...waren ja nicht so berauschend, trotzdem hält sich CALY in meinem depot noch mit am besten... :(
Friday March 2, 7:42 pm Eastern Time
Press Release
Calypte Reports Fourth Quarter and Year-End 2000 Results
ALAMEDA, Calif.--(BUSINESS WIRE)--March 2, 2001--Calypte Biomedical Corporation (Nasdaq: CALY - news) announced today its fourth quarter and year-end financial results for the period ending December 31, 2000. Revenues for the three months ended December 31, 2000 were $576,000, as compared to $903,000 for the three months ended December 31, 1999. The net loss attributable to common stockholders for the fourth quarter was $3.8 million, or a net loss attributable to common stockholders of $0.15 per share, compared with a net loss attributable to common stockholders of $2.5 million, or a net loss attributable to common stockholders of $0.12 per share for the fourth quarter of 1999.
Revenues for the year ended December 31, 2000 were $3.3 million, as compared to $3.7 million for 1999. The net loss attributable to common stockholders for the year ended December 31, 2000 was $12.2 million and the net loss per share attributable to common stockholders for 2000 was $0.52, compared to a loss of $10.1 million and $0.52 per share for 1999. Cash balances on December 31, 2000 totaled $1.2 million. Overall, Calypte ended the year with $0.5 million in product backorders, bringing revenues essentially in line with revenues at year-end 1999.
Sales of Calypte's HIV-1 EIA screening test were essentially unchanged between 1999 and 2000. International sales of the Company's screening test were insignificant in 2000, but the Company expects such sales to constitute an increasing proportion of revenues in 2001 and thereafter now that it has received regulatory approval of its HIV-1 EIA product in countries such as the Republic of South Africa, the People's Republic of China, and Malaysia. The Company is actively pursuing product approval in several other countries.
The impact of so-called ``Triple X'' legislation, which essentially eliminated the availability of 30-year life insurance policies after 1999, caused noticeable increases in fourth quarter 1999 revenues as testing associated with final applications for 30-year policies was completed, making comparisons with the fourth quarter 1999 difficult. Sales of the Company's Western Blot supplemental tests declined in 2000 versus 1999, consistent with the trend Calypte has experienced for the past few years. The Company expects revenues from supplemental tests to increase in 2001, however, as a result of its recently signed agreement to supply Organon-Teknika with HIV-1 serum Western Blot tests.
Accomplishments for 2000
Nancy Katz, President, Chief Executive Officer and Chief Financial Officer of Calypte, said, ``Although I am disappointed with the financial results for the year, I believe that the strategic and operational milestones position us to realize our goals for 2001. Among many significant accomplishments, we achieved the following:
- We secured agreements in key countries - specifically China,
Brazil and 40 countries throughout Sub-Saharan Africa, including
South Africa, and most recently Malaysia - and we're shipping
product to South Africa and China, where a 180-person sales force
is marketing our product.
- We have secured export certificates from the FDA for our products
from all facilities and early in 2001 received final approval to
begin manufacturing in our Alameda facility. We closed our
Berkeley facility at the end of February 2001.
- We were extremely active on the advocacy front and secured
relationships with Planned Parenthood, Whitman Walker Clinic and a
variety of influential community leaders and organizations,
outreach that we believe enhanced our visibility within important
constituencies for Calypte. We also supported legislation recently
passed by Congress that requires Congress to update existing
standards to account for advances in safety technology, such as
Calypte's needleless HIV-1 urine screening test, that will help
prevent needlestick injuries to health care workers.
- In 2000, we made significant inroads with the domestic insurance
marketplace. We added major insurance companies to our customer
list, including New York Life, Cigna and Unum Provident.
- We secured a Memorandum of Understanding with Marukin Diagnostics
Inc., positioning Calypte to become the exclusive distributor of
Marukin's Urinary Total Bile Acid Sulfate (UBAS) Assay in the
insurance markets of the United States and Canada. The Marukin
test will make urine a more broad-based testing application, so
that a single urine specimen can be used to test for HIV-1
antibody, cotinine, illegal drugs and now liver function.
- On the new product front, in addition to the Marukin test, we also
entered into a collaboration with the Osborn Scientific Group to
develop two urine-based rapid HIV antibody tests, which are in the
early stages of development. We are also exploring additional new
tests to identify other infectious diseases that will be
applicable to the domestic and international markets.``
Adjustment to Third Quarter Revenues
During the quarter ended September 30, 2000, the Company recognized $242,000 in product sales revenues which related to transactions with two customers. Upon further review of the transactions, it was determined that one transaction in the amount of $86,000 should be recognized in the Company's December 31, 2000 quarter and a second transaction in the amount of $156,000 should be recognized in the first quarter of 2001.
Accordingly, Calypte's previously reported results for the third quarter of fiscal 2000 have been restated. Third quarter revenues were revised from $1,077,000 to $835,000. The revision increased the net loss for the third quarter from $3,029,000 to $3,103,000 and increased the net loss per share from $0.12 to $0.13.
Goals for 2001
Ms. Katz continued, ``Our accomplishments in 2000 put us in a position to achieve our primary objective for 2001: to grow revenue to between $7 million and $8 million. The first two months of 2001 have been strong for Calypte, giving us reason to be optimistic about the prospects for growth throughout the year. We believe that the groundwork we established in 2000 will enable us to reach our revenue target, including the following:
- We began the year with backorders of $0.5 million and are capable
of meeting our orders with the expansion of our manufacturing
capacity in Alameda.
- We closed the Berkeley facility in February, which will provide
$500,000 in annual cost savings.
- In addition to existing contracts with insurance companies and
reference labs, we're contractually obligated to ship one million
tests to China in 2001 and to provide Organon-Teknika's customers
with our product.
- Calypte is targeting opportunities in new international markets,
including Brazil, Mexico, Hungary, Thailand, France, the
Philippines and Korea. We are investigating a plan to begin
limited manufacturing operations in China.
- We are optimistic about achieving ISO Certification, which would
enable us to ship our products to Europe.
- We have also added six new sales professionals to support our
efforts in selling to the domestic market, bringing our sales
staff to nine.
- On the new product front, we expect to demonstrate the feasibility
and conduct clinical trials for an HIV rapid test and other urine-
and serum-based diagnostic tests. We also expect to launch the
sale of bile acid salts assay in the U.S. in conjunction with
Marukin and hope to introduce additional new products by the end
of the year.
``The difference between achieving $7 million in revenue and $8 million in revenue by year-end will be a function of the milestones we accomplish, as I have just described. As we have stated in the past, we expect to achieve profitability by the end of 2002. I look forward to realizing the goals I have established for Calypte in 2001.''
Calypte Biomedical Corporation (NASDAQ: CALY - news) 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. 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 sells 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, 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 and debenture agreements 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 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 periodic report on Form 10-K for the year ended December 31, 2000.
Calypte Biomedical has scheduled a conference call to discuss financial results for the fourth quarter and year-end 2000 at 11:00 AM (EST) on Monday, March 5, 2001. All interested parties are invited to listen to this call. To listen to the call from the US, please dial 1-800-252-8302 and ask to be connected to the Calypte conference call. International callers please dial 212-896-6112. 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 (EST) on Monday, March 5, 2001 until Monday, March 12, 2001 at 1:00 PM (EST). To access the rebroadcast domestically, please dial: 1- 800-633-8284, reservation #: 18174797. 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 Year Ended
December 31, December 31,
--------------------- ---------------------
2000 1999 2000 1999
--------- --------- --------- ---------
Revenues:
Product sales $ 576 $ 903 $ 3,296 $ 3,728
--------- --------- --------- ---------
Operating expenses:
Product costs 1,579 1,339 5,891 4,721
Research and
development costs 642 686 2,254 4,123
Selling, general and
administrative costs 2,131 1,418 7,568 5,081
--------- --------- --------- ---------
Total expenses 4,352 3,443 15,713 13,925
--------- --------- --------- ---------
Loss from operations (3,776) (2,540) (12,417) (10,197)
Interest income,
interest expense,
and other income 17 30 175 173
--------- --------- --------- ---------
Loss before
income taxes (3,759) (2,510) (12,242) (10,024)
Income taxes - - (2) (2)
--------- --------- --------- ---------
Net loss (3,759) (2,510) (12,244) (10,026)
Less dividends on
mandatorily
redeemable Series A
preferred stock (30) (30) (120) (120)
--------- --------- --------- ---------
Net loss attributable
to common stockholders $ (3,789) $ (2,540) $ (12,364) $ (10,146)
========= ========= ========= =========
Net loss per share
attributable to
common stockholders
(basic and diluted) $ (0.15) $ (0.12) $ (0.52) $ (0.52)
========= ========= ========= =========
Weighted average
shares used to
compute net loss per
share attributable to
common stockholders
(basic and diluted) 25,341 20,422 23,859 19,333
========= ========= ========= =========
CALYPTE BIOMEDICAL CORPORATION AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
(Unaudited)
December 31, December 31,
2000 1999
------------ ------------
Cash, cash equivalents, and restricted cash $ 1,203 $ 2,652
Securities available for sale - 503
Working capital (deficit) (875) 1,860
Total Assets 5,006 7,821
Current portion of notes payable 471 844
Long-term portion of capital lease obligations 78 50
Mandatorily redeemable Series A preferred stock 2,336 2,216
Total stockholders' equity (deficit) (1,531) 1,330
--------------------------------------------------
Contact:
Calypte Biomedical Corporation
Nancy Katz, 510/749-5100
President, CEO and CFO
or
Abernathy MacGregor Group
Winnie Lerner, 212/371-5999
