VIVOS INC - Quarter Report: 2014 March (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Form 10-Q
(Mark One)
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x
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
FOR THE QUARTERLY PERIOD ENDED: March 31, 2014
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OR
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o
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TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
FOR THE TRANSITION PERIOD FROM __________ TO __________
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COMMISSION FILE NUMBER 000-53497
ADVANCED MEDICAL ISOTOPE CORPORATION
(Exact name of registrant as specified in its charter)
Delaware
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80-0138937
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.)
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6208 W. Okanogan Ave.,
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) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o
Indicate by check mark whether the registrant 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 x No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer
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o
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Accelerated filer
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o
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Non-accelerated filer
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o
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Smaller reporting company
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x
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(Do not check if a smaller reporting company) |
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 May 15, 2014 was 130,476,469.
1
TABLE OF CONTENTS
Page
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||||
PART I - FINANCIAL INFORMATION
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||||
Item 1.
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Financial Statements
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3
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||
Condensed Balance Sheets as of March 31, 2014 (unaudited) and December 31, 2013
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3
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|||
Condensed Statements of Operations for the Three Months ended March 31, 2014 (unaudited) and the Three Months March 31, 2013 (unaudited)
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4
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|||
Condensed Statement of Changes in Stockholders’ Equity (Deficit) for the period ended March 31, 2014 (unaudited)
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5
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|||
Condensed Statements of Cash Flow for the Three Months ended March 31, 2014 (unaudited) and the Three Months ended March 31, 2013 (unaudited)
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6
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|||
Notes to Condensed Financial Statements (unaudited)
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7
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|||
Item 2.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations
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22
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Item 3.
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Quantitative and Qualitative Disclosures About Market Risk
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33
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Item 4.
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Controls and Procedures
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33
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PART II - OTHER INFORMATION
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||||
Item 1A.
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Risk Factors
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34
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Item 2.
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Unregistered Sales of Equity Securities and Use of Proceeds
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34
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Item 6.
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Exhibits
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34
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SIGNATURES
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34
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2
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements.
Advanced Medical Isotope Corporation
Condensed Balance Sheets
March 31,
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December 31,
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|||||||
2014
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2013
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|||||||
(unaudited)
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||||||||
ASSETS
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||||||||
Current Assets:
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||||||||
Cash
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$
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91,641
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$
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-
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||||
Prepaid expenses
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24,143
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3,281
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||||||
Prepaid expenses paid with stock, current portion
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78,866
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107,763
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||||||
Inventory
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8,475
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8,475
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||||||
Total current assets
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203,125
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119,519
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||||||
Fixed assets, net of accumulated depreciation
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13,373
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14,913
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||||||
Other assets:
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||||||||
License fees, net of amortization
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5,713
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7,171
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||||||
Patents and intellectual property
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35,482
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35,482
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||||||
Debt issuance costs
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42,324
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19,786
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||||||
Deposits
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5,406
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5,406
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||||||
Total other assets
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88,925
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67,845
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||||||
Total assets
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$
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305,423
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$
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202,277
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||||
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
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||||||||
Current liabilities:
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||||||||
Accounts payable and accrued expenses
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$
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1,189,191
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$
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1,221,063
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||||
Accrued interest payable
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1,305,756
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1,195,385
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||||||
Payroll liabilities payable
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74,168
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81,514
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||||||
Short term loan payable
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349,913
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349,913
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||||||
Convertible notes payable, net
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485,402
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375,259
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||||||
Derivative liability
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1,803,570
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1,476,615
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||||||
Related party convertible notes payable, net
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4,188,090
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4,158,819
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Current portion of capital lease obligations
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244,648
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309,145
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||||||
Total current liabilities
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9,640,738
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9,167,713
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||||||
Long term liabilities:
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||||||||
Capital lease obligations, net of current portion
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-
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-
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||||||
Total liabilities
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9,640,738
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9,167,713
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||||||
Stockholders’ Equity (Deficit):
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||||||||
Preferred Stock, $.001 par value, 20,000,000 shares authorized;
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||||||||
zero issued and outstanding
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- |
-
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||||||
Common stock, $.001 par value; 200,000,000 shares authorized;
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||||||||
128,241,129 and 120,807,808 shares issued and outstanding, respectively
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128,240
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120,807
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||||||
Paid in capital
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27,758,372
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27,052,282
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||||||
Accumulated deficit
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(37,221,927
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)
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(36,138,525
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)
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||||
Total stockholders’ equity (deficit)
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(9,335,315
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)
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(8,965,436
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)
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||||
Total liabilities and stockholders’ equity (deficit)
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$
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305,423
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$
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202,277
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The accompanying notes are an integral part of these condensed financial statements.
3
Advanced Medical Isotope Corporation
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||||||||
Condensed Statements of Operations
(unaudited)
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||||||||
Three months ended March 31,
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||||||||
2014
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2013
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|||||||
Revenues
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$
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14,054
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$
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24,804
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||||
Operating expenses
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||||||||
Cost of materials
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251
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4,559
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||||||
Sales and marketing expenses
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600
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900
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||||||
Depreciation and amortization
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2,998
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100,905
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||||||
Professional fees
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185,177
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248,264
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||||||
Stock options granted
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58,187
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403,600
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||||||
Payroll expenses
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189,563
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189,835
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||||||
General and administrative expenses
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122,971
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572,073
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||||||
Total operating expenses
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559,747
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1,520,136
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||||||
Operating loss
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(545,693
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)
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(1,495,332
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)
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||||
Non-operating income (expense)
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||||||||
Interest expense
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(393,283
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)
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(404,490
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)
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||||
Net loss on settlement of debt
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(32,630
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)
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(118,031
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)
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||||
Recognized income from grants
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-
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48,430
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||||||
Gain on derivative liability
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(111,796
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)
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1,363,909
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|||||
Non-operating income (expense), net
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(537,709
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)
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889,818
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)
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||||
Loss before Income Taxes
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(1,083,402
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)
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(605,514
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)
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||||
Income Tax Provision
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-
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-
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||||||
Net Loss
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$
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(1,083,402
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)
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$
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(605,514
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)
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||
Loss per common share
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$
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(0.01
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)
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$
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(0.01
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)
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||
Weighted average common shares outstanding
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106,653,383
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86,850,782
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The accompanying notes are an integral part of these condensed financial statements.
4
Advanced Medical Isotope Corporation
|
||||||||||||||||||||
Condensed Statement of Changes in Stockholders’ Equity (Deficit)
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||||||||||||||||||||
(unaudited)
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||||||||||||||||||||
Common Stock
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Paid in
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Accumulated
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||||||||||||||||||
Shares
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Amount
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Capital
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Deficit
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Total
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||||||||||||||||
Balances at December 31, 2013 (audited)
|
120,807,808
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$
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120,807
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$
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27,052,282
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$
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(36,138,525
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)
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$
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(8,965,436
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)
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|||||||||
Common stock issued for:
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||||||||||||||||||||
Cash and the exercise of warrants
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100,000
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100
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5,900
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- |
6,000
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|||||||||||||||
Services
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171,250
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171
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10,729
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- |
10,900
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|||||||||||||||
Accounts payable
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100,000
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100
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7,400
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- |
7,500
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|||||||||||||||
Loan fees on convertible debt
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210,400
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210
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53,394
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- |
53,604
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|||||||||||||||
Debt converted
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6,851,671
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6,852
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475,980
|
- |
482,832
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|||||||||||||||
Options and warrants issued for services
|
- | - |
58,187
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- |
58,187
|
|||||||||||||||
Beneficial conversion feature
|
- | - |
94,500
|
- |
94,500
|
|||||||||||||||
Net loss
|
- | - | - |
(1,083,402)
|
(1,083,402
|
)
|
||||||||||||||
Balances at March 31, 2014
|
128,241,129
|
128,240
|
27,758,372
|
(37,221,927)
|
(9,335,315
|
)
|
The accompanying notes are an integral part of these condensed financial statements.
5
Advanced Medical Isotope Corporation
|
||||||||
Condensed Statements of Cash Flow
|
||||||||
(unaudited)
|
||||||||
Three months ended
|
||||||||
March 31,
|
||||||||
2014
|
2013
|
|||||||
CASH FLOW FROM OPERATING ACTIVITIES:
|
||||||||
Net Loss
|
$
|
(1,083,402
|
)
|
$
|
(605,514
|
)
|
||
Adjustments to reconcile net loss to net cash
|
||||||||
used by operating activities:
|
||||||||
Depreciation of fixed assets
|
1,540
|
112,947
|
||||||
Amortization of licenses and intangible assets
|
1,458
|
11,162
|
||||||
Amortization of convertible debt discount
|
545,263
|
172,515
|
||||||
Amortization of debt issuance costs
|
13,607
|
368,407
|
||||||
Amortization of prepaid expenses paid with stock
|
28,897
|
-
|
||||||
Common stock issued for services
|
10,900
|
7,800
|
||||||
Common stock issued for interest
|
-
|
90,284
|
||||||
Warrants exercised for services
|
-
|
20,000
|
||||||
Stock options and warrants issued for services
|
58,187
|
403,600
|
||||||
Gain on derivative liability
|
(111,796
|
)
|
(1,363,909
|
)
|
||||
Loss on settlement of debt
|
32,630
|
118,032
|
||||||
Changes in operating assets and liabilities:
|
||||||||
Accounts receivable
|
-
|
20,880
|
||||||
Inventory
|
-
|
(4,375
|
||||||
Prepaid expenses
|
(20,862
|
)
|
1,127
|
)
|
||||
Accounts payable
|
(24,372
|
)
|
93,383
|
|||||
Payroll liabilities
|
(7,346
|
)
|
(61,349
|
)
|
||||
Accrued interest
|
127,589
|
122,346
|
||||||
Grant money used to offset expenditures
|
-
|
(48,430
|
)
|
|||||
Net cash used by operating activities
|
(427,707
|
)
|
(541,094
|
)
|
||||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
Cash used to acquire patents and intellectual property
|
-
|
(14,750
|
)
|
|||||
Cash used to acquire equipment
|
-
|
(9,754
|
)
|
|||||
Net cash used by investing activities
|
-
|
(24,504
|
)
|
|||||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
Payments on Washington Trust debt
|
-
|
(11,453
|
)
|
|||||
Principal payments on capital lease
|
(64,497
|
)
|
(117,765
|
)
|
||||
Debt issuance costs
|
(36,145
|
)
|
-
|
|||||
Payments on short term loan
|
-
|
(35,846
|
)
|
|||||
Proceeds from convertible debt
|
623,990
|
229,272
|
||||||
Principal payments on convertible debt
|
(10,000
|
)
|
-
|
|||||
Principal payments on long-term debt
|
- |
-
|
||||||
Proceeds on sale of stock for cash
|
- |
562,500
|
||||||
Proceeds from exercise of warrants
|
6,000
|
-
|
||||||
Net cash provided by financing activities
|
519,348
|
626,708
|
||||||
Net increase (decrease) in cash
|
91,641
|
61,110
|
||||||
Cash, beginning of period
|
-
|
6,411
|
||||||
CASH, END OF PERIOD
|
$
|
91,641
|
$
|
67,521
|
||||
Supplemental disclosures of cash flow information:
|
||||||||
Cash paid for interest
|
$
|
126,494
|
$
|
25,795
|
||||
Cash paid for income taxes
|
$
|
-
|
$
|
-
|
The accompanying notes are an integral part of these condensed financial statements.
6
Advanced Medical Isotope Corporation
Notes to Condensed Financial Statements
For the three months ended March 31, 2014 (unaudited) and the year ended December 31, 2013
NOTE 1: BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES
The accompanying condensed 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 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, 2014, are not necessarily indicative of the results that may be expected for any future period or the fiscal year ending December 31, 2014.
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.
Fair Value of Financial Instruments
Fair Value of Financial Instruments, requires disclosure of the fair value information, whether or not recognized in the balance sheet, where it is practicable to estimate that value. As of March 31, 2014 and December 31, 2013, the balances reported for cash, prepaid expenses, accounts receivable, accounts payable, and accrued expenses, approximate the fair value because of their short maturities.
The Company adopted ASC Topic 820 (originally issued as SFAS 157, “Fair Value Measurements”) as of January 1, 2008 for financial instruments measured as fair value on a recurring basis. ASC Topic 820 defines fair value, established a framework for measuring fair value in accordance with accounting principles generally accepted in the United States and expands disclosures about fair value measurements.
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. ASC Topic 820 established a three-tier fair value hierarchy which prioritizes the inputs used in measuring fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (level 1 measurements) and the lowest priority to unobservable inputs (level 3 measurements). These tiers include:
Level 1, defined as observable inputs such as quoted prices for identical instruments in active markets;
Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active; and
Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions, such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.
The Company measures certain financial instruments at fair value on a recurring basis. Assets and liabilities measured at fair value on a recurring basis were calculated using the Black-Scholes pricing model and are as follows at March 31, 2014:
Total
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Assets
|
||||||||||||||||
Total Assets Measured at Fair Value
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||||
Liabilities
|
||||||||||||||||
Derivative Liability
|
$
|
1,803,570
|
$
|
-
|
$
|
-
|
$
|
1,803,570
|
||||||||
Total Liabilities Measured at Fair Value
|
$
|
1,803,570
|
$
|
-
|
$
|
-
|
$
|
1,803,570
|
7
Advanced Medical Isotope Corporation
Notes to Condensed Financial Statements
For the three months ended March 31, 2014 (unaudited) and the year ended December 31, 2013
NOTE 1:
|
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES- continued
|
Recent Accounting Pronouncements
There are no recently issued accounting pronouncements that the Company believes are applicable or would have a material impact on the financial statements of the Company.
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. This raises substantial doubt about the Company’s ability to continue as a going concern. Historically, the Company has relied upon outside investor funds to maintain the Company’s operations and develop the Company’s business. The Company anticipates it will continue to require funding from investors for working capital as well as business expansion during this fiscal year and it 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, the Company’s 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 it operates.
The Company anticipates a requirement of $1.5 million in funds over the next twelve months to maintain current operation activities. In addition the Company anticipates spending from approximately $2 million to $7 million over that period to fund the initial deployment of the Company’s brachytherapy products should FDA clearance be obtained, a modest distribution capability for third party isotopes and equipment and the potential acquisition of a controlling interest in a European company with which it is having discussions. As of March 31, 2014 the Company has $91,641 cash on hand which means there will be an anticipated shortfall of the full $2 to $7 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 the Company’s current lease commitments that will necessitate liquidation of the Company if it is unable to raise additional capital. The current level of cash is not enough to cover the fixed and variable obligations of the Company.
Assuming the Company is successful in the Company’s sales/development effort it believes that it will be able to raise additional funds through the sale of the Company’s stock to either current or new stockholders. There is no guarantee that the Company will be able to raise additional funds or to do so at an advantageous price.
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.
8
Advanced Medical Isotope Corporation
Notes to Condensed Financial Statements
For the three months ended March 31, 2014 (unaudited) and the year ended December 31, 2013
NOTE 3: FIXED ASSETS
|
Fixed assets consist of the following at March 31, 2014 and December 31, 2013:
|
March 31, 2014
|
December 31, 2013
|
|||||||
Production equipment
|
$
|
2,131,377
|
$
|
2,131,377
|
||||
Building
|
446,772
|
446,772
|
||||||
Leasehold improvements
|
3,235
|
3,235
|
||||||
Office equipment
|
32,769
|
32,769
|
||||||
2,614,153
|
2,614,153
|
|||||||
Less accumulated depreciation
|
(2,600,780
|
)
|
(2,599,240
|
)
|
||||
$
|
13,373
|
$
|
14,913
|
Accumulated depreciation related to fixed assets is as follows:
|
March 31, 2014
|
December 31, 2013
|
|||||||
Production equipment
|
$
|
2,120,738
|
$
|
2,119,830
|
||||
Building
|
446,772
|
446,772
|
||||||
Leasehold improvements
|
3,235
|
3,235
|
||||||
Office equipment
|
30,035
|
29,403
|
||||||
$
|
2,600,780
|
$
|
2,599,240
|
Depreciation expense for the above fixed assets for the three months ended March 31, 2014 and 2013, respectively, was $1,540 and $112,947.
9
Advanced Medical Isotope Corporation
Notes to Condensed Financial Statements
For the three months ended March 31, 2014 (unaudited) and the year ended December 31, 2013
NOTE 4: INTANGIBLE ASSETS
|
|||
Intangible assets consist of the following at March 31, 2014 and December 31, 2013:
|
March 31, 2014
|
December 31, 2013
|
|||||||
License Fee
|
$
|
112,500
|
$
|
112,500
|
||||
Less accumulated amortization
|
(106,787
|
)
|
(105,329
|
)
|
||||
5,713
|
7,171
|
|||||||
Patents and intellectual property
|
35,482
|
35,482
|
||||||
Intangible assets net of accumulated amortization
|
$
|
41,195
|
$
|
42,653
|
Amortization expense for the above intangible assets for the nine months ended March 31, 2014 and 2013, respectively, was $1,458 and $11,162.
NOTE 5: RELATED PARTY TRANSACTIONS
Loans from Stockholder
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 the line of credit was paid off and replaced with a loan in the initial principal amount of $199,908 from James C. Katzaroff and Carlton M. Cadwell. Mr. Katzaroff is the Company’s chief executive officer, and Mr. Katzaroff and Mr. Cadwell are directors and beneficial owners of more than 10% of the Company’s common stock. 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, at which time the note was extended for another year to October 31, 2010, at which time the note was extended for another year to October 31, 2011, at which time the note was extended for another year to October 31, 2012 with monthly payments increasing to $4,090, at which time the note was extended for another year to October 31, 2013 with monthly payments increasing to $4,100. There is no security held as collateral for this loan. The Company paid this loan in full as of December 31, 2013.
Related Party Convertible Notes Payable
The Company issued various shares of common stock and convertible promissory notes during the three months ended March 31, 2014 to a director and major stockholder. The details of these transactions are outlined in Note 10: Stockholders’ Equity - Common Stock Issued for Convertible Debt.
10
Advanced Medical Isotope Corporation
Notes to Condensed Financial Statements
For the three months ended March 31, 2014 (unaudited) and the year ended December 31, 2013
NOTE 5: RELATED PARTY TRANSACTIONS - continued
Rent Expenses
On July 17, 2007, the Company entered into a lease at 6208 West Okanogan Avenue, Kennewick, Washington, 99336 which has been used as the Company’s production center. The original term of the lease was five years, commencing on August 1, 2007, however, subsequent to July 31, 2012 the Company began renting this space on a month to month basis at $11,904 per month. The landlord of this space is a non-affiliated stockholder of the Company, who holds less than 5 percent of the total outstanding shares. In January 2014, the Company entered into a new 12-month lease for its corporate offices for a monthly rent of $1,500 from an entity controlled by Carlton M. Cadwell, a significant shareholder and a Director of the Company
Rental expense for the three months ended March 31, 2014 and 2013 consisted of the following:
Three months ended March 31, 2014
|
Three months ended March 31, 2013
|
|||||||
Office and warehouse lease effective August 1, 2007
|
||||||||
Monthly rental payments
|
$
|
35,712
|
$
|
35,713
|
||||
Corporate office
|
4,500
|
8,730
|
||||||
Total Rental Expense
|
$
|
40,212
|
$
|
44,443
|
11
Advanced Medical Isotope Corporation
Notes to Condensed Financial Statements
For the three months ended March 31, 2014 (unaudited) and the year ended December 31, 2013
NOTE 6: PREPAID EXPENSES PAID WITH STOCK
The Company issued stock for prepaid services for the year ended December 31, 2013 in the amount of $78,000 of which $26,000 expired in 2013 and was expensed and recorded as stock issued for services and $19,500 expired in the three months ending March 31, 2014 and was expensed and recorded as stock issued for services. The $32,500 balance will expire through December 2014. The Company also issued stock for prepaid services for the year ended December 31, 2013 in the amount of $69,550 of which $17,388 expired in 2013 and was expensed and recorded as stock issued for services and $5,796 expired in the three months ending March 31, 2014 and was expensed and recorded as stock issued for services. The $46,366 balance will expire through December 2014. The Company also issued stock for prepaid services for the year ended December 31, 2013 in the amount of $3,600 of which $0 expired in 2013 and $3,600 expired in the three months ending March 31, 2014 and was expensed and recorded as stock issued for services. Prepaid expenses are expected to mature as follows:
For the twelve month period ending December 31, 2014
|
$
|
78,866
|
||
Thereafter
|
-
|
|||
$
|
78,866
|
NOTE 7: SHORT TERM LOAN PAYABLE
The Company had research costs of $349,913 that was converted to an unsecured promissory note May 1, 2013. The note calls for 10% interest and is due May 1, 2014. Interest in the amount of $32,019 has been accrued on this note as of March 31, 2014.
12
Advanced Medical Isotope Corporation
Notes to Condensed Financial Statements
For the three months ended March 31, 2014 (unaudited) and the year ended December 31, 2013
NOTE 8: CONVERTIBLE NOTES PAYABLE
As of March 31, 2014 and December 31, 2013 the Company had the following convertible notes outstanding:
March 31, 2014
|
December 31, 2013
|
|||||||||||||||
Principal (net)
|
Accrued Interest
|
Principal (net)
|
Accrued Interest
|
|||||||||||||
July and August 2012 $1,060,000 Convertible Notes, 12% interest, due December 2013 and January 2014 (18 month notes), $170,000 and $180,000 outstanding , net of debt discount of $0 and $8,576, respectively
|
$ | 170,000 | $ | 33,944 | $ | 171,424 | $ | 30,610 | ||||||||
May 2013 $224,000 Convertible Note, 12% interest, due November 2014 (18 month note), $0 and $30,000, net of debt discount of $0 and $17,450, respectively
|
- | - | 12,550 | 2,257 | ||||||||||||
April 2013 $72,280 Convertible Note, 0% interest for the first 90 days, due April 2014, with a 10% original issue discount, $0 and $16,646 outstanding, net of debt discount of $0 and $4,241, respectively
|
- | - | 12,405 | - | ||||||||||||
June 2013 $34,560 Convertible Note, 0% interest for the first 90 days, due June 2014, with a 10% original issue discount, $0 and $34,650 outstanding, net of debt discount of $0 and $14,676, respectively
|
- | - | 19,884 | 3,456 | ||||||||||||
July 2013 $53,000 Convertible Note, 8% interest, due February 2014, $0 and $53,000 outstanding, net of debt discount of $0 and $19,395, respectively
|
- | - | 33,605 | 2,033 | ||||||||||||
July 2013 $30,024 Convertible Note, 10% one-time interest, due July 2014, with a 10% original issue discount, $0 and $30,024 outstanding, net of debt discount of $0 and $15,876, respectively
|
- | - | 14,148 | 3,002 | ||||||||||||
August 2013 $53,000 Convertible Note, 8% interest, due March 2014, $0 and $53,000 outstanding, net of debt discount of $0 and $28,716, respectively
|
- | - | 24,284 | 1,464 | ||||||||||||
September 2013 $10,000 Convertible Note, 10% interest, due September 2014 (12 month note), $10,000 and $10,000 outstanding, net of debt discount of $82 and $131, respectively
|
9,918 | 583 | 9,869 | 330 | ||||||||||||
September 2013 $30,000 Convertible Note, 12% interest, due September 2014, with a $1,500 original issue discount, $30,000 and $30,000 outstanding, net of debt discount of $16,946 and $17,945, respectively
|
13,054
|
2,100 | 12,055 | 937 | ||||||||||||
October 2013 $37,500 Convertible Note, 8% interest, due July 2014, $37,500 and $37,500 outstanding, net of debt discount of $13,909 and $26,182, respectively
|
23,591 | 1,482 | 11,318 | 682 | ||||||||||||
October 2013 $97,700 Convertible Note, 8% interest, due April 2014, with a 12% original issue discount, $97,700 and $97,700 outstanding, net of debt discount of $16,194 and $64,774, respectively
|
81,506 | 5,862 | 32,926 | 1,954 | ||||||||||||
November 2013 $42,500 Convertible Note, 8% interest, due August 2014, $42,500 and $42,500 outstanding, net of debt discount of $20,559 and $34,368, respectively
|
21,941 | 1,133 | 8,132 | 494 |
13
Advanced Medical Isotope Corporation
Notes to Condensed Financial Statements
For the three months ended March 31, 2014 (unaudited) and the year ended December 31, 2013
NOTE 8: CONVERTIBLE NOTES PAYABLE - continued
March 31, 2014
|
December 31, 2013
|
||||||||||||||||
Principal (net)
|
Accrued Interest
|
Principal (net)
|
Accrued Interest
|
||||||||||||||
November 2013 $27,800 Convertible Note, 10% one-time interest, due November 2014, with a 10% original issue discount, $27,800 and $27,800 outstanding, net of debt discount of $18,305 and $24,296, respectively
|
9,495 | 1,042 | 3,504 | 2,780 | |||||||||||||
December 2013 $27,500 Convertible Note, 8% interest, due September 2014, $27,500 and $27,500 outstanding, net of debt discount of $13,732 and $26,005, respectively
|
13,768 | 642 | 1,495 | 90 | |||||||||||||
December 2013 $69,120 Convertible Note, 0% interest for the first 90 days, due December 2014, with a 10% original issue discount, $69,120 and $69,120 outstanding, net of debt discount of $48,100 and $65,143, respectively
|
21,020 | 4,320 | 3,977 | 6,912 | |||||||||||||
December 2013 $55,000 Convertible Note, 12% interest, due December 2014, with a $3,300 original issue discount, $55,000 and $55,000 outstanding, net of debt discount of $38,569 and $51,317, respectively
|
16,431 | 1,760 | 3,683 | 442 | |||||||||||||
January 2014 $50,000 Convertible Note, 8% interest, due January 2015, $50,000 and $0 outstanding, net of debt discount of $36,999 and $0, respectively
|
13,001 | 980 | - | - | (1) | ||||||||||||
January 2014 $50,000 Convertible Note, 8% interest, due January 2015, $50,000 and $0 outstanding, net of debt discount of $41,182 and $0, respectively
|
8,818 | 945 | - | - | (2) | ||||||||||||
January 2014 $55,500 Convertible Note, 10% interest, due October 2014, with a $5,500 original issue discount, $55,500 and $0 outstanding, net of debt discount of $41,676 and $0, respectively
|
13,824 | 1,040 | - | - | (3) | ||||||||||||
January 2014 $55,500 Convertible Note, 10% interest, due October 2014, with a $5,500 original issue discount, $50,000 and $0 outstanding, net of debt discount of $37,912 and $0, respectively
|
12,088 | 1,028 | - | - | (4) | ||||||||||||
January 2014 $50,000 Convertible Note, 12% interest, due January 2015, $50,000 and $0 outstanding, net of debt discount of $41,370 and $0, respectively
|
8,630 | 970 | - | - | (5) | ||||||||||||
February 2014 $50,000 Convertible Note, 8% interest, due February 2015, $50,000 and $0 outstanding, net of debt discount of $32,387 and $0, respectively
|
17,613 | 450 | - | - | (6) | ||||||||||||
February 2014 $46,080 Convertible Note, 8% interest, due February 2015, $46,080 and $0 outstanding, net of debt discount of $38,096 and $0, respectively
|
7,984 | 492 | - | - | (7) | ||||||||||||
February 2014 $28,800 Convertible Note, 10% one-time interest, due February 2015, with a 10% original issue discount, $28,800 and $0 outstanding, net of debt discount of $25,170 and $0, respectively
|
3,630 | 250 | - | - | (8) | ||||||||||||
February 2014 $51,700 Convertible Note, 12% interest, due February 2015, with a $3,300 original issue discount, $51,700 and $0 outstanding, net of debt discount of $43,768 and $51,317, respectively
|
7,932 | 846 | - | - | (9) | ||||||||||||
March 2014 $37,500 Convertible Note, 8% interest, due December 2014, $37,500 and $0 outstanding, net of debt discount of $36,005 and $0, respectively
|
1,495 | 313 | (10) | ||||||||||||||
March 2014 $50,000 Convertible Note, 10% interest, due March 2015, $50,000 and $0 outstanding, net of debt discount of $48,630 and $0, respectively
|
1,370 | 417 | - | - | (11) | ||||||||||||
March 2014 $165,910 Convertible Note, 10% interest, due April 2015, with a $16,450 original issue discount, $165,910 and $0 outstanding, net of debt discount of $157,617 and $0, respectively
|
8,293 | 1,382 | - | - | (12) | ||||||||||||
Total Convertible Notes Payable, Net
|
$ | 485,402 | $ | 61,981 | $ | 375,259 | $ | 57,443 |
14
Advanced Medical Isotope Corporation
Notes to Condensed Financial Statements
For the three months ended March 31, 2014 (unaudited) and the year ended December 31, 2013
NOTE 8: CONVERTIBLE NOTES PAYABLE – continued
(1) The Company borrowed $50,000 January 2014, due January 2015. The holder of the note has the right, after the first one hundred eighty days of the note (June 27, 2014), to convert the note and accrued interest into common stock at a price per share equal to the lesser of $0.09 or 58% of the lowest trade price in the 10 trading days previous to the conversion. The Company recorded a debt discount of $46,249 related to the conversion feature and original issue discount. Interest expense for the amortization of the debt discount is calculated on a straight-line basis over the twelve month life of the note. During the three months ended March 31, 2014, interest expense of $980 was recorded and total amortization of $9,250 was recorded resulting in a debt discount of $36,999 at March 31, 2014.
(2) The Company borrowed $50,000 January 2014, due January 2015. The holder of the note has the right, after the first one hundred eighty days of the note (July 8, 2014), to convert the note and accrued interest into common stock at a price per share equal to the lesser of $0.09 or 58% of the lowest trade price in the 10 trading days previous to the conversion. The Company recorded a debt discount of $49,636 related to the conversion feature and original issue discount. Interest expense for the amortization of the debt discount is calculated on a straight-line basis over the twelve month life of the note. During the three months ended March 31, 2014, interest expense of $945 was recorded and total amortization of $8,454 was recorded resulting in a debt discount of $41,182 at March 31, 2014.
(3) The Company borrowed 55,500 January 2014, due October 2014. The holder of the note has the right, after the first one hundred eighty days of the note (August 10, 2014), to convert the note and accrued interest into common stock at a price per share equal to the lesser of $0.28 or 60% of the lowest trade price in the 25 trading days previous to the conversion. The Company has the right to prepay the note during the first ninety days following the date of the note. During that time the amount of any prepayment would equal 111.2% of the outstanding principal balance of the note plus accrued interest ($63,259). The Company recorded a debt discount of $55,500 related to the conversion feature of the note, along with a derivative liability at inception. Interest expense for the amortization of the debt discounts is calculated on a straight-line basis over the twelve month life of the note. During the three months ending March 31, 2014, total amortization was recorded in the amount of $13,824 resulting in a debt discount of $41,676 at March 31, 2014.
(4) The Company borrowed $55,500 January 2014, due October 2014. The holder of the note has the right, after the first one hundred eighty days of the note (August 10, 2014), to convert the note and accrued interest into common stock at a price per share equal to the lesser of $0.28 or 60% of the lowest trade price in the 25 trading days previous to the conversion. The Company has the right to prepay the note during the first ninety days following the date of the note. During that time the amount of any prepayment would equal 111.2% of the outstanding principal balance of the note plus accrued interest ($63,259). The Company recorded a debt discount of $50,000 related to the conversion feature of the note, along with a derivative liability at inception. Interest expense for the amortization of the debt discounts is calculated on a straight-line basis over the twelve month life of the note. During the three months ending March 31, 2014, total amortization was recorded in the amount of $12,088 resulting in a debt discount of $37,912 at March 31, 2014.
(5) The Company borrowed $50,000 January 2014, due January 2015. The holder of the note has the right, after the first one hundred eighty days of the note (July 27, 2015), to convert the note and accrued interest into common stock at a price per share equal to 60% of the lowest trade price in the 15 trading days previous to the conversion. The Company recorded a debt discount of $50,000 related to the conversion feature and original issue discount. Interest expense for the amortization of the debt discount is calculated on a straight-line basis over the twelve month life of the note. During the three months ended March 31, 2014, interest expense of $970 was recorded and total amortization of $8,630 was recorded resulting in a debt discount of $41,370 at March 31, 2014.
15
Advanced Medical Isotope Corporation
Notes to Condensed Financial Statements
For the three months ended March 31, 2014 (unaudited) and the year ended December 31, 2013
NOTE 8: CONVERTIBLE NOTES PAYABLE – continued
(6) The Company borrowed $50,000 February 2014, due February 2015. The holder of the note has the right, after the first one hundred eighty days of the note (August 10, 2014), to convert the note and accrued interest into common stock at a price per share equal to the lesser of $0.07 or 58% of the lowest trade price in the 10 trading days previous to the conversion. The Company recorded a debt discount of $37,307 related to the conversion feature and original issue discount. Interest expense for the amortization of the debt discount is calculated on a straight-line basis over the twelve month life of the note. During the three months ended March 31, 2014, interest expense of $0 was recorded and total amortization of $4,920 was recorded resulting in a debt discount of $32,387 at March 31, 2014.
(7) The Company borrowed $46,080 February 2014, due February 2015. The holder of the note has the right, after the first one hundred eighty days of the note (August 10, 2014), to convert the note and accrued interest into common stock at a price per share equal to the lesser of $0.08 or 60% of the lowest trade price in the 25 trading days previous to the conversion. The Company has the right to prepay the note during the first ninety days following the date of the note. During that time the amount of any prepayment would equal 111.2% of the outstanding principal balance of the note ($51,240) with no interest on the note. The Company had the right to prepay the note and accrued interest during the next ninety days following the date of the note. During that time the amount of any prepayment would equal 111.2% ($51,240) of the outstanding principal balance of the note plus a onetime interest charge of 10% applied to the principal ($5,124) for a total repayment amount of $56,364. The Company recorded a debt discount of $42,653 related to the conversion feature of the note, along with a derivative liability at inception. Interest expense for the amortization of the debt discounts is calculated on a straight-line basis over the twelve month life of the note. During the three months ending March 31, 2014, total amortization was recorded in the amount of $4,557 resulting in a debt discount of $38,096 at March 31, 2014.
(8) The Company borrowed $28,800 February 2014, due February 2015, with a one-time interest charge of 10%. The holder of the note has the right to convert the note and accrued interest into common stock at a price per share equal to the lesser of $0.195 or 60% of the lowest trade price in the 25 trading days previous to the conversion. The note has an original issue discount of $2,800 which has been added to the principal balance of the note and is being recognized in interest expense over the life of the note. The Company recorded a debt discount of $28,800 related to the conversion feature and original issue discount, along with a derivative liability at inception. Interest expense for the amortization of the debt discount is calculated on a straight-line basis over the twelve month life of the note. During the three months ended March 31, 2014, interest expense of $2,780 was recorded and total amortization of $3,630 was recorded resulting in a debt discount of $25,170 at March 31, 2014.
(9) The Company borrowed $51,700 February 2014, due February 2015. The holder of the note has the right to convert the note and accrued interest into common stock at a price per share equal to the lesser of $0.195 or 60% of the lowest trade price in the 25 trading days previous to the conversion. The note has an original issue discount of $3,300 which has been added to the principal balance of the note and is being recognized in interest expense over the life of the note. The Company recorded a debt discount of $51,700 related to the conversion feature and original issue discount. Interest expense for the amortization of the debt discount is calculated on a straight-line basis over the twelve month life of the note. During the three months ended March 31, 2014, interest expense of $442 was recorded and total amortization of $7,932 was recorded resulting in a debt discount of $43,768 at March 31, 2014.
16
Advanced Medical Isotope Corporation
Notes to Condensed Financial Statements
For the three months ended March 31, 2014 (unaudited) and the year ended December 31, 2013
NOTE 8: CONVERTIBLE NOTES PAYABLE – continued
(10) The Company borrowed $37,500 March 2014, due December 2014, with interest at 8%. The holder of the note has the right, after the first one hundred eighty days of the note (September 16, 2014), to convert the note and accrued interest into common stock at a price per share equal to 61% (representing a discount rate of 39%) of the average of the lowest five trading prices for the Common Stock during the ten trading day period ending one trading day prior to the date of Conversion Notice. The Company has the right to prepay the note and accrued interest during the first one hundred eighty days following the date of the note. During that time the amount of any prepayment during the first sixty days is 130% of the outstanding amounts owed while the amount of the prepayment increases every subsequent thirty days to 135%, 140%, 145%, and 150% of the outstanding amounts owed. The Company recorded a debt discount of $37,500 related to the conversion feature of the note, along with a derivative liability at inception. Interest expense for the amortization of the debt discounts is calculated on a straight-line basis over the eighteen month life of the note. During the three months ending March 31, 2014, total amortization was recorded in the amount of $1,495 resulting in a debt discount of $36,005 March 31, 2014. Also during the three months ending March 31, 2014, interest expense of $90 was recorded for the note.
(11) The Company borrowed $50,000 March 2014, due March 2015. The holder of the note has the right, after the first one hundred eighty days of the note (September 18, 2014), to convert the note and accrued interest into common stock at a price per share equal to 60% of the lowest trade price in the 25 trading days previous to the conversion. The Company recorded a debt discount of $50,000 related to the conversion feature of the note, along with a derivative liability at inception. Interest expense for the amortization of the debt discounts is calculated on a straight-line basis over the twelve month life of the note. During the three months ending March 31, 2014, total amortization was recorded in the amount of $1,370 resulting in a debt discount of $48,630 at March 31, 2014.
(12) The Company borrowed $165,910 March 2014, due April 2015. The holder of the note has the right to convert the note and accrued interest into common stock at a price per share equal to the lesser of $1.00 or 65% of the average of the three lowest trading prices in the 20 trading days previous to the conversion. The note has an original issue discount of $16,450 which has been added to the principal balance of the note and is being recognized in interest expense over the life of the note. The Company recorded a debt discount of $163,394 related to the conversion feature and original issue discount. Interest expense for the amortization of the debt discount is calculated on a straight-line basis over the twelve month life of the note. During the three months ended March 31, 2014, $442 of interest expense was recorded, and total amortization of $5,777 was recorded resulting in a debt discount of $157,617 at March 31, 2014.
17
Advanced Medical Isotope Corporation
Notes to Condensed Financial Statements
For the three months ended March 31, 2014 (unaudited) and the year ended December 31, 2013
NOTE 9: COMMON STOCK OPTIONS AND WARRANTS
The Company recognizes in the financial statements compensation related to all stock-based awards, including stock options and warrants, based on their estimated grant-date fair value. The Company has estimated expected forfeitures and is recognizing compensation expense only for those awards expected to vest. All compensation is recognized by the time the award vests.
The following schedule summarizes the changes in the Company’s stock options during the three months ended March 31, 2014:
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, 2013
|
10,350,000
|
$
|
0.08-0.28
|
3.78 years
|
$
|
-
|
$
|
0.14
|
||||||||||||
Options granted
|
-
|
$
|
-
|
-
|
$
|
-
|
||||||||||||||
Options exercised
|
-
|
$
|
-
|
-
|
$
|
-
|
||||||||||||||
Options expired
|
(965,000
|
)
|
$
|
0.15
|
-
|
$
|
0.02
|
|||||||||||||
Balance at March 31, 2014
|
9,385,000
|
$
|
0.08-0.28
|
3.92 years
|
$
|
-
|
$
|
0.13
|
||||||||||||
Exercisable at December 31, 2013
|
8,975,000
|
$
|
0.08-0.28
|
2.96 years
|
$
|
-
|
$
|
0.13
|
||||||||||||
Exercisable at March 31, 2014
|
8,160,000
|
$
|
0.08-0.28
|
3.92 years
|
$
|
-
|
$
|
0.13
|
The following schedule summarizes the changes in the Company’s stock warrants during the three months ended March 31, 2014:
Weighted
|
Weighted
|
|||||||||||||||||||
Warrants Outstanding
|
Average
|
Average
|
||||||||||||||||||
Number
|
Exercise
|
Remaining
|
Aggregate
|
Exercise
|
||||||||||||||||
Of
|
Price
|
Contractual
|
Intrinsic
|
Price
|
||||||||||||||||
Shares
|
Per Share
|
Life
|
Value
|
Per Share
|
||||||||||||||||
Balance at December 31, 2013
|
40,103,548
|
$
|
0.06-0.25
|
3.19 years
|
$
|
50,796
|
$
|
0.11
|
||||||||||||
Warrants granted
|
-
|
$
|
-
|
-
|
$
|
-
|
||||||||||||||
Warrants exercised
|
(100,000
|
)
|
$
|
0.06
|
-
|
$
|
0.06
|
|||||||||||||
Warrants expired
|
(500,000
|
)
|
$
|
0.06
|
-
|
$
|
0.06
|
|||||||||||||
Balance at March 31, 2014
|
39,503,548
|
$
|
0.06-0.25
|
3.13 years
|
$
|
3,155,003
|
$
|
0.08
|
||||||||||||
Exercisable at December 31, 2013
|
40,103,548
|
$
|
0.06-0.25
|
3.19 years
|
$
|
50,796
|
$
|
0.11
|
||||||||||||
Exercisable at March 31, 2014
|
39,503,548
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$
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0.06-0.25
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3.14 years
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$
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3,155,003
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$
|
0.08
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18
Advanced Medical Isotope Corporation
Notes to Condensed Financial Statements
For the three months ended March 31, 2014 (unaudited) and the year ended December 31, 2013
NOTE 10: STOCKHOLDERS’ EQUITY
Common Stock Issued for Cash and the Exercise of Warrants
In January 2014, the Company issued 100,000 restricted shares of its common stock shares in exchange for $6,000 and the cancellation of 100,000 warrants attached to the convertible notes received in July 2012.
Common Stock Issued for Services
In February 2014 the Company issued 71,250 restricted shares of its common stock, representing $5,000, to a consultant for services.
In March 2014 the Company issued 100,000 restricted shares of its common stock representing $5,900, to a consultant for services.
Common Stock Issued for Accounts Payable
In January 2014 the Company issued 100,000 restricted shares of its common stock to a consultant in payment of $7,500 in fees owed.
Common Stock Issued for Convertible Debt
The Company issued 10,400 shares of its common stock and a convertible promissory note in the amount of $26,000 with interest payable at 10% per annum in January 2014 to our major stockholder, who is also a Director. The Note matures in January of 2015. 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 $0.095 per share. The value of the $26,000 debt plus the $0.095 fair market value of the 10,400 shares at the date of the agreement was prorated to arrive at the allocation of the original $26,000 debt and the value of the 10,400 shares and the beneficial conversion feature. The computation resulted in an allocation of $24,096 toward the debt and $952 to the shares and $952 to the beneficial conversion feature. The $952 value of the shares and the $952 value of the beneficial conversion feature are then amortized to interest over the twelve month life of the debt. Interest expense of $400 has been accrued and added to the note payable bringing the total debt balance related to this convertible promissory note to $24,496 as of March 31, 2014. Additionally, $540 worth of interest expense on the notes principal balance has been recognized in the accompanying financial statements for the three months ending March 31, 2014.
In February 2014 the Company issued a 12% Convertible Promissory Note in the amount of $55,000 to an unrelated company. The note calls for a 200,000 restricted shares of the Company’s common stock to be issued a loan fee. The note is not convertible by the holder for the first 180 days, in which time the Company can repay the note plus interest. If the Company repays the note within the first 30 days the interest rate is calculated at 25% of the note balance, if paid between 31 days and 179 days the interest rate is calculated at 35% of the note balance, and if repaid after 180 days the interest rate is calculated at 45% of the note balance.
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Advanced Medical Isotope Corporation
Notes to Condensed Financial Statements
For the three months ended March 31, 2014 (unaudited) and the year ended December 31, 2013
NOTE 10: STOCKHOLDERS’ EQUITY– continued
Common Stock Issued for Debt Converted
During the months of January, February, and March 2014 the Company issued 6,447,872 shares of unrestricted stock in exchange for convertible debt raised in 2013. The Company also issued 403,799 shares of unrestricted stock representing of the accrued interest on the convertible debt that was converted.
NOTE 11: SUPPLEMENTAL CASH FLOW INFORMATION
During the three months ended March 31, 2014 the Company issued 100,000 shares of common stock for an extinguishment of $7,500 worth of debt.
During the three months ended March 31, 2014 the Company issued 210,400 shares of common stock as a loan fee of $53,604.
During the three months ended March 31, 2014, the Company issued 6,851,676 shares of stock to settle convertible notes payable with a principal note balance, accrued interest, interest expense, debt discount, and derivative liabilities valued at $450,202 and the Company recognized a $32,630 loss on extinguishment of debt.
During the three months ended March 31, 2014, the Company increased additional paid in capital and increased debt discount for $94,500 for a beneficial conversion feature on a convertible note.
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Advanced Medical Isotope Corporation
Notes to Condensed Financial Statements
For the three months ended March 31, 2014 (unaudited) and the year ended December 31, 2013
NOTE 12: SUBSEQUENT EVENTS
In April 2014 the Company issued a 10% Convertible Promissory Note in the amount of $32,000 to an unrelated company. The note is not convertible by the holder for the first 180 days, in which time the Company can repay the note plus interest. If the Company repays the note within the first 180 days the Company will pay 145% of the unpaid note balance plus interest.
During the month of April 2014 the Company issued 2,146,185 shares of unrestricted stock in exchange for convertible debt raised in 2013. The Company also issued 83,955 shares of unrestricted stock representing of the accrued interest on the convertible debt that was converted.
In April 2014 the Company received $13,000 in exchange for a convertible 10%, one year note. The note plus interest is convertible at the option of the note holder into common stock share at $0.095 per share. In addition the Company issued the note holder 5,200 shares of its common stock as a loan origination fee.
The Company has evaluated subsequent events pursuant to ASC Topic 855 and has determined that there are no additional subsequent events to disclose.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Except for statements of historical fact, certain information described in this Form 10-K report contains “forward-looking statements” that involve substantial risks and uncertainties. You can identify these statements by forward-looking words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “should,” “will,” “would” or similar words. The statements that contain these or similar words should be read carefully because these statements discuss the Company’s future expectations, including its expectations of its future results of operations or financial position, or state other “forward-looking” information. Advanced Medical Isotope Corporation believes that it is important to communicate its future expectations to its investors. However, there may be events in the future that the Company is not able to accurately predict or to control. Further, the Company urges you to be cautious of the forward-looking statements which are contained in this Form 10-K report because they involve risks, uncertainties and other factors affecting its operations, market growth, service, products and licenses. The risk factors in the section captioned “Risk Factors” in Item 1A of the Company’s Form 10-K, as well as other cautionary language in this Form 10-K report, describe such risks, uncertainties and events that may cause the Company’s actual results and achievements, whether expressed or implied, to differ materially from the expectations the Company describes in its forward-looking statements. The occurrence of any of the events described as risk factors could have a material adverse effect on the Company’s business, results of operations and financial position.
General Development of Business
Advanced Medical Isotope Corporation (“we” or 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.
SMSC had limited activity from inception and was considered dormant from the period May 1, 2000 through December 31, 2005. On September 6, 2006, SMSC changed its name to Advanced Medical Isotope Corporation.
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 in exchange for 100,000 shares of Series A Preferred Stock (which Series A Preferred Stock was later converted to shares of the Company’s common stock in March 2009). The Company conducted the acquisition in order to obtain cash and NHTI’s technology.
On June 13, 2007, the Company acquired the assets of the life sciences business segment of Isonics Corporation (Isonics), a California corporation. The Company acquired the assets in exchange for $850,000 cash payment for the purpose of combining the assets into its 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.
On August 1, 2007, the Company began renting office and warehouse space, known as the Production Facility located in Kennewick, Washington. The Company oversaw the design, construction and commissioning of the Production Facility and obtained the required licenses. In August, 2008 the Company began producing F-18 FDG for regional distribution at the Production Facility.
On October 28, 2010, the Company received $1,215,000 net proceeds from a Department of Energy grant for the Proposed Congressionally Directed Project entitled “Research to Develop and Test an Advanced Resorbable Brachytherapy Seed Research for Controlled Delivery of Yttrium-90 Microspheres in Cancer Treatment.” This grant reimbursed the Company for expenditures related to the development of its Brachytherapy project from April 1, 2010 through March 31, 2012.
On October 29, 2010, the Company received notification it had been awarded $244,479 grant funds from the Qualified Therapeutic Discovery Project Program for this same Brachytherapy Project. The $244,479 grant was received February 4, 2011. This grant reimburses the Company for eligible expenditures made during the twelve months ended December 31, 2010.
On October 29, 2010, the Company received notification it had been awarded $244,479 grant funds from the Qualified Therapeutic Discovery Project Program for the Molybdenum Project. On December 3, 2010, the Company received $205,129 and the remaining $39,350 of the grant was received February 4, 2011. The grant funds received in 2010 reimburses the Company for eligible expenditures made during the twelve months ended December 31, 2009.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
In January 2013, the Company’s linear accelerator located at the Company’s Production Facility in Kennewick, Washington was shut down for maintenance and repairs.
On October 26, 2013, the Company was notified that a Molybdenum-99 production process with Russia has been postponed.
On November 3, 2013, the Company filed a 510(k) Pre-Market Notification for FDA clearance for its Yttrium-90 RadioGel™ brachytherapy device. In February 2014, the FDA notified the Company that that it had determined that the Yttriium-90 RadioGel™ brachytherapy device had been classified as a Class III medical device, unless reclassified.
Based on the Company’s financial history since inception, its auditor has expressed substantial doubt as to the Company’s ability to continue as a going concern. The Company has a limited amount of revenue and has accumulated deficits since inception. If the Company cannot obtain sufficient funding, the Company would have to delay the implementation of its business strategy and might not be able to continue operations.
Narrative Description of Business
The Company is a late stage development company engaged primarily in the development of brachytherapy devices and medical isotopes for diagnostic and therapeutic applications. The Company’s focus is on transitioning to full operations upon receipt of FDA clearance for its patented brachytherapy cancer products. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area. Annual sales of brachytherapy products exceed $1 billion, about half of which are in the United States. The Company intends to outsource material aspects of manufacturing, distribution, sales and marketing for its products in the United States and to enter into licensing arrangements outside of the United States, though the Company will evaluate its alternatives before finalizing its plans.
The Company is also engaged in the development of other medical isotopes for therapeutic and diagnostic purposes and engages in limited operations consisting of the operation of a nuclear accelerator (though this accelerator has been shut down for repairs and maintenance since January 2013) and the sales of third party isotopes.
The Company’s overall 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. The Company’s shorter-term objective is to obtain regulatory approval for its brachytherapy products and to then commercialize those products.
The Company’s board has approved a three year business strategy focused on transitioning to full operations, following the FDA approval to begin marketing its brachytherapy cancer products. Should the Company first receive regulatory approval outside of the United States, the Company could commence operations in the applicable territories.
The business strategy results from the Company’s development of a family of three brachytherapy devices and the Company’s belief that there is: (1) strong market potential for these products in the United States and internationally, (2) the potential for attractive operating margins from the commercialization of such devices, (3) a considerably smaller capital requirement to complete the regulatory process and deploy these devices, as compared to the capital required for most of the other initiatives the Company is developing and (4) a material potential for the Company to receive advances and minimum guarantees from international licensees of these products when they are ready for such licensing activities.
Following receipt of required regulatory approvals and financing, in the United States, the Company intends to outsource material aspects of manufacturing, distribution, sales and marketing. Outside of the United States, the Company intends generally to enter into licensing arrangements. The Company will evaluate its alternatives before finalizing its plans.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
Narrative Description of Business- continued
The Board approved of two secondary priorities for 2014 and 2015:
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Expansion of the Company’s sales agency activities for isotopes and related equipment manufactured by third parties. This activity requires very little capital, facilitates the Company’s interaction with potential partners, customers and vendors and should be immediately cash positive. In 2013, the Company derived approximately $101,745 of revenue from such activities. By expanding this activity, the Company expects to be able to raise less capital through the sale of securities, thereby reducing dilution for shareholders.
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Potential acquisitions. No definitive agreements or commitments have been entered into by the Company pertaining to potential acquisitions. Except for stock acquisitions, potential acquisitions would be subject to the Company’s receipt of sufficient financing.
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The Company’s business strategy also contemplates that the Company will resume operation of its linear accelerator located in Kennewick, consider building a larger cyclotron production facility in Southern California in partnership with a major medical facility and continue its research and development activities for other isotopes and technologies, though the pace of all activities will be subject to its financial capabilities and the needs and performance of the Company’s strategic priorities, particularly the successful launch and growth of the brachytherapy products.
Over the next year to two years, the Company anticipates a requirement of about $1.5 million per year to maintain current operating activities and from approximately $2 million to $5 million to fund: (1) the FDA approval process and initial deployment of the brachytherapy products, (2) initial regulatory approval processes outside of the United States and (3) a sales capability for third party isotopes and equipment. The continued deployment of the brachytherapy products and a worldwide regulatory approval effort would require additional resources and personnel. The principal variables in the timing and amount of spending for the brachytherapy products in 2014 will be FDA’s classification of the Company’s brachytherapy products as Class II or Class II devices (or otherwise) and any requirements for clinical studies. Thereafter, the principal variables in the amount of the Company’s spending and its financing requirements would be the timing of any approvals and the nature of the Company’s arrangements with third parties for manufacturing, sales, distribution and licensing of those products and the products’ success in the U.S. and elsewhere.
There can be no assurance regarding the outcome of the Company’s regulatory, financing or commercial efforts. If some of the anticipated results are delayed or do not occur, the Company’s anticipated spending and capability to fund that spending would decline. Conversely, if the Company has the financial capacity to do so, the Company could spend additional sums to grow its businesses more rapidly and to maintain or accelerate research and development activities for future products and technologies.
In the longer-term, subject to the success of the Company’s brachytherapy products and the Company’s financial constraints, the Company intends to take steps toward the commercialization of other isotopes, businesses and technologies intended to help improve the diagnosis and treatment of cancer and other illnesses. Among those longer-term projects being considered by the Company are potential solutions for the impending severe shortages of Molybendum-99 and its derivative product Technetium-99m, the most widely used isotopes for diagnostic purposes.
Collaborations
The Company is engaged in collaborative efforts with U.S. national laboratories and universities and with international teaming partners. These collaborative effort projects include complementary isotope manufacturing technologies as well as isotope devices. The Company has active research collaborations for its brachytherapy products with Washington State University and the University of Utah. The Company also has agreements to produce isotopes in conjunction with the University of Missouri at Columbia, Pacific Northwest National Laboratory, operated by Battelle, and the University of Utah.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
Narrative Description of Business- continued
Products
The cornerstone equipment selected for the Company’s Production Facility is a proton linear accelerator. The Company’s proton linear accelerator is designed to replace large and cyclotron systems with significant infrastructure and utility requirements, such as electrical and air-handling, 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 its experience in the industry, it is the Company’s 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.
From August 2008 through January 2013, the Company manufactured and sold F-18 FDG from its Production Facility in its local region around Kennewick, WA. F-18 is an important isotope in the radiopharmaceutical industry, and is primarily synthesized into fluorodeoxyglucose (FDG) for use in positron emission tomography (PET) scans. FDG is the primary PET imaging isotope. It is used for medical and diagnostic purposes, such as cancer detection, heart imaging, and brain imaging. When operating, the Company’s linear accelerator is capable of producing a variety of isotopes and future manufacturing and sales could expand beyond F-18 FDG. The Company intends to resume operation of its linear accelerator in 2014, subject to the receipt of sufficient financing.
Other regional production facilities are being considered throughout the U.S. and abroad, including a larger cyclotron production facility in Southern California in partnership with a major medical facility.
New Products in Development
Brachytherapy Products
The Company has exclusively licensed Yttrium-90 (Y-90) polymer composite technology from Battelle Memorial Institute, developed at Pacific Northwest National Laboratory, a leading research institute for government and commercial customers. The license agreement grants the Company the exclusive right to manufacture and market products using the Yttrium-90 isotope carried by an injectable water-based biodegradable polymer. The use of Yttrium 90 (Y-90) for treatment of cancers is well established.
Subject to receipt of all required regulatory approvals from the FDA in the United States and analogous regulators outside of the United States, the Company plans to introduce a new Y-90-based brachytherapy product line for a range of applications for the delivery of a prescribed dose of radiation to a target site.
After receipt of the requisite regulatory clearances, the Company plans initially to introduce three products based on the patented technologies licensed from Battelle:
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Y-90 RadioGel™ device combines Y-90 particles with a polymer carrier that may be injected directly into the tumor. The Y-90 RadioGel™ device enables delivery of higher radiation doses to tumors than can be achieved with traditional seeds and with greater sparing of nearby normal tissues.
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Y-90 Fast-Resorbable Polymer Seeds - Y-90 contained within a polymer seed, as opposed to metal or glass. This product would be used in place of treating cancers with currently marketed titanium or glass seeds.
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Y-90 Polymer Topical Paste - This product may be applied directly to tissue surfaces after surgical tumor removals (also referred to as “resections”) to treat residual tumor cells.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
New Products in Development - continued
Based upon its studies and analyses, or general application of experience with current brachytherapy devices and Yttrium-90, the Company believes that its brachytherapy products are likely to offer the following benefits, among others, for patients and medical professionals:
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Maximizing Therapeutic Index: The short-range beta particles emitted by Y-90 deliver radiation energy within a tight range. This enables radiation to be selectively delivered to target tissues while minimizing radiation dose to nearby normal tissues. High therapeutic indices imply that more radiation energy may be imparted to cancer tissues, with less radiation reaching adjacent normal tissues.
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Half Life: The industry-standard products have a half-life of 17 days, meaning the patient is radioactive for over two months. The Company’s brachytherapy products use the yttrium-90 isotope, which has a half-life of just 2.7 days. A patient treated with Y-90 would be close to radiation free in 10 days.
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Optimized Delivery Method: Current brachytherapy devices place permanent metal particles seeds in the prostate by using up to 30 large needles. By contrast, the Company’s biodegradable polymer carrying Y-90 particles may be administered with small-gauge needles.
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No Permanent Seeds Remaining: Current brachytherapy devices place permanent metal seeds in the tumor. The Company’s Y-90 RadioGel™ device utilizes a biodegradable, non-toxic polymer that is ultimately absorbed by the body. This eliminates the possibility of a long-term seed migration or other problems that may sometimes arise when seeds remain in the body.
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Good Safety Profile: Current brachytherapy devices utilize isotopes that emit x-rays (akin to gamma radiation). X-rays or gamma radiation travels within and outside of the body and the isotopes used in current brachytherapy products can remain radioactive for more than two months. The Company’s brachytherapy products use the Yttrium-90 isotope, which is a beta-emitter. The Yttrium-90 beta-emissions travel only a short distance and has a short half life of 2.7 days.
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Potential Lower Cost: Yttrium-90 supplies are readily accessible and are relatively inexpensive. The elimination of the metal or glass enclosures greatly reduces manufacturing costs.
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On November 3, 2013, the Company filed a 510(k) Pre-Market Notification for FDA clearance for its Yttrium-90 RadioGel™ brachytherapy device. The FDA, which previously advised the Company that it would review the product as a medical device, has further advised the Company that it has determined that the product is classified by statute as a Class III medical device, unless the device is reclassified. The Company intends to seek such reclassification, unless the additional steps required for approval of this product as a Class III medical device are more efficient. The Company has obtained input from the FDA regarding its alternatives and will seek further input to expedite the process. In addition, the Company is discussing with the FDA if additional trials will be necessary prior to marketing the device. If additional trials are necessary, there will be additional cost and time to reach marketing clearance or approval.
Subject to receipt of regulatory approval and sufficient financing, the Company is contemplating the commercialization of the brachytherapy products in the United Sates by partnering with established manufacturers and distributors of medical devices. Outside of the United States, the Company is considering seeking licensing arrangements with established medical device and drug companies.
There can be no assurance as to the timing or receipt of regulatory approvals, the receipt of adequate financing for commercialization of the products, or the market’s acceptance for these products.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
New Products in Development - continued
Brachytherapy Market
Brachytherapy is the use of radiation to destroy cancerous tumors by placing a radiation source inside or next to the treatment area. According to Global Industry Analysts, by 2016 the U.S. brachytherapy market will reach $2 billion. It is estimated that the U.S. market represents approximately half of the global market. The Company believes there are significant opportunities in prostate, breast, liver, pancreatic, head and neck cancers. The 2013 U.S. estimated new cases according to the American Cancer Society are 240,000 prostate cancer, 235,000 breast cancer, and 31,000 liver cancer.
In 2010, the Company paid a $10,000 non-refundable advance for an exclusive license from Battelle Memorial Institute regarding certain technology for the production of a brachytherapy seed. The license agreement also requires the payment of a royalty based on a percent of net sales for licensed products sold.
In February 2011, the Company paid $5,000 for a one year option to negotiate an exclusive license from Battelle Memorial Institute for certain patents for the production of a brachytheraphy gel technology. Effective March 2012, the Company entered into an exclusive license agreement with Battelle Memorial Institute regarding the use of its patented brachytheraphy gel technology. This license agreement included a $17,500 nonrefundable license fee and a royalty based on a percent of gross sales for licensed products sold. The license agreement also includes a minimum royalty amount to be paid each year, starting with $5,000 payable in January 2013. The Company made such payment.
Molybdenum-99 and Technetium-99
Because of the Company’s financial constraints and focus on the brachytherapy products, the Company has delayed the potential implementation of production activities pertaining to Molybdenum-99 and Technetium-99.
Sales Agency Activities:
The Company is engaged in sales agency activities for worldwide distribution of O-18 enriched water. In addition, the Company has the ability to act as a sales agency for other stable isotopes as well as radioactive isotopes.
Competitors
There are established competitors in all of the markets in which the Company has products or currently plans to have products. According to the World Nuclear Association, the main world isotope suppliers are Covidien (Ireland), MDS Nordion (Canada), IRE (Europe), NTP (South Africa), Isotop-NIIAR (Russia) and ANSTO (Australia). Most medical radioisotopes made in nuclear reactors are sourced from relatively few research reactors. Most of the world's supply of Mo-99 for this comes from only five reactors, all of them 43 to 52 years old (in mid 2010). A number of incidents in 2008 pointed up shortcomings and unreliability in the supply of medical isotopes, particular technetium.
The current brachytherapy market in the U.S. is estimated at $300 million per year. There are many brachytherapy devices currently marketed in the U.S. and globally. The traditional iodine-125 (I-125) and palladium-103 (Pd-103) technologies for brachytherapy are well entrenched with powerful market players controlling the market. The industry-standard I-125-based therapy was developed by Oncura, which is a unit of General Electric Company (NYSE:GE), but the product is currently marketed by Theragenics Corporations (TGX). Additionally, C.R. Bard, a major industry player competes in the I-125 brachytherapy marketplace. These market competitors are also involved in the distribution of Pd-103 based products, which are clearly the market share leader. Cs-131 therapies are beginning to take some market share.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
Employees
As of December 31, 2013, the Company had seven employees, of whom three were full-time employees. The Company utilizes eight to ten independent contractors to assist with its operations. The Company does not have a collective bargaining agreement with any of its employees, and believes its relations with its employees are good.
Raw Materials
The Company obtains supplies, hardware, handling equipment and packaging from several different U.S. and foreign suppliers. Some of the materials used in the products the Company manufactures are currently available only from a limited number of suppliers, many of which are international suppliers. The Company obtains many of its stable isotopes from suppliers in Russia. The Company plans to expand the availability of its supplies and products utilizing manufacturing capability at reactors located at the U.S. Department of Energy's National Laboratories (“National Laboratories”) as well as production capabilities at various universities and foreign countries other than Russia. This strategy is intended to reduce the risk associated with concentrating isotope production at a single facility.
Customers
The Company’s customers for sales of stable isotopes have included a broad range of hospitals, universities, research centers and national laboratories, in addition to academic and government institutions. These customers are located in major U.S. and international markets.
The Company’s sales for 2013 consisted of F-18 (15.5% of total revenues) and Consulting Income (12.2% of total revenues) and Stable Isotopes (72.4%). Sales of F-18 for 2013 were to two regional hospitals, Kadlec Hospital in Richland, Washington and Kennewick General Hospital in Kennewick, WA. Consulting revenues consist of providing a company with assistance in strategic targetry services, and research into production of radiophamaceuticals and the operations of radioisotope production facilities. Stable Isotopes consist of longer lived isotopes purchased from Russia and sold in England.
The Company anticipates that customers for its brachytherapy products will include those institutions and individuals that currently purchase brachytherapy products or other oncology treatment products.
Patents, Trademarks, Licenses
License Agreement:
The Company has made the following investments in patent licenses and intellectual property during 2013:
Patent filing costs totaling $7,716 and $77,412, were capitalized during the twelve months ended December 31, 2013 and 2012. During the years ended December 31, 2013 and 2012 the Company impaired $332,709 and $0, respectively, worth of patent and intellectual property. This left a total $35,482 and $360,475 of capitalized patents and intellectual property costs at December 31, 2013 and 2012, respectively. The patents are pending and are being developed, and as such, the patents and filing costs associated with them are not being amortized. Management has determined the economic life of the patents to be 10 years, and amortization, over such 10-year period and on a straight-line basis, will begin once the patents have been issued and the Company begins utilization of the patents through production and sales, resulting in revenues. The Company evaluates the recoverability of intangible assets, including patents on a continual basis. Several factors are used to evaluate intangibles, including, but not limited to, management’s plans for future operations, recent operating results and projected and expected undiscounted future cash flows.
In February 2011, the Company paid $5,000 for a one year option to negotiate an exclusive license agreement with Battelle Memorial Institute regarding its patents for the production of a radiogel technology. This fee was fully expensed in the twelve months ended December 31, 2011. Effective March 2012, the Company entered into an exclusive license agreement with Battelle Memorial Institute regarding the use of a patented brachytherapy gel technology. This license agreement requires a $17,500 nonrefundable license fee and a payment of a royalty based on a percent of gross sales for licensed products sold. The agreement also requires payment of a minimum royalty amount to be paid each year starting with 2013. The $5,000 minimum royalty amount for the year 2013 was paid in February, 2014.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
Government Regulation
Significant areas of regulation and intervention include the following:
Environmental and Health Compliance. The Company is committed to conducting its activities so that there is no or only minimal impact to the environment; there is no assurance, however, that the Company’s activities will not at times result in liability under environmental and health regulations.
The Company has spent approximately $950,000 on its facility to meet environmental regulation, including the cost of confinement of the facility, exhaust and air balance systems and waste storage facilities. As the Company expands its manufacturing capability, it will be subject to extensive government regulation and intervention both in the United States and in all foreign jurisdictions in which it conduct business.
The current ongoing continuing costs of compliance are immaterial. Future costs and expenses resulting from such liability may, however, materially negatively impact the Company’s operations and financial condition. Overall, environmental and health laws and regulations will continue to affect the Company’s businesses worldwide.
Import/Export Regulation. The Company is subject to significant regulatory oversight of the Company’s import and export operations due to the nature of its product offerings. Penalties for non-compliance can be significant, and violation can result in adverse publicity and financial risk for the Company.
Financial Accounting Standards. The Company’s financial results can be impacted by new or modified financial accounting standards.
Other Regulations. The Company’s operations are subject to rules and regulations administered by the U.S. Nuclear Regulatory Commission, Department of Energy, Food and Drug Administration, Department of Transportation, Department of Homeland Security, the Washington State Department of Health and other regulatory bodies. To the extent that these regulations are or become burdensome, business development could be adversely affected.
Available Information
The Company prepares and files annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and certain other information with the United States Securities and Exchange Commission (the “SEC”). Persons may read and copy any materials the Company files with the SEC at the SEC’s public reference room at 100 F Street, NE, Washington D.C. 20549, on official business days during the hours of 10 a.m. to 3 p.m. Eastern Time. Information may be obtained on the operation of the public reference room by calling the SEC at 1-800-SEC-0330. The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC at http://www.sec.gov. Moreover, the Company maintains a website at http://www.isotopeworld.com that contains important information about the Company, including biographies of key management personnel, as well as information about the Company’s business. This information is publicly available (i.e., not password protected) and is updated regularly. The content on any website referred to in this Form 10-K report is not incorporated by reference into this Form 10-K report, unless (and only to the extent) expressly so stated herein.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
Results of Operations
Comparison of the Three Months Ended March 31, 2014 and 2013
The following table sets forth information from our statements of operations for the three months ended March 31, 2014 and 2013.
Three Months Ended
March 31, 2014
|
Three Months Ended
March 31, 2013
|
|||||||
Revenues
|
$
|
14,054
|
$
|
24,804
|
||||
Operating expenses
|
559,758
|
1,520,136
|
||||||
Operating loss
|
(545,694
|
)
|
(1,495,332
|
)
|
||||
Non-operating income (expense)
|
||||||||
Recognized income from grants
|
-
|
48,430
|
||||||
Gain (loss) on derivative liability
|
(111,796
|
)
|
1,363,909
|
|||||
Net loss on settlement
|
(32,630
|
)
|
(118,031
|
)
|
||||
Interest expense
|
(393,283
|
)
|
(404,490
|
)
|
||||
Net income (loss)
|
$
|
(1,083,402
|
)
|
$
|
(605,514
|
)
|
Revenue
Revenue was $14,054 for the three months ended March 31, 2014 and $24,804 for the three months ended March 31, 2013. The decrease was the result of F-18 sales. In July 2008 we established our linear accelerator production center and began the production and marketing of F-18 in August 2008. F-18 sales accounted for $21,750 of the total three months ended March 31, 2013 revenues and $0 of the total three months ended March 31, 2014 revenues. Revenues for F-18 were lower in the three months ended March 31, 2014 as a result of our linear accelerator being down and having no production for several months; thereby decreasing the number of doses sold for the three months ended March 31, 2014 (0) from the three months ended March 31, 2013 (72). Consulting revenues consisted of $14,054 and $3,054 for the three months ended March 31, 2014 and 2013, respectively. Consulting revenues consist of providing a company with assistance in strategic targetry services, and research into production of radiophamaceuticals and the operations of radioisotope production facilities. No proprietary information belonging to our Company is shared during the process of this consulting.
Revenue for the three months ended March 31, 2014 and 2013 consists of the following:
Three months ended
March 31, 2014
|
Three months ended
March 31, 2013
|
||||||||
F-18 |
$
|
-
|
$
|
21,750
|
|||||
Stable Isotopes
|
-
|
-
|
|||||||
Consulting
|
14,054
|
3,054
|
|||||||
$
|
14,054
|
$
|
24,804
|
30
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
Results of Operations – Comparison of the Nine Months Ended September 30, 2013 and 2012 - continued
Operating Expenses
Operating expenses for the three months ended March 31, 2014 and 2013 was $559,747 and $1,520,136, respectively. The decrease in operating expenses from 2013 to 2014 can be attributed to the decrease in Depreciation and Amortization expenses ($100,905 for the three months ended March 31, 2013 versus $2,998 for the three months ended March 31, 2014); and the decrease in Professional Fees expenses ($248,264 for the three months ended March 31, 2013 versus $185,177 for the three months ended March 31, 2014); and the decrease in Stock Options Granted expense ($403,600 for the three months ended March 31, 2013 versus $58,187 for the three months ended March 31, 2014); and the decrease in General and Administrative Expenses ($572,073 for the three months ended March 31, 2013 versus $122,971 for the three months ended March 31, 2014.
Operating expenses for the three months ended March 31, 2014 and 2013 consists of the following:
Three months ended
March 31, 2014
|
Three months ended
March 31, 2013
|
|||||||
Cost of materials
|
$
|
251
|
$
|
4,559
|
||||
Depreciation and amortization expense
|
2,998
|
100,905
|
||||||
Professional fees
|
185,177
|
248,264
|
||||||
Stock options granted
|
58,187
|
403,600
|
||||||
Payroll expenses
|
189,563
|
189,835
|
||||||
General and administrative expenses
|
122,971
|
572,073
|
||||||
Sales and marketing expense
|
600
|
900
|
||||||
$
|
559,747
|
$
|
1,520,136
|
Non-Operating Income (Expense)
Non-operating income (expense) for the three months ended March 31, 2014 varied from the three months ended March 31, 2013 primarily due to an increase of loss on derivative liability to $(111,796) for the three months ended March 31, 2014 from a gain of $1,363,909 for the three months ended March 31, 2013; and an decrease in recognized income from grants from $48,403 for the three months ended March 31, 2013 to $0 for the three months ended March 31, 2014. Part of this increase in non-operating expense was offset by an decrease in net loss on settlement of debt from $(118,031) for the three months ended March 31, 2013 versus $(32,631) for the three months ended March 31, 2014.
Non-Operating income (expense) for the three months ended March 30, 2014 and 2013 consists of the following:
Three months ended
March 31, 2014
|
Three months ended
March 31, 2013
|
|||||||
Interest expense
|
$
|
(393,283
|
)
|
$
|
(404,490
|
)
|
||
Net loss on settlement of debt
|
(32,630
|
)
|
(118,031
|
)
|
||||
Recognized income from grants
|
-
|
48,430
|
||||||
Gain (loss) on derivative liability
|
(111,796
|
)
|
1,363,909
|
|||||
$
|
(537,709
|
)
|
$
|
889,818
|
Net Loss
Our net loss for the three months ended March 31, 2014 and 2013 was $1,083,402 and $605,514, respectively.
31
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
Liquidity and Capital Resources
At March 31, 2014, the Company had negative working capital of $9,437,613, as compared to $8,758,007 at March 31, 2013. During the three months ended March 31, 2014 the Company experienced negative cash flow from operations of $427,707 and it expended $0 for investing activities while adding $519,348 of cash flows from financing activities. As of March 31, 2014, the Company had $0 commitments for capital expenditures.
Cash used in operating activities decreased from $541,094 for the three month period ending March 31, 2013 to $427,707 for the three month period ending March 31, 2014. Cash used in operating activities was primarily a result of the Company’s net loss, partially offset by non-cash items, such as loss on derivative liability and amortization and depreciation, included in that net loss and common stock and stock options issued for services and other expenses. Cash used in investing activities decreased from $24,504 for the three month period ended March 31, 2013 to $0 for the three month period ended March 31, 2014. Cash was used to acquire equipment and patents during the 2013 three month period. Cash provided from financing activities decreased from $626,708 for the three month period ending March 31, 2013 to $519,348 for the three month period ending March 31, 2014. The decrease in cash provided from financing activities was primarily a result of decrease in proceeds from convertible debt and a decrease in proceeds from the exercise of options and warrants, partially offset with a decrease in payments on convertible debt
The Company has generated material operating losses since inception. The Company has incurred a net loss of $37,221,927 from January 1, 2006 through March 31, 2014, including a net loss of $1,083,402 for the three months ended March 31, 2014, and a net loss of $605,514 for the three months ended March 31, 2013. The Company expects to continue to experience net operating losses. Historically, the Company has relied upon investor funds to maintain its operations and develop the Company’s business. The Company anticipates raising additional capital within the next twelve months from investors for working capital as well as business expansion, although the Company can provide no assurance that additional investor funds will be available on terms acceptable to the Company. If the Company is unable to obtain additional financing to meet its working capital requirements, it may have to curtail its business.
Based on the current cash run rate, approximately $1,500,000 will be needed to fund operations for an additional year. As disclosed in the risk factors, the Company is presently taking steps to raise additional funds to continue operations for the next 12 months and beyond. In addition the Company anticipates spending from approximately $2 million to $7 million over that period to fund the initial deployment of its brachytherapy products should FDA clearance be obtained, a modest distribution capability for third party isotopes and equipment and the potential acquisition of a controlling interest in a European company with which the Company is having discussions. The Company anticipates initially funding a portion of the foregoing requirements with private placements of Company securities. Thereafter, the Company anticipates that funding also would be provided by revenues derived from the business activities, including, potentially, advances from foreign licensees for the brachytherapy products. If some of the foregoing business activities do not occur or are delayed, the Company anticipated spending would decline. If the Company has the financial capacity to do so, the Company might spend additional sums to grow the foregoing businesses more rapidly. 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 its current lease commitments that will necessitate liquidation of the Company if the Company is unable to raise additional capital. The current level of cash is not enough to cover the fixed and variable obligations of the Company.
The recent economic events, including the inherent instability and volatility in global capital markets, as well as the lack of liquidity in the capital markets, could impact its ability to obtain financing and its ability to execute its business plan. The Company believes healthcare institutions will continue to purchase the medical solutions that it distributes.
The preparation of financial statements and related disclosures in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the amounts reported in the unaudited condensed consolidated financial statements and accompanying notes. 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. During the period ended March 31, 2014, we believe there have been no significant changes to the items disclosed as significant accounting policies in management's notes to the consolidated financial statements in our annual report on Form 10-K for the year ended December 31, 2013, filed on March 31, 2014.
32
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
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.
This item is not applicable to us because we are a smaller reporting company as defined by Rule 12b-2 under the Securities Exchange Act of 1934.
Item 4. Controls and Procedures.
Disclosure Controls and Procedures
Based on an evaluation as of the date of the end of the period covered by this report, the Company’s Chief Executive Officer and Chief Financial Officer conducted an evaluation of the effectiveness of the design and operation of the Company’s disclosure controls and procedures, as required by Exchange Act Rule 13a-15. Based on that evaluation, the Company’s Chief Executive Officer and Chief Financial Officer concluded that, because of the disclosed material weaknesses in the Company’s internal control over financial reporting, the Company’s disclosure controls and procedures were ineffective as of the end of the period covered by this report to ensure that information required to be disclosed by the Company in the reports that the Company files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified by the SEC’s rules and forms.
Disclosure controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in the Company’s reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in the Company’s reports filed under the Exchange Act is accumulated and communicated to management, including the Company’s Chief Executive Officer and the Company’s Chief Financial Officer, to allow timely decisions regarding required disclosure.
Changes in Internal Control Over Financial Reporting
There has been no change in our internal control over financial reporting that occurred during this current fiscal quarter (our first fiscal quarter of 2014) that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
The term “internal control over financial reporting” is defined as a process designed by, or under the supervision of, the registrant’s principal executive and principal financial officers, or persons performing similar functions, and effected by the registrant’s board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:
(a) Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the registrant;
(b) Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the registrant are being made only in accordance with authorizations of management and directors of the registrant; and
(c) Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the registrant’s assets that could have a material effect on the financial statements.
33
PART II
Item 1A. Risk Factors.
There have been no material changes to the risk factors set forth in Item 1A in our Form 10-K report for the year ended December 31, 2013.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Item 6. Exhibits.
Exhibit
|
||||
Number
|
Description
|
|||
10.1
|
Form of Non-Statutory Stock Option Agreement (incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed on March 15, 2012).
|
|||
31.1
|
*
|
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes – Oxley Act of 2002
|
||
31.2
|
*
|
Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes – Oxley Act of 2002
|
||
32.1
|
*
|
Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350
|
||
99.1
|
**
|
Temporary Hardship Exemption
|
||
101.INS
|
*
|
XBRL Instance Document
|
||
101.SCH
|
*
|
XBRL Taxonomy Extension Schema
|
||
101.CAL
|
*
|
XBRL Taxonomy Extension Calculation Linkbase
|
||
101.DEF
|
*
|
XBRL Taxonomy Extension Definition Linkbase
|
||
101.LAB
|
*
|
XBRL Taxonomy Extension Label Linkbase
|
||
101.PRE
|
*
|
XBRL Taxonomy Extension Presentation Linkbase
|
* Filed herewith.
** Previously filed.
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 hereunto duly authorized.
ADVANCED MEDICAL ISOTOPE CORPORATION
|
||
Date: May 14, 2014
|
By:
|
/s/ James C. Katzaroff
|
Name:
|
James C. Katzaroff
|
|
Title:
|
Chairman and Chief Executive Officer
|
|
(Principal Executive Officer)
|
Date: May 14, 2014
|
By:
|
/s/ L. Bruce Jolliff
|
Name:
|
L. Bruce Jolliff
|
|
Title:
|
Chief Financial Officer
|
|
(Principal Financial and Accounting Officer)
|
34