U. S. SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
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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 March 31, 2009.
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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: 001-16695
AMDL, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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33-0413161
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(State of Incorporation)
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(I.R.S. employer identification no.)
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2492 Walnut Avenue, Suite 100
Tustin, California
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92780-7039
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(Address of principal executive offices)
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(Zip Code)
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Registrants telephone number, including area code: (714) 505-4460
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or 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.
þ
Yes
o
No
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post
such files).
o
Yes
o
No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer or a smaller reporting company. See definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
Large accelerated filer
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Accelerated filer
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Non-accelerated filer
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(Do not check if a smaller reporting company)
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Smaller Reporting company
þ
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
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Yes
þ
No
The number
of outstanding shares of the registrants common stock on
May 14
th
, 2009 was 17,383,574.
AMDL, INC.
INDEX TO FORM 10-Q
i
PART 1 FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
AMDL, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
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March 31,
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December 31,
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2009
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2008
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(Unaudted)
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(Audited)
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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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3,290,229
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$
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2,287,283
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Accounts receivable, net
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10,081,366
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13,575,534
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Inventories
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2,133,160
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1,563,991
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Prepaid expenses and other current assets
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1,837,870
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1,006,960
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Current assets of discontinued operations
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1,372,309
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1,435,021
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Total current assets
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18,714,934
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19,868,789
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Property and equipment, net
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11,910,852
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11,709,508
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Intangible assets, net
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5,184,491
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5,311,568
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Other assets
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4,212,911
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4,072,432
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Non-current assets of discontinued operations
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1,780,046
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1,789,934
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Total assets
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$
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41,803,234
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$
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42,752,231
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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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1,770,114
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$
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1,675,539
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Accrued salaries and wages
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990,601
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822,201
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Income taxes payable
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91,751
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472,860
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Deferred revenue
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43,824
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87,538
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Current portion of notes payable
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2,666,009
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2,662,610
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Current liabilities of discontinued operations
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930,719
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1,151,515
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Total current liabilities
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6,493,018
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6,872,263
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Other long-term liabilities
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362,138
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353,811
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Notes payable, net of current portion and debt discount
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874,147
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581,305
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Total liabilities
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7,729,303
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7,807,379
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Commitments and contingencies
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Stockholders equity:
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Preferred stock, $0.001 par value; 25,000,000
shares authorized; none issued and outstanding
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Common stock, $0.001 par value; 100,000,000 shares
authorized; 17,383,574 and 16,006,074 shares
issued at March 31, 2009 and December 31, 2008,
respectively; 15,931,906 and 15,826,074 shares
outstanding at March 31, 2009 and December 31,
2008, respectively
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15,932
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15,826
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Additional paid-in capital
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68,859,186
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68,192,411
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Accumulated other comprehensive income
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2,485,883
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2,443,452
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Accumulated deficit
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(37,287,070
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)
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(35,706,837
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Total stockholders equity
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34,073,931
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34,944,852
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Total liabilities and stockholders equity
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$
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41,803,234
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$
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42,752,231
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See accompanying notes to unaudited condensed consolidated financial statements.
1
AMDL, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
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Three Months Ended March 31,
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2009
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2008
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Net revenues
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$
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2,711,737
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$
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2,941,193
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Cost of sales
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1,585,573
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1,517,541
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Gross profit
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1,126,164
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1,423,652
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Operating expenses:
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Research and development
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92,684
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8,695
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Selling, general and administrative
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2,590,769
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2,797,947
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2,683,453
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2,806,642
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Loss from operations
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(1,557,289
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(1,382,990
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Other expense:
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Interest expense
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(234,217
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(84,521
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Other expense, net
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(36,109
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(61,964
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Total other expense, net
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(270,326
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(146,485
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Loss before provision for income taxes and discontinued operations
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(1,827,615
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(1,529,475
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Provision for income taxes
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110,502
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149,062
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Loss before discontinued operations
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(1,938,117
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(1,678,537
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Income from discontinued operations, net
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247,026
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206,341
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Net loss
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(1,691,091
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(1,472,196
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Other comprehensive income:
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Foreign currency translation gain
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42,431
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783,432
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Comprehensive loss
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$
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(1,648,660
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$
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(688,764
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Basic and diluted income (loss) per common share:
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Loss before discontinued operations
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$
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(0.12
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$
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(0.11
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Income from discontinued operations
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0.01
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0.01
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Net loss
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$
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(0.11
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$
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(0.10
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Weighted average common shares outstanding basic and diluted
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15,851,815
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15,130,345
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See accompanying notes to unaudited condensed consolidated financial statements.
2
AMDL, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
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Three Months Ended March 31,
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2009
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2008
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Cash flows from operating activities:
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Net loss
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$
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(1,691,091
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$
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(1,472,196
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Less: income from discontinued operations
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247,026
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206,341
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(1,938,117
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(1,678,537
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)
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Adjustments to reconcile net loss before discontinued operations to net
cash provided by (used in) operating activities:
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Depreciation and amortization
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352,441
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304,645
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Accretion of debt discount and amortization of debt issuance costs
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69,965
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Fair market value of options granted to employees and directors for
services
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157,155
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105,542
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Fair market value of common stock, warrants and options expensed for
services
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105,925
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527,425
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Fair value adjustment to warrants accounted for as liabilities
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35,558
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Provision for bad debts
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202,817
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69,764
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Changes in operating assets and liabilities:
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Accounts receivable
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3,307,879
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(904,282
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)
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Related party account with Jade Capital
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(614,301
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Inventories
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(567,218
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90,440
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Prepaid expenses and other assets
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(831,172
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(98,333
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)
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Accounts payable, accrued expenses and accrued salaries and wages
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269,767
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294,522
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Income taxes payable
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(381,648
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)
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17,984
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Deferred revenue
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(43,817
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)
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(41,807
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)
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Net cash provided by (used in) operating activities of continuing
operations
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739,535
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(1,926,938
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)
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Net cash provided by operating activities of discontinued operations
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101,457
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114,872
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Net cash provided by (used in) operating activities
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840,992
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(1,812,066
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)
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Cash flows from investing activities:
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Purchase of property and equipment
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(407,156
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(299,652
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)
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Return of amounts advanced on note receivable
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13,936
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Net cash used in investing activities of continuing operations
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(407,156
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(285,716
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)
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Net cash used in investing activities of discontinued operations
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(4,181
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)
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Net cash used in investing activities
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(407,156
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)
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(289,897
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)
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Cash flows from financing activities:
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Proceeds from issuance of Senior Notes, net of cash issuance costs of
$113,400
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566,600
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Payments on notes payable
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(1,393,595
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)
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Proceeds from issuance of common stock, net of cash offering costs of
$123,875
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876,129
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Proceeds from the exercise of warrants
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6,983
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Net cash provided by (used in) financing activities
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566,600
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(510,483
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)
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Effect of exchange rates on cash and cash equivalents
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2,510
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24,816
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Net change in cash and cash equivalents
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1,002,946
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(2,587,630
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)
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Cash and cash equivalents, beginning of period
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2,287,283
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6,157,493
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Cash and cash equivalents, end of period
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$
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3,290,229
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$
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3,569,863
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See accompanying notes to unaudited condensed consolidated financial statements.
3
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Three Months Ended March 31, 2009 and 2008
NOTE 1 MANAGEMENTS REPRESENTATION
The accompanying condensed consolidated balance sheet as of December 31, 2008, which has been
derived from audited financial statements, and the unaudited interim condensed consolidated
financial statements have been prepared by AMDL, Inc. (the Company) in accordance with accounting
principles generally accepted in the United States of America for interim financial information and
pursuant to the rules and regulations of the Securities and Exchange Commission. 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 and the disclosures made are
adequate to make the information not misleading.
Operating results for the three months ended March 31, 2009 are not necessarily indicative of the
results that may be expected for the year ending December 31, 2009. It is suggested that these
condensed consolidated financial statements be read in conjunction with the audited consolidated
financial statements and notes thereto for the year ended December 31, 2008 included in the
Companys Annual Report on Form 10-K. The report of the Companys independent registered public
accounting firm on the consolidated financial statements included in Form 10-K contains a
qualification regarding the substantial doubt about the Companys ability to continue as a going
concern.
NOTE 2 ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Nature of Business
The predecessor to the Company 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
obtaining 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.
On September 28, 2006, the Company acquired 100% of the outstanding shares of Jade Pharmaceutical,
Inc. (JPI). JPI operates primarily through two wholly owned Peoples Republic of China (PRC or
China) based subsidiaries, Jiangxi Bio-Chemical Pharmacy Company Limited (JJB) and Yangbian
Yiqiao Bio-Chemical Pharmacy Company Limited (YYB). Through JPI, the Company manufactures and
distributes generic, homeopathic, and over-the-counter pharmaceutical products, beauty products and
supplements in China.
Discontinued Operations and Assets Held for Sale
On January 22, 2009, the Companys board of directors authorized management to sell the operations
of YYB. In accordance with the Financial Accounting Standards Boards (FASB) Statement of
Financial Accounting Standards (SFAS) No. 144,
Accounting for the Impairment or Disposal of
Long-lived Assets
(SFAS 144), the Company has classified the assets, liabilities, operations and
cash flows of YYB as discontinued operations for all periods presented. The Company is in the
process of negotiating a sale transaction. Based on preliminary estimates of the proceeds from the
sale, there has been no adjustment to the carrying value of the net assets of YYB at March 31,
2009.
Summarized operating results of discontinued operations for the three months ended March 31, 2009
and 2008 are as follows:
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|
|
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|
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|
|
Three months ended March 31,
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2009
|
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2008
|
|
|
|
|
|
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Revenue
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|
$
|
594,839
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|
$
|
646,553
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Income before income taxes
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|
$
|
277,743
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|
|
$
|
257,935
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|
4
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Three Months Ended March 31, 2009 and 2008
Included in income from discontinued operations, net are income tax expenses of $30,717 and $51,594
for the three months ended March 31, 2009 and 2008, respectively. YYBs tax rate is 15% through
2010 in accordance with the Western Region Development Concession Policy of the PRC government.
The following table summarizes the carrying amount at March 31, 2009 and December 31, 2008 of the
major classes of assets and liabilities of the Companys business classified as discontinued
operations:
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|
|
|
|
|
|
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
Accounts receivable, net
|
|
$
|
892,229
|
|
|
$
|
930,769
|
|
Inventories
|
|
|
476,839
|
|
|
|
423,842
|
|
Other current assets
|
|
|
3,241
|
|
|
|
80,410
|
|
|
|
|
|
|
|
|
|
|
$
|
1,372,309
|
|
|
$
|
1,435,021
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-lived assets:
|
|
|
|
|
|
|
|
|
Property and equipment
|
|
$
|
1,733,179
|
|
|
$
|
1,742,739
|
|
Other
|
|
|
46,867
|
|
|
|
47,195
|
|
|
|
|
|
|
|
|
|
|
$
|
1,780,046
|
|
|
$
|
1,789,934
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
$
|
463,979
|
|
|
$
|
685,360
|
|
Debt
|
|
|
466,740
|
|
|
|
466,155
|
|
|
|
|
|
|
|
|
|
|
$
|
930,719
|
|
|
$
|
1,151,515
|
|
|
|
|
|
|
|
|
Going Concern
The condensed 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 incurred net losses
before discontinued operations of $1,938,117 and $1,678,537 for the three months ended March 31,
2009 and 2008, respectively, and had an accumulated deficit of $37,287,070 at March 31, 2009. In
addition, despite generating cash from operating activities of continuing operations of $739,535
for the three months ended March 31, 2009, the Company used cash in operating activities of
continuing operations of $1,926,938 during the three months ended March 31, 2008.
At May 10
th
, 2009, the Company had cash on hand in the U.S. and
China of approximately $5,000,000. The
Companys operations in China currently generate positive cash from operations, but the
availability of any cash from the Companys operations in China and the timing thereof may be
uncertain. The Companys receivables in China have been outstanding for extended periods, and the
Company has experienced increased delays in collection. The Companys U.S. operations currently
require approximately $425,000 per month to fund the cost associated with its general U.S.
corporate functions, payment by corporate of the salaries of the Companys executives in China, and
the expenses related to the further development of the DR-70 test kit. In lieu of reinvesting all
cash flow from Chinese operations in China, currently the necessary funds to meet the Companys
cash flow obligations in the U.S. are being transferred from JPI and/or JJB to AMDL in the United
States. Assuming (i) JJB does not undertake significant new activities which require additional
capital, (ii) the current level of revenue from the sale of DR-70 test kits does not increase in
the near future, (iii) the Company does not conduct any full scale clinical trials for the DR-70
test kit or the combination immunogene therapy (CIT) technology in the U.S. or China, (iv) JPI
continues to generate sufficient cash to exceed its cash requirements, (v) no outstanding warrants
are exercised, and (vi) no additional equity or debt financings are completed, the amount of cash
on hand is expected to be sufficient to meet the Companys projected
5
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Three Months Ended March 31, 2009 and 2008
operating expenses on a month to month basis as long as JPI or JJB continues to generate enough
cash from operations that can be timely sent to the U.S. to meet the cash needs of the Company in
the U.S.
The monthly cash requirement does not include any extraordinary items or expenditures, including
payments to the Mayo Clinic on clinical trials for the DR-70 test kit or expenditures related to
further development of the CIT technology, as no significant expenditures are anticipated other
than the legal fees incurred in furtherance of patent protection for the CIT technology.
Managements near and long-term operating strategies focus on (i) obtaining China State Food and
Drug Administration (SFDA) approval for the DR-70 test kit, (ii) further developing and marketing
of the DR-70 test kit, (iii) funding the growth of JPIs existing products, (iv) seeking a large
pharmaceutical partner for the Companys CIT technology, (v) selling different formulations of
Human Placental Extract (HPE)-based products in the U.S. and internationally, and (vi)
introduction of new products. 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.
There are significant risks and uncertainties which could negatively affect the Companys
operations. These are principally related to (i) the absence of a distribution network for the
Companys DR-70 test kits, (ii) the early stage of development of the Companys CIT technology and
the need to enter into a strategic relationship with a larger company capable of completing the
development of any ultimate product line including the subsequent marketing of such product, (iii)
the absence of any commitments or firm orders from the Companys distributors, (iv) possible
disruption in producing products in China as a result of relocation of the Companys facilities
and/or delays or failure in either the Good Manufacturing Process (GMP) recertification process
or the SFDA production license approval process, and (v) credit risks associated with new
distribution agreements in China. The Companys limited sales to date for the DR-70 test kit and
the lack of any purchase requirements in the existing distribution agreements make it impossible to
identify any trends in the Companys business prospects. Moreover, if either AcuVector and/or the
University of Alberta are successful in their claims (See Note 9), the Company may be liable for
substantial damages, the Companys rights to the CIT technology will be adversely affected, and the
Companys future prospects for licensing the CIT technology will be significantly impaired.
The Companys only sources of additional funds to meet continuing operating expenses, fund
additional research and development, complete the acquisition of production rights for new
products, fund additional working capital, and conduct clinical trials which may be required to
receive SFDA approval are the sale of securities, and cash flow generated from JPIs operations.
Management is actively seeking additional debt and/or equity financing, but no assurances can be
given that such financing will be obtained or what the terms thereof will be. Additionally, there
is no assurance as to whether the Company will continue to conduct JPIs operations on a profitable
basis or that JPIs operations will generate positive cash flow. The Company may need to
discontinue a portion or all of its operations if it is unsuccessful in generating positive cash
flow or financing its operations through the issuance of securities.
These items, among others, raise substantial doubt about the Companys ability to continue as a
going concern. The condensed consolidated financial statements do not include any adjustments to
reflect the possible future effects on the recoverability and classification of assets or the
amount and classification of liabilities that may result from the outcome of this uncertainty.
Principles of Consolidation
The accompanying condensed consolidated financial statements include the accounts and transactions
of the Company and its wholly owned subsidiaries. Intercompany transactions and balances have been
eliminated in consolidation.
6
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Three Months Ended March 31, 2009 and 2008
Use of Estimates
The preparation of 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, provisions for doubtful accounts, realizability of
inventories, recoverability of long-lived assets, valuation and useful lives of intangible assets,
and valuation of options, warrants and deferred tax assets. Actual results could differ from those
estimates.
Revenue Recognition
Revenues from the wholesale sales of over-the counter and prescription pharmaceuticals are
recognized when persuasive evidence of an arrangement exists, title and risk of loss have passed to
the buyer, the price is fixed or readily determinable and collection is reasonably assured,
provided the criteria in the Security and Exchange Commissions (SEC) Staff Accounting Bulletin
(SAB) No. 101
Revenue Recognition in Financial Statements
, (as amended by SAB No. 104) are met.
In conjunction with the launch of the Companys Nalefen Skin Care HPE products, distributors of the
products were offered limited-time discounts to allow for promotional expenses incurred in the
distribution channel. Distributors are not required to submit proof of the promotional expenses
incurred. The Company accounts for the promotional expenses in accordance with Emerging Issues Task
Force (EITF) Issue No. 01-9,
Accounting for Consideration Given by a Vendor to a Customer
(Including a Reseller of the Vendors Products)
. Accordingly, the promotional discounts granted in
prior periods were netted against revenue in the condensed consolidated statements of operations
and comprehensive loss. Accounts receivable presented in the accompanying condensed consolidated
balance sheets have been reduced by the promotional discounts, as customers are permitted by the
terms of the distribution contracts to net the discounts against payments on the related invoices.
Any provision for sales promotion discounts and estimated returns are accounted for in the period
the related sales are recorded. 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.
In accordance with 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 Revenue
On June 14, 2007, JPI (through JJB) entered into an agreement and letter of intent with Shanghai
Jiezheng (formerly known as Shanghai XiangEn) to begin direct distribution of pharmaceutical
products through retail stores. The retail stores are owned by independent third parties who sell
JJBs products at retail to consumers. Shanghai Jiezheng and JPI collaborated with the owners in
re-branding the retail stores as JPGreen Health and Beauty Clinics.
During 2007, JJB received a one-time, non-refundable up front fee from each of eight sub-operators
of the retail stores in the aggregate amount of $314,762, which will be recognized over the two
year contract period with the sub-operators. The Company deferred recognition of these fees until
the retail stores opened. JJB is amortizing the up-front fees over the two year contract period.
The Company recorded up-front fees of approximately $40,000 as revenues for each of the three
months ended March 31, 2009 and 2008, respectively. In the first half of 2008, numerous existing
beauty and spa businesses indicated their interest in becoming JP Green product sellers, without
JPIs involvement in direct ownership or management. Based on the perceived level of interest and
the relative low cost of this strategy, the Company decided to abandon the JP Green store concept
and pursue a strategy of retail distribution through independent, non-branded stores. Although the
Company does not expect any significant additional involvement in the operations of the eight
sub-operators, the up-front fees will continue to be amortized over the two-year contract period.
Deferred revenue related to the up-front fees amounted to $43,824 and $87,538 at March 31, 2009 and
December 31, 2008, respectively.
7
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Three Months Ended March 31, 2009 and 2008
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.
Impairment of Long-Lived Assets
In accordance with SFAS 144, 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 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 March 31, 2009. 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 long-lived assets and prevent future impairment.
Derivative Financial Instruments
The Company applies the provisions of SFAS No. 133,
Accounting for Derivative Instruments and
Hedging Activities
(SFAS 133). Derivatives within the scope of SFAS 133 must be recorded on the
balance sheet at fair value. The Company issued Convertible Debt in September 2008, and recorded a
derivative asset related to the limitation on bonus interest rights held by Convertible Debt
holders in the event of a change in control or bankruptcy. The fair value of the derivative asset
was $125,000 at both March 31, 2009 and December 31, 2008.
Risks and Uncertainties
Manufacturing and Distribution Operations in China
JJB, YYB, and Golden Success, a minimally active shell corporation acquired in 2008, operate as
wholly owned foreign enterprises (WFOE) 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 such entities would receive if they
operated through a joint venture with a Chinese partner.
8
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Three Months Ended March 31, 2009 and 2008
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 condensed 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. All foreign exchange transactions must take place through authorized institutions and are
subject to various currency exchange, corporate and tax regulations.
Regulatory Environment
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. Prior to July 3, 2008, the Company was not permitted to sell the DR-70
test kit in the U.S. except on a research use only basis, as regulated by the United States Food
and Drug Administration (USFDA). 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 DR-70 test kit or that they will not be withdrawn.
Prior to May 2002, the Companys focus was on obtaining foreign distributors for its DR-70 test
kit. In May 2002, the Company decided to begin the USFDA process under Section 510(k) of the Food,
Drug and Cosmetic Act for approval of its intent to market the DR-70 test kit as an aid in
monitoring patients with colorectal cancer. On July 3, 2008, the Company received a letter of
determination from the USFDA that the DR-70 test kit was substantially equivalent to the existing
predicate device being marketed. The letter grants the Company the right to market the DR-70 test
kit as a device to monitor patients who have been previously diagnosed with colorectal cancer.
Although the Company has obtained approval from the USFDA to market the then current formulation of
the DR-70 test kit, it has been determined that one of the key components of the DR-70 test kit,
the anti-fibrinogen-HRP is limited in supply and additional quantities cannot be purchased. There
are currently enough DR-70 test kit components to perform approximately 1.2 million individual
tests (31,000 test kits) over the next 12-18 months. Based on current and anticipated orders, this
supply is adequate to fill all orders. The Company now anticipates that it will attempt to locate a
substitute anti-fibrinogen-HRP and perform additional quality assurance testing in order to create
a significant supply of the current version of the DR-70 test kit.
Part of the Companys research and development efforts through 2010 will include the testing and
development of an enhanced and improved version of the DR-70 test kit. Pilot studies show that the
new version could be superior to the current version. The Company has completed negotiations with
a third party to take the lead on necessary clinical studies. It is anticipated that this version
will be submitted to the USFDA in the latter half of 2010.
In June 2007, the Chinese approval process fundamentally changed. Under the new SFDA guidelines,
the SFDA is unlikely to approve the marketing of the DR-70 test kit without one of the following:
approval by the USFDA, sufficient clinical trials in China, or product approval from a country
where the DR-70 test kit is registered and approved for marketing and export. JPI intends to
proceed with all of these options in an attempt to meet the new SFDA guidelines, but even though
USFDA approval of a limited supply formulation of the DR-70 test kit has been received, there can
be no assurances that JPI will obtain approval for marketing the DR-70 test kit in China or what
the timing thereof may be. The estimated time to complete the SFDA approval process is a year and a
half to two years.
9
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Three Months Ended March 31, 2009 and 2008
In order to comply with the new SFDA guidelines, in September of 2008, the Company retained Jyton &
Emergo Medical Technology, a China based company to:
|
|
|
Compile technical file and prepare clinical protocol;
|
|
|
|
|
Clinical trial preparation and design;
|
|
|
|
|
Clinical trial supervision and monitoring;
|
|
|
|
|
When appropriate, apply for SFDA approval.
|
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. Therefore, the Company is subject to substantial business risks and uncertainties
inherent in such an entity, including the potential of business failure.
Concentrations of Credit Risk
Cash
From time to time, the Company maintains cash balances at certain institutions in excess of the
FDIC limit. As of March 31, 2009, the Company had no cash balances in excess of this limit.
Additionally, the Company held $3,282,524 in uninsured cash accounts at its foreign subsidiaries.
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. A reserve for uncollectible amounts and estimated
sales returns is provided based on historical experience and a specific analysis of the accounts
which management believes is sufficient. Accounts receivable is net of a reserve of doubtful
accounts and sales returns of $276,384 and $73,446 at March 31, 2009 and December 31, 2008,
respectively. Although the Company expects to collect amounts due, actual collections may differ
from the estimated amounts.
As of March 31, 2009, amounts due from four customers, each with receivables in excess of 10% of
accounts receivable, comprised 21%, 16%, 15% and 10% of outstanding accounts receivable. As of
December 31, 2008, amounts due from six customers, each with receivables in excess of 10% of
accounts receivable, comprised 19%, 14%, 13%, 13%, 12% and 12% of outstanding accounts receivable.
For the three months ended March 31, 2009, one customer comprised 16% of net revenues. For the
three months ended March 31, 2008, two customers comprised 20% and 12% of net revenues.
Historically, the majority of the Companys customers were in the pharmaceutical industry.
Consequently, there has been a concentration of receivables and revenues within that industry,
which is subject to normal credit risk. Beginning in the third quarter of 2008, the Company entered
into contracts with three new customers and a fourth contract with an existing customer for the
regional distribution of HPE-based beauty products, marketed under the brand name Nalefen, within
China. The new customers specialize in the distribution of cosmetic products and were granted
credit terms of 120 days. There were no significant sales of the beauty products to the new
customers during the quarter ended March 31, 2009. Accounts receivable from such customers
represented 41% and 58% of outstanding accounts receivable at March 31, 2009 and December 31, 2008,
respectively. Although the Company has limited history with customers in the cosmetic distribution
industry, management considers the industry to be subject to normal credit risk.
Basic and Diluted Income (Loss) Per Share
Basic net loss per common share from continuing operations is computed based on the
weighted-average number of shares outstanding for the period. Diluted net loss per share from
continuing operations is computed by dividing net
10
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Three Months Ended March 31, 2009 and 2008
loss by the weighted-average shares outstanding assuming all dilutive potential common shares were
issued. In periods of losses from continuing operations, basic and diluted loss per share before
discontinued operations are the same as the effect of shares issuable upon the conversion of debt
and issuable upon the exercise of stock options and warrants is anti-dilutive. Basic and diluted
income per share from discontinued operations are also the same, as SFAS No. 128,
Earnings Per
Share
, requires the use of the denominator used in the calculation of loss per share from
continuing operations in all other calculations of earnings per share presented, despite the
dilutive effect of potential common shares.
The impact under the treasury stock method of stock options and warrants would have been
incremental shares of none and 374,538 for the three months ended March 31, 2009 and 2008,
respectively. Additionally, 2,204,559 shares of common stock issuable upon conversion of debt
would have been considered in calculating diluted earnings per share for the quarter ended March
31, 2009, had the inclusion of such shares been dilutive.
Diluted income per share excludes the impact of 9,465,380 and 5,582,814 options and warrants
outstanding or issuable upon the conversion of debt because the exercise price per share for those
options and warrants exceeds the average market price of the Companys common stock during the
quarters ended March 31, 2009 and 2008, respectively.
Supplemental Cash Flow Information
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
Cash paid during the period for interest
|
|
$
|
57,000
|
|
|
$
|
102,000
|
|
|
|
|
|
|
|
|
Cash paid during the period for taxes
|
|
$
|
492,000
|
|
|
$
|
74,000
|
|
|
|
|
|
|
|
|
Supplemental disclosure of non-cash activities:
|
|
|
|
|
|
|
|
|
Warrants issued in connection with Senior Notes, included in debt
issuance costs and debt discount
|
|
$
|
472,736
|
|
|
$
|
|
|
|
|
|
|
|
|
|
Reclassification of amounts recorded to additional paid-in capital to
warrant liability, including $110,858 recorded to retained earnings
upon implementation of EITF 07-5, representing the change in value of
the warrants from date of issuance to January 1, 2009
|
|
$
|
209,166
|
|
|
$
|
|
|
|
|
|
|
|
|
|
Reclassification of warrant liability to additional paid-in capital
upon expiration of share adjustment terms
|
|
$
|
133,866
|
|
|
$
|
|
|
|
|
|
|
|
|
|
Fair value of warrants issued for services, included in prepaid expense
|
|
$
|
17,500
|
|
|
$
|
|
|
|
|
|
|
|
|
|
Recent Accounting Pronouncements
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 was effective for fiscal years beginning after November 15, 2007. FASB
Staff Position No. FAS 157-2 (FSP 157-2),
Effective Date of FASB Statement No. 157
was issued in
February 2008. FSP 157-2 delays the effective date of SFAS No. 157, for nonfinancial assets and
nonfinancial liabilities, except for items that are recognized or disclosed at fair value at least
once a year, to fiscal years beginning after November 15, 2008, and for interim periods within
those fiscal years. The Company adopted SFAS No. 157 for its nonfinancial assets and liabilities
on January 1, 2009. The adoption of SFAS No. 157 had no impact on the Companys condensed
consolidated financial position or results of operations.
11
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Three Months Ended March 31, 2009 and 2008
In November 2007, the FASBs EITF ratified Issue No. 07-1,
Accounting for Collaborative
Arrangements,
(EITF 07-1) which defines collaborative arrangements and establishes reporting and
disclosure requirements for such arrangements. The Company adopted EITF 07-1 on January 1, 2009.
The adoption of EITF 07-1 had no impact on the Companys condensed
consolidated financial statements.
In December 2007, the FASB issued SFAS No. 141(R),
Business Combinations
. SFAS No. 141(R) replaces
SFAS No. 141,
Business Combinations.
SFAS No. 141(R) retains the fundamental requirements in SFAS
No. 141 that the acquisition method of accounting be used for all business combinations and for an
acquirer to be identified for each business combination. SFAS No. 141(R) amends the recognition
provisions for assets and liabilities acquired in a business combination, including those arising
from contractual and non-contractual contingencies. SFAS No. 141(R) also amends the recognition
criteria for contingent consideration. In addition, under SFAS No. 141(R), changes in an acquired
entitys deferred tax assets and uncertain tax positions after the measurement period will impact
income tax expense. The Company adopted SFAS No. 141(R) on January 1, 2009. SFAS No. 141(R) will
impact the Companys condensed consolidated financial statements if and when the Company engages in
a business combination.
In December 2007, the FASB issued SFAS No. 160,
Noncontrolling Interests in Consolidated Financial
Statements An Amendment of ARB No. 51
. SFAS No. 160 establishes new accounting and reporting
standards for the non-controlling interest in a subsidiary and for the deconsolidation of a
subsidiary. The Company adopted SFAS No. 160 on January 1, 2009. The adoption of SFAS No. 160 did
not have a material impact on the condensed consolidated financial statements.
In April 2008, the FASB issued Staff Position No. 142-3,
Determination of the Useful Life of
Intangible Assets
(FSP 142-3). FSP 142-3 amends the factors that should be considered in
developing renewal or extension assumptions used to determine the useful life of a recognized
intangible asset under SFAS No. 142,
Goodwill and Other Intangible Assets
. The Company adopted FSP
142-3 on January 1, 2009. The adoption of FSP No. 142-3 had no impact on the Companys condensed
consolidated financial statements.
In May 2008, the FASB issued SFAS No. 162,
The Hierarchy of Generally Accepted Accounting
Principles
(SFAS No. 162). SFAS No. 162 identifies the sources of accounting principles and the
framework for selecting the principles used in the preparation of financial statements. SFAS No.
162 is effective 60 days following the SECs approval of the Public Company Accounting Oversight
Board amendments to AU Section 411,
The Meaning of Present Fairly in Conformity with Generally
Accepted Accounting Principles
. Management does not currently expect the adoption of SFAS No. 162
to have a material impact on the condensed consolidated financial statements.
In May 2008, the FASB issued Staff Position No. APB 14-1 (FSP APB 14-1), which clarifies the
accounting for convertible debt instruments that may be settled fully or partially in cash upon
conversion. FSP APB 14-1 requires entities to separately measure and account for the liability and
equity components of qualifying convertible debt and amortize the value of the equity component to
interest cost over the estimated life of the convertible debt instrument. By amortizing the value
of the equity component, an entity will effectively recognize interest cost at its non-convertible
debt borrowing rate. FSP APB 14-1 also requires re-measurement of the liability and equity
components upon extinguishment of a convertible debt instrument, which may result in a gain or loss
recognized in the financial statements for the extinguishment of the liability component. FSP APB
14-1 requires retrospective application for all instruments that were outstanding during any
periods presented. The Company adopted FSP APB 14-1 on January 1, 2009. The adoption of FSP APB
14-1 had no impact on the Companys condensed consolidated financial statements.
In June 2008, the FASB ratified EITF Issue No. 07-5,
Determining Whether an Instrument (or an
Embedded Feature) Is Indexed to an Entitys Own Stock
(EITF 07-5). EITF 07-5 provides that an
entity should use a two step approach to evaluate whether an equity-linked financial instrument (or
embedded feature) is indexed to its own stock, including evaluating the instruments contingent
exercise and settlement provisions. The Company adopted EITF 07-5 on January 1, 2009. As a result,
the Company reclassified certain warrants as liabilities and recorded a cumulative effect gain of
approximately $111,000 to retained earnings for the decrease in fair value of the warrants at the
date of issuance compared with the fair value at the date of implementation of EITF 07-5.
Adjustment features within the warrants that resulted in liability classification expired prior to
March 31, 2009. As a result, the warrants were reclassified back to
12
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Three Months Ended March 31, 2009 and 2008
equity as of March 31, 2009. The Company recorded a loss of approximately $36,000 to other expense
in the quarter ended March 31, 2009 as a result of adjusting the warrant liability to fair value at
the date that the adjustment features expired.
In April 2009, the FASB issued Staff Position No. FAS 107-1 and APB 28-1,
Interim Disclosures about
Fair Value of Financial Instruments
(FSP FAS 107-1 and APB 28-1), which requires publicly traded
companies to include in their interim financial reports certain disclosures about the carrying
value and fair value of financial instruments previously required only in annual financial
statements and to disclose changes in significant assumptions used to calculate the fair value of
financial instruments. FSP FAS 107-1 and APB 28-1 is effective for all interim reporting periods
ending after June 15, 2009, with early adoption permitted for interim reporting periods ending
after March 15, 2009. The Company is evaluating the effect that FSP FAS 107-1 and APB 28-1 will
have on its disclosures for the second quarter of 2009.
NOTE 3 INVENTORIES
Inventories consist of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
|
(Unaudited)
|
|
|
(Audited)
|
|
Raw materials
|
|
$
|
1,246,383
|
|
|
$
|
719,389
|
|
Work-in-process
|
|
|
14,457
|
|
|
|
11,808
|
|
Finished goods
|
|
|
872,320
|
|
|
|
832,794
|
|
|
|
|
|
|
|
|
|
|
$
|
2,133,160
|
|
|
$
|
1,563,991
|
|
|
|
|
|
|
|
|
NOTE 4 PREPAID EXPENSES, OTHER CURRENT ASSETS, AND OTHER ASSETS
Prepaid expenses and other current assets consist of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
|
(Unaudited)
|
|
|
(Audited)
|
|
Material deposits
|
|
$
|
1,292,376
|
|
|
$
|
627,390
|
|
Due from officers and directors
|
|
|
10,093
|
|
|
|
9,693
|
|
Current deferred tax asset
|
|
|
92,915
|
|
|
|
92,798
|
|
Other
|
|
|
442,486
|
|
|
|
277,079
|
|
|
|
|
|
|
|
|
|
|
$
|
1,837,870
|
|
|
$
|
1,006,960
|
|
|
|
|
|
|
|
|
Other assets consist of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
|
(Unaudited)
|
|
|
(Audited)
|
|
Deposits, primarily product licenses
|
|
$
|
3,004,040
|
|
|
$
|
3,000,354
|
|
Debt issuance costs (Note 7)
|
|
|
1,043,190
|
|
|
|
906,408
|
|
Convertible Debt derivative
|
|
|
125,000
|
|
|
|
125,000
|
|
Refundable deposits
|
|
|
40,681
|
|
|
|
40,670
|
|
|
|
|
|
|
|
|
|
|
$
|
4,212,911
|
|
|
$
|
4,072,432
|
|
|
|
|
|
|
|
|
Revenues have not yet been generated from the product licenses. At the time commercial sales of
the product begin, the product licenses will be reclassified to intangible assets and amortized to
cost of goods sold using the straight-line method over the estimated useful life of the related
product.
13
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Three Months Ended March 31, 2009 and 2008
NOTE 5 INTANGIBLE ASSETS
Intangible assets consist of the following at March 31, 2009 (Unaudited):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of
|
|
|
|
|
|
|
Gross
|
|
|
|
|
|
|
Foreign
|
|
|
|
|
|
|
Carrying
|
|
|
Accumulated
|
|
|
Currency
|
|
|
|
|
|
|
Value
|
|
|
Amortization
|
|
|
Translation
|
|
|
Net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets subject to amortization:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intellectual property
|
|
$
|
2,000,000
|
|
|
$
|
(766,667
|
)
|
|
$
|
|
|
|
$
|
1,233,333
|
|
Production rights
|
|
|
1,916,622
|
|
|
|
(371,136
|
)
|
|
|
155,899
|
|
|
|
1,701,385
|
|
Land use rights
|
|
|
1,354,765
|
|
|
|
(111,009
|
)
|
|
|
211,862
|
|
|
|
1,455,618
|
|
Non-compete agreements
|
|
|
324,415
|
|
|
|
(182,308
|
)
|
|
|
32,750
|
|
|
|
174,857
|
|
Customer relationships
|
|
|
214,328
|
|
|
|
(86,788
|
)
|
|
|
26,796
|
|
|
|
154,336
|
|
Trade name and logo
|
|
|
530,829
|
|
|
|
(144,588
|
)
|
|
|
78,721
|
|
|
|
464,962
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
6,340,959
|
|
|
$
|
(1,662,496
|
)
|
|
$
|
506,028
|
|
|
$
|
5,184,491
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible assets consist of the following at December 31, 2008 (Audited):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of
|
|
|
|
|
|
|
Gross
|
|
|
|
|
|
|
Foreign
|
|
|
|
|
|
|
Carrying
|
|
|
Accumulated
|
|
|
Currency
|
|
|
|
|
|
|
Value
|
|
|
Amortization
|
|
|
Translation
|
|
|
Net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets subject to amortization:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intellectual property
|
|
$
|
2,000,000
|
|
|
$
|
(741,667
|
)
|
|
$
|
|
|
|
$
|
1,258,333
|
|
Production rights
|
|
|
1,916,622
|
|
|
|
(318,986
|
)
|
|
|
154,007
|
|
|
|
1,751,643
|
|
Land use rights
|
|
|
1,354,765
|
|
|
|
(99,094
|
)
|
|
|
209,839
|
|
|
|
1,465,510
|
|
Non-compete agreements
|
|
|
324,415
|
|
|
|
(163,652
|
)
|
|
|
32,483
|
|
|
|
193,246
|
|
Customer relationships
|
|
|
214,328
|
|
|
|
(77,904
|
)
|
|
|
26,569
|
|
|
|
162,993
|
|
Trade name and logo
|
|
|
530,829
|
|
|
|
(129,041
|
)
|
|
|
78,055
|
|
|
|
479,843
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
6,340,959
|
|
|
$
|
(1,530,344
|
)
|
|
$
|
500,953
|
|
|
$
|
5,311,568
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In August 2001, the Company acquired intellectual property rights and an assignment of a US patent
application for its CIT 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. During 2003, two
lawsuits were filed challenging the Companys ownership of this intellectual property. The value
of the intellectual property will be diminished if either of the lawsuits is successful (see Note
9).
As part of the acquisition of the technology, the Company agreed to pay Dr. Chang a 5% royalty on
net sales of products developed with the Companys CIT technology. The Company has not paid any
royalties to Dr. Chang to date as there have been no sales of such products.
NOTE 6 INCOME TAXES
The Company recorded tax provisions of $110,502 and $149,062 for the three months ended March 31,
2009 and March 31, 2008, respectively, or 6% and 10% of its pre-tax losses for the respective three
month periods. The difference between the effective tax rates and the 34% federal statutory rate
resulted primarily from losses generated in the United States with no corresponding tax benefit,
due to the full valuation reserve on net deferred tax assets, and foreign earnings taxed at the
rates in effect in local jurisdictions. The Companys Chinese operations operate under tax holiday
and incentive programs. JJB has been granted a 50% waiver of income taxes for 2008 through 2010.
14
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Three Months Ended March 31, 2009 and 2008
The Company utilizes the asset and liability method of accounting for income taxes as set forth in
SFAS No. 109,
Accounting for Income Taxes
. As a result of the Companys cumulative losses in the
U.S., management has concluded that a full valuation allowance should be recorded in the U.S.
The Company files federal, state and foreign income tax returns in jurisdictions with varying
statutes of limitations. The 2005 through 2008 tax years generally remain subject to examination by
federal and most state tax authorities. In China, the 2002 through 2008 tax years generally remain
subject to examination by tax authorities. The Company is not currently under examination for any
tax year by any jurisdiction.
Current deferred tax assets of $92,915 and $92,798 have been included in prepaid expenses and other
current assets in the condensed consolidated balance sheets as of March 31, 2009 and December 31,
2008, respectively.
NOTE 7 NOTES PAYABLE
Notes payable consists of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2009
|
|
|
2008
|
|
|
|
(Unaudited)
|
|
|
(Audited)
|
|
Convertible Debt, net of unamortized discount, inclusive of
bonus interest, of $3,761,938 and $3,762,000 at March 31,
2009 and December 31, 2008, respectively
|
|
$
|
62
|
|
|
$
|
|
|
Senior Notes payable, net of unamortized discount of $883,353
and $496,195 at March 31, 2009 and December 31, 2008,
respectively
|
|
|
874,147
|
|
|
|
581,305
|
|
Bank debt
|
|
|
3,132,687
|
|
|
|
3,128,765
|
|
|
|
|
|
|
|
|
|
|
|
4,006,896
|
|
|
|
3,710,070
|
|
Less: Bank debt associated with discontinued operations of YYB
|
|
|
466,740
|
|
|
|
466,155
|
|
Less: Current portion of long-term debt
|
|
|
2,666,009
|
|
|
|
2,662,610
|
|
|
|
|
|
|
|
|
|
|
$
|
874,147
|
|
|
$
|
581,305
|
|
|
|
|
|
|
|
|
Convertible Debt
The significant terms of the Companys convertible debt are described in the notes to the Companys
Annual Report on Form 10-K for the year ended December 31, 2008.
Senior Notes Payable
The significant terms of the Companys Senior Notes Payable are described in the notes to the
Companys Annual Report on Form 10-K for the year ended December 31, 2008. Senior Notes
outstanding at December 31, 2008 mature on the earlier of December 8, 2010 or upon the completion
of the closing of a credit facility or loans by the Company or its subsidiaries with a financial
institution or bank of not less than $8 million in a transaction or series of transactions.
On January 30, 2009, the Company conducted the second and final closing (the Final Closing) of
the 12% Senior Note offering whereby the Company sold an additional $680,000 principal amount of
12% Senior Notes and five year warrants to purchase a total of 544,000 shares of common stock at
$1.13 per share. Accordingly, a total of $1,757,500 in 12% Senior Notes and Warrants to purchase
1,406,000 shares of common stock in the 12% Senior Note Offering were sold in 2008 and 2009. The
Senior Notes issued in January 2009 mature on the earlier of the second anniversary of the closing
date or upon the completion of the closing of a credit facility or loans by the Company or its
subsidiaries with a financial institution or bank of not less than $8 million in a transaction or
series of transactions.
15
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Three Months Ended March 31, 2009 and 2008
The Company incurred debt issuance costs of $156,376 and debt discounts of $429,760 in association
with the Final Closing of the Senior Notes, including $42,976 and $429,760, respectively, related
to the issuance of 54,400 and 544,000 warrants for the purchase of the Companys common stock at
$1.13 per share, issued to brokers and Senior Note holders, respectively. These warrants were
valued using the Black-Scholes option pricing model, using the following assumptions: (i) no
dividend yield, (ii) weighted-average volatility of 120% (iii) weighted-average risk-free interest
rate of 1.85%, and (iv) weighted-average expected life of 5 years. Those debt issuance costs are
included in other assets in the condensed consolidated balance sheet at March 31, 2009. Debt
issuance costs and debt discount are being amortized over the life of the debt using the effective
interest method.
In connection with the 12% Senior Note offering, the Company agreed to file a registration
statement with the SEC on From S-3 by July 31, 2009, covering the secondary offering and resale of
the Warrant Shares sold in the 12% Senior Note offering. In the event the registration statement is
not declared effective prior to October 31, 2009, or the Company does not maintain effectiveness of
the registration statement, the Company must issue additional warrants in an amount equal to 1% of
the warrant shares per month, up to a maximum of 6% (or warrants to purchase up to 56,892 shares),
issuable upon exercise of the warrants subject to registration. Based upon managements
consideration of the likelihood of completing the required registration, the Company has not
accrued any liability related to the additional warrants issuable pursuant to the registration
rights agreement. If it becomes probable that the Company will be required to issue additional
warrants, the estimated value of the warrants will be recognized in earnings pursuant to FSP EITF
00-19-2,
Accounting for Registration Payment Arrangements.
Bank Debt
At March 31, 2009 and December 31, 2008, the Company had RMB denominated indebtedness equal to
$3,132,687 (RMB 21.4 million) and $3,128,765 (RMB 21.4 million), respectively, owed to two
financial institutions, representing working capital and construction advances made to JJB and YYB
prior to the Companys acquisition of JPI. These notes are secured by substantially all the assets
of JJB and YYB and bear interest at rates ranging from 5.3% 9.5% per annum.
The Company acquired JPI and its subsidiaries in September 2006 from Jade Capital Group Limited
(Jade). Prior to Jades purchase of certain assets, including land and buildings, of JiangXi
Shangrao Pharmacy Co. Ltd (KangDa), and the subsequent sale of those assets and liabilities to
the Company, KangDa had bank loans of $5,692,000 secured by the assets transferred to Jade.
Pursuant to an agreement between Jade and KangDa, Jade assumed bank loans of $4,667,000, and KangDa
continued to owe the bank $1,025,000. The loans were not separable or assumable, and therefore
became technically due when the assets of JJB and YYB were acquired. The Company reached a verbal
agreement with the bank to allow repayment by JPI of the loans under their original terms through
December 31, 2008, however, this agreement was not formalized in writing.
In March 2008, the Company agreed to repay RMB 17.1 million ($2,412,145) of mature loans to the
bank by the second quarter of 2008. The Company made payments totaling RMB 16.2 million
($2,282,402) in the year ended December 31, 2008. In March, 2009, the Company and the bank agreed
to extend the due date on approximately $2.5 million (RMB 17.2 million) to December 31, 2009. The
remaining $0.6 million, owed primarily by YYB, is due and payable. The Company expects to pay all
remaining past due balances to the bank in 2009, pending the completion of additional bank funding
in China or the sale of YYB.
16
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Three Months Ended March 31, 2009 and 2008
Debt Repayment Obligations
The following table sets forth the contractual repayment obligations under the Companys notes
payable, excluding those related to discontinued operations. The table assumes that Convertible
Debt will be repaid at maturity, and excludes interest payments, except for bonus interest payable
under the terms of the Convertible Debt instruments. The table also assumes that maturity of the
Senior Notes will not occur before the two year anniversary of the date of issuance.
|
|
|
|
|
2009
|
|
$
|
2,665,946
|
|
2010
|
|
|
4,839,500
|
|
2011
|
|
|
680,000
|
|
|
|
|
|
|
|
$
|
8,185,446
|
|
|
|
|
|
NOTE 8 EMPLOYMENT CONTRACT TERMINATION LIABILITY
In October 2008, the Companys former chief executive officer agreed to retire from his employment
with the Company. The Company negotiated a settlement of its employment contract with the former
chief executive under which he received $150,000 upon the effective date of the agreement,
including $25,000 for reimbursement of his legal expenses. In addition the Company agreed to pay
$540,000 in monthly installments of $18,000, commencing January 31, 2009, to continue certain
insurance coverages, and to extend the term of options previously granted which would have expired
shortly after termination of employment. Pursuant to SFAS No. 146,
Accounting for Costs Associated
with Exit or Disposal Activities
, the Company recorded a liability of approximately $517,000 for
the present value of the monthly installments and insurance coverages due under the settlement
agreement. Approximately $225,426 and $237,000 are included in accrued salaries and wages and
$226,667 and $280,000 are included in other long-term liabilities in the accompanying condensed
consolidated balance sheets at March 31, 2009 and December 31, 2008, respectively.
NOTE 9 COMMITMENTS AND CONTINGENCIES
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 CIT 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 result in
the case. As the final outcome is not determinable, no accrual or loss relating to this action is
reflected in the accompanying condensed 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 CIT 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 CIT technology,
just that the University has an equitable interest therein or the revenues there from.
17
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Three Months Ended March 31, 2009 and 2008
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 CIT 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.
Production License Acquisition Agreements
In 2006 and 2007, the Company entered into a $6.7 million purchase commitment with Jiangxi YiBo
Medicine Technology Development Co., Ltd (YiBo) for the acquisition of generic drug production
technical information to be used in the Companys SFDA generic drug applications for ten medicines.
The Company has received regulatory approval for three of the medicines and has made deposits to
YiBo for the remaining seven medicines. The deposits paid to YiBo are refundable if the Company is
unsuccessful in obtaining SFDA manufacturing licenses for the products purchased. The Companys
remaining obligation to YiBo totals approximately $1,780,000 at March 31, 2009. When paid, these
amounts will be capitalized and amortized over the expected economic life of the products which are
subject to the production licenses obtained from the SFDA.
Licensing Agreements
The Company has agreed to pay a 5% royalty on net sales of products developed from the Companys
CIT technology. The Company has not paid any royalties to date as there have been no sales of such
products.
Contingent Issuance of Shares Acquisition of JPI
In 2006, pursuant to the Stock Purchase and Sale Agreement (the Purchase Agreement), the Company
acquired 100% of the outstanding shares of JPI from Jade. The terms of the Purchase Agreement
provided that additional purchase consideration of 100,000 shares of the Companys common stock
(the Escrow Shares) was deposited in an escrow account held by a third party escrow agent and
administered pursuant to an Escrow Agreement. The Escrow Agreement provided that if, within one
year from and after the closing of the Purchase Agreement, Jade or its shareholders demonstrated
that the SFDA had issued a permit or the equivalent regulatory approval for the Company to sell and
distribute the DR-70 test kit in the PRC without qualification, in form and substance satisfactory
to the Company, then the escrow agent would promptly disburse the Escrow Shares to Jade or its
shareholders.
Due to changes in the SFDAs regulatory and administrative processes regarding the approval of both
drug and device applications, approval of the DR-70 test kit by the SFDA has been delayed in ways
that could not have been anticipated at the date of the Purchase Agreement. The Board of Directors
has amended the Escrow Agreement on three occasions, to extend the date by which the SFDAs
approval of the DR-70 test kit must be achieved. The most recent amendment, which became effective
March 24, 2009, provided that if Jade has not notified the escrow agent that the SFDA has issued
the approval to market the DR-70 test kit before March 28, 2010, 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. The shares are included in the number of shares issued as presented
on the face of the accompanying condensed consolidated balance sheets, however, they are not
considered issued for financial accounting purposes. In the event the Escrow Shares are released to
Jade, the Company will record the fair value of the Escrow Shares issued as goodwill.
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
18
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Three Months Ended March 31, 2009 and 2008
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 condensed consolidated balance sheets.
Tax Matters
The Company is required to file federal and state income tax returns in the United States and
various other income tax returns in foreign jurisdictions. The preparation of these income tax
returns requires the Company to interpret the applicable tax laws and regulations in effect in such
jurisdictions, which could affect the amount of tax paid by the Company. The Company, in
consultation with its tax advisors, bases its income tax returns on interpretations that are
believed to be reasonable under the circumstances. The income tax returns, however, are subject to
routine reviews by the various taxing authorities in the jurisdictions in which the Company files
its income tax returns. As part of these reviews, a taxing authority may disagree with respect to
the interpretations the Company used to calculate its tax liability and therefore require the
Company to pay additional taxes.
Change in Control Severance Plan
On November 15, 2001, the board of directors adopted an Executive Management Change in Control
Severance Pay Plan. The plan covered the persons who at any time during the 90-day period ending on
the date of a change in control (as defined in the plan), were employed by the Company as Chief
Executive Officer and/or president and provided for cash payments upon a change in control. The
Change in Control Severance Pay Plan was terminated in April 2009.
NOTE 10 SHARE-BASED COMPENSATION
The Company has six share-based compensation plans under which it may grant common stock or
incentive and non-qualified stock options to officers, employees, directors and independent
contractors. A detailed description of the Companys share-based compensation plans and option
grants outside the option plans is contained in the notes to the audited December 31, 2008
financial statements.
On January 7, 2009, the Company adopted the 2008-2009 Performance and Equity Incentive Plan
(Performance Plan) whereby up to 1,000,000 shares of the Companys common stock may be issued
under the Performance Plan. The Board of Directors approved the grant of 870,000 shares of the
Companys common stock under the Performance Plan, subject to stockholder approval of the
Performance Plan. The grant of the 870,000 shares is also subject to the attainment of specific
comprehensive income targets during the five quarterly periods beginning with the quarter ended
December 31, 2008. Because stockholder approval of the Performance Plan is required, expense
related to options earned for periods prior to the receipt of such approval will not be recorded
until the approval is obtained. As of March 31, 2009, the Companys stockholders have not approved
the Performance Plan. Of the shares available under the performance
plan, 174,000 shares of the Companys common stock have been
earned and 174,000 are expected to be forfeited, based on
managements preliminary review of the comprehensive
income targets for the fourth quarter of 2008 and the first quarter of 2009, respectively.
Also, on January 7, 2009, the Company granted 120,000 shares of common stock to the Companys
independent directors, subject to stockholder approval. The grant of the 120,000 shares is based on
performance through 2008. However, because shareholder approval is required, the shares will be
expensed when the approval is obtained. As of March 31, 2009, the Companys stockholders have not
approved this grant of common stock to the Companys independent directors.
For the three months ended March 31, 2009 and 2008, the Company recorded share-based compensation
expense of $157,155 and $105,542, respectively. Substantially all of such compensation expense is
reflected in the accompanying condensed consolidated statements of operations and comprehensive
loss within the selling, general and administrative
19
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Three Months Ended March 31, 2009 and 2008
line item. Share-based compensation expense recognized in the periods presented is based on awards
that have vested or are ultimately expected to vest. Historically, options have vested upon grant,
thus it was not necessary for management to estimate forfeitures. Options granted in 2008 vest
ratably over 24 months. Based on historical turnover rates and the vesting pattern of the options,
the Companys management has assumed that there will be no forfeitures of unvested options.
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. The Black-Scholes model requires subjective assumptions,
including future stock price volatility and expected time to exercise, which greatly affect the
calculated values. The expected volatility is based on the historical volatility of the Companys
stock price. 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 Company does not expect to pay dividends in the
foreseeable future, thus the dividend yield is zero. These factors could change in the future,
affecting the determination of stock-based compensation expense in future periods.
The Company did not grant options in the three months ended March 31, 2009. The Company used the
following weighted-average assumptions in determining fair value of its employee and director stock
options granted in the three months ended March 31, 2008:
|
|
|
|
|
Expected volatility
|
|
|
111
|
%
|
Expected term
|
|
5 years
|
Risk-free interest rate
|
|
|
2.48
|
%
|
Dividend yield
|
|
|
|
%
|
The weighted-average grant date fair value of employee and director stock options granted during
the three months ended March 31, 2008 was $2.35.
The following is a summary of the changes in stock options outstanding during the three months
ended March 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
Weighted
|
|
|
Average
|
|
|
|
|
|
|
|
Average
|
|
|
Remaining
|
|
|
|
|
|
|
|
Exercise
|
|
|
Contractual
|
|
|
|
Options
|
|
|
Price
|
|
|
Life (Years)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding, December 31, 2008
|
|
|
2,757,001
|
|
|
$
|
3.75
|
|
|
|
|
|
Expired
|
|
|
(245,000
|
)
|
|
|
6.15
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding, March 31, 2009
|
|
|
2,512,001
|
|
|
$
|
3.52
|
|
|
|
2.52
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and Exercisable at March 31, 2009
|
|
|
2,266,793
|
|
|
$
|
3.52
|
|
|
|
2.37
|
|
|
|
|
|
|
|
|
|
|
|
The aggregate intrinsic value of options outstanding at March 31, 2009, considering only options
with positive intrinsic values and based on the closing stock price, was $0.
At March 31, 2009, total unrecognized stock-based compensation cost related to unvested stock
options was $576,240, which is expected to be expensed over a weighted average period of 0.9 years.
20
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Three Months Ended March 31, 2009 and 2008
NOTE 11 FINANCING ACTIVITIES
Cash Financing Activities
The Company has funded its operations primarily through a series of Regulation S and Regulation D
companion offerings (the Offerings). The Offerings have historically consisted of units of one
share of common stock and warrants to purchase a number of shares of common stock equal to one-half
the number of shares of common stock included in the units (Units). The Units are priced at a
discount of 25% from the average closing prices of the Companys common stock for the five
consecutive trading days prior to the close of the offering, as quoted on the NYSE Alternext US
Exchange, and the exercise price of the warrants is set at 115% of the average closing price.
December 2007 Offering
In December, 2007, the Company conducted the closing of a private placement (December 2007
Offering) of Units. On March 5, 2008 the Company conducted the second closing of the December
2007 Offering. In the second closing the Company received $1,000,000 in aggregate gross proceeds
from the sale of a total of 323,626 units at $3.09 per unit and issued warrants to purchase 161,813
shares at an exercise price of $4.74 per share. In connection with the second closing of the
December 2007 Offering, the Company paid a finders fee of $100,000 and other expenses and fees of
$42,729, including $18,854 that were paid subsequent to the first quarter of 2008.
After the closing of the December 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 April
22, 2008.
Convertible Debt
In September 2008, the Company raised $2,084,401, net of cash issuance costs of $425,599, from the
issuance of Convertible Debt, consisting primarily of broker commissions and legal fees. See Note
7. Additionally, the Company issued broker warrants to purchase 209,166 shares at an exercise price
of $2.69, which were valued at $209,166. The warrants are exercisable after March 15, 2009. The
warrants issued were valued using the Black-Scholes option pricing model with the following
assumptions: expected volatility of 95%; risk-free interest rate of 2.59%; expected term of five
years; and dividend yield of 0%. The warrants were recorded as a component of additional paid-in
capital and debt issuance costs, included in other assets in the accompanying condensed
consolidated balance sheet. The Company has reserved approximately 3,796,000 shares for the
conversion of principal and interest due under the debt, and the shares issuable upon the exercise
of warrants that will be issued upon conversion of the debt.
Senior Notes Warrants
In December 2008, the Company issued warrants to purchase a total of 948,200 shares of the
Companys common stock at an exercise price of $1.00 per share in connection with the first closing
of the Senior Note financing. In January 2009, the Company issued warrants to purchase a total of
598,400 shares of the Companys common stock at an exercise price of $1.13 per share in connection
with the final closing of the Senior Note financing.
Non-Cash Financing Activities
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. The Shares were issued pursuant to an exemption under Section 4(2) of the
Securities Act. No underwriter was involved in this issuance. During the three months ended March
31, 2008, the Company recorded selling, general and administrative expense of $204,375 related to
the agreement.
On November 27, 2007, the Board of Directors authorized the issuance of 75,000 shares of common
stock to Boston Financial Partners Inc. pursuant to an amendment to the consulting agreement dated
September 16, 2003, for financial advisory services to be provided from November 1, 2007 through
October 31, 2008. The shares were valued at $336,000 based on the trading price of the common
stock on the measurement date. During the three months ended March 31, 2008, the Company recorded
general and administrative expense of $84,000 related to the agreement.
21
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Three Months Ended March 31, 2009 and 2008
On November 27, 2007, the Board of Directors authorized the issuance of up to 300,000 shares of
common stock, to be earned at the rate of 25,000 shares per month to Madden Consulting, Inc. for
financial advisory services to be provided from December 26, 2007 through December 26, 2008. The
Company issued 25,000 shares in the three months ended March 31, 2008 that were valued at $104,250
based on the trading price of the common stock on the measurement date. During the three months
ended March 31, 2008, the Company recorded general and administrative expense of $104,250 related
to the agreement and the January 2008 issuance of 25,000 shares. This agreement was terminated on
January 29, 2008 and the remaining obligation to issue 250,000 shares was cancelled.
On February 5, 2008, the Board of Directors authorized the issuance of 300,000 shares of common
stock to LWP1 pursuant to a consulting agreement dated February 3, 2008 for financial advisory
services to be provided from February 3, 2008 through May 3, 2009. The shares are issuable in two
increments of 150,000. The shares vest over a fifteen month period and are being valued monthly as
the shares are earned based on the trading price of the common stock on the monthly anniversary
date. In accordance with EITF 96-18,
Accounting for Equity Instruments that are Issued to Other
Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services
(EITF 96-18), the
shares issued will be periodically valued through the vesting period. During the three months ended
March 31, 2009 and 2008, the Company recorded general and administrative expense of $55,000 and
$134,800 related to the agreement.
On June 17, 2008, the Company entered into an agreement for financial consulting services. In
connection with the agreement, the Company granted warrants to purchase 150,000 shares of common
stock at an exercise price of $3.50. The warrants, which were approved by the Companys board of
directors, were granted in partial consideration for financial consulting services, vests over a
twelve month period, and expire in five years. The warrants were initially valued at $315,000,
based on the application of the Black Scholes option valuation model with the following
assumptions: expected volatility of 95%; average risk-free interest rate of 3.66%; expected term of
5 years; and dividend yield of 0%. In accordance with EITF 96-18, the warrants will be periodically
revalued through the vesting period. As of March 31, 2009, the estimated cumulative value of the
vested and unvested warrants, based on the periodic revaluation, is $116,000. The value of the
vested portion of the warrants is recorded to additional paid in capital and prepaid expense in the
month that vesting occurs. The resulting prepaid asset is being expensed over the 36 month term of
the consulting contract. The Company recognized $11,134 of expense in the quarter ended March 31,
2009 with respect to the warrants. Additionally, $75,139 related to vested warrants that have not
been expensed based on the 36 month term of the consulting agreement is included in prepaid
consulting at March 31, 2009.
On January 22, 2009, the Company entered into an agreement with B&D Consulting for investor
relations services through July 7, 2010. The Company granted B&D Consulting 400,000 shares of the
Companys common stock in exchange for services. In accordance with EITF 96-18, the shares issued
will be periodically valued through the vesting period. During the three months ended March 31,
2009, the Company recorded general and administrative expense of $29,665 related to the agreement.
On March 31, 2009, the Company issued 12,500 shares of the Companys common stock to a consultant
for investor relations services. The Company recorded $10,126 of expense in the quarter ended
March 31, 2009 with respect to the shares issued, based on the value of the stock at the date the
shares were earned.
Warrants
A summary of activity with respect to warrants outstanding follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
Average
|
|
|
|
|
|
|
|
Exercise
|
|
|
|
Warrants
|
|
|
Price
|
|
|
|
|
|
|
|
|
|
|
Outstanding, December 31, 2008
|
|
|
5,252,699
|
|
|
$
|
3.38
|
|
Issued
|
|
|
598,400
|
|
|
|
1.13
|
|
|
|
|
|
|
|
|
Outstanding, March 31, 2009
|
|
|
5,851,099
|
|
|
$
|
3.15
|
|
|
|
|
|
|
|
|
22
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Three Months Ended March 31, 2009 and 2008
NOTE 12 SEGMENT REPORTING
The Company evaluates performance based on sales, gross profit and income (loss) before
discontinued operations. In 2009, the Company has two reportable segments: (i) China, which
consists of manufacturing and wholesale distribution of pharmaceutical and cosmetic products to
distributors, hospitals, clinics and similar institutional entities in China, and (ii) Corporate,
which comprises the development of in-vitro diagnostics and the Companys CIT technology, as well
as the development of the Companys HPE-based products for markets outside of China. The 2008
segment information has been restated to eliminate separate reporting for China-Direct, a retail
concept that was under development, but abandoned in favor of an expanded distributor-based
strategy in 2008. The results previously reported for China-Direct have been combined with China.
The following is information for the Companys reportable segments for the three months ended March
31, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
China
|
|
Corporate
|
|
Total
|
Net revenue
|
|
$
|
2,688,667
|
|
|
$
|
23,070
|
|
|
$
|
2,711,737
|
|
Gross profit
|
|
$
|
1,111,169
|
|
|
$
|
14,995
|
|
|
$
|
1,126,164
|
|
Depreciation
|
|
$
|
206,387
|
|
|
$
|
13,901
|
|
|
$
|
220,288
|
|
Amortization
|
|
$
|
107,153
|
|
|
$
|
25,000
|
|
|
$
|
132,153
|
|
Interest expense
|
|
$
|
55,702
|
|
|
$
|
178,515
|
|
|
$
|
234,217
|
|
Income (loss) before discontinued operations
|
|
$
|
398,564
|
|
|
$
|
(2,336,681
|
)
|
|
$
|
(1,938,117
|
)
|
Identifiable assets of continuing operations
|
|
$
|
35,579,385
|
|
|
$
|
3,071,494
|
|
|
$
|
38,650,879
|
|
Capital expenditures
|
|
$
|
300,719
|
|
|
$
|
106,437
|
|
|
$
|
407,156
|
|
The following is information for the Companys reportable segments for the three months ended March
31, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
China
|
|
Corporate
|
|
Total
|
Net revenue
|
|
$
|
2,932,973
|
|
|
$
|
8,220
|
|
|
$
|
2,941,193
|
|
Gross profit
|
|
$
|
1,422,229
|
|
|
$
|
1,423
|
|
|
$
|
1,423,652
|
|
Depreciation
|
|
$
|
174,787
|
|
|
$
|
2,328
|
|
|
$
|
177,115
|
|
Amortization
|
|
$
|
102,530
|
|
|
$
|
25,000
|
|
|
$
|
127,530
|
|
Interest expense
|
|
$
|
83,616
|
|
|
$
|
905
|
|
|
$
|
84,521
|
|
Income (loss) before discontinued operations
|
|
$
|
739,049
|
|
|
$
|
(2,417,586
|
)
|
|
$
|
(1,678,537
|
)
|
Capital expenditures
|
|
$
|
297,346
|
|
|
$
|
2,306
|
|
|
$
|
299,652
|
|
At December 31, 2008, identifiable assets associated with continuing operations of the China and
Corporate segments totaled $35,803,941 and $3,723,335, respectively, and $39,527,276 in the
aggregate.
Virtually all of the Companys revenues for the three months ended March 31, 2009 and 2008 were
from foreign customers.
23
AMDL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the Three Months Ended March 31, 2009 and 2008
NOTE 13 RELATED PARTY TRANSACTIONS
At March 31, 2009 and December 31, 2008, the Company has a receivable of $10,093 and $9,693,
respectively, due from certain former directors of YYB and JJB for advances. These advances are
non-interest bearing and are due on demand.
NOTE 14 SUBSEQUENT EVENTS
On May 4, 2009, the Company conducted a first closing (First Closing) of a private offering for
the sale of units consisting of $1,327,250 principal amount of 12% Series 2 Senior Notes (Series 2
Notes) and five year warrants to purchase a total of 2,123,600 shares of the Companys common
stock at $0.98 per share (the Warrant Shares).
In connection with the offer and sale of securities to the purchasers in the First Closing of the
offering, the Companys exclusive placement agent was Cantone Research, Inc., a FINRA member broker
dealer. Cantone Research, Inc. and all participating brokers received aggregate cash sales
commissions of $132,725 and $39,818 in non-accountable expenses for services in connection with the
First Closing. In addition, in the First Closing the Company issued placement agent warrants to
purchase a total of 212,360 shares. In connection with the offering, the Company agreed to file a
registration statement by July 31, 2009 with the Securities and Exchange Commission on Form S-3
covering the resale of all of the Warrant Shares sold in the offering.
24
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Our management intends for this discussion and analysis to provide the reader with information
that will assist in understanding our financial statements, the changes in certain key items in
those financial statements from period to period, and the primary factors that accounted for those
changes, as well as how certain accounting principles affect our financial statements. The
following discussion and analysis should be read in conjunction with our financial statements and
notes thereto included in this report on Form 10-Q and in our Annual Report on Form 10-K for the
year ended December 31, 2008. Operating results are not necessarily indicative of results that may
occur in future periods.
This report includes various forward-looking statements that are subject to risks and
uncertainties, many of which are beyond our control. Our actual results could differ materially
from those anticipated in these forward looking statements as a result of various factors,
including, but not limited to, risks associated with doing business in China and internationally,
demand for our products, governmental regulation and required licensing of our products and
manufacturing operations, dependence on distributors, foreign currency fluctuation, technological
changes, intense competition and dependence on management and those risks set forth below under
Part II Item 1A Risk Factors and set forth in Part I Item 1A Risk Factors in our Annual
Report on Form 10-K for the year ended December 31, 2008. Forward-looking statements discuss
matters that are not historical facts and include, but are not limited to, discussions regarding
our operating strategy, sales and marketing strategy, regulatory strategy, industry, economic
conditions, financial condition, liquidity and capital resources and results of operations. Such
statements include, but are not limited to, statements preceded by, followed by or that otherwise
include the words believes, expects, anticipates, intends, estimates, projects, can,
could, may, will, would, or similar expressions. For those statements, we claim the
protection of the safe harbor for forward-looking statements contained in the Private Securities
Litigation Reform Act of 1995. You should not unduly rely on these forward-looking statements,
which speak only as of the date on which they were made. They give our expectations regarding the
future, but are not guarantees. We undertake no obligation to update publicly or revise any
forward-looking statements, whether because of new information, future events or otherwise, unless
required by law.
Overview
The Company
We are an integrated pharmaceutical company with three distinct business divisions that
include: (i) IV Diagnostics, (ii) China-based Integrated Pharmaceuticals and (iii) Cancer
Therapeutics. Collectively, these business units focus on the development, manufacturing,
distribution and sales of high quality generic pharmaceuticals, nutritional supplements, cosmetic
and medical diagnostic products in the U.S., China, Korea, Taiwan and other markets throughout the
world. We currently employ approximately 500 people, of which 490 are located in China.
25
IV Diagnostics
DR-70 Test Kit
AMDL was founded in 1987 as a bio-tech research and development firm that had one product, its
proprietary DR-70 test kit. On July 3, 2008, we received a letter of determination from the USFDA
that the DR-70 test kit was substantially equivalent to the existing predicate device,
carcinoembryonic antigen, being marketed. The determination letter grants us the right to market
the DR-70 test kit as a device to monitor patients who have previously been diagnosed with
colorectal cancer. We are attempting to sell our DR-70 test kit to reference and clinical
laboratories in the U.S. and internationally.
License Agreement with MyGene International, Inc.
On April 3, 2008, we announced that we had entered into an exclusive sublicense (subject to
certain terms and conditions) agreement with MyGene International, Inc. (MGI, USA) for the MyHPV
chip kit, a diagnostic product for screening cervical cancer through in-vitro genotype testing in
women with the Human Papilloma Virus (HPV). The agreement between us and MGI provided for an
exclusive sublicense to use the patents, trademark, and technology in manufacturing, promoting,
marketing, distributing, and selling the MyHPV chip kit in the countries of China (including Hong
Kong), Taiwan, Singapore, Malaysia, Thailand, Cambodia, and Vietnam. This agreement is considered
null and void as of the original date of execution because MGI did not have direct ownership of the
intellectual property necessary to offer the sub-license to AMDL. We are exploring the opportunity
to become the exclusive distributor of the MyHPV chip kit in the countries noted previously through
an agreement with BIOMEDLAB (BML) of Seoul, South Korea. BML is the manufacturer of the MyHPV chip
kit in South Korea, which has Korean FDA approval for this product.
The MyHPV Chip Kit
The MyHPV chip kit was approved as a diagnostic reagent for use in Korea by the Korean Food
and Drug Administration (KFDA). The test can diagnose HPV infection and each genotype of HPV at
the same time. The features of MyHPV chip kit include:
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pre-diagnosis of cervical cancer;
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diagnosis of HPV infection and the genotype of HPV infection;
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diagnosis for low copy of HPV infection;
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diagnosis of multiple HPV infections;
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simple and easy sample collecting;
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accurate and prompt results; and
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identification of a total of 24 types of HPV infections.
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Regulatory Approval of the MyHPV Chip Kit
We expect that under the terms of any new agreement with BML, we would be required to obtain
all regulatory market approvals necessary to import, market, promote and sell the MyHPV chip kit in
any of the markets covered by the agreement if an agreement with BMI is consummated.
Research and Development
During the quarter ended March 31, 2009, we spent $92,684 on research and development related
to the DR-70 test kit, as compared to $8,695 for the same period in 2008. These expenditures were
incurred as part of the Companys efforts to improve the existing DR-70 test kit and develop the
next generation DR-70 test kit.
We expect expenditures for research and development to grow in 2009 due to additional staff
and consultants needed to support an agreement with Mayo Clinic to conduct a clinical
study for the validation of AMDLs next generation version of its USFDA-approved DR-70 test kit.
Through this validation study, AMDL and Mayo Clinic will perform clinical diagnostic testing to
compare AMDLs DR-70 test kit with a newly developed, next generation test. The primary goal of the
study is to determine whether AMDLs next generation DR-70 test kit serves as a higher-performing
test to its existing predicate test and can lead to improved accuracy in the detection of
early-stage cancers.
For USFDA regulatory approval on the new test, AMDL intends to perform an additional study to
demonstrate the safety and effectiveness of the next generation test for monitoring colorectal
cancer. The validation study will run for three months and final results are expected in the third
or fourth quarter of 2009. In addition, additional expenses will be incurred for consultants and
laboratories for the reformulation of the HPE-based cosmetics as well as laboratories involved in
testing the safety and effectiveness of the product.
26
China-based Integrated Pharmaceuticals
Through JPI, we manufacture and distribute generic, homeopathic over-the-counter
pharmaceutical products and supplements. JPI manufactures and distributes its products through JJB
and YYB.
Discontinued Operations and Assets Held for Sale
On January 22, 2009, our board of directors authorized management to sell the operations of
YYB. In accordance with SFAS 144, we classified the assets, liabilities, operations and cash flows
of YYB as discontinued operations for all periods presented. Management is in the process of
negotiating a sale transaction. Based on preliminary estimates of the proceeds from the sale,
there has been no adjustment to the carrying value of the net assets of YYB at March 31, 2009.
The following table summarizes the carrying amount at March 31, 2009 and December 31, 2008 of
the major classes of assets and liabilities of the Companys business classified as discontinued
operations:
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March 31,
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December 31,
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2009
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2008
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Current assets:
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Accounts receivable, net
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$
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892,229
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$
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930,769
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Inventories
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476,839
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423,842
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Other current assets
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3,241
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80,410
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$
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1,372,309
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$
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1,435,021
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Long-lived assets:
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Property and equipment
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$
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1,733,179
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$
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1,742,739
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Other
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46,867
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47,195
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$
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1,780,046
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$
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1,789,934
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Current liabilities:
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Accounts payable and accrued liabilities
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$
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463,979
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$
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685,360
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Debt
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466,740
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466,155
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$
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930,719
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$
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1,151,515
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Operations of JJB
JJB manufactures and markets numerous diagnostic, pharmaceutical, nutritional supplement and
cosmetic products. JJB is acquiring production rights for other pharmaceutical products which will
require the approval of the SFDA. Historically, the top selling products in China are HPE-based
Solutions (anti-aging cosmecutical), Domperidone (anti-emetic), Levofloxacin Lactate Injections (IV
antibiotics) and Glucose solutions (pharmaceutical).
Facilities
The SFDA requires that all facilities engaged in the manufacture of pharmaceutical products
obtain GMP certification. In February 2008, JJBs GMP certification expired for the small volume
parenteral solutions injection plant lines that were engaged in manufacturing the Companys HPE
injectible product, Goodnak, and all other small volume parenteral solutions. JJB ceased small
volume parenteral solutions operations at this facility while undertaking $1.5 million in
modifications necessary to bring the facility and its operations into compliance. The renovations
are almost complete and JJB expects to resume operation of the parenteral small injectible lines in
the second quarter of 2009.
We were notified by the Chinese Military Department of its intent to annex one of JJBs plants
that is located near a military installation. The proposed area to be annexed contains the
facilities that are used to manufacture large and small volume parenteral solutions, including the
production lines for which the Company is attempting to obtain GMP certification. Discussions
regarding annexation are proceeding and we expect that JJB will be compensated fairly for
27
the facility upon annexation. JJB intends to find a new single center site in Jiangxi
Province, China to relocate its operations and combine them with operations related to any product
lines retained from YYBs manufacturing, sales and distribution operations after the sale of YYB.
The extent of any product lines retained from the sale of YYB cannot be determined, as we are in
negotiations for the sale of YYB. For purposes of reporting the results of discontinued
operations, we have assumed that all product lines manufactured and sold by YYB will be sold with
the business. We may have to spend significant time and resources finding, building and equipping
the new location and restarting the relocated operations. In addition, such new facilities will
need to obtain GMP certification for all manufacturing operations.
Marketing and Distribution
JJB has established a marketing program consisting of approximately forty sales managers and a
network of distributors who market JJBs products.
JJB sells directly to hospitals and retail stores and indirectly to other customers through
distributors. One primary distributor has 29 retail outlets throughout China. JJB is developing
educational programs for hospitals, doctors, clinics and distributors with respect to JJBs product
lines. These educational programs are intended to improve sales and promotion of JJBs products.
As JJBs resources permit, both JJB and YYB, to the extent certain product lines are retained
after the proposed sale of 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.
New Beauty Formulations of the HPE-Based Anti-Aging Product
During 2008, JJB finalized the formulations of the following HPE-based cosmetic products:
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Hydrating Firming Cream (Dry-Mix skin)
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Hydrating Firming Cream (Oily skin)
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Renergie Hydrating Cleanser
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Intense Hydrating Cleanser
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Visable Renewing Hydrating Softener
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Smoothing Renewing Eye Moisturizer
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These new products consist of capsules and an easy-to-apply lotion version and are marketed
under the trade name Nalefen Skin Care. These new products complement our existing high quality
injectible and extract formulations. Additionally, the Company has contracted with YiBo to develop
a capsule version of the Goodnak product.
We plan to sell both products through both new and existing distribution channels within the
Henan, Sichuan, Guizhou, Shanxi, Xinjiang, Gansu, Hunan, Zhejiang, Fujian, Liaoning and
Heilongjiang Provinces of China. Together these regions have a combined population of more than 376
million people.
Distribution Channels for Beauty Product Lines
During the third quarter 2008, JJB entered into distribution agreements with four beauty
product distribution companies to open new distribution lines. Sales to these distributors in
2008 consisted primarily of our HPE Solutions. In order to support the development of this channel,
the distribution agreements included an allowance for the promotion and marketing of new
Goodnak/Nalefen line of skin care lotions.
This allowance was necessary to develop extensive distribution of the Nalefen line. In
addition to the allowance described above, the Company granted distributors of the Nalefen line
payment terms of 120 days.
28
The existing contracts expired and JJB is currently in negotiations to renew the agreements.
As a result, revenue in the first quarter of 2009 was adversely impacted, as there were no sales of
HPE solutions. We anticipate that the new lotion formulations will also be sold through these same
distributors in mid or late 2009, when the new contracts are finalized and the products are
launched. We may have to offer additional allowances at that time.
In addition to China, we believe that some of the beauty products will be good candidates for
export to the North American and South American markets. We entered into an agreement with a U.S.
cosmetic laboratory that is assisting in reformulation of the Chinese based formula for the U.S.
and South American markets. Subsequent to the reformulation, the products will be tested at a US
laboratory for safety and effectiveness. It is estimated that this process will be complete by the
end of the third quarter of 2009.
The Current Chinese Economic and Market Environment
We operate in a challenging economic and regulatory environment that has undergone significant
changes in technology and in patterns of global trade. The current economic and market environment
in China is uncertain. In its January 28, 2009 report, the International Monetary Fund estimated
that Chinas economy will grow at a rate of approximately 6.7 percent in 2009, as measured by the
gross domestic product. In addition, Chinas health care spending is projected to increase by
nearly 40% to $17.3 billion, with a government proposal to bring universal healthcare to 90% of its
1.3 billion citizens by 2011, as reported by the American Free Press. While this data appears
promising, the proposal, however, could result in additional controls over the pricing of certain
drugs which could, in turn, negatively impact our business prospects in China and the carrying
amount of production rights acquired from YiBo.
Research and Development
In the past, JJB entered into joint research and development agreements with outside research
institutes, but all of the prior joint research agreements have expired.
JJB has been in informal discussion with the local government in Nanchang, Jiangxi
Pharmaceutical Research Institute and the Academy of Military Medical Sciences to create a Cancer
Therapeutic & Rapid Test Research and Development base. The laboratory will use the equipment,
facilities and human resources from Jiangxi Pharmaceutical Research institute together with
professional guidance from the Academy of Military Medical Sciences. Discussions are in a
preliminary stage, and the potential impact on our operations cannot be ascertained at this time.
Cancer Therapeutics
In 2001, AMDL acquired the CIT technology, which forms the basis for a proprietary cancer
vaccine. Our CIT technology is a U.S. patented technology (patent issued May 25, 2004). The Cancer
Therapeutics division is engaged in commercializing the CIT technology.
29
Critical Accounting Policies and Estimates
Our condensed consolidated financial statements have been prepared in accordance with
accounting principles generally accepted in the United States of America. The preparation of these
condensed consolidated 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 condensed consolidated 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 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 SFAS 144, 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 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 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 March 31, 2009. 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.
30
Revenue Recognition.
Revenues from the wholesale sales of over-the counter and prescription
pharmaceuticals are recognized when persuasive evidence of an arrangement exists, title and risk of
loss have passed to the buyer, the price is fixed or readily determinable and collection is
reasonably assured, provided the criteria in the Security and Exchange Commissions (SEC) Staff
Accounting Bulletin (SAB) No. 101
Revenue Recognition in Financial Statements
, (as amended by SAB
No. 104) are met.
In conjunction with the launch of the Companys Nalefen Skin Care HPE products, distributors
of the products were offered limited-time discounts to allow for promotional expenses incurred in
the distribution channel. Distributors are not required to submit proof of the promotional expenses
incurred. We account for the promotional expenses in accordance with EITF Issue No. 01-9,
Accounting for Consideration Given by a Vendor to a Customer (Including a Reseller of the Vendors
Products)
. Accordingly, the promotional discounts granted in prior periods were netted against
revenue in the condensed consolidated statements of operations and comprehensive loss. Accounts
receivable presented in the accompanying condensed consolidated balance sheets have been reduced by
the promotional discounts, as customers are permitted by the terms of the distribution contracts to
net the discounts against payments on the related invoices.
Any provision for sales promotion discounts and estimated returns are accounted for in the
period the related sales are recorded. 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. In accordance with 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 condensed consolidated
operating results and cash flows from operating activities.
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 when 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 condensed consolidated results of operations and comprehensive loss and cash
flows from operating activities.
Stock-Based Compensation Expense.
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
31
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.
We account for equity awards issued to employees in accordance with the provisions of SFAS No.
123(R),
Share-Based Payment
(SFAS 123(R)). SFAS 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 the portion expected to
vest as compensation expense over the period the employee is required to provide service in
exchange for the award, usually the vesting period.
Derivative Financial Instruments.
We apply the provisions of SFAS No. 133,
Accounting for
Derivative Instruments and Hedging Activities
(SFAS 133). Derivatives within the scope of SFAS
133 must be recorded on the balance sheet at fair value. We issued convertible debt in September
2008, and recorded a derivative asset related to the limitation on bonus interest rights held by
convertible debt holders in the event of a change in control or bankruptcy.
32
Results of Operations
Quarter Ended March 31, 2009 Compared to Quarter Ended March 31, 2008
Net Revenues.
For the quarter ended March 31, 2009, our aggregate net revenues from product
sales decreased 7.8% to $2,711,737 from $2,941,193 for the same period in 2008.
Corporate
Net revenues for the quarter ended March 31, 2009 for AMDL was $23,070 compared to $8,220 for
the same period in 2008. This increase is due to increased orders for the DR-70 test kits.
With USFDA approval of DR-70 test kit, we expect sales to increase in 2009. We are currently
in discussions with distributors for the DR-70 test kit. The proposed agreements would grant our
distributor an exclusive right to distribute the DR-70 test kit within the US, Canada and Latin
America. It is anticipated that one or more distribution agreements will be in place by the second
quarter of 2009.
The statement concerning future sales is a forward-looking statement that involves certain
risks and uncertainties which could result in sales below those achieved for the year ended
December 31, 2008. Sales of DR-70 test kits in 2009 could be negatively impacted by potential
competing products, lack of adequate supply and overall market acceptance of our products.
We are currently unable to conduct a marketing program for the DR-70 test kit to a limited
supply of one of the key components of the DR- 70 test kit. The anti-fibrinogen-HRP is limited in
supply and additional quantities cannot be purchased. We currently have two lots remaining which
are estimated to produce approximately 31,000 kits. Based on our current and anticipated orders,
this supply is adequate to fill all orders.
An integral part of our research and development through 2010 is the testing and development
of an improved version of the DR-70 test kit. The Company is reviewing various alternatives and
believes that a replacement anti-fibrinogen-HRP will be identified, tested and USFDA approved
before the current supply is exhausted.
Pilot studies show that the new version could be superior to the current version. It is
anticipated that this version will be submitted to the USFDA in the later half of 2010.
China
China net revenues were $2,688,667 for the quarter ended March 31, 2009 as compared to
$2,932,973 for the same period in 2008 primarily due the lack of sales of HPE solutions due to
cessation of production in the small injectible line and the expiration of contracts with beauty
distributors that sell topical HPE solution.
China sales by product as a percentage of total China sales were as follows:
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|
Three months ended March 31,
|
|
|
2009
|
|
2008
|
Domperidone Tablet
|
|
|
64
|
%
|
|
|
47
|
%
|
HPE Solutions
|
|
|
|
|
|
|
38
|
%
|
Levofloxacin Lactate Injection
|
|
|
12
|
%
|
|
|
6
|
%
|
GS Solution
|
|
|
8
|
%
|
|
|
2
|
%
|
GNS Solution
|
|
|
5
|
%
|
|
|
3
|
%
|
NaCl Solution
|
|
|
5
|
%
|
|
|
2
|
%
|
Compound Benzoic Acid and Camphor Solution
|
|
|
4
|
%
|
|
|
|
|
Other
|
|
|
2
|
%
|
|
|
2
|
%
|
33
We expect that the small injectible line will receive GMP recertification in the second
quarter of 2009. We are currently renegotiating the contracts with the beauty product
distributors.
Gross Profit.
The Companys gross profit for the quarter ended March 31, 2009 was $1,126,164
as compared to $1,423,652 for the quarter ended March 31, 2008. This decline was also due to the
decline in HPE solution sales.
Corporate
Gross profit increased approximately 953.8% to $14,995 for the quarter ended March 31, 2009
from $1,423 for the quarter ended March 31, 2008 due to increased sales volume of the DR-70 test
kit.
China
Chinas gross profit was $1,111,169 for the quarter ended March 31, 2009, a 21.9% decrease
over the same period in 2008 where gross profit was $1,422,229. Gross profit as compared to sales
decreased from 48.5% for the quarter ended March 31, 2008 to 41.3% for the quarter ended March 31,
2009. This decrease can be attributed to a change in the product mix which shifted away from those
produced on the small injectible manufacturing line and HPE Solutions to other less profitable
products, as well as an increase in the cost of raw materials and an increase in manufacturing
overhead.
The major components of cost of sales include raw materials, wages and salary and production
overhead. Production overhead is comprised of depreciation of building, land use rights, and
manufacturing equipment, amortization of production rights, utilities and repairs and maintenance.
Management anticipates future gross profit margins for the year ending December 31, 2009 for
China to increase due to the resumption of manufacturing at the JJBs small injectable line upon
the anticipated receipt of the GMP certification. 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,
2008. Gross profit could be negatively impacted by continued facility disruption, potential
competing products and overall market acceptance of the Companys products.
Research and Development.
In the past, JJB entered into joint research and development
agreements with outside research institutes, but all of the prior joint research agreements have
expired.
All research and development costs incurred during the quarter ended March 31, 2009 were
incurred by AMDL. These costs comprised of funding the necessary research and development of the
current DR-70 test kit and preparing for the next generation DR-70 test kit.
During the quarter ended March 31, 2009, we spent $92,684 on research and development related
to the DR-70 test kit, compared to $8,695 for the same period in 2008.
We expect research and development expenditures to increase during the remainder of 2009 due
to:
|
|
|
Additional expenditures for research and development is needed in China for SFDA approval
of DR-70 test kit and the need for clinical trials in China for SFDA approval of DR-70 test
kit;
|
|
|
|
|
The need for research and development for an updated version of the DR-70 test kit in the
US, clinical trials for such tests and funds for ultimate USFDA approval; and
|
|
|
|
|
Research and development for the HPE-based cosmetic product.
|
Selling, General and Administrative Expenses.
Selling
,
general and administrative expenses
for the Company were $2,590,769 for the quarter ended March 31, 2009 as compared to $2,797,947 for
the same period in 2008.
34
Selling, general and administrative expenses are anticipated to decrease in 2009 as AMDL is
initiating programs to review all contracts and agreements to reduce costs.
Corporate
We incurred selling, general and administrative expenses of $2,044,384 for the quarter ended
March 31, 2009 as compared to $2,408,892 for the same period in 2008. Corporate selling, general
and administrative expenses consist primarily 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 quarter ended March 31, 2009 of
approximately $157,000 for options issued to employees and directors and approximately $95,000 for
common stock, options and warrants issued to consultants for services. The decrease in selling,
general and administrative expense incurred is primarily a result of decreases in payroll expenses
and professional fees.
The table below details the major components of selling, general and administrative expenses
incurred at Corporate:
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31,
|
|
|
2009
|
|
2008
|
Investor relations (including value of warrants/options)
|
|
$
|
313,769
|
|
|
$
|
532,507
|
|
Salary and wages (including value of options)
|
|
$
|
647,944
|
|
|
$
|
887,933
|
|
Directors fees (including value of options)
|
|
$
|
96,377
|
|
|
$
|
206,025
|
|
Consulting fees
|
|
$
|
62,585
|
|
|
$
|
48,307
|
|
Accounting and other professional fees
|
|
$
|
326,428
|
|
|
$
|
273,618
|
|
Legal
|
|
$
|
206,224
|
|
|
$
|
174,049
|
|
China
China incurred selling, general and administrative expenses of $546,385 for the quarter ended
March 31, 2009 as compared to $389,055 for the same period as in 2008. Major components were
amortization, payroll and related taxes, transportation charges, meals and entertainment and
insurance. Selling, general and administrative expenses increased 40.4% for the quarter ended March
31, 2009 when compared to the same period 2008. The increase is primarily due to an increase in the
provision for bad debts of approximately $123,000 for the three months ended March 31, 2009
compared with the same period in 2008.
Interest Expense.
Interest expense for the quarters ended March 31, 2009 and 2008 was
$234,217 and $84,521, respectively. The increase relates to interest on our Convertible Debt
financing in September 2008 and the Senior Note financings in December 2008 and January 2009.
Corporate
Interest expense increased to $178,515 for the three months ended March 31, 2009 from $905 for
the same period in 2008 as a result of the issuance of our 10% Convertible Debt and 12% Senior
Notes.
China
JPI incurred interest expense of $55,702 and $83,616 for the quarter ended March 31, 2009 and
2008, respectively. These expenses represent interest paid to financial institutions in connection
with debt obligations. Approximately $2.3 million of debt was repaid by JPI in 2008, resulting in
a reduction in interest expense in 2009.
Loss before discontinued operations.
As a result of the factors described above, for the
quarter ended March 31, 2009 the Companys loss before discontinued operations was $1,938,117, or
$0.12 per share compared to the quarter ended March 31, 2008 when the Companys loss before
discontinued operations was $1,678,537, or $0.11 per share.
35
Results of Discontinued Operations
Summarized operating results of discontinued operations for the three months ended March 31, 2009
and 2008 are as follows:
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
2008
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
594,839
|
|
|
$
|
646,553
|
|
Income before income taxes
|
|
$
|
277,743
|
|
|
$
|
257,935
|
|
Included in income from discontinued operations, net are income tax expenses of $30,717 and $51,594
for the three months ended March 31, 2009 and 2008, respectively.
Liquidity and Capital Resources
From December 31, 2008 to March 31, 2009, our cash and cash equivalents increased by
$1,002,946, compared to a net decrease in cash and cash equivalents of $2,587,630 in the first
three months of 2008. We continue to attempt to raise
additional debt or equity financing as our operations historically have not produced sufficient
cash to offset the cash drain of growth in our pharmaceutical business and our general operating
and administrative expenses. Our US operations
require approximately $425,000 per month. Our China operations may not generate cash flow in the
future or such cash flows may not be available to support the US operations on a timely basis. To
the extent that funds are not available to meet these operating needs, we will have to restrict or
discontinue operations.
Operating activities
. We generated $739,535 from continuing operating activities in the three
months ended March 31, 2009, compared with cash used in continuing operating activities of
$1,926,938 for the three months ended March 31, 2008. Losses from continuing operations of
$1,938,117 and $1,678,537 for the periods ended March 31, 2009 and 2008, respectively, were offset
by non-cash expenses, including depreciation, amortization, debt discount accretion, stock-based
compensation to management, directors and consultants, warrant
revaluation and provision for bad debts of $923,861 and
$1,007,376 for the respective periods. However, the Company was able
to generate $1,753,751 in cash from continuing operating activities
from changes in operating assets and liabilities in the three months ended March 31, 2009, as compared to an investment of working
capital from changes in operating assets and liabilities of $1,255,777 for the three months ended March 31, 2008. The improvement in our working
capital position is primarily due to collections of accounts receivable. The Company granted 120
day terms to four large customers in the third and fourth quarter of 2008 which accommodation was
needed to properly market our Nalefen product line. These agreements expired in the first quarter
of 2009, and we are in the process of negotiating new contracts with these distributors. As a
result, the receivable balances are generating cash flow as payments are received, with no offset
for new credit granted.
As
of April 30, 2009, there was approximately $5,479,000 in accounts receivable aging in
excess of 120 days. The majority of these receivables are related to the beauty distributors that
were granted 120 day terms. Management in China has committed to closely monitoring the accounts
receivable aging and collection efforts. The cessation of revenues from the HPE solutions while
the renegotiations are taking place will have a materially negative impact on cash flow in the
second quarter of 2009.
Investing activities.
We used $407,156 in investing activities in the three months ended
March 31, 2009 compared with $289,897 in the three months ended March 31, 2008. In both periods,
we made expenditures in an effort to regain our GMP certification for JJBs small injectible
manufacturing lines. Renovations necessary for GMP recertification of the facility at JJB are
complete and recertification is expected to be received in the second quarter of 2009. In 2009, we
also acquired lab and office equipment for our U.S. facility to support our DR-70 test kit
initiatives.
Financing activities.
In the quarter ended March 31, 2009, we raised $566,600, net of
offering expenses, from the issuance of senior debt. We used $510,483 in financing activities in
the quarter ended March 31, 2008 through the repayment of $1,393,595 owed on bank debt in China,
offset by $883,112 in proceeds from the issuance of common stock and the exercise of warrants.
Future Capital Needs
We expect to incur additional capital expenditures at our China and U.S. facilities in 2009 in
the form of upgrading our information technology systems and additional manufacturing lines as well
as upgrading existing
manufacturing lines in China to enable additional products to be manufactured. It is
anticipated that these projects will be funded primarily through the proceeds of the expected sale
of YYBs manufacturing facilities, and the proceeds received from the military upon relocation of
JJBs facility that is subject to annexation, and secondarily through additional debt or equity
financing. In addition to the planned capital expenditures, China will require additional working
capital investment to support any growth in sales volume.
36
Funds will also be necessary in the U.S. to continue our collaboration with the Mayo Clinic
for clinical trials of the DR-70 test kit and /or for formulating, testing and advertising expense
related to the HPE-based cosmetic line.
Without completion of the sale of YYB and adequate reimbursement from the military for the
relocation of the JJB facility and/or additional debt or equity financing we will not be able to
fund the costs of any needed additional capital expenditures, our working capital needs or
additional or new research and development activities. There is no assurance we will be able to
generate sufficient funds internally or sell any debt or equity securities to generate sufficient
funds for these activities, or whether such funds, if available, will be obtained on terms
satisfactory to us. The Company may need to discontinue or delay its capital expenditures, research
activities and other investments if funds are not available to support managements operational
plans.
China Credit Facilities
When JPI acquired JJB and YYB, KangDa Pharmaceutical Company, a predecessor of JJB, had a
credit facility and bank loan from Industrial and Commercial Bank of China (ICBC) of
approximately RMB 38 million, or $4.7 million, (the KangDa Credit Facility), which was assumed by
JPI through agreement with KangDa. The assumption of the loan was not formalized with the bank,
however, the bank made a verbal agreement to allow the Company to continue under the original terms
of the credit agreement. The loan from ICBC is secured by a pledge of the real property on which
our Chinese manufacturing facilities are located. Currently, approximately $3.1 million is due and
payable on the KangDa Credit Facility. In March, 2009, we entered into an agreement with the bank
to extend the due date on approximately $2.5 million (RMB 17.2 million) to December 31, 2009. The
remaining $0.6 million debt, owed primarily by YYB, is due and payable.
Negotiations continue regarding the credit facility with banks in China. The delay in
obtaining this credit facility is due to a tight credit market due to the general economic market.
The credit market is expected to improve in the second half of 2009 at which time JPI will
re-evaluate the loan process. Should funding through credit facilities in China become available,
it will be used to finance the activities previously enumerated. No assurances can be given that
any additional credit facilities will be available from banks in China.
Going Concern
The condensed consolidated financial statements have been prepared assuming we 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. We incurred net losses before
discontinued operations of $1,938,117 and $1,678,537 for the three months ended March 31, 2009 and
2008, respectively, and had an accumulated deficit of $37,287,070 at March 31, 2009. In addition,
despite generating cash from operating activities of continuing operations of $739,535 for the
three months ended March 31, 2009, we used cash in operating activities of continuing operations of
$1,926,938 during the three months ended March 31, 2008.
On May 4, 2009, we closed the first tranche of our Series 2 note offering, generating net cash
proceeds of $92,900, before legal costs and regulatory fees. At May 10, 2009, we had cash on hand
in the U.S. and China of approximately $5,000,000. Our operations in China currently generate positive
cash from operations, but the availability of any cash from our operations in China and the timing
thereof may be uncertain. Our receivables in China have been outstanding for extended periods, and
we have experienced increased delays in collection. Our U.S. operations currently require
approximately $425,000 per month to fund the cost associated with our general U.S. corporate
functions, payment by corporate of the salaries of our executives in China, and the expenses
related to the further development of the DR-70 test kit. In lieu of reinvesting all cash flow from
Chinese operations in China, currently the necessary funds to meet our cash flow obligations in the
U.S. are being transferred from JPI and/or JJB to AMDL in the United States. Assuming (i) JJB does
not undertake significant new activities which require additional capital, (ii) the current level
of revenue from the sale of DR-70 test kits does not increase in the near future, (iii) we do not
conduct any full scale clinical trials for the DR-70 test kit or our CIT technology in the U.S. or
China, (iv) JPI continues to generate sufficient cash to exceed its cash requirements, (v) no
outstanding warrants are exercised, and (vi) no additional equity or debt financings are completed,
the amount of cash on hand is expected to be sufficient to meet our projected operating expenses on
a month to month basis as long as JPI or JJB continues to generate enough cash from operations that
can be timely sent to the U.S. to meet the cash needs of the Company in the U.S.
37
The monthly cash requirement does not include any extraordinary items or expenditures,
including payments to the Mayo Clinic on clinical trials for our DR-70 test kit or expenditures
related to further development of our CIT technology, as no significant expenditures are
anticipated other than the legal fees incurred in furtherance of patent protection for the CIT
technology.
Our near and long-term operating strategies focus on (i) obtaining SFDA approval for the DR-70
test kit, (ii) further developing and marketing of DR-70, (iii) funding the growth of JPIs
existing products, (iv) seeking a large pharmaceutical partner for our CIT technology, (v) selling
different formulations of HPE-based products in the U.S. and internationally and (vi) introduction
of new products. 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 our technologies, or other
business transactions that would generate sufficient resources to assure continuation of our
operations and research and development programs.
There are significant risks and uncertainties which could negatively affect our operations.
These are principally related to (i) the absence of a distribution network for our DR-70 test 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
line including the subsequent marketing of such product, (iii) the absence of any commitments or
firm orders from our distributors, (iv) possible disruption in producing products in China as a
result of relocation of our facilities and/or delays or failure in either the GMP recertification
process or the SFDA production license approval process and (v) credit risks associated with new
distribution agreements in China. Our limited sales to date for the DR-70 test kit and the lack of
any purchase requirements in the existing distribution agreements make it impossible to identify
any trends in our business prospects. Moreover, 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.
Our only sources of additional funds to meet continuing operating expenses, fund additional
research and development, complete the acquisition of production rights for new products, fund
additional working capital, and conduct clinical trials which may be required to receive SFDA
approval are the sale of securities, and cash flow generated from JPIs operations. We are actively
seeking additional debt or equity financing, but no assurances can be given that such financing
will be obtained or what the terms thereof will be. Additionally, there is no assurance as to
whether we will continue to conduct JPIs operations on a profitable basis or that JPIs operations
will generate positive cash flow. We may need to discontinue a portion or all of its operations if
we are unsuccessful in generating positive cash flow or financing for our operations through the
issuance of securities.
These items, among others, raise substantial doubt about our ability to continue as a going
concern. The condensed consolidated financial statements do not include any adjustments to reflect
the possible future effects on the recoverability and classification of assets or the amount and
classification of liabilities that may result from the outcome of this uncertainty.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not
required to provide the information required under this item.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures.
Our management, with the participation of our principal executive officer and principal
financial officer, has evaluated the effectiveness of our disclosure controls and procedures (as
such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of March 31, 2009.
Based on this evaluation, our principal executive officer and our principal financial officer
concluded that our disclosure controls and procedures subject to the limitations described in Form
10-K, were not effective at the reasonable assurance level during the period and as of the end of
the period covered by this quarterly report to ensure that information required to be disclosed by
us in reports that we file or submit under the Exchange Act is recorded, processed, summarized and
reported within the time periods specified in the SEC rules and forms and that such information is
accumulated and communicated to our management, including our principal executive officer and our
principal financial officer, as appropriate, to allow timely decisions regarding required
disclosures.
38
In the course of continuing our review of the effectiveness of our internal controls over
financial reporting at March 31, 2009, we identified the following material weaknesses that
individually or in the aggregate may materially affect our internal controls over financial
reporting:
a) We did not maintain effective controls to ensure there are adequate analysis,
documentation, reconciliation, and review of accounting records and supporting data.
b) We do not have adequate controls in place to identify and approve non-recurring
transactions such that the validity and proper accounting can be determined on a timely basis.
c) We do not have adequate procedures in place to detect related party transactions which
give rise to potential conflicts of interest.
d) A lack of clear policy regarding delegated authority has contributed to a lapse in
corporate oversight regarding such transactions.
The
Company has implemented and is in the process of testing the
following remediation plans;
1. authorized the addition of staff members and outside consultants with appropriate levels
of experience and accounting expertise to the finance department and information technology
department to ensure that there is sufficient depth and experience to implement and monitor the
appropriate level of control procedures related to all of our US and China locations;
2. taken steps to unify the financial reporting of all of our China entities and are in the
initial planning phase of upgrading, where possible, certain of our information technology
systems impacting financial reporting. We are currently planning further integration of
information technology policy and procedures and evaluating them as they impact all our
subsidiaries to provide accurate and complete financial reporting information;
3. hired an accounting manager for our Chinese operating entities who is familiar with
recording transactions in conformity with accounting principles generally accepted in the United
States of America and who reports to the Chief Financial Officer. Management will monitor the
progress of the accounting manager who will manage the process of instituting additional
procedures for future accounting periods that will cause transactions in China to be reported in
a timely manner and according to the appropriate accounting principles;
4. purchased and are instituting a company wide accounting software system that will
increase the efficiency of information transfer between JJB, YYB, JPI and AMDL. The
implementation process began in April of 2008 in the United States and will roll out to China by
mid-year 2009.
5. issued policies and procedures regarding the delegation of authority and conducted
training sessions with appropriate individuals at our subsidiary locations. We are monitoring the
implementation of such policies through detailed review of significant transactions on a
quarterly basis.
Notwithstanding the material weaknesses discussed above, our management has concluded that the
condensed consolidated financial statements included in this Quarterly Report on Form 10-Q fairly
present in all material respects the Companys financial condition, results of operations, and cash
flows for the period ended March 31, 2009 in conformity with accounting principles generally
accepted in the United States of America.
Changes in Internal Control Over Financial Reporting.
Except as set forth above, there have not been any changes in our internal control over
financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange
Act) during the three months ended March 31, 2009 that have materially affected, or are reasonably
likely to materially affect, our internal control over financial reporting.
39
AMDL, INC.
PART II OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
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 CIT
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 the Company 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 has performed extensive due diligence to
determine that AcuVector had no interest in the technology when the Company acquired it. The
Company has recently initiated action to commence discovery in this case, and AcuVector has taken
no action to advance the proceedings since filing the complaint in 2002. 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 condensed consolidated financial statements.
We are also defending a companion case filed in the same court by the Governors of the
University of Alberta against us and Dr. Chang. 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 us to Dr. Chang for the CIT 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 AMDL is not the owner of the CIT technology, just that the
University has an equitable interest therein for the revenues there from. As the final outcome is
not determinable, no accrual or loss relating to this action is reflected in the accompanying
condensed consolidated financial statements. No significant discovery has as yet been conducted in
the case.
Accordingly, if either AcuVector and/or the University is successful in their claims, we may
be liable for substantial damages, our rights to the technology will be adversely affected, and our
future prospects for exploiting or licensing the CIT technology will be significantly impaired.
ITEM 1A. RISK FACTORS
Our business involves significant risks which are described below.
Limited product development activities; our product development efforts may not result in
commercial products.
We intend to continue to pursue SFDA approval of the DR-70 test kit and licensing of our CIT
technology. Due to limited cash resources, we are limited in the number of additional products we
can develop at this time. Successful cancer detection and treatment product development is highly
uncertain, and very few research and development projects produce a commercial product. Product
candidates like the DR-70 test kit or the CIT technology that appear promising in the early phases
of development, such as in early animal or human clinical trials, may fail to reach the market for
a number of reasons, such as:
|
|
|
the product candidate did not demonstrate acceptable clinical trial results even though
it demonstrated positive preclinical trial results;
|
|
|
|
|
the product candidate was not effective in treating a specified condition or illness;
|
|
|
|
|
the product candidate had harmful side effects on humans;
|
|
|
|
|
the necessary regulatory bodies, such as the SFDA, did not approve our product candidate
for an intended use;
|
|
|
|
|
the product candidate was not economical for us to manufacture and commercialize; and
|
|
|
|
|
the product candidate is not cost effective in light of existing therapeutics.
|
40
Of course, there may be other factors that prevent us from marketing a product including, but
not limited to, our limited cash resources. We cannot guarantee we will be able to produce
commercially successful products. Further, clinical trial results are frequently susceptible to
varying interpretations by scientists, medical personnel, regulatory personnel, statisticians and
others, which may delay, limit or prevent further clinical development or regulatory approvals of a
product candidate. Also, the length of time that it takes for us to complete clinical trials and
obtain regulatory approval in multiple jurisdictions for a product varies by jurisdiction and by
product. We cannot predict the length of time to complete necessary clinical trials and obtain
regulatory approval.
Our
cash position in the U.S. and China as of May 10, 2009 of
approximately $5,000,000 is not
sufficient to fully implement all of our various business strategies for the DR-70 test kit or to
market the DR-70 test kit or our HPE-based products internationally by ourselves. Even if we are
successful in obtaining additional financing, and notwithstanding any cash generated from our
pharmaceutical operations in China which may be available to us, our short-term strategies are to
engage outside distributors and license our products to others, although there can be no assurances
that our products can be successfully licensed and/or marketed.
Our operations in China involve significant risk.
JJB and YYB operate as WFOEs in China. 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 us to incur additional expenditures or could impose additional
regulation on the prices charged for our pharmaceutical products, which could have a material
impact on our condensed consolidated financial position, results of operations and cash flows.
As in the case of JJB, the Chinese government has the right to annex or take facilities it
deems necessary. Currently, a portion of JJBs facility that produces large and small volume
parenteral solutions has been identified for annexation by the Chinese Military Department. The
outcome of this event cannot be predicted at this time, but if the Chinese government takes this
facility, although we expect that JJB will be compensated fairly for the facility, JJB will have to
spend significant time and resources finding another location and restarting those operations in
another area. We intend to consolidate JJB and any operations related to product lines retained
after the planned sale of YYB in a single facility in a new location. Such new location will need
to obtain GMP certification. Such annexation, or the threat of such annexation, may negatively
impact our results of operation and financial condition.
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
U.S. 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.
We may not be able to continue to operate our business if we are unable to attract additional
operating capital.
The current level of our revenues is not sufficient to finance all of our operations on a
long-term basis. We manage our cash generated from operations in China and currently transfer funds
previously advanced to JPI to meet our U.S. operating cash needs. We continue to attempt to raise
additional debt or equity financing as our operations do not produce sufficient cash to offset the
cash drain of growth in pharmaceutical sales and our general operating and administrative expenses.
Accordingly, our business and operations are substantially dependent on our ability to raise
additional capital to: (i) finance the costs of SFDA approval for the DR-70 test kit in China; (ii)
supply capital to JPI to move to new facilities; (iii) supply working capital for the expansion of
sales and the costs of marketing of new and existing products; and (iv) fund ongoing selling,
general and administrative expenses of our business. If we do not receive additional financing, or
if our China operations do not or cannot support our operating cash needs in the U.S., the Company
will have to restrict or discontinue certain operations in both China and the U.S. No assurances
can be given that our China pharmaceutical operations will generate enough cash to meet our cash
needs in the US to enable us to pay our continuing obligations when due or to continue to operate
our business.
41
At
May 10, 2009, we had cash on hand in the U.S. and China of
approximately $5,000,000. Our
operations in China currently generate positive cash from operations, but the availability of any
cash from our operations in China and the
timing thereof may be uncertain. Our receivables in China have been outstanding for extended
periods, and we have experienced delays in collection. Accordingly, there can be no assurances that
any funds from our China operations will be available to defray operating expenses in the U.S. in
the future. Our U.S. operations require approximately $425,000 per month to fund the costs
associated with our financing activities; SEC and NYSE reporting; legal and accounting expenses of
being a public company; other general administrative expenses; research and development, regulatory
compliance, and distribution activities related to DR-70 test kit; the operation of a USFDA
approved pharmaceutical manufacturing facility; the development of international distribution of
the Companys planned HPE-based cosmetics product line; and compensation of executive management in
the US and China. In lieu of reinvesting all cash flow from Chinese operations in China, currently
the necessary funds to meet our cash flow obligations in the United States are being transferred
from JPI and/or JJB to AMDL in the United States. Assuming (i) JJB and YYB do not undertake
significant new activities which require additional capital, (ii) the current level of revenue from
the sale of DR-70 test kits does not increase in the near future, (iii) we do not conduct any full
scale clinical trials for the DR-70 test kit or our CIT technology in the U.S. or China, (iv) JPI
continues to generate sufficient cash to meet or exceed its cash requirements, (v) no outstanding
warrants are exercised, and (vi) no additional equity or debt financings are completed, the amount
of cash on hand is expected to be sufficient to meet our projected operating expenses on a month to
month basis as long as JPI or JJB continues to generate enough cash from operations which can be
timely sent to the U.S. to meet the operating expenses of the Company in the U.S.
Our independent registered public accounting firm has included a going concern paragraph in their
report on our consolidated financial statements.
While our independent registered public accounting firm expressed an unqualified opinion on
our consolidated financial statements, our independent registered public accounting firm did
include an explanatory paragraph indicating that there is substantial doubt about our ability to
continue as a going concern due to our significant operating loss in 2007, our negative cash flows
from operations through December 31, 2008 and our accumulated deficit at December 31, 2008. Our
ability to continue as an operating entity currently depends, in large measure, upon our ability to
generate additional capital resources. In light of this situation, it is not likely that we will be
able to raise equity. While we seek ways to continue to operate by securing additional financing
resources or alliances or other partnership agreements, we do not at this time have any commitments
or agreements that provide for additional capital resources. Our financial condition and the going
concern emphasis paragraph may also make it more difficult for us to maintain existing customer
relationships and to initiate and secure new customer relationships.
Adverse conditions in the global economy and disruption in financial markets could impair our
revenues and results of operations.
As widely reported, financial markets in the United States, Europe and Asia have been
experiencing extreme disruption in recent months, including, among other things, extreme volatility
in security prices, severely diminished liquidity and credit availability, rating downgrades of
certain investments and declining valuations of others. These conditions have impaired our ability
to access credit markets and finance operations already. There can be no assurance that there will
not be a further deterioration in financial markets and confidence in major economies. We are
impacted by these economic developments, both domestically and globally, as our business requires
additional capital to build inventories and exploit new markets. In addition, the current
tightening of credit in financial markets adversely affects the ability of our customers to obtain
financing for significant purchases and operations, and has resulted in a decrease in orders for
our products, and increases the number of days outstanding of our accounts receivable in China. Our
customers ability to pay for our products may also be impaired, which may lead to an increase in
our allowance for doubtful accounts and write-offs of accounts receivable. We are unable to predict
the likely duration and severity of the current disruption in financial markets and adverse
economic conditions in the U.S., China and other countries. Should these economic conditions result
in us not meeting our revenue objectives, our operating results and financial condition could be
adversely affected.
Our current products cannot be sold in certain countries if we do not obtain and maintain
regulatory approval.
We manufacture, distribute and market our products for their approved indications. These
activities are subject to extensive regulation by numerous state and federal governmental
authorities in the U.S., such as the USFDA and the Centers for Medicare and Medicaid Services
(formerly Health Care Financing Administration) and the SFDA in China as well as by certain foreign
countries, including some in the European Union. Currently, we (or our distributors) are required
in the U.S. and in foreign countries to obtain approval from those countries regulatory
authorities before we
42
can market and sell our products in those countries. Obtaining regulatory
approval is costly and may take many years, and after it is obtained, it remains costly to
maintain. The USFDA and foreign regulatory agencies have substantial
discretion to terminate any clinical trials, require additional testing, delay or withhold
registration and marketing approval and mandate product withdrawals. In addition, later discovery
of unknown problems with our products or manufacturing processes could result in restrictions on
such products and manufacturing processes, including potential withdrawal of the products from the
market. If regulatory authorities determine that we have violated regulations or if they restrict,
suspend or revoke our prior approvals, they could prohibit us from manufacturing or selling our
products until we comply, or indefinitely.
Our future prospects will be negatively impacted if we are unsuccessful in pending litigation over
the CIT technology.
As noted above, we are engaged in litigation with AcuVector and with the Governors of the
University of Alberta over our CIT technology. Although these cases are still in the early stages
of discovery, we believe they are without merit and that we will receive a favorable judgment in
both. However, if either AcuVector or the University is successful in their claims, we may be
liable for substantial damages, our rights to the technology will be adversely affected, and our
future prospects for exploiting or licensing the CIT technology will be significantly impaired.
The value of intangible assets may not be equal to their carrying values.
One of our intangible assets includes the CIT technology, which we acquired from Dr. Chang in
August 2001. We also purchased certain intangible assets in our acquisition of JPI and purchased
additional production rights in 2007. Whenever events or changes in circumstances indicate that the
carrying amount may not be recoverable, we are required to evaluate the carrying value of such
intangibles, including the related amortization periods. Whenever events or changes in
circumstances indicate that the carrying value of an intangible asset may not be recoverable, we
determine whether there has been impairment by comparing the anticipated undiscounted cash flows
from the operation and eventual disposition of the product line with its carrying value. If the
undiscounted cash flows are less than the carrying value, the amount of the impairment, if any,
will be determined by comparing the carrying value of each intangible asset with its fair value.
Fair value is generally based on either a discounted cash flows analysis or market analysis. Future
operating income is based on various assumptions, including regulatory approvals, patents being
granted, and the type and nature of competing products.
Patent approval for eight original claims related to the CIT technology was obtained in May
2004 and a continuation patent application was filed in 2004 for a number of additional claims. No
regulatory approval has been requested for our CIT technology and we do not have the funds to
conduct the clinical trials which would be required to obtain regulatory approval for our CIT
technology. Accordingly, we are seeking a strategic partner to license the CIT technology from us.
If we cannot attract a large pharmaceutical company to license our CIT technology and conduct the
trials required to obtain regulatory approval, or if regulatory approvals or patents are not
obtained or are substantially delayed, or other competing technologies are developed and obtain
general market acceptance, or market conditions otherwise change, our CIT technology and other
intangible technology may have a substantially reduced value, which could be material. As
intangible assets represent a substantial portion of assets in our condensed consolidated balance
sheet, any substantial deterioration of value would significantly impact our reported condensed
consolidated financial position and our reported condensed consolidated operating results.
Some of the production right intangible assets purchased from YiBo by JPI have not yet
received manufacturing permits or been commercialized. We may have to recognize impairments of some
of these intangible assets in the future.
If our intellectual property positions are challenged, invalidated or circumvented, or if we fail
to prevail in future intellectual property litigation, our business could be adversely affected.
The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and
often involve complex legal, scientific and factual questions. To date, there has emerged no
consistent policy regarding breadth of claims allowed in such companies patents. Third parties may
challenge, invalidate or circumvent our patents and patent applications relating to our products,
product candidates and technologies. In addition, our patent positions might not protect us against
competitors with similar products or technologies because competing products or technologies may
not infringe our patents.
43
We face substantial competition, and others may discover, develop, acquire or commercialize
products before or more successfully than we do.
We operate in a highly competitive environment. Our products compete with other products or
treatments for diseases for which our products may be indicated. Additionally, some of our
competitors market products or are actively engaged in research and development in areas where we
are developing product candidates. Large pharmaceutical corporations have greater clinical,
research, regulatory and marketing resources than we do. In addition, some of our competitors may
have technical or competitive advantages over us for the development of technologies and processes.
These resources may make it difficult for us to compete with them to successfully discover, develop
and market new products.
We have limited sales of the DR-70 test kit and are reliant on our distributors for sales of our
products.
Prior to the acquisition of JPI, virtually all of our operating revenues came from sales to
two distributors of the DR-70 test kits in foreign countries and from sales to a few domestic
customers of certain OEM products. For the year ended December 31, 2008, and the quarter ended
March 31, 2009, virtually all of our revenues in the U.S. were derived from sales of DR-70 test
kits. Historically, we have not received any substantial orders from any of our customers or
distributors of DR-70 test kits. Moreover, none of our distributors or customers is contractually
required to buy any specific number of DR-70 test kits from us. Accordingly, based upon this fact,
historical sales, any projection of future orders or sales of DR-70 test kits is unreliable. In
addition, the amount of DR-70 test kits purchased by our distributors or customers can be adversely
affected by a number of factors, including their budget cycles and the amount of funds available to
them for product promotion and marketing.
JPI is reliant on its distributors for sales of its products.
Most of JPIs products are sold to distributors. JPIs distributors are not required to
purchase any minimum quantity of products; however, many of JPIs distribution agreements are
subject to termination and cancellation if minimum quantities of specified products are not
purchased by the distributors. JPI has never terminated any distributor for failure to meet the
minimum quantity sales targets.
We are subject to risks associated with our foreign distributors.
Our business strategy includes the continued dependence on foreign distributors for our DR-70
test kits and local distributors in China for JPIs products. To date, we have not been successful
in generating a significant increase in sales for DR-70 test kits through distribution channels in
existing markets or in developing distribution channels in new markets. We are also subject to the
risks associated with our distributors operations, including: (i) fluctuations in currency
exchange rates; (ii) compliance with local laws and other regulatory requirements; (iii)
restrictions on the repatriation of funds; (iv) inflationary conditions; (v) political and economic
instability; (vi) war or other hostilities; (vii) overlap of tax structures; and (viii)
expropriation or nationalization of assets. The inability to manage these and other risks
effectively could adversely affect our business.
We do not intend to pay dividends on our common stock in the foreseeable future.
We currently intend to retain any earnings to support our growth strategy and do not
anticipate paying dividends in the foreseeable future.
If we fail to comply with the rules under the Sarbanes-Oxley Act related to accounting controls
and procedures or if the material weaknesses or other deficiencies in our internal accounting
procedures are not remediated, our stock price could decline significantly.
Section 404 of the Sarbanes-Oxley Act required annual management assessments of the
effectiveness of our internal controls over financial reporting commencing December 31, 2007 and
requires a report by our independent registered public accounting firm addressing the effectiveness
of our internal control over financial reporting commencing for the year ending December 31, 2009.
Our management has concluded that the consolidated financial statements included in our Annual
Report on Form 10-K as of December 31, 2008 and 2007 and for the two years ended December 31, 2008,
fairly present in all
material respects our consolidated financial condition, results of operations
and cash flows in conformity with accounting principles generally accepted in the U.S.
44
Our management has evaluated the effectiveness of our internal control over financial
reporting as of December 31, 2008 and 2007 based on the control criteria established in a report
entitled Internal Control Integrated Framework,
issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this
evaluation, our management has concluded that our internal control over financial reporting was not
effective as of December 31, 2008 and 2007. During its evaluation, as of December 31, 2008 our
management identified material weaknesses in our internal control over financial reporting and
other deficiencies as described in Item 9A of our Annual Report on Form 10-K. As a result, our
investors could lose confidence in us, which could result in a decline in our stock price.
We are taking steps to remediate our material weaknesses, as described in Item 9A of our
Annual Report on Form 10-K. If we fail to achieve and maintain the adequacy of our internal
controls, we may not be able to ensure that we can conclude in the future that we have effective
internal controls over financial reporting in accordance with Section 404 of the Sarbanes-Oxley
Act. Moreover, effective internal controls, particularly those related to revenue recognition, are
necessary for us to produce reliable financial reports and are important to helping prevent
financial fraud. If we cannot provide reliable financial reports or prevent fraud, our business and
operating results could be harmed, investors could lose confidence in our reported financial
information, and the trading price of our stock could decline significantly. In addition, we cannot
be certain that additional material weaknesses or other significant deficiencies in our internal
controls will not be discovered in the future.
Our stock price is volatile, which could adversely affect your investment.
Our stock price, like that of other international bio-pharma and/or cancer diagnostic and
treatment companies, is highly volatile. Our stock price may be affected by such factors as:
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clinical trial results;
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product development announcements by us or our competitors;
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regulatory matters;
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announcements in the scientific and research community;
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intellectual property and legal matters;
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broader industry and market trends unrelated to our performance;
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economic markets in Asia; and
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competition in local Chinese markets where we sell JPIs product.
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In addition, if our revenues or operating results in any period fail to meet the investment
communitys expectations, there could be an immediate adverse impact on our stock price.
Our stock price and financing may be adversely affected by outstanding warrants and convertible
securities.
We have a significant number of warrants outstanding and a large amount of convertible notes
which over hang the market for the Companys common stock. As of March 31, 2009, we had (i)
warrants outstanding that are currently exercisable for up to an aggregate of 5,851,099 shares of
common stock at a weighted average of $3.15 per share, (ii) 2,530,917 shares of common stock
potentially issuable on conversion of our 10% convertible notes at $1.20 per share, and (iii)
warrants to purchase 1,265,458 shares of common stock issuable on conversion of the 10% convertible
notes at a formula price based on the market price on the date of conversion. The existence of,
and/or exercise of all or a portion of these securities, create a negative and potentially
depressive effect on our stock price because investors recognize that they over hang the market
at this time.
45
We have limited product liability insurance.
We currently produce products for clinical studies and for investigational purposes. We are
producing our products in commercial sale quantities, which will increase as we receive various
regulatory approvals in the future. There can be no assurance, however, that users will not claim
that effects other than those intended may result from our products, including, but not limited to
claims alleged to be related to incorrect diagnoses leading to improper or lack of treatment in
reliance on test results. In the event that liability claims arise out of allegations of defects in
the design or manufacture of our products, one or more claims for damages may require the
expenditure of funds in defense of such
claims or one or more substantial awards of damages against us, and may have a material
adverse effect on us by reason of our inability to defend against or pay such claims. We carry
product liability insurance for any such claims, but only in an amount equal to $2,000,000 per
occurrence, and $2,000,000 aggregate liability, which may be insufficient to cover all claims that
may be made against us.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
All unregistered sales of equity securities during the period of this quarterly report have
been disclosed in our Current Report on Form 8-K filed January 30, 2009.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
ITEM 5. OTHER INFORMATION
None.
ITEM 6. EXHIBITS
(a) Exhibits: See Exhibit Index herein
46
AMDL, INC.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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AMDL, INC.
(Registrant)
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Date: May 15, 2009
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By:
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/s/ Douglas C. MacLellan
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Douglas C. MacLellan, President and
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Chief Executive Officer (Principal Executive Officer)
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Date: May 15, 2009
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By:
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/s/ Akio Ariura
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Akio Ariura, Chief Operating Officer, Chief
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Financial Officer and Secretary (Principal
Financial Officer and Principal Accounting Officer)
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47
EXHIBIT INDEX
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Exhibit
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Number
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Description:
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31.1
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Certification of Chief Executive Officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002. (Filed
herewith.)
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31.2
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Certification of Chief Financial Officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002. (Filed herewith.)
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32.1
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Certification of Chief Executive Officer pursuant to 18
U.S.C. § 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002. (Filed herewith.)
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32.2
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Certification of Chief Financial Officer pursuant to 18
U.S.C. § 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002. (Filed herewith.)
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48
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