NON INVASIVE MONITORING SYSTEMS INC /FL/ - Quarter Report: 2009 April (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 April
30,
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
180, Miami, Florida 33137
(Address
of principal executive offices) (Zip code)
Registrant’s
telephone number, including area code: (305) 861-0075
4400 Biscayne Boulevard,
Suite 680, Miami, Florida 33137
(Former
name or former address, if changed since last report)
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 ¨ Accelerated
filer ¨ Non-accelerated
filer ¨ Smaller reporting company
x
Indicate by check mark whether the
registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes ¨No x
68,060,637 shares of the Company’s
common stock, par value $0.01 per share, were outstanding as of June 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 April 30, 2009 (unaudited) and July 31,
2008
|
3
|
|
Condensed
Consolidated Comprehensive Statements of Operations for the Three and Nine
months ended April 30, 2009 and 2008 (unaudited)
|
4
|
|
Condensed Consolidated
Statement of Shareholders’ Equity for the Nine months ended April 30, 2009
(unaudited)
|
5
|
|
Condensed Consolidated
Statements of Cash Flows for the Nine months ended April 30, 2009 and 2008
(unaudited)
|
6
|
|
Notes
to unaudited condensed consolidated financial statements
|
7
|
|
ITEM
2.
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MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
18
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ITEM
3.
|
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
23
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ITEM
4T.
|
CONTROLS
AND PROCEDURES
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23
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PART
II. OTHER INFORMATION
|
||
ITEM
1.
|
LEGAL
PROCEEDINGS
|
24
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ITEM
1A.
|
RISK
FACTORS
|
24
|
ITEM
2.
|
UNREGISTERED
SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
|
24
|
ITEM
3.
|
DEFAULTS
UPON SENIOR SECURITIES
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24
|
ITEM
4.
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SUBMISSION
OF MATTERS TO A VOTE OF SECURITY HOLDERS
|
24
|
ITEM
5.
|
OTHER
INFORMATION
|
24
|
ITEM
6.
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EXHIBITS
|
24
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SIGNATURES
|
25
|
2
NON-INVASIVE
MONITORING SYSTEMS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands, except share and per share data)
April 30, 2009
|
July 31, 2008
|
|||||||
|
(Unaudited)
|
|||||||
ASSETS
|
||||||||
Current
assets
|
||||||||
Cash
|
$ | 1,337 | $ | 86 | ||||
Royalties
and other receivables
|
75 | 43 | ||||||
Inventories
|
748 | 173 | ||||||
Advances
to contract manufacturer
|
302 | 659 | ||||||
Prepaid
expenses, deposits, and other current assets
|
94 | 28 | ||||||
Total
current assets
|
2,556 | 989 | ||||||
Tooling
and equipment, net
|
476 | 470 | ||||||
Total
assets
|
$ | 3,032 | $ | 1, 459 | ||||
LIABILITIES
AND SHAREHOLDERS' EQUITY
|
||||||||
Current
liabilities
|
||||||||
Notes
payable – other
|
$ | 56 | $ | 19 | ||||
Accounts
payable and accrued expenses
|
303 | 474 | ||||||
Customer
deposits
|
9 | – | ||||||
Other
liabilities
|
– | 2 | ||||||
Total
current liabilities
|
368 | 495 | ||||||
Total
liabilities
|
$ | 368 | $ | 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
and 1,000 shares issued and outstanding, respectively; liquidation
preference $4,337
|
3 | 1 | ||||||
Common
Stock, par value $0.01 per share; 100,000,000 shares
authorized;
68,060,637
and 68,039,065 shares issued and outstanding, respectively
|
681 | 680 | ||||||
Additional
paid in capital
|
21,238 | 18,256 | ||||||
Accumulated
deficit
|
(19,326 | ) | (18,035 | ) | ||||
Accumulated
other comprehensive income
|
6 | – | ||||||
Total
shareholders' equity
|
2,664 | 964 | ||||||
Total
liabilities and shareholders' equity
|
$ | 3,032 | $ | 1,459 |
The
accompanying notes are an integral part of these unaudited condensed
consolidated financial statements.
3
NON-INVASIVE
MONITORING SYSTEMS, INC.
CONDENSED
CONSOLIDATED COMPREHENSIVE STATEMENTS OF OPERATIONS - Unaudited
(In
thousands, except per share amounts)
Three
months ended April 30,
|
Nine
months ended April 30,
|
|||||||||||||||
2009
|
2008
|
2009
|
2008
|
|||||||||||||
Revenues
|
||||||||||||||||
Product
sales, net
|
$ | 149 | $ | 12 | $ | 271 | $ | 41 | ||||||||
Royalties
|
20 | 26 | 177 | 150 | ||||||||||||
Research,
consulting and warranty
|
– | 1 | 2 | 3 | ||||||||||||
Total
revenues
|
169 | 39 | 450 | 194 | ||||||||||||
Operating
costs and expenses
|
||||||||||||||||
Cost
of sales
|
57 | 15 | 118 | 41 | ||||||||||||
Selling,
general and administrative
|
494 | 463 | 1,438 | 1,384 | ||||||||||||
Research
and development
|
77 | 49 | 168 | 125 | ||||||||||||
Total
operating costs and expenses
|
628 | 527 | 1,724 | 1,550 | ||||||||||||
Operating
loss
|
(459 | ) | (488 | ) | (1,274 | ) | (1,356 | ) | ||||||||
Interest
income (expense), net
|
– | – | (8 | ) | 10 | |||||||||||
Other
expense
|
(9 | ) | – | (9 | ) | – | ||||||||||
Net
loss
|
$ | (468 | ) | $ | (488 | ) | $ | (1,291 | ) | $ | (1,346 | ) | ||||
Other
comprehensive income
|
||||||||||||||||
Currency
translation adjustment
|
6 | – | 6 | – | ||||||||||||
Comprehensive
net loss
|
$ | (462 | ) | $ | (488 | ) | $ | (1,285 | ) | $ | (1,346 | ) | ||||
Loss
per common share:
|
||||||||||||||||
Net
loss
|
$ | (468 | ) | $ | (488 | ) | $ | (1,291 | ) | $ | (1,346 | ) | ||||
Deemed
dividend on Series D Preferred Stock
|
– | 1,150 | 1,078 | 1,150 | ||||||||||||
Net
loss attributable to common shareholders
|
$ | (468 | ) | $ | (1,638 | ) | $ | (2,369 | ) | $ | (2,496 | ) | ||||
Weighted
average number of common shares outstanding - Basic and
diluted
|
68,061 | 67,849 | 68,047 | 67,545 | ||||||||||||
Basic
and diluted loss per common share
|
$ | (0.01 | ) | $ | (0.02 | ) | $ | (0.03 | ) | $ | (0.04 | ) |
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 Nine months ended April 30, 2009
(In
thousands, except share data)
Preferred Stock
|
Additional
|
Accum-
|
Accumu-
lated Other
Compre-
|
|||||||||||||||||||||||||||||||||||||||||||||
Series B
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Series C
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Series D
|
Common Stock
|
Paid-in-
|
ulated
|
hensive
|
||||||||||||||||||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Deficit
|
Income
|
Total
|
|||||||||||||||||||||||||||||||||||||
Balance
at July 31, 2008
|
100 | $ | – | 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
|
– | – | – | – | – | – | – | – | 146 | – | – | 146 | ||||||||||||||||||||||||||||||||||||
Currency
translation adjustment
|
– | – | – | – | – | – | – | – | – | – | 6 | 6 | ||||||||||||||||||||||||||||||||||||
Net
loss
|
– | – | – | – | – | – | – | – | – | (1,291 | ) | – | (1,291 | ) | ||||||||||||||||||||||||||||||||||
Balance
at April 30, 2009
|
100 | $ | – | 62,048 | $ | 62 | 2,891 | $ | 3 | 68,060,637 | $ | 681 | $ | 21,238 | $ | (19,326 | ) | $ | 6 | $ | 2,664 |
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)
Nine
months ended April 30, 2009 and 2008
2009
|
2008
|
|||||||
Operating
activities
|
||||||||
Net
loss
|
$ | (1,291 | ) | $ | (1,346 | ) | ||
Adjustments
to reconcile net loss to net cash used in operating
activities
|
||||||||
Deferred
warranty income
|
(2 | ) | (3 | ) | ||||
Depreciation
and amortization
|
74 | 7 | ||||||
Stock
based compensation expense
|
146 | 274 | ||||||
Loss
on disposal of assets
|
9 | – | ||||||
Changes
in operating assets and liabilities
|
||||||||
Royalties
and other receivables
|
(32 | ) | 37 | |||||
Inventories
|
(579 | ) | (162 | ) | ||||
Advances
to contract manufacturer
|
357 | (270 | ) | |||||
Prepaid
expenses, deposits and other current assets
|
(66 | ) | (3 | ) | ||||
Accounts
payable and accrued expenses
|
(24 | ) | 60 | |||||
Customer
deposits
|
9 | - | ||||||
Net
cash used in operating activities
|
(1,399 | ) | (1,406 | ) | ||||
Investing
activities
|
||||||||
Fixed
asset purchases
|
(227 | ) | (321 | ) | ||||
Certificates
of deposits redeemed
|
– | 400 | ||||||
Net
cash (used in) provided by investing activities
|
(227 | ) | 79 | |||||
Financing
activities
|
||||||||
Net
proceeds from issuance of common stock and exercise of options and
warrants
|
2 | 86 | ||||||
Net
proceeds from issuance of Series D Preferred Stock
|
2,837 | 1,490 | ||||||
Proceeds
from issuance of notes payable
|
363 | - | ||||||
Repayments
of notes payable
|
(326 | ) | (500 | ) | ||||
Net
cash provided by financing activities
|
2,876 | 1,076 | ||||||
Effect
of exchange rate changes on cash
|
1 | - | ||||||
Net
increase (decrease) in cash
|
1,251 | (251 | ) | |||||
Cash,
beginning of period
|
86 | 1,156 | ||||||
Cash,
end of period
|
$ | 1,337 | $ | 905 | ||||
Supplemental disclosure
|
||||||||
Cash
paid for interest
|
$ | 8 | $ | 23 | ||||
Supplemental schedule of non-cash
activities
|
||||||||
Satisfaction
of liability for tooling development in progress
|
$ | 142 | $ | - | ||||
Transfer
of demonstration units from inventory to fixed assets
|
$ | 4 | $ | - |
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)
April 30,
2009
The
condensed consolidated balance sheet as of July 31, 2008 has been derived
from audited financial statements. 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 April 30,
2009, and results of operations and cash flows for the interim periods ended
April 30, 2009 and 2008. The results of operations for the three and
nine months ended April 30, 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. Certain reclassifications have been made to prior period
consolidated financial statements to be consistent with the current period’s
presentation.
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”) clearance 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 cleared intended uses as an aid to temporarily increase
local circulation, to provide temporary relief of minor aches and pains, and
local muscle relaxation. The clearance 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. In June 2009, the FDA authorized the
expansion of intended use claims for the Exer-Rest® to
include a claim of reducing morning stiffness. These authorizations
to market the Exer-Rest® in the
United States complement NIMS’ existing international clearance to market the
Exer-Rest® as a
class IIa medical device (CE120) in Canada, the United Kingdom, the European
Economic Area, India, the Middle East and certain other markets that recognize
FDA and/or CE certifications 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).
7
NON-INVASIVE
MONITORING SYSTEMS, INC.
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
April 30,
2009
NIMS, an
ISO 13485 certified company, began marketing operations in the United States in
2009 upon receiving the FDA clearance described above. The Company is
also permitted to sell Exer-Rest® in
Canada, the United Kingdom, the European Economic Area, India, the Middle East
and certain other markets that recognize FDA and/or CE certifications, and began
international marketing operations during 2008.
Sing Lin
also has 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 and other markets.
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
$1.3 million for each of the nine month periods ended April 30, 2009 and 2008,
and has experienced cash outflows from operating activities. The
Company also has an accumulated deficit of $19.3 million as of April 30, 2009,
and has substantial purchase commitments at April 30, 2009 (see Note 9).
These matters raise substantial doubt about the Company’s ability to continue as
a going concern.
Although
the Company has commenced sales of the Exer-Rest® in the
United States and has 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 the next 12
months. 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 April 30, 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.
Tooling
and Equipment. 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)
April 30,
2009
As of
July 31, 2008, the Company had net operating loss carryforwards of approximately
$10.6 million available to offset future taxable income for federal and state
income tax purposes. The net operating loss carryforwards expire in
various years through 2028 and 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 fiscal year ended July 31,
2008.
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 nine months ended April 30, 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 two years on all Exer-Rest® products
sold and are accrued based on management’s estimates and the history of warranty
costs incurred. There were no material warranty costs incurred during
the nine months ended April 30, 2009 and 2008, and management estimates that the
Company’s accrued warranty expense at April 30, 2009 will be sufficient to
offset claims made for units under warranty.
Stock-based
compensation. The Company follows SFAS No. 123R, “Share Based Payment,” which
requires all share-based payments, including grants of stock options, to be
recognized in the income statement as an operating expense, based on their fair
values. Stock-based compensation is included in general and
administrative expenses for all periods presented.
Fair Value of
Financial Instruments. Fair value estimates discussed herein
are based upon certain market assumptions and pertinent information available to
management as of April 30, 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 $6,000 of foreign currency
translation adjustments in the nine months ended April 30, 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.
9
NON-INVASIVE
MONITORING SYSTEMS, INC.
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
April 30,
2009
3.
|
INVENTORIES
|
The
Company’s inventory consisted of the following at April 30, 2009 and July 31,
2008 (in thousands):
April
30, 2009
|
July
31, 2008
|
|||||||
Work-in-progress,
including sub-assemblies
|
$ | 66 | $ | 66 | ||||
Finished
goods
|
682 | 107 | ||||||
Total
inventories
|
$ | 748 | $ | 173 |
4.
|
STOCK
BASED COMPENSATION
|
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 recorded stock based compensation of $41,000 and $42,000, respectively,
for the three months ended April 30, 2009 and 2008, and $146,000 and $274,000,
respectively, for the nine months ended April 30, 2009 and 2008. All
stock based compensation is included in the Company’s selling, general and
administrative expenses. The fair value of the Company’s stock option awards is
expensed over the vesting life of the underlying stock options using the graded
vesting method, with each tranche of vesting options valued
separately.
The
Company granted 265,000 and 340,000 stock options, respectively, during the
three and nine months ended April 30, 2009, and 20,000 and 792,500 options,
respectively, during the three and nine months ended April 30,
2008. The fair values of options granted are estimated on the date of
their grant using the Black-Scholes option pricing model based on the
assumptions included in the table below. 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 nine
months ended April 30, 2009 and 2008 was estimated using the following
assumptions:
Nine months ended
April 30, 2009
|
Nine months ended
April 30, 2008
|
|||
Expected
volatility
|
91.63%
- 110.18%
|
77.00%
- 112.82%
|
||
Expected
dividend yield
|
0.00%
|
0.00%
|
||
Risk-free
interest rate
|
1.50%
- 2.83%
|
2.45%
- 4.23%
|
||
Expected
life
|
4.0
- 5.5 years
|
3.0
- 5.0 years
|
||
Forfeiture
rate
|
0.00%
- 2.50%
|
0.00%
- 2.50%
|
10
NON-INVASIVE
MONITORING SYSTEMS, INC.
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
April 30,
2009
A summary
of the Company’s stock option activity for the nine months ended April 30, 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
|
340,000 | $ | 0.338 | |||||||||||||
Options
exercised
|
(26,666 | ) | $ | 0.150 | ||||||||||||
Options
forfeited or expired
|
(50,833 | ) | $ | 0.334 | ||||||||||||
Options
outstanding, April 30, 2009
|
2,336,831 | $ | 0.567 | 3.65 | $ | 76,533 | ||||||||||
Options
expected to vest, April 30, 2009
|
2,322,042 | $ | 0.568 | 3.63 | $ | 76,003 | ||||||||||
Options
exercisable, April 30, 2009
|
1,770,831 | $ | 0.583 | 3.02 | $ | 55,333 |
Of the
2,336,831 options outstanding at April 30, 2009, 1,251,000 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 nine month periods ended April 30, 2009 and 2008 were granted outside
of shareholder approved plans.
The
intrinsic value of the 26,666 options exercised during the nine months ended
April 30, 2009 was $8,000 on the dates exercised, and the intrinsic value of the
1,296,557 options exercised during the nine months ended April 30, 2008 was
$406,000 on the dates exercised. On January 24, 2008, Gary Macleod,
the Company’s former Chief Executive Officer and Director, provided the Company
with a notice of cashless exercise with respect to options to purchase 1,500,000
shares of common stock issued to him on November 11, 2005, which vested in full
upon his termination as Chief Executive Officer in December 2007. On
February 29, 2008, the Company entered into a Separation and Release Agreement
with Mr. Macleod (the “Separation Agreement”). Pursuant to the
Separation Agreement, Mr. Macleod was entitled to exercise options for 1,101,226
shares and received 550,000 shares for such cashless exercise, and forfeited
options to purchase 398,774 shares, which if not forfeited would have resulted
in an issuance of an additional 199,165 shares. Mr.
Macleod also forfeited options to purchase 25,000 shares of the Company’s common
stock awarded in October 2007.
A summary
of the status of the Company’s unvested options and changes during the nine
months ended April 30, 2009 is presented below.
Stock Options
|
Weighted Average
Grant Date Fair Value
|
|||||||
Unvested
at July 31, 2008
|
476,000 | $ | 0.492 | |||||
Options
granted
|
340,000 | $ | 0.249 | |||||
Options
vested
|
(250,000 | ) | $ | 0.467 | ||||
Unvested
at April 30, 2009
|
566,000 | $ | 0.363 |
As of
April 30, 2009, there was $134,000 of unrecognized costs related to outstanding
stock options. These costs are expected to be recognized over a
weighted average period of 1.39 years.
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.
11
NON-INVASIVE
MONITORING SYSTEMS, INC.
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
April 30,
2009
The
$56,000 notes payable balance at April 30, 2009 relates to the third-party
financing of certain of the Company’s insurance policies. The notes
are self-amortizing, 7.69% installment loans which mature at various dates from
December 2009 to January 2010.
6.
|
SHAREHOLDERS'
EQUITY
|
During
the nine months ended April 30, 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 nine months ended
April 30, 2008, the Company received $86,000, from existing optionholders for
the exercise of options to purchase 195,331 shares of Common Stock, and issued
550,000 shares of Common Stock to Mr. Macleod pursuant to the cashless exercise
described in Note 4, above.
Series
D Convertible Preferred Stock.
In April
2008, the Company authorized a new series of its Preferred Stock, par value
$1.00 per share (the “Preferred Stock”), designated as Series D Convertible
Preferred Stock (the “Series D Preferred Stock”). 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.
April 2008
Offering. On April 7, 2008, the Company completed the sale of
an aggregate of 1,000 shares of 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 an executive officer of the Company, a holder of more than 10%
of the outstanding Common Stock and a director and executive officer of the
Company who also holds 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 $1,500,000, of
which $795,000 was paid by the Related Party Investors.
December 2008
Offering. In December 2008, the Company sold an aggregate of
491 additional shares of its Series D Preferred Stock to certain private
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 in the December 2008 Offering
include a director of the Company, an entity controlled by the Company’s
Chairman and certain of the Related Party Investors that participated in the
April 2008 Offering (collectively, the “December Related Party
Investors”). The aggregate purchase price for the Series D Preferred
Stock was $736,500, of which $382,500 was paid by the December Related Party
Investors. Of the $382,500 paid by the December Related Party
Investors, $282,200 was paid from the proceeds of their respective interests in
the Revolver described in Note 5 above.
12
NON-INVASIVE
MONITORING SYSTEMS, INC.
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
April 30,
2009
January 2009
Offering. 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 price paid for the shares issued in the January 2009 offering was $2.1
million.
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 $0.53, $0.36, $0.38 and $0.43, respectively,
on each of April 7, 2008, December 1, 2008, December 2, 2008 and January 28,
2009, resulting in beneficial conversion features of $1,150, $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 $2.2 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 portion of the
$2.2 million aggregate intrinsic value applicable to a closing date is deemed a
dividend paid to the investors on such closing date. Such deemed
dividends have been recorded as increases in losses attributable to common
shareholders and, in the absence of retained earnings, as reductions 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 nine months
ended April 30, 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.
Potential
common shares not included in calculating diluted net loss per share are as
follows:
April 30, 2009
|
April 30, 2008
|
|||||||
Stock
options
|
2,336,831 | 1,958,330 | ||||||
Stock
warrants
|
325,000 | 325,000 | ||||||
Series
C Preferred Stock
|
1,551,200 | 1,551,200 | ||||||
Series
D Preferred Stock
|
14,455,000 | 5,000,000 | ||||||
Total
|
18,668,031 | 8,834,530 |
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
nine months ended April 30, 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 nine months ended April
30, 2009, the Company recorded $14,000 and $36,000, respectively, of rent
expense on a straight-line basis related to the Miami lease. 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
4,000 and 5,000 square feet of space in the Hialeah warehouse at a rate
substantially equivalent to market lease rates for comparable properties in the
Hialeah area. In the three months ended April 30, 2009, the Company
recorded $9,000 of rent expense related to the Hialeah warehouse.
13
NON-INVASIVE
MONITORING SYSTEMS, INC.
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
April 30,
2009
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 as Director 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 nine months ended April 30, 2009 totaling $10,000 and
$22,000, respectively, to account for the sharing of costs under this
arrangement. No such costs were recorded in the three and nine months
ended April 30, 2008. Accounts payable to SafeStitch and Aero totaled
approximately $7,000 at April 30, 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
April 30, 2009, the Company had approximately $1.3 million on deposit with Great
Eastern Bank of Florida, including approximately $1.3 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. 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
4,000 and 5,000 square feet of space in the Hialeah warehouse at a rate
substantially equivalent to market lease rates for comparable properties in the
Hialeah area.
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. Either party may terminate the Agreement with
ninety days prior written notice. Upon termination, each party’s
obligations under the Agreement will be limited to obligations related to
confirmed orders placed prior to the termination date.
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 nine months ended April 30,
2009. These amounts have been recorded as tooling costs, and are
included in tooling and equipment, net.
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.
14
NON-INVASIVE
MONITORING SYSTEMS, INC.
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
April 30,
2009
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 per product costs at the time the Agreement was executed multiplied by
volume commitments. Through April 30, 2009, the Company had paid Sing
Lin $891,000 in connection with orders placed through that date. Of
this amount, $302,000 is included in advances to contract manufacturer in the
accompanying unaudited condensed consolidated financial
statements. As of April 30, 2009, aggregate future purchase
commitments under the Agreement totaled approximately $12.3
million.
10.
|
LONG-LIVED
ASSETS
|
The
Company’s long-lived assets include furniture and equipment, tooling, websites,
leasehold improvements, patents and trademarks and long-term
investments. Tooling and equipment, net of accumulated depreciation,
consists of the following at April 30, 2009 (in thousands):
April
30, 2009
|
July
31, 2008
|
|||||||
Tooling
and equipment
|
$ | 471 | $ | 442 | ||||
Furniture
and fixtures, leasehold improvements, office equipment and
computers
|
76 | 51 | ||||||
Website
and software
|
26 | – | ||||||
573 | 493 | |||||||
Less
accumulated depreciation
|
(97 | ) | (23 | ) | ||||
Tooling
and equipment, net
|
$ | 476 | $ | 470 |
Depreciation
expense was $22,000 and $2,000 during the three months ended April 30, 2009 and
2008, respectively, and $74,000 and $7,000 during the nine months ended April
30, 2009 and 2008, respectively. Depreciation on the tooling
commenced in August 2008 based upon an estimated useful life of five
years. Nine Exer-Rest® SL and
TL demonstration units are included in furniture and fixtures at an aggregate
cost of $27,000. These units were placed in service in fiscal 2009,
and are being depreciated based upon a five-year estimated useful
life. Four Exer-Rest® AT
demonstration units were previously included in furniture and fixtures at an
aggregate cost of $19,000. These units were disposed of in the three
months ended April 30, 2009 and the Company recorded a $9,000 loss on the
disposal which is included in other expense in the accompanying unaudited
condensed consolidated financial statements.
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.
15
NON-INVASIVE
MONITORING SYSTEMS, INC.
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
April 30,
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 April 30, 2009, the Company has not elected to use the
fair value option allowed by SFAS 159.
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. Prior to the issuance of SFAS 162, GAAP hierarchy was
defined in the American Institute of Certified Public Accountants (AICPA)
Statement on Auditing Standards (SAS) No. 69, “The Meaning of Present Fairly in
Conformity With Generally Accepted Accounting
Principles.” SFAS 162 became effective in November 2008.
The adoption of SFAS 162 did not have a material impact on the
Company’s 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.
In April
2009, the FASB issued FASB Staff Position FAS-157-4, “Determining Fair Value When the
Volume and Level of Activity for the Asset or Liability Have Significantly
Decreased and Identifying Transactions That Are Not Orderly” (“FSP FAS
157-4”). FSP FAS 157-4 provides guidelines for making fair value
measurements more consistent with the principles presented in SFAS
157. FSP FAS 157-4 provides additional authoritative guidance in
determining whether a market is active or inactive and whether a transaction is
distressed. FSP FAS 157-4 is applicable to all assets and liabilities
(i.e. financial and nonfinancial) and will require enhanced
disclosures. FSP FAS 157-4 will be effective for the Company’s fiscal
year beginning August 1, 2009. The Company is currently evaluating
the potential impact of the adoption of FSP FAS 157-4 on its consolidated
financial statements.
16
NON-INVASIVE
MONITORING SYSTEMS, INC.
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
April 30,
2009
In April
2009, the FASB issued FASB Staff Positions FAS 115-2 and FAS 124-2, “Recognition and Presentation of
Other-Than-Temporary Impairments” (“FSP FAS 115-2”) and (“FSP FAS
124-2”). FSP FAS 115-2 and FSP FAS 124-2 provide additional guidance
to provide greater clarity about the credit and noncredit component of an
other-than-temporary impairment event and to improve presentation and disclosure
of other than temporary impairments in the financial statements. FSP
FAS 115-2 and FSP FAS 124-2 will be effective for the Company’s fiscal year
beginning August 1, 2009. The Company is currently evaluating the
potential impact of the adoption of FSP FAS 115-2 on its consolidated financial
statements.
In April
2009, the FASB issued FASB Staff Position FAS 107-1 and APB 28-1, “Interim Disclosures about Fair
Value of Financial Instruments” (“FSP FAS 107-1”) and (“APB
28-1”). FSP FAS 107-1 amends FASB Statement No. 107, “Disclosures about Fair Value of
Financial Instruments”, to require disclosures about fair value of
financial instruments in interim as well as in annual financial statements and
amends APB Opinion No. 28 “Interim Financial
Reporting”, to require those disclosures in interim financial
statements. FSP FAS 107-1 and APB 28-1 will be effective for the
Company’s fiscal year beginning August 1, 2009. The Company is
currently evaluating the potential impact of the adoption of FSP FAS 107-1 on
its consolidated financial statements.
In May
2009, the FASB issued SFAS No. 165, “Subsequent
Events.” SFAS No. 165 establishes general standards of
accounting for and disclosure of events that occur after the balance sheet date
but before financial statements are issued or ready to be issued. SFAS No.
165 will be effective for the Company’s fiscal year ending July 31,
2009. The Company does not expect SFAS No. 165 to have any
effect on its consolidated financial statements.
17
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.
18
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., one of the world’s
leading verification and certification bodies. 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 nine months
ended April 30, 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.
19
NON-INVASIVE
MONITORING SYSTEMS, INC
Critical Accounting Policies
and Estimates
The
discussion and analysis of our financial condition and results of operations set
forth below under “Results of Operations” and “Liquidity and Capital Resources”
should be read in conjunction with our financial statements and notes thereto
appearing elsewhere in this Form 10-Q. The preparation of these
financial statements requires us to make estimates and judgments that affect the
reported amounts of assets, liabilities, revenues and expenses, and related
disclosure of contingent assets and liabilities. On an on-going
basis, we evaluate our estimates, including those related to royalties,
inventory, tooling and equipment and contingencies. We base our
estimates on historical experience and on various other assumptions that are
believed to be reasonable under the circumstances, the results of which form the
basis for making judgments about the carrying values of assets and liabilities
that are not readily apparent from other sources. A more detailed
discussion on the application of these and other accounting policies can be
found in Note 2 in the Notes to the Financial Statements set forth in Item 7 of
our Annual Report on Form 10-KSB for the year ended July 31,
2008. Actual results may differ from these estimates.
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 April 30, 2009, we had entered into agreements
with distributors in the Middle East and India.
Three and Nine months ended
April 30, 2009 Compared to Three and Nine months Ended April 30,
2008
Revenue. Total
revenues increased from $39,000 for the three months ended April 30, 2008, to
$169,000 for the three months ended April 30, 2009. This $130,000
increase resulted from a $137,000 increase in product sales, offset in part by a
$6,000 decrease in royalties. Total revenues increased from $194,000
for the nine months ended April 30, 2008 to $450,000 for the nine months ended
April 30, 2009, an increase of $256,000, primarily resulting from a $230,000
increase in product sales and a $27,000 increase in royalties. Platform
unit sales for the three and nine months ended April 30, 2009 increased 2,000%
and 800%, respectively, over the comparable periods in the prior
year. These increases in product sales were primarily attributable to
the delivery of the initial order of Exer-Rest® SL
models to a new overseas distributor and the delivery of Exer-Rest® SL
and TL models to individual customers upon commencement of United States sales
in February 2009.
Combined
royalties from VivoMetrics and SensorMedics were $20,000 and $26,000 for the
three months ended April 30, 2009 and 2008 respectively. The decrease
in royalty revenue was primarily due to revisions to previously estimated
royalties from VivoMetrics on sales of the LifeShirt®. Royalty
revenues were $177,000 and $150,000 for the nine months ended April 30, 2009 and
2008, respectively. Increases in royalty revenue resulted from higher
reported sales of licensed products in the nine months ended April 30, 2009 as
compared to the same periods in 2008. We expect royalty revenues from
LifeShirt® sales to
decrease in future periods due to reported reductions in VivoMetrics’ sales
force.
Cost of Sales. Cost
of sales for the three and nine months ended April 30, 2009 was $57,000 and
$118,000, respectively, as compared to $15,000 and $41,000, respectively, for
the three and nine months ended April 30, 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 and because 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 increased to $494,000 for the
three months ended April 30, 2009 from $463,000 for the three months ended April
30, 2008. This $31,000 increase was primarily attributed to the
establishment of our Toronto demonstration center and increased wages,
professional fees and marketing and sales expenses in the 2009 fiscal period,
offset by reduced legal and auditing fees. SG&A expenses
increased $54,000 to $1.4 million for the nine months ended April 30, 2009 from
$1.4 million for the nine months ended April 30, 2008. The increase
in the 2009 period was the result of increases in wages, professional fees,
trade show costs, travel, sales and marketing and the establishment of our
Toronto demonstration center, offset in part by lower stock-based compensation
and severance expenses. The nine months ended April 30, 2008 included
$126,000 of severance costs related to the termination of our former Chief
Executive Officer. Stock-based compensation expense, which is
included in SG&A expense, decreased from $42,000 and $274,000, respectively,
for the three and nine months ended April 30, 2008 to $41,000 and $146,000,
respectively, for the three and nine months ended April 30, 2009. The
decrease in stock-based compensation was primarily due to a decrease in the
number of options granted during the nine months ended April 30,
2009.
Research and development
costs. Research and development costs increased from $49,000
for the three months ended April 30, 2008 to $77,000 for the three months ended
April 30, 2009, an increase of $28,000. Research and development
costs increased from $125,000 for the nine months ended April 30, 2008 to
$168,000 for the nine months ended April 30, 2009, an increase of
$43,000. The increases in the 2009 fiscal periods relate primarily to
costs incurred in pursuit of FDA clearance to market the Exer-Rest® in the
US, which clearance was granted in January 2009.
20
NON-INVASIVE
MONITORING SYSTEMS, INC
Total operating costs and
expenses. Total operating costs and expenses increased
$101,000 from $527,000 for the three months ended April 30, 2008 to $628,000 for
the three months ended April 30, 2009. Total operating costs and
expenses increased $174,000 from approximately $1.6 million for the nine months
ended April 30, 2008 to approximately $1.7 million for the nine months ended
April 30, 2009. These increases were 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 income was negligible in each of the three
month periods ended April 30, 2009 and 2008. Net interest expense was
$8,000 for the nine months ended April 30, 2009, primarily attributable to
interest accruing on the Revolver described below. Net interest
income was $10,000 for the nine months ended April 30, 2008 from interest earned
on cash balances in interest bearing accounts.
Liquidity and Capital
Resources
Our
operations have been primarily financed through private sales of our equity
securities. At April 30, 2009, we had cash of approximately $1.3
million and working capital of approximately $2.2 million. We expect
these funds will be sufficient to expand our marketing efforts in the US and
Canada for the remainder of the 2009 calendar 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 2009 calendar 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 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 $1.4 million for each of the nine month
periods ended April 30, 2009 and 2008. Reduced payments to Sing Lin
for inventory purchases were offset by increased use of cash for other working
capital items.
Net cash
used in investing activities was $227,000 for the nine months ended April 30,
2009 primarily due to the $171,000 final payment for the purchase of tooling
from Sing Lin, improvements to our Miami office and Toronto demonstration center
and development of our new website. Our investing activities provided
$79,000 of net cash for the nine months ended April 30, 2008 due to the
redemption of $400,000 of certificates of deposit held in restricted cash,
offset in part by $300,000 of payments for tooling development under the Sing
Lin agreement.
Net cash
provided by financing activities was $2.9 million for the nine months ended
April 30, 2009, as compared to $1.1 million for the nine months ended April 30,
2008. 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, as compared to the issuance of 1,000 shares
of Series D Preferred Stock in April 2008.
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 $161,000
and $136,000 in the nine months ended April 30, 2009 and 2008,
respectively. There can be no assurances that the Company will
continue to receive similar royalty payments, and we expect a modest decline in
royalties for the foreseeable future.
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, which acceptance occurred in
September 2008, 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 April 30, 2009, we have paid Sing
Lin $891,000 in connection with orders placed through that date, and we will be
required to make additional payments totaling approximately $238,000 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.
21
NON-INVASIVE
MONITORING SYSTEMS, INC
Series D Preferred Stock
Offerings. In April 2008, we authorized 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”). 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 has a $1,500 per share liquidation preference, and is issued at
$1,500 per share, which is equivalent to $0.30 per share of Common Stock on an
“as-converted” basis.
April 2008 Series D Preferred Stock
Offering. On April 7, 2008, we completed the sale of an
aggregate of 1,000 shares of our 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. 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.
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 unaudited
consolidated 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
$468,000 and $488,000 for the three months ended April 30, 2009 and 2008
respectively, and $1.3 million and $1.3 million for the nine months ended April
30, 2009 and 2008 respectively. In addition, the Company has an
accumulated deficit of $19.3 million as of April 30, 2009, and has substantial
purchase commitments at April 30, 2009 (see Note 9 to the accompanying unaudited
consolidated financial statements). These matters raise substantial
doubt about the Company’s ability to continue as a going
concern.
22
NON-INVASIVE
MONITORING SYSTEMS, INC
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 April 30, 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 April 30, 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.
23
NON-INVASIVE
MONITORING SYSTEMS, INC
PART II. OTHER
INFORMATION
Item
1. Legal
Proceedings
None.
Item
1A. Risk
Factors
In addition to the Risk Factors set
forth in Item 1 in our Report on Form 10-KSB for the fiscal year ended July 31,
2008, investors should be aware of the following additional risk
factor:
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
None.
Item
3. Defaults
upon Senior Securities
None.
Item
4. Submissions of Matters to a
Vote of Security Holders.
None.
Item
5. Other
Information
None.
Item
6. Exhibits
Index
10.1
|
First
Amendment to Letter of Agreement, dated as of April 21, 2009 between the
Company and Cardinal Health 211, Inc. (as successor in interest to
SensorMedics Corporation) (incorporated by reference to Exhibit 10.1 to
our Form 8-K filed on June 9,
2009)..
|
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.
|
24
NON-INVASIVE
MONITORING SYSTEMS, INC
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: June
15, 2009
|
By:
|
/s/ Dr. Marvin A. Sackner
|
|
Dr.
Marvin A. Sackner, Chief Executive Officer
|
|||
Dated: June
15, 2009
|
By:
|
/s/ Adam S. Jackson
|
|
Adam
S. Jackson, Chief Financial
Officer
|
25
EXHIBIT
INDEX
10.1
|
First
Amendment to Letter of Agreement, dated as of April 21, 2009 between the
Company and Cardinal Health 211, Inc. (as successor in interest to
SensorMedics Corporation) (incorporated by reference to Exhibit 10.1 to
our Form 8-K filed on June 9,
2009).
|
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.
|