Advanced Biomedical Technologies Inc. - Quarter Report: 2009 April (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D. C. 20549
FORM
10-Q
x
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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 quarter ended April 30, 2009
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OR
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¨
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TRANSITION REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
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Commission file number 000-53051
Advanced
BioMedical Technologies, Inc.
(Exact
name of registrant as specified in its charter)
Nevada
(State or
other jurisdiction of incorporation or organization)
18
Lake Ridge Drive
Middletown,
NY 10940
(Address
of principal executive offices, including zip code.)
(718)
766-7898
(Registrant's
telephone number, including area code)
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the Registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days. YES x NO ¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a small reporting
company. See the definitions of “large accelerated filer,”
“accelerated filer” and “small reporting company” in Rule 12b-2 of the Exchange
Act.
Large
accelerated filer
|
¨
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Accelerated
filer
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¨
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Non-accelerated
filer
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¨
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Smaller
reporting company
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x
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Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Act). Yes ¨ No x
As of
June 12, 2009, there are 55,614,000 shares of common stock
outstanding.
All
references in this Report on Form 10-Q to the terms “we”, “our”, “us”, the
“Company”, “ABMT” and the “Registrant” refer to Advanced BioMedical
Technologies, Inc.
ITEM 1. FINANCIAL
STATEMENTS
The
accompanying condensed unaudited financial statements of Advanced BioMedical
Technologies, Inc., formerly known as Geostar Mineral Corporation, a Nevada
corporation are condensed and, therefore, do not include all disclosures
normally required by accounting principles generally accepted in the United
States of America. These statements should be read in conjunction with the
Company's most recent annual financial statements for the year ended October 31,
2008 included in our Annual Report on Form 10-K filed with the U.S.
Securities and Exchange Commission (“SEC”) on February 13, 2009. In the opinion
of management, all adjustments necessary for a fair presentation have been
included in the accompanying condensed financial statements and consist of only
normal recurring adjustments. The results of operations presented in the
accompanying condensed financial statements for the period ended April 30, 2009
are not necessarily indicative of the operating results that may be expected for
the full year ending October 31, 2009.
ADVANCED
BIOMEDICAL TECHNOLOGIES, INC
AND
SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS
AS OF
APRIL 30, 2009
(UNAUDITED)
ADVANCED
BIOMEDICAL TECHNOLOGIES, INC AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
CONTENTS
Pages
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Condensed
Consolidated Balance Sheets as of April 30, 2009 (unaudited) and October
31, 2008 (audited)
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F-1
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Condensed
Consolidated Statements of Operations and Comprehensive Loss for the three
months and six months ended April 30, 2009 and 2008 (unaudited) and the
period from inception September 25, 2002 through April 30, 2009
(unaudited)
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F-
2
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Consolidated
Statements of Cash Flows for the six months ended April 30, 2009 and 2008
(unaudited) and the period from inception September 25, 2002 through April
30, 2009 (unaudited)
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F-3
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Notes
to Condensed Consolidated Financial Statements (unaudited)
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F4-F9
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AND
SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
Assets
April 30 2009
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October 31 2008
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Unaudited
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Audited
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CURRENT
ASSETS
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Cash
and cash equivalents
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$
86,805
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$
78,876
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Other
receivables and prepaid expenses
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15,936
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8,161
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Total
Current Assets
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102,741
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87,037
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PROPERTY
AND EQUIPMENT, NET
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78,726
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80,743
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TOTAL
ASSETS
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$ 181,467
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$ 167,780
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LIABILITIES AND STOCKHOLDERS'
DEFICIT
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CURRENT
LIABILITIES
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Other
payables and accrued liabilities
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$
19,768
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$
26,992
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Due
to a noncontrolling stockholder of a subsidiary
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4,501
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3,123
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Due
to a stockholder
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293,608
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85,156
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Due
to a director
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239,831
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251,713
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Due
to a related company
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390,625
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389,667
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Due
to a related party
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280,961
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161,553
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Total
Current Liabilities
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1,229,294
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918,204
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COMMITMENTS
AND CONTINGENCIES
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-
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-
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EQUITY
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||
ABMT
Shareholder's equity
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||
Common
stock, $0.00001 par value, 100,000,000 shares authorized and 55,614,000
shares issued and outstanding as of April 30, 2009 and 50,510,000 shares
issued and outstanding as of October 31, 2008
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556
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505
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Additional
paid-in capital
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376,596
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392,074
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Accumulated
deficit during development stage
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(1,340,831)
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(1,060,813)
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Accumulated
other comprehensive loss
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(84,148)
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(82,190)
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Total
AMBT Stockholders' Deficit
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(1,047,827)
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(750,424)
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Noncontrolling
interests
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-
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-
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Total
Equity
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(1,047,827)
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(750,424)
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TOTAL
LIABILITIES AND STOCKHOLDERS' DEFICIT
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$181,467
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$
167,780
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The
accompanying notes are an integral part of these condensed consolidated
financial statements
ADVANCED
BIOMEDICALTECHNOLOGIES, INC AND SUBSIDIARIES
(A
DEVELOPMENT STAGE COMPANY)
FINANCIAL STATEMENTS
(UNAUDITED)
NOTE
1 BASIS OF PRESENTATION
The
accompanying unaudited condensed consolidated financial statements have been
prepared in accordance with accounting principles generally accepted in the
United States of America for interim financial information. Accordingly, they do
not include all of the information and footnotes required by generally accepted
accounting principles for complete financial statements.
In the
opinion of management, the unaudited condensed consolidated financial statements
contain all adjustments consisting only of normal recurring accruals considered
necessary to present fairly the Company's financial position at April 30, 2009,
the consolidated results of operations for the three and six months ended April
30, 2009 and 2008 and for the period from September 25, 2002 (inception) to
April 30, 2009 and consolidated statements of cash flows for the six months
ended April 30, 2009 and 2008 . The consolidated results for the three months
and six months ended April 30, 2009 are not necessarily indicative of the
results to be expected for the entire fiscal year ending October 31, 2009. These
consolidated financial statement should be read in conjunction with the
consolidated financial statements and notes for the year ended October 31, 2008
appearing in the Company's annual report on Form 10-K as filed with the
Securities and Exchange Commission on February 13, 2009.
NOTE
2 ORGANIZATION
Advanced
BioMedical Technologies, Inc. (fka “Geostar Mineral Corporation” or ”Geostar”)
(“ABMT”) was incorporated in Nevada on September 12, 2006.
Shenzhen
Changhua Biomedicine Engineering Company Limited (“Shenzhen Changhua”) was
incorporated in the People’s Republic of China (“PRC”) on September 25, 2002 as
a limited liability company with a registered capital of $724,017. Shenzhen
Changhua is owned by two stockholders in the proportion of 70% and 30%
respectively. Shenzhen Changhua plans to develop, manufacture and market
self-reinforced, re-absorbable degradable PA screws, robs and binding ties for
fixation on human fractured bones. The Company is currently conducting clinical
trials on its products and intends to raise additional capital to produce and
market its products commercially pending the approval from the State Food and
Drug Administration (“SFDA”) of the PRC on its products. The Company has no
revenue since its inception and, in accordance with Statement of Financial
Accounting Standard (“SFAS”) No. 7, “Accounting and Reporting by Development
Stage Enterprise,” is considered a Development Stage Company.
Masterise
Holdings Limited (“Masterise”) was incorporated in the British Virgin Islands on
May 31, 2007 as an investment holding company. Masterise is owned as to 63% by
the spouse of Shenzhen Changhua’s 70% majority stockholder and 37% by a third
party corporation.
On
January 29, 2008, Masterise entered into a Share Purchase Agreement (“the
Agreement”) with a stockholder of Shenzhen Changhua whereupon Masterise acquired
70% of Shenzhen Changhua for US$64,100 in cash. The acquisition was completed on
February 25, 2008. As both Masterise and Shenzhen Changhua are under common
control and management, the acquisition was accounted for as a reorganization of
entities under common control. Accordingly, the operations of Shenzhen Changhua
for the three months ended January 31, 2009 and 2008 were included in the
consolidated financial statements as if the transactions had occurred
retroactively.
On
December 31, 2008, ABMT consummated a Share Exchange Agreement (“the Exchange
Agreement”) with the stockholders of Masterise pursuant to which Geostar issued
50,000 shares of Common Stock to the stockholders of Masterise for 100% equity
interest in Masterise.
Concurrently,
on December 31, 2008, a major stockholder of ABMT also consummated an Affiliate
Stock Purchase Agreement (the “Affiliate Agreement”) with thirteen individuals
including all the stockholders of Masterise, pursuant to which the major
stockholder sold a total of 5,001,000 shares of Geostar’s common stock for a
total aggregate consideration of $5,000, including 4,438,250 shares to the
stockholders of Masterise.
On
consummation of the Exchange Agreement and the Affiliate Agreement, the 70%
majority stockholder of Masterise became a 80.7% stockholder of
ABMT.
The
merger of ABMT and Masterise is being treated for accounting purposes as a
capital transaction and recapitalization by Masterise (“the accounting
acquirer”) and a re-organization by ABMT (“the accounting acquiree”). The
financial statements have been prepared as if the re-organization had occurred
retroactively.
Accordingly,
these financial statements include the following:
(1)
|
The
balance sheet consisting of the net assets of the acquirer at historical
cost and the net assets of the acquiree at historical
cost.
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(2)
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The
statement of operations including the operations of the acquirer for the
periods presented and the operations of the acquiree from the date of the
transaction.
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ABMT,
Masterise and Shenzhen Changhua are hereinafter referred to as (“the
Company”)
NOTE
3 PRINCIPLES OF CONSOLIDATION
The
accompanying consolidated financial statements include the financial statements
of ABMT and its wholly owned subsidiaries, Masterise and its 70% owned
subsidiary, Shenzhen Changhua. The minority interests represent the
noncontrolling stockholders’ 30% proportionate share of the results of Shenzhen
Changhua.
All
significant inter-company balances and transactions have been eliminated in
consolidation.
NOTE
4 RELATED PARTY TRANSACTIONS
As of
April 30, 2009, the Company owed $293,608 to a stockholder which is unsecured
and repayable on demand. Interest is charged at 7% per annum on the amount
owed.
As of
April 30, 2009, the Company owed $280,961 to a related party which is unsecured
and repayable on demand. Interest is charged at 7% per annum on the amount
owed.
Total
interest expenses on advances from a stockholder and a related party accrued for
the three months and six months ended April 30, 2009 and 2008 and for the period
from September 25, 2002 (inception) through April 30, 2009 are $8,623, $210,
$13,740, $210 and $19,293 respectively.
As of
April 30, 2009, the Company owed $4,501 to a noncontrolling stockholder of a
subsidiary which is unsecured, interest free and repayable on
demand.
As of
April 30, 2009, the Company owed $239,831 to a director for advances made on an
unsecured basis, repayable on demand and interest free.
As of
April 30, 2009, the Company owed $390,625 to a related company on an unsecured
basis, repayable on demand and interest free.
Imputed
interest charged at 5% per annum on the amounts owed to a noncontrolling
stockholder of a subsidiary, a director, and a related company is $7,925, $8,351
$15,981, $15,735 and $133,053 for the three months and six months ended April
30, 2009 and 2008 and for the period from September 25, 2002 (inception) through
April 30, 2009 respectively.
NOTE
5 STOCKHOLDERS’ EQUITY
(A)
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Changes
in equity
|
The
following table summarizes the changes in equity for the six months ended April
30, 2009 (in thousands):
ABMT
Common
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|||||||
Stockholders'
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Noncontrolling
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Total
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|||||
Equity
|
Interests
|
Equity
|
|||||
Balance
at October 31, 2008
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$
|
(750)
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$
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-
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$
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(750)
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|
Common
stock
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|||||||
Additional
paid-in capital
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(15)
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-
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(15)
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||||
Net
loss for the period
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(280)
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-
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(280)
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||||
Other
comprehensive loss
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(2)
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-
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(2)
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||||
Balance
at April 30, 2009
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$
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(1,047)
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$
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-
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$
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(1,047)
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(B)
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Common
stock
|
On
December 31, 2008, the Company issued 510,400 shares of common stock in reverse
merger for the recapitalization of Masterise and re-organization of
ABMT.
On March
13, 2009, the Company’s Board of Directors authorized a stock split, effected as
a stock dividend, of ten shares of common stock for every one share
of common stock held by stockholders of record as of the close of business on
February 17, 2009. Following the stock split, the Company’s issued and
outstanding shares increased from 5,561,400 shares of common stock to 55,614,000
shares of common stock. All basic and diluted loss per share and average shares
outstanding information have been adjusted to reflect the aforementioned stock
dividend.
NOTE
6 RECENT ACCOUNTING PRONOUNCEMENTS
In
December 2007, the Financial Accounting Standards Board (FASB) issued SFAS
No. 141 (revised 2007), “Business Combinations” (“SFAS 141R”). SFAS 141R
establishes principles and requirements for how an acquirer recognizes and
measures in its financial statements the identifiable assets acquired, the
liabilities assumed, any non-controlling interest in the acquiree and the
goodwill acquired. SFAS 141R also establishes disclosure requirements to enable
the evaluation of the nature and financial effects of the business combination.
This statement is effective for use beginning January 1, 2009. The Company
does not expect adoption of SFAS 141R will have a material impact on its
financial position and results of operations.
In
December 2007, the FASB issued SFAS No. 160, “Non-controlling Interests in
Consolidated Financial Statements – an amendment of ARB No. 51” (“SFAS
160”). This statement improves the relevance, comparability, and
transparency of the financial information that a reporting entity provides in
its consolidated financial statements by establishing accounting and reporting
standards that require the ownership interests in subsidiaries held by parties
other than the parent and the amount of consolidated net income attributable to
the parent and to the non-controlling interest be clearly identified and
presented on the face of the consolidated statement of income, changes in a
parent’s ownership interest while the parent retains its controlling financial
interest in its subsidiary be accounted for consistently, when a subsidiary is
deconsolidated, any retained non-controlling equity investment in the former
subsidiary be initially measured at fair value, entities provide sufficient
disclosures that clearly identify and distinguish between the interests of the
parent and the interests of the non-controlling owners. SFAS 160
affects those entities that have an outstanding non-controlling interest in one
or more subsidiaries or that deconsolidate a subsidiary. SFAS 160 is
effective for fiscal years, and interim periods within those fiscal years,
beginning on or after December 15, 2008. Upon adoption of this statement, the
Company has recognized its noncontrolling interests as equity in the
consolidated balance sheets, has reflected net income attributable to
noncontrolling interests in consolidated net income and has provided, in Note
5(A), a summary of changes in equity attributable to noncontrolling interests,
changes attributable to ABMT and changes in total equity.
In March
2008, the FASB issued SFAS No. 161, “Disclosures about Derivative
Instruments and Hedging Activities, an amendment of FASB Statement No. 133”
(SFAS 161). This statement is intended to improve transparency in financial
reporting by requiring enhanced disclosures of an entity’s derivative
instruments and hedging activities and their effects on the entity’s financial
position, financial performance, and cash flows. SFAS 161 applies to
all derivative instruments within the scope of SFAS 133, “Accounting for
Derivative Instruments and Hedging Activities” (SFAS 133) as well as related
hedged items, bifurcated derivatives, and non-derivative instruments that are
designated and qualify as hedging instruments. Entities with instruments subject
to SFAS 161 must provide more robust qualitative disclosures and expanded
quantitative disclosures. SFAS 161 is effective prospectively for
financial statements issued for fiscal years and interim periods beginning after
November 15, 2008, with early application permitted. The Company does not
expect adoption of SFAS 161 will have a material effect on its financial
position and results of operations.
In
May 2008, the FASB released SFAS No. 162, “The Hierarchy of Generally Accepted
Accounting Principles.” SFAS No. 162 identifies the sources
of accounting principles and the framework for selecting the principles used in
the preparation of financial statements of non-governmental entities that
presented in conformity with generally accepted accounting principles in the
United States of America. SFAS No. 162 will be effective 60 days following the
SEC’s approval of the PCAOB amendments to AU Section 411, The Meaning of Present Fairly in
Conformity With Generally Accepted Accounting Principles. The
Company does not expect adoption of SFAS 162 will have a material effect on its
financial position and results of operations.
In May
2008, the FASB issued SFAS No. 163, “Accounting for Financial Guarantee
Insurance Contracts, an interpretation of FASB Statement No. 60.” The
scope of this Statement is limited to financial guarantee insurance (and
reinsurance) contracts, as described in this Statement, issued by enterprises
included within the scope of Statement 60. Accordingly, this Statement does not
apply to financial guarantee contracts issued by enterprises excluded from the
scope of Statement 60 or to some insurance contracts that seem similar to
financial guarantee insurance contracts issued by insurance enterprises (such as
mortgage guaranty insurance or credit insurance on trade receivables). This
Statement also does not apply to financial guarantee insurance contracts that
are derivative instruments included within the scope of FASB Statement No. 133,
“Accounting for Derivative Instruments and Hedging Activities.” The Company does
not expect adoption of SFAS 163 will have a material effect on its financial
position and results of operations.
In
October 2008, FASB issued FSP FAS 157-3, “Determining the Fair Value of a
Financial Asset When the Market for That Asset Is Not Active”, to clarify
guidance on determining the fair value of a financial asset under SFAS No. 157
in a market that is not active. FSP FAS 157-3 was effective upon issuance,
including prior periods for which financial statements had not been issued. The
adoption of this statement effective September 30, 2008 did not have a material
impact on the Company’s financial position or results of
operations.
In
November 2008, the Emerging Issues Task Force issued EITF No. 08 – 7,
“Accounting for Defensive Intangible Assets” (“EITF 08 -7”) that clarifies
accounting for defensive intangible assets subsequent to initial measurement.
EITF 08 – 7 applies to acquired intangible assets which an entity has no
intention of actively using, or intends to discontinue use of, the intangible
asset but holds it (locks up) to prevent others from obtaining access to it
(i.e., a defensive intangible asset). Under EITF 08 – 7, the Task Force reached
a consensus that an acquired defensive asset should be accounted for as a
separate unit of accounting (i.e., an asset separate from other assets of the
acquirer); and the useful life assigned to an acquired defensive asset should be
based on the period during which the asset would diminish in value. ETIF 08 – 7
is effective for defensive intangible assets acquired in fiscal years beginning
on or after December 15, 2008. The Company does not believe EITF 08 - 7 will
have a significant impact on the Company’s consolidated financial
statements.
NOTE
7 GOING CONCERN
As
reflected in the accompanying unaudited condensed financial statements, the
Company has an accumulated deficit of $1,340,831 at April 30, 2009 that includes
a net loss of $280,018 for the six months ended April 30, 2009. The
Company’s total current liabilities exceed its total current assets by
$1,126,553 and the Company used cash in operations of $262,575. These factors
raise substantial doubt about its ability to continue as a going
concern. In view of the matters described above, recoverability of a
major portion of the recorded asset amounts shown in the accompanying condensed
balance sheet is dependent upon continued operations of the Company, which in
turn is dependent upon the Company’s ability to raise additional capital, obtain
financing and succeed in its future operations. The financial
statements do not include any adjustments relating to the recoverability and
classification of recorded asset amounts or amounts and classification of
liabilities that might be necessary should the Company be unable to continue as
a going concern.
Management
has taken the following steps to revise its operating and financial
requirements, which it believes are sufficient to provide the Company with the
ability to continue as a going concern. The Company is actively
pursuing additional funding and strategic partners, which will enable the
Company to implement its business plan. Management believes that
these actions as successful will allow the Company to continue its operations
through the next fiscal year.
ITEM 2. MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
This
section of the report includes a number of forward-looking statements that
reflect our current views with respect to future events and financial
performance. Forward-looking statements are often identified by words like:
believe, expect, estimate, anticipate, intend, project and similar expressions,
or words which, by their nature, refer to future events. You should not place
undue certainty on these forward-looking statements, which apply only as of the
date of this annual report. These forward-looking statements are subject to
certain risks and uncertainties that could cause actual results to differ
materially from historical results or our predictions.
Overview
The
following discussion is an overview of the important factors that management
focuses on in evaluating our businesses, financial condition and operating
performance and should be read in conjunction with the financial statements
included in this Quarterly Report on Form 10-Q. This discussion
contains forward-looking statements that involve risks and
uncertainties. Actual results could differ materially from those
anticipated in these forward looking statements as a result of any number of
factors, including those set forth in this Quarterly Report as well as under the
section entitled “Risk Factors” and elsewhere in the Company’s most recent
Annual Report on Form 10-K filed on February 13, 2009.
The
Company is subject to a number of risks similar to other companies in the
medical device industry. These risks include but are not limited to rapid
technological change, uncertainty of market acceptance of our products,
uncertainty of regulatory approval, competition from substitute products and
larger companies, the need to obtain additional financing, compliance with
government regulation, protection of proprietary technology, product liability,
and the dependence on key individuals.
All
written and oral forward-looking statements made in connection with this
Quarterly Report on Form 10-Q that are attributable to us or persons acting on
our behalf are expressly qualified in their entirety by these cautionary
statements. Given the uncertainties that surround such statements, you are
cautioned not to place undue reliance on such forward-looking
statements.
Our
Business
We are
engaged in the business of designing, developing, manufacturing and the planned
future marketing of self-reinforced, re-absorbable biodegradable internal
fixation devices. Our polyamide materials are protected by Patent no.
ZL97119073.9, PRC, issued by the Chinese Intellectual Property Rights Bureau, is
used in producing screws, binding wires, rods and related products. These
products are used in a variety of applications which include orthopedic trauma,
sports related medical treatment, or cartilage injuries. Our products
are biodegradable internal fixation devices which are made of a very unique
material called Polyamide (“PA”). Our PA products, such as screws,
rods, and binding wires consist of enhanced fibers and high molecular polymers
which are designed to facilitate quick healing of complex fractures in many
areas of the human skeletal system. Our products offer a number of
significant advantages over existing metal implants and the first generation of
degradable implants (i.e. PLLA) for patients, surgeons and other customers
including:
|
1.
|
A
notably reduced need for a secondary surgery to remove implant due to
post-operative complications, therefore avoiding unnecessary
risk and expense on all patient
care;
|
|
2.
|
Enhancing
the performance of the materials by manufacturing them to be easily fitted
to each patient, forming an exact
fit;
|
|
3.
|
Improving
the biological activity of materials. Clinical trial results have shown
that as PA implants degrade, they promote a progressive shift of load to
the new bone creating micro-motion and thereby avoiding bone atrophy due
to ‘stress shielding’
|
|
4.
|
Reducing
the chance of post-operative
infection;
|
|
5.
|
Effectively
controlling the degeneration speed, so that there will be no complications
in treating repeat injuries;
|
|
6.
|
Ease
of post-operative care i.e. no distortion during x-ray
imaging;
|
|
7.
|
Simple
and cost-effective to manufacture.
|
Our
products are designed to replace the traditional internal fixation device made
of stainless steel and titanium and overcome the limitations of previous
generations of products such as PLA and PLLA. Our laboratory statistics show
that our PA products have a higher mechanical strength, last longer in
degradation ratio and are more evenly absorbed form outer layer inwards as
compared with similar materials such as PLA and
PLLA. Thus PA allows increased restoration time for bone
healing and re-growth. The Company’s PA Degradable and Absorbable
Screw (“PA Screw”) and Degradable and Absorbable Binding Wire (“PA Binding Wire)
are currently being tested in human trials under permit from China’s State Food
and Drug Administration (“SFDA”). As of April 30, 2009, the Company
completed 55 success PA Screw trial cases, and 53 success PA Binding
Wire. We anticipate that the final 5 cases of PA Screw will be
completed by the end of the second fiscal quarter of 2009. This delay is caused
by lack of suitable volunteers in the trials. Upon the completion of these
trials, the Company will apply for the China’s SFDA’s final
approval. The company will continuously perform on trials exceeding
the requirement of 60 cases in order to gather more accurate statistic
data.
Process
of Human Trials
As of
April 30, 2009, for medical study and comparison purpose, the company has
completed a total of 67 successful clinical human trial cases, including 55
cases on ankle fractures. Under SFDA Regulations, a total number of 60 cases
must be completed before approval is considered. Amended SFDA regulations,
unlike previous regulations, require the applicant to specify the position on
the body where the clinical trial is carried out. For these reasons, only 55
cases on the ankle fracture are statistically included by the SFDA as final
successful clinical trial cases. Our SFDA application has specified the ankle
fracture as the body part of our clinical trial. This is because bones around
this part carry most of the body weight. Therefore, the company needs to
complete the remaining 5 cases in order to meet the SFDA requirements.
Currently, we have been conducting human trials at the 6 state level hospitals
recognized by SFDA for clinical trials in different cities throughout China;
including Nanchang, Changsha, Luoyang, Nanning and Tianjin.
The
company anticipates that we will complete all clinical trial cases
and can file immediately for the SFDA final approval by the third fiscal quarter
of 2009. Furthermore, we can foresee that following the SFDA final
approval, the company will be in revenue as early as first quarter of 2010. The
company is looking forward to starting the application process for the PA Biding
Wires with the SFDA by the end of 2009 with sufficient funding in
place.
There can
be no assurance that the company will be able to obtain any further clearances
or approvals, if required, to market its products for their intended uses on a
timely basis, if at all. Moreover, regulatory approvals, if granted, may include
significant limitations on the indicated uses for which a product may be
marketed. Delays in the receipt of or the failure to obtain such clearances or
approvals, the need for additional clearances or approvals, the loss of
previously received clearances or approvals, unfavorable limitations or
conditions of approval, or the failure to comply with existing or future
regulatory requirements could have a material adverse effect on the Company’s
business, financial condition and results of operations.
GOVERNMENT
REGULATION
Medical
implant devices/products manufactured or marketed by the company in China are
subject to extensive regulations by the SFDA. Pursuant to the related laws and
acts, as amended, and the regulations promulgated there under (the "SFDA
Regulations"), the SFDA regulates the clinical testing, manufacture, labeling,
distribution and promotion of medical devices. The SFDA also has the
authority to request repair, replacement, or refund of the cost of any device
manufactured or distributed by the Company.
Under the
SFDA Regulations, medical devices are classified into three classes (class I, II
or III), the basis of the controls deemed necessary by the SFDA to reasonably
assure their safety and efficacy. Under the SFDA's regulations, class I devices
are subject to general controls [for example, labeling and adherence to Good
Manufacturing Practices (“GMP”) requirements] and class II devices are subject
to general and special controls. Generally, class III devices are those which
must receive premarket approval by the SFDA to ensure their safety and efficacy
(for example, life-sustaining, life-supporting and certain implantable devices,
or new devices which have not been found substantially equivalent to legally
marketed class I or class II devices). The Company is classified as a
manufacturer of class III medical devices. Current SFDA enforcement policy
prohibits the marketing of approved medical devices for unapproved
uses.
Before a
new device can be introduced into the market in China, the manufacturer
generally must obtain SFDA marketing clearance through clinical
trials. Since the company is classified as a manufacturer of Class
III medical devices, the company must carry out all clinical trials in
pre-selected SFDA approved hospitals.
Manufacturers
of medical devices for marketing in China are required to adhere to GMP
requirements. Enforcement of GMP requirements has increased significantly in the
last several years and the SFDA has publicly stated that compliance will be more
strictly scrutinized. From time to time the SFDA has made changes to the GMP and
other requirements that increase the cost of compliance. Changes in existing
laws or requirements or adoption of new laws or requirements could have a
material adverse effect on the company’s business, financial condition and
results of operations. There can be no assurance that the company will not incur
significant costs to comply with applicable laws and requirements in the future
or that applicable laws and requirements will not have a material adverse effect
upon the company’s business, financial condition and results of
operations.
Regulations
regarding the development, manufacturing and sale of the company’s products are
subject to change. The company cannot predict the impact, if any, that such
changes might have on its business, financial condition and results of
operations.
Results
of Operations
The
“Results of Operations” discussed in this section merely reflect the information
and results of the Company for the period from January 25, 2002 (Shenzhen
Changhua’s date of inception) to April 30, 2009.
Revenues
The
Company is in its development stage and does not have any revenue. The
management team is continuously looking for fundraising possibilities for
product improvement, machinery upgrades, facility expansions, continuous
research and development, and sales and marketing preparation.
Our
facility is located in Shenzhen, China which is built to meet the GMP standards.
Our facility covers about 865 square meters, which includes the combined
facilities of offices, laboratories, and workshops. There is one production line
for the PA Screw and another production line for the PA Binding Wire. The annual
production capabilities of each production line are 100,000 pieces for PA Screw,
and 240,000 packs for the PA Binding Wires. Both production lines, at
their maximum production capacities are capable of generating approximately
$27,000,000 in annual revenue.
Estimate
current production lines in full capacity
|
|
|
|
|||
|
Output
Quantity (Max.)
|
Price
at ex-factory (U$)
|
Total
Turnover (U$)
|
|||
PA
Screw
|
100,000
|
(piece)
|
150
|
|
15,000,000
|
|
PA
Binding Wire
|
240,000
|
(pack)
|
50
|
|
12,000,000
|
|
|
|
|
|
Total:
|
27,000,000
|
|
The
Company will market its products through a hybrid sales force comprised of a
managed network of independent regional distributors/sales agents (80%) and
direct sales representatives (20%) in China.
There are
two ways the company will generate revenue, 1) through our nationwide and
regional distributors and 2) through our direct manufacturing
sales.
Marketing
and Sales Goals:
1)
|
First
quarter of 2010: $1,579,500 in revenues; Distribution of our
product in approximately 32 hospitals immediately following SFDA
approval.
|
2)
|
Second
quarter 2010: $2,754,000 revenues; Distribution of our product
in approximately 56 hospitals.
|
3)
|
Third
quarter 2010: $5,062,500 revenues; Distribution of our product
in approximately 105 hospitals.
|
4)
|
Fourth
quarter 2010: $9,720,000 revenues; Distribution of our product
in approximately 210 hospitals.
|
In
general, we estimate that the Company will distribute product to a total of 210
hospitals and expect to generate total revenues of $19,116,000 in the year
2010. We also expect a continuous increase of affiliated hospitals
and anticipate large increases in revenue due to marketing results of the PA
Screw in China and the utilization of the Company’s secured funding to bring the
remaining family of self-reinforced, re-absorbable PA products to
market.
China’s Marketing Analysis and Sales
Strategy:
We have
established long term relationships with many hospitals and national
distributors in China. Ms. WANG Hui, the Company’s CEO, has over 20
years sales experience in medical distribution. She will be in charge of our
sales programs. Professor LIU, Shangli, our chief medical advisor, is one of the
highest ranked orthopedic doctors in China as well as being highly renowned in
the rest of the world. He will assist the Company in nationwide
product promotion and joint projects with associated academic institutions and
medical schools.
During
product development and clinical trial stages we developed close relationships
with many major national hospitals. We expect these relationships to
boost our revenue generation following SFDA final approval. In order to better
serve our customers, including hospitals, distributors, patients and the general
public, the Company will set up Regional Service Offices to provide technical
support, product information, and customer aid service.
China’s
market for PA devices depends on 3 major conditions:
|
-
|
Patients
|
|
-
|
Advanced
technology level
|
|
-
|
Performance
and price of the materials
|
The
demand for internal fixation medical devices has rapidly increased during the
last decade. Total market sales have increased more than 15% each
year. There are over 1 million bone fractures in patients in China
requiring about 4 million bone bolts/screws each year. Research shows
that in the next 10 years, China will have a booming aging population and the
population in China will continue to increase. New and improved
medical technology will continue to rapidly grow throughout hospitals in China,
and material optimization and product pricing is expected to directly stimulate
increased sales.
The
Company has advantages and more opportunities over others competitors due
to:
|
-
|
No
other similar patent registrations in
China.
|
|
-
|
We
are the only company qualified and permitted to perform PA clinical trials
by SFDA
|
|
-
|
We
have a timing advantage over other companies in China which would have to
go through the preclinical testing for the SFDA permit on clinical
trials.
|
|
-
|
Under
existing regulations by SFDA, it will take at least 3 years for clinical
trials.
|
Number
of Hospitals in China in year 2007
|
|
|
|
|
|||
Statistic
and Census report by Ministry of Health of People's Republic of
China.
|
|
||||||
|
|
|
|
|
|
|
|
|
Total
|
Non-Profit
|
Profit
|
Government
|
Society
|
Private
|
|
Hospitals
|
19852
|
15759
|
4019
|
9832
|
6446
|
3574
|
|
General
Hospital
|
13372
|
11062
|
2269
|
5854
|
5460
|
2058
|
|
TCM
Hospital
|
2720
|
2404
|
314
|
2257
|
171
|
292
|
|
TCM-WM
Hospital
|
245
|
137
|
106
|
98
|
58
|
89
|
|
Minority
Hospital
|
200
|
184
|
16
|
180
|
6
|
14
|
|
Specialist
Hospital
|
3282
|
1951
|
1302
|
1432
|
738
|
1112
|
|
Nursing
Hospital
|
33
|
21
|
12
|
11
|
13
|
9
|
|
|
|
|
|
|
|
|
|
TCM
Hospital: Traditional Chinese Medicine Hospital
|
|
||||||
WM
Hospital: Western Medicine Hospital
|
|
||||||
Minority
Hospital: The hospitals located in Autonomous Region (Province)
in China
|
|
By the
end of 2010, we anticipate that there will be over 210 hospitals carrying our
products. Thereafter, we predict an increase of 50% - 75%
annually. By the year 2015 we estimate over 1500 hospitals
participating. Based on the sales figures for a single product (PA
Screw), the Company’s projected annual revenues would be
$270,000,000.
Potential
Revenue in year 2015 (Estimated) :
|
PA
Screw
|
Hospitals
|
1500
|
Monthly
consumption:
|
100
|
Month
|
12
|
Sales
price:
|
$150.00
|
Total
National Market Size:
|
$270,000,000
|
In
general, technological advancements and the marketing potential within Asia are
the biggest factors in driving significant growth within the global orthopedic
devices market. Another major factor that positively influences this
market is the growing number of aging baby boomers with active
lifestyles. This sector represents a large portion of the total
population.
Research and
Development
There is
substantial research and development (R&D) activity in the market indicating
a favorable growth trend. While revenues for active lifestyle
participants registered a compound annual growth rate (CAGR) of 17.4 percent for
the period 2002-2006; R&D expenditure for the same period recorded a higher
growth of 18.4 percent. Increasing R&D expenditure is considered
a key indicator of the future direction of the orthopedic market as it points to
sustained technological development and innovation.
The
Company believes that Asia holds tremendous growth potential for orthopedic
device manufacturers due to its fundamental population
advantage. Asia accounts for more than 50 percent of the population
in the world, but its share of the global orthopedic devices market is
comparatively low at approximately 10 percent. Within the region,
Japan contributes to a majority of market revenues, indicating large potential
for growth in relatively under-penetrated countries such as China and
India.
In future
periods, we expect research and development expenses to grow as we continue to
invest in basic research, clinical trials, product development and in our
intellectual property.
Finance
Costs
As of
April 30, 2009, a stockholder and a related party had loaned a total of $574,569
to the Company as unsecured loans repayable on demand and interest is charged at
7% per annum on the amount due. Total interest expenses on advances from a
stockholder and a related party accrued for the three and six months ended April
30, 2009 and 2008 are $8,623 and $210 respectively.
Three
months ended
|
Six
months ended
|
September
25, 2002
|
||||||||
April
30,
|
April
30,
|
(inception)
through
|
||||||||
2009
|
2008
|
2009
|
2008
|
April
30, 2009
|
||||||
Interest
paid to a stockholder and related party
|
8,623
|
210
|
13,740
|
210
|
19,293
|
As of
April 30, 2009, a director and a related company had loaned a total of $630,456
to the Company as an unsecured loan repayable on demand and imputed interest is
computed at 5% per annum on the amount due. Total imputed interest expenses
recorded as additional paid-in capital amounted to $7,925, $8,351 and $133,053
for the three and six months ended April 30, 2009 and 2008 and for the period
from January 25, 2002 (inception) through April 30, 2009,
respectively.
Three
Months ended Jan. 31, 2009
|
2008
|
Six
Months ended April 30, 2009
|
2008
|
September
25, 2002 (inception) through April 30 2009
|
|
Interest
Paid to a director and related company
|
(7,925)
|
(8,351)
|
(15,981)
|
(15,735)
|
(133,053)
|
Net Loss
The net
loss for the three months ended April 30, 2009 and 2008 are $150,829 and $44,594
respectively. We do not have any revenue but have to incur operating expenses
for the upkeep of the Company and the clinical trials.
The net
loss for the six months ended April 30, 2009 and 2008 and for
the period from September 25, 2002 (inception) through April 30, 2009 are $280,018,
$87,007 and $1,340,831 respectively. We are in Clinical Trial phase and do not
have a SFDA permit to produce, market or sell in China.
We
therefore do not have any revenue from inception to April 30, 2009 but have to incur
operating expenses for the upkeep of the Company and the clinical
trials.
Liquidity
and Capital Resources
We had a
working capital deficit of $1,126,553 as of April 30, 2009 compared to a working
capital deficit of $831,167 as of October 31, 2008. Our working capital deficit
increased as a result of the fact that we are in Clinical Trial phase and do not
have a SFDA permit to produce, market or sell in China. We had no revenues
during the period and that our sole source of financing came in the form of a
loan from our related parties and stockholders.
Cash
Flows
Net Cash
Used in Operating Activities.
Net cash
used in operating activities was $262,575 in the six months ended April 30,
2009. This amount was attributable primarily to the net loss after adjustment
for non-cash items, such as depreciation, imputed interest on advances from a
stockholder and a related party, and others like decrease in other receivables
and prepaid expenses.
Net Cash
Used in Investing Activities.
We
recorded $14,267 net cash used in investing activities in the six months ended
April 30, 2009. This amount reflected purchases of property and equipment,
primarily for research and development to our facilities.
Net Cash
Provided by Financing Activities.
Net cash
provided by financing activities in the six months ended April 30, 2009 was
$284,098, which represented advances from related parties.
Operating Capital and Capital
Expenditure Requirements
Our
ability to continue as a going concern and support the commercialization of
current products is dependent upon our ability to obtain additional financing in
the near term. We anticipate that such funding will be in the form of equity
financing from sales of our common stock. However, there is no assurance that we
will be able to raise sufficient funding from the sale of our common stock to
fund our business plan should we decide to proceed. We anticipate continuing to
rely on advances from our related parties and stockholders in order to continue
to fund our business operations
We
believe that our existing cash, cash equivalents at April 30, 2009, will be
insufficient to meet our cash needs. The management is actively
pursuing additional funding and strategic partners, which will enable the
Company to implement our business plan, business strategy, to continue research
and development, clinical trials or further development that may
arise.
We intend
to spend more to support the commercialization of current products and on
research and development activities, including new products development,
regulatory and compliance, clinical studies, and the enhancement and protection
of our intellectual property portfolio.
OFF-BALANCE
SHEET ARRANGEMENTS
We do not
have any off-balance sheet arrangements that have or are reasonably likely to
have a current or future effect on our financial condition, changes in financial
condition, revenues or expenses, results of operations, liquidity, capital
expenditures or capital resources that are material to our
investors.
CRITICAL
ACCOUNTING POLICIES
The
preparation of our 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. On an
ongoing basis, we evaluate our estimates, including but not limited to those
related to income taxes and impairment of long-lived assets. We base our
estimates on historical experience and on various other assumptions and factors
that are believed to be reasonable under the circumstances, the results of which
form the basis for making judgments about the carrying values of assets and
liabilities that are not readily apparent from other sources. Based on our
ongoing review, we plan to adjust to our judgments and estimates where facts and
circumstances dictate. Actual results could differ from our
estimates.
We
believe the following critical accounting policies are important to the
portrayal of our financial condition and results and require our management's
most difficult, subjective or complex judgments, often because of the need to
make estimates about the effect of matters that are inherently
uncertain.
|
1.
|
Property
and equipment
|
Property
and equipment are stated at cost, less accumulated
depreciation. Expenditures for additions, major renewals and
betterments are capitalized and expenditures for maintenance and repairs are
charged to expense as incurred.
Depreciation
is provided on a straight-line basis, less estimated residual value over the
assets estimated useful lives. The estimated useful lives are as
follows:
Plant
and machinery
|
5
Years
|
|
Motor
vehicles
|
5
Years
|
|
Office
equipment
|
5
Years
|
|
Office
Improvement
|
5
Years
|
|
2.
|
Long-lived
assets
|
In
accordance with SFAS No. 144, “Accounting for the impairment or disposal of
Long-Lived Assets", long-lived assets and certain identifiable intangible assets
held and used by the Company are reviewed for impairment whenever events or
changes in circumstances indicate that the carrying amount of an asset may not
be recoverable. For purposes of evaluating the recoverability of long-lived
assets, the recoverability test is performed using undiscounted net cash flows
related to the long- lived assets. The Company reviews long-lived assets to
determine that carrying values are not impaired.
|
3.
|
Fair
value of financial instruments
|
SFAS No.
107, "Disclosure About Fair Value of Financial Instruments," requires certain
disclosures regarding the fair value of financial instruments. The carrying
amounts of other receivables, prepaid expenses, amounts due from related
parties, other payables and accrued liabilities and due to related parties
approximate their fair values because of the short-term nature of the
instruments. The management of the Company is of the opinion that the Company is
not exposed to significant interest or credit risks arising from these financial
statements.
|
4.
|
Government grant
|
Government
grant represents a subsidy from the local government and is unconditional. The
Company recognizes the grant upon receipt from the local government and is
accounted for as an offset of research and development expenses.
|
5.
|
Income
taxes
|
The
Company accounts for income taxes under the SFAS No. 109, “Accounting for Income
Taxes”. Under SFAS No. 109, deferred tax assets and liabilities are
recognized for the future tax consequences attributable to differences between
the financial statement carrying amounts of existing assets and liabilities and
their respective tax bases. Deferred tax assets and liabilities are
measured using enacted tax rates expected to apply to taxable income in the
years in which those temporary differences are expected to be recovered or
settled. Under SFAS No. 109, the effect on deferred tax assets and
liabilities of a change in tax rates is recognized in income in the period that
includes the enactment date.
|
6.
|
Research
and Development
|
Research
and development costs related to both present and future products are expensed
as incurred.
|
7.
|
Foreign
currency translation
|
The
financial statements of the Company’s subsidiary denominated in currencies other
than US $ are translated into US $ using the closing rate method. The
balance sheet items are translated into US $ using the exchange rates at the
respective balance sheet dates. The capital and various reserves are
translated at historical exchange rates prevailing at the time of the
transactions while income and expenses items are translated at the average
exchange rate for the year. All exchange differences are recorded
within equity.
RECENT
ACCOUNTING PRONOUNCEMENTS
In
December 2007, the Financial Accounting Standards Board (FASB) issued SFAS
No. 141 (revised 2007), “Business Combinations” (“SFAS 141R”). SFAS 141R
establishes principles and requirements for how an acquirer recognizes and
measures in its financial statements the identifiable assets acquired, the
liabilities assumed, any non-controlling interest in the acquiree and the
goodwill acquired. SFAS 141R also establishes disclosure requirements to enable
the evaluation of the nature and financial effects of the business combination.
This statement is effective for use beginning January 1, 2009. The Company
does not expect adoption of SFAS 141R will have a material impact on its
financial position and results of operations.
In
December 2007, the FASB issued SFAS No. 160, “Non-controlling Interests in
Consolidated Financial Statements – an amendment of ARB No. 51” (“SFAS
160”). This statement improves the relevance, comparability, and
transparency of the financial information that a reporting entity provides in
its consolidated financial statements by establishing accounting and reporting
standards that require the ownership interests in subsidiaries held by parties
other than the parent and the amount of consolidated net income attributable to
the parent and to the non-controlling interest be clearly identified and
presented on the face of the consolidated statement of income, changes in a
parent’s ownership interest while the parent retains its controlling financial
interest in its subsidiary be accounted for consistently, when a subsidiary is
deconsolidated, any retained non-controlling equity investment in the former
subsidiary be initially measured at fair value, entities provide sufficient
disclosures that clearly identify and distinguish between the interests of the
parent and the interests of the non-controlling owners. SFAS 160
affects those entities that have an outstanding non-controlling interest in one
or more subsidiaries or that deconsolidate a subsidiary. SFAS 160 is
effective for fiscal years, and interim periods within those fiscal years,
beginning on or after December 15, 2008. Upon adoption of this statement, the
Company has recognized its noncontrolling interests as equity in the
consolidated balance sheets, has reflected net income attributable to
noncontrolling interests in consolidated net income and has provided, in Note
5(A), a summary of changes in equity attributable to noncontrolling interests,
changes attributable to ABMT and changes in total equity.
In March
2008, the FASB issued SFAS No. 161, “Disclosures about Derivative
Instruments and Hedging Activities, an amendment of FASB Statement No. 133”
(SFAS 161). This statement is intended to improve transparency in financial
reporting by requiring enhanced disclosures of an entity’s derivative
instruments and hedging activities and their effects on the entity’s financial
position, financial performance, and cash flows. SFAS 161 applies to
all derivative instruments within the scope of SFAS 133, “Accounting for
Derivative Instruments and Hedging Activities” (SFAS 133) as well as related
hedged items, bifurcated derivatives, and non-derivative instruments that are
designated and qualify as hedging instruments. Entities with instruments subject
to SFAS 161 must provide more robust qualitative disclosures and expanded
quantitative disclosures. SFAS 161 is effective prospectively for
financial statements issued for fiscal years and interim periods beginning after
November 15, 2008, with early application permitted. The Company does not
expect adoption of SFAS 161 will have a material effect on its financial
position and results of operations.
In
May 2008, the FASB released SFAS No. 162, “The Hierarchy of Generally Accepted
Accounting Principles.” SFAS No. 162 identifies the sources
of accounting principles and the framework for selecting the principles used in
the preparation of financial statements of non-governmental entities that
presented in conformity with generally accepted accounting principles in the
United States of America. SFAS No. 162 will be effective 60 days following the
SEC’s approval of the PCAOB amendments to AU Section 411, The Meaning of Present Fairly in
Conformity With Generally Accepted Accounting Principles. The
Company does not expect adoption of SFAS 162 will have a material effect on its
financial position and results of operations.
In May
2008, the FASB issued SFAS No. 163, “Accounting for Financial Guarantee
Insurance Contracts, an interpretation of FASB Statement No. 60.” The
scope of this Statement is limited to financial guarantee insurance (and
reinsurance) contracts, as described in this Statement, issued by enterprises
included within the scope of Statement 60. Accordingly, this Statement does not
apply to financial guarantee contracts issued by enterprises excluded from the
scope of Statement 60 or to some insurance contracts that seem similar to
financial guarantee insurance contracts issued by insurance enterprises (such as
mortgage guaranty insurance or credit insurance on trade receivables). This
Statement also does not apply to financial guarantee insurance contracts that
are derivative instruments included within the scope of FASB Statement No. 133,
“Accounting for Derivative Instruments and Hedging Activities.” The Company does
not expect adoption of SFAS 163 will have a material effect on its financial
position and results of operations.
In
October 2008, FASB issued FSP FAS 157-3, “Determining the Fair Value of a
Financial Asset When the Market for That Asset Is Not Active”, to clarify
guidance on determining the fair value of a financial asset under SFAS No. 157
in a market that is not active. FSP FAS 157-3 was effective upon issuance,
including prior periods for which financial statements had not been issued. The
adoption of this statement effective September 30, 2008 did not have a material
impact on the Company’s financial position or results of
operations.
In
November 2008, the Emerging Issues Task Force issued EITF No. 08 – 7,
“Accounting for Defensive Intangible Assets” (“EITF 08 -7”) that clarifies
accounting for defensive intangible assets subsequent to initial measurement.
EITF 08 – 7 applies to acquired intangible assets which an entity has no
intention of actively using, or intends to discontinue use of, the intangible
asset but holds it (locks up) to prevent others from obtaining access to it
(i.e., a defensive intangible asset). Under EITF 08 – 7, the Task Force reached
a consensus that an acquired defensive asset should be accounted for as a
separate unit of accounting (i.e., an asset separate from other assets of the
acquirer); and the useful life assigned to an acquired defensive asset should be
based on the period during which the asset would diminish in value. ETIF 08 – 7
is effective for defensive intangible assets acquired in fiscal years beginning
on or after December 15, 2008. The Company does not believe EITF 08 - 7 will
have a significant impact on the Company’s consolidated financial
statements.
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
Under the
supervision and with the participation of our management, including our
principal executive officer and principal financial officer, we have conducted
an evaluation of the effectiveness of the design and operation of our disclosure
controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the
Securities and Exchange Act of 1934, as of the end of the period covered by this
report. Based on this evaluation, our principal executive officer and
principal financial officer concluded as of the evaluation date that our
disclosure controls and procedures were effective such that the material
information required to be included in our Securities and Exchange Commission
reports is recorded, processed, summarized and reported within the time periods
specified in SEC rules and forms relating to our company, particularly during
the period when this report was being prepared.
Additionally,
there were no significant changes in our internal controls or in other factors
that could significantly affect these controls subsequent to the evaluation
date. We have not identified any significant deficiencies or material
weaknesses in our internal controls, and therefore there were no corrective
actions taken.
PART
II – OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS
Currently
we are not involved in any pending litigation or legal proceeding.
ITEM
1A. RISK FACTORS
We are a
smaller reporting company as defined by Rule 12b-2 of the Securities Exchange
Act of 1934 and are not required to provide the information under this
item.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
None.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. SUBMISSIONS OF MATTERS TO A
VOTE OF SECURITY HOLDERS
None.
ITEM
5. OTHER INFORMATION
None.
ITEM
6. EXHIBITS
The
following documents are filed as a part of this report or are incorporated by
reference to previous filings, if so indicated:
Exhibit No.
|
Description
|
3.1
|
Articles
of Incorporation (1)
|
3.2
|
Bylaws
(1)
|
31.1
|
Section
302 Certification of Chief Executive Officer*
|
31.2
|
Section
302 Certification of Chief Financial Officer *
|
32.1
|
Section
906 Certification of Chief Executive Officer *
|
32.2
|
Section
906 Certification of Chief Financial Officer
*
|
*filed
herewith
(1)
Incorporated by reference to the Form SB-2 registration statement filed on
January 16, 2007.
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.
June 15,
2009
By:
|
|
ADVANCED
BIOMEDICAL TECHNOLOGIES, INC.
|
|
BY: /s/ Chi Ming
YU
|
|
Chi
Ming YU, President and Director
|
|
BY: /s/Wang
Hui
|
|
Wang
Hui, Director and Chief Executive Officer
|
|
BY: /s/ Kai
GUI
|
|
Kai
GUI, Director, Secretary and Chief Financial
Officer
|