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 wholly 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, 2014, results of operations for the three months ended March 31, 2014 and 2013, and cash flows for the
three months ended March 31, 2014 and 2013. The results of operations for the three months ended March 31, 2014 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, 2013.
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, 2014, it had an accumulated deficit of approximately $104.6 million. Through
March 31, 2014, 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.
The Company’s consolidated 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 financial statements do not include any
adjustments that might be necessary from the outcome of this uncertainty. Notwithstanding the foregoing, the Company believes it
has made progress in recent years 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. However, the Company has replaced its prior agreements with Konica Minolta with a new licensing agreement, and therefore
will no longer receive direct payments from Konica Minolta, and will have to pay a royalty to Konica Minolta should the Company
sell any products licensed from Konica Minolta.
At March 31, 2014, the Company had negative
working capital of approximately $1.3 million and the stockholders’ deficit was approximately $1.3 million, primarily due
to recurring net losses from operations, deemed dividends on warrants and preferred stock, offset by proceeds from the exercise
of options and warrants. In addition, the Company is past due on payroll tax liabilities totaling $200,000.
The Company’s capital-raising efforts
are ongoing. If sufficient capital cannot be raised by the end of 2014, 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 and additional NCI, NHI 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 had warrants exercisable for approximately
11.6 million shares of its common stock outstanding at March 31,
2014,
with exercise prices of $0.40, $0.68, $0.80 and $1.08 per share. Exercises of these warrants would generate a total of approximately
$7.9 million in cash, assuming full exercise, although the Company cannot be assured that holders will exercise any warrants.
Management may obtain additional funds through the private sale of preferred stock or debt securities, public and private sales
of common stock, and grants, if available.
Assuming the Company receives FDA approval
for its LuViva cervical cancer detection device in 2014, the Company currently anticipates an early 2015 product launch in the
United States. Product launch outside the United States began in the second half of 2013.
The Company’s significant accounting
policies were set forth in the audited financial statements and notes thereto for the year ended December 31, 2013 included in
its annual report on Form 10-K, filed with the Securities and Exchange Commission (“SEC”).
The preparation of financial statements in
conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions
that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the
financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ
from those estimates. Significant areas where estimates are used include the allowance for doubtful accounts, inventory valuation
and input variables for Black-Scholes, Monte Carlo simulations and Lattice Model calculations.
The accompanying consolidated financial statements,
as of and for the quarter ended March 31, 2014, includes the accounts of Guided Therapeutics, Inc. and its wholly owned subsidiary.
Newly effective accounting standards updates
and those not effective until after March 31, 2014, are not expected to have a significant effect on the Company’s financial
position or results of operations.
The Company considers all highly liquid investments
with an original maturity of three months or less when purchased to be a cash equivalent.
The Company, from time to time during the periods
covered by these consolidated financial statements, may have bank balances in excess of its insured limits. Management has deemed
this a normal business risk.
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, 2014 and December 31, 2013 our inventories
were as follows (in thousands):
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.
The majority of the Company’s revenues
were from product sales of approximately $122,000, grants with NIH totaling approximately $13,000, as well as other income from
royalties of approximately $5,000, for the three months ended March 31, 2014. Revenue for the same period in 2013, was from product
sales of approximately $132,000, grants with NIH and NCI totaling approximately $97,000, as well as other income from royalty and
miscellaneous receipts of approximately $70,000 for the three months ended March 31, 2013.
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.
The Company does not accrue interest receivable on past due accounts.
Revenue from the sale of the Company’s
products is recognized upon shipment of such products to its customers. The Company recognizes revenue from contracts on a straight
line basis, over the terms of the contract. The Company recognizes revenue from grants based on the grant agreement, at the time
the expenses are incurred.
The Company defers payments received
as revenue until earned based on the related contracts on a straight line basis, over the terms of the contract.
The Company accounts for income taxes
in accordance with the liability method. Under the liability method, the Company recognizes 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. The Company establishes 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. As of December 31, 2013, the Company had
approximately $59.8 million of net operating loss (“NOL”) carry forward. There was no provision for income taxes at
March 31, 2014. A full valuation allowance has been recorded related to any deferred tax assets created from the NOL.
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 warrants
classified as equity instruments at date of issuance is estimated using the Black-Scholes Model. The fair value of warrants classified
as liabilities at the date of issuance is estimated using the Monte Carlo Simulation model.
3. FAIR VALUE OF FINANCIAL INSTRUMENTS
The guidance for fair value measurements, ASC820,
Fair Value Measurements and Disclosures
, establishes the authoritative definition of fair value, sets out a framework for
measuring fair value, and outlines the required disclosures regarding fair value
measurements. Fair value is the price that
would be received to sell an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market
for the asset or liability in an orderly transaction between market participants at the measurement date. The Company uses a three-tier
fair value hierarchy based upon observable and non-observable inputs as follow:
|
|
·
|
Level 1 – Quoted market prices in active markets for identical assets and liabilities;
|
|
|
·
|
Level 2 – Inputs, other than level 1 inputs, either directly or indirectly observable;
and
|
|
|
·
|
Level 3 – Unobservable inputs developed using internal estimates and assumptions (there
is little or no market date) which reflect those that market participants would use.
|
The Company records its derivative activities
at fair value, which consisted of warrants as of March 31, 2014. The fair value of the warrants was estimated using the Monte Carlo
Simulation model. Gains and losses from derivative contracts are included in net gain (loss) from derivative contracts in the statement
of operations. The fair value of the Company’s derivative warrants is classified as a Level 3 measurement, since unobservable
inputs are used in the valuation.
The following table presents the fair value
for those liabilities measured on a recurring basis as of March 31, 2014 and December 31, 2013:
FAIR VALUE MEASUREMENTS ( In Thousands)
|
Description
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
|
Asset/(Liability)
Total
|
|
|
|
Warrants
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(1,548
|
)
|
|
$
|
(1,548
|
)
|
|
$
|
(1,548
|
)
|
|
December 31, 2013
|
|
|
|
Warrants
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(1,007
|
)
|
|
$
|
(1,007
|
)
|
|
$
|
(1,007
|
)
|
|
March 31, 2014
|
|
4. STOCK OPTIONS
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, 2014 and 2013,
stock-based compensation for options attributable to employees, officers and directors was approximately $298,000 and $430,000,
respectively. Compensation costs for stock options, which vest over time, are recognized over the vesting period. As
of March 31, 2014, the Company had approximately $1.5 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 13,255,219 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.
Certain option granted to management vest based upon market and performance conditions.
A summary of the Company’s activity under
the Plan as of March 31, 2014 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, 2014
|
6,531,192
|
|
$ 0.66
|
|
6.97
|
|
$ 625,412
|
|
Granted
|
2,109,511
|
|
0.51
|
|
|
|
|
|
Exercised / Expired
|
(220,000)
|
|
0.30
|
|
|
|
|
|
Outstanding, March 31, 2014
|
8,420,703
|
|
$ 0.63
|
|
6.97
|
|
$ 558,747
|
|
|
|
|
|
|
|
|
|
|
Vested and exercisable, March 31, 2014
|
5,771,724
|
|
$ 0.61
|
|
5.85
|
|
$ 558,747
|
The Company estimates the fair value of stock
options using a Black-Scholes and Lattice valuation models. 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.
5. LITIGATION AND CLAIMS
From time to time, the Company may be involved
in various legal proceedings and claims arising in the ordinary course of business. Management believes that the dispositions of
these matters, individually or in the aggregate, are 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, 2014 and December 31, 2013,
there was no accrual recorded for any potential losses related to pending litigation.
6. STOCKHOLDERS' EQUITY
Common Stock
The Company has authorized 145 million shares
of common stock with $0.001 par value, 71,770,239 of which were outstanding as of March 31, 2014. During the three months ended
March 31, 2014, the Company issued 220,000 shares in connection with the exercise of outstanding options.
For the three months ended March 31, 2014,
the Company issued 1,025,002 shares of common stock for its Series B preferred stock conversion, as well as 46,276 shares of common
stock as payment of accrued dividends on the Series B preferred stock.
Preferred Stock; Series B Convertible 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 preferred stock as redeemable convertible preferred stock, none of which remain outstanding, and 3,000
shares of preferred stock as Series B Preferred Stock, of which 1,737 and 2,147 shares were issued and outstanding as of March
31, 2014 and December 31, 2013 respectively.
Pursuant to the terms
of the Series B Preferred Stock set forth in the Certificate of Designations, Preferences and Rights designating the Preferred
Stock (the “Preferred Stock Designation”), shares of Series B Preferred Stock are convertible into common stock by
their holder at any time, and will be mandatorily convertible upon the achievement of certain conditions, including the receipt
of certain approvals from the U.S. Food and Drug Administration and the achievement by the Company of specified average trading
prices and volumes for the common stock. The original conversion price was $0.68 per share, such that each share of Preferred Stock
would convert into 1,471 shares of common stock, subject to customary adjustments, including any accrued but unpaid dividends and
pursuant to certain anti-dilution provisions, as set forth in the Preferred Stock Designation. As a result of anti-dilution provisions,
the current conversion price is set at $0.40 per share, such that each share of Preferred Stock would convert into 2,500 shares
of common stock.
Holders of the Series
B Preferred Stock are entitled to quarterly dividends at an annual rate of 10.0%, payable in cash or, subject to certain conditions,
common stock, at the Company’s option. Accrued dividends totaled approximately $53,000 at March 31, 2014. Each share of Series
B Preferred Stock is entitled to a number of votes equal to the number of shares of common stock into which the Series B Preferred
Stock is convertible. As long as shares of the Series B Preferred Stock are outstanding, and until the receipt of certain approvals
from the U.S. Food and Drug Administration and the achievement by the Company of specified average trading prices and volumes for
the common stock, the Company may not incur indebtedness for borrowed money secured by the Company’s intellectual property
or in excess of $2.0 million without the prior consent of the holders of two-thirds of the outstanding shares of Series B Preferred
Stock. The Company may redeem the Series B Preferred Stock after the second anniversary of issuance, subject to certain conditions.
Upon the Company’s liquidation or sale to or merger with another corporation, each share of Series B Preferred Stock will
be entitled to a liquidation preference of $1,000 per share, plus any accrued but unpaid dividends.
The Series B Preferred Stock was issued with
Tranche A warrants to purchase 1,858,089 shares of common stock and Tranche B warrants purchasing 1,858,088 shares of common stock,
both at an exercise price of $1.08 per share. Pursuant to the terms of the Tranche B warrants, their exercise price will be reduced,
and the number of shares of common stock into which those warrants are exercisable will be increased, if the Company issues shares
at a price below the then-current exercise price. The exercise price of Tranche B warrants is currently $0.40 per share, convertible
into 5,016,840 shares of common stock. As a result of these provisions, the Company is required to account for the warrants as
a liability recorded at fair value each period. The Company values the warrants using a Monte Carlo Simulation model. Of the $2.6
million in proceeds from issuance of the Series B Preferred Stock, the Company originally allocated $873,000 to the fair value
of the warrants. At March 31, 2014 and December 31, 2013, the fair value of these warrants was approximately $1.0 million and $1.5
million, respectively.
Stock Options
See Note 4, Stock Options.
Warrants
We have issued warrants to purchase our common stock from time to
time in connection with certain financing arrangements.
The Company had the following shares reserved for the warrants as
of March 31, 2014:
Warrants
(Underlying Shares)
|
|
Exercise Price
|
|
Expiration Date
|
|
471,856
|
(1)
|
$0.80 per share
|
|
July 26, 2014
|
|
3,590,522
|
(1)
|
$0.80 per share
|
|
March 1, 2015
|
|
6,790
|
(2)
|
$1.01 per share
|
|
September 10, 2015
|
|
439,883
|
(3)
|
$0.68 per share
|
|
March 31, 2016
|
|
285,186
|
(4)
|
$1.05 per share
|
|
November 20, 2016
|
|
1,858,089
|
(5)
|
$1.08 per share
|
|
May 23, 2018
|
|
5,016,840
|
(6)
|
$0.40 per share
|
|
May 23, 2018
|
__________
(1)
Consists of outstanding warrants issued in connection with a warrant exchange program in June
2012.
|
|
(2)
|
Consists of outstanding warrants issued in
conjunction with a private placement on September 10, 2010.
|
|
|
(3)
|
Consists of outstanding warrants issued in
conjunction with a buy back of our minority interest in our subsidiary in December 2012, which were issued in February 2014.
|
|
|
(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 May 24, 2013.
|
|
|
(6)
|
Consists of outstanding warrants issued in
conjunction with a private placement on May 24, 2013. Underlying shares increased from 1,858,089 to 5,016,840, and exercise price
decreased from $1.08 per share to $0.40 per share, pursuant to the terms of the warrants, as a result of a 2013 warrant exchange
program.
|
7. 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 on preferred stock
by the weighted average number of common shares outstanding during the period.
8. NOTES PAYABLE
Short Term Notes Payable
At March 31, 2014, the Company maintained notes
payable and accrued interest to related parties totaling $177,000 and third parties totaling $ 201,000. These notes are short term,
straight-line amortizing notes. The notes carry an annual interest rate of 10%.
Notes Payable
At December 31, 2012, the Company was past
due on two short-term notes totaling approximately $419,000 of principal and accrued interest. Interest charged on these notes
prior to amendment ranged between 15-18%. On February 27, 2013, the Company renegotiated one of the two past due notes. The new
note accrued interest at 6% and was paid in full during the quarter ended June 30, 2013. On April 16, 2013, the Company renegotiated
the other note. The renegotiated note accrues interest at 9.0%, with a 16.0% default rate, requires monthly payments of $10,000,
including interest, and matures November 2015. The balance due on this note was approximately $203,000 and $208,000 at March 31,
2014 and December 31, 2013, respectively. As of March 31, 2014, the note is accruing interest at the default rate, of which $63,000
is payable during the year ending December 31, 2014 and $105,000 is payable during the year ending December 31, 2015.
8. SUBSEQUENT EVENTS
On April 23, 2014, the
Company entered into a securities purchase agreement (the “Purchase Agreement”), with Hanover Holdings I, LLC, an affiliate
of Magna Group (“Magna”). Pursuant to the Purchase Agreement, the Company sold Magna a senior convertible note with
an initial principal amount of $1.5 million (the “Initial Convertible Note”), for a purchase price of $1.0 million
(an approximately 33.3% original issue discount). Additionally, Magna is irrevocably bound to purchase, on the tenth trading day
after the effective date of a resale registration statement, an additional senior convertible note with an initial principal amount
of $2.0 million and an 18-month term (the “Additional Convertible Note” and, with the Initial Convertible Note, the
“Convertible Notes”), for a fixed purchase price of $2.0 million, subject only to conditions outside of Magna’s
control or that Magna cannot cause not to be satisfied, none of which are related to the market price of the Company’s common
stock.
With respect to the Initial
Convertible Note, $200,000 of the outstanding principal amount (together with any accrued and unpaid interest with respect to such
portion of the principal amount) was automatically extinguished (without any cash payment by the Company) once the Company properly
filed a registration statement with the SEC on April 30, 2014 covering the resale by Magna of shares of the Company’s common
stock issued or issuable upon conversion of the Convertible Notes and (2) no event of default, or an event that with the passage
of time or giving of notice would constitute an event of default, had occurred on or prior to such date. Moreover, $300,000 of
the outstanding principal amount of the Initial Convertible Note (together with any accrued and unpaid interest with respect to
such portion of the principal amount) was automatically extinguished (without any cash payment by the Company) once the resale
registration statement was declared effective by the SEC on May 12, 2014 and the prospectus contained therein became available
for use by Magna for its resale of the shares of common stock issued or issuable upon conversion of the Convertible Notes and (2)
no event of default, or an event that with the passage of time or giving of notice would constitute an event of default, had occurred
on or prior to such date.
The Initial Convertible
Note matures on October 23, 2015 (subject to extension as provided in the Initial Convertible Note) and, in addition to the approximately
33.3% original issue discount, accrues interest at an annual rate of 6.0%. If issued, the Additional Convertible Note will mature
18 months from the date of issuance and will accrue interest at the same rate. The Convertible Notes are convertible at any time,
in whole or in part, at Magna’s option, into shares of the Company’s common stock, at a conversion price equal to the
lesser of $0.55 per share and a discount from the lowest daily volume-weighted average price of the Company’s common stock
in the five trading days prior to conversion. The discount is 20% if the conversion takes place prior to December 19, 2014, and
25% if after that date. At no time will Magna be entitled to convert any portion of the Convertible Notes to the extent that after
such conversion, Magna (together with its affiliates) would beneficially own more than 9.99% of the outstanding shares of the Company’s
common stock as of such date. As long as Magna or its affiliates beneficially own any of the shares issued upon conversion, they
may not engage in any “short sale” transactions in the Company’s common stock and may not sell more than the
greater of $15,000 or 15% of the trading volume of the common stock in any single trading day.
The Initial Convertible
Note includes and, if issued, the Additional Convertible Note will include, customary event of default provisions. The Initial
Convertible Note provides and, if issued, the Additional Convertible Note will provide for a default interest rate of 16%. Upon
the occurrence of an event of default, Magna may require the Company to pay in cash the “Event of Default Redemption Price”
which is defined in the Convertible Notes to mean the greater of (i) the product of (A) the amount to be redeemed multiplied by
(B) 135% (or 100% if an insolvency related event of default) and (ii) the product of (X) the conversion price in effect
at that time multiplied by (Y) the product of (1) 135% (or 100% if an insolvency related event of default) multiplied by (2) the
greatest closing sale price of the common stock on any trading day during the period commencing on the date immediately preceding
such event of default and ending on the date the Company makes the entire payment required to be made under this provision.
The Company has the right
at any time to redeem all or a portion of the total outstanding amount then remaining under the Convertible Notes in cash at a
25% premium.
The Company paid to Magna
a commitment fee for entering into the Purchase Agreement equal to 5% of the total purchase price for the Convertible Notes under
the Purchase Agreement in the form of 321,820 shares of common stock (the “Commitment Shares”), calculated using a
per share price of $0.465, representing the average of the daily volume-weighted average prices of a share of common stock for
the second trading day immediately preceding closing date for the transaction. The Company also paid $50,000 of reasonable attorneys’
fees and expenses incurred by Magna in connection with the transaction.
The Purchase Agreement
contains customary representations, warranties and covenants by, among and for the benefit of the parties. The Purchase Agreement
also provides for indemnification of Magna and its affiliates in the event that Magna incurs losses, liabilities, obligations,
claims, contingencies, damages, costs and expenses related to the Company’s breach of any of its representations, warranties
or covenants under the Purchase Agreement.
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. 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 that may be set forth under "Risk Factors"
below and elsewhere in this report, as well as in our annual report on Form 10-K for the year ended December 31, 2013 and subsequently
filed quarterly reports on Form 10-Q. Examples of these uncertainties and risks include, but are not limited to:
|
|
·
|
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 FDA and corresponding foreign agencies;
|
|
|
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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;
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the lack of immediate alternate sources of supply for some critical components of our products;
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our patent and intellectual property position;
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the need to fully develop the marketing, distribution, customer service and technical support and other functions critical to the success of our product lines;
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the dependence on potential strategic partners or outside investors for funding, development assistance, clinical trials, distribution and marketing of some of our products; and
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other risks and uncertainties described from time to time in our reports filed with the SEC.
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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, including
lung and esophageal. Our technology, including products in research and development, primarily relates to biophotonics technology
for the non-invasive detection of cancers.
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, 2014, we had an accumulated deficit of about $104.6 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 2014 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.
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.
Stock Option Plan:
We
measure 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:
We have issued
warrants, which allow the warrant holder to purchase one share of stock at a specified price for a specified period of time. We
record 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. Since the inventory is
stated at the lower of cost or market, we also estimated an allowance for the potential losses on the sale of inventory.
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.
RECENT DEVELOPMENTS
On April 23, 2014, we entered into a securities
purchase agreement (the “Purchase Agreement”), with Hanover Holdings I, LLC, an affiliate of Magna Group (“Magna”).
Pursuant to the Purchase Agreement, we sold Magna a senior convertible note with an initial principal amount of $1.5 million (the
“Initial Convertible Note”), for a purchase price of $1.0 million (an approximately 33.3% original issue discount).
Additionally, Magna is irrevocably bound to purchase, on the tenth trading day after the effective date of a resale registration
statement, an additional senior convertible note with an initial principal amount of $2.0 million and an 18-month term (the “Additional
Convertible Note” and, with the Initial Convertible Note, the “Convertible Notes”), for a fixed purchase price
of $2.0 million, subject only to conditions outside of Magna’s control or that Magna cannot cause not to be satisfied, none
of which are related to the market price of the Company’s common stock. See Note 8 to the financial statements accompanying
this report.
RESULTS OF OPERATIONS
COMPARISON OF THE THREE MONTHS ENDED MARCH
31, 2014 AND 2013
Service Revenue: Service revenue
decreased to approximately $19,000 for the quarter ended March 31, 2014, from approximately $167,000 for the same period in 2013.
Service revenue was lower for the first quarter 2014 due to the decreased revenue from NCI and NIH during the three months then
ended.
Sales Revenue, Cost of Sales and Gross Loss
from Devices and Disposables: Sales revenue from the sale of LuViva devices and disposables for the three months ended March 31,
2014, was approximately $122,000. Related costs of sales and net realizable value expenses were approximately $192,000, which resulted
in a gross loss on the device and disposables of approximately $70,000. Sales revenue from the sale of LuViva devices and disposables
for the three months ended March 31, 2013, was approximately $132,000. Related costs of sales were approximately $158,000, which
resulted in a gross loss on the device and disposables of approximately $26,000.
Research and Development Expenses: Research
and development expenses decreased to approximately $607,000 for the three months ended March 31, 2014, compared to $813,000 for
the same period in 2013. The decrease, of approximately $206,000, was primarily due to a decrease in expenses associated
with our esophageal cancer technology and LuViva devices in production mode.
Sales and Marketing Expenses: Sales
and marketing expenses were approximately $283,000 during the three months ended March 31, 2014, compared to $164,000 for the same
period in 2013. 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 $1.1 million during the three months ended March 31, 2014, compared to approximately
$1.0 million for the same period in 2013. The increase of approximately $99,000, or 9.5%, is primarily related to increase
in general operating expenses.
Other Income: Other income for the three
months ended March 31, 2014, was approximately $2,000, which represents miscellaneous income and receipts; compared to other income
of approximately $75,000 for the three months ended March 31, 2013. Other income in the three months ended March 31, 2013, consists
of a one-time payment from our previous insurance company for policy dividends.
Interest Expense: Interest expense
increased to approximately $27,000 for the three months ended March 31, 2014, as compared to approximately $15,000 for the same
period in 2013, primarily due to accrued interest on our short term notes payable.
Fair Value of Warrants Expense: Fair value
of warrants expense recovery was approximately $541,000 for the year three months ended March 31, 2014, as compared to none for
the same period in 2013.
Net loss was approximately $1.6 million during
the three months ended March 31, 2014, compared to $1.8 million for the same period in 2013, for the reasons outlined above.