Calypte Biomedical Announces Third Quarter and Nine-Month Financial Results
Friday November 14, 9:29 pm ET
ALAMEDA, Calif., Nov. 14 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (OTC Bulletin Board: CYPT - News), 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 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: tclemensen@rubensteinir.com
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