GUIDED THERAPEUTICS INC - Quarter Report: 2009 June (Form 10-Q)
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 June 30, 2009
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.)
|
4955
Avalon Ridge Parkway, Suite 300
Norcross,
Georgia 30071
(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 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
August 14, 2009, the registrant had outstanding 16,852,823 shares of Common
Stock.
GUIDED
THERAPEUTICS, INC. AND SUBSIDIARIES
INDEX
Part
I. Financial Information
|
3
|
Item
1. Financial Statements
|
3
|
Consolidated
Balance Sheets -
|
|
December
31, 2008 (Audited) and June 30, 2009 (Unaudited)
|
3
|
Unaudited
Consolidated Statements of Operations -
|
|
Six
months ended June 30, 2008 and 2009
|
4
|
Unaudited
Consolidated Statements of Cash Flows -
|
|
Six
months ended June 30, 2008 and 2009
|
5
|
Notes
to Financial Statements (Unaudited)
|
6
|
Item
2. Management's Discussion and Analysis
of Financial Condition and Results of Operations
|
18
|
Item
3. Quantitative and Qualitative Disclosures
About Market Risk
|
22
|
Item
4T. Controls and Procedures
|
22
|
Part
II. Other Information
|
23
|
Item
2. Unregistered Sales of Equity Securities and Use
of Proceeds
|
23
|
Item
5. Other Information
|
23
|
Item
6. Exhibits
|
23
|
Signatures
|
24
|
2
PART
I - FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS
GUIDED
THERAPEUTICS, INC. (FORMERLY SPECTRX, INC.) AND
SUBSIDIARIES
|
||||||||
CONSOLIDATED
BALANCE SHEETS
|
||||||||
AS
OF
|
||||||||
(In
Thousands Except Per Share Data)
|
||||||||
ASSETS
|
December
31,
|
June
30,
|
||||||
2008
|
2009
|
|||||||
CURRENT
ASSETS:
|
(Audited)
|
(Unaudited)
|
||||||
Cash
and cash equivalents
|
$ | 68 | $ | 20 | ||||
Accounts
receivable, net of allowance for doubtful accounts of $25 at
December
31, 2008 and June 30, 2009
|
164 | 387 | ||||||
Other
current assets
|
46 | 20 | ||||||
Total
current assets
|
278 | 427 | ||||||
Property
and equipment, net
|
11 | 7 | ||||||
Deferred
debt issuance costs, net
|
512 | 341 | ||||||
Capitalized
cost of internally developed software
|
23 | 44 | ||||||
Other
assets
|
51 | 51 | ||||||
Total
noncurrent assets
|
597 | 443 | ||||||
TOTAL
ASSETS
|
$ | 875 | $ | 870 | ||||
LIABILITIES
AND CAPITAL DEFICIT
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Short
term notes payable
|
75 | 201 | ||||||
Notes
payable – past due
|
581 | 635 | ||||||
Accounts
payable
|
1,337 | 1,361 | ||||||
Accrued
liabilities
|
794 | 905 | ||||||
Deferred
revenue
|
167 | 625 | ||||||
Dividends
payable – Series A
|
1,600 | 1,720 | ||||||
Advances
payable – Roche
|
381 | 381 | ||||||
Total
current liabilities
|
4,935 | 5,828 | ||||||
OTHER
LIABILITIES:
|
||||||||
3rd
Party Investment in Subsidiary
|
- | 104 | ||||||
Convertible
notes payable, including accrued interest and net of debt discount
and
unfunded
subscriptions of $4.6 million and $3.6 million, at December 31, 2008
and
June
30, 2009 respectively, to debt holders and related parties
|
3,583 | 4,934 | ||||||
TOTAL
LIABILITIES
|
$ | 8,518 | $ | 10,866 | ||||
COMMITMENTS
& CONTINGENCIES (Note 6)
|
||||||||
CAPITAL
DEFICIT:
|
||||||||
Series
A convertible preferred stock, $.001 par value; 5,000 shares
authorized,
336
shares issued and outstanding as of December 31, 2008 and June 30,
2009
(liquidation
preference $7,755 as of December 31, 2008 and June 30,
2009)
|
3,069 | 2,725 | ||||||
Common
stock, $.001 par value; 100,000 shares authorized, 15,623 and 16,852
shares
issued
and outstanding as of December 31, 2008 and June 30, 2009.
|
16 | 17 | ||||||
Additional
paid-in capital
|
58,784 | 59,451 | ||||||
Treasury
stock, at cost
|
(104 | ) | (104 | ) | ||||
Accumulated
deficit
|
(69,408 | ) | (72,085 | ) | ||||
TOTAL
CAPITAL DEFICIT
|
(7,643 | ) | (9,996 | ) | ||||
TOTAL
LIABILITIES AND CAPITAL DEFICIT
|
$ | 875 | $ | 870 | ||||
The
accompanying notes are an integral part of these consolidated
statements.
|
3
GUIDED
THERAPEUTICS INC. (FORMERLY SPECTRX, INC.) AND
SUBSIDIARIES
|
||||||||||||||||
UNAUDITED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
||||||||||||||||
FOR
THE THREE MONTHS ENDED
|
FOR
THE SIX MONTHS ENDED
|
|||||||||||||||
JUNE
30,
|
JUNE
30,
|
|||||||||||||||
(In
Thousands Except Per Share Data)
|
(In
Thousands Except Per Share Data)
|
|||||||||||||||
2008
|
2009
|
2008
|
2009
|
|||||||||||||
REVENUE:
|
||||||||||||||||
Service
revenue
|
$ | 449 | $ | 242 | $ | 774 | $ | 423 | ||||||||
COSTS
AND EXPENSES:
|
||||||||||||||||
Research
and development
|
606 | 339 | 1,076 | 643 | ||||||||||||
Sales
and Marketing
|
6 | 14 | 16 | 28 | ||||||||||||
General
and administrative
|
574 | 411 | 1,011 | 875 | ||||||||||||
Total
|
1,186 | 764 | 2,103 | 1,546 | ||||||||||||
Operating
loss
|
(737 | ) | (522 | ) | (1,329 | ) | (1,123 | ) | ||||||||
OTHER
INCOME / INTEREST EXPENSE, net
|
(467 | ) | (864 | ) | (658 | ) | (1,576 | ) | ||||||||
LOSS INCOME
FROM CONTINUING OPERATIONS
|
(1,204 | ) | (1,386 | ) | (1,987 | ) | (2,699 | ) | ||||||||
PROVISION
FOR INCOME TAXES
|
- | - | - | - | ||||||||||||
NET
LOSS
|
(1,204 | ) | (1,386 | ) | (1,987 | ) | (2,699 | ) | ||||||||
PREFERRED
STOCK DIVIDENDS
|
(70 | ) | (57 | ) | (148 | ) | (120 | ) | ||||||||
NET
LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
|
$ | (1,274 | ) | $ | (1,443 | ) | $ | (2,135 | ) | $ | (2,819 | ) | ||||
BASIC
AND DILUTED NET (LOSS) PER SHARE ATTRIBUTABLE TO COMMON
STOCKHOLDERS, FROM CONTINUING OPERATIONS
|
||||||||||||||||
$ | (0.09 | ) | $ | (0.09 | ) | $ | (0.16 | ) | $ | (0.18 | ) | |||||
WEIGHTED-AVERAGE SHARES BASIC AND DILUTTED | 13,354 | 16,362 | 13,575 | 16,033 |
The
accompanying notes are an integral part of these consolidated
statements.
4
GUIDED
THERAPEUTICS INC. (FORMERLY SPECTRX, INC.) AND
SUBSIDIARIES
|
||||||||
UNAUDITED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
||||||||
FOR
THE SIX MONTHS ENDED
|
||||||||
JUNE
30,
|
||||||||
2008
|
2009
|
|||||||
(In
Thousands)
|
||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
Net
loss
|
$ | (1,987 | ) | $ | (2,699 | ) | ||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||
Depreciation
and amortization
|
4 | 4 | ||||||
Amortization
and accretion of deferred financing costs,
notes
and warrants
|
276 | 1,141 | ||||||
Stock
based compensation
|
24 | 203 | ||||||
Changes
in operating assets and liabilities:
|
||||||||
Accounts
receivable
|
25 | (223 | ) | |||||
Other
current assets
|
(5 | ) | 26 | |||||
Accounts
payable
|
264 | 24 | ||||||
Deferred
Revenue
|
133 | 458 | ||||||
Accrued
liabilities
|
602 | 746 | ||||||
Total
adjustments
|
1,323 | 2,379 | ||||||
Net
cash used in operations
|
(664 | ) | (320 | ) | ||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
Additions
to capitalized software costs
|
- | (21 | ) | |||||
Net
cash used investing activities
|
- | (21 | ) | |||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
Proceeds
from issuance of convertible notes payable to
debt
holders and related parties
|
831 | 126 | ||||||
Proceeds
from 3rd party investment in subsidiary
|
- | 104 | ||||||
Proceeds
from subscription receivable
|
- | 63 | ||||||
Net
cash provided by financing activities
|
831 | 293 | ||||||
NET
CHANGE IN CASH AND CASH EQUIVALENTS
|
167 | (48 | ) | |||||
CASH
AND CASH EQUIVALENTS, beginning of year
|
3 | 68 | ||||||
CASH
AND CASH EQUIVALENTS, end of period
|
$ | 170 | $ | 20 | ||||
SUPPLEMENTAL
SCHEDULE OF:
|
||||||||
NONCASH
INVESTING AND FINANCING ACTIVITIES:
|
||||||||
Conversion
of preferred stock into common stock
|
$ | 456 | $ | 343 | ||||
Notes
payable and accrued interest converted into common stock
|
$ | - | $ | 242 | ||||
Dividends
in the form of preferred stock and redeemable convertible
preferred
Stock
|
$ | 14 | $ | 120 | ||||
Interest | $ | 420 | $ | 623 | ||||
The
accompanying notes are an integral part of these consolidated
statements.
|
5
GUIDED
THERAPEUTICS, INC. (FORMERLY SPECTRX, INC.) AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
1. BASIS
OF PRESENTATION
The
unaudited interim financial statements included herein have been prepared by
Guided Therapeutics, Inc. (formerly SpectRx, Inc.), collectively with its wholly
owned subsidiaries Interscan, Inc., (“Interscan”) (formerly Guided Therapeutics,
Inc.) and Sterling Medivations, Inc. d/b/a SimpleChoice (“Sterling”),
collectively referred to herein as the “Company.” 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 December 31, 2008 and June 30, 2009, results of
operations for the three and six months ended June 30, 2008 and 2009, and cash
flows for the six months ended June 30, 2008 and 2009. The results of operations
for the six months ended June 30, 2009 are not necessarily indicative of the
results for a full fiscal year. Certain information and footnote disclosures
normally included in financial statements prepared in accordance with accounting
principles generally accepted in the United States have been condensed or
omitted. 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/A, as amended, for
the year ended December 31, 2008.
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 June 30, 2009, it had an
accumulated deficit of approximately $72.1 million. Through June 30, 2009, the
Company has devoted substantial resources to research and development efforts.
The Company first generated revenue from product sales in 1998, but 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. At June 30, 2009, the
Company’s current liabilities exceeded current assets by approximately $5.4
million and it had a capital deficit due principally to its recurring losses
from operations. As of June 30, 2009, the Company was past due on
payments due under its Convertible Notes payable in the amount of approximately
$635,000 and under a 90-day 17% convertible, unsecured note payable in the
amount of $50,000. In December 2008, the Company issued $2.3 million
in 2008 Convertible Notes (see Note 8). Of this amount, $1.3 million
represents existing loans that were converted into 2008 Convertible Notes.
During 2009 the Company has issued additional short term notes to fund
operations.
If
sufficient capital cannot be raised at some point in the third quarter of 2009,
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. As of the date
hereof, this effort is on-going. These factors raise substantial doubts about
the Company’s ability to continue as a going concern. Additional debt or equity
financing will be required for the Company to continue its business activities.
The consolidated financial statements do not include any adjustments that might
be required from the outcome of this uncertainty. If additional funds do not
become available, the Company has plans to curtail operations by reducing
discretionary spending and staffing levels. If funds are not obtained, the
Company will have to curtail its operations and attempt to operate by only
pursuing activities for which it has external financial support, such as under
the Konica Minolta Optical, Inc. (“KMOT”) development agreement (described
below) and additional National Cancer Institute (“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.
6
The
Company has been seeking a new strategic partner and on April 30, 2009, signed a
one-year exclusive negotiation and development agreement of optimization of its
microporation system for manufacturing, regulatory approval, commercialization
and clinical utility with KMOT. The exclusive negotiation agreement will expire
on April 29, 2010; however, it can be renewed for an additional year by consent
between KMOT and the Company. We were paid a fee in this regard of
$500,000, with the balance of $250,000 payable by November 1,
2009. This agreement resulted in significant revenue for the Company
a portion of which is deferred over the life of the contract. Currently, we are
working on extending the agreement for an additional year and considering a
long-term agreement with KMOT.
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, 2008
included in our annual report on Form 10-K/A, as amended, filed with the
Securities and Exchange Commission (“SEC”).
Effective
January 1, 2007, we adopted the provision of the Financial Accounting Standard
Board (“FASB”) Interpretation No. 48, “Accounting for Uncertainty in Income
Taxes, an interpretation of FASB Statement No. 109” (“FIN 48”). FIN 48 clarifies
the accounting for uncertainties in income taxes recognized in a company’s
financial statements in accordance with Statement of Financial Accounting
Standard (“SFAS”) No. 109 and prescribes a recognition threshold and measurement
attributable for financial disclosure of tax provisions taken or expected to be
taken on a tax return. In addition, FIN 48 provides guidance on derecognition,
classification, interest and penalties, accounting in interim periods,
disclosure and transition. The adoption of FIN 48 did not impact our financial
position, results of operations or cash flows for the six months ended June 30,
2009.
SUBSEQUENT EVENTS
The Company has performed a review of events
subsequent to the balance sheet date through August 18, 2009, the date the
financial statements were issued.
RECENT
ACCOUNTING PRONOUNCEMENTS
In April
2009, the FASB issued three Final Staff Positions (“FSP”) on Financial
Accounting Standards (“FAS”) to provide additional guidance and disclosures
regarding fair value measurements and impairments of securities. These three
FSPs are effective for interim and annual periods ending after June 15,
2009.
FSP FAS
157-4, “Determining Fair Value When the Volume and Level of Activity for the
Asset or Liability Have Significantly Decreased and Identifying Transactions
That Are Not Orderly,” provides guidance for estimating fair value when the
volume and level of activity for an asset or liability have significantly
decreased. FSP FAS 157-4 did not have a material impact on
the Company’s consolidated financial statements.
FSP FAS
115-2 and FAS 124-2, “Recognition and Presentation of Other-Than-Temporary
Impairments,” amends the other-than-temporary impairment guidance for debt
securities to make the guidance more operational and to improve the presentation
and disclosure of other-than-temporary impairments on debt and equity securities
in financial statements. FSP FAS 115-2 and FAS 124-2 did not have a
material impact on the Company’s consolidated financial statements.
FSP FAS
107-1 and Accounting Principles Board (“APB”) 28-1, “Interim Disclosures about
Fair Value of Financial Instruments,” requires disclosure about fair value of
financial instruments for interim reporting periods of publicly traded companies
as well as in annual financial statements. The Company reviewed the
requirements of FSP FAS 107-1 and complies with its requirements.
On
January 12, 2009, the FASB issued FSP 99-20-1, “Amendments to the Impairment
Guidance of EITF Issue No. 99-20.” FASB FSP 99-20-1 amends the
impairment guidance in EITF No. 99-20, “Recognition of Interest Income and
Impairment on Purchased Beneficial Interests and Beneficial Interests that
Continue to be Held by a Transferor in Securitized Financial Assets.” The intent
of the FSP is to reduce complexity and achieve more consistent determinations as
to whether other-than-temporary impairments of available for sale or held to
maturity debt securities have occurred. The FSP is effective for interim and
annual reporting periods ending after December 15, 2008. The adoption of this
FSP did not have an impact on the Company’s consolidated financial
statements.
7
Employers’
Disclosures about Postretirement Benefit Plan Assets
In
December 2008, the FASB issued FSP FAS No. 132(R)-1, “Employers’ Disclosures
about Postretirement Benefit Plan Assets.” This FSP amends FASB
Statement No. 132(R) (“SFAS No. 132(R)”), “Employers’ Disclosures about Pensions
and Other Postretirement Benefits,” to provide guidance on an employer’s
disclosures about plan assets of a defined benefit pension or other
postretirement plan. FSP FAS No. 132(R)-1 also includes a technical
amendment to SFAS No. 132(R) that requires a nonpublic entity to disclose net
periodic benefit cost for each annual period for which a statement of income is
presented. The required disclosures about plan assets are effective
for fiscal years ending after December 15, 2009. The technical
amendment was effective upon issuance of FSP FAS No. 132(R)-1. The
adoption of the technical amendment of FSP FAS No. 132(R)-1 had no impact on its
consolidated financial position and results of operations.
Disclosures
by Public Entities (Enterprises) about Transfers of Financial Assets and
Interests in Variable Interest Entities
In
December 2008, the FASB issued FSP FAS No. 140-4, “Disclosures by Public
Entities (Enterprises) about Transfers of Financial Assets and Interests in
Variable Interest Entities.” This FSP amends SFAS No. 140,
“Accounting for Transfers and Servicing of Financial Assets and Extinguishments
of Liabilities,” to require public entities to provide additional disclosures
about transfers of financials assets. FSP FAS No. 140-4 also amends
FIN No. 46(R)-8, “Consolidation of Variable Interest Entities,” to require
public enterprises, including sponsors that have a variable interest entity, to
provide additional disclosures about their involvement with a variable interest
entity. FSP FAS No. 140-4 also requires certain additional
disclosures, in regards to variable interest entities, to provide greater
transparency to financial statement users. FSP FAS No. 140-4 is
effective for the first reporting period (interim or annual) ending after
December 15, 2008, with early application encouraged. The adoption of
FSP FAS No. 140-4 had no impact on its consolidated financial position and
results of operations.
Determination
of the Useful Life of Intangible Assets
In April
2008, the FASB issued FSP FAS 142-3, “Determination of the Useful Life of
Intangible Assets,” which amends the factors that should be considered in
developing renewal or extension assumptions used to determine the useful life of
intangible assets under FASB 142 “Goodwill and Other Intangible Assets.”
The intent of this FSP is to improve the consistency between the useful life of
a recognized intangible asset under SFAS No.142 and the period of the expected
cash flows used to measure the fair value of the asset under SFAS No. 141
(revised 2007) “Business Combinations” and other U.S. generally accepted
accounting principles. FSP FAS No. 142-3 is effective for the first reporting
period (interim or annual) ending after December 15, 2008, with early
application encouraged. The adoption of FSP FAS No. 142-3 had no impact on its
consolidated financial position and results of operations.
Disclosure
about Derivative Instruments and Hedging Activities
In March
2008, the FASB issued SFAS No. 161, “Disclosure about Derivative Instruments and
Hedging Activities,” an amendment of FASB Statement No. 133, (SFAS No. 161).
This statement requires that objectives for using derivative instruments be
disclosed in terms of underlying risk and accounting designation. The Company
was required to adopt SFAS No. 161 on January 1, 2009. The adoption of SFAS No.
161 had no impact on the Company’s consolidated financial
statements.
8
Delay
in Effective Date
In
February 2008, the FASB issued FSP FAS No. 157-2, “Effective Date of FASB
Statement No. 157.” This FSP delays the effective date of SFAS
No. 157 for all nonfinancial assets and nonfinancial liabilities, except those
that are recognized or disclosed at fair value on a recurring basis (at least
annually) to fiscal years beginning after November 15, 2008, and interim
periods within those fiscal years. The impact of adoption was not material to
the Company’s consolidated financial condition or results of
operations.
3. INVENTORIES
BY TYPE
Inventories
are stated at the lower of cost or market using the first-in, first-out method.
At December 31, 2008 and June 30, 2009, the Company had no
inventory.
4. STOCK-BASED
COMPENSATION
Prior to
December 31, 2005, the Company used the intrinsic value method for valuing its
employee/director awards of stock options and recording the related compensation
expense, if any, in accordance with APB Opinion No. 25, “Accounting for Stock
Issued to Employees,” and related interpretations. No stock-based employee or
director compensation cost for stock options is reflected in the Company’s net
loss, as all options granted have exercise prices equal to the market value of
the underlying common stock on the date of grant. The Company records
compensation expense related to options granted to non-employees based on the
fair value of the award.
Effective
January 1, 2006, the Company adopted SFAS No. 123 (Revised 2004), "Share Based
Payment," which requires public companies to measure the cost of employee,
officer and director services received in exchange for stock-based awards at the
fair value of the award on the date of grant. SFAS No. 123R
supersedes the Company's previous accounting under SFAS No. 123, "Accounting for
Stock-Based Compensation," which permitted the Company to account for such
compensation under APB Opinion No. 25, "Accounting for Stock Issued to
Employees.” In accordance with APB No. 25 and related
interpretations, no compensation cost had been recognized in connection with the
issuance of stock options, as all options granted under the Company's stock
option plan had an exercise price equal to or greater than the market value of
the underlying common stock on the date of the grant.
The
Company applied the modified prospective transition method upon adoption of SFAS
No. 123R. Under the modified prospective transition method,
compensation cost is required to be recorded as earned for all unvested stock
options outstanding at the beginning of the first year of adoption of SFAS
No.123R based upon the grant date fair value estimated in accordance with the
original provisions of SFAS No. 123 and for compensation cost for all
share-based payments granted or modified subsequently based on fair value
estimated, in accordance with the provisions of SFAS No. 123R. The
Company's financial statements, as of and for the year ended December 31, 2008,
reflect the impact of SFAS No. 123R but, in accordance with the modified
prospective transition method, the Company's financial statements for prior
periods have not been restated to reflect, and do not include, the impact of
SFAS No. 123R.
For the
quarter ended June 30, 2009, share-based compensation for options attributable
to employees and officers was approximately $88,000 and has been included in the
Company's second quarter 2009 statement of operations. Compensation
costs for stock options, which vest over time, are recognized over the vesting
period. As of June 30, 2009, the Company had approximately $529,000 of
unrecognized compensation cost related to granted stock options, to be
recognized over the remaining vesting period of approximately four
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 6,455,219 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.
9
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 June 30, 2009 and changes during
the six months then ended is as follows:
Shares
|
Weighted
average
exercise
price
|
Weighted
average
remaining
contractural
(years)
|
Aggregate
intrinsic
value
(thousands)
|
|||||||||||||
Outstanding,
January 1, 2009
|
4,306,500 | $ | 0.47 | |||||||||||||
Granted
|
1,000,000 | $ | 0.38 | |||||||||||||
Granted
|
125,000 | $ | 0.00 | |||||||||||||
Cancelled
|
(10,000 | ) | $ | 6.25 | ||||||||||||
Outstanding,
June 30, 2009
|
5,421,500 | $ | 0.36 | 5.43 | $ | 104 | ||||||||||
Vested
and exercisable, June 30, 2009
|
3,509,769 | $ | 0.49 | 6.39 | $ | 0 |
In
connection with the adoption of SFAS No. 123R, the Company reassessed its
valuation technique and related assumptions. The Company estimates
the fair value of stock options using a Black-Scholes valuation model,
consistent with the provisions of SFAS No. 123R, SEC Staff Accounting Bulletin
No. 107 and our prior period pro forma disclosures of net earnings, including
the fair value of stock-based compensation. Key input assumptions
used to estimate the fair value of stock options include the expected term until
exercise of the option, expected volatility of our stock, the risk free interest
rate, option forfeiture rates and dividends, if any. The expected
term of the options is based on a historical weighted average of exercised
options. The expected volatility is derived from the historical
volatility of our stock on the Over the Counter Bulletin Board for a period that
matches the expected life of the option. The risk-free interest rate
is the yield from a Treasury Bond or note corresponding to the expected term of
the option. Option forfeiture rates are based on our historical
forfeiture rates.
On
January 15, 2009, the Company issued options to purchase 1,000,000 shares of
common stock to Mark Faupel, its Chief Executive Officer, at an exercise price
of $0.38. The vesting period of the options is identical to the vesting periods
of the options issued to all employees in 2008.
On May
21, 2009, the Company issued options to purchase 20,000 shares of common stock
each, to all of its five directors, in lieu of their 2009 board-member
compensation for the calendar year 2009. On the same day, Director James was
issued 25,000 options to purchase additional shares for his service on other
board committees. The total share value of the directors’ fees of $48,750 will
be expensed during current year 2009.
5. LITIGATION
None
6. STOCKHOLDERS'
EQUITY
Common
Stock
10
On
October 25, 2007, the Company’s stockholders approved an increase in the number
of authorized shares of common stock from 50,000,000 to a total of 100,000,000
shares and a reverse stock split in a ratio ranging from one-for-two to
one-for-ten of all issued and outstanding shares of common stock, the final
ratio to be determined within the sole discretion of the Board of Directors. As
of the filing date of this report, no reverse stock split had taken
place.
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.
Redeemable Convertible Preferred
Stock
The board
of directors designated 525,000 shares of the preferred stock as redeemable
convertible preferred stock, none of which remain outstanding.
Series
A Convertible Preferred Stock
At June
30, 2009, the Company had outstanding 306,434 shares of series A convertible
preferred stock, having a stated value of $15.00 per share. The original
conversion price of the series A convertible preferred was $1.50. As
a result of the restructuring of certain notes payable in March 2007, the
conversion price of the series A preferred stock was reduced from $1.50 to $0.65
and the warrant exercise price was reduced from $2.25 to $0.81. The re-pricing
of the series A convertible preferred stock and the associated warrants
triggered a deemed dividend of approximately $3.8 million in
total. The deemed dividend has no effect on total capital
deficit.
The
holders of the series A convertible preferred stock are entitled to receive
dividends per share at the per annum rate of 5% per share. Under the
terms of the series A convertible preferred stock, the dividend is accrued from
the original issue date and payable beginning March 26, 2006 and is thereafter
payable quarterly in cash or stock, at the end of each calendar quarter, out of
funds legally available therefor. The Company has experienced net losses since
its inception, and, as of June 30, 2009, it had an accumulated deficit of
approximately $72.1 million. The Company believes that no funds are legally
available at this time and no dividend can be paid in stock or in cash. The
series A convertible preferred stockholders have the right to vote on an
as-converted basis.
Each
share of series A convertible preferred stock is convertible into the number of
shares of common stock equal to the quotient obtained by dividing the sum of (i)
$15.00 (as adjusted for changes in the series A convertible preferred stock by
stock split, stock dividend, and the like) referred to as the invested amount,
plus (ii) all declared or accrued but unpaid dividends on such shares of series
A convertible preferred stock, by the conversion price per share. The
per share conversion price was $1.50, but was reset to $0.65 in March 2007 (see
Note 8). The conversion price is subject to adjustment under certain
circumstances to protect the holders of series A convertible preferred stock
from dilution relative to certain issuances of common stock, or securities
convertible into or exercisable for common stock. Subject to certain
exceptions, if the Company issues common stock, or such other securities, at a
price per share less than the then effective conversion price, the conversion
price will be adjusted to equal such lower per share consideration.
Stock
Options
Under the
Company’s 1995 Stock Plan (the “Plan”), a total of 1,033,719 shares remained
available at June 30, 2009 and 5,421,500 shares were subject to stock options
outstanding as of that date, bringing the total number of shares subject to
stock options outstanding and those remaining available for issue to 6,455,219
shares of common stock as of June 30, 2009. 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.
11
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 exercised under this
plan. At June 30, 2009, options exercisable for 6,090 shares were
outstanding 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 June 30, 2009:
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
|
1,701,500
|
$ 0.16
|
7.90
|
1,282,095
|
$ 0.14
|
|
$
0.30 - $ 0.33
|
2,506,000
|
$ 0.20
|
6.19
|
1,610,896
|
$ 0.21
|
|
$
0.34 - $ 0.70
|
1,039,000
|
$ 0.01
|
0.20
|
441,778
|
$ 0.03
|
|
$
1.10 - $ 4.46
|
33,000
|
$ 1.65
|
3.58
|
33,000
|
$ 1.65
|
|
$
5.00 - $ 9.00
|
97,000
|
$ 6.43
|
1.55
|
97,000
|
$ 6.43
|
|
$
10.13 - $ 16.50
|
45,000
|
$
11.25
|
0.90
|
45,000
|
$
11.25
|
|
Total
|
5,421,500
|
$ 0.36
|
5.43
|
3,509,769
|
$ 0.49
|
In
December 2001, as a result of the acquisition of Sterling, the Company granted
options to purchase 22,024 shares of common stock at an exercise price of $7.29
per share in exchange for all the outstanding options, vested and unvested, of
Sterling. As of June 30, 2009, 6,090 of these shares have not been
exercised.
Warrants
The
Company has the following shares reserved for the warrants outstanding as of
June 30, 2009:
Warrants
|
Exercise
Price
|
Expiration
Date
|
|||
189,000
|
(1)
|
0.65
|
08/30/2013
|
||
400,000
|
(2)
|
0.65
|
02/05/2014
|
||
68,000
|
(3)
|
0.65
|
11/20/2013
|
||
100,000
|
(4)
|
2.00
|
07/07/2009
|
||
7,485,061
|
(5)
|
0.78
|
02/23/2012
|
||
15,000
|
(6)
|
0.78
|
03/01/2012
|
||
400,000
|
(7)
|
0.65
|
04/02/2013
|
||
240,385
|
(8)
|
0.78
|
07/04/2014
|
||
11,558,878
|
(9)
|
0.65
|
12/01/2014
|
||
20,456,324
|
(1)
|
Consists
of amended and restated warrants to purchase common stock at a purchase
price of $1.50 per share, associated with the settlement of a dispute in
August of 2005, the warrant modification required adding five years to the
warrant terms. These warrants are exercisable either in cash or in stock,
if the fair market value is greater than the exercise price, and are
subject to repricing on the same terms as the series A convertible
preferred stock. As of March 2007, the exercise price was
adjusted from $1.50 to $0.65 per share. At March 31, 2007, approximately
$6,000 was charged to expense, based on the
repricing.
|
(2)
|
Consists
of amended and restated warrants to purchase common stock at a purchase
price of $1.50 per share, associated with the settlement of a dispute in
August 2005, which settlement resulted in adding five years to the warrant
terms. These warrants are exercisable either in cash or in stock, if the
fair market value is greater than the exercise price, and are subject to
repricing on the same terms as the series A convertible preferred
stock. As of March 2007, the exercise price was adjusted from
$1.50 to $0.65 per share. At March 31, 2007, approximately $11,000 was
charged to expense, based on the
repricing.
|
12
(3)
|
Consists
of amended and restated warrants to purchase common stock at a purchase
price of $1.50 per share, associated with the settlement of a dispute in
August 2005, which settlement resulted in adding five years to the warrant
terms. These warrants are exercisable either in cash or in stock, if the
fair market value is greater than the exercise price, and are subject to
repricing on the same terms as the series A convertible preferred
stock. As of March 2007, the exercise price was adjusted from
$1.50 to $0.65 per share. At March 31, 2007, approximately $2,000 was
charged to expense, based on the
repricing.
|
(4)
|
Consists
of warrants to purchase common stock at a purchase price of $2.00 per
share issued as part of the extension of a bridge loan financing in
February 2004. These warrants are exercisable in cash and not subject to
any repricing.
|
(5)
|
Consists
of warrants to purchase common stock at a purchase price of $0.78 per
share issued in conjunction with an amended and restated loan agreement,
executed in March 2007. On March 12, 2007, the relative fair value of the
warrants was approximately $2.3 million (including $.3 million attributed
to 661,000 warrants for placement agent fees treated as debt issuance
cost), and the relative fair value of the beneficial conversion feature
was approximately $1.5 million. The debt discount, consisting of the
beneficial conversion feature and warrants, will accrete over the 36-month
term of the convertible notes payable under the agreement using the
effective interest method. In addition, debt issuance costs totaling
approximately $811,000 ($520,000 cash costs and $291,000 warrant value for
661,000 warrants issued to the placement agents and others) will also be
amortized over thirty-six months, using the effective interest
method.
|
(6)
|
Consists
of warrants to purchase common stock at a purchase price of $0.78 per
share, issued in conjunction with an amended and restated loan agreement,
executed in March 2007. These warrants are exercisable either
in cash or in stock, if the fair market value is greater than the exercise
price. The fair value of these warrants was approximately
$6,000 at March 31, 2007. This amount has been expensed in the
Company’s statement of operations for the nine months ended September 30,
2007.
|
(7)
|
Consists
of warrants to purchase common stock at a purchase price of $0.65 per
share, issued in conjunction with a short term loan agreement, executed on
April 2, 2008. These warrants are subject to reset to the same prices as
the Company's Series A preferred stock and /or Senior notes that are
currently outstanding and can be exercisable either in cash or in stock,
if the fair market value is greater than the exercise
price.
|
(8)
|
Consists
of warrants to purchase common stock at a purchase price of $0.78 per
share issued in conjunction with the July 14, 2008, Subordinated
Convertible Notes. These warrants are subject to reset to the same prices
the Company's Series A preferred stock and /or Senior notes that are
currently outstanding and can be exercisable either in cash or in stock,
if the fair market value is greater than the exercise
price.
|
(9)
|
Consists
of warrants to purchase common stock at a purchase price of $0.65 per
share issued in conjunction with the December 1, 2008, Subordinated
Convertible Notes. These warrants are subject to reset to the same prices
the Company's Series A preferred stock and/or Senior notes that are
currently outstanding and can be exercisable either in cash or in stock,
if the fair market value is greater than the exercise
price.
|
In
connection with certain financing, which became due and payable as of January
30, 2004, and under an agreement dated February 6, 2004, the Company agreed to
cause its subsidiary, InterScan, to issue to the lenders party to the agreement,
InterScan warrants exercisable for the number of shares of common stock of
InterScan equal to 5% of all shares of common stock of InterScan as of and after
the issuance of InterScan securities in an InterScan financing, as defined in
the agreement. The exercise price per share of common stock of
InterScan will equal 5% of the per share purchase price paid by the purchasers
in such InterScan financing. As of June 30, 2009, no such InterScan
financing had occurred.
7. (LOSS)
INCOME PER COMMON SHARE
(Loss)
income per common share is computed using SFAS No. 128, “Earnings per
Share.” SFAS No.
128 established standards for the computation, presentation and disclosure of
earnings per share.
Basic
net (loss) or income per share attributable to common stockholders amounts are
computed by dividing the net (loss) or income plus preferred stock dividends and
deemed dividends by the weighted average number of shares outstanding during the
period.
13
8. NOTES
PAYABLE
On April
13, 2009, the Company issued a 15% note to John E. Imhoff, as part of the 2009
Convertible Notes, in the amount of $535,660 to replace the notes purchased by
Dr. Imhoff that were previously owned by the Selling Investors, in the amounts
of $154,403, $102,470, $158,787 and $150,000, respectively, under the same terms
and conditions. With the re-purchase of the 2008 Convertible Notes by John E.
Imhoff, 2,464,360 warrants, previously issued to the Selling Investors, were
cancelled and issued to John E. Imhoff. Thereafter, three of the four
Selling Investors kept 150,000, 102,400 and 150,000 warrants, respectively,
under the same terms and conditions.
On April
15, 2009, the Company issued a 17% unsecured note to John E. Imhoff, as part of
the 2009 bridge loans, in the amount of $35,000 to replace the notes purchased
by Dr. Imhoff that were previously issued to Dolores Maloof on April 3, 2009 and
William Zachary on March 26, 2009, in the amounts of $25,000 and $10,000,
respectively, under the same terms and conditions.
The
Company issued 17% unsecured notes to the following related parties on the dates
indicated (see Note 9):
Noteholder
|
Original
Loan Amount
|
Original
Loan Date(s)
|
Loan
Maturity Date
|
Loan
Status
|
Ronald
W. Hart
|
$10,000
|
04/10/09
|
10/09/09
|
Current
|
John
E. Imhoff
|
$35,000
|
04/15/09
|
10/14/09
|
Current
|
Dolores
Maloof
|
$25,000
|
04/17/09
|
05/27/09
|
Past
Due
|
Ronald
W. Hart
|
$6,000
|
04/23/09
|
10/22/09
|
Current
|
On June
19, 2009, the Company issued a 15% unsecured note in the amount of $10,000 to a
new investor.
In March
and April 2008, the Company issued four short-term unsecured promissory notes
(the “Director Notes”) to its Company directors in the amounts of $10,000
each. This financing was to provide working capital for the Company.
The notes were non-interest bearing, matured sixty days from funding and were
considered past due. However, subsequent to the third quarter of 2008, these
notes were surrendered in exchange for 2008 Convertible Notes.
14
On April
10, 2008, the Company issued a new short-term unsecured promissory note to
Dolores Maloof in the amount of $400,000. The note matured on July 10, 2008,
with an interest rate of 13%, and contained an obligation to issue a total of
400,000 warrants to purchase shares of the Company’s common stock at $0.65 per
share. Under the agreement governing the note, the note was past due;
however, subsequent to the third quarter of 2008, these notes were surrendered
in exchange for 2008 Convertible Notes.
Between
May 23 and July 7, 2008, the Company received a total of $625,000, as part of a
new note purchase agreement, effective July 7, 2008. The notes carried 30%
warrant coverage at 78 cents. However, subsequent to the third quarter of 2008,
these notes were surrendered in exchange for 2008 Convertible Notes (see Note
10).
Between
August 6 and December 1, 2008, the Company received a total of $610,000, as well
as subscription agreements totaling ($440,000) pursuant to the 2008 Loan
Agreement (see Note 9). The 2008 Convertible Notes issued pursuant to the 2008
Loan Agreements are due and payable on December 1, 2011, carry a 15% interest
rate, contain an option to convert into the Company’s common stock or into other
financing, and were issued along with Warrants for five shares of the Company’s
common stock per dollar invested at an exercise price of $0.65 per
share.
On
December 1, 2008, the Company entered into a Note Purchase Agreement (the "2008
Loan Agreement ") with 29 existing and new lenders (the "Lenders"), pursuant to
which the Company issued approximately $2.3 million in aggregate principal
amount of 15% subordinated secured convertible notes due December 1, 2011 (the
“2008 Convertible Notes”) and warrants exercisable for 11,558,878 shares of the
Company’s common stock (the “2008 Warrants”).
The 2008
Convertible Notes are subordinated to the existing senior secured obligations of
the Company, which are secured by (a) a first in priority lien on all of
the Company’s assets; (b) a guaranty by the Company's wholly owned subsidiary,
InterScan; (c) a lien on all of InterScan's assets; and (d) a pledge on all
issued and outstanding stock of the Company and InterScan. No payments
will be due under the 2008 Convertible Notes until they mature on December 1,
2011 (the "Maturity Date"). The 2008 Convertible Notes bear interest at
15% per year, payable on the Maturity Date, absent an event of default, in which
case the interest rate increases to 20%.
The 2008
Convertible Notes are convertible into approximately 3,556,580 shares of the
Company’s common stock, at a conversion rate of $0.65 per share subject to
certain adjustments. The 2008 Warrants are immediately exercisable for
11,558,878 shares at an exercise price of $0.65 per share, subject to certain
adjustments. The 2008 Loan Agreement also provides certain registration rights
to the Lenders with respect to the shares of the Company’s common stock
underlying the 2008 Notes and Warrants. On December 1, 2008, the relative fair
value of the warrants was approximately $1.7 million. The debt discount will
accrete over the 36-month term of the 2008 Convertible Notes payable using the
effective interest method.
Approximately
$1.3 million of the proceeds from the 2008 Loan Agreement was used to convert
existing debt into 2008 Convertible Notes as described below. The remaining
funds were used in product development, working capital and other corporate
purposes. At June 30, 2009, one Lender has a subscription agreement totaling
$85,000 outstanding, relating to the December 1, 2008 financing.
The
unsecured note issued to Dolores Maloof on April 10, 2008 in the aggregate
principal amount of $400,000, plus interest, was converted into the 2008
Convertible Note, as were notes issued under the note purchase agreement, dated
July 7, 2008, in aggregate principal amount of $625,000, plus interest, held by
John E. Imhoff and eleven other designated investors.
On
February 3, 2006, InterScan obtained a $1.5 million loan, evidenced by
promissory notes in favor of each of the investors. Proceeds of the loan
were used by InterScan to fund its product development work and its general
working capital needs, and to reimburse the Company for certain expenses
incurred or to be incurred by it on behalf of InterScan. The interest rate
on the notes was 10% per annum and the notes matured on August 2,
2006. Subsequently, these promissory notes, plus interest, totaling
approximately $1.6 million, were converted into the 2007 Convertible
Notes.
15
On March
12, 2007, the Company completed a restructuring of its then-existing
indebtedness by entering into an Amended and Restated Loan Agreement (“Amended
Loan”) with existing and new creditors. Pursuant to the Amended Loan, the
Company’s then-existing indebtedness was restructured and consolidated into new
13% senior secured convertible notes (the “2007 Convertible Notes”). The
aggregate principal amount of the Amended Loan is approximately $4.8 million due
on March 1, 2010. No interest is due until maturity, absent an event
of default under the Amended Loan. If an event of default occurs and is
continuing, the interest rate on the Amended Loan becomes 18%. The
2007 Convertible Notes are convertible into of the Company’s common stock at
$0.65 per share, or 7,285,061 shares of common stock, and were issued with
approximately 7.2 million warrants, exercisable immediately at $0.78 per share
for the Company’s common stock. Additionally, accrued interest on the
Convertible Notes is convertible into shares of common stock of the Company on
the same terms. In addition, 661,000 warrants at an exercise price of $0.78 were
also issued to the placement agent and others in conjunction with this
financing, as well as a warrant to purchase 15,000 shares of the Company’s
common stock at $0.78, as part of interest expense to a non-converting bridge
note holder, as interest on the notes payable. The fair value of the
warrant to purchase 15,000 shares of the Company’s common stock was
approximately $6,000 at December 31, 2007. This amount was expensed
in the Company’s statement of operations for the period then
ended. The conversion price and the exercise price of the warrants
are subject to adjustments for anti-dilution.
On March
12, 2007, the relative fair value of the warrants was approximately $3.3 million
(including $.3 million attributed to 661,000 warrants for placement agent fees
treated as debt issuance cost), and the relative fair value of the beneficial
conversion feature was approximately $1.3 million. The debt discount, consisting
of the beneficial conversion feature and warrants, will accrete over the
36-month term of the Convertible Notes payable using the effective interest
method. In addition, debt issuance costs totaling approximately $811,000
($520,000 cash costs and $291,000 warrant value for 661,000 warrants issued to
the placement agents and others will also be amortized over 36 months, using the
effective interest method. At June 30, 2009, approximately $3.5 million of debt
discount remained unamortized.
The
Amended Loan is a senior secured obligation of the Company’s and is secured
by (a) a first in priority lien on all of the Company’s assets; (b) a
guaranty by Sterling; (c) a lien on all of Sterling's assets; and (d) a pledge
on all issued and outstanding stock of Sterling and InterScan, except for the
sale of the Company’s SimpleChoice business unit and related intellectual
property.
The
Amended Loan also provides certain registration rights with respect to the
shares of the Company’s common stock underlying the 2007 Convertible Notes and
warrants to the lenders. In addition, the 2007 Convertible Notes will
automatically convert into convertible preferred stock of the Company, upon any
completion of a convertible preferred financing of $5 million or
more. The penalty for the late registration of the underlying common
stock, as outlined in the Amended Loan, is calculated as 1/90th of 1% for each
late day. This calculation resulted in a penalty accrual of approximately
$91,000 for the year ended December 31, 2007, as the Company currently expects
that the registration statement will not be filed.
Of the
proceeds from the Amended Loan, approximately $1.9 million was used to convert
debt from the previous loans into debt from the Amended Loan, and approximately
$1.2 million was used to retire debt from the previous loans.
The
issuance of the 2007 Convertible Notes and the warrants changed the conversion
price of the Company's series A convertible preferred stock from $1.50 to $0.65,
the exercise price of certain of the Company's warrants from $2.25 to $0.81 and
the exercise price of certain of the Company’s warrants issued in August 2005
from $1.50 to $0.65, as described above under Note 6 (Stockholders’ Equity). The
re-pricing of the series A convertible preferred stock and the associated
warrants triggered a deemed dividend of approximately $3.8 million in
total. The deemed dividend has no net effect on stockholders’
equity.
Subject
to customary adjustments (which include full ratchet anti-dilution provisions),
the 2007 Convertible Notes associated with the Amended Loan are convertible into
approximately 7,285,061 common shares and the warrants are exercisable for
approximately 7,946,061 shares of common stock, including warrants issued to
placement agent. The warrants are currently exercisable. The 2007 Convertible
Notes are convertible into the Company’s common stock at a price of $0.65 per
share and the warrants permit the holders to purchase shares of the Company’s
common stock at a price of $0.78 per share; both are subject to certain
adjustments. The Amended Loan also provides certain registration
rights with respect to the shares of the Company’s common stock underlying the
2007 Convertible Notes and warrants to the Amended Loan lenders. The
2007 Convertible Notes will automatically convert into convertible preferred
stock, upon the completion of a convertible preferred financing of $5 million or
more.
16
The
issuance of the 2007 Convertible Notes and warrants was exempt from registration
under the Securities Act of 1933, as amended (the "Securities Act"), pursuant to
Section 4(2) of the Securities Act and Rule 506 of Regulation D promulgated
thereunder. The facts relied upon to make the section 4(2) exemption
available were: (i) no underwriters were involved in the issuance and sale
of the convertible notes and warrants; (ii) the Amended Loan lenders were
accredited, were experienced with transactions of this nature and had the
ability to fend for themselves; (iii) the 2007 Convertible Notes and warrants
were acquired by the Amended Loan lenders for investment only and not with a
view to or for sale in connection with any distribution thereof, (iv)
appropriate restrictive legends were affixed to the 2007 Convertible Notes and
warrants, and (vi) the sales of the 2007 Convertible Notes and warrants were
made without general solicitation or advertising.
Furthermore,
InterScan, our wholly owned subsidiary entered into an agreement with a third
party investor who paid $104,000 in certain Intellectual Property (IP) royalty
payment on behalf of InterScan. InterScan has the option of paying the third
party back in common shares to be issued or allowed the Investor to own 49% of
InterScan.
9. RELATED
PARTY TRANSACTIONS
On April
13, 2009, the Company issued a 15% note to John E. Imhoff, as part of the 2009
Convertible Notes, in the amount of $535,660 to replace the notes purchased by
Dr. Imhoff that were previously owned by four investors (the “Selling
Investors”), in the amounts of $154,403, $102,470, $158,787 and $150,000, under
the same terms and conditions. With the re-purchase of the 2008 Convertible
Notes by John E. Imhoff, 2,464,360 warrants, previously issued to the Selling
Investors, were cancelled and issued to John E. Imhoff. Thereafter,
three of the four Selling Investors kept 150,000, 102,400 and 150,000 warrants,
respectively, under the same terms and conditions.
On April
15, 2009, the Company issued a 17% unsecured note to John E. Imhoff, as part of
the 2009 bridge loans, in the amount of $35,000 to replace the notes purchased
by Dr. Imhoff that were previously issued to Dolores Maloof on April 3, 2009 and
William Zachary on March 26, 2009, in the amounts of $25,000 and $10,000,
respectively, under the same terms and conditions.
The
Company issued 17% unsecured notes to the following persons on the dates
indicated:
Noteholder
|
Original
Loan Amount
|
Original
Loan Date(s)
|
Loan
Maturity Date
|
Loan
Status
|
Ronald
W. Hart
|
$10,000
|
04/10/09
|
10/09/09
|
Current
|
John
E. Imhoff
|
$35,000
|
04/15/09
|
10/14/09
|
Current
|
Dolores
Maloof
|
$25,000
|
04/17/09
|
05/27/09
|
Past
Due
|
Ronald
W. Hart
|
$6,000
|
04/23/09
|
10/22/09
|
Current
|
John
E. Imhoff
|
$65,000
|
07/07/09
|
01/06/10
|
Current
|
On
December 1, 2008, the Company entered into the 2008 Loan Agreement. Among the
Lenders were John E. Imhoff, William Zachary, Jr., Michael C. James, Dr. Ronald
W. Hart and Ronald W. Allen, all directors of the Company.
In March
and April 2008, the Company issued four Director Notes to its Company directors
in the amounts of $10,000 each.
10. SUBSEQUENT
EVENTS
The
Company issued 17% unsecured note to the following related party on the date
indicated (see Note 8 & 9):
17
Noteholder
|
Original
Loan Amount
|
Original
Loan Date(s)
|
Loan
Maturity Date
|
Loan
Status
|
John
E. Imhoff
|
$65,000
|
07/07/09
|
01/06/10
|
Current
|
On July
15, 2009, the Company issued a 15% unsecured note in the amount of $100,000 to a
new investor.
On July
23, 2009 and July 30, 2009, the Company was paid for and issued a Subscription
Agreement to Guided Medical Solutions, Inc., in the amounts of $500,000 and
$175,000, respectively, in connection with its 2009 financing, slated to close
in the third quarter of 2009.
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:
|
·
|
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;
|
|
·
|
the
need to fully develop the marketing, distribution, customer service and
technical support and other functions critical to the success of our
product lines; and
|
|
·
|
the
dependence on potential strategic partners or outside investors for
funding, development assistance, clinical trials, distribution and
marketing of some of our products.
|
The
following discussion should be read in conjunction with our financial statements
and notes thereto included elsewhere in this report.
OVERVIEW
We were
incorporated on October 27, 1992 under the name of SpectRx, Inc. The company
name was changed to Guided Therapeutics, Inc. in December 2007. Since
the company’s inception, we have raised capital through the sale of preferred
stock, issuance of debt securities, public and private sales of common stock,
funding from collaborative arrangements and sales of assets. Following our
initial funding in early 1993, we immediately began research and development
activities with the objective of commercializing less invasive diagnostic,
screening and monitoring products. We commercialized the BiliChek in 1998, which we later
sold to Respironics, Inc. in 2003. We attempted to commercialize a
diabetes screening instrument with Roche, and a glucose monitoring product with
Abbott. We also conducted a joint venture with Welch Allyn, Inc.
related to our cervical cancer detection technology from 1999 to
2002.
In
December 2001, we acquired 100% of the common stock of Sterling Medivations,
Inc. d/b/a SimpleChoice, a company formed for the purpose of developing and
marketing insulin-delivery products, which we sold in May of 2007.
18
We have a
limited operating history upon which our prospects can be evaluated. 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 June 30, 2009, we have an accumulated deficit of about
$72.1 million. To date, we have engaged primarily in research and development
efforts. We first generated revenues from product sales in 1998, but 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 will require substantial development,
regulatory, sales and marketing, manufacturing and other expenditures. We expect
our operating losses to continue through at least the end of 2009 as we continue
to expend substantial resources to introduce our cervical cancer detection
product, 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. For 2008 and 2009, a
majority of our revenues came from our KMOT and LifeScan contract
revenue. We expect that the majority of our revenue in 2009 will be
derived from research contract revenue. Our other products for
cervical cancer detection are still in development.
CRITICAL
ACCOUNTING POLICIES
The
accounting policies that we believe are the most critical to an investor's
understanding of our financial results and conditions 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,
those 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 sales of products or
services upon shipment of products or when services are rendered. We also
recognize milestone revenue from collaborative partners when a milestone has
been accomplished or when we, and our partner, agree that a milestone has been
reached. If collectibility of accounts receivable for milestones or services is
doubtful, revenues and gains are recognized on the basis of cash received. We
have relied upon SEC Staff Accounting Bulletin, or SAB, 101 and SAB 104 for
guidance in recognizing revenue and related costs.
Service
Revenues: Service revenues are considered to have been earned
when we have substantially accomplished what we must do to be entitled to the
benefits represented by the service revenues. Accordingly, we record revenue
from service contracts where the service is completed and the customer is
invoiced in accordance with the terms of a written, duly executed service
contract or purchase order.
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.
Inventory
Valuation: Inventories are valued at the lower of cost or
market value and have been reduced by an allowance for excess and obsolete
inventories, if necessary.
RESULTS
OF OPERATIONS
COMPARISON
OF THE THREE MONTHS ENDED JUNE 30, 2009 AND 2008
19
Net
loss attributable to common stockholders was $1.4 million during the three
months ended June 30, 2009, as compared to net loss attributable to common
stockholders of $1.3 million during the three months ended June 30,
2008.
Net loss
was approximately $1.4 million during the three months ended June 30, 2009,
versus a net loss of $1.2 million for the three months ended June 30,
2008.
Operating
loss was approximately $522,000 for the three months ended June 30, 2009,
compared to an operating loss of approximately $737,000, for the same period in
2008.
Revenue: Net
revenue decreased to $242,000 for the three months ended June 30, 2009, from
$449,000 for the same period in 2008. Net revenue was lower for the three months
ended June 30, 2009 than the comparable period in 2008, due to the decrease in
revenue from contracts relating to our ISF technology.
Research
and Development Expenses: Research and development expenses decreased
to approximately $339,000 for the three months ended June 30, 2009, compared to
$606,000 for the same period in 2008. The decrease, of
approximately $267,000, was primarily due to a decrease in research and
development for the cervical cancer detection products and glucose monitoring
expenses, as clinical trials associated with these programs were substantially
completed.
General
and Administrative Expenses: General and administrative expenses
decreased to $411,000 during the three months ended June 30, 2009, compared to
$574,000 for the same period in 2008. The decrease is primarily related to a
significant reduction in operating activities during the three months ended June
30, 2009
Other
Income and Interest Expense: Other income interest expense, net increased to
approximately $864,000 for the three months ended June 30, 2009, as compared to
expense of approximately $467,000 for the same period in 2008. The increase is
primarily due to increase in amortization of loan discount, as well as an
increase in interest expense on higher loan balance for the three months ended
June 30, 2009.
COMPARISON
OF THE SIX MONTHS ENDED JUNE 30, 2009 AND 2008
Net loss
attributable to common stockholders was approximately $2.8 million during the
six months ended June 30, 2009, as compared to net loss attributable to common
stockholders of $2.1 million during the six months ended June 30,
2008. Net loss was approximately $2.7 million during the six months
ended June 30, 2009, as compared to net loss of $2.0 million during the six
months ended June 30, 2008.
Revenue: Net
revenue decreased to approximately $423,000 for the six months ended June 30,
2009 from $774,000 for the same period in 2008. Net revenue decrease was
primarily due to the decrease in revenue from contracts relating to our ISF
technology.
Research
and Development Expenses: Research and development expenses decreased
to approximately $643,000 for the six months ended June 30, 2009, compared to
$1.1 million for the same period in 2008. The decrease of approximately $457,000
was primarily due to a decrease in research and development for the cervical
cancer detection products and glucose monitoring expenses, as clinical trials
associated with these programs were substantially completed.
General
and Administrative Expenses: General and administrative expenses
decreased to $875,000 during the six months ended June 30, 2009, compared to
$1.0 million for the same period in 2008. The slight decrease is
primarily related to a reduction in operating activities during the six months
ended June 30, 2009.
Other
Income and Interest Expense: Other income and interest expense, net increased to
approximately $1.6 million for the six months ended June 30, 2009, as compared
to expenses of approximately $658,000 for the same period in 2008. The increase
is primarily due to increase in amortization of loan discount, as well as an
increase in interest expense on higher loan balance for the six months ended
June 30, 2009.
20
LIQUIDITY
AND CAPITAL RESOURCES
We have
financed our operations since inception primarily through private sales of debt
and private and public sales of our equity securities. At June 30,
2009, we had approximately $20,000 in cash and negative working capital of
approximately $5.4 million.
Our major
cash flows in the quarter ended June 30, 2009, consisted of cash out-flows of
approximately $320,000 from operations (including approximately $2.7 million of
net loss), offset in part by cash used in investing activities of $21,000 due to
a capitalization of software costs, as well as, cash provided by financing
activities of $293,000 due to proceeds received from issuance of new notes
payable.
We have
historically also received funds from milestone payments and reimbursements from
our collaborative partners. We are currently seeking a collaborative
partner for our glucose monitoring technology. Until we reach an
agreement with a new partner, we expect minimal or no such milestones or
reimbursements.
As
previously disclosed, on December 1, 2008, the Company entered into the 2008
Loan Agreement with 28 existing and new lenders (the "Lenders"), pursuant to
which we issued approximately $2.3 million in aggregate principal amount of the
2008 Convertible Notes, due December 1, 2011, and the 2008 Warrants exercisable
for 11,558,878 shares of our common stock.
The 2008
Convertible Notes are subordinate to our existing senior secured obligations,
which are secured by (a) a first in priority lien on all of our assets; (b)
a guaranty by our wholly owned subsidiary, InterScan; (c) a lien on all of
InterScan's assets; and (d) a pledge on all the issued and outstanding stock of
GT and InterScan. No payments will be due under the 2008 Convertible Notes
until they mature on December 1, 2011. The 2008 Convertible Notes bear
interest at 15% per year, payable on the Maturity Date, absent an event of
default, in which case, the interest rate increases to 20%.
The 2008
Convertible Notes are convertible into approximately 3,556,580 shares of our
common stock, at a conversion rate of $0.65 per share, subject to certain
adjustments. The 2008 Warrants are immediately exercisable for
11,558,878 shares at an exercise price of $0.65 per share, subject to certain
adjustments. The 2008 Loan Agreement also provides certain registration rights
to the Lenders with respect to the shares of our common stock underlying the
2008 Notes and Warrants.
On
December 1, 2008, the relative fair value of the warrants was approximately $1.7
million. The debt discount will accrete over the 36-month term of the 2008
Convertible Notes payable using the effective interest method.
Approximately
$1.3 million of the proceeds from the 2008 Loan Agreement was used to convert
existing debt into 2008 Convertible Notes as described below. The remaining
funds, less fees and expenses, were used in product development, working capital
and other corporate purposes.
On March
12, 2007, we completed a restructuring of our then-existing indebtedness by
entering into an Amended and Restated Loan Agreement (“Amended Loan”) with
existing and new creditors. Pursuant to the Amended Loan, the
existing loans under the then-existing indebtedness were restructured and
consolidated into new 13% Senior Secured Convertible Notes (the “2007
Convertible Notes”). The aggregate principal amount of the Amended Loan is
approximately $4.8 million due on March 1, 2010. No interest is due
until maturity, absent an event of default under the Amended Loan. If an
event of default occurs and is continuing, the interest rate on the Amended Loan
becomes 18%. The 2007 Convertible Notes are convertible into
our common stock at $0.65 per share, or 7,285,061 shares of common stock, and
were issued with approximately 7.2 million warrants, exercisable immediately at
$0.78 per share for our common stock. Additionally, accrued interest on the 2007
Convertible Notes is convertible into shares of our common stock, on the same
terms. In addition, 661,000 warrants at an exercise price of $0.78 were also
issued to the placement agent and others in conjunction with this financing, as
well as a warrant to purchase 15,000 shares of our common stock at $0.78, as
part of interest expense to a non-converting bridge note holder, as interest on
the notes payable. The conversion price and the exercise price of the
warrants are subject to adjustments for anti-dilution.
21
On March
12, 2007, the relative fair value of the warrants was approximately $2.3 million
(including $.3 million attributed to 661,000 warrants for placement agent
treated as debt issuance cost), and the relative fair value of the beneficial
conversion feature was approximately $1.3 million. The debt discount, consisting
of the beneficial conversion feature and warrants, will accrete over the
36-month term of the 2007 Convertible Notes payable using the effective interest
method. In addition, debt issuance costs totaling approximately $811,000
($520,000 cash costs and $291,000 warrant value for 661,000 warrants given to
placement agent and others) will also be amortized over 36 months, using the
effective interest method.
The
Amended Loan is our senior secured obligation and is secured by (a) a first
in priority lien on all of our assets; (b) a guaranty by Sterling; (c) a lien on
all of Sterling's assets (except the SimpleChoice business); and (d) a pledge on
all issued and outstanding stock of Sterling and
InterScan.
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 third quarter of
2009, excluding any amounts due on redeemable convertible preferred stock,
although we need to secure a collaborative partner to move forward with our
continuous glucose program and will need additional funding to complete our
pivotal trials for our cervical cancer detection product in a timely
fashion. 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 United States 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.
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
4T. CONTROLS AND PROCEDURES
Disclosure
controls and procedures are controls and other procedures that are designed to
ensure that information required to be disclosed by the Company in the reports
it files or submits under the Securities Exchange Act of 1934, as amended (the
“Exchange Act”) is recorded, processed, summarized, and reported, within the
time periods specified by the Securities and Exchange Commission (“SEC”) rules
and forms. Disclosure controls and procedures include, without limitation,
controls and procedures designed to ensure that information required to be
disclosed by the Company in the reports it files or submits under the Exchange
Act is accumulated and communicated to management, including the Chief Executive
Officer and Chief Financial Officer, as appropriate to allow timely decisions
regarding required disclosure. Notwithstanding the foregoing, a control system,
no matter how well designed and operated, can provide only reasonable, not
absolute, assurance that it will uncover or detect failures within the Company
to disclose material information otherwise required to be set forth in the
Company’s periodic reports.
Under the
supervision of, and with the participation of our management, including our
Chief Executive Officer and Chief Financial Officer, we conducted an evaluation
of the effectiveness of our disclosure controls and procedures, as defined in
Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as of the end of the
period covered by this report, and, based upon this evaluation, the Chief
Executive Officer and Chief Financial Officer have concluded that these controls
and procedures were ineffective as of June 30, 2009, due to the existence of
previously disclosed material weaknesses in our internal control over financial
reporting primarily related to inadequate resources in our accounting and
financial reporting group, that we have yet to fully remediate.
There
have been no changes in the Company’s internal controls over financial reporting
that occurred during the quarter ended June 30, 2009 that have materially
affected, or are reasonably likely to materially affect, its internal control
over financial reporting.
22
PART II - OTHER
INFORMATION
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF
PROCEEDS
None
ITEM
5. OTHER INFORMATION
None
ITEM
6. EXHIBITS
EXHIBIT
INDEX
EXHIBITS
Exhibit Number
|
Exhibit
Description
|
31
|
Rule
13a-14(a)/15d-14(a) Certification
|
32
|
Section
1350 Certification
|
23
SIGNATURES
In
accordance with the requirements of the Exchange Act, the registrant 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:
|
August
18, 2009
|
24