VIVOS INC - Quarter Report: 2009 March (Form 10-Q)
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Form
10-Q
(Mark
One)
|
|
x
|
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
FOR
THE QUARTERLY PERIOD ENDED: MARCH
31, 2009
|
o
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TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT
FOR
THE TRANSITION PERIOD FROM __________ TO __________
COMMISSION
FILE NUMBER 0-53497
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ADVANCED MEDICAL ISOTOPE
CORPORATION
(Exact
name of registrant as specified in its charter)
Delaware
|
80-0138937
|
(State or other jurisdiction
of incorporation or organization)
|
(I.R.S.
Employer Identification
No.)
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8131
W. Grandridge Blvd. Suite 101,
Kennewick WA 99336
(Address
of principal executive offices, Zip Code)
(509) 736-4000
(Registrant’s
telephone number, including area code)
Indicate
by check mark whether the registrant (1) filed all reports required to be filed
by Section 13 or 15(d) of the Exchange Act during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports),
and (2) has been subject to such filing requirements for the past 90 days. Yes
x No
o
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding
12 months (or for such shorter period that the registrant was required to submit
and post such files). Yes o No o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
definitions of “large accelerated filer,” “accelerated filer” and
“smaller reporting company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer
|
o
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Accelerated
filer
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o
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Non-accelerated
filer
|
o
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Smaller
reporting company
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x
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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 o No x
The
number of shares of registrant’s common stock outstanding, as of April 30, 2009
was 50,341,680.
i
TABLE
OF CONTENTS
Page
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PART
I - FINANCIAL INFORMATION
|
|||
Item
1. Financial Statements
|
1
|
||
Balance
Sheets as of March 31, 2009 and December 31, 2008
|
1
|
||
Statements
of Operations for the three months ended March 31,
2009
|
2
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||
Statements
of Shareholders’ Equity (Deficit) for the period ended March
31,2009
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3
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||
Statements
of Cash Flows for the three months ended March 31, 2009 and the three
months ended March 31, 2008
|
4-5
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||
Notes
to Condensed Consolidated Financial Statement
|
6-14
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||
Item
2. Management’s Discussion and Analysis or
Plan of Operation
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14
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||
Item
3. Quantitative and Qualitative Disclosures
About Market Risk
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24
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||
Item
4. Controls and Procedures
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25
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PART
II - OTHER INFORMATION
|
|||
Item
1. Legal Proceedings
|
26
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||
Item
2. Unregistered Sales of Equity Securities
and Use of Proceeds
|
26
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||
Item
3. Defaults Upon Senior
Securities
|
27
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||
Item
4. Submission of Matters to a Vote of
Security Holders
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27
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||
Item
5. Other Information
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27
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||
Item
6. Exhibits
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27
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SIGNATURES
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28
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ii
Item
1. Financial Statements.
Advanced
Medical Isotope Corporation
(A
Development Stage Company)
Balance
Sheets
March
31,
|
December
31,
|
||||||||
2009
|
2008
|
||||||||
(unaudited)
|
|||||||||
ASSETS
|
|||||||||
Current
Assets:
|
|||||||||
Cash
and cash equivalents
|
$ | 221,170 | $ | 86,631 | |||||
Accounts
receivable
|
12,600 | 35,747 | |||||||
Prepaid
expenses
|
4,042 | 3,000 | |||||||
Prepaid
expenses paid with stock, current portion
|
73,969 | 140,579 | |||||||
Inventory
|
888 | 7,100 | |||||||
Total
current assets
|
312,669 | 273,057 | |||||||
Fixed
assets, net of accumulated depreciation
|
2,138,366 | 2,272,784 | |||||||
Other
assets:
|
|||||||||
License
fees, net of amortization
|
20,833 | 27,083 | |||||||
Patents
|
25,192 | 24,594 | |||||||
Prepaid
expenses paid with stock, long-term portion
|
87,500 | 96,875 | |||||||
Deposits
|
180,406 | 155,406 | |||||||
Total
other assets
|
313,931 | 303,958 | |||||||
Total
assets
|
$ | 2,764,966 | 2,849,799 | ||||||
LIABILITIES AND SHAREHOLDERS’ EQUITY
(DEFICIT)
|
|||||||||
Current
liabilities:
|
|||||||||
Accounts
payable
|
$ | 491,447 | $ | 580,258 | |||||
Accrued
interest payable
|
35,418 | 188,956 | |||||||
Payroll
liabilities payable
|
5,900 | 9,098 | |||||||
Preferred
stock redeemable as common
|
- | 3,182,405 | |||||||
Loans
from shareholder
|
204,335 | 194,599 | |||||||
Convertible
notes payable
|
447,322 | 257,481 | |||||||
Current
portion of capital lease obligations
|
2,097,934 | 2,138,853 | |||||||
Total
current liabilities
|
3,282,356 | 6,551,650 | |||||||
Long
term liabilities:
|
|||||||||
Capital
lease obligations, net of current portion
|
- | - | |||||||
Total
liabilities
|
3,282,356 | 6,551,650 | |||||||
Shareholders’
Equity (Deficit):
|
|||||||||
Preferred
stock, $.001 par value; 100,000 authorized;
|
|||||||||
0
and 95,000 shares issued and outstanding, respectively
|
- | 95 | |||||||
Common
stock, $.001 par value; 100,000,000 shares authorized;
|
|||||||||
49,691,124
and 36,778,612 shares issued and outstanding,
|
|||||||||
respectively
|
49,691 | 36,779 | |||||||
Subscriptions
receivable
|
- | ||||||||
Paid
in capital
|
14,078,230 | 9,546,087 | |||||||
Accumulated
deficit prior to the development stage
|
(2,884,043 | ) | (2,884,043 | ) | |||||
Deficit
accumulated during the development stage
|
(11,761,268 | ) | (10,400,769 | ) | |||||
Total shareholders’ equity (deficit) | (517,390 | ) | (3,701,851 | ) | |||||
Total liabilities and shareholders’ equity (deficit) | $ | 2,764,966 | ) | $ | 2,849,799 | ) |
The
accompanying notes are an integral part of these financial
statements
1
Advanced
Medical Isotope Corporation
|
||||||||||||
(A
Development Stage Company)
|
||||||||||||
Statements
of Operations
|
||||||||||||
(unaudited)
|
||||||||||||
From
inception of
|
||||||||||||
development
stage
|
||||||||||||
Three
months ended
|
on
January 1, 2006
|
|||||||||||
March
31,
|
through
March 31,
|
|||||||||||
2009
|
2008
|
2009
|
||||||||||
Revenues
|
$ | 60,975 | $ | 32,335 | $ | 459,272 | ||||||
Cost
of goods sold
|
21,836 | 17,537 | 233,134 | |||||||||
Gross
profit
|
39,139 | 14,798 | 226,138 | |||||||||
Operating
expenses
|
||||||||||||
Sales
and marketing expenses
|
165 | 7,698 | 51,898 | |||||||||
Start
up costs
|
- | - | 62,510 | |||||||||
Depreciation
and amortization
|
140,668 | 320,302 | 3,129,681 | |||||||||
Impairment
expense
|
- | - | 903,535 | |||||||||
Professional
fees
|
169,687 | 252,433 | 2,637,831 | |||||||||
Stock
options granted
|
87,236 | 638,628 | 2,031,075 | |||||||||
Payroll
expenses
|
100,129 | 140,924 | 871,915 | |||||||||
General
and administrative
|
||||||||||||
expenses
|
112,939 | 106,753 | 860,689 | |||||||||
Total
operating expenses
|
610,824 | 1,466,738 | 10,549,134 | |||||||||
Operating
loss
|
(571,685 | ) | (1,451,940 | ) | (10,322,996 | ) | ||||||
Non-operating
income (expense):
|
||||||||||||
Interest
expense
|
(181,870 | ) | (16,076 | ) | (733,828 | ) | ||||||
Investment
loss
|
- | - | (28,500 | ) | ||||||||
Loss
on settlement of debt
|
(606,944 | ) | - | (675,944 | ) | |||||||
Non-operating
income (expense), net
|
(788,814 | ) | (16,076 | ) | (1,438,272 | ) | ||||||
Loss
before Income Taxes
|
(1,360,499 | ) | (1,468,016 | ) | (11,761,268 | ) | ||||||
Income
Tax Provision
|
- | - | - | |||||||||
Net
loss
|
$ | (1,360,499 | ) | $ | (1,468,016 | ) | $ | (11,761,268 | ) | |||
Loss
per common share
|
$ | (0.03 | ) | $ | (0.04 | ) | ||||||
Weighted
average common shares
|
||||||||||||
outstanding
|
39,334,865 | 33,025,124 | ||||||||||
The
accompanying notes are an integral part of these financial
statements.
|
2
Advanced
Medical Isotope Corporation
|
||||||||||||||||||||||||||||||||||||
(A
Development Stage Company)
|
||||||||||||||||||||||||||||||||||||
Statement
of Changes in Shareholders’ Equity (Deficit) (unaudited)
|
||||||||||||||||||||||||||||||||||||
Accumulated
|
Deficit
|
|||||||||||||||||||||||||||||||||||
Deficit
|
Accumulated
|
|||||||||||||||||||||||||||||||||||
Series
A Preferred
|
Prior to | During | ||||||||||||||||||||||||||||||||||
Stock
|
Common
Stock
|
Paid in |
Subscriptions
|
Development
|
Development
|
|||||||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Receivable
|
Stage
|
Stage
|
Total
|
||||||||||||||||||||||||||||
Balances at December 31, | ||||||||||||||||||||||||||||||||||||
2008
|
95,000 | $ | 95 | 36,778,612 | $ | 36,779 | $ | 9,546,087 | $ | - | $ | (2,884,043 | ) | $ | (10,400,769 | ) | $ | (3,701,851 | ) | |||||||||||||||||
Common stock issued for: | ||||||||||||||||||||||||||||||||||||
Debt settlement January | ||||||||||||||||||||||||||||||||||||
2009
($.27 per share)
|
- | - | 190,000 | 190 | 51,110 | - | - | - | 51,300 | |||||||||||||||||||||||||||
Services
February 2009
|
||||||||||||||||||||||||||||||||||||
($.42
per share)
|
- | - | 80,000 | 80 | 33,520 | - | - | - | 33,600 | |||||||||||||||||||||||||||
Debt
settlement March
|
||||||||||||||||||||||||||||||||||||
2009
($.35 per share)
|
- | - | 150,000 | 150 | 52,350 | - | - | - | 52,500 | |||||||||||||||||||||||||||
Debt
settlement March
|
||||||||||||||||||||||||||||||||||||
2009
($.35 per share)
|
- | - | 33,333 | 33 | 11,633 | - | - | - | 11,666 | |||||||||||||||||||||||||||
Services
March 2009
|
||||||||||||||||||||||||||||||||||||
($.35
per share)
|
- | - | 25,000 | 25 | 8,725 | - | - | - | 8,750 | |||||||||||||||||||||||||||
Loan
fee March 2009
|
- | - | ||||||||||||||||||||||||||||||||||
($.28
per share)
|
40,000 | 40 | 10,992 | - | - | - | 11,032 | |||||||||||||||||||||||||||||
Cash
March 2009
|
||||||||||||||||||||||||||||||||||||
($.27
per share)
|
- | - | 37,037 | 37 | 9,963 | - | - | - | 10,000 | |||||||||||||||||||||||||||
Cash
March 2009
|
||||||||||||||||||||||||||||||||||||
($.15
per share)
|
- | - | 1,500,000 | 1,500 | 223,500 | - | - | - | 225,000 | |||||||||||||||||||||||||||
Convert
95,000 convertible
|
||||||||||||||||||||||||||||||||||||
preferred shares ($.351 | ||||||||||||||||||||||||||||||||||||
per
share)
|
(95,000 | ) | (95 | ) | 10,857,142 | 10,857 | 3,800,095 | - | - | - | (3,810,857 | ) | ||||||||||||||||||||||||
Debt
settlement January
|
||||||||||||||||||||||||||||||||||||
2009
through issuance
|
||||||||||||||||||||||||||||||||||||
of 500,000, 3 year, stock | ||||||||||||||||||||||||||||||||||||
options
exercisable at
|
||||||||||||||||||||||||||||||||||||
$.50
per share
|
- | - | - | - | 228,654 | - | - | - | 228,654 | |||||||||||||||||||||||||||
Intrinsic
value of convertible
|
||||||||||||||||||||||||||||||||||||
debt
issued March 2009
|
- | - | - | - | 14,365 | - | - | - | 14,365 | |||||||||||||||||||||||||||
Vesting
of stock options
|
||||||||||||||||||||||||||||||||||||
March
2009
|
- | - | - | - | 87,236 | - | - | - | 87,236 | |||||||||||||||||||||||||||
Net
loss
|
- | - | - | - | - | - | - | (1,360,499 | ) | (1,360,499 | ) | |||||||||||||||||||||||||
Balances
at March 31,
|
||||||||||||||||||||||||||||||||||||
2009
(unaudited)
|
- | $ | - | 49,691,124 | $ | 49,691 | $ | 14,078,230 | $ | - | $ | (2,884,043 | ) | $ | (11,761,268 | ) | $ | (517,390 | ) | |||||||||||||||||
The
accompanying notes are an integral part of these financial
statements.
|
3
Advanced
Medical Isotope Corporation
|
||||||||||||
(A
Development Stage Company)
|
||||||||||||
Statements
of Cash Flow
|
||||||||||||
(unaudited)
|
||||||||||||
From
inception of
|
||||||||||||
development
stage on
|
||||||||||||
Three
months ended
|
Three
months ended
|
January
1, 2006 through
|
||||||||||
March
31, 2009
|
March
31, 2008
|
March
31, 2009
|
||||||||||
CASH
FLOW FROM OPERATING ACTIVITIES:
|
||||||||||||
Net
Loss
|
$ | (1,360,499 | ) | $ | (1,468,016 | ) | $ | (11,761,268 | ) | |||
Adjustments
to reconcile net loss to net cash
|
||||||||||||
used
by operating activities:
|
||||||||||||
Depreciation
of fixed assets
|
134,418 | 9,562 | 444,987 | |||||||||
Amortization
of licenses and intangible assets
|
6,250 | 310,740 | 2,707,007 | |||||||||
Amortization
of convertible debt discount
|
115,238 | - | 154,436 | |||||||||
Amortization
of prepaid expenses paid with stock
|
75,985 | 87,075 | 609,782 | |||||||||
Impairment
of intangible assets
|
- | - | 903,535 | |||||||||
Common
stock issued for services
|
33,600 | - | 1,777,312 | |||||||||
Stock
options issued for services
|
87,236 | 638,628 | 1,167,105 | |||||||||
Stock
issued for repairs and maintenance
|
- | - | 7,875 | |||||||||
Loss
on settlement of debt
|
606,944 | - | 606,944 | |||||||||
Loss
on conversion of shareholder loan
|
- | - | 40,000 | |||||||||
Changes
in operating assets and liabilities:
|
||||||||||||
Accounts
receivable
|
23,147 | 7,275 | (12,600 | ) | ||||||||
Inventory
|
6,212 | 15,975 | (888 | ) | ||||||||
Prepaid
expenses
|
(1,042 | ) | (28,750 | ) | (4,042 | ) | ||||||
Deposits
|
(25,000 | ) | - | (180,408 | ) | |||||||
Accounts
payable
|
144,789 | 26,420 | 651,808 | |||||||||
Payroll
liabilities
|
(3,198 | ) | (36,579 | ) | 5,900 | |||||||
Stock
based consulting fees payable
|
(30,850 | ) | 66,048 | 181,794 | ||||||||
Accrued
interest rolled into notes payable
|
- | - | 142,375 | |||||||||
Accrued
interest
|
18,090 | - | 207,046 | |||||||||
Net
cash used by operating activities
|
(168,680 | ) | (371,622 | ) | (2,351,300 | ) | ||||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||||
Cash
acquired from investment
|
- | - | 310,000 | |||||||||
Cash
used to acquire equipment
|
- | (1,203,427 | ) | (2,583,353 | ) | |||||||
Cash
used to acquire patents
|
(598 | ) | - | (25,192 | ) | |||||||
Cash
used to acquire intangible assets
|
- | - | (658,750 | ) | ||||||||
Net
cash used in investing activities
|
(598 | ) | (1,203,427 | ) | (2,957,295 | ) | ||||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||||
Proceeds
received from bank line of credit
|
- | - | 219,908 | |||||||||
Payments
on line of credit
|
- | (20,000 | ) | (219,908 | ) | |||||||
Proceeds
from Washington Trust debt
|
- | - | 199,908 | |||||||||
Payments
on Washington Trust debt
|
(8,364 | ) | - | (13,673 | ) | |||||||
Proceeds
from capital lease
|
- | 1,197,611 | 2,445,156 | |||||||||
Principal
payments on capital lease
|
(40,919 | ) | (44,492 | ) | (347,222 | ) | ||||||
Proceeds
from convertible note
|
100,000 | - | 775,000 | |||||||||
Proceeds
from officers related party debt
|
22,800 | - | 70,800 | |||||||||
Payments
on officers related party debt
|
(4,700 | ) | - | (52,700 | ) | |||||||
Proceeds
received from shareholder loan
|
- | - | 80,000 | |||||||||
Proceeds
from cash sales of common shares
|
235,000 | 655,280 | 2,044,996 | |||||||||
Proceeds
from exercise of options and warrants
|
- | 72,500 | 125,000 | |||||||||
Proceeds
from subscription shares payable
|
- | - | 202,500 | |||||||||
Net
cash provided by financing activities
|
303,817 | 1,860,899 | 5,529,765 | |||||||||
The
accompanying notes are an integral part of these financial
statements.
|
4
Advanced
Medical Isotope Corporation
|
||||||||||||
(A
Development Stage Company)
|
||||||||||||
Statements
of Cash Flow (continued)
|
||||||||||||
(unaudited)
|
||||||||||||
Statements of Cash Flow
(unaudited) - continued
|
||||||||||||
Net
increase in cash and cash equivalents
|
134,539 | 285,850 | 221,170 | |||||||||
Cash
and cash equivalents, beginning of period
|
86,631 | 54,508 | - | |||||||||
CASH
AND CASH EQUIVALENTS, END OF PERIOD
|
$ | 221,170 | $ | 340,358 | $ | 221,170 | ||||||
Supplemental
disclosures of cash flow information:
|
||||||||||||
Cash
paid for interest
|
$ | 48,542 | $ | 16,076 | $ | 92,816 | ||||||
Cash
paid for income taxes
|
$ | - | $ | - | $ | - |
5
Advanced
Medical Isotope Corporation
Notes
to Consolidated Financial Statements
For
the three months ended March 31, 2009 and the year ended December 31,
2008
NOTE
1: BASIS OF
PRESENTATION
The
accompanying condensed consolidated financial statements of the Company have
been prepared without audit, pursuant to the rules and regulations of the
Securities and Exchange Commission. Certain information and disclosures required
by accounting principles generally accepted in the United States have been
condensed or omitted pursuant to such rules and regulations. These
condensed consolidated financial statements reflect all adjustments that, in the
opinion of management, are necessary to present fairly the results of operations
of the Company for the period presented. The results of operations for the three
months ended March 31, 2009, are not necessarily indicative of the results that
may be expected for any future period or the fiscal year ending December 31,
2009.
Reclassification
Certain
expenses for the period ended March 31, 2008 were reclassified to conform with
the expenses for the period ended March 31, 2009. Certain liabilities at
December 31, 2008 were reclassified to conform with the liabilities at March 31,
2009.
NOTE
2: GOING
CONCERN
The
accompanying financial statements have been prepared on a going concern basis,
which contemplates the realization of assets and satisfaction of liabilities in
the normal course of business. As shown in the accompanying financial
statements, the Company has suffered recurring losses and used significant cash
in support of its operating activities and the Company’s cash position is not
sufficient to support the Company’s operations. Historically, we have relied
upon outside investor funds to maintain our operations and develop our business.
We anticipate we will continue to require funding from investors for working
capital as well as business expansion during this fiscal year and we can provide
no assurance that additional investor funds will be available on terms
acceptable to us. These factors, among others, may indicate that the
Company will be unable to continue as a going concern for a reasonable time. In
addition, our ability to continue as a going concern must be considered in light
of the problems, expenses and complications frequently encountered by entrance
into established markets and the competitive environment in which we
operate.
We
anticipate a requirement of $3 million in funds over the next twelve months to
maintain current operation activities. In addition we anticipate a requirement
of approximately $7 million in funds over the next twelve months due to the
anticipation of adding additional staff in the future assuming we are successful
in selling our medical isotopes and/or the start of development by us on future
manufacturing sites or other projects. Currently we have $221,170 cash on hand
which means there will be an anticipated shortfall of nearly the full $10
million requirement in additional funds over the next twelve months. There are
currently commitments to vendors for products and services purchased, plus, the
employment agreements of the CFO and other employees of the company and our
current lease commitments that will necessitate liquidation of the Company if we
are unable to raise additional capital. The current level of cash is not enough
to cover the fixed and variable obligations of the Company.
Assuming
we are successful in our sales/development effort we believe that we will be
able to raise additional funds through the sale of our stock to either current
or new shareholders. There is no guarantee that we will be able to raise
additional funds or to do so at an advantageous price.
6
Advanced
Medical Isotope Corporation
Notes
to Consolidated Financial Statements
For
the three months ended March 31, 2009 and the year ended December 31,
2008
NOTE
2: GOING CONCERN -
continued
The
financial statements do not include any adjustments relating to the
recoverability and classification of liabilities that might be necessary should
the Company be unable to continue as a going concern. The Company’s
continuation as a going concern is dependent upon its ability to generate
sufficient cash flow to meet its obligations on a timely basis and ultimately to
attain profitability. The Company plans to seek additional funding to
maintain its operations through debt and equity financing and to improve
operating performance through a focus on strategic products and increased
efficiencies in business processes and improvements to the cost
structure. There is no assurance that the Company will be successful
in its efforts to raise additional working capital or achieve profitable
operations. The financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
NOTE
3: FIXED
ASSETS
Fixed
assets consist of the following at March 31, 2009 and December 31,
2008:
March
31, 2009
|
December
31, 2008
|
|||||||
Production
equipment
|
$ | 2,113,218 | 2,113,218 | |||||
Building
|
446,772 | 446,772 | ||||||
Leasehold
improvements
|
3,235 | 3,235 | ||||||
Office
equipment
|
20,128 | 20,128 | ||||||
2,583,353 | 2,583,353 | |||||||
Less
accumulated depreciation
|
(444,987 | ) | (310,569 | ) | ||||
$ | 2,138,366 | 2,272,784 |
Accumulated
depreciation related to fixed assets is as follows:
March
31, 2009
|
December
31, 2008
|
|||||||
Production
equipment
|
$ | 358,420 | 252,759 | |||||
Building
|
82,060 | 54,707 | ||||||
Office
equipment
|
3,760 | 2,543 | ||||||
Leasehold
improvements
|
747 | 560 | ||||||
$ | 444,987 | $ | 310,569 |
Depreciation
expense for the above fixed assets for the three months ended March 31, 2009 and
the three months ended March 31, 2008, respectively, was $134,418 and
$9,562.
7
Advanced
Medical Isotope Corporation
Notes
to Consolidated Financial Statements
For
the three months ended March 31, 2009 and the year ended December 31,
2008
NOTE
4: INTANGIBLE
ASSETS
Intangible
assets consist of the following at March 31, 2009 and December 31,
2008:
|
||||||||
March
31, 2009
|
December
31, 2008
|
|||||||
Intellectual
property
|
$ | - | $ | 250,750 | ||||
Contracts
and agreements
|
- | 213,000 | ||||||
Customer
lists
|
- | 195,000 | ||||||
License
Fee
|
75,000 | 2,972,625 | ||||||
Patents
|
25,192 | 24,594 | ||||||
100,192 | 3,655,969 | |||||||
Less
accumulated amortization
|
(54,167 | ) | (2,700,757 | ) | ||||
Less
Impairment Expense
|
- | (903,535 | ) | |||||
Intangible
assets net of accumulated amortization
|
$ | 46,025 | $ | 51,677 | ||||
Amortization
expense for the above intangible assets for the three months ended March
31, 2009 and the three months ended March 31, 2008, respectively, was
$6,250 and $310,740.
|
NOTE
5: RELATED PARTY
TRANSACTIONS
Indebtedness
from related parties
The
Company had a $200,000 revolving line of credit with Washington Trust Bank that
was to expire in September 2009. The Company had $199,908 in borrowings under
the line of credit as of October 28, 2008 at which time it was paid off and
replaced with a loan from two of the major shareholders. The loan calls for
$4,066 monthly payments, including 8% interest, beginning November 30, 2008,
with a balloon payment for the balance at October 31, 2009. There is no security
held as collateral for this loan. As of March 31, 2009, the balance was $186,235
and all payments were current on this shareholder loan.
During
the first three months of 2009 the Company received a total of $22,800 from a
shareholder and officer in the form of a loan and the Company repaid $4,700 of
this loan, leaving a balance of $18,100 as of March 31, 2009. All of the $18,100
balance was repaid in April 2009. There was no interest obligation on this loan
to the Company.
8
Advanced
Medical Isotope Corporation
Notes
to Consolidated Financial Statements
For
the three months ended March 31, 2009 and the year ended December 31,
2008
NOTE
5: RELATED PARTY TRANSACTIONS -
continued
Rent
expenses
The
Company began renting office and warehouse space, known as the Production
Facility, effective August 1, 2007, located in Kennewick, Washington from a
shareholder holding less that 5% of the total shares outstanding. The lease
agreement calls for monthly rental payments starting at $3,500, increasing every
August 1st until
they become $4,762 as of August 1, 2011. During the three months ended March 31,
2009 and the three months ended March 31, 2008 the Company incurred rent
expenses for this facility totaling $11,340 and $10,500 respectively. In
addition, the lease agreement called for the issuance of $187,500 in common
stock valued at $.40 per share for a total of 416,667 shares. The company
recognized the issuance of all 416,667 shares in 2007 and will amortize the
$187,500 value of that stock over the sixty month term of the lease. For the
three months ended March 31, 2009 and the three months ended March 31, 2008 the
Company amortized $9,375 and $9,375, respectively, of this stock issuance and
recognized it as rent expense.
Additionally,
in June 2008, the Company entered into a twelve month lease for its corporate
offices with three four month options to renew, but in no event will the lease
extend beyond May 31, 2010. The lease agreement calls for monthly rental
payments of $5,061 per month. During the three months ended March 31, 2009 and
the three months ended March 31, 2008 the Company incurred rent expenses for
this facility totaling $15,184 and $0, respectively.
Future
minimum rental payments required under the Company’s current rental agreements
in excess of one year as of March 31, 2009, are as follows:
Production
|
Corporate
|
|||||||||||
Facility
|
Offices
|
|
Total
|
|||||||||
Twelve
months ended March 31, 2010
|
$ | 47,779 | $ | 60,736 | $ | 108,515 | ||||||
Twelve
months ended March 31, 2010
|
51,602 | 10,123 | 61,725 | |||||||||
Twelve
months ended March 31, 2012
|
55,730 | - | 55,730 | |||||||||
Twelve
months ended March 31, 2013
|
19,047 | - | 19,047 | |||||||||
Total
|
$ | 174,158 | $ | 70,859 | $ | 245,017 |
Rental
expense for the three months ended March 31, 2009 and the three months ended
March 31, 2008 consisted of the following:
Three
Months ended March 31,
2009
|
Three
Months ended March 31,
2008
|
|||||||
Office
and warehouse lease effective August 1, 2007
|
||||||||
Monthly
rental payments
|
$ | 11,340 | $ | 10,500 | ||||
Rental
expense in the form of stock issuance
|
9,375 | 9,375 | ||||||
Corporate
office
|
15,184 | - | ||||||
Total
Rental Expense
|
$ | 35,899 | $ | 19,875 |
9
Advanced
Medical Isotope Corporation
Notes
to Consolidated Financial Statements
For
the three months ended March 31, 2009 and the year ended December 31,
2008
NOTE
6: PREPAID EXPENSES PAID
WITH STOCK
The
Company has issued stock to companies for various service agreements extending
beyond March 31, 2009; however all of which are expected to expire sometime
within the next twelve months. Additionally, the Company issued stock for
prepaid rent which will expire annually through July 2012 at the rate of $37,500
per year. Prepaid Expenses are expected to mature as follows:
For
the twelve month period ending March 31, 2010
|
$ | 73,969 | ||
For
the twelve month period ending March 31, 2011
|
37,500 | |||
For
the twelve month period ending March 31, 2012
|
37,500 | |||
For
the twelve month period ending March 31, 2013
|
12,500 | |||
$ |
161,469
|
NOTE
7: INCOME TAXES
At March
31, 2009, the Company has net operating loss carry forwards available to offset
future taxable income if any of approximately $10,600,000, which will begin to
expire in 2028. The utilization of the net operating loss carry forwards is
dependent upon the tax laws in effect at the time the net operating loss carry
forwards can be utilized. The Tax Reform Act of 1986 significantly limits the
annual amount that can be utilized for certain of these carry forwards as a
result of the changes in ownership.
In July
2006, the FASB issued FASB Interpretation No. 48, “Accounting for Uncertainty in
Income Taxes – and interpretation of FASB Statement No. 109” (“FIN 48”), which
clarifies the accounting and disclosure for uncertainty in tax positions, as
defined. FIN 48 seeks to reduce the diversity in practice associated with
certain aspects of the recognition and measurement related to accounting for
income taxes. The Company is subject to provisions of FIN 48 as of January 1,
2007, and has analyzed filing positions in all of the Federal and state
jurisdictions where it is required to file income tax returns. Upon review of
the Company’s historical tax filings and consultation with its tax advisors, the
Company believes that it has taken tax positions in preceding years that could
potentially result in reductions to its cumulative net operating loss
carry-forwards of approximately $1,395,015. The Company is subject to audit by
the IRS and the State of Delaware for the prior three years.
The
Company, as a matter of policy, would record any interest and penalties
associated with taxes as a component of income tax expenses.
10
Advanced
Medical Isotope Corporation
Notes
to Consolidated Financial Statements
For
the three months ended March 31, 2009 and the year ended December 31,
2008
NOTE
8: STOCKHOLDERS’
EQUITY
Common
stock sale
In March
2009 the Company issued 37,037 shares for cash of $10,000 at $.27 per
share.
In March
2009 the Company issued 1,500,000 shares for cash of $225,000 at $.15 per share.
The Company granted 750,000 warrants in conjunction with this transaction. The
warrants have an exercise price of $0.15 and a two year life.
Preferred
stock
The
Company issued 95,000 shares of preferred stock in September, 2006 to Utek
Corporation for the Company’s purchase of technology from Utek. A board member
of the Company acquired the 95,000 shares of the Company’s Series A Preferred
Stock from Utek in February 2009. In March 2009 the board member
converted the 95,000 shares of the Company’s Series A Preferred Stock and the
related accrued interest into 10,857,142 shares of the Company’s common stock.
The value of the transaction totaled $3,810,857 based on common stock’s average
closing price for the ten trading days before the date of conversion of $0.351
per share. The Company’s Preferred Stock Redeemable as Common
liability was reduced by $3,182,405, accrued interest was reduced by $171,628,
preferred stock was reduced by $95, and a loss on settlement of debt of $456,823
has been recognized in the accompanying financial statements for the three
months ended March 31, 2009.
Common
stock issued for services and debt settlement
During
January 2009, the Company issued 190,000 shares of its common stock in payment
of accounts payable for business consulting services. The value of the
transaction totaled $51,300 based on the quoted market price of stock on the
transaction date, or $.27 per share. The company’s accounts payable was reduced
by $52,500 and a gain on settlement of debt of $1,200 has been recognized in the
accompanying financial statements for the three months ended March 31,
2009.
During
February 2009, the Company issued 80,000 shares of its common stock in exchange
for business consulting services. The value of the transaction totaled $33,600
based on the quoted market price of stock on the transaction date, or $.42 per
share. Stock-based compensation expense of $33,600 has been recognized in the
accompanying financial statements for the three months ended March 31,
2009.
During
March 2009, the Company issued 150,000 shares of its common stock in payment of
accounts payable for business consulting services. The value of the transaction
totaled $52,500 based on the quoted market price of stock on the transaction
date, or $.35 per share. The Company’s account payable was reduced by $50,000
and loss on settlement of debt of $2,500 has been recognized in the accompanying
financial statements for the three months ended March 31, 2009.
During
March 2009, the Company issued 33,333 shares of its common stock in payment of
accounts payable for business consulting services. The value of the transaction
totaled $11,667 based on the quoted market price of stock on the transaction
date, or $.35 per share. The Company’s accounts payable was reduced by $12,000
and gain on settlement of debt of $333 has been recognized in the accompanying
financial statements for the three months ended March 31, 2009.
During
March 2009, the Company issued 25,000 shares of its common stock in exchange for
business consulting services. The value of the transaction totaled $8,750 based
on the quoted market price of stock on the transaction date, or $.35 per share.
Stock-based compensation expense of $8,750 has been recognized in the
accompanying financial statements for the three months ended March 31,
2009.
11
Advanced
Medical Isotope Corporation
Notes
to Consolidated Financial Statements
For
the three months ended March 31, 2009 and the year ended December 31,
2008
NOTE
8: STOCKHOLDERS’ EQUITY –
continued
Common
stock issued for convertible debt
In March
2009, the Company issued 40,000 shares of its common stock and a convertible
promissory note in the amount of $100,000 with interest payable at 10% per
annum. The Note matures in March of 2010. The entire outstanding principal
balance and any outstanding fees or interest is due and payable in full on the
Maturity Date. At the option of the holder, the note and interest is
convertible into the Company’s common stock at $0.30 per share. The
value of the $100,000 debt plus the $0.35 fair market value of the 40,000 shares
at the date of the agreement was prorated to arrive at the allocation of the
original $100,000 debt and the value of the 40,000 shares and the beneficial
conversion feature. The computation resulted in an allocation of
$74,603 toward the debt and $11,032 to the shares and $14,365 to the beneficial
conversion feature. The $11,032 value of the shares and the $14,365
value of the beneficial conversion feature are then amortized to interest over
the twelve month life of the debt. Interest expense of $1,058 has
been recognized in the accompanying financial statements for the three months
ending March 31, 2009.
Common
stock options
Options
granted to non-employees, accounted for under the fair value method
During
February 2009, the Company granted three consultants options to purchase 500,000
shares of the Company’s common stock, at an exercise price of $.50 per share.
The options are fully vested and expire February 5, 2012. The quoted market
price of the common stock at the time of issuance of the options was $.49 per
share. The Company valued the options in accordance with SFAS 123(R). The fair
value of the options totaled $228,654 using the Black-Scholes option pricing
model. The Company’s accounts payable was reduced by $79,500 and a
loss on settlement of debt of $149,154 has been recognized in the accompanying
financial statements for the three months ended March 31, 2009.
The fair
value of the options was estimated at the date of grant using the Black-Scholes
option-pricing model with the following assumptions:
Risk-free interest rate
|
1.37 | % | ||
Dividend yield
|
0.00 | % | ||
Volatility factor
|
211.2 | % | ||
Weighted average expected life
|
3
years
|
|
Weighted
|
|
Weighted | |||||||||||||||||
Options Outstanding
|
Average
|
Average
|
||||||||||||||||||
Number
|
Exercise
|
Remaining
|
Aggregate
|
Exercise
|
||||||||||||||||
Of
|
Price
|
Contractual
|
Intrinsic
|
Price
|
||||||||||||||||
Shares
|
Per Share
|
Life
|
Value
|
Per Share
|
||||||||||||||||
Balance
at December 31, 2008
|
5,609,021 | $ | 0.15-1.05 |
1.52
years
|
$ | 424,138 | $ | 0.75 | ||||||||||||
Options
granted
|
1,250,000 | 0.15-0.50 |
2.34
years
|
150,000 | 0.29 | |||||||||||||||
Options
exercised
|
- | - | - | - | - | |||||||||||||||
Options
expired
|
(2,389,986 | ) | 1.05 | - | - | 1.05 | ||||||||||||||
Balance
at March 31, 2009
|
4,469,035 | $ | 0.15-1.05 |
2.32 years
|
$ | 574,138 | $ | 0.46 | ||||||||||||
Exercisable
at December 31, 2008
|
5,609,021 | $ | 0.15-1.05 |
1.52
years
|
$ | 424,138 | $ | 0.75 | ||||||||||||
Exercisable
at March 31, 2009
|
4,469,035 | $ | 0.15-1.05 |
3.86
years
|
$ | 574,138 | $ | 0.46 |
12
Advanced
Medical Isotope Corporation
Notes
to Consolidated Financial Statements
For
the three months ended March 31, 2009 and the year ended December 31,
2008
NOTE
9: SUPPLEMENTAL CASH FLOW
INFORMATION
During
the three months ended March 31, 2008, the Company had the following non-cash
investing and financing activities:
|
·
|
Decreased
Common Stock Subscriptions Payable by $185,688 and increased common stock
by $826 and increased paid in capital by
$184,862.
|
During
the three months ended March 31, 2009, the Company had the following non-cash
investing and financing activities:
|
·
|
Decreased
trade accounts payable by $114,500 and increased paid in capital by
$115,093 and increased common stock by $373 and decreased loss on
settlement of debt by $966.
|
|
·
|
Decreased
Accrued Interest Payable by $171,628 and decreased Preferred Stock
Redeemable by $3,182,405 and decreased Preferred Stock by $95 and
increased Paid In Capital by $3,800,095 and increased Common Stock by
$10,857 and increased loss on settlement of debt by
$456,824.
|
NOTE
10: SUBSEQUENT EVENTS
In April
2009 the Company received $50,000 in exchange for a one year convertible note at
ten percent interest. The note and the interest can be converted into stock at
$.40 at election of note holder. The note holder also received 20,000 shares of
common stock for entering into this transaction.
In April
2009 the Company sold 55,556 shares of its common stock at $.27 per
share.
In April
2009 the Company sold 525,000 shares of its common stock at $.20 per share plus
an equal amount of one year warrants, exercisable at $0.40.
In April
2009 the Company purchased a cyclotron for $235,000 to establish a second
production facility at a site yet to be determined.
In April
2009 the Company issued 50,000 shares of its common stock valued at $0.31 per
share on the date of issuance, in exchange for rent.
In May
2009 the Company named a new member to the Company’s Board of Directors and
issued that member 200,000, three year, options to purchase the Company’s common
stock at an exercise price of $0.26 per share.
13
Item 2. Management’s Discussion and Analysis
or Plan of Operation.
Advanced
Medical Isotope Corporation (the “Company”) was incorporated under the laws of
Delaware on December 23, 1994 as Savage Mountain Sports Corporation (“SMSC”) for
the purpose of acquiring or investing in businesses which were developing and
marketing active sports products, equipment, and apparel. In April 2000, Earth
Sports Products, Inc (“ESP”), a corporation registered in Washington, merged
with SMSC. In April 2000, HHH Entertainment, Inc (“HHH”), a Nevada corporation,
merged with SMSC. As of the date of merger, HHH was the only stockholder of
SMSC.
The
Company has had limited activity since inception and was considered dormant from
the period May 1, 2000 through December 31, 2005. On September 6, 2006, the
Company changed its name to Advanced Medical Isotope Corporation. The
Company began planned principal operations in August 2007, but has not
generated significant revenue. The Company plans to wholesale medical isotopes
as well as to develop, produce and market medical isotopes.
On
September 27, 2006, the Company acquired the assets of Neu-Hope
Technologies, Inc (“NHTI”), a Florida corporation and a subsidiary of UTEK
Corporation (“UTEK”), a Delaware Corporation, and $310,000 from UTEK for 100,000
shares of Series A Preferred Stock. 95,000 shares of Series Preferred
Stock were issued to UTEK and 5,000 shares were issued to Aware Capital
Corporation. At any time after September 27, 2007, UTEK’s 100,000
Series A Preferred Stock shares can be converted to our Common Stock in the
amount of $3,350,000. The number of Common Stock shares shall be calculated
based on the previous 10-day average closing price on the day of conversion. As
of the end of trading on December 31, 2008, the 10-day average closing price was
$0.422. In December 2007, 5,000 shares of the Company’s Series A preferred
stock were converted to 299,642 shares of common stock at $.559 per share by
Aware Capital Corporation. UTEK can then receive 7,541,469 shares of
our Common Stock for its 95,000 shares of Series A Preferred Stock.
In March
2009 one of the members of the Board of Directors converted 95,000 shares of the
Company’s Series A Preferred Stock into 10,857,142 shares of the Company’s
common stock. The board member acquired the Company’s Series A Preferred Stock
from UTEK in February 2009. The Series A Preferred Stock conversion was based on
the Company’s common stock’s average closing price for the ten trading days
before the date of conversion.
The
Company conducted the acquisition in order to obtain cash and NHTI’s
technology. UTEK provides its clients with externally developed
technologies from universities, university incubators, federal labs, medical
centers, and corporate research laboratories worldwide. To effectuate a
technology transfer, such as our purchase of NHTI, UTEK creates a newly formed
company to acquire a new technology from a university, medical center,
corporation or federal research laboratory and then sell this newly formed
company to a client, such as Advanced Medical Isotope Corporation for securities
or cash.
14
Item
2. Management’s
Discussion and Analysis or Plan of Operation -
continued
Organizational
History - continued
The
assets acquired by the Company were recorded at the value which the preferred
stock can be converted into common stock, $3,350,000, as follows:
As
of
September
27, 2006
|
||||
Cash
|
$
|
310,000
|
||
License
fee
|
3,040,000
|
|||
Net
assets acquired
|
$
|
3,350,000
|
The
Company did not have any relationship with UTEK before the acquisition of Neu
Hope Technologies. UTEK is a public corporation. It is our
understanding that Dr. Clifford M. Gross, PhD, Chairman and Chief Executive
Officer, Ms. Carole R. Wright, Chief Financial Officer and Mr. Douglas
Schaedler, Chief Operating Officer, make the investment decisions on behalf of
UTEK.
UTEK, a
publicly-held corporation, also entered into a technology transfer agreement
with Manakoa Services Corporation. Manakoa Services Corporation has
recently changed its name to TeslaVision Corporation. Mr. Katzaroff
is an officer and a director of TeslaVision Corporation. TeslaVision
Corporation is not a shell company but is not current in its
reporting. Other than Mr. Katzaroff’s service as an officer of both
corporations, there is no relationship between TeslaVision Corporation and
Advanced Medical Isotope Corporation.
On June
13, 2007, the Company acquired the assets of the life sciences business segment
of Isonics Corporation (Isonics), a California corporation. Isonics is a
non-related business of the Company and neither company owns stock in the other.
The Company acquired the assets in exchange for $850,000 cash payment for the
purpose of combining the assets into our business of marketing medical isotopes.
The assets acquired consist of intellectual property, agreements with third
party companies for purchase and marketing of isotopes, customer lists, and
equipment located in Buffalo, New York. Intellectual property, agreements with
third parties and customer lists are stated at the Companies estimation of fair
market value at the time of acquisition. None of the acquired assets hold
any ongoing liabilities or contractual obligations that would result in
additional cash transactions required by the Company.
Based on
our financial history since inception, our auditor has expressed substantial
doubt as to our ability to continue as a going concern. We are a development
stage company that has a limited amount of revenue which has accumulated
deficits since inception. If we cannot obtain sufficient funding, we may
have to delay the implementation of our business
strategy.
General
Description
We are
engaged in the production and distribution of medical isotopes and medical
isotope technologies that are changing the practice of medicine
and ushering in a new era of improved patient care. Isotopes are
a form of chemical element with the same atomic number as another element
but with a different atomic mass. Medical isotopes are used in
molecular imaging, therapy, and nuclear medicine to diagnose, manage and treat
diseases.
Currently,
more than 15 million nuclear medicine procedures are performed each year in the
U.S. Approximately one-third of all patients admitted to U.S. hospitals
undergo at least one medical procedure that employs the use of medical
isotopes.
We employ
innovative production methods to offer a wide range of reliable, domestically
produced medical isotopes as well as in vivo delivery
systems to aid medical practitioners and medical researchers in the
timely diagnosis and effective treatment of diseases such as cancer, heart
disease, neurological disorders, and many other medical
conditions.
Our
objective is to empower physicians, medical researchers, and ultimately,
patients, by providing them with essential medical isotopes that, until now,
have not been practical or economical to produce, in an effort to
detect, manage, and cure human disease, and improve the lives of
patients.
15
Item
2. Management’s
Discussion and Analysis or Plan of Operation -
continued
Products
We
currently offer the following products
Stable
Isotopes:
We
currently offer worldwide distribution of O-18 enriched water and a wide
range of other stable isotopes. Our product line includes stable
isotopes of the following elements: Antimony, Barium, Cadmium, Calcium, Cerium,
Chromium, Copper, Dysprosium, Erbium, Europium, Gadolinium, Gallium, Germanium,
Hafnium, Indium, Iron, Krypton, Lanthanum, Lead, Lutetium, Magnesium, Mercury,
Molybdenum, Neodymium, Nickel, Osmium, Palladium, Platinum, Potassium, Rhenium,
Rubidium, Ruthenium, Samarium, Selenium, Silicon, Silver, Strontium, Sulphur,
Tellurium, Thallium, Tin, Titanium, Tungsten, Vanadium, Xenon, Ytterbium, Zinc,
and Zirconium.
Many of
our products are used in connection with Positron Emission Tomography
(“PET”). In cancer, changes in biochemistry occur before tumor mass
forms. As a result, PET can often identify the presence of disease earlier than
a test which looks for a tumor mass. Isotopes identified by PET
include radiopharmaceutical Fluorodeoxyglucose (“FDG”), a sugar compound that is
labeled with radioactive fluoride.
Radio
Pharmaceuticals:
F-18 FDG: We currently offer
regional distribution of F-18 FDG from our Kennewick, WA production
facility. Other regional production facilities are planned throughout
the U.S. and abroad, including Los Angeles, Oahu, Idaho and
Montana.
Indium-111: We plan to
offer Indium Chloride and Indium Oxine during the first six months of
2009.
Radio
Chemicals:
F-18: We currently offer
regional distribution of F-18 from our Kennewick, WA production
facility. Other regional production facilities are planned
throughout the U.S. and abroad. This is the primary PET imaging
isotope. It is used for medical and diagnostic purposes, such as cancer
detection, heart imaging, and brain imaging.
Iodine-124: This
is a radiotracer primarily used in PET imaging and to create images of human
thyroid. Other treatment uses include apoptosis, cancer biotherapy, glioma,
heart disease, mediastinal micrometastases, and thyroid cancer.
Indium-111: We
currently offer In-111 Chloride bulk solution for U.S. distribution.
This radio chemical is used for infection imaging, cancer treatments, and tracer
studies.
Strontium-82: Used as a
myocardial imaging agent, early detection of coronary artery disease, PET
imaging, blood flow tracers
Germanium-68: It is used for
study of thrombosis and atherosclerosis, PET imaging, detection of pancreatic
cancer, and attenuation correction.
Actinium-225: Used for
advanced research in therapy of leukemia and other cancers. It holds great
promise for treating HIV/AIDS.
Generators:
Strontium-82/Rubidium-82
generators: Used as a myocardial imaging agent, early detection of
coronary artery disease, PET imaging, blood flow tracers.
Germanium-68/Gallium-68
generators: It is used for study of thrombosis and atherosclerosis,
PET imaging, detection of pancreatic cancer, and attenuation
correction.
Actinium-225/Bismuth-213
generators: Actinium-225
is the parent of Bismuth-213, an isotope which has been used in animal trials to
kill human HIV virus. Bismuth-213 has been used in human
clinical trials for the treatment of Acute Myelogenous Leukemia
(AML).
16
Item 2. Management’s Discussion and Analysis
or Plan of Operation -
continued
Products - continued
Within
the next three years, we intend to offer the following isotopes:
Carbon-11: Used in
cancer diagnosis/staging. Radiotracer in PET scans to study normal/abnormal
brain functions related to various drug addictions and is also used to
evaluate disease such as Alzheimer’s, epilepsy, Parkinson’s and heart
disease.
Cobalt-57: Used
for gamma camera calibration. Also used as radiotracer in research and a
source for X-ray fluorescence spectroscopy.
Copper-64: PET scanning,
planar imaging, SPECT imaging, dosimetry studies, cerebral and myocardial
blood flow. This isotope is used in stem cell research, and cancer
treatments.
Iodine-123: Used
in brain, thyroid, kidney, and myocardial imaging, cerebral blood flow
(ideal for imaging) and neurological disease (Alzheimer's).
Molybdenum-99 / Technitium
99: It is the favored choice among medical professionals
because its chemical properties allow it to be bonded to many different chemical
materials, thus allowing use for a wide variety of diagnoses.
Thallium-201: Used
in clinical cardiology, heart imaging, myocardial perfusion studies and
cellular dosimetry.
Manufacturing
The
cornerstone equipment selected for our production center is a proton linear
accelerator. Our proton linear accelerator is designed to replace large
and demanding cyclotron systems for the production of positron emitting
isotopes. Large amounts of fluorine-18, carbon-11, nitrogen-13, and oxygen-15
can be produced for synthesis into compounds used in oncology, cardiology,
neurology, and molecular imaging. The radio-labeled glucose analog, FDG, can be
synthesized and distributed for use in Positron Emission
Tomography.
Based on
our experience in the industry, it is our belief that no other
accelerator in North America has sufficient flexibility to produce the
full spectrum of PET imaging radioisotopes, as well as other high-demand
isotopes, both short and long lived, for diagnostic and therapeutic
applications.
We are
also engaged in a number of collaborative efforts with U.S. national
laboratories and universities, along with several international teaming
partners. These collaborative effort projects include complementary
isotope manufacturing technologies as well as isotope devices. We
have entered into agreements to produce isotopes at
Idaho State University, the University of Missouri at Columbia, the
State University of New York at Buffalo, and the University of Utah. These
regional university centers will allow us to become a local supplier for the
short-lived isotopes like Fluorine 18 as well as being a domestic supplier of
several other isotopes in demand by the medical community.
In
November 2007, we entered into an agreement with the Idaho Accelerator Center
(IAC), located on the campus of Idaho State University in Pocatello, ID, to
create a regional medical isotope production center. The IAC will
investigate the production of a variety of isotopes at IAC facilities and we
will proceed with conceptual planning for production facility
development. We intend to use the IAC to develop and manufacture
medical isotopes.
In
January 2008, we entered into a five-year agreement with Central
Pharmaceutical Services, Inc. (“CRS”) for the joint production and marketing of
Indium-111, an isotope used in specialized diagnostic imaging applications. CRS
is an advanced biomedical research and development facility established by the
State University of New York at Buffalo. By labeling In-111 to antibodies and
peptides that transport it to specific parts of the body, physicians can image
colorectal cancer, prostate cancer, and neuro-endocrine tumors. In-111 can also
be used to radiolabel white blood cells, platelets and red blood cells for
diagnostic purposes. The comprehensive agreement with CRS is designed
to enable us to complement production capacity of a variety of high-value
medical isotopes with our Kennewick, Wash. facility. Several other
radio-chemicals are also under consideration for production in the near future
at the Buffalo, N.Y. facility. The agreement with CRS allows for the
initial product to be Indium-111, a radioisotope produced from the stable
isotope cadmium-112. CRS will provide irradiation facilities as well as
production expertise and chemical syntheses.
In May
2008, we entered into a research agreement with the University of Utah related
to the use of brachytherapy seeds for cancer treatments. Pursuant to
the research agreement, we will pay total project costs that will not exceed
$45,150. We hope to work with the University of Utah to develop and
manufacture cancer treatments using brachytherapy seeds.
17
Item 2. Management’s Discussion and Analysis
or Plan of Operation -
continued
Manufacturing - continued
In June
2008, we entered into a research agreement with the University of Missouri
related to the production of radio isotopes. Pursuant to the research
agreement, we will pay total project costs that will not exceed
$75,000. We also entered into an option agreement in June 2008 with
the University of Missouri. The option agreement gives us a one-year
option to enter into a licensing agreement to utilize certain intellectual
property held by the University of Missouri for the production of medical,
research, and industrial radioisotopes. If the University of
Missouri’s intellectual property functions as early analysis have indicated,
this production facility could be a manufacturing source of critical health care
radio isotopes.
Customers
Our
customers include a broad range of hospitals, universities, research centers and
national laboratories, in addition to academic and government
institutions. These customers are located in essentially all major
U.S. and international markets. In July 2008, we began production of
F-18 in our production facilities in Kennewick, Washington. Sales of
F-18 for the quarter ended March 31, 2009 totaled approximately 87% of total
revenue.
The
company is also working with United Pharmacy Partners Inc (UPPI). UPPI has a
network of approximately 120 nuclear pharmacies within the United States. We
have entered into an affiliation agreement with UPPI to provide to the UPPI
network preferred prices and special terms and conditions for certain products
that we anticipate to manufacture or re-sell during 2009 and 2010.
Competitors
The
suppliers of radioisotopes for diagnosis, treatment, and research for a wide
variety of diseases, in particular cancer, vary in size and product
offerings. Competition is limited because there are many
complications and regulatory hurdles, including licensing, government approvals
and capital outlays associated with starting an isotope company. Many
current competitors are international companies.
Further,
competition is limited as some competitors are closing their facilities or
limiting their production. In November 2007, Canadian supplier MDS Nordion was
forced to shut down its radioisotope production facility. At one time, the U.S.
government was supposed to be the source of medical isotopes, but over the
course of the last two decades, it has either closed or failed to adequately
fund its production facilities.
About 90%
of all the non PET radioisotopes used in the United States are imported from two
companies. Approximately half of these were imported directly from
the now-defunct MDS Nordion plant and the other half supplied by Covidien
(formerly Mallinkrodt). The remaining 10% that are produced in the
United States are manufactured in a fragmented, piecemeal manner with companies
producing a single isotope instead of a wide variety.
Employees
As
of March 31, 2009, we had six full time employees. At any given time,
we utilize eight to ten contract employees to assist with the company
operations. We do not have a collective bargaining agreement with any
of our employees and we believe our relations with our employees are
good.
18
Item
2. Management’s
Discussion and Analysis or Plan of Operation -
continued
Research and Development /
Intellectual Property
The
Company has made through acquisitions the following investments in patent
licenses and intellectual property during 2007:
●
|
$75,000
for a patent license fee, good for the life of the patent, for the
production of Actinium 225;
|
●
|
$3,040,000
of preferred stock issuance for a patent license, good for the life of the
patent, of a Neutron Generator; and
|
|
●
|
$658,750
for the purchase of a company in order to acquire the rights of
intellectual property related to the process for the production of
isotopes, customer lists, contracts and agreements with third party
companies, and certain equipment. The amortization of these
items is computed using the straight-line method over the following
estimated useful lives:
|
Intellectual
property
|
3
years
|
Contracts
and agreements
|
3
years
|
Customer
lists
|
2
years
|
In
January 2007 AMIC received a license for United States Patent 6,680,993.
The patent concerns methods and processes directed to the preparation of
Actinium-225 and daughters having high radiochemical and radionuclidic
purity. These isotopes may be used for the preparation of therapeutic
radiopharmaceuticals such as those containing monoclonal antibodies, proteins,
peptides, antisense, statin, natural products and hormones. Additionally,
the alpha-emitting radionuclide Actinium-225 and its daughters may be used for
both therapeutic and diagnostic purposes.
Results
of Operations
The
following table sets forth information from our statements of operations for the
three months ended March 31, 2009 and 2008.
Three Months Ended
March 31, 2009
|
Three Months Ended
March 31, 2008
|
|||||||
Revenues
|
$ | 60,975 | $ | 32,335 | ||||
Cost
of goods sold
|
21,836 | 17,537 | ||||||
Gross
profit
|
39,139 | 14,798 | ||||||
Operating
expenses
|
610,824 | 1,466,738 | ||||||
Operating
loss
|
(571,685 | ) | (1,451,940 | ) | ||||
Non-operating
expenses
|
(606,944 | ) | - | |||||
Interest
expense
|
(181,870 | ) | (16,076 | ) | ||||
Net
income (loss)
|
$ | (1,360,499 | ) | $ | (1,468,016 | ) |
Details
related to Revenues and Cost of Goods Sold for the three months ended March 31,
2009 and 2008.
Three Months Ended
March 31, 2009
|
Three Months Ended
March 31, 2008
|
|||||||||
Revenues
|
||||||||||
Stable
Isotopes
|
$ | 7,875 | $ | 32,335 | ||||||
F-18
|
53,100 | - | ||||||||
Total
Revenue
|
$ | 60,975 | $ | 32,335 | ||||||
Cost
of Goods Sold
|
||||||||||
Stable
Isotopes
|
$ | 6,500 | $ | 17,537 | ||||||
F-18
|
15,336 | - | ||||||||
Total
Cost of Goods Sold
|
$ | 21,836 | $ | 17,537 |
19
Item
2. Management’s
Discussion and Analysis or Plan of Operation -
continued
Revenue
Revenue
was $60,975 for the three months ended March 31, 2009 and $32,335 for the three
months ended March 31, 2008. During 2007 we began our stable isotope marketing
program which was acquired through the purchase of the Life Science division of
Isonics, Inc. During the three months ended March 31, 2008, we continued the
stable isotope marketing program generating all of the $32,335 revenues for that
period compared to $7,875 of the three months ended March 31, 2009 revenues
attributable to stable isotopes. In July 2008 we established our linear
accelerator production center and began the production and marketing of F-18 in
August 2008, accounting for $53,100 of the total three months ended March 31,
2009 revenues.
Cost of Goods
Sold
Cost of
Goods Sold for the three months ended March 31, 2009 was
$21,836. Cost of goods sold for the three months ended March 31, 2008
was $17,537. The cost of goods sold of $17,537 for the three months ended March
31, 2008, 54.2% of revenues, was our cost of the stable isotopes included in
revenues. The $21,836 cost of goods sold for the three months ended March 31,
2009 consists of $6,500, 82.5% of associated revenues for stable isotopes and
$15,336, 28.9% of associated revenues, was our costs for the F-18 production
(consisting mostly of supplies). The reason for the increase in the cost of
goods sold percentage from the three months ended March 31, 2008 (54.2%) to the
three months ended March 31, 2009 (82.5%) for stable isotopes was due to a
reduction in sales price for stable isotopes we were able to obtain. We have
worked with our supplier in an attempt to reduce our costs for stable isotopes
in an effort to keep the cost of goods sold in line with available pricing for
the product.
Operating
Expenses
Operating
expenses for the three months ended March 31, 2009 and 2008 was $610,824 and
$1,466,738 respectively. The decrease in operating expenses from 2008
to 2009 can be attributed largely to amortization of licenses and intangible
assets ($6,250 for the three months ended March 31, 2009 versus $310,740 for the
three months ended March 31, 2008), professional fees ($169,687 for the three
months ended March 31, 2009 versus $252,433 for the three months ended March 31,
2008), stock options granted ($87,236 for the three months ended March 31, 2009
versus $638,628 for the three months ended March 31, 2008) and payroll expense
($100,129 for the three months ended March 31, 2009 versus $140,924 for the
three months ended March 31, 2008) and an increase in depreciation ($134,418 for
the three months ended March 31, 2009 versus $9,562 for the three months ended
March 31, 2008).
Three Months Ended
March 31, 2009
|
Three Months Ended
March 31, 2008
|
|||||||
Depreciation
and amortization expense
|
$ | 140,668 | $ | 320,302 | ||||
Professional
fees
|
169,687 | 252,433 | ||||||
Stock
options granted
|
87,236 | 638,628 | ||||||
Payroll
expenses
|
100,129 | 140,924 | ||||||
General
and administrative expenses
|
112,939 | 106,753 | ||||||
Sales
and marketing expense
|
165 | 7,698 | ||||||
$ | 610,824 | $ | 1,466,738 |
Non-Operating
Expense
Non
operating expense for the three months ended March 31, 2009 and 2008 was
$788,814 and $16,076, respectively. The increase in non-operating loss is due to
an increase in interest expense ($181,870 for the three months ended March 31,
2009 versus $16,076 for the three months ended March 31, 2008), and loss on
settlement of debt ($606,944 for the three months ended March 31, 2009 versus $0
for the three months ended March 31, 2008).
Net Loss
Our net
loss for the three months ended March 31, 2009 and 2008 was $1,360,499, and
$1,468,016, respectively.
20
Item
2. Management’s
Discussion and Analysis or Plan of Operation -
continued
Liquidity
and Capital Resources
At March
31, 2009, we had negative working capital of $2,969,687, as compared to
$6,278,593 at December 31, 2008. During the three months ended March 31, 2009 we
experienced negative cash flow from operations of $168,680, and we expended $598
for investing activities while adding $303,817 from financing
activities. As of March 31, 2009, we had $0 commitments for capital
expenditures.
We have
generated material operating losses since inception. We have incurred a net loss
of $11,761,268 from January 1, 2006 (inception) through March 31, 2009,
including a net loss of $1,360,499 for the three months ended March 31, 2009. We
expect to continue to experience net operating losses. Historically, we have
relied upon outside investor funds to maintain our operations and develop our
business. We anticipate raising additional capital within the next twelve months
from investors for working capital as well as business expansion and we can
provide no assurance that additional investor funds will be available on terms
acceptable to us. If we are unable to obtain additional financing to meet our
working capital requirements, we may have to curtail our business.
Based on
the current cash run rate, approximately $1,000,000 will be needed to fund
operations for an additional year. As disclosed in the risk factors, we are
presently taking steps to raise additional funds to continue operations for the
next 12 months and beyond. We will need to raise an additional
$10,000,000 in the next year to develop three isotope manufacturing centers and
complete our aggressive growth plans. We may, however, choose to
modify our growth and operating plans to the extent of available funding, if
any.
The
recent economic events, including the substantial decline in global capital
markets, as well as the lack of liquidity in the capital markets, could impact
our ability to obtain financing and our ability to execute our business plan.
Although market conditions have deteriorated, we believe healthcare institutions
will continue to purchase the medical solutions that we distribute. As a
development stage company with modest sales from our inception, we are unable to
determine the effect of the recent economic crises on our sales.
Contractual
Obligations (payments due by period)
Contractual
Obligation
|
Total
Payments Due
|
Less
than 1 Year
|
1-3
Years
|
3-5
Years
|
More
than 5 Years
|
||||||||||||
Capital
Lease Obligation
|
2,097,934
|
354,400 | 1,208,609 | 534,925 | |||||||||||||
Production
center lease
|
174,158 |
|
47,779 | 126,379 | |||||||||||||
Corporate
office lease
|
70,859 | 60,736 | 10,123 | ||||||||||||||
License
agreement with Regents of the University of California
|
385,000 | 25,000 | 120,000 | 180,000 |
60,000
each
year
|
The
capital lease obligations represent two lease agreements for $1,875,000 and
$631,000, secured by equipment and personal guarantee of two of the major
shareholders we obtained during September 2007. The purpose of the lease
agreements is to acquire a Pulsar 10.5 PET Isotope Production System for a
contracted amount of $1,875,000 plus ancillary equipment and facility for
$631,000.
For the
three months ended March 31, 2009 and the year ended December 31, 2008, we had
no long term liability reported on the financial statements due to the Company
being out of compliance with the terms of the debt and therefore being subjected
to the possibility of the entire loan being called due. The long term liability
is related to two capital lease obligations we obtained in September 2007 that
are secured by equipment and the personal guarantee of the two major
shareholders. The lease allowed the company to acquire a Pulsar 7 PET Isotope
Production System and ancillary equipment.
21
Item
2. Management’s
Discussion and Analysis or Plan of Operation -
continued
Critical
Accounting Policies
The
Securities and Exchange Commission (“SEC”) defines “critical accounting
policies” as those that require application of management's most difficult,
subjective or complex judgments, often as a result of the need to make estimates
about the effect of matters that are inherently uncertain and may change in
subsequent periods. Not all of the accounting policies require management to
make difficult, subjective or complex judgments or estimates. However, the
following policies could be deemed to be critical within the SEC
definition.
Use
of estimates
The
preparation of financial statements in accordance with generally accepted
accounting principles requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and the disclosure of
contingent assets and liabilities at the date of financial statements and the
reported amounts of revenues and expenses during the reporting period. Actual
results could differ from those estimates.
Fixed
Assets
Fixed
assets are carried at the lower of cost or net realizable value. Production
equipment with a cost of $2,500 or greater and other fixed assets with a cost of
$1,500 or greater are capitalized. Major betterments that extend the useful
lives of assets are also capitalized. Normal maintenance and repairs are charged
to expense as incurred. When assets are sold or otherwise disposed of, the cost
and accumulated depreciation are removed from the accounts and any resulting
gain or loss is recognized in operations.
Depreciation
is computed using the straight-line method over the following estimated useful
lives. Leasehold improvements and capital lease assets are amortized
over the shorter of the life of the lease or the estimated life of the
asset.
Management
of the Company periodically reviews the net carrying value of all of its
equipment on an asset by asset basis. These reviews consider the net realizable
value of each asset, as measured in accordance with the preceding paragraph, to
determine whether impairment in value has occurred, and the need for any asset
impairment write-down. Although management has made its best estimate
of the factors that affect the carrying value based on current conditions, it is
reasonably possible that changes could occur which could adversely affect
management’s estimate of net cash flows expected to be generated from its
assets, and necessitate asset impairment write-downs.
License
Fees
License
fees are stated at cost, less accumulated amortization. Amortization of license
fees is computed using the straight-line method over the estimated economic
useful life of the assets. The Company periodically reviews the
carrying values of patents in accordance with SFAS No. 144 and any impairments
are recognized when the expected future operating cash flows to be derived from
such assets are less than their carrying value.
Intangible
Assets
Intangible
assets resulted from the purchase, for cash, from Isonics Corporation, the
rights to intellectual property related to the production of isotopes, customer
lists, contracts and agreements with third party companies, and certain
equipment. The Company allocated the purchase price to each of the assets based
upon the Companies believe of the long term value of each of those assets and
comparison to replacement cost, where that information was available. Intangible
assets are stated at cost, less accumulated amortization. Amortization of
intangible assets is computed using the straight-line method over the estimated
economic useful life of the assets. The Company periodically reviews the
carrying values of intangible assets in accordance with SFAS No. 144 and any
impairments are recognized when the expected future operating cash flows to be
derived from such assets are less than their carrying value.
Revenue
Recognition
The
Company applies the provision of SEC Staff Accounting Board (“SAB”) No. 104,
Revenue Recognition.
SAB No. 104, which supersedes SAB No. 101, Revenue Recognition in Financial
Statements, provides guidance on the recognition, presentation and
disclosure of revenue in financial statements. SAB No. 104 outlines the basic
criteria that must be met to recognize revenue and provides guidance for the
disclosure of revenue recognition policies. The Company recognized revenue
related to product sales when (i) persuasive evidence of the arrangement exists,
(ii) shipment has occurred, (iii) the fee is fixed or determinable, and (iv)
collectability is reasonably assured.
22
Item
2. Management’s
Discussion and Analysis or Plan of Operation -
continued
The
Company recognizes revenue once an order has been received and shipped to the
customer. Prepayments, if any, received from customers prior to the time
products are shipped are recorded as deferred revenue. In these cases, when the
related products are shipped, the amount recorded as deferred revenue is
recognized as revenue. The Company does not accrue for sales returns and other
allowances as it has not experienced any returns or other
allowances.
Research
and Development Costs
Research
and developments costs, including salaries, research materials, administrative
expenses and contractor fees, are charged to operations as incurred. The cost of
equipment used in research and development activities which has alternative uses
is capitalized as part of fixed assets and not treated as an expense in the
period acquired. Depreciation of capitalized equipment used to perform research
and development is classified as research and development expense in the year
computed.
Fair
value of financial instruments
The
carrying amounts of cash, receivables and accrued liabilities approximate fair
value due to the short-term maturity of the instruments.
Stock-based
compensation
Effective
January 1, 2006, the Company adopted SFAS No. 123 (Revised 2004), Share-Based Payment, which
requires that compensation related to all stock-based awards, including stock
options, be recognized in the financial statements based on their estimated
grant-date fair value. The Company has estimated expected forfeitures, as
required by SFAS No. 123R, and is recognizing compensation expense only for
those awards expected to vest. All compensation is recognized by the time the
award vests.
Recently
Issued Accounting Pronouncements
In April
2009, the FASB issued FSP FAS 157-4, “Determining Fair Value When the
Volume and Level of Activity for the Asset or Liability Have Significantly
Decreased and Identifying Transactions That Are Not Orderly.” This FSP
provides additional guidance for estimating fair value in accordance with FASB
Statement No. 157, Fair Value Measurements, when the volume and level of
activity for the asset or liability have significantly decreased. This FSP also
includes guidance on identifying circumstances that indicate a transaction is
not orderly. This FSP emphasizes that even if there has been a significant
decrease in the volume and level of activity for the asset or liability and
regardless of the valuation technique(s) used, the objective of a fair value
measurement remains the same. Fair value is the price that would be received to
sell an asset or paid to transfer a liability in an orderly transaction (that
is, not a forced liquidation or distressed sale) between market participants at
the measurement date under current market conditions. FSP FAS 157-4 is effective
for interim and annual reporting periods ending after June 15, 2009, and is
applied prospectively. We do not believe that the implementation of this
standard will have a material impact on our financial statements.
In April
2009, the FASB issued FSP FAS 107-1 and APB 28-1, “Interim Disclosures about Fair Value
of Financial Instruments”. This FSP amends FASB Statement No. 107, “Disclosures about Fair Value of
Financial Instruments” to require disclosures about fair value of
financial instruments for interim reporting periods of publicly traded companies
as well as in annual financial statements. This FSP also amends APB Opinion No.
28, Interim Financial Reporting, to require those disclosures in summarized
financial information at interim reporting periods. FSP FAS 107-1 and APB 28-1
are effective for interim and annual reporting periods ending after June 15,
2009. We do not believe that the implementation of this standard will have a
material impact on our financial statements.
In April
2009, the FASB issued FSP FAS 115-2 and FAS 124-2, “Recognition and Presentation of
Other-Than-Temporary Impairments”. This FSP amends the
other-than-temporary impairment guidance for debt securities to make the
guidance more operational and to improve the presentation and disclosure of
other-than-temporary impairments in the financial statements. The most
significant change the FSP brings is a revision to the amount of
other-than-temporary loss of a debt security recorded in earnings. FSP FAS 115-2
and FAS 124-2 are effective for interim and annual reporting periods ending
after June 15, 2009. We do not believe that the implementation of this standard
will have a material impact on our financial statements.
23
Item
2. Management’s
Discussion and Analysis or Plan of Operation -
continued
In
November of 2008, the SEC released a proposed roadmap regarding the potential
use by U.S. issuers of financial statements prepared in accordance with
International Financial Reporting Standards (“IFRS”). IFRS is a
comprehensive series of accounting standards published by the International
Accounting Standards Board (“IASB”). Under the proposed roadmap, the Company may
be required in fiscal 2015 to prepare financial statements in accordance with
IFRS. However, the SEC will make a determination in 2011 regarding the mandatory
adoption of IFRS. We are currently assessing the impact that this potential
change would have on our consolidated financial statements, and we will continue
to monitor the development of the potential implementation of IFRS.
In March
2009, FASB unanimously voted for the FASB “Accounting Standards
Codification” (the “Codification”) to be effective beginning on
July 1, 2009. Other than resolving certain minor inconsistencies in current
United States Generally Accepted Accounting Principles (“GAAP”), the
Codification is not supposed to change GAAP, but is intended to make it easier
to find and research GAAP applicable to particular transactions or specific
accounting issues. The Codification is a new structure which takes accounting
pronouncements and organizes them by approximately ninety accounting topics.
Once approved, the Codification will be the single source of authoritative U.S.
GAAP. All guidance included in the Codification will be considered authoritative
at that time, even guidance that comes from what is currently deemed to be a
non-authoritative section of a standard. Once the Codification becomes
effective, all non-grandfathered, non-SEC accounting literature not included in
the Codification will become non-authoritative.
Other
recent accounting pronouncements issued by the FASB (including its Emerging
Issues Task Force (“EITF”), the American Institute of Certified Public
Accountants (“AICPA”), and the SEC did not or are not believed by us to have a
material impact on our present or future financial statements.
The
Company has adopted all recently issued accounting pronouncements. The adoption
of the accounting pronouncements, including those not yet effective, is not
anticipated to have a material effect on the financial position or results of
operations of the Company.
Off-Balance
Sheet Arrangements
We do not
have any off balance sheet arrangements that are reasonably likely to have a
current or future effect on our financial condition, revenues, and results of
operations, liquidity or capital expenditures.
Item
3. Quantitative and Qualitative Disclosures About Market
Risk.
N/A.
24
Item 4T. Controls and
Procedures.
(a)
Disclosure Controls and Procedures
Our
principal executive officer and principal financial officer have evaluated the
effectiveness of the Company’s disclosure controls and procedures (as defined in
Rules 13a-15(e) or 15d-15(e) under the Securities Exchange Act of
1934, as amended (the “Exchange Act”)) as of the end of the period covered by
this Quarterly Report on Form 10-Q.
Management
is responsible for establishing and maintaining adequate internal controls over
financial reporting. Based upon management’s knowledge of our
operations and accounting functions, management’s assessment concerning the
effectiveness of our internal controls and disclosure controls and procedures is
that those are not effective to provide reasonable assurance that material
information required to be included in our periodic SEC reports is recorded,
processed, summarized and reported within the time periods specified in the SEC
rules and forms, and accumulated and communicated to our senior management,
including our CEO, to allow timely decisions regarding required
disclosures.
Our known
material weaknesses include:
Resources: As of March 31,
2009 we had one full-time employee in general management and no full-time
employees with the requisite expertise in the key functional areas of finance
and accounting. As a result, there is a lack of proper segregation of
duties necessary to insure that all transactions are accounted for accurately
and in a timely manner.
Written Policies &
Procedures: We need to prepare written policies and procedures for
accounting and financial reporting to establish a formal process to close our
books monthly on an accrual basis and account for all transactions, including
equity transactions, and prepare, review and submit SEC filings in a timely
manner.
Audit Committee: We do not
have, and are not required, to have an audit committee. An audit
committee would improve oversight in the establishment and monitoring of
required internal controls and procedures.
Given the
existence of these material weaknesses, management believes that other,
non-identified material weaknesses may have existed and continue to
exist. These material weaknesses will be remedied as described
below.
Management
is committed to improving its internal controls and will (1) perform an
assessment of its internal control using the COSO framework or other framework
as deemed appropriate, (2) continue to use third party specialists to address
shortfalls in staffing and to assist us with accounting and finance
responsibilities, (3) increase the frequency of independent reconciliations of
significant accounts which will mitigate the lack of segregation of duties until
there are sufficient personnel and (4) prepare and implement sufficient written
policies and checklists for financial reporting and closing processes and
(5) may consider appointing an audit committee comprised of independent
board members in the future.
This
annual report does not include an attestation report by our registered public
accounting firm regarding our internal controls over financial
reporting.
(b)
Changes in Internal Controls
There
have not been any changes in the Company’s internal control over financial
reporting (as such term is defined in Rules 13a-15(f) and
15d-15(f) under the Exchange Act) during the quarter ended March 31,
2009 that have materially affected, or are reasonably likely to materially
affect, the Company’s internal control over financial reporting.
25
Item 1. Legal
Proceedings.
We are not a party to any pending legal
proceeding, nor is our property the subject of a pending legal proceeding, that
is not in the ordinary course of business or otherwise material to the financial
condition of our business. None of our directors, officers or affiliates is
involved in a proceeding adverse to our business or has a material interest
adverse to our business.
There have been no material changes
from the disclosure provided in Part 1, Item 1A of our Annual Report on Form
10-K for the year ended December 31, 2008.
Item 2. Unregistered Sales of Equity
Securities and Use of Proceeds.
Common
stock sale
In March
2009 the Company issued 37,037 shares for cash of $10,000 at $.27 per
share.
In March
2009 the Company issued 1,500,000 shares for cash of $225,000 at $.15 per share.
The Company granted 750,000 warrants in conjunction with this transaction. The
warrants have an exercise price of $0.15 and a two year life.
Preferred
stock
The
Company issued 95,000 shares of preferred stock in September, 2006 to Utek
Corporation for the Company’s purchase of technology from Utek. A board member
of the Company acquired the 95,000 shares of the Company’s Series A Preferred
Stock from Utek in February 2009. In March 2009 the board member
converted the 95,000 shares of the Company’s Series A Preferred Stock and the
related accrued interest into 10,857,142 shares of the Company’s common stock.
The value of the transaction totaled $3,810,857 based on common stock’s average
closing price for the ten trading days before the date of conversion of $0.351
per share. The Company’s Preferred Stock Redeemable as Common
liability was reduced by $3,182,405, accrued interest was reduced by $171,628,
preferred stock was reduced by $95, and a loss on settlement of debt of $456,823
has been recognized in the accompanying financial statements for the three
months ended March 31, 2009.
Common
stock issued for services and debt settlement
During
January 2009, the Company issued 190,000 shares of its common stock in payment
of accounts payable for business consulting services. The value of the
transaction totaled $51,300 based on the quoted market price of stock on the
transaction date, or $.27 per share. The company’s accounts payable was reduced
by $52,500 and a gain on settlement of debt of $1,200 has been recognized in the
accompanying financial statements for the three months ended March 31,
2009.
During
February 2009, the Company issued 80,000 shares of its common stock in exchange
for business consulting services. The value of the transaction totaled $33,600
based on the quoted market price of stock on the transaction date, or $.42 per
share. Stock-based compensation expense of $33,600 has been recognized in the
accompanying financial statements for the three months ended March 31,
2009.
During
March 2009, the Company issued 150,000 shares of its common stock in payment of
accounts payable for business consulting services. The value of the transaction
totaled $52,500 based on the quoted market price of stock on the transaction
date, or $.35 per share. The Company’s account payable was reduced by $50,000
and loss on settlement of debt of $2,500 has been recognized in the accompanying
financial statements for the three months ended March 31, 2009.
During
March 2009, the Company issued 33,333 shares of its common stock in payment of
accounts payable for business consulting services. The value of the transaction
totaled $11,667 based on the quoted market price of stock on the transaction
date, or $.35 per share. The Company’s accounts payable was reduced by $12,000
and gain on settlement of debt of $333 has been recognized in the accompanying
financial statements for the three months ended March 31, 2009.
26
Item 2. Unregistered Sales of Equity
Securities and Use of Proceeds - continued
Common stock issued for services and
debt settlement - continued
During
March 2009, the Company issued 25,000 shares of its common stock in exchange for
business consulting services. The value of the transaction totaled $8,750 based
on the quoted market price of stock on the transaction date, or $.35 per share.
Stock-based compensation expense of $8,750 has been recognized in the
accompanying financial statements for the three months ended March 31,
2009.
Common
stock issued for convertible debt
In March
2009, the Company issued 40,000 shares of its common stock and a convertible
promissory note in the amount of $100,000 with interest payable at 10% per
annum. The Note matures in March of 2010. The entire outstanding principal
balance and any outstanding fees or interest is due and payable in full on the
Maturity Date. At the option of the holder, the note and interest is
convertible into the Company’s common stock at $0.30 per share. The
value of the $100,000 debt plus the $0.35 fair market value of the 40,000 shares
at the date of the agreement was prorated to arrive at the allocation of the
original $100,000 debt and the value of the 40,000 shares and the beneficial
conversion feature. The computation resulted in an allocation of
$74,603 toward the debt and $11,032 to the shares and $14,365 to the beneficial
conversion feature. The $11,032 value of the shares and the $14,365
value of the beneficial conversion feature are then amortized to interest over
the twelve month life of the debt. Interest expense of $1,058 has
been recognized in the accompanying financial statements for the three months
ending March 31, 2009.
Item 3. Defaults Upon Senior
Securities.
Not
applicable.
Item 4. Submission of Matters to a Vote of
Security Holders.
Not
applicable.
Not
applicable.
Item 6. Exhibits.
27
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 hereunto
duly authorized.
ADVANCED
MEDICAL ISOTOPE CORPORATION
|
||
Date:
May 20, 2009
|
By:
|
/s/
James C.
Katzaroff
|
Name:
|
James
C. Katzaroff
|
|
Title:
|
Chairman
and Chief Executive
Officer
|
28