SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(D) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date of
Report (Date of earliest event reported): June 15, 2010
NEOSTEM,
INC.
(Exact
Name of Registrant as Specified in Charter)
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Delaware
(State
or Other Jurisdiction
of
Incorporation)
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0-10909
(Commission
File
Number)
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22-2343568
(IRS
Employer
Identification
No.)
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420 Lexington Avenue, Suite
450, New York, New York 10170
(Address
of Principal Executive Offices)(Zip Code)
(212)
584-4180
Registrant's
Telephone Number
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
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o
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
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o
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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o
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
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o
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
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Item
8.01 Other Events
On June
15, 2010, NeoStem, Inc. issued a press release with respect to the progress of
the manufacturing facility of Suzhou Erye Pharmaceutical ("Erye"), the Company's
51% owned subsidiary. Erye passed the government inspection by
the State Food and Drug Administration (“SFDA”) in China to manufacture
penicillin powder for injection and cephalosporin powder for injection at its
new manufacturing facility which provides 50% greater manufacturing capacity
than its existing plant. These two production lines produced the
materials for over 70% of Erye's product sales in 2009. Once fully certified and
operational, these production lines, coupled with the approval of the lines
earlier in 2010 for solvent crystallization sterile penicillin and freeze dried
raw sterile penicillin, will allow Erye to relocate over 90% of its
2009 sales to the new facility.
A copy of
the Company’s press release, dated June 15, 2010, is attached hereto as Exhibit
99.1. and incorporated herein by reference.
Risk
Factors
Erye's
production will be concentrated in two production lines.
The two production lines recently
approved accounted for over 70% of Erye's product sales in 2009. Any
interruptions in production with respect to those lines once they are
operational at the new facility will have a material adverse effect on Erye's
business and ours.
Erye will
be operating in a new facility.
There are inherent problems in
commencing operations at any new production facility. If Erye
encounters operational difficulties in commencing production at its new
facility, it could have a material adverse effect on Erye's business and
ours.
Forward-Looking
Statements
Certain
statements in this Form 8-K are forward-looking statements that involve a
number of risks and uncertainties. Such forward-looking statements include
statements about the business of Erye. For such statements, the Company
claims the protection of the Private Securities Litigation Reform Act of
1995. Actual events or results may differ materially from the Company’s
expectations. Factors that could cause actual results to differ materially
from the forward-looking statements include, but are not limited to, the risk of
concentration of Erye's products on a small number of production lines, the risk
of operating difficulties at its new facility and the risk that notwithstanding
increased capacity, Erye will not be able to sell additional volume of products,
or will not be able to sell additional volume of products at acceptable prices,
due to among other reasons, competition (including competition from larger
pharmaceutical companies), government price regulations, or other
causes. Additional factors that could cause actual results to differ
materially from those stated or implied by the Company’s forward-looking
statements are disclosed in the Company’s reports filed with the Securities and
Exchange Commission.
-2-
2. Warrant Grant.
On June
17, 2010, Shi Mingsheng, Erye’s Chairman, was awarded under the NeoStem Non-US
Equity Compensation Plan a warrant approved by the Compensation Committee of
NeoStem’s Board of Directors. Warrants were granted to purchase 600,0000
shares of common stock, exercisable at a price of $2.36 per share (fair market
value on the date of grant), subject to vesting on the last day of the month in
which certain performance conditions or business milestones for Erye are
satisfied. As previously disclosed, (i) Mr. Shi is a principal
shareholder of Fullbright Finance Limited, which is the beneficial owner of
approximately 7.8% of the Company’s Common Stock, and (ii) Mr. Shi is a
principal shareholder of Suzhou Erye Economy and Trading Co. Ltd (“EET”), which
is the owner of a 49% interest in Erye.
Item
9.01. Financial Statements and Exhibits
(d) Exhibits.
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Exhibit
No.
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Description
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99.1
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Press
release, dated June 15, 2010
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-3-
SIGNATURE
Pursuant to the requirements of the
Securities Exchange Act of 1934, NeoStem, Inc. has duly caused this Report to be
signed on its behalf by the undersigned hereunto duly authorized.
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NEOSTEM,
INC.
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By:
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/s/
Catherine M. Vaczy
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Name:
Catherine M. Vaczy
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Title:
Vice President and General Counsel
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Date: June 18,
2010
-4-
NeoStem's
Suzhou Erye Pharmaceutical Subsidiary Passes Government Inspection for Two
Significant Manufacturing Lines in its New Facility
Press Release Source: NeoStem,
Inc. On Tuesday June 15, 2010, 8:00 am EDT
NEW YORK,
June 15 /PRNewswire-Asia-FirstCall/ -- NeoStem, Inc. ("NeoStem" or the
"Company") (NYSE Amex: NBS), an international biopharmaceutical company with
operations in the U.S. and China, announced that its Suzhou Erye pharmaceutical
subsidiary ("Erye") passed the government inspection by the State Food and Drug
Administration ("SFDA") in China to manufacture penicillin powder for injection
and cephalosporin powder for injection at its new manufacturing facility
which provides 50% greater manufacturing capacity than its existing plant. These
two production lines produced the materials for over 70% of Erye's product sales
in 2009. Coupled with the approval of the lines earlier in 2010 for solvent
crystallization sterile penicillin and freeze dried raw sterile penicillin, Erye
will be able to relocate over 90% of its 2009 sales to the new facility, placing
the process well ahead of the original 2011 goal.
NeoStem's
Chairman and CEO, Robin Smith, commented, "Erye's relocation to the new facility
is ahead of schedule and we are extremely excited about the increased
manufacturing capabilities it will provide. Once fully certified and
operational, these production lines will bring Erye another step closer to its
goal of becoming one of the largest antibiotic producers in Eastern
China."
About
NeoStem, Inc.
NeoStem,
Inc. is engaged in the development of stem cell-based therapies and building of
a network of adult stem cell collection centers in the U.S. and China that are
focused on enabling people to donate and store their own (autologous) stem cells
for their personal use in times of future medical need. The Company is also the
licensee of various stem cell technologies, including a worldwide exclusive
license to VSEL(TM) Technology which uses very small embryonic-like stem cells,
shown to have several physical characteristics that are generally found in
embryonic stem cells, and is pursuing the licensing of other technologies for
therapeutic use. NeoStem's majority-controlled Chinese pharmaceutical operation,
Suzhou Erye, manufactures and distributes generic antibiotics in China. For more
information, please visit: http://www.neostem.com
..
Forward-Looking
Statements
This
press release contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Forward-looking statements
reflect management's current expectations, as of the date of this press release,
and involve certain risks and uncertainties. Forward looking statements include
statements herein with respect to the affect of the two new manufacturing lines
on the Company's revenue including with respect to their final certification,
about which no assurances can be given. The Company's actual results could
differ materially from those anticipated in these forward- looking statements as
a result of various factors. Factors that could cause future results to
materially differ from the recent results or those projected in forward-looking
statements include the "Risk Factors" described in the Company's Annual Report
on Form 10-K filed with the Securities and Exchange Commission on March
31, 2010, as well as other periodic filings made with the Securities and
Exchange Commission. The Company's further development is highly dependent on
future medical and research developments and market acceptance, which is outside
its control.
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NeoStem,
Inc.
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CCG
Investor Relations, Inc.
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Robin
Smith, CEO
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Lei
Huang, Account Manager
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Phone:
+1 (212) 584-4174
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Phone:
+1 (646) 833-3417
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E-mail:
rsmith@neostem.com
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E-mail:
lei.huang@ccgir.com
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http://www.neostem.com
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http://www.ccgirasia.com
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Crocker
Coulson, President
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Phone:
+1 (646) 213-1915
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E-mail:
crocker.coulson@ccgir.com
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