NON INVASIVE MONITORING SYSTEMS INC /FL/ - Quarter Report: 2009 October (Form 10-Q)
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
Washington, DC. 20549
FORM 10-Q
(Mark One)
| þ | Quarterly Report Pursuant to Section 13 or 15 (d) of the Securities Exchange Act of 1934 |
for
the Quarterly Period ended October 31, 2009
or
| o | 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 | (I.R.S. employer identification no.) | |
| organization) |
4400 Biscayne Blvd., Suite 180, Miami, Florida 33137
(Address of principal executive offices) (Zip code)
(Address of principal executive offices) (Zip code)
Registrant’s telephone number, including area code: (305) 575-4200
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 þ No o
Indicate by check mark
whether the registrant has submitted electronically and posted on its corporate
Web site, if any, every Interactive Data File required to be submitted and
posted pursuant to Rule 405 of Regulation S-T during the preceding
12 months (or for such shorter period that the registrant was required to
submit and post such files). Yes o No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large
accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the
Exchange Act.
| Large accelerated filer o | Accelerated filer o | Non-accelerated filer o | Smaller reporting company þ |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes o No þ
68,385,637 shares of the Company’s common stock, par value $0.001 per share, were outstanding
as of December 10, 2009.
NON-INVASIVE MONITORING SYSTEMS, INC.
TABLE OF CONTENTS FOR FORM 10-Q
PART I. FINANCIAL INFORMATION |
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ITEM 1. FINANCIAL STATEMENTS |
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| Exhibit 3.1 | ||||||||
| Exhibit 31.1 | ||||||||
| Exhibit 31.2 | ||||||||
| Exhibit 32.1 | ||||||||
| Exhibit 32.2 | ||||||||
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NON-INVASIVE MONITORING SYSTEMS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
| October 31, 2009 | July 31, 2009 | |||||||
| (Unaudited) | ||||||||
ASSETS |
||||||||
Current assets |
||||||||
Cash |
$ | 518 | $ | 886 | ||||
Royalties and other receivables, net |
139 | 60 | ||||||
Inventories, net |
884 | 911 | ||||||
Advances to contract manufacturer |
120 | 144 | ||||||
Prepaid expenses, deposits, and other current assets |
48 | 75 | ||||||
Total current assets |
1,709 | 2,076 | ||||||
Tooling and equipment, net |
432 | 460 | ||||||
Total assets |
$ | 2,141 | $ | 2,536 | ||||
LIABILITIES AND SHAREHOLDERS’ EQUITY |
||||||||
Current liabilities |
||||||||
Notes payable — other |
$ | 12 | $ | 34 | ||||
Accounts payable and accrued expenses |
269 | 242 | ||||||
Customer deposits |
9 | 9 | ||||||
Total current liabilities |
290 | 285 | ||||||
Total liabilities |
$ | 290 | $ | 285 | ||||
Commitments (Note 10) |
— | — | ||||||
Shareholders’ equity |
||||||||
Series B Preferred Stock, par value $1.00 per share;
100 shares authorized, issued and outstanding; liquidation preference $10 |
— | — | ||||||
Series C Convertible Preferred Stock, par value $1.00 per share;
62,048 shares authorized, issued and outstanding; liquidation preference $62 |
62 | 62 | ||||||
Series D Convertible Preferred Stock, par value $1.00 per share; 5,500 shares authorized;
2,891 shares issued and outstanding; liquidation preference $4,337 |
3 | 3 | ||||||
Common Stock, par value $0.01 per share; 100,000,000 shares authorized;
68,385,637 shares issued and outstanding |
684 | 684 | ||||||
Additional paid in capital |
21,365 | 21,327 | ||||||
Accumulated deficit |
(20,238 | ) | (19,803 | ) | ||||
Accumulated other comprehensive loss |
(25 | ) | (22 | ) | ||||
Total shareholders’ equity |
1,851 | 2,251 | ||||||
Total liabilities and shareholders’ equity |
$ | 2,141 | $ | 2,536 | ||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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NON-INVASIVE MONITORING SYSTEMS, INC.
CONDENSED CONSOLIDATED COMPREHENSIVE STATEMENTS OF OPERATIONS — Unaudited
(In thousands, except per share amounts)
| Three months ended October 31, | ||||||||
| 2009 | 2008 | |||||||
Revenues |
||||||||
Product sales, net |
$ | 155 | $ | 6 | ||||
Royalties |
42 | 63 | ||||||
Research, consulting and warranty |
— | 1 | ||||||
Total revenues |
197 | 70 | ||||||
Operating costs and expenses |
||||||||
Cost of sales |
67 | 5 | ||||||
Selling, general and administrative |
536 | 505 | ||||||
Research and development |
40 | 53 | ||||||
Total operating costs and expenses |
643 | 563 | ||||||
Operating loss |
(446 | ) | (493 | ) | ||||
Other income (expense) |
||||||||
Interest expense, net |
— | (5 | ) | |||||
Other income |
11 | — | ||||||
Total other income (expense) |
11 | (5 | ) | |||||
Net loss |
$ | (435 | ) | $ | (498 | ) | ||
Other comprehensive income |
||||||||
Foreign currency translation adjustment |
(3 | ) | — | |||||
Comprehensive net loss |
$ | (438 | ) | $ | (498 | ) | ||
Net loss attributable to common shareholders |
$ | (435 | ) | $ | (498 | ) | ||
Weighted average number of common
shares outstanding — basic and diluted |
68,386 | 68,039 | ||||||
Basic and diluted loss per common share |
$ | (0.01 | ) | $ | (0.01 | ) | ||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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NON-INVASIVE MONITORING SYSTEMS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY — Unaudited
For the three months ended October 31, 2009
(Dollars in Thousands)
| Accumu- | ||||||||||||||||||||||||||||||||||||||||||||||||
| lated Other | ||||||||||||||||||||||||||||||||||||||||||||||||
| Preferred Stock | Additional | Accum- | Compre- | |||||||||||||||||||||||||||||||||||||||||||||
| Series B | Series C | Series D | Common Stock | Paid-in- | ulated | hensive | ||||||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Capital | Deficit | Loss | Total | |||||||||||||||||||||||||||||||||||||
Balance at July 31, 2009 |
100 | $ | — | 62,048 | $ | 62 | 2,891 | $ | 3 | 68,385,637 | $ | 684 | $ | 21,327 | $ | (19,803 | ) | (22 | ) | $ | 2,251 | |||||||||||||||||||||||||||
Stock based compensation |
— | — | — | — | — | — | — | — | 38 | — | — | 38 | ||||||||||||||||||||||||||||||||||||
Currency translation adjustment |
— | — | — | — | — | — | — | — | — | — | (3 | ) | (3 | ) | ||||||||||||||||||||||||||||||||||
Net loss |
— | — | — | — | — | — | — | — | — | (435 | ) | — | (435 | ) | ||||||||||||||||||||||||||||||||||
Balance at October 31, 2009 |
100 | $ | — | 62,048 | $ | 62 | 2,891 | $ | 3 | 68,385,637 | $ | 684 | $ | 21,365 | $ | (20,238 | ) | (25 | ) | $ | 1,851 | |||||||||||||||||||||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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NON-INVASIVE MONITORING SYSTEMS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS — Unaudited
(Dollars in thousands)
Three months ended October 31, 2009 and 2008
| 2009 | 2008 | |||||||
Operating activities |
||||||||
Net loss |
$ | (435 | ) | $ | (498 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities |
||||||||
Deferred warranty income |
— | (1 | ) | |||||
Depreciation and amortization |
31 | 27 | ||||||
Stock based compensation expense |
38 | 65 | ||||||
Foreign currency transaction gain |
(11 | ) | — | |||||
Changes in operating assets and liabilities |
||||||||
Accounts and royalties receivable, net |
(80 | ) | 4 | |||||
Inventories, net |
15 | (133 | ) | |||||
Advances to contract manufacturer |
24 | 31 | ||||||
Prepaid expenses, deposits and other current assets |
27 | 10 | ||||||
Accounts payable and accrued expenses |
46 | 193 | ||||||
Customer deposits |
— | 43 | ||||||
Net cash used in operating activities |
(345 | ) | (259 | ) | ||||
Investing activities |
||||||||
Fixed asset purchases |
(3 | ) | (50 | ) | ||||
Net cash used in investing activities |
(3 | ) | (50 | ) | ||||
Financing activities |
||||||||
Net proceeds from issuance of notes payable |
— | 300 | ||||||
Repayments of notes payable |
(22 | ) | (10 | ) | ||||
Net cash (used in) provided by financing activities |
(22 | ) | 290 | |||||
Effect of exchange rate changes on cash |
2 | — | ||||||
Net increase (decrease) in cash |
(368 | ) | (19 | ) | ||||
Cash, beginning of period |
886 | 86 | ||||||
Cash, end of period |
$ | 518 | $ | 67 | ||||
Supplemental schedule of non-cash activities |
||||||||
Reversal of accrual for tooling development in progress |
$ | — | $ | 29 | ||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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NON-INVASIVE MONITORING SYSTEMS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
October 31, 2009
The condensed consolidated balance sheet as of July 31, 2009, which has been derived from
audited financial statements, and the unaudited condensed interim financial statements included
herein have been prepared by Non-Invasive Monitoring Systems, Inc. (together with its
consolidated subsidiaries, the “Company” or “NIMS”) in accordance with accounting principles
generally accepted in the United States (“GAAP”) for interim financial information and the
instructions to the quarterly report on Form 10-Q and Rule 8-03 of Regulation S-X. Accordingly,
they do not include all of the information and footnotes required by GAAP for complete financial
statements. These statements reflect adjustments, all of which are of a normal, recurring
nature, and which are, in the opinion of management, necessary to present fairly the Company’s
financial position as of October 31, 2009, and results of operations and cash flows for the
interim periods ended October 31, 2009 and 2008. The results of operations for the three months
ended October 31, 2009, are not necessarily indicative of the results for a full year. Certain
information and footnote disclosure normally included in financial statements prepared in
accordance with GAAP have been condensed or omitted. The Company’s accounting policies continue
unchanged from July 31, 2009. These financial statements should be read in conjunction with the
financial statements and notes thereto included in the Company’s annual report on Form 10-K for
the year ended July 31, 2009.
1. ORGANIZATION AND BUSINESS
Organization. Non-Invasive Monitoring Systems, Inc., a Florida corporation (together with
its consolidated subsidiaries, the “Company” or “NIMS”), 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. 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 10).
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NON-INVASIVE MONITORING SYSTEMS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
October 31, 2009
October 31, 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 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 $0.4 million and $0.5 million for each of the three months ended
October 31, 2009 and 2008, and has experienced cash outflows from operating activities. The
Company also has an accumulated deficit of $20.2 million as of October 31, 2009, and has
substantial purchase commitments at October 31, 2009 (see Note 10). 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 7), 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 additional capital as 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.
Cash and Cash Equivalents. The Company considers all highly liquid short-term investments
purchased with an original maturity date of three months or less to be cash equivalents. The
Company includes overnight repurchase agreements securing its depository bank accounts (sweep
accounts) in its cash balances. At October 31, 2009 and July 31, 2009, the Company had
approximately $481,000 and $821,000, respectively, on deposit in such sweep accounts.
Allowances for Doubtful Accounts. The Company provides an allowance for royalties and other
receivables it believes it may not collect in full. Receivables are written off when they are
deemed to be uncollectible and all collection attempts have ceased. The amount of bad debt
recorded each period and the resulting adequacy of the allowance at the end of each period are
determined using a combination of the Company’s historical loss experience, customer-by-customer
analysis of the Company’s accounts receivable each period and subjective assessments of the
Company’s future bad debt exposure.
Inventories. Inventories are stated at lower of cost or market using the first-in, first-out
method, and are evaluated at least annually for impairment. Inventories at October 31, 2009 and
July 31, 2009 primarily consist of finished Exer-Rest® units and purchased
sub-assemblies to be used by the Company’s US-based contract manufacturer in production of the
Exer-Rest® AT. Provisions for potentially obsolete or slow-moving inventory are made
based on management’s analysis of inventory levels, historical obsolescence and future sales
forecasts.
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NON-INVASIVE MONITORING SYSTEMS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
October 31, 2009
October 31, 2009
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 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. The Company recognizes income tax
benefits for loss carryforwards, however these tax benefits are 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.
As of July 31, 2009, the Company had net Federal and State operating loss carry forwards of
approximately $10.7 million and Foreign operating loss carry forwards of $0.2 million available
to offset future taxable income. The net operating loss carryforwards expire in various years
through 2029 and may be subject to limitation due to change of ownership provisions under
Section 382 of the Internal Revenue Code and similar state provisions.
The Company files its tax returns as prescribed by the laws of the jurisdictions in which it
operates. Tax years ranging from 2005 to 2009 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. Advertising and
promotional costs for the three months ended October 31, 2009 and 2008 totaled $25,000 and
$4,000, respectively, and are included in selling, general and administrative costs and expenses
for all periods presented.
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
domestically and one year for products sold outside of the U.S. and are accrued based on
management’s estimates and the history of warranty costs incurred. There were no material
warranty costs incurred during the three months ended October 31, 2009 and 2008, and management
estimates that the Company’s accrued warranty expense at October 31, 2009 will be sufficient to
offset claims made for units under warranty.
Stock-based compensation. The Company recognizes all share-based payments, including grants of
stock options, in the income statement as an operating expense, based on their grant date fair
values. Stock-based compensation expense is recognized over the vesting life of the underlying
option and is included in selling, general and administrative costs and 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 October 31,
2009 and July 31, 2009. The respective carrying value of certain on-balance-sheet financial
instruments such as cash and cash equivalents, royalties and other receivables, 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 loss. Foreign currency translation
adjustments totaled $3,000 and $0, respectively, for the three months ended October 31, 2009 and
2008.
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NON-INVASIVE MONITORING SYSTEMS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
October 31, 2009
October 31, 2009
Comprehensive Income (Loss). Comprehensive income (loss) is defined as the change in equity of
a business enterprise during a period from transactions and other events and circumstances from
non-owner sources, including foreign currency translations.
Subsequent events. The Company has evaluated subsequent events through December 14, 2009, which
is the date the financial statements were issued.
3. INVENTORIES
The Company’s inventory consisted of the following at October 31, 2009 and July 31, 2009
(in thousands):
| October 31, 2009 | July 31, 2009 | |||||||
Work-in-progress, including sub-assemblies and spare parts |
$ | 11 | $ | 11 | ||||
Finished goods |
873 | 900 | ||||||
Total inventories |
$ | 884 | $ | 911 | ||||
The inventory balances above are net of valuation adjustments to work-in-progress and finished
goods inventories of $55,000 and $58,000, respectively.
4. STOCK BASED COMPENSATION
The Company measures the cost of employee, officer and director services received in
exchange for an award of equity instruments based on the grant-date fair value of the award.
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 recorded stock based compensation of $38,000 and $65,000,
respectively, for the three months ended October 31, 2009 and 2008. All stock based
compensation is included in the Company’s selling, general and administrative expenses.
The Company’s 2000 Stock Option Plan (the “2000 Plan”), as amended, provides for a total of
2,000,000 shares of Common Stock. The 2000 Plan allows the issuance of incentive stock options,
stock appreciation rights and restricted stock awards. The exercise price of the options is
determined by the compensation committee of the Company’s Board of Directors, but incentive
stock options must be granted at an exercise price not less than the fair market value of the
Company’s Common Stock as of the grant date or an exercise price of not less than 110% of the
fair value for a 10% shareholder. Options expire up to ten years from the date of the grant and
are exercisable according to the terms of the individual option agreements.
The Company did not grant any stock options during the three months ended October 31, 2009 and
granted 75,000 stock options during the three months ended October 31, 2008. The weighted
average grant date fair value of the options granted during the three months ended October 31,
2008 was $0.32 per share. 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 three
months ended October 31, 2009 and 2008 was estimated using the following assumptions:
| Three months ended | Three months ended | |||||
| October 31, 2009 | October 31, 2008 | |||||
Expected volatility |
n/a | 110.18 | % | |||
Expected dividend yield |
n/a | 0.00 | % | |||
Risk-free interest rate |
n/a | 2.83 | % | |||
Expected life |
n/a | 5.0 years | ||||
Forfeiture rate |
n/a | 0.00 | % | |||
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NON-INVASIVE MONITORING SYSTEMS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
October 31, 2009
October 31, 2009
A summary of the Company’s stock option activity for the three months ended October 31, 2009 is
as follows:
| Weighted | ||||||||||||||||
| Weighted | average | |||||||||||||||
| Average | remaining | Aggregate | ||||||||||||||
| Exercise | contractual | intrinsic | ||||||||||||||
| Shares | Price | term (years) | Value | |||||||||||||
Options outstanding, July 31, 2009 |
2,336,831 | $ | 0.567 | |||||||||||||
Options granted |
— | $ | ||||||||||||||
Options exercised |
— | $ | ||||||||||||||
Options forfeited or expired |
— | $ | ||||||||||||||
Options outstanding, October 31, 2009 |
2,336,831 | $ | 0.567 | 3.15 | $ | 106,199 | ||||||||||
Options expected to vest, October 31,
2009 |
2,316,290 | $ | 0.568 | 3.12 | $ | 104,497 | ||||||||||
Options exercisable, October 31 , 2009 |
1,879,831 | $ | 0.595 | 2.59 | $ | 71,749 | ||||||||||
Of the 2,336,831 options outstanding at October 31, 2009, 1,251,000 were issued under the 2000
Plan and 1,085,831 were issued outside of shareholder approved plans. There were no options
exercised, forfeited or expired during the three month period ended October 31, 2009.
As of October 31, 2009, there was $53,000 of unrecognized costs related to outstanding stock
options. These costs are expected to be recognized over a weighted average period of 1.77
years.
A summary of the status of the Company’s non-vested options and changes during the three months
ended October 31, 2009 is presented below.
| Weighted Average | ||||||||
| Stock Options | Grant Date Fair Value | |||||||
Non-vested at July 31, 2009 |
497,000 | $ | 0.345 | |||||
Options granted |
— | $ | — | |||||
Options vested |
(40,000 | ) | $ | 0.581 | ||||
Non-vested at October 31, 2009 |
457,000 | $ | 0.324 | |||||
5. ROYALTIES
The Company is a party to two licensing agreements and receives royalty income from the
sale of its diagnostic monitoring hardware and software from SensorMedics and VivoMetrics.
Royalty income from these licenses amounted to $42,000 and $63,000 for the three months ended
October 31, 2009 and 2008, respectively. Royalties from SensorMedics amounted to $42,000 and
$43,000 for the three months ended October 31, 2009 and 2008, respectively. Royalties from
VivoMetrics amounted to $0 and $20,000 for the three months ended October 31, 2009 and 2008,
respectively. VivoMetrics ceased operations in July 2009 and filed for Chapter 11 bankruptcy
protection in October 2009. VivoMetrics has not made a royalty payment since July 2009, and
aggregate royalties receivable at October 31, 2009 of $14,000 are net of a $10,000 allowance for
doubtful accounts to reserve all outstanding receivables from VivoMetrics.
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NON-INVASIVE MONITORING SYSTEMS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
October 31, 2009
October 31, 2009
6. NOTES PAYABLE
The $12,000 notes payable balance at October 31, 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.
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 7 below.
7. SHAREHOLDERS’ EQUITY
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 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.
December 2008 Offering. In December 2008, the Company sold an aggregate of 491 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 two directors of the Company, an entity
controlled by the Company’s Chairman and a holder of more than 10% of the Company’s Common Stock
(collectively, the “Related Party Investors”). The aggregate purchase price for the Series D
Preferred Stock was $736,500, of which $382,500 was paid by the Related Party Investors. Of the
$382,500 paid by the Related Party Investors, $282,200 was paid from the proceeds of their
respective interests in the Revolver described in Note 6 above.
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.
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NON-INVASIVE MONITORING SYSTEMS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
October 31, 2009
October 31, 2009
The Series D Preferred Stock was issued in each of the above transactions at $1,500 per share,
which is equivalent to $0.30 per share of Common Stock on an “as-converted” basis. The closing
price of the Common Stock on the over-the-counter bulletin
board was $0.36, $0.38 and $0.43, respectively, on each of December 1, 2008, December 2, 2008
and January 28, 2009, resulting in beneficial conversion features of $300, $400 and $650,
respectively, per share of Series D Preferred Stock on the respective issue dates. In
accordance with GAAP, the $1.1 million aggregate beneficial conversion feature of the Series D
Preferred Stock on the issue dates was deemed a discount on the issuance of the shares and was
recorded as an increase to additional paid in capital in the balance sheet. Because the Series
D Preferred Stock was immediately convertible to Common Stock, the portion of the $1.1 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.
8. BASIC AND DILUTED LOSS PER SHARE
Basic net loss per common share is computed by dividing net loss attributable to common
shareholders 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 three months ended October 31,
2009 and 2008, no dilution adjustment has been made to the weighted average outstanding common shares because the assumed exercise of outstanding options and warrants and the conversion of
preferred stock would be anti-dilutive.
Potential common shares not included in calculating diluted net loss per share are as follows:
| October 31, 2009 | October 31, 2008 | |||||||
Stock options |
2,336,831 | 2,111,830 | ||||||
Stock warrants |
— | 325,000 | ||||||
Series C Preferred Stock |
1,551,200 | 1,551,200 | ||||||
Series D Preferred Stock |
14,455,000 | 5,000,000 | ||||||
Total |
18,343,031 | 8,988,030 | ||||||
9. RELATED PARTY TRANSACTIONS
The Company signed a five year lease for office space in Miami, Florida with a company
owned by Dr. Phillip Frost, who is the beneficial owner of more than 10% of the Company’s Common
Stock. 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 months ended October 31, 2009, the Company recorded approximately
$15,000 of rent expense on a straight-line basis related to the Miami lease.
The Company signed a three year lease for warehouse space in Hialeah, Florida with a company
jointly controlled by Dr. Frost and Dr. Jane Hsiao, the Company’s Chairman. The rental payments
under the Hialeah warehouse lease, which commenced February 1, 2009, are approximately $5,000
per month for the first year and escalate 3.5% annually over the life of the lease. In the
three months ended October 31, 2009, the Company recorded approximately $14,000 of rent expense
related to the Hialeah warehouse.
Adam Jackson, the Company’s Chief Financial Officer, also serves as the Chief Financial Officer
and supervises the accounting staffs of SafeStitch Medical, Inc. (“SafeStitch”), a
publicly-traded, developmental-stage medical device manufacturer, and Aero Pharmaceuticals, Inc.
(“Aero”), a privately held pharmaceutical distributor. The Company’s Chairman, Dr. Jane Hsiao,
also serves as Chairman of SafeStitch and President of Aero. Director Steven Rubin also serves
as a director of SafeStitch and Secretary of Aero, and director Rao Uppaluri also serves as
Treasurer of Aero. The total salaries of the accounting staffs of NIMS, SafeStitch and Aero
have been shared under a board-approved cost sharing arrangement since March 2008. For the
three months ended October 31, 2009 and 2008, the Company has recorded selling, general and
administrative expense of $7,000 and $12,000, respectively, to account for the sharing of costs
under this arrangement. Accounts payable to SafeStitch and Aero related to this arrangement
totaled approximately $2,000 and $3,000, respectively, at October 31, 2009 and July 31, 2009.
Dr. Hsiao is a director of Great Eastern Bank of Florida, a bank where the Company maintains a
bank account in the normal course of business. As of October 31, 2009, the Company had
approximately $506,000 on deposit with Great Eastern Bank of Florida, including approximately
$481,000 secured by repurchase contracts for US Government securities.
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NON-INVASIVE MONITORING SYSTEMS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
October 31, 2009
October 31, 2009
10. COMMITMENTS
Leases.
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. The Company signed a three year lease for warehouse space in
Hialeah, Florida commencing February 1, 2009. The rental payments under this warehouse lease
are approximately $5,000 per month for the first year and escalate 3.5% annually over the life
of the lease.
Product Development and Supply Agreement.
On September 4, 2007, the Company executed a Product Development and Supply Agreement (the
“Agreement”) with Sing Lin Technologies Co. Ltd., a company based in Taichung, Taiwan (“Sing
Lin”). Pursuant to the Agreement, the Company consigned to Sing Lin the development and design
of the next generation Exer-Rest®, Somno-Ease™ and Exer-Rest® Plus
devices. Sing Lin will also manufacture all of the Company’s acceleration therapeutic
platforms. The Agreement commenced as of September 3, 2007 and has a term that extends three
years from the acceptance of the first run of production units by NIMS. Thereafter, the
Agreement automatically renews for successive one year terms unless either party sends the other
a notice of non-renewal at least ninety days before the end of the then-current term. 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. 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.
The Company has committed to purchase approximately $2.6 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 $4.1 million and $8.8 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 October 31, 2009, the Company had paid Sing Lin $1.6 million in
connection with orders placed through that date. Of this amount, $120,000 is included in
advances to contract manufacturer in the accompanying unaudited condensed consolidated financial
statements. As of October 31, 2009, aggregate future purchase commitments under the Agreement
totaled approximately $13.9 million. As of November 30, 2009, the Company had not placed orders
sufficient to satisfy its commitment to purchase a minimum number of units in the first year
after acceptance of the final product. The Company’s discussions with Sing Lin are ongoing, and
the Company expects its commitments under the Agreement to be modified to reflect current market
conditions. There can be no assurance that the Agreement will be modified on terms acceptable
to the Company or at all, or that Sing Lin will not attempt to enforce its rights under the
Agreement.
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NON-INVASIVE MONITORING SYSTEMS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
October 31, 2009
October 31, 2009
11. LONG-LIVED ASSETS
The Company’s long-lived assets include furniture and equipment, tooling, websites,
leasehold improvements, patents and trademarks. Tooling and equipment, net of accumulated
depreciation, consists of the following at October 31, 2009 (in thousands):
| Estimated | October 31, | July 31, | ||||||||
| Useful Life | 2009 | 2009 | ||||||||
Tooling and equipment |
5 years | $ | 471 | $ | 471 | |||||
Furniture and fixtures, leasehold
improvements, office equipment and
computers |
3 – 5 years | 97 | 94 | |||||||
Website and software |
3 years | 26 | 26 | |||||||
| 594 | 591 | |||||||||
Less accumulated depreciation |
(162 | ) | (131 | ) | ||||||
Tooling and equipment, net |
$ | 432 | $ | 460 | ||||||
Depreciation expense was $31,000 and $27,000 during the three months ended October 31, 2009 and
2008, respectively. Depreciation on the tooling commenced in August 2008 based upon an
estimated useful life of five years. Eleven Exer-Rest® SL and TL demonstration units
are included in furniture and fixtures at an aggregate cost of $34,000.
All patents and trademarks have been fully amortized since October 31, 2007.
12. RECENT ACCOUNTING PRONOUNCEMENTS
Effective August 1, 2009, the Company adopted authoritative guidance which established
accounting and reporting standards for the noncontrolling interest in a subsidiary and for the
deconsolidation of a subsidiary. It clarifies that a noncontrolling interest in a subsidiary is
an ownership interest in the consolidated entity that should be reported as equity in the
consolidated financial statements. The adoption of this guidance has not had a material impact
on the Company’s consolidated financial statements.
Effective August 1, 2009, the Company adopted authoritative guidance which established
principles and requirements for how the acquirer of a business recognizes and measures in its
financial statements the identifiable assets acquired, the liabilities assumed and any
noncontrolling interest in the acquiree. This guidance also established principles for
recognizing and measuring the goodwill acquired in a business combination and determining what
information to disclose to enable users of the financial statements to evaluate the nature and
financial effects of a business combination. In April 2009, the FASB amended and clarified this
guidance regarding the initial recognition and measurement, subsequent measurement and
accounting, and related disclosures arising from contingencies in a business combination. Under
the amended guidance, assets acquired and liabilities assumed in a business combination that
arise from contingencies should be recognized at fair value on the acquisition date if fair
value can be determined during the measurement period. If fair value cannot be determined,
acquired contingencies should be accounted for using existing guidance. The adoption of this
guidance applies to business combinations for which the acquisition date is on or after August
1, 2009, and has not had a material impact on the Company’s consolidated financial statements.
Effective August 1, 2009, the Company adopted authoritative guidance which defines collaborative
arrangements and establishes reporting requirements for transactions between participants in a
collaborative arrangement and between participants in the arrangement and third parties. The
adoption of this guidance has not had a material impact on the Company’s consolidated financial
statements.
Effective August 1, 2009, the Company adopted authoritative guidance for 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 previously issued guidance regarding derivative accounting. The adoption of
this guidance has not had a material impact on the Company’s consolidated financial statements.
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NON-INVASIVE MONITORING SYSTEMS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
October 31, 2009
October 31, 2009
Effective August 1, 2009, the Company adopted authoritative guidance which provides guidelines
for making fair value measurements when the volume and level of activity for an asset or
liability have significantly decreased and identifying
transactions that are not orderly. This guidance establishes guidelines for determining whether
a market is active or inactive and whether a transaction is distressed. This guidance is
applicable to all assets and liabilities (i.e. financial and nonfinancial) and will require
enhanced disclosures. The adoption of this guidance has not had a material impact on the
Company’s consolidated financial statements.
Effective August 1, 2009, the Company adopted authoritative guidance which requires disclosures
about fair value of financial instruments in interim, as well as in annual, financial
statements. The adoption of this guidance has not had a material impact on the Company’s
consolidated financial statements.
Effective August 1, 2009, the Company adopted authoritative guidance which provides additional
guidance to enhance clarity about the credit and noncredit components of an other-than-temporary
impairment event and to improve presentation and disclosure of other-than-temporary impairments
in the financial statements. The adoption of this guidance has not had a material impact on the
Company’s consolidated financial statements.
In June 2009, the Financial Accounting Standards Board (“FASB”) established the FASB Accounting
Standards Codification™ (“Codification”) as the source of authoritative accounting principles
recognized by the FASB to be applied by nongovernmental entities in the preparation of financial
statements in accordance with GAAP. All existing accounting standard documents are superseded
by the Codification and any accounting literature not included in the Codification will not be
authoritative. However, rules and interpretive releases of the SEC issued under the authority
of federal securities laws will continue to be sources of authoritative GAAP for SEC
registrants. The Codification became effective beginning with the Company’s first fiscal
quarter of 2010. The Codification does not change or alter existing GAAP and, therefore, has
not had any impact on the Company’s consolidated financial statements.
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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; current and future purchase commitments; competition; dependence on management;
changes in healthcare rules and regulations; risks related to proprietary rights; government
regulation; other factors described herein as well as the factors contained in “Item 1A — Risk
Factors” of our Annual Report on Form 10-K for the year ended July 31, 2009. 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.
Numerous 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; however VivoMetrics ceased operations in July 2009 and filed a
Chapter 11 petition for bankruptcy protection in October 2009. We continue to receive royalties
from SensorMedics however there can be no assurance as to the amount of future royalty revenue that
will be derived from these patent assignments. VivoMetrics is no longer marketing the
LifeShirt® system and the company does not expect any future royalties from VivoMetrics.
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 1 Therapeutic Vibrator approval from the
FDA. Accordingly, we ceased sales and marketing efforts in the U.S. for this platform pending FDA
approval.
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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 are being 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 2010 fiscal
year as we expand marketing activities in the US, Canada, the UK, Europe, India and Latin America.
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. Such data can be transmitted to a 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. The LifeShirt® was sold exclusively by VivoMetrics until July 2009, and
has not been marketed since VivoMetrics ceased operations and filed for bankruptcy protection.
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 8 of our
Annual Report on Form 10-K for the year ended July 31, 2009. Actual results may differ from these
estimates.
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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 October 2008 and in the U.S. in February 2009. We
expect to increase our sales activity throughout fiscal 2010 in North America with the addition of
dedicated sales personnel, increased advertising and marketing, promotional pricing and the
establishment of demonstration centers. We expect to increase our sales activity in international
markets through the enlistment of local distributors.
Three months ended October 31, 2009 compared to three months ended October 31, 2008
Revenue. Total revenues increased from $70,000 for the three months ended October 31, 2008,
to $197,000 for the three months ended October 31, 2009. This $127,000 increase resulted from a
$149,000 increase in product sales, offset in part by a $21,000 decrease in royalty revenues.
Exer-Rest® platform unit sales during the three months ended October 31, 2009
increased approximately 2,600% over the three months ended October 31, 2008, This increase in
product sales was primarily attributable to the delivery of Exer-Rest® SL models to
overseas distributors and the delivery of Exer-Rest® SL and TL models to individual
customers in the US.
Combined royalties from VivoMetrics and SensorMedics were $42,000 and $63,000 for the three
months ended October 31, 2009 and 2008, respectively. The $21,000 decrease is primarily
attributable to the loss of revenue from VivoMetrics due to their cessation of operations. We do
not expect any future royalties from VivoMetrics and we expect fiscal 2010 royalty revenue to be
significantly below fiscal 2009 levels.
Cost of Sales. Cost of sales for the three months ended October 31, 2009 and 2008 was $67,000
and $5,000, respectively. This $62,000 increase was primarily related to the increased number of
units sold in the first three months of the 2010 fiscal year. As a percentage of revenue, cost of
sales was lower in the first three months of fiscal 2010 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 first three months of fiscal 2009 were sold at a substantial discount to our current
pricing.
Selling, general and administrative costs and expenses. Selling, general and administrative
(“SG&A”) costs and expenses increased to $536,000 for the three months ended October 31, 2009 from
$505,000 for the three months ended October 31, 2008. This $31,000 increase was primarily
attributable to increases in payroll, advertising, rent and marketing and sales expenses, offset in
part by reduced auditing fees, international travel and stock-based compensation expense. The
increases in payroll and rent expense were primarily attributable to the February 2009
establishment and staffing of our Hialeah, Florida warehouse and the March 2009 establishment and
staffing of our Toronto demonstration center. SG&A costs and expenses include stock based
compensation expense, which totaled $38,000 for the three months ended October 31, 2009, as
compared to $65,000 for the three months ended October 31, 2008. The decrease in stock-based
compensation was primarily due to a decrease in the number of options granted during the first
three months of fiscal 2010. We expect SG&A costs and expenses to increase throughout the 2010
fiscal year as we add administrative, marketing and sales personnel and expand our marketing
programs.
Research and development costs. Research and development costs decreased to $40,000 for the
three months ended October 31, 2009 from $53,000 for the three months ended October 31, 2008, a
decrease of $13,000. The higher costs in the three months ended October 31, 2008 related primarily
to our pursuit of FDA clearance to market the Exer-Rest® in the US, which clearances
were granted in January and June 2009.
Total operating costs and expenses. Total operating costs and expenses increased $70,000 from
$563,000 to $643,000. This increase was primarily attributable to the increase in cost of sales
related to higher sales volume, as well as the higher SG&A costs and expenses and lower research
and development expenses discussed above.
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Interest income (expense), net. Net interest income was negligible in each of the three month
periods ended October 31, 2009 and 2008. Net interest expense was $0 and $5,000 for the three
months ended October 31, 2009 and 2008, respectively
Liquidity and Capital Resources
Our operations have been primarily financed through private sales of our equity
securities. At October 31, 2009, we had cash of approximately $518,000 and working capital of
approximately $1.4 million. We expect these funds will be sufficient to expand our marketing
efforts in the US and Canada through the first three months of the 2010 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 first quarter of
the 2010 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 $345,000 and $259,000 for three months ended October
31, 2009 and 2008, respectively. 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 $3,000 and $50,000 for three months ended October
31, 2009 and 2008, respectively. The $50,000 used in the three months ended October 31, 2008
included payments to Sing Lin for production tooling to be used in the manufacture of
Exer-Rest® platforms.
Net cash used by financing activities was $22,000 for the three months ended October 31, 2009,
primarily for the repayment of notes financing insurance premiums. Net cash provided by financing
activities was $290,000 for the three months ended October 31, 2008, primarily from the $300,000
proceeds from the Revolver described in Note 6 to the accompanying financial statements.
Under the agreement with Sing Lin, we are committed to purchase approximately $2.6 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 $4.1 million and $8.8
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 October 31,
2009, we have paid Sing Lin $1.6 million in connection with orders placed through that date, and we
will be required to make additional payments totaling approximately $79,000 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 2010 fiscal year. As of
November 30, 2009, we had not placed orders sufficient to satisfy our first-year purchase
commitment under the Agreement. Our discussions with Sing Lin are ongoing, and we expect our
commitments under the Agreement to be modified to reflect current market conditions. There can be
no assurance that the Agreement will be modified on terms acceptable to us or at all, or that Sing
Lin will not attempt to enforce its rights under the Agreement.
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.
December 2008 Series D Preferred Stock Offering. On December 2, 2008, we completed the sale
of an aggregate of 491 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. Marvin Sackner, a director and executive officer of the Company who also
holds more than 10% of the outstanding Common Stock, Frost Gamma Investments Trust (“Frost Gamma”),
a holder of more than 10% of the outstanding Common Stock, Hsu Gamma Investments, LP (“Hsu Gamma”),
an entity controlled by our Chairman, and a director (collectively, the “Related Party Investors”).
The aggregate purchase price for the Series D Preferred Stock was $736,500, of which $382,500 was
paid by the Related Party Investors. Of the $382,500 paid by the Related Party Investors, $282,200
was paid from the proceeds of their respective interests in the Revolver described in Note 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.
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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.
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 $435,000 and $498,000, respectively, for the three months
ended October 31, 2009 and 2008. In addition, the Company has an accumulated deficit of $20.2
million as of October 31, 2009, and has substantial purchase commitments at October 31, 2009 (see
Note 10 to the accompanying financial statements). These matters raise substantial doubt about the
Company’s ability to continue as a going concern.
| ITEM 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK. |
Not required for smaller reporting companies as defined in Rule 12b-2 of the Exchange
Act.
| ITEM 4. | 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 October 31, 2009 were effective to
ensure that information required to be disclosed by us in reports that we file or submit under the
Exchange Act is recorded, processed, summarized and reported within the time periods specified in
the Securities and Exchange Commission’s rules and forms.
There were no material changes in our internal controls over financial reporting or in other
factors that could materially affect, or are reasonably likely to affect, our internal controls
over financial reporting during the quarter ended October 31, 2009. Because of its inherent
limitations, internal control over financial reporting may not prevent or detect misstatements.
Also, projections of any evaluation of effectiveness to future periods are subject to the risk that
controls may become inadequate because of changes in conditions, or that the degree of compliance
with the policies or procedures may deteriorate.
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PART II. OTHER INFORMATION
| Item 1. | Legal Proceedings. |
None.
| Item 1A. | Risk Factors. |
None.
| 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. |
On November 16, 2009 the Board of Directors amended our By-Laws to (i) provide that the annual
meetings of shareholders may take place on a date designated by the Board of Directors, replacing a
provision that set a specific date for such meetings and (ii) conform the By-Laws to the Articles
of Incorporation to provide that he number of directors be between one and eight. The By-Laws and
the amendments thereto are attached hereto as Exhibit 3.1.
| Item 6. | Exhibits Index. |
| 3.1 | By-Laws, as amended. |
|||
| 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. |
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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: December 14, 2009 | By: | /s/ Dr. Marvin A. Sackner | ||
| Dr. Marvin A. Sackner, Chief Executive Officer | ||||
| Dated: December 14, 2009 | By: | /s/ Adam S. Jackson | ||
| Adam S. Jackson, Chief Financial Officer | ||||
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EXHIBIT INDEX
| 3.1 | By-laws, as amended. |
|||
| 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. |