Filed pursuant to Rule 424(b)(3)
Registration No. 333-177244
PROSPECTUS SUPPLEMENT NO. 2
1,820,000 Shares of Common Stock
of
Guided Therapeutics, Inc.
This prospectus
supplement no. 2 supplements and amends the prospectus dated April 10, 2012, previously supplemented on April 19, 2012, which constitutes
part of our registration statement on Form S-1 (No. 333-
177244
) relating to up to 1,820,000 shares
of our common stock that may be offered for sale by the stockholders named in the prospectus. This prospectus supplement includes
our attached quarterly report on Form 10-Q, which was filed with the Securities and Exchange Commission on May 14, 2012.
This prospectus supplement should be read in
conjunction with the prospectus, which is to be delivered with this prospectus supplement. This prospectus supplement is qualified
by reference to the prospectus, except to the extent that the information in this prospectus supplement updates and supersedes
the information contained in the prospectus.
This prospectus supplement is not complete
without, and may not be delivered or utilized except in connection with, the prospectus.
Investing in our common stock involves a
high degree of risk. We urge you to carefully read the “Risk Factors” section beginning on page 3 of the prospectus.
Neither the Securities and Exchange Commission
nor any state securities commission has approved or disapproved of these securities or determined if this prospectus supplement
is truthful or complete. Any representation to the contrary is a criminal offense.
The date of this prospectus supplement is May
15, 2012.
UNITED STATES SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
[X] QUARTERLY REPORT UNDER SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
[ ] TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT 1934
For the quarterly period ended March 31, 2012
Commission File No. 0-22179
GUIDED THERAPEUTICS, INC.
(Exact Name of Registrant as Specified in Its
Charter)
Delaware
(State or other jurisdiction of incorporation
or organization)
|
|
58-2029543
(I.R.S. Employer Identification No.)
|
|
5835 Peachtree Corners East, Suite D
Norcross, Georgia 30092
(Address of principal executive offices) (Zip Code)
|
(770) 242-8723
(Registrant’s telephone number, including
area code)
Indicate by check mark whether the registrant: (1) has filed all
reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days: Yes [ ] No [ X ]
Indicate by check mark whether the registrant
has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted
and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant
was required to submit and post such files). Yes [ X ] No [ ]
Indicate by check mark whether the registrant is a large accelerated
filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See definitions of “large accelerated
filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-12 of the Exchange Act (Check
one):
Large Accelerated filer _____ Accelerated filer ____ Non-accelerated
filer_____ Smaller Reporting Company [X]
Indicate by check mark whether the registrant is a shell company
(as defined in Rule 12b-2 of the Exchange Act.
Yes [ ] No [X]
As of May 7, 2012, the registrant had outstanding 52,946,645 shares
of Common Stock.
GUIDED THERAPEUTICS, INC. AND SUBSIDIARY
INDEX
Part I. Financial Information
|
3
|
|
|
Item 1. Financial Statements
|
3
|
|
|
Condensed Consolidated Balance Sheets (Unaudited) -
|
|
March 31, 2012 and December 31, 2011
|
3
|
|
|
Condensed Consolidated Statements of Operations (Unaudited)
|
|
Three months ended March 31, 2012 and 2011
|
4
|
|
|
Condensed Consolidated Statements of Cash Flows (Unaudited)
|
|
Three months ended March 31, 2012 and 2011
|
5
|
|
|
Notes to Condensed Financial Statements (Unaudited)
|
6
|
|
|
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
|
12
|
|
|
Item 3. Quantitative and Qualitative Disclosures About Market Risk
|
15
|
|
|
Item 4. Controls and Procedures
|
15
|
|
|
Part II. Other Information
|
16
|
|
|
Item 1. Legal Proceedings
|
16
|
|
|
Item 1A. Risk Factors
|
16
|
|
|
Item 5. Other Information
|
16
|
|
|
Item 6. Exhibits
|
16
|
|
|
Signatures
|
17
|
|
|
PART I - FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
GUIDED THERAPEUTICS, INC. AND SUBSIDIARY
|
CONDENSED CONSOLIDATED BALANCE SHEETS
|
(Unaudited in Thousands Except Share Data)
|
|
|
AS OF
|
ASSETS
|
|
March 31, 2012
|
|
December 31, 2011
|
CURRENT ASSETS:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
1,004
|
|
|
$
|
2,200
|
|
Accounts receivable, net of allowance for doubtful accounts of $4 and $20 at March 31, 2012 and December 31, 2011
|
|
|
38
|
|
|
|
117
|
|
Inventory, net of reserves of $64 at March 31, 2012 and December 31, 2011
|
|
|
608
|
|
|
|
520
|
|
Other current assets
|
|
|
45
|
|
|
|
54
|
|
Total current assets
|
|
|
1,695
|
|
|
|
2,891
|
|
Property and equipment, net
|
|
|
1,088
|
|
|
|
1,033
|
|
Other assets
|
|
|
302
|
|
|
|
386
|
|
Total noncurrent assets
|
|
|
1,390
|
|
|
|
1,419
|
|
|
|
|
|
|
|
|
|
|
TOTAL ASSETS
|
|
$
|
3,085
|
|
|
$
|
4,310
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES:
|
|
|
|
|
|
|
|
|
Short-term notes payable
|
|
$
|
—
|
|
|
$
|
30
|
|
Current portion of long term debt
|
|
|
24
|
|
|
|
25
|
|
Notes payable – past due
|
|
|
375
|
|
|
|
362
|
|
Accounts payable
|
|
|
863
|
|
|
|
1,102
|
|
Accrued liabilities
|
|
|
687
|
|
|
|
757
|
|
Deferred revenue
|
|
|
228
|
|
|
|
453
|
|
Total current liabilities
|
|
|
2,177
|
|
|
|
2,729
|
|
Long-term debt payable, less current portion
|
|
|
—
|
|
|
|
4
|
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES
|
|
|
2,177
|
|
|
|
2,733
|
|
|
|
|
|
|
|
|
|
|
COMMITMENTS & CONTINGENCIES (Note 4)
|
|
|
|
|
|
|
|
|
STOCKHOLDERS’ EQUITY:
|
|
|
|
|
|
|
|
|
Common stock, $.001 Par value; 100,000 shares authorized, 52,697 and 52,211 shares issued and outstanding as of March, 31 2012
and December 31, 2011, respectively
|
|
|
53
|
|
|
|
52
|
|
Additional paid-in capital
|
|
|
86,957
|
|
|
|
86,614
|
|
Treasury stock, at cost
|
|
|
(104
|
)
|
|
|
(104
|
)
|
Accumulated deficit
|
|
|
(86,102
|
)
|
|
|
(85,089
|
)
|
TOTAL GUIDED THERAPEUTICS STOCKHOLDERS’ EQUITY
|
|
|
804
|
|
|
|
1,473
|
|
|
|
|
|
|
|
|
|
|
Non-controlling interest
|
|
|
104
|
|
|
|
104
|
|
|
|
|
|
|
|
|
|
|
TOTAL STOCKHOLDERS’ EQUITY
|
|
|
908
|
|
|
|
1,577
|
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
$
|
3,085
|
|
|
$
|
4,310
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
|
|
|
|
|
GUIDED THERAPEUTICS, INC. AND SUBSIDIARY
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|
(Unaudited, in Thousands Except Share Data)
|
|
|
2012
|
|
2011
|
REVENUE:
|
|
|
|
|
|
|
|
|
Contract and grant revenue
|
|
$
|
718
|
|
|
$
|
767
|
|
|
|
|
|
|
|
|
|
|
COSTS AND EXPENSES:
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
714
|
|
|
|
696
|
|
Sales and marketing
|
|
|
70
|
|
|
|
49
|
|
General and administrative
|
|
|
930
|
|
|
|
762
|
|
Total
|
|
|
1,714
|
|
|
|
1,507
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
|
(996
|
)
|
|
|
(740
|
)
|
|
|
|
|
|
|
|
|
|
OTHER INCOME
|
|
|
—
|
|
|
|
37
|
|
INTEREST EXPENSE
|
|
|
(17
|
)
|
|
|
(23
|
)
|
|
|
|
|
|
|
|
|
|
LOSS BEFORE INCOME TAXES
|
|
|
(1,013
|
)
|
|
|
(726
|
)
|
|
|
|
|
|
|
|
|
|
PROVISION FOR INCOME TAXES
|
|
|
—
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
NET LOSS
|
|
$
|
(1,013
|
)
|
|
$
|
(726
|
)
|
BASIC AND DILUTED NET LOSS PER SHARE
|
|
$
|
(0.02
|
)
|
|
$
|
(0.02
|
)
|
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE SHARES OUTSTANDING
|
|
|
52,471
|
|
|
|
47,851
|
|
The accompanying notes are an integral part
of these condensed consolidated financial statements.
GUIDED THERAPEUTICS, INC. AND SUBSIDIARY
|
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
|
(Unaudited, in Thousands)
|
|
|
|
FOR THE THREE MONTHS ENDED MARCH 31,
|
|
|
2012
|
|
2011
|
CASH FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(1,013
|
)
|
|
$
|
(726
|
)
|
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Bad debt recovery
|
|
|
(16
|
)
|
|
|
—
|
|
Depreciation and amortization
|
|
|
75
|
|
|
|
4
|
|
Stock based compensation
|
|
|
198
|
|
|
|
142
|
|
Conversion of interest to principal
|
|
|
—
|
|
|
|
23
|
|
Gain on debt renegotiated
Changes in operating assets and liabilities:
|
|
|
—
|
|
|
|
(23
|
)
|
Inventory
|
|
|
(88
|
)
|
|
|
—
|
|
Accounts receivable
|
|
|
96
|
|
|
|
(58
|
)
|
Other current assets
|
|
|
8
|
|
|
|
6
|
|
Accounts payable
|
|
|
(239
|
)
|
|
|
36
|
|
Deferred revenue
|
|
|
(225
|
)
|
|
|
(253
|
)
|
Accrued liabilities
|
|
|
(70
|
)
|
|
|
(108
|
)
|
Other assets
|
|
|
84
|
|
|
|
(62
|
)
|
Total adjustments
|
|
|
(177
|
)
|
|
|
(293
|
)
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(1,190
|
)
|
|
|
(1,019
|
)
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Additions to capitalized software costs
|
|
|
—
|
|
|
|
(53
|
)
|
Additions to fixed assets
|
|
|
(130
|
)
|
|
|
(16
|
)
|
Net cash used in investing activities
|
|
|
(130
|
)
|
|
|
(69
|
)
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Proceeds from options and warrants exercised
|
|
|
146
|
|
|
|
175
|
|
Payments on notes and loan payables
|
|
|
(22
|
)
|
|
|
(48
|
)
|
Net cash provided by financing activities
|
|
|
124
|
|
|
|
127
|
|
|
|
|
|
|
|
|
|
|
NET CHANGE IN CASH AND CASH EQUIVALENTS
|
|
|
(1,196
|
)
|
|
|
(961
|
)
|
CASH AND CASH EQUIVALENTS, beginning of year
|
|
|
2,200
|
|
|
|
3,268
|
|
CASH AND CASH EQUIVALENTS, end of period
|
|
$
|
1,004
|
|
|
$
|
2,307
|
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL SCHEDULE OF:
|
|
|
|
|
|
|
|
|
Cash paid for:
|
|
|
|
|
|
|
|
|
Interest
|
|
$
|
5
|
|
|
$
|
1
|
|
NONCASH INVESTING AND FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Conversion of accounts payable into common stock
|
|
$
|
—
|
|
|
$
|
27
|
|
Settlement of debt upon conversion of warrants
|
|
$
|
—
|
|
|
$
|
42
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part
of these condensed consolidated financial statements.
GUIDED THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (UNAUDITED)
1. BASIS OF PRESENTATION
The accompanying unaudited condensed consolidated
financial statements included herein have been prepared in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”)
for interim financial reporting and with the instructions to Form 10-Q and Article 10 of Regulation S-X by Guided Therapeutics,
Inc. (formerly SpectRx, Inc.), together with its majority owned subsidiary InterScan, Inc., (“Interscan”) (formerly
Guided Therapeutics, Inc.), collectively referred to herein as the “Company”. Accordingly, they do not include all
information and footnotes required by GAAP for complete financial statements. These statements reflect adjustments, all of
which are of a normal, recurring nature, and which are, in the opinion of management, necessary to present fairly the Company’s
financial position as of March 31, 2012, results of operations for the three months ended March 31, 2012 and 2011, and cash flows
for the three months ended March 31, 2012 and 2011. The results of operations for the three months ended March 31, 2012 are not
necessarily indicative of the results for a full fiscal year. Preparing financial statements requires the Company’s management
to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses and disclosure
of contingent assets and liabilities. Actual results could differ from those estimates. These financial statements should be read
in conjunction with the financial statements and notes thereto included in the Company’s annual report on Form 10-K for the
year ended December 31, 2011.
The Company's prospects must be considered
in light of the substantial risks, expenses and difficulties encountered by entrants into the medical device industry. This industry
is characterized by an increasing number of participants, intense competition and a high failure rate. The Company has experienced
net losses since its inception and, as of March 31, 2012, it had an accumulated deficit of approximately $86.1 million. Through
March 31, 2012, the Company has devoted substantial resources to research and development efforts. The Company does not have significant
experience in manufacturing, marketing or selling its products. The Company's development efforts may not result in commercially
viable products and it may not be successful in introducing its products. Moreover, required regulatory clearances or approvals
may not be obtained. The Company's products may not ever gain market acceptance and the Company may not ever achieve levels of
revenue to sustain further development costs and support ongoing operations or achieve profitability. The development and commercialization
of the Company's products will require substantial development, regulatory, sales and marketing, manufacturing and other expenditures.
The Company expects operating losses to continue through the foreseeable future as it continues to expend substantial resources
to complete development of its products, obtain regulatory clearances or approvals and conduct further research and development.
Going Concern
The Company’s financial statements have
been prepared and presented on a basis assuming it will continue as a going concern. The factors below raise substantial
doubt about the Company’s ability to continue as a going concern. The consolidated financial statements do not include any
adjustments to reflect the possible future effect on the recoverability and classification of assets or the amounts and classifications
of liabilities that may result should the Company be unable to continue as a going concern. Notwithstanding the foregoing, the
Company believes it has made progress in stabilizing its financial situation by execution of multiyear contracts from Konica Minolta
Opto, Inc., a subsidiary of Konica Minolta, Inc., a Japanese corporation based in Tokyo (“Konica Minolta”) and grants
from the National Cancer Institute (“NCI”), while at the same time simplifying its capital structure and significantly
reducing debt.
At March 31, 2012, the Company’s has
a negative working capital of approximately $482,000 and it had stockholders’ equity of approximately $908,000, primarily
due to the recurring losses. As of March 31, 2012, the Company was past due on payments due under its notes payable in the amount
of approximately $375,000.
The Company’s capital-raising efforts
are ongoing. If sufficient capital cannot be raised during the fourth quarter of 2012, the Company has plans to curtail operations
by reducing discretionary spending and staffing levels, and attempting to operate by only pursuing activities for which it has
external financial support, such as under its development agreement with Konica Minolta and additional NCI or other grant funding.
However, there can be no assurance that such external financial support will be sufficient to maintain even limited operations
or that the Company will be able to raise additional funds on acceptable terms, or at all. In such a case, the Company might be
required to enter into unfavorable agreements or, if that is not possible, be unable to continue operations, and to the extent
practicable, liquidate and/or file for bankruptcy protection.
The Company could receive additional funding
from Konica Minolta or other strategic partners as well as new federal grants that could bring in an additional $700,000. It also
has warrants exercisable for approximately 30.8 million shares of its common stock outstanding, a substantial majority of which
have an exercise price of $0.65 per share. Through March 31, 2012, exercises of these warrants have generated approximately $1.3
million and would generate a total of approximately $18.4 million in cash, assuming full exercise. Management may obtain additional
funds through the private sale of preferred stock or debt securities, public and private sales of common stock, funding from collaborative
arrangements, and grants, if available, and believes that such financing will be sufficient to support planned operations through
the first quarter of 2013.
Assuming the Company receives FDA approval
for its LuViva cervical cancer detection device in 2012, the Company currently anticipates an early 2013 product launch in the
United States. Product launch outside the United States is expected in the second half of 2012
, but
cannot be assured it will be able to launch on these timetables, or at all.
2. SIGNIFICANT ACCOUNTING POLICIES
The Company’s significant accounting
policies were set forth in the audited financial statements and notes thereto for the year ended December 31, 2011 included in
its annual report on Form 10-K, filed with the Securities and Exchange Commission (“SEC”).
Accounting Standards Updates
Newly effective accounting standards updates
and those not effective until after March 31, 2012, are not expected to have a significant effect on the Company’s financial
position or results of operations.
Cash Equivalents
The Company considers all highly liquid investments
with an original maturity of three months or less when purchased to be a cash equivalent.
Concentration of Credit Risk
The Company, from time to time during the periods
covered by these consolidated financial statements, may have bank balances in excess of their insured limits. Management has deemed
this as a normal business risk.
Property and equipment
Property and equipment are recorded at cost.
Depreciation is computed using the straight-line method over estimated useful lives of three to seven years. Leasehold improvements
are depreciated at the shorter of the useful life of the asset or the remaining lease term. Depreciation expense is included in
general and administrative expense on the statement of operations. Expenditures for repairs and maintenance are expensed as incurred.
Inventory Valuation
All inventories are stated at lower of cost
or market, with cost determined substantially on a “first-in, first-out” basis. Selling, general, and administrative
expenses are not inventoried, but are charged to expense when purchased. At March 31, 2012 and December 31, 2011our inventories
are as follows:
|
|
|
March 31, 2012
|
|
|
|
December 31, 2012
|
|
Raw materials
|
|
$
|
540,479
|
|
|
$
|
433,007
|
|
Work in process
|
|
|
129,148
|
|
|
|
149,069
|
|
Finished goods
|
|
|
1,960
|
|
|
|
1,960
|
|
Inventory reserve
|
|
|
(64,036
|
)
|
|
|
(64,036
|
)
|
Total
|
|
$
|
607,551
|
|
|
$
|
520,000
|
|
Revenues
Majority of the Company’s revenues were
from the Konica Minolta and NCI. Revenue from these customers totaled approximately $631,000 or 91% and approximately $757,000
or 99% of total revenue for the three months ended March 31, 2012 and 2011, respectively.
Accounts Receivable
The Company performs periodic credit evaluations
of its customers’ financial condition and generally does not require collateral. The Company reviews all outstanding accounts
receivable for collectability on a quarterly basis. An allowance for doubtful accounts is recorded for any amounts deemed uncollectable.
Revenue Recognition
The Company recognizes revenue from contracts
on a straight line basis, over the terms of the contract. We recognize revenue from grants based on the grant agreement, at the
time the expenses are incurred. Revenue from the sale of the Company’s products is recognized upon shipment of such products
to its customers.
Deferred Revenue
We defer payments received as revenue
until earned based on the related contracts on a straight line basis, over the terms of the contract.
Stock Option Plan
The Company measures the cost of employees
services received in exchange for equity awards, including stock options, based on the grant date fair value of the awards. The
cost will be recognized as compensation expense over the vesting period of the awards.
Warrants
The Company has issued warrants, which allow the warrant holder
to purchase one share of stock at a specified price for a specified period of time. The Company records equity instruments including
warrants issued to non-employees based on the fair value at the date of issue. The fair value of the warrants at date of issuance
is estimated using the Black-Scholes Model.
Other Income
Other income consists of a contract
with Konica Minolta for approximately $10,000 per month for reimbursement of contractual expenses. The related expenses are netted
against the reimbursement and the differential is booked as other income. For the three months ended March 31, 2012 other income
of approximately $30,000 were classified as revenue and for the same period in 2011, such amount of approximately $30,000 were
classified as other income.
3. STOCK-BASED COMPENSATION
The Company records compensation expense related
to options granted to non-employees based on the fair value of the award.
Compensation cost is recorded as earned for
all unvested stock options outstanding at the beginning of the first year based upon the grant date fair value estimates, and for
compensation cost for all share-based payments granted or modified subsequently, based on fair value estimates.
For the quarter ended March 31, 2012, stock-based
compensation for options attributable to employees, officers and directors was approximately $198,000 and has been included in
the Company's first quarter 2012 statement of operations. Compensation costs for stock options, which vest over time,
are recognized over the vesting period. As of March 31, 2012, the Company had approximately $1.9 million of unrecognized compensation
cost related to granted stock options, to be recognized over the remaining vesting period of approximately three years.
The Company has a 1995 stock option plan (the
“Plan”) approved by its stockholders for officers, directors and key employees of the Company and consultants to the
Company. Participants are eligible to receive incentive and/or nonqualified stock options. The aggregate
number of shares that may be granted under the Plan is 8,255,219 shares. The Plan is administered by the compensation
committee of the board of directors. The selection of participants, grant of options, determination of price and other
conditions relating to the exercise of options are determined by the compensation committee of the board of directors and administered
in accordance with the Plan.
Both incentive stock options and non-qualified
options granted to employees, officers and directors under the Plan are exercisable for a period of up to 10 years from the date
of grant, at an exercise price that is not less than the fair market value of the common stock on the date of the grant. The
options typically vest in installments of 1/48 of the options outstanding every month.
A summary of the Company’s activity under the Plan as of March
31, 2012 and changes during the three months then ended is as follows:
|
|
Shares
|
|
Weighted
average
exercise
price
|
|
Weighted
average
remaining
contractual
(years)
|
|
Aggregate
intrinsic
value
(thousands)
|
Outstanding, January 1, 2012
|
|
|
6,862,167
|
|
|
$
|
0.70
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
2,500
|
|
|
$
|
0.70
|
|
|
|
|
|
|
|
|
|
Exercised / Expired
|
|
|
(100,000
|
)
|
|
$
|
3.33
|
|
|
|
|
|
|
|
|
|
Outstanding, March 31, 2012
|
|
|
6,764,667
|
|
|
$
|
0.66
|
|
|
|
7.40
|
|
|
$
|
1,539
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and exercisable, March 31, 2012
|
|
|
4,910,835
|
|
|
$
|
0.44
|
|
|
|
6.61
|
|
|
$
|
2,217
|
|
The Company estimates the fair value of stock
options using a Black-Scholes valuation model. Key input assumptions used to estimate the fair value of stock options include the
expected term, expected volatility of the Company’s stock, the risk free interest rate, option forfeiture rates, and dividends,
if any. The expected term of the options is based upon the historical term until exercise or expiration of all granted options.
The expected volatility is derived from the historical volatility of the Company’s stock on the OTCBB market for a period
that matches the expected term of the option. The risk-free interest rate is the constant maturity rate published by the U.S. Federal
Reserve Board that corresponds to the expected term of the option.
4. LITIGATION AND CLAIMS
As previously reported,
in October 2010, the Company received a letter from an attorney representing Dolores M. Maloof and James E. Funderburke, two stockholders
of the Company (together, the “Claimants”), asserting, among other things, that an August 2005 Warrant Agreement entered
into by the Company and the Claimants (the “2005 Agreement”) had been modified by a subsequent agreement. While the
Company disputed the Claimants’ assertion that an agreement modifying the 2005 Agreement had been reached, the Company determined
to negotiate with the Claimants with the goal of terminating the 2005 Agreement and the rights granted thereunder to the Claimants.
The 2005 Agreement, among other terms, provided for the Company to pay to the Claimants 7.5% of all net proceeds from any license
or sale of the Company’s cervical cancer detection technology, without limitation.
Upon completion of negotiations with the Claimants,
the Company entered into an Agreement and Release, on August 30, 2011 (the “Agreement”), by which the Claimants agreed
to terminate all of their rights under the 2005 Agreement and release all claims. Accordingly, under the Agreement, the 2005 Agreement
and all rights of the Claimants thereunder, including the right to receive 7.5% of proceeds from the sale or license of the Company’s
cervical cancer technology, were canceled. In exchange, the Company agreed to issue warrants to the Claimants to purchase an aggregate
of 2.6 million shares of the Company’s common stock at an exercise price of $0.01 per share (the “Warrants”),
to pay certain royalties related to the sale of disposables in conjunction with the Company’s cervical cancer detection technology
and to make certain additional payments related to non-ordinary course asset sales or a sale of the Company by merger, with such
royalties and related payments subject to certain “caps” limiting their amounts. During 2011, the Company had issued
the 2.6 million warrants and recorded approximately $3.6 million of warrant expenses relating to the settlement. There was no expense
relating to this settlement in the three months ended March 31, 2012 and 2011.
The Warrants were issued
in September 2011, are immediately exercisable and will expire on March 1, 2013. The shares underlying the Warrants are
subject to a Registration Rights Agreement, dated August 30, 2011 (the “Registration Rights Agreement”), which
obligates the Company, within 60 days, to register the shares issuable upon exercise of the Warrants for resale by the Claimants
under the Securities Act of 1933, as amended. The royalties payable pursuant to the Agreement to the Claimants consist of a 2%
royalty on gross revenues generated from the sale of disposables (only) used in conjunction with the Company’s cervical cancer
detection technology. The cumulative royalty payable is capped at $7.2 million, and may not, together with the additional payments
due in conjunction with certain non-ordinary course disposition of assets or a merger of the Company, exceed $12 million. The royalties
are payable until the earlier of the sale of the Company by merger and the sale or exclusive license of all or substantially all
of the Company’s cervical cancer detection technology. The Agreement further provides that, in the event of one or more non-ordinary
course asset sales by the Company, or a sale of the Company by merger, the Claimants will be entitled to an aggregate of 3% of
the proceeds therefrom (net of any direct and customary transaction expenses), provided that the aggregate payment due under this
provision is capped at the lesser of $9.5 million and the amount by which $12.0 million exceeds the cumulative amount of all payments
previously paid to the Claimants in royalties or by reason of prior non-ordinary course asset sales.
From time to time, the Company may be involved
in various other legal proceedings and claims arising in the ordinary course of business. Management believes that the disposition
of these additional matters which may occur, individually or in the aggregate, is not expected to have a material adverse effect
on the Company’s financial condition. However, depending on the amount and timing of such disposition, an unfavorable resolution
of some or all of these matters could materially affect the future results of operations or cash flows in a particular period.
As of March 31, 2012 and December 31, 2011,
there was no accrual recorded for any potential losses related to pending litigation.
5. STOCKHOLDERS' EQUITY
Common Stock
The Company has authorized 100 million shares
of common stock with $0.001 par value, 52,696,519 of which were outstanding as of March 31, 2012.
Preferred Stock
The Company has authorized 5,000,000 shares
of preferred stock with a $.001 par value. The board of directors has the authority to issue these shares and to set dividends,
voting and conversion rights, redemption provisions, liquidation preferences, and other rights and restrictions. The board of directors
designated 525,000 shares of the preferred stock as redeemable convertible preferred stock, none of which remain outstanding.
Stock Options
Under the Plan,
a total of 1,490,552 shares remained available at March 31, 2012 and 6,764,667
shares were
outstanding as of that date, bringing the total number of shares subject to stock options outstanding and those remaining available
for issue to 8,255,219
shares of common stock as of March 31, 2012. The Plan allows
the issuance of incentive stock options, nonqualified stock options, and stock purchase rights. The exercise price of options is
determined by the Company’s board of directors, but incentive stock options must be granted at an exercise price equal to
the fair market value of the Company’s common stock as of the grant date. Options historically granted have generally become
exercisable over four years and expire ten years from the date of grant.
In January 2002, the Company assumed the Sterling
Medivations 2000 Stock Option Plan, which authorizes the issuance of up to 93,765 shares of the Company’s common stock. No
options have been issued under this plan.
The following table sets forth or the range
of exercise prices, number of shares issuable upon exercise, weighted average exercise price, and remaining contractual lives by
groups of similar price as of March 31, 2012:
|
Options Outstanding
|
|
Options Exercisable
|
Range of Exercise Prices
|
Number
of Shares
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Contractual
Life (years)
|
|
Number
of Shares
|
Weighted
Average
Price
|
|
$ 0.00 - $ 0.26
|
850,500
|
$ 0.25
|
4.66
|
|
850,500
|
$ 0.25
|
|
$ 0.30 - $ 0.33
|
2,123,500
|
$ 0.32
|
6.29
|
|
2,121,417
|
$ 0.32
|
|
$ 0.34 - $ 1.00
|
2,354,667
|
$ 0.65
|
8.25
|
|
1,670,572
|
$ 0.56
|
|
$ 1.10 - $ 4.46
|
1,436,000
|
$ 1.47
|
9.29
|
|
243,347
|
$ 1.39
|
|
Total
|
6,764,667
|
$ 0.66
|
7.40
|
|
4,885,836
|
$ 0.44
|
|
|
|
|
|
|
|
|
|
|
|
Warrants
The Company has the following shares reserved for the warrants outstanding
as of March 31, 2012:
|
|
|
|
|
Warrants
|
|
Exercise
|
|
Expiration
|
(Underlying Shares)
|
|
Price
|
|
Date
|
|
25,705,814
|
(1)
|
|
|
$0.65
|
|
|
|
03/01/2013
|
|
|
2,686,523
|
(2)
|
|
|
$0.65
|
|
|
|
07/26/2012
|
|
|
2,070,000
|
(3)
|
|
|
$0.01
|
|
|
|
03/01/2013
|
|
|
285,186
|
(4)
|
|
|
$1.05
|
|
|
|
11/20/2016
|
|
|
6,790
|
(5)
|
|
|
$1.01
|
|
|
|
09/10/2015
|
|
|
30,754,313
|
|
|
|
|
|
|
|
|
|
Warrants (Underlying Shares) Exercise Price Expiration Date 25,705,814 (1) $0.65 03/01/2013 2,686,523 (2) $0.65 07/26/2012 2,070,000 (3) $0.01 03/01/2013 285,186 (4) $1.05 11/20/2016 6,790 (5) $1.01 09/10/2015 30,754,313
|
|
(1)
|
Consists of outstanding warrants issued in connection with various financings,
but amended or originally issued on February 26, 2010 to expire on March 1, 2013. During the quarter ended March 31, 2012, warrants
for 212,804 shares of common stock were exercised.
|
|
(2)
|
Consists of outstanding warrants issued in connection with Series A conversion
on February 26, 2010 to expire on July 26, 2012.
|
|
(3)
|
Consists of warrants to purchase common stock at a purchase price of $0.01
per share issued in conjunction with the settlement of a claim. During the quarter ended March 31, 2012, warrants for 250,000 shares
of common stock were exercised.
|
|
(4)
|
Consists of outstanding warrants issued in conjunction with a private placement
on November 21, 2011.
|
|
(5)
|
Consists of outstanding warrants issued in conjunction with a private placement
on September 10, 2010.
|
6. LOSS PER COMMON SHARE
Basic net loss per share attributable to common
stockholders amounts are computed by dividing the net loss plus preferred stock dividends and deemed dividends by the weighted
average number of common shares outstanding during the period.
7. NOTES PAYABLE
Loan Payable
At December 31, 2009, the Company maintained
a line of credit in the amount of $75,000 with Pacific International Bank of Seattle, Washington. This line was converted to a
36 months straight-line amortizing loan on February 24, 2010, with monthly principal and interest payment of $2,226 per month due
February 2013. Interest is charged at a rate of 7.5%. At March 31, 2012, a balance of approximately $24,000 was outstanding, which
is classified as current loan payable.
Notes Payable – Past Due
At December 31, 2011, the Company was past
due on two short-term notes totaling approximately $362,000 of principal and accrued interest. These notes are due on demand and
interest is charged at rates ranging between 15-18 %. The principal and accrued interest balance at March 31, 2012 is approximately
$375,000.
8. SUBSEQUENT EVENTS
On April 16, 2012, the Company announced the
appointment of Linda Rosenstock, M.D., M.P.H. to its Board of Directors. The addition of Dr. Rosenstock increases the size of the
company’s board to seven. She will stand for election at the company’s Annual Stockholder’s Meeting scheduled
for June 15, 2012.
On March 7, 2012 we received an email from
Konica Minolta Opto indicating that the esophageal cancer program and budget was likely to be approved for the fiscal year May
1, 2012 to April 30, 2013. On April 1, 2012 the research and development arm of Konica Minolta Opto was transferred to the general
R&D division of Konica Minolta Holdings. This division has not yet agreed to proceed with the program and we believe that while
we have been informed that the technical review of the program has been completed successfully, continuation of the program and
funding may be conditional upon additional review of the potential business opportunity and long term relationship between the
Company and Konica Minolta, including the eventual structure of a licensing agreement or joint partnership. We believe that these
issues will be resolved over the coming weeks, however there is no precise timetable for completion and no guarantee that the program
or funding will continue under conditions acceptable to the Company.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Statements in this report which express "belief,"
"anticipation" or "expectation," as well as other statements which are not historical facts, are forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.
These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially
from historical results or anticipated results, including those set forth under "Risk Factors" below and elsewhere in
this report. Examples of these uncertainties and risks include, but are not limited to:
|
·
|
the dependence on potential strategic partners
or outside investors for funding, development assistance, clinical trials, distribution and marketing of some of our products.
|
|
·
|
access to sufficient debt or equity capital to meet our operating and financial needs;
|
|
·
|
the effectiveness and ultimate market acceptance of our products;
|
|
·
|
whether our products in development will prove safe, feasible and effective;
|
|
·
|
whether and when we or any potential strategic partners will obtain approval from the U.S FDA and corresponding foreign agencies;
|
|
·
|
our need to achieve manufacturing scale-up in a timely manner, and our need to provide for the efficient manufacturing of sufficient quantities of our products;
|
|
·
|
the lack of immediate alternate sources of supply for some critical components of our products;
|
|
·
|
our patent and intellectual property position; and
|
|
·
|
the need to fully develop the marketing, distribution, customer service and technical support and other functions critical to the success of our product lines.
|
The following discussion should be read in
conjunction with our financial statements and notes thereto included elsewhere in this report.
OVERVIEW
We are a medical technology company focused
on developing innovative medical devices that have the potential to improve healthcare. Our primary focus is the development of
our LuViva non-invasive cervical cancer detection device and extension of our cancer detection technology into other cancers, especially
lung and esophageal. Our technology, including products in research and development, primarily relates to biophotonics technology
for the non-invasive detection of cancers, including cervical cancer.
We are a Delaware corporation, originally incorporated
in 1992 under the name “SpectRx, Inc.,” and, on February 22, 2008, changed our name to Guided Therapeutics, Inc. At
the same time, we renamed our majority owned subsidiary, InterScan, which originally had been incorporated as “Guided Therapeutics.”
Since our inception, we have raised capital
through the private sale of preferred stock and debt securities, public and private sales of common stock, funding from collaborative
arrangements, and grants.
Our prospects must be considered in light of
the substantial risks, expenses and difficulties encountered by entrants into the medical device industry. This industry is characterized
by an increasing number of participants, intense competition and a high failure rate. We have experienced operating losses since
our inception and, as of March 31, 2012, we have an accumulated deficit of about $86.1 million. To date, we have engaged primarily
in research and development efforts. We do not have significant experience in manufacturing, marketing or selling our products.
Our development efforts may not result in commercially viable products and we may not be successful in introducing our products.
Moreover, required regulatory clearances or approvals may not be obtained in a timely manner, or at all. Our products may not ever
gain market acceptance and we may not ever generate significant revenues or achieve profitability. The development and commercialization
of our products requires substantial development, regulatory, sales and marketing, manufacturing and other expenditures. We expect
our operating losses to continue through at least the end of 2012 as we continue to expend substantial resources to introduce LuViva,
further the development of our other products, obtain regulatory clearances or approvals, build our marketing, sales, manufacturing
and finance organizations and conduct further research and development.
Our product revenues to date have been limited.
In 2011 and 2010, the majority of our revenues were from private sales of our common stock, grants from the NCI and our collaborative
arrangements with Konica Minolta. We expect that the majority of our revenue in 2012 will be derived from similar sources.
CRITICAL ACCOUNTING POLICIES
Our material accounting policies, which we
believe are the most critical to an investors understanding of our financial results and condition, are discussed below. Because
we are still early in our enterprise development, the number of these policies requiring explanation is limited. As we begin to
generate increased revenue from different sources, we expect that the number of applicable policies and complexity of the judgments
required will increase.
Currently, our policies that could require
critical management judgment are in the areas of revenue recognition, reserves for accounts receivable and inventory valuation.
Revenue Recognition:
We recognize revenue from contracts on a straight line basis, over the terms of the contract. We recognize revenue from grants
based on the grant agreement, at the time the expenses are incurred. Revenue from the sale of the Company’s products is recognized
upon shipment of such products to its customers.
Valuation of Deferred
Taxes:
We account for income taxes in accordance with the liability method. Under the liability method, we recognize deferred
assets and liabilities based upon anticipated future tax consequences attributable to differences between financial statement carrying
amounts of assets and liabilities and their respective tax bases. We establish a valuation allowance to the extent that it is more
likely than not that deferred tax assets will not be utilized against future taxable income.
Valuation of Equity Instruments
Granted To Employee, Service Providers and Investors:
On the date of issuance, the instruments are recorded at their fair value
as determined using the Black-Scholes valuation model. See Note 3 to the consolidated financial statements accompanying this report
for the assumptions used in the Black-Scholes valuation.
Stock Option Plan:
The Company
measures the cost of employees services received in exchange for equity awards, including stock options, based on the grant date
fair value of the awards. The cost will be recognized as compensation expense over the vesting period of the awards.
Warrants:
The Company has issued
warrants, which allow the warrant holder to purchase one share of stock at a specified price for a specified period of time. The
Company records equity instruments including warrants issued to non-employees based on the fair value at the date of issue. The
fair value of the warrants at date of issuance is estimated using the Black-Scholes Model.
Allowance for Inventory Valuation:
We estimate losses
from obsolete and damaged inventories quarterly and revise our reserves as a result.
Allowance for Accounts Receivable:
We estimate losses
from the inability of our customers to make required payments and periodically review the payment history of each of our customers,
as well as their financial condition, and revise our reserves as a result.
RESULTS OF OPERATIONS
COMPARISON OF THE THREE MONTHS ENDED MARCH
31, 2012 AND 2011
Revenue: Net revenue decreased to
approximately $718,000 for the quarter ended March 31, 2012, from approximately $767,000 for the same period in 2011. Net revenue
was lower for the first quarter 2012 due to the timing of the contracts relating to our cancer detection technology.
Research and Development Expenses: Research
and development expenses increased to approximately $714,000 for the three months ended March 31, 2012, compared to $696,000 for
the same period in 2011. The increase, of approximately $18,000, was primarily due to an increase in research and development
for our cervical cancer detection product, as we prepare for marketing and production.
Sales and Marketing Expenses: Sales
and marketing expenses were approximately $70,000 during the three months ended March 31, 2012, compared to $49,000 for the same
period in 2011. The increase was primarily due to efforts underway in marketing our cervical cancer detection product.
General and Administrative Expenses: General
and administrative expenses increased to approximately $930,000 during the three months ended March 31, 2012, compared to approximately
$762,000 for the same period in 2011. The increase of approximately $168,000, or 22%, is primarily related to an increase
in stock based compensation and material modification associated with our cervical cancer detection product.
Net Interest and Other Income: Other
income for the three months ended March 31, 2012 was zero compared to $37,000 in 2011. In the three months ended March 31,
2012, we had approximately $30,000 in reimbursed expenses from Konica Minolta related to an expatriate Konica Minolta employee,
which was recorded as other income. Interest expense decreased to approximately $17,000 for the three months ended March 31, 2012,
as compared to approximately $23,000 for the same period in 2011 primarily due to repayment of notes during the quarter ended March
31, 2012.
Net loss was approximately $1.0 million during
the three months ended March 31, 2012, compared to $726,000 for the same period in 2011, for the reasons outlined above.
Net loss attributable to common stockholders
was approximately $1.0 million during the three months ended March 31, 2012, compared to a net loss attributable to common
stockholder of approximately $726,000 during the three months ended March 31, 2011.
LIQUIDITY AND CAPITAL RESOURCES
Since our inception, we have raised capital
through the private sale of preferred stock and debt securities, public and private sales of common stock, funding from collaborative
arrangements, and grants. At March 31, 2012, we had cash of approximately $1.0 million and a negative working capital of approximately
$482,000.
Our major cash flows in the quarter ended March
31, 2012, consisted of cash out-flows of approximately $1.2 million from operations, including approximately $1.0 million of net
loss, cash outflow of $130,000 from investing activities and a net change from financing activities of $124,000, which primarily
represents the proceeds received from excise of outstanding warrants and options, offset in part by cash utilized for loan repayment.
In March 2011, we extended our existing agreement
with Konica Minolta for development of our biophotonic platform specific to the detection of esophageal cancer for an additional
year, effective May 1, 2011. In this agreement, we are providing Konica Minolta with technical, regulatory and clinical development
of our biophotonic platform device for esophageal cancer detection. We received approximately $1.72 million in 2011 from
Konica Minolta under this development agreement and expect to receive a total of $2.2 million for the third year of development
(May 1, 2012 to April 30, 2013). While at this time our expectation is that our agreement with Konica Minolta will be extended
for an additional year, the contract has yet to be signed and there is no certainty that it will be extended.
On November 21, 2011, we completed a private
placement of 2,056,436 shares of common stock at a purchase price of $0.84 per share, pursuant to which we raised approximately
$1.7 million. For each share of common stock issued, subscribers received warrants exercisable for the purchase of 1/10 of one
share of common stock (in the aggregate, 285,186 shares) at an exercise price of $1.05 per share. The warrants have a five-year
term.
We will be required to raise additional funds
through public or private financing, additional collaborative relationships or other arrangements in addition to these sources.
We believe our existing and available capital resources will be sufficient to satisfy our funding requirements through the first
quarter of 2013. We are evaluating various options to further reduce our cash requirements to operate at a reduced rate, as well
as options to raise additional funds, including loans using certain assets as collateral.
Substantial capital will be required to develop
our products, including completing product testing and clinical trials, obtaining all required U.S. and foreign regulatory approvals
and clearances, and commencing and scaling up manufacturing and marketing our products. Any failure to obtain capital would have
a material adverse effect on our business, financial condition and results of operations.
Our financial statements have been prepared
and presented on a basis assuming we will continue as a going concern. The above factors raise substantial doubt about our
ability to continue as a going concern, as more fully discussed in Note 1 to the consolidated financial statements contained herein
and in the report of our independent registered public accounting firm accompanying our financial statements contained in our annual
report on Form 10-K for the year ended December 31, 2011.
Off-Balance Sheet Arrangements
We have no material off-balance sheet arrangements,
no special purpose entities, and no activities that include non-exchange-traded contracts accounted for at fair value.
ITEM 3. QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not applicable.
ITEM 4. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
The Company under the supervision and with
the participation of management, including the Chief Executive Officer (principal executive officer) and the Chief Financial Officer
(principal financial officer), evaluated the effectiveness of our “disclosure controls and procedures” (as defined
in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934 (the “Exchange Act”)) as of March 31, 2012.
The controls and System currently used by the Company to calculate and record inventory is not operating effectively. Additionally,
the Company lacks the resources to properly research and account for complex transactions. The combination of these controls deficiencies
have resulted in a material weakness in our internal control over financial reporting.
Based on that evaluation, the Chief Executive
Officer and the Chief Financial Officer concluded that our disclosure controls and procedures (as defined in Exchange Act Rules
13a-15(e) and 15d-15(e)) were not effective as of March 31, 2012 to provide reasonable assurance that (1) information required
to be disclosed by us in the reports we file or submit under the Exchange Act is recorded, processed, summarized, and reported
within the time periods specified in the Securities and Exchange Commission’s rules and forms, and (2) information required
to be disclosed by us in the reports we file or submit under the Exchange Act is accumulated and communicated to our management,
including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required
disclosures.
The effectiveness of any system of controls
and procedures is subject to certain limitations, and, as a result, there can be no assurance that our controls and procedures
will detect all errors or fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not
absolute, assurance that the objectives of the control system will be attained.
Changes in Internal Control Over
Financial Reporting
There has been no change in our internal
control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended
March 31, 2012 that has materially affected, or is reasonably likely to materially affect, our internal control over financial
reporting.
PART II - OTHER INFORMATION
ITEM 1A. RISK FACTORS
Please
refer to Part I, Item 1A, “Risk Factors,” in our annual report on Form 10-K for the year ended December 31, 2011,
for information regarding factors that could affect our results of operations, financial condition and liquidity.
ITEM 6. EXHIBITS
EXHIBIT INDEX
EXHIBITS
Exhibit Number
|
Exhibit Description
|
|
|
3.1
|
Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 of the Company’s report on Form 8-K, filed March 23, 2012).
|
31
|
Rule 13a-14(a)/15d-14(a) Certification
|
32
|
Section 1350 Certification
|
101
|
XBRL
|
SIGNATURES
In accordance with the requirements of the Exchange Act, the registrant
has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
GUIDED THERAPEUTICS, INC.
|
/s/ MARK L. FAUPEL
|
By:
|
Mark L. Faupel
|
|
President, Chief Executive Officer and
|
|
Acting Chief Financial Officer
|
Date:
|
May 14, 2012
|
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