UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
x
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
FOR THE
QUARTERLY PERIOD ENDED SEPTEMBER 30, 2009
OR
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For the
Transition Period from __________________ to
_________________________
Commission
File Number 0-10909
NEOSTEM,
INC.
(Exact
name of registrant as specified in its charter)
DELAWARE
|
22-2343568
|
(State
or other jurisdiction of
|
(I.R.S.
Employer
|
incorporation
or organization)
|
Identification
No.)
|
|
|
420
LEXINGTON AVE, SUITE 450 NEW YORK, NEW
YORK
|
10170
|
(Address
of principal executive offices)
|
(zip
code)
|
Registrant’s
telephone number, including area code: 212-584-4180
(Former
name, former address and former fiscal year, if changed since last
report)
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days. Yes x No
o
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this
chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files).
Yes o No
o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer o
|
Accelerated
filer o
|
|
|
Non-accelerated
filer o (Do
not check if a smaller reporting company)
|
Smaller
reporting company x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
Yes o No x
36,512,700
SHARES, $.001 PAR VALUE, AS OF NOVEMBER 4, 2009
(Indicate
the number of shares outstanding of each of the issuer's classes of common
stock, as of the latest practicable date)
INDEX
|
|
Page No.
|
Part
I - Financial Information:
|
|
|
|
|
Item
1.
|
Consolidated
Financial Statements (Unaudited):
|
|
|
|
|
|
Consolidated
Balance Sheets
|
|
|
At
September 30, 2009 and December 31, 2008
|
3
|
|
|
|
|
Consolidated
Statements of Operations
|
|
|
for
the three months and nine months
|
|
|
ended September
30, 2009 and 2008
|
4
|
|
|
|
|
Consolidated
Statements of Cash Flows
|
|
|
for
the nine months ended
|
5
|
|
September
30, 2009 and 2008
|
|
|
|
|
|
Notes
to Unaudited Consolidated Financial Statements
|
6-28
|
|
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
35-46
|
|
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures About
|
|
|
Market
Risk
|
46
|
|
|
|
Item
4.
|
Controls
and Procedures
|
46
|
|
|
|
Part
II - Other Information:
|
|
|
|
|
Item
1.
|
Legal
Proceedings
|
47
|
|
|
|
Item
1A.
|
Risk
Factors
|
47
|
|
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of
|
|
|
Proceeds
|
47-48
|
|
|
|
Item
3.
|
Defaults
Upon Senior Securities
|
48
|
|
|
|
Item
4.
|
Submission
of Matters to a Vote of Securityholders
|
48
|
|
|
|
Item
5.
|
Other
Information
|
48
|
|
|
|
Item
6.
|
Exhibits
|
49-50
|
|
|
|
|
Signatures
|
51
|
PART
I. FINANCIAL INFORMATION
Item
1. Consolidated Financial Statements
NEOSTEM,
INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
(Unaudited)
|
|
September 30,
2009
|
|
|
December 31,
2008
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
5,848,801
|
|
|
$
|
430,786
|
|
Restricted
cash
|
|
|
180,327
|
|
|
|
-
|
|
Accounts
receivable
|
|
|
163,655
|
|
|
|
7,193
|
|
Prepaid
expenses and other current assets
|
|
|
196,256
|
|
|
|
92,444
|
|
Total
current assets
|
|
|
6,389,039
|
|
|
|
530,423
|
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net
|
|
|
721,373
|
|
|
|
99,490
|
|
Goodwill
|
|
|
558,169
|
|
|
|
558,169
|
|
Intangible
Asset
|
|
|
607,381
|
|
|
|
633,789
|
|
Other
assets
|
|
|
326,879
|
|
|
|
2,445
|
|
|
|
$
|
8,602,841
|
|
|
$
|
1,824,316
|
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
342,027
|
|
|
$
|
508,798
|
|
Accrued
liabilities
|
|
|
1,335,980
|
|
|
|
427,767
|
|
Notes
payable
|
|
|
146,700
|
|
|
|
-
|
|
Unearned
revenues
|
|
|
199,028
|
|
|
|
9,849
|
|
Dividends
Payable
|
|
|
655,868
|
|
|
|
-
|
|
Capitalized
lease obligations – current portion
|
|
|
-
|
|
|
|
14,726
|
|
Total
current liabilities
|
|
|
2,679,603
|
|
|
|
961,140
|
|
Total
liabilities
|
|
|
2,679,603
|
|
|
|
961,140
|
|
|
|
|
|
|
|
|
|
|
Convertible
Redeemable Series D Preferred stock; liquidation value $12.50 per share;
1,293,251 shares issued and outstanding
|
|
|
7,737,448
|
|
|
|
-
|
|
Stockholders’
Equity:
|
|
|
|
|
|
|
|
|
Preferred
stock; authorized, 5,000,000 shares
|
|
|
|
|
|
|
|
|
Series
B convertible redeemable preferred stock,
|
|
|
|
|
|
|
|
|
liquidation
value 10 shares of common stock per share; $0.01 par value; authorized,
825,000 shares; issued and outstanding, 10,000 shares
|
|
|
100
|
|
|
|
100
|
|
|
|
|
|
|
|
|
|
|
Common
stock, $.001 par value; authorized,
|
|
|
|
|
|
|
|
|
500,000,000
shares; issued and outstanding,
|
|
|
|
|
|
|
|
|
8,593,970
at September 30, 2009 and
|
|
|
|
|
|
|
|
|
7,715,006
at December 31, 2008
|
|
|
8,593
|
|
|
|
7,715
|
|
Additional
paid-in capital
|
|
|
52,612,679
|
|
|
|
40,849,670
|
|
Accumulated
deficit
|
|
|
(54,427,998
|
)
|
|
|
(39,994,309
|
)
|
Accumulated
other comprehensive loss
|
|
|
(7,584
|
)
|
|
|
-
|
|
Total
stockholders’ equity
|
|
|
(1,814,210)
|
|
|
|
863,176
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
8,602,841
|
|
|
$
|
1,824,316
|
|
See
accompanying notes to consolidated financial statements
NEOSTEM,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS
(Unaudited)
See
accompanying notes to consolidated financial statements
|
|
Three Months Ended
September 30,
|
|
|
Nine Months Ended
September 30,
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
Revenues
|
|
$
|
85,067
|
|
|
$
|
25,248
|
|
|
$
|
157,709
|
|
|
$
|
49,469
|
|
Direct
costs
|
|
|
53,121
|
|
|
|
8,839
|
|
|
|
92,940
|
|
|
|
12,747
|
|
Gross
profit
|
|
|
31,946
|
|
|
|
16,409
|
|
|
|
64,769
|
|
|
|
36,722
|
|
Selling,
general, administrative and research
|
|
|
7,263,243
|
|
|
|
1,935,743
|
|
|
|
13,809,439
|
|
|
|
6,839,461
|
|
Operating
loss
|
|
|
(7,231,297
|
)
|
|
|
(1,919,334
|
)
|
|
|
(13,744,670
|
)
|
|
|
(6,802,739
|
)
|
Other
income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
13,123
|
|
|
|
686
|
|
|
|
25,816
|
|
|
|
2,398
|
|
Interest
expense
|
|
|
(1,038
|
)
|
|
|
(3,066
|
)
|
|
|
(58,966
|
)
|
|
|
(10,335
|
)
|
Net
loss
|
|
|
(7,219,212
|
)
|
|
|
(1,921,714
|
)
|
|
|
(13,777,820
|
)
|
|
|
(6,810,676
|
)
|
Dividends
Series D Preferred Stock
|
|
|
(404,141
|
)
|
|
|
-
|
|
|
|
(655,868
|
)
|
|
|
-
|
|
Net
loss attributable to Common Shareholders
|
|
$
|
(7,623,353
|
)
|
|
$
|
(1,921,714
|
)
|
|
$
|
(14,433,688
|
)
|
|
$
|
(6,810,676
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss per common share
|
|
$
|
(0.90
|
)
|
|
$
|
(0.30
|
)
|
|
$
|
(1.78
|
)
|
|
$
|
(1.22
|
)
|
Weighted
average
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
common
shares outstanding
|
|
|
8,511,150
|
|
|
|
6,381,588
|
|
|
|
8,096,469
|
|
|
|
5,594,701
|
|
NEOSTEM,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
For the Nine Months Ended
September 30,
|
|
|
|
2009
|
|
|
2008
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(14,433,688)
|
|
|
$
|
(6,810,676)
|
|
Adjustments to reconcile net
loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
Common
shares issued and stock options granted for services
rendered
|
|
|
3,832,116
|
|
|
|
3,175,610
|
|
Depreciation
and amortization
|
|
|
96,506
|
|
|
|
58,928
|
|
Bad
debt provision
|
|
|
-
|
|
|
|
21,500
|
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
(156,464)
|
|
|
|
(8,413)
|
|
Prepaid
expenses and other assets
|
|
|
(436,831)
|
|
|
|
(87,295)
|
|
Unearned
revenues
|
|
|
189,179
|
|
|
|
2,251
|
|
Accrued
dividends
|
|
|
655,868
|
|
|
|
-
|
|
Accounts
payable, accrued expenses, and other current liabilities
|
|
|
741,443
|
|
|
|
9,845
|
|
Net
cash used in operating activities
|
|
|
(9,511,871)
|
|
|
|
(3,638,250)
|
|
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
|
Acquisition
of equipment
|
|
|
(690,981)
|
|
|
|
(7,296)
|
|
Net
cash used in investing activities
|
|
|
(690,981)
|
|
|
|
(7,296)
|
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
Net
Proceeds from issuance of convertible redeemable preferred stock and
warrants
|
|
|
15,669,220
|
|
|
|
-
|
|
Net
Proceeds from issuance of Common Stock
|
|
|
-
|
|
|
|
2,148,635
|
|
Proceeds
from advances on notes payable
|
|
|
1,431,453
|
|
|
|
131,617
|
|
Payments
of capitalized lease obligations
|
|
|
(14,726)
|
|
|
|
(18,574) |
|
Cash
restricted as collateral for bank loan
|
|
|
(180,327)
|
|
|
|
|
|
Repayments
of notes payable
|
|
|
(1,284,753)
|
|
|
|
(125,992)
|
|
Net
cash provided by financing activities
|
|
|
15,620,867
|
|
|
|
2,135,686
|
|
Net
increase/(decrease) in cash and cash equivalents
|
|
|
5,418,015
|
|
|
|
(1,509,860)
|
|
Cash
and cash equivalents at beginning of period
|
|
|
430,786
|
|
|
|
2,304,227
|
|
Cash
and cash equivalents at end of period
|
|
$
|
5,848,801
|
|
|
$
|
794,367
|
|
|
|
Nine Months Ended
September 30,
|
|
|
|
2009
|
|
|
2008
|
|
Supplemental Disclosure
of Cash Flow Information:
|
|
|
|
|
|
|
Cash
paid during the period for:
|
|
|
|
|
|
|
Interest
|
|
$
|
17,823
|
|
|
$
|
10,335
|
|
Supplemental
Schedule of Non-cash Financing Activities:
|
|
|
|
|
|
|
|
|
Issuance
of restricted common stock for services
|
|
|
343,433
|
|
|
|
-
|
|
Issuance
of common stock for services rendered
|
|
|
313,515
|
|
|
|
500,284
|
|
Forfeiture
of restricted common stock for compensation
|
|
|
-
|
|
|
|
(8,021)
|
|
Issuance
of common stock for compensation
|
|
|
555,750
|
|
|
|
132,534
|
|
Issuance
of warrants for services
|
|
|
92,868
|
|
|
|
345,403
|
|
Issuance
of common stock for payment of debt
|
|
|
-
|
|
|
|
5,646
|
|
Compensatory
element of stock options
|
|
|
2,766,566
|
|
|
|
1,466,835
|
|
Vesting
of restricted common stock during period
|
|
|
103,417
|
|
|
|
732,929
|
|
See
accompanying notes to consolidated financial statements.
NEOSTEM,
INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED
FINANCIAL STATEMENTS
Note 1 - The
Company
NeoStem,
Inc. (“NeoStem” or the “Company”) was incorporated under the laws of the
State of Delaware in September 1980 under the name Fidelity Medical Services,
Inc. Our corporate headquarters is located at 420 Lexington Avenue, Suite
450, New York, NY 10170, our telephone number is (212) 584-4180 and our website
address is www.neostem.com.
NeoStem
is engaged in the business of developing stem cell therapies, pursuing
anti-aging initiatives and is operating a network of adult stem cell collection
centers that are focused on enabling people to donate and store their own
(autologous) stem cells when they are young and healthy for their personal use
in times of future medical need.
As part
of our adult stem cell banking business we have developed a network of adult
stem cell collection centers in major metropolitan areas of the United
States. Each collection center agreement is effectively a license
that grants a physician practice the right to participate in our stem cell
collection network and access to our stem cell banking technology, which
includes our know-how, trade secrets, copy rights and other intellectual
property rights owned by us and utilized in connection with the delivery of stem
cell collection services. Our stem cell banking technology is
proprietary and the subject of pending patent applications. The terms
of NeoStem’s collection center agreements are substantially similar. NeoStem
grants to each physician practice serving as a collection center a non-exclusive
license to use its trademarks and intellectual property but otherwise retains
all rights thereto, and each collection center is bound by confidentiality
obligations to NeoStem and non-competition provisions. NeoStem provides adult
stem cell processing and storage services, as well as expertise and certain
business, management and administrative services of a non-clinical nature in
support of each physician practice serving as a collection center. In each case,
the physician practice agrees that NeoStem will be its exclusive provider of
adult stem cell processing and storage, management and other specified services.
The agreements also make clear that since NeoStem is not licensed to practice
medicine, NeoStem cannot and does not participate in clinical care or clinical
decision making, both of which are exclusively the responsibility of the
collection center (i.e., the responsibility of the physician or the medical
practice). The agreements provide for the payment to NeoStem by the
collection center of specified upfront licensing fees and license maintenance
fees. As part of the licensing program, NeoStem also provides
marketing and administrative support services. NeoStem does not have any equity
or other ownership interest in any of the physician medical practices that serve
as collection centers. Each of the agreements is for a multi-year
period, depending on the particular center, and typically has an automatic
renewal provision for consecutive one year periods at the end of the initial
term that also permits either party to terminate prior to renewal. The
agreements may also relate to a territory from which patients seek collection
services. The agreements contain insurance obligations and indemnification
provisions, limitations on liability and other standard provisions. Generally,
the agreements may be terminated by either party with prior written notice in
the event of an uncured material breach by the other party and may be terminated
by either party in the event of the other party’s bankruptcy, insolvency,
receivership or other similar circumstances, or, depending on the agreement,
certain other specified occurrences.
We have
also entered the research and development arenas, through the acquisition of a
worldwide exclusive license of VSELTM
Technology, an early-stage technology that utilizes very small embryonic-like
stem cells that exist in adult human bone marrow. Very small embryonic-like stem
cells have many physical characteristics typically found in embryonic stem
cells, including the ability to differentiate into specialized cells found in
substantially all the different types of cells and tissue that make up the body.
We have also licensed the rights to other stem cell technologies and continue to
seek additional opportunities in this arena.
On
January 19, 2006, we consummated the acquisition of the assets of NS California,
Inc., a California corporation (“NS California”) relating to NS California’s
business of collecting and storing adult stem cells. Effective with the
acquisition, the business of NS California became our principal business, rather
than our historic business of providing capital and business guidance to
companies in the healthcare and life science industries. The Company
provides adult stem cell processing, collection and banking services with the
goal of making stem cell collection and storage widely available, so that the
general population will have the opportunity to store their own stem cells for
future healthcare needs. The Company is also pursuing other technologies to
advance its position in the field of stem cell tissue regeneration.
On August
9, 2007, the Company’s Common Stock commenced trading on the American Stock
Exchange (now NYSE Amex) under the symbol “NBS.”
In
connection with carrying out its expansion objectives in the People’s Republic
of China (“PRC”), NeoStem has recently established a wholly foreign owned
subsidiary in China, known as NeoStem (China), Inc. (“WFOE” or “NeoStem China”).
The WFOE is domiciled in Qingdao and under its scope of business approved by the
Chinese regulatory authorities, the WFOE may engage in the research &
development, transfer and technological consultation service of bio-technology,
regenerative medical technology and anti-aging technology (excluding the
development or application of human stem cell, gene diagnosis and treatment
technologies); consultation of economic information; import, export and
wholesaling of machinery and equipments (the import and export do not involve
the goods specifically stipulated in/by state-operated trade, import &
export quota license, export quota bidding, export permit, etc.). As of
September 30, 2009 we have invested $2,900,000 to capitalize the WFOE. In
furtherance of complying with PRC’s foreign investment prohibition on stem cell
research and development, clinical trials and related activities, we conduct our
current business in the PRC via the following two domestic variable interest
entities (“VIEs”):
Qingdao
Niao Bio-Technology Ltd. (“Qingdao Niao”) is a Chinese domestic company
controlled by the WFOE through various business agreements. Under its scope of
business approved by the registration authorities, Qingdao Niao may engage in
research and development in, transfer of and technical consultation in bio-cell
technology, gene technology and regenerative medical technology. Qingdao Niao is
wholly owned by a PRC national who is also Qingdao Niao’s Legal Representative
and Executive Director.
Beijing
Ruijieao Bio-Technology Ltd. (“Beijing Ruijieao”) is a Chinese domestic company
controlled by the WFOE through various business agreements. Under its scope of
business approved by the registration authorities, Beijing Ruijieao may engage
in technology development, technology transfer, technology consultation and
technology services. Beijing Ruijieao is wholly owned by a PRC national who is
also Beijing Ruijieao’s Legal Representative and Executive Director. The main
activity of Beijing Ruijieao is to establish an R&D lab in Beijing and to
act as one of the sharing beneficiaries of any potential financial benefits
generated from commercialization of successful clinical trials conducted jointly
from collaborations between the lab and partner hospitals.
The
capital investment in these VIEs is funded by NeoStem through the WFOE and
recorded as interest-free loans to the shareholders of Qingdao Niao and Beijing
Ruijieao. As of
September 30, 2009 approximately $307,500
has been loaned to the shareholder of Qingdao Niao to capitalize Qingdao Niao
and approximately $16,000 has been loaned to the shareholder of Beijing Ruijieao
to capitalize Beijing Ruijieao.
According
to the current PRC regulation, the development and application of human stem
cell technology are placed in the “prohibited” category, off limits to foreign
investors. This policy prohibition precludes NeoStem from participating directly
in stem cell related business in China. NeoStem does not have direct ownership
interests in either Qingdao Niao or Beijing Ruijieao. Under various contractual
agreements, the shareholders of the VIEs are required to transfer their
ownership interests in these entities to the WFOE in China in the event Chinese
laws and regulations allow foreign investors to hold ownership interests in the
VIEs, or to our designees at any time for the amount of, to the extent permitted
by Chinese laws, outstanding loans. The shareholders of the VIEs have entrusted
us to appoint the directors and senior management personnel of the VIEs on their
behalf. Through the WFOE, we have entered into exclusive technical and
management service agreements with each VIE, under which the WFOE is providing
technical and management services to the VIEs in exchange for substantially all
net income of the VIEs. In addition, shareholders of the VIEs have pledged their
equity interests in the VIEs to the WFOE as collateral for non-payment of loans
or for fees on technical and management services due to us, which equity pledge
agreements are now required to be registered with the relevant administration of
industry and commerce to make the equity pledges become effective.
In
November 2008 (amended in July and August 2009), the Company entered into an
Agreement and Plan of Merger (the “Merger Agreement”) with China
Biopharmaceuticals Holdings, Inc. (“CBH”), pursuant to which (subject to
shareholder approval and certain other conditions) CBH would be merged with and
into a wholly-owned subsidiary of the Company (the “Merger”). The Merger
Agreement provided that, among other things, at the effective time of the
Merger, the only material assets of CBH would be CBH’s 51% interest in Suzhou
Erye Pharmaceuticals Company Ltd. (“Erye”), a Sino-foreign joint venture with
limited liability organized under the laws of the PRC, and at least $550,000 in
cash. Erye specializes in research and development, production and sales
of pharmaceutical products, as well as chemicals used in pharmaceutical
products. Erye, which has been in business for more than 50 years,
currently manufactures over 100 drugs on seven Good Manufacturing Practices
(GMP) lines, including small molecule drugs. The approval of
Merger-related transactions was submitted for stockholder consideration at
Special Meetings of Stockholders of the Company and CBH each held on October 29,
2009, and was approved. The Merger closed on October 30,
2009.
Note 2 - Summary of
Significant Accounting Policies
The
accompanying unaudited consolidated financial statements have been prepared in
accordance with accounting principles generally accepted in the United States of
America for interim financial information and with the instructions for Form
10-Q and Article 8 of Regulation S-X. 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 statements. In
the opinion of management, the statements contain all adjustments (consisting
only of normal recurring accruals) necessary to present fairly the financial
position as of September 30, 2009 and December 31, 2008, the results of
operations for the three and nine months ended September 30, 2009 and 2008 and
the cash flows for the three and nine months
ended September 30, 2009 and 2008. The results of
operations for the three and nine months ended September 30, 2009 are not
necessarily indicative of the results to be expected for the full
year.
The
December 31, 2008 consolidated balance sheet has been derived from the audited
consolidated financial statements at that date included in the Company's Annual
Report on Form 10-K. These unaudited consolidated financial statements should be
read in conjunction with the consolidated financial statements and notes thereto
included in the Company's Annual Report on Form 10-K.
In
June 2009, the Financial Accounting Standards Board (“FASB”) approved the
“FASB Accounting Standards Codification” (“ASC”) as the single source of
authoritative nongovernmental U.S. GAAP to be launched on July 1, 2009. The
ASC does not change current U.S. GAAP, but is intended to simplify user access
to all authoritative U.S. GAAP by providing all the authoritative literature
related to a particular topic in one place. All existing accounting standard
documents will be superseded and all other accounting literature not included in
the ASC will be considered nonauthoritative. The Codification is effective for
interim and annual periods ending after September 15, 2009. The ASC is
effective for us during our interim period ending September 30, 2009 and
will not have an impact on our financial condition or results of
operations.
Principles of Consolidation:
The consolidated financial statements include the accounts of NeoStem, Inc. (a
Delaware corporation) and its wholly-owned subsidiaries, NeoStem Therapies,
Inc., Stem Cell Technologies, Inc. and NeoStem (China) Inc. and its variable
interest entities, Qingdao Niao Bio-Technology Ltd and Beijing Ruijiao
Bio-Technology Ltd. All intercompany transactions and balances have been
eliminated.
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
estimates and assumptions that affect certain reported amounts and disclosures.
Accordingly, actual results could differ from those estimates.
Cash Equivalents: Short-term
cash investments, which have a maturity of ninety days or less when purchased,
are considered cash equivalents in the consolidated statement of cash
flows.
Concentrations of
Credit-Risk: Financial instruments that potentially subject the Company
to significant concentrations of credit risk consist principally of cash. The
Company places its cash accounts with high credit quality financial
institutions, which at times may be in excess of the FDIC insurance
limit.
Allowance for Doubtful Accounts:
The Company establishes an allowance for doubtful accounts to provide for
accounts receivable that may not be collectible. In establishing the allowance
for doubtful accounts, the Company analyzes the collectability of individual
large or past due accounts customer-by-customer and establishes reserves for
accounts that it determines to be doubtful of collection. There was no allowance
for doubtful accounts necessary at September 30, 2009 and December 31,
2008.
Property and Equipment: The
cost of property and equipment is depreciated over the estimated useful lives of
the related assets of 3 to 10 years. The cost of computer software programs are
amortized over their estimated useful lives of five years. Depreciation is
computed on the straight-line method. Repairs and maintenance expenditures that
do not extend original asset lives are charged to expense as
incurred.
Income Taxes: The Company, in
accordance with SFAS 109, “Accounting for Income Taxes,” recognizes (a) the
amount of taxes payable or refundable for the current year and (b) deferred tax
liabilities and assets for the future tax consequences of events that have been
recognized in an enterprise’s financial statement or tax returns. We continue to
evaluate under guidance provided by the ASC, the accounting for uncertainty in
tax positions. The guidance requires companies to recognize in their
financial statements the impact of a tax position if the position is more likely
than not of being sustained on audit. The position ascertained inherently
requires judgment and estimates by management. For the nine months
ended September 30, 2009 and the year ended December 31, 2008, we do not believe
we have any material uncertain tax positions that would require us to
measure and reflect the potential lack of sustainability of a position on audit
in our financial statements. We will continue to evaluate our tax positions in
future periods to determine if measurement and recognition in our financial
statements.
Comprehensive Income (Loss):
Refers to revenue, expenses, gains and losses that under generally
accepted accounting principles are included in comprehensive income but are
excluded from net income as these amounts are recorded directly as an adjustment
to stockholders’ equity. At December 31, 2008 there were no such
adjustments required. At September 30, 2009 a $7,584 exchange rate loss was
recognized which has been reflected on the balance sheet as accumulated other
comprehensive loss as a separate component of stockholder’s equity, in
accordance with the consolidation of a foreign operation.
Goodwill: Goodwill represents
the excess of the purchase price over the fair value of the net assets acquired
in a business combination. The Company reviews recorded goodwill for potential
impairment annually or upon the occurrence of an impairment indicator. The
Company performed its annual impairment tests as of December 31, 2008 and
determined no impairment exists. The Company will perform its future annual
impairment as of the end of each fiscal year, or earlier if circumstances would
indicate.
Intangible Asset: ASC 350-10
requires purchased intangible assets other than goodwill to be amortized over
their useful lives unless those lives are determined to be indefinite. Purchased
intangible assets are carried at cost less accumulated amortization.
Definite-lived intangible assets, which consist of patents and rights associated
with the VSELTM
Technology which constitutes the principal assets acquired in the acquisition of
Stem Cell Technologies, Inc., have been assigned a useful life and are amortized
on a straight-line basis over a period of twenty years.
Impairment of Long-lived
Assets: We
review long-lived assets and certain identifiable intangibles to be held and
used for impairment on an annual basis and whenever events or changes in
circumstances indicate that the carrying amount of an asset exceeds the fair
value of the asset. If other events or changes in circumstances indicate that
the carrying amount of an asset that we expect to hold and use may not be
recoverable, we will estimate the undiscounted future cash flows expected to
result from the use of the asset or its eventual disposition, and recognize an
impairment loss. The impairment loss, if determined to be necessary, would be
measured as the amount by which the carrying amount of the assets exceeds the
fair value of the assets.
Accounting for Stock Based
Compensation: In December 2004, the FASB issued ASC 718-10, 718-20 and
505-50 formerly, (SFAS No. 123(R), "Share-Based Payment" ("SFAS No. 123(R)")).
ASC 718-10, 718-20 and 505-50 establish standards for the accounting for
transactions in which an entity exchanges its equity instruments for goods or
services. This statement focuses primarily on accounting for transactions in
which an entity obtains employee services in share-based payment transactions.
ASC 718-10, 718-20 and 505-50 requires that the fair value of such equity
instruments be recognized as an expense in the historical financial statements
as services are performed. Prior to ASC 718-10, 718-20 and 505-50, only certain
pro forma disclosures of fair value were required. The Company has adopted ASC
718-10, 718-20 and 505-50 effective January 1, 2006. The Company determines
value of stock options by the Black-Scholes option pricing model. The value of
options issued since January 1, 2006 or that were unvested at January 1, 2006
are being recognized as an operating expense ratably on a monthly basis over the
vesting period of each option. With regard to stock options and warrants issued
to non-employees the Company has adopted ASC 505-50 formerly (EITF 96-18
“Accounting for Equity Instruments That Are Issued to Other Than Employees for
Acquiring or in Conjunction with Selling Goods and Services.”)
Earnings Per Share: Basic
(loss)/earnings per share is based on the weighted effect of all common shares
issued and outstanding, and is calculated by dividing net (loss)/income
available to common stockholders by the weighted average shares outstanding
during the period. Diluted (loss)/earnings per share, which is calculated by
dividing net (loss)/income available to common stockholders by the weighted
average number of common shares used in the basic earnings per share calculation
plus the number of common shares that would be issued assuming conversion of all
potentially dilutive securities outstanding, is not presented as it is
anti-dilutive in all periods presented. For the three and nine months
ended September 30, 2009 and 2008 the Company incurred net losses and
therefore no common stock equivalents were utilized in the calculation of
earnings per share. At September 30, 2009 and 2008 the Company had common stock
equivalents outstanding as follows:
|
|
September 30,
2009
|
|
|
September 30,
2008
|
|
Stock
Options
|
|
|
4,633,300
|
|
|
|
1,700,300
|
|
Warrants
|
|
|
18,196,780
|
|
|
|
4,770,997
|
|
Series
D Stock, Common stock equivalents
|
|
|
12,932,510
|
|
|
|
-
|
|
Advertising Policy: All
expenditures for advertising are charged against operations as
incurred.
Revenue Recognition: The
Company initiated the collection and banking of autologous adult stem cells in
the fourth quarter of 2006. The Company recognizes revenue related to the
collection and cryopreservation of autologous adult stem cells when the
cryopreservation process is completed which is generally twenty four hours after
cells have been collected. Revenue related to advance payments of storage fees
is recognized ratably over the period covered by the advanced payments. The
Company earns revenue, in the form of license fees, from physicians seeking to
establish autologous adult stem cell collection centers. These license fees are
billed upon signing of the collection center agreement and qualification of the
physician by the Company’s credentialing committee and at various times during
the term of license agreement based on the terms of the specific agreement.
During the quarter ended June 30, 2009, the Company modified its revenue
recognition policy relative to these license fees to recognize such fees as
revenues ratably over the appropriate period of time to which the revenue
element relates. Previously these license fees were recognized in full when
agreements were signed and the physician had been qualified by the Company’s
credentialing committee. This modification of our revenue recognition policy did
not have a material impact on our results of operations. The Company also
receives licensing fees from a licensee for use of our technology and knowledge
to operate an adult stem cell banking operation in China, which licensing fees
are recognized as revenues ratably over the appropriate period of time to which
the revenue element relates. In addition, the Company earns royalties for the
use of its name and scientific information in connection with its License and
Referral Agreement with Promethean Corporation (see “Related Party Transactions”
below), which royalties are recognized as revenue when they are
received.
Fair Value
Measurements: We follow the provisions of ASC 820, Fair Value Measurements and
Disclosures related to financial assets and liabilities that are being
measured and reported on a fair value basis. Fair value is the price that would
be received to sell an asset or paid to transfer a liability in an orderly
transaction between market participants in the principal market at the
measurement date (exit price). We are required to classify fair value
measurements in one of the following categories:
Level 1
inputs which are defined as quoted prices (unadjusted) in active markets for
identical assets or liabilities that the reporting entity has the ability to
access at the measurement date.
Level 2
inputs which are defined as inputs other than quoted prices included within
Level 1 that are observable for the assets or liabilities, either directly or
indirectly.
Level 3
inputs are defined as unobservable inputs for the assets or
liabilities.
Financial
assets and liabilities are classified based on the lowest level of input that is
significant to the fair value measurement. Our assessment of the significance of
a particular input to the fair value measurement requires judgment, and may
effect the valuation of the fair value of assets and liabilities and their
placement within the fair value hierarchy levels.
Note 3 – Recent Accounting
Pronouncements
In June
2008, FASB issued ASC 815-40 (formerly EITF No. 07-5, "Determining Whether an Instrument
(or an Embedded Feature) Is Indexed to an Entity's Own Stock") ("ASC
815-40"). ASC 815-40 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 instrument's contingent
exercise and settlement provisions. This statement is effective for financial
statements issued for fiscal years beginning after December 15, 2008. Early
application is not permitted. At the present time we do not have any such equity
instruments but we are assessing the potential impact of this statement on our
future financial condition and results of operations.
In April
2009, the FASB issued ASC 805-10,805-20 and 805-30 (formerly FASB Staff Position
No. 141(R)-1, Accounting for
Assets Acquired and Liabilities Assumed in a Business Combination That Arise
from Contingencies) (“ASC 805”). ASC 805 amends and clarifies ASC 805
(formerly SFAS No. 141(R)). ASC 805 requires an acquirer to recognize at fair
value, at the acquisition date, an asset acquired or a liability assumed in a
business combination that arises from a contingency if the acquisition-date fair
value of that asset or liability can be determined during the measurement
period. If the fair value cannot be determined during the measurement period, an
asset or a liability shall be recognized at the acquisition date if the asset or
liability can be reasonably estimated and if information available before the
end of the measurement period indicates that it is probable that an asset
existed or that a liability had been incurred at the acquisition date ASC 805
amends the disclosure requirements of ASC 805 to include business
combinations that occur either during the current reporting period or after the
reporting period but before the financial statements are issued. ASC 805 is
effective for fiscal years beginning after December 15, 2008 and interim periods
within those years. The adoption of ASC 805 has resulted in NeoStem
expensing currently pre-merger costs associated with the proposed merger with
China BioPharmaceuticals Holdings, Inc., which amounted to $2,232,000 in the
nine months ended September 30, 2009. This statement was
effective January 1, 2009.
In
December 2008, the FASB issued ASC 860-10 (formerly FASB Staff Position FAS
140-4 and FIN 46(R)-8, Disclosures by Public Entities
(Enterprises) about Transfers of Financial Assets and Interests in Variable
Interest Entities) (“ASC 860”). This document increases
disclosure requirements for public companies and is effective for reporting
periods (interim and annual) that end after December 15, 2008. The purpose of
ASC 860 is to improve disclosures by public entities and enterprises until the
pending amendments to ASC 860 (formerly FASB Statement No. 140, Accounting for Transfers and
Servicing of Financial Assets and Extinguishments of Liabilities, and
FASB Interpretation No. 46 (revised December 2003), Consolidation of Variable Interest
Entities), are finalized and approved by the Board. ASC 860 amends ASC
815 to require public entities to provide additional disclosures about
transferors’ continuing involvements with transferred financial assets. It also
amends ASC 860 to require public enterprises, including sponsors that have a
variable interest in a variable interest entity, to provide additional
disclosures about their involvement with variable interest entities. We
implemented the requirements of ASC 860 in the second quarter of 2009. As the
requirements of this literature only impact our disclosures, there was no impact
to our financial results.
In April
2009, the FASB issued ASC 820-10 (formerly FASB Staff Position No. 157-4, Determining Fair Value When the
Volume and Level of Activity for the Asset or Liability Have Significantly
Decreased and Identifying Transactions That Are Not Orderly) (“ASC 820”).
ASC 820 provides additional guidance for estimating fair value in accordance
with SFAS No. 157 when the volume and level of activity for the asset or
liability have significantly decreased. ASC 820 also includes guidance on
identifying circumstances that indicate a transaction is not orderly. ASC 820
requires the disclosure of the inputs and valuation technique used to measure
fair value and a discussion of changes in valuation techniques and related
inputs, if any, during the period. ASC 820 also requires that the entity define
major categories for equity securities and debt securities to be major security
types. ASC 820 is effective for interim and annual reporting periods ending
after June 15, 2009. We have adopted ASC 820 in our quarter ended June 30, 2009.
The adoption of ASC 820 did not have a material impact on our financial position
or results of operations.
In April
2009, the FASB issued ASC 320-10 (formerly FASB Staff Position No. 115-2 and FAS
124-2, Recognition and
Presentation of Other-Than-Temporary Impairments) (“ASC 320”). This FSP
amends the other-than-temporary impairment guidance in U.S. GAAP for debt
securities to make the guidance more operational and to improve the presentation
and disclosure of other-than-temporary impairments on debt and equity securities
in the financial statements. This FSP does not amend existing recognition and
measurement guidance related to other-than-temporary impairments of equity
securities. ASC 320 requires the entity to assess whether the impairment is
other-than-temporary if the fair value of a debt security is less than its
amortized cost basis at the balance sheet date. This statement also provides
guidance to assessing whether or not the impairment is other-than-temporary and
guidance on determining the amount of the other-than-temporary impairment that
should be recognized in earnings and other comprehensive income. ASC 320 also
requires an entity to disclose information that enables users to understand the
types of securities held, including those investments in an unrealized loss
position for which the other-than-temporary impairment has or has not been
recognized. ASC 320 is effective for interim and annual reporting periods ending
after June 15, 2009. The adoption of ASC 320 did not have a material impact on
our financial position or results of operations.
In April
2009, the FASB issued ASC 825-10 (formerly FASB Staff Position
No. FAS 107-1 and APB 28-1, Interim Disclosures about Fair Value
of Financial Instruments) (“ASC 825”). ASC 825 amends ASC 825
(formerly FASB Statement No. 107, Disclosures about Fair Value of
Financial Instruments), to require disclosures about fair value of
financial instruments at interim reporting periods. This Staff Position is
effective for interim reporting periods ending after June 15, 2009, with
early adoption permitted for periods ending after March 15, 2009 provided
ASC 320 (described above) are also early adopted. We adopted ASC 825 in our
quarter ended June 30, 2009. The adoption of ASC 825 did not have a material
impact on our financial position or results of operations.
In May 2009, the FASB
issued ASC 855-10 (formerly Statement No. 165, Subsequent Events) (“ASC
855”). ASC 855
establishes general standards of accounting for and disclosure of events that
occur after the balance sheet date but before the financial statements are
issued or are available to be issued. We have adopted Statement 165 in our
quarter ended June 30, 2009. The adoption of ASC 855 did not have a material
impact on our financial position or results of operations.
In June
2009, the FASB issued Statement No. 166, Accounting for Transfers of
Financial Assets, an amendment of FASB Statement No. 140. Statement
166 eliminates the concept of a “qualifying special-purpose entity” from
Statement 140 and changes the requirements for derecognizing financial assets.
We will adopt Statement 166 in 2010 and are currently evaluating the impact of
its pending adoption on our consolidated financial statements.
In June
2009, the FASB issued Statement No. 167, Amendments to FASB Interpretation
No. 46(R) . Statement 167 amends the evaluation criteria to identify
the primary beneficiary of a variable interest entity provided by FASB
Interpretation No. 46(R) , Consolidation of Variable Interest
Entities—An Interpretation of ARB No. 51 . Additionally, Statement
167 requires ongoing reassessments of whether an enterprise is the primary
beneficiary of the variable interest entity. We will adopt Statement 167 in 2010
and are currently evaluating the impact of its pending adoption on our
consolidated financial statements.
Note 4 - Notes
Payable
In order
to move forward certain research and development activities, strategic
relationships in various clinical and therapeutic areas as well as to support
activities related to the Company’s proposed merger (the “Merger”) with China
Biopharmaceuticals Holdings, Inc., proposed share exchange (the “Share
Exchange”) relating to the Shandong New Medicine Research Institute of
Integrated Traditional and Western Medicine Limited Liability Company
(“Shandong”), other initiatives in China as well as other ongoing obligations of
the Company, on February 25, 2009 and March 6, 2009, respectively, the Company
issued promissory notes to RimAsia Capital Partners L.P. (“RimAsia”), a
principal stockholder of the Company, in the principal amounts of $400,000 and
$750,000, respectively. The notes bore interest at the rate of 10%
per annum and were due and payable on October 31, 2009, except that all
principal and accrued interest on the Notes was immediately due and payable in
the event the Company raised over $10 million in equity financing prior to
October 31, 2009. The notes contained standard events of default and
in the event of a default that was not subsequently cured or waived, the
interest rate would increase to a rate of 15% per annum and, at the option of
RimAsia and upon notice, the entire unpaid principal balance together with all
accrued interest thereon would be immediately due and payable. The
notes or any portion thereof could be prepaid at any time and from time to time
at the discretion of the Company without premium or penalty. On April 9, 2009
these notes and the related accrued interest were repaid from the proceeds of an
$11 million offering of units consisting of shares of the Company’s Series D
Convertible Redeemable Preferred Stock and warrants to purchase shares of Common
Stock.
In July,
2009, in order to facilitate working capital requirements in China, NeoStem
China issued a promissory note to China Xingye Bank in the amount of RMB
1,000,000 ($146,700). The note is due on January 1, 2010 and bears an interest
rate of 4.86%. The loan is collateralized by cash in a restricted bank account
totaling 1,229,000 RMB (approximately $180,300).
Note 5 –
Convertible Redeemable Preferred Stock
In April
2009, the Company completed a private placement financing totaling $11 million
(the “April 2009 Private Placement”). This financing consisted of the
issuance of 880,000 units priced at $12.50 per unit, with each unit (the “Series
D Units”) consisting of one share of the Company’s Series D Convertible
Redeemable Preferred Stock (the “Series D Stock”) and ten warrants with each
warrant to purchase one share of Common Stock (the “Series D Warrants”). A total
of 880,000 shares of Series D Stock and 8,800,000 Series D Warrants were
issued. RimAsia, a principal stockholder in the Company, purchased
$5,000,000 in Series D Units in the April 2009 Private Placement and thus
acquired 400,000 shares of Series D Stock and 4,000,000 Series D Warrants. In
June 2009, with a final closing on July 6, 2009, the Company completed an
additional private placement financing totaling approximately $5 million with
net proceeds of $4,679,220 (the “June 2009 Private Placement”). This
financing consisted of the issuance of 400,280 Series D Units priced at $12.50
per unit, and a total of 400,280 shares of Series D Stock and 4,002,800 Series D
Warrants were issued. The Company paid $324,280 in fees and issued 12,971 Series
D Units to agents that facilitated the June 2009 Private Placement. The Series D
Units issued to the selling agents were comprised of 12,971 shares of the Series
D Stock and 129,712 Series D Warrants. Fullbright Finance Limited, a beneficial
holder of more than 5% of the Company’s stock, purchased an aggregate of
$800,000 in Series D Units in the June 2009 Private Placement and thus acquired
64,000 shares of Series D Stock and 640,000 Series D Warrants; the Company
understands that all securities purchased by Fullbright in the June 2009 Private
Placement were pledged to RimAsia and subsequently, to the
Company. In total, in the April 2009 and June 2009 Private
Placements, the number of shares of Series D Stock issued was 1,293,251
(converted into 12,932,510 shares of Common Stock upon stockholder approval on
October 29, 2009) and the number of Series D Warrants issued was
12,932,512.
Upon the
affirmative vote of holders of a majority of the voting power of the Company’s
Common Stock required pursuant to the Company’s Amended and Restated By-Laws and
the NYSE Amex, each share of Series D Stock was to automatically be converted
into ten (10) shares of Common Stock at an initial conversion price of $1.25 per
share based on an original issue price of $12.50 per share; provided that if by
October 31, 2009 such affirmative vote was not achieved, the Company would be
required to redeem all shares of Series D Stock at a redemption price per share
of $12.50 plus the accrued dividends as of such date. The conversion
of the Series D Stock was submitted for stockholder approval at the NeoStem
Special Meeting of Stockholders held on October 29, 2009 and was approved, and
the Series D Stock converted into an aggregate of 12,972,310 shares of the
Company’s Common Stock. The total cash required to redeem the Series D Stock
would have been $16,165,638 plus accrued dividends. The Series D
Stock had an accruing dividend of ten percent (10%) per annum, payable (i)
annually in cash on April 9th, provided that the shares of Series D Stock
remained outstanding on such date or (ii) upon a liquidation, dissolution or
winding up of the Company. The Series D Stock (i) ranked senior to
all of the Company’s capital stock with respect to the payment of dividends and
to the distribution of assets upon liquidation, dissolution or winding up, (ii)
did not have any voting rights, (iii) did not have any anti-dilution protection
other than standard protection for stock splits and combinations, and (iv) did
not have any preemptive rights. By June 30, 2009 the Company
had received $4,304,220 of the net proceeds from the June 2009 Private Placement
and the balance of $375,000 was received on July 6, 2009. The Company has
accounted for the issuance of all Series D Stock and Series D Warrants in the
June 2009 Private Placement as of June 30, 2009. The combined net
proceeds from the two private placements were $15,669,220. Since the April and
June 2009 Private Placements represent a combination of equities we are required
to account for the value of all equity securities associated with these private
placements and assign a portion of the net proceeds received to each
equity instrument. We apportioned and assigned the net proceeds of the two
private placements as follows: the value assigned to the Series D Stock was
$7,685,768, which includes the contingent value of the beneficial conversion to
common stock of $6,618,000, and the value assigned to the Series D Warrants was
$7,983,452.
The Series
D Warrants have a per share exercise price equal to $2.50 and are callable by
the Company if the common stock trades at a price equal to not less than $3.50
for a specified period of time. Subject to the affirmative vote of
the Company’s shareholders and the rules of the NYSE Amex, the Series D
Warrants are exercisable for a period of five years. The
exercisability of the Series D Warrants was submitted for stockholder approval
at the NeoStem Special Meeting of Stockholders held on October 29, 2009, was
approved and the Series D Warrants became exercisable through October
2014.
Note 6 - Stockholders’
Equity
Common
Stock:
In
January 2009, the Company entered into an agreement with a physician who was
retained as a consultant. The term of this agreement is January 2009
through December 31, 2011. As part of the consideration for providing
services, the physician is to receive $24,000 annually, by the issuance of
shares of the Company’s Common Stock under the Company’s 2003 Equity
Participation Plan, as amended (the “2003 Equity Plan”) in equal monthly
installments of $2,000 on the last day of each month during the term of the
agreement at a per share purchase price equal to the closing price of the Common
Stock on the last day of each month, which payment shall be made in cash in the
event shares under the 2003 Equity Plan or any successor plan are
unavailable. During the three and nine months ended September 30,
2009, 3,265 and 15,298 shares of Common Stock were issued,
respectively, to the physician pursuant to this agreement. The issuance of
Common Stock resulted in charges to operations for the three and nine months
ended September 30, 2009 of $6,000 and $18,000, respectively.
In
January 2009, the Company entered into an agreement with a consultant which has
been providing investor relations services to the Company since 2005, pursuant
to which this consultant was retained to provide additional investor
relations/media relations services from January 1, 2009 to May 31,
2009. In consideration for providing services under this agreement,
the Company agreed to issue to the consultant an aggregate of 40,000 shares of
restricted Common Stock, to vest as to 8,000 shares on the last day of each
month of January through May 2009. The issuance of such securities was subject
to the approval of the NYSE Amex, which approval was obtained in May 2009. The stock issued to this
consultant had a value of $27,600 of which $0 and $27,600 were charged to
operations during the three and nine months ended September 30, 2009,
respectively, based on the vesting of the Common Stock.
In January 2009, the
Company issued to its grant consultant, 20,000 shares of restricted Common
Stock, with a value of $13,800 as a bonus under the consultant’s Consulting
Agreement with the Company dated February 8, 2008, in consideration for such
consultant being instrumental in the Company receiving a Congressionally
Directed Grant which was included in the Department of Defense Fiscal Year 2009
Appropriations Bill. The issuance of such securities was approved by
the NYSE Amex, which approval was obtained in January 2009. The
Company has entered into a new consulting agreement with this grant consultant
for a one-year term commencing as of January 1, 2009. In
consideration for services, the consultant will be issued shares of the
Company’s restricted Common Stock equal to a value of $60,000 based on the
closing price of the Company’s Common Stock on the date of execution of the
agreement, which has been determined to be 67,416 shares, to vest as to one-half
of such shares on September 30, 2009 and the remaining one-half of such shares
on December 31, 2009. The issuance of such securities was approved by the
NYSE Amex, which approval was obtained in May 2009. For the three and nine
months ended September 30, 2009 the Company has recognized $15,000 and $60,000,
respectively, as an operating expense relating to these shares.
In
January 2009, the Company issued to a marketing consultant 12,000 shares of
restricted Common Stock, with a value of $8,280, pursuant to the terms of a
three month consulting agreement entered into in October 2008, scheduled to vest
pursuant to the agreement as to 4,000 shares at the end of each 30 day period
during the term. The issuance of such securities was approved by the
NYSE Amex, which approval was obtained in January 2009. The issuance of Common
Stock resulted in charges to operations for the three and nine months ended
September 30, 2009 of $0 and $8,280, respectively.
In
January 2009, the Company issued to a member of its Scientific Advisory Board
20,000 shares of Common Stock under the 2003 Equity Plan, with a value of
$15,000, in consideration of this individual’s contribution to a special project
related to the design of a cardiac stem cell clinical trial for end stage
cardiomiopathy anticipated to be conducted in the People’s Republic of China.
The issuance of Common Stock resulted in charges to operations for the three and
nine months ended September 30, 2009 of $0 and $15,000,
respectively.
In
February 2009, the Company entered into a consulting agreement with a one year
term commencing March 1, 2009, with a physician to provide services to the
Company including providing medical expertise in the areas of apheresis and
laboratory medicine and to serve (as needed) as medical director for centers in
the Company’s stem cell collection center network as well as other related
activities, in partial consideration for which the physician is to receive a
one-time payment of 10,000 shares of Common Stock under the 2003 EPP, which
shares were issued as of February 2009. These shares had a value of
$8,000. The issuance of Common Stock resulted in charges to operations for the
three and nine months ended September 30, 2009 of $0 and $8,000,
respectively.
In March
2009, the Company entered into an agreement with a consultant, pursuant to which
this consultant was retained to provide additional financial market related
services for a three month period. In partial consideration for
providing services under this agreement, the Company agreed to issue to the
consultant an aggregate of 25,000 shares of restricted Common Stock, with a
value of $17,250, to vest as to one-third of the shares at the end of each
monthly period during the term. The issuance of such securities was approved by
the NYSE Amex, which approval was obtained in May 2009. Based on these vesting
terms, the Company has recognized $0 and $17,250 as an operating expense in the
three and nine months ended September 30, 2009, respectively. This
consultant was also issued a five year warrant to purchase 25,000 shares of
restricted Common Stock at a per share exercise price of $1.00, with a value of
$16,867. (See Warrants below).
In April
2009, the Company entered into an agreement with a consultant to provide
financial market related services to the Company. In partial
consideration for providing services under this agreement, the Company agreed to
issue to the consultant an aggregate of 20,000 shares of Common Stock, with a
value of $19,800. The issuance of such securities was approved by the NYSE Amex,
which approval was obtained in May 2009. The Company has recognized
$0 and $19,800 as an operating expense in the three and nine months ended
September 30, 2009, respectively.
In April
2009, the Company entered into an agreement with a consultant to provide support
services in connection with the Merger to the Company. In partial
consideration for providing services under this agreement, the Company agreed to
issue to the consultant an aggregate of 10,000 shares of Common Stock, with a
value of $11,800. The issuance of such securities was approved by the NYSE Amex,
which approval was obtained in May 2009. The Company has
recognized $0 and $11,800 as an operating expense in the three and nine months
ended September 30, 2009, respectively.
In May
2009, the Compensation Committee of the Board of Directors approved awards under
a Board of Directors Compensation Plan to members of the Board acting in their
capacity as Board members and to the Board Secretary, which included the
issuance of options under the Company’s newly adopted 2009 Equity
Compensation Plan (the “2009 Equity Plan”) and the authorization for the Chairs
of the Board and Board Committees to be issued for each Chair they
hold, either $25,000 or 25,000 shares of fully vested Common Stock under the
2009 Equity Plan. Accordingly, an aggregate of $50,000 was paid and
50,000 shares of Common Stock were awarded. The Common Stock issued
had a value of $97,500, and $0 and $97,500 was charged to operations during the
three months and nine months ended September 30, 2009,
respectively.
In May
2009, the Company entered into a one month agreement with a consultant to
provide consulting services in the area of pharmaceutical research and the
development of strategic transactions. In partial consideration for
providing services under this agreement, the Company issued to the consultant
6,250 shares of Common Stock. The Common Stock issued had a value of
$11,876, and $0 and $11,876 was charged to operations during the three months
and nine months ended September 30, 2009, respectively. The
consultant joined the Company as its Vice President, Drug Development and
Regulatory Affairs in July 2009.
In July
2009, the Company granted under its 2009 Equity Plan, an aggregate of 525,000
shares of Common Stock to two executive officers of the Company. Robin
Smith, the Company’s Chief Executive Officer, received 500,000 shares of Common
Stock with a value of $855,000; 300,000 shares vested immediately and 200,000
will vest upon achievement of a business milestone; $513,000 was charged to
operations during the three months and nine months ended September 30,
2009. Catherine Vaczy, the Company’s Vice President and General Counsel,
received 25,000 shares of Common Stock with a value of $42,750, which vested
immediately, in connection with an extension of her employment agreement:
$42,750 was charged to operations during the three months and nine months ended
September 30, 2009.
In August
2009, the Company entered into a two year Consulting Agreement with the Chairman
of its Scientific Advisory Board. In partial consideration for
providing services under this Agreement, the Company issued to this advisor
50,000 shares of Common Stock under the 2009 Equity Plan. The Common
Stock issued had a value of $94,500, and resulted in a charge to operations of
$94,500 for the three and nine months ended September 30, 2009.
In August
2009, the Company entered into a two and one-half month agreement with a
consultant to provide web-based and other corporate promotional services to the
Company. In partial consideration for providing services under this
agreement, the Company agreed to issue to the consultant an aggregate of 8,000
restricted shares of Common Stock, with a value of $14,960. The issuance of such
securities was approved by the NYSE Amex, which approval was obtained in
September 2009. The Company has recognized $14,960 as an operating
expense in the three and nine months ended September 30,
2009.
Warrants:
The
Company has issued common stock purchase warrants from time to time to investors
in private placements, certain vendors, underwriters, and directors and officers
of the Company. A total of 18,196,780 shares of common stock
are reserved for issuance upon exercise of outstanding warrants as of September
30, 2009 at prices ranging from $.50 to $8.00 and expiring through June
2014.
In
February 2009, the Company issued to a consultant a five year warrant to
purchase 5,000 shares of Common Stock at a purchase price of $1.40 per share,
with a value of $3,338. This warrant was issued in consideration of services
rendered after the expiration of an October 2007 consulting agreement with the
Company pursuant to which this consultant was engaged to create marketing
materials for our sales and marketing staff. The issuance of this warrant was
approved by the NYSE Amex and vested on issuance.
In March
2009, the Company entered into an agreement with a consultant to provide
financial market related services for a three month period beginning March
2009. As partial consideration for providing services under this
agreement, the Company agreed to issue to the consultant a five year warrant to
purchase 25,000 shares of restricted Common Stock at a per share exercise price
of $1.00, with a value of $16,867, vesting in its entirety at the end of the
term. The issuance of such securities was approved by the NYSE
Amex, which approval was obtained in May 2009. The Company recognized
$0 and $16,867 as an operating expense for the three and nine months ended
September 30, 2009, respectively.
In the
Company’s August 2007 public offering, units were issued comprised of shares of
the Company’s Common Stock, and Class A warrants to purchase an aggregate of
635,000 shares of Common Stock. The Company also issued to its
underwriter group warrants (the “Underwriter Warrants”) to purchase an aggregate
of 95,250 shares of Common Stock. The Class A Warrants were issued
pursuant to the terms of a Restated Warrant Agreement made as of August 14, 2007
between the Company and the Class A Warrant agent. The Underwriter
Warrants were issued individually to each member of the underwriting
group. The Underwriter Warrants had a higher exercise price ($6.50)
than that of the Class A Warrants, and unlike the Class A Warrants, could not be
exercised for a period of one year from the date of issuance and contained
provisions for cashless exercise. In September, 2008 the Company made the
determination that certain of the Underwriter Warrants totaling 86,865 shares of
Common Stock, should be accounted for as a derivative liability and reported on
our balance sheet as such. Upon the closing of our August 2007 public offering
the fair value and thus the derivative liability value of these certain
Underwriter Warrants was $195,551. At December 31, 2008 the derivative liability
value associated with these certain Underwriter Warrants was $0 and at September
30, 2009 the derivative liability value of these Underwriter Warrants was $
41,143 and has been reflected as an accrued liability on our balance sheet.
During the three months ended September 30, 2009 the Company recognized a credit
to operating expense of $(1,749) and for the nine months ended September 30,
2009 an operating expense of $41,143.
In the
April and June 2009 Private Placements (described in Note 5 - Redeemable
Preferred Stock, above), as part of the Series D Units issued at $12.50 per
unit, the Company issued 8,800,000 Series D Warrants, and 4,002,800 Series D
Warrants, respectively, to investors, each to purchase one share of Common
Stock. The Company also issued 129,712 Series D Warrants to selling
agents that facilitated the June 2009 Private
Placement. The Series D Warrants have a per share exercise
price equal to $2.50 and are callable by the Company if the Common Stock trades
at a price equal to not less than $3.50 for a specified period of
time. Subject to the affirmative vote of the Company’s shareholders
and the rules of the NYSE Amex, the Series D Warrants are exercisable for a
period of five years. The exercisability of all 12,932,512 Series D
Warrants was submitted for stockholder approval at the NeoStem Special Meeting
of Stockholders held on October 29, 2009, was approved and the Series D Warrants
became exercisable through October 2014. The combined net proceeds
from the two private placements were $15,679,220. Since the April and June 2009
Private Placements represent a combination of equities we are required to
account for the value of all equity securities associated with these private
placements and assign a portion of the net proceeds received to each equity
instrument. We apportioned and assigned the net proceeds of the two private
placements as follows: the value assigned to the Series D Stock was $7,685,768,
which includes the contingent value of the beneficial conversion to common stock
of $6,618,000, and the value assigned to the Series D Warrants was
$7,983,452.
On May 1,
2009, the Company entered into a three year consulting agreement effective March
3, 2009 (the “Effective Date”) whereby the consultant would provide to the
Company consulting services in the area of stem cell therapy in orthopedics for
the development of business in Asia. Pursuant to this agreement, as
partial compensation for such services, the Company agreed to issue to this
consultant a warrant to purchase up to an aggregate of 24,000 shares of Common
Stock at an exercise price of $0.50 (the closing price of the Common Stock on
the Effective Date) which shall vest and become exercisable as to one-third of
such shares on each of the first, second and third anniversaries of the
Effective Date. The value of such warrants is approximately
$27,163. The issuance of such securities was approved by the NYSE
Amex. The Company has recognized $3,773 as an operating expense in the three and
nine months ended September 30, 2009.
Warrant
activity is as follows:
|
|
Number of
Shares
|
|
|
Range of
Exercise Price
|
|
|
Weighted
Average
Exercise
Price
|
|
|
Weighted
Average
Remaining
Contractual
Term
(years)
|
|
|
Aggregate
Intrinsic
Value
|
|
Balance
December 31, 2008
|
|
|
5,322,333 |
|
|
$ |
0.50
- $8.00 |
|
|
$ |
3.66 |
|
|
|
|
|
|
|
|
|
Granted
|
|
|
12,986,512 |
|
|
|
|
|
|
|
2.49 |
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expired
|
|
|
(112,065
|
) |
|
|
|
|
|
|
8.43 |
|
|
|
|
|
|
|
|
|
Cancelled
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
September 30, 2009
|
|
|
18,196,780 |
|
|
$ |
0.50
- $8.00 |
|
|
$ |
2.80 |
|
|
|
4.28 |
|
|
|
1,170,432 |
|
|
|
|
|
|
|
Number
|
|
|
Weighted Average
Remaining
|
|
|
Number
|
|
Exercise Price
|
|
|
Outstanding
September 30, 2009
|
|
|
Contractual Life
(years)
|
|
|
Exercisable
September 30, 2009
|
|
$
|
0.50
to
|
|
$ |
3.02 |
|
|
|
16,252,221 |
|
|
|
4.44
|
|
|
|
3,254,047 |
|
$
|
3.02
to
|
|
$ |
5.27 |
|
|
|
183,750 |
|
|
|
2.42
|
|
|
|
183,750 |
|
$
|
5.27
to
|
|
$ |
7.51 |
|
|
|
802,761 |
|
|
|
2.93
|
|
|
|
802,761 |
|
$
|
7.51
to
|
|
$ |
8.00 |
|
|
|
958,048 |
|
|
|
3.09
|
|
|
|
958,048 |
|
|
|
|
|
|
|
|
|
18,196,780 |
|
|
|
4.28
|
|
|
|
5,198,606 |
|
See Note
10, Subsequent Events, for information on a proposal submitted to NeoStem
stockholders at the NeoStem Special Meeting of Stockholders held on October 29,
2009, to allow privately issued warrants (warrants issued other than to the
public or the underwriters in NeoStem’s August 2007 public offering) with
exercise prices ranging from $4.00 to $8.00 to be repriced to a range of
approximately $3.82 to $6.81. Such proposal was approved, and
warrants to purchase approximately 1,203,890 shares of Common Stock were so
repriced effective on October 30, 2009, the date of closing of the
Merger.
Options:
The
Company’s 2003 Equity Participation Plan (the “2003 Equity Plan”) and 2009
Equity Compensation Plan (the “2009 Equity Plan”) permit the grant of share
options and shares to its employees, directors, consultants and advisors for up
to an aggregate of 6,300,000 shares of Common Stock as stock-based
compensation. All stock options under the 2003 Equity Plan and the
2009 Equity Plan are generally granted at the fair market value of the Common
Stock at the grant date. Stock options vest either on the date of grant, ratably
over a period determined at time of grant, or upon the accomplishment of
specified business milestones, and generally expire 10 years from the grant
date.
On May 8,
2009, the stockholders of the Company at its annual meeting of stockholders
adopted the 2009 Equity Plan, which previously had been approved by the Board of
Directors subject to stockholder approval on April 9, 2009. The 2009
Equity Plan makes up to 3,800,000 shares of Common Stock of the Company
available for issuance to employees, consultants, advisors and directors of the
Company and its subsidiaries pursuant to incentive or non-statutory stock
options, restricted and unrestricted stock awards and stock appreciation
rights.
The 2003 Equity Plan and
the 2009 Equity Plan are sometimes collectively referred to as the Company’s
“U.S. Equity Plan.”
Effective
January 1, 2006, the Company’s U.S. Equity Plan has been accounted for in
accordance with the recognition and measurement provisions of ASC
718-10, 718-20 and 505-50. ASC 718-10, 718-20 and 505-50 require compensation
costs related to share-based payment transactions, including employee stock
options, to be recognized in the financial statements. In addition, the Company
adheres to the guidance set forth within Securities and Exchange Commission
("SEC") Staff Accounting Bulletin ("SAB") No. 107, which provides the Staff's
views regarding the interaction between ASC 718-10, 718-20 and 505-50 and
certain SEC rules and regulations and provides interpretations with respect to
the valuation of share-based payments for public companies.
The
Company's results included share-based compensation expense of $1,368,179 and $
323,424 for the three months ended September 30, 2009 and 2008, respectively and
$ 2,766,566 and $ 1,525,649 for the nine months ended September 30, 2009 and
2008, respectively. Such amounts have been included in the consolidated
statements of operations within general and administrative
expenses.
Stock
option compensation expense is the estimated fair value of options granted
amortized on a straight-line basis over the requisite service period for the
entire portion of the award and those options that vested upon the
accomplishment of business milestones. Options vesting on the accomplishment of
business milestones will not be recognized for compensation purposes until such
milestones are accomplished. At September 30, 2009 there were options to
purchase 275,000 shares outstanding that will vest on the accomplishment of
certain business milestones.
The
weighted average estimated fair value of stock options granted in the three
months ended September 30, 2009 and 2008 were $1.77 and $ 1.00,
respectively and for the nine months ended September 30, 2009 and 2008 the
weighted average estimated fair value of stock options granted were $
1.83 and $ 1.40
respectively. The fair value of options at the date of grant was estimated using
the Black-Scholes option pricing model. During the nine months ended September
30, 2009 and the years ended 2008, 2007 and 2006, the Company took into
consideration the guidance under ASC 718-10 and SAB No. 107 when reviewing and
updating assumptions. The expected volatility is based upon historical
volatility of our stock and other contributing factors. The expected term is
based upon observation of actual time elapsed between date of grant and exercise
of options for all employees. Previously such assumptions were
determined based on historical data.
The range
of assumptions made in calculating the fair values of options are as
follows:
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
Expected
term (in years)
|
|
10
|
|
|
10
|
|
|
10
|
|
|
10
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expected
volatility
|
|
187%
to 197%
|
|
|
119%
to 158%
|
|
|
187%
to 217%
|
|
|
100%
to 158%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expected
dividend yield
|
|
0%
|
|
|
0%
|
|
|
0%
|
|
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Risk-free
interest rate
|
|
3.33%
to 3.66%
|
|
|
3.64%
to 4.09%
|
|
|
3.33%
to 3.81%
|
|
|
3.64%
to 4.19%
|
|
Stock
option activity under the US Equity Plan is as follows:
|
|
|
|
|
Range of
Exercise Price
|
|
|
Weighted
Average
Exercise Price
|
|
|
Weighted
Average
Remaining
Contractual
Term
|
|
|
Aggregate
Intrinsic
Value
|
|
Balance
December 31, 2008
|
|
|
1,725,300 |
|
|
$ |
0.71 - $25.00 |
|
|
$ |
3.96 |
|
|
|
|
|
|
|
Granted
|
|
|
2,920,000 |
|
|
|
|
|
|
|
1.83 |
|
|
|
|
|
|
|
Exercised
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expired
|
|
|
(2,000
|
) |
|
|
|
|
|
|
.94 |
|
|
|
|
|
|
|
Cancelled
|
|
|
(10,000
|
) |
|
|
|
|
|
|
7.00 |
|
|
|
|
|
|
|
Balance
September 30, 2009
|
|
|
4,633,300 |
|
|
$ |
0.71 - $25.00 |
|
|
$ |
2.62 |
|
|
|
5.70 |
|
|
$ |
503,700 |
|
Vested
and Exercisable at September 30, 2009
|
|
|
2,718,300 |
|
|
|
|
|
|
$ |
3.01 |
|
|
|
|
|
|
$ |
300,285 |
|
(1)
|
—
All options are exercisable for a period of ten
years.
|
|
|
|
|
|
|
Number
|
|
|
Weighted
Average
Remaining
|
|
|
Number
|
|
|
Exercise Price
|
|
|
Outstanding
September 30, 2009
|
|
|
Contractual Life
(years)
|
|
|
Exercisable
September 30, 2009
|
|
$ |
0.71
to
|
|
$
|
4.17
|
|
|
|
3,742,000
|
|
|
|
9.44
|
|
|
|
1,992,000
|
|
$ |
4.17
to
|
|
$
|
7.63
|
|
|
|
800,200
|
|
|
|
7.35
|
|
|
|
639,200
|
|
$ |
7.63
to
|
|
$
|
11.08
|
|
|
|
50,000
|
|
|
|
6.20
|
|
|
|
46,000
|
|
$ |
11.08
to
|
|
$
|
14.54
|
|
|
|
3,000
|
|
|
|
4.42
|
|
|
|
3,000
|
|
$ |
14.54
to
|
|
$
|
25.00
|
|
|
|
38,100
|
|
|
|
5.77
|
|
|
|
38,100
|
|
|
|
|
|
|
|
|
|
4,633,300
|
|
|
|
|
|
|
|
2,718,300
|
|
Options
are usually granted at an exercise price at least equal to the fair value of the
Common Stock at the grant date and may be granted to employees, directors,
consultants and advisors of the Company.
As of
September 30, 2009, there was approximately $3,679,418 of total unrecognized
compensation costs related to unvested stock option awards of which $1,828,748
of unrecognized compensation expense is related to stock options that vest over
a weighted average life of 5 years. The balance of
$1,850,669 of unrecognized compensation costs is related to stock options that
vest based on the accomplishment of business milestones.
|
|
Options
|
|
|
Weighted Average
Grant Date Fair
Value
|
|
Non-Vested
at December 31, 2008
|
|
|
435,250
|
|
|
$
|
2.90
|
|
Issued
|
|
|
2,920,000
|
|
|
|
1.82
|
|
Expired
|
|
|
(2,000
|
)
|
|
|
7.00
|
|
Canceled
|
|
|
(10,000
|
)
|
|
|
.93
|
|
Vested
|
|
|
(1,428,250)
|
|
|
|
1.83
|
|
Exercised
|
|
|
-
|
|
|
|
|
|
Non-Vested
at September 30, 2009
|
|
|
1,915,000
|
|
|
$
|
2.07
|
|
The total
value of shares vested during the nine months ended September 30, 2009 was $
2,766,566.
The
number of remaining shares authorized to be issued for the U.S. Equity Plan is
as follows
Shares
authorized for Issuance under the 2003 Equity Plan
|
|
|
2,500,000
|
|
Shares
authorized for Issuance under the 2009 Equity Plan
|
|
|
3,800,000
|
|
Options
Outstanding
|
|
|
(4,633,300)
|
|
Common
Stock Issued
|
|
|
(1,414,950)
|
|
Options
Exercised
|
|
|
(2,500
|
)
|
Remaining
shares authorized to be issued as of September 30, 2009
|
|
|
248,250
|
|
See Note
10, Subsequent Events, for information on proposals submitted for stockholder
approval at the NeoStem Special Meeting of Shareholders held on October 29,
2009, which were approved and authorized the following: (i) an
amendment to the 2003 Equity Plan which would allow options issued thereunder to
be repriced to the greater of $0.80 and fair market value on the date of closing
of the Merger and (ii) a proposed increase to the 2009 Equity Plan to increase
the number of shares available for issuance thereunder from 3,800,000 to
9,750,000. Pursuant thereto, (i) options issued under the 2003 Plan
to purchase an aggregate of 754,250 shares of Common Stock with exercise prices
ranging from $2.39 to $25.00, were repriced to $1.90 (the fair market value on
the date of grant, which was the closing price of a share of Common Stock on the
NYSE Amex on October 30, 2009, the date of closing of the Merger), and (ii) the
number of shares available for issuance under the 2009 Equity Plan was increased
to 9,750,000, and certain stock and option grants to NeoStem
executive officers, employees, consultants and advisors were effective either
upon the approval of the increase in the 2009 Plan or closing of the
Merger.
Note 7 - Segment
Information
Historically,
the Company’s operations have been conducted in only one geographical segment
and since March 31, 2007 the Company has realized revenue only from the banking
of adult autologous stem cells. In September, 2009 the Company established
NeoStem (China), Inc. (“NeoStem China” or the “WFOE”) as a wholly foreign owned
subsidiary of NeoStem. The WFOE is domiciled in Qingdao and under its scope of
business approved by the Chinese regulatory authorities, the WFOE may engage in
the research & development, transfer and technological consultation service
of bio-technology, regenerative medical technology and anti-aging technology
(excluding the development or application of human stem cell, gene diagnosis and
treatment technologies); consultation of economic information; import, export
and wholesaling of machinery and equipments (the import and export do not
involve the goods specifically stipulated in/by state-operated trade, import
& export quota license, export quota bidding, export permit, etc.). In
furtherance of complying with PRC’s foreign investment prohibition on stem cell
research and development, clinical trials and related activities, we conduct our
current business in the PRC via two domestic variable interest entities. To date
operations in China have been limited. Our segment data is as
follows:
|
|
Three Months Ended
September 30,
|
|
|
Nine Months Ended
September 30,
|
|
|
|
2009
|
|
|
2008
|
|
|
2009
|
|
|
2008
|
|
Revenues
earned from external customers:
|
|
|
|
|
|
|
|
|
|
|
|
|
United
States
|
|
$
|
85,067
|
|
|
$
|
25,248
|
|
|
$
|
157,709
|
|
|
$
|
49,469
|
|
China
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income/(loss)
from operations:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United
States
|
|
$
|
(6,084,059
|
)
|
|
$
|
(1,921,714
|
)
|
|
$
|
(11,745,941
|
)
|
|
$
|
(6,810,676
|
)
|
China
|
|
$
|
(1,539,294
|
)
|
|
|
-
|
|
|
$
|
(2,687,747
|
)
|
|
|
-
|
|
Note 8 - Related Party
Transactions
In order
to move forward certain research and development activities, strategic
relationships in various clinical and therapeutic areas as well as to support
activities related to the Company’s proposed Merger and Share Exchange
transactions, other initiatives in China as well as other ongoing obligations of
the Company, on February 25, 2009 and March 6, 2009, respectively, the Company
issued promissory notes to RimAsia Capital Partners , L. P. (“RimAsia”), a
principal stockholder of the Company, in the principal amounts of $400,000 and
$750,000, respectively. The notes bore interest at the rate of 10%
per annum and were due and payable on October 31, 2009, except that all
principal and accrued interest on the Notes was immediately due and payable in
the event the Company raised over $10 million in equity financing prior to
October 31, 2009. The notes contained standard events of default and
in the event of a default that was not subsequently cured or waived, the
interest rate would increase to a rate of 15% per annum and, at the option of
RimAsia and upon notice, the entire unpaid principal balance together with all
accrued interest thereon would be immediately due and payable. The
notes or any portion thereof could be prepaid at any time and from time to time
at the discretion of the Company without premium or penalty. On April 9, 2009
these notes and the related accrued interest were repaid from the proceeds of
the April 2009 Private Placement. In addition, April 9, 2009 NeoStem paid
RimAsia $472,559 for reimbursement of funds advanced by RimAsia in connection
with NeoStem’s expansion activities in China.
In order
to accelerate the establishment of Qingdao Niao for research and development
purposes in the PRC, in April 2009 Suzhou Erye Pharmaceuticals Company Ltd.
(“Erye”) advanced in Renminbi the U.S. dollar equivalent of $176,000 to the
shareholder of Qingdao Niao on our behalf. In May 2009 we repaid the
amount of $176,000 to Erye. Erye is owned 51% by CBH (with which we
entered into the Merger Agreement in November 2008 and consummated the Merger on
October 30, 2009) and 49% by Erye Economy and Trading Co. Ltd (of which
Fullbright Finance Limited, a beneficial holder of more than five percent of the
Company’s stock, is a wholly-owned subsidiary).
On April
30, 2009 the Company entered into a License and Referral Agreement with
Promethean Corporation (“Promethean”) through its subsidiary Ceres Living, Inc.
(“Ceres”) to use certain Company marks and publications in connection with
certain sales and marketing activities relating to its nutritional supplement
known as AIO Premium Cellular (the “Product”); and in connection with the
license, Ceres will pay to the Company or the Stem for Life Foundation specified
fees for each unit of the Product sold; and Ceres shall
engage in a referral service with respect to the Company’s adult stem cell
collection and storage activities. Ceres will receive a specified fee from the
Company for each client referred who completes and pays for a stem cell
collection. The term of the agreement is three years with each party having the
right to renew annually, thereafter. The CEO of Promethean is in an exclusive
relationship with the CEO of the Company. The Company has earned $3,700 in
royalties in connection with this agreement.
As part
of the stem cell initiatives undertaken by NeoStem, on June 15, 2009, NeoStem
signed a ten-year, exclusive, royalty bearing agreement with Enhance BioMedical
Holdings Limited (“Enhance”) to provide Enhance with the training, technical,
and other assistance required for Enhance to offer stem cell based therapies in
Taiwan, Shanghai, and five other provinces in eastern China including Jiangsu,
Zhejiang, Fujian, Anhui and Jiangxi. This agreement also gives NeoStem the
option to acquire up to a 20% fully diluted equity interest in Enhance for a
period of five years. NeoStem will receive certain milestone payments as well as
be entitled to a stated royalty on the revenues derived from Enhance’s offering
these stem cell based therapies. Enhance was an investor in the April
2009 Private Placement, pursuant to which it purchased $5 million of Series D
Units, and thus acquired 400,000 shares of Series D Stock (which converted into
4,000,000 shares of Common Stock upon stockholder approval on October 29, 2009)
and 4,000,000 Series D Warrants, each to purchase one share of Common Stock at
an exercise price of $2.50 per share (which became exercisable upon stockholder
approval on October 29, 2009).
The
Company has entered into an agreement for the lease of executive office space
from SLG Graybar Sublease LLC (the “Landlord”) at Suite 450, 420 Lexington
Avenue, New York, with a lease term effective April 1, 2009 through June 30,
2013 (the “Lease”). Rental, storage and utility payments are
currently in the aggregate approximate monthly amount of $20,600. To
help defray the cost of the Lease, the Company has licensed to third parties the
right to occupy certain of the offices in Suite 450 and use certain business
services. Such license payments currently total approximately $11,360
per month and the license agreements are for periods of one year or
less. The CEO of one such licensee, Promethean Corporation, is in an
exclusive relationship with the Company’s CEO. The Lease was entered into
pursuant to an assignment and assumption of the original lease from the original
lessor thereof, DCI Master LDC (the lead investor in a private placement by the
Company in June 2006) and affiliates of DCI Master LDC and Duncan Capital Group
LLC (a former financial advisor to and an investor in the Company), for which
original lease a principal of such entities acted as guarantor (the
“Guarantor”), a consent to such assignment from the Landlord and a lease
modification agreement between the Company and the Landlord, such documents
being dated April 13, 2009 with effective delivery April 17,
2009. The Company was credited with an amount remaining as a security
deposit with the Landlord from such original lessor (the “Security Deposit
Credit”), was required to deposit an additional amount with the Landlord to
replenish the original amount of security for the Lease and pay an amount equal
to the Security Deposit Credit to the Guarantor of the original
lease. The total payments made by the Company for such security
deposit and payment of the Security Deposit Credit to the Guarantor were in the
approximate aggregate amount of $157,100. Richard Berman, a director of the
Company, utilizes an office in Suite 450 in his capacity as a member of the
Company’s Audit Committee and Nominating Committee and Chairman of the Company’s
Compensation Committee, and for other business purposes.
In May
2009, Qingdao Niao, the Chinese domestic company controlled by the WOFE, NeoStem
China, through various business arrangements, entered into leases
with Beijing Zhong-guan-cun Life Science Park Development Corp., Ltd. pursuant
to which Qingdao Niao is leasing laboratory, office and storage space in Beijing
for the aggregate monthly amount of approximately $23,000. Lease
payments are due quarterly in advance, and upon entering into the lease a three
month security deposit was required in addition to the first quarterly
payment. The term of the leases is for approximately three
years.
As of
July 1, 2009, the Company entered into an Amendment No. 1 to the Agreement and
Plan of Merger dated as of November 2, 2009 with China Biopharmaceuticals
Holdings, Inc. (“CBH”), China Biopharmaceuticals Corp., CBH’s wholly-owned
subsidiary (“CBC”) and CBH Acquisition LLC, NeoStem’s wholly-owned
subsidiary. Pursuant to the terms of the Amendment, the following
provisions were then in effect:
·
|
The
number of shares of NeoStem Common Stock to be issued to the CBH Common
Stockholders was reduced to an aggregate of 7,150,000 shares (such that
the Exchange Ratio in the Merger will be 0.19255), with no additional
shares being escrowed;
|
·
|
The
number of shares to be issued to RimAsia Capital Partners, L.P.
("RimAsia") will be increased to 6,458,009 shares of Common Stock and
8,177,512 shares of NeoStem Series C Convertible Preferred Stock, each
with a liquidation preference of $1.125 and convertible to shares of
NeoStem Common Stock at an initial conversion price of $.90 (with the
Class B warrants to be issued to RimAsia eliminated), in
exchange for certain advances made or to be made by RimAsia and described
below;
|
·
|
125,000
shares of NeoStem Common Stock will be issued to Erye Economy and Trading
Co. Ltd. (“EET”) (the 49% holder of Suzhou Erye Pharmaceuticals Company
Ltd. (“Erye”), 51% of which is owned by CBH and which 51% will be
acquired by NeoStem in the Merger) or its designee for assistance in
effectuating the Merger;
|
·
|
The
number of shares to be issued to Steven E. Globus and Chris Mao,
respectively a director and CEO of CBH, in exchange for satisfaction of
loans made by them to CBH, shall be reduced to an aggregate of
approximately 17,158 shares;
|
·
|
Conditions
to closing were amended to (a) add a condition that in order to satisfy
its obligations under a memorandum of understanding with EET, CBH shall
have caused Erye to transfer the land and building for its principal
manufacturing facility to EET or its affiliate for a sum to be agreed
upon, and for EET or its affiliate to lease that facility back to Erye at
a nominal fee for a term through construction of Erye's new manufacturing
facility and until such date as Erye’s new facility is completed and fully
operational (which transaction will remove a significant asset from the
CBH balance sheet) and (b) provide that instead of a spinoff of the CBC
shares as a liquidating distribution to the shareholders of CBH, such
shares may be privately sold or transferred to a liquidating
trust;
|
·
|
Eric
Wei (a principal of RimAsia) will be added to the current NeoStem Board of
Directors after the Merger is effected, and thereafter, Shi Mingsheng (a
principal of EET and Fullbright and a current director of CBH) will also
be added after receipt of PRC
approvals;
|
·
|
Privately
issued NeoStem warrants outstanding immediately prior to the closing of
the Merger shall be amended to reduce their exercise price if the current
exercise price is $4.00 and above;
|
·
|
The
Compensation Committee of NeoStem’s Board of Directors may in lieu of
lowering the exercise price of outstanding options to $.80 as provided in
the original merger agreement, lower the exercise price to a price which
is greater than $.80 (but not less than fair market value) and provide
alternative cash or equity consideration to eligible NeoStem employees,
directors, advisors and
consultants;
|
·
|
The
outside date for completion of the Merger is extended to October 31,
2009.
|
As of
August 27, 2009, the Company, CBH and Subco entered into Amendment No. 2 to the
Agreement and Plan of Merger, dated November 2, 2008, as amended by Amendment
No. 1, dated as of July 1, 2009 (as amended, the “Agreement and Plan of
Merger”). Capitalized terms used herein and not defined shall have
the meanings given those terms in the Agreement and Plan of
Merger. Pursuant to the terms of Amendment No. 2 to the Agreement and
Plan of Merger, the following provisions were then in effect:
· The
Exchange Ratio was amended to equal the quotient of 7,150,000 shares divided by
the sum of (x) the number of shares of CBH stock outstanding as of the Effective
Time and (y) the number of shares of CBH common stock issuable upon exercise of
in-the-money warrants of CBH immediately prior to the Effective Time, subject to
adjustment as set forth in the Agreement and Plan of Merger. As of
the date of Amendment No. 2, the Exchange Ratio was 0.1921665.
· The
exchange offer with respect to the outstanding CBH Common Stock Purchase
Warrants was eliminated. Accordingly, Preliminary Statement E(3) and
Exhibit B, the closing condition set forth in Section 6.2.20 of the Agreement
and Plan of Merger, and all references to the Series C Warrants therein, were
deleted. Section 2.4 of the Agreement and Plan of Merger was amended
to provide that at the Effective Time, each holder of a CBH Common Stock
Purchase Warrant (other than RimAsia) would receive, in aggregate, in exchange
for his or her CBH Common Stock Purchase Warrants the rights under those CBH
Common Stock Purchase Warrants.
· The
Agreement and Plan of Merger contemplates that as a condition of Closing,
certain approvals from PRC regulatory authorities shall have been obtained prior
to Closing, including approvals with respect to the Merger, and the terms of the
Amended and Restated Erye Joint Venture Agreement, the Erye Articles of
Incorporation and related organizational documents. It also
contemplates certain assurances from PRC Governmental Authorities. In Amendment
No. 2, CBH agreed to cause Erye to use reasonable commercial efforts to obtain
such approvals prior to the Closing. Contrary to Amendment No. 1, however, the
parties will not enter into an escrow agreement, and there will be no provision
such that the consideration to be paid or issued by NeoStem in connection with
the Merger is held in escrow, subject to a right of NeoStem to receive back all
such consideration and rescind the Merger if any such PRC regulatory approvals
are not obtained. Any references to a possible escrow arrangement were deleted.
Mr. Shi and Madame Jian shall use reasonable efforts to expedite the receipt of
all PRC approvals and shall be paid an aggregate of 203,338 shares of NeoStem
Common Stock when all PRC approvals are received (for clarification this
replaced the provision previously included in Amendment No. 1).
As of
July 1, 2009, NeoStem, CBH, CBC and RimAsia, which is a significant investor in
the Company and CBH, entered into a Funding Agreement pursuant to which it was
agreed that RimAsia would supply additional funding to both NeoStem and CBH in
an amount up to $1.6 million (including, as of September 30, 2009, approximately
$1 million advanced on behalf of NeoStem and approximately $427,000
advanced on behalf of CBH), which amount would be deemed settled upon its
receipt of the increased amount of NeoStem securities to be received by RimAsia
as part of the Merger consideration, which increase was agreed to in the July
amendment to the Merger Agreement. If less than $1.6 million had been
advanced at that time, the difference would be paid to NeoStem at the closing of
the Merger. In the event the Merger had not received shareholder
approval by October 31, 2009, NeoStem would have been required to repay RimAsia
all payments incurred or made by RimAsia on behalf of NeoStem. The Merger
and related transactions were presented for stockholder approval at a Special
Meeting of Stockholders held on October 29, 2009 and were approved. As of
October 29, 2009 approximately $1,070,000 had been advanced on behalf of NeoStem
and approximately $846,000 had been advanced on behalf of CBH, by RimAsia. The
amount of funds advanced by RimAsia has exceeded the upper limit of $1.6
million resulting in additional funds due RimAsia in the amount of approximately
$316,000, which will be paid to RimAsia from cash due CBH being disbursed in
connection with the closing of the Merger.
In July
2009, the WOFE entered into a cooperation agreement with NeoStem’s PRC
consultant, Shandong Life and Science Institute, a not-for-profit organization
under PRC law, to organize and convene various clinical trials. This agreement
requires funding by the WOFE in the amount of RMB 5,000,000 (approximately
$730,000).
In July
2009, in connection with NeoStem’s determination to terminate its proposed Share
Exchange transaction in favor of independently building out its stem cell
business in China, NeoStem expanded its relationship with Shandong Life Science
and Technology Research Institute (“SLSI”), of which Dr. Cai Jianqian of the
Shandong Provincial Association of Chinese Medicine is President, to provide for
commitments from SLSI in addition to those agreed to effective April 23, 2009
(described below). In return, NeoStem agreed to grant to SLSI an
additional 100,000 shares under its 2009 Non-U.S. Based Equity Plan (the “2009
Non-U.S. Plan”), subject to approval of the 2009 Non-U.S. Plan at the Company’s
Special Meeting of Shareholders. The 2009 Non-U.S. Plan was approved
at the Special Meeting. Previously, effective April 23, 2009, the
Company had entered into a Consulting Agreement with SLSI. Through
SLSI, Dr. Cai Jianqian will provide consulting services to NeoStem in the area
of business development, strategic planning and government affairs in the
healthcare industry in the PRC, including the introduction of NeoStem to
hospitals and medical practices within the PRC to advance NeoStem’s strategic
relationships. In return, NeoStem will pay SLSI an annual fee of $100,000 and
issue SLSI an aggregate of 250,000 options under the NeoStem, Inc. 2009 Non-U.S.
Plan, also subject to the approval of the 2009 Non-U.S. Plan at the Special
Meeting, which was approved, to become exercisable over approximately a two year
period. Dr. Cai Jianqian became acquainted with the Company through
her son Chris Peng Mao, former CEO of CBH.
On July
6, 2009, the Company entered into an employment agreement with Alan Harris,
M.D., Ph.D. (the “Employment Agreement”), pursuant to which Dr. Harris will
serve as the Company’s Vice President of Drug Development and Regulatory Affairs
for a period of three years from July 6, 2009 (the “Commencement Date”), unless
such term is earlier terminated by Dr. Harris or the Company in accordance with
the provisions of the Employment Agreement. In this capacity, Dr.
Harris will be responsible for overseeing the research, development and
regulatory activities of the Company; overseeing the regulatory activities of
the Company; assisting in the preparation and submission of grant applications
for funding; advancing the Company’s intellectual property portfolio, as well as
other activities. In consideration for his services to the Company,
Dr. Harris shall receive a fixed annual salary of $240,000 and shall be entitled
to participate in the Company’s compensation and employee benefit plans and
programs.
On the
Commencement Date, Dr. Harris was granted an option to purchase 150,000 shares
of the Company’s Common Stock under the Company’s 2009 Equity Plan at an
exercise price equal to the closing price of the Common Stock on the date of
grant. The option vests as to 50,000 shares immediately and as to the
remaining 100,000 shares on the one year anniversary of the Commencement
Date. Upon (i) shareholder approval of the proposal to expand the
option pool available under the 2009 Equity Plan (approved at the Special
Meeting of Shareholders on October 29, 2009) and (ii) the consummation of the
Merger with CBH (October 30, 2009) , Dr. Harris shall be granted an option to
purchase 200,000 shares of Common Stock at an exercise price equal to the
closing price of the Common Stock on the date of grant. This option
shall vest as to 100,000 shares on the second anniversary of the Commencement
Date and as to the remaining 100,000 shares on the third anniversary of the
Commencement Date. The options granted to Dr. Harris shall be subject
to written option grant agreements. In the event Dr. Harris is
terminated other than for Cause (as defined in the Employment Agreement) within
thirty days of a vesting date, the vesting of the applicable shares of Common
Stock shall accelerate.
Additionally,
upon the achievement of certain Milestones as set forth in the Employment
Agreement, Dr. Harris shall receive a cash bonus of $15,000, payable within
thirty days of the achievement of a Milestone. Dr. Harris shall also
receive (i) reimbursement of $1,500 per month for health benefits; (ii) a $1,000
per month car allowance; and (iii) reimbursement for all reasonable travel and
other reasonable expenses (in accordance with the Company’s policy) incurred by
him in connection with the performance of his duties and obligations under the
Employment Agreement.
The
Company may terminate Dr. Harris’ employment prior to the expiration of the
three-year term immediately upon written notice to Dr. Harris. Dr.
Harris may terminate his employment with the Company upon sixty days prior
written notice. If the Company terminates Dr. Harris’ employment
other than for Cause (as defined in the Employment Agreement), the Company shall
pay Dr. Harris severance equal to two months of base salary, payable on Dr.
Harris’ regular payroll dates. Except as describe above, Dr. Harris’
options shall not vest beyond his termination date. No other payments
shall be made, or benefits provided, to Dr. Harris by the Company except as
otherwise required by law. Dr. Harris previously executed a
Confidentiality, Non-Compete and Inventions Assignment Agreement pursuant to
which Dr. Harris agreed to be bound by certain non-compete provisions and
certain non-solicitation provisions during the term of his employment with the
Company.
On July
8, 2009, pursuant to a letter agreement (the “Letter Agreement”)
entered into with Catherine M. Vaczy, Esq., the Vice President and General
Counsel the Company, the Company reinstated and extended Ms. Vaczy’s employment
agreement dated January 26, 2007, which employment agreement was amended on
January 9, 2008 and August 29, 2008 (the “Original
Agreement”). The Letter Agreement was effective as of July 8,
2009 (the “Effective
Date”) and continues for a one year term (the “Term”). In
consideration for Ms. Vaczy’s services during the Term, Ms. Vaczy shall receive
a base salary of $182,500.
Upon the
Effective Date, Ms. Vaczy shall receive (i) a stock award under the Company’s
2009 Equity Compensation Plan for 25,000 shares of Common Stock and (ii) an
option grant for 200,000 shares of Common Stock under the Company’s 2009 Equity
Compensation Plan with an exercise price equal to the closing price of the
Common Stock on the date of grant, which option shall vest with respect to
100,000 shares on the Effective Date and with respect to the remaining 100,000
shares upon shareholder approval of the Company’s proposed merger with CBH
(approved at the Special Meeting of Shareholders on October 29,
2009). Options granted to Ms. Vaczy shall remain exercisable for a
period of two years following her termination of employment with the
Company. Additionally, upon shareholder approval of (i) the proposal
to expand the option pool available under the 2009 Equity Compensation Plan and
(ii) the merger with CBH (both approved at the Special Meeting of Shareholders
on October 29, 2009), Ms. Vaczy shall be granted an option for 100,000 shares of
Common Stock, which option shall vest in full on the first anniversary of the
Effective Date. Ms. Vaczy shall also be entitled to a $5,000 cash
bonus upon the achievement of each of two stated business
milestones. Pursuant to the Letter Agreement, any severance payments
to which Ms. Vaczy may become entitled under her Original Agreement shall be
based upon her then-current salary for a three-month period.
On July
29, 2009, the Company amended the terms of its employment agreement with its
Chief Executive Officer, Dr. Robin Smith, to extend the term of Dr. Smith’s
employment to December 31, 2011 and subject to consummation of the
proposed Merger with CBH (which occurred on October 30, 2009), awarded to
Dr. Smith a $275,000 cash bonus for 2009 and comparable minimum annual bonuses
for 2010 and 2011.
Effective
as of July 27, 2009, NeoStem (China), Inc., a wholly foreign owned subsidiary of
the Company in China (the “WFOE”), entered into an employment agreement with
Peter Sun (the “Employment Agreement”), pursuant to which Mr. Sun will serve as
the WFOE’s General Manager for a period of three years from July 27, 2009 (the
“Commencement Date”), unless such term is earlier terminated by Mr. Sun or the
WFOE in accordance with the provisions of the Employment
Agreement. In this capacity, Mr. Sun will be responsible for
overseeing the entire business, from the validation of WFOE’s business plan, to
the execution of the WFOE’s strategy. Pursuant to the Employment
Agreement, in consideration for his services to the WFOE, Mr. Sun shall receive
a fixed annual salary and a monthly allowance to cover various expenses incurred
by him in connection with the performance of his duties and obligations under
the Employment Agreement. He shall also be entitled to receive
employee benefits as required by Labor Contract Law of the People’s Republic of
China (the “Chinese Labor Contract Law”). Upon the approval by the
Company’s shareholders of its proposed Merger with CBH and the Company’s
Non-U.S. Plan (both of which approved at the Special Meeting of Shareholders on
October 29, 2009), subject to the rules of the NYSE Amex and further subject to
all the terms and conditions of the Non-U.S. Plan, Mr. Sun shall be granted a
stated warrant under the Non-U.S. Plan at an exercise price equal to the closing
price of the Common Stock on the date of grant, subject to approval of the
Company’s Compensation Committee of Board which vests based on the achievement
of certain milestones as set forth in the Employment Agreement.
The
Company or Mr. Sun may terminate this Employment Agreement according to certain
provisions of Chinese Labor Contract Law. If Mr. Sun’s employment is
terminated due to causes set forth under Chinese Labor Contract Law, the Company
shall pay Mr. Sun the severance based on the number of years he has worked for
the Company at the rate of one month’s wages for each full year
worked. Mr. Sun has also executed a Confidentiality and Non-Compete
Agreement pursuant to which Mr. Sun agreed to be bound by certain non-compete
provisions and certain non-solicitation provisions.
As of
August 31, 2009, the Company entered into a consulting agreement (the
“Consulting Agreement”) with Wayne Marasco, M.D., Ph.D., the Chairman of the
Company’s Scientific Advisory Board, pursuant to which Dr. Marasco will serve as
a scientific advisor to the Company for a period of two years from August 31,
2009 (the “Commencement Date”), unless such term is earlier terminated by Dr.
Marasco or the Company in accordance with the provisions of the Consulting
Agreement. In consideration for his services to the Company, Dr.
Marasco shall receive an annual fee of $185,000 payable in equal monthly
installments.
On the
Commencement Date, Dr. Marasco was issued 50,000 shares of the Company’s Common
Stock under the Company’s 2009 Equity Plan. Dr. Marasco was also
granted an option to purchase 150,000 shares of the Company’s Common Stock under
the Company’s 2009 Equity Plan at an exercise price equal to the closing price
of the Common Stock on the date of grant, vesting as to one-third of the shares
on the Commencement Date and as to one-third of the shares on each of the first
and second anniversaries of the Commencement Date, provided, that on each
vesting date Dr. Marasco continues to be providing services as a consultant and
shall otherwise be subject to all the terms of the 2009 Equity Plan, except if
he is terminated without cause (as defined in the 2009 Equity Plan, “Cause”),
all such options shall vest immediately. Upon (i) shareholder
approval of the proposal to expand the option pool available under the 2009
Equity Plan and (ii) the consummation of the Merger with CBH (which occurred on
October 30, 2009), Dr. Marasco shall be granted an option to purchase 150,000
shares of Common Stock at an exercise price equal to the closing price of the
Common Stock on the date of grant. This option shall vest as to
one-third of the shares on the date of grant and as to one-third of the shares
on each of the first and second anniversaries of the date of
grant. In the event Dr. Marasco is terminated without Cause, all such
options shall vest immediately. Dr. Marasco is eligible for
additional cash and option grants under the Consulting Agreement and also
remuneration for consulting services outside the scope of the Consulting
Agreement, and shall receive reimbursement of certain expenses.
Either
party may terminate the Consulting Agreement upon 90 days prior written notice;
provided, that in the event Dr. Marasco is terminated without Cause prior to
August 31, 2010, he shall receive a payment equal to one year’s fee, paid at the
same rate as the fee would otherwise be paid under the Consulting Agreement. Dr.
Marasco previously executed a Confidentiality, Proprietary Information and
Inventions Agreement.
NeoStem,
Inc. has entered into an agreement for the lease of space from Rivertech
Associates II, LLC, c/o The Abbey Group (the “Landlord”) at 840 Memorial Drive,
Cambridge, Massachusetts with a lease term effective September 1, 2009 through
August 31, 2012 (the “Lease”). The space will be used for general
office, research and development, and laboratory space (inclusive of an adult
stem cell collection center). The base rent under the Lease is
$283,848 for the first year, $356,840 for the second year and $369,005 for the
third year. In addition, the Company will be responsible for certain
costs and charges specified in the Lease, including utilities, operating
expenses and real estate taxes. The security deposit is $84,141,
which may be reduced to $56,094 if Company has not defaulted in the performance
of its obligations under the lease prior to the second lease year. To
help defray the cost of the Lease, Company will share with Alnara Pharmaceutical
Inc. (“AP”) certain of the leased premises and AP will pay the Company $5,000 a
month.
Note 10 - Subsequent
Events
The
following are the subsequent events that management believes materially effect
the financial position or results of operations or are otherwise informative to
the reader of these financial statements from October 1, 2009 to November 4,
2009.
Effective
October 2, 2009 (the “Termination Date”), Mark Weinreb resigned as President of
NeoStem. In connection with Mr. Weinreb’s resignation, NeoStem and Mr. Weinreb
entered into a Separation Agreement and General Release dated as of September
29, 2009 (the “Agreement”). Under the terms of the Agreement, NeoStem will (i)
continue to pay Mr. Weinreb’s regular salary of $17,500 per month through
December 31, 2009; (ii) pay Mr. Weinreb a bonus of $32,500 ($7,500 of which was
his standard quarterly bonus); and (iii) make COBRA payments for a period of one
year on Mr. Weinreb’s behalf for himself and his family. All unvested options to
purchase NeoStem Common Stock shall be forfeited as of the Termination Date,
except that options to purchase an aggregate of 20,000 shares of common stock
(half at an exercise price of $4.95 and the balance at $1.63) shall not be
forfeited and shall vest in accordance with their terms upon the completion of
NeoStem’s Merger with CBH. All of Mr. Weinreb’s outstanding options issued under
the NeoStem, Inc. 2003 Equity Participation Plan (the “2003 Plan”) will be
repriced so that the exercise price is the greater of $0.80 or fair market value
on the date of the repricing, if NeoStem’s stockholders approve a Company
repricing of options granted under the 2003 Plan and the NeoStem Board of
Directors so (and at such time as it) reprices options issued under the 2003
Plan in that manner. The repricing was effected on October 30, 2009,
and the exercise price was adjusted to $1.90 per share. All of Mr.
Weinreb’s outstanding options will be amended so that the period during which he
may exercise a vested option ends on the earlier of: (i) the original expiration
date of each such option; (ii) the second anniversary of the Termination Date;
and (iii) the date on which NeoStem may determine in good faith that Mr. Weinreb
has violated the terms of a previously-executed Employee Confidentiality,
Invention Assignment and Non-Compete Agreement (the “Covenant Agreement”);
provided that NeoStem agreed that an option to purchase 100,000 shares at $1.95
issued under the NeoStem, Inc. 2009 Equity Compensation Plan (the “2009 Plan”)
will remain exercisable for its original ten year term unless (iii), above, is
applicable. Mr. Weinreb remains subject to the terms of a November 2, 2008
Lock-Up and Voting Agreement which provides that he may not sell any shares of
common stock for a period of six months following the closing of the Merger;
provided, that subject to the approval of CBH, commencing December 1, 2009, Mr.
Weinreb may sell up to 30,000 shares of common stock per calendar month in
accordance with applicable securities laws. The Agreement contains other
customary terms and provisions, including mutual releases and non-disparagement
provisions, as well as remedies for breaches of the Agreement and the Covenant
Agreement. The Agreement became effective on October 6, 2009.
As of
October 2, 2009, NeoStem entered into indemnification agreements with its chief
executive officer, chief financial officer, general counsel, certain other
employees and each of its directors pursuant to which NeoStem has agreed to
indemnify such party to the full extent permitted by law, subject to certain
exceptions, if such party becomes subject to an action because such party is a
director, officer, employee, agent or fiduciary of NeoStem.
Effective
as of October 9, 2009, the Company entered into an agreement with a consultant
who has previously provided services to the Company, pursuant to which this
consultant was retained to provide additional financial market related services
for a two month period. In consideration for providing services under
this agreement, the Company agreed to issue to the consultant an aggregate of
25,000 shares of restricted Common Stock, to vest as to one-half of the shares
at the end of each monthly period during the term, and a five year warrant to
purchase 25,000 shares of restricted Common Stock at a per share exercise price
of $2.10 (with certain cashless exercise provisions), to vest in its entirety at
the end of the term. The issuance of such securities is subject to the approval
of the NYSE Amex.
Effective
as of October 9, 2009, the Company entered into an agreement with a financial
advisor who has previously provided services to the Company, pursuant to which
this advisor was retained to provide additional financial advisory services for
a two month period. In consideration for providing services under
this agreement, the Company agreed to issue to the consultant an aggregate of
50,000 shares of restricted Common Stock, to vest as to one-half of the shares
at the end of each monthly period during the term, and a five year warrant to
purchase 25,000 shares of restricted Common Stock at a per share exercise price
of $2.10 (with cashless exercise provisions), to vest in its entirety at the end
of the term. The issuance of such securities is subject to the approval of the
NYSE Amex.
SPECIAL MEETING OF
SHAREHOLDERS HELD ON OCTOBER 29, 2009
On
October 7, 2009, the United States Securities and Exchange Commission (the
“Commission”) declared effective NeoStem’s Registration Statement on Form S-4
filed with the Commission. The Registration Statement, including the joint proxy
statement/prospectus contained therein, was used in connection with NeoStem's
acquisition by merger (the “Merger”) of China Biopharmaceuticals Holdings, Inc.
(“CBH”) into a wholly-owned subsidiary of NeoStem. The acquisition was subject
to customary closing conditions, including approval by the shareholders of each
company which approval was obtained at meetings of shareholders held on October
29, 2009. The Merger closed on October 30, 2009. In
addition to approval of the issuance of securities in the Merger, several other
proposals were presented for consideration at the NeoStem meeting of
shareholders (the “NeoStem Special Meeting”). Following is a list of
all the proposals presented at the NeoStem Special Meeting, all of which
received the requisite shareholder approval:
|
1.
|
To
consider and vote upon the issuance of securities of NeoStem pursuant to
the terms and conditions of the Agreement and Plan of Merger, dated as of
November 2, 2008, as such agreement may be amended from time to time (the
“Agreement and Plan of Merger”), by and among NeoStem, China
Biopharmaceuticals Holdings, Inc. (“CBH”), CBH Acquisition LLC, a
wholly-owned subsidiary of NeoStem (“Subco”), and China Biopharmaceuticals
Corp., a wholly-owned subsidiary of CBH, pursuant to which CBH will merge
with and into Subco, with Subco as the surviving entity (the
“Merger”). (For more information, see below, and Note 9,
Commitments, to the Unaudited Consolidated Financial Statements included
herein.) The Merger closed on October 30,
2009.
|
|
2.
|
To
consider and vote upon an amendment to NeoStem’s Amended and Restated
Certificate of Incorporation to increase the number of shares of preferred
stock, par value $0.01 per share, authorized for issuance from 5,000,000
shares to 20,000,000 shares (and a corresponding increase in NeoStem’s
total authorized shares from 505,000,000 to
520,000,000). This amendment was filed with the Secretary
of State of Delaware upon the closing of the
Merger.
|
|
3.
|
To
consider and vote upon the issuance of NeoStem Common Stock in order to
permit the potential conversion of the 8,177,512 shares of Series C
Convertible Preferred Stock to be issued to RimAsia in the Merger into
9,086,124 shares of NeoStem Common Stock upon the election of the holders
thereof. The Series C Convertible Preferred Stock were issued
to RimAsia upon the closing of the
Merger.
|
|
4.
|
To
consider and vote upon the issuance of NeoStem Common Stock in order to
permit (i) the potential exercise of up to 13,932,512 warrants (including
12,932,512 Series D warrants) and (ii) the automatic conversion of the
Series D Convertible Preferred Stock into 12,932,510 shares of NeoStem
Common Stock, together with the elimination of certain restrictions
regarding certain warrant exercises and stock conversions. Upon
shareholder approval, all 13,932,512 warrants became immediately fully
exercisable and the Series D Convertible Preferred Stock automatically
converted into an aggregate of 12,932,510 shares of NeoStem Common
Stock.
|
|
5.
|
To
consider and vote upon an amendment to NeoStem’s Amended and Restated
Certificate of Incorporation to effect a reverse stock split of NeoStem
Common Stock at a ratio within the range of 1:2 to 1:5, as determined by
the NeoStem Board of Directors, solely in the event it is deemed by the
NeoStem Board of Directors necessary for NeoStem to maintain its listing
with the NYSE Amex or to list NeoStem Common Stock on any other
exchange.
|
|
6.
|
To
consider and vote upon an amendment to the NeoStem, Inc. 2009 Equity
Compensation Plan (the “2009 Plan”) to increase the number of shares of
NeoStem Common Stock authorized for issuance thereunder from 3,800,000
shares to 9,750,000 shares. Upon the approval of this amendment
on October 29, 2009, options to purchase an aggregate of 1,360,000 shares
of NeoStem Common Stock were granted to NeoStem employees, advisors and
consultants, of which 1,200,000 were granted to executive officers of
NeoStem. Upon the closing of the Merger, certain additional
stock and option grants to NeoStem executive officers, employees,
directors and advisors also became effective. See
below.
|
|
7.
|
To
consider and vote upon the adoption of the NeoStem, Inc. 2009 Non-U.S.
Based Equity Compensation Plan (the “2009 Non-U.S. Plan”) with respect to
the 4,700,000 shares of NeoStem Common Stock authorized for issuance
thereunder. Upon the closing of the Merger and/or receipt of
certain PRC approvals, certain stock and warrant grants to non-U.S.
personnel became effective. See
below.
|
|
8.
|
To
consider and vote upon an amendment to NeoStem’s Amended and Restated
Certificate of Incorporation to provide for the classification of the
Board of Directors into three classes and certain related provisions
regarding the Board of Directors. This amendment was filed with
the Secretary of State of Delaware upon the closing of the Merger,
pursuant to which the terms of Drew Bernstein, Eric Wei and Shi Mingsheng
(at such time as he becomes a director) will expire in 2010, the terms of
Edward Geehr and Steven Myers will expire in 2011, and the terms of
Richard Berman and Robin Smith will expire in
2012.
|
|
9.
|
To
consider and vote upon (i) an amendment to NeoStem’s 2003 Equity
Participation Plan (the “2003 Plan”) to grant the NeoStem Board of
Directors or an appropriate committee thereof the authority to reprice
options, (ii) a one-time repricing of the exercise price of certain
NeoStem options and warrants to purchase shares of NeoStem Common Stock
and (iii) giving the Board of Directors or an appropriate
committee thereof discretion to issue certain cash or equity awards in
connection with the one-time repricing. Pursuant to this authority,
effective upon the closing of the Merger, substantially all options issued
under the 2003 Equity Plan were eligible to be repriced to the greater of
$0.80 and fair market value on the date of closing of the Merger, and the
compensation committee authorized certain discretionary
grants. See below. Further, upon the closing of the
Merger, privately issued warrants (warrants issued other than to the
public or the underwriters in NeoStem’s August 2007 public offering) with
exercise prices ranging from $4.00 to $8.00 were repriced to a range of
approximately $3.82 to $6.81. See
below.
|
MERGER AND RELATED
TRANSACTIONS
On
October 30, 2009, China Biopharmaceuticals Holdings, Inc. (“CBH”) merged
with and into CBH Acquisition LLC (“Merger Sub”), a wholly-owned subsidiary of
NeoStem, with Merger Sub as the surviving entity (the “Merger”) in
accordance with the terms of the Agreement and Plan of Merger, dated November 2,
2008, as amended (“Merger Agreement”) by and between NeoStem, Merger Sub, CBH
and China Biopharmaceuticals Corp., a wholly-owned subsidiary of CBH
(“CBC”). As a result of the Merger, NeoStem acquired CBH’s 51%
ownership interest in Suzhou Erye Pharmaceuticals Company Ltd. (“Erye”), a
Sino-foreign joint venture with limited liability organized under the laws of
the People’s Republic of China. Erye specializes in research and
development, production and sales of pharmaceutical products, as well as
chemicals used in pharmaceutical products. Erye, which has been in
business for more than 50 years, currently manufactures over 100 drugs on seven
Good Manufacturing Practices (GMP) lines, including small molecule
drugs. Suzhou Erye Economy and Trading Co. Ltd. (“EET”) owns
the remaining 49% ownership interest in Erye. Merger Sub and EET have
negotiated a revised joint venture agreement, which, subject to approval by the
requisite PRC governmental authorities, will become effective.
Pursuant
to the terms of the Merger Agreement, NeoStem issued an aggregate of 13,608,009
shares of Common Stock and 8,177,512 shares of Series C Convertible Preferred
Stock in exchange for outstanding CBH securities. All of the shares
of common stock of CBH issued and outstanding immediately prior to the effective
time of the Merger were converted into the right to receive, in the aggregate,
7,150,000 shares of common stock of NeoStem, or an exchange ratio of
0.1921665.
All of
the shares of CBH Series B Convertible Preferred Stock issued and outstanding
immediately prior to the merger (which shares were held by Rim Asia Capital
Partners L.P. (“RimAsia”)) were converted into the right to receive, in the
aggregate, (i) 6,458,009 shares of NeoStem Common Stock and (ii) 8,177,512
shares of Series C Convertible Preferred Stock of NeoStem, each with a
liquidation preference of $1.125 per share and initially convertible into
9,086,124 shares of NeoStem Common Stock at an initial conversion price of $0.90
per share (the 6,458,009 shares of Common Stock and the 8,177,512 shares of
Series C Convertible Preferred Stock being included in the aggregate numbers set
forth in the prior paragraph). In connection therewith, all
outstanding warrants to purchase shares of CBH Common Stock held by RimAsia
immediately prior to the Effective Time were cancelled. Warrants to
purchase shares of CBH Common Stock (other than warrants held by RimAsia) were
replaced with new NeoStem Class E warrants or were otherwise cancelled in
accordance with the terms of such holder’s existing warrant. Class E
warrants to purchase an aggregate of 192,308 shares of NeoStem common stock at
an exercise price of $6.50 per share and an aggregate of 1,410,883 shares of
NeoStem common stock at an exercise price of $6.56 per share,
are effectively outstanding as of October 30, 2009.
NeoStem
issued 9,532 shares of NeoStem Common Stock to Stephen Globus, a director of
CBH, and 7,626 shares of NeoStem Common Stock to Chris Peng Mao, the Chief
Executive Officer of CBH, in exchange for the cancellation and the satisfaction
in full of indebtedness in the aggregate principal amount of $90,000, plus any
and all accrued but unpaid interest thereon, and other obligations of CBH to
Messrs. Globus and Mao.
For
assistance in effecting the merger, 125,000 shares of NeoStem Common Stock were
issued to Fullbright Finance Limited (“Fullbright”) as the designee of EET, of
which Fullbright is a wholly-owned subsidiary. In addition, an
aggregate of 203,338 shares of NeoStem Common Stock will be issued to Fullbright
as the designee of Shi Mingsheng (the Chairman of the Board of Directors of Erye
and a holder of approximately two-thirds of EET) and Madam Zhang Jian (General
Manager of Erye and a holder of approximately 10% of EET) in connection with the
transactions contemplated by the Merger to assist in obtaining the receipt of
all applicable approvals of the People’s Republic of China. Further,
Mr. Shi and Madam Zhang will receive an aggregate of 350,000 Merger Bonus (as
defined below) shares (175,000 each) after receipt of PRC approvals and the
closing of the Merger.
Following
consummation of the Merger, NeoStem now owns 51% of the ownership interests in
Erye, and EET continues to own the remaining 49% ownership interest. As noted
above, Merger Sub and EET have negotiated a revised joint venture agreement,
which, subject to approval by the requisite PRC governmental authorities, will
become effective. Pursuant to the terms and conditions of the Joint
Venture Agreement, dividend distributions to EET and Merger Sub will be made in
proportion to their respective ownership interests in Erye; provided, however,
that for the three-year period commencing on the first day of the first fiscal
quarter after the Joint Venture Agreement becomes effective, (i) 49% of
undistributed profits (after tax) will be distributed to EET and lent back to
Erye by EET for use by Erye in connection with the construction of a new plant
for Erye; (ii) 45% of the net profit (after tax) will be provided to Erye as
part of the new plant construction fund, which will be characterized as paid-in
capital for Merger Sub’s 51% interest in Erye; and (iii) 6% of the net profit
will be distributed to Merger Sub directly for NeoStem’s operating
expenses.
As a
result of the Merger, and the automatic conversion of NeoStem's Series D
Convertible Preferred Stock into an aggregate of 12,932,510 shares of NeoStem
Common Stock, which was also approved at the Special Meeting, the ownership of
the NeoStem Common Stock outstanding is approximately as follows:
|
|
Number
of Shares*
|
|
|
Percentage
Ownership
|
|
|
Beneficial
Ownership*
|
|
RimAsia
Capital Partners, L.P.
|
|
|
11,458,009 |
|
|
|
31.4 |
% |
|
|
50.5 |
% |
Erye
Economy & Trading Co. Ltd/ Fullbright Finance Limited (including Madam
Zhang and Mr. Shi)
|
|
|
4,234,918 |
|
|
|
11.6 |
% |
|
|
14.1 |
% |
Enhance
Biomedical Holding Corporation
|
|
|
4,000,000 |
|
|
|
11.0 |
% |
|
|
19.8 |
% |
HHolders
of Series D Convertible Redeemable Preferred Stock as converted into
common stock (excluding RimAsia, EET/Fullbright and Enhance
Biomedical)
|
|
|
4,292,510 |
|
|
|
11.8 |
% |
|
|
21.1 |
% |
Historic
NeoStem Shareholders (other than those listed above)
|
|
|
7,947,749 |
|
|
|
21.8 |
% |
|
|
- |
|
Former
CBH Shareholders (other than those listed above)
|
|
|
4,520,735 |
|
|
|
12.4 |
% |
|
|
- |
|
*The
shares reflected in the number of shares column above (i) does not include (a)
9,086,124 shares of common stock which may be acquired by RimAsia by virtue of
conversion of the Company's Series C Convertible Preferred Stock or (b) shares
which may be acquired upon exercise of outstanding NeoStem stock options and
warrants (5,000,000 held by RimAsia, 1,040,000 held by EET/Fullbright and
4,000,000 held by Enhance), and (ii) does include an aggregate of 553,338 shares
of common stock to be issued to Fullbright, Mr. Shi and Madam Zhang upon the
receipt of PRC approvals as described in this Note 10. The beneficial
ownership column reflects any of such shares which might be issued in the next
60 days in computing beneficial ownership in accordance with SEC
rules.
The
description of the Merger contained in this Note 10 does not purport to be
complete and is qualified in its entirety by reference to the Merger Agreement,
as amended, which was attached to the Company's Joint Proxy Statement/Prospectus
dated October 7, 2009.
Pursuant
to the terms of the Merger Agreement in connection with the consummation of the
transactions contemplated thereunder, the board of directors of NeoStem expanded
the size of the board from five to seven members and appointed Eric Wei (the
Managing Partner of RimAsia) and Shi Mingsheng (the Chairman of EET and
Fullbright) to fill the newly created board positions, effective immediately
after the Effective Time and the date of receipt of all PRC approvals,
respectively, to serve until the election and qualification of his successor or
his earlier death, resignation or removal. Mr. Wei and Mr. Shi will
not serve on any of NeoStem's standing committees. As previously
disclosed, Joseph Zuckerman resigned from NeoStem's Board of Directors as of the
Effective Time and Edward C. Geehr, M.D. has been appointed effective as of the
Effective Time to the Company’s Board of Directors to replace Dr.
Zuckerman. Dr. Geehr will also take Dr. Zuckerman’s seat on the
Nominating Committee as of the Effective Time of the
Merger.
CERTAIN RELATIONSHIPS AND
TRANSACTIONS
As of
July 1, 2009, NeoStem, CBH, CBC and RimAsia (of which Mr. Wei is managing
partner), which is a significant investor in the Company and CBH, entered into a
Funding Agreement pursuant to which it was agreed that RimAsia would supply
additional funding to both NeoStem and CBH in an amount up to $1.6 million,
which amount would be deemed settled upon its receipt of the increased amount of
NeoStem securities to be received by RimAsia as part of the Merger
consideration, which increase was agreed to in the July 2009 amendment to the
Merger Agreement. If less than $1.6 million had been advanced at that
time, the difference would be paid to NeoStem at the closing of the
Merger. The Merger closed on October 30, 2009. As of October 29, 2009
approximately $1,070,000 had been advanced on behalf of NeoStem and
approximately $846,000 had been advanced on behalf of CBH, by RimAsia. The
amount of funds advanced by RimAsia has exceeded the upper limit of $1.6
million resulting in additional funds due RimAsia in the amount of approximately
$316,000, which will be paid to RimAsia from cash due CBH being disbursed in
connection with the closing of the Merger
Immediately
prior to the closing of the Merger, in order to accelerate satisfaction of
certain CBH obligations to EET, CBH and EET caused Erye to split-off its real
estate assets into a new entity, with the end result that, subject to PRC
approvals, (a) Erye is bound to transfer the land and building for its principal
manufacturing facility to EET or its affiliate for a nominal sum to be agreed
upon by the parties, and (b) EET or its affiliate is bound to lease such
principal manufacturing facility back to Erye at a nominal fee for a term
through the construction and validation period of Erye’s new manufacturing
facility and until such date as Erye’s new facility is completed and fully
operational, such that Erye is assured that there is no interruption of its
operations by reason of such transfers and agreements. The land and building
have a book value on CBH’s books of approximately $ 6.7 million (and an unknown
estimated fair market value).
Pursuant
to the Joint Venture Agreement between Merger Sub and EET, during the three year
period commencing on the first day of the first fiscal quarter after the Joint
Venture Agreement becomes effective, 45% of the net profit after tax will be
provided to Erye, rather than distributed to NeoStem, to fund construction of
Erye’s new plant, thereby benefitting EET. Shi Mingsheng and Madam Zhang Jian
own approximately 63% and 10%, respectively, of EET.
COMPENSATORY
ARRANGEMENTS
Adoption
of the Non-US Based Equity Compensation Plan
On
October 29, 2009, the stockholders of NeoStem duly adopted the Non-US Based
Equity Compensation Plan (“Non-US Plan”) at the Special
Meeting. Persons eligible to receive restricted and unrestricted
stock awards, warrants, stock appreciation rights or other awards under the
Non-US Plan are those service providers to NeoStem and its subsidiaries and
affiliates providing services outside of the United States, including employees
and consultants of NeoStem and its subsidiaries and affiliates, who, in the
opinion of the Compensation Committee, are in a position to contribute to
NeoStem’s success. A description of the Non-US Plan is set forth in
the Joint Proxy Statement/Registration Statement on Form S-4. On
October 29, 2009, upon the adoption of the Non-US Plan, NeoStem issued 225,000
shares of common stock and warrants (option-like equity grants) to purchase an
aggregate of 1,350,000 shares of common stock. On November 2, 2009, an
additional 300,000 shares and warrants to purchase 300,000 shares were also
issued to a service provider under the Non-US Plan. Upon receipt of PRC
approvals, 175,000 Merger Bonus shares will be issued to each of Mr. Shi
Mingsheng and Madame Zhang Jian under the Non-US Plan.
Amendment
to the 2009 Plan
On
October 29, 2009, the Company amended its 2009 Equity Compensation Plan (the
"2009 Plan") to increase the number of shares of common stock available for
issuance under the 2009 Plan from (a) 3,800,000, to (b) 9,750,000. The 2009
Plan, as amended, was duly adopted by the stockholders of NeoStem at the Special
Meeting. Persons eligible to receive restricted and unrestricted
stock awards, options, stock appreciation rights or other awards under the 2009
Plan are those employees, consultants and directors of NeoStem and its
subsidiaries who, in the opinion of the Compensation Committee, are in a
position to contribute to its success. A description of the 2009 Plan
is set forth in the Joint Proxy Statement/Registration Statement on Form
S-4.
Equity
Awards
On
October 29, 2009, upon shareholder approval of the Merger and the increase in
the shares available under the 2009 Plan, NeoStem issued options to purchase an
aggregate of 1,360,000 shares of common stock at an exercise price of $2.04 per
share (the closing price of a share of NeoStem common stock on the NYSE Amex on
the date of grant) to its officers, directors, employees and consultants, of
which 1,200,000 were issued to executive officers and none were issued to
non-employee directors. Of such options, NeoStem issued the following
awards to its principal executive officer, principal financial officer and named
executive officers: (i) to Robin L. Smith, its Chairman and CEO, an
option to purchase 750,000 shares, scheduled to vest as to 250,000 shares on the
achievement of a specified business milestone, as to an additional 250,000
shares on July 8, 2010 and as to the remaining 250,000 shares on July 8, 2011;
(ii) to Catherine M. Vaczy, its Vice President and General Counsel, an option to
purchase 100,000 shares which vests in its entirety on July 8, 2010; and (iii)
to Larry A. May, its CFO, an option to purchase 150,000 shares, which vested
upon grant.
On
October 30, 2009, upon the closing of the Merger, NeoStem issued options to
purchase an aggregate of 500,000 shares of common stock to its officers,
directors, consultants and advisors, of which 200,000 were issued to executive
officers and 150,000 were issued to non-employee directors. In
addition, upon the closing of the Merger, NeoStem issued the following
equity awards: (i) to Robin L. Smith, 175,000 shares and (ii) to Catherine M.
Vaczy, 150,000 shares. Such shares of NeoStem Common Stock were
granted (as described in the Form S-4) in accordance with the terms of the
Merger Agreement which provided that the Compensation Committee of the NeoStem
Board of Directors (the “Compensation Committee”) has the authority to grant as
bonuses in connection with the transactions contemplated by the Merger, in its
discretion, up to an aggregate of 1,000,000 shares, or options to purchase up to
1,000,000 shares of NeoStem Common Stock, in any combination, under any equity
compensation plan (“Merger Bonus” shares).
Amendment
to the 2003 Equity Participation Plan (the “2003 Plan”)
On
October 30, 2009, NeoStem amended its 2003 Equity Participation Plan (the “2003
Plan”) to grant the NeoStem Board of Directors or an appropriate committee
thereof the authority to reprice options, (ii) a one-time repricing of the
exercise price of certain NeoStem options and warrants to purchase shares of
NeoStem Common Stock (the “Repricing”) and (iii) giving the Board of Directors
or an appropriate committee thereof discretion to issue certain cash or equity
awards in connection with the Repricing. A description of the
Repricing is set forth in the Joint Proxy Statement/Registration Statement on
Form S-4.
On
October 30, 2009, NeoStem implemented the Repricing. NeoStem repriced
an aggregate of 754,250 outstanding options (of which 500,500 were held by
executive officers and none were held by non-employee directors) with a range of
exercise prices from $2.39 to $25.00 to a strike price of $1.90 (the closing
price of a share of NeoStem common stock on the NYSE Amex on the date of the
repricing). The following outstanding stock options held by NeoStem’s
principal executive officer, principal financial officer and named executive
officers were amended to reduce the strike price to $1.90: (i) for Robin L.
Smith, an aggregate of 374,000 options with exercise prices ranging from $4.95
to $25.00; (ii) for Catherine M. Vaczy, an aggregate of 71,000 options with
exercise prices ranging from $4.95 to $10.00; and (iii) for Larry A. May, an
aggregate of 55,500 options with exercise prices ranging from $4.95 to $18.00.
NeoStem also repriced privately issued warrants (warrants issued other than to
the public or the underwriters in NeoStem’s August 2007 public offering) to
purchase approximately 1,203,890 shares of Common Stock with exercise prices
ranging from $4.00 to $8.00, to a range of approximately $3.82 to
$6.81. Certain named executive officers of NeoStem are holders of
warrants to purchase shares of NeoStem Common Stock at $8.00 per share for which
their exercise prices were reduced to approximately $6.18 per share. An
aggregate of 27,427 of such warrants are held by named executive officers in the
following quantities: Robin L. Smith (25,427) and Catherine M. Vaczy (2,000);
and an aggregate of 34,092 of such warrants are held by two non-employee
directors.
On
October 30, 2009, NeoStem effected option awards pursuant and subject to the
Company’s 2009 Equity Compensation Plan and stockholder approval received at the
Special Meeting to issue discretionary grants of cash or equity awards in
connection with the option repricing, as described in the Joint Proxy
Statement/Registration Statement on Form S-4. Options (“Discretionary Options”)
were awarded to officers, directors, employees, consultants and advisors to
purchase an aggregate of 562,274 shares of common stock (of which 325,109 were
awarded to executive officers and 26,774 were awarded to non-employee directors)
at an exercise price of $1.90 (the closing price of a share of NeoStem common
stock on the date of grant), and an aggregate of approximately $201,000 in cash
awards which may be paid upon the achievement of business
milestones. Of such Discretionary Options, NeoStem issued the
following awards to its principal executive officer, principal financial officer
and named executive officers: (i) to Robin L. Smith, its Chairman and
CEO, an option to purchase 229,678 shares, which vested upon grant; (ii) to
Catherine M. Vaczy, its Vice President and General Counsel, an option to
purchase 53,955 shares, which vested upon grant; and (iii) to Larry A. May, its
CFO, an option to purchase 41,476 shares, which vested as to 31,620 shares on
the grant date and an aggregate of 9,856 shares will vest upon the achievement
of business milestones.
On
November 4, 2009, the Company’s Compensation Committee approved the following
with regard to compensation matters for the Company’s Board of
Directors: (i) the grant of options under the Company’s 2009 Equity
Compensation Plan to purchase an aggregate of 750,000 shares of Common Stock to
members of the Company’s Board of Directors, and 100,000 granted to
the Board Secretary, Catherine Vaczy, in consideration for Board services, with
an exercise price equal to the fair market value of the Common Stock on the date
of grant and vesting as to one-third of the shares on each of the first, second
and third year anniversaries of the date of grant; (ii) the grant of options
under the Company’s 2009 Equity Compensation Plan to purchase an aggregate of
200,000 shares of Common Stock to members of the Company’s Board of Directors
who serve as board or committee chairpersons, in consideration for such
services, with an exercise price equal to the fair market value of the Common
Stock on the date of grant and vesting as to one-third of the shares on each of
the first, second and third year anniversaries of the date of grant; and (iii)
the grant of stock awards for an aggregate of 180,000 shares of Common Stock
under the Company’s 2009 Equity Compensation Plan that are fully vested upon
issuance to two Directors and the issuance to one such Director of cash in the
amount of $20,000 in recognition of past service. Additionally, a
grant to an employee was approved, of options to purchase 20,000 shares of
Common Stock with an exercise price equal to the fair market value of the Common
Stock on the date of grant and vesting as to one-half of the shares on the first
and second one year anniversaries of the date of grant.
Note 11 – Modification of
Revenue Recognition Policy
During
the quarter ended June 30, 2009, the Company modified its revenue recognition
policy relative to the license fees it recognizes from physicians seeking to
establish autologous adult stem cell collection centers, to recognize such fees
as revenues ratably over the appropriate period of time to which the revenue
element relates. Previously these license fees were recognized in full when
agreements were signed and the physician had been qualified by the Company’s
credentialing committee. In previous reports we have described these fees as
“start-up” fees. Effective with the filing of the Form 10-Q for the quarterly
period ended June 30, 2009, we have re-characterized these fees as license fees
in order to better describe the nature of the relationship between NeoStem and
these physicians and physician practices and the nature of the fees received. If
this modified revenue recognition policy had been in place during the year ended
December 31, 2006 and in each subsequent reporting period, the impact of
accounting for revenues and its corresponding impact on net loss for each of the
years ended December 31, 2006, 2007 and 2008 and the nine months ended September
30, 2008 and 2009 would have been as follows, reflecting for each such period
the relevant amounts as reported and as if adjusted:
|
|
2006
|
|
|
2007
|
|
|
2008
|
|
|
Nine
Months Ended September 30, 2008
|
|
|
Nine
Months Ended September 30, 2009
|
|
Total
Revenue as Reported
|
|
$
|
45,724
|
|
|
$
|
231,664
|
|
|
$
|
83,541
|
|
|
$
|
49,468
|
|
|
$
|
157,709
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
Revenue if Adjusted
|
|
$
|
36,002
|
|
|
$
|
57,148
|
|
|
$
|
145,924
|
|
|
$
|
104,768
|
|
|
$
|
182,934
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bad
Debt Expense as Reported
|
|
$
|
-
|
|
|
$
|
19,500
|
|
|
$
|
21,500
|
|
|
$
|
-
|
|
|
$
|
-
|
|
Bad
Debt Expense if Adjusted
|
|
$
|
-
|
|
|
$
|
4,500
|
|
|
$
|
9,450
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Loss as Reported
|
|
$
|
(6,051,400
|
)
|
|
$
|
(10,445,473
|
)
|
|
$
|
(9,242,071
|
)
|
|
$
|
(7,623,353
|
)
|
|
$
|
(14,433,688
|
)
|
Net
Loss if Adjusted
|
|
$
|
(6,061,122
|
)
|
|
$
|
(10,604,989
|
)
|
|
$
|
(9,167,638
|
)
|
|
$
|
(7,678,653
|
)
|
|
$
|
(14,408,463
|
)
|
Change
|
|
$
|
(9,722
|
)
|
|
$
|
(159,516
|
)
|
|
$
|
74,433
|
|
|
$
|
55,300
|
|
|
$
|
25,225
|
|
%
of Net Loss
|
|
|
0.16
|
%
|
|
|
1.53
|
%
|
|
|
0.81
|
%
|
|
|
0.73
|
%
|
|
|
0.17
|
%
|
The
Company has determined that this modification of our revenue recognition policy
does not require a retroactive application to our previously issued financial
statements for the periods set forth above because the impact on the financial
statements taken as a whole during such periods is not
material.
ITEM
2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
FORWARD
LOOKING STATEMENTS
General
This
Quarterly Report on Form 10-Q and the documents incorporated herein contain
"forward-looking statements" within the meaning of the Private Securities
Litigation Reform Act of 1995. Such forward-looking statements involve known and
unknown risks, uncertainties and other factors which may cause the actual
results, performance or achievements of the Company, or industry results, to be
materially different from any future results, performance or achievements
expressed or implied by such forward-looking statements. When used in this
Quarterly Report, statements that are not statements of current or historical
fact may be deemed to be forward-looking statements. Without limiting the
foregoing, the words "plan," "intend," "may," "will," "expect," "believe,"
"could," "anticipate," "estimate," or "continue" or similar expressions or other
variations or comparable terminology are intended to identify such
forward-looking statements. Additionally, statements concerning our ability to
successfully develop the adult stem cell business at home and abroad, the future
of regenerative medicine and the role of adult stem cells in that future, the
future use of adult stem cells as a treatment option and the role of VSELs in
that future, and the potential revenue growth of such business are
forward-looking statements. Our future operating results are
dependent upon many factors, and the Company's further development is highly
dependent on future medical and research developments and market acceptance,
which is outside its control. Forward-looking statements may not be
realized due to a variety of factors, including, without limitation, (i) the
Company’s ability to manage the business despite continuing operating losses and
cash outflows; (ii) the Company’s ability to obtain sufficient capital or a
strategic business arrangement to fund its operations and expansion plans,
including meeting its financial obligations under various licensing and
other strategic arrangements and the successful commercialization of the
relevant technology; (iii) the Company’s ability to build the management and
human resources and infrastructure necessary to support the growth of the
business; (iv) competitive factors and developments beyond the
Company’s control; (v) scientific and medical developments beyond the
Company’s control; (vi) the Company’s inability to obtain appropriate
governmental licenses or any other adverse effect or limitations caused by
government regulation of the business; (vii) whether any of the Company’s
current or future patent applications result in issued patents and the Company’s
ability to obtain and maintain other rights to technology required or desirable
for the conduct of its business; (viii) whether any potential strategic benefits
of various licensing transactions will be realized and whether any potential
benefits from the acquisition of these new licensed technologies will be
realized; (ix) whether the Company can obtain the consents it may require to
sublicensing arrangements from technology licensors in connection with
technology development; (x) the Company’s ability to maintain its NYSE Amex
listing; and (xi) the other factors discussed in Item 1A, “Risk Factors”
contained in the Company’s Annual Report on Form 10-K for the year ended
December 31, 2008 (the “Form 10-K”) and in other reports that we file with the
SEC.
Merger;
China Expansion
Additional
risks and uncertainties relate to (i) the Company’s merger transaction
(“Merger”) pursuant to an Agreement and Plan of Merger with China
Biopharmaceuticals Holdings, Inc., a Delaware corporation ("CBH"), China
Biopharmaceuticals Corp., a British Virgin Islands corporation and wholly-owned
subsidiary of CBH, and CBH Acquisition LLC, a Delaware limited liability company
and wholly-owned subsidiary of NeoStem to acquire a 51% ownership interest in
Suzhou Erye Pharmaceuticals Company Ltd., a Sino-foreign joint venture with
limited liability organized under the laws of the People’s Republic of China;
and (ii) the Company’s other expansion activities in China, that may cause
actual future experience and results to differ materially from those discussed
in these forward-looking statements. Important factors (i) related to the Merger
that might cause such a difference include, but are not limited to, (a) costs
related to the Merger; (b) the inability to integrate the Company’s and CBH's
businesses successfully and grow such merged businesses as anticipated; (c) the
need for outside financing to meet capital requirements; and (d) failure to have
an effective Joint Venture Agreement satisfactory to the parties and regulatory
authorities; (ii) related to the Company’s other initiatives in China that might
cause such a difference include, but are not limited to, (a) costs related to
funding these initiatives; (b) the successful application under Chinese law of
the variable interest entity structure to the Company’s business, which
structure the Company is relying on to conduct its business in China due to the
fact that the Catalogue Guiding Foreign Investment in Industries in China
categorizes the stem cell business as a prohibited business in China; (c) the
inability to integrate the Company and the business operations in China
successfully and grow such merged businesses as anticipated; and (d) the need
for outside financing to meet capital requirements; and (iii) related to each of
the Merger and the Company’s other expansion activities in China, respectively,
the other events and factors disclosed in the Company’s Current Reports on Form
8-K dated November 2, 2008 and July 2, 2009, respectively, relating to the
Merger and expansion into China, respectively, and other risk factors contained
in periodic Company filings with the SEC and disclosed in the Proxy
Statement/Registration Statement on Form S-4 filed with the SEC in connection
with the Merger. The Company’s filings with the Securities and Exchange
Commission are available for review at www.sec.gov under “Search for Company
Filings.” Readers are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof. Except as
required by law, the Company undertakes no obligation to update any
forward-looking statements, whether as a result of new information, future
events or otherwise.
GENERAL
NeoStem
is engaged in a platform business of operating a commercial autologous (donor
and recipient are the same) adult stem cell bank and is pioneering the
pre-disease collection, processing and long-term storage of stem cells from
adult donors so that they can access such stem cells for their own future
medical treatment. We are managing a network of adult stem cell collection
centers in major metropolitan areas of the United States. We have also entered
the research and development arenas, through the acquisition of a worldwide
exclusive license to VSELTM
Technology, an early-stage technology that utilizes very small embryonic-like
stem cells that exist in adult human bone marrow. Very small embryonic-like stem
cells have many physical characteristics typically found in embryonic stem
cells, including the ability to differentiate into specialized cells found in
substantially all the different types of cells and tissue that make up the body.
Additionally, we are pursuing other technologies to advance our position in the
field of stem cell tissue regeneration.
The adult
stem cell industry is a field independent of embryonic stem cell research which
NeoStem believes is more likely to be burdened by regulatory, legal, ethical and
technical issues than adult stem cell research. Embryonic stem cell research is
also burdened with the issues of tissue compatibility. Medical
researchers, scientists, medical institutions, physicians, pharmaceutical
companies and biotechnology companies are currently developing therapies for the
treatment of disease using adult stem cells. As these adult stem cell
therapies obtain necessary regulatory approvals and become standard of care,
patients will need a service to collect, process and bank their stem cells.
NeoStem intends to provide this service.
Initial participants in
our collection center network have been single physician practices who opened
collection centers in California, Pennsylvania and Nevada. Revenues generated by
these early adopters have not been significant and are not expected to become
significant. However, these centers have served as a platform for the
development of NeoStem’s business model and today NeoStem is focusing on
multi-physician and multi-specialty practices joining its network in major
metropolitan areas but continues to align with physicians that have a client
base who have indicated a particular interest in stem cell collection and
storage. Toward this end, NeoStem signed an agreement in June 2008
for a New York City stem cell collection center to be opened by Bruce Yaffe,
M.D., of Yaffe, Ruden and Associates, which facility became operational in
November 2008. In July 2008, NeoStem signed an agreement for a Santa Monica,
California based stem cell collection center to be opened by Stem Collect of
Santa Monica LLC at The Hall Center. This facility became operational
in the fall of 2008. Additionally, NeoStem signed an agreement with Celvida LLC
pursuant to which a Southern Florida stem cell collection center located in
Coral Gables, a suburb of Miami, became operational in September
2008. In March 2009, the Company signed an agreement to open a
collection center with the Giampapa Institute for Anti-Aging Medical Therapy in
Montclair, New Jersey, which facility became operational shortly thereafter. In
addition, in May 2009 the Company entered into a collection agreement with
Primary Caring of Malibu, based in California, which facility also became
operational shortly thereafter.
During
2008, parallel to growing the platform business and the efforts we undertook in
that regard to establish a network of collection centers in certain major
metropolitan areas of the United States, we recognized the need to acquire a
revenue generating business in the United States or abroad and began exploring
acquisition opportunities of revenue generating businesses. In
November 2008, NeoStem entered into the Merger Agreement with China
Biopharmaceuticals Holdings, Inc. (“CBH”) to acquire the 51% interest in Suzhou
Erye Pharmaceuticals Company Ltd. (“Erye”) a Sino-foreign limited liability
joint venture organized under the laws of the PRC, which has been in business
for more than 50 years and currently manufactures over 100 drugs on seven Good
Manufacturing Practices (GMP) lines, including small molecule drugs. Erye
specializes in research and development, production and sales of pharmaceutical
products, as well as chemicals used in pharmaceutical products. The Merger
Agreement was amended in July 2009 and again in August 2009. The
proposed Merger and related transactions were submitted to a vote of the NeoStem
stockholders at a Special Meeting of Shareholders held on October 29, 2009, and
to a vote of the CBH stockholders held on the same day, and were approved by the
stockholders of both companies. The Merger was consummated on October
30, 2009. Also in November 2008, NeoStem entered into the Share
Exchange Agreement to obtain benefits from Shandong New Medicine Research
Institute of Integrated Traditional and Western Medicine Limited Liability
Company, a China limited liability company. Subsequently, NeoStem
decided to separately pursue its stem cell initiatives in China and in July 2009
terminated the Share Exchange Agreement.
The
Company has begun other initiatives to expand its operations into China,
including with respect to technology licensing, establishment of stem cell
processing and storage capabilities and research and clinical
development. RimAsia, a principal stockholder of the Company and a
principal securityholder of CBH, has been facilitating certain of these efforts
and has paid certain expenses that the Company has agreed to reimburse
(approximately $473,000 of which was reimbursed out of the proceeds of the
private placement financing of preferred stock and warrants in April 2009 which
raised gross proceeds of $11 million, described below). In connection
with the expansion into China, the Company has established the WFOE and put in
place variable interest entity arrangements with respect to each of Qingdao Niao
and Beijing Ruijieao with respect to these activities (described
below). The Company believes that these activities will be sufficient
to help the Company expand into the China market and shall be a substitute for
its moving forward with closing the transactions under the Share Exchange
Agreement.
In
February and March 2009, in order to move forward certain research and
development activities, strategic relationships in various clinical and
therapeutic areas as well as to support activities related to the Merger
Agreement and Share Exchange Agreement, and other ongoing obligations of the
Company, the Company issued promissory notes (the “RimAsia Notes”) totaling
$1,150,000 to RimAsia, which notes bore interest at a rate equal to 10% per
annum and mature on October 31, 2009 except that they matured earlier in the
case of an equity financing by the Company that raised in excess of
$10,000,000. The RimAsia Notes plus accrued interest were paid in April
2009 (as described below). Additionally, as of July 1, 2009, NeoStem,
CBH, CBC and RimAsia entered into a Funding Agreement pursuant to which it was
agreed that RimAsia would supply additional funding to both NeoStem and CBH in
an amount up to
$1.6
million (including, as of September 30, 2009, approximately $1 million advanced
on behalf of NeoStem and approximately $427,000 advanced on behalf of CBH),
which amount would be deemed settled upon its receipt of the increased amount of
NeoStem securities to be received by RimAsia as part of the Merger
consideration, which increase was agreed to in the July 2009 amendment to the
Merger Agreement. If less than $1.6 million had been advanced at that
time, the difference was to be paid to NeoStem at the closing of the
Merger. In the event the Merger had not received shareholder approval
by October 31, 2009, NeoStem would have been required to repay RimAsia all
payments incurred or made by RimAsia on behalf of NeoStem. The Merger
and related transactions were presented for stockholder approval at a Special
Meeting of Stockholders held on October 29, 2009 and were approved. As of
October 29, 2009 approximately $1,070,000 had been advanced on behalf of NeoStem
and approximately $846,000 had been advanced on behalf of CBH, by RimAsia. The
amount of funds advanced by RimAsia has exceeded the upper limit of $1.6
million resulting in additional funds due RimAsia in the amount of approximately
$316,000, which will be paid to RimAsia from cash due CBH being disbursed in
connection with the closing of the Merger.
The
Company has engaged in various capital raising activities to pursue its business
opportunities. In April and June of 2009, respectively, it raised
gross proceeds of approximately $11 million and $5 million, respectively,
through the private placement of its Series D Preferred Stock and Series D
Warrants.
The acquisition of the
VSEL technology was made through our acquisition of our subsidiary Stem Cell
Technologies, Inc. (“SCTI”) in a stock-for-stock exchange. Although
the funds obtained through the acquisition of SCTI funded certain early
obligations under NeoStem’s agreements relating to the VSEL technology,
substantial additional funds will be needed and additional research and
development activities will be required to meet its development obligations
under the License Agreement and develop the VSEL
technology. NeoStem has applied for Small Business Innovation
Research (SBIR) grants and may also seek to obtain funds through applications
for other State and Federal grants, grants abroad, direct investments, strategic
arrangements as well as other funding sources to help offset all or a portion of
these costs.
During
the quarter ended March 31, 2009 the Company took steps to improve its
cryopreservation operations and reduce its fixed overhead by entering into a
four year agreement with Progenitor Cell Therapy LLC (“PCT”) to outsource
cryopreservation operations to PCT. Prior to commencing these services, PCT
agrees to provide certain preliminary services consisting of technology transfer
and protocol review and revision to ensure that the processing and storage
services are cGMP compliant. The agreement sets forth agreed upon
fees for the delivery of the services as well as providing for a one-time
payment of $35,000 for the preliminary services associated with the transfer of
the Company’s cryopreservation process and standard operating
practices to PCT’s laboratory and incorporation into PCT’s existing
standard operating practices. An initial payment of $20,000 was paid
upon commencement of services during the quarter ended March 31,
2009. The transfer of cryopreservation operations was completed in
April 2009, the final $15,000 was paid and the Company’s laboratory in Los
Angeles was closed in June 2009. The Company did not suffer any significant
losses as a result of closing this laboratory. In addition, the Company believes
the shifting of our cryopreservation activities from a fixed cost to a variable
cost will allow the Company to utilize its cash in a more strategic
fashion.
In March
2009, the Company and PCT expanded PCT’s services to include its developing a
plan to set up a stem cell processing and manufacturing operation in Beijing,
China that the Company would pursue in partnership with an off-shore
entity. This plan would support research and cell therapy development
and manufacturing operations. The plan will include a conceptual
architectural design, cost estimates for construction, facility validation to
meet cGMP standards, equipment requirements and estimated costs of equipment
procurement, and other related matters. PCT’s fees for this work will
be $100,000 (of which $50,000 was paid in March 2009) plus
expenses.
In
connection with carrying out its expansion objectives in the PRC, NeoStem has
recently established a wholly foreign owned subsidiary in China, known as
NeoStem (China), Inc. (“WFOE”). The WFOE may engage in the research &
development, transfer and technological consultation service of bio-technology,
regenerative medical technology and anti-aging technology excluding the
development or application of human stem cell, gene diagnosis and treatment
technologies; consultation of economic information; import, export and
wholesaling of machinery and equipments (the import and export do not involve
the goods specifically stipulated in/by state-operated trade, import &
export quota license, export quota bidding, export permit, etc.). In
furtherance of complying with the PRC’s foreign investment prohibition on
stem cell research and development, clinical trials and related activities,
NeoStem’s current business in the PRC is conducted via two domestic variable
interest entities (“VIEs”): Qingdao Niao Bio-Technology Ltd. (“Qingdao Niao”)
and Beijing Ruijieao Bio-Technology Ltd. (“Beijing Ruijieao”), each a Chinese
domestic company controlled by the WFOE through various business
agreements.
As of
September 30, 2009, the WFOE has been capitalized in the total amount of
approximately $2,900,000. The capital investment in the two VIEs is funded by
NeoStem through the WFOE and recorded as interest-free loans to the shareholders
of Qingdao Niao and Beijing Ruijieao. As of September 30, 2009, the total amount
of interest free loans to these shareholders of the VIEs was approximately
$323,500. The Company expects that the WFOE will require substantial additional
funding in order for the Company to continue its expansion plans in China
associated with its stem cell business.
In May
2009, Qingdao Niao entered into leases with Beijing Zhong-guan-cun Life Science
Park Development Corp., Ltd. pursuant to which Qingdao Niao is leasing
laboratory, office and storage space in Beijing for the aggregate monthly amount
of approximately $23,000. Lease payments are due quarterly in
advance, and upon entering into the lease a three month security deposit was
required in addition to the first quarterly payment. The term of the
leases is for approximately three years. It is anticipated that Beijing Ruijieao
will take over the lease.
In June
2009, Qingdao Niao entered into a three year co-operation agreement with the
Qingdao Second Sanatorium of Jinan Military Command (“Second Sanatorium”). As
both a leading comprehensive hospital within the PLA network and as one of the
principal healthcare centers in charge of ensuring the well-being of senior and
retired military officials in China, Qingdao Second Sanatorium is a key player
within the domestic anti-aging and cosmetics arena. Qingdao Niao intends to
collaborate with Second Sanatorium to offer both stem cell based therapies for a
variety of conditions as well as stem cell based anti-aging and cosmetics
therapies.
In June
2009, Qingdao Niao entered into a co-operation agreement with Shandong Wendeng
Orthopedic Hospital (“Wendeng Hospital”) to conduct and develop clinical
research and the clinical application of autologous stem cells for the treatment
of a variety of orthopedic conditions for a term of five years. Wendeng Hospital
is considered to be one of the leading specialist orthopedic hospitals in China,
with close to 90% of their inpatient capacity dedicated to orthopedic cases.
Qingdao Niao intends to establish its first onshore patient treatment facility
in collaboration with Wendeng Hospital.
In July
2009, the WOFE entered into a cooperation agreement with NeoStem’s PRC
consultant, Shandong Life Science and Technology Research Institute (“SLSI”), a
not-for-profit organization under PRC law, to organize and convene various
clinical trials. This agreement requires funding by the WOFE in the amount of
RMB 5,000,000 (approximately $730,000).
In order
to advance our regenerative medicine business here and abroad, in February
2009, the Company entered into a License Agreement with Vincent Giampapa,
M.D., F.A.C.S pursuant to which the Company acquired a world-wide,
exclusive, royalty bearing, perpetual and irrevocable license, with the right to
sublicense, to certain innovative stem cell technology and applications for
cosmetic facial and body procedures and skin rejuvenation. In addition, in
January 2009, the Company and Dr. Giampapa entered into a three year consulting
agreement whereby Dr. Giampapa will provide consulting services in the
anti-aging area.
In order
to advance our regenerative medicine business abroad and expand our expertise
into a new area, effective March 2009, the Company entered into a
License Agreement with Regenerative Sciences, LLC (“RSI”), pursuant to which the
Company acquired an exclusive, royalty bearing, perpetual and irrevocable
license, with the right to sublicense, for the Asia territory, to use an
innovative process that rapidly grows a patient’s own adult stem cells to treat
a variety of musculoskeletal diseases. The licensed procedure
has been developed by RSI, a Colorado-based company focused on developing a
medical procedure for the treatment of chronic orthopedic
conditions. In addition, effective March 2009, the Company and RSI
entered into a three year consulting agreement whereby RSI will provide to the
Company consulting services in the area of stem cell therapy in orthopedics for
the development of business in Asia.
In April
2009, the Company entered into a License Agreement with Vincent Falanga,
M.D., pursuant to which the Company acquired a world-wide, exclusive,
royalty bearing license, with the right to sublicense, to certain innovative
stem cell technology and applications for wound healing, continuing until the
later of ten years from the first commercial sale or the last to expire patent
claim.
In June
2009, the Company and Enhance BioMedical Holdings Limited ("Enhance
BioMedical"), a Shanghai corporation and a subsidiary of Enhance Holding
Corporation ("Enhance Holding"), entered into an agreement to develop a stem
cell collection and treatment network in Shanghai, Taiwan and the Chinese
provinces of Jiangsu, Zhejiang, Fujian, Anhui and Jiangxi using NeoStem’s
proprietary stem cell technologies. Enhance BioMedical has healthcare
provider relationships with numerous hospitals and doctors in Taiwan and
Shanghai, as well as in the five provinces in China to which the agreement
relates. Enhance BioMedical operates the Anti-Aging and Prevention
Medical Center in Taipei, Taiwan, with facilities focused on stem cell research
and development and anti-aging therapies. The agreement is a
ten-year, exclusive, royalty bearing agreement (which subject to certain terms
and conditions, is renewable for a subsequent ten (10) year term at the option
of Enhance BioMedical) pursuant to which the Company will provide Enhance
BioMedical with the training, technical, and other assistance required for
Enhance Biomedical to offer stem cell based therapies in Shanghai, Taiwan and
the five eastern China provinces. This agreement also gives NeoStem
the option to acquire up to a 20% fully diluted equity interest in Enhance for a
period of five years. NeoStem will receive certain milestone payments as well as
be entitled to a stated royalty on the revenues derived from Enhance
BioMedical’s offering these stem cell based therapies. In addition, NeoStem
may be eligible to receive other fees in connection with assisting in the
launching of the Network. Enhance BioMedical was an investor in the April 2009
Private Placement, pursuant to which it purchased $5 million of Series D Units,
and thus acquired 400,000 shares of Series D Stock (automatically convertible
into 4,000,000 shares of Common Stock upon stockholder approval) and 4,000,000
Series D Warrants, each to purchase one share of Common Stock at an exercise
price of $2.50 per share (to become exercisable upon stockholder
approval). Approval of the conversion of the Series D Stock and the
exercisability of the Series D Warrants was obtained at the NeoStem Special
Meeting of Stockholders held on October 29, 2009. Upon such approval
and the consummation of the Merger, Enhance BioMedical became the beneficial
owner of approximately 19.8% of the Company.
All of
the activities above are designed to broaden the scope of the Company’s
operations and to enter into the arena of advanced stem cell and regenerative
medicine therapies in the United States and China. While the Company continues
to pursue its platform business of operating a commercial autologous adult stem
cell bank, it has made a determination that the platform business will be
enhanced if the Company acquires and develops advanced stem cell regenerative
medicine therapies.
With
regard to the Merger, it is not anticipated that in the next year this
acquisition will generate sufficient excess cash flow to support NeoStem’s
platform business and therefore NeoStem will also need to raise substantial
additional funds to fund its platform business and/or acquire another revenue
generating business. NeoStem’s history of losses and liquidity problems may make
it difficult to raise additional funding. There can be no assurance that NeoStem
will be able to obtain additional funding on terms acceptable to NeoStem. Any
equity financing may be dilutive to stockholders and debt financing, if
available, may involve significant restrictive covenants.
During
the quarter ended June 30, 2009, the Company modified its revenue recognition
policy relative to the license fees it recognizes from physicians seeking to
establish autologous adult stem cell collection centers, to recognize such fees
as revenues ratably over the appropriate period of time to which the revenue
element relates. Previously these license fees were recognized in full when
agreements were signed and the physician had been qualified by the Company’s
credentialing committee. In previous reports we have described these fees as
“start-up” fees. Effective with the filing of the Form 10-Q for the quarterly
period ended June 30, 2009, we have re-characterized these fees as license fees
in order to better describe the nature of the relationship between NeoStem and
these physicians and physician practices and the nature of the fees received. If
this modified revenue recognition policy had been in place during the year ended
December 31, 2006 and in each subsequent reporting period, the impact of
accounting for revenues and its corresponding impact on net loss for each of the
years ended December 31, 2006, 2007 and 2008 and the nine months ended September
30, 2008 and 2009 would have been as follows, reflecting for each such period
the relevant amounts as reported and as if adjusted:
|
|
2006
|
|
|
2007
|
|
|
2008
|
|
|
Nine
Months Ended September 30, 2008
|
|
|
Nine
Months Ended September 30, 2009
|
|
Total
Revenue as Reported
|
|
$
|
45,724
|
|
|
$
|
231,664
|
|
|
$
|
83,541
|
|
|
$
|
49,468
|
|
|
$
|
157,709
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
Revenue if Adjusted
|
|
$
|
36,002
|
|
|
$
|
57,148
|
|
|
$
|
145,924
|
|
|
$
|
104,768
|
|
|
$
|
182,934
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bad
Debt Expense as Reported
|
|
$
|
-
|
|
|
$
|
19,500
|
|
|
$
|
21,500
|
|
|
$
|
-
|
|
|
$
|
-
|
|
Bad
Debt Expense if Adjusted
|
|
$
|
-
|
|
|
$
|
4,500
|
|
|
$
|
9,450
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Loss as Reported
|
|
$
|
(6,051,400
|
)
|
|
$
|
(10,445,473
|
)
|
|
$
|
(9,242,071
|
)
|
|
$
|
(7,623,353
|
)
|
|
$
|
(14,433,688
|
)
|
Net
Loss if Adjusted
|
|
$
|
(6,061,122
|
)
|
|
$
|
(10,604,989
|
)
|
|
$
|
(9,167,638
|
)
|
|
$
|
(7,678,653
|
)
|
|
$
|
(14,408,463
|
)
|
Change
|
|
$
|
(9,722
|
)
|
|
$
|
(159,516
|
)
|
|
$
|
74,433
|
|
|
$
|
55,300
|
|
|
$
|
25,225
|
|
%
of Net Loss
|
|
|
0.16
|
%
|
|
|
1.53
|
%
|
|
|
0.81
|
%
|
|
|
0.73
|
%
|
|
|
0.17
|
%
|
The
Company has determined that this modification of our revenue recognition policy
does not require a retroactive application to our previously issued financial
statements for the periods set forth above because the impact on the financial
statements taken as a whole during such periods is not material.
Three
and Nine Months Ended September 30, 2009 compared to Three and Nine Months Ended
September 30, 2008
Revenue
For the
three months ended September 30, 2009, total revenues were $85,100 compared to
approximately $25,200 for the three months ended September 30,
2008. The revenues generated in the three months ended September 30,
2009 were principally from stem cell collection fees and monthly stem cell
storage fees totaling $79,100, and the balance was from licensing fees derived
from physicians in our collection center network. The revenues generated in the
three months ended September 30, 2008 were from stem cell collection fees and
monthly stem cell storage fees in the period in the amount of $ 11,600 and the
balance of $ 13,000 were licensing fees associated with fees earned from our
physicians in our collection center network.
For the
nine months ended September 30, 2009, total revenues were approximately $157,700
compared to $49,500 for the nine months ended September 30, 2008. The
revenues generated in the nine months ended September 30, 2009 were principally
from stem cell collection fees and monthly stem cell storage fees totaling
$133,600, the balance were from licensing fees derived from physicians in our
collection center network totaling and $9,000 in other revenue. The revenues
generated in the nine months ended September 30, 2008 were from stem cell
collection fees and monthly stem cell storage fees in the period in the amount
of $21,500 and the balance of $ 28,000 were licensing fees associated with fees
earned from our physicians in our collection center network.
Operating
Expenses
Selling,
general, administrative and research expenses for the three months ended
September 30, 2009 have increased by $5,327,500 or 275% over the three months
ended September 30, 2008, from $1,935,700 to $7,263,200.
Historically,
the Company has used a variety of equity instruments to minimize its use of cash
and to pay for services and to incentivize staff, consultants and
other service providers. The use of these instruments has resulted in
significant charges to the results of operations. In general, these equity
instruments were used to pay for staff and consultant compensation, director
fees, marketing activities, investor relations and other activities. In the
quarter ended September 30, 2009 the use of equity instruments to pay for such
expenses resulted in charges to selling, general, administrative and research
expenses of $2,073,500, an increase of $1,305,900 over the quarter ended
September 30, 2008.
Operating
expenses funded by cash were $5,189,700 for the three months ended September 30,
2009 compared with $1,168,100 in cash funded expenses for the three months ended
September 30, 2008, an increase of $4,021,600, which was the result
of:
|
·
|
The
activities related to our merger with CBH have increased our expenses by
$1,396,900 primarily from the legal and professional services utilized to
prepare for public filings and shareholder approval of our merger and
related matters.
|
|
·
|
Our
efforts to establish an operation in China to provide advanced
therapies, processing and storage, as well as research and
development capabilities has resulted in an increase in our operating
expenses by approximately $1,528,100 and included expenditures for rent of
laboratory space, legal expenses associated with establishing our
subsidiary company and related operations in China, consultants retained
to support our implementation and introduction of advanced therapies in
China, recruiting fees for identifying senior managers for our
operation in China and travel.
|
Our
operating expenses in the United States increased $1,096,600.
|
·
|
VSELTM
Technology Research in the United States has increased $511,900, in
particular, operation of our Boston research laboratory and related staff
increased operating expense by $ 309,300, fees paid to consultants to
support our research efforts have increased VSELTM
Technology research expenses by $99,400, clinical studies initiated during
the quarter increased our operating expenses by $45,000, patents and other
legal expenses increased our research expenses by $38,500, and increases
in a various other areas of
$19,700.
|
|
·
|
Administrative,
sales and marketing expense increased by approximately $584,800. Salary
and wages increased $468,900 principally as the result of $368,500 for tax
payments and tax withholdings the Company paid on behalf of certain staff
members in connection with common stock grants made during the
quarter. The balance of the increase in salary and wages was
the result of staff increases and contractual salary increases. Travel and
entertainment increased $51,500, rent increased $27,500 as a result of
leasing office space in New York and taxes increased
$24,500. The balance of the increase, $12,400, represents the
netting of increases in recruiting expenses, investor relations, and other
operating expenses offset by reductions in legal expenses, marketing
expenses and other expenses.
|
Selling,
general administrative and research expenses for the nine months ended September
30, 2009 have increased by $ 6,969,900 or 102% over the nine months ended
September 30, 2008, from $ 6,839,500 to $13,809,400.
Historically,
the Company has used a variety of equity instruments to minimize its use of
cash and to pay for services and to incentivize staff,
consultants and other service providers. The use of these instruments has
resulted in significant charges to the results of operations. In
general, these equity instruments were used to pay for staff and consultant
compensation, director fees, marketing activities, investor relations and other
activities. In the nine months ended September 30, 2009, the use of equity
instruments to pay for such expenses resulted in charges to selling, general,
administrative and research expenses of $3,832,100, an increase of $656,500 over
the nine months ended September 30, 2008.
Operating
expenses funded by cash were $9,977,300 for the nine months ended September 30,
2009 compared with $3,663,600 in cash funded expenses for the nine months ended
September 30, 2008, an increase of $ 6,313,700, which was the result
of:
|
·
|
The
activities related to our merger with CBH have increased our expenses by $
2,232,000 primarily from the legal and professional services utilized to
prepare for public filings and shareholder approval of our merger and
related matters.
|
|
·
|
Our
efforts to establish an operation in China to provide processing and
storage as well as research and development capabilities and advanced
therapies has resulted in an increase in our operating expenses by
approximately $2,542,750 and included expenditures for staff, rent of
laboratory space, legal expenses associated with establishing our
subsidiary company and related operations in China, consultants retained
to support our implementation and introduction of advanced therapies in
China, recruiting fees for identifying senior managers for our
operation in China and travel.
|
Our
operating expenses in the United States increased $1,549,600.
|
·
|
VSELTM
Technology Research in the United States has increased $949,800, in
particular, operations of our Boston research laboratory and related staff
costs increased operating expense by $504,200, fees paid to consultants to
support our research efforts have increased VSEL research expenses
by $123,100, payments to the University of Louisville in
connection with our obligations for the VSELTM
Technology licensed in November 2007 increased research expenses by
$81,300, the cost of clinical studies increased our research expenses by
$110,200, patent and legal expenses increased $91,500, and amortization of
intangible assets as well as other related miscellaneous costs combined to
increase our research expenses by
$39,500.
|
|
·
|
Administrative,
sales and marketing expense increased by approximately $599,800. Salary
and wages increased $305,500, principally as the result of $368,500 for
tax payments and tax withholdings the Company paid on behalf of certain
staff members in connection with common stock grants made during the
quarter offset by reductions in certain benefits and staff reductions.
Legal and consulting fees increased $105,302 as the result of licensing
agreements completed in the period, the May 2009 annual shareholders
meeting, and several periodic and other reports filed with the SEC not
related to our Merger activities. Investor communications costs
have increased by $145,200 as the result of increased efforts to make
investors aware of the Company’s expansion into the development of stem
cell therapies and into China. Director fees increased $50,000 as the
result of a new Directors’ compensation plan introduced in April 2009.
Expenses associated with recruiting key staff increased costs by $52,500.
The costs required to maintain our listing on NYSE Amex increased by
$17,600 and taxes have increased $47,500. In June 2009, the Company
completed its transfer of stem cell cryopreservation operations to
Progenitor Cell Therapy and the Company closed its laboratory in Los
Angeles, California. The transfer of cryopreservation operations increased
expenses for the period by $35,000. Surplus equipment was transferred
to our Boston laboratory and there were no other losses associated with
the closure. These cost increases were offset by a decrease in marketing
expense of $136,400 due to more focused in efforts New York and the Los
Angeles areas. The balance of the decrease, $53,700 represents a
combination of increases and decreases in various expenses including
reductions in travel and entertainment and investment banking fees, offset
by increases in computer expenses, operating expenses and occupancy
costs.
|
For the
three months ended September 30, 2009, interest income increased by $12,400 as
the result of investing the net proceeds of the April and June 2009 Private
Placements in money market funds. Until the Series D Preferred Stock
automatically converted into Common Stock upon stockholder approval on October
29, 2009, the Series D Preferred Stock required an annual dividend of 10% to be
paid on April 9th of each
year if it was still outstanding on such date (see below). This dividend was
being recorded ratably each month and resulted in a charge to operating results
of $404,100 for the quarter ended September 30, 2009.
For the
nine months ended September 30, 2009, interest income increased by $23,400 as
the result of investing the net proceeds of the April and June 2009 Private
Placements in money market funds. Interest expense increased by
$48,600 primarily due to the expense associated with increase in derivative
value of warrants issued in connection with our public offering in 2007 and
interest paid on $1,150,000 of promissory notes issued to RimAsia in February
and March 2009. These notes were repaid in April 2009 upon the closing of the
April 2009 Private Placement of Series D Preferred Stock. The Series D Preferred
Stock required an annual dividend of 10% payable on April 9th of each
year if the Series D Preferred Stock was outstanding at that time. This dividend
was being recorded ratably each month and resulted in a charge to operating
results of $655,900 for the nine months ended September 30, 2009. The
conversion of the Series D Preferred Stock into Common Stock was one of the
proposals submitted to stockholders and approved at the NeoStem Special Meeting
of Stockholders held on October 29, 2009. Upon such approval, the
Series D Preferred Stock automatically converted into Common Stock and thus no
dividends will be payable.
For the
reasons cited above, the net loss for the three months ended September 30, 2009
increased to $7,623,400 from $1,921,700 for the three months ended September 30,
2008 and the net loss for the nine months ended September 30, 2009 increased to
$14,433,700 from $6,810,700 for the nine months ended September 30,
2008.
LIQUIDITY
AND CAPITAL RESOURCES
General
At
September 30, 2009, the Company had working capital of
$3,709,400. The Company generates revenues from its adult stem cell
collection activities; however, our revenues generated from such activities have
not been significant. During the nine months ended September 30,
2009, the Company met its immediate cash requirements through existing cash
balances, short-term loans aggregating $1,150,000 and offerings of preferred
stock and warrants raising aggregate gross proceeds of approximately $16
million.
During
the first quarter of 2009, the Company issued promissory notes to RimAsia (the
“RimAsia Notes”), a principal stockholder of the Company, which aggregated
$1,150,000 (see Note 4 - Notes Payable). In April 2009, the Company completed a
private placement financing totaling $11 million (the “April 2009 Private
Placement”). The financing consisted of the issuance of 880,000 units
priced at $12.50 per unit (“Series D Units”), with each Series D Unit consisting
of one share of the Company’s Series D Convertible Redeemable Preferred Stock
(“Series D Stock”) and ten warrants (“Series D Warrants”) with each Series D
Warrant to purchase one share of Common Stock. A total of 880,000 Series D
Preferred shares and 8,800,000 warrants were issued. In June 2009 with a
final closing on July 6, 2009, the Company completed an additional private
placement financing with net proceeds of $4,679,220 (the “June 2009 Private
Placement”). This financing consisted of the issuance of 400,280
Series D Units priced at $12.50 per unit. A total of 400,280 Series D Preferred
Stock and 4,002,800 Series D Warrants were issued. The Company paid $324,280 in
fees and issued 12,971 Series D Units to agents that facilitated the June 2009
Private Placement. The Series D Units issued to the selling agents
were comprised of 12,971 shares of Series D Stock and 129,712 Series D Warrants.
In total, in the April 2009 and June 2009 Private Placements, the number of
shares of Series D Stock issued was 1,293,251 and the number of Series D
Warrants issued was 12,932,512.
Upon the
affirmative vote of holders of a majority of the voting power of the Company’s
Common Stock required pursuant to the Company’s Amended and Restated By-Laws and
the NYSE Amex (which was obtained on October 29, 2009), each share of Series D
Stock was to be automatically converted into ten (10) shares of Common Stock at
an initial conversion price of $1.25 per share based on an original issue price
of $12.50 per share; provided that if by October 31, 2009 such affirmative vote
was not achieved, the Company would be required to redeem all shares of Series D
Stock at a redemption price per share of $12.50 plus the accrued dividends as of
such date. The total cash required to redeem the Series D Stock would have been
$16,165,638 plus accrued dividends. The Series D Stock had an
accruing dividend of ten percent (10%) per annum, payable annually in cash on
April 9th. The Series D Warrants have a per share exercise price equal to $2.50
and are callable by the Company if the Common Stock trades at a price equal to a
minimum of $3.50 for a specified period of time. Subject to the
affirmative vote of the Company’s stockholders and the rules of the NYSE Amex,
the Series D Warrants were to become exercisable for five
years. Pursuant to stockholder approval obtained at the Special
Meeting of Stockholders held on October 29, 2009, the Series D Stock
automatically converted into 12,932,510 shares of Common Stock and the Series D
Warrants became exercisable for a period of five years through October
2014.
As a
result of NeoStem exploring acquisition opportunities of revenue generating
businesses, in November 2008 NeoStem entered into the Merger Agreement with CBH
(amended in July and August 2009) to acquire the 51% ownership interest in Erye,
which manufactures over 100 drugs on seven cGMP lines, and the Share Exchange
Agreement with respect to Shandong. The Merger closed on
October 30, 2009. The Company is also engaged in other initiatives to
expand its operations into China including with respect to technology licensing,
establishment of stem cell processing and storage capacities and research and
clinical development, which the Company decided to pursue in lieu of
consummating the transactions under the Share Exchange Agreement. In June, 2009
the Company established NeoStem China as a wholly foreign owned subsidiary of
NeoStem. NeoStem China, a wholly foreign owned entity, is domiciled in Qingdao
and under its scope of business approved by the Chinese regulatory authorities,
the WFOE may engage in the research & development, transfer and
technological consultation service of bio-technology, regenerative medical
technology and anti-aging technology (excluding the development or application
of human stem cell, gene diagnosis and treatment technologies); consultation of
economic information; import, export and wholesaling of machinery and equipments
(the import and export do not involve the goods specifically stipulated in/by
state-operated trade, import & export quota license, export quota bidding,
export permit, etc.). In furtherance of complying with PRC’s foreign investment
prohibition on stem cell research and development, clinical trials and related
activities, we conduct our current business in the PRC via two domestic variable
interest entities. To date operations in China have been limited. The Company
has incurred and expects to continue to incur substantial expenses in connection
with these China activities. Neither the Merger transactions nor the
Company’s other expansion activities into China are expected to generate
sufficient excess cash flow to support NeoStem’s platform business or its
initiatives in China in the near term.
As of
July 1, 2009, NeoStem, CBH, CBC and RimAsia, which is a significant investor in
the Company and CBH, entered into a Funding Agreement pursuant to which it was
agreed that RimAsia would supply additional funding to both NeoStem and CBH in
an amount up to $1.6 million (including, as of September 30,
2009 approximately $1million advanced on behalf of NeoStem and
approximately $427,000 advanced on behalf of CBH), which amount would
be deemed settled upon its receipt of the increased amount of NeoStem securities
to be received by RimAsia as part of the Merger consideration, which increase
was agreed to in the July 2009 amendment to the Merger Agreement. If
less than $1.6 million had been advanced at that time, the difference was to be
paid to NeoStem at the closing of the Merger. In the event the Merger
had not received shareholder approval by October 31, 2009, NeoStem would have
been required to repay RimAsia all payments incurred or made by RimAsia on
behalf of NeoStem. The Merger and related transactions were approved
at the Special Meeting of Stockholders held on October 29, 2009. As of October
29, 2009 approximately $1,070,000 had been advanced on behalf of NeoStem and
approximately $846,000 had been advanced on behalf of CBH, by RimAsia. The
amount of funds advanced by RimAsia has exceeded the upper limit of $1.6
million resulting in additional funds due RimAsia in the amount of approximately
$316,000, which will be paid to RimAsia from cash due CBH being disbursed in
connection with the closing of the Merger.
The
following chart represents the net funds provided by or used in operating,
financing and investment activities for each period indicated:
|
|
Nine
Months Ended
|
|
|
|
September
30, 2009
|
|
|
September
30, 2008
|
|
Cash
used in operating activities
|
|
$
|
(9,511,900
|
)
|
|
$
|
(3,368,300
|
)
|
Cash
used in investing activities
|
|
$
|
(691,000
|
)
))
|
|
$
|
(7,300
|
)
|
Cash
provided by financing activities
|
|
$
|
15,620,900
|
|
|
$
|
2,135,700
|
|
At
September 30, 2009 the Company had a cash balance of $5,848,800, working capital
of $3,709,400 and stockholders’ deficit of $1,814,200. The Company incurred a
net loss of $14,433,700 for the nine months ended September 30,
2009. Our cash used for operating activities in the nine months ended
September 30, 2009 totaled $ 9,511,900, which is the sum of (i) our net loss,
adjusted for non-cash expenses totaling $3,928,600 which includes common stock,
common stock options and common stock purchase warrants issued for services
rendered in the amount of $3,832,100 and depreciation and amortization of
$96,500; (ii) an increase in cash provided from unearned revenue from
advance payments from customers and licensees of $189,200, increases in accounts
payable and accrued expenses of $741,400 and an increase in accrued dividends of
$655,900 and; (iii) cash used for payments of security deposits and
other assets of $325,400 and increases in accounts receivable $156,500 and
prepaid assets of $111,400.
The
Company has opened a research laboratory in Boston, MA to support the research
and development requirements of our VSELTM
Technology. The outfitting of this laboratory has required the Company to
purchase approximately $550,000 of laboratory equipment during the period. As
development projects expand, the need for additional capital expenditures for
our research laboratory will increase. Our expansion into China resulted in the
purchase of several specialized medical instruments and office equipment that
will used to deliver advanced therapies in China totaling approximately $82,600
of capital expenditures. As our plans for delivery of such services become
finalized we expect to acquire additional medical equipment to support this
initiative. The balance of our capital expenditures have been made to improve
our communications within the Company and to support additional
staff.
In July,
2009, in order to facilitate working capital requirements in China, NeoStem
China issued a promissory note to China Xingye Bank in the amount of RMB
1,000,000 ($146,700). The note is due on January 1, 2010 and bears an interest
rate of 4.86%. The loan is collateralized by cash in a restricted bank account
totaling 1,229,000 RMB (approximately $180,300).
The
Company relied on the RimAsia Notes issued to RimAsia for $1,150,000 and its
existing cash balances to meet its cash requirement for the three months ended
March 31, 2009. In April 2009, the Company completed a private placement
financing totaling $11 million which was and is being used to fund current
operations. Approximately $1,162,000 of such gross proceeds was
utilized to repay the RimAsia Notes plus accrued interest and approximately
$473,000 was utilized to reimburse RimAsia for certain costs advanced by RimAsia
in connection with the Company’s expansion activities into China. In June 2009
the Company completed a second private placement totaling $5 million which will
also be used to fund current operations. The Company believes that it
will need to raise additional capital to fund its expansion into advanced
technologies and therapies in the US and China including with respect to its
VSEL technology licensed from the University of Louisville and its other
regenerative technologies, including relating to anti-aging of skin, wound
healing and orthopedic applications. It currently intends to
accomplish this through additional financing activities, acquisitions of revenue
generating businesses and ultimately the growth of its revenue generating
activities in China. In addition the Company will seek grants for scientific and
clinical studies from the National Institutes of Health and other funding
agencies but there is no assurance that we will be successful in obtaining such
grants. It also anticipates that certain of its recent collaborative marketing
efforts will drive revenues particularly in its stem cell collection business.
The Company’s history of losses and liquidity problems may make it difficult to
raise additional funds. There can be no assurance that the Company will be
successful in obtaining additional funding on terms acceptable to the Company or
otherwise generating additional capital or revenue. Any equity financing may be
dilutive to stockholders and debt financing, if available, may involve
significant restrictive covenants.
SEASONALITY
NeoStem
does not believe that its operations are seasonal in nature.
OFF-BALANCE
SHEET ARRANGEMENTS
NeoStem
does not have any off-balance sheet arrangements.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK.
Not
applicable to smaller reporting companies.
ITEM
4. CONTROLS AND PROCEDURES
Evaluation
of Disclosure Controls and Procedures
Disclosure
controls and procedures are the Company’s controls and other procedures that are
designed to ensure that information required to be disclosed in the reports that
the Company files or submits under the Securities Exchange Act of 1934, as
amended (the “Exchange Act”) is recorded, processed, summarized and reported in
a complete, accurate and appropriate manner, within the time periods specified
in the Securities and Exchange Commission’s rules and forms. Disclosure controls
and procedures include, without limitation, controls and procedures designed to
ensure that information required to be disclosed in the reports that the Company
files under the Exchange Act is accumulated and communicated to management,
including the Chief Executive Officer and Chief Financial Officer, as
appropriate, to allow timely decisions regarding required disclosure. As of the
end of the Company’s third fiscal quarter ended September 30, 2009 covered by
this report, the Company carried out an evaluation, with the participation of
the Company's management, including the Company's Chief Executive Officer and
Chief Financial Officer, of the effectiveness of the Company's disclosure
controls and procedures pursuant to Rule 13a-15 of the Exchange Act. Based on
that evaluation, the Company's Chief Executive Officer and Chief Financial
Officer concluded that the Company's disclosure controls and procedures were
effective, at the reasonable assurance level, in ensuring that information
required to be disclosed by the Company in the reports that it files or submits
under the Securities Exchange Act is recorded, processed, summarized and
reported, within the time periods specified in the SEC's rules and forms and is
accumulated and communicated to management, including the Chief Executive
Officer and Chief Financial Officer, as appropriate to allow timely decisions
regarding required disclosure. Due to the inherent limitations
of control systems, not all misstatements may be detected. These inherent
limitations include the realities that judgments in decision-making can be
faulty and the breakdowns can occur because of a simple error or mistake.
Additionally, controls can be circumvented by the individual acts of some
persons, by collusion of two or more people, or by management override of the
control. Our controls and procedures can only provide reasonable, not absolute,
assurance that the above objectives have been met.
Changes in Internal Controls Over
Financial Reporting
There
have been no changes in the Company's internal controls over financial
reporting, as such term is defined in Exchange Act Rule 13a-15, that occurred
during the quarter ended September 30, 2009 that have materially affected, or
are reasonably likely to materially affect, the Company's internal control over
financial reporting.
NEOSTEM,
INC.
PART
II
OTHER
INFORMATION
ITEM
1. LEGAL PROCEEDINGS
Previously
reported on the Company’s Annual Report on Form 10-K for the year ended December
31, 2008.
ITEM
1A. RISK FACTORS
Not
applicable to smaller reporting companies.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF
PROCEEDS
Previously
reported on the Company’s Current Reports on Form 8-K dated April 13, 2009, June
29, 2009 and July 6, 2009, and as follows:
In
January 2009, the Company entered into an agreement with a consultant which has
been providing investor relation services to the Company since 2005, pursuant to
which this consultant was retained to provide additional investor
relations/media relations services from January 1, 2009 to May 31,
2009. In consideration for providing services under this agreement,
the Company agreed to issue to the consultant an aggregate of 40,000 shares of
restricted Common Stock, to vest as to 8,000 shares on the last day of each
month of January through May 2009. The issuance of such securities
was subject to the approval of the NYSE Amex, which approval was obtained in May
2009.
In
January 2009, the Company issued to its grant consultant 20,000 shares of
restricted Common Stock as a bonus under the consultant’s Consulting Agreement
with the Company dated February 8, 2008, in consideration for such consultant
being instrumental in securing the Company’s inclusion in the Department of
Defense Fiscal Year 2009 Appropriations Bill in the net amount of approximately
$680,000. The issuance of such securities was subject to the approval
of the NYSE Amex, which approval was obtained in January 2009. The
Company has entered into a new consulting agreement with such grant consultant
for a one-year term commencing as of January 1, 2009, pursuant to which it will
provide assistance to the Company in the following areas: (i) with
regard to negotiation, drafting and finalization of contracts; (ii) in the
development of strategic plans; (iii) with regard to funding from various
agencies of the State of New Jersey and Federal government; and (iv) with other
assignments it may receive from time to time. In consideration for
such services, the consultant will be issued shares of the Company’s restricted
Common Stock equal to a value of $60,000 based on the closing price of the
Company’s Common Stock on the date of execution of the agreement, which has been
determined to be 67,416 shares, to vest as to one-half of such shares on June
30, 2009 and the remaining one-half of such shares on December 31,
2009. The issuance of such securities was subject to the approval of
the NYSE Amex, which approval was obtained in May 2009.
In
January 2009, the Company issued to a marketing consultant 12,000 shares of
restricted Common Stock pursuant to the terms of a three month consulting
agreement entered into in October 2008, scheduled to vest pursuant to the
agreement as to 4,000 shares at the end of each 30 day period during the
term. The issuance of such securities was subject to the approval of
the NYSE Amex, which approval was obtained in January 2009.
In
February 2009, the Company issued to a consultant a five year warrant to
purchase 5,000 shares of restricted Common Stock at a purchase price of $1.40
per share. This warrant was issued in consideration of services rendered after
the expiration of an October 2007 consulting agreement with the Company pursuant
to which this consultant was engaged to create marketing materials for our sales
and marketing staff. The issuance of this warrant was subject to the approval of
the NYSE Amex and vested on issuance.
In March
2009, the Company entered into an agreement with a consultant which has been
providing financial market related services to the Company since 2008, pursuant
to which this consultant was retained to provide additional financial market
related services for a three month period. In partial consideration
for providing services under this agreement, the Company agreed to issue to the
consultant an aggregate of 25,000 shares of restricted Common Stock, to vest as
to one-third of the shares at the end of each monthly period during the term and
a five year warrant to purchase 25,000 shares of restricted Common Stock at a
per share exercise price of $1.00, vesting in its entirety at the end of the
term. The issuance of such securities was subject to the approval of the
NYSE Amex, which approval was obtained in May 2009.
On May 1,
2009, the Company entered into a three year consulting agreement effective March
3, 2009 (the “Effective Date”) whereby the consultant will provide to the
Company consulting services in the area of stem cell therapy in orthopedics for
the development of business in Asia. Pursuant to this agreement, as
partial compensation for such services, the Company agreed to issue to this
consultant a warrant to purchase up to an aggregate of 24,000 shares of
restricted Common Stock at an exercise price of $0.50 (the closing price of the
Common Stock on the Effective Date) which shall vest and become exercisable as
to one-third of such shares on each of the first, second and third anniversaries
of the Effective Date. The issuance of such securities is subject to
the approval of the NYSE Amex.
In April
2009, the Company entered into an agreement with a consultant to provide
financial market related services to the Company. In partial
consideration for providing services under this agreement, the Company agreed to
issue to the consultant an aggregate of 20,000 shares of restricted Common
Stock. The issuance of such securities was subject to the approval of the NYSE
Amex, which approval was obtained in May 2009.
In April
2009, the Company entered into an agreement with a consultant to provide support
services in connection with our pending Merger to the Company. In
partial consideration for providing services under this agreement, the Company
agreed to issue to the consultant an aggregate of 10,000 shares of restricted
Common Stock. The issuance of such securities was subject to the approval of the
NYSE Amex, which approval was obtained in May 2009.
In August
2009, the Company entered into a two and one-half month agreement with a
consultant to provide web-based and other corporate promotional services to the
Company. In partial consideration for providing services under this
agreement, the Company agreed to issue to the consultant an aggregate of 8,000
restricted shares of Common Stock. The issuance of such securities was subject
to the approval of the NYSE Amex, which approval was obtained in September
2009.
The offer
and sale by the Company of the securities described above were made in reliance
upon the exemption from registration provided by Section 4(2) of the
Securities Act of 1933, as amended (the “Securities Act”), for transactions by
an issuer not involving a public offering. The offer and sale of such securities
were made without general solicitation or advertising to “accredited investors,”
as such term is defined in Rule 501(a) of Regulation D promulgated
under the Securities Act.
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
Exhibit
|
|
Description
|
|
Reference
|
|
|
|
|
|
2(a)
|
|
Amendment
No. 1 to Agreement and Plan of Merger, made and entered into as of the 1st
day of July, 2009, by and among NeoStem, Inc., CBH Acquisition LLC, China
Biopharmaceuticals Holdings, Inc., and China Biopharmaceuticals Corp.
(1)
|
|
Annex
A
|
|
|
|
|
|
2(b)
|
|
Amendment
No. 2 to Agreement and Plan of Merger, made and entered into as of the
27th
day of August, 2009, by and among NeoStem, Inc., CBH Acquisition LLC,
China Biopharmaceuticals Holdings, Inc., and China Biopharmaceuticals
Corp. (1)
|
|
Annex
A
|
|
|
|
|
|
2(c)
|
|
Notice
dated July 13, 2009 regarding termination of Share Exchange Agreement
(2)
|
|
2.2
|
|
|
|
|
|
3.1
|
|
Restated
Certificate of Incorporation with Certificate of Designations for Series D
Preferred Stock as certified June 23, 2009 (3)
|
|
4.3
|
|
|
|
|
|
3.2
|
|
Certificate
of Amendment of Certificate of Incorporation filed October 30, 2009 with
regard to increase in authorized shares*
|
|
3.2
|
|
|
|
|
|
3.3
|
|
Certificate
of Amendment of Certificate of Incorporation filed October 30, 2009 with
regard to board classification*
|
|
3.3
|
|
|
|
|
|
3.4
|
|
Certificate
of Designations of Series C Convertible Preferred Stock filed October 30,
2009*
|
|
3.4
|
|
|
|
|
|
3.5
|
|
Certificate
of Merger of China BioPharmaceuticals Holdings, Inc. with and into CBH
Acquisition LLC filed October 30, 2009*
|
|
3.5
|
|
|
|
|
|
10(a)
|
|
Funding
Agreement made as of July 1, 2009 by and between NeoStem, Inc., China
Biopharmaceuticals Holdings, Inc., China Biopharmaceuticals Corp., and
RimAsia Capital Partners L.P. (4)
|
|
10.2
|
|
|
|
|
|
10(b)
|
|
Employment
Agreement dated July 6, 2009 between NeoStem, Inc. and Alan Harris, M.D.,
Ph.D. (5)
|
|
10.1
|
|
|
|
|
|
10(c)
|
|
Letter
Agreement dated July 8, 2009 between NeoStem, Inc. and Catherine M. Vaczy,
Esq. (5)
|
|
10.2
|
|
|
|
|
|
10(d)
|
|
Amendment
dated July 29, 2009 to Employment Agreement dated May 26, 2006 with Robin
Smith (6)
|
|
10.1
|
|
|
|
|
|
10(e)
|
|
Employment
Agreement dated August 17, 2009 between NeoStem, Inc. and Anthony Salerno
(1)
|
|
|
|
|
|
|
|
10(f)
|
|
Separation
Agreement and General Release made as of September 29, 2009, by and
between Mark Weinreb and NeoStem, Inc. (7)
|
|
10(xxx)
|
|
|
|
|
|
10(g)
|
|
Commercial
Lease dated as of September 1, 2009 between NeoStem, Inc. and Rivertech
Associates II, LLC, c/o The Abbey Group (8)
|
|
10.1
|
|
|
|
|
|
10(h)
|
|
Form
of Indemnification Agreement (7)
|
|
10.2
|
|
|
|
|
|
31.1
|
|
Certification
of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.*
|
|
31.1
|
|
|
|
|
|
31.2
|
|
Certification
of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.*
|
|
31.2
|
|
|
|
|
|
32.1
|
|
Certification
of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002.**
|
|
32.1
|
|
|
|
|
|
32.2
|
|
Certification
of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002.**
|
|
32.2
|
|
(1)
|
Filed
with the Securities and Exchange Commission as an exhibit, numbered as
indicated above, to the Company’s Pre-Effective Amendment No. 2 to
Registration Statement on Form S-4/A, File No. 333-160578, which exhibit
is incorporated here by reference.
|
|
(2)
|
Filed
as an exhibit, numbered as indicated above, to the Quarterly Report of the
Company on Form 10-Q for the quarter ended June 30, 2009, which exhibit is
incorporated here by reference.
|
|
(3)
|
Filed
with the Securities and Exchange Commission as an exhibit, numbered as
indicated above, to the Company’s Post-Effective Amendment No. 1 to
Registration Statement on Form S-8, File No. 333-159282, which exhibit is
incorporated here by reference.
|
|
(4)
|
Filed
as an exhibit, numbered as indicated above, to the Current Report of the
Company on Form 8-K, dated July 1, 2009, which exhibit is incorporated
here by reference.
|
|
(5)
|
Filed
as an exhibit, numbered as indicated above, to the Current Report of the
Company on Form 8-K, dated July 6, 2009, which exhibit is incorporated
here by reference.
|
|
(6)
|
Filed
as an exhibit, numbered as indicated above, to the Current Report of the
Company on Form 8-K, dated July 29, 2009, which exhibit is incorporated
here by reference.
|
|
(7)
|
Filed
with the Securities and Exchange Commission as an exhibit, numbered as
indicated above, to the Company’s Pre-Effective Amendment No. 4 to
Registration Statement on Form S-4/A, File No. 333-160578, which exhibit
is incorporated here by reference.
|
|
(8)
|
Filed
with the Securities and Exchange Commission as an exhibit, numbered as
indicated above, to the Company’s Pre-Effective Amendment No. 3 to
Registration Statement on Form S-4/A, File No. 333-160578, which exhibit
is incorporated here by reference.
|
|
|
|
|
|
*
Filed herewith
**
Furnished herewith
|
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.
|
NEOSTEM,
INC. (Registrant)
|
|
|
|
|
By:
|
/s/ Robin
Smith M.D.
|
|
|
Robin
Smith M.D., Chief Executive Officer
|
|
|
|
|
Date: November
6, 2009
|
|
By:
|
/s/ Larry
A. May
|
|
|
Larry
A. May, Chief Financial Officer
|
|
|
|
|
Date: November
6, 2009
|
Exhibit
31.1
CERTIFICATION
I, Robin
Smith, M.D., certify that:
1. I
have reviewed this Quarterly Report on Form 10-Q of NeoStem, Inc.;
2. Based
on my knowledge, this quarterly report does not contain any untrue statement of
a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were
made, not misleading with respect to the period covered by this quarterly
report;
3. Based
on my knowledge, the financial statements, and other financial information
included in this quarterly report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as
of, and for, the periods presented in this quarterly report;
4. The
registrant's other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules
13a-15(e) and 15d-15(e)) and internal control over financial reporting (as
defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and
have:
a) Designed
such disclosure controls and procedures, or caused such disclosure controls and
procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries,
is made known to us by others within those entities, particularly during the
period in which this quarterly report is being prepared;
b)
Designed such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles;
c)
Evaluated the effectiveness of the registrant's disclosure controls and
procedures and presented in this quarterly report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the
period covered by this quarterly report based on such evaluation;
and
d)
Disclosed in this quarterly report any change in the registrant’s internal
control over financial reporting that occurred during the registrant’s most
recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an
annual report) that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over financial reporting;
and
5. The
registrant’s other certifying officer and I have disclosed, based on our most
recent evaluation of internal control over financial reporting to the
registrant's auditors and the audit committee of the registrant's board of
directors (or persons performing the equivalent functions):
a) All
significant deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably likely to
adversely affect the registrant's ability to record, process, summarize and
report financial information; and
b) Any
fraud, whether or not material, that involves management or other employees who
have a significant role in the registrant's internal control over financial
reporting.
Date:
November 6, 2009
/s/ Robin Smith,
M.D.
Name:
Robin Smith, M.D.
Title:
Chief Executive Officer of NeoStem, Inc.
A signed
original of this written statement required by Section 302 has been provided to
NeoStem, Inc. and will be retained by NeoStem, Inc. and furnished to the
Securities and Exchange Commission or its staff upon request.
Exhibit
31.2
CERTIFICATION
I, Larry
A. May, certify that:
1. I
have reviewed this Quarterly Report on Form 10-Q of NeoStem, Inc.;
2. Based
on my knowledge, this quarterly report does not contain any untrue statement of
a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were
made, not misleading with respect to the period covered by this quarterly
report;
3. Based
on my knowledge, the financial statements, and other financial information
included in this quarterly report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as
of, and for, the periods presented in this quarterly report;
4. The
registrant's other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules
13a-15(e) and 15d-15(e)) and internal control over financial reporting (as
defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and
have:
a) Designed
such disclosure controls and procedures, or caused such disclosure controls and
procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries,
is made known to us by others within those entities, particularly during the
period in which this quarterly report is being prepared;
b)
Designed such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles;
c)
Evaluated the effectiveness of the registrant's disclosure controls and
procedures and presented in this quarterly report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the
period covered by this quarterly report based on such evaluation;
and
d)
Disclosed in this quarterly report any change in the registrant’s internal
control over financial reporting that occurred during the registrant’s most
recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an
annual report) that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over financial reporting;
and
5. The
registrant’s other certifying officer and I have disclosed, based on our most
recent evaluation of internal control over financial reporting to the
registrant's auditors and the audit committee of the registrant's board of
directors (or persons performing the equivalent functions):
a) All
significant deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably likely to
adversely affect the registrant's ability to record, process, summarize and
report financial information; and
b) Any
fraud, whether or not material, that involves management or other employees who
have a significant role in the registrant's internal control over financial
reporting.
Date:
November 6, 2009
/s/ Larry A.
May
Name:
Larry A. May
Title:
Chief Financial Officer of NeoStem, Inc.
A signed
original of this written statement required by Section 302 has been provided to
NeoStem, Inc. and will be retained by NeoStem, Inc. and furnished to the
Securities and Exchange Commission or its staff upon request.
Exhibit 32.1
CERTIFICATION
PURSUANT TO
18
U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report of NeoStem, Inc. (the “Company”) on Form
10-Q for the period ended September 30, 2009 filed with the Securities and
Exchange Commission on the date hereof (the “Report”), I, Robin Smith, M.D.,
Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002,
that:
(1)
|
The
Report fully complies with the requirements of Section 13(a) or 15(d) of
the Securities Exchange Act of 1934 as amended;
and
|
(2)
|
The
information contained in the Report fairly presents, in all material
respects, the financial condition of the Company as of the dates presented
and the results of operations of the Company for the periods
presented.
|
Dated: November
6, 2009
/s/ Robin Smith,
M.D.
Robin
Smith, M.D.
Chief
Executive Officer
The
foregoing certification is being furnished solely pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of Section 1350, Chapter 63
of Title 18, United States Code) and is not being filed as part of the Form 10-Q
or as a separate disclosure document.
A signed
original of this written statement required by Section 906 has been provided to
NeoStem, Inc. and will be retained by NeoStem, Inc. and furnished to the
Securities and Exchange Commission or its staff upon request.
Exhibit
32.2
CERTIFICATION
PURSUANT TO
18
U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report of NeoStem, Inc. (the “Company”) on Form
10-Q for the period ended September 30, 2009 filed with the Securities and
Exchange Commission on the date hereof (the “Report”), I, Larry A. May, Chief
Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350,
as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002,
that:
(1)
|
The
Report fully complies with the requirements of Section 13(a) or 15(d) of
the Securities Exchange Act of 1934 as amended ;
and
|
(2)
|
The
information contained in the Report fairly presents, in all material
respects, the financial condition of the Company as of the dates presented
and the results of operations of the Company for the periods
presented.
|
Dated: November
6, 2009
/s/ Larry A.
May
Larry A.
May
Chief
Financial Officer
The
foregoing certification is being furnished solely pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of Section 1350, Chapter 63
of Title 18, United States Code) and is not being filed as part of the Form 10-Q
or as a separate disclosure document.
A signed
original of this written statement required by Section 906 has been provided to
NeoStem, Inc. and will be retained by NeoStem, Inc. and furnished to the
Securities and Exchange Commission or its staff upon request.