für dich aus dem SEC 10QSB Filing in übersicht:
CALYPTE BIOMEDICAL CORP filed this Form 10QSB on 08/15/05
Entire Document
Entire Subdocument
Page 7
CALYPTE BIOMEDICAL CORPORATION AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2005 and 2004
(unaudited)
(1) The Company
Calypte Biomedical Corporation (the "Company") develops, manufactures, and
distributes in vitro diagnostic tests, primarily for the diagnosis of Human
Immunodeficiency Virus ("HIV") infection. Historically, the Company has
manufactured and marketed urine-based HIV-1 diagnostic screening tests and urine
and serum-based Western Blot supplemental tests for use in laboratories, which
it refers to as its "Legacy Business." Since the Company began marketing its
urine diagnostic testing products following their approval by the FDA and
through the second quarter of 2005, its revenues have been almost exclusively
generated from sales of these products. The Legacy Business tests are
manufactured in formats that make them most suitable for high-volume laboratory
settings.
Over the last two years, however, the Company has been broadening its historical
focus to include other HIV tests, such as a blood-based incidence test and
various rapid tests using other specimens. In the last quarter of 2004, the
Company introduced its HIV-1 BED incidence EIA test (the "BED Incidence Test")
that detects HIV-1 infections that have occurred within approximately the prior
6 months and that can be used by public health agencies to identify those
regions and the populations within them where HIV transmission is occurring most
recently. The Company is currently focusing on the development and
commercialization of its new test products for the rapid detection of antibodies
to HIV-1 and HIV Type 2, a second type of HIV ("HIV-2"), in blood, oral fluid
and urine samples using a lateral flow dipstick design (the "HIV-1/2 Rapid
Tests") and the commercialization of the BED Incidence Test on a worldwide
basis.
Rapid tests provide test results in less than 20 minutes and are particularly
suitable for point-of-care testing, especially in lesser developed countries
which lack the medical infrastructure to support laboratory based testing. The
Company has completed field trials of its HIV-1/2 Rapid Tests that have
validated its prototype products. The Company has recently completed clinical
trials in Uganda and China and is currently engaged in clinical trials in other
countries in pursuit of regulatory approvals for these tests.
In April 2005 the Company announced its plans to restructure its business (the
"Plan") to consolidate its domestic operations and focus its capital resources
on the global commercialization of the HIV-1/2 Rapid Tests and the BED Incidence
Test. As part of the Plan, the Company announced its plans to discontinue its
production of the Legacy Business products manufactured at its facility in
Rockville, Maryland and to pursue various options ranging from selling the
Legacy Business to discontinuing manufacturing operations at the Rockville
facility pending a final determination of its disposition.
In furtherance of the Plan, on April 18, 2005, the Company entered into a
non-binding letter of intent to sell the Legacy Business to Maxim Biomedical,
Inc. ("Maxim"). Effective May 1, 2005, the Company entered into a manufacturing
services and management agreement (the "Agreement") with Maxim pursuant to which
Maxim will manufacture, ship and perform quality control procedures for the
Company in connection with the Legacy Business. Under the terms of the
Agreement, Maxim has hired some of the Company's ex-employees and the Company
transferred its inventory to Maxim for use under the Agreement. Pursuant to the
Agreement, Maxim has the right, but not the obligation, to purchase the assets
of the Legacy Business on terms to be negotiated between the parties. The
Company will remain liable for its Rockville facility and equipment lease
obligations; however, it expects to reduce its operating expenses through this
arrangement. The Company expects that by year-end its Legacy Business will be
classified as a discontinued operation.
Additionally, during the third quarter of 2005, the Company expects to complete
the transition of its corporate headquarters to the Portland, Oregon area, where
its research and development operations are located. During the second quarter
of 2005, the Company incurred severance costs for certain personnel terminated
at Rockville and accrued severance costs for certain administrative personnel
not transitioning to Oregon. The Company may also be liable for lease costs for
its California offices through July 2007 in the event it is unable to sublease
that facility. The Company accrued approximately $535,000 in the second quarter
of 2005 for transition-related costs resulting from its restructuring
activities. The Company also incurred approximately $1.2 million of expense in
the second quarter of 2005 related to the transfer of its inventory to Maxim
under the Agreement.
Upon successful completion of the transition of the Legacy Business, the Company
believes that it will have significantly reduced its monthly operating burn rate
as compared with historical levels. If it is unable to complete a sale, it may
incur costs to decommission the Rockville facilities; on-going facility lease
costs at Rockville, until and unless sub-lease opportunities are available, and
on-going lease or lease termination costs associated with leased equipment. The
Company cannot currently estimate those costs, but the Company expects that they
would increase its cash burn rate in comparison with the sale alternative. Under
either scenario, the revenue stream from the Company's Legacy Business products
will have been eliminated and it will rely on revenues from the sale of its BED
Incidence Test and, following regulatory approvals, from the sale of its HIV-1/2
Rapid Tests internationally.
7
|
Thread abonnieren
