NON INVASIVE MONITORING SYSTEMS INC /FL/ - Quarter Report: 2009 January (Form 10-Q)
UNITED
STATES
SECURITIES AND EXCHANGE
COMMISSION
Washington,
DC. 20549
FORM
10-Q
(Mark
One)
x
|
Quarterly
Report Pursuant to Section 13 or 15 (d) of the Securities Exchange Act of
1934 for the Quarterly Period ended January
31,
2009
|
or
¨
|
Transition
Report Pursuant to Section 13 or 15 (d) of the Securities Exchange Act of
1934 for the Transition Period from _______________ to
____________________
|
Commission
File Number 000-13176
NON-INVASIVE MONITORING SYSTEMS,
INC.
|
(Exact
name of registrant as specified in its
charter)
|
Florida
|
59-2007840
|
|
(State
or other jurisdiction of incorporation or
organization)
|
|
(I.R.S.
employer identification
no.)
|
4400 Biscayne Blvd., Suite 680, Miami,
Florida 33137
(Address
of principal executive offices) (Zip code)
Registrant’s
telephone number, including area code: (305) 861-0075
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 x No
o
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 the definitions of “large
accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule
12b-2 of the Exchange Act.
Large accelerated filer o Accelerated
filer o Non-accelerated
filer o 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 o No x
68,060,637 shares of the Company’s
common stock, par value $0.001 per share, were outstanding as of March 1,
2009.
NON-INVASIVE
MONITORING SYSTEMS, INC.
TABLE
OF CONTENTS FOR FORM 10-Q
PART
I. FINANCIAL
INFORMATION
|
||
ITEM
1.
|
FINANCIAL
STATEMENTS
|
|
Condensed
Consolidated Balance Sheets as of January 31, 2009 (unaudited) and July
31, 2008
|
3
|
|
Condensed
Consolidated Statements of Operations for the Three and Six Months
ended January 31, 2009 and 2008 (unaudited)
|
4
|
|
Condensed Consolidated
Statements of Shareholders’ Equity for the Six Months ended January
31, 2009 (unaudited)
|
5
|
|
Condensed Consolidated
Statements of Cash Flows for the Six Months ended January 31, 2009 and
2008 (unaudited)
|
6
|
|
Notes
to unaudited condensed consolidated financial statements
|
7
|
|
ITEM
2.
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
17
|
ITEM
3.
|
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
22
|
ITEM
4T.
|
CONTROLS
AND PROCEDURES
|
22
|
PART
II. OTHER
INFORMATION
|
||
ITEM
1.
|
LEGAL
PROCEEDINGS
|
23
|
ITEM
1A.
|
RISK
FACTORS
|
23
|
ITEM
2.
|
UNREGISTERED
SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
|
23
|
ITEM
3.
|
DEFAULTS
UPON SENIOR SECURITIES
|
23
|
ITEM
4.
|
SUBMISSION
OF MATTERS TO A VOTE OF SECURITY HOLDERS
|
23
|
ITEM
5.
|
OTHER
INFORMATION
|
23
|
ITEM
6.
|
EXHIBITS
|
24
|
SIGNATURES
|
25
|
2
NON-INVASIVE
MONITORING SYSTEMS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands, except share and per share data)
January 31, 2009
|
July 31, 2008
|
|||||||
ASSETS
|
(Unaudited)
|
|||||||
Current
assets
|
||||||||
Cash
|
$ | 1,854 | $ | 86 | ||||
Royalties
and other receivables
|
130 | 43 | ||||||
Inventories
|
591 | 173 | ||||||
Advances
to contract manufacturer
|
417 | 659 | ||||||
Prepaid
expenses, deposits, and other current assets
|
22 | 28 | ||||||
Total
current assets
|
3,014 | 989 | ||||||
Tooling
and equipment, net
|
447 | 470 | ||||||
Total
assets
|
$ | 3,461 | $ | 1, 459 | ||||
|
||||||||
LIABILITIES
AND SHAREHOLDERS' EQUITY
|
||||||||
Current liabilities
|
||||||||
Notes
payable – other
|
$ | - | $ | 19 | ||||
Accounts
payable and accrued expenses
|
316 | 474 | ||||||
Customer
deposits
|
60 | 2 | ||||||
|
||||||||
Total
current liabilities
|
376 | 495 | ||||||
|
||||||||
Total
liabilities
|
$ | 376 | $ | 495 | ||||
Commitments
(Note 9)
|
– | – | ||||||
Shareholders' equity
|
||||||||
Series
B Preferred Stock, par value $1.00 per share;
|
||||||||
100
shares authorized, issued and outstanding; liquidation preference
$10
|
– | – | ||||||
Series
C Convertible Preferred Stock, par value $1.00 per share;
|
||||||||
62,048
shares authorized, issued and outstanding; liquidation preference
$62
|
62 | 62 | ||||||
Series
D Convertible Preferred Stock, par value $1.00 per share; 5,500 shares
|
||||||||
authorized;
2,891 shares issued and outstanding; liquidation preference
$4,337
|
3 | 1 | ||||||
Common
Stock, par value $0.01 per share; 100,000,000 shares
authorized;
|
||||||||
68,060,637
shares issued and outstanding
|
681 | 680 | ||||||
Additional
paid in capital
|
21,197 | 18,256 | ||||||
Accumulated
deficit
|
(18,858 | ) | (18,035 | ) | ||||
Total
shareholders' equity
|
3,085 | 964 | ||||||
Total
liabilities and shareholders' equity
|
$ | 3,461 | $ | 1,459 |
The
accompanying notes are an integral part of these unaudited condensed
consolidated financial statements.
3
NON-INVASIVE
MONITORING SYSTEMS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS - Unaudited
(In
thousands, except per share amounts)
Three months ended January 31,
|
Six months ended January 31,
|
|||||||||||||||
2009
|
2008
|
2009
|
2008
|
|||||||||||||
Revenues
|
||||||||||||||||
Product
sales, net
|
$ | 117 | $ | 14 | $ | 123 | $ | 28 | ||||||||
Royalties
|
93 | 53 | 156 | 125 | ||||||||||||
Research,
consulting and warranty
|
1 | 1 | 2 | 2 | ||||||||||||
Total
revenues
|
211 | 68 | 281 | 155 | ||||||||||||
Operating costs and expenses
|
||||||||||||||||
Cost
of sales
|
56 | 16 | 61 | 27 | ||||||||||||
Selling,
general and administrative
|
439 | 557 | 944 | 920 | ||||||||||||
Research
and development
|
38 | 27 | 91 | 76 | ||||||||||||
Total
operating costs and expenses
|
533 | 600 | 1,096 | 1,023 | ||||||||||||
Operating loss
|
(322 | ) | (532 | ) | (815 | ) | (868 | ) | ||||||||
Interest
income (expense), net
|
(3 | ) | 3 | (8 | ) | 10 | ||||||||||
Net
loss
|
$ | (325 | ) | $ | (529 | ) | $ | (823 | ) | $ | (858 | ) | ||||
|
||||||||||||||||
Deemed
dividend on Series D Preferred Stock
|
$ | 1,078 | $ | – | $ | 1,078 | $ | – | ||||||||
Net
loss attributable to common shareholders
|
$ | (1,403 | ) | $ | (529 | ) | $ | (1,901 | ) | $ | (858 | ) | ||||
Weighted
average number of common shares outstanding - Basic and
diluted
|
68,042 | 67,458 | 68,041 | 67,397 | ||||||||||||
|
||||||||||||||||
Basic
and diluted loss per common share
|
$ | (0.02 | ) | $ | (0.01 | ) | $ | (0.03 | ) | $ | (0.01 | ) |
The
accompanying notes are an integral part of these unaudited condensed
consolidated financial statements.
4
NON-INVASIVE
MONITORING SYSTEMS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY -
Unaudited
For
the Six Months ended January 31, 2009
(Dollars
in Thousands)
Preferred Stock
|
Additional
|
|||||||||||||||||||||||||||||||||||||||||||
Series B
|
Series C
|
Series D
|
Common Stock
|
Paid-in-
|
Accumulated
|
|||||||||||||||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Deficit
|
Total
|
||||||||||||||||||||||||||||||||||
Balance
at July 31, 2008
|
100 | $ | 0 | 62,048 | $ | 62 | 1,000 | $ | 1 | 68,039,065 | $ | 680 | $ | 18,256 | $ | (18,035 | ) | $ | 964 | |||||||||||||||||||||||||
Issuance
of series D preferred stock
|
– | – | – | – | 1,891 | 2 | – | – | 2,835 | – | 2,837 | |||||||||||||||||||||||||||||||||
Fair
value of beneficial conversion feature of Series D Preferred
Stock
|
– | – | – | – | – | – | – | – | 1,078 | – | 1,078 | |||||||||||||||||||||||||||||||||
Deemed
dividend to Series D Preferred Stockholders, charged to additional
paid-in-capital in the absence of retained earnings
|
– | – | – | – | – | – | – | – | (1,078 | ) | – | (1,078 | ) | |||||||||||||||||||||||||||||||
Common
stock issued for cash on exercise of options
|
– | – | – | – | – | – | 13,333 | 1 | 1 | – | 2 | |||||||||||||||||||||||||||||||||
Cashless
exercise of 13,333 options
|
– | – | – | – | – | – | 8,239 | – | – | – | – | |||||||||||||||||||||||||||||||||
Stock
based compensation
|
– | – | – | – | – | – | – | – | 105 | – | 105 | |||||||||||||||||||||||||||||||||
Net
loss
|
– | – | – | – | – | – | – | – | – | (823 | ) | (823 | ) | |||||||||||||||||||||||||||||||
Balance
at January 31, 2009
|
100 | $ | 0 | 62,048 | $ | 62 | 2,891 | $ | 3 | 68,060,637 | $ | 681 | $ | 21,197 | $ | (18,858 | ) | $ | 3,085 |
The
accompanying notes are an integral part of these unaudited condensed
consolidated financial statements.
5
NON-INVASIVE
MONITORING SYSTEMS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS - Unaudited
(Dollars
in thousands)
Six
Months ended January 31, 2009 and 2008
2009
|
2008
|
|||||||
Operating
activities
|
||||||||
Net
loss
|
$ | (823 | ) | $ | (858 | ) | ||
Adjustments
to reconcile net loss to net cash used in operating
activities
|
||||||||
Deferred
warranty income
|
(2 | ) | (2 | ) | ||||
Depreciation
and amortization
|
52 | 5 | ||||||
Stock
based compensation expense
|
105 | 232 | ||||||
Changes
in operating assets and liabilities
|
||||||||
Royalties
receivable
|
(86 | ) | 13 | |||||
Inventories
|
(417 | ) | (112 | ) | ||||
Advances
to contract manufacturer
|
241 | - | ||||||
Prepaid
expenses and other assets
|
5 | 26 | ||||||
Accounts
payable and accrued expenses
|
(16 | ) | (14 | ) | ||||
Customer
deposits
|
60 | - | ||||||
Net
cash used in operating activities
|
(881 | ) | (710 | ) | ||||
Investing
activities
|
||||||||
Fixed
asset purchases
|
(171 | ) | (332 | ) | ||||
Net
cash used in investing activities
|
(171 | ) | (332 | ) | ||||
Financing
activities
|
||||||||
Net
proceeds from issuance of common stock and exercise of options and
warrants
|
2 | 84 | ||||||
Net
proceeds from issuance of Series D Preferred Stock
|
2,837 | - | ||||||
Proceeds
from issuance of notes payable
|
300 | - | ||||||
Repayments
of notes payable
|
(319 | ) | (21 | ) | ||||
Net
cash provided by financing activities
|
2,820 | 63 | ||||||
Net
increase (decrease) in cash
|
1,768 | (979 | ) | |||||
Cash,
beginning of period
|
86 | 1,156 | ||||||
Cash,
end of period
|
$ | 1,854 | $ | 177 | ||||
Supplemental disclosure
|
||||||||
Cash
paid for interest
|
$ | 8 | $ | 17 | ||||
Supplemental schedule of non-cash
activities
|
||||||||
Reversal
of accrual for tooling development in progress
|
$ | 142 | $ | - |
The
accompanying notes are an integral part of these unaudited condensed
consolidated financial statements.
6
NON-INVASIVE
MONITORING SYSTEMS, INC.
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
January
31, 2009
The
condensed consolidated balance sheet as of July 31, 2008, which has been
derived from audited financial statements, and the unaudited condensed interim
financial statements included herein have been prepared by Non-Invasive
Monitoring Systems, Inc. (together with its consolidated subsidiaries, the
“Company” or “NIMS”) in accordance with accounting principles generally accepted
in the United States (“GAAP”) for interim financial information and the
instructions to the quarterly report on Form 10-Q and Rule 8-03 of
Regulation S-X. Accordingly, they do not include all of the
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 January 31,
2009, and results of operations and cash flows for the interim periods ended
January 31, 2009 and 2008. The results of operations for the three
and six months ended January 31, 2009, are not necessarily indicative of the
results for a full year. Certain information and footnote disclosure
normally included in financial statements prepared in accordance with GAAP have
been condensed or omitted. The Company’s accounting policies continue
unchanged from July 31, 2008. 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-KSB for the year ended July 31,
2008.
1.
|
ORGANIZATION
AND BUSINESS
|
Organization. Non-Invasive
Monitoring Systems, Inc., a Florida corporation, began business as a medical
diagnostic monitoring company to develop computer-aided continuous monitoring
devices to detect abnormal respiratory and cardiac events using sensors on the
body’s surface. It has ceased to operate in this market and has
licensed the rights to its technology to the SensorMedics division of ViaSys
Healthcare Inc. (which is now a unit of Cardinal Health, Inc. (“SensorMedics”)),
and to VivoMetrics, Inc. (“VivoMetrics”). The Company is now focused
on developing and marketing its Exer-Rest® line of
acceleration therapeutic platforms based upon unique, patented whole body
periodic acceleration (“WBPA”) technology. The Exer-Rest® line of
acceleration therapeutic platforms currently includes the Exer-Rest® AT, SL
and TL models.
NIMS
received US Food and Drug Administration (“FDA”) approval in January 2009 to
market the full Exer-Rest® line of
products as Class I (Exempt) Medical Devices as described in the Company’s
510(k) premarket notification submission. The submission included 23
investigational and clinical studies on the vasodilatation properties of WBPA,
as well as a controlled, four week clinical trial in a group of patients with
chronic aches and pains carried out at the Center of Clinical Epidemiology and
Biostatistics at the University of Pennsylvania Medical School. The
submission supported Exer-Rest® safety
and efficacy for the granted intended uses as an aid to temporarily increase
local circulation, to provide temporary relief of minor aches and pains, and
local muscle relaxation. The approval was based upon the FDA’s
determination that the Exer-Rest® line of
devices was exempt from the premarket notification requirements of the Federal,
Food Drug and Cosmetic Act. This approval to market the
Exer-Rest® in the
United States complements NIMS’ existing international approval to market the
Exer-Rest® as a
class IIa medical device (CE120) in Canada, the United Kingdom, the European
Economic Area and other major world markets with the intended use described
above plus the claim of improving joint mobility.
Business. The
Company receives revenue from royalties on sales of diagnostic monitoring
hardware and software by SensorMedics and VivoMetrics.
Additionally, the Company receives revenues from sales of parts and service and
from sales of acceleration therapeutics platforms used for research
purposes. In fiscal year 2009, NIMS began commercial sales of its
third generation Exer-Rest®
therapeutic platforms.
During
the calendar years 2005 to 2007, the Company designed, developed and
manufactured the first Exer-Rest® platform
(now the Exer-Rest® AT), a
second generation acceleration therapeutics platform, and updated its operations
to promote the Exer-Rest® AT
overseas as an aid to improve circulation and joint mobility, and to relieve
minor aches and pains.
The
Company has developed a third generation of Exer-Rest®
acceleration therapeutic platforms (designated the Exer-Rest® SL and
the Exer-Rest® TL) that
are being manufactured by Sing Lin Technologies Co. Ltd. (“Sing Lin”) based in
Taichung, Taiwan (see Note 9).
NIMS, an
ISO 13485 certified company, is also permitted to sell Exer-Rest® in
Canada, the United Kingdom, the European Economic Area and other major world
markets, and began international marketing operations during 2008.
Exer-Rest® is
regulated as a Class IIa medical device with CE certification outside the
US.
7
NON-INVASIVE
MONITORING SYSTEMS, INC.
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
January
31, 2009
Sing Lin
will also have distribution rights to the Company’s acceleration therapeutics
platforms in certain Far East markets. The Company has also engaged
Sing Lin to build the Somno-Ease™
platform, a variation of the Exer-Rest® that is
designed to aid patients with sleep disorders as well as provide feedback for
slow rhythmic breathing exercises for the relief of stress associated with daily
living. The Company is also developing a further product line
extension called Exer-Rest® Plus, a
device that combines the features of the Exer-Rest® and
Somno-Ease™ for
future marketing in the United States.
The
Company’s financial statements have been prepared and presented on a basis
assuming it will continue as a going concern. As reflected in the
accompanying financial statements the Company had net losses in the amount of
$823,000 and $858,000 for the six months ended January 31, 2009 and 2008,
respectively, and has experienced cash outflows from operating
activities. The Company also has an accumulated deficit of $18.9
million as of January 31, 2009, and has substantial purchase commitments at
January 31, 2009 (see Note 9). These matters raise substantial doubt about
the Company’s ability to continue as a going concern.
Although
the Company raised approximately $2.8 million from the sales of its Series D
Preferred Stock in December 2008 and January 2009 (see Note 6), the Company will
likely need to generate additional funds during fiscal year
2009. Absent any significant revenues from product sales, additional
debt or equity financing will be required for the Company to continue its
business activities, which are currently focused on the production, marketing
and commercial sale of the Exer-Rest®. It
is management’s intention to obtain any additional capital needed to continue
its business activities through new debt or equity financing, but there can be
no assurance that it will be successful in this regard. The
accompanying financial statements do not include any adjustments that might be
necessary from the outcome of this uncertainty.
2.
|
SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
|
Consolidation. The
condensed consolidated financial statements include the accounts of the Company
and its wholly-owned subsidiaries, Non-Invasive Monitoring Systems of Florida,
Inc., which has no current operations, and NIMS of Canada, Inc., a Canadian
corporation. All inter-company accounts and transactions have been
eliminated in consolidation.
Use of
Estimates. The preparation of financial statements in
conformity with GAAP 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
reported amounts of revenues and expenses during the reporting
period. Such items include input variables relating to valuation of
stock based compensation and other financial instruments. Actual
results could differ from these estimates.
Inventories. Inventories
are stated at lower of cost or market using the first-in, first-out
method. Inventories at January 31, 2009 primarily consist of finished
Exer-Rest® units
and purchased sub-assemblies to be used by the Company’s US-based contract
manufacturer in production of the Exer-Rest®
AT.
Furniture,
Equipment and Tooling. These assets are stated at cost and depreciated or
amortized using the straight-line method, over their estimated useful
lives.
Long-lived
Assets. The Company reviews its long-lived assets for impairment whenever
events or changes in circumstances indicate that the carrying amount may not be
recoverable. In performing the review for recoverability, the Company
estimates the future undiscounted cash flows expected to result from the use of
the asset and its eventual disposition. If the sum of the expected future
cash flows is less than the carrying amount of the assets, an impairment loss is
recognized as the difference between the fair value and the carrying amount of
the asset.
Income
Taxes. The Company provides for income taxes in accordance
with Statement of Financial Accounting Standards (“SFAS”) No. 109, “Accounting for Income Taxes”
(“SFAS No. 109”) using an asset and liability based
approach. Deferred income tax assets and liabilities are recorded to
reflect the tax consequences in future years of temporary differences between
the carrying amounts of assets and liabilities for financial statement and
income tax purposes. SFAS No. 109 provides that the Company recognize
income tax benefits for loss carryforwards. The tax benefits
recognized must be reduced by a valuation allowance if it is more likely than
not that loss carryforwards will expire before the Company is able to realize
their benefit, or if future deductibility is uncertain. For financial
statement purposes, the deferred tax asset for loss carryforwards has been fully
offset by a valuation allowance since it is uncertain whether any future benefit
will be realized.
8
NON-INVASIVE
MONITORING SYSTEMS, INC.
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
January
31, 2009
As of
July 31, 2008, the Company had a net operating loss carryforward of
approximately $10.6 million available to offset future taxable income for
federal and state income tax purposes. The net operating loss
carryforward may be subject to limitation due to change of ownership provisions
under Section 382 of the Internal Revenue Code and similar state
provisions.
Effective
August 1, 2007, the Company adopted the provisions of the Financial Accounting
Standards 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 SFAS No.
109 and prescribes a recognition threshold and measurement attribute for
financial disclosure of tax positions 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 January
31, 2009.
The
Company files its tax returns as prescribed by the laws of the jurisdictions in
which it operates. Tax years ranging from 2005 to 2008 remain open to
examination by various taxing jurisdictions as the statute of limitations has
not expired. It is the Company’s policy to include income tax
interest and penalties expense in its tax provision.
Revenue
Recognition. Revenue from product sales is recognized when
persuasive evidence of an arrangement exists, the goods are shipped and title
has transferred, the price is fixed or determinable, and the collection of the
sales proceeds is reasonably assured. The Company recognizes royalties as
they are earned, based on reports from licensees. Research and consulting
revenue and revenue from sales of extended warranties on therapeutic platforms
are recognized over the term of the respective agreements.
Advertising
Costs. The Company expenses all costs of advertising as
incurred. There were no material advertising costs incurred during
the six months ended January 31, 2009 and 2008.
Research and
Development Costs. Research and development costs are expensed
as incurred, and primarily consist of payments to third parties for research and
development of the Exer-Rest® device
and regulatory testing and other costs to obtain FDA approval.
Warranties. The
Company’s warranties are one-year on all products sold and are accrued based on
management’s estimates and the history of warranty costs
incurred. There were no actual warranty costs incurred during the six
months ended January 31, 2009 and 2008 and Management estimates that the
Company’s accrued warranty expense at January 31, 2009 will be sufficient to
offset claims made for units under warranty.
Fair Value of
Financial Instruments. Fair value estimates discussed herein
are based upon certain market assumptions and pertinent information available to
management as of January 31, 2009. The respective carrying value of
certain on-balance-sheet financial instruments such as royalties receivable,
accounts payable, accrued expenses and notes payable approximate fair values
because they are short term in nature or they bear current market interest
rates.
Foreign Currency
Translation. The functional currency for the Company’s foreign
subsidiary is the local currency. Assets and liabilities are translated at
exchange rates in effect at the balance sheet date while income and expense
amounts are translated at average exchange rates during the period. The
resulting foreign currency translation adjustments are disclosed as a separate
component of stockholders’ equity and other comprehensive income. There were no
material foreign currency translation adjustments in the six months ended
January 31, 2009.
Comprehensive
Income (Loss). Comprehensive income (loss) is defined as the
change in equity of a business enterprise during a period from transactions and
other events and circumstances from non-owner sources, including foreign
currency translations. The Company’s comprehensive net loss is equal
to its net loss for all periods presented.
3.
|
INVENTORIES
|
The
Company’s inventory consists of the following at January 31, 2009 (in
thousands):
Work-in-progress,
including sub-assemblies
|
$ | 66 | ||
Finished
goods
|
525 | |||
Total
inventories
|
$ | 591 |
9
NON-INVASIVE
MONITORING SYSTEMS, INC.
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
January
31, 2009
4.
|
STOCK
BASED COMPENSATION
|
The
Company accounts for stock-based compensation in accordance with SFAS
No. 123 (Revised 2004), “Share-Based Payment” (“SFAS
No. 123R”) which requires a public entity to measure the cost of employee,
officer and director services received in exchange for an award of equity
instruments based on the grant-date fair value of the
award. Compensation cost is recognized over the vesting period of the
award.
The
Company recorded stock based compensation of $40,000 and $100,000, respectively,
for the three months ended January 31, 2009 and 2008, and $105,000 and $232,000,
respectively, for the six months ended January 31, 2009 and 2008. All
stock based compensation is included in the Company’s selling, general and
administrative expenses.
The
Company’s 2000 Stock Option Plan (the “2000 Plan”), as amended, provides for a
total of 2,000,000 shares of Common Stock. The 2000 Plan allows the
issuance of incentive stock options, stock appreciation rights and restricted
stock awards. The exercise price of the options is determined by the
compensation committee of the Company’s Board of Directors, but incentive stock
options must be granted at an exercise price not less than the fair market value
of the Company’s Common Stock as of the grant date or an exercise price of not
less than 110% of the fair value for a 10% shareholder. Options
expire up to ten years from the date of the grant and are exercisable according
to the terms of the individual option agreements.
The
Company granted zero and 75,000 options, respectively, during the three and six
months ended January 31, 2009, and 225,000 and 772,500 options, respectively,
during the three and six months ended January 31, 2008. The intrinsic
value of the 26,666 options exercised during the six months ended January 31,
2009 was $8,000 on the dates exercised, and the intrinsic value of the 181,998
options exercised during the six months ended January 31, 2008 was $78,000 on
the dates exercised.
A summary
of the Company’s stock option activity for the six months ended January 31, 2009
is as follows:
Shares
|
Weighted
Average
Exercise
Price
|
Weighted
average
remaining
contractual
term (years)
|
Aggregate
Intrinsic
Value
|
|||||||||||||
Options
outstanding, July 31, 2008
|
2,074,330 | $ | 0.593 | |||||||||||||
Options
granted
|
75,000 | $ | 0.400 | |||||||||||||
Options
exercised
|
(26,666 | ) | $ | 0.150 | ||||||||||||
Options
forfeited or expired
|
(50,833 | ) | $ | 0.334 | ||||||||||||
Options
outstanding, January 31, 2009
|
2,071,831 | $ | 0.598 | 3.49 | $ | 55,333 | ||||||||||
Options
expected to vest, January 31, 2009
|
2,063,538 | $ | 0.599 | 3.48 | $ | 55,333 | ||||||||||
Options
exercisable, January 31, 2009
|
1,725,831 | $ | 0.576 | 3.25 | $ | 55,333 |
Of the
2,071,831 options outstanding at January 31, 2009, 986,000 were issued under the
2000 Plan and 1,085,831 were issued outside of shareholder approved
plans. All of the options exercised, forfeited and expired during the
three and six month periods ended January 31, 2009 and 2008 were originally
granted outside of shareholder approved plans.
The
Company estimates the fair value of stock options using a Black-Scholes
valuation model, consistent with provisions of SFAS No.123R, Securities and
Exchange Commission (SEC) Staff Accounting Bulletin No. 107 (“SAB No. 107”) and
the Company's prior pro forma disclosures of net loss, 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 the Company's stock, the risk free interest rate,
option forfeiture rates, and dividends, if any. The expected term of
stock option awards granted is generally based upon the “simplified” method for
“plain vanilla” options discussed in SAB No. 107, as amended by SEC Staff
Accounting Bulletin No. 110. The expected volatility is derived from
historical volatility of the Company's stock on the U.S. over-the-counter
bulletin board for a period that matches the expected term 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. The Company
has not paid cash dividends and does not expect to pay cash dividends in the
future. Forfeiture rates are based on management’s
estimates. The fair value of each option granted during the six
months ended January 31, 2009 and 2008 was estimated using the following
assumptions:
10
NON-INVASIVE
MONITORING SYSTEMS, INC.
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
January
31, 2009
Six months ended
January 31, 2009
|
Six months ended
January 31, 2008
|
|||
Expected
volatility
|
110.18%
|
77.00%
|
||
Expected
dividend yield
|
0.00%
|
0.00%
|
||
Risk-free
interest rate
|
2.83%
|
3.08%
|
||
Expected
life
|
5.0
years
|
5.0
years
|
||
Forfeiture
rate
|
0.00%
|
0.00%
|
Compensation
costs for stock options are recognized over the vesting period. As of
January 31, 2009, there was $118,000 of unrecognized costs related to
outstanding stock options. These costs are expected to be recognized
over a weighted average period of 1.14 years. A summary of the status
of the Company’s non-vested options and changes during the six months ended
January 31, 2009 is presented below.
Stock Options
|
Weighted Average
Grant Date Fair Value
|
|||||||
Non-vested
at July 31, 2008
|
476,000 | $ | 0.492 | |||||
Options
granted
|
75,000 | $ | 0.319 | |||||
Options
vested
|
(205,000 | ) | $ | 0.448 | ||||
Non-vested
at January 31, 2009
|
346,000 | $ | 0.491 |
On
February 23, 2009, the Company issued an aggregate of 265,000 options to
purchase the Company’s common stock under the 2000 Plan, each at an exercise
price of $0.32 per share. The options were granted to directors,
officers, employees and consultants.
5.
|
NOTES
PAYABLE
|
On August
28, 2008 the Company entered into a Note and Security Agreement (the
“Agreement”) with four persons (the “Lenders”), pursuant to which the Lenders
granted the Company a revolving credit line (the “Revolver”) in the aggregate
amount of $300,000, secured by all of the Company’s personal
property. The Lenders included a holder of more than 10% of the
outstanding Common Stock, a director and executive officer of the Company who
also holds more than 10% of the outstanding Common Stock and an entity
controlled by the Company’s Chairman. The Company was permitted to
borrow and reborrow from time to time under the Revolver until October 31, 2008
(the “Maturity Date”). The interest rate payable on amounts
outstanding under the Revolver was 11% per annum, and increased to 16% after the
Maturity Date or after an Event of Default. All amounts owing under
the Revolver were required to be repaid by the Maturity Date, and amounts
outstanding were prepayable at any time. On August 29, 2008 the
Company drew down $300,000 under the Revolver. The Revolver was
amended, effective October 31, 2008, to extend the Maturity Date until November
30, 2008. All principal and interest outstanding under the Revolver
as of November 30, 2008 was repaid with proceeds from the sale of Series D
Preferred Stock on December 1, 2008 as described in Note 6 below.
6.
|
SHAREHOLDERS'
EQUITY
|
During
the six months ended January 31, 2009, the Company received $2,000 from an
existing option holder for the exercise of options to purchase 13,333 shares of
Common Stock, and 8,239 shares were issued to another option holder upon the
cashless exercise of 13,333 options. During the six months ended
January 31, 2008, the Company received $84,000 from existing option holders for
the exercise of options to purchase 181,998 shares of Common
Stock.
11
NON-INVASIVE
MONITORING SYSTEMS, INC.
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
January
31, 2009
Series D Preferred Stock. In
December 2008, the Company sold an aggregate of 491 shares of its Series D
Convertible Preferred Stock (the “Series D Preferred Stock”), to certain private
investors (collectively, the “Investors”) at a price of $1,500 per share
pursuant to Stock Subscription Agreements entered between December 1, 2008 and
December 2, 2008 (the sale of 286 shares closed on December 1, 2008 and the sale
of 205 shares closed on December 2, 2008). The Investors include a
director of the Company, a holder of more than 10% of the outstanding Common
Stock, a director and executive officer of the Company who also holds
more than 10% of the outstanding Common Stock and an entity controlled by the
Company’s Chairman (collectively, the “Related Party Investors”). The
aggregate purchase price for the Series D Preferred Stock was $736,500, of which
$382,500 was paid by the Related Party Investors. Of the $382,500
paid by the Related Party Investors, $282,200 was paid from the proceeds of
their respective interests in the Revolver described in Note 5
above.
On
January 28, 2009, pursuant to Stock Subscription Agreements accepted by the
Company on that date, the Company completed the sale of an aggregate of 1,400
additional shares of Series D Preferred Stock at a price of $1,500 per share to
certain of the Related Party Investors that participated in the December 2008
offering described above. The aggregate proceeds of the January 2009
offering was $2.1 million.
The
Series D Preferred Stock has no preference with respect to dividends to the
Company’s common stock, and is entitled to receive dividends when, as and if
declared by the Company’s Board of Directors, together with the holders of the
common stock, ratably on an “as-converted” basis. Each holder of a
share of the Series D Preferred Stock has the right, at any time, to convert
such share of Series D Preferred Stock into shares of Common Stock at an initial
rate of 5,000 shares of Common Stock per share of Series D Preferred
Stock. The holders of the Series D Preferred Stock are entitled to
vote, on an “as-converted basis,” together with the holders of the Common Stock
and holders of any other series of Preferred Stock or other class of the
Company’s capital stock which are granted such voting rights as a single class
on all matters, except as otherwise provided by law. In the event of
any liquidation, dissolution or winding up of the affairs of the Company, either
voluntarily or involuntarily, the holders of the Series D Preferred Stock will
be entitled to a liquidation preference of $1,500 per share of Series D
Preferred Stock prior to any distribution to the holders of the Common
Stock. The Series D Preferred Stock ranks (1) pari passu in respect of the
preferences as to dividends, distributions and payments upon the liquidation,
dissolution or winding up of the Company to all shares of Series C Preferred
Stock, par value $1.00 per share, of the Company and (2) senior in respect of
the preferences as to dividends, distributions and payments upon the
liquidation, dissolution or winding up of the Company to all shares of Common
Stock. The Series D Preferred Stock is not redeemable.
The
Series D Preferred Stock was issued in each of the above transactions at $1,500
per share, which is equivalent to $0.30 per share of Common Stock on an
“as-converted” basis. The closing price of the Common Stock on the
over-the-counter bulletin board was $0.36, $0.38 and $0.43, respectively, on
each of December 1, 2008, December 2, 2008 and January 28, 2009, resulting in
beneficial conversion features of $300, $400 and $650, respectively, per share
of Series D Preferred Stock on the respective issue dates. In
accordance with the guidance in FASB Emerging Issues Task Force Issue
Nos. 98-5, “Accounting
for Convertible Securities with Beneficial Conversion Features or Contingently
Adjustable Conversion Ratio,” and 00-27, “Application of Issue No. 98-5 to
Certain Convertible Instruments,” the $1.1 million aggregate beneficial
conversion feature of the Series D Preferred Stock on the issue dates was deemed
a discount on the issuance of the shares and was recorded as an increase to
additional paid in capital in the balance sheet. Because the Series D
Preferred Stock was immediately convertible to Common Stock, the $1.1 million
aggregate intrinsic value is deemed a dividend paid to the investors on each
closing date. The dividend has been recorded as an increase in loss
attributable to common shareholders and, in the absence of retained earnings, as
a reduction of additional paid in capital.
7.
|
BASIC
AND DILUTED LOSS PER SHARE
|
Basic net
loss per common share is computed by dividing net loss attributable to common
shares by the weighted average number of common shares outstanding during the
period. Diluted net loss per common share is computed giving effect
to all dilutive potential common shares that were outstanding during the
period. Diluted potential common shares consist of incremental shares
issuable upon exercise of stock options and warrants and conversion of preferred
stock. In computing diluted net loss per share for the six months
ended January 31, 2009 and 2008, no dilution adjustment has been made to the
weighted average outstanding common shares because the assumed exercise of
outstanding options and warrants and the conversion of preferred stock would be
anti-dilutive.
12
NON-INVASIVE
MONITORING SYSTEMS, INC.
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
January
31, 2009
Potential common shares not included in calculating diluted net loss
per share are as follows:
January 31, 2009
|
January 31, 2008
|
|||||||
Stock
options
|
2,071,831 | 3,463,330 | ||||||
Stock
warrants
|
325,000 | 325,000 | ||||||
Series
C Preferred Stock
|
1,551,200 | 1,551,200 | ||||||
Series
D Preferred Stock
|
14,455,000 | – | ||||||
Total
|
18,403,031 | 5,339,530 |
8.
|
RELATED
PARTY TRANSACTIONS
|
Dr.
Marvin A. Sackner, the Company’s CEO and director, formerly leased office space
to the Company on a month to month basis in North Bay Village, Florida under an
arrangement with the Company which was discontinued effective October 31,
2007. The Company reimbursed Dr. Sackner for the cost of the space
monthly. The amount reimbursed to Dr. Sackner by the Company for the
six months ended January 31, 2008 was $5,000.
The
Company signed a five year lease for office space in Miami, Florida with a
company owned by one of the Company’s major shareholders. The rental
payments under the Miami office lease, which commenced January 1, 2008, are
approximately $4,000 per month for the first year and escalate 4.5% annually
over the life of the lease. In the three and six months ended January
31, 2009, the Company recorded $13,000 and $22,000, respectively, of rent
expense on a straight-line basis related to the Miami lease.
Adam
Jackson, the Company’s Chief Financial Officer, also serves as the Chief
Financial Officer and supervises the accounting staffs of SafeStitch Medical,
Inc. (“SafeStitch”), a publicly-traded, developmental-stage medical device
manufacturer, and Aero Pharmaceuticals, Inc. (“Aero”), a privately held
pharmaceutical distributor. The Company’s Chairman, Dr. Jane Hsiao,
also serves as Chairman of SafeStitch and President of Aero. Director
Steven Rubin also serves as a director of SafeStitch and Secretary of Aero, and
director Rao Uppaluri also serves as Treasurer of Aero. The total
salaries of the accounting staffs of NIMS, SafeStitch and Aero have been shared
under a board-approved cost sharing arrangement since March 2008. The
Company has recorded General and Administrative expense for the three and six
months ended January 31, 2009 totaling $10,000 and $22,000, respectively, to
account for the sharing of costs under this arrangement. The Company
had no accounts payable to SafeStitch or Aero outstanding at January 31,
2009.
Dr. Hsiao
is a director of Great Eastern Bank of Florida, a bank where the Company
maintains a bank account in the normal course of business. As of
January 31, 2009, the Company had approximately $1.8 million on deposit with
Great Eastern Bank of Florida, including approximately $1.8 million secured by
repurchase contracts for US Government securities.
9.
|
COMMITMENTS
|
Leases.
The
Company leased office space in Sarasota, Florida at a rate of approximately
$3,000 per month under a lease which expired in November 2008. The
Company signed a five year lease for office space in Miami, Florida commencing
January 1, 2008. The rental payments under the Miami office lease are
approximately $4,000 per month for the first year and escalate 4.5% annually
over the life of the lease.
Product
Development and Supply Agreement.
On
September 4, 2007, the Company executed a Product Development and Supply
Agreement (the “Agreement”) with Sing Lin Technologies Co. Ltd., a company based
in Taichung, Taiwan ("Sing Lin"). Pursuant to the Agreement, the
Company consigned to Sing Lin the development and design of the next generation
Exer-Rest®,
Somno-Ease™ and Exer-Rest® Plus
devices. Sing Lin will also manufacture all of the Company’s
acceleration therapeutic platforms. The Agreement commenced as of
September 3, 2007 and has a term that extends three years from the acceptance of
the first run of production units by NIMS. Thereafter, the Agreement
automatically renews for successive one year terms unless either party sends the
other a notice of non-renewal.
Pursuant
to the Agreement, Sing Lin designed, developed and manufactured the tooling
required to manufacture the acceleration therapeutic platforms for a total cost
to the Company of $471,000. Sing Lin will utilize the tooling in the
performance of its production obligations under the Agreement. The
Company paid Sing Lin $150,000 of the tooling cost upon execution of the
Agreement and $150,000 upon the Company’s approval of the product prototype
concepts and designs. The balance of the final tooling cost became
due and payable in September 2008 upon acceptance of the first units produced
using the tooling, and was paid in full during the six months ended January 31,
2009 These amounts have been recorded as tooling costs, and are
included in tooling and equipment, net.
13
NON-INVASIVE
MONITORING SYSTEMS, INC.
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
January
31, 2009
Under the
Agreement, the Company also grants Sing Lin the exclusive distribution rights
for the products in certain countries in the Far East, including Taiwan, China,
Japan, South Korea, Malaysia, Indonesia and certain other
countries. Sing Lin has agreed not to sell the Products outside its
geographic areas in the Far East.
The
Company has committed to purchase approximately $2.2 million of Exer-Rest® and
Somno-Ease™ units within one year of the September 2008 acceptance of the final
product. Additionally, the Company has agreed to purchase $3.5
million and $7.5 million of Exer-Rest®,
Exer-Rest® Plus and
Somno-Ease™ products in the second and third years following such acceptance,
respectively. These purchase commitment amounts are based upon
estimated product costs at the time the Agreement was executed, and may change
subject to the Company’s prior approval. Through January 31, 2009,
the Company had paid Sing Lin $672,000 in connection with orders placed through
that date. Of this amount, $417,000 is included in advances to
contract manufacturer in the accompanying unaudited condensed financial
statements. As of January 31, 2009, aggregate future purchase
commitments under the Agreement totaled approximately $12.5
million.
10.
|
LONG-LIVED
ASSETS
|
The
Company’s long-lived assets include furniture and equipment, tooling, patents
and trademarks and long-term investments.
Tooling
and equipment, net of accumulated depreciation, consists of the following at
January 31, 2009 (in thousands):
Tooling
and equipment
|
$ | 471 | ||
Furniture
and fixtures, office equipment and computers
|
52 | |||
523 | ||||
Less
accumulated depreciation
|
(75 | ) | ||
Tooling
and equipment, net
|
$ | 447 |
Depreciation
expense was $52,000 and $5,000 during the six months ended January 31, 2009 and
2008, respectively. Depreciation on the tooling commenced in August
2008 based upon an estimated useful life of five years. Four
Exer-Rest® AT
demonstration units are included in furniture and fixtures at an aggregate cost
of $19,000. These units were placed in service in fiscal 2008, and
are being depreciated based upon a five-year estimated useful life.
Patents
and trademarks have been fully amortized as of October 31, 2007. The
Company’s long-term investments consist of 940,000 shares (approximately a 2%
interest) of LifeShirt.com, Inc. (now VivoMetrics, Inc.), a privately-held
company. These shares were obtained as consideration for the
Company’s assignment of all of its rights, title and interest in certain patents
and intellectual property as well as a non-exclusive, worldwide license under
all of the Company’s patents and intellectual property for use in connection
with certain products to VivoMetrics. The shares are carried at zero
value in the accompanying financial statements. The Company was
informed that, in July 2008, VivoMetrics entered into a series of debt and
equity transactions with its largest creditor to effect a recapitalization which
diluted the Company’s holdings to the point where NIMS’ investment became
worthless.
11.
|
RECENT
ACCOUNTING PRONOUNCEMENTS
|
Effective
August 1, 2008, the Company adopted SFAS 157, which defines fair value,
establishes a framework for measuring fair value and requires additional
disclosures about fair value measurements. In February 2008, the
Financial Accounting Standards Board (“FASB”) delayed the effective date of SFAS
157 for one year for all nonfinancial assets and nonfinancial liabilities,
except for those items that are recognized or disclosed at fair value in the
financial statements on a recurring basis. On October 10, 2008, the
FASB issued FSP FAS 157-3, “Determining the Fair Value of a
Financial Asset in a Market That Is Not Active.” The FSP was
effective upon issuance, including periods for which financial statements have
not been issued. The FSP clarified the application of SFAS 157 in an
inactive market and provided an illustrative example to demonstrate how the fair
value of a financial asset is determined when the market for that financial
asset is inactive. Management has determined that the adoption of
SFAS 157 and the FSP did not have a material impact on the Company’s financial
position and results of operations.
14
NON-INVASIVE
MONITORING SYSTEMS, INC.
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
January
31, 2009
Effective
August 1, 2008, the Company adopted SFAS No. 159, “The Fair Value Option for Financial
Assets and Financial Liabilities- including an amendment of FASB Statement
115” (“SFAS 159”). This statement provides companies with an
option to report selected financial assets and liabilities at fair
value. As of January 31, 2009, the Company has not elected to use the
fair value option allowed by SFAS 159. Management has determined that
the adoption of SFAS 159 did not have a material effect on the Company’s
financial position and results of operations.
In
December 2007, the FASB issued Statement of Financial Accounting Standards No.
141 (revised 2007), “Business
Combinations” (“SFAS No.141R”). SFAS No. 141R will replace
SFAS 141, and establishes principles and requirements for how the acquirer in a
business combination reorganizes and measures in its financial statements the
identifiable assets acquired, the liabilities assumed and any noncontrolling
interest in the acquiree; recognizes and measures the goodwill acquired in the
business combination or gain from a bargain purchase; and determines what
information to disclose to enable users of the financial statements to evaluate
the nature and financial effects of the business combination. SFAS
No. 141R applies prospectively to business combinations for which the
acquisition date is on or after the beginning of the first annual reporting
period beginning on or after December 15, 2008. Currently, the
Company does not anticipate that this Statement will have a significant impact
on its financial statements, however the Company will be required to expense
costs related to any acquisitions consummated after July 31, 2009.
In
December 2007, the FASB issued Statement of Financial Accounting Standards No.
160, “Non-Controlling
Interests in Consolidated Financial Statements – an amendment of ARB No.
51” (“SFAS No. 160”). This statement requires that
noncontrolling or minority interests in subsidiaries be presented in the
consolidated statement of financial position within equity, but separate from
the parents’ equity, and that the amount of the consolidated net income
attributable to the parent and to the noncontrolling interest be clearly
identified and presented on the face of the consolidated statement of
income. SFAS No. 160 will be effective for the Company’s fiscal year
beginning August 1, 2009. Currently, the Company does not anticipate
that this statement will have a significant impact on its financial
statements.
In
June 2007, the FASB ratified Emerging Issues Task Force Issue
No. 07-3, “Accounting for
Nonrefundable Advance Payments for Goods or Services to Be Used in Future
Research and Development Activities” (“EITF 07-3”). EITF 07-3
requires non-refundable advance payments for goods and services to be used in
future research and development activities to be recorded as an asset and the
payments to be expensed when the research and development activities are
performed. EITF 07-3 became effective for the Company’s fiscal year
beginning August 1, 2008. Management has determined that the
application of this standard has not had a significant impact on its financial
statements.
In
December 2007, the FASB ratified the consensus reached on Emerging Issues Task
Force Issue No. 07-1, “Accounting for Collaborative
Arrangements Related to the Development and Commercialization of Intellectual
Property” (“EITF 07-1”). EITF 07-1 defines collaborative
arrangements and establishes reporting requirements for transactions between
participants in a collaborative arrangement and between participants in the
arrangement and third parties. EITF 07-1 will be effective for the
Company’s fiscal year beginning August 1, 2009. The Company is currently
evaluating the potential impact of this standard on the financial
statements.
In May
2008, the FASB issued SFAS No. 162, “The Hierarchy of Generally Accepted
Accounting Principles” (“SFAS 162”). SFAS 162 identifies the
sources of accounting principles and the framework for selecting the principles
used in the preparation of financial statements that are presented in conformity
with GAAP. SFAS 162 will become effective 60 days following the SEC’s
approval of the Public Company Accounting Oversight Board amendments to AU
Section 411, “The Meaning of
Present Fairly in Conformity With Generally Accepted Accounting
Principles.” The Company does not expect the adoption of SFAS
162 to have a material impact on its consolidated financial
statements.
In April
2008, the FASB issued EITF 07-05, “Determining whether an Instrument
(or Embedded Feature) Is Indexed to an Entity’s Own Stock” ("EITF
07-05"). EITF 07-05 provides guidance on determining what types of
instruments or embedded features in an instrument held by a reporting entity can
be considered indexed to its own stock for the purpose of evaluating the first
criteria of the scope exception in paragraph 11(a) of SFAS 133. EITF 07-05 will
be effective for the Company’s fiscal year beginning August 1, 2009 and early
application is not permitted. The Company is currently evaluating the potential
impact of EITF 07-05 on its consolidated financial statements.
15
NON-INVASIVE
MONITORING SYSTEMS, INC.
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
January
31, 2009
12.
|
SUBSEQUENT
EVENTS
|
On
February 23, 2009, the Company issued an aggregate of 265,000 options to
purchase the Company’s common stock under the 2000 Plan, each at an exercise
price of $0.32 per share. The options were granted to directors,
officers, employees and consultants.
The
Company signed a three year lease for retail space in Toronto, Canada to create
a product demonstration center, commencing March 1, 2009. Rental
payments under the Toronto demonstration center lease are approximately $1,200
per month.
In
February 2009, the Company began storing its finished goods inventory in a
Hialeah, Florida warehouse owned by a company jointly controlled by the
Company’s Chairman and a beneficial owner of more than 10% of the Company’s
Common Stock. The Company anticipates executing a lease for between
3,000 and 4,000 square feet of space in the Hialeah warehouse before the end of
March 2009 at a rate substantially equivalent to market lease rates for
comparable properties in the Hialeah area.
16
NON-INVASIVE
MONITORING SYSTEMS, INC
ITEM
2.
|
MANAGEMENT'S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS.
|
Cautionary
Statement Regarding Forward-looking Statements.
This
Interim Report on Form 10-Q contains, in addition to historical information,
certain forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995 (“PLSRA”), Section 27A of the Securities Act of
1933, as amended (the “Securities Act”), and section 21E of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”) regarding Non-Invasive
Monitoring Systems, Inc. (the “Company” or “NIMS,” also referred to as “us”,
“we” or “our”). These forward-looking statements represent our
expectations or beliefs concerning the Company’s operations, performance,
financial condition, business strategies, and other information and that involve
substantial risks and uncertainties. For this purpose, any statements
contained in this Report that are not statements of historical fact may be
deemed to be forward-looking statements. Without limiting the
generality of the foregoing, words such as “may,” “will,” “expect,” “believe,”
“anticipate,” “intend,” “could,” “estimate,” or “continue” or the negative or
other variations thereof or comparable terminology are intended to identify
forward-looking statements. The Company’s actual results of
operations, some of which are beyond the Company’s control, could differ
materially from the activities and results implied by the forward-looking
statements. Factors that could cause or contribute to such
differences include, but are not limited to the Company’s: history of
operating losses and accumulated deficit; need for additional financing;
dependence on future sales of the Exer-Rest® and
Somno-Ease™ motion
platforms; competition; dependence on management; risks related to proprietary
rights; government regulation; other factors described herein as well as the
factors contained in the “Risk Factors” section of Item 1 of our Annual Report
on Form 10-KSB for the year ended July 31, 2008. We do not undertake
any obligation to update forward-looking statements, except as required by
applicable law. We intend that all forward-looking statements be
subject to the safe harbor provisions of the PSLRA. These
forward-looking statements are only predictions and reflect our views as of the
date they are made with respect to future events and financial
performance.
Overview
We are
primarily engaged in the development, manufacture and marketing of non-invasive,
whole body periodic acceleration (“WBPA”) therapeutic platforms, which are
motorized platforms that move a subject repetitively from head to
foot. Our acceleration therapeutic platforms are the inventions of
Marvin A. Sackner, M.D., our founder, Chief Executive Officer and a
director. Dr. Sackner holds 32 United States patents and is a past
President of the American Thoracic Society, past Chairman of the Pulmonary
Disease Subspecialty Board and a past Member of the American Board of Internal
Medicine. Twenty-six peer reviewed scientific publications attest to
the benefits of whole body periodic acceleration in animal and human research
investigations. The application of this technology causes release of
beneficial substances such as nitric oxide from the inner lining of blood
vessels to the same extent as moderate to strenuous exercise. These
findings are not being claimed as an intended use of the device for marketing
purposes, but demonstrate a potential mechanism for its
benefits.
Prior to
2002, our primary business was the development of computer assisted,
non-invasive diagnostic monitoring devices and related software designed to
detect abnormal respiratory, cardiac, and other medical conditions from sensors
placed externally on the body’s surface. We assigned our patents for
these ambulatory monitoring devices to the SensorMedics division of ViaSys
Healthcare Inc. (which is now a unit of Cardinal Health, Inc. (“SensorMedics”)),
for cash and royalties on sales. We also assigned the patents to
VivoMetrics, Inc. (“VivoMetrics”), then a related party, for an equity ownership
interest in VivoMetrics (now carried at zero value for financial reporting
purposes) and royalties on sales and leasing of VivoMetrics’ LifeShirt®
systems. In April 2002, VivoMetrics received FDA clearance to market
the LifeShirt®
system. We continue to receive royalties from both SensorMedics and
VivoMetrics, however there can be no assurance as to the amount of royalty
revenue that will be derived from these patent assignments.
In 2002,
we began restructuring our operations and business strategy to focus on the
research, development, manufacturing, marketing, and sales of non-invasive,
motorized, WBPA platforms. These acceleration therapeutic
platforms are intended for use in the home, wellness centers and clinics as an
aid to improve circulation and joint mobility, relieve minor aches and pains,
relieve troubled sleep and as a mechanical feedback device for slow rhythmic
breathing exercise for stress management. These platforms are
targeted for use by individuals who have physical limitations and are incapable
of exercising or using traditional exercise equipment. The platforms
are also targeted to healthy individuals who are unwilling to exercise or wish
to implement WBPA therapy in conjunction with a regular exercise
routine. The Company’s first such platform, the AT-101, was initially
registered with the United States Food and Drug Administration (the “FDA”)
as a Class 1 (exempt) powered exercise device and was sold to physicians and
their patients. In January 2005, the FDA disagreed with our device
classification, and requested that we cease commercial sales and marketing
efforts for the AT-101 until we received a Class 1Therapeutic Vibrator approval
from the FDA. Accordingly, we ceased sales and marketing efforts in
the U.S. for this platform pending FDA approval.
17
NON-INVASIVE
MONITORING SYSTEMS, INC
In
January 2005 we began development of a less costly and more efficient
second generation version of the AT-101, the Exer-Rest® (now
designated the Exer-Rest®
AT). The Company entered into a Product and Development and Supply
Agreement with Sing Lin Technology Co., Ltd. (“Sing Lin”) of Taichung, Taiwan on
September 4, 2007. Under this agreement, Sing Lin will manufacture
new third generation versions of our patented Exer-Rest®
motorized platforms (designated the Exer-Rest® SL and
the Exer-Rest®
TL). In January 2008, we received ISO 13485 certification for Canada,
the United Kingdom and Europe from SGS United Kingdom Ltd., the world’s leading
verification and certification body. ISO 13485 certification is
recognized and accepted worldwide as a sign of design and manufacturing quality
for medical devices. In addition to our ISO certification, NIMS’
Exer-Rest® AT
acceleration therapeutic platform (Class IIa) was awarded CE0120 certification,
which requires several safety related conformity tests including clinical
assessment for safety and effectiveness. The CE0120 marking is often
referred to as a “passport” that allows manufacturers from anywhere in the world
to sell their goods throughout the European market as well as in many other
countries.
We have
determined that it is in the best interest of NIMS and its shareholders to focus
the Company’s time and resources on developing and marketing the Exer-Rest® line of
acceleration therapeutic platforms. These devices will be marketed
and sold by NIMS in the US, Canada, the UK, Europe, India and Latin America, and
by Sing Lin in certain Far East markets. In January 2009, NIMS
received FDA approval to market the Exer-Rest® in the
United States as a Class I Exempt medical device, and we commenced sales and
deliveries of Exer-Rest® units in
the US in February 2009.
The
development of the Exer-Rest® has
necessitated additional expenditures and commitments of capital, and we
anticipate experiencing losses through the end of the 2009 fiscal year as we
commence sales in the US, Canada, the UK, Europe, India and Latin
America. We raised approximately $2.8 million in the six months
ended January 31, 2009 to produce inventory and initiate sales and marketing
efforts in Canada and the US. If we are unsuccessful in achieving
significant revenues from these efforts, we will likely need to raise additional
capital to fulfill our business plan, but no commitment to raise such
additional capital exists or can be assured. If we are unsuccessful
in our efforts to raise such additional capital, if required, we may not be able
to continue operations.
Products
Exer-Rest® Therapeutic
Vibrators. The Exer-Rest® AT
therapeutic vibrator is based upon the design and concept of our original AT-101
therapeutic vibrator, but has the dimensions and appearance of a commercial
extra long twin bed, is more efficient, less costly and priced
lower. QTM Incorporated (“QTM”), an FDA registered manufacturer
(Oldsmar, FL) manufactured the device, which was built in accordance with ISO
and FDA Good Manufacturing Practices. Sales of the Exer-Rest ® AT began
overseas in October 2007. The Exer-Rest® SL and
Exer-Rest® TL,
which are being manufactured by Sing Lin, further advance the acceleration
therapeutic platform technology. The SL and TL models combine
improved drive technology for quieter operation, a more comfortable
“memory-foam” mattress, more convenient operation with a multi-function wireless
remote and a more streamlined look to improve the WBPA
experience. Overseas deliveries of Exer-Rest® SL and
Exer-Rest® TL
platforms began in October 2008, and US deliveries of these models began in
February 2009. The Somno-Ease™, a
variation of the Exer-Rest®
currently in development, is designed to aid patients with sleep disorders as
well as provide feedback for slow rhythmic breathing exercises for the relief of
stress associated with daily living. The Somno-Ease™ will have a
similar appearance to the Exer-Rest® SL and
TL models, but produces slower motion over a greater travel distance than
Exer-Rest® and is
based upon the notion of “rocking” the adult to sleep analogous to rocking a
baby to sleep. The Exer-Rest® Plus,
which is also in development, will combine the features of both the
Exer-Rest® and
Somno-Ease™.
LifeShirt®. The
LifeShirt® is a
patented Wearable Physiological Computer that incorporates transducers,
electrodes and sensors into a low turtle neck sleeveless
garment. These transducers are connected to a miniaturized, battery
powered, electronic module for collection of respiratory and cardiac
data. In addition, the monitored patient can enter symptoms with
intensity, mood, and medication information for integration with the physiologic
information collected with the LifeShirt®
garment. Data can be mailed to VivoMetrics, Inc.’s Data Collection
Center for quality control, generation of reports, and database
storage. Vital and physiological signs can be obtained
non-invasively, continuously, cheaply, and reliably with the comfortably worn
LifeShirt® garment
system while at rest, during exercise, at work, and during sleep. We
licensed the patent rights for the LifeShirt® to
VivoMetrics in 1999, then assigned the patent rights to them in 2000 and
currently collect royalties from VivoMetrics.
Recent Accounting
Pronouncements
Effective
August 1, 2008, we adopted SFAS 157, which defines fair value, establishes a
framework for measuring fair value and requires additional disclosures about
fair value measurements. In February 2008, the Financial Accounting
Standards Board (“FASB”) delayed the effective date of SFAS 157 for one year for
all nonfinancial assets and nonfinancial liabilities, except for those items
that are recognized or disclosed at fair value in the financial statements on a
recurring basis. On October 10, 2008, the FASB issued FSP FAS 157-3,
“Determining the Fair Value of
a Financial Asset in a Market That Is Not Active.” The FSP was
effective upon issuance, including periods for which financial statements have
not been issued. The FSP clarified the application of SFAS 157 in an
inactive market and provided an illustrative example to demonstrate how the fair
value of a financial asset is determined when the market for that financial
asset is inactive. We have determined that the adoption of SFAS 157
and the FSP did not have a material impact on our financial position and results
of operations.
18
NON-INVASIVE
MONITORING SYSTEMS, INC
Effective
August 1, 2008, we adopted SFAS No. 159, “The Fair Value Option for Financial
Assets and Financial Liabilities- including an amendment of FASB Statement
115” (“SFAS 159”). This statement provides companies with an
option to report selected financial assets and liabilities at fair
value. As of January 31, 2009, we have not elected to use the fair
value option allowed by SFAS 159. We have determined that the
adoption of SFAS 159 did not have a material effect on our financial position
and results of operations.
In
December 2007, the FASB issued Statement of Financial Accounting Standards No.
141 (revised 2007), “Business
Combinations” (“SFAS No.141R”). SFAS No. 141R will replace
SFAS 141, and establishes principles and requirements for how the acquirer in a
business combination reorganizes and measures in its financial statements the
identifiable assets acquired, the liabilities assumed and any noncontrolling
interest in the acquiree; recognizes and measures the goodwill acquired in the
business combination or gain from a bargain purchase; and determines what
information to disclose to enable users of the financial statements to evaluate
the nature and financial effects of the business combination. SFAS
No. 141R applies prospectively to business combinations for which the
acquisition date is on or after the beginning of the first annual reporting
period beginning on or after December 15, 2008. Currently, we do not
anticipate that this Statement will have a significant impact on our financial
statements, however we will be required to expense costs related to any
acquisitions consummated after July 31, 2009.
In
December 2007, the FASB issued Statement of Financial Accounting Standards No.
160, “Non-Controlling
Interests in Consolidated Financial Statements – an amendment of ARB No.
51” (“SFAS No. 160”). This statement requires that
noncontrolling or minority interests in subsidiaries be presented in the
consolidated statement of financial position within equity, but separate from
the parents’ equity, and that the amount of the consolidated net income
attributable to the parent and to the noncontrolling interest be clearly
identified and presented on the face of the consolidated statement of
income. SFAS No. 160 will be effective for our fiscal year beginning
August 1, 2009. Currently, we do not anticipate that this Statement
will have a significant impact on our financial statements.
In
June 2007, the FASB ratified Emerging Issues Task Force Issue
No. 07-3, “Accounting for
Nonrefundable Advance Payments for Goods or Services to Be Used in Future
Research and Development Activities” (“EITF 07-3”). EITF 07-3
requires non-refundable advance payments for goods and services to be used in
future research and development activities to be recorded as an asset and the
payments to be expensed when the research and development activities are
performed. EITF 07-3 became effective for our fiscal year beginning
August 1, 2008. We have determined that the application of this
standard has not had a significant impact on our financial
statements.
In
December 2007, the FASB ratified the consensus reached on Emerging Issues Task
Force Issue No. 07-1, “Accounting for Collaborative
Arrangements Related to the Development and Commercialization of Intellectual
Property” (“EITF 07-1”). EITF 07-1 defines collaborative
arrangements and establishes reporting requirements for transactions between
participants in a collaborative arrangement and between participants in the
arrangement and third parties. EITF 07-1 will be effective for our fiscal
year beginning August 1, 2009. We are currently evaluating the potential
impact of this standard on our financial statements.
In May
2008, the FASB issued SFAS No. 162, “The Hierarchy of Generally Accepted
Accounting Principles” (“SFAS 162”). SFAS 162 identifies the
sources of accounting principles and the framework for selecting the principles
used in the preparation of financial statements that are presented in conformity
with GAAP. SFAS 162 will become effective 60 days following the SEC’s
approval of the Public Company Accounting Oversight Board amendments to AU
Section 411, “The Meaning of
Present Fairly in Conformity With Generally Accepted Accounting
Principles.” We do not expect the adoption of SFAS 162 to have
a material impact on our consolidated financial statements.
In April
2008, the FASB issued EITF 07-05, “Determining whether an Instrument
(or Embedded Feature) Is Indexed to an Entity’s Own Stock” ("EITF
07-05"). EITF 07-05 provides guidance on determining what types of
instruments or embedded features in an instrument held by a reporting entity can
be considered indexed to its own stock for the purpose of evaluating the first
criteria of the scope exception in paragraph 11(a) of SFAS 133. EITF 07-05 will
be effective for our fiscal year beginning August 1, 2009 and early application
is not permitted. We are currently evaluating the potential impact of EITF 07-05
on our consolidated financial statements.
19
NON-INVASIVE
MONITORING SYSTEMS, INC
Results of
Operations
In
January 2005, we began developing the Exer-Rest® line of
acceleration therapeutic platforms, which were designed to be more efficient and
less expensive than the original AT-101 platform. The Exer-Rest® AT
platform was first available for delivery to certain locations outside of the
United States in October 2007. Prior to the first export sales of the
Exer-Rest® AT, we
continued to sell the AT-101 in certain locations outside of the United
States. In anticipation of the launch of the Exer-Rest line, in July
2006 we wrote down as obsolete our existing inventory of AT-101 platforms and
parts to zero value. The newest Exer-Rest® SL and
TL platforms, which have been developed under our agreement with Sing Lin,
became available for sale overseas in the first quarter of our 2009 fiscal year
and in the U.S. in February 2009. We expect to increase our sales
activity throughout fiscal 2009 in North America with aggressive marketing,
promotional pricing and the establishment of demonstration centers, and in
international markets through the enlistment of local
distributors. As of January 31, 2009, we had entered into agreements
with distributors in the Middle East and India.
Three and Six Months ended
January 31, 2009 Compared to Three and Six Months Ended January 31,
2008
Revenue. Total
revenues increased from $68,000 for the three months ended January 31, 2008, to
$211,000 for the three months ended January 31, 2009. This $143,000
increase resulted from a $103,000 increase in product sales and a $40,000
increase in royalties. Total revenues increased from $155,000 for the
six months ended January 31, 2008 to $281,000 for the six months ended January
31, 2009, an increase of $126,000, primarily resulting from a $95,000 increase
in product sales and a $31,000 increase in royalties. Platform unit sales
for the three and six months ended January 31, 2009 increased 333% and 250%,
respectively, over the comparable periods in the prior year. This
increase in product sales was primarily attributable to the delivery of the
initial order of Exer-Rest™ SL
models to a new overseas distributor.
Combined
royalties from VivoMetrics and SensorMedics were $93,000 and $53,000 for the
three months ended January 31, 2009 and 2008 respectively, and $156,000 and
$125,000 for the six months ended January 31, 2009 and 2008,
respectively. Increases in royalty revenue resulted from higher
reported sales of licensed products in the three and six months ended January
31, 2009 as compared to the same periods in 2008.
Cost of Sales. Cost
of sales for the three and six months ended January 31, 2009 was $56,000 and
$61,000, respectively, as compared to $16,000 and $27,000, respectively, for the
three and six months ended January 31, 2008. As a percentage of
revenue, cost of sales was lower in the 2009 periods primarily due to a greater
mix of the less costly Exer-Rest™ SL and
TL units delivered. Additionally, the majority of units delivered in
the 2008 periods were sold at a substantial discount to our current
pricing.
Selling, general and administrative
expenses. Selling,
general and administrative (“SG&A”) expenses decreased to $439,000 for the
three months ended January 31, 2009 from $557,000 for the three months ended
January 31, 2008. The 2008 period included $126,000 of severance
costs related to the termination of our former Chief Executive
Officer. This savings was offset in part by increased wages,
professional fees and marketing and sales expenses in the 2009
period. SG&A expenses increased to $944,000 for the six months
ended January 31, 2009 from $920,000 for the six months ended January 31,
2008. This $24,000 increase was the result of increases in wages,
professional fees, trade show costs, travel, sales and marketing and office
expenses in 2009, offset in part by lower stock-based compensation and severance
expenses. Stock-based compensation expense, which is included in
SG&A expense, decreased from $100,000 and $232,000, respectively, for the
three and six months ended January 31, 2008 to $40,000 and $105,000,
respectively, for the three and six months ended January 31,
2009. The decrease in stock-based compensation was primarily due to a
decrease in the number of options granted during the six months ended January
31, 2009.
Research and development
costs. Research and development costs increased from $27,000
for the three months ended January 31, 2008 to $38,000 for the three months
ended January 31, 2009, an increase of $11,000. Research and
development costs increased from $76,000 for the six months ended January 31,
2008 to $91,000 for the six months ended January 31, 2009, an increase of
$15,000. The increases in the 2009 periods relate primarily to costs
incurred in pursuit of FDA approval to market the Exer-Rest® in the
US, which approval was granted in January 2009.
Total operating
expenses. Total operating expenses decreased $67,000 from
$600,000 for the three months ended January 31, 2008 to $533,000 for the three
months ended January 31, 2009. This decrease was due primarily to the
decrease in SG&A expense, offset in part by increased cost of
sales. Total operating expenses increased $73,000 from approximately
$1.0 million for the six months ended January 31, 2008 to approximately $1.1
million for the six months ended January 31, 2009. This increase was
primarily attributable to the increase in cost of sales related to higher sales
volume, as well as higher SG&A expense and increased research and
development expense related to our pursuit of FDA approval to market the
Exer-Rest®.
Interest income (expense),
net. Net interest expense was $3,000 and $8,000 for the three and six
months ended January 31, 2009 attributable to interest accruing on the Revolver
described below. Net interest income was $3,000 and $10,000 for the
three and six months ended January 31, 2008 from interest earned on cash
balances in interest bearing accounts.
20
NON-INVASIVE
MONITORING SYSTEMS, INC
Net loss. Net loss
decreased from $529,000 for the three months ended January 31, 2008 to $325,000
for the three months ended January 31, 2009, a decrease of $204,000. Net loss decreased from
$858,000 for the six months ended January 31, 2008 to $823,000 for the six
months ended January 31, 2009, a decrease of $35,000. These decreases
were primarily due to the increases in revenue described above.
Liquidity and Capital
Resources
Our
operations have been primarily financed through private sales of our equity
securities. At January 31, 2009, we had cash of approximately $1.9
million and working capital of approximately $2.6 million. We expect
these funds will be sufficient to expand our marketing efforts in the US and
Canada for the remainder of the 2009 fiscal year. If we are not able
to generate significant revenue with these expanded marketing efforts, we will
likely be required to obtain additional external financing to continue
operations beyond the end of the fiscal year. No assurance can be
given that such additional financing will be available on acceptable terms or at
all. Our ability to sell additional shares of our stock and/or borrow
cash could be materially adversely affected by the recent economic turmoil in
the Global equity and credit markets. Current economic conditions
have been, and continue to be, volatile and the volatility has reached
unprecedented levels in recent months. Continued instability in these market
conditions may limit our ability to access the capital necessary to fund and
grow our business and to replace, in a timely manner, maturing
liabilities.
Net
cash used in operating activities was $881,000 for the six months ended January
31, 2009, up from $710,000 for the six months ended January 31, 2008, an
increase of $171,000 primarily due to inventory purchases and increases in
royalties receivable.
Net cash
used in investing activities decreased to $171,000 for the six months ended
January 31, 2009 from $332,000 for the six months ended January 31,
2008. The $171,000 final payment for the purchase of tooling from
Sing Lin was made in the 2009 period, while the initial $300,000 deposit for the
tooling was made in the 2008 period.
Net cash
provided by financing activities increased to $2.8 million from $63,000 for the
six months ended January 31, 2009 and 2008 respectively. The increase
was principally due to the issuance of 1,891 shares of Series D Preferred Stock
in the December 2008 and January 2009 transactions described below.
In
January 2009, the Company accepted $2,000 for the exercise of 13,333 outstanding
options and issued an additional 8,239 shares of the Company’s Common Stock in
the cashless exercise of an additional 13,333 options.
Aggregate
collections of royalty payments from VivoMetrics and SensorMedics were $76,000
and $95,000 in the six months ended January 31, 2009 and 2008,
respectively. There can be no assurances that the Company will
continue to receive similar royalty payments.
At July
31, 2008, we had available net operating loss carryforwards of approximately
$10.6 million which expire in various years through 2028. The net
operating loss carryforwards may be subject to limitation due to change of
ownership provisions under Section 382 of the Internal Revenue Code and
similar state provisions.
Under the
Agreement with Sing Lin, we are committed to purchase approximately $2.2 million
of Exer-Rest® and
Somno-Ease™ units
within one year of acceptance of the final product and an additional $3.5
million and $7.5 million of products in the second and third years following
acceptance of the final product, respectively. Under the Agreement,
the Company must pay a portion of the product purchase price at the time
production orders are placed, with the balance due upon
delivery. Through January 31, 2009, we have paid Sing Lin $672,000 in
connection with orders placed through that date, and we will be required to make
additional payments totaling approximately $278,000 upon taking delivery of the
units currently in production. We began taking delivery of units from
Sing Lin in October 2008 and we expect such deliveries to continue periodically
throughout the 2009 fiscal year.
Series D Preferred Stock
Offerings
April 2008 Series D Preferred Stock
Offering. On April 7, 2008, we completed the sale of an
aggregate of 1,000 shares of a new series of our Preferred Stock, par value
$1.00 per share (the “Preferred Stock”), designated as Series D Convertible
Preferred Stock (the “Series D Preferred Stock”), to certain private investors
(collectively, the “Investors”) pursuant to a Stock Purchase Agreement entered
into on April 3, 2008 (the “Stock Purchase Agreement”). The Investors
include Marvin Sackner, a director and executive officer of the Company who also
holds more than 10% of the outstanding Common Stock; Steven Mrha, an executive
officer of the Company, and Frost Gamma Investments Trust (“Frost Gamma”), a
holder of more than 10% of the outstanding Common Stock (collectively, the
“Related Party Investors”). Dr. Jane Hsiao, who became a director and
Chairman in October 2008, is trustee of one of the Investors which is not one of
the Related Party Investors. The aggregate purchase price for the
Series D Preferred Stock was $1.5 million, of which $795,000 was paid by the
Related Party Investors. Each holder of a share of the Series D
Preferred Stock has the right, at any time, to convert such share of Series D
Preferred Stock into shares of the Company’s common stock at an initial rate of
5,000 shares of common stock per share of Series D Preferred
Stock. The Series D Preferred Stock was issued at $1,500 per share,
which is equivalent to $0.30 per share of Common Stock on an “as-converted”
basis. The April 7, 2008 closing price of the Common Stock on the
over-the-counter bulletin board was $0.53 per share, resulting in a $1,150
intrinsic value per share of Series D Preferred Stock on the issue
date. The $1.2 million aggregate intrinsic value of the Series D
Preferred Stock on the issue date was deemed a dividend paid to the Investors on
the closing date and as an increase in loss attributable to common shareholders
in the financial statements for the period then ended.
21
NON-INVASIVE
MONITORING SYSTEMS, INC
December 2008 Series D Preferred
Stock Offering. On December 2, 2008, we completed the sale of
an aggregate of 491 additional shares of our Series D Preferred Stock to certain
investors pursuant to stock purchase agreements entered between December 1, 2009
and December 2, 2008 (the sale of 286 shares closed on December 1, 2008 and the
sale of 205 shares closed on December 2, 2008). These investors
include Dr. Sackner, Frost Gamma, Hsu Gamma Investments, LP (“Hsu Gamma”), an
entity controlled by our Chairman, and a director (collectively, the “New
Related Party Investors”). The aggregate purchase price for the
Series D Preferred Stock was $736,500, of which $382,500 was paid by the New
Related Party Investors. Of the $382,500 paid by the New Related
Party Investors, $282,200 was paid from the proceeds of their respective
interests in the Revolver described below. (See Note 6 to the
accompanying financial statements.) The closing prices of
the Common Stock on the over-the-counter bulletin board on December 1 and 2,
2008 were $0.36 and $0.38 per share, respectively, resulting in a $168,000
aggregate intrinsic value on the issue dates. The $168,000 aggregate
intrinsic value of the Series D Preferred Stock on the issue dates was deemed a
dividend paid to the investors on the closing dates and as an increase in loss
attributable to common shareholders in the financial statements for the period
then ended.
January 2009 Series D Preferred
Stock Offering. On January 28, 2009, we completed the sale of
700 additional shares of our Series D Preferred Stock to each of Frost Gamma and
Hsu Gamma (1,400 total shares) for aggregate proceeds of $2.1
million. The January 28, 2009 closing price of the Common Stock on
the over-the-counter bulletin board was $0.43 per share, resulting in a $65,000
intrinsic value per share of Series D Preferred Stock on the issue
date. The $910,000 aggregate intrinsic value of the Series D
Preferred Stock on the issue date was deemed a dividend paid to the investors on
the closing date and as an increase in loss attributable to common shareholders
in the financial statements for the period then ended.
August 2008 Revolver
Loan. On August 28, 2008 we entered into a Note and Security
Agreement (the “Agreement”) with four persons (the “Lenders”), pursuant to which
the Lenders granted us a revolving credit line (the “Revolver”) in the aggregate
amount of $300,000, secured by all of the Company’s personal
property. The Lenders included Dr. Sackner, Frost Gamma and Hsu
Gamma. We were permitted to borrow and reborrow from time to time
under the Revolver until October 31, 2008 (the “Maturity Date”). The
interest rate payable by us on amounts outstanding under the Revolver was 11%
per annum, and increased to 16% after the Maturity Date or after an Event of
Default. We were required to repay all amounts owing under the
Revolver by the Maturity Date, and amounts outstanding were prepayable at any
time. On August 29, 2008 we drew down $300,000 under the
Revolver. The Revolver was amended, effective October 31, 2008, to
extend the Maturity Date until November 30, 2008. All principal and
interest outstanding under the Revolver as of November 30, 2008 was repaid with
proceeds from the sale of Series D Preferred Stock on December 1, 2008 as
described above. (See Notes 5 and 6 to the accompanying financial
statements.)
The
Company’s financial statements have been prepared and presented on a basis
assuming it will continue as a going concern. As reflected in the
accompanying financial statements the Company had net losses in the amount of
$325,000 and $529,000 for the three months ended January 31, 2009 and 2008
respectively, and $823,000 and $858,000 for the six months ended
January 31, 2009 and 2008 respectively. In addition, the Company has
an accumulated deficit of $18.9 million as of January 31, 2009, and has
substantial purchase commitments at January 31, 2009 (see Note 9 to the
accompanying financial statements). These matters raise substantial doubt
about the Company’s ability to continue as a going concern.
ITEM
3.
|
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK.
|
Not
required for smaller reporting companies as defined in Rule 12b-2 of the
Exchange Act.
ITEM
4T.
|
CONTROLS
AND PROCEDURES.
|
We
carried out an evaluation, under the supervision and with the participation of
our management, including our Chief Executive Officer and Chief Financial
Officer, of the effectiveness of our disclosure controls and procedures, as
defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934
(the “Exchange Act”) as of the end of the period covered by this
report. Based on that evaluation, our Chief Executive Officer and
Chief Financial Officer have concluded that our disclosure controls and
procedures as of January 31, 2009 were effective to ensure that information
required to be disclosed by us in reports that we file or submit under the
Exchange Act is recorded, processed, summarized and reported within the time
periods specified in the Securities and Exchange Commission’s rules and
forms.
There
were no material changes in our internal controls over financial reporting or in
other factors that could materially affect, or are reasonably likely to affect,
our internal controls over financial reporting during the quarter
ended January 31, 2009. Because of its inherent limitations,
internal control over financial reporting may not prevent or detect
misstatements. Also, projections of any evaluation of effectiveness
to future periods are subject to the risk that controls may become inadequate
because of changes in conditions, or that the degree of compliance with the
policies or procedures may deteriorate.
22
NON-INVASIVE
MONITORING SYSTEMS, INC
PART II. OTHER
INFORMATION
Item
1. Legal
Proceedings
None.
Item
1A. Risk
Factors
The current recessionary economic
environment and concurrent market instability may materially and adversely
affect our ability to obtain credit or secure funds through sales of our stock,
which may materially and adversely affect our ability to fund our
operations.
We have funded our operations to date
primarily through sales of our stock in private placements and through borrowing
cash under credit facilities available to us from stockholders and other
individuals. Our ability to sell additional shares of our stock
and/or borrow cash could be materially adversely affected by the recent economic
turmoil in the World’s equity and credit markets. There can therefore
be no assurance that we will be able to raise such funds on acceptable terms or
at all, which may materially adversely affect our ability to continue our
operations. Additionally, the current economic turmoil could also
reduce the demand for new and innovative medical devices, resulting in delayed
market acceptance of our products. Such delay could have a material
adverse impact on our expected cash flows, results of operations and financial
position.
Item
2. Unregistered Sales of Equity
Securities and Use of Proceeds
Issuance of
Common Stock. On January 13, 2009, the Company issued 8,239
shares of its common stock to an option holder upon the cashless exercise of
13,333 options. On January 19, 2009 the Company issued 13,333 shares
of its common stock upon exercise of options by a former director of the Company
at an exercise price of $ 0.15 per share for total consideration of $
2,000. The proceeds will be used for general working capital
purposes. The Company issued the above-described Common Stock in
reliance upon the exemption from registration provided by Section 4(2) of the
Securities Act of 1933, as amended and/or Regulation D promulgated under the
Securities Act of 1933. The securities described above were issued to
accredited investors. The exercised options restrict transfer of
Common Stock acquired upon exercise thereof unless an applicable exemption
exists under the securities laws, and a legend was placed on the stock
certificates representing the Common Stock issued upon exercise to the effect
that the shares were not registered and absent registration could only be
transferred with an appropriate exemption.
Issuance of
Preferred Stock. As reported in Forms 8-K filed December 4,
2008 and January 29, 2009, we issued an aggregate of 1,891 shares of Series D
Preferred Stock. The Series D Preferred Stock has no preference with
respect to dividends to our Common Stock, and is entitled to receive dividends
when, as and if declared by our Board of Directors, together with the holders of
the Common Stock, ratably on an “as-converted” basis. Each holder of
a share of Series D Preferred Stock shall have the right, at any time, to
convert such share of Series D Preferred Stock into shares of Common Stock at an
initial rate of 5,000 shares of Common Stock per share of Series D Preferred
Stock. The holders of the Series D Preferred Stock will be entitled to vote,
together with the holders of the Common Stock and holders of any other series of
Preferred Stock or other class of our capital stock which are granted such
voting rights as a single class on all matters, except as otherwise provided by
law. In the event of any liquidation, dissolution or winding up of
our affairs, either voluntarily or involuntarily, the holders of the Series D
Preferred Stock will be entitled to a liquidation preference of $1,500 per share
of Series D Preferred Stock prior to any distribution to the holders of the
Common Stock. The Series D Preferred Stock ranks (1) pari passu in respect of the
preferences as to dividends, distributions and payments upon the liquidation,
dissolution or winding up of the Company to all shares of our Series C Preferred
Stock, par value $1.00 per share, and (2) senior in respect of the preferences
as to dividends, distributions and payments upon the liquidation, dissolution or
winding up of the Company to all shares of Common Stock. The Series D
Preferred Stock is not redeemable.
Item
3. Defaults
upon Senior Securities
None.
Item
4. Submissions of Matters to a
Vote of Security Holders.
None.
Item
5. Other
Information
None.
23
NON-INVASIVE
MONITORING SYSTEMS, INC
Item
6.
|
Exhibits Index
|
|||
3.1
|
Articles
of Incorporation of the Company, as amended (Incorporated by reference
from Exhibit 3.1 to Form 8-K filed on April 8, 2008).
|
|||
3.2
|
Amendment
to Articles of Incorporation of the Company (with respect to Certificate
of Designation of Series D Preferred Stock) (Incorporated by reference
from Exhibit 3.1 to Form 8-K filed on December 4,
2008).
|
|||
10.1
|
First
Amendment to the Note and Security Agreement dated as of August 28, 2009
between the Registrant and the Lenders named therein (Incorporated by
reference from Exhibit 10.1 to Form 8-K filed November 5,
2008).
|
|||
10.2
|
Form
of Subscription Agreement (Incorporated by reference from Exhibit 10.1 to
Form 8-K filed on December 4, 2008).
|
|||
31.1
|
Certification
of Chief Executive Officer Pursuant to Rules 13a–14 and 15d-14 under the
Securities Exchange Act of 1934.
|
|||
31.2
|
Certification
of Chief Financial Officer Pursuant to Rules 13a–14 and 15d-14 under the
Securities Exchange Act of 1934.
|
|||
32.1
|
Certification
of Chief Executive Officer Pursuant to 18 U.S.C. 1350 as enacted Pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|||
32.2
|
Certification
of Chief Financial Officer Pursuant to 18 U.S.C. 1350 as enacted Pursuant
to Section 906 of the Sarbanes-Oxley Act of
2002.
|
24
SIGNATURES
In
accordance with the requirements of the Exchange Act the Registrant has duly
caused this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
Dated: March
16, 2009
|
By:
|
/s/ Dr. Marvin A. Sackner
|
|
Dr.
Marvin A. Sackner, Chief Executive
Officer
|
Dated: March
16, 2009
|
By:
|
/s/ Adam S. Jackson
|
|
Adam
S. Jackson, Chief Financial
Officer
|
25
EXHIBIT
INDEX
3.1
|
Articles
of Incorporation of the Company, as amended (Incorporated by reference
from Exhibit 3.1 to Form 8-K filed on April 8,
2008).
|
3.2
|
Amendment
to Articles of Incorporation of the Company (with respect to Certificate
of Designation of Series D Preferred Stock) (Incorporated by reference
from Exhibit 3.1 to Form 8-K filed on December 4,
2008).
|
10.1
|
First
Amendment to the Note and Security Agreement dated as of August 28, 2009
between the Registrant and the Lenders named therein (Incorporated by
reference from Exhibit 10.1 to Form 8-K filed November 5,
2008).
|
10.2
|
Form
of Subscription Agreement (Incorporated by reference from Exhibit 10.1 to
Form 8-K filed on December 4,
2008).
|
31.1
|
Certification
of Chief Executive Officer Pursuant to Rules 13a–14 and 15d-14 under the
Securities Exchange
Act of 1934.
|
31.2
|
Certification
of Chief Financial Officer Pursuant to Rules 13a–14 and 15d-14 under the
Securities Exchange
Act of 1934.
|
32.1
|
Certification
of Chief Executive Officer Pursuant to 18 U.S.C. 1350 as enacted Pursuant
to Section 906of
the Sarbanes-Oxley Act of 2002.
|
32.2
|
Certification
of Chief Financial Officer Pursuant to 18 U.S.C. 1350 as enacted Pursuant
to Section 906 of
the Sarbanes-Oxley Act of
2002.
|