Calypte Biomedical Announces Third Quarter and Nine-Month Financial
Results ALAMEDA, Calif., Nov. 14 /PRNewswire-FirstCall/ -- Calypte
Biomedical Corporation (BULLETIN BOARD: CYPT) , the developer and
marketer of the only two FDA approved HIV-1 antibody tests for use
with urine samples, today announced financial results for the third
quarter and nine-months ended September 30, 2003. Revenues for the
quarter totaled $897,000, versus revenues of $493,000 for the
comparable period in 2002 and $749,000 for the previous quarter
ended June 30, 2003. The net loss attributable to common
stockholders for the quarter was $7.3 million, or $0.11 per common
share, compared to a net loss of $1.5 million, or $0.51 per common
share for the three months ended September 30, 2002. The net loss
for the third quarter of 2003 and 2002 included a $4.8 million loss
and a $1.3 million gain, respectively, in non-cash items that were
primarily related to the grants of common stock, options and
warrants as compensation for services and non-cash interest expense
related primarily to the accounting for Calypte's convertible debt
financing instruments. For the nine months ended September 30,
2003, revenues totaled $2.4 million, versus revenues of $2.9
million for the same period last year. The net loss attributable to
common stockholders was $21.6 million, or $0.75 per common share,
compared to a net loss of $7.2 million, or $3.41 per common share
for the nine months ended September 30, 2002. The net loss for the
nine months ended September 30, 2003 and 2002 included a $12.8
million loss and a $2.1 million loss, respectively, in non-cash
items that were primarily related to the grants of common stock,
options and warrants as compensation for services and non-cash
interest expense related primarily to the accounting for Calypte's
convertible debt financing instruments. "Calypte has met challenges
this quarter and is continuing to pursue its international
marketing goal for rapid urine testing and this product development
cycle," stated Tony Cataldo, Calypte's Executive Chairman. "The
HIV/AIDS testing market is vast and Calypte is dedicated to
achieving a significant penetration into that market in the coming
quarters." Following are the company's most significant milestones
since the last quarterly release together with the progress made in
the development of its rapid HIV products and the strengthening of
the balance sheet: * The company submitted an application with the
U.S. Food and Drug Administration (FDA) for an Investigational
Device Exemption (IDE) for its HIV-1/2 lateral flow antibody Rapid
Blood Test to be performed on whole blood. This represents the
Company's first application in connection with several rapid HIV
diagnostic tests the Company has under development. The Company
expects to submit a similar application for its urine-based HIV-1/2
Rapid Test sometime next year. * The company believes that there is
strong demand for a rapid urine product and is moving forward with
international clinical trials and is in the initial planning stages
to establish the manufacturing locations necessary to produce
product and file for approvals in key African countries as well as
China. Further to this end, as part of its association with the
Marr Group, it is forming a joint venture in China to manage this
important market. * Calypte completed a $10 million equity
financing agreement with Marr Technologies, B.V. via the issuance
of 20,000,000 restricted shares of common stock at a price of $.50
per share. * Calypte also concluded a $10 million debt facility
from Marr Technologies, B.V. this week. The monies can be drawn
down during next spring in the form of 12-month notes bearing
simple interest at 5%. In order to obtain full access to the line
the company has committed to moving to a major stock exchange no
later than the end of the first quarter of 2004. This provides an
extra $10 million in available working capital in 2004, as
necessary, while the company seeks to bring its HIV rapid products
to market. Calypte exited the quarter ended September 30, 2003 with
$9.0 million in cash, $6.5 million in working capital, and a
9-month average burn rate for 2003 of $1.1 million. Commenting on
these events, Mr. Oyakawa, Calypte's President and Chief Operating
Officer stated, "We believe we now have sufficient capital to
execute most of our business plan. Our focus for the next two
quarters will be operations -- en route to rapid urine revenues,
which we anticipate no later than the summer of next year.
Execution of these goals will be the highest priority." Further
information is available in the company's SEC Form 10-QSB filed
earlier today. As noted therein, Calypte was contacted by the San
Francisco District Office of the Securities and Exchange Commission
(the "Commission") on October 28, 2003 and advised of an informal
inquiry being conducted by the enforcement staff of the Commission
regarding the Company. The staff has requested, among other things,
documents and information related to certain press releases issued
by the Company. The Commission has advised the Company that the
inquiry should not be construed as an indication by the Commission
or its staff that any violation of law has occurred. The Company is
in the process of voluntarily providing information sought by the
Commission and intends to cooperate with the Commission in
connection with its informal inquiry. Independently, the Company's
Audit Committee is investigating the matter and intends to make
recommendations, if applicable, to the board of directors.
Calypte's independent auditors, KPMG LLP, have informed the Company
that they will not complete their quarterly review until such time
as the Company's Audit Committee completes its investigation and
the same is reviewed by KPMG LLP. Calypte management will host a
conference call Monday November 17, to discuss the Company's third
quarter financial results as well as provide an update on the
Company's current activities at 12:00 p.m. Eastern Time. The call
can be accessed in the U.S. by dialing 800-901-5217 and outside of
the U.S. by dialing 617-786-2964. The participant passcode is
58765973. The conference call will also be Web cast live at
http://www.calypte.com/. An audio replay of the call will be
available, beginning approximately 1 hour after the conference call
ends, by dialing 888-286-8010 in the US, or 617-801-6888 from
outside of the U.S. The account code for the playback is 13337320.
The webcast will also be available for replay on the company's
website. 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. 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 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 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 for the year ended December 31, 2002 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, 2003 2002 2003 2002 Revenues:
Product sales $897 $493 $2,430 $2,861 Cost of product sales 1,750
1,542 4,714 4,569 Gross Margin (Loss) on product sales (853)
(1,049) (2,284) (1,708) Other operating expenses: Research and
development costs 304 219 953 640 Selling, general and
administrative costs 2,754 1,565 12,371 4,867 Total other operating
expenses 3,058 1,784 13,324 5,507 Loss from operations (3,911)
(2,833) (15,608) (7,215) Interest income (expense) (primarily
non-cash for both periods) (3,282) 1,326 (6,054) (1,210) Gain on
settlement of debt - - - 1,319 Other income (expense) (30) 12 174
33 Loss before income taxes (7,223) (1,495) (21,488) (7,073) Income
taxes - - (2) (2) Net loss (7,223) (1,495) (21,490) (7,075) Less
dividends on mandatorily redeemable Series A preferred stock (30)
(30) (90) (90) Net loss attributable to common stockholders
$(7,253) $(1,525) $(21,580) $(7,165) Net loss per share
attributable to common stockholders (basic and diluted) $ (0.11) $
(0.51) $ (0.75) $ (3.41) Weighted average shares used to compute
net loss per share attributable to common stockholders (basic and
diluted) 68,862 2,976 28,796 2,098 CALYPTE BIOMEDICAL CORPORATION
AND SUBSIDIARY CONSOLIDATED BALANCE SHEET DATA (in thousands)
Unaudited September December 30, 31, 2003 2002 Cash and cash
equivalents $ 8,960 $ 147 Working capital 6,455 (5,549) Total
Assets 15,261 3,297 Convertible notes and debentures, net of
discount 801 2,181 Other long term liabilities 1,654 33 Mandatorily
redeemable Series A preferred stock 2,666 2,576 Total stockholders'
equity (deficit) 4,683 (7,494) Investor Relations Contact: Tim
Clemensen 212-843-9337 email: DATASOURCE: Calypte Biomedical
Corporation CONTACT: Tim Clemensen of Rubenstein Investor
Relations, +1-212-843-9337, for Calypte Biomedical; or Richard
Brounstein, CFO of Calypte Biomedical Corporation, +1-510-749-5100
Web site: http://www.calypte.com/
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