Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) today announced
its operating results for the quarter and nine months ended September
30, 2012.
Revenue for the third quarter of 2012 was $693,000, including revenue of
$43,000 on the sale of three LuViva® Advanced Cervical Scan
demonstration units in the quarter. This compares to revenue of $1.0
million in the third quarter of 2011. Revenue for the first nine months
of 2012 was $2.3 million compared to $2.7 million for the first nine
months of 2011. The variability in revenue was primarily due to the
timing of receipts accrued under the Company’s contracts with Konica
Minolta.
The net loss available to common stockholders for the third quarter of
2012 was $986,000, or $0.02 per share, compared to a net loss available
to common stockholders of $2.7 million, or $0.05 per share, in the
comparable quarter of 2011. The net loss available to common
stockholders for the first nine months of 2012 was $3.2 million, or
$0.06 per share, compared to a net loss available to common stockholders
of $3.9 million, or $0.08 per share, in the comparable period of 2011.
The decreased loss reported in the three and nine month periods ended
September 30, 2012 was due primarily to a claim settlement of
approximately $2.3 million recorded in the third quarter of 2011.
Cash on hand at September 30, 2012 was approximately $2.6 million as
compared to $2.2 million at December 31, 2011. Offsetting the cash
outflow from operations in the third quarter was a net change from
financing activities of approximately $3.0 million, which primarily
represents proceeds received from the exercise of outstanding warrants
and options. Warrants exercisable for approximately 15.9 million shares
of the Company’s common stock, or 56.3% of eligible warrants, were
tendered as part of the Company’s warrant exchange program completed in
July 2012. New warrants issued in the exchange program, representing
approximately 15.1 million shares, were exercised in the third quarter
of 2012, resulting in approximately $2.9 million in cash proceeds to the
Company.
At September 30, 2012, the Company had approximately $461,000 of
inventory on hand. Management believes that available capital resources,
including funds from partnerships and grants, should be sufficient to
support existing operations through the first quarter of 2013.
Outstanding warrants exercisable for approximately 12.4 million shares
of common stock at $0.65 per share that will expire on March 1, 2013
could generate approximately $8.0 million in cash proceeds to the
Company, assuming full exercise.
“We are pleased to be able to report our progress with the FDA,” said
Mark L. Faupel, Ph.D., Chief Executive Officer and President of Guided
Therapeutics. “The filing of our PMA Amendment comes with FDA’s prior
review regarding its key contents and puts us on a track, if approved,
for a U.S. launch of LuViva® next year. In the meantime, we expect to
comply with the Third Edition CE mark requirements around the end of
this year. This will provide LuViva® with access to the 27 countries of
the European Union. We will also utilize a portion of this testing to
meet Canadian Standards Association, or CSA, mark requirements, which,
while not mandatory, is valued by many of the institutions our Canadian
distributor is targeting for sales. We believe we remain on track to
ship additional units to Canada in the fourth quarter for the launch.”
Dr. Faupel added, “We are also moving ahead with the ramp up of our
distributor network. During the quarter we formalized our relationship
for Turkey and added an experienced marketing manager for Europe to help
manage our distribution activities there and in the Middle East and
Africa. We continue to participate in European trade shows and
conferences including the International Federation of Gynaecology and
Obstetrics and Medica, educating hundreds of doctors and potential
distributors about our technology and positioning LuViva® to become part
of the standard of care in the diagnosis of cervical disease.”
Conference Call
Guided Therapeutics will hold a conference call at 11:00 a.m. EST
Wednesday, November 14, 2012, to discuss its financial results and
corporate developments. Interested parties are invited to listen to the
call live over the Internet at http://www.guidedinc.com/investors.htm
or http://www.viavid.com.
The live call is also available by dialing (888) 510-1786 or for
international callers (719) 325-2308. A replay of the teleconference
will be available on http://www.guidedinc.com/investors.htm.
A replay will also be available until November 21, 2012 by dialing (877)
870-5176, or for international callers (858) 384-5517, and using pin
number 3514457.
About Guided Therapeutics
Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) is developing a
rapid and painless testing platform for the early detection of disease
based on its patented biophotonic technology that utilizes light to
detect disease at the cellular level. The Company’s first product is the
LuViva® Advanced Cervical Scan, a non-invasive device used to
detect cervical disease instantly and at the point of care. In a
multi-center clinical trial, with women at risk for cervical disease,
the technology was able to detect cervical cancer up to two years
earlier than conventional modalities, according to published reports.
Guided Therapeutics has also entered into a partnership with Konica
Minolta to develop a non-invasive test for the early detection of
esophageal cancer using the technology platform. For more information,
visit: www.guidedinc.com.
The Guided Therapeutics LuViva® Advanced
Cervical Scan is an investigational device and is limited by federal law
to investigational use. LuViva, the wave logo and "Early detection,
better outcomes" are registered trademarks owned by Guided Therapeutics,
Inc.
Forward-Looking Statements Disclaimer: A number of the matters and
subject areas discussed in this news release that are not historical or
current facts deal with potential future circumstances and developments.
The discussion of such matters and subject areas is qualified by the
inherent risks and uncertainties surrounding future expectations
generally and also may materially differ from Guided Therapeutics’
actual future experience involving any of or more of such matters and
subject areas. Such risks and uncertainties include those related to the
early stage of products in development, the uncertainty of market
acceptance of products, the uncertainty of development or effectiveness
of distribution channels, the intense competition in the medical device
industry, the uncertainty of capital to develop products, the
uncertainty of regulatory approval of products, dependence on licensed
intellectual property, as well as those that are more fully described
from time to time under the heading “Risk Factors” in Guided
Therapeutics’ reports filed with the SEC, including Guided Therapeutics’
Annual Report on Form 10-K for the fiscal year ended December 31, 2011,
and subsequent quarterly reports.
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GUIDED THERAPEUTICS, INC. AND SUBSIDIARY
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Unaudited Condensed Consolidated Statements of Operations
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For the Three Months and Nine Months Ended September 30, 2012
and 2011
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Three Months Ended
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Nine Months Ended
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September 30
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September 30
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In thousands, except per share data
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2012
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2011
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2012
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2011
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Revenue
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Contract and grant revenue
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$
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693
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$
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1,021
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2,326
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2,701
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Sales – devices and disposables
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43
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--
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72
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--
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Cost of goods sold
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55
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--
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130
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--
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Gross loss
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(12
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--
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(58
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--
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Cost and Expenses
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Research and development
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787
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709
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2,397
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2,024
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Sales and marketing
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132
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80
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271
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200
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General and administration
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712
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2,881
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2,714
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4,351
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Total operating expense
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1,651
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3,670
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5,382
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6,575
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Operating Loss
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(970
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(2,649
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)
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(3,114
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)
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(3,874
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)
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Interest (Expense) and Other Income
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(16
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)
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(12
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(52
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(9
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Net Loss Attributable to Common Stockholders
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$
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(986
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$
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(2,661
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$
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(3,166
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$ (3,883
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Basic and Diluted Net Loss per Share
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$
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(0.02
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$
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(0.05
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$
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(0.06
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$
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(0.08
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Basic and Diluted
Weighted Average Shares Outstanding
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60,827
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48,813
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55,810
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48,379
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Selected Balance Sheet Data (Unaudited)
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(In thousands)
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September 30, 2012
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December 31, 2011
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Cash & Cash Equivalents
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$
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2,609
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$
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2,200
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Inventory
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461
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520
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Working Capital
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607
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162
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Total Assets
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4,771
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4,310
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Accumulated Deficit
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(90,911
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(85,089
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Stockholders’ Equity
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2,124
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1,577
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