital markets due to the extensive work of our executive chairman. The demonstrated demand for our product worldwide give us confidence for improving results in the quarters to come."
For the nine months ended September 30, 2002, Calypte reported revenues of $2.9 million, compared with $4.5 million in the same period one-year prior. The net loss attributable to common stockholders for the nine-month period of 2002 was $7.2 million, or $0.11 per common share, compared to a net loss of $8.1 million, or $0.27 per common share for the nine months ended September 30, 2001.
Calypte will hold a conference call today at 11:00 a.m. (EDT). Investors can access the call from the investor section of the Calypte web site, www.calypte.com, or by dialing 888-747-3510. If you are unable to listen to the live call, a replay will be available for 48 hours and can be accessed by dialing 888-266-2081 with access code 6262603. The replay will also be on Calypte's web site for 45 days.
About Calypte Biomedical
Calypte Biomedical Corporation, headquartered in Alameda, California, is a public healthcare company dedicated to the development and commercialization of urine-based diagnostic products and services for Human Immunodeficiency Virus Type 1 (HIV-1), sexually transmitted diseases and other infectious 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, as well as an FDA-approved serum HIV-1 antibody Western Blot test. 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. Calypte markets its products in countries worldwide through international distributors and strategic partners. Refer to current product package inserts for complete information on product performance characteristics.
Statements in this press release that are not historical facts are forward-looking statements within the meaning of the Securities Act of 1933, as amended. 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 that occur after the date hereof 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/A (No.1) 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 Ended Nine Months Ended
September 30, September 30,
-------------------- --------------------
2002 2001 2002 2001
-------- -------- -------- --------
Revenues:
Product sales $ 493 $ 1,465 $ 2,861 $ 4,478
-------- -------- -------- --------
Cost of product sales 1,542 1,486 4,569 5,218
-------- -------- -------- --------
Gross Margin
(Loss) on product
sales (1,049) (21) (1,708) (740)
Other operating expenses:
Research and
development costs 219 351 640 1,201
Selling, general and
administrative costs 1,565 1,249 4,867 5,343
-------- -------- -------- --------
Total other
operating
expenses 1,784 1,600 5,507 6,544
-------- -------- -------- --------
Loss from
operations (2,833) (1,621) (7,215) (7,284)
Interest income 1 1 3 8
Interest expense (150) (6) (216) (39)
Non-cash interest income
(expense) 1,475 -- (997) (1,318)
Other income (expense) 12 -- 33 524
-------- -------- -------- --------
Loss before
income taxes (1,495) (1,626) (8,392) (8,109)
Income taxes -- -- (2) (2)
-------- -------- -------- --------
Net loss before
extraordinary
item (1,495) (1,626) (8,394) (8,111)
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
-------- -------- -------- --------
Net loss (1,495) (1,626) (7,075) (7,966)
Less dividends on
mandatorily redeemable
Series A preferred stock (30) (30) (90) (90)
-------- -------- -------- --------
Net loss attributable to
common stockholders $ (1,525) $ (1,656) $ (7,165) $ (8,056)
======== ======== ======== ========
Net loss per share
attributable to common
stockholders (basic and
diluted) $ (0.02) $ (0.05) $ (0.11) $ (0.27)
======== ======== ======== ========
Weighted average shares
used to compute net loss
per share attributable
to common stockholders
(basic and diluted) 89,286 33,153 62,951 29,373
======== ======== ======== ========
CALYPTE BIOMEDICAL CORPORATION AND SUBSIDIARY
CONSOLIDATED BALANCE SHEET DATA
(in thousands)
Unaudited
Sept. 30, Dec. 31,
2002 2001
-------- --------
Cash, cash equivalents, and restricted cash $ 19 $ 287
Working capital (2,977) (4,289)
Total Assets 2,843 4,262
Current notes payable 543 411
Long-term portion of capital lease obligations 15 22
Non-current convertible notes and debentures, net
of discount of $2,788 at September 30, 2002 1,213 --
Mandatorily redeemable Series A preferred stock 2,546 2,456
Total stockholders' equity (6,258) (5,500)
CONTACT: Calypte Biomedical Corporation
Richard Brounstein, 510/749-5156
rbrounstein@calypte.com
www.calypte.com
or
Lippert/Heilshorn & Associates (Investor Relations)
Brendan Lahiff/Kirsten Chapman, 415/433-3777
brendan@lhai-sf.com
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