UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q/A
(Mark One)
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
For the quarterly period ended June 30, 2009
OR
[ ] TRANSACTION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the transition period from _______ to _______
COMMISSION FILE NO. 001-33088
IVIVI TECHNOLOGIES, INC.
(Name of Small Business Issuer in its Charter)
New Jersey 22-2956711
(State or Other Jurisdiction (I.R.S. Employer
of Incorporation or organization) Identification
Number)
|
135 Chestnut Ridge Rd., Montvale, New Jersey 07645
(Address of Principal Executive Offices)
Issuer's Telephone Number, including area code: (201) 476-9600
Indicate by check mark whether the Issuer (1) has filed all reports required to
be filed by Section 13 or 15(d) of the Exchange Act during the past 12 months
(or for such shorter period that the Issuer was required to file such reports),
and (2) has been subject to such filing requirements for the past 90 days:
YES [X] NO [ ]
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 (ss.232.405 of
this chapter) during the preceding 12 months (or for such shorter period that
the registrant was required to submit and post such files).
YES [ ] NO [ ]
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]
(Do not check if a smaller reporting company)
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Indicate by check mark whether the registrant is a shell company (as defined in
Rule 12b-2 of the Exchange Act)
YES [ ] NO [X]
Indicate the number of shares outstanding of each of the issuer's classes of
common stock, as of the latest practicable date:
11,241,033 shares of Common Stock, no par value, as of September 13, 2009
EXPLANATION PARAGRAPH
As a result of the Proxy Statement being filed on October 14, 2009, the Company
was required to amend its June 30, 2009 Form 10-Q, in accordance with applicable
guidance, to reflect the Discontinued Operations impact resulting from the Asset
Purchase Agreement, for which the Company seeks shareholder approval within such
Proxy.
IVIVI TECHNOLOGIES, INC.
INDEX
Part I. Financial Information Page No.
Item 1. Financial Statements:
Balance Sheets as of June 30, 2009 (Unaudited) and
March 31, 2009 3
Statements of Operations for the three months ended
June 30, 2009 and 2008 (Unaudited) 4
Statement of Stockholders' Equity for the three months
ended June 30, 2009 (Unaudited) 5
Statements of Cash Flows for the three months ended
June 30, 2009 and 2008 (Unaudited) 6
Notes to the Financial Statements (Unaudited) 7
Item 2. Management's Discussion and Analysis of Financial Condition
and Results of Operations 30
Item 3. Quantitative and Qualitative Disclosures about Market Risk 47
Item 4. Controls and Procedures 47
Part II. Other Information 49
Item 1. Legal Proceedings 49
Item 1A. Risk Factors 50
Item 6. Exhibits 51
Signatures 55
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PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
IVIVI TECHNOLOGIES, INC.
BALANCE SHEETS
JUNE 30, 2009 MARCH 31, 2009
----------------------------------------
(See Note 1)
----------------------------------------
(UNAUDITED)
ASSETS
Current assets:
Assets of discontinued operations $ 1,313,206 $ 894,660
Assets of discontinued operations, held for sale 1,555,924 1,470,125
------------------- -------------------
Total assets $ 2,869,130 $ 2,364,785
=================== ===================
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Liabilities of discontinued operations $ 1,813,310 $ 1,413,688
------------------- -------------------
Stockholders' equity:
Preferred stock, no par value, 5,000,000 shares
authorized, no shares issued and outstanding - -
Common stock, no par value; 70,000,000 shares
authorized, 11,241,033 and 11,241,033 shares issued
and outstanding, respectively 26,199,461 26,199,461
Additional paid-in capital 15,349,520 13,398,213
Accumulated deficit (40,395,661) (38,549,077)
Treasury stock, at cost, 650,000 and 650,000 shares
outstanding, respectively (97,500) (97,500)
------------------- -------------------
Total Stockholders' Equity 1,055,820 951,097
------------------- -------------------
Total Liabilities and Stockholders' Equity $ 2,869,130 $ 2,364,785
=================== ===================
The accompanying notes are an integral part of these unaudited financial statements.
3
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IVIVI TECHNOLOGIES, INC.
STATEMENTS OF OPERATIONS
FOR THE THREE MONTHS ENDED JUNE 30,
(UNAUDITED)
2009 2008
------------------- -------------------
(See Note 1)
------------------- -------------------
Continuing Operations $ - $ -
------------------- -------------------
Discontinued Operations:
Operating loss (1,292,449) (2,247,475)
Interest income 3,711 45,160
Interest expense (557,846) -
------------------- -------------------
Loss from discontinued operations (1,846,584) (2,202,315)
------------------- -------------------
Net loss $ (1,846,584) $ (2,202,315)
=================== ===================
Net loss per share, basic and diluted:
Loss from Continuing Operations $ - $ -
Loss from Discontinued Operations (0.16) (0.21)
------------------- -------------------
Net loss $ (0.16) $ (0.21)
=================== ===================
Weighted average shares outstanding 11,241,033 10,715,130
=================== ===================
The accompanying notes are an integral part of these unaudited financial statements.
4
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IVIVI TECHNOLOGIES, INC.
STATEMENTS OF STOCKHOLDERS' EQUITY
FOR THE THREE MONTHS ENDED JUNE 30, 2009
(UNAUDITED)
Common Stock Additional Total
----------------------------- Paid-In Accumulated Treasury Stockholders'
Shares Amount Capital Deficit Stock Equity
------------ ------------ ------------ ------------ ------------ ------------
Balance - April 1, 2009 11,241,033 $ 26,199,461 $ 13,398,213 $(38,549,077) $ (97,500) $ 951,097
Issuance of convertible debt
to Emigrant Capital Corp.,
net of issuance costs of
$180,000 1,820,000 1,820,000
Share based compensation 131,307 131,307
Net loss (1,846,584) (1,846,584)
------------ ------------ ------------ ------------ ------------ ------------
Balance - June 30, 2009 11,241,033 $ 26,199,461 $ 15,349,520 $(40,395,661) $ (97,500) $ 1,055,820
============ ============ ============ ============ ============ ============
The accompanying notes are an integral part of these unaudited financial statements.
5
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IVIVI TECHNOLOGIES, INC.
STATEMENTS OF CASH FLOWS
FOR THE THREE MONTHS ENDED JUNE 30,
(UNAUDITED)
2009 2008
--------------------- --------------------
(See Note 1)
-------------------------------------------
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss $ (1,846,584) $ (2,202,315)
Less: Loss from discontinued operations (1,846,584) (2,202,315)
--------------------- --------------------
Net cash flow result of continuing operations - -
--------------------- --------------------
CASH FLOWS FROM DISCONTINUED OPERATIONS:
Adjustments to reconcile net loss from discontinued
operations to net cash used by discontinued operations:
Depreciation and amortization 28,500 69,365
Share based compensation 131,307 309,535
Amortization of deferred revenue - (15,625)
Accretion of debt discount 493,096 -
Bad debt recovery (40,500) -
Other - (715)
Changes in asset and liability components of discontinued
operations:
(Increase) decrease in:
Accounts receivable 9,310 187,193
Deposits with and amounts due from affiliate 31,766 96,664
Inventory (16,835) (138,312)
Equipment in use and under rental agreements 4,764 (7,570)
Prepaid expenses and other current assets 101,560 28,177
Decrease in:
Accounts payable and accrued expenses (93,474) (34,109)
--------------------- --------------------
(1,197,090) (1,707,712)
--------------------- --------------------
CASH FLOWS FROM INVESTING ACTIVITIES OF DISCONTINUED OPERATIONS:
Purchases of property and equipment - (7,975)
Increase in restricted cash (271) -
Payments for patents and trademarks (71,038) (96,218)
--------------------- --------------------
(71,309) (104,193)
--------------------- --------------------
CASH FLOWS FROM FINANCING ACTIVITIES OF DISCONTINUED OPERATIONS:
Proceeds from issuance of convertible debt to Emigrant
Capital Corp., net of issuance costs of $180,000 1,820,000 -
--------------------- --------------------
1,820,000 -
--------------------- --------------------
Net change in cash and cash equivalents attributable to
continuing operations - -
--------------------- --------------------
Net increase (decrease) in cash and cash equivalents attributable to
discontinued operations 551,601 (1,811,905)
Cash and cash equivalents included in assets of discontinued
operations:
beginning of period 220,136 6,600,154
--------------------- --------------------
end of period $ 771,737 $ 4,788,249
===================== ====================
The accompanying notes are an integral part of these unaudited financial statements.
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IVIVI TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS
JUNE 30, 2009
(UNAUDITED)
NOTE 1 -- BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES
BASIS OF PRESENTATION
The accompanying financial statements have been prepared in accordance with
accounting principles generally accepted in the United States of America for
interim financial information and the instructions to Form 10-Q for smaller
reporting companies (as defined in Rule 12b-2 of the Exchange Act) and do not
include all the information and footnotes required by accounting principles
generally accepted in the United States of America for complete financial
statements. In the opinion of management, all adjustments (consisting of normal
recurring accruals) considered necessary for a fair presentation of the results
for the interim periods have been included. Operating results for the three
months ended June 30, 2009 are not necessarily indicative of the results that
may be expected for the fiscal year ending March 31, 2010.
The accompanying financial statements and related notes and the information
included under the heading "Management's Discussion and Analysis of Financial
Condition and Results of Operations" should be read in conjunction with our
audited financial statements and related notes thereto included on our Annual
Report on Form 10-K for the fiscal year ended March 31, 2009.
RECLASSIFICATION OF HISTORICAL FINANCIAL STATEMENTS
The condensed financial statements have been reclassified as of June 30, 2009,
and March 31, 2009, and for the three months ended June 30, 2009 and 2008, to
reflect the Company's entering into an Asset Purchase Agreement as of September
24, 2009 ("APA", all as more fully disclosed below), pursuant to which , upon
completion of the transactions subject to the Asset Purchase Agreement, the
Company will effectively dispose of all its assets of a continuing business
nature, with such assets being reflected as "Assets of Discontinued Operations,
Held for Sale". The balance of the Company's assets will be collected,
liquidated and/or amortized, with available proceeds being used to service the
remaining liabilities from discontinued operations. Principally, all proceeds
from the disposition of assets under the APA will be used to service principal
maturities, and related interest arising from the Company's convertible debt
obligations to Emigrant Capital Corp.
The resulting discontinued operations adjustments discussed above have had no
impact on previously reported total assets, equity, revenues and net loss; such
presentation is a reporting requirement resulting from the proxy statement
requiring shareholder vote on the APA.
7
IVIVI TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS
JUNE 30, 2009
(UNAUDITED)
The effect of the reclassifications on the Company's condensed financial
statements as of June 30, 2009, and for the three month periods ended June 30,
2009 and 2008 are set forth below:
UNAUDITED BALANCE SHEET
RECLASSIFICATIONS AS AT: JUNE 30, 2009
---------------------------------------------------------------
(As Originally Adj. (Reclass-
Reported) No. ifications) (Reclassified)
---------------------------------------------------------------
Current assets:
Cash and cash equivalents $ 771,737 2 $ (771,737) $ -
Accounts receivable, net 129,504 1 (129,504) -
Inventory 117,081 1 (117,081) -
Deposits with and amounts due from affiliate 72,555 2 (72,555) -
Prepaid insurance 61,989 2 (61,989) -
Prepaid expenses 7,213 2 (7,213) -
Receivable relating to litigation settlement 350,000 2 (350,000) -
Assets of discontinued operations - 2 1,313,206 1,313,206
Assets of discontinued operations, held
for sale - 1 1,555,924 1,555,924
------------------ ------------------ ------------------
Total current assets 1,510,079 1,359,051 2,869,130
Property and equipment, net 289,836 1 (289,836) -
Equipment in use or under rental agreements, net 25,720 1 (25,720) -
Inventory long-term, net 111,243 1 (111,243) -
Intangible assets, net 882,540 1 (882,540) -
Restricted cash 49,712 2 (49,712) -
------------------ ------------------ ------------------
Total Assets $ 2,869,130 $ - $ 2,869,130
================== ================== ==================
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued expenses $ 1,284,574 3 $ (1,284,574) $ -
Convertible debt 493,096 3 (493,096) -
Liabilities of discontinued operations - 3 1,813,310 1,813,310
------------------ ------------------ ------------------
Total current liabilities 1,777,670 35,640 1,813,310
------------------ ------------------ ------------------
Deferred revenue 35,640 3 (35,640) -
------------------ ------------------ ------------------
Stockholders' Equity:
Common stock, no par value 26,199,461 26,199,461
Additional paid-in capital 15,349,520 15,349,520
Accumulated deficit (40,395,661) (40,395,661)
Treasury stock, at cost (97,500) (97,500)
------------------ ------------------ ------------------
Total Stockholders' Equity 1,055,820 - 1,055,820
------------------ ------------------ ------------------
Total Liabilities and Stockholders' Equity $ 2,869,130 $ - $ 2,869,130
================== ================== ==================
8
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BALANCE SHEET RECLASSIFICATIONS AS AT: MARCH 31, 2009
---------------------------------------------------------------
(As Originally Adj. (Reclass-
Reported) No. ifications) (Reclassified)
---------------------------------------------------------------
Current assets:
Cash and cash equivalents $ 220,136 2 $ (220,136) $ -
Accounts receivable, net 98,314 1 (98,314) -
Inventory 178,379 1 (178,379) -
Deposits with and amounts due from affiliate 104,321 2 (104,321) -
Prepaid insurance 86,708 2 (86,708) -
Prepaid expenses 53,646 2 (53,646) -
Receivable relating to litigation settlement 350,000 2 (350,000) -
Other current assets 30,408 2 (30,408) -
Assets of discontinued operations - 2 894,660 894,660
Assets of discontinued operations,
held for sale - 1 1,470,125 1,470,125
- -
------------------ ------------------ ------------------
Total current assets 1,121,912 1,242,873 2,364,785
Property and equipment, net 313,413 1 (313,413) -
Equipment in use or under rental agreements, net 34,656 1 (34,656) -
Inventory long-term, net 33,110 1 (33,110) -
Intangible assets, net 812,253 1 (812,253) -
Restricted cash 49,441 2 (49,441) -
------------------ ------------------ ------------------
Total Assets $ 2,364,785 $ - $ 2,364,785
================== ================== ==================
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued expenses $ 1,378,048 3 $ (1,378,048) $ -
Liabilities of discontinued operations - 3 1,413,688 1,413,688
------------------ ------------------ ------------------
Total current liabilities 1,378,048 35,640 1,413,688
------------------ ------------------ ------------------
Deferred revenue 35,640 3 (35,640) -
------------------ ------------------ ------------------
Stockholders' Equity:
Common stock, no par value 26,199,461 26,199,461
Additional paid-in capital 13,398,213 13,398,213
Accumulated deficit (38,549,077) (38,549,077)
Treasury stock, at cost (97,500) (97,500)
------------------ ------------------ ------------------
Total Stockholders' Equity 951,097 - 951,097
------------------ ------------------ ------------------
Total Liabilities and Stockholders' Equity $ 2,364,785 $ - $ 2,364,785
================== ================== ==================
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THREE MONTHS ENDED JUNE 30, 2009
---------------------------------------------------------------
(As Originally Adj. (Reclass-
Reported) No. ifications) (Reclassified)
---------------------------------------------------------------
Revenue - Continuing operations:
Rentals $ 4,380 4 $ (4,380) $ -
Direct sales 38,701 4 (38,701) -
Sales and revenue share on RecoverCare
contract 91,277 4 (91,277) -
Revenue - Discontinued operations: - 4 134,358 134,358
------------------ ------------------ ------------------
Total Revenue - Continuing Operations 134,358 (134,358) -
------------------ ------------------ ------------------
Total Revenue - Discontinued Operations - 134,358 134,358
------------------ ------------------ ------------------
Costs and expenses - Continuing operations:
Cost of rentals - 4 - -
Cost of direct sales 6,308 4 (6,308) -
Cost of sales on RecoverCare contract 12,373 4 (12,373) -
Cost of licensing sales on Allergan contract - 4 - -
Loss on termination of Allergan contract - 4 - -
Research and development 493,755 4 (493,755) -
Sales and marketing 92,571 4 (92,571) -
General and administrative 821,800 4 (821,800) -
Costs and expenses - Discontinued operations: - 4 1,426,807 1,426,807
------------------ ------------------ ------------------
1,426,807 - 1,426,807
------------------ ------------------ ------------------
Operating Loss:
Loss from continuing operations (1,292,449) 1,292,449 -
------------------ ------------------ ------------------
Loss from discontinued operations - (1,292,449) (1,292,449)
------------------ ------------------ ------------------
Interest income - continuing operations 3,711 4 (3,711) -
Interest expense - continuing operations (557,846) 4 557,846 -
Interest income - discontinued operations - 4 3,711 3,711
Interest expense - discontinued operations - 4 (557,846) (557,846)
------------------ ------------------ ------------------
Net Loss from continuing operations (1,846,584) 1,846,584 -
------------------ ------------------ ------------------
Net Loss from discontinued operations - (1,846,584) (1,846,584)
------------------ ------------------ ------------------
Net loss $ (1,846,584) $ - $ (1,846,584)
================== ================== ==================
NET LOSS PER SHARE, BASIC AND DILUTED:
Loss from Continuing Operations $ (0.16) $ 0.16 $ -
================== ================== ==================
Loss from Discontinued Operations $ - $ (0.16) $ (0.16)
================== ================== ==================
Weighted average shares outstanding 11,241,033 - 11,241,033
================== ================== ==================
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THREE MONTHS ENDED JUNE 30, 2008
---------------------------------------------------------------
---------------------------------------------------------------
(As Originally Adj. (Reclass-
Reported) No. ifications) (Reclassified)
---------------------------------------------------------------
Revenue - Continuing operations:
Rentals $ 168,736 4 $ (168,736) $ -
Direct sales 99,049 4 (99,049) -
Sales and revenue share on RecoverCare contract - 4 - -
Licensing sales and fess 115,411 4 (115,411) -
Revenue - Discontinued operations: - 4 383,196 383,196
------------------ ------------------ ------------------
Total Revenue - Continuing Operations 383,196 (383,196) -
------------------ ------------------ ------------------
Total Revenue - Discontinued Operations - 383,196 383,196
------------------ ------------------ ------------------
Costs and expenses - Continuing operations:
Cost of rentals 10,214 4 (10,214) -
Cost of direct sales 12,260 4 (12,260) -
Cost of licensing sales on Allergan contract 129,770 4 (129,770) -
Research and development 531,068 4 (531,068) -
Sales and marketing 677,222 4 (677,222) -
General and administrative 1,270,137 4 (1,270,137) -
Costs and expenses - Discontinued operations: - 4 2,630,671 2,630,671
------------------ ------------------ ------------------
2,630,671 - 2,630,671
------------------ ------------------ ------------------
Operating Loss:
Loss from continuing operations (2,247,475) 2,247,475 -
------------------ ------------------ ------------------
Loss from discontinued operations - (2,247,475) (2,247,475)
------------------ ------------------ ------------------
Interest income - continuing operations 45,160 4 (45,160) -
Interest income - discontinued operations - 4 45,160 45,160
------------------ ------------------ ------------------
Net Loss from continuing operations (2,202,315) 2,202,315 -
------------------ ------------------ ------------------
Net Loss from discontinued operations - (2,202,315) (2,202,315)
------------------ ------------------ ------------------
Net loss $ (2,202,315) $ - $ (2,202,315)
================== ================== ==================
NET LOSS PER SHARE, BASIC AND DILUTED:
Loss from Continuing Operations $ (0.21) $ 0.21 $ -
================== ================== ==================
Loss from Discontinued Operations $ - $ (0.21) $ (0.21)
================== ================== ==================
Weighted average shares 10,715,130 - 10,715,130
================== ================== ==================
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RECLASSIFICATION ADJUSTMENTS TO REFLECT THE ASSET PURCHASE AGREEMENT ("APA") AND
CONTEMPLATED DISCONTINUANCE OF BUSINESS ACTIVITIES: JUNE 30, 2009 MARCH 31, 2009
----------------------------- -----------------------------
DR CR DR CR
----------------------------- -----------------------------
ADJUSTMENT NUMBER 1
----------------------------------
Assets of discontinued operations, held for sale 1,555,924 1,470,125
Accounts receivable, net 129,504 98,314
Inventory 117,081 178,379
Property and equipment, net 289,836 313,413
Equipment in use or under rental agreements, net 25,720 34,656
Inventory long-term, net 111,243 33,110
Intangible assets, net 882,540 812,253
To record assets held for sale under APA from discontinued operations
ADJUSTMENT NUMBER 2
----------------------------------
Assets of discontinued operations,
retained, to be collected and/or liquidated, in partial
settlement of liabilities of discontinued operations 541,469 674,524
Assets of discontinued operations, cash 771,737 220,136
Total assets of discontinued operations not held for sale 1,313,206 894,660
Deposits with and amounts due from affiliate 72,555 104,321
Prepaid insurance 61,989 86,708
Prepaid expenses 7,213 53,646
Receivable relating to litigation settlement 350,000 350,000
Other current assets - 30,408
Restricted cash 49,712 49,441
Cash and cash equivalents 771,737 220,136
To record assets from discontinued operations, not held for sale
ADJUSTMENT NUMBER 3
----------------------------------
Accounts payable and accrued expenses 1,284,574 1,378,048
Convertible debt 493,096 -
Deferred revenue 35,640 35,640
Liabilities of discontinued operations 1,813,310 1,413,688
To record reclassification of liabilities to discontinued operations, not held for sale
ADJUSTMENT NUMBER 4
----------------------------------
Revenues - Continuing Operations:
Rentals 4,380 168,736
Direct sales 38,701 99,049
Sales and revenue share on RecoverCare contract 91,277 -
Licensing sales and fess - 115,411
Costs and expenses - Continuing operations:
Cost of rentals - 10,214
Cost of direct sales 6,308 12,260
Cost of sales on RecoverCare contract 12,373 -
Cost of licensing sales on Allergan contract - 129,770
Research and development 493,755 531,068
Sales and marketing 92,571 677,222
General and administrative 821,800 1,270,137
Interest income - continuing operations 3,711 45,160
Interest expense - continuing operations 557,846 -
Discontinued Operations:
Revenues 134,358 383,196
Costs and expenses 1,426,807 2,630,671
Interest income - continuing operations 3,711 45,160
Interest expense - continuing operations 557,846 -
To record reclassification of operations to discontinued operations
12
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IVIVI TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS
JUNE 30, 2009
(UNAUDITED)
GOING CONCERN
The accompanying financial statements have been prepared on a going concern
basis, which contemplates the realization of assets and the settlement of
liabilities and commitments in the normal course of business. As reflected in
the accompanying financial statements, we had a net loss of $1,846,584 and
$2,202,315 (all of which resulted from our discontinued operations),
respectively, for the quarters ended June 30, 2009 and 2008 and a working
capital deficiency from discontinued operations of $267,591 at June 30, 2009,
prior to our decision to cease operations. We had a net loss of $7,333,604 and
$7,503,091, respectively, (all of which resulted from our discontinued
operations), for the fiscal years ended March 31, 2009 and 2008, and a
corresponding working capital deficit of $256,136 at March 31, 2009, also prior
to our decision to cease operations. At June 30, 2009, we had cash balances of
approximately $772,000 (included in "Assets of Discontinued Operations" not held
for sale) which is not sufficient to meet our current cash requirements for the
next twelve months, subsequent to the filing of this Form 10-Q/A on October 13,
2009.
EMIGRANT CAPITAL CORP. DEBT AND FORBEARANCE AGREEMENT
On April 7, 2009, we closed on a $2.5 million loan with Emigrant Capital Corp.
(see Note 2 - Loan Agreement). However, we were not able to generate sufficient
cash flow from our operations to repay principal on this loan of $2,500,000 plus
interest on August 30, 2009.
On September 2, 2009, we announced that we had entered into a Forbearance
Agreement (the "Forbearance Agreement") dated August 31, 2009 with Emigrant
Capital Corp. (the "Lender"). Pursuant to the terms of the Forbearance
Agreement, the Lender had agreed to forbear, through September 9, 2009 (unless a
termination event occurred under the Forbearance Agreement), from requiring us
to repay the principal and interest due under the Convertible Promissory Note
(the "Note") in the principal amount of $2.5 million. The maturity date under
the Note was August 30, 2009.
The Forbearance Agreement also provides for an increase in the interest rate
under the Note to the lesser of (i) 18% or (ii) the maximum rate permitted by
law during the forbearance period. The Lender agreed to the forbearance in order
to provide us with the ability to continue (i) negotiating the Asset Purchase
Agreement transaction with entities controlled by, or associated with Mr. Steven
M. Gluckstern (all as more fully described below), our Chairman, President,
Chief Executive Officer and Chief Financial Officer, and (ii) solicit other
proposals.
The Forbearance Agreement was amended on September 9, 14, 21, and on September
24, 2009, we announced that we had successfully negotiated the currently
governing Amended and Restated Forbearance Agreement, where the Lender agreed to
extend forbearance through November 30, 2009, allowing us to complete the
transactions described in the Asset Purchase Agreement, as more fully described
below. Other than the changes in the forbearance periods, as described above,
there were no other amendments or changes to the Forbearance Agreement.
13
IVIVI TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS
JUNE 30, 2009
(UNAUDITED)
On September 24, 2009 we executed an Asset Purchase Agreement (the "Asset
Purchase Agreement") with Ivivi Technologies, LLC (the "Buyer") an entity
associated with Steven M. Gluckstern, our Chairman, President, Chief Executive
Officer and Chief Financial Officer and Ajax Capital, LLC ("Ajax"), an entity
controlled by Steven M. Gluckstern. Pursuant to the terms of such Asset Purchase
Agreement, at the closing, we would sell substantially all of our assets to the
Buyer, other than cash and certain other excluded assets, and the Buyer would
assume certain specified ordinary course liabilities of ours as set forth in
such Asset Purchase Agreement. The aggregate purchase price to be paid to us
under the terms of the Asset Purchase Agreement is expected to equal the sum of
(i) the amount necessary to pay in full the principal, and accrued interest, as
of closing, under our loan with the Lender, which was approximately $2.7 million
as of September 30, 2009 (the "Loan") and (ii) additional cash, however, that
the sum of the amounts specified in clauses (i) and (ii) would not be in excess
of $3.15 million. The closing of the transactions contemplated by the Asset
Purchase Agreement would be subject to certain customary conditions, including
the receipt of approval by our shareholders of the transactions contemplated by
the Asset Purchase Agreement.
Under the terms of the Asset Purchase Agreement, we continue to have the right
to solicit other proposals regarding the sale of our assets and equity until
receipt of the approval by our shareholders of the transactions contemplated by
such Asset Purchase Agreement. Prior to the receipt of approval by our
shareholders, we also maintain the right to terminate the transaction under
specified circumstances in order to enter into a definitive agreement
implementing a Superior Proposal (as defined in the Asset Purchase Agreement).
If we terminate the transaction and enter into a Superior Proposal, we would be
required to pay the Buyer a $90,000 termination fee
14
IVIVI TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
JUNE 30, 2009
(UNAUDITED)
In connection with the signing of the Asset Purchase Agreement, we, the Buyer,
and certain of our shareholders, who have the power to vote approximately 39.5%
(and together with our common stock held by Steven M. Gluckstern, approximately
51.3%) of our common stock, entered into a Voting Agreement (each, a "Voting
Agreement"). Pursuant to each Voting Agreement, the signatory shareholders agree
to vote their shares of our common stock in favor of the transactions
contemplated by the Asset Purchase Agreement. In the event that we terminate the
transactions with the Buyer in connection with a Superior Proposal, the Voting
Agreements would also terminate.
There can be no assurance that we will be able to complete the transactions
contemplated by the Asset Purchase Agreement. In the event the transaction with
the Buyer is completed, following the closing, it is likely that our liabilities
will exceed our available cash and our board of directors may elect to liquidate
us and utilize our available cash and assets to repay our outstanding creditors
to the extent of our, then, remaining assets and distribute such remaining
assets, if any, to our shareholders. We anticipate the settling and payment of
liabilities will exhaust our available liquidity.
In addition, following the closing we will remain liable under our lease for our
Montvale, New Jersey office. The lease, which has a monthly rent of $15,613,
will terminate in October 2014. We are currently discussing options with the
landlord.
In the event we do not successfully complete the transactions contemplated by
the Asset Purchase Agreement or complete another transaction, we will not be
able to meet our obligations under the Loan and the Lender will have the right
to foreclose under the Loan, which is secured by all of our assets. In such an
event, we would have to cease our operations or file for bankruptcy protection.
15
IVIVI TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
JUNE 30, 2009
(UNAUDITED)
In the fourth quarter of the fiscal year ended March 31, 2008, we retained two
firms, including Foundation, to assist us in pursuing alternative strategies and
financings relating to our business. In December 2008, we terminated our
relationship with one of the firms. Through June 30, 2009, we paid $130,000 and
issued warrants to one of the entities including $100,000 of fees relating to
our Loan Agreement. Additional fees of $150,000 were paid to these entities
subsequent to June 30, 2009, including $125,000 of fees relating to our current
transaction being negotiated. Additional fees may be due to Foundation in the
event of a Superior Proposal or other future successful financing or other
transactions by us.
These factors, among others, raise substantial doubt about our ability to
continue as a going concern, which will be dependent on our ability to raise
additional funds to finance our operations or seek alternative transactions. The
accompanying financial statements do not include any adjustments that might be
necessary if we are unable to continue as a going concern.
16
IVIVI TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
JUNE 30, 2009
(UNAUDITED)
ORGANIZATIONAL MATTERS
ORGANIZATION
Ivivi Technologies, Inc. ("We", "Us", "the Company" or "Ivivi"), formerly AA
Northvale Medical Associates, Inc., was incorporated under the laws of the state
of New Jersey on March 9, 1989. We are authorized under our Certificate of
Incorporation to issue 70,000,000 common shares, no par value, and 5,000,000
preferred shares, no par value.
NATURE OF BUSINESS
Prior to executing the Asset Purchase Agreement on September 24, 2009 and the
recognition of discontinued operations reporting, the following describes the
nature of our historical business.
We sell and rent non-invasive electro-therapeutic medical devices. These
products are sold or rented primarily through our distributors and customers
located in the United States with additional markets in Mexico.
Our medical devices are subject to extensive and rigorous regulation by the FDA,
as well as other federal and state regulatory bodies. On December 15, 2008, we
announced that we had received FDA 510(k) clearance for our currently marketed
targeted pulsed electromagnetic field (tPEMF(TM)) therapeutic products.
NASDAQ DELISTING
On June 23, 2009, our common stock was suspended from trading on the Nasdaq
Stock Market. On June 26, 2009, our common stock commenced trading on the OTC
Bulletin Board under the symbol IVVI.OB.
FDA MATTERS
On April 3, 2008, we filed a 510(k) submission with the Food and Drug
Administration (FDA) for a small, compact transcutaneous electrical nerve
stimulation(TENS)product utilizing our targeted pulsed electromagnetic field
(tPEMF) therapy technology for the symptomatic relief and management of chronic,
intractable pain, for relief of pain associated with arthritis and for the
adjunctive treatment of post-surgical and post-trauma acute pain. The FDA
requested additional information from us in a letter dated April 25, 2008.
During October 2008, we requested a voluntary withdrawal of this 510(k).
On December 15, 2008, we announced that we had received FDA 510(k) marketing
clearance for our currently marketed tPEMF therapeutic SofPulse products.
17
IVIVI TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
JUNE 30, 2009
(UNAUDITED)
On April 9, 2009, the FDA issued an order to manufacturers of remaining
pre-amendments class III devices (including shortwave diathermy devices not
generating deep heat, which is the classification for our SofPulse devices) for
which regulations requiring submission of Premarket Approval Applications (PMA)
have not been issued. The order requires the manufacturers to submit to the FDA,
a summary of, and a citation to, any information known or otherwise available to
them respecting such devices, including adverse safety or effectiveness
information concerning the devices which has not been submitted under the
Federal Food, Drug, and Cosmetic Act. The FDA is requiring the submission of
this information in order to determine, for each device, whether the
classification of the device should be revised to require the submission of a
PMA or a notice of completion of a Product Development Protocol ("PDP"), or
whether the device should be reclassified into class I or II. Summaries and
citations were due by August 7, 2009. We submitted our summary with citations to
the FDA on August 7, 2009 for our shortwave diathermy devices not generating
deep heat, complying with this order. Our products are being marketed during
this process.
On July 2, 2009, we filed a 510(k) submission for marketing clearance with the
FDA for a TENS device known as ISO-TENS which uses tPEMF technology. This new
device is proposed for commercial distribution for the symptomatic relief of
chronic intractable pain; adjunctive treatment of post-surgical or post
traumatic acute pain; and adjunctive therapy in reducing the level of pain
associated with arthritis. We believe the ISO-TENS will enable penetration into
various chronic pain markets if FDA clearance is obtained. The FDA requested
additional information related to this submission which has been provided.
Pursuant to the terms of the APA we will transfer our rights under all of our
FDA approved devices, and form 510(k)submissions to the Buyer.
FAIR VALUE OF FINANCIAL INSTRUMENTS
FASB No. 157, "Fair Value Measurements" (Statement No. 157), which defines fair
value, establishes a framework for measuring fair value, and expands disclosures
about fair value measurements. Statement No. 157 applies to other accounting
pronouncements that require or permit fair value measurements and does not
require any new fair value measurements. In February 2008, the FASB issued FASB
Staff Position 157-2, which provides for a one-year deferral of the provisions
of Statement No. 157 for non-financial assets and liabilities that are
recognized or disclosed at fair value in the financial statements on a
non-recurring basis. Effective April 1, 2008, we adopted the provisions of
Statement No. 157 for financial assets and liabilities, as well as for any other
assets and liabilities that are carried at fair value on a recurring basis. The
adoption of the provisions of Statement No. 157 related to financial assets and
liabilities and other assets and liabilities that are carried at fair value on a
recurring basis did not materially impact the company's financial position and
18
IVIVI TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
JUNE 30, 2009
(UNAUDITED)
results of operations. For certain of our financial instruments, including
accounts receivable, inventories, accounts payable and accrued expenses, the
carrying amounts approximate fair value due to their relatively short
maturities.
In February 2007, the Financial Accounting Standards Board issued Statement of
Financial Accounting Standards No. 159 ("FAS 159"), "The Fair Value Option for
Financial Assets and Financial Liabilities", which permits entities to choose to
measure many financial instruments and certain other items at fair value which
are not currently required to be measured at fair value. Effective April 1,
2008, we adopted the provisions of Statement No. 159 for financial assets and
liabilities. The adoption of the provisions of Statement No. 159 related to
financial assets and liabilities that are carried at fair value on a recurring
basis did not materially impact the company's financial position and results of
operations.
INTANGIBLE ASSETS OF DISCONTINUED OPERATIONS, HELD FOR SALE
Intangible assets consist of patents and trademarks of $882,540, net of
accumulated amortization of $82,392 at June 30, 2009. Amortization expense of
patent and trademarks totaled $751 and $23,027 for the quarters ended June 30,
2009 and 2008, respectively. Patents and trademarks are amortized over their
legal life once they are issued by the U.S. or other governmental patent and
trademark office. The Company contemplates the sale of the intangible assets
pursuant to the APA discussed above, in this note 1.
19
IVIVI TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
JUNE 30, 2009
(UNAUDITED)
ACCOUNTS PAYABLE AND ACCRUED EXPENSES OF DISCONTINUED OPERATIONS
At June 30, 2009, accounts payable and accrued expenses consisted of the
following:
Total
-----
Research and development $ 450,007
Professional fees 341,004
Intellectual Property 101,877
Compensation and Employee Benefits 73,322
Insurances 67,938
Interest on convertible debt 64,750
Consulting 44,027
Accrued rent 34,112
Deposits with RecoverCare 14,445
Other 93,092
------------
Total accounts payable and accrued
expenses of discontinued operations $ 1,284,574
============
|
At June 30, 2009, our Balance Sheet included $14,445 of deposits received from
RecoverCare which is the upfront fee of $535 for each of the 27 Roma units held
by RecoverCare on that date and which were not placed into service by them at
June 30, 2009.
LOSS PER SHARE - CONTINUING AND DISCONTINUED OPERATIONS
We use SFAS No. 128, "Earnings Per Share" for calculating the basic and diluted
loss per share. We compute basic loss per share by dividing net loss and net
loss attributable to common shareholders by the weighted average number of
common shares outstanding. Diluted loss per share is computed similar to basic
loss per share except that the denominator is increased to include the number of
additional common shares that would have been outstanding if the potential
shares had been issued and if the additional shares were dilutive. Common
equivalent shares are excluded from the computation of net loss per share since
their effect is anti-dilutive.
Per share basic and diluted net loss from discontinued operations amounted to
$0.16 for the quarter ended June 30, 2009 and $0.21 for the quarter ended June
30, 2008. There were 6,363,534 potential shares and 6,068,656 potential shares
that were excluded from the shares used to calculate diluted earnings per share,
as their inclusion would reduce net loss per share, for the quarters ended June
30, 2009 and 2008, respectively.
20
IVIVI TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
JUNE 30, 2009
(UNAUDITED)
COMMON SHARE OPTIONS AND WARRANTS ISSUED SHARE BASED COMPENSATION
We follow the provisions of SFAS 123(R) "SHARE-BASED PAYMENT," using the
modified prospective method. Under this method, we recognized compensation cost
based on the grant date fair value, using the Black Scholes option value model,
for all share-based payments granted on or after April 1, 2006 plus any awards
granted to employees prior to April 1, 2006 that remained unvested at that time.
We use the fair value method for equity instruments granted to non-employees and
use the Black Scholes option value model for measuring the fair value of
warrants and options. The share-based fair value compensation is determined as
of the date of the grant or the date at which the performance of the services is
completed (measurement date) and is recognized over the periods in which the
related services are rendered.
As of June 30, 2009, we have used the following assumptions in the Black Scholes
option pricing model: (i) dividend yield of 0%; (ii) expected volatility of
44%-287.5%; (iii) average risk free interest rate of 1.78%-5.03%; (iv) expected
life of 1 to 6.5 years; and (v) estimated forfeiture rate of 5%. The foregoing
option valuation model requires input of highly subjective assumptions. Because
common share purchase options granted to employees and directors have
characteristics significantly different from those of traded options, and
because changes in the subjective input assumptions can materially affect the
fair value of estimates, the existing model does not, in the opinion of our
management, necessarily provide a reliable single measure of the fair value of
common share purchase options we have granted to our employees and directors.
During the quarters ended June 30, 2009 and 2008, our share based compensation
expense was allocated to the following component accounts of discontinued
operations:
2009 2008
-------- --------
Cost of rentals $ -- $ 11
Research and development 25,015 16,858
Sales and marketing 18,458 20,878
General and administrative 87,834 271,788
-------- --------
$131,307 $309,535
======== ========
|
21
IVIVI TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
JUNE 30, 2009
(UNAUDITED)
NOTE 2 - LOAN AGREEMENT
On April 7, 2009, we closed on our $2.5 million loan (the "Financing") with the
Lender. Under the terms of the loan agreement (the "Loan Agreement"), as of the
date of this filing, we have borrowed an aggregate of $2.5 million. Borrowings
under the Financing are evidenced by a note (the "Note"), which bears interest
at a rate of 12% per annum (which increased to 18% after August 30, 2009 in
accordance with the terms of the Note and in connection with the Forbearance
Agreement described in Note 1). The Note is currently convertible into our
common stock at a conversion price of $0.23 per share.
In connection with the Financing, we issued warrants to the Lender (the
"Warrants"). The Warrants are currently exercisable for $3.0 million of our
common stock at an exercise price of $0.23 per share. The Warrants also provide
for cashless exercise.
In addition to customary mechanical adjustments with respect to stock splits,
reverse stock splits, recapitalizations, stock dividends, stock combinations and
similar events, the Note and the Warrants provide for certain "weighted average
anti-dilution" adjustments whereby if shares of our common stock or other
securities convertible into or exercisable or exchangeable for shares of our
common stock (such other securities, including, without limitation, convertible
notes, options, stock purchase rights and warrants, "Convertible Securities")
are issued by us other than in connection with certain excluded securities (as
defined in the Note and the Warrant and which include a Qualified Financing and
stock awards under our 2009 Equity Incentive Stock Plan), the conversion price
of the Note and the Warrants will be reduced to reflect the "dilutive" effect of
each such issuance (or deemed issuance upon conversion, exercise or exchange of
such Convertible Securities) of our common stock relative to the holders of the
Note and the Warrants.
22
IVIVI TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
JUNE 30, 2009
(UNAUDITED)
Because the convertible debentures included detachable warrants that were
immediately exercisable at an exercise price on the date of loan at $0.23 per
share, which was less than the market value of the shares on that date of $0.29
per share, we determined that warrants to have fair value utilizing the
Black-Scholes option-pricing model in excess of the notes' proceeds of
$2,500,000. We have used the following assumptions in the Black Scholes option
pricing model to determine the fair value of the warrants: (i) dividend yield of
0%; (ii) expected volatility of 41%-506%; (iii) average risk free interest rate
of 3.8%; and, (iv) expected life of 5 months. Consequently, we determined that
the value of the warrants to be $2,500,000, the amount of the proceeds of the
convertible note, which we credited to additional paid-in capital. The fair
value of the immediately convertible warrants is being charged to interest
expense and accreted to the convertible debenture in the accompanying financial
statements from the date of the loan, April 7, 2009, to the extended maturity
date of August 30, 2009. For the three months ended June 30, 2009, we charged
$493,096 to interest expense from discontinued operations in our Statement of
Operations. This amount was accreted to the convertible debenture liability, a
liability component of discontinued operations, on our Balance Sheet at June 30,
2009.
In connection with the Financing, Steven Gluckstern, our Chairman, President,
Chief Executive Officer and Chief Financial Officer, and a consultant of ours
(currently one of our employees and an affiliate of the Buyer) entered into a
participation arrangement with the Lender whereby Mr. Gluckstern and the
consultant invested $425,000 and $100,000, respectively with the Lender and
shall have a right to participate with the Lender in the Note and the Warrant.
As a result of such relationship, our Board of Directors, including its
independent members, approved the transactions contemplated by the Loan
Agreement.
NOTE 3 - DEFERRED REVENUE OF DISCONTINUED OPERATIONS
At June 30, 2009, our deferred revenue account balance of $35,640 represents
funds received from a customer for an extended one year service contract fee
beginning October 1, 2009. Beginning October 1, 2009, we will amortize this
amount over 12 months on a straight-line basis, and reflect such revenue in
discontinued operations.
23
IVIVI TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
JUNE 30, 2009
(UNAUDITED)
NOTE 4 - RELATED PARTY TRANSACTIONS
MANAGEMENT SERVICES AGREEMENT
We entered into a management services agreement, dated as of August 15, 2001,
with ADM Tronics Unlimited, Inc. ("ADM) under which ADM provides us and its
subsidiaries, Sonotron Medical Systems, Inc. and Pegasus Laboratories, Inc.,
with management services and allocates portions of its real property facilities
for use by us and the other subsidiaries for the conduct of our respective
businesses. Pursuant to the terms of the APA we will transfer our rights and
obligations under the management services agreement to the Buyer.
The management services provided by ADM under the management services agreement
include administrative, technical, engineering and regulatory services with
respect to our products. We pay ADM for such services on a monthly basis
pursuant to an allocation determined by ADM based on a portion of its applicable
costs plus any invoices it receives from third parties specific to us. As we
have added employees to our marketing and sales staff and administrative staff
following the consummation of initial public offering, our reliance on the use
of the management services of ADM has been reduced.
We also use office, manufacturing and storage space in a building located in
Northvale, NJ, currently leased by ADM, pursuant to the terms of the management
services agreement to which we, ADM and two of ADM's subsidiaries are parties.
Pursuant to the management services agreement, ADM determines, on a monthly
basis, the portion of space utilized by us during such month, which may vary
from month to month based upon the amount of inventory being stored by us and
areas used by us for research and development, and we reimburse ADM for our
portion of the lease costs, real property taxes and related costs based upon the
portion of space utilized by us. We have incurred approximately $10,000 and
$16,000 for the use of such space during the quarters ended June 30, 2009 and
2008, respectively.
ADM determines the portion of space allocated to us and each subsidiary on a
monthly basis, and we and the other subsidiaries are required to reimburse ADM
for our respective portions of the lease costs, real property taxes and related
costs.
We have incurred approximately $11,000 and $18,500 of general and administrative
expense representing ADM's allocations for management services and the use of
real property provided to us by ADM pursuant to the management services
agreement during the quarters ended June 30, 2009 and 2008, respectively. In
addition, billings by us to ADM for general and administrative expenses amounted
to $4,250 and $0 during the quarters ended June 30, 2009 and 2008, respectively.
24
IVIVI TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
JUNE 30, 2009
(UNAUDITED)
MANUFACTURING AGREEMENT
We, ADM and one subsidiary of ADM, Sonotron Medical Systems, Inc., are parties
to a second amended and restated manufacturing agreement. Under the terms of the
agreement, ADM has agreed to serve as the exclusive manufacturer of all current
and future medical and non-medical electronic and other devices or products to
be sold or rented by us. For each product that ADM manufactures for us, we pay
ADM an amount equal to 120% of the sum of (i) the actual, invoiced cost for raw
materials, parts, components or other physical items that are used in the
manufacture of the product and actually purchased for us by ADM, if any, plus
(ii) a labor charge based on ADM's standard hourly manufacturing labor rate,
which we believe is more favorable than could be attained from unaffiliated
third-parties. We generally purchase and provide ADM with all of the raw
materials, parts and components necessary to manufacture our products and as a
result, the manufacturing fee we pay to ADM generally is 120% of the labor rate
charged by ADM. On April 1, 2007, we instituted a procedure whereby ADM invoices
us for finished goods at ADM's costs plus 20%.
Under the terms of the agreement, if ADM is unable to perform its obligations
under our manufacturing agreement or is otherwise in breach of any provision of
our manufacturing agreement, we have the right, without penalty, to engage third
parties to manufacture some or all of our products. In addition, if we elect to
utilize a third-party manufacturer to supplement the manufacturing being
completed by ADM, we have the right to require ADM to accept delivery of our
products from these third-party manufacturers, finalize the manufacture of the
products to the extent necessary and ensure that the design, testing, control,
documentation and other quality assurance procedures during all aspects of the
manufacturing process have been met. Although we believe that there are a number
of third-party manufacturers available to us, we cannot assure you that we would
be able to secure another manufacturer on terms favorable to us or at all or how
long it will take us to secure such manufacturing. The initial term of the
agreement expired on March 31, 2009, subject to automatic renewals for
additional one-year periods, and which was renewed through March 31, 2010,
unless either party provides three months' prior written notice to the other
prior to the end of the relevant term of its desire to terminate the agreement.
We purchased approximately $40,000 and $325,000 of finished goods and certain
components from ADM at contracted rates during the quarters ended June 30, 2009
and 2008, respectively.
Pursuant to the terms of the APA we will transfer our rights and
obligations under the manufacturing agreement to the Buyer.
25
IVIVI TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
JUNE 30, 2009
(UNAUDITED)
SERVICES AGREEMENT
Effective February 1, 2008, we entered into an agreement to share certain
information technology (IT) costs with ADM. During the quarters ended June 30,
2009 and 2008, there have been no cost reimbursements under this agreement.
Pursuant to the terms of the APA we will transfer our rights and
obligations under the IT cost sharing services agreement to the Buyer.
Effective August 1, 2009, we entered into an agreement with ADM to provide the
following services and which cancels our Management Services and Services
agreements described above:
O ADM will provide us with engineering services, including quality control and
quality assurance services along with regulatory compliance services, warehouse
fulfillment services and network administration services including hardware and
software services.
O ADM will be paid at the rate of $26,000 per month by us for these services and
the four full time engineers and three part time engineers currently employed by
us will be terminated by us.
O The services agreement may be cancelled by either party upon sixty days
notice. Pursuant to the terms of the APA we will transfer our rights and
obligations under this service agreement to the Buyer.
The net result of our activity with ADM at June 30, 2009 is summarized as
follows, with such assets included in "Assets From Discontinued Operations":
Balance, beginning of period $ 104,321
Advances to ADM --
Purchases from ADM (40,127)
Charges to ADM 4,250
Charges from ADM (10,856)
Payments to ADM 18,263
Payments from ADM (3,296)
---------
Balance, end of period $ 72,555
=========
|
26
IVIVI TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
JUNE 30, 2009
(UNAUDITED)
NOTE 5 - CONCENTRATIONS
We maintain cash balances which, at times, exceed federally insured limits.
During the three month period ended June 30, 2009, four customers accounted for
57% of our direct sales revenue, two customers accounted for 100% of our rental
revenue and one customer accounted for 100% of our sales and revenue share on
RecoverCare contract. During the three month period ended June 30, 2008, three
customers accounted for 86% of our direct sales revenue, two customers accounted
for 59% of our rental revenue and one customer accounted for 100% of our
licensing sales and fees revenue. As of June 30, 2009, two customers accounted
for 87% of our accounts receivable and as of June 30, 2008, one customer
accounted for 39% for our accounts receivable. The loss of these major customers
could have a material adverse impact on our operations and cash flow.
NOTE 6 - RECENT ACCOUNTING PRONOUNCEMENTS
On October 10, 2008, the FASB issued Staff Position ("FSP") FAS 157-3,
"Determining the Fair Value of a Financial Asset When the Market for That Asset
Is Not Active." This FSP clarifies the application of FASB Statement No. 157,
Fair Value Measurements, in a market that is not active and provides an example
to illustrate key considerations in determining the fair value of a financial
asset when the market for that financial asset is not active. We have completed
our evaluation of the impact of the effect of the adoption of FSP FAS 157-3, and
have determined it would have no impact on the Company's financial position,
results of operations or cash flows.
In December 2007, the FASB issued SFAS No. 141R, "Business Combinations". This
standard establishes principles and requirements for how an acquirer recognizes
and measures in its financial statements the identifiable assets acquired, the
liabilities assumed, any non-controlling interest in the acquired entity and the
goodwill acquired. This statement also establishes disclosure requirements which
will enable users to evaluate the nature and financial effects of the business
combination. SFAS No.141R is effective for us for acquisitions made after April
1, 2009. The adoption of SFAS No. 141R has not had an impact on our condensed
consolidated financial statements. In December 2007, the FASB issued SFAS No.
160, "Non-controlling Interests in Consolidated Financial Statements". This
standard outlines the accounting and reporting for ownership interest in a
subsidiary held by parties other than the parent. SFAS No. 160 was adopted April
1, 2009, and did not have an impact on our condensed consolidated financial
statements.
27
IVIVI TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
JUNE 30, 2009
(UNAUDITED)
In March 2008, the FASB issued SFAS No. 161, "Disclosures about Derivative
Instruments and Hedging Activities - An Amendment of FASB Statement No. 133".
This statement is intended to improve financial reporting of derivative
instruments and hedging activities by requiring enhanced disclosures about (a)
how and why an entity uses derivative instruments, (b) how derivative
instruments and related hedged items are accounted for under SFAS 133 and its
related interpretations and (c) how derivative instruments and related hedged
items affect an entity's financial position, financial performance and cash
flows. The provisions of SFAS 161 are effective for fiscal years beginning after
November 15, 2008. SFAS 161 was adopted on April 1, 2009 and did not have an
impact on our condensed consolidated financial statements.
SFAS 165. In May 2009, the FASB issued FASB Statement No. 165, "SUBSEQUENT
EVENTS" ("SFAS 165"), which establishes general standards of and accounting for
and disclosure of events that occur after the balance sheet date but before
financial statements are issued or are available to be issued. This SFAS was
effective for interim and annual periods ending after June 15, 2009. The
adoption of SFAS 165 had no impact on the Company's financial condition, results
of operations or cash flows.
In June 2009, the Financial Accounting Standards Board (FASB) issued SFAS No.
168, "The FASB Accounting Standards CodificationTM and the Hierarchy of
Generally Accepted Accounting Principles--a replacement of FASB Statement No.
162," (SFAS 168). SFAS 168 replaces SFAS No. 162, "The Hierarchy of Generally
Accepted Accounting Principles," and establishes the FASB Accounting Standards
CodificationTM (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 conformity with GAAP. Rules and
interpretive releases of the Securities and Exchange Commission (SEC) under
authority of federal securities laws are also sources of authoritative GAAP for
SEC registrants. The FASB will no longer issue new standards in the form of
Statements, FASB Staff Positions, or Emerging Issues Task Force Abstracts;
instead the FASB will issue Accounting Standards Updates. Accounting Standards
Updates will not be authoritative in their own right as they will only serve to
update the Codification. The issuance of SFAS 168 and the Codification does not
change GAAP. SFAS 168 becomes effective for the Company for the period ending
September 30, 2009. Management has determined that the adoption of SFAS 168 will
not have an impact on its consolidated financial statements and will only
present the challenge of disclosing the Company's accounting positions in
accordance with the Codification.
Management does not believe that any other recently issued, but not yet
effective accounting pronouncements, if adopted, would have a material effect on
the accompanying financial statements.
28
IVIVI TECHNOLOGIES, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
JUNE 30, 2009
(UNAUDITED)
NOTE 7 - LEGAL PROCEEDINGS
On August 17, 2005, we filed a complaint against Conva-Aids, Inc. t/a New York
Home Health Care Equipment, or NYHHC, and Harry Ruddy in the Superior Court of
New Jersey, Law Division, Docket No. BER-L-5792-05, alleging breach of contract
with respect to a distributor agreement that we and NYHHC entered into on or
about August 1, 2004. On April 30, 2008, during a conference before the Hon.
Brian R. Martinotti J.S.C. all claims were settled and the terms of the
settlement were placed on the record. The settlement calls for the defendants to
dismiss with prejudice all counterclaims filed against us and to pay us the sum
of $120,000 in installments. The terms provide for an initial payment of $15,000
and the balance to be paid in equal monthly installments of $5,000. In the event
of default defendants shall be liable for an additional payment of $30,000,
interest at the rate of 8% per annum as well as costs and attorney's fees. The
settlement was documented in a written agreement executed by the parties and the
initial payment of $15,000 was paid on June 18, 2008. The defendants defaulted
on the payment due July 2008 and we were advised that the defendants filed for
protection under Chapter 11 of the United States Bankruptcy Code on July 21,
2008. As of June 30, 2009, we have only recognized the cash received. We have
filed our proof of claim with the Bankruptcy Court.
On October 10, 2006, we received a demand for arbitration by Stonefield
Josephson, Inc. with respect to a claim for fees for accounting services in the
amount of $105,707, plus interest and attorney's fees. Stonefield Josephson had
previously invoiced Ivivi for fees for accounting services in an amount which
Ivivi refuted. We pursued claims against Stonefield Josephson. We filed a
complaint against Stonefield Josephson in the Superior Court of New Jersey Law
Division Docket No.BER-l-872-08 on January 31, 2008. A commencement of
arbitration notice initiated by Stonefield Josephson was received by us on March
11, 2008. In March and April motions were filed by us and Stonefield Josephson
which sought various forms of relief including the forum for resolution of the
claims. On June 3, 2008, the court determined that the language in the
engagement agreement constituted a forum selection clause and the claims should
be decided in California. On June 19, 2008, we filed a complaint against
Stonefield Josephson in the Superior Court of California, Los Angeles County. On
July 18, 2008, the court denied our request for reconsideration of the order
dated June 3, 2008.
On January 19, 2009, the arbitrator rendered the award and found in our favor
and determined that no additional fees were owed by Ivivi to Stonefield. The
arbitrator further found Ivivi to be the prevailing party. The award is final.
As a result, at March 31, 2009, we reversed $105,707 which we previously
included in professional fees and accrued expenses for invoices received by us
during the quarters ended March 2006 and December 2005. The entire matter was
settled at mediation on June 23, 2009. We agreed to accept payment of $350,000
in settlement of any and all claims and the parties agreed to dismiss all
pending suits. The settlement was a compromise and Stonefield Josephson did not
admit liability. At June 30, 2009 we recorded the settlement in our Balance
Sheet as Receivable Relating to Litigation Settlement and as a credit to
professional fees - legal in General and Administrative Expense in our Statement
of Operations for the year ended March 31, 2009, all of which was reclassified
into discontinued operations. We received $350,000 on July 7, 2009.
Other than the foregoing, we are not a party to, and none of our property is the
subject of, any pending legal proceedings other than routine litigation that is
incidental to our business.
NOTE 8 - SUBSEQUENT EVENTS
Subsequent Events have been evaluated through October 14, 2009, the date the
financial statements included in this Form 10-Q/A were filed with the Securities
and Exchange Commission ("SEC"). Also refer to Note 1 to these unaudited
condensed financial statements for details of the APA subsequent event
unrecognized impact.
29
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF DISCONTINUED OPERATION'S
FINANCIAL CONDITION AND RESULTS OF DISCONTINUED OPERATIONS
THE FOLLOWING DISCUSSION CONTAINS FORWARD-LOOKING STATEMENTS AND INVOLVES
NUMEROUS RISKS AND UNCERTAINTIES, INCLUDING, BUT NOT LIMITED TO, THOSE DESCRIBED
UNDER "ITEM 1A. BUSINESS-RISK FACTORS" OF OUR ANNUAL REPORT ON FORM 10-K FOR THE
YEAR ENDED MARCH 31, 2009. ACTUAL RESULTS MAY DIFFER MATERIALLY FROM THOSE
CONTAINED IN ANY FORWARD-LOOKING STATEMENTS. THE FOLLOWING DISCUSSION SHOULD BE
READ IN CONJUNCTION WITH THE AUDITED FINANCIAL STATEMENTS AND NOTES THERETO
INCLUDED ELSEWHERE IN THIS QUARTERLY REPORT ON FORM 10-Q/A.
SUPERVISION AND REGULATION -- SECURITIES AND EXCHANGE COMMISSION
We maintain a website at www.ivivitechnologies.com. We make available free of
charge on our website all electronic filings with the Securities and Exchange
Commission (including proxy statements and reports on Forms 8-K, 10-K and 10-Q
and any amendments to these reports) as soon as reasonably practicable after
such material is electronically filed with or furnished to the Securities and
Exchange Commission. The Securities and Exchange Commission maintains an
internet site (http://www.sec.gov) that contains reports, proxy and information
statements, and other information regarding issuers that file electronically
with the Securities and Exchange Commission.
We have also posted policies, codes and procedures that outline our corporate
governance principles, including the charters of the board's audit and
nominating and corporate governance committees, and our Code of Ethics covering
directors and all employees and the Code of Ethics for senior financial officers
on our website. These materials also are available free of charge in print to
stockholders who request them in writing. The information contained on our
website does not constitute a part of this report.
OVERVIEW
Historically we have been an early-stage medical technology company focusing on
designing, developing and commercializing proprietary electrotherapeutic
technologies. Electrotherapeutic technologies employ pulsed electromagnetic
signals for various medical therapeutic applications. As described more fully
throughout this filing, the Company is currently anticipating the closing an
Asset Purchase Agreement, as entered into on September 24, 2009. Upon the
closing of such Agreement, the Company may liquidate, and discontinue all
operations. All further description of the business in the OVERVIEW Section
relates to the operation of the business during points in time prior to
September 24, 2009.
Based on mathematical and biophysical models of the electrochemical properties
of specific biochemical signaling pathways, we develop and design proprietary
tPEMF signals. Research using our tPEMF signals has suggested, and we believe,
that these signals improve specific physiological processes, including those
that generate the body's natural anti-inflammatory response, as well as tissue
repair. Our tPEMF technology is currently utilized to address pathological
conditions, including post operative pain and edema. We are also developing
applications for increasing angiogenesis (new blood vessel growth), a critical
component for tissue growth and repair.
We attempt to protect our technology and products through patents and patent
applications. We have built a portfolio of patents and applications covering our
technology and products, including its hardware design and methods. As of the
date of this report, we have two issued U.S. patents, one petition pending for
one issued U.S. patent and sixteen non-provisional pending U.S. patent
applications covering various embodiments and end use indications for tPEMF and
related signals and configurations.
30
Our medical devices are subject to extensive and rigorous regulation by the FDA,
as well as other federal and state regulatory bodies. Our currently marketed
devices, the SofPulse M-10, Roma and Torino PEMF products are cleared by the FDA
for the palliative treatment of post-operative pain and edema in superficial
soft tissue. Our devices are also CE marked (Conformite Europeenne), cleared by
Health Canada, and ready for commercialization in the European Union ("EU") and
Canada for the promotion of wound healing, reduction of pain and post-operative
edema. Additionally, The Centers for Medicare and Medicaid Services, ("CMS")
provides coverage for regenerative chronic wound (e.g., diabetic ulcers) healing
in medical center settings.
On April 9, 2009, the FDA issued an order to manufacturers of remaining
pre-amendments class III devices (including shortwave diathermy devices not
generating deep heat, which is the classification for our SofPulse devices) for
which regulations requiring submission of Premarket Approval Applications (PMA)
have not been issued. The order requires the manufacturers to submit to the FDA,
a summary of, and a citation to, any information known or otherwise available to
them respecting such devices, including adverse safety or effectiveness
information concerning the devices which has not been submitted under the
Federal Food, Drug, and Cosmetic Act. The FDA is requiring the submission of
this information in order to determine, for each device, whether the
classification of the device should be revised to require the submission of a
PMA or a notice of completion of a Product Development Protocol ("PDP"), or
whether the device should be reclassified into class I or II. Summaries and
citations were due by August 7, 2009. We submitted our summary with citations to
the FDA on August 7, 2009 for our shortwave diathermy devices not generating
deep heat, complying with this order. Our products are currently being marketed
during this process.
On July 2, 2009, we filed a 510(k) submission for marketing clearance with the
FDA for a TENS device known as ISO-TENS which uses tPEMF technology. This new
device is proposed for commercial distribution for the symptomatic relief of
chronic intractable pain; adjunctive treatment of post-surgical or post
traumatic acute pain; and adjunctive therapy in reducing the level of pain
associated with arthritis. We believe the ISO-TENS will enable penetration into
various chronic pain markets if FDA clearance is obtained. The FDA requested
additional information related to this submission which has been provided.
In addition, the FDA could subject us to other sanctions set forth under
"Government Regulation."
Our products consist of the following three components:
o the proprietary targeted pulsed electromagnetic field (tPEMF) signal;
o a signal generator; and
o applicators.
31
The signal generator produces a specific tPEMF signal that is pulsed through the
applicator. The applicator transmits the tPEMF signal into the soft tissue
target, penetrating medical dressings, casts, coverings, clothing and virtually
all other non-metallic materials. Our products can be used immediately following
acute injury, trauma and surgical wounds, as well as in chronic conditions, and
requires no alteration of standard clinical practices to accommodate the therapy
provided by tPEMF. We have performed rigorous scientific and clinical studies
designed to optimize tPEMF signal parameters. These studies have allowed us to
develop portable, easy to use products, which have greatly expanded
post-operative applications. Product cost has been reduced which may lower the
cost of healthcare utilizing our product. We continue to focus our research and
development activities on optimizing the signal parameters of our tPEMF
technology in order to produce improved clinical outcomes and smaller more
efficient, less costly, products utilizing less power.
Since the mid-1990s, our products have been used in over 1,000,000 treatments
(15 minute application to a single target area of a patient is one treatment) by
healthcare professionals on medical conditions, such as:
o acute or chronic wounds, including post surgical wounds;
o edema and pain following plastic and reconstructive surgery; and
o pain associated with the inflammatory phase of chronic conditions.
We are currently a party to agreements with distributors to assist us in the
marketing and distribution of our products. As of the date of this report, we
have engaged two domestic third-party distributors to assist us in marketing our
products in the United States in the chronic wound care market and one
distributor in Mexico to assist us in marketing our products. We are also
actively pursuing exclusive arrangements with strategic partners we believe have
leading positions in our target markets, in order to establish nationwide, and
in some cases worldwide, marketing and distribution channels for our products.
Generally, under these arrangements, the strategic partners would be responsible
for marketing, distributing and selling our products while we continue to
provide the related technology, products and technical support. Through this
approach, we expect to achieve broader marketing and distribution capabilities
in multiple target markets. Under the terms of the APA, these marketing benefits
will inure to the benefit of the Buyer.
GOING CONCERN
The accompanying financial statements have been prepared on a going concern
basis, which contemplates the realization of assets and the settlement of
liabilities and commitments in the normal course of business. As reflected in
the accompanying financial statements, we had a net loss of $1,846,584 and
$2,202,315 (all of which resulted from our discontinued operations),
respectively, for the quarters ended June 30, 2009 and 2008 and a working
capital deficiency from discontinued operations of $267,591 at June 30, 2009,
prior to our decision to cease operations. We had a net loss of $7,333,604 and
$7,503,091, respectively, (all of which resulted from our discontinued
operations), for the fiscal years ended March 31, 2009 and 2008, and a
corresponding working capital deficit of $256,136 at March 31, 2009, also prior
to our decision to cease operations. At June 30, 2009, we had cash balances of
approximately $772,000 (included in "Assets of Discontinued Operations" not held
for sale) which is not sufficient to meet our current cash requirements for the
next twelve months, subsequent to the filing of this Form 10-Q/A on October 13,
2009.
Emigrant Capital Corp Debt and Forbearance Agreement
On April 7, 2009, we closed on a $2.5 million loan with Emigrant Capital Corp.
(See Note 2 - Loan Agreement). However, we were not able to generate sufficient
cash flow from our operations to repay principal on this loan of $2,500,000 plus
interest on August 30, 2009.
On September 2, 2009, we announced that we had entered into a Forbearance
Agreement (the "Forbearance Agreement") dated August 31, 2009 with Emigrant
Capital Corp. (the "Lender"). Pursuant to the terms of the Forbearance
Agreement, the Lender had agreed to forbear, through September 9, 2009 (unless a
termination event occurred under the Forbearance Agreement), from requiring us
to repay the approximate $2.5 million in principal, plus accrued interest due
under the Convertible Promissory Note (the "Note"). The maturity date under the
Note was initially August 30, 2009. The Forbearance Agreement also provided for
an increase in the interest rate under the Note to the lesser of (i) 18% or (ii)
the maximum rate permitted by law during the forbearance period. The Lender
agreed to the forbearance in order to provide us with the ability to continue
(i) negotiating the previously announced transaction with the Buyer , an entity
associated with, Steven Gluckstern, our Chairman, President, Chief Executive
Officer and Chief Financial Officer, and (ii) solicit other proposals.
The Forbearance Agreement was amended on September 9, 14, 21, and on September
24, 2009, we announced that we had successfully negotiated the currently
governing Amended and Restated Forbearance Agreement, where the Lender agreed to
extend forbearance through November 30, 2009, allowing us to complete the
transactions described in the Asset Purchase Agreement, as more fully described
below. Other than the changes in the forbearance periods, as described above,
there were no other amendments or changes to the Forbearance Agreement.
32
On September 24, 2009 we executed an Asset Purchase Agreement (the "Asset
Purchase Agreement") with Ivivi Technologies, LLC (the "Buyer") an entity
associated with Steven M. Gluckstern, our Chairman, President, Chief Executive
Officer and Chief Financial Officer and Ajax Capital, LLC ("Ajax"), an entity
controlled by Steven M. Gluckstern. Pursuant to the terms of such Asset Purchase
Agreement, at the closing, we would sell substantially all of our assets to the
Buyer, other than cash and certain other excluded assets, and the Buyer would
assume certain specified ordinary course liabilities of ours as set forth in
such Asset Purchase Agreement. The aggregate purchase price to be paid to us
under the terms of the Asset Purchase Agreement is expected to equal the sum of
(i) the amount necessary to pay in full the principal, and accrued interest, as
of closing, under our loan with the Lender, which was approximately $2.7 million
as of September 30, 2009 (the "Loan") and (ii) additional cash , however, that
the sum of the amounts specified in clauses (i) and (ii) would not be in excess
of $3.15 million. The closing of the transactions contemplated by the Asset
Purchase Agreement would be subject to certain customary conditions, including
the receipt of approval by our shareholders of the transactions contemplated by
the Asset Purchase Agreement.
Under the terms of the Asset Purchase Agreement, we and Foundation Ventures, LLC
("Foundation"), our investment banker, continue to have the right to solicit
other proposals regarding the sale of our assets and equity until receipt of the
approval by our shareholders of the transactions contemplated by such Asset
Purchase Agreement. Prior to the receipt of approval by our shareholders, we
also maintain the right to terminate the transaction under specified
circumstances in order to enter into a definitive agreement implementing a
Superior Proposal (as defined in the Asset Purchase Agreement). If we terminate
the transactions with the Buyer to enter into a Superior Proposal, we would be
required to pay the Buyer a $90,000 termination fee .
In connection with the signing of the Asset Purchase Agreement, we, the Buyer
and certain of our shareholders, who have the power to vote approximately 39.5%
(and together with our common stock held by Steven M. Gluckstern, approximately
51.3%) of our common stock, entered into a Voting Agreement (each, a "Voting
Agreement"). Pursuant to each Voting Agreement, the signatory shareholders agree
to vote their shares of our common stock in favor of the transactions
contemplated by the Asset Purchase Agreement. In the event that we terminate the
transactions with the Buyer in connection with a Superior Proposal, the Voting
Agreements would also terminate.
There can be no assurance that we will be able to complete the transactions
contemplated by the Asset Purchase Agreement. In the event the transaction with
the Buyer is completed, following the closing, it is likely that our liabilities
will exceed our available cash and our board of directors may elect to liquidate
us and utilize our available cash and assets to repay our outstanding creditors
to the extent of our, then, remaining assets and distribute such remaining
assets, if any, to our shareholders. We anticipate the settling and payment of
liabilities will exhaust our available liquidity as such time.
In addition, following the closing we will remain liable under our lease for our
Montvale, New Jersey office. The lease, which has a monthly rent of $15,613,
will terminate in October 2014. We are currently discussing options with the
landlord.
In the event we do not successfully complete the transactions contemplated by
the Asset Purchase Agreement or complete another transaction, we will not be
able to meet our obligations under the Loan and the Lender will have the right
to foreclose under the Loan, which is secured by all of our assets. In such an
event, we would have to cease our operations or file for bankruptcy protection.
33
In the fourth quarter of the fiscal year ended March 31, 2008, we retained two
firms, including Foundation, to assist us in pursuing alternative strategies and
financings relating to our business. In December 2008, we terminated our
relationship with one of the firms. Through June 30, 2009, we paid $130,000 and
issued warrants to one of the entities including $100,000 of fees relating to
our Loan Agreement. Additional fees of $150,000 were paid to these entities
subsequent to June 30, 2009, including $125,000 of fees relating to our current
transaction being negotiated
Additional fees may be due Foundation in the event of a Superior Proposal or
other future successful financing or other transactions by us.
These factors, among others, raise substantial doubt about our ability to
continue as a going concern, which will be dependent on our ability to raise
additional funds to finance our operations or seek alternative transactions. The
accompanying financial statements do not include any adjustments that might be
necessary if we are unable to continue as a going concern.
Loan Agreement
On April 7, 2009, we closed on our $2.5 million loan (the "Financing") with the
Lender. Under the terms of the loan agreement (the "Loan Agreement"), as of the
date of this filing, we have borrowed an aggregate of $2.5 million. Borrowings
under the Financing are evidenced by a note (the "Note"), which bears interest
at a rate of 12% per annum (which increased to 18% after August 31, 2009 in
accordance with the terms of the Note and in connection with the Forbearance
Agreement described in Note 1). The Note is currently convertible into our
common stock at a conversion price of $0.23 per share.
In connection with the Financing, we issued warrants to the Lender (the
"Warrants"). The Warrants are currently exercisable for $3.0 million of our
common stock at an exercise price of $0.23 per share.
In addition to customary mechanical adjustments with respect to stock splits,
reverse stock splits, recapitalizations, stock dividends, stock combinations and
similar events, the Note and the Warrants provide for certain "weighted average
anti-dilution" adjustments whereby if shares of our common stock or other
securities convertible into or exercisable or exchangeable for shares of our
common stock (such other securities, including, without limitation, convertible
notes, options, stock purchase rights and warrants, "Convertible Securities")
are issued by us other than in connection with certain excluded securities (as
defined in the Note and the Warrant and which include a Qualified Financing and
stock awards under our 2009 Equity Incentive Stock Plan), the conversion price
of the Note and the Warrants will be reduced to reflect the "dilutive" effect of
each such issuance (or deemed issuance upon conversion, exercise or exchange of
such Convertible Securities) of our common stock relative to the holders of the
Note and the Warrants.
Because the convertible debentures included detachable warrants that were
immediately exercisable at an exercise price on the date of loan at $0.23 per
share, which was less than the market value of the shares on that date of $0.29
per share, we determined that warrants to have fair value utilizing the
Black-Scholes option-pricing model in excess of the notes' proceeds of
$2,500,000. We have used the following assumptions in the Black Scholes option
pricing model to determine the fair value of the warrants: (i) dividend yield of
0%; (ii) expected volatility of 41%-506%; (iii) average risk free interest rate
of 3.8%; and, (iv) expected life of 5 months. Consequently, we determined that
the value of the warrants to be $2,500,000, the amount of the proceeds of the
convertible note, which we credited to additional paid-in capital. The fair
value of the immediately convertible warrants is being charged to interest
expense and accreted to the convertible debenture in the accompanying financial
statements from the date of the loan, April 7, 2009, to the extended maturity
date of August 30, 2009. For the three months ended June 30, 2009, we charged
$493,096 to interest expense from discontinued operations in our Statement of
Operations. This amount was accreted to the convertible debenture liability, a
liability component of discontinued operations, on our Balance Sheet at June 30,
2009.
In connection with the Financing, Steven Gluckstern, our Chairman, President,
Chief Executive Officer and Chief Financial Officer, and a consultant of ours
(currently one of our employees and an affiliate of the Buyer) entered into a
participation arrangement with the Lender whereby Mr. Gluckstern and the
consultant invested $425,000 and $100,000, respectively with the Lender and
shall have a right to participate with the Lender in the Note and the Warrant.
As a result of such relationship, our Board of Directors, including its
independent members, approved the transactions contemplated by the Loan
Agreement.
34
Nasdaq Delisting
On June 23, 2009, our common stock was suspended from trading on the Nasdaq
Stock Market. On June 26, 2009, our common stock commenced trading on the OTC
Bulletin Board under the symbol IVVI.OB.
FDA MATTERS
All of our submissions are being sold under the terms of the Asset Purchase
Agreement.
On April 3, 2008, we filed a 510(k) submission with the Food and Drug
Administration (FDA) for a small, compact transcutaneous electrical nerve
stimulation (TENS) product utilizing our targeted pulsed electromagnetic field
(tPEMF) therapy technology for the symptomatic relief and management of chronic,
intractable pain, for relief of pain associated with arthritis and for the
adjunctive treatment of post-surgical and post-trauma acute pain. The FDA
requested additional information from us in a letter dated April 25, 2008.
During October 2008, we requested a voluntary withdrawal of this 510(k).
On December 15, 2008, we announced that we had received FDA 510(k) marketing
clearance for our currently marketed tPEMF therapeutic SofPulse products.
On April 9, 2009, the FDA issued an order to manufacturers of remaining
pre-amendments class III devices (including shortwave diathermy devices not
generating deep heat, which is the classification for our SofPulse devices) for
which regulations requiring submission of Premarket Approval Applications (PMA)
have not been issued. The order requires the manufacturers to submit to the FDA,
a summary of, and a citation to, any information known or otherwise available to
them respecting such devices, including adverse safety or effectiveness
information concerning the devices which has not been submitted under the
Federal Food, Drug, and Cosmetic Act. The FDA is requiring the submission of
this information in order to determine, for each device, whether the
classification of the device should be revised to require the submission of a
PMA or a notice of completion of a Product Development Protocol ("PDP"), or
whether the device should be reclassified into class I or II. Summaries and
citations were due by August 7, 2009. We submitted our summary with citations to
the FDA on August 7, 2009 for our shortwave diathermy devices not generating
deep heat, complying with this order. Our products are currently marketed during
this process.
On July 2, 2009, we filed a 510(k) submission for marketing clearance with the
FDA for a TENS device known as ISO-TENS which uses tPEMF technology. This new
device is proposed for commercial distribution for the symptomatic relief of
chronic intractable pain; adjunctive treatment of post-surgical or post
traumatic acute pain; and adjunctive therapy in reducing the level of pain
associated with arthritis. We believe the ISO-TENS will enable penetration into
various chronic pain markets if FDA clearance is obtained. The FDA requested
additional information related to this submission which has been provided.
We continue to be engaged in research and development activities for additional
medical applications of our technology and we expect to file 510(k) submissions
or other marketing applications for such additional uses in the future, with
the future benefits, if any, inuring to the Buyer.
RECOVERCARE CONTRACT
Under the terms of the Asset Purchase Agreement, our rights under the
RecoverCare Contract are being assigned to buyer.
On December 18, 2008, we signed a distribution agreement with RecoverCare (the
"Contract") to exclusively sell or rent our products into long term acute care
hospitals (LTACHS) in the United States and the non-exclusive right to sell or
rent our products into acute care facilities and Veterans Administration long
term care facilities in the Unites States.
Effective January 1, 2009, we transferred our rental agreements with current
customers in these markets to RecoverCare. The Contract has a three year term
and the distribution and revenue share portion of the Contract is effective
January 1, 2009, with an upfront fee to RecoverCare of $26,000 for certain
expenses incurred by them on our behalf. Under the terms of the Contract, we
have an obligation to repurchase new Roma units for $535 from RecoverCare in the
event the Contract is terminated by mutual consent of the parties. At the
termination of the Contract, used Roma units may be purchased by us at reduced
rates at our discretion.
35
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
The preparation of financial statements and related disclosures in conformity
with accounting principles generally accepted in the United States requires
management to make estimates and assumptions that affect the amounts reported in
the financial statements and accompanying notes. Estimates are used for, but not
limited to, the accounting for the allowance for doubtful accounts, inventories,
income taxes and loss contingencies. Management bases its estimates on
historical experience and on various other assumptions that are believed to be
reasonable under the circumstances. Actual results could differ from these
estimates under different assumptions or conditions.
We believe the following critical accounting policies, among others, may be
impacted significantly by judgment, assumptions and estimates used in the
preparation of our financial statements:
o In applying SFAS 144 "Accounting for the Impairment or Disposal of
Long-Lived Assets", we have determined that all of the Company's assets and
liabilities, and all of its operating activities and cash flows are the result
of discontinued operations, pursuant to the Company's asset disposition plans
under the APA, all as more fully described in Note 1 to the unaudited condensed
financial statements, and elsewhere within in the Form 10-Q/A. Post APA closing,
the Company believes that it will be required to liquidate its remaining assets
from discontinued operations in partial satisfaction of its liabilities
resulting from discontinued operations and cease all profit motivated
activities, and remain as a "public shell".
o We recognize revenue from rental and direct sale of our products from
distributors of our products and a revenue share arrangement with RecoverCare.
o Rental revenue is recognized as earned on either a monthly or pay-per-use
basis in accordance with individual customer agreements or in accordance with
our distributor agreements. Rental revenue recognition commences after the end
of the trial period. All of our rentals are terminable by either party at any
time.
o Direct sales revenue is recognized when our products are shipped to end
users including medical facilities and distributors. Shipping and handling
charges and costs have not been material. We have no post shipment obligations
except the warranty we provide with each unit and sales returns have been
immaterial.
o We record our sales and revenue share in our agreement with RecoverCare
as follows:
RecoverCare purchases Torinos, Applicators and other disposable equipment from
us at stated prices and revenue is recorded in Sales and Revenue Share on
RecoverCare Contract at the time this inventory is shipped to RecoverCare.
Rental accounts we serviced as of January 1, 2009 will continue to be serviced
by RecoverCare and we will share the revenue collected by RecoverCare on these
accounts subject to the terms of the Contract. Our revenue share on these
accounts is recorded by us upon receipt by us of the rental invoices sent by
RecoverCare to these customers.
36
o We provide an allowance for doubtful accounts determined primarily
through specific identification. We review our long lived assets for impairment
annually and at March 31, 2009, no impairment was noted.
o Assets of Discontinued Operations - held for sale include inventory and
equipment in use or under rental agreements which consists of our
electroceutical units and accessories rented to third parties and Roma units
held by RecoverCare that were not "in use". Rented equipment is depreciated on a
straight-line basis over three years, the estimated useful lives of the units.
o We apply Statement of Financial Accounting Standards No. 128, "Earnings
Per Share" (FAS 128). Net loss per share is computed by dividing net loss by the
weighted average number of common shares outstanding plus common stock
equivalents representing shares issuable upon the assumed exercise of stock
options and warrants. Common stock equivalents were not included for the
reporting periods, as their effect would be anti-dilutive.
o In April 2006, we adopted the fair value recognition provisions of SFAS
No. 123(R), Accounting for Stock-based Compensation, to account for compensation
costs under our stock option plans. We previously utilized the intrinsic value
method under Accounting Principles Board Opinion No. 25, Accounting for Stock
Issued to Employees (as amended). As of June 30, 2009, we have used the
following assumptions in the Black Scholes option pricing model: (i) dividend
yield of 0%; (ii) expected volatility of 44%-287.5%; (iii) average risk free
interest rate of 1.78%-5.03%; (iv) expected life of 1 to 6.5 years; and (v)
estimated forfeiture rate of 5%.
o We apply FASB No. 157, "Fair Value Measurements" (Statement No. 157),
which defines fair value, establishes a framework for measuring fair value, and
expands disclosures about fair value measurements. Statement No. 157 applies to
other accounting pronouncements that require or permit fair value measurements
and does not require any new fair value measurements. In February 2008, the FASB
issued FASB Staff Position 157-2, which provides for a one-year deferral of the
provisions of Statement No. 157 for non-financial assets and liabilities that
are recognized or disclosed at fair value in the financial statements on a
non-recurring basis. Effective April 1, 2008, we adopted the provisions of
Statement No. 157 for financial assets and liabilities, as well as for any other
assets and liabilities that are carried at fair value on a recurring basis. The
adoption of the provisions of Statement No. 157 related to financial assets and
liabilities and other assets and liabilities that are carried at fair value on a
recurring basis did not materially impact the company's financial position and
results of operations. For certain of our financial instruments, including
accounts receivable, inventories, accounts payable and accrued expenses, the
carrying amounts approximate fair value due to their relatively short
maturities.
37
o We apply the Financial Accounting Standards No. 159 ("FAS 159"), "The
Fair Value Option for Financial Assets and Financial Liabilities", which permits
entities to choose to measure many financial instruments and certain other items
at fair value which are not currently required to be measured at fair value.
Effective April 1, 2008, we adopted the provisions of Statement No. 159 for
financial assets and liabilities. The adoption of the provisions of Statement
No. 159 related to financial assets and liabilities that are carried at fair
value on a recurring basis did not materially impact the company's financial
position and results of operations.
o We use the fair value method for equity instruments granted to
non-employees and use the Black Scholes option value model for measuring the
fair value of warrants and options. The stock based fair value compensation is
determined as of the date of the grant or the date at which the performance of
the services is completed (measurement date) and is recognized over the periods
in which the related services are rendered.
RECENT ACCOUNTING PRONOUNCEMENTS
On October 10, 2008, the FASB issued Staff Position ("FSP") FAS 157-3,
"Determining the Fair Value of a Financial Asset When the Market for That Asset
Is Not Active." This FSP clarifies the application of FASB Statement No. 157,
"Fair Value Measurements", in a market that is not active and provides an
example to illustrate key considerations in determining the fair value of a
financial asset when the market for that financial asset is not active. We have
completed our evaluation of the impact of the effect of the adoption of FSP FAS
157-3, and have determined it would have no impact on the Company's financial
position, results of operations or cash flows.
In December 2007, the FASB issued SFAS No. 141R, "Business Combinations". This
standard establishes principles and requirements for how an acquirer recognizes
and measures in its financial statements the identifiable assets acquired, the
liabilities assumed, any non-controlling interest in the acquired entity and the
goodwill acquired. This statement also establishes disclosure requirements which
will enable users to evaluate the nature and financial effects of the business
combination. SFAS No.141R is effective for us for acquisitions made after April
1, 2009. The adoption of SFAS No. 141R has not had an impact on our condensed
consolidated financial statements. In December 2007, the FASB issued SFAS No.
160, "Non-controlling Interests in Consolidated Financial Statements". This
standard outlines the accounting and reporting for ownership interest in a
subsidiary held by parties other than the parent. SFAS No. 160 was adopted April
1, 2009, and did not have an impact on our condensed consolidated financial
statements.
In March 2008, the FASB issued SFAS No. 161, "Disclosures about Derivative
Instruments and Hedging Activities - An Amendment of FASB Statement No. 133".
This statement is intended to improve financial reporting of derivative
instruments and hedging activities by requiring enhanced disclosures about (a)
how and why an entity uses derivative instruments, (b) how derivative
instruments and related hedged items are accounted for under SFAS 133 and its
related interpretations and (c) how derivative instruments and related hedged
items affect an entity's financial position, financial performance and cash
flows. The provisions of SFAS 161 are effective for fiscal years beginning after
November 15, 2008. SFAS 161 was adopted on April 1, 2009 and did not have an
impact on our condensed consolidated financial statements. SFAS 165. In May
2009, the FASB issued FASB Statement No. 165, "SUBSEQUENT EVENTS" ("SFAS 165"),
which establishes general standards of and accounting for and disclosure of
events that occur after the balance sheet date but before financial statements
are issued or are available to be issued. This SFAS was effective for interim
and annual periods ending after June 15, 2009. The adoption of SFAS 165 had no
impact on the Company's financial condition, results of operations or cash
flows.
38
In June 2009, the Financial Accounting Standards Board (FASB) issued SFAS No.
168, "The FASB Accounting Standards CodificationTM and the Hierarchy of
Generally Accepted Accounting Principles--a replacement of FASB Statement No.
162," (SFAS 168). SFAS 168 replaces SFAS No. 162, "The Hierarchy of Generally
Accepted Accounting Principles," and establishes the FASB Accounting Standards
CodificationTM (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 conformity with GAAP. Rules and
interpretive releases of the Securities and Exchange Commission (SEC) under
authority of federal securities laws are also sources of authoritative GAAP for
SEC registrants. The FASB will no longer issue new standards in the form of
Statements, FASB Staff Positions, or Emerging Issues Task Force Abstracts;
instead the FASB will issue Accounting Standards Updates. Accounting Standards
Updates will not be authoritative in their own right as they will only serve to
update the Codification. The issuance of SFAS 168 and the Codification does not
change GAAP. SFAS 168 becomes effective for the Company for the period ending
September 30, 2009. Management has determined that the adoption of SFAS 168 will
not have an impact on its consolidated financial statements and will only
present the challenge of disclosing the Company's accounting positions in
accordance with the Codification.
Management does not believe that any other recently issued, but not yet
effective accounting pronouncements, if adopted, would have a material effect on
the accompanying financial statements.
RESULTS OF OPERATIONS OF CONTINUING OPERATIONS - NONE
In September 2009, we decided to discontinue operations and seek a buyer for our
business or its assets; and, accordingly, we have no continuing operations.
RESULTS OF OPERATIONS OF DISCONTINUED OPERATIONS
QUARTER ENDED JUNE 30, 2009 COMPARED TO QUARTER ENDED JUNE 30, 2008
NET LOSS - Net loss decreased $355,731 to $1,846,584, or $0.16 per share, for
the quarter ended June 30, 2009 compared to $2,202,315, or $0.21 per share, for
the quarter ended June 30, 2008. The decrease in net loss primarily resulted
from (i) decreases in our loss from discontinued operations of $955,026, or 43%,
partially offset by (ii) decreases in interest income of $41,449, or 92%, and
(iii) increase in interest expense of $557,846, or 100%.
DISCONTINUED OPERATIONS COMPONENT ANALYSIS AND DISCUSSION
REVENUE FROM DISCONTINUED OPERATIONS- Total revenue decreased by $248,838, or
65%, to $134,358 for the quarter ended June 30, 2009 as compared to $358,196 for
the quarter ended June 30, 2008. The decrease in revenue was due to (i) a
decrease in our licensing sales and fees of $115,411, or 100%, as a result of
our termination of our agreement with Allergan on November 19, 2008, (ii) a
decrease in our rental revenue of $164,356, or 97%, as a result of the reduction
in our sales and marketing staff and the transition of our wound care marketing
efforts under the terms of our agreement with RecoverCare, and (iii) a decrease
in our direct sales of $60,348, or 61%, as a result of the reduction in our
sales and marketing staff, partially offset by an increase in our sales and
revenue share on the RecoverCare contract of $91,277, or 100%.
On December 18, 2008, we signed a distribution agreement with RecoverCare (the
"Contract") to exclusively sell or rent our products into long term acute care
hospitals (LTACHS) in the United States and the non-exclusive right to sell or
rent our products into acute care facilities and Veterans Administration long
term care facilities in the Unites States.
Effective January 1, 2009, we transferred our rental agreements with current
customers in these markets to RecoverCare. The Contract has a three year term
and the distribution and revenue share portion of the Contract is effective
January 1, 2009, with an upfront fee to RecoverCare of $26,000 for certain
expenses incurred by them on our behalf. Under the terms of the Contract, we
have an obligation to repurchase new Roma units for $535 from RecoverCare in the
event the Contract is terminated by mutual consent of the parties. At the
termination of the Contract, used Roma units may be purchased by us at reduced
rates at our discretion.
RecoverCare purchases Torinos, Applicators and other disposable equipment from
us at stated prices and revenue is recorded in Sales and Revenue Share on
RecoverCare Contract at the time this inventory is shipped to RecoverCare.
Rental accounts we serviced as of January 1, 2009 will continue to be serviced
by RecoverCare and we will share the revenue collected by RecoverCare on these
accounts subject to the terms of the Contract. Our revenue share on these
accounts is recorded by us upon receipt by us of the rental invoices sent by
RecoverCare to these customers.
39
After January 1, 2009, RecoverCare will request Roma units from us for rental or
sales to their customers. RecoverCare has agreed to pay us an upfront fee of
$535 for each Roma unit sent to them which is recorded by us as deposits from
RecoverCare in Accounts Payable and Accrued Expenses in our Balance Sheet and
these Roma units are included in Equipment in Use or Under Rental Agreements in
our Balance Sheet until such time as we are notified by RecoverCare that the
Roma unit is "in use" by a customer of RecoverCare. Once we receive notification
that a Roma unit is "in use", we record the $535 in Sales and Revenue Share on
RecoverCare Contract and our cost to Cost of Sales on RecoverCare Contract in
our Statement of Operations.
In addition, we record a revenue share (a percentage of the amount invoiced by
RecoverCare less the $535 upfront fee previously received), in Sales and Revenue
Share on RecoverCare Contract in our Statement of Operations, based upon the
Contract, each month upon notification from RecoverCare that a Roma unit has
been rented by their customer and a copy of the invoice is sent to us by
RecoverCare. In the event RecoverCare sells a Roma unit, then we record the sale
in Sales and Revenue Share on RecoverCare Contract in our Statement of
Operations at fixed prices, as defined in the Contract, for the sale of a Roma
unit by RecoverCare.
Under the terms of the Contract, we shipped 64 Roma units to RecoverCare during
the period January 1, 2009 through June 30, 2009, of which 37 Roma units were
"in use" by RecoverCare customers at June 30, 2009. During the quarter ended
June 30, 2009, we recorded $10,700 as Sales and Revenue Share on RecoverCare
Contract in our Statement of Operations for the 20 Roma units that were placed
"in use" during the quarter. In addition, we recorded $10,867 as Sales and
Revenue Share on RecoverCare Contract in our Statement of Operations from the
sale of Torinos, Applicators and other disposable equipment to RecoverCare
during the quarter ended June 30, 2009. Further, we recorded $69,710 as Sales
and Revenue Share on RecoverCare Contract in our Statement of Operations for the
quarter ended June 30, 2009. This revenue represents our portion of the revenue
share for the period April through June 2009, from accounts we transferred to
RecoverCare on January 1, 2009.
At June 30, 2009, our Balance Sheet included a liability of $14,445 for deposits
received from RecoverCare which is the upfront fee of $535 for each of the 27
Roma units held by RecoverCare on that date and which, were not placed into
service by them at June 30, 2009.
Under the terms of the Asset Purchase Agreement, our rights under the
RecoverCare Contract are being assigned to buyer.
We recorded $0 and $94,277 in the quarters ended June 30, 2009 and 2008,
respectively, which represented sales of SofPulse units to Allergan and we
recorded $0 and $15,625 in the quarters ended June 30, 2009 and 2008,
respectively, which represents the amortized portion of the initial milestone
payment of $500,000 that was received from Allergan in November 2006 and is
included in sales to licensee and fees on our Statements of Operations.
Royalties received from Allergan during the quarters ended June 30, 2009 and
2008 were $0 and $5,509, respectively. On November 19, 2008 we terminated our
agreement with Allergan.
COST OF RENTALS FROM DISCONTINUED OPERATIONS- Cost of rentals decreased $10,214,
or 100%, to $0 for the quarter ended June 30, 2009 from $10,514 for the quarter
ended June 30, 2008, primarily as a result of the implementation of our
agreement with RecoverCare. Our cost of rentals for the quarter ended June 30,
2008 consisted of product costs of $2,531, freight of $1,473 and depreciation on
our Roma units under rental agreements of $6,210.
40
DISCONTINUED OPERATIONS COST OF DIRECT SALES - Cost of direct sales decreased
$5,952 or 49%, to $6,308 for the quarter ended June 30, 2009 from $12,260 for
the quarter ended June 30, 2008 as a result of the implementation of our
agreement with RecoverCare and the mix of products sold and the unit cost of
these products during the quarter ended June 30, 2009 versus the prior year
period.
Purchases of finished goods and certain components from ADM were $40,127 and
$324,614 for the quarters ended June 30, 2009 and 2008, respectively.
DISCONTINUED OPERATIONS COSTS OF SALES ON RECOVERCARE CONTRACT - Cost of sales
on RecoverCare contract increased $12,373, or 100%, to $12,373 for the quarter
ended June 30, 2009 from $0 for the quarter ended June 30, 2008 as a result of
the implementation of our agreement with RecoverCare. Our cost of sales on
RecoverCare contract for the quarter ended June 30, 2009 consisted of product
costs of $8,201 and depreciation on our Roma units under rental agreements of
$4,172.
DISCONTINUED OPERATIONS COSTS OF LICENSING SALES ON ALLERGAN CONTRACT - Cost of
licensing sales decreased $129,770, or 100%, to $0 for the quarter ended June
30, 2009 from $129,770 for the quarter ended June 30, 2008.
We recorded $0 and $129,770 as product cost to cost of licensing sales on
Allergan contract for the quarters ended June 30, 2009 and 2008, respectively.
The negative gross margin on the sale of our SofPulse units to Allergan was
$35,493 for the quarter ended June 30, 2008 as a result of the initial
production of the Allergan products.
DISCONTINUED OPERATIONS RESEARCH AND DEVELOPMENT COSTS - Research and
development expense decreased $37,313, or 7%, to $493,755 for the quarter ended
June 30, 2009 from $531,068 for the quarter ended June 30, 2008. The decrease
resulted primarily from decreases in consulting expenses of $37,073, decreases
in salary and salary related expenses of $16,340, and decreased patent
amortization expense of $22,276 partially offset by increases in research and
development studies of $21,073, increases in travel costs of $11,278 and
increased share based compensation expense of $8,157.
SELLING AND MARKETING EXPENSES OF DISCONTINUED OPERATIONS - Sales and marketing
expenses decreased $584,651, or 86%, to $92,571, for the quarter ended June 30,
2009 as compared to $677,222 for the quarter ended June 30, 2008. The decrease
resulted primarily from decreased salary and salary related costs of $248,177,
decreased travel costs of $99,013, decreased commission expenses of $33,297, a
decrease in advertising costs of $41,616, decreased marketing costs of $43,957,
a decrease in consulting expenses of $60,576, a decrease in bad debt expense of
$40,272, a decrease in shipping costs of $7,107, a decrease in warranty and
repairs expenses of $3,067, a decrease in share based compensation of $2,420,
and decreases in depreciation and amortization expense of $5,877. The decreases
in our sales and marketing expenses during the quarter ended June 30, 2009 as
compared with the quarter ended June 30, 2008 resulted primarily from the
reduction in our sales force of seven sales and sales related administrative
personnel which occurred on August 31, 2008 and the implementation of our
agreement with RecoverCare.
GENERAL AND ADMINISTRATIVE EXPENSES OF DISCONTINUED OPERATIONS- General and
administrative expenses decreased $448,337, or 35%, to $821,800 for the quarter
ended June 30, 2009 as compared to $1,270,137 for the quarter ended June 30,
2008. The decrease resulted primarily from decreases in salary and salary
related costs of $120,040, decreased rent and occupancy expenses of $8,353,
decreased share based compensation expense of $182,870, decreased investor
relations expenses of $41,264, decreased public relations expenses of $32,054, a
decrease in accounting fee expense of $43,444, decreased legal fees expense of
$64,483 and decreased general office expenses of $19,837 (primarily decreased
telephone expenses of $5,719, decreased computer expenses of $8,378 and
decreased expenses for office supplies and equipment of $6,347), partially
offset by increased consulting expenses of $18,202, increased travel related
expenses of $29,960 and increased Nasdaq listing fees expense of $13,950.
DISCONTINUED OPERATIONS INTEREST INCOME - Interest income decreased $41,449, or
92%, to $3,711 from $45,160 as a result of lower cash balances in our money
market accounts and lower interest rates on our deposits during the quarter
ended June 30, 2009 as compared to the quarter ended June 30, 2008.
DISCONTINUED OPERATIONS INTEREST EXPENSE - Interest expense increased $557,846,
or 100%, to $557,846 from $0 as a result of our accrual of interest expense, in
the amount of $64,750, on our convertible debt issued to Emigrant Capital Corp.
at the default interest rate of 18% per annum and the accretion of the effective
interest on the debt discount due to the convertible feature of the note and the
valuation of attached warrants in the amount of $493,096.
41
LIQUIDITY AND CAPITAL RESOURCES OF DISCONTINUED OPERATIONS
Currently, we have $2.5 million of debt outstanding under our Loan Agreement. On
September 2, 2009, we announced that we had entered into a Forbearance Agreement
(the "Forbearance Agreement") dated August 31, 2009 with Emigrant Capital Corp.
(the "Lender"). Pursuant to the terms of the Forbearance Agreement, the Lender
had agreed to forbear, through September 9, 2009 (unless a termination event
occured under the Forbearance Agreement), from requiring us to repay the
principal and interest due under the Convertible Promissory Note (the "Note") in
the principal amount of $2.5 million. The maturity date under the Note was
August 30, 2009. The Forbearance Agreement also provided for an increase in the
interest rate under the Note to the lesser of (i) 18% or (ii) the maximum rate
permitted by law during the forbearance period. The Lender agreed to the
forbearance in order to provide us with the ability to continue (i) negotiating
the previously announced potential transaction with Ajax Capital, LLC ("Ajax"),
an entity controlled by Steven Gluckstern, our Chairman, President, Chief
Executive Officer and Chief Financial Officer, and (ii) solicit other proposals.
The Forbearance Agreement also provides for an increase in the interest rate
under the Note to the lesser of (i) 18% or (ii) the maximum rate permitted by
law during the forbearance period. The Lender agreed to the forbearance in order
to provide us with the ability to continue (i) negotiating the Asset Purchase
Agreement transaction with Ajax Capital, LLC ("APA","Ajax", all as more fully
described below), an entity controlled by Steven Gluckstern, our Chairman,
President, Chief Executive Officer and Chief Financial Officer, and (ii) solicit
other proposals.
The Forbearance Agreement was amended on September 9, 14, 21, and on September
24, 2009, we announced the currently governing amendment, extending the Lender's
forbearance through November 30, 2009, allowing us to complete the transactions
described in the Asset Purchase Agreement, as more fully described below. Other
than the changes in the forbearance periods, as described above, there were no
other amendments or changes to the Forbearance Agreement.
On September 24, 2009 we executed an Asset Purchase Agreement (the "Asset
Purchase Agreement") with Ivivi Technologies, LLC (the "Buyer") an entity
associated with Steven M. Gluckstern, our Chairman, President, Chief Executive
Officer and Chief Financial Officer and Ajax Capital, LLC ("Ajax"), an entity
controlled by Steven M. Gluckstern. Pursuant to the terms of such Asset Purchase
Agreement, at the closing, we would sell substantially all of our assets to the
Buyer, other than cash and certain other excluded assets, and the Buyer would
assume certain specified ordinary course liabilities of ours as set forth in
such Asset Purchase Agreement. The aggregate purchase price to be paid to us
under the terms of the Asset Purchase Agreement is expected to equal the sum of
(i) the amount necessary to pay in full the principal, and accrued interest, as
of closing, under our loan with the Lender, which was approximately $2.7 million
as of September 30, 2009 (the "Loan") and (ii) additional cash , however, that
the sum of the amounts specified in clauses (i) and (ii) would not be in excess
of $3.15 million. The closing of the transactions contemplated by the Asset
Purchase Agreement would be subject to certain customary conditions, including
the receipt of approval by our shareholders of the transactions contemplated by
the Asset Purchase Agreement.
Under the terms of the Asset Purchase Agreement, we and Foundation Ventures, LLC
("Foundation"), our investment banker, continue to have the right to solicit
other proposals regarding the sale of our assets and equity until receipt of the
approval by our shareholders of the transactions contemplated by such Asset
Purchase Agreement. Prior to the receipt of approval by our shareholders, we
also maintain the right to terminate the transaction under specified
circumstances in order to enter into a definitive agreement implementing a
Superior Proposal (as defined in the Asset Purchase Agreement). If we terminate
the transaction and enter into a Superior Proposal, we would be required to pay
the Buyer a $90,000 termination fee.
In connection with the signing of the Asset Purchase Agreement, we, the Buyer
and certain of our shareholders, who have the power to vote approximately 39.5%
(and together with our common stock held by Steven M. Gluckstern, approximately
51.3%) of our common stock, entered into a Voting Agreement (each, a "Voting
Agreement"). Pursuant to each Voting Agreement, the signatory shareholders agree
to vote their shares of our common stock in favor of the transactions
contemplated by the Asset Purchase Agreement. In the event that we terminate the
transactions with the Buyer in connection with a Superior Proposal, the Voting
Agreements would also terminate.
There can be no assurance that we will be able to complete the transactions
contemplated by the Asset Purchase Agreement. In the event the transaction with
the Buyer is completed, following the closing, it is likely that our liabilities
will exceed our available cash and our board of directors may elect to liquidate
us and utilize our available cash and assets to repay our outstanding creditors
to the extent of our, then, remaining assets and distribute such remaining
assets, if any, to our shareholders. We anticipate the settling and payment of
liabilities will exhaust our available liquidity.
42
In addition, following the closing we will remain liable under our lease for our
Montvale, New Jersey office. The lease, which has a monthly rent of $15,613,
will terminate in October 2014. We are currently discussing options with the
landlord.
In the event we do not successfully complete the transactions contemplated by
the Asset Purchase Agreement or complete another transaction, we will not be
able to meet our obligations under the Loan and the Lender will have the right
to foreclose under the Loan, which is secured by all of our assets. In such an
event, we would have to cease our operations or file for bankruptcy protection.
We have had significant losses from discontinued operations for the quarters
ended June 30, 2009 and 2008 as well as for our fiscal years ended March 31,
2009 and 2008. At June 30, 2009, we had an accumulated deficit of approximately
$40.4 million. Our losses have been funded principally through the proceeds of
our private placement financings, our initial public offering and other funding
arrangements. We have generated limited revenues of approximately $134,000 and
$383,000 for our quarters ended June 30, 2009 and 2008, and $1.5 million and
$1.6 million for our fiscal years ended March 31, 2009 and 2008, respectively,
primarily from the rental and sale of our products, and we expect to incur
additional losses, as well as negative cash flow from operations. Our losses
have been funded principally through the proceeds of our private placement
financings and our IPO as well as our loan from Emigrant Capital Corp. (see
"Loan Agreement").
Our financial statements, as contained in this Form 10-Q/A, have been prepared
on a going concern basis, which contemplates the realization of assets and the
settlement of liabilities and commitments in the normal course of business. As
reflected in the accompanying financial statements, we had a net loss of
$1,846,584 and $2,202,315, respectively, for the quarters ended June 30, 2009
and 2008 and a working capital deficiency of $267,591 at June 30, 2009, prior to
our decision to cease operations on September 24, 2009. We had a net loss of
$7,333,604 and $7,503,091, respectively, for the fiscal years ended March 31,
2009 and 2008 and a working capital deficiency of $256,136 at March 31, 2009,
also prior to our decision to cease operations on September 24, 2009. In
addition, at June 30, 2009, we had cash balances of approximately $772,000 which
was not sufficient to meet our cash requirements for the next twelve months.
On April 7, 2009, we closed on a $2.5 million loan with Emigrant Capital Corp.
(see "Loan Agreement"). However, we do not expect to be able to generate
sufficient cash flow from our operations to meet our obligations.
In the fourth quarter of 2008, we retained two firms, including Foundation, to
assist us in pursuing alternative strategies and financings relating to our
business. In December 2008, we terminated our relationship with one of the
firms. Through June 30, 2009, we paid $130,000 and issued warrants to one of the
entities including $100,000 of fees relating to our Loan Agreement. Additional
fees of $150,000 were paid to these entities subsequent to June 30, 2009,
including $125,000 of fees relating to our current transaction being negotiated.
Additional fees may be due to Foundation in the event of a Superior Proposal or
other future successful financing or other transactions by us.
These factors, among others, raise substantial doubt about our ability to
continue as a going concern, which will be dependent on our ability to raise
additional funds to finance our operations or seek alternative transactions. The
accompanying financial statements do not include any adjustments that might be
necessary if we are unable to continue as a going concern.
As of June 30, 2009, we had cash and cash equivalents of approximately $772,000
as compared to cash and cash equivalents of approximately $4,788,000 at June 30,
2008. There was no source or use of cash attributable to continuing operations
for the three months ended June 30, 2009 and 2008.
Net cash used in discontinued operations was approximately $1.2 million during
the quarter ended June 30, 2009 compared to approximately $1.7 million during
the quarter ended June 30, 2008.
Net cash used in discontinued operations during the quarter ended June 30, 2009
resulted primarily from our net loss of approximately $1.8 million during the
period, increases in inventory of approximately $17,000 and decreases in
accounts payable and accrued expenses of approximately $93,000 partially offset
by decreases in accounts receivable of approximately $9,000, decreases in
prepaid expenses and other current assets of approximately $102,000, decreases
in deposits with and amounts due to affiliates of approximately $32,000,
decreases in equipment in use or under rental agreements of approximately $5,000
and by non-cash charges of approximately $612,000.
43
Net cash used in discontinued operations during the quarter ended June 30, 2008
resulted primarily from our net loss of approximately $2.2 million, increases in
inventory of approximately $138,000, increases, increases in equipment in use or
under rental agreements of approximately $8,000 and decreases in accounts
payable and accrued expenses of approximately $34,000, partially offset by
increases in accounts receivable of approximately $187,000, increases in
deposits with and amounts due from affiliate of approximately $97,000, decreases
in prepaid expenses and other current assets of approximately $28,000 and by
non-cash charges of approximately $363,000.
Net cash used in discontinued operations for investing activities during the
quarter ended June 30, 2009 resulted primarily from the purchase of and payments
for patents and trademarks of approximately $71,000. Net cash used for investing
activities during the quarter ended June 30, 2008 resulted from purchases of
property, plant and equipment of approximately $8,000 and payments for patents
and trademarks of approximately $96,000.
Net cash provided by discontinued operations financing activities was $1,820,000
during the quarter ended June 30, 2009 compared to net cash provided by
financing activities of $0 during the quarter ended June 30, 2008. The proceeds
of $1,820,000 came from the issuance of convertible debt to Emigrant Capital
Corp., net of issuance costs of $180,000 comprised of investment banker fees of
$100,000 and legal fees of approximately $80,000.
We have funded and continue to fund research and development at various
facilities. Under the terms of the Asset Purchase Agreement we are responsible
for all expenses incurred by the facilities up until the closing of the Asset
Purchase Agreement. At Closing, the benefits of our research and development
will inure to the buyer.
We are funding approximately $385,000 for additional cardiovascular studies. To
this end, during the fiscal year ended March 31, 2009, we paid $100,000 to MD
Imaging Network for a Cardiovascular - EFFECT trial and image storage. We did
not make any payments to MD Imaging Network for a Cardiovascular - EFFECT trial
and image storage during the three months ended June 30, 2009.
Further, we paid $50,000 to Stanford University during fiscal year ended March
31, 2009 and, at June 30, 2009 we have accrued an additional $150,000 for a
contribution for studies relating to the cardiovascular research program at
Stanford University. The remaining $85,000 has not been paid or accrued by us as
of June 30, 2009. We did not make any payments to Stanford University toward
this contribution during the three months ended June 30, 2009. These amounts may
be increased if we expand our current studies or if we pursue additional studies
and we will need to raise additional capital in such circumstances.
44
We were a party to a sponsored research agreement with Montefiore Medical Center
pursuant to which we funded research in the fields of pulsed electro-magnetic
frequencies at Montefiore Medical Center's Department of Plastic Surgery that
commenced on October 17, 2004 and expires on December 31, 2009. We were notified
prior to our fiscal year ended March 31, 2007, that the research being conducted
at Montefiore Medical Center's Department of Plastic Surgery has concluded and
this agreement will not be renewed. We expect to receive the data from this
study during the fall of 2009. We paid $70,000 during the fiscal year ended
March 31, 2009 for this data and, at June 30, 2009 the remaining balance of
$20,000 is included in our accrued liabilities in our financial statements.
We fund research in the field of neurosurgery under the supervision of Dr.
Casper, of Montefiore Medical Center's Department of Neurosurgery. Dr. Casper
also uses our product in this research. The research will be conducted over a
period of several years but our funding is determined yearly, based on annual
budgets mutually approved. We expensed $75,000 and $83,500 during the quarters
ended June 30, 2009 and 2008, respectively, to continue Dr. Casper's research.
During the quarters ended June 30, 2009 and 2008, we have paid $79,250 and $0,
respectively.
In June, 2007, we entered into a Research Agreement with Indiana State
University to conduct randomized, double-blind animal wound studies to assist us
in determining optimal signal configurations and dosing regimens. The total cost
of the research studies is approximately $160,000 of which we expensed
approximately $12,000 and $18,000 during the quarters ended June 30, 2009 and
2008, respectively. For the quarters ended June 30, 2009 and 2008, respectively,
we have paid approximately $0 and $74,000 towards this research and we accrued
$40,000 as of June 30, 2009 for the research performed through June 30, 2009 and
we expect to expense the remainder, approximately $23,000, during our fiscal
year ended March 31, 2010.
On May 1, 2008 we signed a research agreement with the Henry Ford Health System.
The principal investigator, Dr. Fred Nelson in the Department of Orthopedics
will study our prototype device using targeted tPEMF signal configurations on
human patients, with established osteoarthritis of the knee, who are active at
least part of the day. We received IRB approval at The Henry Ford Health System
to begin the double- blind randomized controlled study and the institution began
enrolling patients during August 2008. The estimated total cost of the research
with the Henry Ford Health System is approximately $112,000, of which
approximately $53,000 has been incurred by the institution through June 30,
2009. For the quarter ended June 30, 2009, we have paid $0 towards this research
and we accrued approximately $26,000 as of June 30, 2009 for the research
performed through June 30, 2009.
We entered into a management services agreement, dated as of August 15, 2001,
with ADM under which ADM provides us and its subsidiaries, Sonotron Medical
Systems, Inc. and Pegasus Laboratories, Inc., with management services and
allocates portions of its real property facilities for use by us and the other
subsidiaries for the conduct of our respective businesses. Pursuant to the terms
of the APA we will transfer our rights and obligations under the management
services agreement to the Buyer.
The management services provided by ADM under the management services agreement
include administrative, technical, engineering and regulatory services with
respect to our products. We pay ADM for such services on a monthly basis
pursuant to an allocation determined by ADM based on a portion of its applicable
costs plus any invoices it receives from third parties specific to us. As we
have added employees to our marketing and sales staff and administrative staff
following the consummation of initial public offering, our reliance on the use
of the management services of ADM has been reduced.
45
We also use office, manufacturing and storage space in a building located in
Northvale, NJ, currently leased by ADM, pursuant to the terms of the management
services agreement to which we, ADM and two of ADM's subsidiaries are parties.
Pursuant to the management services agreement, ADM determines, on a monthly
basis, the portion of space utilized by us during such month, which may vary
from month to month based upon the amount of inventory being stored by us and
areas used by us for research and development, and we reimburse ADM for our
portion of the lease costs, real property taxes and related costs based upon the
portion of space utilized by us. We have incurred approximately $10,000 and
$16,000 for the use of such space during the quarters ended June 30, 2009 and
2008, respectively.
ADM determines the portion of space allocated to us and each subsidiary on a
monthly basis, and we and the other subsidiaries are required to reimburse ADM
for our respective portions of the lease costs, real property taxes and related
costs.
We, ADM and one subsidiary of ADM, Sonotron Medical Systems, Inc., are parties
to a second amended and restated manufacturing agreement. Under the terms of the
agreement, ADM has agreed to serve as the exclusive manufacturer of all current
and future medical and non-medical electronic and other devices or products to
be sold or rented by us. For each product that ADM manufactures for us, we pay
ADM an amount equal to 120% of the sum of (i) the actual, invoiced cost for raw
materials, parts, components or other physical items that are used in the
manufacture of the product and actually purchased for us by ADM, if any, plus
(ii) a labor charge based on ADM's standard hourly manufacturing labor rate,
which we believe is more favorable than could be attained from unaffiliated
third-parties. We generally purchase and provide ADM with all of the raw
materials, parts and components necessary to manufacture our products and as a
result, the manufacturing fee we pay to ADM generally is 120% of the labor rate
charged by ADM. On April 1, 2007, we instituted a procedure whereby ADM invoices
us for finished goods at ADM's costs plus 20%.
Under the terms of the agreement, if ADM is unable to perform its obligations
under our manufacturing agreement or is otherwise in breach of any provision of
our manufacturing agreement, we have the right, without penalty, to engage third
parties to manufacture some or all of our products. In addition, if we elect to
utilize a third-party manufacturer to supplement the manufacturing being
completed by ADM, we have the right to require ADM to accept delivery of our
products from these third-party manufacturers, finalize the manufacture of the
products to the extent necessary and ensure that the design, testing, control,
documentation and other quality assurance procedures during all aspects of the
manufacturing process have been met. Although we believe that there are a number
of third-party manufacturers available to us, we cannot assure you that we would
be able to secure another manufacturer on terms favorable to us or at all or how
long it will take us to secure such manufacturing. The initial term of the
agreement expires on March 31, 2009, subject to automatic renewals for
additional one-year periods, and which was renewed through March 31, 2010,
unless either party provides three months' prior written notice to the other
prior to the end of the relevant term of its desire to terminate the agreement.
46
We purchased approximately $40,000 and $325,000 of finished goods and certain
components from ADM at contracted rates during the quarters ended June 30, 2009
and 2008, respectively. Pursuant to the terms of the APA we will transfer our
rights and obligations under the manufacturing agreement to the Buyer.
Effective February 1, 2008, we entered into an agreement to share certain
information technology (IT) costs with ADM. During the quarters ended June 30,
2009 and 2008, there have been no cost reimbursements under this agreement.
Pursuant to the terms of the APA we will transfer our rights and obligations
under the IT cost sharing agreement to the Buyer.
Effective August 1, 2009, we entered into an agreement with ADM to provide the
following services and which cancels our Management Services, Manufacturing and
Services agreements described above:
o ADM will provide us with engineering services, including quality control
and quality assurance services along with regulatory compliance services,
warehouse fulfillment services and network administration services
including hardware and software services.
o ADM will be paid at the rate of $26,000 per month by us for these services
and the four full time engineers and three part time engineers currently
employed by us will be terminated by us. It is expected that these four
full time engineers will be employed by ADM.
o The services agreement may be cancelled by either party upon sixty days
notice. Pursuant to the terms of the APA we will transfer our rights and
obligations under the services agreement to the Buyer.
OFF-BALANCE SHEET ARRANGEMENTS
We do not have any off-balance sheet arrangements that have or are reasonably
likely to have a current or future effect on our financial condition, changes in
financial condition, revenues or expenses, results of operations, liquidity,
capital expenditures or capital resources that is material to investors.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
MARKET RISK RELATED TO INTEREST RATES AND FOREIGN CURRENCY
We are exposed to market risks related to changes in interest rates; however, we
believe those risks to be not material in relation to our operations. We do not
have any derivative financial instruments.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures (as such term is defined in Rules
13(d)-15(e) under the Exchange Act that are designed to ensure that information
required to be disclosed in our Exchange Act reports are recorded, processed,
summarized and reported within the time periods specified in the Securities and
Exchange Commission rules and forms, and that such information is accumulated
and communicated to management, including our Chief Executive Officer and Chief
Financial Officer, as appropriate, to allow timely decisions regarding required
disclosure.
47
Management necessarily applies its judgment in assessing the costs and benefits
of such controls and procedures, which, by their nature, can provide only
reasonable assurance regarding management's control objectives.
As of the end of the period covered by this Quarterly Report on Form 10-Q, we
carried out an evaluation, with the participation of our management, including
our Chief Executive Officer and Chief Financial Officer, of the effectiveness of
our disclosure controls and procedures pursuant to Securities Exchange Act Rule
13a-15. Based upon that evaluation as of June 30, 2009, our Chief Executive
Officer and Chief Financial Officer concluded that our disclosure controls and
procedures are effective, at the reasonable assurance level, in ensuring that
information required to be disclosed by us in the reports that we file or submit
under the Securities Exchange Act is accumulated and communicated to our
management including our Chief Executive Officer and Chief Financial Officer, to
ensure that such information is recorded, processed, summarized and reported,
within the time periods specified in the Securities and Exchange Commission's
rules and forms.
We will continue to review and evaluate the design and effectiveness of our
disclosure controls and procedures on an ongoing basis and to improve our
controls and procedures over time and correct any deficiencies that we may
discover in the future. Our goal is to ensure that our senior management has
timely access to all material financial and non-financial information concerning
our business. While we believe the present design of our disclosure controls and
procedures is effective to achieve our goals, future events affecting our
business may cause us to modify our disclosure controls and procedures.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal controls over financial reporting
that occurred during our the fiscal quarter ended June 30, 2009 that have
materially affected, or are reasonably likely to materially affect, our internal
controls over financial reporting.
INTEREST RATE RISK
As of June 30, 2009, our cash included approximately $772,000 of money market
bank accounts. Due to the fact that money market accounts are available for
withdrawals on a daily basis and traditional the investments are of a short-term
duration, an immediate 10% change in interest rates would not have a material
effect on the fair market value of our money market accounts. Therefore, we
would not expect our operating results or cash flows to be affected to any
significant degree by the effect of a sudden change in market interest rates on
our money market accounts. Our loan with Emigrant Capital Corp. is at a fixed
interest rate.
48
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS.
On August 17, 2005, we filed a complaint against Conva-Aids, Inc. t/a New York
Home Health Care Equipment, or NYHHC, and Harry Ruddy in the Superior Court of
New Jersey, Law Division, Docket No. BER-L-5792-05, alleging breach of contract
with respect to a distributor agreement that we and NYHHC entered into on or
about August 1, 2004. On April 30, 2008, during a conference before the Hon.
Brian R. Martinotti J.S.C. all claims were settled and the terms of the
settlement were placed on the record. The settlement calls for the defendants to
dismiss with prejudice all counterclaims filed against us and to pay us the sum
of $120,000 in installments. The terms provide for an initial payment of $15,000
and the balance to be paid in equal monthly installments of $5,000. In the event
of default defendants shall be liable for an additional payment of $30,000,
interest at the rate of 8% per annum as well as costs and attorney's fees. The
settlement was documented in a written agreement executed by the parties and the
initial payment of $15,000 was paid on June 18, 2008. The defendants defaulted
on the payment due July 2008 and we were advised that the defendants filed for
protection under Chapter 11 of the United States Bankruptcy Code on July 21,
2008. As of June 30, 2009, we have only recognized the cash received. We have
filed our proof of claim with the Bankruptcy Court.
On October 10, 2006, we received a demand for arbitration by Stonefield
Josephson, Inc. with respect to a claim for fees for accounting services in the
amount of $105,707, plus interest and attorney's fees. Stonefield Josephson had
previously invoiced Ivivi for fees for accounting services in an amount which
Ivivi refuted. We pursued claims against Stonefield Josephson. We filed a
complaint against Stonefield Josephson in the Superior Court of New Jersey Law
Division Docket No.BER-l-872-08 on January 31, 2008. A commencement of
arbitration notice initiated by Stonefield Josephson was received by us on March
11, 2008. In March and April motions were filed by us and Stonefield Josephson
which sought various forms of relief including the forum for resolution of the
claims. On June 3, 2008, the court determined that the language in the
engagement agreement constituted a forum selection clause and the claims should
be decided in California. On June 19, 2008, we filed a complaint against
Stonefield Josephson in the Superior Court of California, Los Angeles County. On
July 18, 2008, the court denied our request for reconsideration of the order
dated June 3, 2008. On January 19, 2009, the arbitrator rendered the award and
found in our favor and determined that no additional fees were owed by Ivivi to
Stonefield. The arbitrator further found Ivivi to be the prevailing party. The
award is final. As a result, at March 31, 2009, we reversed $105,707 which we
previously included in professional fees and Accrued expenses for invoices
received by us during the quarters ended March 2006 and December 2005. The
entire matter was settled at mediation on June 23, 2009. We agreed to accept
payment of $350,000 in settlement of any and all claims and the parties agreed
to dismiss all pending suits. The settlement was a compromise and Stonefield
Josephson did not admit liability. At June 30, 2009 we recorded the settlement
in our Balance Sheet as a component of Assets of Discontinued Operations not
held for sale. We received $350,000 on July 7, 2009.
Other than the foregoing, we are not a party to, and none of our property is the
subject of, any pending legal proceedings other than routine litigation that is
incidental to our business.
49
ITEM 1A. RISK FACTORS
AN INVESTMENT IN OUR COMMON STOCK IS SPECULATIVE AND INVOLVES A HIGH DEGREE OF
RISK. YOU SHOULD CAREFULLY CONSIDER THE RISKS DESCRIBED BELOW, TOGETHER WITH THE
OTHER INFORMATION CONTAINED IN THIS INTERIM REPORT ON FORM 10-Q/A, AND OUR
ANNUAL REPORT FOR THE YEAR ENDED MARCH 31, 2009 AS FILED ON FORM 10-K, BEFORE
BUYING OUR COMMON STOCK. THESE RISKS COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR
BUSINESS, FINANCIAL CONDITION AND RESULTS OF OPERATIONS AND THE VALUE OF OUR
COMMON STOCK.
EXCEPT AS SET FORTH BELOW, THERE HAVE BEEN NO MATERIAL CHANGES TO THE RISK
FACTORS CONTAINED IN OUR ANNUAL REPORT ON FORM 10-K FOR THE YEAR ENDED MARCH 31,
2009.
RISKS AFFECTING OUR BUSINESS
WE MAY BE REQUIRED TO LIQUIDATE OUR ASSETS FROM DISCONTINUED OPERATIONS IN
PARTIAL SETTLEMNT OF OUR ASSOCIATED LIABILITIES
If we are required to liquidate, the fair value of our liabilities may exceed
the fair value of the assets, and our shareholders' may not receive any return
of capital upon liquidation.
IF WE ARE UNABLE TO REPAY OUR OUTSTANDING LOAN BY THE EXTENDED DUE DATE, WE WILL
BE IN DEFAULT UNDER OUR LOAN AGREEMENT WITH OUR LENDER
We have $2.5 million of debt outstanding under our loan agreement. The loan
matured, plus interest, on August 30, 2009 but, the Lender has granted us a
forbearance through September 21, 2009 and we are currently negotiating a
further extension.
There can be no assurance that we will be able to complete the transactions
contemplated by the Asset Purchase Agreement as described in Note 1 of our
financial statements. In the event the transaction with the Buyer is completed,
following the closing, it is likely that our liabilities will exceed our
available cash and our board of directors may elect to liquidate us and utilize
our available cash and assets to repay our outstanding creditors to the extent
of our, then, remaining assets and distribute such remaining assets, if any, to
our shareholders. We anticipate the settling and payment of liabilities will
exhaust our available liquidity.
In addition, following the closing we will remain liable under our lease for our
Montvale, New Jersey office. The lease, which has a monthly rent of $15,613,
will terminate in October 2014. We are currently discussing options with the
landlord.
In the event we do not successfully complete the Asset Purchase Agreement or
complete another transaction, we will not be able to meet our obligations under
the Loan and the Lender will have the right to foreclose under the Loan, which
is secured by all of our assets. In such an event, we would have to cease our
operations or file for bankruptcy protection.
50
ITEM 6. EXHIBITS.
Exhibit No. Description
----------- -----------
3.1 Restated Certificate of Incorporation of Ivivi Technologies,
Inc. (1)
3.2 Amended and Restated By-Laws of Ivivi Technologies, Inc. (1)
4.1 Form of Stock Certificate of Ivivi Technologies, Inc. (2)
4.2 Warrant issued to certain investors (one in a series of
warrants with identical terms) (3)
4.3 Form of Warrant issued to Placement Agent (3)
4.4 Warrant issued to certain investors (one in a series of
warrants with identical terms) (4)
4.5 Registration Rights Agreement among Ivivi Technologies, Inc.
and certain investors (included as Exhibit E to form of
Subscription Agreement filed as Exhibit 10.19)
4.6 Registration Rights Agreement among Ivivi Technologies, Inc.
and certain investors (included as Exhibit C to form of
Subscription Agreement filed as Exhibit 10.20)
4.7 Registration Rights Agreement among Ivivi Technologies, Inc.
and certain investors (2)
4.8 Form of Warrant issued to consultants (2)
4.9 Form of Warrant issued to certain advisors (2)
4.10 Registration Rights Agreement, dated as of October 15, 2007,
between Ivivi Technologies, Inc. and the investor named therein
(11)
10.1 2004 Amended and Restated Stock Option Plan, as amended(1)
10.2 Second Amended and Restated Manufacturing Agreement, dated as
of June 15, 2006, among Ivivi Technologies, Inc., ADM Tronics
Unlimited, Inc., and certain subsidiaries of ADM
TronicsUnlimited, Inc. (6)
10.3 Management Services Agreement, dated August 15, 2001, among
Ivivi Technologies, Inc., ADM Tronics Unlimited, Inc. and
certain subsidiaries of ADM Tronics Unlimited, Inc., as amended
(7)
10.4 Form of Indemnification Agreement between Ivivi Technologies,
Inc. and each of its directors and officers (9)
51
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10.5 Amended and Restated Voting Agreement among the parties named
therein (9)
10.6 Agreement, effective as of February 10, 2005, between Ivivi
Technologies, Inc. and ADM Tronics Unlimited, Inc. (5)
10.7 Master Clinical Trial Agreement, dated as of January 9, 2006,
between Ivivi Technologies, Inc. and Cleveland Clinic Florida
(6)
10.8 Form of Distribution Agreement (5)
10.9 Amended and Restated Employment Agreement, dated October 18,
2007, between Ivivi Technologies, Inc. and Andre' DiMino (13)
10.10 Amended and Restated Employment Agreement, dated October 18,
2007, between Ivivi Technologies, Inc. and David Saloff (13)
10.11 Employment Agreement, dated as of July 13, 2006, between Ivivi
Technologies, Inc. and Alan Gallantar (7)
10.12 Amendment to Employment Agreement between Ivivi Technologies
Inc. and Alan Gallantar dated December 31, 2009
10.13 Option Agreement, dated as of June 16, 2006, between Ivivi
Technologies, Inc. and Steven M. Gluckstern (6)
10.14 Share Purchase Right Agreement, dated as of November 8, 2005,
between Ivivi Technologies, Inc. and Steven Gluckstern (6)
10.15 Subscription Agreement between Ivivi Technologies, Inc. and
certain investors (2)
10.16 Subscription Agreement between Ivivi Technologies, Inc. and
certain investors (2)
10.17 Exclusive Distribution Agreement, dated as of November 9, 2006,
between Ivivi Technologies, Inc. and Inamed Medical Products
Corporation (10) +
10.19 Lease Agreement, dated as of June 18, 2007, between Ivivi
Technologies, Inc. and Mack-Cali East Lakemont LLC (12)
10.20 Employment Agreement as of December 31, 2008 between Steven M.
Gluckstern and Ivivi Technologies, Inc.(13)
10.21 Amendment to Employment Agreement dated April 2, 2009 between
Steven M. Gluckstern and Ivivi Technologies, Inc.(14)
10.22 Amendment to Employment Agreement dated April 2, 2009 between
Alan Gallantar and Ivivi Technologies, Inc.(14)
10.23 Amendment to Employment Agreement dated April 2, 2009 between
Andre' DiMino and Ivivi Technologies, Inc.(14)
52
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10.24 Amendment to Employment Agreement dated April 2, 2009 between
David Saloff and Ivivi Technologies, Inc.(14)
10.25 Loan Agreement dated April 7, 2009 between Emigrant Capital
Corp. and Ivivi Technologies, Inc.(14)
10.26 Consulting Agreement, dated October 17, 2006, between Ivivi
Technologies, Inc and Arthur Pilla (12)
10.27 Consulting Agreement, dated January 1, 2004, between Ivivi
Technologies, Inc. and Berish Strauch, M.D.(3)
10.28 Service Agreement, dated August 1, 2009, between Ivivi
Technologies, Inc. and ADM Tronics Unlimited, Inc. and
Subsidiaries *
14.1 Ivivi Technologies, Inc. Code of Ethics for Senior Financial
Officers, Executive Officers and Directors (2)
31.1 Certification of Chief Executive Officer and Chief Financial
Officer pursuant to Section 302 of the Sarbanes-Oxley Act of
2002 *
32 Certification pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 *
99.1 Audit Committee charter (2)
-----------------
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* Filed herewith.
+ Portions of this document have been omitted and filed separately with the
Securities and Exchange Commission pursuant to a request or confidential
treatment in accordance with Rule 406 of the Securities Act.
(1) Incorporated by reference to Ivivi Technologies, Inc.'s Registration
Statement on Form S-8, filed with the Securities and Exchange Commission on
February 13, 2007.
(2) Incorporated by reference to Amendment No. 7 to Ivivi Technologies, Inc.'s
Registration Statement on Form SB-2, filed with the Securities and Exchange
Commission on October 13, 2006.
(3) Incorporated by reference to Ivivi Technologies, Inc.'s Registration
Statement on Form SB-2, filed with the Securities and Exchange Commission on
February 11, 2005.
(4) Incorporated by reference to Amendment No. 3 to Ivivi Technologies, Inc.'s
Registration Statement on Form SB-2, filed with the Securities and Exchange
Commission on April 20, 2006.
53
(5) Incorporated by reference to Amendment No. 2 to Ivivi Technologies, Inc.'s
Registration Statement on Form SB-2, filed with the Securities and Exchange
Commission on May 13, 2005.
(6) Incorporated by reference to Amendment No. 4 to Ivivi Technologies, Inc.'s
Registration Statement on Form SB-2, filed with the Securities and Exchange
Commission on June 19, 2006.
(7) Incorporated by reference to Amendment No. 5 to Ivivi Technologies, Inc.'s
Registration Statement on Form SB-2, filed with the Securities and Exchange
Commission on August 29, 2006.
(8) Incorporated by reference to Amendment No. 1 to Ivivi Technologies, Inc.'s
Registration Statement on Form SB-2, filed with the Securities and Exchange
Commission on March 3, 2005.
(9) Incorporated by reference to Amendment No. 6 to Ivivi Technologies, Inc.'s
Registration Statement on Form SB-2, filed with the Securities and Exchange
Commission on September 14, 2006.
(10) Incorporated by reference to Ivivi Technologies, Inc.'s Quarterly Report on
Form 10-QSB for the quarter ended September 30, 2006, filed with the Securities
and Exchange Commission on December 4, 2006.
(11) Incorporated by reference to Ivivi Technologies, Inc.'s Current Report on
Form 8-K filed with the Securities and Exchange Commission on October 16, 2007.
(12) Incorporated by reference to Ivivi Technologies, Inc.'s Annual Report on
Form 10-KSB filed with the Securities and Exchange Commission on June 29, 2007.
(13) Incorporated by reference to Ivivi Technologies, Inc.'s Current Report on
Form 8-K filed with the Securities and Exchange Commission on January 2, 2009.
(14) Incorporated by reference to Ivivi Technologies, Inc.'s Current Report on
Form 8-K filed with the Securities and Exchange Commission on April 8, 2009.
54
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
IVIVI TECHNOLOGIES INC.
(Registrant)
Dated: October 14, 2009
By: /s/ Steven Gluckstern
--------------------------
Steven Gluckstern President,
Chief Executive Officer
(Principal Executive Officer)
and Chief Financial Officer
(Principal Financial Officer and
Principal Accounting Officer)
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