LISATA THERAPEUTICS, INC. - Quarter Report: 2010 March (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
x
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
FOR THE
QUARTERLY PERIOD ENDED MARCH 31, 2010
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
53,034,089
SHARES, $.001 PAR VALUE, AS OF May 17, 2010
(Indicate
the number of shares outstanding of each of the issuer's classes of common
stock, as of the latest practicable date)
I
N D E X
Page No.
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||
Part
I - Financial Information:
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||
Item
1.
|
Consolidated
Financial Statements (Unaudited):
|
3
|
Consolidated
Balance Sheets At March 31, 2010 and December 31,
2009
|
3
|
|
Consolidated
Statements of Operations for the three months ended March 31,
2010 and 2009
|
4
|
|
Consolidated
Statements of Cash Flows for the three months ended March 31, 2010
and 2009
|
5
|
|
Notes
to Unaudited Consolidated Financial Statements
|
6-29
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
30-35
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
36
|
Item
4T.
|
Controls
and Procedures
|
36
|
Part
II - Other Information:
|
||
Item
1.
|
Legal
Proceedings
|
38
|
Item
1A.
|
Risk
Factors
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38
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
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39
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Item
3.
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Defaults
Upon Senior Securities
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40
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Item
4.
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Removed
and Reserved
|
40
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Item
5.
|
Other
Information
|
40
|
Item
6.
|
Exhibits
|
40
|
Signatures
|
41
|
2
PART
I. FINANCIAL INFORMATION
Item
1. Consolidated Financial Statements
NEOSTEM,
INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
(Unaudited)
March 31,
|
December 31,
|
|||||||
2010
|
2009
|
|||||||
ASSETS
|
||||||||
Current
Assets
|
||||||||
Cash
and cash equivalents
|
$ | 11,418,201 | $ | 7,159,369 | ||||
Short
term investments
|
1,145,512 | 287,333 | ||||||
Restricted
cash
|
4,711,568 | 4,714,610 | ||||||
Account
receivable trade, less allowance for doubtful accounts of $292,148
and $273,600, respectively
|
5,495,845 | 5,725,241 | ||||||
Inventories
|
17,574,429 | 12,979,008 | ||||||
Prepaids
and other current assets
|
1,481,196 | 933,657 | ||||||
Total
current assets
|
41,826,751 | 31,799,218 | ||||||
Property,
plant and equipment, net
|
24,858,274 | 21,271,405 | ||||||
Prepaid
land use rights, net
|
4,676,317 | 4,698,567 | ||||||
Goodwill
|
34,425,728 | 34,425,728 | ||||||
Intangible
assets, net
|
||||||||
Lease
rights
|
546,799 | 633,136 | ||||||
Customer
list, net
|
14,696,186 | 15,079,567 | ||||||
Other
intangible assets, net
|
733,586 | 747,288 | ||||||
Total
intangible assets
|
50,402,299 | 50,885,719 | ||||||
Other
assets
|
238,941 | 238,941 | ||||||
$ | 122,002,582 | $ | 108,893,850 | |||||
LIABILITIES
AND EQUITY
|
||||||||
Current
liabilities
|
||||||||
Accounts
payable
|
$ | 8,907,401 | $ | 8,263,718 | ||||
Accrued
liabilities
|
3,200,622 | 2,965,525 | ||||||
Bank
loans
|
2,200,500 | 2,197,500 | ||||||
Notes
payable
|
12,581,856 | 9,793,712 | ||||||
Unearned
revenues
|
3,300,496 | 2,273,105 | ||||||
Other
current liabilities
|
976,772 | - | ||||||
Total
Current Liabilities
|
31,167,647 | 25,493,560 | ||||||
Long-term
liabilities
|
||||||||
Deferred
tax liability
|
4,380,126 | 4,440,748 | ||||||
Amount
due related party
|
7,473,686 | 7,234,291 | ||||||
COMMITMENTS
AND CONTINGENCIES
|
||||||||
Convertible
Redeemable Series C Preferred stock;
|
13,720,048 | 13,720,048 | ||||||
8,177,512
shares designated, liquidation value $12.50 per share;
|
||||||||
8,177,512
shares issued and outstanding at March 31, 2010, and
|
||||||||
December
31, 2009.
|
||||||||
EQUITY
|
||||||||
Shareholders'
Equity
|
||||||||
Preferred
stock; authorized, 20,000,000 shares
|
||||||||
Series
B convertible redeemable preferred stock
|
100 | 100 | ||||||
liquidation
value, 1 share of common stock, $.01 par value;
|
||||||||
825,000
shares designated; issued and outstanding,
|
||||||||
10,000
shares at December 31, 2009 and 2008
|
||||||||
Common
stock, $.001 par value, authorized 500,000,000 shares
|
43,947 | 37,193 | ||||||
issued
and outstanding, 43,947,142 at March 31, 2010
|
||||||||
and
37,193,491 shares at December 31, 2009
|
||||||||
Additional
paid-in capital
|
106,329,414 | 95,709,491 | ||||||
Accumulated
deficit
|
(76,384,965 | ) | (71,699,191 | ) | ||||
Accumulated
other comprehensive loss
|
(54,720 | ) | (67,917 | ) | ||||
Total
shareholders' equity
|
29,933,776 | 23,979,676 | ||||||
Noncontrolling
interests
|
35,327,299 | 34,025,527 | ||||||
Total
equity
|
65,261,075 | 58,005,203 | ||||||
$ | 122,002,582 | $ | 108,893,850 |
See
accompanying notes to consolidated financial statements
3
NEOSTEM,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended March 31,
|
||||||||
2010
|
2009
|
|||||||
Revenues
|
$ | 15,833,178 | $ | 45,138 | ||||
Cost
of revenues
|
10,851,618 | 25,517 | ||||||
Gross
profit
|
4,981,560 | 19,621 | ||||||
Research
and Development
|
1,300,158 | 254,628 | ||||||
Selling,
general and administrative
|
6,289,698 | 1,621,941 | ||||||
Operating
loss
|
(2,608,296 | ) | (1,856,948 | ) | ||||
Other
income (expense):
|
||||||||
Other
income/(expense), net
|
(164,073 | ) | 304 | |||||
Interest
expense
|
(8,519 | ) | (10,599 | ) | ||||
(172,592 | ) | (10,295 | ) | |||||
Loss
from operations before provision for income taxes and noncontrolling
interests
|
(2,780,888 | ) | (1,867,243 | ) | ||||
Provision
for income taxes
|
502,944 | - | ||||||
Net
loss
|
(3,283,832 | ) | (1,867,243 | ) | ||||
Less
- income from operations attributable to noncontrolling
interests
|
1,328,653 | - | ||||||
Net
loss attributable to controlling interests
|
(4,612,485 | ) | (1,867,243 | ) | ||||
Preferred
dividends
|
99,698 | - | ||||||
Net
loss attributable to common shareholders
|
$ | (4,712,183 | ) | $ | (1,867,243 | ) | ||
Basic
and diluted loss per share
|
$ | (0.12 | ) | $ | (0.24 | ) | ||
Weighted
average common shares outstanding
|
40,023,386 | 7,802,894 |
See
accompanying notes to consolidated financial statements
4
NEOSTEM,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(Unaudited)
For Three Months Ended
|
||||||||
March 31,
|
||||||||
|
2010
|
2009
|
||||||
Cash flows from operating activities: | ||||||||
Net
loss
|
$ | (3,283,832 | ) | $ | (1,867,243 | ) | ||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||
Common
Stock, stock options and warrants issued as payment for compensation,
and services rendered
|
2,055,104 | 199,643 | ||||||
Depreciation
and amortization for intangible assets and prepaid land use
rights
|
767,624 | 29,892 | ||||||
Bad
debt expense
|
18,550 | - | ||||||
Deferred
tax liability
|
(60,622 | ) | - | |||||
Other
|
12,723 | - | ||||||
Changes
in operating assets and liabilities:
|
||||||||
Prepaid
expenses and other current assets
|
(547,539 | ) | (43,830 | ) | ||||
Accounts
receivable
|
210,846 | (4,916 | ) | |||||
Inventories
|
(4,595,421 | ) | - | |||||
Unearned
revenues
|
1,027,391 | 14,678 | ||||||
Accounts
payable, accrued expenses and other current liabilities
|
1,813,364 | 418,777 | ||||||
Net
cash used in operating activities
|
(2,581,812 | ) | (1,252,999 | ) | ||||
Cash
flows from investing activities:
|
||||||||
Restricted
cash released as collateral for bank loan
|
3,042 | - | ||||||
Proceeds
used in purchasing short term investments
|
(858,179 | ) | - | |||||
Acquisition
of property and equipment
|
(3,764,324 | ) | (5,695 | ) | ||||
Net
cash used in investing activities
|
(4,619,461 | ) | (5,695 | ) | ||||
Cash
flows from financing activities:
|
||||||||
Proceeds from exercise of warrants
|
1,750,000 | - | ||||||
Net
proceeds from issuance of capital stock
|
6,821,569 | - | ||||||
Payment
from related party
|
166,847 | - | ||||||
Repayment
of notes payable
|
(3,812,159 | ) | (55,841 | ) | ||||
Proceeds
from notes payable
|
6,603,303 | 1,283,720 | ||||||
Payment
of dividends
|
(69,455 | ) | - | |||||
Repayment
of capitalized lease obligations
|
- | (7,180 | ) | |||||
Net
cash provided by financing activities
|
11,460,105 | 1,220,699 | ||||||
Net
increase/(decrease) in cash and cash
equivalents
|
4,258,832 | (37,995 | ) | |||||
Cash
and cash equivalents at beginning of year
|
7,159,369 | 430,786 | ||||||
Cash
and cash equivalents at end of year
|
$ | 11,418,201 | $ | 392,791 | ||||
Supplemental
Disclosure of Cash Flow Information:
|
||||||||
Cash
paid during the period for:
|
||||||||
Interest
|
$ | 200,482 | $ | 10,599 | ||||
Income
Taxes
|
533,942 | - | ||||||
Supplemental
Schedule of non-cash financing activities
|
||||||||
Issuance
of restricted common stock for services
|
- | 104,850 | ||||||
Issuance
of common stock for services rendered
|
5,997 | 51,079 | ||||||
Issuance
of warrants for services
|
145,785 | 42,918 | ||||||
Compensatory
element of stock options
|
1,685,633 | 59,770 | ||||||
Vesting
of restricted common stock during period
|
29,167 | 45,876 |
See
accompanying notes to consolidated financial statements.
5
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. The Company’s corporate headquarters is located at 420 Lexington
Avenue, Suite 450, New York, NY 10170, its telephone number is (212) 584-4180
and its website address is www.neostem.com.
In 2009,
through the Company’s expansion efforts within China and with the acquisition of
a controlling interest in Suzhou Erye Pharmaceuticals Company Ltd.(“Erye”), the
Company transitioned into a multi-dimensional international biopharmaceutical
company with product and service revenues, global research and development
capabilities and operations in three distinct business units: (i) U.S. adult
stem cells, (ii) China adult stem cells, and (iii) China pharmaceuticals,
primarily including antibiotics. These business units are expected to provide
platforms for the accelerated development and commercialization of innovative
technologies and products in both the U.S. and China.
In the
U.S. the Company is a leading provider of adult stem cell collection, processing
and storage services enabling healthy individuals to donate and store their stem
cells for personal therapeutic use. Similar to the banking of cord blood,
pre-donating cells at a younger age helps to ensure a supply of one’s own stem
cells should they be needed for future medical treatment. The Company’s current
network of U.S. adult stem cell collection centers is focused primarily on the
Southern California and Northeast markets. During 2010, the Company has begun to
enter into new agreements for collection centers with the goal of expanding its
coverage to ten centers by the end of 2010. Each collection center agreement is
effectively a license that grants a physician practice the right to participate
in the Company’s stem cell collection network and access to its stem cell
banking technology, which includes its 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. The Company’s 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 fees that typically
include 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,
non-compete provisions 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.
In 2009,
the Company began several China-based, adult stem cell initiatives including:
(i) creating a separate China-based stem cell operation, (ii) constructing a
stem cell research and development laboratory and processing facility in
Beijing, (iii) establishing relationships with hospitals to provide stem
cell-based therapies, and (iv) obtaining product licenses covering several adult
stem cell therapeutics focused on regenerative medicine. In 2010, the Company
expects to begin offering stem cell banking services and certain stem cell
therapies to patients in China, as well as to foreigners traveling to China
seeking medical treatments that are either unavailable or cost prohibitive in
their home countries.
The
cornerstone of the Company’s China pharmaceuticals business is the 51% ownership
interest it acquired in Erye in October 2009. 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”). As a result of the Merger, NeoStem
acquired CBH’s 51% ownership interest in Erye, a Sino-foreign joint venture with
limited liability organized under the laws of the People’s Republic of
China. Erye was founded more than 50 years ago and represents an
established, vertically-integrated pharmaceutical business. Historically, Erye
has concentrated its efforts on the manufacturing and distribution of generic
antibiotic products and has received more than 160 production certificates from
the State Food and Drug Administration of China (“SFDA”), covering both
antibiotic prescription drugs and active pharmaceutical
intermediates.
6
Principles of Consolidation:
The consolidated financial statements include the accounts of NeoStem, Inc. (a
Delaware corporation) and its wholly owned and partially owned subsidiaries as
listed below:
Entity
|
Percentage of Ownership
|
Location
|
||
NeoStem,
Inc.
|
Parent Company
|
United
States of America
|
||
NeoStem
Therapies, Inc.
|
100%
|
United
States of America
|
||
Stem
Cell Technologies, Inc.
|
100%
|
United
States of America
|
||
NeoStem
(China) Inc.
|
100%
|
People’s
Republic of China
|
||
Qingdao
Niao Bio-Technology Ltd.*
|
*
|
People’s
Republic of China
|
||
Beijing
Ruijiao Bio-Technology Ltd.*
|
*
|
People’s
Republic of China
|
||
China
Biopharmaceuticals Holdings, Inc. (Merger Sub)
|
100%
|
United
States of America
|
||
Suzhou
Erye Pharmaceuticals Company Ltd.
|
51%
owned by Merger Sub
|
People’s
Republic of China
|
* Because
certain PRC regulations currently restrict, or prohibit foreign entities from
holding certain licenses and controlling certain businesses in China, the
Company created a wholly foreign-owned entity, or WFOE, NeoStem (China), to
implement its expansion initiatives in China. To comply with China’s foreign
investment regulations with respect to stem cell-related activities, these
business initiatives in China are conducted via two Chinese domestic entities,
Qingdao Niao Bio-Technology Ltd., or Qingdao Niao, and Beijing Ruijieao
Bio-Technology Ltd., or Beijing Ruijieao, that are controlled by the WFOE
through various contractual arrangements and under the principles of
consolidation the Company consolidates 100% of their operations.
Basis of Presentation: The
consolidated balance sheet as of March 31, 2010, the consolidated
statements of operations for the three months ended March 31, 2010 and
2009, and the consolidated statements of cash flows for the three months ended
March 31, 2010 and 2009 and related disclosures contained in the
accompanying notes are unaudited. The condensed consolidated balance sheet as of
December 31, 2009 is derived from the audited consolidated financial
statements included in the annual report filed on Form 10-K with the U.S.
Securities and Exchange Commission (the “SEC”). The condensed consolidated
financial statements are presented on the basis of accounting principles that
are generally accepted in the United States of America for interim financial
information and in accordance with the instructions of the SEC on Form 10-Q and
Rule 10-01 of Regulation S-X. Accordingly, they do not include all the
information and footnotes required by accounting principles generally accepted
in the United States for a complete set of financial statements. In the opinion
of management, all adjustments (which include only normal recurring adjustments)
necessary to present fairly the condensed consolidated balance sheet as of
March 31, 2010 and the results of operations and cash flows for the periods
ended March 31, 2010 and 2009 have been made. The results for the three
months ended March 31, 2010 are not necessarily indicative of the results
to be expected for the year ending December 31, 2010 or for any other
period. The condensed consolidated financial statements should be read in
conjunction with the audited consolidated financial statements and the
accompanying notes for the year ended December 31, 2009 included in the
Company’s Annual Report on Form 10-K filed with the SEC.
Certain
reclassifications have been made to prior year amounts to conform to the current
year presentation.
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 the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date of
the consolidated financial statements. Estimates also affect the reported
amounts of revenues and expenses during the reporting
period. 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.
Concentrations of Risk:
Financial instruments that potentially subject the Company to significant
concentrations of credit risk consist principally of cash. Cash includes cash on
hand and demand deposits in accounts maintained with banks within the People’s
Republic of China and the United States. The Company places its cash accounts
with high credit quality financial institutions, which at times may be in excess
of the FDIC insurance limit. Total cash in these banks at March 31, 2010 and
December 31, 2009 amounted to $11,418,201 and $7,159,369 of which $1,612,888 and
$431,717 deposits are federally-insured, respectively, of which
$267,370
and $296,989 are covered by such insurance. The Company has not
experienced any losses in such accounts and believes it is not exposed to any
risks on its cash in bank accounts. At March 31, 2010, the Company
had invested approximately $3,929,353 in money market accounts.
There is
no sales concentration risk for the Company since there are no sales to one
customer individually accounting for more than 10% of the total sales revenue
for the three months ended March 31, 2010 and 2009.
7
For the
three months ended March 31, 2010 as a result of the acquisition of Erye, two
major suppliers provided approximately 31% of Erye’s purchases of raw materials
with each supplier individually accounting for 16% and 15 %, respectively.
As of March 31, 2010, the total accounts payable to the two major suppliers was
25% of the total accounts payable.
Restricted Cash: Restricted cash
represents cash required to be deposited with banks as collateral for the
balance of bank notes payable and are subject to withdrawal restrictions
according to the agreement with the bank. The required deposit rate is
approximately 30-50% of the notes payable balance.
Accounts Receivable: Accounts
receivable are carried at original invoice amount less an estimate made for
doubtful receivables. The Company applies judgment in connection with
establishing the allowance for doubtful accounts. Specifically, the Company
analyzes the aging of accounts receivable balances, historical bad debts,
customer concentration and credit-worthiness, current economic trends and
changes in the Company’s customer payment terms. Significant changes in customer
concentrations or payment terms, deterioration of customer credit-worthiness or
weakening economic trends could have a significant impact on the collectability
of the receivables and the Company’s operating results. If the financial
condition of the Company’s customers were to deteriorate, resulting in an
impairment of their ability to make payments, additional allowances may be
required. Management regularly reviews the aging of receivables and changes in
payment trends by its customers, and records a reserve when it believes
collection of amounts due are at risk. There were allowance for doubtful
accounts necessary at March 31, 2010 and December 31, 2009 in the amount of
$292,148 and $273,600 respectively.
Inventories: Inventories are stated
at the lower of cost or market using the first-in, first-out basis. The Company
reviews its inventory periodically and will reduce inventory to its net
realizable value depending on certain factors, such as product demand, remaining
shelf life, future marketing plans, obsolescence and slow-moving
inventories.
March 31,
|
December 31,
|
|||||||
2010
|
2009
|
|||||||
Raw
materials and supplies
|
$ | 5,417,493 | $ | 6,338,826 | ||||
Work
in process
|
3,719,223 | 666,720 | ||||||
Finished
goods
|
8,437,713 | 5,973,462 | ||||||
Total
inventory
|
$ | 17,574,429 | $ | 12,979,008 |
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.
March 31,
|
December 31,
|
|||||||
2010
|
2009
|
|||||||
Machinery
and Equipment
|
$ | 3,262,911 | $ | 3,289,333 | ||||
Lab
Equipment
|
759,536 | 704,154 | ||||||
Furniture
and Fixtures
|
303,048 | 273,171 | ||||||
Vehicles
|
192,480 | 75,317 | ||||||
Software
|
89,457 | 81,704 | ||||||
Leasehold
Improvements
|
63,375 | 58,425 | ||||||
Construction
in Progress
|
20,707,597 | 17,075,057 | ||||||
25,378,404 | 21,557,161 | |||||||
Accumulated
Depreciation
|
(520,130 | ) | (285,756 | ) | ||||
Total
fixed assets
|
$ | 24,858,274 | $ | 21,271,405 |
Depreciation
expense was approximately $ 259,369 and $20,757 for the three months ended
March 31, 2010 and 2009, respectively.
Construction-In-Progress:
Construction-in-progress represents the costs incurred in connection with the
construction of buildings or new additions to the Company’s plant facilities.
Interest incurred during the period of construction, if material, is
capitalized. Construction-in-progress is not depreciated until the assets are
completed and placed into service.
Erye is
constructing a new factory and will relocate to the new place after the entire
project is completed. Construction in progress is related to this production
facility and is being built in accordance with the PRC’s Good Manufacturing
Practices (“GMP”) Standard. The Company expects that the construction will be
completed in 2011; however, certain elements of the project will be completed
and put into service in 2010. The estimated additional cost to
complete construction will be approximately $8.2 million. No depreciation is
provided for construction-in-progress until such time the assets are completed
and placed into service.
8
As of
March 31, 2010, the Company had construction-in-progress which amounted to
$20,707,597. For the three months ended March 31, 2010, the Company capitalized
interest as part of construction-in-progress which amounted to
$629,104.
Income Taxes : The Company,
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. The Company continues to evaluate 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 three months
ended March 31, 2010 and 2009, management does not believe the Company has any
material uncertain tax positions that would require it to measure and
reflect the potential lack of sustainability of a position on audit in its
financial statements. The Company will continue to evaluate its uncertain tax
positions in future periods to determine if measurement and recognition in its
financial statements is necessary. The Company does not believe there
will be any material changes in its unrecognized tax positions over the next
12 months.
Comprehensive Income (Loss):
The accumulated other comprehensive loss balance at March 31, 2010 and December
31, 2009 is comprised entirely of cumulative losses resulting from foreign
currency translation. Comprehensive loss for the three months ended
March 31, 2010 and 2009 was as follows:
March 31,
|
||||||||
2010
|
2009
|
|||||||
Net
loss
|
$ | (3,283,832 | ) | $ | (1,867,243 | ) | ||
Other
comprehensive income (loss)
|
||||||||
Foreign
currency translation
|
13,197 | - | ||||||
Total
other comprehensive loss
|
13,197 | - | ||||||
Comprehensive
loss
|
(3,270,635 | ) | ||||||
Comprehensive
income attributable to the noncontrolling interest
|
1,335,120 | - | ||||||
Comprehensive
loss attributable to NeoStem
|
$ | (4,605,755 | ) | $ | (1,867,243 | ) |
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 performs its annual impairment test as of December 31 each
year. See Note 4.
Prepaid Land Use Rights:
According to
Chinese law, the government owns all the land in China. Companies or individuals
are authorized to possess and use the land only through land use rights granted
by the Chinese government. Prepaid land use rights are recognized ratably over
the lease term of 50 years.
Intangible Asset - patent
rights: 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 primarily 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 nineteen years.
Intangible asset – product rights -
approved Drugs: The Company obtained
various official registration certificates or official approvals for clinical
trials representing patented pharmaceutical formulas. No amortization is
recorded when the Company intends to and has the ability to sell the patent or
formulas within two months; otherwise the patent costs will be subject to
amortization over its estimated useful life which is generally fifteen years.
Such costs comprise purchase costs of patented pharmaceutical formulas and costs
incurred for patent application. Product rights are accounted for on an
individual basis.
Impairment of Long-lived
Assets: The
Company reviews 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 the Company expects to hold and use may not
be recoverable, the Company 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.
9
Accounting for Share-Based Payment
Expense: The Company records share-based payment expense at
fair value. The Company utilizes the Black-Scholes valuation method
for determination of share-based payment expense. The Company
accounts for share-based payment transactions with non-employees in which
services are received in exchange for the equity instruments based upon the fair
value of the equity instruments issued. Generally, the Company
recognizes the fair value of share-based payment expense in net income on a
straight-line basis over the requisite service period. See Note
9. For those awards that contain performance conditions, expense is
generally recognized when the performance condition is deemed probable of
occurring.
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 shareholders 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 shareholders 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 such
potentially dilutive securities are anti-dilutive in all periods presented. For
the three months ended March 31, 2010 and March 31, 2009, the Company
incurred net losses and therefore no common stock equivalents were utilized in
the calculation of earnings per share. At March 31, 2010 and 2009, the Company
had common stock equivalents outstanding as follows:
March 31,
|
March 31,
|
|||||||
2010
|
2009
|
|||||||
Stock
Options
|
10,065,574 | 1,718,300 | ||||||
Warrants
|
17,762,611 | 5,305,692 | ||||||
Series
C Preferred Stock, (if converted)
|
9,086,124 | - |
Advertising Policy: All
expenditures for advertising are charged against operations as incurred.
Advertising costs for the three months ended March 31, 2010 and 2009 amounted to
$99,898 and $47,571, respectively, and are recorded within selling, general and
administrative expense.
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
typically 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 in revenue recognition
policy did not have a material impact on the results of operations. The Company
also receives licensing fees from a licensee for use of its 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.
The
Company recognizes revenue from product sales when title has passed, the risks
and rewards of ownership have been transferred to the customer, the fee is fixed
and determinable, and the collection of the related receivable is probable which
is generally at the time of delivery.
Three Months Ended
|
||||||||
March 31,
|
||||||||
2010
|
2009
|
|||||||
Revenues:
|
||||||||
Prescription
drugs and intermediary pharmaceutical products
|
$ | 15,771,255 | $ | - | ||||
Stem
Cell Revenues
|
37,500 | 42,610 | ||||||
Other
Revenues
|
24,423 | 2,528 | ||||||
$ | 15,833,178 | $ | 45,138 |
Fair Value
Measurements: The Company follows 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 defined as the
exchange 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). The Company is required
to classify fair value measurements in one of the following
categories:
10
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. The
Company’s 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.
The
Company determined the fair value of funds invested in short term investments,
which are considered trading securities, to be level 1 inputs measured by
quoted prices of the securities in active markets. The Company determined the
fair value of funds invested in money market funds to be level 2 inputs, which
does not entail material subjectivity because the methodology employed does not
necessitate significant judgment, and the pricing inputs are observed from
actively quoted markets. The following table sets forth by level within the fair
value hierarchy the Company’s financial assets and liabilities that were
accounted for at fair value on a recurring basis as of March 31,
2010.
March 31, 2010
|
||||||||||||
Fair Value Measurements Using Fair Value Hierarchy
|
||||||||||||
Level 1
|
Level 2
|
Level 3
|
||||||||||
Money
Market Funds
|
$ | - | $ | 3,929,353 | $ | - | ||||||
Short
term investments
|
$ | 1,145,512 | $ | - | $ | - |
December 31, 2009
|
||||||||||||
Fair Value Measurements Using Fair Value Hierarchy
|
||||||||||||
Level 1
|
Level 2
|
Level 3
|
||||||||||
Money
Market Funds
|
$ | - | $ | 1,030,980 | $ | - | ||||||
Short
term investments
|
$ | 287,333 | $ | - | $ | - |
Some of
the Company’s financial instruments are not measured at fair value on a
recurring basis but are recorded at amounts that approximate fair value due to
their liquid or short-term nature, such as cash and cash equivalents, restricted
cash, accounts receivable, accounts payable, and notes payable.
Foreign Currency Translation:
As the Company’s
Chinese pharmaceutical business is a self-contained and integrated entity, and
the Company’s Chinese stem cell business’ future cash flow is expected to be
sufficient to service its additional financing requirements, the Chinese
subsidiaries’ functional currency is the Renminbi (“RMB”), and the Company’s
reporting currency is the US dollar. Results of foreign operations
are translated at the average exchange rates during the period, assets and
liabilities are translated at the unified exchange rate as quoted by the
People’s Bank of China at the end of each reporting period. Cash flows are also
translated at average translation rates for the period, therefore, amounts
reported on the consolidated statement of cash flows will not necessarily agree
with changes in the corresponding balances on the consolidated balance
sheet.
This
quotation of the exchange rates does not imply free convertibility of RMB to
other foreign currencies. All foreign exchange transactions continue to take
place either through the People’s Bank of China or other banks authorized to buy
and sell foreign currencies at the exchange rate quoted by the People’s Bank of
China.
Translation
adjustments resulting from this process are included in accumulated other
comprehensive income (loss) and amounted to $54,720 and $67,917 as of March 31,
2010 and December 31, 2009, respectively. Assets and liabilities at March 31,
2010 were translated at 6.817 RMB to 1 US dollar and at December 31, 2009 assets
and liabilities were translated at 6.826 RMB to 1 US dollar. The average
translation rates applied to income statement accounts and the statement of cash
flows for the three months ended March 31, 2010 were 6.819 RMB to 1 US
dollar. Since the CBH acquisition closed in October 2009 and
significant China-based stem cell operations began after March 31, 2009, there
was no translation required for the income statement accounts and the statement
of cash flows for the three months ended March 31, 2009.
11
Economic and Political Risks:
The Company faces
a number of risks and challenges since a significant amount of its assets are
located in China and its revenues are derived primarily from its operations in
China. China is a developing country with a young economic market system
overshadowed by the state. Its political and economic systems are very different
from the more developed countries and are still in the stage of change. China
also faces many social, economic and political challenges that may produce major
shocks and instabilities and even crises, in both its domestic arena and its
relationship with other countries, including but not limited to the United
States. Such shocks, instabilities and crises may in turn significantly and
negatively affect the Company’s performance.
Research and Development
Costs:
Research and development (“R&D”) expenses include salaries, benefits,
and other headcount related costs, clinical trial and related clinical
manufacturing costs, contract and other outside service fees, and facilities and
overhead costs. R&D costs are expensed when incurred. The Company
expenses the costs associated with research and development activities when
incurred.
Shipping and Handling Costs:
Shipping and
handling costs are included in selling, general and administrative expense and
were $148,292 and $0 for the three months ended March 31, 2010 and 2009,
respectively.
Statutory Reserves: Pursuant
to laws applicable to entities incorporated in the PRC, the PRC subsidiaries are
prohibited from distributing their statutory capital and are required to
appropriate from PRC GAAP profit after tax to other non-distributable reserve
funds. These reserve funds include one or more of the following: (i) a general
reserve, (ii) an enterprise expansion fund and (iii) a staff bonus and welfare
fund. Subject to certain cumulative limits, the general reserve fund requires
annual appropriation at 10% of after tax profit (as determined under accounting
principles generally accepted in the PRC at each year-end); the appropriation to
the other fund are at the discretion of the subsidiaries.
The
general reserve is used to offset future extraordinary losses. A subsidiary may,
upon a resolution passed by the shareholders, convert the general reserve into
capital. The staff welfare and bonus reserve is used for the collective welfare
of the employees of the subsidiary. The enterprise expansion reserve is for the
expansion of the subsidiary’s operations and can be converted to capital subject
to approval by the relevant authorities. These reserves represent appropriations
of the retained earnings determined in accordance with Chinese law, and are not
distributable as cash dividends to the parent company,
NeoStem. Statutory reserves are $1,182,402 and $1,126,300 as of March
31, 2010 and December 31, 2009, respectively.
Relevant
PRC statutory laws and regulations permit payment of dividends by the Company’s
PRC subsidiaries only out of their retained earnings, if any, as determined in
accordance with PRC accounting standards and regulations. As a result of these
PRC laws and regulations, the Company’s PRC subsidiaries are restricted in their
ability to transfer a portion of their net assets either in the form of
dividends, loans or advances. The restricted amount was $1,182,402 at
March 31, 2010.
Note 3 – Recent Accounting
Pronouncements
In June
2009, the Financial Accounting Standards Board (the “FASB’) issued an amendment
to the accounting and disclosure requirements for transfers of financial assets,
which is effective January 1, 2010. The amendment eliminates the concept of
a qualifying special-purpose entity, changes the requirements for derecognizing
financial assets and requires enhanced disclosures to provide financial
statement users with greater transparency about transfers of financial assets,
including securitization transactions, and an entity’s continuing involvement in
and exposure to the risks related to transferred financial
assets. The adoption of this standard did not have a material impact
on the consolidated financial statements.
In June
2009, the FASB amended the existing accounting and disclosure guidance for the
consolidation of variable interest entities, which is effective January 1,
2010. The amended guidance requires enhanced disclosures intended to provide
users of financial statements with more transparent information about an
enterprise’s involvement in a variable interest entity. The adoption
of this standard did not have a material impact on the consolidated financial
statements.
In
January 2010, the FASB amended the existing disclosure guidance on fair
value measurements, which is effective January 1, 2010, except for
disclosures about purchases, sales, issuances, and settlements in the roll
forward of activity in Level 3 fair value measurements, which is effective
January 1, 2011. Among other things, the updated guidance requires
additional disclosure for the amounts of significant transfers in and out of
Level 1 and Level 2 measurements and requires certain Level 3 disclosures on a
gross basis. Additionally, the updates amend existing guidance to require a
greater level of disaggregated information and more robust disclosures about
valuation techniques and inputs to fair value measurements. Since the amended
guidance requires only additional disclosures, the adoption of the provisions
effective January 1, 2010 did not, and for the provisions effective in 2011
will not, impact the Company’s financial position or results of
operations.
12
Note 4 –
Acquisitions
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 was founded more
than 50 years ago, currently manufactures and has received more than 160
production certifications from the SFDA covering both antibiotic prescription
drugs and active pharmaceutical intermediaries. 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, has been approved by the requisite PRC governmental
authorities.
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. The fair value of these shares were
$10,796,500.
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,
were effectively outstanding as of October 30, 2009 and expired by March
10, 2010, with a fair value of $590,800. The fair value of the common stock
issued to RimAsia was $9,751,600 and the fair value of the Series C Preferred
Stock was $13,720,012. The fair value of the Series C Convertible Preferred
Stock has been allocated to the two economic elements of the Series C
Convertible Preferred stock; the fair value of the beneficial conversion feature
of the preferred stock to NeoStem Common Stock is $5,542,500 and the fair value
of the preferred stock is $8,177,512.
The fair
value of the identifiable net assets acquired in the merger was $39,467,800. The
fair value of the equity issued as consideration by NeoStem was $35,073,600 and
the fair value of the noncontrolling interests of Erye was $33,698,200. The
goodwill that has been created by this acquisition is reflective of the values
and opportunities of expanded access to healthcare in the Peoples Republic of
China, the designation of certain antibiotics as essential medicines in China,
and that a majority of Erye’s antibiotics are on the central or provincial
governments’ drug formularies. Due to the structure of the transaction, none of
the goodwill is expected to be tax deductible.
13
The
summary of assets acquired and liabilities assumed on October 30, 2009 is as
follows:
Cash
& Restricted Cash
|
$ | 4,451,200 | ||
Accounts
Receivable
|
6,199,500 | |||
Inventories
|
12,469,000 | |||
Other
Current Asset
|
2,899,900 | |||
Property,
Plant & Equipment
|
18,922,600 | |||
Intangibles
|
20,905,900 | |||
Goodwill
|
33,867,600 | |||
Accounts
Payable
|
$ | 6,256,800 | ||
Other
Liabilities
|
3,071,100 | |||
Deferred
Tax Liability
|
4,720,800 | |||
Notes
Payable
|
9,618,100 | |||
Amounts
due Related Party
|
7,478,100 |
The total
cost of the acquisition has been allocated to the assets acquired and the
liabilities assumed based upon their estimated fair values at the date of the
acquisition. The estimated purchase price allocation is subject to
revision based on additional valuation work that is being
conducted. The final allocation is pending the receipt of this
valuation work and the completion of the Company’s internal review, which is
expected during fiscal 2010.
A
preliminary allocation of the consideration transferred to the net assets of CBH
was made as of the Merger date. During the three months ended March
31, 2010, the Company continued to review its preliminary allocation of the
purchase price associated with the Merger and made the following retrospective
adjustments as of the Merger date:
The
Company determined that finished goods inventory acquired in connection with the
merger was incorrectly valued and should have been increased by approximately
$1,917,000 to step-up such inventory to fair value at the Merger
date. Such finished goods inventory has been sold through by December
31, 2009. Therefore, at December 31, 2009, there is no effect on the
reported balance of inventories in the consolidated balance sheets.
The
Company determined that the fair value of the acquired customer list intangible
asset was incorrectly valued by approximately $1,700,000 due to the inclusion of
future tax benefits that will not be realized for local Chinese tax purposes in
the Company’s estimates of future cash flows used to value this intangible
asset.
The
Company determined that it had incorrectly accounted for the book/tax basis
differences that arose in recording the fair value of the net assets acquired in
connection with the Merger. Such increases to fair value, while
deductible for book purposes, are not deductible for local Chinese tax purposes
but require recognition of the impact such non-deductibility will have on future
tax expense. Specifically, the Company did not establish at the
Merger date deferred tax liabilities of approximately $4,720,800 for such
book/tax basis differences.
The
Company evaluated the materiality of these errors from both a qualitative and
quantitative perspective and concluded that these errors were immaterial to the
consolidated financial statements taken as a whole for the fiscal year ended
December 31, 2009. The effect of these immaterial errors and related
retrospective adjustments at December 31, 2009 and for the year then ended are
summarized as follows:
14
As
Previously Reported
|
Adjustment
|
As
Restated
|
||||||||||
Consolidated Balance Sheet
|
||||||||||||
Assets:
|
||||||||||||
Current
Assets
|
$ | 31,799,218 | $ | - | $ | 31,799,218 | ||||||
Property,
plant and equipment, net
|
21,299,381 | (27,976 | ) | 21,271,405 | ||||||||
Intangible
Assets
|
||||||||||||
Goodwill
|
29,862,123 | 4,563,605 | 34,425,728 | |||||||||
Land
use rights, net
|
4,698,567 | - | 4,698,567 | |||||||||
Lease
rights
|
633,136 | - | 633,136 | |||||||||
Customer
list, net
|
16,756,147 | (1,676,580 | ) | 15,079,567 | ||||||||
Other
intangibles
|
747,288 | - | 747,288 | |||||||||
Other
assets
|
238,941 | - | 238,941 | |||||||||
$ | 106,034,801 | $ | 2,859,049 | $ | 108,893,850 | |||||||
Liabilities
and Equity
|
||||||||||||
Current
liabilities
|
$ | 25,493,560 | $ | - | $ | 25,493,560 | ||||||
Deferred
tax liability
|
- | 4,440,748 | 4,440,748 | |||||||||
Amount
due related party
|
7,234,291 | - | 7,234,291 | |||||||||
Convertible
redeemable Series C preferred stock
|
13,720,048 | - | 13,720,048 | |||||||||
Preferred
stock Series B convertible, redeemable
|
100 | - | 100 | |||||||||
Common
stock
|
37,193 | - | 37,193 | |||||||||
Additional
paid in capital
|
95,709,491 | - | 95,709,491 | |||||||||
Accumulated
deficit
|
(70,878,816 | ) | (820,375 | ) | (71,699,191 | ) | ||||||
Accumulated
other comprehensive loss
|
(67,917 | ) | - | (67,917 | ) | |||||||
Non
controlling interests
|
34,786,851 | (761,324 | ) | 34,025,527 | ||||||||
Total
equity
|
59,586,902 | (1,581,699 | ) | 58,005,203 | ||||||||
$ | 106,034,801 | $ | 2,859,049 | $ | 108,893,850 |
Consolidated Statement of Operations
|
As Previously
Reported
|
Adjustment
|
As Restated
|
|||||||||
Revenues
|
$ | 11,565,118 | $ | - | $ | 11,565,118 | ||||||
Cost
of revenues
|
7,587,175 | 1,917,044 | 9,504,219 | |||||||||
Gross
Profit
|
3,977,943 | (1,917,044 | ) | 2,060,899 | ||||||||
Research
and Development
|
4,318,805 | - | 4,318,805 | |||||||||
Selling,
general and administrative
|
23,459,600 | (28,417 | ) | 23,431,183 | ||||||||
Operating
Loss
|
(23,800,462 | ) | (1,888,627 | ) | (25,689,089 | ) | ||||||
Other
income (expense):
|
||||||||||||
Other
income/(expense), net
|
(1,431 | ) | - | (1,431 | ) | |||||||
Interest
expense
|
(37,757 | ) | - | (37,757 | ) | |||||||
(39,188 | ) | - | (39,188 | ) | ||||||||
Loss
from operations before provision for income taxes and non-controlling
interests
|
(23,839,650 | ) | (1,888,627 | ) | (25,728,277 | ) | ||||||
Provision
for income taxes
|
344,200 | (280,049 | ) | 64,151 | ||||||||
Net
loss
|
(24,183,850 | ) | (1,608,578 | ) | (25,792,428 | ) | ||||||
Less
- Income from operations attributable to non-controlling
interests
|
1,088,667 | (788,203 | ) | 300,464 | ||||||||
Net
Loss attributable to controlling Interests
|
(25,272,517 | ) | (820,375 | ) | (26,092,892 | ) | ||||||
Preferred
Dividends
|
5,611,989 | - | 5,611,989 | |||||||||
Net
Loss attributable to common shareholders
|
$ | (30,884,506 | ) | $ | (820,375 | ) | $ | (31,704,881 | ) | |||
Basic
and diluted loss per share
|
$ | (2.37 | ) | $ | (2.44 | ) | ||||||
Weighted
average common shares outstanding
|
13,019,518 | 13,019,518 |
15
Consolidated
Statement of Equity
|
As
Previously Reported
|
Adjustment
|
As
Restated
|
|||||||||
Preferred
stock Series B convertible, redeemable
|
$ | 100 | $ | - | $ | 100 | ||||||
Common
stock
|
37,193 | - | 37,193 | |||||||||
Additional
paid in capital
|
95,709,491 | - | 95,709,491 | |||||||||
Accumulated
deficit
|
(70,878,816 | ) | (820,375 | ) | (71,699,191 | ) | ||||||
Accumulated
other comprehensive loss
|
(67,917 | ) | - | (67,917 | ) | |||||||
Non
controlling interests
|
34,786,851 | (761,324 | ) | 34,025,527 | ||||||||
Total
equity
|
$ | 59,586,902 | $ | (1,581,699 | ) | $ | 58,005,203 | |||||
Consolidated
Statement of Cash Flow
|
As
Previously Reported
|
Adjustment
|
As
Restated
|
|||||||||
Cash
flows from operating activities:
|
||||||||||||
Net
Loss attributable to controlling interests
|
$ | (25,272,517 | ) | $ | (820,375 | ) | $ | (26,092,892 | ) | |||
Income
from operations attributable to non-controlling interests
|
1,088,667 | (788,203 | ) | 300,464 | ||||||||
Adjustments
to reconcile net loss to net cash used in
|
||||||||||||
operating
activities:
|
||||||||||||
Common
Stock, stock options and warrants issued
|
||||||||||||
as
payment for compensation, services rendered and interest
expense
|
12,323,997 | - | 12,323,997 | |||||||||
Depreciation
and amortization
|
577,043 | (28,417 | ) | 548,626 | ||||||||
Bad
debt expense
|
(90,216 | ) | - | (90,216 | ) | |||||||
Deferred
tax liability
|
- | (280,049 | ) | (280,049 | ) | |||||||
Realization
of step in basis of inventory received at date of
acquisition
|
- | 1,917,044 | 1,917,044 | |||||||||
Changes
in operating assets and liabilities:
|
||||||||||||
Prepaid
expenses and other current assets
|
1,796,691 | - | 1,796,691 | |||||||||
Accounts
receivable
|
571,689 | - | 571,689 | |||||||||
Inventory
|
(2,427,095 | ) | - | (2,427,095 | ) | |||||||
Other
assets
|
(238,941 | ) | - | (238,941 | ) | |||||||
Unearned
revenues
|
1,991,816 | - | 1,991,816 | |||||||||
Payments
to related party
|
(243,777 | ) | - | (243,777 | ) | |||||||
Accounts
payable, accrued expenses
|
||||||||||||
and
other current liabilities
|
1,259,895 | - | 1,259,895 | |||||||||
Net
cash used in operating activities
|
(8,662,748 | ) | - | (8,662,748 | ) | |||||||
Cash
associated with Merger
|
696,456 | - | 696,456 | |||||||||
Acquisition
of property and equipment
|
(2,387,555 | ) | - | (2,387,555 | ) | |||||||
Net
cash provided by/(used) in investing activities
|
(1,691,099 | ) | - | (1,691,099 | ) | |||||||
Net
proceeds from issuance of Series D Preferred Stock
|
15,669,220 | - | 15,669,220 | |||||||||
Proceeds
from bank loan
|
2,197,500 | - | 2,197,500 | |||||||||
Restricted
cash pledged as collateral for bank loan
|
(959,890 | ) | - | (959,890 | ) | |||||||
Proceeds
from notes payable
|
2,918,269 | - | 2,918,269 | |||||||||
Proceeds
from sale of convertible debentures
|
(2,742,669 | ) | - | (2,742,669 | ) | |||||||
Net
cash provided by financing activities
|
17,082,430 | - | 17,082,430 | |||||||||
Net
increase in cash
|
6,728,583 | - | 6,728,583 | |||||||||
Cash
and cash equivalents at beginning of year
|
430,786 | - | 430,786 | |||||||||
Cash
and cash equivalents at end of year
|
$ | 7,159,369 | $ | - | $ | 7,159,369 |
16
Presented
below is the unaudited proforma information as if the acquisition had occurred
at the beginning of the three months ended March 31, 2009 along with a
comparison to the actual March 31, 2010 quarterly results:
Q1 2010
|
Q1 2009
|
|||||||
(as reported)
|
(proforma)
|
|||||||
Pharmaceutical
sales
|
$ | 15,771,255 | $ | 12,690,762 | ||||
Stem
cell and other revenue
|
61,923 | 45,138 | ||||||
Total
revenues
|
$ | 15,833,178 | $ | 12,735,900 | ||||
Gross
Profit
|
4,981,560 | 4,068,858 | ||||||
Research
and development
|
1,300,158 | 227,487 | ||||||
Selling,
general and administrative
|
6,289,698 | 3,485,783 | ||||||
Operating
income/(loss)
|
(2,608,296 | ) | 355,588 | |||||
Net
income/(loss) before noncontrolling interests
|
(3,283,832 | ) | 11,268 | |||||
Net
income attributable to noncontrolling interests
|
1,328,653 | 920,470 | ||||||
Net
loss attributable to common shareholders
|
(4,712,183 | ) | (909,203 | ) | ||||
Net
loss per Share
|
$ | (0.12 | ) | $ | (0.04 | ) |
The
unaudited supplemental pro forma data reflect the application of the following
adjustments:
Amortization
of customer list, $383,379
Amortization
of lease, $86,337
Amortization
of land use rights, $15,264
Utilization
of deferred tax liability, $60,623
The
unaudited supplemental pro forma financial information should not be considered
indicative of the results that would have occurred if the Merger had been
consummated on January 1, 2009, nor are they indicative of future
results.
Note 5 – Intangible
Asset
At March
31, 2010, the Company’s intangible assets consisted of patent applications and
rights associated with the VSEL Technology which constitutes the principal
assets acquired in the acquisition of Stem Cells Technologies, Inc.; patent
rights owned by Erye, a lease right between Erye and Erye Economic Trade (the
49% shareholder of Erye) for the use of Erye’s current manufacturing plant in
Suzhou and Erye’s customer list.
As of
March 31, 2010 and December 31, 2009, the Company’s intangible assets and
related accumulated amortization consisted of the following:
March 31, 2010
|
December 31, 2009
|
|||||||||||||||||||||||||||
Gross
|
Accumulated
Amortization
|
Net
|
Gross
|
Accumulated
Amortization
|
Net
|
|||||||||||||||||||||||
Intangible
assets obtained in the CBH acquisition
|
||||||||||||||||||||||||||||
Lease
rights
|
690,694 | (143,895 | ) | 546,799 | 690,694 | (57,558 | ) | 633,136 | ||||||||||||||||||||
Customer
list
|
15,335,149 | (638,963 | ) | 14,696,186 | 15,335,149 | (255,582 | ) | 15,079,567 | ||||||||||||||||||||
Patents
|
150,332 | (7,300 | ) | 143,032 | 150,332 | (2,733 | ) | 147,599 | ||||||||||||||||||||
Intangible
assets obtained in the Stem Cell Technologies, Inc.
|
||||||||||||||||||||||||||||
VSEL
patent rights
|
672,777 | (82,223 | ) | 590,554 | 672,777 | (73,088 | ) | 599,689 | ||||||||||||||||||||
Total
Intangible Assets
|
$ | 16,848,952 | $ | (872,381 | ) | $ | 15,976,571 | $ | 16,848,952 | $ | (388,961 | ) | $ | 16,459,991 |
2010
|
$ | 1,448,635 | ||
2011
|
1,872,914 | |||
2012
|
1,585,125 | |||
2013
|
1,585,125 | |||
2014
|
1,585,125 | |||
Thereafter
|
7,899,646 |
17
Note 6– Accrued
Liabilities
Accrued
liabilities are as follows:
March 31,
|
December 31
|
|||||||
2010
|
2009
|
|||||||
Income
taxes payable
|
$ | 1,891,896 | $ | 1,842,007 | ||||
VAT taxes payable | 340,158 | 0 | ||||||
Salaries
and related taxes
|
326,471 | 531,655 | ||||||
Professional
fees
|
135,000 | 116,787 | ||||||
Franchise
taxes
|
- | 138,982 | ||||||
Collection
cost
|
105,640 | 85,163 | ||||||
Dividends
payable
|
99,698 | 69,453 | ||||||
Rent
expense
|
69,111 | 69,111 | ||||||
Interest
payable
|
57,650 | - | ||||||
Warrant
liability
|
37,042 | 35,995 | ||||||
Other
|
137,956 | 76,372 | ||||||
$ | 3,200,622 | $ | 2,965,525 |
Note 7 – Notes
Payable
In
December, 2009, in order to facilitate working capital requirements in China,
NeoStem (China) issued a promissory note to the Bank of Rizhao Qingdao Branch in
the amount of RMB 4,400,000 ($645,480). The note is due on June 21, 2010 and
bears an interest rate of 4.05%. The loan is collateralized by cash in a
restricted bank account totaling 5,189,400 RMB (approximately $759,200). In
addition, in January 2010 NeoStem (China) entered into a pledge agreement with
the bank pledging all of its interest in its VIEs as additional collateral for
the loan.
The
Company’s subsidiary Erye has 81,365,889 RMB ($11,936,376) of notes payables as
of March 31, 2010. Notes are payables to the banks who issue bank notes to
Erye’s creditors. Notes payable are interest free and usually mature after a
three to six months period. In order to issue notes payable on behalf
of the Company, the banks required collateral, such as cash deposit which was
approximately 30%-50% of notes to be issued, or properties owned by companies.
Restricted
cash put up for collateral for the balance of notes payable at March 31, 2010
and December 31, 2009, amounted to 26,929,041 RMB (approximately
$3,950,490) and 26,999,300 RMB (approximately $3,955,400),
respectively. At March 31, 2010 and December 31, 2009 the restricted
cash amounted to 33.1% and 40.4% of the notes payable Erye issued, and the
remainder of the notes payable is collateralized by pledging the land use right
Erye owns, which amounts to approximately $1,834,000, and $1,840,000 at March
31, 2010 and December 31, 2009, respectively.
Note 8 – Convertible
Redeemable Series C Preferred Stock
On
October 30, 2009, pursuant to the terms of the Merger Agreement, the Company
issued 8,177,512 shares of Series C Convertible Preferred Stock in exchange for
certain outstanding CBH securities. The terms and conditions of the
Series C Preferred Stock are as follows:
The
holders of shares of Convertible Redeemable Series C Preferred Stock (“Series C
Preferred Stock”) are entitled to receive an annual dividend of 5% of the Agreed
Stated Value, payable annually on the first day of January. Payment of the
annual dividend may be either in cash or in kind as determined by the NeoStem
Board of Directors. The annual dividend shall be cumulative and shall begin to
accrue on outstanding shares of Series C Preferred Stock from and after the date
of issuance. In the event of a liquidation of NeoStem, after payment or
provision for payment of debts and other liabilities of NeoStem, the holders of
the Series C Preferred Stock then outstanding shall be entitled to be paid out
of the assets of NeoStem available for distribution to its stockholders, before
and in preference to any payment or declaration and setting apart for payment of
any amount shall be made in respect of any junior stock, an amount equal to
$1.125 per share plus an amount equal to all accrued dividends unpaid thereon,
whether or not declared. All shares of Series C Preferred Stock shall rank as to
payment upon the occurrence of any liquidation event senior to the NeoStem
Common Stock and, unless the terms of such other series shall provide otherwise,
senior to all other series of the NeoStem Preferred Stock. Each share of the
Series C Preferred Stock shall be convertible, at the option of the holder
thereof, without the payment of additional consideration, into such number of
fully paid and non-assessable shares of the NeoStem Common Stock equal to the
quotient obtained by dividing $1.00 per share plus all accrued dividends unpaid
thereon, whether or not declared, together with any other dividends declared but
unpaid thereon, by $0.90, subject to adjustment. Beginning any time after the
date of issuance of the Series C Preferred Stock, if the closing price of the
sale of shares of NeoStem Common Stock on the NYSE Amex (or NeoStem’s principal
securities exchange, if other than the NYSE Amex) exceed $2.50 per share,
subject to adjustment, for a period of 20 out of 30 consecutive trading days,
and if the dollar value of the trading volume of the NeoStem Common Stock for
each day during such 20 out of 30 consecutive trading days equals or exceeds
$250,000, NeoStem may require the holders of Series C Preferred Stock to convert
such stock to NeoStem Common Stock, on ten days notice, based on the conversion
price. Prior to the seventh anniversary of issuance of the Series C Preferred
Stock, NeoStem may at the option of the NeoStem Board of Directors and after
giving the holders of shares Series C Preferred Stock an opportunity to convert
all their shares of Series C Preferred Stock into shares of NeoStem Common
Stock, redeem in whole, but not in part, all the shares of Series C Preferred
Stock then outstanding by paying in cash, for each share, an amount equal to the
sum of the original issue price and all accrued but unpaid annual dividends. At
any time following the seventh anniversary of the issuance of the Series C
Preferred Stock, following the written request of the holders of not less than a
majority of the shares of Series C Preferred Stock then outstanding,
NeoStem shall redeem all of the shares of Series C Preferred Stock (or, if less,
the maximum amount it may lawfully redeem) by paying in cash, for each share, an
amount equal to the sum of the original issue price and all accrued but unpaid
annual dividends on such share. Based on these terms the Company has classified
the Series C Preferred Stock as temporary equity on its balance sheet. The total
fair value of the Series C Preferred Stock was approximately $13,720,000. The
value of the Series C Convertible Preferred Stock has been allocated to the two
economic elements of the Series C Convertible Preferred stock; the value of the
beneficial conversion feature of the preferred stock to NeoStem Common Stock is
$5,542,500 and the value of the preferred stock is $8,177,500. The Series C
Convertible Preferred shareholders are not required to hold the preferred stock
for any minimum period of time before exercising the conversion feature
therefore the value of the beneficial conversion feature was recognized
immediately, on October 30, 2009, as a dividend of $5,542,500. At December 31,
2009 the Company accrued cash dividends of $69,453 which was paid in February
2010. At March 31, 2010, accrued dividends were $99,698 which were
included in accrued liabilities in the consolidated balance
sheet.
18
Note 9 – Shareholders’
Equity
Common
Stock:
The
authorized Common Stock of the Company is 500 million shares, par value $0.001
per share.
On
February 18, 2010, the Company completed a public offering of its common stock,
selling 5,750,000 shares priced at $1.35 per share. The Company received
approximately $6,821,600 in net proceeds from the offering, after underwriting
discounts, commissions and expenses, of approximately $940,000.
Warrants:
The
Company has issued common stock purchase warrants from time to time to investors
in private placements, and certain vendors, underwriters, and directors and
officers of the Company. A total of 17,762,611 shares of Common Stock are
reserved for issuance upon exercise of outstanding warrants as of March 31, 2010
at prices ranging from $0.50 to $6.50 and expiring through April
2017.
Effective
as of January 4, 2010, the Company entered into a one-year agreement with a
consultant to provide investor relations services to the Company. In
consideration for providing services under this agreement, the Company agreed to
pay a retainer of $8,000 per month, at the beginning of the month and each month
thereafter during the primary term of the agreement and issue to the consultant
a five year warrant to purchase 200,000 shares of restricted common stock at a
per share exercise price of $2.00 to vest 50,000 each of the last day of each of
the fiscal quarters. The issuance of such securities is subject to the approval
of the NYSE Amex, which approval was obtained in January 2010. This warrant has
a value of $242,700 and resulted in a charge to operations of $126,406 for the
three months ended March 31, 2010.
Effective
as of February 26, 2010, the Company entered into an agreement with a consultant
to provide to the Company necessary information for designing a successful
marketing plan and product list for the penetration (Phase II) of Federal, State
and local government markets. In consideration for providing the
services, the Company agreed to pay a retainer of $20,000 each month and a five
year warrant in the Company's standard form to purchase 275,000 shares of Common
Stock which shall have a per share exercise price of $1.42 and shall vest and
become exercisable in its entirety on such date after the Effective Date that
certain milestones in performance are achieved; provided that if such date is
prior to May 14, 2010 then the warrant shall vest on May 14,
2010. The issuance of such securities is subject to the approval of
the NYSE Amex. This warrant has a value of $324,858 and resulted in no charge to
operations for the three months ended March 31, 2010 as the recognition criteria
associated with the related milestones had not been achieved.
Effective
as of March 11, 2010, the Company entered into an agreement with a law firm
which has been providing legal services to the Company since 2006, pursuant to
which this firm was retained to provide additional legal services with regard to
negotiation, drafting and finalization of contracts; in the development of
strategic plans; with regard to funding from various agencies of the State of
New Jersey and the Federal government. In consideration for providing
the services, the Company agreed to issue a five year warrant to purchase 52,000
shares of restricted Common Stock at a per share exercise price of $1.42,
vesting as to one-half of the shares on June 30, 2010 and one-half of the shares
on December 31, 2010. The issuance of such securities is subject to
the approval of the NYSE Amex. This warrant has a value of $57,621 and resulted
in a charge to operations of $11,264 for the three months ended March 31,
2010.
19
On March
15, 2010, the Company and RimAsia and an affiliate of the Company, made certain
agreements with respect to outstanding warrants. RimAsia exercised
its warrant to purchase 1,000,000 shares of the Company’s common stock, par
value $0.001 per share (“Common Stock”),
exercisable at a per share exercise price of $1.75, which was issued
to RimAsia in a private placement completed by the Company in September 2008
(the “September 2008
Warrant”) resulting in proceeds to the Company totaling $1,750,000.
The condition for such exercise was that the Company would modify certain terms
of RimAsia’s warrant to purchase 4,000,000 shares of Common Stock, issued to
RimAsia in a private placement completed by the Company in April 2009 (the
“Series D Warrant”). RimAsia currently is subject to the terms of a
lock-up agreement. The Series D Warrant was amended
to provide for (i) a three (3) year extension of the Termination Date (as
defined in the Series D Warrant) and (ii) an increase in the average closing
price that triggers the Company’s redemption option under the Series D Warrant
from $3.50 to $5.00 (the Series D Warrant so amended and restated, the “Amended and Restated
Warrant”). The expiration date of the September 2008 Warrant was
September 1, 2013. The change in terms resulted in a charge to other expense
totaling approximately $188,000.
Number of Shares
|
Weighted
Average Exercise
Price
|
Weighted
Average
Remaining
Contractual Term
(years)
|
Aggregate
Intrinsic Value
|
|||||||||||||
Balance
at December 31, 2009
|
19,838,802 | $ | 3.00 | |||||||||||||
Granted
|
527,000 | 1.64 | ||||||||||||||
Exercised
|
(1,000,000 | ) | ||||||||||||||
Expired
|
(1,603,191 | ) | 6.55 | |||||||||||||
Cancelled
|
- | 1.75 | ||||||||||||||
Balance
at March 31, 2010
|
17,762,611 | $ | 2.71 | 4.51 | $ | 926,245 |
At March
31, 2010 the outstanding warrants by range of exercise prices are as
follows:
Weighted Average
|
||||||||||||
Number Outstanding
|
Remaining
|
Number Exercisable
|
||||||||||
Exercise Price
|
March 31, 2010
|
Contractual Life (years)
|
March 31, 2010
|
|||||||||
$0.50
to $2.80
|
15,769,221 | 4.77 | 15,251,561 | |||||||||
$2.80
to $5.10
|
311,511 | 2.60 | 311,511 | |||||||||
$5.10
to $6.50
|
1,681,879 | 2.49 | 1,681,879 | |||||||||
17,762,611 | 4.52 | 17,244,951 |
Options:
The
Company’s 2003 Equity Participation Plan (the “2003 EPP”) permits the grant of
share options and shares to its employees, directors, consultants and advisors
for up to 2,500,000 shares of Common Stock as stock compensation. All
stock options under the 2003 EPP are generally granted at the fair market value
of the Common Stock at the grant date. Employee stock options vest ratably over
a period determined at time of grant and generally expire 10 years from the
grant date.
On May 8,
2009, the shareholders of the Company at its annual meeting of shareholders
adopted the 2009 Equity Plan, which previously had been approved by the Board of
Directors subject to shareholder 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.
On
October 29, 2009, the shareholders of NeoStem approved and 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
3,800,000, to 9,750,000.
The 2003
Equity Plan and the 2009 Equity Plan are sometimes collectively referred to as
the Company’s “U.S. Equity Plan.”
On
October 29, 2009, the shareholders of NeoStem adopted the Non-US Based Equity
Compensation Plan (“Non-U.S. Plan”) at the special meeting of NeoStem
shareholders and authorized that 4,700,000 shares be reserved for this
plan. Persons eligible to receive restricted and unrestricted stock
awards, warrants, stock appreciation rights or other awards under the Non-U.S.
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. On October 29, 2009, upon the adoption of the Non-US
Plan, NeoStem issued 100,000 shares of common stock and warrants (option-like
equity grants) to purchase an aggregate of 1,350,000 shares of common
stock.
20
The three
month periods ended March 31, 2010 and 2009 include share-based payment expense
totaling $1,685,633 and $59,770, respectively. Options vesting on the
accomplishment of business milestones will not be recognized for compensation
purposes until such milestones are accomplished. At March 31, 2010 there were
options to purchase 1,013,575 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 March 31, 2010 was $1.35. The fair value of options at the date of
grant was estimated using the Black-Scholes option pricing model. The expected
volatility is based upon historical volatility of the Company’s 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.
The range
of assumptions made in calculating the fair values of options are as follows
(the same assumptions were used for warrants, the term for the warrant is based
on the life of the warrant):
Three Months Ended
|
||
March 31, 2010
|
||
Expected
term (in years)
|
10
|
|
Expected
volatility
|
107%
- 124%
|
|
Expected
dividend yield
|
0%
|
|
Risk-free
interest rate
|
2.30%
- 3.80%
|
Stock
option activity under the U.S. Equity Plan is as follows:
Number of Shares
(1)
|
Weighted
Average
Exercise Price
|
Weighted Average
Remaining
Contractual Term
|
Average Intrinsic
Value
|
|||||||||||||
Balance
at December 31, 2009
|
8,340,574 | $ | 1.93 | |||||||||||||
Granted
|
75,000 | $ | 1.41 | |||||||||||||
Exercised
|
- | |||||||||||||||
Expired
|
- | |||||||||||||||
Cancelled
|
- | |||||||||||||||
Balance
at March 31, 2010
|
8,415,574 | $ | 1.92 | 8.68 | $ | 515,120 | ||||||||||
Vested
and Exercisable at March 31, 2010
|
4,328,944 | $ | 277,870 |
Number Outstanding
March 31, 2010
|
Weighted Average Remaining
Contractual Term
|
Number Exercisable
March 31, 2010
|
||||||||||
Exercise Price
|
||||||||||||
$ 0.71
to $ 3.57
|
8,243,524 | 8.8 | 4,156,894 | |||||||||
$ 3.57
to $ 6.43
|
146,700 | 2.2 | 146,700 | |||||||||
$ 6.43
to $ 9.28
|
6,750 | 6.7 | 6,750 | |||||||||
$ 9.28
to $12.14
|
7,500 | 4.1 | 7,500 | |||||||||
$12.14
to $15.00
|
11,100 | 3.8 | 11,100 | |||||||||
8,415,574 | 4,328,944 |
21
Stock
option activity under the Non U.S. Equity Plan is as follows:
Number
of Shares
(1)
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term
|
Average
Intrinsic
Value
|
|||||||||||||
Balance
at December 31, 2009
|
1,650,000 | $ | 2.04 | 9.80 | ||||||||||||
Granted
|
- | |||||||||||||||
Exercised
|
- | |||||||||||||||
Expired
|
- | |||||||||||||||
Cancelled
|
- | |||||||||||||||
Balance
at March 31,2010
|
1,650,000 | $ | 2.04 | 9.58 | $ | - | ||||||||||
Vested
and Exercisable at March 31, 2010
|
50,000 | $ | - |
Number Outstanding
|
Weighted Average Remaining
|
Number Exercisable
|
||||||||||
Exercise Price
|
March 31, 2010
|
Contractual Life (years)
|
March 31, 2010
|
|||||||||
2.04
|
1,650,000 |
9.6
|
50,000 | |||||||||
1,650,000 |
9.6
|
50,000 |
The
summary of options vesting during 2010 is as follows:
The total
fair value of shares vested during the three months ended March 31, 2010 was
$1,685,633.
The
number of remaining shares authorized to be issued under the various equity
plans are as follows:
US Equity Plan
|
Non US Equity
Plan
|
|||||||
Shares
Authorized for Issuance under 2003 Equity Plan
|
2,500,000 | - | ||||||
Shares
Authorized for Issuance under 2009 Equity Plan
|
9,750,000 | - | ||||||
Shares
Authorized for Issuance under Non US Equity Plan
|
- | 4,700,000 | ||||||
12,250,000 | 4,700,000 | |||||||
Outstanding
Options - US Equity Plan
|
(8,415,574 | ) | - | |||||
Exercise of options | (2,500 | ) | - | |||||
Outstanding
Options - Non US Equity Plan
|
- | (1,650,000 | ) | |||||
Common
shares issued under the option plans
|
(2,129,607 | ) | (875,000 | ) | ||||
Total
common shares remaining to be issued under the Option
Plans
|
1,702,319 | 2,175,000 |
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 March 31, 2010, there
was approximately $8,065,662 of total unrecognized compensation costs related to
unvested stock option awards of which $6,095,373 of unrecognized compensation
expense is related to stock options that vest over a weighted average life of
1.1 years. The balance of unrecognized compensation costs, $1,970,289, is
related to stock options that vest based on the accomplishment of business
milestones.
22
Note 10 – Income
Taxes
Since the
year 2000, the Company has had several changes in ownership which has resulted
in a limitation on the Company’s ability to apply net operating losses to future
taxable income. Approximately $7,000,000 of net operating losses had
expired due to these limitations. At December 31, 2009, the Company had net
operating loss carryforwards of approximately $26,450,000 applicable to future
Federal income taxes. The tax loss carryforwards are subject to annual
limitations and expire at various dates through 2029. The Company has recorded a
full valuation allowance against its net deferred tax asset because of the
uncertainty that the utilization of the net operating loss and deferred revenue
and fees will be realized.
The
Company determined that a book/tax basis difference exists in recording the fair
value of the intangible assets acquired in connection with the
Merger. Such increases to fair value, while deductible for book
purposes, are not deductible for local Chinese tax purposes but require
recognition of the impact such non-deductibility will have on future tax
expense. Specifically, the Company established as of the Merger date
deferred tax liabilities of approximately $4,720,800 for such book/tax basis
difference. This deferred tax liability will be recognized ratably as
amortization of certain intangible assets occurs.
Note 11 – 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 one industry
segment, 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, the Company conducts its current business in the PRC via two
domestic variable interest entities. To date these operations in China have been
limited. On October 30, 2009, in connection with the Merger, the Company
acquired CBH’s 51% ownership interest in Erye which specializes in research and
development, production and sales of pharmaceutical products, as well as
chemicals used in pharmaceutical products. As a result the Company now
operates in the United States and China.
For the three months
|
||||||||
ended March 31
|
||||||||
2010
|
2009
|
|||||||
United
States
|
||||||||
Stem
Cell Revenues
|
$ | 37,500 | $ | 42,610 | ||||
Other
Revenues
|
21,151 | 2,528 | ||||||
China
|
||||||||
Prescription
drugs and intermediary pharmaceutical products
|
15,771,255 | - | ||||||
Other
Revenues
|
3,272 | - | ||||||
$ | 15,833,178 | $ | 45,138 | |||||
Income/(loss)
from operations:
|
||||||||
United
States
|
$ | (5,485,599 | ) | $ | (1,856,948 | ) | ||
China
|
2,877,303 | - | ||||||
$ | (2,608,296 | ) | $ | (1,856,948 | ) | |||
Total
Assets
|
||||||||
United
States
|
8,464,136 | $ | 1,810,869 | |||||
China
|
113,538,446 | - | ||||||
$ | 122,002,582 | $ | 1,810,869 |
23
Note 12 – Related Party
Transactions
In
October 2007, the Company entered into a three month consulting agreement with
Matthew Henninger pursuant to which he agreed to provide services as a business
consultant in areas requested by the Company, including financial analysis
projects and acquisition target analysis. As compensation for these
services, pursuant to the agreement he was entitled to receive a cash fee of
$8,333 payable each month during the term of the agreement as well as a fee in
the event a transaction was effected during the term as a result of the
performance of the consultant’s services. In January 2008, the
Company and the consultant entered into an agreement whereby the consultant
agreed to accept in satisfaction of his final payment under the agreement, 4,902
shares of the Company’s Common Stock issued under and pursuant to the terms of
the Company’s 2003 Equity Participation Plan (“EPP”) based on the fair market
value of the Common Stock on the date of approval by the Compensation Committee
of the Company’s Board of Directors. The fair value of these shares was $8,333
and charged to consulting expense in 2008. No other fee was
paid. The consultant is currently in an exclusive relationship with
the Company’s Chief Executive Officer.
Pursuant
to the terms and subject to the conditions set forth in the Merger Agreement,
all of the shares of common stock, par value $.01 per share, of CBH, or CBH
Common Stock, issued and outstanding immediately prior to the effective time of
the Merger, or the Effective Time, were converted into the right to receive, in
the aggregate, 7,150,000 shares of the Company’s Common Stock. Additionally,
subject to the cancellation of outstanding warrants to purchase shares of CBH
Common Stock held by RimAsia (a beneficial holder of more than 5% of the
Company’s voting securities), and the sole holder of shares of Series B
Convertible Preferred Stock, par value $0.01 per share, of CBH, or the CBH
Series B Preferred Stock, all of the shares of CBH Series B Preferred Stock
issued and outstanding immediately prior to the Effective Time were converted
into the right to receive, in the aggregate, (i) 6,458,009 shares of the
Company’s common stock (having an approximate value of $12,270,217 as of the
Effective Time) and (ii) 8,177,512 shares of the Company’s Series C Preferred
Stock (having an approximate value of $13,720,012 as of the Effective Time),
each with a liquidation preference of $1.125 per share and convertible into
9,086,124 shares of the Company’s common stock at an initial exercise price of
$0.90.
At the
Effective Time, the Company issued 9,532 shares of its common stock (having an
approximate value of $18,110) to Stephen Globus, a director of CBH, and 7,626
shares of its common stock (having an approximate value of $14,489) to Chris
Peng Mao, then 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. Additionally,
the Company agreed to bear 50% of up to $450,000 of CBH’s expenses post-Merger,
and satisfaction of the liabilities of Messrs. Globus and Mao will count toward
that obligation.
For
assistance in effecting the Merger, 125,000 shares of the Company’s common stock
(having an approximate value of $237,500) were issued to EET, the holder of a
49% interest in Erye. In addition, an aggregate of 203,338 shares of the
Company’s common stock (having an approximate value of $386,350) was issued to
Shi Mingsheng (an officer and director of Erye and the majority shareholder of
EET and nominated as the Company’s director) and Madam Zhang Jian (an officer
and director of CBH, an officer of Erye and a significant shareholder of
EET).
As a
result of the Merger, the Company owns 51% of Erye, and EET owns the remaining
49% ownership interest. In connection with the Merger, the Company and EET
negotiated a revised joint venture agreement which, finalized and approved by
the requisite PRC governmental authorities, will govern the Company’s respective
rights and obligations with respect to Erye. Pursuant to the terms and
conditions of the revised joint venture agreement, dividend distributions to EET
and NeoStem 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 the Company’s 51% interest in Erye; and
(iii) 6% of the net profit will be distributed to the Company directly for the
Company’s operating expenses. In the event of the sale of all of the assets of
Erye or liquidation of Erye, the Company will be entitled to receive the return
of such additional paid-in capital before distribution of Eyre’s assets is made
based upon the ownership percentages of NeoStem and EET, and upon an initial
public offering of Erye which raises at least 50,000,000 RMB (or approximately
U.S. $7,300,000), we will be entitled to receive the return of such additional
paid-in capital.
In
connection with the Merger, the exercise price of certain of the Company’s
outstanding warrants was reduced. Certain of the Company’s executive officers
and directors held warrants to purchase the Company’s common stock at $8.00 per
share, and following the Merger, the exercise price of such warrants was reduced
to approximately $6.18 per share. These warrants are held by the Company’s
Chairman and CEO - Robin L. Smith (25,427), the Company’s Vice President and
General Counsel - Catherine M. Vaczy (2,000), and the Company’s directors -
Richard Berman (11,364) and Steven Myers (22,728).
In
connection with the Merger, each of the then officers and directors of CBH, and
each of RimAsia (then a beneficial holder of more than 5% of the Company’s
voting securities), Erye and EET, as well as certain holders of CBH Common Stock
at the Effective Time, entered into a lock-up and voting agreement, pursuant to
which they agreed to vote their shares of CBH Common Stock in favor of the
Merger and to the other transactions contemplated by the Merger Agreement and
agreed not to sell their CBH Common Stock and/or the Company’s common stock from
November 2, 2008 through the expiration of the six-month period immediately
following the consummation of the Merger . Similarly, the Company’s officers and
directors entered into a lock-up and voting agreement, pursuant to which they
agreed to vote their shares of the Company’s common stock in favor of the Merger
and to the other transactions contemplated by the Merger Agreement and agreed
not to sell their shares of the Company’s common stock during the same
period.
24
Robin L.
Smith, the Company’s Chairman and Chief Executive Officer, and Steven Myers, a
member of the Company’s Board of Directors and Audit, Compensation and
Nominating Committees (of which Nominating Committee Mr. Myers became Chairman
in March 2009), were holders of CBH Common Stock at the time. Dr. Smith was the
beneficial owner of 389,966 shares of CBH Common Stock that were acquired
commencing in 2005. Mr. Myers was the beneficial owner of 285,714 shares of CBH
Common Stock that were acquired in 2005. Based on the $2.03 closing price of the
Company’s common stock on September 18, 2009 and the conversion of CBH Common
Stock into the Company’s Common Stock in the Merger, the approximate transaction
value of the holdings in CBH of each of Dr. Smith and Mr. Myers was $152,126 and
$111,457, respectively.
In the
Company’s private placement of units in November 2008, Fullbright Finance
Limited (“Fullbright”), then a beneficial holder of more than 5% of the
Company’s voting securities, a corporation organized in the British Virgin
Islands, and the principal shareholders of which are Madam Zhang Jian, then an
officer and director of CBH and an officer of Erye, Shi Mingsheng, then an
officer and director of CBH, a director of Erye and Chairman of Fullbright,
purchased 400,000 units for an aggregate consideration of $500,000. The per unit
price was $1.25 and each unit was comprised of one share of the Company’s common
stock and one redeemable five-year warrant to purchase one share of the
Company’s common stock at a purchase price of $1.75 per share. In connection
with Fullbright’s purchase of the units, EET, the principal shareholders of
which are also the principal shareholders of Fullbright, borrowed $500,000 from
RimAsia, and the units acquired by Fullbright were pledged to RimAsia as
collateral therefor. Further, in the Company’s June/July 2009 private placement,
Fullbright acquired, for a purchase price of $800,000, 64,000 shares of the
Company’s Series D Stock which was converted into 640,000 shares of the
Company’s common stock, together with warrants to purchase 640,000 shares of the
Company’s common stock.
In the
November 2008 private placement, Fullbright purchased 400,000 units for an
aggregate consideration of $500,000, each unit comprised of one share of NeoStem
Common Stock and one redeemable five-year warrant to purchase one share of
NeoStem Common Stock at a purchase price of $1.75 per share, at a per-unit price
of $1.25. In connection with Fullbright's purchase of the units, EET,
the principal shareholders of which are also the principal shareholders of
Fullbright, borrowed $500,000 from RimAsia Capital Partners, L.P. (a principal
stockholder of the Company), and the units acquired by Fullbright were pledged
to RimAsia as collateral therefor which pledge has terminated.
On
February 25, 2009 and March 6, 2009, respectively, the Company issued promissory
notes, or the Notes, to RimAsia (then a beneficial holder of more than 5% of the
Company’s voting securities) in the principal amounts of $400,000 and $750,000,
respectively. The Notes had an interest rate of 10% per annum and were due and
payable on October 31, 2009 or earlier, in the event the Company raised over $10
million through an equity financing. These Notes were paid in full in
April 2009. The Notes contained standard events of default and in the event
of a default that is not subsequently cured or waived, the interest rate would
have increased 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 have been immediately due and payable. The Notes or any portion
thereof could have been prepaid at any time and from time to time at the
Company’s discretion without premium or penalty.
In April
2009, RimAsia (then a beneficial holder of more than 5% of the Company’s voting
securities) purchased the Company’s Series D Convertible Redeemable Preferred
Stock and warrants for aggregate consideration of $5,000,000. A portion of the
proceeds were used to repay the principal and interest on the Notes issued to
RimAsia in February and March 2009 and certain other costs advanced by RimAsia
in connection with the Company’s expansion activities in China. Mr. Wei, now the
Company’s director, is managing partner of RimAsia.
On April
23, 2009, the Company entered into a Consulting Agreement with Shandong Life
Science and Technology Research Institute, or SLSI, of which Ms. Cai Jianqian is
President. Ms. Cai is the mother of former CBH Chief Executive Officer Chris
Peng Mao who is currently the Company’s Director, Asian Expansion and Strategic
Development. Ms. Cai also was a CBH stockholder at the time the Company entered
into the Consulting Agreement. Pursuant to the Consulting Agreement, Ms. Cai
will provide consulting services to the Company in the area of business
development, strategic planning and government affairs in the healthcare
industry in the PRC. In return for the consulting services, the Company has
agreed to pay SLSI an annual fee of $100,000 and the Company issued SLSI 250,000
warrants under the Company’s 2009 Non-U.S. Plan, to become exercisable over
approximately a two year period. In addition, in connection with expanding the
Company’s relationship with SLSI in July 2009, the Company agreed to grant to
SLSI an additional 100,000 shares under the 2009 Non-U.S. Plan (having an
approximate value of $204,000). Grants under the 2009 Non-U.S. Plan are subject
to, among other things, applicable law including any required registration in
the PRC.
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 $3,885 in
royalties in connection with this agreement during the three months ended March
31, 2010.
25
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 (convertible into
4,000,000 shares of Common Stock upon stockholder approval, which approval was
obtained 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.
At March
31, 2010, Erye owed EET $7,473,800. Included in the amount owed to
EET are:
·
|
Dividends
paid and loaned back to Erye amounting to $7,702,800 and accrued interest
of $227,500, the interest rate on this loan is 5.31%. Erye
received an interest payment of approximately $192,000 in February
2010.
|
·
|
Advances
to EET of $668,100;
|
·
|
A
non interest bearing loan from EET of $387,600 due 2011;
and
|
A
receivable due NeoStem from EET of
$175,992.
|
Note 13 – Commitments and
Contingencies
On May
26, 2006, the Company entered into an employment agreement with Dr. Robin L.
Smith, pursuant to which agreement, as amended to date, Dr. Smith serves as the
Chief Executive Officer of the Company.
Effective
as of September 27, 2009, Dr. Smith’s annual base salary is
$332,750. On July 29, 2009, the Company amended the terms of its
employment agreement with Dr. Smith by means of a letter agreement to extend the
term of Dr. Smith’s employment to December 31, 2011 and subject to the
consummation of the Merger with CBH (which Merger was consummated on October 30,
2009), award Dr. Smith a $275,000 cash bonus for 2009 and comparable minimum
annual bonuses for 2010 and 2011. As of April 13, 2010, $100,000 of
the bonus for 2009 was due Dr. Smith. The Company maintains key-man
life insurance on Dr. Smith in the amount of $3,000,000. As of
October 30, 3009, the Compensation Committee approved the reimbursement to Dr.
Smith of premiums, up to $4,000 annually, for disability insurance covering Dr.
Smith. The Company has also agreed to pay membership and annual fees
for a club in New York of Dr. Smith’s choice for business entertaining and
meetings, and a car allowance equal to $1,000 per month,.
Per Dr.
Smith’s January 26, 2007 letter agreement with the Company, upon termination of
Dr. Smith’s employment by the Company without cause or by Dr. Smith with good
reason, the Company shall pay to Dr. Smith her base salary at the time of
termination for the two year period following such
termination. Dr. Smith’s September 27, 2007 letter agreement
provides that such payment of severance can be made instead in 12 equal monthly
installments beginning the date of termination. In addition, per Dr.
Smith’s May 26, 2006 employment agreement, upon termination of Dr. Smith’s
employment by the Company without cause or by Dr. Smith for good reason, Dr.
Smith is entitled to: (i) a pro-rata bonus based on the annual bonus received
for the prior year; (ii) COBRA payments for a one year period; and (iii) have
all options vest as well as all options that would have vested during the
12-month period following the date of termination, become fully vested and
remain exercisable for a maximum of 48 months (but in no event longer than the
original term of exercise.) Upon termination of Dr. Smith’s employment by the
Company for cause or by Dr. Smith without good reason, Dr. Smith is entitled to:
(i) the payment of all amounts due for services rendered under the agreement up
until the termination date; and (ii) have all vested options remain exercisable
for a period of ninety days (all stock options which have not vested shall be
forfeited.) Upon termination for death or disability, Dr. Smith (or
her estate) is entitled to: (i) the payment of all amounts due for services
rendered under the agreement until the termination date; (ii) family COBRA
payments for the applicable term; and (iii) have all vested options, as well as
all options which would have vested during the 12-month period following the
date of termination, become fully vested and remain exercisable for a maximum of
48 months (but in no event longer than the original term of
exercise).
26
Per Dr.
Smith’s May 26, 2006 employment agreement, upon a change in control of the
Company, options held by Dr. Smith shall be governed by the terms of applicable
agreements and equity compensation plans, but in any event at least 75% of Dr.
Smith’s then unvested options shall become immediately vested and exercisable
upon a change in control. Further, in the event Dr. Smith voluntarily terminates
her employment without good reason following a change in control, Dr. Smith
shall be entitled to: (i) the payment of base salary for one year; (ii) a
pro-rata bonus based on the annual bonus received for the prior year; (iii)
COBRA payments for a one year period; and (iv) have all vested options, as well
as all options which would have vested during the 12-month period following the
date of termination, become fully vested and remain exercisable for a maximum of
48 months (but in no event longer than the original term of
exercise).
On
January 26, 2007, the Company entered into an employment agreement with
Catherine M. Vaczy pursuant to which agreement, as amended to date, Ms. Vaczy
continues to serve as the Company’s Vice President and General
Counsel.
Ms.
Vaczy’s January 26, 2007 employment agreement, as amended on January 9, 2008 and
August 29, 2008, or the Original Agreement, expired by its terms on December 31,
2008. However, effective July 8, 2009, the Company entered into another letter
agreement, or the Extension, with Ms. Vaczy pursuant to which the Original
Agreement was extended, subject to certain different and additional terms. The
Extension provides that Ms. Vaczy’s base salary during the one-year term will be
$182,500. The Extension additionally provides for (i) a 25,000 share stock award
upon execution under the 2009 Plan where the Company also pays the associated
payroll taxes; and (ii) a $5,000 cash bonus upon each of two milestone
objectives established by the Board of Directors (one of which was met as of
December 31, 2009). Pursuant to the Original Agreement, as extended and
otherwise amended to date, Ms. Vaczy was also entitled to payment of certain
perquisites and/or reimbursement of certain expenses incurred by her in
connection with the performance of her duties and obligations under the letter
agreement (including a car allowance equal to $1,000 per month), and to
participate in any incentive and employee benefit plans or programs which may be
offered by the Company and in all other plans in which the Company executives
participate.
As of
October 29, 2009, the Compensation Committee of the Board (i) awarded Ms. Vaczy
a $50,000 cash bonus, 50% of which was payable currently and the remaining 50%
payable upon the achievement of a business milestone (which was achieved in
February 2010), (ii) increased Ms. Vaczy’s salary from $182,500 to $191,000
effective as of November 1, 2009, and (iii) approved the payment of dues to a
private club of Ms. Vaczy’s choosing for business entertaining and meetings (not
to exceed $6,000 annually).
In the
event Ms. Vaczy’s employment is terminated prior to the end of the term, for any
reason, earned but unpaid cash compensation and unreimbursed expenses due as of
the date of such termination would be payable in full. In addition, in the event
Ms. Vaczy’s employment is terminated prior to the end of the term for any reason
other than by the Company with cause or Ms. Vaczy without good reason, Ms. Vaczy
or her executor of her last will or the duly authorized administrator of her
estate, as applicable, would be entitled to receive certain specified severance
payments, paid in accordance with the Company’s standard payroll practices for
executives. In no event would such payments exceed the remaining
salary payments in the term. Any severance payments set forth in the
Original Agreement to which Ms. Vaczy may become entitled shall be based on Ms.
Vaczy’s then salary for a three month and not an annual
period. In the event her employment is terminated prior to the
end of the term by the Company without cause or by Ms. Vaczy for good reason,
all options granted by the Company will immediately vest and become exercisable
in accordance with their terms. Any options provided for in the
Extension, as well as other options granted or to be granted to Ms. Vaczy, shall
remain exercisable despite any termination of employment for a period of not
less than two years from the date of termination of employment.
On
October 29, 2009, the Compensation Committee adopted that certain Additional
Compensation Plan providing that contingent cash bonuses, in the total amount of
$200,806, would be payable upon the occurrence of a “Cash Flow
Event”. Of such amounts, two members of the Company’s Board of
Directors, one former member of the Company’s Board of Directors, the Company’s
CEO, CFO and General Counsel participated in a total of $134,232 of such
amount.
Pursuant
to the terms of the Director Compensation Plan adopted on November 4, 2009, as
amended, each non-employee director of the Company, including employees of
partially owned joint ventures, are entitled to quarterly cash compensation
equal to $15,000, payable in arrears. Based on the current Board
structure, this will equal approximately $360,000 annually.
As of
October 2, 2009, the Company 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 the Company 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 the
Company’s director, officer, employee, agent or fiduciary.
27
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, NY 10170 with a lease term effective April 1, 2009
through June 30, 2013 (the “Lease”). Rental payments are currently in
the aggregate approximate monthly amount of $20,400. To help defray
the cost of the Lease, the Company 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 $5,000
per month and the license agreements are for periods of less than one
year. 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. Pursuant to the
Lease, the Company is obligated to pay on a monthly basis fixed annual rent and
certain items as additional rent including utility payments. The
Lease requires the Company to maintain insurance in specified types and amounts,
contains certain other standard commercial terms such as tenant’s assumption of
its pro-rata share of certain Landlord costs, tenant’s reimbursement obligations
for certain other Landlord costs including insurance, provision for certain
additional charges and maintenance of certain systems within the premises,
contains restrictions on subletting and provisions for costs and payments
relating thereto and notice, recapture and Landlord leaseback provisions
relating to subletting, permits licensing by tenant of up to five offices or
workstations with notice to Landlord, requires the tenant to maintain and repair
certain systems, contains default and liquidated and other damage provisions
(including acceleration of all rent and additional rent due for the remainder of
the term upon a Landlord termination due to a tenant default and double payments
on a holdover after expiration or termination), interest on late payments,
tenant waivers and indemnity of Landlord, Landlord right of relocating tenant
within the building, Landlord right of termination provisions including on five
days’ notice if rent is not timely paid, on 15 days’ notice if other defaults
are uncured and also in certain insolvency related instances, and requires
consent of the Landlord in certain circumstances and provides for tenant to pay
the costs associated therewith. In January 2005, NS California
began leasing space at Good Samaritan Hospital in Los Angeles, California at an
annual rental of approximately $26,000 for use as its stem cell processing and
storage facility. The lease expired on December 31, 2005, but the Company
continued to occupy the space on a month-to-month until it closed the facility
in April 2009 and transferred its processing and storage operations
to state of the art facilities operated by leaders in cell
processing. The Company utilizes Progenitor Cell Therapy
LLC, with whom the Company entered into a Cell Processing and Storage Customer
Agreement in January 2009, to process and store for commercial purposes at the
cGMP level at its California and New Jersey facilities. In September
2009, NeoStem, Inc. 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 is being
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 is 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 the Company has not defaulted in the
performance of its obligations under the lease prior to the second lease
year.
In May
2009, Qingdao Niao, the Chinese domestic company controlled by NeoStem (China),
Inc. 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. In February 2010, this lease was assigned to the Company’s
subsidiary, NeoStem (China), Inc.
Rent for
these facilities for the three months ended March 31, 2010 and 2009 was
approximately $452,511 and $62,248, respectively.
In
November, 2007, the Company entered into an acquisition agreement with UTEK
Corporation ("UTEK") and Stem Cell Technologies, Inc., a wholly owned subsidiary
of UTEK ("SCTI"), pursuant to which the Company acquired all the issued and
outstanding common stock of SCTI in a stock-for-stock exchange. SCTI contains an
exclusive, worldwide license to a technology developed by researchers at the
University of Louisville to identify and isolate rare stem cells from adult
human bone marrow, called very small embryonic like stem cells. Concurrent with
the SCTI acquisition, NeoStem entered into a sponsored research agreement
(“SRA”) with the University of Louisville under which NeoStem has been
supporting further research in the laboratory of Mariusz Ratajczak, M.D., Ph.D.
a co-inventor of the VSEL™ technology and head of the Stem Cell Biology Program
at the James Brown Cancer Center at the University of Louisville. The SRA, which
has been periodically amended, called for payments in 2008 of $50,000 and 2009
of $65,337.
Under the
License Agreement, SCTI agreed to engage in a diligent program to develop the
VSEL technology. Certain license fees and royalties are to be paid to University
of Louisville Research Foundation (“ULRF”) from SCTI, and SCTI is responsible
for all payments for patent filings and related applications. Portions of the
license may be converted to a non-exclusive license if SCTI does not diligently
develop the VSEL™ technology or terminated entirely if SCTI chooses to not pay
for the filing and maintenance of any patents thereunder. The License Agreement,
which has an initial term of 20 years, calls for the following specific
payments: (i) reimbursement of $29,000 for all expenses related to patent filing
and prosecution incurred before the effective date (“Effective Date”) of the
license agreement; (ii) a non-refundable prepayment of $20,000 creditable
against the first $20,000 of patent expenses incurred after the Effective Date;
(iii) a non-refundable license issue fee of $46,000; (iv) a non-refundable
annual license maintenance fee of $10,000 upon issuance of the licensed patent
in the United States; (v) a royalty of 4% on net sales; (vi) specified milestone
payments; and (vii) specified payments in the event of sublicensing. Pursuant to
a February 2009 amendment to the License Agreement the payments under (ii) and
(iii) became due and were paid in March 2009. The License Agreement also
contains certain provisions relating to "stacking," permitting SCTI to pay
royalties to ULRF at a reduced rate in the event it is required to also pay
royalties to third parties exceeding a specified threshold for other technology
in furtherance of the exercise of its patent rights or the manufacture of
products using the VSEL technology. Effective as of February 23, 2010, the
Company entered into Amendment No. 3 to the SRA with the University of
Louisville which amends the research plan and currently provides for additional
payments during 2010 of up to $72,342 of which $68,725 was paid upon execution
of Amendment No. 3. No later than April 30, 2010, the parties shall agree on any
desired revisions to the research or research period under Amendment No. 3. This
date was extended until May 15, 2010. On May 14, 2010, the parties executed
Amendement No. 4 to the SRA extending the research period until December 31,
2011 and providing for total payments of $181,196 over the term of the SRA.
.
28
As of
December 31, 2009, NeoStem, Inc. (the “Company”), NeoStem (China) , Inc., its
subsidiary and Progenitor Cell Therapy, LLC, a Delaware limited liability
company ("PCT”), entered into an Agreement (the “Agreement”) whereby NeoStem and
NeoStem China engaged PCT to perform the services necessary to construct in
Beijing, China a facility consisting of a clean room for adult stem cell
clinical trial processing and other stem cell collections which will have the
processing capacity on an annual basis sufficient for at least 10,000 samples,
research and development laboratory space, collection and stem cell storage area
and offices, together with the furnishings and equipment and (2) the
installation of quality control systems consisting of materials management,
equipment maintenance and calibration, environmental monitoring and compliance
and adult stem cell processing and preservation which comply with cGMP standards
and regulatory standards that would be applicable in the United
States under GTP standards, as well as all regulatory requirement applicable to
the program under the laws of the People's Republic of China. The
aggregate cost of the program, including the phase 1 equipment purchases, is
expected to be approximately $3 million. The project is anticipated
to take approximately 7 months to complete. PCT has agreed to provide
at least 90 days of support services to NeoStem for an additional fee after
completion of the project, which is renewable at NeoStem's request for an
additional 90 days.
In
connection with the issuance to investors and service providers of many of the
shares of the Company’s Common Stock and Warrants to purchase Common Stock
described herein, the Company granted the holders registration rights providing
for the registration of such shares of Common Stock and shares of Common Stock
underlying warrants on a registration statement to be filed with the Securities
and Exchange Commission so as to permit the resale of those
shares. Certain of the registration rights agreements provided for
penalties for failure to file or failure to obtain an effective registration
statement. With respect to satisfying its obligations to the holders
of these registration rights, the Company is in various
positions. The Company filed a registration statement as required for
some of the holders, but to date, the Company has not had such registration
statement declared effective. As to some holders, the Company has not
yet satisfied its obligation to file. Certain holders with
outstanding registration rights have waived their registration
rights. No holder has yet asserted any claim against the Company with
respect to a failure to satisfy any registration obligations. Were
someone to assert a claim against the Company for breach of registration
obligations, the Company believes it has several defenses that would result in
relieving it from any liability, although no assurances can be
given. The Company also notes that damage claims may be limited, as
(i) all shares of Common Stock as to which registration rights attached are
currently salable under Rule 144 of the Securities Act and (ii) during much of
the relevant periods the warrants with registration rights generally have been
out of the money. Accordingly, were holders to assert claims against
the Company based on breach of the Company’s obligation to register, the Company
believes that the Company’s maximum exposure from non-related parties would not
be material.
On April
28, 2010, EET repaid the receivable due NeoStem in the amount of
$175,922.
On May
17, 2010, RimAsia Capital Partners LP ("RimAsia"), the holder of 8,177,512
shares of Series C Convertible Preferred Stock ("Series C Preferred Stock")
issued by NeoStem, Inc. (the “Company”) converted its 8,177,512 shares of Series
C Preferred Stock into 9,086,124 shares of the Company's common stock at a
conversion price of $0.90. The Series C Preferred Stock was issued to
RimAsia as part of the merger consideration paid to RimAsia in connection with
the Company's acquisition of China Biopharmaceuticals Holdings, Inc. on October
30, 2009. Each share of Series C Preferred Stock had a liquidation
preference of $1.125 per share and was convertible into 9,086,124 shares of the
Company's common stock at a conversion price of $0.90 per share.
Following
this conversion, there will be zero shares of Series C Preferred Stock
outstanding and RimAsia will not be entitled to receive any dividends on such
shares, to receive notices or to vote such shares or to exercise or to enjoy any
other powers, preferences or rights in respect thereof; provided however that
RimAsia will be entitled to receive a cash payment on January 1, 2011, which is
the next dividend payment date, equal to any dividends accrued but unpaid
through May 17, 2010. Immediately following this conversion, the
Company will have 53,034,089 shares of common stock
outstanding.
29
The
following Management’s Discussion and Analysis of Financial Condition and
Results of Operations contains forward-looking statements that involve risks and
uncertainties. Our actual results could differ materially from those anticipated
in these forward-looking statements as a result of various factors, including
those set forth under “Cautionary Note Regarding Forward-Looking Statements” and
under “Risk Factors” and elsewhere in this annual report. The following
discussion should be read in conjunction with our consolidated financial
statements and related notes thereto included elsewhere in this annual
report.
The
Merger
As
reported on our Current Report on Form 8-K dated November 6, 2008, on November
2, 2008 we entered into the Merger Agreement with CBH. On October 30, 2009, the
Merger was consummated, the effect of which was our acquisition of CBH’s 51%
ownership interest in Erye. In connection with the Merger we established a
wholly owned subsidiary through which we acquired our interest in
Erye.
Erye was
founded more than 50 years ago and represents an established,
vertically-integrated pharmaceutical business, focused primarily on antibiotics.
Suzhou Erye Economy and Trading Co. Ltd., or EET, owns the remaining 49%
ownership interest in Erye. We and EET have negotiated a revised joint venture
agreement or the Joint Venture Agreement and will govern our ownership of
Erye.
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 distributions will be made as
follows: (i) the 49% of undistributed profits (after tax) of the joint venture
due EET will be distributed to EET and lent back to Erye to help finance costs
in connection with their construction of and relocation to a new facility and;
(ii) of the net profit (after tax) of the joint venture due Merger Sub, 45% will
be provided to Erye as part of the new facility construction fund and will be
characterized as paid-in capital for Merger Sub’s 51% interest in Erye, and 6%
will be distributed to Merger Sub directly. As of March 31, 2010
distributions totaling approximately $7,158,000 had been deferred and EET has
received and lent back approximately $7,702,800.
The
Overview
In 2009,
through our expansion efforts within China and with the acquisition of a
controlling interest in Suzhou Erye Pharmaceuticals Ltd., or Erye, we
transitioned into a multi-dimensional international biopharmaceutical company
with product and service revenues, global research and development capabilities
and operations in three distinct business units: (i) U.S. adult stem cells, (ii)
China adult stem cells, and (iii) China pharmaceuticals. These business units
are expected to provide platforms for the accelerated development and
commercialization of innovative technologies and products in both the U.S. and
China.
|
•
|
U.S.
adult stem cells — We will continue to focus on growing our stem cell
collection, processing and storage business and expanding our research and
development activities for diagnostic and therapeutic
applications.
|
|
•
|
China
adult stem cells — We are in the process of launching several stem
cell-focused initiatives which include therapeutic applications, as well
as related collection, processing and
storage.
|
|
•
|
China
pharmaceuticals — Our ownership interest in Erye, a leading antibiotics
producer in China, positions us to take advantage of China’s growth in
healthcare spending through Erye’s existing pharmaceutical product
portfolio, as well as from products we may develop or
license.
|
Results
of Operations
Three
Months Ended March 31, 2010 Compared to the Three Months Year Ended March 31,
2010
Revenue
For the
three months ended March 31, 2010, total revenues were $15,833,200 compared to
$45,100 for the three months ended March 31, 2009. Revenues for the three months
ended March 31, 2010 were comprised of $15,771,300 of pharmaceutical product
sales and $61,900 related to stem cell collections, license fees, royalties and
other revenue. The pharmaceutical product sales represent sales generated by
Erye. The stem cell revenues generated in the three months ended
March 31, 2010 and 2009 were derived from a combination of revenues from the
collection of autologous adult stem cells and license fees collected from
collection centers in our collection center network. For the three months ended
March 31, 2010, we earned $44,800 from the collection and storage of autologous
adult stem cells and $13,900 of license fees. For the three months ended March
31, 2009, we earned $44,600 from the collection and storage of autologous adult
stem cells and $500 from license fees. The increase in stem cell collection and
storage revenue in 2010 compared to 2009 was due primarily to our efforts on
recruiting clients into the existing network in the Northeast and Southern
California. Cost of Sales for the three months ended March 31, 2010 is comprised
of Cost of Goods sold of $10,826,300 related to the sale of our pharmaceutical
products, and $25,400 of direct costs related to the cost of collecting
autologous stem cells from clients.
30
Gross
margin for the three months ended March 31, 2010 totaled $4,981,600 of which 99%
is attributable to the sale of pharmaceutical products and the balance is
attributable to our stem cell collection operations.
Operating
Expenses
For the
three months ended March 31, 2010 operating expenses totaled $7,589,900 compared
to $1,876,600 for the three months ended March 31, 2009, representing an
increase of $5,713,300 or 304%.
Historically,
to minimize our use of cash, we have used a variety of equity and equity-linked
instruments to pay for services and to incentivize employees, consultants and
other service providers. The use of these instruments has resulted in
significant charges to the results of operations. In general, these equity and
equity-linked instruments were used to pay for employee and consultant
compensation, director fees, marketing services, investor relations and other
activities. For the three months ended March 31, 2010 the use of equity and
equity-linked instruments to pay for such expenses resulted in charges to
selling, general, administrative and research expenses of $1,866,600
representing an increase of $1,666,900 over the three months ended March 31,
2009.
The
composition of our charges for the use of equity and equity linked instruments
are as follows:
|
·
|
$1,588,700
relate to recurring expenses associated with options issued to employees
and consultants that vest over
time;
|
|
·
|
$97,000
relate to expenses associated with options issued to employees and
consultants that vest upon achievement of certain business
milestones;
|
|
·
|
$35,100
relate to expenses associated with the issuance of common stock and the
vesting of restricted stock to consultants for providing services;
and
|
|
·
|
$145,800
relate to expenses associated with warrants issued to consultants for the
payment of business services.
|
For the
three months ended March 31, 2010, our selling, general, administrative were
$6,289,700 compared to $1,621,900 for the three months ended March 31, 2009,
representing an increase of $4,676,800, which was the result of:
|
·
|
Our
efforts to establish a stem cell operation in China to provide advanced
therapies, related processing and storage, as well as research and
development capabilities totaled $1,401,500 an increase of $1,268,500.
Such expenses included expenditures for the rental 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. In addition these operating expenses reflect charges resulting
from issuing various equity instruments to incentivize staff members and
consultants totaling $551,500.
|
|
·
|
Administrative
expenses increased by approximately $3,168,700. Approximately $1,181,500
of this increased operating expense was the result of the Merger with Erye
and the attendant operating expenses of this operation. The Company’s US
administrative operating expenses increased by $1,987,200. The use of
equity instruments to incentivize staff, compensate directors and pay for
services totaled $1,015,100, an increase of $915,500 over three months
ended March 31, 2009. Salaries and wages increased by $540,800 as the
result of increased staffing levels, contractual salary increases, bonus
payments and tax payments and tax withholdings we paid on behalf of
certain executive and other staff members in connection with common stock
grants made during year. Professional fees, including legal and accounting
fees increased by $85,100 as the result of our expanded operations in
China. Investor relations services increased by $149,100, fees for
preparing documents for various SEC filings and increased communications
with shareholders and investors. Additionally, travel and
entertainment increased by $33,800 primarily as a result of the Company’s
expanded operations in China, rent increased by $52,500 as a result of the
leasing of office space in New York, franchise taxes
increased $91,300, during the quarter ending March 31, 2009 the
Board of Directors adopted a Directors cash compensation plan which
increased administrative expense by $76,000 and the majority of the
balance of the increase in administrative expense resulted from increases
and decreases in office expenses, insurance and other
expenses.
|
|
·
|
As
a result of completing the Merger with CBH, our activities associated with
the Merger ended thus reducing the use of our attorney, accountant and
other professional services and reducing our operating costs by $287,000
over 2009.
|
|
·
|
Sales
and marketing expenses increased by $517,600 over three months ended March
31, 2009. Approximately $74,700 of this increased operating expense was
related to the sales and marketing efforts of Erye and $383,400 related to
amortization of intangible assets acquired in the Merger. The
use of equity instruments to incentivize staff, and pay for services
totaled $156,000 an increase of $114,000 over three months ended March 31,
2009 and other US sales and marketing costs decreased by
approximately $54,900 due reductions in consulting fees and marketing
expenses.
|
31
For the
three months ended March 31, 2010, our research and development expenses
totaled $1,300,000 compared to $254,600 for the three months ended
March 31, 2009, representing an increase of $1,045,500, which was the result
of:
The use
of equity instruments to incentivize research staff totaled $143,600, an
increase of $106,500 over the three months ended March 31, 2009. Research
related to our VSEL TM
technology increased operating expenses by $819,000. Our acquisition of Erye
added $117,900 of research and development expense to our operating expenses.
The balance of the increase in research and development expense is related to
costs associated with our wound healing research.
Dividends
on Convertible Redeemable Series C Preferred Stock.
In
connection with the Merger, the Company issued 8,177,512 shares of Convertible
Redeemable Series C Preferred Stock (“Series C Preferred Stock”) which calls for
annual dividend of 5% based on the stated value of the preferred stock. For the
three months ended March 31, 2010 we recorded a dividend of $99,700, as the
prorated dividend due.
Noncontrolling
Interests
When the
Company acquired China Biopharmaceutical Holdings, Inc it acquired a 51%
interest in Erye Pharmaceutical Co. Ltd. (“Erye”). In preparing our
financial statements the full operations of Erye are reflected in these results
as of October 30, 2009. We account for the 49% minority shareholder share of
Erye’s net income with a charge to Noncontrolling Interests. For the three
months ended March 31, 2010Erye’s minority shareholders’ share of net income
totaled $1,328,700.
Other
Income and Expense
During
the quarter the Company recognized interest expense of approximately $92,500
primarily related to a loan to Erye from its minority shareholder which $84,000
was capitalized as part of the cost of construction of Erye’s new manufacturing
plant. In accordance with the Joint Venture Agreement that governs the operation
of Erye the minority shareholder has agreed to loan back to Erye dividends it is
entitled to for three years starting in 2008, to help fund the construction of
the new manufacturing facility. At March 31, 2010 these loans totaled
$7,702,800. The loan calls for interest to accrue at rate of 5%
annually.
In
connection with RimAsia’s exercise of 1,000,000 warrants and purchasing common
stock in March 2010 the term of its remaining warrants was increased was
increased by three year. This change in terms increased the
underlying value of this warrant, based on a Black-Scholes valuation, and as a
result the Company charged $188,000 to other income and expense for this
increase in value.
Provision
for taxes
The
provision for taxes of $502,900 represents income taxes due on income of Erye
for three months ended March 31, 2010 and is net of utilization of the deferred
tax liability associated with amortization of intangible assets acquired in the
merger of $60,600.
NeoStem
— Liquidity and Capital Resources
At March
31, 2010 we had a cash balance of $11,418,200, working capital of $10,659,100
and stockholders’ equity of $29,933,800.
Three
months ended March 31, 2010
We
incurred a net loss of $3,283,800 for the three months ended March 31, 2010. The
following chart represents the net funds provided by or used in operating,
financing and investment activities for each period indicated:
The
Three Months Ended
|
||||||||
March
31, 2010
|
March
31, 2009
|
|||||||
Cash
(used) in operating activities
|
$ | (2,581,800 | ) | $ | (1,253,000 | ) | ||
Cash
provided/(used) in investing activities
|
$ | (4,619,500 | ) | $ | (5,700 | ) | ||
Cash
provided by financing activities
|
$ | 11,460,100 | $ | 1,220,700 |
32
Operating
Activities
Our cash
used for operating activities in the three months ended March 31, 2010 totaled
$2,581,800, which is the sum of (i) our net loss, adjusted for non-cash expenses
totaling $2,822,700 which includes, principally, common stock, common stock
options and common stock purchase warrants issued for services rendered in the
amount of $2,055,100 and depreciation and amortization of $767,600; (ii) an
increase in cash was provided from unearned revenue from advance payments from
customers and licensees of $1,027,400, increases in accounts payable and accrued
expenses of $1,813,400 and a reduction in accounts receivable of $210,000; (iii)
cash used for prepaids and payments of other assets of $547,500 and increases in
inventory of $4,595,400.
Under the
License Agreement, SCTI agreed to engage in a diligent program to develop the
VSEL technology. Certain license fees and royalties are to be paid to University
of Louisville Research Foundation (“ULRF”) from SCTI, and SCTI is responsible
for all payments for patent filings and related
applications. Portions of the license may be
converted to a non-exclusive license if SCTI does
not diligently develop the VSEL™ technology or terminated
entirely if SCTI chooses to not pay for the filing
and maintenance of any
patents thereunder. The License Agreement, which has an
initial term of 20 years, calls for the following specific
payments: (i) reimbursement of $29,000 for all expenses related to
patent filing and prosecution incurred before the effective date (“Effective
Date”) of the license agreement; (ii) a non-refundable prepayment of $20,000
creditable against the first $20,000 of patent expenses incurred after the
Effective Date; (iii) a non-refundable license issue fee of $46,000; (iv) a
non-refundable annual license maintenance fee of $10,000 upon issuance of the
licensed patent in the United States; (v) a royalty of 4% on net
sales; (vi) specified milestone payments; and (vii) specified payments in the
event of sublicensing. Pursuant to a February 2009 amendment to
the License Agreement the payments under (ii) and (iii) became due and were paid
in March 2009. The License Agreement also contains certain provisions relating
to "stacking," permitting SCTI to pay royalties to ULRF at
a reduced rate in the event it
is required to also pay royalties to third parties
exceeding a specified threshold for other technology
in furtherance of the exercise of
its patent rights or the manufacture of
products using the VSEL technology. Effective as of
February 23, 2010, we entered into Amendment No. 3 to our SRA with the
University of Louisville which amends the research plan and currently provides
for additional payments during 2010 of up to $72,342 of which $68,725 was paid
upon execution of Amendment No. 3. No later than April 30, 2010, the
parties shall agree on any desired revisions to the research or research period
under Amendment No. 3. This date was extended until May 15,
2010. On May 14, 2010, the parties executed Amendement No. 4 to the
SRA extending the research period until December 31, 2011 and providing for
total payments of $181,196 over the term of the SRA.
During the quarter the Company invested approximately
$858,200 in cash in short term investments.
Investing
Activities
During
the three months ended March 31, 2009 we spent approximately $3.8 million for
property and equipment. Erye is building a new production facility and during
the three months ended March 31, 2010 $3.2 million was spent on
construction. This plant is expected to be fully operational in 2011.
In March 2010 we made our first payment of $370,000 for the stem cell laboratory
we are building in Beijing and construction efforts started April 1, 2010.The
balance of our capital expenditures were spent on equipping our laboratory in
Boston and other Neostem stem cell operations in China,
Financing
Activities
During
the three months ended March 31, 2010, we met our immediate cash requirements
through existing cash balances, a public of offering of our commons stock which
raised approximately $7 million, the exercise of a warrant for one million
shares that raised approximately $1.75 million dollars, the issuance of notes
payable for our operations in China and the use of equity and equity-linked
instruments to pay for services and compensation.
In
December, 2009, in order to facilitate working capital requirements in China,
NeoStem (China) issued a promissory note to the Bank of Rizhao Qingdao Branch in
the amount of RMB 4,400,000 ($645,500). The note is due on June 21, 2010 and
bears an interest rate of 4.05%. The loan is collateralized by cash in a
restricted bank account totaling 5,189,400 RMB (approximately $759,200). In
addition, in January, 2010 NeoStem (China) entered into a pledge agreement with
the bank pledging all of its interest in its VIEs as additional collateral for
the loan.
The
Company’s subsidiary Erye has RMB 81,365,900 ($11,936,400) of notes
payables as of March 31, 2010 and 62,457,000 RMB ($9,150,000) of notes payable
as of December 31, 2009. Notes are payable to the banks who issue bank notes to
Erye’s creditors. Notes payable are interest free and usually mature after a
three to six months period. In order to issue notes payable on behalf
of the Company, the banks required collateral, such as cash deposits which were
approximately 30%-50% of the value of notes to be issued, or properties owned by
companies. At March 31, 2010, 26,929,000 RMB (approximately $3,950,500) of
restricted cash were put up for collateral for the balance of notes payable
which was approximately 40.4% of the notes payable the Company issued, and the
remaining of the notes payable is collateralized by pledging the land use right
the Company owns. The use of notes payable to pay creditors is a
feature of the money and banking system of China and we expect these types of
notes to be a continuing feature of Erye’s capital
structure.
33
On
February 18, 2010 the Company, completed a public offering of its common stock,
selling 5,750,000 shares priced at $1.35 per share. The Company received
approximately $6,822,000 in net proceeds from the offering, after underwriting
discounts, commissions and other expenses, of approximately
$940,000.
On March
15, 2010, NeoStem, Inc. (the “Company”) and RimAsia Capital Partners, L.P., a
Cayman Islands exempted limited partnership (“RimAsia”) and an
affiliate of the Company, made certain agreements with respect to outstanding
warrants. RimAsia exercised its warrant to purchase 1,000,000 shares
of the Company’s common stock, par value $0.001 per share (“Common Stock”),
exercisable at a per share exercise price of $1.75, which was issued
to RimAsia in a private placement completed by the Company in September 2008
(the “September 2008
Warrant”) resulting in proceeds to the Company totaling
$1,750,000. The condition for such exercise was that the Company
would modify certain terms of RimAsia’s warrant to purchase 4,000,000 shares of
Common Stock, issued to RimAsia in a private placement completed by the Company
in April 2009 (the “Series D Warrant”). RimAsia currently is subject
to the terms of a lock-up agreement. The Series D
Warrant was amended to provide for (i) a three (3) year
extension of the Termination Date (as defined in the Series D Warrant) and (ii)
an increase in the average closing price that triggers the Company’s redemption
option under the Series D Warrant from $3.50 to $5.00 (the Series D Warrant so
amended and restated, the “Amended and Restated
Warrant”). The expiration date of the September 2008 Warrant was
September 1, 2013.
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 distributions will be made as
follows: (i) the 49% of undistributed profits (after tax) of the joint venture
due EET will be distributed to EET and lent back to Erye to help finance costs
in connection with their construction of and relocation to a new facility and;
(ii) of the net profit (after tax) of the joint venture due Merger Sub, 45% will
be provided to Erye as part of the new facility construction fund and will be
characterized as paid-in capital for Merger Sub’s 51% interest in Erye, and 6%
will be distributed to Merger Sub directly and At March 31, 2010 these loans
totaled $7,702,800 plus accrued interest of $227,500. The loan calls for
interest to accrue at rate of 5% annually in addition, during the quarter EET
received an interest payment of approximately $192,000.
Liquidity
and Capital Requirements Outlook
With our
acquisition of a controlling interest in Erye and expansion into China, we have
transitioned from being a one-dimensional U.S. service provider with nominal
revenues to being a multi-dimensional international biopharmaceutical company
with current revenues and operations in three distinct business units — U.S.
adult stem cells, China adult stem cells and China pharmaceuticals. The
following is an overview of our collective liquidity and capital
requirements.
Erye is
constructing a new pharmaceutical manufacturing facility and began transferring
its operations in January 2010. The relocation will continue as the
new production lines are completed and receive cGMP certification through 2011.
The new facility is estimated to cost approximately $30 million, of which
approximately $20 million has been paid for through March 31, 2010. To date,
construction has been self-funded by Erye and EET, the holder of the minority
joint venture interest in Erye. The remaining $10 million is expected to be
funded from a combination of proceeds from the Company’s February 2010 common
stock offering in which it raised net proceeds of approximately $7.1 million,
the proceeds from the exercise by RimAsia in March 2010 of a warrant to purchase
1,000,000 shares of Common Stock at a per share purchase price of $1.75
resulting in gross proceeds to the Company of $1,750,000 or a future capital
raise (in each of the prior cases such funding would be in the form of a loan
from the Company, an Erye line of credit and the reinvestment of certain
dividends by Erye’s shareholders). We have agreed for a period of three years to
reinvest in Erye approximately 90% of the net earnings we would be entitled to
receive under the Joint Venture Agreement by reason of our 51% interest in
Erye.
We are
also engaged in other initiatives to expand our operations into China including
with respect to technology licensing, establishment of stem cell processing and
storage capabilities and research and clinical development. In June 2009 we
established NeoStem (China) as our wholly foreign-owned subsidiary. To comply
with PRC’s foreign investment regulations regarding stem cell research and
development, clinical trials and related activities, we conduct our current stem
cell business in the PRC through two domestic variable interest entities. We
have incurred and expect to continue to incur substantial expenses in connection
with our China activities.. In order to implement the establishment
of the Beijing Facility, as of December 31, 2009, our Company, our
WFOE subsidiary NeoStem (China), and PCT entered into the PCT
Agreement, whereby NeoStem and NeoStem (China) engaged PCT to perform the
services necessary (1) to construct the Beijing Facility, consisting of a clean
room for adult stem cell clinical trial processing and other stem cell
collections which will have the processing capacity on an annual basis
sufficient for at least 10,000 samples, research and development laboratory
space, collection and stem cell storage area and offices, together with the
furnishings and equipment, and (2) to effect the installation of quality control
systems consisting of materials management, equipment maintenance and
calibration, environmental monitoring and compliance and adult stem cell
processing and preservation which comply with cGMP standards and regulatory
standards that would be applicable in the United States under GTP standards, as
well as all regulatory requirements applicable to the program under the laws of
the PRC. The aggregate cost of the program, including the Phase 1
equipment purchases, is expected to be approximately $3,000,000. The project
commenced on April 1, 2010, and is anticipated to take approximately seven
months to complete. We have the option to terminate the PCT Agreement without
cause upon providing no less than 60 days written notice to PCT, subject to our
obligation to pay for any services performed up to the date of termination and
certain costs and expenses incurred by PCT.
34
We expect
to rely partly on dividends paid to us under the Joint Venture Agreement,
attributable to our 51% ownership interest in Erye, to meet our future cash
needs. However, there can be no assurance that the WFOE in China will receive
payments uninterrupted or at all as arranged under our contracts with the VIEs.
In addition, pursuant to the Joint Venture Agreement that governs the ownership
and management of Erye, for the next three years: (i) 49% of undistributed
profits (after tax) will be distributed to EET and loaned back to Erye for use
in connection with its construction of the new Erye facility; (ii) 45% of the
net profit after tax will be provided to Erye as part of the new facility
construction fund, which will be characterized as paid-in capital for our 51%
interest in Erye; and (iii) only 6% of the net profit will be distributed to us
directly for our operating expenses.
The
payment of dividends by entities organized under PRC law to non-PRC entities is
subject to limitations. Regulations in the PRC currently permit payment of
dividends by our WFOE and Erye only out of accumulated distributable earnings,
if any, as determined in accordance with accounting standards and regulations in
China. Moreover, our WFOE and Erye will be required to set aside a certain
percentage of their accumulated after-tax profit each year, if any, to fund
certain mandated reserve funds (for our WFOE, such percentage is at least 10%
each year until its reserves have reached at least 50% of its registered
capital), and these reserves are not payable or distributable as cash dividends.
In addition, Erye is also required to reserve a portion of its after-tax profits
for its employee welfare and bonus fund, the amount of which is subject to the
discretion of the Erye board of directors. In addition, if Erye incurs debt on
its own behalf in the future, the instruments governing the debt may restrict
Erye’s or the joint venture’s ability to pay dividends or make other
distributions to us. This may diminish the cash flow we receive from Erye’s
operations, which would have a material adverse effect on our business,
operating results and financial condition.
Our
interests in China will be subject to China’s rules and regulations on currency
conversion. In particular, the initial capitalization and operating expenses of
the two VIEs are funded by our WFOE. In China, the State Administration for
Foreign Exchange, or the SAFE, regulates the conversion of the Chinese Renminbi
into foreign currencies. Currently, foreign investment enterprises are required
to apply to the SAFE for Foreign Exchange Registration Certificates, or IC Cards
of Enterprises with Foreign Investment. Foreign investment enterprises holding
such registration certificates, which must be renewed annually, are allowed to
open foreign currency accounts including a “basic account” and “capital
account.” Currency translation within the scope of the “basic account,” such as
remittance of foreign currencies for payment of dividends, can be effected
without requiring the approval of the SAFE. However, conversion of currency in
the “capital account,” including capital items such as direct investments,
loans, and securities, require approval of the SAFE. According to the Notice of the General Affairs
Department of the State Administration of Foreign Exchange on the Relevant
Operating Issues Concerning the Improvement of the Administration of Payment and
Settlement of Foreign Currency Capital of Foreign-invested Enterprises
promulgated on
August 29, 2008, or the SAFE Notice 142. To apply to a bank for
settlement of foreign currency capital, a foreign invested enterprise shall
submit the documents certifying the uses of the RMB funds from the settlement of
foreign currency capital and a detailed checklist on use of the RMB funds from
the last settlement of foreign currency capital. It is stipulated that only if
the funds for the settlement of foreign currency capital are of an amount not
more than US$50,000 and are to be used for enterprise reserve, the above
documents may be exempted by the bank. This SAFE Notice 142, along with the
recent practice of Chinese banks of restricting foreign currency conversion for
fear of “hot money” going into China, have limited and may continue to limit our
ability to channel funds to the two VIE entities for their operation. We are
exploring options with our PRC counsels and banking institutions in China as to
acceptable methods of funding the operation of the two VIEs, including advances
from Erye, but there can be no assurance that acceptable funding alternatives
will be identified.
Neither
Erye nor our other expansion activities into China are expected to generate
sufficient excess cash flow to support our platform business or our initiatives
in China in the near term.
We
believe that we will need to raise additional capital to fund the development of
advanced stem cell technologies and therapies in the U.S. and China, including
the VSEL TM
technology licensed from the University of Louisville and other regenerative
technologies. In the U.S., we currently intend to fund our operating activities
through additional financings, including potentially additional warrant and
option exercises, the 6% of net profits to which we are entitled from Erye, and,
ultimately, the growth of our revenue generating activities in China. In
addition, we will continue to seek grants for scientific and clinical studies
from the National Institutes of Health and other governmental agencies, but
there can be no assurance that we will be successful in obtaining such grants.
At March 31, 2010, we had a cash balance of $11.4 million. The
trading volume of our common stock, coupled with our history of operating losses
and liquidity problems, may make it difficult for us to raise capital on
acceptable terms or at all. The demand for the equity and debt of small cap
biopharmaceutical companies like ours is dependent upon many factors, including
the general state of the financial markets. As demonstrated over the last year,
during times of extreme market volatility, capital may not be available on
favorable terms, if at all. Our inability to obtain such additional capital on
acceptable terms could materially and adversely affect our business operations
and ability to continue as a going concern.
The
following table reflects a summary of NeoStem’s contractual cash obligations as
of March 31, 2010:
35
Total
|
Less
than 1 Year
|
1-
3 Years
|
3-5
Years
|
More
than 5 Years
|
||||||||||||||||
Employement
Agreements
|
$ | 4,130,021 | $ | 2,184,583 | $ | 1,945,438 | $ | - | $ | - | ||||||||||
Facility
Leases
|
2,325,409 | 901,325 | 1,424,084 | - | - | |||||||||||||||
License
Fees
|
180,000 | 30,000 | 90,000 | 60,000 | - | |||||||||||||||
Consulting
Agreements
|
1,441,283 | 967,533 | 473,750 | - | - | |||||||||||||||
Design
& Construction of Laboratory
|
2,714,100 | 2,714,100 | - | - | - | |||||||||||||||
Director
Fees
|
270,000 | 270,000 | - | - | - | |||||||||||||||
$ | 11,060,813 | $ | 7,067,451 | $ | 3,933,272 | $ | 60,000 | $ | - |
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
4T. CONTROLS AND PROCEDURES
(a) 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
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. 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. Controls and procedures can only provide reasonable, not absolute,
assurance that the above objectives have been met.
As of the
end of the Company's quarter ended March 31, 2010 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 due to the material weaknesses discussed below the Company's
disclosure controls and procedures were not 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.
China
Biopharmaceuticals, Inc. (“CBH”), which was acquired by the Company on October
30, 2009, previously identified the material weaknesses identified
below. Because the acquisition was completed in the fourth quarter of
2009, the Company has not had sufficient time to remediate the material
weaknesses previously identified by CBH.
As a
result of the Merger with CBH, the Company acquired cash and 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 represents 98% of the consolidated revenue of
11,565,118 reported for the year ended December 31, 2009 and offset the
Company’s net loss, attributable to common shareholders, of $30,884,506
with net income of 2,386,541 for the year ended December 31, 2009 (Note, Erye’s
net income were only for the two months following the
acquisition).
36
Prior to
the merger, in its assessment of its internal control over financial reporting
as of December 31, 2008, CBH identified in substance the material weaknesses set
forth below. As of September 30, 2009, CBH reported that such
material weaknesses had not been remediated and continued to exist.
1.
Insufficient U.S.GAAP qualified accounting and finance personnel.
As U.S.
GAAP closing process relates to non-routine transactions and estimates, CBH did
not have sufficient US GAAP qualified accounting and finance personnel necessary
to close its books at its subsidiaries in China. CBH's subsidiaries
in China did not maintain books and records in accordance with US GAAP and had
to make adjusting entries to prepare and report financial statements in
accordance with US GAAP. Because the accounting personnel were not
familiar with U.S.GAAP non-routine transactions and estimates were not properly
accounted for under US GAAP. This material weakness resulted in adjustments to
several significant accounts and disclosures and contributed to other material
weakness described below.
2. Lack
of Internal Audit System.
CBH did
not have an internal audit department and therefore was unable to effectively
prevent and detect control lapses and errors in
the accounting of certain key areas like
revenue recognition, purchase
approvals, inter-company
transactions, cash receipt and
cash disbursement authorizations, inventory
safeguard and proper accumulation for cost of products, in
accordance with the appropriate costing method used by CBH.
3.
Financial Statement Closing Process.
CBH's
controls over the financial statement close process related to account
reconciliation and analyses, including bank accounts, certain long-lived assets
and accrued liabilities, were not effective. As a result, a large volume of
adjustments were necessary to completely and accurately present the financial
statements in accordance with US GAAP.
As of
March 31, 2010, the Company was unable to conclude that the above material
weaknesses previously reported by CBH had been fully remediated.
Since the
acquisition of CBH in the fourth quarter of 2009, the Company is in the process
of implementing the following remediation plans.
While the
Company has sufficient US GAAP qualified accounting and financial personnel at
the parent level, the accounting and financial accounting personnel at Company’s
subsidiary, Erye, continue to need additional training on US
GAAP. The Company plans to remediate this by deploying its finance
and accounting personnel to Erye to account for non-routine, complex
transactions at the Erye level and to assist with Erye’s closing processes from
time to time and use the services of another accounting firm for this role as
well as provide additional training of Erye’s personnel so they can do the
accounting for Erye without significant participation from the Company’s finance
and accounting personnel.
The
Company does not believe its size warrants an internal audit staff. The Company
intends to use the services of another public accounting firm as an internal
accounting staff in 2010 to review
and assess key risk areas such as revenue recognition, purchase
approvals, inter-company transactions, cash receipt and cash disbursement
authorizations, inventory safeguard and proper accumulation for cost of products
as well as complex, non-routine transactions and will participate in the closing
processes.
The
parent Company’s Chief Financial Officer and Vice President of Finance, each of
whom is US GAAP qualified, will participate in the quarterly financial statement
closing process at the Erye subsidiary. The Company will establish a process
whereby the accounting reconciliation and analyses prepared as part of the
financial statement closing process are reviewed by the parent Company’s Chief
Financial Officer and its Vice President of Finance.
In
addition, the Company believes that the oversight provided by its audit
committee, which, unlike CBH's audit committee, is comprised of three
independent and financially sophisticated members, at least one of whom
qualifies as an “audit committee financial expert” as defined in applicable SEC
rules, will support and further the remediation steps set forth
above.
(b)
Changes in Internal Control 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 Company's last fiscal quarter to which this report relates that have
materially affected, or are reasonably likely to materially affect, the
Company's internal control over financial reporting, except that during the last
fiscal quarter we extended the parent company internal controls to our new
operations in China.
37
NEOSTEM,
INC.
PART
II
OTHER
INFORMATION
ITEM
1. LEGAL PROCEEDINGS
There are
no material changes to the disclosures provided in the Company’s Annual Report
on Form 10-K for the year ended December 31, 2009.
ITEM
1A. RISK FACTORS
We
are a company with a limited operating history and have incurred substantial
losses and negative cash flow from operations in the past, and we expect to
continue to incur losses and negative cash flow for the near term.
We are a
company with a limited operating history, limited capital, and limited sources
of revenue. Since our inception in 1980, we have incurred net losses of
approximately $76.4 million through March 31, 2010. We incurred net
losses of approximately $4.6 million for the three month period ended March 31,
2010, approximately $25.3 million for the year ended December 31, 2009 and
approximately $9.2 million for the year ended December 31, 2008, and we expect
to incur additional operating losses and negative cash flow in the future. The
revenues from our adult stem cell collection, processing and storage business
are not sufficient to cover costs attributable to that business. We expect to
incur losses and negative cash flow for the foreseeable future as a result of
our activities under license and sponsored research agreements relating to our
VSELTM
technology and other research and development efforts to advance stem cell and
other therapeutics, both in the U.S. and China. We also expect to
continue to incur significant expenses related to sales, marketing, general and
administrative and product research and development in connection with the
development of our business.
Although
Erye, a Chinese pharmaceutical company in which we recently acquired a 51%
interest, had revenue of $15.8 million for the three months ended March 31, 2010
and $11.4 million in revenue for the year ended December 31, 2009 (this
reflects Erye’s operations for
the two months ended December 31, 2009 since the merger was effective October
30, 2009), it has only a limited history of earnings. Moreover, Erye is expected
to incur significant expenses in the near term due to: (1) costs related to
stabilizing and streamlining its operations; (2) costs related to the relocation
of its production operations to a new facility currently under construction; (3)
research and development costs related to new drug projects; and (4) costs
related to expanding its existing sales network for new drug distribution.
Pursuant to the current joint venture agreement that governs the ownership and
management of Erye, or the Joint Venture Agreement, which is subject to PRC
government approval, for the next three years (i) 49% of undistributed profits,
after tax, will be distributed to Suzhou Erye Economy and Trading co. Ltd., or
EET, which owns the remaining 49% of Erye, and loaned back to Erye for use in
connection with its construction of the new Erye facility; (ii) 45% of the net
profit after tax will be provided to Erye as part of the new facility
construction fund, which will be characterized as paid-in capital for our 51%
interest in Erye; and (iii) only 6% of the net profit will be distributed to us
directly for our operating expenses. As a result, we will not be able
to supplement our cash flow fully from the operations and income expected to be
generated by Erye.
We
will need substantial additional capital to continue operations and additional
capital may not be available on acceptable terms, or at all.
We will
require substantial additional capital to fund our business plan, including
additional research and development activities related to our adult stem cell
technologies and drug development efforts, and to support marketing efforts in
the U.S. and China. Our actual cash requirements may differ materially from
those currently estimated.
At March
31, 2010, we had a cash balance of $11.4 million. The trading volume
of our common stock, coupled with our history of operating losses and liquidity
problems, may make it difficult for us to raise capital on acceptable terms or
at all. The demand for the equity and debt of small cap biopharmaceutical
companies like ours is dependent upon many factors, including the general state
of the financial markets. As demonstrated over the last year, during times of
extreme market volatility, capital may not be available on favorable terms, if
at all. Our inability to obtain such additional capital on acceptable terms
could materially and adversely affect our business operations and ability to
continue as a going concern.
38
We
have a significant number of securities convertible into, or allowing the
purchase of our common stock. Investors could be subject to increased dilution.
Also, the issuance of additional shares as a result of such conversion or
purchase, or their subsequent sale, could adversely affect the price of our
common stock.
Investors
in our company will be subject to increased dilution upon conversion of our
preferred stock and upon the exercise of outstanding stock options and
warrants. There were 53,034,089 shares of our common stock
outstanding as of May 17, 2010. As of that date, preferred stock
outstanding could be converted into 10,000 shares of our common stock and stock
options and warrants outstanding that are exercisable represented an
additional 27,978,185 shares of our common stock that could be issued (for
which cash would need to be remitted to us for exercise) in the
future. Most of the outstanding shares of our common stock, as well
as the vast majority of the shares of our common stock that may be issued under
our outstanding options and warrants, are not restricted from trading or have
the contractual right to be registered.
Any
significant increase in the number of shares offered for sale could cause the
supply of our common stock available for purchase in the market to exceed the
purchase demand for our common stock. Such supply in excess of demand could
cause the market price of our common stock to decline.
Actual
and beneficial ownership of large quantities of our common stock by our
executive officers, directors, and other substantial stockholders, may
substantially reduce the influence of other stockholders.
As of May
17, 2010, our executive officers, directors, and 5%-or-more stockholders
collectively beneficially owned 44,413,482 shares of our common
stock. These beneficial holdings represent 67.9% of our common stock
on a fully-diluted basis. As a result, such persons may have the ability to
exercise enhanced control over the approval process for actions that require
stockholder approval, including: the election of our directors and the approval
of mergers, sales of assets or other significant corporate transactions or other
matters submitted for stockholder approval. Because of the beneficial ownership
position of these persons and entities, other stockholders may have less
influence over matters submitted for stockholder approval. Furthermore, at
certain times the interests of our substantial stockholders may conflict with
the interests of our other stockholders.
Some
of our directors and officers have positions of responsibility with other
entities, and therefore have loyalties and fiduciary obligations to both our
company and such other entities. These dual positions subject such persons to
conflicts of interest in related party transactions which may cause such related
party transactions to have consequences to the our company that are less
favorable than those which our Company could have attained in comparable
transactions with unaffiliated entities.
Eric H.C.
Wei, a member of our Board of Directors, is also the Managing Partner of RimAsia
Capital Partners, L.P., or RimAsia. RimAsia, a substantial stockholder of our
company, beneficially owns 46.3% of our common stock as of May 17, 2010. Shi
Mingsheng (who became a director of our company in March 2010) and Madam Zhang
Jian (the General Manager of Erye), together with certain other persons, have
shared voting and dispositive power over the shares of our common stock held by
Fullbright Finance Limited, or Fullbright. Fullbright is a substantial
stockholder of our company, beneficially owning 8.6% of our common stock as of
May 17, 2010. These relationships create, or, at a minimum, appear to create
potential conflicts of interest when members of our company’s senior management
are faced with decisions that could have different implications for our company
and the other entities with which our directors or officers are
associated.
Although
our company has established procedures designed to ensure that material related
party transactions are fair to the company, no assurance can be given as to how
potentially conflicted board members or officers will evaluate their fiduciary
duties to our company and to other entities that they may owe fiduciary duties,
respectively, or how such individuals will act in such circumstances.
Furthermore, the appearance of conflicts, even if such conflicts ultimately do
not harm our company, might adversely affect the public’s perception of our
business, as well as its relationship with its existing customers, licensors,
licensees and service providers and its ability to enter into new relationships
in the future.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF
PROCEEDS
On March
15, 2010, RimAsia exercised its warrant to purchase 1,000,000 shares of the
Company’s common stock, par value $0.001 per share, exercisable at a per share
exercise price of $1.75, which was issued to RimAsia in a private placement
completed by the Company in September 2008 resulting in proceeds to the Company
totaling $1,750,000.
The offer
and sale of the securities described above were made in reliance upon the
exemption from registration provided by Section 4 (2) of 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 an “accredited investor,” as such term is defined in Rule 501(a)
of Regulation D promulgated under the Securities Act.
39
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
None
ITEM
4. REMOVED AND RESERVED
ITEM
5. OTHER INFORMATION
None
ITEM
6. EXHIBITS
(a)
Exhibits
Exhibit
|
Description
|
Reference
|
||
1(a)
|
Underwriting
Agreement, dated as of February 11, 2010, between NeoStem, Inc. and Roth
Capital Partners, LLC (1)
|
1.1
|
||
4(a)
|
Amended
and Restated Warrant, dated March 15, 2010, issued to RimAsia Capital
Partners, L.P. (2)
|
4.1
|
||
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 on February 12, 2010 as an
exhibit, numbered as indicated above, to our Current Report on Form 8-K
dated February 11, 2010, which exhibit is incorporated here by
reference.
|
(2)
|
Filed
with the Securities and Exchange Commission on March 18, 2010 as an
exhibit, numbered as indicated above, to our Current Report on Form 8-K
dated March 15, 2010, which exhibit is incorporated here by
reference.
|
* Filed herewith
**
Furnished herewith
40
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:
May 17, 2010
|
By:
|
/s/
Larry A. May
|
|
Larry
A. May, Chief Financial Officer
|
||
Date:
May 17, 2010
|
By:
|
/s/
Christopher C. Duignan
|
|
Christopher
C. Duignan, Chief Accounting Officer
|
||
Date:
May 17,
2010
|
41