U.S. SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-QSB
(Mark One)
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þ
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
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For the quarterly period ended September 30, 2007
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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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For the transition period from
to
Commission File Number 1-16695
AMDL, Inc.
(Exact name of small business issuer as specified in its charter)
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Delaware
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33-0413161
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(State or other jurisdiction
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(IRS Employer
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of incorporation or organization)
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Identification No.)
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2492 Walnut Avenue, Suite 100, Tustin, California 92780
(Address of principal executive offices)
(714) 505-4460
(Issuers telephone number)
Not Applicable
(Former name, former address and former fiscal year, if changed since last report)
Indicate by checkmark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act).
Yes
o
No
þ
Check whether the issuer (1) filed all reports required to be filed by Section 13 or 15(d) of
the Exchange Act of 1934 during the past 12 months (or for such shorter period that the registrant
was required to file such reports), and (2) has been subject to such filing requirements for the
past 90 days.
Yes
þ
No
o
As of November 16, 2007, the Company had 12,929,317 shares (includes 100,000 shares held in
escrow) of its $0.001 par value common stock outstanding.
PART I FINANCIAL INFORMATION
Item 1. Financial Statements
AMDL, INC.
CONDENSED CONSOLIDATED BALANCE SHEET
(Unaudited)
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September 30,
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2007
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ASSETS
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Current assets:
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Cash and cash equivalents
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$
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1,228,022
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Accounts receivable, net
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3,055,584
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Inventories
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835,505
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Prepaid consulting
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797,063
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Other prepaid expenses and current assets
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1,990,679
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Total current assets
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7,906,853
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Property and equipment, net
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10,994,939
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Intangible assets, net
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5,137,616
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Other assets
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2,116,601
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Total assets
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$
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26,156,009
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LIABILITIES AND STOCKHOLDERS EQUITY
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Current liabilities:
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Accounts payable and accrued expenses
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$
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2,692,786
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Value added and other taxes payable
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558,240
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Deferred revenue
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279,344
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Current portion of notes payable
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3,248,864
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Total current liabilities
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6,779,234
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Notes payable, net of current portion
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1,891,561
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Total liabilities
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8,670,795
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Stockholders equity:
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Preferred stock, $0.001 par value; 25,000,000
shares authorized; no shares issued and
outstanding
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Common stock, $0.001 par value; 100,000,000
shares authorized; 12,679,317 shares issued and
12,579,317 shares outstanding
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12,579
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Additional paid-in capital
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54,704,855
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Accumulated other comprehensive gain
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569,526
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Accumulated deficit
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(37,801,746
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)
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Total stockholders equity
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17,485,214
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$
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26,156,009
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See accompanying notes to condensed consolidated financial statements.
3
AMDL, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(Unaudited)
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Three Months Ended
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Nine Months Ended
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September 30,
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September 30,
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2007
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2006
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2007
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2006
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Net revenues
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$
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5,808,376
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$
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21,005
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$
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9,646,056
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$
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54,105
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Cost of sales
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2,226,692
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8,972
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4,186,051
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21,460
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Gross profit
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3,581,684
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12,033
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5,460,005
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32,645
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Operating expenses:
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Research and development
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2,407
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162,894
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15,534
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282,139
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Selling, general and administrative
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3,090,059
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819,265
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8,330,604
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2,340,319
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Total operating expenses
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3,092,466
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982,159
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8,346,138
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2,622,458
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Gain (loss) from operations
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489,218
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(970,126
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)
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(2,886,133
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)
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(2,589,813
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)
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Other income (expense):
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Loss on the disposal of equipment
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(1,555
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)
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(3,855
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)
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Interest income
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1,996
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7,789
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7,584
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22,489
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Interest expense
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(87,081
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)
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(276,045
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Total other income (expense), net
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(86,640
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)
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7,789
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(272,316
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)
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22,489
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Income (loss) before provision for
income taxes
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402,578
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(962,337
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(3,158,499
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)
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(2,567,324
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)
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Provision for income taxes
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19,470
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108,154
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Net income
(loss)
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383,108
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(962,337
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)
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(3,266,603
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)
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(2,567,324
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)
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Other
comprehensive income:
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Foreign currency translation gain
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247,918
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591,254
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Comprehensive gain (loss)
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$
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631,026
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$
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(962,337
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)
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$
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(2,675,349
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)
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$
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(2,567,324
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)
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Basic income (loss) per common share
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$
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0.05
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$
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(0.13
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)
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$
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(0.24
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)
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$
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(0.38
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)
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Diluted
income (loss) per common share
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$
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0.05
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$
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$
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$
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Weighted average common shares
outstanding basic
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12,550,666
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7,372,750
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11,357,055
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6,689,326
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Weighted average common shares
outstanding diluted
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12,773,521
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7,372,750
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11,357,055
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6,689,326
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See accompanying notes to condensed consolidated financial statements.
4
AMDL, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
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Nine Months Ended
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September 30, 2007
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September 30, 2006
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CASH FLOWS FROM OPERATING ACTIVITIES:
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Net loss
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$
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(3,266,603
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)
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$
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(2,567,324
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)
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Adjustments to reconcile net loss to net cash used in operating activities:
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Depreciation and amortization
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884,812
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81,463
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Loss on disposal of equipment
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3,855
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Fair market value of common stock, warrants and options issued for
services
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1,744,164
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481,525
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Fair market value of options granted to employees and directors for
services
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1,577,610
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240,300
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Changes in operating assets and liabilities:
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Accounts receivable
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(1,176,945
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)
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Inventories
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(94,847
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)
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4,983
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Prepaid expenses and other current assets
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(1,928,412
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)
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21,115
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Other assets
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(465,166
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)
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Accounts payable and accrued expenses
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(34,868
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)
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220,630
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Deferred revenue
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279,344
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Value added and other taxes payable
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558,240
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Net cash used in operating activities
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(1,918,816
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)
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(1,517,308
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)
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CASH FLOWS FROM INVESTING ACTIVITIES:
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Purchases of property and equipment
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(1,946,551
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)
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(2,797
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)
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Purchases of
production rights
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(1,340,853
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)
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Cash paid for JPI acquisition, net of cash acquired
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(373,104
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)
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Net cash used in investing activities
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(3,287,404
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)
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(375,901
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)
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CASH FLOWS FROM FINANCING ACTIVITIES:
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Proceeds from issuance of common stock, net of offering costs of $757,014
in 2007 and $354,571 in 2006
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4,572,497
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1,457,924
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Proceeds from exercise of options
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|
271,200
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|
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Proceeds from exercise of warrants
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|
|
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|
|
42,241
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|
|
|
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|
Net cash provided by financing activities
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|
|
4,843,697
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|
|
|
1,500,165
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|
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|
|
|
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|
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Effect of exchange rates on cash and cash equivalents
|
|
|
(5,572
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)
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Net change in cash and cash equivalents
|
|
|
(356,951
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)
|
|
|
(393,044
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)
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Cash and cash equivalents, beginning of the period
|
|
|
1,584,973
|
|
|
|
1,398,092
|
|
|
|
|
|
|
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Cash and cash equivalents, end of period
|
|
$
|
1,228,022
|
|
|
$
|
1,005,048
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
|
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|
|
|
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|
Cash paid during the period for interest
|
|
$
|
276,045
|
|
|
$
|
|
|
|
|
|
|
|
|
|
Cash paid during the period for income taxes
|
|
$
|
108,199
|
|
|
$
|
2,881
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL DISCLOSURE OF NON-CASH ACTIVITIES:
|
|
|
|
|
|
|
|
|
Value of
common stock recorded as prepaid consulting and accrued expenses
|
|
$
|
1,893,600
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase in debt and fixed assets due to purchase price adjustment
|
|
$
|
214,617
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to condensed consolidated financial statements.
5
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Nine Months Ended September 30, 2007 and 2006
NOTE 1 MANAGEMENTS REPRESENTATION
The accompanying unaudited consolidated financial statements have been prepared by AMDL, Inc. (the
Company) in accordance with accounting principles generally accepted in the United Sates of
America for interim financial information and pursuant to the instructions to Form 10-QSB and Item
310(b) of Regulation S-B promulgated by the United States Securities and Exchange Commission
(SEC). Accordingly, they do not include all of the information and footnotes required by
accounting principles generally accepted in the United States of America for complete financial
statement presentation. In the opinion of management, all adjustments (consisting primarily of
normal recurring accruals) considered necessary for a fair presentation have been included.
Operating results for the nine months ended September 30, 2007 are not necessarily indicative of
the results that may be expected for the year ending December 31, 2007. The results of operations
for the nine months ended September 30, 2007 and 2006 are not comparable due to the acquisition of
Jade Pharmaceutical Inc. (JPI) on September 28, 2006. JPIs results of operations have been
included in the Companys consolidated financial results since the date of acquisition. It is
suggested that these consolidated financial statements be read in conjunction with the audited
consolidated financial statements and notes thereto for the year ended December 31, 2006 included
in the Companys Annual Report on Form 10-KSB/A.
NOTE 2 ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
AMDL, Inc.
AMDL, Inc.s predecessor was incorporated on May 13, 1988 and the Company reorganized as a Delaware
corporation on June 7, 1989. Since inception, the Company has primarily been engaged in the
commercial development of and the obtaining of various governmental regulatory approvals for the
marketing of its proprietary diagnostic tumor-marker test kit (DR-70
®
) to detect the
presence of multiple types of cancer. The Companys product line also includes a selection of
diagnostic test kits for several types of cancer, infectious diseases, endocrinology, diabetes,
nephrology and allergy.
Acquisition of JPI
On September 28, 2006, pursuant to the Stock Purchase and Sale Agreement dated May 12, 2006, the
Company acquired 100% of the outstanding shares of JPI from Jade Capital Group Limited (Jade).
JPI has two wholly-owned Peoples Republic of China (PRC or China) based subsidiaries, Yangbian
Yiqiao Bio-Chemical Pharmacy Company Limited (YYB) and Jiangxi Jiezhong Bio-Chemical Pharmacy
Company Limited (JJB). YYB and JJB are engaged in the manufacture and distribution of
over-the-counter and prescription pharmaceuticals in China. YYB is located in Tuman City, Jilin
Province, PRC and JJB is located in Shangrao, Jian Province, PRC. Together, YYB and JJB have over
130 licenses to produce pharmaceuticals in China.
The aggregate purchase price was $9,116,896, consisting of 2,643,000 shares of the Companys common
stock valued at $7,929,000 (based on the closing price of the Companys common stock on the date of
acquisition), options to purchase 500,000 shares of the Companys common stock valued at $595,000
(based on the Black-Scholes option pricing model) and $592,896 in acquisition related transaction
costs.
The terms of the Stock Purchase and Sale Agreement provided that additional purchase consideration
of an additional 100,000 shares of the Companys common stock (the Escrow Shares) were deposited
in an escrow account held by a third party escrow agent. The Escrow Agreement required that if,
within one year from and after the closing of the Stock Purchase and Sale Agreement, Jade or its
shareholders have demonstrated that the Peoples Republic of China State Federal Drug Agency or
other appropriate agency (SFDA) has issued a permit or the equivalent regulatory approval for the
Company to sell and distribute DR-70
®
in the PRC without qualification, in form and
substance satisfactory to the Company, then the escrow agent will promptly disburse the Escrow
Shares to Jade or its shareholders.
6
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Nine Months Ended September 30, 2007 and 2006
The Board of Directors on August 10, 2007, extended the required approval date to March 28, 2008.
If Jade has not notified the escrow agent that the SFDA has issued the approval to market
DR-70
®
before March 28, 2008, or if the Company disputes that the purported approval is
satisfactory, the Escrow Shares shall be delivered by the escrow agent to the Company for
cancellation. In the event the Escrow Shares are released to Jade, the Company will record the
fair value of the 100,000 shares of common stock issued as goodwill.
In accordance with Statement of Financial Accounting Standards (SFAS) No. 141,
Business
Combinations,
the Company has allocated the total purchase price to tangible and intangible assets
acquired and liabilities assumed based on their estimated fair values.
The purchase consideration has been allocated as follows:
|
|
|
|
|
|
|
Fair Value
|
|
Purchase consideration:
|
|
|
|
|
Transaction costs, primarily legal and accounting
|
|
$
|
592,896
|
|
Estimated fair value of common stock issued
|
|
|
7,929,000
|
|
Estimated fair value of options to purchase common stock
|
|
|
595,000
|
|
|
|
|
|
|
|
$
|
9,116,896
|
|
|
|
|
|
|
|
|
|
|
Allocation:
|
|
|
|
|
Tangible assets acquired:
|
|
|
|
|
Cash
|
|
$
|
197,140
|
|
Accounts receivable
|
|
|
1,440,680
|
|
Inventories
|
|
|
550,623
|
|
Property and equipment
|
|
|
9,268,300
|
|
Land use rights
|
|
|
1,405,829
|
|
Prepayments, primarily product licenses
|
|
|
1,292,531
|
|
Identifiable intangible assets acquired:
|
|
|
|
|
Non-compete agreements
|
|
|
324,415
|
|
Customer relationships
|
|
|
214,328
|
|
Trade name and logo
|
|
|
530,829
|
|
|
|
|
|
Total assets acquired
|
|
|
15,224,675
|
|
|
|
|
|
Liabilities assumed:
|
|
|
|
|
Current liabilities
|
|
|
(1,440,373
|
)
|
Current and long-term debt
|
|
|
(4,667,406
|
)
|
|
|
|
|
Total liabilities assumed
|
|
|
(6,107,779
|
)
|
|
|
|
|
|
|
$
|
9,116,896
|
|
|
|
|
|
The fair values assigned to identifiable intangible assets acquired were based on an appraisal
performed by an independent third party using estimates and assumptions determined by management.
The fair values of the non-compete agreements, customer relationships and trade name and logo were
determined using an income approach and discounted cash flow techniques.
During the nine months ended September 30, 2007, the Company determined that certain values
assigned to property and equipment and debt required an adjustment, and accordingly, increased the
values assigned to property and equipment and debt by $214,617.
During the
three months ended September 30, 2007, the Company determined
that certain values assigned to land use rights, non-corporate
agreements, customer relationships and trade name and logo should be
adjusted. Accordingly, land use rights was increased by $205,060
while non-complete agreements, customer relationships and trade name
and logo were decreased proportionately.
7
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Nine Months Ended September 30, 2007 and 2006
The following unaudited financial information presents the pro forma results of operations and
gives effect to the JPI acquisition as if the acquisition was consummated on January 1, 2006. It
is based on historical information and does not necessarily reflect the actual results that would
have occurred and is not necessarily indicative of future results of operations of the combined
companies.
|
|
|
|
|
|
|
|
|
|
|
For the Three Months
|
|
|
For the Nine Months
|
|
|
|
Ended
|
|
|
Ended
|
|
|
|
September 30, 2006
|
|
|
September 30, 2006
|
|
Net revenues
|
|
$
|
1,996,608
|
|
|
$
|
5,125,211
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(170,408
|
)
|
|
$
|
(946,051
|
)
|
|
|
|
|
|
|
|
Basic and diluted loss per share
|
|
$
|
(0.03
|
)
|
|
$
|
(0.14
|
)
|
|
|
|
|
|
|
|
Weighted average common shares outstanding basic and diluted
|
|
|
5,680,267
|
|
|
|
6,689,326
|
|
|
|
|
|
|
|
|
Going Concern
The accompanying consolidated financial statements have been prepared assuming the Company will
continue as a going concern, which contemplates, among other things, the realization of assets and
satisfaction of liabilities in the normal course of business. The Company has incurred net losses
of $3,226,603 and $2,567,324 during the nine months ended September 30, 2007 and 2006,
respectively, and had an accumulated deficit of $37,801,746 at September 30, 2007. In addition,
the Company used cash in operations of $1,918,816 and $1,517,308 during the nine months ended
September 30, 2007 and 2006, respectively. At November 15, 2007, the Company had cash on hand of
approximately $605,000 and cash is being depleted at the rate of approximately $310,000 per month.
Assuming (i) the current level of revenue from the sale of DR-70
®
kits does not increase
in the near future, (ii) the Company does not require new cancer samples to satisfy the FDA
concerns on its pending 510(k) application; (iii) the Company does not conduct any full scale
clinical trials for DR-70
®
or its combination immunogene therapy technology in the U.S.
or China, (iv) JPI generates sufficient cash to meet or exceed its cash requirements, and (v) no
outstanding options or warrants are exercised, the amount of cash on hand is expected to be
sufficient to meet the Companys projected operating expenses only through mid January 2008.
The Companys near and long-term operating strategies focus on (i) obtaining Food and Drug
Administration (FDA) and Chinas State Food and Drug Administration (FDA) approval for
DR-70
®
, (ii) seeking a large pharmaceutical partner for our combination immunogene
therapy technology, (iii) increasing sales of JPIs existing products and expanding JPIs
distribution networks, (iv) funding the research and development, licensing and/or purchase of new
products, and (v) wholesale distribution to retail stores known as Jade Healthy Supermarkets.
The Companys only source of additional funds to meet continuing operating expenses, to fund
additional research and development, to promote JPIs products or to conduct clinical trials which
may be required to receive FDA approval is the sale of securities.
Management recognizes that the Company must generate additional capital resources to enable it to
continue as a going concern. Managements plans include seeking financing, alliances or other
partnership agreements with entities interested in the Companys technologies, or other business
transactions that would generate sufficient resources to assure continuation of the Companys
operations and research and development programs.
In addition, on April 26, 2006, the American Stock Exchange (AMEX) sent a letter to the Company
stating that based on a review of Companys Form 10-KSB for the year ended December 31, 2005, the
Company did not meet certain of the AMEXs Continued Listing Standards as set forth in Part 10 of
the AMEX Company Guide. Specifically, the Company did not meet the requirement of stockholders
equity of $4,000,000 and the Company had losses from continuing operations in three out of its four
most recent fiscal years. In the letter, AMEX gave the Company until May 26, 2006 to submit a plan
of action that the Company has taken and will take to bring the Company into compliance with the
AMEX Company Continued Listing Standards.
8
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Nine Months Ended September 30, 2007 and 2006
On July 17, 2006, the American Stock Exchange sent a letter to the Company stating that the Company
has made a reasonable demonstration of its ability to regain compliance with the AMEX Continued
Listing Standards, and based on that demonstration, the AMEX is prepared to continued the listing of
the Companys common stock through the end of the third quarter of 2006 subject to certain
conditions, including the closing of the JPI acquisition. On November 10, 2006, AMEX advised the
Company that the plan period would remain open until the Company has been able to demonstrate
compliance with the Continued Listing Standards for two consecutive fiscal quarters. As of
November 15, 2007, AMEX has not notified the Company about whether it has demonstrated compliance
with the Continued Listing Standards. Delisting from AMEX may impact our ability to raise capital
in the future.
These items, among other matters, raise substantial doubt about the Companys ability to continue
as a going concern.
The consolidated financial statements do not include any adjustments related to recoverability and
classification of assets or the amount and classification of liabilities that might result should
the Company be unable to continue as a going concern.
Reverse Stock Split
On September 28, 2006, the Company effected a one-for-five reverse stock split of its common stock.
All share and per share information for the periods presented herein have been retroactively
restated to reflect the reverse stock split as if it had occurred at the beginning of each period
presented.
Principles of Consolidation
The accompanying consolidated financial statements include the accounts and transactions of AMDL,
Inc. and its wholly owned subsidiary, JPI and its wholly owned subsidiaries, from date of acquisition. Intercompany transactions and
balances have been eliminated in consolidation.
Revenue Recognition
The Company generates revenues from wholesale sales of over-the-counter and prescription
pharmaceuticals, and the direct distribution of pharmaceutical products through retail outlets
known as Jade Healthy Supermarkets.
The Company recognizes revenue in accordance with the Securities and Exchange Commissions (SEC)
Staff Accounting Bulletin (SAB) No. 101,
Revenue Recognition in Financial Statements,
as amended
by SAB No. 104. Accordingly, revenue is recognized when all of the following criteria are met: (1)
persuasive evidence of an arrangement exists, (2) delivery has occurred or services have been
rendered, (3) the sellers price to the buyer is fixed and determinable, and (4) collectibility is
reasonably assured.
Wholesale Sales
Revenues from the wholesale sales of over-the counter and prescription pharmaceuticals are
recognized when title and risk of loss have passed to the buyer and provided the criteria in SAB
No. 101 (as amended by SAB 104) are met. Buyers generally have limited rights of return, and the Company provides for
estimated returns at the time of sale based on historical experience. Returns from customers
historically have not been material. Actual returns and claims in any future period may differ
from the Companys estimates.
Direct Distribution
On June 14, 2007, JPI (through JJB) entered into an agreement and letter of intent with Shanghai
XiangEn Food Company Co. Ltd. (Shanghai XiangEn) to begin direct distribution of pharmaceutical
products through retail stores known as the Jade Healthy Supermarkets (Retail Stores). The
Retail Stores are operated by independent
9
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Nine Months Ended September 30, 2007 and 2006
third parties who sell JJBs products at retail to consumers. Originally, Shanghai
XiangEn would recruit sub-operators for the Retail Stores. As of November 13, 2007 there were
eight Retail Stores in operation. JJB received a one-time, non-refundable up front fee from each
of the sub-operators of the Retail Stores in the aggregate amount of $314,762. JJB advanced $557,093 for general working capital
purposes, including leasehold improvements and equipment to Shanghai XiangEn and the sub-operators
in the establishment of the Retail Stores. JJB consigns inventories to the operators of the Retail
Stores for sale to consumers. As a result, the sub-operators do not take ownership of the
inventories at their stores until the products are sold to the consumer. Revenues from the sale of
JJBs products at the Retail Store level will be recognized by the Company at the time products are
sold by the Retail Stores. Through September 30, 2007, the
Retail Stores had not generated any sales, accordingly, no revenues
were recognized in the accompanying statements of operations for the
three and nine months ended September 30, 2007. Under the terms of the original agreement with Shanghai XiangEn, JJB
was required to pay commission to Shanghai XiangEn based on two percent (2%) of the gross sales of the products sold at retail by
the sub-operators of the Retail Stores. Pursuant to an amended agreement, this commission has been
waived in the future.
During the
three months ended June 30, 2007, the Company received $314,762 in up-front fees from
store sub-operators before the Retail Stores were opened. In addition, at September 30, 2007, JJB
accrued $20,645 for commissions to Shanghai XiangEn for finding the sub-operators. The Company
deferred recognition of these fees until the Retail Stores opened. JJB will begin amortizing
the up-front fees over the two year contract period. At September 30, 2007, all eight Retail
Stores were opened, and accordingly, the Company recorded
approximately $39,000 of the up-front
fees received as revenues.
In accordance with Emerging Issues Task Force (EITF) Issue No. 06-3,
How Taxes Collected from
Customers and Remitted to Governmental Authorities Should Be Presented in the Income Statement
(That Is, Gross Versus Net Presentation)
, JPIs revenues are reported net of value added taxes
(VAT) collected.
Accounting for Shipping and Handling Revenue, Fees and Costs
The Company classifies amounts billed for shipping and handling as revenue in accordance with EITF
Issue No. 00-10,
Accounting for Shipping and Handling Fees and Costs.
Shipping and handling fees
and costs are included in cost of sales.
Other Comprehensive Income and Foreign Currency Translation
Statement of Financial Accounting Standards (SFAS) No. 130,
Reporting Comprehensive Income
,
establishes standards for the reporting and display of comprehensive income and its components in a
full set of general-purpose financial statements. Comprehensive income is defined to include all
changes in equity except those resulting from investments by owners and distribution to owners.
The accompanying consolidated financial statements are presented in United States dollars. The
functional currency of JPI is the Renminbi (RMB). The balance sheet accounts of JPI are
translated into United States dollars from RMB at period end exchange rates and all revenues and
expenses are translated into United States dollars at average exchange rates prevailing during the
periods in which these items arise. Capital accounts are translated at their historical exchange
rates when the capital transactions occurred. Translation gains and losses are accumulated as
accumulated other comprehensive income (loss), a separate component of stockholders equity.
Translation gains were $591,254 for the nine months ended September 30, 2007.
The RMB is not freely convertible into foreign currency and all foreign exchange transactions must
take place through authorized institutions. No representation is made that the RMB amounts could
have been, or could be, converted into United States dollars at the rates used in translation.
Research and Development
Internal research and development costs are expensed as incurred. Third party research and
development costs are expensed when the contracted work has been performed or as milestone results
have been achieved.
10
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Nine Months Ended September 30, 2007 and 2006
Cash Equivalents
The Company considers all highly liquid investments with original maturities of three months or
less when purchased to be cash equivalents.
Inventories
JPI records inventories at the lower of weighted average cost or net realizable value. Major
components of inventories are raw materials, and packaging materials, direct labor and production
overhead. AMDLs inventories consist primarily of raw materials and related materials, and are stated
at the lower of cost or market with cost determined on a first-in, first-out (FIFO) basis. The
Company regularly monitors inventories for excess or obsolete items and makes any valuation
corrections when such adjustments are needed. Once established, write-downs are considered
permanent adjustments to the cost basis of the obsolete or excess inventories.
Property and Equipment
Property and equipment is stated at cost. Depreciation is computed using the straight-line method
over estimated useful lives as follows:
|
|
|
|
|
Office equipment
|
|
|
3 to 10 years
|
|
Buildings and improvements
|
|
|
5 to 30 years
|
|
Machinery and equipment, including lab equipment
|
|
|
5 to 15 years
|
|
Maintenance and repairs are charged to expense as incurred. Renewals and improvements of a major
nature are capitalized. At the time of retirement or other disposition of property and equipment,
the cost and accumulated depreciation are removed from the accounts and any resulting gains or
losses are reflected in the consolidated statement of operations.
Intangible Assets
Intangible assets consist of intellectual property, land use rights, non-compete agreements,
customer relationships and trade name and logo.
Intellectual Property
In August 2001, the Company acquired intellectual property rights and an assignment of a US patent
application for combination immunogene therapy technology for $2,000,000. The technology was
purchased from Dr. Lung-Ji Chang, who developed it while at the University of Alberta, Edmonton,
Canada. The $2,000,000 acquisition price is being amortized over the expected useful life of the
technology, which the Company has currently determined to be 20 years, based upon an estimate of
three years to perfect the patent plus 17 years of patent life.
Land Use Rights
The Company leases certain parcels of land from the Chinese government for original terms ranging
from 40 to 50 years. The Company has capitalized $1,405,829 as land use rights, which are being
amortized on the straight-line basis over the weighted-average remaining lease terms of 33 years.
The land use rights are pledged with a bank as security for some of the loans granted to the
Company (see Note 8).
Non-Compete Agreements
Non-compete agreements were entered into with Jade and certain of its officers, the estimated fair
value of which was $324,415. The non-compete agreements are being amortized over their 5-year term
using the straight-line method.
11
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Nine Months Ended September 30, 2007 and 2006
Customer Relationships
In
connection with the acquisition of JPI, the Company capitalized
$214,328, which is the estimated
fair value of certain customer relationships and is being amortized on the straight-line basis over
their estimated useful life of 7 years.
Trade Name and Logo
In
connection with the acquisition of JPI, the Company capitalized
$530,829, which is the estimated
fair value related to JPIs trade names and logos and is being amortized on the straight-line basis
over their estimated useful life of 10 years.
Production Rights
During the three months ended September 30, 1007, JPI acquired licenses for the right to produce
five products, two of which went into production. JPI capitalized $1,340,853 for these rights and is
amortizing this amount on a straight-line basis over the estimated useful life of 10 years.
Impairment of Long-Lived Assets
In accordance with SFAS No. 144,
Accounting for the Impairment or Disposal of Long-Lived Assets
,
the Company evaluates the carrying value of its long-lived assets for impairment whenever events or
changes in circumstances indicate that such carrying values may not be recoverable. The Company
uses its best judgment based on the current facts and circumstances relating to its business when
determining whether any significant impairment factors exist.
The Company considers the following factors or conditions, among others, that could indicate the
need for an impairment review:
|
|
|
significant under performance relative to expected historical or projected future
operating results;
|
|
|
|
|
market projections for cancer research technology;
|
|
|
|
|
its ability to obtain patents, including continuation patents, on technology;
|
|
|
|
|
significant changes in its strategic business objectives and utilization of the assets;
|
|
|
|
|
significant negative industry or economic trends, including legal factors;
|
|
|
|
|
potential for strategic partnerships for the development of its patented technology;
|
|
|
|
|
changing or implementation of rules regarding manufacture or sale of pharmaceuticals in
China; and
|
|
|
|
|
ability to maintain Good Manufacturing Process (GMP) certifications.
|
If the Company determines that the carrying values of long-lived assets may not be recoverable
based upon the existence of one or more of the above indicators of impairment, the Companys
management performs an undiscounted cash flow analysis to determine if impairment exists. If
impairment exists, the Company measures the impairment based on the difference between the assets
carrying amount and its fair value, and the impairment is charged to operations in the period in
which the long-lived asset impairment is determined by management. Based on its analysis, the
Company believes that no indicators of impairment of the carrying value of its long-lived assets
existed at September 30, 2007.
There can be no assurance, however, that market conditions will not change or demand for the
Companys products will continue or allow the Company to realize the value of its technologies and
prevent future long-lived asset impairment.
12
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Nine Months Ended September 30, 2007 and 2006
Accounting for Stock-Based Compensation
All issuances of the Companys common stock for non-cash consideration have been assigned a per
share amount equaling either the market value of the shares issued or the value of consideration
received, whichever is more readily determinable. The majority of non-cash consideration received
pertains to services rendered by consultants and others and has been valued at the market value of
the shares on the measurement date.
The Company accounts for equity instruments issued to consultants and vendors in exchange for goods
and services in accordance with the provisions of EITF Issue No. 96-18,
Accounting for Equity
Instruments that are Issued to Other than Employees for Acquiring, or in Conjunction with Selling
Goods or Services,
and EITF Issue No. 00-18,
Accounting Recognition for Certain Transactions
Involving Equity Instruments Granted to Other than Employees.
The measurement date for the fair
value of the equity instruments issued is determined at the earlier of (i) the date at which a
commitment for performance by the consultant or vendor is reached or (ii) the date at which the
consultant or vendors performance is complete. In the case of equity instruments issued to
consultants, the fair value of the equity instrument is recognized over the term of the consulting
agreement.
In accordance with EITF Issue No. 00-18, an asset acquired in exchange for the issuance of fully
vested, non-forfeitable equity instruments should not be presented or classified as an offset to
equity on the grantors balance sheet once the equity instrument is granted for accounting
purposes. Accordingly, the Company records the fair value of the fully vested, non-forfeitable
common stock issued for future consulting services as prepaid expense
in its condensed consolidated balance
sheet.
At September 30, 2007, the Company had five stock-based compensation plans.
On January 1, 2006, the Company adopted SFAS No. 123 (revised 2004),
Share-Based Payment
(SFAS No.
123(R)), which establishes standards for the accounting of transactions in which an entity
exchanges its equity instruments for goods or services, primarily focusing on accounting for
transactions where an entity obtains employee services in share-based payments transactions. SFAS
No. 123(R) requires a public entity to measure the cost of employee services received in exchange
for an award of equity instruments, including stock options, based on the grant-date fair value of
the award and to recognize it as compensation expense over the period the employee is required to
provide service in exchange for the award, usually the vesting period. SFAS No. 123(R) supersedes
the Companys previous accounting under Accounting Principles Board Opinion (APB) No. 25,
Accounting for Stock Issued to Employees,
for periods beginning in fiscal 2006. In March 2005, the
SEC issued SAB No. 107 relating to SFAS No. 123(R). The Company has applied the provisions of SAB
No. 107 in its adoption of SFAS No. 123(R).
The Company adopted SFAS No. 123(R) using the modified prospective transition method, which
required the application of the accounting standard as of January 1, 2006, the first day of the
Companys fiscal year 2006. The Companys consolidated
financial statements for the three and nine months
ended September 30, 2007 and 2006 reflect the impact of SFAS No. 123(R). SFAS No. 123(R) requires
companies to estimate the fair value of share-based payment awards on the date of grant using an
option-pricing model. The value of the portion of the award that is ultimately expected to vest is
recognized as expense over the requisite service period in the
Companys consolidated statements of
operations.
Stock-based compensation expense recognized during the period is based on the value of the portion
of share-based payment awards that is ultimately expected to vest during the period. Stock-based
compensation expense recognized in the Companys consolidated
statements of operations for the three and nine
months ended September 30, 2007 and 2006 includes compensation expense for share-based payment awards
granted based on the grant-date fair value estimated in accordance with the provisions of
SFAS No. 123(R). Stock based compensation of $1,507,310 and
$240,300 related to employees and
directors was recognized during the nine months ended
September 30, 2007 and 2006, respectively. Stock based
compensation of $377,710 and $0 related to employees and directors
was recognized during the three months ended September 30, 2007
and 2006, respectively.
13
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Nine Months Ended September 30, 2007 and 2006
As stock-based compensation expense recognized in the consolidated statement operations is based on
awards ultimately expected to vest, it has been reduced for estimated forfeitures. SFAS No. 123(R)
requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent
periods if actual forfeitures differ from those estimates. The
estimated forfeiture rate for the periods ended September 30,
2007 and 2006 was 0% since options generally vest immediately upon
grant.
Summary of Assumptions and Activity
The fair value of stock-based awards to employees and directors is calculated using the
Black-Scholes option pricing model, even though the model was developed to estimate the fair value
of freely tradable, fully transferable options without vesting restrictions, which differ
significantly from the Companys stock options. The Black-Scholes model also requires subjective
assumptions, including future stock price volatility and expected time to exercise, which greatly
affect the calculated values. The expected term of options granted is derived from historical data
on employee exercises and post-vesting employment termination behavior. The risk-free rate
selected to value any particular grant is based on the U.S. Treasury rate that corresponds to the
pricing term of the grant effective as of the date of the grant. The expected volatility is based
on the historical volatility of the Companys stock price.
These factors could change in the future, affecting the determination of stock-based compensation
expense in future periods. The Company used the following weighted-average assumptions in
determining fair value of stock options:
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
2006
|
Dividend yield
|
|
|
|
|
|
|
|
|
Expected volatility
|
|
|
353
|
%
|
|
|
108
|
%
|
Risk-free interest rate
|
|
|
4.92
|
%
|
|
|
4.76
|
%
|
Expected term
|
|
|
5.0
|
years
|
|
|
1.0
|
year
|
The Company issued 427,000 options to employees and directors during the nine months ended
September 30, 2007 which resulted in compensation expense of $1,507,310 which is included in
general and administrative expenses.
The following is a summary of stock option activity as of September 30, 2007 and changes during the
nine months then ended:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
Remaining
|
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
Contractual
|
|
|
Aggregate
|
|
|
|
Number
|
|
|
Exercise
|
|
|
Term
|
|
|
Intrinsic
|
|
|
|
of Shares
|
|
|
Price
|
|
|
(Years)
|
|
|
Value
|
|
Options outstanding at January 1, 2007
|
|
|
1,562,637
|
|
|
$
|
4.35
|
|
|
|
3.35
|
|
|
|
|
|
Granted
|
|
|
427,000
|
|
|
$
|
4.06
|
|
|
|
|
|
|
|
|
|
Expired/forfeited
|
|
|
(293,402
|
)
|
|
$
|
5.02
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
(113,000
|
)
|
|
$
|
2.40
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding and exercisable at
September 30, 2007
|
|
|
1,583,235
|
|
|
$
|
3.59
|
|
|
|
3.33
|
|
|
$
|
76,540
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At September 30, 2007, there was no unrecognized compensation cost related to employee and director
stock options.
The aggregate intrinsic value set forth in the above table represents the total pre-tax intrinsic
values, based on the Companys closing stock price of $3.28 as of September 30, 2007.
At September 30, 2007, options to purchase a total of 2,093,235 shares (including non employees) of
the Companys common stock were exercisable at a weighted-average exercise price of $3.97 per
share, of which options to purchase 678,001 shares were in the money.
14
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Nine Months Ended September 30, 2007 and 2006
Basic and Diluted Income (Loss) Per Share
Basic loss per common share is computed based on the weighted-average number of shares outstanding
for the period. Diluted loss per share is computed by dividing net loss by the weighted-average
shares outstanding assuming all potentially dilutive common shares were issued. Basic and diluted
loss per share are the same as the effect of stock options and warrants on loss per share are
anti-dilutive and thus not included in the diluted loss per share
calculation. Diluted net income per share is computed using the
weighted-average number of outstanding shares of common stock and,
when dilutive, potential common shares outstanding during the
period. Potential common shares consists primarily of incremental
shares issuable upon the assumed exercise of stock options and
warrants to purchase common stock using the treasury stock method.
Employee stock options and warrants to purchase common stock with
exercise prices greater than the average market price of the common
stock were excluded from the diluted calculation as their inclusion
would have been anti-dilutive. However, the impact
under the treasury stock method of dilutive stock options and warrants would have resulted in
incremental shares of 344,499 and 129,761 for the nine months ended September 30, 2007 and 2006,
respectively, and 218,025 and 26,456 for the three months ended
September 30, 2007 and 2006, respectively.
Income Taxes
The Company accounts for income taxes under SFAS No. 109,
Accounting for Income Taxes.
Under SFAS
109, deferred tax assets and liabilities are recognized for the future tax consequences
attributable to differences between the financial statement carrying amounts of existing assets and
liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using
enacted tax rates expected to apply to taxable income in the years in which those temporary
differences are expected to be recovered or settled. A valuation allowance is provided for
significant deferred tax assets when it is more likely than not that such assets will not be
recovered.
JJB has been granted a 100% waiver on corporate income taxes in China for 2007. YYBs tax rate is
15% through 2010 in accordance with the Western Region Development Concession Policy of the PRC
government.
Value Added Tax Payable
The Company is subject to a value added tax (VAT) at a rate of 17% on all product sales in the
PRC. The VAT payable on product sales is computed net of VAT paid on purchases by the Company in
the PRC.
Use of Estimates
The preparation of consolidated financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make certain estimates
and assumptions that affect the reported amounts of assets and liabilities at the date of the
financial statements and the reported amounts of revenues and expenses during the reporting period.
Significant estimates made by management are, among others, realization of accounts receivable and
inventories, determination of prepaid consulting fees, recoverability of long-lived assets, determination of
useful lives of intangibles, determination of values of stock options
and warrants, and
valuation of deferred tax assets. Actual results could differ from those estimates.
Risks and Uncertainties
The Companys proprietary test kit is deemed a medical device or biologic, and as such is governed
by the Federal Food and Drug and Cosmetics Act and by the regulations of state agencies and various
foreign government agencies Currently, the Company is not permitted to sell DR-70
®
in
the United States, although the Company is in the process of seeking regulatory approval. The
Company has received regulatory approval from various foreign governments to sell its products and
is in the process of obtaining regulatory approval in other foreign markets. There can be no
assurance that the Company will maintain the regulatory approvals required to market its products
or that they will not be withdrawn.
Prior to May 2002, the Companys focus was on obtaining foreign distributors for its DR-70(R) kit.
In May 2002, the Company decided to begin the FDA process under Section 510(k) of the Food, Drug
and Cosmetic Act for approval of its intent to market DR-70
®
as an aid in monitoring
patients with colorectal cancer. The Company conducted clinical trials comparing its
DR-70
®
to the currently accepted assay, CEA (carcinoembryonic antigen), and it submitted
the results to the FDA in September 2003. In January 2004, the FDA responded to the Companys
submission. The FDA identified deficiencies in the Companys application and advised its
consultant, Diagnostic Oncology CRO, Inc. (DOCRO) that based upon the data submitted, the FDA
determined that the DR-70
®
kit was
15
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Nine Months Ended September 30, 2007 and 2006
not substantially equivalent to any other device, which has gone through the 510(k) approval
process. The FDA further advised that if the Company had data which it believes shows that the
DR-70
®
kit has substantial equivalence, it could submit such additional information for
the FDAs consideration. In January 2005, DOCRO supplied additional data and submitted a new
application to the FDA proposing that DR-70
®
be used in tandem with CEA in monitoring
colorectal cancer patients. In June 2005, the FDA issued a non-substantially equivalent letter and
pointed out several areas of concern regarding the new application for use of DR-70
®
as
an adjunctive test with CEA. Representatives of the Company met with the FDA to go over their
concerns. The Company is revising its strategy regarding FDA approval of DR-70
®
and the
Company is reviewing additional patient data which supports substantial equivalence to CEA.
Company management met with the FDA on January 25, 2007. This was a Pre-IDE meeting to obtain
further guidance on the Companys submission of DR-70
®
. After a responsive submission
is filed, the FDA will likely raise other issues in furtherance of the approval process. The
Company received additional questions from the FDA regarding the Pre-IDE submission which was
responded to in May 2007.
On
November 13, 2007, the Company received a memorandum of Review
Issues from the United States Food and Drug Administration
(US FDA) which addresses the pending application for
510(k) approval of DR-70® as an aid in monitoring the disease
status in patients who have been previously diagnosed with colorectal
cancer. Unlike prior communications from the US FDA, the US FDA did
not raise the issue of whether the Companys test was
substantially equivalent to the existing predicate test, CEA. The
memorandum includes requests for clarification of the intended use
statement and clinical outcome measures.
The US FDA requested a response to the
comments within 30 days, but also indicated a request for more
time could be made. The Company is analyzing the comments and has not
yet determined whether it can supply the requested information within
the next 30 days. While the company is optimistic about its ability
to perform the studies requested, until the requested studies are
re-run, the Company is unable to assess what the probable response of
the FDA will be to the new documentation, and no assurances can be
given that the Company will ever receive FDA clearance for the
commercial sale of DR-70® in the United States.
The Company is subject to the risk of failure in maintaining its existing regulatory approvals, in
obtaining other regulatory approval, as well as the delays until receipt of such approval, if
obtained.
Operations in China
JJB and YYB operate as WFOEs in the PRC. Risks associated with operating as a WFOE include
unlimited liability for claims arising from operations in China and potentially less favorable
treatment from governmental agencies in China than JJB and YYB would receive if JJB and YYB
operated through a joint venture with a Chinese partner.
JJB and YYB are subject to the Pharmaceutical Administrative Law, which governs the licensing,
manufacture, marketing and distribution of pharmaceutical products in China and sets penalty
provisions for violations of provisions of the Pharmaceutical Administrative Law. Compliance with
changes in law may require the Company to incur additional expenditures which could have a material
impact on the Companys consolidated financial position, results of operations and cash flows.
The value of the RMB fluctuates and is subject to changes in Chinas political and economic
conditions. Historically, the Chinese government has benchmarked the RMB exchange ratio against
the United States dollar, thereby mitigating the associated foreign currency exchange rate
fluctuation risk; however, no assurances can be given that the risks related to currency deviations
of the RMB will not increase in the future. Additionally, the RMB is not freely convertible into
foreign currency and all foreign exchange transactions must take place through authorized
institutions.
As JPI is
a British Virgin Island Company, it does not have a license to
operate in China and is therefore unable to open a RMB bank account.
Accordingly, JPI entered into an agreement with Shenzhen Jiekang
Technologies Ltd (Jiekang) to hold funds as a trustee for JPI even though no
formal trust agreement exists. This type of transaction is common in
China and is adopted by many overseas companies without an operations
license. The balance of the amount at September 30, 2007 is
approximately $908,000, which is included in current assets in the accompanying balance sheet.
The Company is unsecured in this arrangement and accordingly may not be
able to recover this amount if Jiekang becomes insolvent.
Concentration of Risk
From time to time, the Company maintains cash balances at certain institutions in excess of the
FDIC limit. As of September 30, 2007, the Company had approximately $212,000 in excess of this
limit.
Customers
The Company grants credit to customers within the PRC and does not require collateral. The
Companys ability to collect receivables is affected by economic fluctuations in the geographic
areas and the industry served by the Company. Reserve for uncollectible amounts and estimated
sales returns are provided based on past experience and a specific analysis of the accounts which
management believes are sufficient. Accounts receivable of $3,055,584 at September 30, 2007, is
net of reserves for doubtful accounts and sales returns of $37,567. Although the Company expects
to collect amounts due, actual collections may differ from estimated amounts.
16
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Nine Months Ended September 30, 2007 and 2006
As of September 30, 2007, there was one customer that comprised more than 10% of outstanding
accounts receivable. For the nine months ended September 30, 2007 there was one customer which
comprised more than 10% of revenues.
The majority of the Companys customers are in the pharmaceutical industry. Consequently, there is
a concentration of receivables within this industry, which is subject to normal credit risk.
There is no prior operating history or experience with respect to the Jade Healthy Supermarkets
which are operated by independent third parties. JJB and YYB consign inventory to these stores.
Five Jade Healthy Supermarkets were operating at
September 30, 2007, however, due to the short duration of operations, the Company is unable at this
time to assess the credit risk with respect to these operations.
Fair Value of Financial Instruments
The Companys financial instruments consist of cash, accounts receivable, accounts payable and
accrued expenses and notes payable. Pursuant to SFAS No. 107,
Disclosures About Fair Value of
Financial Instruments,
the Company is required to estimate the fair value of its financial
instruments at the balance sheet date. The Company considers the carrying value of its financial
instruments to approximate their fair values due to their short maturities and rates currently
available to the Company for similar debt instruments.
Recent Accounting Pronouncements
In July 2006, the Financial Accounting Standards Board (FASB) issued FASB interpretation No. 48,
Accounting for Uncertainty in Income Taxes an interpretation of FASB Statement No. 109
(FIN
48), which clarifies the accounting and disclosure for uncertainty in tax positions, as defined.
FIN 48 seeks to reduce the diversity in practice associated with certain aspects of the recognition
and measurement related to accounting for income taxes. The Company is subject to the provisions
of FIN 48 as of January 1, 2007. The Company believes that its income tax filing position and
deductions will be sustained on audit and does not anticipate any adjustments that will result in a
material change to its financial position. Therefore, no reserves for uncertain income tax
positions have been recorded pursuant to FIN 48. The cumulative effect, if any, of applying FIN 48
is to be reported as an adjustment related to the adoption of FIN 48. The Companys policy for
recording interest and penalties associated with income tax audits is to record such items as a
component of income taxes.
In September 2006, the FASB adopted SFAS No. 157,
Fair Value Measurements
. SFAS No. 157
establishes a framework for measuring fair value and expands disclosure about fair value
measurements. Specifically, this standard establishes that fair value is a market-based
measurement, not an entity specific measurement. As such, the value measurement should be
determined based on assumptions the market participants would use in pricing an asset or liability,
including, but not limited to assumptions about risk, restrictions on the sale or use of an asset
and the risk of non-performance for a liability. The expanded disclosures include disclosure of
the inputs used to measure fair value and the effect of certain of the measurements on earnings for
the period. SFAS No. 157 is effective for fiscal years beginning after November 15, 2007. The
Company has not yet determined the effect adoption of SFAS No. 157 will have on its consolidated
financial position or results of operations.
In February 2007, the FASB issued SFAS No. 159,
The Fair Value Option for Financial Assets and
Financial Liabilities
(SFAS 159). SFAS No. 159 permits companies to choose to measure many
financial instruments and certain other items at fair value. SFAS No. 159 is effective for
financial statements issued for fiscal years beginning after November 15, 2007. Early adoption is
permitted. The Company has not yet determined if it will elect to apply any of the provisions of
SFAS No. 159 or what the effect of adoption of the statement would have, if any, on its
consolidated financial statements.
17
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Nine Months Ended September 30, 2007 and 2006
NOTE 3 SEGMENT REPORTING
The Company has adopted SFAS No. 131,
Disclosures about Segments of an Enterprise and Related
Information.
SFAS No. 131 requires public companies to report information about segments of their
business in their annual financial statements and requires them to report selected segment
information in their quarterly reports issued to shareholders. It also requires entity-wide
disclosures about the products and services an entity provides, the material countries in which it
holds assets and reports revenues and its major customers. During the nine months ended September
30, 2006, 91% of our net revenues were to customers in foreign countries and during the nine months ended September 30, 2007,
99% of our revenues were to customers in foreign countries.
During the nine months
ended September 30, 2007, approximately 1% of the Companys net revenues were from sales of
DR-70(R) with remaining sales related to JPIs products. For the nine months ended September 30,
2007, sales of DR-70(R) were made to two foreign and one domestic customers. The foreign customers
are located in Korea ($74,475) and in Taiwan ($17,625).
At September 30, 2007, the Company had three reportable segments. In China, there are two
segments, (i) wholesale distribution to distributors, hospitals, clinics and similar institutional
entities (China-Wholesale); and (ii) wholesale sales to operators of Jade Healthy Supermarkets which sell to
consumers directly (China-Direct Distribution). In the United States (U.S.) there is only one segment, sales to
distributors and institutional entities (Corporate). The Company evaluates performance based on sales, gross
profit and net income (loss). The following is information for the
Companys reportable segments for the nine months ended September 30, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
China-Wholesale
|
|
China-Direct
Distribution
|
|
Corporate
|
|
Total
|
Net revenue
|
|
$
|
9,513,272
|
|
|
$
|
39,084
|
|
|
$
|
93,700
|
|
|
$
|
9,646,056
|
|
Gross profit
|
|
$
|
5,344,500
|
|
|
$
|
39,084
|
|
|
$
|
76,421
|
|
|
$
|
5,460,005
|
|
Depreciation
|
|
$
|
639,744
|
|
|
$
|
|
|
|
$
|
4,740
|
|
|
$
|
644,484
|
|
Amortization
|
|
$
|
165,329
|
|
|
$
|
|
|
|
$
|
75,000
|
|
|
$
|
240,329
|
|
Interest expense
|
|
$
|
276,045
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
276,045
|
|
Net income (loss)
|
|
$
|
2,787,289
|
|
|
$
|
39,084
|
|
|
$
|
(6,092,976
|
)
|
|
$
|
(3,266,603
|
)
|
Identifiable assets
|
|
$
|
22,515,975
|
|
|
$
|
557,093
|
|
|
$
|
3,082,941
|
|
|
$
|
26,156,009
|
|
Capital expenditures
|
|
$
|
3,275,073
|
|
|
$
|
|
|
|
$
|
12,331
|
|
|
$
|
3,287,404
|
|
No information for the nine months ended September 30, 2006 is presented because JPI was not acquired until September 28, 2006.
JPI through JJB has initiated a new line of business where it engages in direct distribution of
pharmaceutical products through retail outlets known as Jade Healthy Supermarkets operated by
Shanghai XiangEn Food Company Co. Ltd. (Shanghai XiangEn). There are currently eight retail
stores, none of which were opened as of September 30, 2007. The Company has also signed a
Memorandum of Understanding with Shanghai XiangEn to negotiate and execute a Definitive Purchase
Agreement for the purchase of Shanghai XiangEn. JJB and Shanghai XiangEn are exploring
opportunities to open additional Retail Stores in other major cities throughout China, but as of
November 13, 2007 have not decided to open any additional retail stores at this time.
NOTE 4 OTHER PREPAID EXPENSES AND CURRENT ASSETS
Other prepaid expenses and current assets at September 30, 2007 comprise the following:
|
|
|
|
|
Deposits
|
|
$
|
362,270
|
|
Other receivables
|
|
|
1,476,872
|
|
Advance to related parties
|
|
|
22,085
|
|
Other prepaids
|
|
|
129,452
|
|
|
|
|
|
|
|
$
|
1,990,679
|
|
|
|
|
|
Other
receivables include approximately $557,000 from Shanghai XiangEn Food
Company Ltd (XiangEn) representing advances of working
capital and start up operating expenses for the Jade Healthy
Supermarkets. JPI has entered into a Letter of Intent to acquire
XiangEn subject to all requisite approvals from appropriate Chinese
governmental authorities.
JPI
entered into an agreement with Jiekang to hold funds as
trustees for JPI, which funds were advanced by AMDL to JPI. At
September 30, 2007 approximately $908,000 is held as trustee for
JPI by Jiekang. See Note 2.
18
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Nine Months Ended September 30, 2007 and 2006
NOTE 5 OTHER ASSETS
Other
assets consist of the following at September 30, 2007:
|
|
|
|
|
Deposit production
rights
|
|
$
|
1,609,556
|
|
Deposit supplier
|
|
|
399,064
|
|
Advances to
employees
|
|
|
85,122
|
|
Other
|
|
|
22,859
|
|
|
|
|
|
|
|
$
|
2,116,601
|
|
|
|
|
|
|
During the nine months ended September 30, 2007
JPI acquired production rights to seven new
medical products. Five of the agreements were signed with Jiangxi
Yibo Medicine Technology Development Co., Ltd during the quarter
ended September 30, 2007. The total consideration for these
production rights was approximately $4,200,000. See Note 10.
A deposit
was made to the supplier of raw materials for the human placenta
histosolutions. Management was made aware of the potential near term
shortage of this raw material and made a deposit to ensure a
disruption of supply does not occur.
Advances
were made to certain managers and employees. These advances are
unsecured, bear no interest and are due on demand.
NOTE 6 INTANGIBLE ASSETS
Intangible assets consist of the following at September 30, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-
|
|
|
|
|
|
|
|
|
|
|
|
Reclassification
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
|
Gross
|
|
|
Adjustment
|
|
|
of Gross
|
|
|
Adjusted
|
|
|
|
|
|
|
|
|
|
|
Amortization
|
|
|
|
Carrying
|
|
|
due to currency
|
|
|
Carrying
|
|
|
Carrying
|
|
|
Accumulated
|
|
|
|
|
|
|
Period
|
|
|
|
Value
|
|
|
translation
|
|
|
Value
|
|
|
Value
|
|
|
Amortization
|
|
|
Net
|
|
|
(in years)
|
|
Assets subject to
amortization:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intellectual property
|
|
$
|
2,000,000
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
2,000,000
|
|
|
$
|
(616,667
|
)
|
|
$
|
1,383,333
|
|
|
|
20
|
|
Production rights
|
|
|
1,340,853
|
|
|
|
|
|
|
|
|
|
|
|
1,340,853
|
|
|
|
(17,824
|
)
|
|
|
1,323,029
|
|
|
|
10
|
|
Land use rights
|
|
|
1,200,769
|
|
|
|
104,794
|
|
|
|
205,060
|
|
|
|
1,510,623
|
|
|
|
(37,947
|
)
|
|
|
1,472,676
|
|
|
|
33
|
|
Non-compete agreements
|
|
|
382,389
|
|
|
|
9,812
|
|
|
|
(57,974
|
)
|
|
|
334,227
|
|
|
|
(73,069
|
)
|
|
|
261,158
|
|
|
|
5
|
|
Customer relationships
|
|
|
254,926
|
|
|
|
9,546
|
|
|
|
(40,598
|
)
|
|
|
223,874
|
|
|
|
(34,796
|
)
|
|
|
189,078
|
|
|
|
7
|
|
Trade name and logo
|
|
|
637,317
|
|
|
|
31,067
|
|
|
|
(106,488
|
)
|
|
|
561,896
|
|
|
|
(53,554
|
)
|
|
|
508,342
|
|
|
|
10
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
5,816,254
|
|
|
$
|
155,219
|
|
|
$
|
|
|
|
$
|
5,971,474
|
|
|
$
|
(833,857
|
)
|
|
$
|
5,137,616
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOTE 7 ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts payable and accrued expenses at September 30, 2007 comprise the following:
|
|
|
|
|
Accounts payable
|
|
$
|
1,395,414
|
|
Accrued payroll and related expenses
|
|
|
239,543
|
|
Accrued
consulting fee (see Note 8)
|
|
|
817,500
|
|
Other liabilities and accrued expenses
|
|
|
240,329
|
|
|
|
|
|
|
|
$
|
2,692,786
|
|
|
|
|
|
NOTE 8 EQUITY TRANSACTIONS
On April 20, 2006, the Board of Directors authorized the issuance of up to of 120,000 shares of
common stock to First International Capital Group, Ltd. (First International) pursuant to an
amendment to the consulting agreement dated July 22, 2005, for financial advisory services to be
provided from July 23, 2006 through January 22, 2007. The Company issued 116,000 shares of common
stock as consideration for the services to be provided by First International under the amendment.
The shares were valued at $348,000 based on the trading price of the common stock on the
measurement date. During the nine months ended September 30, 2007, the Company recorded general
and administrative expense of $37,419 related to this agreement.
On September 22, 2006, the Board of Directors authorized the issuance of 5,653 shares of common
stock to Aurelius Consulting Group, Inc. as consideration for marketing services provided from
December 22, 2006 through March 21, 2007. The shares were valued at $22,498 based on the trading
price of the common stock on the measurement date. During the nine months ended September 30,
2007, the Company recorded $20,248 to general and administrative expenses related to this
agreement.
On October 5, 2006, the Board of Directors authorized the issuance of 84,000 shares of common stock
to First International, pursuant to an amendment to the consulting agreement dated July 22, 2005 as
consideration for financial advisory services to be provided from January 23, 2007 through March
22, 2007. The shares were valued at $204,960 based on the trading price of the common stock on the
measurement date. The Company recorded general and administrative expense of $204,960 related to
the agreement during the nine months ended September 30, 2007.
On October 24, 2006, the Company issued 140,000 shares of common stock to Lynx Consulting Group,
Inc. for consulting services to be performed through April 30, 2007. The shares were valued at
$548,800 based on the trading price of the common stock on the
measurement date. The Company recorded
$343,000 as general and administrative expense during the nine months ended September 30, 2007.
19
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Nine Months Ended September 30, 2007 and 2006
On November 15, 2006, the Board of Directors authorized the issuance of warrants to purchase 25,000
shares of common stock at an exercise price of $4.52 per share to Savannah Capital Management, Inc.
(Savannah) as consideration for investor public relations services to be provided from November
15, 2006 through February 15, 2007. The warrants were valued at $84,000 using the Black-Scholes
pricing model. The Company recorded general and administrative expense of $42,000 during the nine
months ended September 30, 2007.
On March 2, 2007, the Board of Directors authorized the issuance of 190,000 shares of common stock
to Boston Financial Partners, Inc. pursuant to an amendment to the consulting agreement dated
September 16, 2003, as consideration for financial advisory services to be provided from March 1,
2007 through September 1, 2007. The shares were valued at $558,600 based on the trading price of
the common stock on the measurement date. During the nine months ended September 30, 2007, the
Company recorded general and administrative expense of $558,600 related to the agreement.
Also on March 2, 2007, the Board of Directors authorized the issuance of 150,000 shares of common
stock to First International pursuant to an amendment to the consulting agreement dated July 22,
2005, as consideration for financial advisory services to be provided from March 22, 2007 through
September 22, 2007. The shares were valued at $517,500 based on the trading price of the common
stock on the measurement date. During the nine months ended September 30, 2007, the Company
recorded general and administrative expense of $517,500.
On April 24, 2007, the Board of Directors authorized the issuance of warrants to purchase 25,000
shares of common stock to Brookstreet Securities Corporation, a consultant, as consideration for
financial advisory services. The common shares issuable on exercise of the warrants are
exercisable at $3.68 per share. The warrants were valued at $35,000 using the Black-Scholes option
pricing model which amount was charged to consulting expense in the nine months ended September 30,
2007.
On September 14, 2007, the Board of Directors authorized the issuance of 250,000 shares of common
stock to First International pursuant to an amendment to the consulting agreement dated July 22,
2005, for financial advisory services to be provided from September 22, 2007 through September 22,
2008. The shares were valued at $817,500 based on the trading price of the common stock on the
measurement date. During the nine months ended September 30, 2007, the Company recorded general and
administrative expense of $20,438 related to the agreement and the
balance of $797,063 is included
in prepaid consulting at September 30, 2007. The shares of
common stock were not issued as of September 30, 2007
pending American Stock Exchange approval. Therefore, the balance is included as an accrued expense
at September 30, 2007 and was reclassified to equity upon
issuance of the shares in October 2007.
The Company issued 10,000 options to a consultant and an investor during the nine months ended
September 30, 2007 which resulted in compensation expense of $35,300 which is included in general
and administrative expense. In pricing these options, the Company used the Black-Scholes pricing
model with the following weighted-average assumptions: expected volatility of 353%; risk-free
interest rate of 4.92%; expected term of one year; and dividend yield of 0%.
Between April 14, 2007 and June 7, 2007, the Company conducted a combined private offering (April
2007 Offering) under Regulation D and Regulation S for the sale to accredited investors of shares
of common stock and warrants to purchase a number of shares of common stock equal to one-half the
number of shares sold in the April 2007 Offering. On May 4, 2007, the Company conducted the first
closing of the April 2007 Offering and received approximately $3,789,500 in aggregate gross
proceeds, exclusive of placement agent fees and expenses of approximately $492,600 from the sale of
a total of 1,443,620 shares. The shares were sold at a price of $2.625 per share, representing a
discount of 25% from the average of the closing prices for the five consecutive trading days prior
to the second trading day before the closing date. The exercise price of the warrant shares issued
in the April 2007 Offering was $3.68. On June 7, 2007, the Company conducted the second closing of
the April 2007 Offering for the sale. The Company received approximately $1,540,900 in aggregate
gross proceeds, exclusive of placement agent fees and expenses of approximately $200,400 from the
sale of a total of 587,000 shares in the second closing.
20
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Nine Months Ended September 30, 2007 and 2006
The shares were sold at a price of $2.625 per share and three year warrants to purchase an
additional 293,500 shares, which warrants are exercisable at $3.86 per share. Warrants to purchase
an additional 58,700 shares were also issued to the placement agents at the same exercise price in
the second closing.
In connection with the April 2007 Offering, we utilized the services of Galileo Asset Management,
S.A. (Galileo), a Swiss corporation for sales to non-U.S. persons, and Securities Network, LLC
(Network), a NASD member broker-dealer as our placement agent for sales in the United States.
For their services, Galileo and Network received commissions and a non-accountable expense
allowance in the aggregate of approximately $693,000 and warrants to purchase an aggregate of
203,023 shares of the Companys common stock. In connection with
the April 2007 Offering, the
Company has also agreed to pay Galileo and Network a six percent (6%) cash commission upon exercise
of the warrants by the purchasers. In addition, the Company incurred additional legal and other
costs totaling approximately $64,000 in connection with the April 2007 Offering. The Company
charged all of these costs to additional paid-in capital, since the investment was treated as a
purchase of shares of common stock.
After the closing of the April 2007 Offering, the Company filed a registration statement with the
Securities and Exchange Commission to register the shares of the Companys common stock, shares
issuable upon exercise of the related investor warrants, and shares issuable upon exercise of the
warrants issued to the placement agents. The registration statement was declared effective on June
29, 2007.
NOTE 9 NOTES PAYABLE
At September 30, 2007, the Company had $5,140,425 in outstanding indebtedness owed to two financial
institutions, representing working capital and construction advances. These notes are secured by
substantially all the assets of JJB and YYB and bear interest at rates ranging from 5.31% to 9.45%
per annum. Any remaining unpaid principal and accrued interest is due at maturity on various dates
through December 31, 2008.
Future aggregate maturities of notes payable at September 30, 2007 are as follows:
|
|
|
|
|
Years ending December 31,
|
|
|
|
|
2007
|
|
$
|
3,248,864
|
|
2008
|
|
|
1,891,561
|
|
|
|
|
|
|
|
|
5,140,425
|
|
Less current portion
|
|
|
(3,248,864
|
)
|
|
|
|
|
|
|
$
|
1,891,561
|
|
|
|
|
|
Prior to the purchase of certain assets of JiangXi Shangrao Pharmacy Co. Ltd (Kangda) by JJB,
Kangda had bank loans of $5,357,000 secured by land and buildings which were subsequently
transferred to JJB. Pursuant to an agreement between JJB, Kangda and the bank, JJB assumed bank
loans of $4,332,000, and Kangda continued to owe the bank $1,025,000. A new bank loan to reflect this assumption has not been made. However, a debt payment extension
has been executed whereby the payment terms of the loan have been extended. As of September 30,
2007, a total of approximately $696,000 was due but has not been repaid. The verbal agreement with
the bank to extend the terms of the loan will apply until a new bank loan agreement is finalized.
NOTE 10 COMMITMENTS AND CONTINGENCIES
Operating Leases
The Company leases its laboratory and manufacturing space under a non-cancelable two year operating
lease agreement that expires on December 1, 2008. The lease requires monthly lease payments of
$6,600. JPIs main office is located in the Di Wang Building of Shenzen and is leased for
approximately $6,515 per month through November 2007.
21
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Nine Months Ended September 30, 2007 and 2006
Litigation
On February 22, 2002, AcuVector Group, Inc. (AcuVector) filed a Statement of Claim in the Court
of Queens Bench of Alberta, Judicial District of Edmonton relating to the Companys combination
immunogene therapy technology acquired from Dr. Chang in August 2001.
The claim alleges damages of $CDN 20 million and seeks injunctive relief against Dr. Chang for,
among other things, breach of contract and breach of fiduciary duty and against us for interference
with the alleged relationship between Dr. Chang and AcuVector. The claim for injunctive relief
seeks to establish that the AcuVector license agreement with Dr. Chang is still in effect. The
Company performed extensive due diligence to determine that AcuVector had no interest in the
technology when the Company acquired it. The Company is confident that AcuVectors claims are
without merit and that the Company will receive a favorable judgment. As the final outcome is not
determinable, no accrual or loss relating to this action is reflected in the accompanying
consolidated financial statements.
The Company is also defending a companion case filed in the same court by the Governors of the
University of Alberta filed against the Company and Dr. Chang in August 2003. The University of
Alberta claims, among other things, that Dr. Chang failed to remit the payment of the Universitys
portion of the monies paid by the Company to Dr. Chang for the combination immunogene technology
purchased by us from Dr. Chang in 2001. In addition to other claims against Dr. Chang relating to
other technologies developed by him while at the University, the University also claims that the
Company conspired with Dr. Chang and interfered with the Universitys contractual relations under
certain agreements with Dr. Chang, thereby damaging the University in an amount which is unknown to
the University at this time. The University has not claimed that the Company is not the owner of
the combination immunogene therapy technology, just that the University has an equitable interest
therein or the revenues therefrom.
If either AcuVector or the University is successful in their claims, the Company may be liable for
substantial damages, its rights to the technology will be adversely affected, and its future
prospects for exploiting or licensing the combination immunogene therapy technology will be
significantly impaired.
In the ordinary course of business, there are other potential claims and lawsuits brought by or
against the Company. In the opinion of management, the ultimate outcome of these matters will not
materially affect the Companys operations or financial position or are covered by insurance
Suspension of Product Sales
The sale of one of the Companys products, Yuxingcao, has been temporarily prohibited in the PRC
due to safety concerns. Although the Company considers its products safe, the prohibition will
remain in effect until such time as the government determines the source of the unsafe products.
The PRC authority has allowed the commercial sales of some Yuxingcao products in October 2006 but
not the one produced by the Company. No products have been returned during the nine months ended
September 30, 2007.
Management believes there will be no claims from customers on the sale of Yuxingcao as the quality
of the product is not an issue. It is the current policy of the relevant authorities in the PRC to
prohibit the sales of Yuxingcao-related products. No estimate is known at this time for the
resumption of the commercial sales of Yuxingcao.
Consulting Agreements
The Company has various agreements with consultants whereby the consultants perform corporate
development services of attracting investors. During the nine months ended September 30, 2007 and
2006, the Company paid cash, and issued stock and warrants to third parties under these agreements.
22
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Nine Months Ended September 30, 2007 and 2006
On
September 20, 2006, JPI entered into an agents contract with Shenzen Jie Kang to assist in
marketing and consulting for the Jade Healthy Supermarket venture. The contract requires an
initial payment of approximately $31,000 for each authorized distributor retained and a commission
based on the schedule below:
|
|
|
commission of 2% on the amount of goods or services sold to the distributor if total
sales delivered to the distributor exceeds $63,000 in any single month;
|
|
|
|
|
additional commission of 1% if total sales delivered to the distributor exceeds
$189,000 in any single month;
|
|
|
|
|
Special bonus of 2% on total amount of goods delivered exceeds $251,000 in any single
month; and
|
|
|
|
|
An additional allowance progressively increased with the number of distributors
successfully solicited.
|
An agency agreement was signed between JJB and Shanghai
Xiang En on June
14, 2007. Pursuant to the agency agreement, JJB appointed Shanghai as the agent to solicit
interested parties to operate the chain stores in the name of Jade for the purpose of
distributing JPIs products and healthy products of Esmond Nature Inc. The contract term is for a
period of two years. If the shares of Shanghai are subsequently acquired by JPI or its group
companies, the agency contract will be automatically terminated. A one-time fee of approximately
$38,000 is paid by the sub-operators upon their signing of the
sub-agency agreement with Shanghai. The original agency agreement was
amended to have Shanghai Xiangen assume management responsibility for
the Jade Healthy Supermarket.
See Note 8 for a summary of non-cash consulting agreements.
Indemnities and Guarantees
The Company has executed certain contractual indemnities and guarantees, under which it may be
required to make payments to a guaranteed or indemnified party. The Company has agreed to
indemnify its directors, officers, employees and agents to the maximum extent permitted under the
laws of the State of Delaware. In connection with a certain facility lease, the Company has
indemnified its lessor for certain claims arising from the use of the facilities. Pursuant to the
Sale and Purchase Agreement, the Company has indemnified the holders of registrable securities for
any claims or losses resulting from any untrue, allegedly untrue or misleading statement made in a
registration statement, prospectus or similar document. Additionally, the Company has agreed to
indemnify the former owners of JPI against losses up to a maximum of $2,500,000 for damages
resulting from breach of representations or warranties in connection with the JPI acquisition. The
duration of the guarantees and indemnities varies, and in many cases is indefinite. These
guarantees and indemnities do not provide for any limitation of the maximum potential future
payments the Company could be obligated to make. Historically, the Company has not been obligated
to make any payments for these obligations and no liabilities have been recorded for these
indemnities and guarantees in the accompanying consolidated balance sheet.
Construction in Progress
JJB began a renovation project of their manufacturing facility to increase efficiency and
facilitate the manufacturing process. Major improvements for the quarter ended September 30, 2007
include improvement of the factorys water supply, improve drainage and upgrade pipes. The
outstanding commitment is approximately $420,000.
Purchase of Production Rights
During the quarter ended September 30, 2007, the Company entered into product license agreements with Jiangxi Yibo
Medicine Technology Development Co., Ltd for five new products. The total
consideration to be paid under these agreements is approximately $4,200,000. As of
September 30, 2007, $1,600,000 has been paid and is classified
as a current asset in the accompanying balance sheet, leaving an
outstanding commitment of $2,600,000. During the three months ended
September 30, 2007 two products went into production and
$1,340,854 was capitalized and is being amortized on a straight line
basis over the estimated useful life of 10 years.
23
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Nine Months Ended September 30, 2007 and 2006
NOTE 11 SUBSEQUENT EVENTS
On November 7,
2007, JPIs subsidiary, JJB, signed the fourth round of regional distribution
agreements for its new anti-aging and skin care injectible product under the brand name Goodnak.
JJB has signed three new Central Region exclusive, one-year renewable Distribution and Agency
Agreements that were signed between JJB and Henan Yinji Bio-chemistry Co.,
Ltd. (HYB), Chengdu Fairyland Cosmetics Co., Ltd. (CFC), Guizhou Camry Beauty Technology
Co., Ltd. (GCB). These agreements cover the key cities in Henan, Sichuan and Guizhou Provinces
that have a combined population of approximately 134.4 million
people. These three separate
agreements in combination, require these new distributors to purchase a minimum of $6,790,944 of
JJBs new HPH product during the one-year period of the contracts and a minimum initial order of
US$4,061,250.
On October 4,
2007, the Company issued 250,000 shares of its common stock to First International
under Amendment No. 5 to the Consulting Agreement originally dated July 22,
2005. The shares were valued at $817,500, the value on the measurement date and this amount will
be charged to general and administrative expense over the period of Amendment No. 5, ending on
September 22, 2008.
JPI through JJB has
initiated a new line of business where it engages in retail outlets
and direct distribution of pharmaceutical products through cooperatively operated retail outlets.
There are currently five retail outlets that began operation in July 2007. Three of the outlets
are currently owned by Shanghai XiangEn Food Company Ltd (XiangEn). The Company has signed a
Memorandum of Understanding with XiangEn to negotiate and execute a Definitive Purchase Agreement
for the purchase of these outlets. It is the intent of JPI to expand on this initial effort and
expand current operations through cooperative relationships in major cities throughout China.
On October 11,
2007, JJB signed an agreement with Heze Mudan Medicals Co. Ltd. to
distribute Domperidone tablets in the Province of Shandong and the surrounding areas, one of the
most affluent regions in China. The contract is subject to minimum sales which will be reviewed
annually and is expected to add at least $2.3 million in annual revenues.
On October 12, 2007, the Company filed a new application with the U.S. Food and Drug Administration
(FDA) under Section 510(k) of the Food, Drug and Cosmetic
Act along with new statistical data to
obtain approval to market DR-70 in the United States as an aid in monitoring patients with
colorectal cancer. The nature and timing of the FDAs response to the Companys submission of the
application cannot be anticipated, nor can there be any assurance that the FDA will clear DR-70 for
use in the United States. The Company cannot predict the length of time it will take for the FDA
to review the new application or whether approval will ultimately be obtained
24
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Nine Months Ended September 30, 2007 and 2006
On October 30, 2007, the Company negotiated with Noble International Investments, Inc. (Noble)
for Noble to act as its placement agent in connection with the sale of common stock and warrants
(collectively the Securities) on terms acceptable to the Company to one or more financial
investors until December 31, 2007. The Company paid Noble a $15,000 retainer and delivered a
letter regarding the terms of Nobles engagement along with a Term Sheet regarding the offering of
the Securities. Noble immediately thereafter demanded that the Company advance an additional
$50,000 for due diligence expenses that was not agreed or provided for in the letter. The Company
claims, among other things, that the letter was not executed and delivered by Noble before it was
voided, that Noble neither acted or negotiated in good faith from the outset, and Noble never
intended to obtain financing on the terms outlined in the Term Sheet, or at all. Noble did not
deliver any investors for the Securities. Notwithstanding the forgoing, Noble now claims that it
is entitled to a so-called break up fee of $150,000 which was provided in the letter. No action
has been filed on this claim by Noble.
On November 2, 2007, JPIs subsidiary JJB has signed the third round of regional distribution
agreements for its new anti-aging and skin care injectible product under the brand name Goodnak.
JJB has signed three new Western Regional exclusive, one-year renewable Distribution and Agency
Agreements that were signed between Jade Pharmas subsidiary JJB and Xian Maryland Cosmetics Co.,
Ltd. (XMC), Lanzhou Charm Trade Co., Ltd. (LCT) and Wulumuqi Ozi Cosmetics Co., Ltd. (WOC).
These agreements cover the key cities in Shanxi, Xinjiang and Gansu Provinces. These two separate
agreements in combination, require these new distributors to purchase a minimum of $6,844,206 of
JJBs new HPH product during the one-year period of the contracts and a minimum initial order of
$3,422,102.
On November 13, 2007, the Company received a memorandum of Review Issues from the United States
Food and Drug Administration (US FDA) which addresses the pending application for 510(k) approval
of DR-70
®
as an aid in monitoring the disease status in patients who have been previously diagnosed
with colorectal cancer. Unlike prior communications from the US FDA, the US FDA did not raise the
issue of whether the Companys test was substantially equivalent to the existing predicate test,
CEA. The memorandum includes requests for clarification of the intended use statement and clinical
outcome measures.
The US FDA requested a response to the comments within 30 days, but also indicated a request for
more time could be made. The Company is analyzing the comments and has not yet determined whether
it can supply the requested information within the next 30 days. While the company is optimistic
about its ability to perform the studies requested, until the requested studies are re-run, the
Company is unable to assess what the probable response of the FDA will be to the new
documentation, and no assurances can be given that the Company will ever receive FDA clearance for
the commercial sale of DR-70
®
in the United States.
25
Item 2. Managements Discussion and Analysis or Plan of Operation.
Forward Looking Statements
This Form 10-QSB contains forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. Such forward-looking statements made by the Company involve known
and unknown risks, uncertainties and other factors which may cause the actual results, performance
or achievements of the Company to be materially different from any future results, performance or
achievements expressed or implied by such forward-looking statements. Factors that could cause
actual results to differ materially from the forward looking statements include, but are not
limited to, risks associated with doing business in China and internationally, demand for the
Companys products, governmental regulation and required licensing of the Companys products and
manufacturing operations, dependence on distributors, foreign currency fluctuation, technological
changes, intense competition and dependence on management. Given these uncertainties, readers are
cautioned not to place undue reliance on such forward-looking statements. The Companys management
disclaims any obligation to update forward-looking statements contained herein to reflect any
change in the Companys expectation with regard thereto or any change in events, conditions,
circumstances or assumptions underlying such statement.
Overview
AMDL, Inc.s predecessor was incorporated May 13, 1988 and the Company reorganized as a Delaware
corporation on June 7, 1989.
Since inception, the Company has primarily been engaged in the commercial development of and the
obtaining of various governmental regulatory approvals for the marketing of its proprietary
diagnostic tumor-marker test kit (DR-70
®
) to detect the presence of multiple types of
cancer. The Companys product line also includes a selection of diagnostic test kits for several
types of cancer, infectious diseases, endocrinology, diabetes, nephrology and allergy.
On September 28, 2006, the Company acquired 100% of the outstanding shares of Jade Pharmaceutical
Inc. (JPI). JPI has two wholly owned Peoples Republic of China (PRC or China) based
subsidiaries, Yangbian Yiqiao Bio-Chemical Pharmacy Company Limited (YYB) and Jiangxi
Bio-Chemical Pharmacy Company Limited (JJB) who manufacture and distribute pharmaceutical
products in China.
Acquisition of Jade Pharmaceuticals Inc.
On September 28, 2006, pursuant to the closing of the Stock Purchase and Sale Agreement dated May
12, 2006, we acquired 100% of the outstanding shares of JPI from Jade Capital Group Limited
(Jade). JPI has two wholly-owned PRC based subsidiaries, YYB and JJB. YYB is located in Tuman
City, Jilin Province, PRC and JJB is located in Shangrao, Jiangxi Province, PRC. JPI sells
over-the-counter and prescription pharmaceutical products in the PRC and its business is conducted
through two subsidiaries, JJB and YYB. JJB is a manufacturer of proprietary and generic
pharmaceutical products, including injectibles, capsules, tablets, liquids and medicated skin
products.
The acquisition of JPI provides:
|
|
|
Access to the fastest growing pharmaceutical and consumer market in the world, China;
|
|
|
|
|
A platform to in-license North American drugs for manufacture and sale in China and
Asia;
|
|
|
|
|
A program for DR-70(R) and CIT clinical trials, sales, and marketing into China and
Asia;
|
|
|
|
|
New opportunities for cancer-related product development in China.
|
26
JPIS Sales and Distribution Activities
JPI currently has 75 in house full-time sales people and is expected to increase this number over
the next twelve months to market JPIs new products. Geographically, sales in China are divided as
follows:
|
|
|
|
|
Region
|
|
Percentage
|
|
Central
|
|
|
26
|
%
|
South East
|
|
|
22
|
%
|
North East
|
|
|
20
|
%
|
Eastern
|
|
|
23
|
%
|
North
|
|
|
8
|
%
|
South West
|
|
|
1
|
%
|
As JJBs and YYBs resources permit, both JJB and YYB anticipate expanding their current domestic
Chinese distribution beyond the cities in which they currently sell through the utilization of new
distribution firms in regions currently not covered by existing distributors or the in-house sales
force.
Sales of JJBs products are approximately 40% to individuals and 60% to institutional or hospital
customers. JJB employs regional sales managers and over three hundred representatives who contact
distributors throughout China. There are eighteen distributors who purchase products from JJB.
Distributors have the right to return product only if the product is defective..
YYB has established a multi-level marketing program of approximately forty sales managers and
engages over 1,000 sales representatives who act as individual marketers of YYBs products. YYB
also has eight distributors. 60% of YYBs products are sold to individuals and 40% are sold to
institutional or hospital customers.
Both JJB and YYB are continually developing educational programs for hospitals, doctors, clinics
and distributors with respect to JJBs and YYBs product lines. These educational programs are
intended to improve sales and promotion of JJBs and YYBs products. Both JJB and YYB sell to
hospitals, retail stores and distributors who act as agents. One primary distributor has 29 retail
outlets throughout the PRC. In addition, JJB and YYB have a dedicated sales team that manages its
own direct sales force and retail outlets all over China.
JPI product development strategy will focus on expanded in-house research and development
activities and the in-licensing of new products from third party pharmaceutical research firms.
This product development strategy is expected to provide at least an additional six new products to
the Companys existing family of strong selling products over the next 36 months. Additionally,
JPI is regularly reviewing various other product in-licensing opportunities. JPI is accelerating
its new product development process beyond the nine new products that have already been announced.
It currently has two products under review by the SFDA (China State Food and Drug Administration),
AMDLs DR-70
®
cancer diagnostic test kit and Docetaxel Injectibles. Both products are anticipated
to be approved for sale in China during mid-2008.
JJB has entered into a number of manufacturing and distribution arrangements for product
distribution in China for various existing and to-be-developed JJB products. For example, in 2006
Jiangxi Baikang Medicine Co., Ltd. transferred the product license and manufacturing licenses for
four new drugs (Marine and Sodium Chloride Injection, Lomefloxacin Aspartate Injection, Lysine
Hydrochloride Glucose Injection and Omeprazole Sodium for injection) and two generic medicine
(Roxithromycin capsule and Levofloxacin capsule) to JJB, which products are currently being
manufactured and distributed by JJB.
Commencing in July 2007,
JPI began direct distribution of pharmaceutical products through retail
outlets known as Jade Healthy Supermarkets. The Jade Healthy Supermarkets are small retail
stores operated by others who sell JJBs products at retail to
consumers. JJB advances funds for working capital, leasehold
improvements and equipment to the operators for an up front fee and consigns inventory to the
operator or sub-operator of the store. As of November 15, 2007 there were currently
eight retail stores in operation. Due to management constraints and to operate
within applicable laws and regulations in China, all management
responsibilities were turned over to Shanghai XiangEn. In addition,
Shanghai XiangEn is responsible for supplying equipment and fixtures
for the shops.
27
During the third quarter ended September 30, 2007,
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JPI signed an agreement with Heze Mudan Medicals Co. Ltd. to distribute Domperidone
tablets in the Province of Shandong and the surrounding areas, one of the most affluent
regions in China. Domperidone is an important medicine for treating nausea and vomiting.
JPIs generic version of this product is significantly lower priced than competitors. The
contract is subject to minimum sales which will be reviewed annually and is expected to add
at least $2.3 million in annual revenues to JPI.
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JPIs subsidiary JJB launched a new anti-aging and skin care injectible product under
the brand name Goodnak. This initial product is the first in a new line of anti-aging &
skin care products currently under development by JJB. Goodnak is a high quality injectible
anti-aging & skin care product that contains an amalgam of various therapeutic elements
including human placental histosolution (HPH). JPI has begun selling Goodnak, in August,
through wholesale distribution channels that service high-end beauty salon and plastic
surgery hospitals and or medical cosmetology institutions.
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JPIs subsidiary JJB has signed a key set of regional distribution agreements for its new
anti-aging and skin care injectible product under the brand name Goodnak. This initial
product is the first in a new line of anti- aging & skin care products currently under
development by JJB. JJB has signed three new Southern Region exclusive, one-year renewable
Distribution and Agency Agreements that were signed with Changsha Hongli Co., Ltd. (CHC),
Wenzhou Limeikang Trade., Ltd. (WLT) and Xiamen Larry Beauty Technology Co., Ltd. (XLB).
These agreements cover the key cities in Hunnan, Zhejiang and Fujian Provinces that have a
combined population of approximately 134.4 million people. These two separate agreements in
combination, require these new distributors to purchase a minimum of $7,126,496 of JJBs
new Goodnak product during the one-year period of the contracts and a minimum initial order
of $3,563,248.
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JPIs subsidiary JJB has signed the third round of regional distribution agreements for
its new anti-aging and skin care injectible product under the brand name Goodnak. JJB has
signed three new Western Regional exclusive, one-year renewable Distribution and Agency
Agreements that were signed between JJB and Xian Maryland Cosmetics
Co., Ltd. (XMC), Lanzhou Charm Trade Co., Ltd. (LCT) and Wulumuqi Ozi Cosmetics Co.,
Ltd. (WOC). These agreements cover the key cities in Shanxi, Xinjiang and Gansu Provinces
that have a combined population of approximately 86 million people. These two separate
agreements in combination, require these new distributors to purchase a minimum of
$6,844,206 of JJBs new HPH product during the one-year period of the contracts and a
minimum initial order of $3,422,102.
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During the three months ended September 30, 2007, JPI entered into an agreement with
Jiangxi Yibo Medicine Technology Development Co., Ltd to acquire five new medical products,
two of which went into production. JPI paid approximately $1,340,000 for the license
rights to produce these two products. The application of these products include treatments
for coronary dysfunction, adult rhinallergosis, primary and secondary treatment for
oophoroplasty and breast cancer and acute and chronic virus hepatitis.
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The Current Economic and Market Environment
We operate in a challenging economic environment that has undergone significant changes in
technology and in patterns of global trade. Our goal is to build a broad-based international
pharmaceutical enterprise. We plan to achieve this by combining our cancer detection, gene therapy
research, and vaccine technology with JPIs China based pharmaceutical manufacturing, consumer
sales, and clinical trials expertise.
Research and Development
During the nine months ended September 30, 2007 and 2006, the Company spent $15,534 and $282,139
respectively, on research and development related to DR-70
®
.
28
The Company retained the statistical and regulatory firm R.P. Chiacchierini & Associates, LLC to
provide additional statistical analysis for the U.S. FDA to support the Companys request for
clearance to market DR-70(R) cancer test kits in the U.S. An application has also been submitted
to the Chinese State Food and Drug Administration (SFDA) and Taiwanese Department of Health for
approval of DR-70(R) in those countries.
The Company filed with the U.S. Food & Drug Administration (FDA) for clearance to market its
unique, proprietary DR-70
®
(FDP) ELISA tumor marker test for use as an aid in monitoring patients
previously diagnosed with colorectal cancer. AMDL used the guidance provided at the meeting they
had with the FDA on January 25, 2007. In its submission to the FDA, The Company and its
statistical consultant, Dr. Richard P. Chiacchierini provided statistical evidence that the DR-70
®
(FDP) ELISA is an informative test to validate AMDLs claim that the DR-70
®
(FDP) ELISA is
effective at monitoring colorectal cancer patients.
JJB and YYB currently perform all of their own research and development activities on new products
at their own facilities. Currently, JJB is researching and attempting to develop a liver cancer
treatment, a bone growth stimulant and an antibiotic for the treatment of the urinary system. YYB
is attempting to develop products for the treatment of cardiovascular disease, treatments for
cancer, and a healthy food series. Each of these products will require an additional investment of
funds before these products will be available for sale, assuming product licenses are obtained for
their manufacture.
Due to the growing Chinese economy and the opportunities to expand upon JPIs name recognition and
distribution network versus available capital resources, the overall amount expended for research
and development has been limited. Funds previously allocated for research and development has been
reallocated to:
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Increase in inventory necessary for anticipated demand for product;
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Renovation of current manufacturing facilities to accommodate new products;
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Purchasing or licensing new products;
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Purchase of new machinery to increase capacity for existing products as well as
purchase of machinery to facilitate the manufacture of new products; and
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Increase the distribution network for current as well as new products.
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JPIs research and development takes place at seven locations in China. Two of these are in-house
facilities that include the Research Center of YYB, located in Jiangxi, and the Research Center at
JJB, located in Jilin. Additionally, five collaborative research and development facilities
include: Jilin Traditional Chinese Medicine Research Institute; Baiqiuen Pharmaceutical Research
Institute; Research Center of Nanjing Pharmacy University; Jiangxi Bikang Technology Development
Co. Ltd.; and the Changsha Continental Pharmaceutical Research Institute.
Liquidity and Capital Resources
Total assets increased to $26,156,009 at September 30, 2007 from $19,240,613 at December 31, 2006.
This increase was due primarily to increase in accounts receivable of
approximately $1.2 million,
property and equipment of approximately $1.9 million and intangibles of approximately $1.3 million,
which amount was offset by a decrease in cash of approximately $350,000.
Our total outstanding indebtedness increased to $8,670,795 at September 30, 2007 as compared to
$6,577,457 at December 31, 2006. The primary reason for the increase is due to the increase in
accounts payable, value added and other taxes payable and loan amounts. The change in loan amounts
is primarily due to the fluctuation of the RMB.
During the nine months ended September 30, 2007, our cash and cash equivalents decreased by a net
of approximately $357,000. During the nine months ended September 30, 2007, our primary source of
cash was a private placement of our common stock which generated net
proceeds of $4,572,497. Cash
usage continues to
29
exceed cash generation. As of November 15, 2007, cash on hand was approximately $604,998 and cash
is being depleted at the rate of approximately $310,000 per month. This monthly amount does not
include any expenditures related to further development or attempts to license our combination
immunogene therapy (CIT) technology, as no significant expenditures on the CIT technology are
anticipated other than the legal fees incurred in furtherance of patent protection for the CIT
technology. Assuming (i) the current level of
revenue from the sale of DR-70
®
kits does not increase in the near future, (ii) the
Company does not require new cancer samples to satisfy the FDA concerns on its pending 510(k)
application; (iii) the Company does not conduct any full scale clinical trials for
DR-70
®
or its combination immunogene therapy technology in the U.S. or China, (iv) JPI
generates sufficient cash to meet or exceed its cash requirements, and (v) no outstanding options
or warrants are exercised, the amount of cash on hand is expected to be sufficient to meet the
Companys projected operating expenses only through mid January 2008.
There are significant uncertainties which negatively affect our operations. These are principally
related to (i) the absence of a distribution network for our DR-70
®
kits, (ii) the early
stage of development of our CIT technology and the need to enter into a strategic relationship with
a larger company capable of completing the development of any ultimate product and the subsequent
marketing of such product, (iii) the absence of any commitments or firm orders from our
distributors, and (iv) most of our sales and distribution channels in China are unseasoned.
Moreover, there is no assurance as to when, if ever, we will be able to conduct our operations on a
profitable basis. Our limited sales to date for DR-70
®
, the lack of any purchase
requirements in the existing distribution agreements, and absence of FDA approval make it
impossible to identify any trends in our business prospects for AMDL. There is no assurance we
will be able to generate sufficient revenues or sell any equity securities to generate sufficient
funds when needed, or whether such funds, if available, will be obtained on terms satisfactory to
us. In addition, if either AcuVector and/or the University of Alberta is successful in their
claims, we may be liable for substantial damages, our rights to the CIT technology will be
adversely affected, and our future prospects for licensing the CIT technology will be significantly
impaired.
If sufficient funds are available, the Company expects to incur capital expenditures of $ 2,000,000
at our China facilities in the fourth quarter half of 2007, primarily for the addition of additional
manufacturing lines, the purchase of additional product licenses, and upgrading current
manufacturing facilities. These capital expenditures will enable JPI to increase its production
efficiency. Management anticipates that this capital expenditure will be financed by raising
additional capital through the sale of equity securities. In addition to the capital expenditures,
additional working capital will be needed in China for additional direct manufacturing staff,
general and administrative purposes, consultants, the costs of consigned inventory, salaries for
additional office and sales staff.
Critical Accounting Policies
Our consolidated financial statements have been prepared in accordance with accounting principles
generally accepted in the United States of America. The preparation of these financial statements
requires us to make estimates and judgments that affect the reported amounts of assets,
liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities.
We base our estimates on historical experience and on various other assumptions that are believed
to be reasonable under the circumstances, the results of which form the basis of making judgments
about the carrying values of assets and liabilities that are not readily apparent from other
sources. Actual results may differ from these estimates under different assumptions or conditions
and the differences could be material.
We believe the following critical accounting policies, among others, affect our more significant
judgments and estimates used in the preparation of our financial statements:
Allowance for Doubtful Accounts
. We maintain allowances for doubtful accounts for estimated
losses resulting from the inability of our customers to make required payments. The allowance for
doubtful accounts is based on
30
specific identification of customer accounts and our best estimate of the likelihood of
potential loss, taking into account such factors as the financial condition and payment history of
major customers. We evaluate the collectibility of our receivables at least quarterly. If the
financial condition of our customers were to deteriorate, resulting in an impairment of their
ability to make payments, additional allowances may be required. The differences could be material
and could significantly impact cash flows from operating activities.
Inventories
. JPI records inventories at the lower of weighted average cost or net realizable
value. Major components of inventories are raw materials, packaging materials, direct labor and
production overhead. AMDLs inventories consist primarily of raw materials and related materials,
and are stated at the lower of cost or market with cost determined on a first-in, first-out
(FIFO) basis. The Company regularly monitors inventories for excess or obsolete items and makes
any valuation corrections when such adjustments are needed. Once established, write-downs are
considered permanent adjustments to the cost basis of the obsolete or excess inventories.
We write down our inventories for estimated obsolescence or unmarketable inventory equal to
the difference between the cost of inventories and the estimated market value based upon
assumptions about future demand, future pricing and market conditions. If actual future demand,
future pricing or market conditions are less favorable than those projected by management,
additional write-downs may be required and the differences could be material. Such differences
might significantly impact cash flows from operating activities.
Sales Allowances.
A portion of our business is to sell products to distributors who resell
the products to end customers. In certain instances, these distributors obtain discounts based on
the contractual terms of these arrangements. Sales discounts are usually based upon the volume of
purchases or by reference to a specific price in the related distribution agreement. We recognize
the amount of these discounts at the time the sale is recognized. Additionally, sales returns
allowances are estimated based on historical return data, and recorded at the time of sale. If the
quality or efficacy of our products deteriorates or market conditions otherwise change, actual
discounts and returns could be significantly higher than estimated, resulting in potentially
material differences in cash flows from operating activities.
Valuation of Intangible Assets
. In accordance with Statement of Financial Accounting
Standards (SFAS) No. 144,
Accounting for the Impairment or Disposal of Long-Lived Assets
, the
Company evaluates the carrying value of its long-lived assets for impairment whenever events or
changes in circumstances indicate that such carrying values may not be recoverable. The Company
uses its best judgment based on the current facts and circumstances relating to its business when
determining whether any significant impairment factors exist.
The Company considers the following factors or conditions, among others, that could indicate the
need for an impairment review:
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significant under performance relative to expected historical or projected future
operating results;
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market projections for cancer research technology;
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its ability to obtain patents, including continuation patents, on technology;
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significant changes in its strategic business objectives and utilization of the assets;
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significant negative industry or economic trends, including legal factors;
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potential for strategic partnerships for the development of its patented technology;
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changing or implementation of rules regarding manufacture or sale of pharmaceuticals in
China; and
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ability to maintain Good Manufacturing Process (GMP) certifications.
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If the Company determines that the carrying values of long-lived assets may not be recoverable
based upon the existence of one or more of the above indicators of impairment, the Companys
management performs an undiscounted cash flow analysis to determine if impairment exists. If
impairment exists, the Company measures the
31
impairment based on the difference between the assets carrying amount and its fair value, and the
impairment is charged to operations in the period in which the long-lived asset impairment is
determined by management. Based on its analysis, the Company believes that no indicators of
impairment of the carrying value of its long-lived assets existed at September 30, 2007. There can
be no assurance, however, that market conditions will not change or demand for the Companys
products will continue or allow the Company to realize the value of its technologies and prevent
future long-lived asset impairment
Revenue Recognition.
The Company generates revenues from wholesale sales of over-the-counter
and prescription pharmaceuticals, and the direct distribution of pharmaceutical products through
retail outlets known as Jade Healthy Supermarkets.
The Company recognizes revenue in accordance with the Securities and Exchange Commissions (SEC)
Staff Accounting Bulletin (SAB) No. 101,
Revenue Recognition in Financial Statements
, as amended
by SAB No. 104. Accordingly, revenue is recognized when all of the following criteria are met: (1)
persuasive evidence of an arrangement exists, (2) delivery has occurred or services have been
rendered, (3) the sellers price to the buyer is fixed and determinable, and (4) collectibility is
reasonably assured.
Wholesale Sales.
Revenues from the wholesale sales of over-the counter and prescription
pharmaceuticals are recognized when title and risk of loss have passed to the buyer and provided
the criteria in SAB No. 101 are met. Buyers generally have limited rights of return, and the
Company provides for estimated returns at the time of sale based on historical experience. Returns
from customers historically have not been material. Actual returns and claims in any future period
may differ from the Companys estimates.
Direct Distribution.
Commencing in July 2007, JPI began direct distribution of pharmaceutical
products through the Jade Healthy Supermarkets. The Jade Healthy Supermarkets are small retail
stores operated by independent third parties who sell JJBs products at retail to consumers.
Pursuant to these arrangements, JJB receives a one-time, non-refundable up front fee from the
operator of the retail stores. As of November 15, 2007 there were eight Retail Stores in
operation. JJB received a one-time, non-refundable up front fee from each of the sub-operators of
the Retail Stores. JJB provided leasehold improvements and equipment to the sub-operators in the
establishment of the Retail Stores. JJB consigns inventories to the operators of the Retail Stores
for sale to consumers. As a result, the sub-operators do not take ownership of the inventories at
their stores until the products are sold to the consumer. Revenues from the sale of JJBs products
at the Retail Store level will be recognized by the Company at the time products are sold by the
Retail Stores.
During the three months ended June 30, 2007, the Company received $314,762 in upfront fees
from store operators. The Company deferred recognition of these up front, non-refundable fees
until the retail stores were opened, at which time the Company has no further obligations to the
store operator. At September 30, 2007, all retail stores were opened, and accordingly, the Company
amortized the up front fees received and expensed commissions paid to Shanghai XiangEn for finding
sub-operators as revenues in the accompanying condensed consolidated Statements of Operations and
Comprehensive Income (Loss).
In accordance with Emerging Issues Task Force (EITF) Issue No. 06-3,
How Taxes Collected
from Customers and Remitted to Governmental Authorities Should Be Presented in the Income Statement
(That Is, Gross Versus Net Presentation)
, JPIs revenues are reported net of value added taxes
(VAT) collected.
Deferred Taxes
. We record a valuation allowance to reduce the deferred tax assets to the
amount that is more likely than not to be realized. We have considered estimated future taxable
income and ongoing tax planning strategies in assessing the amount needed for the valuation
allowance. Based on these estimates, all of our deferred tax assets have been reserved. If actual
results differ favorably from those estimates used, we may be able to realize all or part of our
net deferred tax assets. Such realization could positively impact our operating results and cash
flows from operating activities.
32
Litigation
. We account for litigation losses in accordance with SFAS No. 5,
Accounting for
Contingencies
. Under SFAS No. 5, loss contingency provisions are recorded for probable losses at
managements best estimate of a loss, or when a best estimate cannot be made, a minimum loss
contingency amount is recorded. These estimates are often initially developed substantially earlier
than the ultimate loss is known, and the estimates are refined each accounting period, as
additional information is known. Accordingly, we are often initially unable to develop a best
estimate of loss; therefore, the minimum amount, which could be zero, is recorded. As information
becomes known, either the minimum loss amount is increased or a best estimate can be made,
resulting in additional loss provisions. Occasionally, a best estimate amount is changed to a lower
amount when events result in an expectation of a more favorable outcome than previously expected.
Due to the nature of current litigation matters, the factors that could lead to changes in loss
reserves might change quickly and the range of actual losses could be significant, which could
materially impact our results of operations and cash flows from operating activities.
Stock-Based Compensation.
All issuances of the Companys common stock for non-cash
consideration have been assigned a per share amount equaling either the market value of the shares
issued or the value of consideration received, whichever is more readily determinable. The majority
of non-cash consideration received pertains to services rendered by consultants and others and has
been valued at the market value of the shares on the measurement date.
The Company accounts for equity instruments issued to consultants and vendors in exchange for
services in accordance with the provisions of Emerging Issues Task Force (EITF) Issue No. 96-18,
Accounting for Equity Instruments that are Issued to Other than Employees for Acquiring, or in
Conjunction with Selling Goods or Services,
and EITF Issue No. 00-18,
Accounting Recognition for
Certain Transactions Involving Equity Instruments Granted to Other than Employees.
The measurement
date for the fair value of the equity instruments issued is determined at the earlier of (i) the
date at which a commitment for performance by the consultant or vendor is reached or (ii) the date
at which the consultant or vendors performance is complete. In the case of equity instruments
issued to consultants, the fair value of the equity instrument is recognized over the term of the
consulting agreement.
In accordance with EITF Issue No. 00-18, an asset acquired in exchange for the issuance of fully
vested, non-forfeitable equity instruments should not be presented or classified as an offset to
equity on the grantors balance sheet once the equity instrument is granted for accounting
purposes. Accordingly, the Company records the fair value of the fully vested, non-forfeitable
common stock issued for future consulting services as prepaid expenses in its consolidated balance
sheet.
At September 30, 2007, the Company had five stock based compensation plans.
On January 1, 2006, the Company adopted SFAS No. 123 (revised 2004),
Share-Based Payment
(SFAS No.
123(R)), which establishes standards for the accounting of transactions in which an entity
exchanges its equity instruments for goods or services, primarily focusing on accounting for
transactions where an entity obtain employee services in share-based payments transactions. SFAS
No. 123(R) requires a public entity to measure the cost of employee services received in exchange
for an award of equity instruments, including stock options, based on the grant-date fair value of
the award and to recognize it as compensation expense over the period the employee is required to
provide service in exchange for the award, usually the besting period. SFAS No. 123(R) supersedes
the Companys previous accounting under Accounting Principles Board Opinion (APB) No. 25,
Accounting for Stock Issued to Employees
, for periods beginning in fiscal 2006. In March 2005, the
Securities and Exchange Commission issued Staff Accounting Bulletin (SAB) No. 107 relating to
SFAS No. 123(R). The Company has applied the provisions of SAB No. 107 in its adoption of SFAS No.
123(R).
The Company adopted SFAS No. 123(R) using the modified prospective transition method, which
required the application of the accounting standard as of January 1, 2006, the first day of the
Companys fiscal year 2006. The Companys consolidated financial statements for the three and nine
months ended September 30, 2007 and 2006 reflect the impact of SFAS No. 123(R).
33
Stock-based compensation expense recognized during the period is based on the value of the portion
of share-based payment awards that is ultimately expected to vest during the period. Stock-based
compensation expense recognized in the Companys consolidated statements of operations for the
three and nine months ended September 30, 2007 and 2006 included compensation expense for
share-based payment awards granted prior to, but not yet vested as of December 31, 2005 based on
the grant date fair value estimated in accordance with the pro forma provision of SFAS No. 123,
Accounting for Stock-Based Compensation
and compensation expense for the share-based payment awards
granted subsequent to December 31, 2005 based on the grant-date fair value estimated in accordance
with the provisions of SFAS No. 123(R). As stock-based compensation expense recognized in the
consolidated statement operations for the nine months ended September 30, 2007 is based on awards
ultimately expected to vest, it has been reduced for estimated forfeitures. SFAS No. 123(R)
requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent
periods if actual forfeitures differ form those estimates. The
estimated forfeiture rate for the periods ended September 30,
2007 and 2006 was 0% since options generally vest immediately upon
grant.
Results of Operations
Three Months Ended September 30, 2007 Compared to Three Months Ended September 30, 2006
The results of operations for the three months ended September 30, 2007 and 2006 are not comparable
due to the acquisition of JPI on September 28, 2006. JPIs results of operations have been
included in the Companys consolidated results since the date of acquisition.
Net Revenues
. During the three months ended September 30, 2007, the Company generated aggregate
net revenues of $5,769,292 from product sales and $39,084 from the amortization of up front fees,
of which JPI contributed $5,736,192 from product sales and $39,084 from the amortization of up
front fees and AMDL contributed product sales of $33,100.
For the nine months ended September 30, 2007, JPI generated revenues of approximately $171,000 from
the sales of medical and healthy products which were purchased from a third party in Hong Kong and
resold within that region.
During the three months ended September 30, 2007, the Company generated $33,100 from product sales
compared to revenues from product sales for the three months ended September 30, 2006 of $21,500.
The primary reasons for this increase are an increase in the sales price of DR-70
®
,
along with an increase in sales. Management expects that DR-70
®
revenues will remain at
a similar level until either FDA and/or SFDA grants approval of its DR-70
®
kit. No
significant revenues in China are expected from sales of DR-70
®
in the remainder of
2007.
Market acceptance of our DR-70
®
kits has been slower than originally anticipated, in
part due to the fact that the DR-70
®
kit has not yet received FDA approval. Under FDA
rules, the Company is not permitted to market and promote DR-70
®
while the test is
undergoing the FDA submission and review process. In addition, the Company has not consummated any
material new distribution agreements.
During the balance of 2007, we expect sales of OEM products to be at the same level as experienced
for the nine months ended September 30, 2007. JPI is expected to increase its revenues in the
fourth quarter of 2007 due to the continued overall strength of the Chinese economy together with
increases in sales under the recently signed distribution agreements, opening of the Jade Health
Supermarkets and the launching of a new a new anti-aging and skin care injectible product under the
brand name Goodnak. This initial product is the first in a new line of anti-aging & skin care
products currently under development by JJB. Goodnak is a high quality injectible anti-aging and
skin care product that contains an amalgam of various therapeutic elements including human
placental histosolution. JPI has begun selling Goodnak, in August, through wholesale distribution
channels that service high-end beauty salon and plastic surgery hospitals and or medical
cosmetology institutions.
These statements concerning future sales are forward-looking statements that involve certain risks
and uncertainties which could result in a fluctuation of sales above or below those achieved for
the three months ended September 30, 2007 in each category. Sales could also be negatively impacted by
potential competing products and overall market acceptance of the Companys products, both in the
U.S. and China.
34
Research and Development.
Research and development expenses primarily related to DR-70
®
for the three months ended September 30, 2007 were $2,407 compared to $162,894 for the three months
ended September 30, 2006. This decrease was due to less involvement by outside consultants in
preparation for the next FDA submission.
General
and Administrative Expenses
. General and administrative expenses
increased to $3,090,059
from $819,263 for the three months ended September 30, 2007 and 2006, respectively. JPI incurred
$1,085,366 of these general and administrative expenses for the three months ended September 30,
2007. In addition, AMDL incurred more than $1 million additional general and administrative
expenses for (i) consulting and investor relations services; and (ii) the non-cash expenses of the
fair value of options granted as computed under the Black-Scholes model.
Nine Months Ended September 30, 2007 Compared to Nine Months Ended September 30, 2006
The results of operations for the nine months ended September 30, 2007 and 2006 are not comparable
due to the acquisition of JPI on September 28, 2006. JPIs results of operations have been
included in the Companys consolidated results since the date of acquisition.
Net Revenues
. During the nine months ended September 30, 2007, the Company generated aggregate net
revenues of $9,606,972 from product sales and $39,084 from the amortization of up front fees.
Corporate
Net revenues for AMDL were $93,700 for the nine months ended September 30, 2007 compared to
$54,105 for the same period in 2006. The approximate $40,000 increase in revenues for AMDL
products was due to an increase in price charged for DR-70
®
products and a modest
increase in sales of both OEM products and DR-70
®
. During the remainder of 2007, we
expect sales of OEM products to be at the same level as experienced in the third quarter of 2007.
Even, assuming FDA approval of DR-70
®
sometime in late 2007, we expect sales of
DR-70
®
to be low, and any increase in sales is not expected to impact significantly our
operating results for 2007.
Sales of OEM products in the remainder of 2007 could be negatively impacted by potential
competing products and overall market acceptance of the Companys products
.
The statements
concerning future sales of DR-70
®
and OEM products are a forward-looking statement that
involves certain risks and uncertainties which could result in a fluctuation of sales below those
achieved for the year ended December 31, 2006. The continued low level of DR-70
®
and
OEM product sales is disappointing to management of the Company. Our existing distributors have
not been effective and no new distributors were engaged during the nine months ended September 30,
2007. Market acceptance of our DR-70(R) kits has been slower than originally anticipated, in part
due to the fact that the DR-70(R) kit has not yet received FDA approval.
In addition, the Company has not concluded any material new distribution agreements this year
as new potential distributors have experienced similar delays and face similar market acceptance
issues because of the lack of FDA approval.
China-Wholesale
China-Wholesales net revenues was $9,513,271 for
the nine months ended September 30, 2007.
Revenue for the three months ended September 30, 2007 increased by $3,408,225 over the three
months ended June 30, 2007 due in part to increased sales due to new distribution agreements, new
products and an overall increase in utilization of distribution channels established in previous
periods.
Consistent with the quarter ended June 30, 2007, Domperidonen tablets comprised a large
percentage of sales for the three months ended September 30, 2007. The sale of Domperidonen
tablets comprised approximately 29% of
China-Direct
Distribution
The
Company received $314,762 in up-front fees from sub-operators of the
Jade Healthy Supermarkets. The Company deferred recognition of these
fees until opening of these stores. Net revenue was $39,084 of
amortized up-front fees for the nine months ended September 30,
2007.
35
sales for the quarter ended September 30, 2007 compared to approximately 58% of sales for the
three months ended June 30, 2007.
Due to the launching of Goodnak, JPIs new anti-aging and skin care injectible product, the
sales of Human Placenta Tissue injection has increase from 3.8% of sales for the six months ended
June 30, 2007 to 30.55% of sales for the three months ended September 30, 2007.
JPIs top five selling products for the three months ended September 30, 2007 were:
|
|
|
|
|
|
|
Percent of
|
Name
|
|
Total JPI Sales
|
|
Human Placenta Tissue Injections
|
|
|
30.55
|
%
|
Domperidone
|
|
|
28.58
|
%
|
Diavitamin, Calcium Hydrogen Phosphate and Lysince Tablets
|
|
|
9.01
|
%
|
Levofloxacin Lactate and Sodium Chloride Injection
|
|
|
5.53
|
%
|
GS and GNS
|
|
|
8.55
|
%
|
|
|
|
|
|
|
|
|
82.22
|
%
|
|
|
|
|
|
JPI experienced decreases in sales of Gu Yan Lind, Compound Benzoic Acid and Camphor and Iodine
Solutions. The lower sales of Compound Benzoic Acid and Camphor and Iodine Solutions were due to
delays in the renewal of the GMP license application while the temporary prohibition in the sale of
Yuxingcao continues from the second quarter of 2006.
Sales in the third quarter 2007 were favorably impacted by the new distribution agreements
executed during the second and third quarters of 2007.
Gross Profit.
The Companys gross profit for the nine months ended September 30, 2007 was
$5,460,005 or approximately 57%, $5,383,583 of which was contributed by JP. AMDLs gross profit
for the nine months ended September 30, 2007 was $76,422, as compared to gross profit of $32,645
for the nine months ended September 30, 2006, all of which was contributed by AMDL.
Corporate
Gross
profit increased in aggregate dollars approximately $44,000 for the nine months ended September
30, 2006 as compared to the nine months ended September 30, 2006 due to increased sales and a per unit price increase of OEM products and
DR-70
®
.
China-Wholesale
China-Wholesales
gross profit for the nine months ended September 30, 2007 was
$5,344,500. The major
components of cost of sales include raw materials, salary and production overhead. Production
overhead is comprised of depreciation of manufacturing equipment, utilities and repairs and
maintenance. China-Wholesales gross profit for the nine months ended September 30, 2007 was positively
impacted by increased production efficiencies and manufacturing of products with higher margins.
There was an overall increase in the gross profit from approximately 48% for the six months ended
June 30, 2007 to approximately 56% for the nine month period ended September 30, 2007. This
increase is primarily due to the production and sale of Human Placenta Tissue injection which has a
gross profit margin of approximately 83%.
Management
anticipates future gross profit margins for China Wholesale to remain at the same level for the
year ending December 31, 2007. The statement concerning future gross profit margins is a
forward-looking statement that involves certain risks and uncertainties which could result in a
fluctuation of gross margins below those achieved for the year ending December 31, 2007. Gross
profit could be negatively impacted by potential competing products and overall market acceptance
of the Companys products.
China-Direct
Distribution
China-Direct
Distributions revenues and gross profit for the nine months ended
September 30, 2007 was $39,084.
36
Research and Development.
Research and development expense for the Company for the nine months
ended September 30, 2007 was $15,534 compared to $282,139 for the same period in 2006. This decrease was due to less involvement by outside consultants in preparation for the next FDA submission.
Corporate
All research and development costs incurred during the nine months ended September 30, 2007
was almost entirely incurred by AMDL. These costs comprised of funding the necessary research and
development of the DR-70
®
test kit for the FDA as well as funding the application and
research needed to receive approval from the SFDA for marketing the DR-70
®
test kit in
China.
China-Wholesale
and China-Direct Distribution
JPI currently performs all of its own research and development activities on new products at
their own facilities, but only a nominal amount of research and development was conducted during
the nine month period ended September 30, 2007 by JPI.
Selling,
General and Administrative Expenses
. General and administrative expenses for the Company were
$8,330,604 for the nine months ended September 30, 2007 as compared to $2,340,319 for the same
period in 2006, an increase of about 260%, most of which relates to the items set forth in the
table below.
Corporate
We
incurred selling, general and administrative expenses of $6,161,612 primarily consisting of
consulting (including financial consulting) and legal expenses, director and commitment fees,
regulatory compliance, professional fees related to patent protection, payroll, payroll taxes,
investor and public relations, professional fees, and stock exchange and shareholder services
expenses. Also included in selling, general and administrative expenses were non-cash expenses incurred
during the nine months ended September 30, 2007 of approximately
$1,750,000 for common stock,
options and warrants issued to consultants for services and
approximately $1,575,000 for options
issued to employees and directors.
|
|
|
|
|
|
|
Nine months ended
|
|
|
September 30,
|
|
|
2007
|
Investor relations (including value of warrants/options)
|
|
$
|
1,789,668
|
|
Salary and wages (including value of options)
|
|
$
|
2,025,126
|
|
Directors fees (including value of options)
|
|
$
|
826,859
|
|
Consulting fees
|
|
$
|
220,654
|
|
Accounting and other professional fees
|
|
$
|
329,000
|
|
Legal
|
|
$
|
216,871
|
|
China-Wholesale
China-Wholesale
incurred selling, general and administrative expenses of $2,169,971 for the nine months ended
September 30, 2007. Major components were depreciation and amortization, payroll and related
taxes, transportation charges, meals and entertainment and insurance.
China-Direct
Distribution
China-Direct
Distribution did not incur selling, general and administrative
expenses during the nine months ended September 30, 2007.
There was a general increase in the general and administrative expenses for the nine months
ended September 30, 2007 due in part to additional travel required through out China to establish
and promote China-Wholesales existing business and China-direct distribution Jade Healthy Supermarkets and increase in
administrative staff.
Net Loss.
As a result of the above, in the nine months ended September 30, 2007, the Companys net
loss was $3,266,603 or $(0.24) per share as compared to a net loss of $2,567,324 or $(0.38) per
share for the period ended September 30, 2006.
37
Item 3A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
As required by Rule 13a-15 under the Securities Exchange Act of 1934, as amended (the Exchange
Act), we carried out an evaluation under the supervision and with the participation of our
management, including the Chief Executive Officer and President, our Executive Vice President, and
the Secretary and Chief Financial Officer, of the effectiveness of the design and operation of our
disclosure controls and procedures as of September 30, 2007. There are inherent limitations to the
effectiveness of any system of disclosure controls and procedures, including the possibility of
human error and the circumvention or overriding of the controls and procedures. Accordingly, even
effective disclosure controls and procedures can only provide reasonable assurance of achieving
their control objectives. Based upon our evaluation, our Chief Executive Officer and President and
our Secretary and Chief Financial Officer have concluded that, as of September 30, 2007, our
disclosure controls and procedures were not effective to provide reasonable assurance that information
required to be disclosed in the reports that we file or submit under the Exchange Act were recorded,
processed, summarized and reported for the quarter ended September 30, 2007 within the time periods specified in the applicable rules and
forms, and that it was accumulated and communicated to our management, including our Chief Executive
Officer and President, Executive Vice President, and Secretary and Chief Financial Officer, as
appropriate, to allow timely decisions regarding required disclosure.
In the course of continuing our review of the effectiveness of our internal controls of our
financial reporting at September 30, 2007, we identified the following issues that individually or
aggregately may materially affect our internal controls of financial reporting:
|
|
|
The Company did not maintain effective internal control over financial reporting
relating to accurate recording and presentation of certain routine and non-routine
accounting transactions in accordance with GAAP; and
|
|
|
|
|
The Company did not have adequate controls to properly determine and account for (i) the
contractual arrangements with Shenzhen JieKang Technologies Ltd., or (ii) our business
arrangement with Shanghai XiangEn Food Company Ltd. relating to the Retail Stores.
|
In order to remediate these issues, we hired an accounting manager for Chinese operations who is
familiar with GAAP and who reports to our Chief Financial Officer. We have instituted additional
procedures for future accounting periods that will cause the transactions in China to be reported
on a more timely basis and we will continue to ensure that these transactions are recorded in
accordance with GAAP prior to consolidation. We will continue our efforts to improve or modify our
procedures and controls to provide reasonable assurance with respect to the accurate reporting of
transactions and presentation of our financial disclosures.
Notwithstanding the material weaknesses discussed above, our management has concluded that the
consolidated financial statements included in this Quarterly Report on Form 10-QSB fairly present
in all material respects the Companys financial condition, results in operations and cash flows
for the period ended September 30, 2007 in conformity with accounting principles generally accepted
in the United States of America.
Changes in Internal Controls
Except as set forth above, there has been no change in our internal control over financial reporting during the quarter ended
September 30, 2007 that has materially affected, or is reasonably likely to materially affect, our
internal control over financial reporting.
38
PART II OTHER INFORMATION
Item 1. Legal Proceedings.
Inapplicable.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
On March 2, 2007, the Board of Directors authorized the issuance of 150,000 shares of common stock
to First International Capital Group, Ltd. pursuant to an amendment to the consulting agreement
dated July 22, 2005, which also extended the term of the consulting agreement through September 22,
2007. The shares were valued at $517,500 based on the adjusted trading price of the common stock
on the date of issuance. $517,500 was expensed for the nine month period ended September 30, 2007.
The shares were issued pursuant to an exemption under Section 4(2) of the Securities Act. No
underwriter was involved in this issuance.
Also on March 2, 2007, the Board of Directors authorized the issuance of 190,000 shares of common
stock to Boston Financial Partners pursuant to an amendment to the consulting agreement dated
September 16, 2003, which also extended the term of the consulting agreement through September 1,
2007. The shares were valued at $558,600 based on the adjusted trading price of the common stock
on that date. $558,600 was expensed for the nine month period ended September 30, 2007. The shares
were issued pursuant to an exemption under Section 4(2) of the Securities Act. No underwriter was
involved in this issuance.
On September 14, 2007, the Board of Directors authorized the issuance of 250,000 shares of common
stock to First International Capital Group, Ltd. pursuant to an amendment to the consulting
agreement dated July 22, 2005, for financial advisory services to be provided from September 22,
2007 through September 22, 2008. The shares were valued at $817,500 based on the trading price of
the common stock on the date of issuance. During the nine months ended September 30, 2007, the
Company recorded general and administrative expense of $20,438 related to the agreement and the
balance of $797,063 is included in prepaid consulting at September 30, 2007.
Between April 14, 2007 and June 7, 2007, the Company conducted a combined private placement
offering under Regulation D and Regulation S of the Securities Act of 1933, as amended (April 2007
Offering). On May 4, 2007, in connection with the first closing of the April 2007 Offering, the
Company issued 1,443,620 shares of common stock to investors, which generated gross proceeds of
approximately $3,789,000. The shares were sold at $2.625 per share, representing a discount of 25%
from the average of the closing prices for the five consecutive trading days prior to the second
day prior to the first closing date. The investors in the offering also received warrants to
purchase an aggregate of 721,810 shares of common stock. The warrants are exercisable at $3.68 per
share, a price equal to 115% of the average closing price of the Companys common stock, as
reported by the American Stock Exchange, for the five (5) consecutive trading days immediately
prior to the second trading day prior to the closing date. Each warrant became exercisable on
October 31, 2007 and remains exercisable until October 31, 2010. The shares were issued pursuant to
an exemption under Section 4(2) of the Securities Act.
On June 7, 2007, the Company conducted the second closing of the April 2007 Offering. The Company
received approximately $1,540,900 in aggregate gross proceeds, exclusive of placement agent fees
and expenses of approximately $200,400 from the sale of a total of 587,000 shares. The shares in
the second closing were also sold at a price of $2.625 per share and the investors received three
year warrants to purchase an additional 293,500 shares, which warrants are exercisable at $3.86 per
share. Warrants to purchase an additional 58,700 shares were also issued to the placement agents at
the same exercise price.
In connection with the April 2007 Offering, we utilized the services of Galileo Asset Management,
S.A. (Galileo), a Swiss corporation for sales to non-U.S. persons, and Securities Network, LLC
(Network), a NASD member broker-dealer as our placement agent for sales in the United States.
For their services, Galileo and Network received commissions in an aggregate of approximately
$533,000 and warrants to purchase an aggregate of 203,062 shares of the Companys common stock. We
also paid Galileo approximately $160,000 as a three percent (3%) non-accountable expense allowance
in connection with the April 2007 Offering and the Company has also agreed to pay a six percent
(6%) cash commission upon exercise of the Warrants by the purchasers. In addition, the Company
39
incurred additional legal and other costs totaling approximately $64,000 in connection with the
Offering. The Company charged all of these cash costs to additional paid-in capital, since the
investment was treated as a purchase of shares of common stock. Total costs associated with the
sale of stock were $756,674.
We filed a registration statement with the Securities and Exchange Commission to register the
shares of the Companys common stock, shares issuable upon exercise of the related investor
warrants, and shares issuable upon exercise of the warrants issued in the April 2007 Offering,
which registration statement became effective on June 29, 2007.
Item 3. Defaults Upon Senior Securities.
Inapplicable.
Item 4. Submission of Matters to a Vote of Security Holders.
At the Special in Lieu of Annual Meeting of our stockholders, held September 7, 2007, the
stockholders voted on numerous proposals. All votes described below were with respect to
pre-reverse split shares of our common stock
At the meeting, the stockholders elected four directors to serve for one year terms or until their
successors are duly elected and qualify as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares Withheld
|
Nominee/Director
|
|
Shares for
|
|
from Voting
|
William M. Thompson
|
|
|
10,092,618
|
|
|
|
283,085
|
|
Gary L. Dreher
|
|
|
10,112,190
|
|
|
|
263,513
|
|
Edward R. Arquilla
|
|
|
10,204,032
|
|
|
|
171,671
|
|
Douglas C. MacLellan
|
|
|
10,013,473
|
|
|
|
362,230
|
|
Minghui Jia
|
|
|
10,184,760
|
|
|
|
490,493
|
|
The stockholders approved the proposal to authorize the issuance of up to 5,000,000 shares of
common stock below current market prices by a vote of 6,714,492 shares in favor, 435,059 shares
against and 27,135 shares abstained from voting.
The stockholders approved the proposal for the adoption of the 2007 Equity Incentive Plan by a vote
of 6,608,118 shares in favor, 528,001 shares against and 40,568 shares abstained from voting.
Item 5. Other Information.
On August 10, 2007, the Company entered into an Amendment No. 1 to the Escrow Agreement with Jade
Capital Group Limited (Jade), which amendment extend the date from September 28, 2007 to March
28, 2008 on which Chinese SFDA approval for DR-70
®
must be obtained in order to not have
the 100,000 shares of common stock which are held in escrow be cancelled. The Company believed
that there were unanticipated events at the SFDA which warranted the extension.
On October 3, 2007, AMDL, Inc. obtained products liability insurance coverage for Jade
Pharmaceutical Inc.s (JPI) pharmaceutical manufacturing and distribution activities in China
from PICC Property and Casualty Company Limited in the aggregate amount of US $2,000,000 at a cost
of approximately US $65,500 for one year of coverage. The policy was retroactive to October 1,
2006, the date of first operations after the acquisition of JPI and provides that AMDL/JPI shall
retain and indemnify the insurance carrier for liability of US $ 10,000 per claim up to an
aggregate of $50,000 in any year. The prior US based products liability insurance policy provided
for aggregate coverage of US $ 2 million. No carrier contacted by JPI was willing to provide
greater coverage at this time.
40
AMDL believes that the new products liability insurance is adequate for its current needs, but
there can be no assurance, however, that claims from the use of JPIs products would not exceed the
available coverage, or that one or more claims for damages may require the expenditure of
significant funds in defense of such claims. Moreover, one or more substantial awards of damages
against JPI or AMDL could have a material adverse effect on JPI and AMDL by reason of the inability
to defend against or pay such claims, although to date neither AMDL or JPI has received any claim
for damages for the manufacture or use of any of their products by any company or individual.
On November 13, 2007, the Company received a memorandum of review issues from the United States
Food and Drug Administration (US FDA) which addresses the pending application for 510(k) approval
of DR-70
®
as an aid in monitoring the disease status in patients who have been previously diagnosed
with colorectal cancer. Unlike prior communications from the US FDA, the US FDA did not raise the
issue of whether the Companys test was substantially equivalent to the existing predicate test,
CEA. The memorandum includes, among other things, requests for clarification of the intended use
statement and clinical outcome measures.
The US FDA requested a response to the comments within 30 days, but also indicated a
request for more time could be made. The Company is analyzing the comments and has not yet
determined whether it can supply the requested information within the next 30 days. While the
Company is optimistic about its ability to perform the studies requested, until the requested
studies are re-run, the Company is unable to assess what the probable response of the FDA will be
to the new documentation, and no assurances can be given that the Company will ever receive FDA
clearance for the commercial sale of DR-70
®
in the United States.
Item 6. Exhibits.
|
10.44
|
|
Amendment No. 1 to Escrow Agreement dated August 10, 2007 between the Company
and Jade Capital Group Limited, et al.
|
|
|
31.1
|
|
Rule 13a-14(a)/15d-14(a) Certification of Chief Executive Officer
|
|
|
31.2
|
|
Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer
|
|
|
32.1
|
|
Certification Pursuant to 18 U.S.C. § 1350 of Chief Executive Officer
|
|
|
32.2
|
|
Certification Pursuant to 18 U.S.C. § 1350 of Chief Financial Officer
|
41
SIGNATURES
In accordance with the requirements of the Exchange Act, the Registrant caused this report to be
signed on its behalf by the undersigned, thereunto duly authorized.
|
|
|
|
|
|
AMDL, Inc.
|
|
Dated: November 19, 2007
|
By:
|
/s/ Gary L. Dreher
|
|
|
|
GARY L. DREHER, Chief Executive Officer
|
|
|
|
|
|
42
EXHIBIT INDEX
|
|
|
Exhibit No.
|
|
Description
|
10.44
|
|
Amendment No. 1 to Escrow Agreement dated August 10, 2007 between
the Company and Jade Capital Group Limited, et al.
|
|
|
|
31.1
|
|
Rule 13a-14(a)/15d-14(a) Certification of Chief Executive Officer
|
|
|
|
31.2
|
|
Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer
|
|
|
|
32.1
|
|
Certification Pursuant to 18 U.S.C. §1350 of Chief Executive Officer
|
|
|
|
32.2
|
|
Certification Pursuant to 18 U.S.C. §1350 of Chief Financial Officer
|
43
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