UNITED STATES
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): April 1, 2010
NEOSTEM, INC.
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(Exact Name of Registrant as Specified in Charter)
Delaware
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(State or Other Jurisdiction of Incorporation)
0-10909 22-2343568
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(Commission File Number) (IRS Employer Identification No.)
420 Lexington Avenue, Suite 450, New York, New York 10170
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(Address of Principal Executive Offices) (Zip Code)
(212) 584-4180
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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):
[ ] Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange
Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01. Other Events.
On April 1, 2010, NeoStem, Inc. (the "Company") issued a press release
providing an update of the Company's 2010 business outlook. A copy of the
Company's press release is attached hereto as Exhibit 99.1 and is incorporated
herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit Number Description
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99.1 Press Release dated April 1, 2010.
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 hereunto duly authorized.
NEOSTEM, INC.
By: /s/ Catherine M. Vaczy
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Name: Catherine M. Vaczy
Title: Vice President and
General Counsel
Dated: April 1, 2010
Exhibit 99.1
NeoStem Provides 2010 Business Outlook
NEW YORK, April 1 /PRNewswire-Asia-FirstCall/ -- NeoStem, Inc. (NYSE: NBS)
("NeoStem" or the "Company"), an international biopharmaceutical company with
operations in the U.S. and China, today provided an update of its 2010 business
outlook.
"With the acquisition of a 51% interest in Suzhou Erye Pharmaceutical Co. Ltd.
("Erye"), development of our adult stem cell collection network and advances in
the development and commercialization of stem cell therapies, 2009 was a
transformational year for the Company," said Robin Smith, MD, Chairman and CEO
of NeoStem. Since the acquisition, I am pleased to report that both our
aggregate shareholder value and liquidity have increased substantially. In 2010,
we are focused on growing our pharmaceutical platform, expanding our US stem
cell collection network, and implementing and advancing our adult stem cell
initiatives in China."
2010 Outlook
"In 2010, NeoStem remains committed to advancing our stem cell therapeutic
development through the application of our VSELTM technology in the US, while
enhancing our stem cell platform in China with the commercial launch of several
stem cell applications by our partners and the initiation of construction of our
Beijing facility," added Dr. Smith. "Our Erye subsidiary is focused on becoming
one of the largest antibiotic producers in Eastern China by substantially
increasing its capacity once operations are fully transferred to the new
manufacturing facility and the production lines are fully operational, which is
on schedule to be completed in 2011, and enhancing the potential of the new drug
pipeline through in-licensing opportunities and approval of new generic drugs by
the SFDA. With the completion of our recent financing and the exercise of
1,000,000 warrants at a per share exercise price of $1.75, the Company is well
underway to execute our growth plan for 2010 and we look forward to providing
all of our stakeholders with timely updates of our progress."
Stem Cells
Beijing facility -- Buildout of the Company's planned R&D facility has begun. In
addition to supporting the processing and storage activities, the laboratory
will provide a state-of-the-art venue for expanded adult stem cell-related
research and development activities in China. NeoStem is collaborating with
experts in China to develop its intellectual property positions in the stem cell
field and develop adult stem cell-based therapies. These efforts will be
dedicated to the research and development of the stem cell technology and its
application to a number of therapeutic programs, initially including diabetes,
anti-aging and cardiac disease.
Collaborations -- As the world-wide license holder to VSEL (TM) technology, a
promising adult stem cell technology, NeoStem remains in discussions with a
number of researchers to generate data relating to other clinical applications
of very small embryonic-like stem cells, including neural, cardiac, and
ophthalmic disease, to expand our research efforts and maximize the value of
this technology. In this regard, letters of Intent (LOI) have been executed
between the Company's Chinese consultant and Shandong Life Science and
Technology Research Institute and Peking University Diabetes Center, Beijing
Institute of Geriatrics, Ministry of Health and Shandong University.
Commercialization -- The launch of therapeutic programs in People's Republic of
China (PRC) and Taiwan are on track. NeoStem entered into license agreements to
acquire world-wide and exclusive rights to certain innovative stem cell
technologies for wound healing, cosmetic and anti-aging applications and has
leveraged these technologies to establish partnerships. Wendeng Orthopedic
Hospital commenced operations in the first quarter of 2010 with revenues
expected during the second quarter of 2010. Enhance BioMedical Holdings Limited
(EBH) is expected to begin in the second quarter of 2010 adult stem cell
collection and storage activities to enable it to launch the application of
cosmetic and anti-aging therapies in Taiwan during the summer of 2010. EBH is a
strategic investor in NeoStem with a 16.7% beneficial ownership interest.
Stem Cell Collection Network -- NeoStem is on track to have ten stem cell
collection centers in its U.S. network by the end of 2010. In the first quarter,
the Company expanded into the southwestern region of the US with the addition of
the physician group at Westlake Orthopaedics Spine & Sports in Austin, TX. In
the second quarter, NeoStem is preparing to launch an adult stem cell collection
center at its new R&D facility in Cambridge, MA. The collection centers not only
provide expected new sources of revenue but also further strengthen the
Company's leadership in adult stem cell collection and storage.
Pharmaceuticals
With seven products in the drug pipeline, including four that are approved or
pending approval, and a diversified product portfolio, Erye is well positioned
for growth in China's rapidly expanding pharmaceutical market, which is expected
to triple in size by 2013. NeoStem plans to supplement Erye's internal R&D and
expand the product portfolio through strategic product in-licensing and
acquisition opportunities that can leverage its expanded manufacturing capacity
or its strong distribution network.
Erye began transferring its operations to its new manufacturing facility in
January 2010. The relocation will continue as the new production lines are
completed and receive current Good Manufacturing Practices (cGMP) certification
through 2011. In January 2010, Erye received notification that the SFDA has
approved Erye's application for cGMP certification to manufacture solvent
crystallization sterile penicillin and freeze dried raw sterile penicillin at
the new facility, which provides 50% and 100% greater manufacturing capacity,
respectively, than its existing facility. Historically, these two lines have
accounted for approximately 20% of Erye's sales. Additionally, Erye continues to
focus on obtaining SFDA approval for the remainder of its product lines.
About NeoStem, Inc.
NeoStem, Inc. is engaged in the development of stem cell-based therapies,
pursuit of anti-aging initiatives 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 VSELTM 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 success of the Company's VSELTM
technology, the commercialization of stem cell programs, the licensing or
acquisition of new drug opportunities, the construction of facilities, the new
stem cell collection center and future expansions, as well as the future of stem
cell in medical treatment 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 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.
For more information, please contact:
NeoStem, Inc.
Robin Smith, CEO
Phone: +1-212-584-4174
Email: rsmith@neostem.com
Web: http://www.neostem.com
CCG Investor Relations, Inc.
Lei Huang, Account Manager
Phone: +1-646-833-3417
Email: lei.huang@ccgir.com
Web: http://www.ccgirasia.com
Crocker Coulson, President
Phone: +1-646-213-1915
Email: crocker.coulson@ccgir.com