SUNNYVALE, Calif., Nov. 14 /PRNewswire/ -- Biocircuits Corporation
(Nasdaq: BIOC) announced today its financial results for the third quarter
ended September 30, 1996. The Company reported a net loss of approximately
$3.2 million, or $0.60 per share, compared to a net loss of approximately
$1.8 million, or $0.63 per share, recorded in the third quarter of 1995.
In October 1996 and after the end of the third quarter, the Company closed
a private placement which consisted of the sale of 965,231 units at $6.00 per
unit. Proceeds to the Company were approximately $5.3 million, net of
issuance costs. A unit consisted of two shares of common stock and one
warrant, expiring in October 1997. If the warrants are exercised, the Company
will receive gross proceeds of up to an additional $3.3 million.
The Biocircuits IOS(TM) system incorporates a low-cost, compact instrument
and patented, disposable test cartridges and is the first cost-effective,
easy-to-use immunodiagnostic system available for use in physicians' offices
and other point-of-care sites. The initial test cartridge for IOS was a
combined T4 and T Uptake assay to assess thyroid function. The Company
launched the IOS system with the initial test cartridge in March 1996.
Shipments were suspended following discovery of problems in some of the
instrument circuitry and software which required certain modifications.
Shipments to distributors were resumed in late June, following the retrofit of
all units in inventory and in distributor stocks.
To date, the number of instrument sales to distributors and placements in
physicians' offices have been significantly less than the Company's
expectations. In order for the Company to have success in penetrating the
point-of-care immunodiagnostic market and to achieve significant sales of IOS
systems and test cartridges, the Company believes it will need to expand its
menu beyond the initial tests. The Company's initial marketing efforts
indicate that offering a test for Thyroid Stimulating Hormone ("TSH") to
diagnose, and manage thyroid function may be a key element in penetrating the
physicians' office market. In April 1996, the Company filed a 510(k)
pre-market notification with the U.S. Food and Drug Administration ("FDA") for
the TSH assay. In September 1996, the Company announced FDA clearance to
market a qualitative serum pregnancy assay, a test designed to allow
physicians to perform this common pregnancy test in their office during the
patient visit where they can provide more immediate pre-natal care to
patients. Also in September 1996, the Company filed a 510(k) pre-market
notification with the FDA for a quantitative hCG assay, a test to track the
progress of early pregnancies.
The Company is in the process of developing and testing an improved second
generation cartridge for the new assays as well as existing assays. The
Company believes this modified design will be required for the market launch
of the TSH, qualitative serum pregnancy and quantitative hCG tests. The
Company currently expects the improved cartridge to be available in the fourth
quarter of 1996.
In the latter part of the third quarter, the Company implemented a
marketing program to solicit orders that would be consummated upon the market
launch of the TSH assay in the second generation cartridge. Orders taken
under these programs will result in gross revenue of approximately $54,000
that will be booked in the fourth quarter, assuming the TSH assay receives FDA
clearance and is launched during the fourth quarter. In addition, new
promotional programs offered to distributors during the fourth quarter have
resulted in further fourth quarter orders to-date of $58,000.
"While we continue to face challenges, we are encouraged by the result of
these marketing programs and are looking forward to receiving FDA clearance
and launching the TSH assay," said John Kaiser, President and Chief Executive
Officer.
Biocircuits is currently developing three additional assays: a PSA test
for management of prostrate cancer patients, a Digoxin test for monitoring the
therapeutic usage of this drug in the treatment of heart disease and a Free T4
test for diagnosing true clinical thyroid status. The Company plans to
continue to develop additional immunodiagnostic assays commonly requested by
office-based physicians.
Biocircuits is targeting the approximately 41,000 small to medium-sized
physician office practices and free-standing alternate site laboratories which
are licensed under CLIA for high or moderate complexity testing. Most of
these sites do not currently have an immunodiagnostic testing capability. The
IOS system is approved for moderately complex testing.
Biocircuits Corporation, based in Sunnyvale, California, is focused on the
development and commercialization of innovative and cost-effective
immunodiagnostic products.
Actual results may differ materially from the above forward-looking
statements due to a number of important factors, and will be dependent upon
the Company's ability, directly or through third parties, to successfully
manufacture and market its existing products, as well as the timely
development and regulatory approval of additional products. These factors are
more fully discussed in the Company's most recent reports on Forms 10-K and
10-Q and the Company's Resale Registration Statement No. 333-13673.
BIOCIRCUITS CORPORATION
(a development stage company)
STATEMENTS OF OPERATIONS
(in thousands except per share data)
(unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
1996 1995 1996 1995
Revenues
Product sales $ 50 $ -- $ 206 $ --
Operating costs and expenses
Cost of sales 542 -- 1,591 --
Research and development 1,564 1,139 5,579 3,456
Sales, general and
administrative 1,179 700 3,859 1,879
3,285 1,839 11,029 5,335
Loss from operations (3,235) (1,839) (10,823) (5,335)
Other income and expense 7 67 32 96
Net loss $(3,228) $(1,772) $(10,791) $(5,239)
Net loss per share $ (0.60) $ (0.63) $ (2.32) $ (2.01)
Shares used in computing net
loss per share 5,424 2,827 4,650 2,612
Pro forma net loss per
share $ (0.37) $ (0.26) $ (1.34) $ (1.26)
Shares used in computing pro forma
net loss per share(a) 8,610 6,862 8,042 4,148
(a)Including outstanding convertible preferred stock on an if converted
basis.
BIOCIRCUITS CORPORATION
(a development stage company)
CONDENSED BALANCE SHEETS
(in thousands)
(Unaudited)
September 30, December 31,
1996 1995
Assets
Current assets:
Cash, cash equivalents
and short-term investments $ 3,376 $ 6,633
Other current assets 1,521 1,055
Total current assets 4,897 7,688
Property and equipment, net 1,268 975
Restricted cash 376 479
Other assets 137 125
$6,678 $9,267
Liabilities and stockholders' equity
Current liabilities $1,185 $1,497
Long-term obligations 3,877 3,707
Total liabilities 5,062 5,204
Stockholders' equity 1,616 4,063
$6,678 $9,267
SOURCE Biocircuits Corp.
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CONTACT:
John Kaiser, President ''&'' CEO,
408-752-8706, or Donald Hawthorne, Chief Financial Officer,
408-752-8705, both of Biocircuits Corp.
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