Unassociated Document
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K
(Mark
One)
x
|
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For the
fiscal year ended December 31, 2008
OR
o
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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
(State
or other jurisdiction of
incorporation
or organization)
|
22-2343568
(I.R.S.
Employer Identification No.)
|
|
|
420
Lexington Avenue
Suite
450
New
York, New York
|
10170
|
(Address
of principal executive offices)
|
(Zip
Code)
|
|
|
Registrant’s
telephone number, including area code:
|
(212)
584-4180
|
Securities
Registered Pursuant to Section 12(b) of the Act:
Title of Each
Class
|
Name
of Each Exchange
On Which
Registered
|
Common
Stock, $0.001 par value
|
NYSE
Amex
|
Class
A Common Stock Purchase Warrants
|
NYSE
Amex
|
Securities
registered pursuant to Section 12(g) of the
Act: None
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in
Rule 405 of the Securities Act. o
Yes x No
Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or 15(d) of the Securities Exchange Act of
1934.
o
Yes x No
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. x Yes
o No
Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K (§ 229.405 of this Chapter) is not contained herein, and will not
be contained, to the best of registrant’s knowledge, in definitive proxy or
information statements incorporated by reference in Part III of this Form 10-K
or any amendment to this Form 10-K. 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 definition of “large accelerated filer,” “accelerated
filer” and “smaller reporting company” in Rule 12b-2 of the Exchange
Act. (Check one):
Large
accelerated filer o
|
Accelerated
filer o
|
|
|
Non-accelerated
filer o
|
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). o
Yes x No
The
aggregate market value of the voting and non-voting common equity held by
non-affiliates of the registrant as of June 30, 2008 (the last business day of
the most recently completed second fiscal quarter) was approximately $5,382,672,
computed by reference to the closing sales price of $0.99 for the common stock
on the American Stock Exchange reported for such date. (For purposes
of determining this amount, only directors, executive officers, and 10% or
greater stockholders have been deemed affiliates).
On March
27, 2009, 7,749,358 shares of the registrant's common stock, par value $0.001
per share, were outstanding.
Documents
incorporated by reference: Portions of the registrant’s definitive Proxy
Statement for the 2009 Annual Meeting of Stockholders, to be filed with the
Commission not later than 120 days after the close of the registrant’s
fiscal year, have been incorporated by reference, in whole or in part, into
Part III, Items 10, 11, 12, 13 and 14 of this Annual Report on
Form 10-K.
PART
I
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|
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ITEM
1. BUSINESS
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4
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ITEM
1A. RISK FACTORS
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32 |
ITEM
1B. UNRESOLVED STAFF COMMENTS
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|
58 |
ITEM
2. PROPERTIES
|
|
58 |
ITEM
3. LEGAL PROCEEDINGS
|
|
59 |
ITEM
4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
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|
60 |
PART
II
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|
|
ITEM
5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND
ISSUER PURCHASES OF EQUITY SECURITIES
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|
61 |
ITEM
6. SELECTED FINANCIAL DATA
|
|
63 |
ITEM
7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATION
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|
64 |
ITEM
8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
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|
77 |
ITEM
9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
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|
78 |
ITEM
9A. CONTROLS AND PROCEDURES
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|
78 |
ITEM
9B. OTHER INFORMATION
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|
79 |
PART
III
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|
|
ITEM
10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
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80 |
ITEM
11. EXECUTIVE COMPENSATION
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80 |
ITEM 12.
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED
STOCKHOLDER MATTERS
|
|
80 |
ITEM
13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE
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|
80 |
ITEM
14. PRINCIPAL ACCOUNTING FEES AND SERVICES
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|
80 |
PART
IV
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|
|
ITEM
15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
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81
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This
Annual Report on Form 10-K of NeoStem, Inc. (the “Company”) contains
"forward-looking statements" within the meaning of the Private Securities
Litigation Reform Act of 1995. Such forward-looking statements involve known and
unknown risks, uncertainties and other factors which may cause the actual
results, performance or achievements of the Company, or industry results, to be
materially different from any future results, performance or achievements
expressed or implied by such forward-looking statements. When used in this
Annual Report, statements that are not statements of current or historical fact
may be deemed to be forward-looking statements. Without limiting the foregoing,
the words "plan," "intend," "may," "will," "expect," "believe," "could,"
"anticipate," "estimate," or "continue" or similar expressions or other
variations or comparable terminology are intended to identify such
forward-looking statements. Additionally, statements concerning our ability to
successfully develop the adult stem cell business at home and abroad, the future
of regenerative medicine and the role of adult stem cells in that future, the
future use of adult stem cells as a treatment option and the role of VSELs in
that future, and the potential revenue growth of such business are
forward-looking statements. Our future operating results are
dependent upon many factors, and the Company's further development is highly
dependent on future medical and research developments and market acceptance,
which is outside its control. Forward-looking statements may not be
realized due to a variety of factors, including, without limitation, (i) the
Company’s ability to manage the business despite continuing operating losses and
cash outflows; (ii) the Company’s ability to obtain sufficient capital or a
strategic business arrangement to fund its operations and expansion plans,
including meeting its financial obligations under the various
licensing and other strategic arrangements described in this Annual Report and
the successful commercialization of the relevant technology; (iii) the Company’s
ability to build the management and human resources and infrastructure necessary
to support the growth of the business; (iv) competitive factors and developments
beyond the Company’s control; (v) scientific and medical developments
beyond the Company’s control; (vi) the Company’s inability to obtain appropriate
governmental licenses or any other adverse effect or limitations caused by
government regulation of the business; (vii) whether any of the Company’s
current or future patent applications result in issued patents and the Company’s
ability to obtain and maintain other rights to technology required or desirable
for the conduct of its business; (viii) whether any potential strategic benefits
of the licensing transactions described in this Annual Report will be realized
and whether any potential benefits from the acquisition of these new licensed
technologies will be realized; (ix) whether the Company can obtain the consents
it may require to sublicensing arrangements from technology licensors in
connection with technology development; (x) the Company’s ability to maintain
its NYSE Amex listing; and (xi) the other factors discussed in Item 1A, “Risk
Factors” contained herein and in other reports that we file with the
SEC. Additional risks and uncertainties relate to (i) the Company’s
proposed merger transaction (“Merger”) pursuant to an Agreement and Plan of
Merger with China Biopharmaceuticals Holdings, Inc., a Delaware corporation
("CBH"), China Biopharmaceuticals Corp., a British Virgin Islands corporation
and wholly-owned subsidiary of CBH, and CBH Acquisition LLC, a Delaware limited
liability company and wholly-owned subsidiary of NeoStem to acquire a 51%
ownership interest in Suzhou Erye Pharmaceuticals Company Ltd., a Sino-foreign
joint venture with limited liability organized under the laws of the People’s
Republic of China and (ii) proposed share exchange transaction (“Share
Exchange”) pursuant to a Share Exchange Agreement to acquire through a series of
contractual arrangements certain benefits from Shandong New Medicine Research
Institute of Integrated Traditional and Western Medicine Limited Liability
Company, a China limited liability company. Such risks and
uncertainties include, but are not limited to, the other events and factors
disclosed in the Company’s Current Reports on Form 8-K dated November 2, 2008
relating to each such transaction, and other risk factors discussed in Item 1A,
“Risk Factors” contained herein and in other periodic Company filings with the
SEC and to be disclosed in the Proxy Statement/Registration Statement on Form
S-4 anticipated to be filed in connection with the Merger and the Share
Exchange. The Company’s filings with the Securities and Exchange Commission are
available for review at www.sec.gov under
“Search for Company Filings.” Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date
hereof. Except as required by law, the Company undertakes no obligation to
update any forward-looking statements, whether as a result of new information,
future events or otherwise.
PART
I
ITEM
1. BUSINESS
BUSINESS
OVERVIEW
NeoStem,
Inc. (“we,” “NeoStem” or “the Company”) is engaged in a platform
business of operating a commercial autologous (donor and recipient are the same)
adult stem cell bank and is pioneering the pre-disease collection, processing
and long-term storage of stem cells from adult donors that they can access for
their own future medical treatment. We are managing a network of adult stem cell
collection centers in major metropolitan areas of the United States, and believe
that as adult stem cell therapies obtain necessary regulatory approvals and
become standard of care, individuals will need the infrastructure, methods and
procedures being developed by NeoStem to have their stem cells safely collected
and conveniently stored for future therapeutic use. Stem cells, which are very
primitive and undifferentiated cells that have the unique ability to transform
into many different cells (such as white blood cells, nerve cells or heart
muscle cells), can be found in the bone marrow or peripheral blood of adults.
NeoStem only works with adult (not embryonic) stem cells. Using NeoStem’s
process, stem cells migrate, as a result of a mobilizing agent administered in
the days preceding collection, from the bone marrow in which they reside to the
peripheral blood and are collected through a safe, minimally invasive procedure
called “apheresis.” We have also entered the research and development arena,
through the acquisition of a worldwide exclusive license to an early-stage
technology to identify and isolate rare stem cells from adult human bone marrow,
called VSEL (very small embryonic-like) stem cells. VSELs have many physical
characteristics typically found in embryonic stem cells, including the ability
to differentiate into specialized cells found in substantially all the different
types of cells and tissue that make up the body.
The adult
stem cell industry is a field independent of embryonic stem cell research.
NeoStem believes embryonic stem cell research is more likely to be burdened by
governmental, legal, ethical and technical issues than adult stem cell research.
Medical researchers, scientists, medical institutions, physicians,
pharmaceutical companies and biotechnology companies are currently developing
therapies for the treatment of disease using adult stem cells. As
these adult stem cell therapies obtain necessary regulatory approvals and become
standard of care, patients will need a service to collect, process and store
their stem cells. NeoStem intends to provide this
service.
On
January 19, 2006, NeoStem consummated the acquisition of the assets of NS
California, Inc., a California corporation (“NS California”) relating to NS
California’s business of collecting and storing adult stem cells. Effective with
the acquisition, the business of NS California became NeoStem's principal
business, rather than NeoStem's historic business of providing capital and
business guidance to companies in the healthcare and life science
industries. NeoStem now provides adult stem cell processing,
collection and banking services with the goal of making stem cell collection and
storage widely available, so that the general population will have the
opportunity to store their own stem cells for future healthcare needs. Using
NeoStem's proprietary process, NeoStem provides the infrastructure, methods and
systems that allow adults to have their stem cells safely collected and
conveniently banked for future therapeutic use as needed in the treatment of
such life-threatening diseases as diabetes, heart disease and radiation sickness
that may result from a bioterrorist attack or nuclear
accident. According to the National Institutes of Health, there are
over 2,300 clinical trials currently underway relating to the use of adult stem
cells, over 700 relating to autologous use, in the treatment of numerous serious
diseases and conditions, including those that address cardiac disease,
autoimmune disorders such as lupus, multiple sclerosis, peripheral vascular
diseases, and age related musculoskeletal disorders, as well as diabetes,
cancer, neurological disease and wound healing.
Initial
participants in our collection center network have been single physician
practices who opened collection centers in California, Pennsylvania and
Nevada. Revenues generated by these early adopters have not been
significant and are not expected to become significant. However,
these centers have served as a platform for the development of NeoStem’s
business model and today NeoStem is focusing on multi-physician and
multi-specialty practices joining its network in major metropolitan areas.
Toward this end, NeoStem signed an agreement in June 2008 for a New York City
stem cell collection center to be opened by Bruce Yaffe, M.D., Yaffe, Ruden and
Associates, which facility became operational in November 2008. In
July 2008, NeoStem signed an agreement for a Santa Monica, California based stem
cell collection center to be opened by Stem Collect of Santa Monica LLC at The
Hall Center. This facility became operational in the fall of
2008. Additionally, NeoStem signed an agreement with Celvida LLC
pursuant to which a Southern Florida stem cell collection center located in
Coral Gables, a suburb of Miami, became operational in September
2008. In March 2009, NeoStem signed an agreement with Vincent C.
Giampapa, M.D., F.A.C.S., to open a center at the Giampapa Institute for
Anti-Aging Medical Therapy in Montclair, New Jersey.
NeoStem
also entered the research and development arena through its acquisition from the
University of Louisville of the worldwide exclusive license to the VSEL
technology. VSELs have many physical characteristics typically found in
embryonic stem cells, including the ability to differentiate into specialized
cells found in different types of tissue that would be able to interact with the
specific organ in order to repair degenerated, damaged or diseased tissue (the
three “Ds” of aging). NeoStem has the ability to harvest and cryopreserve these
VSELs from individual patients, setting the stage for their use in personalized
regenerative medicine. If VSELs can be expanded from individual patients and
their potential to develop into different types of tissue cells maintained, it
would represent a significant step toward overcoming the two major limitations
in the development of stem cell therapies today, the ethical dilemma regarding
use of embryonic stem cells and the immunological problems associated with using
cells from a third party donor. In connection with the license agreement,
NeoStem also entered into a sponsored research agreement with the University of
Louisville pursuant to which NeoStem is funding research relating to its VSEL
technology at the laboratory of its co-inventor, Mariusz Ratajczak, M.D., Ph.D.,
head of the Stem Cell Biology Program at the James Graham Brown Cancer Center at
the University of Louisville. The acquisition of the VSEL technology was made
through NeoStem's acquisition of its new subsidiary Stem Cell Technologies, Inc.
(“SCTI”) in a stock-for-stock exchange.
Although
certain early obligations under the Company’s agreements relating to the VSEL
technology were paid for with funds supplied by the seller to SCTI prior to the
acquisition, substantial additional funds will be needed and additional research
and development capacity will be required to meet the Company’s development
obligations under the license agreement and develop the VSEL
technology. The Company has applied to the U.S. Small Business
Administration for Small Business Innovation Research (“SBIR”) grants and may
also seek to obtain funds through applications for other State and Federal
grants, grants abroad, direct investments, strategic arrangements as well as
other funding sources to help offset all or a portion of these
costs. A portion of the proceeds from the RimAsia Notes (described
below) are being used to meet funding requirements of developing the VSEL
technology. The Company is seeking to develop increased internal
research capability and sufficient laboratory facilities or establish
relationships to provide such research capability and
facilities. Toward this end, we have hired a Director of Stem Cell
Research and Laboratory Operations and arranged for research facilities at the
facility of a strategic partner. In addition to the research we are currently
funding at the University of Louisville, we are also in discussions relating to
other research to generate data relating to other clinical applications of
VSELs, including neural, cardiac and ophthalmic, to expand our research efforts
and maximize the value of this technology.
In May
2008, we entered into a collection center agreement with the James Graham Brown
Cancer Center at the University of Louisville, further expanding our corporate
and academic relationship. This unique collection center will allow the
collection of large numbers of cells from adults donating them for basic
research as well as clients paying to have their cells stored for their own
future medical need. We believe this is a unique opportunity given the interest
of adult stem cell translational scientists and clinicians at the University in
exploring the therapeutic potential of VSELs and other adult stem cells of the
body. By enabling investigators to have access to large numbers of adult stem
cells from interested and informed study subjects, we believe that translational
adult stem cell research will move forward at an accelerated pace and that
clinical trial designs will be more rapidly implemented to investigate new
research findings. This collection center is anticipated to open in
2009 pending receipt of applicable institutional approvals.
NeoStem
currently generates revenue and earnings from its platform business as follows:
(1) fees from the collection centers in NeoStem's network, (2) client collection
fees, (3) processing center collection fees and (4) storage fees, which
represent recurring revenue paid each year or month. NeoStem has also
established a relationship with CareCredit, a GE Financial Services Company and
the nation’s leading patient financing program to assist its patients who wish
to pay for its services over time—which we believe opens up a broader client
base to us. NeoStem is planning to educate individuals that have a
family history or early diagnosis of diseases being treated with stem cell
therapy as well as those who have banked their infant’s stem cells that can
afford this “bioinsurance.” Additionally, NeoStem is working on establishing
collaborations with high profile medical centers and academic institutions
involved in cutting edge research and clinical trials relating to stem
cells. NeoStem believes that there is a significant need for cell
storage services for first responders and homeland security
personnel. In October 2008, we were advised that we would receive
federal funding from the Department of Defense to evaluate the potential use of
adult stem cell therapy for wound healing. It is anticipated that
this research and the related funding will begin in 2009. The funds
must be distributed to NeoStem prior to October 2010 and the budget we can
submit for the project must not exceed $681,000. NeoStem's other
go-to market strategies include collaboration with cord blood companies, tissue
banks, pharmaceutical companies, concierge medical programs, executive health
plans, regenerative medicine specialists and first responder
groups. In April 2007, NeoStem participated in the founding of The Stem for Life Foundation
(the “Foundation”). The mission of the Foundation is to
heighten public awareness and knowledge of the benefits and promise of adult
stem cells in treating serious medical conditions. The Foundation is
currently seeking a new executive director.
We have
engaged in various capital raising activities to pursue these business
opportunities. In 2007, we raised $2,500,000 in gross proceeds through the
private sale of our common stock, warrants and convertible promissory notes and
in August 2007, we completed a public offering of units consisting of shares of
common stock and warrants to purchase common stock, which raised gross proceeds
of $6,350,000. In 2008, we raised $2,900,000 in gross proceeds through the
private placement of units consisting of shares of common stock and warrants to
purchase common stock. Such capital raising activities have enabled
us to pursue our business plan and begin to grow our adult stem cell collection
and storage business, as well as to pursue acquisition opportunities
including the Merger and the Share Exchange (discussed below). However, fully
developing our business, particularly defining the optimal marketing and
distribution model and identifying and structuring suitable acquisitions, has
taken longer than anticipated. In order to fully develop our business, we will
require additional capital. In order to move forward certain research
and development activities, strategic relationships in various clinical and
therapeutic areas as well as to support activities related to the Merger
Agreement and Share Exchange Agreement, and other ongoing obligations of the
Company, in March and February 2009, the Company issued promissory notes (the
“RimAsia Notes”) totaling $1,150,000 to RimAsia Capital Partners, L.P.
(“RimAsia”), a principal stockholder of the Company. The RimAsia
Notes bear interest at a rate equal to 10% per annum and mature on October 31,
2009 except that they mature earlier in the case of an equity financing by the
Company that raises in excess of $10,000,000.
In 2008,
NeoStem had been actively exploring acquisition opportunities of revenue
generating businesses, both domestically and abroad, including businesses that
are synergistic with its current business or additive to its current
business. In November 2008, we entered into two acquisition
agreements, both of which are currently anticipated to close in the second
quarter of 2009 subject to receipt of all necessary consents and
approvals. On November 2, 2008, the Company entered into an Agreement
and Plan of Merger with China Biopharmaceutical Holdings, Inc., a Delaware
corporation (“CBH”), China Biopharmaceuticals Corp., a British Virgin Islands
corporation and wholly-owned subsidiary of CBH ("CBC"), and CBH
Acquisition LLC (“Merger Sub”), a Delaware limited liability company and a
wholly-owned subsidiary of the Company, pursuant to which CBH, which owns 51% of
the equity of Suzhou Erye Pharmaceuticals Company Ltd (“Erye”), will be merged
with and into Merger Sub with Merger Sub continuing as the surviving company and
as a direct wholly-owned subsidiary of the Company (the “Merger”); provided,
that CBH will spin off all of its shares of capital stock of CBC to CBH’s
stockholders in a distribution so that the only material assets of CBH following
such spin-off (the "Spin-off") will be 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 (the "PRC"), plus net cash which shall not be
less than $550,000. Erye specializes in research and development, production and
sales of pharmaceutical products, as well as chemicals used in pharmaceutical
products. Erye, which has been in business for more than 50 years, currently
manufactures over 100 drugs on seven Good Manufacturing Practices (GMP) lines,
including small molecule drugs. On November 2, 2008, the Company also
entered into a Share Exchange Agreement (the “Share Exchange Agreement”), with
China StemCell Medical Holding Limited, a Hong Kong company (the “HK Entity”),
Shandong New Medicine Research Institute of Integrated Traditional and Western
Medicine Limited Liability Company, a China limited liability company
("Shandong"), Beijing HuaMeiTai Bio-technology Limited Liability Company
(“WFOE”) and Zhao Shuwei, the sole shareholder of the HK Entity (“HK
Shareholder”), pursuant to which NeoStem agreed to acquire from the HK Entity
all of the outstanding interests in the HK Entity, and through a series of
contractual arrangements, obtain certain benefits from Shandong (the “Share
Exchange”). Shandong is engaged in the business (the "Shandong
Business") of research, development, popularization and transference of
regenerative medicine technology (except for those items for which it does not
have special approval) in the PRC. For more information on the Merger
and Share Exchange, see “Business - Merger and Share Exchange” and “Risk Factors
– Risks Relating to the Merger and Share Exchange.” The Company is also taking
certain other initiatives to expand its operations into China.
NeoStem
is also pursuing businesses that are related to its platform business of
collection, processing and storage of adult stem cells which include (i)
“medical tourism” due to advanced stem cell therapies developing at a faster
pace outside the United States, (ii) supplying collected stem cells for the
conduct of adult stem cell research, (iii) storing excess cells collected from a
patient at oncology transplant centers, and (iv) supplying stem cells for
diagnostic and therapeutic use.
On August
29, 2006, NeoStem's stockholders approved an amendment to its certificate of
incorporation to effect a reverse stock split of the NeoStem Common Stock at a
ratio of one-for-ten shares and to change its name from "Phase III Medical,
Inc." to "NeoStem, Inc." On June 14, 2007, NeoStem's stockholders
approved an amendment to NeoStem's certificate of incorporation to effect a
reverse split of our NeoStem Common Stock at a ratio of up to one-for-ten shares
in the event it was deemed necessary by the NeoStem Board of Directors in order
to be accepted onto a securities exchange. On July 9, 2007, the
NeoStem Board of Directors approved a one-for-ten reverse stock split to be
effective upon the initial closing of NeoStem’s public offering in order to
satisfy the listing requirements of the NYSE Amex. On August 9, 2007,
the reverse split was effective and NeoStem Common Stock commenced trading on
the NYSE Amex under the symbol “NBS." Accordingly, all numbers in
this report have been adjusted to reflect both the one-for-ten reverse stock
split which was effective as of August 31, 2006 and the one-for-ten reverse
stock split which was effective as of August 9, 2007.
NeoStem’s
prior business was providing capital and business guidance to companies in the
healthcare and life science industries, in return for a percentage of revenues,
royalty fees, licensing fees and other product sales of the target companies.
Additionally, through June 30, 2002, NeoStem was a provider of extended
warranties and service contracts via the Internet at warrantysuperstore.com.
NeoStem was engaged in the “run off” of such extended warranties and service
contracts through March 2007. For a discussion of NeoStem’s involvement in such
other activities and Company history, see “Former Business
Operations.”
NeoStem
was incorporated under the laws of the State of Delaware in September 1980 under
the name Fidelity Medical Services, Inc. NeoStem'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. The information on its website does not constitute a
part of this report. NeoStem’s information as filed with the
Securities and Exchange Commission is available via a link on its websites as
well as at www.sec.gov.
ADULT
STEM CELL COLLECTION BUSINESS
What
are Stem Cells?
Stem
cells are very primitive and undifferentiated cells that have the unique ability
to transform into many different cells, such as white blood cells, nerve cells
or heart muscle cells. Stem cells can be found throughout the body,
but are found in higher concentrations in the bone marrow and “mobilized”
peripheral blood of adults. Certain processes can cause the stem cells to leave
the bone marrow and enter the blood where they can be
collected. NeoStem currently only works with adult stem cells
collected from peripheral blood through a safe, minimally invasive procedure
called “apheresis.”
Stem
Cells and Regenerative Medicine
NeoStem
is developing its business in the adult stem cell field and seeking to
capitalize on the increasing importance NeoStem believes adult stem cells will
play in the future of regenerative medicine. The use of adult stem cells as a
treatment option for those who develop heart disease, certain types of cancer
and other critical health problems is a burgeoning area of clinical research
today. The adult stem cell industry is a field independent of
embryonic stem cell research. NeoStem believes that embryonic stem cell
therapies have certain barriers to development due to political, ethical, legal
and technical issues. Medical researchers, scientists, medical
institutions, physicians, pharmaceutical companies and biotechnology companies
are currently developing therapies for the treatment of disease using adult stem
cells. As these adult stem cell therapies obtain necessary regulatory
approvals and become standard of care, patients will need a service to collect,
process and store their stem cells. NeoStem intends to provide this
service. According to Robin Young, a leading medical technology
analyst and founder and CEO of RRY Publications who organized the 3rd Annual
Stem Cell Summit held in New York City in February 2008, an increasing number of
physicians are incorporating stem cell therapies into their therapeutic
tools. According to Mr. Young, in the past 24 months, over 11,000
people in the United States had already received stem cell therapies as part of
their conventional treatment and he projects that by 2017 there will be 1.973
million annual procedures using stem cell therapies in multiple medical markets,
generating annual revenues of an estimated $8.5 billion.
The
Future of Adult Stem Cell Therapies Using Cells Collected from Peripheral
Blood
NeoStem
currently only works with adult stem cells collected from peripheral blood, as
opposed to stem cells derived or collected through other methods. An article in
the February 27, 2008 volume of The Journal of the American Medical Association
entitled, "Clinical
Applications of Blood-Derived and Marrow-Derived Stem Cells for Nonmalignant
Diseases" studied a broad array of clinical studies conducted between
January 1997 and December 2007 and concluded that there was evidence that stem
cells harvested from blood or bone marrow do appear to provide
disease-ameliorating effects in certain auto-immune diseases and cardiovascular
disorders. The article also highlighted that the vast majority of
human stem cell trials have focused on clinical applications for hematopoietic
and/or mesenchymal stem cells, both of which may be obtained from peripheral
blood, bone marrow, or umbilical cord blood and placenta. The
National Institutes of Health lists more than 2,300 clinical trials currently
underway investigating adult stem cell use as potential therapies for a
wide-range of diseases, including, cancer, diabetes, heart and vascular disease,
and autoimmune disorders such as lupus, multiple sclerosis and
arthritis. More than 700 of these trials relate to autologous
use.
NeoStem's
ability to provide adult stem cell collection and storage services to the
general population for their future medical use places NeoStem in a unique
position to benefit from the rapidly growing need for autologous, blood-derived
stem cells. NeoStem believes that as clinical understanding of the
benefits of blood-derived stem cells grows and therapies developed from these
cells show medical promise, so does the potential value of a personal supply of
one's own stem cells. With NeoStem's expanding nationwide network of collection
centers, NeoStem is enabling people to donate and store their own stem cells for
their personal use in times of future medical need.
Plan
of Operations
NeoStem
is engaging in a platform business of autologous adult stem cell collection,
processing and storage. NeoStem believes that as adult stem cell therapies
obtain necessary regulatory approvals and become more and more widely used,
individuals will need the infrastructure, methods and procedures being developed
by NeoStem to have their stem cells safely collected and conveniently stored for
future therapeutic use. NeoStem generates revenues from this platform
business as follows:
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collection
center fees;
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initial collection
of adult stem cells;
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processing and
storage of adult stem cells (generating recurring revenue);
and
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utilization
of adult stem cells (when stem cells are
used).
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NeoStem’s
service model creates a source of an individual’s stem cells that enables
physicians to potentially treat a variety of diseases and engage in research to
progress therapeutic development using adult stem cells. NeoStem
derives fees from collection centers operated by physicians who join its network
and anticipates deriving fees from medical institutions joining its
network. Depending on the particular collection center, NeoStem
generates revenues through certain upfront and annual fees from the collection
centers in our network, patient collection fees, processing center fees and
storage fees.
NeoStem
also sees potential revenues from:
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being
a supplier of stem cells for research and clinical
trials;
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government
and military contracts;
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Small
Business Innovation Research (“SBIR”)
grants;
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licensing
of technology; and
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NeoStem
has been
processing and storing the adult stem cells collected with its processes at its
California facility. This space was sufficient for the Company’s past
needs but the Company plans to close this facility by the end of the second
quarter of 2009 and transfer its processing and storage operations to state of
the art facilities operated by leaders in cell processing. It intends
to utilize New England Cryogenic Center, Inc. (“NECC”) with whom
it entered into a Master Services agreement and a first statement of work,
effective as of August 2007, to provide additional processing and cryogenic
storage to the Company at its FDA registered and licensed facility in Newton,
Massachusetts (the “NECC Facility”), to process and store for certain research
purposes, and to utilize 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 current Good Manufacturing
Practices (“cGMP”) level at its California and New Jersey facilities. These
strategic alliances will provide increased processing and storage capacity,
redundancy of storage and an expanded Northeast presence as NeoStem expands its
services in the United States. (See “- Processing and Storage”).
Marketing
and Customers
NeoStem
intends to hire a seasoned sales and marketing executive to lead the efforts in
embarking on a marketing, advertising and sales campaign individually and
through collaborations with others for the purpose of educating physicians and
potential clients on the benefits of adult stem cell collection and storage.
NeoStem’s “Go-To-Market” strategy is to drive this general
awareness. The essence of this strategy is to reach the end-customers
as quickly as possible and to accelerate the adoption curve of our
service. In this regard and in connection with the opening of the New
York City collection center, the Company will embark on a Tri-State area public
awareness program to inform the general population, including the 1,200 patients
per week who presently receive medical care services from Yaffe, Ruden and
Associates, about the importance of stem cell collection and long term storage.
In addition, NeoStem plans to utilize marketing resources to increase the number
of physicians who collaborate with the Company in the operation of collection
centers.
NeoStem
believes several consumer segments may recognize and experience the long-term
benefits from banking their own stem cells. These include:
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Individuals with a
family history of serious diseases that show potential for treatment with
stem cell therapies that are currently under research, e.g., diabetes,
heart disease or cancer;
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Wellness
and regenerative medicine
communities;
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Families
who have already banked the umbilical cord blood from their
newborns;
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High
net worth and educated consumers;
and
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Individuals
at high risk for radiation exposure or hazardous
materials.
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NeoStem
is designing its marketing efforts to educate physicians on the benefits both of
making stem cell collection and storage services available to their adult
patients and participating in our collection program. NeoStem
believes that individuals will find adult stem cell collection appealing as part
of a Bio-Insurance program for the following reasons:
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Finding
a “matching” donor is very
difficult;
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People
can die while on a wait-list for a
donor;
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High
rejection rate of stem cells from a donor due to “graft vs. host” disease
(40% even if a “perfect
match”);
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Risk
of transmission of communicable
disease;
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Possible
reluctance by physicians to collect and use autologous stem cells once a
patient is sick because their bone marrow may have become
compromised;
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Effects
of age on quantity and quality of stem cells;
and
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Financing
options contribute to
affordability.
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Company
Initiatives
NeoStem’s
current initiatives include plans to:
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Strategically
expand and develop NeoStem’s network of collection
centers;
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Develop strategic initiatives
with cord blood companies, tissue banks and pharmaceutical
companies;
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Collaborate with academic
institutions on licensing opportunities, development of collection centers
and provision of collection services for ongoing clinical
trials;
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Develop partnerships with
executive health programs, wellness physicians, concierge medical
programs, medical spas and first responder
groups;
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Expand NeoStem’s intellectual
property portfolio within the stem cell
arena;
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Expand its Government Programs
Initiatives, and in this regard has efforts underway targeting key federal
and state agencies as well as congressional committees in order to raise
awareness of the benefits of adult stem cell therapy as a treatment
option. In October 2008, we were advised that we would receive
federal funding from the Department of Defense to evaluate the potential
use of adult stem cell therapy for wound healing, currently anticipated to
be in the approximate net amount of $681,000;
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Submit grant
applications to National Institutes of Health and others to fund Company
programs; and
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Expand
certain of its operations into China (See “China
Expansion”).
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In
April 2007, NeoStem participated in the founding of the
Foundation. The mission of the Foundation is to heighten public
awareness and knowledge of the benefits and promise of adult stem cells in
treating serious medical conditions. The Foundation is committed to
assisting those who protect us. First Responders (Fire, Police, Rescue and
Military) are at high risk for exposure to radiation, burns, wounds and other
trauma. The Foundation will help provide resources, not just for
those emergency workers, but also to other individuals who become chronically
ill and will be in need of assistance to collect, process and store their own
stem cells now for use in the future. The Foundation was formed under
the Pennsylvania Not-for-Profit Corporation Law and is intended to qualify as a
501(c)(3) corporation under the Internal Revenue Code, as amended. Certain
members of NeoStem’s management are officers and/or sit on the Board of Trustees
of the Foundation. The Foundation is currently seeking a new
executive director.
Adult
Stem Cell Collections
During
2008, we were focused on establishing a nationwide network of collection centers
and participating physicians in certain major metropolitan areas of the United
States to drive growth, in addition to exploring acquisition opportunities of
revenue generating businesses.
Initial
participants in our collection center network have been single physician
practices who opened collection centers in California, Pennsylvania and Nevada.
Revenues generated by these early adopters have not been significant and are not
expected to become significant. However, these centers have served as a platform
for the development of NeoStem’s business model and today NeoStem is focusing on
multi-physician and multi-specialty practices joining its network in major
metropolitan areas. Toward this end, NeoStem has signed
collection agreements as follows:
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An
agreement in June 2008 for a New York City stem cell collection center to
be opened by Bruce Yaffe, M.D., Yaffe, Ruden and
Associates. This facility received a provisional license from
the New York State Department of Health in September 2008 and became
operational in November 2008. This practice is comprised of
over 20 physicians and physician’s assistants and treats over 1,200
patients per week.
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An
agreement in July 2008 for a Santa Monica, California based stem cell
collection center to be opened by Stem Collect of Santa Monica LLC at The
Hall Center. This facility became operational in the fall of
2008. The Hall Center specializes in cutting-edge offerings of
“Functional Medicine” – a science-based practice of medicine –
complemented by an array of holistic wellness
services.
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An
agreement with Celvida LLC (for more information regarding NeoStem’s
relationship with Celvida, see below) pursuant to which a Southern Florida
stem cell collection center located in Coral Gables, a suburb of Miami,
became operational in September
2008.
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An
agreement with Vincent C. Giampapa, M.D., F.A.C.S., in March 2009, to open
a center at the Giampapa Institute for Anti-Aging Medical Therapy in
Montclair, New Jersey. One of the first certified anti-aging
medical physicians in the world, Dr. Giampapa is Director of the Plastic
Surgery Center Internationale as well as The Giampapa Institute and is
renowned for a non-surgical complete facial rejuvenation procedure that
involves the use of adult stem
cells.
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An
agreement in October 2007 to open an adult stem cell collection
center with ProHealthcare Associates, one of the largest and most
prominent multi-specialty practices in the region, with over 100 doctors
and 500,000 patients. In January 2008, ProHealthcare Associates received a
provisional license from the New York State Department of Health and
became operational. In October 2008, it received its final
license.
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The terms
of NeoStem’s collection center agreements are substantially similar. NeoStem
provides adult stem cell processing and storage services, as well as management,
expertise and other services to the collection center. In each case, the
collection center agrees that NeoStem will be the exclusive provider to it of
adult stem cell processing and storage, management and other specified services.
The agreements generally provide for the payment to NeoStem by the collection
center of specified marketing and support fees and annual network services fees,
and provide a fee schedule and the allocation of expenses and revenues among the
parties. Each of the agreements is for a multi-year period, depending on the
particular center, typically has an automatic renewal for consecutive one year
periods at the end of the initial term and may relate to a territory. The
agreements contain insurance obligations and indemnification provisions,
limitations on liability and other standard provisions. NeoStem grants to each
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.
The agreements may be terminated upon prior written notice of a specified period
in advance upon certain uncured material breaches of the agreement or, depending
on the agreement, certain other specified occurrences.
With the
intention of increasing the number and quality of physician practices joining
the collection network, in January 2008, NeoStem entered into a Development
Agreement with CelVida LLC (“CelVida”), an entity formed by individuals
experienced in recruiting and organizing physicians and their practices, to act
as a developer of collection centers to join NeoStem’s network by finding
locations, organizing operating entities and guiding those entities in
constructing, equipping, furnishing and staffing the collection facility.
Pursuant to the terms of the agreement, CelVida may from time to time identify
to NeoStem territories in which it proposes performing due diligence to
determine the feasibility of locating one or more centers in the territory.
NeoStem may, in its discretion, advise whether CelVida may or may not proceed in
the identified territory and in the event CelVida is authorized to proceed,
CelVida has specified time periods in which to complete its due diligence as to
feasibility, organize an operating entity for the center and construct, equip,
furnish and staff a center for operation. So long as these periods are adhered
to and subject to NeoStem’s right to choose at its option not to enter into a
collection center agreement with a proposed entity for a proposed territory,
NeoStem will refrain from engaging in discussions or authorizing any person
other than CelVida to take any action to develop a center in the specified
territory (“exclusivity”). In the event CelVida does not complete each of these
tasks within the specified period of time, then CelVida’s rights to exclusivity
in the territory cease. CelVida is bound by certain confidentiality provisions
and non-competition provisions. The agreement is for an initial term of three
(3) years and may be terminated by either party by giving prior notice to the
other party upon their uncured material breach of the agreement. Pursuant to the
terms of this agreement, in January 2008, NeoStem and CelVida signed a
collection center agreement with respect to the Miami/Coral Gables, Florida
area.
A 2007
development agreement with Stem Collect LLC was terminated by the Company in
August 2008.
On
December 15, 2006, NeoStem entered into a five year agreement (the
“Original HemaCare Agreement”) with HemaCare Corporation (“HemaCare”) pursuant
to which HemaCare agreed to provide NeoStem with collection services for the
procurement of adult stem cells from peripheral blood for the purpose of
long-term storage. HemaCare has been providing services consisting of apheresis
collection of adult stem cells from peripheral blood for long-term storage and
in certain circumstances for research purposes. These services
typically have been provided at either the HemaCare facility or at collection
centers in NeoStem’s network of collection centers, subject to the terms of
HemaCare’s license and other regulatory requirements. HemaCare has operations on
the West Coast and parts of the Northeast. Additionally, under the agreement
HemaCare agreed to provide to NeoStem standard operating procedures (“SOPs”) for
the collection of peripheral blood progenitor cells to be used by NeoStem as its
own SOPs and has been required to keep these SOPs up to date. NeoStem may
continue to use the SOPs for up to ten years following termination of the
agreement, subject to continued payment by NeoStem of a maintenance
fee. These services have been provided to NeoStem on an exclusive
basis.
Under the
Original HemaCare Agreement, the parties agreed to standard confidentiality
obligations during the term of the agreement and for three years thereafter. The
agreement is for a term of five years, subject to earlier termination by either
party, generally upon 180 days’ prior notice. NeoStem will provide to HemaCare
payment for such services as set forth in the agreement, which will be fixed for
a 12 month period and may thereafter be increased based on mutual agreement of
the parties.
On
February 24, 2009, NeoStem, Hemacare and Coral Blood Services, Inc., a
wholly-owned subsidiary of HemaCare (“CBS”) entered into a first amendment to
the Original HemaCare Agreement. Under this amendment, CBS will
provide collection services along with HemaCare, each in such states where such
entity is currently licensed to operate. The amendment also provides
for a reduced notification period for termination of the Original HemaCare
Agreement (generally from 180 to 90 days), adjusted fees and activities and that
each will develop their own standard operating procedures (“SOPs”) and supply
the other with all SOP modifications and amendments.
Since
NeoStem has been developing its own SOPs for its collection business and has the
internal expertise in apheresis it is considering becoming an independently
licensed collector of stem cells to enable it to collect adult stem cells for
storage at the facilities of its network members for those who choose not to
become independently licensed as well as to collect stem cells for research
purposes, subject to its receipt of appropriate licenses.
Processing
and Storage
NeoStem
is currently processing and storing the adult stem cells collected with its
processes at its California facility. The California facility has a biologics
license from the State of California. California requires a laboratory to be in
full compliance with the American Association of Blood Banks (“AABB”) in order
to be licensed. In April 2007, NeoStem received two provisional licenses
from the State of New York for its California facility. The first license
permits NeoStem’s California facility to collect, process and store
hematopoietic progenitor cells (“HPCs”) collected from New York residents. The
second license permits solicitation in New York relating to the collection of
HPCs. A third provisional license received in January 2008, permits the
California facility to collect, process, store and use for medical research HPCs
collected from New York residents. Each license is subject to certain
limitations stated therein. This space was sufficient for the
Company’s past needs but the Company plans to close this facility by the end of
the second quarter of 2009 and transfer its processing and storage operations to
state of the art facilities operated by leaders in cell
processing. It intends to utilize New England Cryogenic Center, Inc.
(“NECC”), with whom it entered into a Master Services agreement and a first
statement of work effective as of August 2007 to provide additional processing
and cryogenic storage to the Company at its FDA registered and licensed facility
in Newton, Massachusetts (the “NECC Facility”), to process and store for certain
research purposes, and to utilize 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.
Effective
as of August 15, 2007, NeoStem entered into a Master Services Agreement (the
"services agreement") with NECC, under which NECC will provide processing and
cryogenic storage services for adult stem cells ("ASCs") collected by NeoStem.
This strategic alliance with NECC, one of the country’s largest cryogenic
laboratories, will provide increased processing and storage capacity, redundancy
of storage and an expanded Northeast presence as NeoStem expands its services
and physician's network in the United States. The services agreement is for an
initial term of five years, with automatic renewal for consecutive two year
periods at the end of the initial term. The parties will enter into a statement
of work for each specific project to be performed by NECC under the services
agreement, with the responsibilities of the parties, specific fees for
processing and cryogenic storage and expense reimbursement to be agreed upon in
each statement of work. The services agreement contains standard confidentiality
and mutual indemnification provisions. NeoStem generally retains the rights to
all inventions and intellectual property developed during the course of
performance of a project under the services agreement, and NECC is bound by
certain non-competition provisions during the term of the services agreement and
for two years thereafter. Either party may terminate the services agreement upon
180 days' written notice prior to the end of then current term, or at any time
upon certain uncured events of default. NECC will continue to store ASCs for not
less than 12 months from the date of any termination so as to enable NeoStem to
make appropriate arrangements for replacement of processing and storage
services. Effective as of August 15, 2007, the parties have entered into the
first statement of work under the services agreement pursuant to which NECC is
to provide processing and cryogenic storage at the NECC
Facility. NECC received a license from the State of New York to
process, store and use for research HPCs collected from New York residents;
however, a new license is needed due to a change of the medical director at
the facility and we are advised that this new license is in
process.
On
October 15, 2008, effective as of October 1, 2008, the parties entered into the
second statement of work (“Second SOW”) under the services agreement to
establish at the NECC Facility research and development capabilities for
NeoStem. As discussed, NeoStem has entered the research
and development arena through its acquisition from the University of Louisville
of a worldwide exclusive license to an early-stage technology to identify and
isolate rare stem cells from adult human bone marrow, called VSEL (very small
embryonic-like) stem cells. The Second SOW relates to the use by
NeoStem of shared laboratory space and equipment at the NECC Facility to perform
company independent research as well as isolation and processing of VSELs. It
also relates to research and development services that may be requested by
NeoStem from New England Cell Therapies and Applied Research (“NECTAR”), a
division of NECC, from time to time at the NECC Facility, and the use by NeoStem
of certain administrative space next to the NECC Facility. The Second SOW calls
for a monthly rental fee to be paid to NECTAR for the shared laboratory space
and the administrative space, of $5,000 for the first twelve months and $6,000
per month thereafter. Services of NECTAR technical and scientific personnel and
equipment, is available for a specified fee. NeoStem also has the right to open
an adult stem cell collection center at the NECC Facility upon receipt of
applicable regulatory approval, subject to the agreement of the parties on
appropriate space. NeoStem will be responsible for all costs involved
in opening and operating any such collection center and for regulatory
compliance. The Second SOW also provides for NECTAR’s use of certain of
NeoStem’s equipment and scientific and technical personnel for specified fees.
The Second SOW has a term of two years and may be earlier terminated by either
party upon 180 days’ prior written notice. The services agreement is for an
initial term of five years, with automatic renewal for consecutive two year
periods at the end of the initial term.
On January 9, 2009, the Company entered
into a Cell Processing and Storage Customer Agreement (the “PCT Agreement”) with
Progenitor Cell Therapy LLC (“PCT”). Under the PCT Agreement, PCT
will provide to the Company autologous adult stem cell processing and storage
services utilizing cGMP standards. Such services will be provided at
both PCT’s California and New Jersey facilities. The Company agrees
to use PCT for processing and storage services for commercial purposes on an
exclusive basis commencing with such time as PCT completes certain preliminary
services and is ready and able to start the processing and storage services as
required by the agreement. PCT agrees to provide to us stem cell
processing and long term storage services for our business on an exclusive
basis. Prior to commencing these services, PCT agrees to provide
certain preliminary services consisting of technology transfer and protocol
review and revision to ensure that the processing and storage services are cGMP
compliant. The agreement sets forth agreed upon fees for the delivery
of the services as well as providing for a one-time payment of $35,000 for the
preliminary services of which $20,000 has been paid to date. The
agreement is for a four year term, subject to earlier termination on 365 days
notice as set forth in the agreement.
On March
6, 2009, the Company and PCT expanded PCT’s services under the PCT Agreement to
include its developing a plan to set up a stem cell processing and manufacturing
operation in Beijing, China that the Company would pursue in partnership with an
off-shore entity. This plan would support research and cell therapy
development and manufacturing operations. The plan will include a
conceptual architectural design, cost estimates for construction, facility
validation to meet cGMP standards, equipment requirements and estimated costs of
equipment procurement, and other related matters. The plan is
required to be completed by April 17, 2009, subject to PCT having received the
technical information reasonably necessary to complete the
plan. PCT’s fees for this work will be $100,000 (of which $50,000 was
paid in March 2009 upon the effectiveness of the agreement) plus
expenses.
Industry
and Geographical Segmental Information
As a
result of NeoStem’s acquisition of substantially all the assets and operations
of NS California on January 19, 2006, NeoStem had operations in two
segments through March 2007. One segment is the collection, processing and
banking of adult stem cells and the other segment was the “run off” of its sale
of extended warranties and service contracts via the Internet. This “run-off” of
warranty and service contracts was completed in March 2007. To date, NeoStem’s
operations have been conducted in only one geographical segment. For
further financial information regarding segments, please see the financial
statements and notes thereto included elsewhere in this annual
report.
Acquisition
of NS California, Inc.
On
January 19, 2006, NeoStem, through a wholly-owned subsidiary, consummated
its acquisition of the assets of NS California relating to NS California’s
business of collecting, processing and storing adult stem cells, pursuant to an
Asset Purchase Agreement dated December 6, 2005. The purchase price
consisted of 50,000 shares of NeoStem Common Stock, plus the assumption of
certain enumerated liabilities of NS California and liabilities under assumed
contracts. NeoStem also entered into employment agreements with NS California’s
chief executive officer and one of its founders as part of the transaction. NS
California was incorporated in California in July 2002, and from its
inception through the acquisition by NeoStem was engaged in the sale of adult
stem cell banking services. In October 2003, NS California leased
laboratory space in a research facility at Cedars Sinai Hospital in California
and entered into an agreement with a third party to provide adult stem cell
collection services. By December 2003, NS California had outfitted its
laboratory with equipment for processing, cryopreservation and storage of adult
stem cells. In May 2004, after a validation process and inspection and
approval by the State of California, NS California received a biologics license
and commenced commercial operations. In January 2005, NS California moved
its adult stem cell processing and storage facility to Good Samaritan Hospital
in California. NS California was compelled to cease operations because it did
not have sufficient assets to complete the revalidation of the new laboratory
and NS California’s biologics license was suspended. In October 2005, NS
California restarted the validation of the laboratory at Good Samaritan
Hospital, and on May 29, 2006 NeoStem was issued a new biologics license
from the State of California. Pursuant to the Asset Purchase Agreement, NS
California was obligated to return to NeoStem (out of the 50,000 shares of
Common Stock issued) 167 shares per day for each day after February 15,
2006 that such biologics license had not been issued up to a total of 10,000. NS
California has returned 10,000 shares to NeoStem.
Prior
Relationship with NS California
On
March 31, 2004, NeoStem entered into a joint venture agreement to assist NS
California in finding uses of and customers for NS California’s services and
technology. NeoStem’s initial efforts concentrated on developing programs
utilizing NS California’s services and technology through government agencies.
That agreement was terminated as a result of the NS California acquisition. On
September 9, 2005, NeoStem signed a revenue sharing agreement with NS
California pursuant to which NeoStem had agreed to fund NS California certain
amounts to pay pre-approved expenses and other amounts based on a formula
relating to NeoStem’s ability to raise capital. Once funded, NS California
would pay NeoStem monthly based on the revenue generated in the previous month
with a minimum payment due each month. That agreement was terminated as a result
of the NS California acquisition.
RESEARCH
AND DEVELOPMENT; THERAPEUTICS MARKETPLACE
In
addition to our platform business of collecting, processing and storing adult
stem cells from the peripheral blood, NeoStem entered the research and
development arena through its acquisition from the University of Louisville of
the worldwide exclusive license to the VSEL technology.
Acquisition
of VSEL Technology
On
November 13, 2007, NeoStem entered into an acquisition agreement with UTEK
Corporation ("UTEK") and Stem Cell Technologies, Inc., a wholly-owned subsidiary
of UTEK ("SCTI"), pursuant to which NeoStem acquired all the issued and
outstanding common stock of SCTI in a stock-for-stock exchange. Pursuant to a
license agreement (the "License Agreement") between SCTI and the University of
Louisville Research Foundation ("ULRF"), SCTI owns 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
VSELs (very small embryonic-like) stem cells. Concurrent with the SCTI
acquisition, NeoStem entered into a sponsored research agreement (the "Sponsored
Research Agreement" or "SRA") with ULRF under which NeoStem will support 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
Graham Brown Cancer Center at the University of Louisville. Certain early
obligations of the Company under the License Agreement and the SRA were paid for
by funds supplied by UTEK to SCTI prior to the acquisition. In
consideration for the acquisition, NeoStem issued to UTEK 400,000 unregistered
shares of its common stock for all the issued and outstanding common stock of
SCTI.
VSELs
have many characteristics typically found in embryonic stem cells, including the
ability to differentiate into specialized cells found in different types of
tissue that would be able to interact with the specific organ in order to repair
degenerated, damaged or diseased tissue (the three "Ds" of aging). NeoStem has
the ability to harvest and cryopreserve these VSELs from individual patients,
setting the stage for their use in personalized regenerative medicine. If VSELs
can be expanded from individual patients and their potential to develop into
different types of tissue cells maintained, it would represent a significant
step toward overcoming the two major limitations in the development of stem cell
therapies today, the ethical dilemma regarding use of embryonic stem cells and
the immunological problems associated with using cells from a third party
donor.
Under the
License Agreement, SCTI agreed to engage in a diligent program to develop the
VSEL technology. Certain license fees, milestone payments and royalties, and
specified payments in the event of sublicensing, are to be paid to ULRF from
SCTI, and SCTI is responsible for all payments for patent filings and related
applications. The License Agreement has an initial term ending the
later of (i) 20 years and (ii) the last to expire patent claim. 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. To date, the
Company has paid: (i) $29,000 for reimbursement of all expenses
related to patent filing and prosecution incurred prior to the effective date
(the “Effective Date”) of the License Agreement; (ii) a nonrefundable prepayment
of $20,000 creditable against the first $20,000 of patent expenses incurred
after the Effective Date; and (iii) a nonrefundable license issue fee equal to
$46,000.
Although
the funds obtained through the acquisition of SCTI funded certain early
obligations under NeoStem’s agreements relating to the VSEL technology,
substantial additional funds will be needed and additional research and
development capacity will be required to meet its development obligations under
the License Agreement and develop the VSEL technology. NeoStem
has applied for Small Business Innovation Research (SBIR) grants and may also
seek to obtain funds through applications for other State and Federal grants,
grants abroad, direct investments, strategic arrangements as well as other
funding sources to help offset all or a portion of these costs. It is
seeking to develop increased internal research capability and sufficient
laboratory facilities or establish relationships to provide such research
capability and facilities. In this regard, in July 2008 NeoStem hired
a Director of Stem Cell Research and Laboratory Operations and in October 2008
it entered into the Second SOW with NECC pursuant to which, among other things,
NeoStem may use shared laboratory space and equipment at the NECC Facility to
perform company independent research as well as isolation and processing of
VSELs.
SCTI has
the right to sublicense the VSEL technology in accordance with the terms of the
License Agreement. The License Agreement also sets forth the parties’ rights and
obligations with regard to patent prosecution, including that SCTI will take the
lead in connection therewith. SCTI can terminate the License Agreement for any
reason upon 60 days' prior written notice, and either party can terminate upon
30 days' prior written notice upon certain uncured material breaches of the
agreement or immediately upon certain bankruptcy related events. 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. ULRF retained the
right under the License Agreement to license and practice the VSEL technology
for noncommercial purposes only, such as education, academic research, teaching
and public service, and also retained the right of publication subject to
certain confidentiality limitations and prior review by SCTI.
VSEL
Technology Research Program
Concurrently
with the License Agreement, NeoStem entered into the Sponsored Research
Agreement with ULRF (“the SRA”). Pursuant to the
SRA, NeoStem will support additional research relating to the VSEL technology to
be carried out in the laboratory of Dr. Ratajczak as principal investigator. In
return, NeoStem will receive the exclusive first option to negotiate a license
to the research results. Under the SRA, NeoStem agrees to support the research
as set forth in a research plan in an amount of $375,000. Such costs
are to be paid by NeoStem in accordance with a payment schedule which sets forth
the timing and condition of each such payment over a two and one-half year
period which commences with the commencement of the research, as follows: (i)
$100,000 (for which there was originally a $50,000 credit) upon receipt of all
approvals and stem cell specimens on which to perform the research (the “First
Payment Date”); (ii) $100,000 on the first yearly anniversary of the First
Payment Date; (iii) $75,000 on the second yearly anniversary of the First
Payment Date; and (iv) $25,000 upon the achievement of each of four specified
milestones. In October 2008, the SRA was amended to provide for
certain additional research to be conducted as work preliminary to the first
research aim under the SRA (“Pre-Aim 1”), for which approximately one-half of
the $50,000 credit was utilized to pay the fee. Pre-Aim 1 was
completed in November 2008. The parties are in discussions to
amend the SRA to accelerate the research based on the research results obtained
from Pre-Aim 1.
Under the
SRA, ULRF retains the rights to intellectual property developed by its employees
in performance of the research relating to the VSEL Technology, and NeoStem and
ULRF jointly own intellectual property developed jointly by employees of ULRF
and NeoStem in performance of the research. So long as NeoStem continues to
support and fund the filing of patent applications and other intellectual
property protection for the same, NeoStem has the first option to negotiate for
an exclusive, worldwide commercial license to ULRF's interest in any such
developed or jointly developed intellectual property. The SRA also establishes
rates for royalties and revenue sharing between the parties in the event no
license agreement is executed with regard to joint intellectual property but one
party chooses to develop or license it to a third party.
The term
of the research under the original SRA is two and one-half years and shall
commence after all applicable institution (e.g., institutional review board
("IRB")) and Federal approvals are obtained and upon the adult stem cell
specimens required for the research being provided to the
laboratory. It is anticipated that the first of the specimens will be
received in April 2009. Certain of SCTI's diligence obligations with
respect to developing the VSEL technology commence upon receipt of these cell
specimens. Either party may terminate the SRA if Dr. Ratajczak is unable to
perform the research and an acceptable successor is not available, or if
required approval of a review committee at the University of Louisville or ULRF
is not given or is withdrawn. NeoStem may terminate the SRA upon 90 days'
written notice to ULRF and either party may terminate the SRA on 30 days'
written notice in the event of uncured defaults or breaches.
Other
Research
NeoStem
had been reviewing its options with regard to establishing an independent
research facility on its own or in collaboration with other commercial or blood
banking entities on the East Coast in order that NeoStem may expand its research
activities relating to the VSEL technology and potentially other research
projects identified from time to time. In this regard, in July
2008 NeoStem hired a Director of Stem Cell Research and Laboratory Operations
and in October 2008 it entered into the Second SOW with NECC pursuant to which,
among other things, NeoStem may use shared laboratory space and equipment at the
NECC facility to perform company independent research as well as isolation and
processing of VSELs. We have also retained PCT to develop the plan
for the facility in Beijing, China which would support research and cell therapy
development as well as manufacturing operations.
NeoStem
is also in discussions relating to other research in the laboratories of other
research scientists to generate data relating to other clinical applications of
VSELS, including neural, cardiac and ophthalmic, among others.
Regenerative
Procedures with Stem Cell Applications; Other Licensing
Arrangements
In
February 2009, NeoStem entered into a License Agreement with Vincent Giampapa,
M.D., F.A.C.S. pursuant to which the Company acquired a world-wide, exclusive,
royalty bearing, perpetual and irrevocable license, with the right to
sublicense, to certain innovative stem cell technology and applications for
cosmetic facial and body procedures and skin rejuvenation. In January
2009, Dr. Giampapa entered into a three year consulting agreement with the
Company to serve as a consultant in anti-aging. As part of his
agreement, he agrees to travel to China a minimum of three times per year for
the purpose of educating, training and assessing medical staff.
INTELLECTUAL
PROPERTY
NeoStem
is seeking patent protection for its technology. NeoStem acquired and
is prosecuting one pending U.S. patent application which had been filed by
NS California. This patent application is directed to a process by which stem
cells from the bone marrow are mobilized, isolated from adult peripheral blood
and stored. In addition, NeoStem has filed a patent application
directed to low-dose, short course, cytokine induction of stem cell
mobilization.
Pursuant
to the License Agreement, SCTI acquired from ULRF the exclusive, world-wide
license to a patent application and know-how relating to very small
embryonic-like (VSEL) stem cells. The U.S. patent application filed
by ULRF on the VSEL technology is being prosecuted by NeoStem. This
patent relates specifically to a method of isolating and using VSELs. SCTI also
received a license under the License Agreement to unpatented inventions and
discoveries contained in certain manuscripts relating to transplantation of
VSELs and mobilization of VSELs in certain circumstances, which has been pursued
in subsequently filed provisional patent applications.
Pursuant
to a license agreement between the Company and Vincent Giampapa, M.D., F.A.C.S.,
the Company has acquired an exclusive, world-wide license to a granted US
patent, patent application and know-how relating to methods and compositions for
the restoration of age-related tissue loss. There can be no assurance that any
of NeoStem’s patent applications will issue as patents or should patents issue
that they will not be found invalid. The patent position of
biotechnology companies generally is highly uncertain and involves complex
legal, scientific and factual questions.
GOVERNMENTAL
REGULATION
For a
description of matters relating to governmental regulation, please see “Risk
Factors - Risks Relating to NeoStem’s Business - We operate in a highly
regulated environment, and NeoStem's failure to comply with applicable
regulations, registrations and approvals would materially and adversely affect
our business,” “Risk Factors - Risks Relating to NeoStem’s Business - Our adult
stem cell collection, processing and storage business was not contemplated by
many existing laws and regulations” and “Risk Factors - Risks Relating to
NeoStem’s Business - Our new research and development activities present
additional risks.”
COMPETITION
For a
description of matters relating to competition, please see “Risk Factors - Risks
Relating to Competition” and “Risk Factors - Risks Relating to NeoStem’s
Business - Our new research and development activities present additional
risks.”
CHINA
INITIATIVES
In
November 2008, NeoStem signed the Merger Agreement and Share Exchange Agreement
(as more fully described below) to begin its expansion into China.
Separately,
in 2009, NeoStem embarked on other activities to expand its operations into
China.
The
rationale behind the Company’s expansion into China is to accelerate stem cell
therapy, research and development and creation of intellectual property
positions in an environment that is more readily accepting of stem cell
therapies. These initiatives will be lead by U.S. researchers and
physicians in collaboration with experts in the People’s Republic of China
(“PRC”) for each clinical indication being pursued. China has a large
population with a rapidly growing middle and upper class who are becoming
focused on regenerative medicine and can afford such services. We
believe that a collaboration involving these two countries will create immediate
commercial, financial and scientific opportunities.
In
February 2009, NeoStem entered into a License Agreement with Vincent
Giampapa, M.D., F.A.C.S. pursuant to which the Company acquired a
world-wide, exclusive, royalty bearing, perpetual and irrevocable license, with
the right to sublicense, to certain innovative stem cell technology and
applications for cosmetic facial and body procedures and skin
rejuvenation. In January 2009, Dr. Giampapa entered into a three year
consulting agreement with the Company to serve as a consultant in
anti-aging. As part of his agreement, he agrees to travel to China a
minimum of three times per year for the purpose of educating training and
assessing medical staff. In January 2009, on behalf of the Company
Dr. Giampapa traveled to China and presented and demonstrated some of
his skin rejuvenation techniques using autologous adult stem cells at
the 2009 International Stem Cell Technology and Applications Summit in Qingdao,
China. His demonstrations were televised by China Central Television (CCTV),
attracting wide public interest as well as professional interest from the
Summit's audience of leading stem cell practitioners.
On March
6, 2009, the Company and PCT expanded their cell processing agreement for
services in the United States to include PCT’s developing a plan to set up a
stem cell processing and manufacturing operation in Beijing, China that the
Company would pursue in partnership with an off-shore entity. This
plan would support research and cell therapy development and manufacturing
operations. The plan will include a conceptual architectural design,
cost estimates for construction, facility validation to meet cGMP standards,
equipment requirements and estimated costs of equipment procurement, and other
related matters. The plan is required to be completed by April 17,
2009, subject to PCT having received the technical information reasonably
necessary to complete the plan.
The
Company has begun other initiatives to expand its operations into China. RimAsia
has been facilitating certain of these efforts and has paid certain expenses
that the Company has agreed to reimburse. The Company intends to set up a wholly
foreign owned enterprise (“WFOE”) which it will own through an offshore entity.
It is expected that the WFOE will enter into a series of contractual
arrangements memorialized by several documents known as variable interest entity
documents (collectively, the “VIE Documents”) with one or more limited liability
companies to be established in China. We intend to cooperate with a research
organization in China in applying for significant governmental grants to fund
certain research and development activities which may help expansion of the
application of the Company’s stem cell technology. NeoStem is classified as a
foreign enterprise under PRC law, and the WFOE is classified as a
foreign-invested enterprise. Because various regulations in the PRC currently
restrict or prohibit foreign-invested entities from holding certain licenses and
controlling businesses in certain industries, including the Company’s business
of stem cell technology research and application, NeoStem hopes to rely on the
contractual relationships memorialized in the VIE Documents to control the
business, personnel, and financial affairs of the PRC limited liability
companies. The Company is exploring the possibility of these expansion
activities being a substitute for its moving forward with closing the
transactions under the Share Exchange Agreement. See Risk Factors -
“Risks Related to Doing Business in China.”
A
schematic of the structure of the China initiatives follows:
The
NeoStem stem cell business model in China can be broken down as
follows:
|
·
|
Provision of regenerative
medicine therapies using neural stem cells for the treatment of a variety
of CNS (central nervous system) conditions such as ALS, cerebral atrophy,
cerebral palsy, external blunt force traumas, Parkinson’s Disease, spinal
cord injuries, and stroke and related
ailments
|
|
·
|
Provision of regenerative
medicine therapies using autologous mesenchymal stem cells extracted from
bone marrow for the treatment of various limb ischemia
conditions
|
|
·
|
Expansion into additional
therapeutic areas using US based
technologies.
|
|
·
|
Collection, processing and
cryogenic preservation and storage of adult stem cells from peripheral
blood for potential future regenerative medical
treatment
|
|
·
|
There are no commercial scale
providers that offer this service in
China
|
|
·
|
Storage is one of the core
businesses of NeoStem in the US; Combined Company will be able to derive
significant operating support and technical knowledge in establishing on a
commercial scale such an operation with international best practices and
standards
|
|
·
|
Provision of stem cell based
treatments for cosmetic and anti-aging
applications
|
|
·
|
Distribution of related health
supplements and nutriceutical
products
|
|
·
|
Distributor network spanning
multiple provinces.
|
|
·
|
Research and commercial
development on VSEL (Very Small Embryonic Like) stem cell technology with
NBS and its US R&D partner, the University of Louisville, the
institution at which the VSEL technology was developed and at which
research with NBS is
continuing
|
|
·
|
Establishment of dedicated
R&D facility in Beijing in conjunction with several major PRC medical
and research institutes is
anticipated
|
|
·
|
Addressable
market for CNS conditions alone is
significant
|
|
·
|
Estimates for CNS market alone
are 25-29 million, comprising 10 million victims of stroke, 10 million
afflicted by cerebellum atrophy, 5 million patients with cerebral palsy,
and the balance suffering from a number of conditions including ALS and
Parkinson’s
|
|
·
|
Domestic market remains largely
untapped
|
|
·
|
PRC Domestic market remains
largely untapped
|
|
·
|
Less than 3,000 patients have
been treated to date throughout
China
|
|
·
|
Medical
tourism also shows potential
|
|
·
|
Estimated 23 million potential
stem cell patients from affluent countries world-wide with one of four
major nervous system diseases that can be treated by stem cell
treatment
|
MERGER
AND
SHARE EXCHANGE
Agreement and Plan of
Merger
On
November 2, 2008, the Company entered into an Agreement and Plan of Merger (the
“Merger Agreement”), with China Biopharmaceuticals Holdings, Inc., a Delaware
corporation ("CBH"), China Biopharmaceuticals Corp., a British Virgin Islands
corporation and wholly-owned subsidiary of CBH ("CBC"), and CBH Acquisition LLC,
a Delaware limited liability company and wholly-owned subsidiary of NeoStem
("Merger Sub"). The Merger Agreement contemplates the merger of CBH with and
into Merger Sub, with Merger Sub as the surviving entity (the “Merger”);
provided, that prior to the consummation of the Merger, CBH will spin off all of
its shares of capital stock of CBC to CBH’s stockholders in a distribution so
that the only material assets of CBH following such spin-off (the "Spin-off")
will be 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 (the "PRC"), plus net cash which
shall not be less than $550,000. Erye specializes in research and development,
production and sales of pharmaceutical products, as well as chemicals used in
pharmaceutical products. Erye, which has been in business for more than 50
years, currently manufactures over 100 drugs on seven Good Manufacturing
Practices (GMP) lines, including small molecule drugs.
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 ("CBH Common
Stock"), issued and outstanding immediately prior to the effective time of the
Merger (the "Effective Time") will be converted into the right to receive, in
the aggregate, 7,500,000 shares of NeoStem Common Stock (of which 150,000 shares
will be held in escrow pursuant to the terms of an escrow agreement to be
entered into between CBH and NeoStem). Subject to the cancellation of
outstanding warrants to purchase shares of CBH Common Stock held by RimAsia
Capital Partners, L.P. ("RimAsia"), a principal stockholder of NeoStem and the
sole holder of shares of Series B Convertible Preferred Stock, par value $0.01
per share, of CBH (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 will be converted into (i) 5,383,009 shares of NeoStem Common
Stock, (ii) 6,977,512 shares of Series C Convertible Preferred Stock, without
par value, of NeoStem, each with a liquidation preference of $1.125 per share
and convertible into shares of NeoStem Common Stock at a conversion price of
$.90 per share, and (iii) warrants to purchase 2,400,000 shares of NeoStem
Common Stock at an exercise price of $0.80 per share.
At the
Effective Time, in exchange for cancellation of all of the outstanding shares of
Series A Convertible Preferred Stock, par value $.01 per share, of CBH (the "CBH
Series A Preferred Stock") held by Stephen Globus, a director of CBH, and/or
related persons, NeoStem will issue to Mr. Globus and/or related persons an
aggregate of 50,000 shares of NeoStem Common Stock. NeoStem also will issue
60,000 shares of NeoStem Common Stock to Mr. Globus and 40,000 shares of NeoStem
Common Stock to Chris Peng Mao, the Chief Executive Officer of CBH, in exchange
for the cancellation and the satisfaction in full of indebtedness in the
aggregate principal amount of $90,000, plus any and all accrued but unpaid
interest thereon, and other obligations of CBH to Globus and Mao. NeoStem will
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.
NeoStem also will issue 200,000 shares to CBC to be held in escrow, payable if
NeoStem successfully consummates its previously announced acquisition of control
of Shandong New Medicine Research Institute of Integrated Traditional and
Western Medicine Limited Liability Company and there are no further liabilities
above $450,000.
Also at
the Effective Time, subject to acceptance by the holders of all of the
outstanding warrants to purchase shares of CBH Common Stock (other than warrants
held by RimAsia), such warrants shall be canceled and the holders thereof shall
receive warrants to purchase up to an aggregate of up to 2,012,097 shares of
NeoStem Common Stock at an exercise price of $2.50 per share.
Upon
consummation of the transactions contemplated by the Merger, NeoStem will own
51% of the ownership interests in Erye, and Suzhou Erye Economy and Trading Co.
Ltd., a limited liability company organized under the laws of the PRC ("EET"),
will own the remaining 49% ownership interest. In connection with the execution
of the Merger Agreement, NeoStem, Merger Sub and EET have negotiated a revised
joint venture agreement (the "Joint Venture Agreement"), which, subject to
finalization and approval by the requisite PRC governmental authorities, will
become effective and will govern the rights and obligations with respect to
their respective ownership interests in Erye. Pursuant to the terms and
conditions of the 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 NeoStem's 51% interest in Erye; and
(iii) 6% of the net profit will be distributed to NeoStem directly for NeoStem’s
operating expenses. In the event of the sale of all of the assets of Erye or
liquidation of Erye, NeoStem 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.
$7,100,000), NeoStem will be entitled to receive the return of such additional
paid-in capital.
Pursuant
to the Merger Agreement, NeoStem has agreed to use its reasonable best efforts to cause the members of NeoStem's Board
of Directors to consist of the following five members promptly following the
Effective Time: Robin L. Smith (Chairman), current Chairman of the Board and
Chief Executive Officer of NeoStem; Madam Zhang Jian, the Chairman and Chief
Financial Officer of CBH, the General Manager of Erye and a 10% holder of EET,
and Richard Berman, Steven S. Myers and Joseph Zuckerman, each a director of
NeoStem (the latter three to be independent directors, as defined under the NYSE
Amex listing standards). NeoStem’s intention thereafter will be
to cause the number of members constituting the NeoStem Board of Directors to be
increased from five to seven, in accordance with NeoStem’s by-laws, as amended,
and to fill the two vacancies created thereby with one additional independent
director (as defined under the NYSE Amex listing standards) to be selected by a
nominating committee of the NeoStem Board of Directors and with Eric Wei, the
managing partner of RimAsia.
The
Merger Agreement acknowledges that in its discretion the Compensation Committee
of NeoStem’s Board of Directors may grant bonuses of up to 1,000,000 shares or
options under any equity compensation plan in connection with the closing of the
transactions under the Merger Agreement. The Merger Agreement also
provides that options outstanding immediately prior to the closing of the
transactions under the Merger Agreement to purchase shares of common stock held
by current employees, advisory board members, directors and certain consultants
of the Company, in the sole discretion of the Compensation Committee, may be
amended, cancelled and reissued or otherwise modified so that the exercise price
shall be $.80 per share.
In
connection with the Merger, NeoStem intends to file with the Securities and
Exchange Commission (the “SEC”) a combined registration statement and proxy
statement on Form S-4 (including any amendments, supplements and exhibits
thereto, the “Proxy Statement/Registration Statement”) with respect to, among
other things, the shares of NeoStem Common Stock to be issued in the Merger (the
"Issuance") and a proposed amendment to NeoStem’s certificate of incorporation
to effect an increase in NeoStem’s authorized shares of preferred stock, without
par value, that may be necessary to consummate the transactions contemplated by
the Merger Agreement (the “Charter Amendment"). The Merger has been approved by
the NeoStem Board of Directors. The Issuance and Charter Amendment contemplated
by the Merger Agreement are subject to approval by the stockholders of NeoStem
and the Merger, the Spin-Off and the other transactions contemplated by the
Merger Agreement are subject to approval by the stockholders of
CBH.
In
connection with execution of the Merger Agreement, each of the officers and
directors of CBH, RimAsia, Erye and EET have entered into a lock-up and voting
agreement, pursuant to which they have 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 are prohibited from selling their CBH Common Stock and/or
NeoStem Common Stock from November 2, 2008 through the expiration of the
six-month period immediately following the consummation of the transactions
contemplated by the Merger Agreement (the "Lock-Up Period"). Similarly, the
officers and directors of NeoStem have entered into a lock-up and voting
agreement, pursuant to which they have agreed to vote their shares of NeoStem
Common Stock in favor of the Issuance and are prohibited from selling their
NeoStem Common Stock during the Lock-Up Period.
The
transactions contemplated by the Merger Agreement are subject to the
authorization for listing on the NYSE Amex (or any other stock exchange on which
shares of NeoStem Common Stock are listed) of the shares to be issued in
connection with the Merger, shareholder approval, approval of NeoStem's
acquisition of 51% ownership interest in Erye by relevant PRC governmental
authorities, receipt of a fairness opinion and other customary closing
conditions set forth in the Merger Agreement. The Merger currently is expected
to be consummated in the second quarter of 2009.
The
foregoing description of the Merger Agreement is not complete and is qualified
in its entirety by reference to the Merger Agreement, which is incorporated by
reference as Exhibit 2(a) hereto.
Share
Exchange
On
November 2, 2008, the Company entered into a Share Exchange Agreement (the
“Share Exchange Agreement”), with China StemCell Medical Holding Limited, a Hong
Kong company (the "HK Entity"), Shandong New Medicine Research Institute of
Integrated Traditional and Western Medicine Limited Liability Company, a China
limited liability company ("Shandong"), Beijing HuaMeiTai Bio-technology Limited
Liability Company (“WFOE”) and Zhao Shuwei, the sole shareholder of the HK
Entity (“HK Shareholder”), pursuant to which NeoStem agreed to acquire from the
HK Entity all of the outstanding interests in the HK Entity, and through a
series of contractual arrangements described below, seeks to obtain certain
benefits from Shandong. Shandong is engaged in the business (the "Shandong
Business") of research, development popularization and transference of
regenerative medicine technology (except for those items for which it does not
have special approval) in the PRC.
The HK
Shareholder owns 100% of the ownership interests in the HK Entity, and the HK
Entity owns 100% of ownership interests in the WFOE. The WFOE seeks to obtain
certain benefits from Shandong through a series of contractual arrangements
memorialized through several documents known as variable interest entity
documents (collectively, the “VIE Documents”). The relevant VIE Documents, to
which the WFOE, Shandong and the founder of Shandong, Dr. Wang Taihua, are
parties, include a power of attorney, an exclusive technical and consulting
service agreement, a loan agreement, a share pledge agreement and an exclusive
option agreement. In November 2008, RimAsia extended a loan to the
WFOE in the amount of $150,000 for the purpose of capitalizing it, which NeoStem
has acknowledged is a cost of closing the Share Exchange that shall be satisfied
at such closing.
Pursuant
to the terms and subject to the conditions set forth in the Share Exchange
Agreement, NeoStem will acquire all of the outstanding shares of capital stock
of the HK Entity (the "HK Shares"), in exchange (the "Share Exchange") for up to
5,000,000 shares (the “Exchange Shares”) of NeoStem Common Stock. The Exchange
Shares will be issuable at the closing of the transactions contemplated by the
Share Exchange Agreement (the "Closing") as follows: (i) 4,000,000 shares of
NeoStem Common Stock will be issued to the HK Shareholder and (ii) 1,000,000
shares of NeoStem Common Stock will be issued to the HK Shareholder in escrow
(the "Escrow Shares"), the certificates for which will be held pursuant to the
terms of an escrow agreement to be entered into between NeoStem and the HK
Shareholder. Subject to the terms and conditions of the escrow agreement,
500,000 Escrow Shares will be released from escrow within 30 days after the
first 50,000,000 RMB (or approximately U.S. $7,100,000) sales revenue are
achieved in the PRC by Shandong (the "Revenue Milestone") and 500,000 Escrow
Shares will be released within 30 days after the last of three collection and
storage banks in three provinces in the PRC (i.e., one such bank in each
such province) is established by Shandong (the "Storage Bank Milestone").
500,000 Escrow Shares will revert to NeoStem if the Revenue Milestone is not met
on or before December 31, 2009 and 500,000 Escrow Shares will revert to NeoStem
if the Storage Bank Milestone is not met on or before the date of the second
anniversary of the Closing.
In
connection with the Share Exchange, NeoStem intends to file with the SEC the
combined Proxy Statement/Registration Statement referred to under Agreement and
Plan of Merger (above), to, among other things, seek stockholder approval of the
Share Exchange. The Share Exchange has been approved by the NeoStem Board of
Directors, subject to approval by the stockholders of NeoStem.
The
transactions contemplated by the Share Exchange Agreement are subject to the
authorization for listing on the NYSE Amex (or any other stock exchange on which
shares of NeoStem Common Stock are listed or quoted) of the Exchange Shares,
stockholder approval, regulatory approval and other customary closing conditions
set forth in the Share Exchange Agreement. The Share Exchange currently is
expected to close in the second quarter of 2009. In addition to the
other closing conditions set forth in the Share Exchange Agreement, NeoStem’s
obligation to close is also conditioned upon the results of due diligence,
including but not limited to, legal, financial and business due diligence, being
reasonably satisfactory to it. NeoStem, as well as the other parties,
also have the right to terminate the Share Exchange Agreement by written notice
to the other parties if the transactions contemplated thereby are not
consummated by March 31, 2009.
The
foregoing description of the Share Exchange Agreement is not complete and is
qualified in its entirety by reference to the Share Exchange Agreement, which is
incorporated by reference as Exhibit 2(b) hereto.
FINANCING
ACTIVITIES
2009
Financing Activities
In order to move forward certain
research and development activities, strategic relationships in various clinical
and therapeutic areas as well as to support activities related to the Merger
Agreement and Share Exchange Agreement, and other ongoing obligations of the
Company, in March and February 2009, the Company issued promissory notes (the
“RimAsia Notes”) totaling $1,150,000 to RimAsia Capital Partners, L.P.
(“RimAsia”), a principal stock holder of the Company. The RimAsia
Notes bear interest at a rate equal to 10% per annum and mature on October 31,
2009 except that they mature earlier in the case of an equity financing by the
Company that raises in excess of $10,000,000.
2008
Financing Activities
On May
21, 2008, NeoStem completed a private placement of securities pursuant to which
$900,000 in gross proceeds was raised (the “May 2008 private placement”). On May
20 and May 21, 2008, NeoStem entered into Subscription Agreements (the
"Subscription Agreements") with 16 accredited investors listed therein (the
"Investors"). Pursuant to the Subscription Agreements, NeoStem issued to each
Investor units comprised of one share of its 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 $1.20. The
warrants are not exercisable for a period of six months and are redeemable by
NeoStem if the NeoStem Common Stock trades at a price equal to or in excess of
$2.40 for a specified period of time. In the May 2008 private placement, NeoStem
issued an aggregate of 750,006 units to Investors consisting of 750,006 shares
of NeoStem Common Stock and 750,006 redeemable warrants, for an aggregate
purchase price of $900,000. Dr. Robin L. Smith, NeoStem’s Chairman and Chief
Executive Officer, purchased 16,667 units for a purchase price of $20,000 and
Catherine M. Vaczy, NeoStem’s Vice President and General Counsel, purchased
7,500 units for a purchase price of $9,000. New England Cryogenic Center, Inc.,
or NECC, one of the largest full-service cryogenic laboratories in the world and
a strategic partner of NeoStem since October 2007, also participated in the
offering. Pursuant to the terms of the Subscription Agreements,
NeoStem was required to prepare and file no later than forty-five days (with
certain exceptions) after the closing of the May 2008 private placement, a
Registration Statement with the SEC to register the shares of NeoStem Common
Stock issued to Investors and the shares of NeoStem Common Stock underlying the
warrants. Such registration statement was filed with the SEC on July
1, 2008.
In
connection with the May 2008 private placement, NeoStem paid as finders’ fees to
accredited investors, cash in the amount of $3,240 and issued five year warrants
to purchase an aggregate of 35,703 shares of NeoStem Common Stock. Such warrants
contain generally the same terms as those sold to the Investors, except they
contain a cashless exercise feature and piggyback registration rights. Cash in
the amount of 4% of the proceeds received by NeoStem from the future exercise of
30,000 of the Investor warrants is also payable to one of the
finders.
On
September 2, 2008, NeoStem completed a private placement of securities pursuant
to which $1,250,000 in gross proceeds was raised (the “September 2008 private
placement”). On September 2, 2008, NeoStem entered into a
subscription agreement with RimAsia Capital Partners, L.P. Pursuant
to the subscription agreement, NeoStem issued to RimAsia one million units, at a
per-unit price of $1.25, 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. The warrants are not
exercisable for a period of six months and are redeemable by NeoStem if the
NeoStem Common Stock trades at a price equal to or in excess of $3.50 for a
specified period of time or the dollar value of the trading volume of the
NeoStem Common Stock for each day during a specified period of time equals or
exceeds $100,000. In the September 2008 private placement, NeoStem
thus issued 1,000,000 units to RimAsia consisting of 1,000,000 shares of NeoStem
Common Stock and 1,000,000 redeemable warrants, for an aggregate purchase price
of $1,250,000. Pursuant to the terms of the subscription agreement,
NeoStem is required to prepare and file no later than 180 days after the closing
of the September 2008 private placement, a registration statement with the SEC
to register the resale of the shares of NeoStem Common Stock issued to RimAsia
and the shares of NeoStem Common Stock underlying the warrants; provided, that
the Company is not liable to pay specified amounts under the terms of the
Subscription Agreement if the Company does not file such a registration
statement in a timely manner because the Company does not have available audited
financial statements required by the SEC of a company with which the Company has
signed a letter of intent to acquire.
On
December 18, 2008, Neostem and RimAsia entered into a letter agreement (the
“Amendment”) pursuant to which, among other things, the warrants issued to
RimAsia in the September 2008 private placement were amended to restrict their
exercisability in the event that such exercise would increase RimAsia’s
beneficial ownership of NeoStem’s Common Stock to above 19.9%. The restriction
on exercisability also applies to warrants issued in any proposed 2009 capital
raise and as further discussed below. The warrants are not
exercisable to the extent that the number of shares of Common Stock to be issued
pursuant to such exercise would exceed, when aggregated with all other shares of
Common Stock beneficially owned by RimAsia at such time, the number of shares of
Common Stock which would result in RimAsia beneficially owning in excess of
19.9% of NeoStem’s Common Stock. Such restrictions on exercisability
shall not apply upon a merger, consolidation or sale of all or substantially all
of the assets of NeoStem if the shareholders of NeoStem prior to such
transaction do not own more than 50% of the entity succeeding to the business of
NeoStem after such transaction, and such restriction does not apply following
any exercise of any mandatory conversion or redemption rights by NeoStem. Such
restriction on exercise shall remain in place until such time as approval of
NeoStem’s shareholders shall be obtained, which proposal is to be included in
the Joint Proxy Statement/Prospectus to be filed in connection with the proposed
Merger. See also above “ – Merger and Share Exchange – Agreement and
Plan of Merger” for information on NeoStem Class B Warrants and NeoStem Class C
Convertible Preferred Stock to be issued to RimAsia in connection with the
Merger, which are also the subject of the Amendment and the restriction on
exercisability and conversion, respectively. See also the description
of the November 2008 private placement (below), in which securities were issued
of which RimAsia may be deemed the beneficial owner, which would also be
included, as appropriate, in any calculation under the
Amendment.
On October 23, 2008, NeoStem completed
a private placement of securities pursuant to which $250,000 in gross proceeds
was raised (the “October 2008 private placement”). On October 15,
2008, NeoStem entered into a subscription agreement with an accredited
investor. Pursuant to the subscription agreement, NeoStem issued to
the investor 200,000 units at a per-unit price of $1.25, each unit comprised of
one share of NeoStem Common Stock and one five-year warrant to purchase one
share of NeoStem Common Stock at a purchase price of $1.75 per share. The
warrants are not exercisable for a period of six months. In the
October 2008 private placement, NeoStem thus issued 200,000 units to the
investor consisting of 200,000 shares of NeoStem Common Stock and 200,000
warrants, for an aggregate purchase price of $250,000. The issuance
of the units was subject to the prior approval of the NYSE Amex, which approval
was obtained on October 23, 2008, and on that date the units were issued.
Pursuant to the terms of
the subscription agreement, NeoStem is required to prepare and file no later
than 180 days after the final closing of the October 2008 private placement, a
registration statement with the SEC to register the resale of the shares of
NeoStem Common Stock issued to the investor and the shares of NeoStem Common
Stock underlying the warrants; provided, that the Company is not liable to pay
specified amounts under the terms of the Subscription Agreement if the Company
does not file such a registration statement in a timely manner because the
Company does not have available audited financial statements required by the SEC
of a company the Company proposes to acquire.
On
November 26, 2008, NeoStem completed a private placement of securities pursuant
to which $500,000 in gross proceeds was raised (the “November 2008 private
placement”). On November 7, 2008, NeoStem entered into a subscription agreement
with Fullbright Finance Limited, a corporation organized under the laws of the
British Virgin Islands and an affiliate of EET. Pursuant to the
subscription agreement, NeoStem issued to the investor 400,000 units at a
per-unit price of $1.25, 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. The warrants are
not exercisable for a period of six months and are redeemable by NeoStem if the
NeoStem Common Stock trades at a price equal to or in excess of $3.50 for a
specified period of time. In the November 2008 private placement, NeoStem thus
issued 400,000 Units to the investor consisting of 400,000 shares of NeoStem
Common Stock and 400,000 redeemable warrants, for an aggregate purchase price of
$500,000. The issuance of the units was subject to the prior approval of the
NYSE Amex. Pursuant to the terms of the subscription agreement,
NeoStem is required to prepare and file no later than 180 days after the final
closing of the November 2008 private placement, a registration statement with
the SEC to register the resale of the shares of NeoStem Common Stock issued to
the investor and the shares of NeoStem Common Stock underlying the warrants;
provided, that the Company is not liable to pay specified amounts under the
terms of the Subscription Agreement if the Company does not file such a
registration statement in a timely manner because the Company does not have
available audited financial statements required by the SEC of a company the
Company proposes to acquire. 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.
2007
Financing Activities
In
January 2007, NeoStem had entered into a strategic alliance with UTEK, a
specialty finance company focused on technology transfer, as part of its plan to
move forward to expand its proprietary position in the adult stem cell
collection and storage arena as well as the burgeoning field of regenerative
medicine. The purpose of the agreement was to identify potential
technology acquisition opportunities that fit NeoStem’s strategic
vision. Through its strategic alliance agreements with companies in
exchange for their equity securities, UTEK assists such companies in enhancing
their new product pipeline by facilitating the identification and acquisition of
innovative technologies from universities and research laboratories worldwide.
UTEK is a business development company with operations in the United States,
United Kingdom and Israel. In January 2007, NeoStem issued 12,000 shares of
NeoStem Common Stock to UTEK, vesting as to 1,000 shares per month commencing
January 2007. See above for information on NeoStem’s acquisition of the
VSEL technology in November 2007 via a transaction with UTEK.
In
January and February 2007, NeoStem raised an aggregate of $2,500,000
through the private placement of 250,000 units at a price of $10.00 per unit to
35 accredited investors (the “January 2007 private placement”). Each unit
was comprised of two shares of NeoStem Common Stock, one redeemable seven-year
warrant to purchase one share of NeoStem Common Stock at a purchase price of
$8.00 per share and one non-redeemable seven-year warrant to purchase one share
of NeoStem Common Stock at a purchase price of $8.00 per share. NeoStem issued
an aggregate of 500,000 shares of NeoStem Common Stock, and warrants to purchase
up to an aggregate of 500,000 shares of NeoStem Common Stock at an exercise
price of $8.00 per share. Emerging Growth Equities, Ltd (“EGE”), the placement
agent for the January 2007 private placement, received a cash fee equal to
$171,275 and was entitled to expense reimbursement not to exceed $50,000.
NeoStem also issued to EGE redeemable seven-year warrants to purchase 34,355
shares of NeoStem Common Stock at a purchase price of $5.00 per share,
redeemable seven-year warrants to purchase 17,127 shares of NeoStem Common Stock
at a purchase price of $8.00 per share and non-redeemable seven-year warrants to
purchase 17,127 shares of NeoStem Common Stock at a purchase price of $8.00 per
share. Pursuant to the terms of the January 2007 private placement, NeoStem
was obligated to prepare and file, no later than ten days after the filing of
NeoStem’s Annual Report on Form 10-K, a registration statement with the SEC
to register the shares of NeoStem Common Stock issued to the investors and the
shares of NeoStem Common Stock underlying the warrants issued to the investors
and to EGE. Such registration statement was filed with the SEC on
February 7, 2007. The January 2007 private placement was conditioned
upon entry by the NeoStem Board of Directors and executive officers into a
lock-up agreement, pursuant to which such directors and officers will not,
without the consent of EGE, sell or transfer their NeoStem Common Stock until
the earlier of: (a) six months following the effective date of the
registration statement filed to register the shares underlying the units, or
(b) twelve months following the sale of the units. This registration
statement was declared effective by the SEC on April 25, 2007.
In
August, 2007, NeoStem raised an aggregate of $6,350,000 through a best efforts
underwritten public offering of 1,270,000 units at a price of $5.00 per unit
(the “August 2007 public offering”). Each unit consisted of one share of NeoStem
Common Stock and a five year Class A warrant to purchase one-half a share of
NeoStem Common Stock at a price of $6.00 per share. Thus, 1,000 units consisted
of 1,000 shares of NeoStem Common Stock and Class A warrants to purchase 500
shares of NeoStem Common Stock. The aggregate number of units sold was
1,270,000, the aggregate number of shares of NeoStem Common Stock included
within the units was 1,270,000 and the aggregate number of Class A Warrants
included within the units was 535,000. Mercer Capital, Ltd. (“Mercer”) acted as
lead underwriter for the August 2007 public offering. In connection with this
offering, NeoStem issued five year warrants to purchase an aggregate of 95,250
shares of NeoStem Common Stock at $6.50 per share to Mercer and other
participating underwriters. After payment of underwriting commissions and
expenses and other costs of the August 2007 public offering, the aggregate net
proceeds to NeoStem were $5,620,000.
2006
Financing Activities
On
December 30, 2005, and in January 2006, NeoStem consummated the
private placement sale to 19 accredited investors of units consisting of
convertible promissory notes and detachable warrants (“the WestPark private
placement”). Gross proceeds raised were $250,000 on December 30, 2005 and
$250,000 in January 2006, totaling an aggregate of $500,000 in gross
proceeds. Each unit was comprised of: (a) a nine month note in the
principal amount of $25,000 bearing 9% simple interest, payable semi-annually,
with the 2nd payment paid upon maturity, convertible into shares of NeoStem
Common Stock at an initial conversion price of $6.00 per share; and
(b) 4,167 detachable three year warrants, each for the purchase of one
share of NeoStem Common Stock at an exercise price of $12.00 per share. The
notes were subject to mandatory conversion by NeoStem if the closing price of
the NeoStem Common Stock had been at least $18.00 for a period of at least 10
consecutive trading days prior to the date on which notice of conversion was
sent by NeoStem to the holders of the promissory notes, and if the underlying
shares were then registered for resale with the SEC. Holders of the units are
entitled to certain registration rights (see below). NeoStem issued to WestPark
Capital, Inc., the placement agent for the WestPark private placement,
(i) 5,000 shares of NeoStem Common Stock (2,500 shares on December 30,
2005 and 2,500 shares in January 2006); and (ii) warrants to purchase
an aggregate of 8,334 shares of NeoStem Common Stock (4,167 on December 30,
2005 and 4,167 in January 2006). By January 2007 all the convertible
promissory notes issued in the WestPark private placement had either been
converted into shares of NeoStem Common Stock or repaid by NeoStem (see
below).
In
May 2006, NeoStem entered into an advisory agreement with Duncan Capital
Group LLC (“Duncan”). Pursuant to the advisory agreement, Duncan provided to
NeoStem on a non-exclusive best efforts basis, services as a financial
consultant in connection with any equity or debt financing, Merger, acquisition
as well as with other financial matters. In return for these services, NeoStem
was paying to Duncan a monthly retainer fee of $7,500 (50% of which could be
paid by NeoStem in shares of its NeoStem Common Stock valued at fair market
value) and reimbursing it for its reasonable out-of-pocket expenses up to
$12,000. Pursuant to the advisory agreement, Duncan also agreed that it or an
affiliate would act as lead investor in a proposed private placement of
securities, for a fee of $200,000 in cash and 24,000 shares of restricted
NeoStem Common Stock. On June 2, 2006 (the “June 2006 private
placement”), NeoStem entered into a securities purchase agreement with 17
accredited investors (the “June 2006 investors”). DCI Master LDC, an
affiliate of Duncan, acted as lead investor. Duncan received its fee as
described above. NeoStem issued to each June 2006 investor shares of its
NeoStem Common Stock at a per-share price of $4.40 along with a five-year
warrant to purchase a number of shares of NeoStem Common Stock equal to 50% of
the number of shares of NeoStem Common Stock purchased by the June 2006
investor (together with the NeoStem Common Stock issued, the “June 2006
securities”). The gross proceeds from this sale were $2,079,000. In
February 2007, the term of this agreement was extended through
December 2007. Additionally, it was amended to provide that the monthly
retainer fee be entirely paid by issuing to Duncan an aggregate of 15,000 shares
of NeoStem Common Stock vesting monthly over the remaining term of the
agreement. The vesting of these shares was accelerated in July 2007 such that
they were fully vested and the advisory agreement was canceled in August
2007.
Pursuant
to the securities purchase agreement for the June 2006 private placement,
NeoStem expanded the size of its Board to four directors, and appointed
Dr. Robin L. Smith as Chairman of the Board and Chief Executive Officer of
NeoStem. Dr. Smith, who was previously Chairman of the Advisory Board of
NeoStem, purchased 5,000 shares of NeoStem Common Stock and warrants to purchase
2,400 shares of NeoStem Common Stock pursuant to the terms of the securities
purchase agreement. NeoStem also agreed to expand the size of the Board upon the
initial closing under the securities purchase agreement to permit DCI Master LDC
to designate one additional independent member to the NeoStem Board of Directors
reasonably acceptable to NeoStem. Richard Berman was originally appointed to the
NeoStem Board of Directors in November 2006 to serve as such designee. The
securities purchase agreement also prohibits NeoStem from taking certain action
without the approval of a majority of the Board of Directors for so long as the
purchasers in the June 2006 private placement own at least 20% of the
NeoStem Common Stock, including making loans, guarantying indebtedness,
incurring indebtedness that is not already included in a Board approved budget
on the date of the securities purchase agreement that exceeds $100,000,
encumbering NeoStem’s technology and intellectual property or entering into new
or amending employment agreements with executive officers. DCI Master LDC was
also granted access to Company facilities and personnel and given other
information rights. Pursuant to the securities purchase agreement, all then
current and future officers and directors of NeoStem were to not, without the
prior written consent of DCI Master LDC, dispose of any shares of capital stock
of NeoStem, or any securities convertible into, or exchangeable for or
containing rights to purchase, shares of capital stock of NeoStem until three
months after the effective date of the registration statement filed with the SEC
to register the securities issued in the June 2006 private placement
(described below). Such registration statement was declared effective on
November 6, 2006.
The
officers of NeoStem, as a condition of the initial closing under the securities
purchase agreement for the June 2006 private placement, entered into letter
agreements with NeoStem pursuant to which they converted an aggregate of
$278,653 of accrued salary into shares of NeoStem Common Stock at a per share
price of $4.40. After adjustments for applicable payroll and withholding taxes
which were paid by NeoStem, NeoStem issued to such officers an aggregate of
37,998 shares of NeoStem Common Stock. NeoStem also adopted an Executive Officer
Compensation Plan, effective as of the date of closing of the securities
purchase agreement and pursuant to the letter agreements each officer agreed to
be bound by the Executive Officer Compensation Plan. In addition to the
conversion of accrued salary, the letter agreements provided for a reduction by
25% in base salary for each officer until NeoStem achieves certain milestones,
the granting of options to purchase shares of NeoStem Common Stock under
NeoStem’s 2003 Equity Participation Plan which become exercisable upon NeoStem
achieving certain revenue milestones and the acceleration of the vesting of
certain options and restricted shares held by the officers. In
January 2007, the milestones relating to the reduction in base salary had
been achieved; however, the same officers (and in addition the Chief Executive
Officer who became an employee in connection with the June 2006 private
placement) agreed to subsequent amendments to or replacements of their
employment agreements which provided instead for a 20% reduction in base salary
and/or agreement by the officer to extend their employment term, as well as
certain additional or amended terms.
In
connection with the securities purchase agreement, on June 2, 2006 NeoStem
entered into a registration rights agreement with each of the June 2006
investors (the “June 2006 registration rights agreement”). Pursuant to the
June 2006 registration rights agreement, NeoStem was obligated to prepare
and file no later than June 30, 2006 a registration statement with the SEC
to register the shares of NeoStem Common Stock and the shares of Common Stock
underlying the warrants issued in the June 2006 private placement. NeoStem
and the June 2006 investors agreed to amend the registration rights
agreement and extend the due date of the registration statement to
August 31, 2006. A registration statement was filed pursuant thereto and
declared effective by the SEC on November 6, 2006.
Pursuant
to the terms of the WestPark private placement (described above), NeoStem agreed
to file with the SEC and have effective by July 31, 2006, a registration
statement registering the resale by the investors in the WestPark private
placement of the shares of NeoStem Common Stock underlying the convertible
promissory notes and the warrants sold in the WestPark private placement. In the
event NeoStem did not do so, (i) the conversion price of the convertible
promissory notes would be reduced by 5% each month, subject to a floor of $4.00;
(ii) the exercise price of the warrants would be reduced by 5% each month,
subject to a floor of $10.00; and (iii) the warrants could be exercised
pursuant to a cashless exercise provision. NeoStem did not have the registration
statement effective by July 31, 2006 and requested that the investors in
the WestPark private placement extend the date by which the registration
statement was required to be effective until February 28, 2007. NeoStem
also offered to the investors the option of (A) extending the term of the
convertible note for an additional four months from the maturity date in
consideration for which (i) NeoStem would issue to the investor for each
$25,000 in principal amount of the convertible note 568 shares of unregistered
NeoStem Common Stock; and (ii) the exercise price per warrant would be
reduced from $12.00 to $8.00, or (B) converting the convertible note into
shares of NeoStem Common Stock in consideration for which (i) the
conversion price per conversion share would be reduced to $4.40;
(ii) NeoStem would issue to the investor for each $25,000 in principal
amount of the Note, 1,136 shares of NeoStem Common Stock; (iii) the
exercise price per warrant would be reduced from $12.00 to $8.00; and
(iv) a new warrant would be issued substantially on the same terms as the
original Warrant to purchase an additional 4,167 shares of NeoStem Common Stock
for each $25,000 in principal amount of the convertible note at an exercise
price of $8.00 per share. Pursuant to this, the investor was also being asked to
waive any and all penalties and liquidated damages accumulated as of the date of
the agreement.
In
September 2006, NeoStem revised the offer relating to the option of
conversion of the WestPark Notes by eliminating the issuance of the additional
1,136 shares of NeoStem Common Stock for each $25,000 in principal amount of the
Note converted. As of October 30, 2006, investors holding $425,000 of the
$500,000 of convertible promissory notes had agreed to convert them into shares
of NeoStem Common Stock and $162,500 (of which $137,500 in principal amount was
subsequently transferred and converted by the transferees) had agreed to extend
the term of the convertible promissory notes on the terms set forth above. On
November 6, 2006, the registration statement was declared effective. In
January 2007, the remaining $75,000 in outstanding convertible promissory
notes were repaid.
During
July and August 2006, NeoStem raised an aggregate of $1,750,000
through the private placement to 34 accredited investors of 397,727 shares of
its NeoStem Common Stock at $4.40 per share and warrants to purchase 198,864
shares of NeoStem Common Stock at $8.00 per share (the “Summer 2006 private
placement”). The terms of the Summer 2006 private placement were substantially
similar to the terms of the June 2006 private placement.
FORMER
BUSINESS OPERATIONS
NeoStem
was incorporated under the laws of the State of Delaware in September 1980
under the name Fidelity Medical Services, Inc. Under prior management it
engaged in various businesses, including the development and sale of medical
imaging products, the retail sale and wholesale distribution of stationery and
related office products in the United Kingdom, operation of a property and
casualty insurance business, and ultimately through June 2002 the sale of
extended warranties and service contracts over the Internet covering automotive,
home, office, personal electronics, home appliances, computers and garden
equipment. In June 2002, management determined, in light of continuing
operating losses, to discontinue its warranty and service contract business and
to seek new business opportunities for NeoStem. NeoStem entered a new line of
business where it provided capital and guidance to companies in multiple sectors
of the healthcare and life science industries, in return for a percentage of
revenues, royalty fees, licensing fees and other product sales of the target
companies. In addition to such activities, since June 2002 NeoStem
continued to “run off” the sale of its warranties and service contracts. This
run off was completed in March 2007.
EMPLOYEES
As of
March 27, 2009, NeoStem had 16 employees, of which 11 are
full-time.
ITEM
1A. RISK FACTORS
THE
RISKS DESCRIBED BELOW ARE NOT THE ONLY RISKS FACING THE COMPANY. ADDITIONAL
RISKS THAT THE COMPANY DOES NOT YET KNOW OF OR THAT IT CURRENTLY THINKS ARE
IMMATERIAL MAY ALSO IMPAIR ITS BUSINESS OPERATIONS. IF ANY OF THE RISKS OCCUR,
ITS BUSINESS STRATEGY, FINANCIAL CONDITION OR OPERATING RESULTS COULD BE
ADVERSELY AFFECTED.
RISKS
RELATING TO THE COMPANY'S FINANCIAL CONDITION AND COMMON STOCK
We
have a history of operating losses and we will continue to incur
losses.
Since our
inception in 1980, we have generated only limited revenues from sales and have
incurred substantial net losses of $9,242,071, $10,445,473 and $6,051,400 for
the years ended December 31, 2008, 2007 and 2006, respectively. We expect to
incur additional operating losses as well as negative cash flow from our adult
stem cell collection, processing and storage business operations until we
successfully commercialize and develop this business, if ever. The
Company will incur losses and negative cash flow for the foreseeable future as a
result of our research and development activities and other operations until the
VSEL technology and such operations can be successfully implemented, integrated
into our business and commercialized, if ever.
We
have a history of liquidity problems, which may affect our ability to raise
capital.
At
December 31, 2008, we had a cash balance of $431,000, negative working capital
of $(431,000) and a stockholders’ equity of $863,200. Our history of
illiquidity and losses may make it difficult for us to raise capital on
favorable terms. We have from time to time raised capital for our activities
through the sale of our equity securities and promissory notes. Most recently,
we raised an aggregate of $1,150,000 in 2009 through the issuance of promissory
notes, and in 2008 we raised an aggregate of $2,900,000 through the private
placement sale of our common stock and warrants to purchase our common
stock. Such capital raising activities have enabled us to pursue our
business plan and begin to grow our adult stem cell collection and storage
business, including expanding marketing and sales activities, as well as to
pursue acquisition opportunities. The funds we obtained through the
acquisition of SCTI funded certain early obligations under our agreements
relating to our VSEL technology; however, we expect that substantial additional
funds will need to be raised in order for us to continue to fund additional
research and development activities relating to the VSEL technology, support
marketing efforts relating to the adult stem cell collection centers in the
Company’s network and to pursue related business opportunities, including
medical tourism and the Company’s expansion activities in China. The
Company has applied for SBIR grants and also anticipates seeking to obtain funds
through applications for other State and Federal grants, grants abroad, direct
investments into SCTI, strategic arrangements as well as other funding sources
to help offset all or a portion of these costs; however, there can be no
assurance that such funding will be received.
We
will need substantial additional financing and/or additional revenues to
continue operations.
We will
require substantial additional capital to fund our current operating plan for
our business, including the development of our VSEL technology and support
marketing efforts relating to the adult stem cell collection centers in the
Company’s network and to pursue related business opportunities, including
medical tourism and expansion into China. In addition, our cash
requirements may vary materially from those now planned because of expenses
relating to marketing, advertising, sales, distribution, research and
development and regulatory affairs, as well as the costs of maintaining,
expanding and protecting our intellectual property portfolio, including
potential litigation costs and liabilities.
If
we are unable to obtain future capital on acceptable terms, this will negatively
affect our business operations and current investors.
We expect
that in the future we will seek additional capital through public or private
financings. Additional financing may not be available on acceptable
terms, or at all. If additional capital is raised through the sale of equity, or
securities convertible into equity, further dilution to then existing
stockholders will result. If additional capital is raised through the incurrence
of debt, our business could be affected by the amount of leverage incurred. For
instance, such borrowings could subject us to covenants restricting our business
activities, paying interest would divert funds that would otherwise be available
to support commercialization and other important activities, and holders of debt
instruments would have rights and privileges senior to those of equity
investors. If we are unable to obtain adequate financing on a timely basis, we
may be required to delay, reduce the scope of or eliminate some of our planned
activities, any of which could have a material adverse effect on the
business.
We
will continue to experience cash outflows.
We
continue to incur expenses, including the salary of our executive officers,
rent, legal, marketing and accounting fees, insurance and general administrative
expenses. We are building the infrastructure for our business and will
experience additional cash outflows in the foreseeable future. It is not
possible at this time to state whether we will be able to finance these cash
outflows or when we will be able to achieve and sustain a positive cash
position. Our ability to become profitable will depend on many factors,
including our ability to successfully commercialize and develop the business. We
cannot assure that we will ever become profitable and we expect to continue to
incur losses. NS California, the company from which we initially
acquired our adult stem cell business, had nominal operations and nominal assets
at the time of our acquisition. From its inception in 2002 through
September 30, 2005, NS California had aggregate revenues of $25,500, and
aggregate losses of $2,357,940. We cannot guarantee that we will be
more successful than NS California in achieving sufficient revenues for
profitability. Even if we do achieve profitability, we cannot guarantee that we
can sustain or increase profitability in the future. If revenues grow slower
than we anticipate, or if operating expenses exceed our expectations or cannot
be adjusted accordingly, then our business, results of operations, financial
condition and cash flows will be materially and adversely affected. Because our
strategy includes acquisitions of other businesses, products or technologies,
acquisition expenses and any cash used to make these acquisitions will reduce
our available cash.
Our
stock has historically had limited trading volume.
Our
common stock currently trades on the NYSE Amex (formerly known as the American
Stock Exchange) and until August 9, 2007 was traded on the Over-the-Counter
Bulletin Board, an electronic, screen-based trading system operated by the
National Association of Securities Dealers, Inc. Our stock has generally been
thinly traded and, although trading volume has increased since it has commenced
trading on the NYSE Amex, we cannot assure you that our stock will continue to
have improved liquidity or that it will increase above current
levels. Our Class A Warrants also trade on the NYSE Amex, but have
had very limited trading volume. As a result, an investor may find it
difficult to dispose of our common stock or warrants.
Our
stock and Class A warrants may be delisted from the NYSE Amex.
On
February 10, 2009, we received notice from the NYSE Amex indicating that
the Company is not in compliance with Section 704 of the NYSE Amex Company Guide
(the “Guide”), which requires a listed company to hold meetings of its
shareholders annually. On November 3, 2008, the Company had announced
that it planned to hold a shareholder meeting to obtain approval of the Share
Exchange Agreement and the Merger Agreement. It had been the
Company’s understanding that this series of events constituted sufficiently
unusual circumstances to permit a single combined meeting to be held in 2009 and
that this would be in compliance with Section 704. The Company was
afforded the opportunity to submit a plan of compliance to the NYSE Amex by
March 10, 2009, that demonstrates it will bring it back into compliance by
August 11, 2009. The Company submitted such a plan on a timely
basis. The Company is also nearing the NYSE Amex’s financial
thresholds for continued listing including minimum shareholders’ equity
requirements and certain other quantitative and qualitative listing
standards. If the plan is not accepted by the NYSE Amex or the
Company’s financial condition does not improve, the Company may be subject to
delisting procedures as set forth in Section 1010 and Part 12 of the
Guide. If the Company is delisted and is not able to relist, or to
list on another exchange, liquidity in our securities may be reduced and an
investor may find it difficult to dispose of our common stock and Class A
Warrants.
Our
stock price could be volatile.
The price
of our common stock has fluctuated widely in the past and may be more volatile
in the future. Factors such as the announcements of government regulation, new
products or services introduced by us or by our competition, healthcare
legislation, trends in health insurance, litigation, fluctuations in operating
results, our success in commercializing our business, market conditions for
healthcare stocks in general as well as economic recession could have a
significant impact on the future price of our common stock. The historically low
volume of trading in our common stock has made it more vulnerable, and it may
continue to be more vulnerable, to rapid changes in price in response to market
conditions.
Sales
of substantial amounts of our common stock in the open market, or the
availability of such shares for sale, could adversely affect the price of our
common stock and other securities.
We had
7,749,358 shares of common stock outstanding as of March 27, 2009. The following
securities that may be exercised for, or are convertible into, shares of our
common stock were issued and outstanding as of March 27, 2009:
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Options.
Stock options to purchase 1,723,300 shares of our common stock at a
weighted average exercise price of approximately $3.95 per
share.
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Class
A Warrants. Warrants to purchase 635,000 shares of our common
stock at an exercise price of $6.00 per share. The Class A
warrants were issued in our public offering in August
2007.
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Underwriters
Warrants. Warrants issued to the underwriter in our public
offering in August 2007 to purchase 95,250 shares of our common stock at
an exercise price of $6.50 per share (130% of the price of the common
stock sold in the public offering).
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Other
Warrants. Warrants to purchase 5,280,692 shares of our common stock at a
weighted average exercise price of approximately $3.61 per
share.
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The vast
majority of the outstanding shares of NeoStem Common Stock, as well as
substantially all the shares of NeoStem Common Stock that may be issued under
our outstanding options, warrants and Class A warrants, are or have the
contractual right to be registered or are otherwise not restricted from
trading.
Our
outstanding warrants may negatively affect our ability to raise additional
capital.
During
the terms of our outstanding warrants, Class A warrants and underwriter
warrants, their holders are given the opportunity to profit from a rise in the
market price of our common stock. So long as these warrants are outstanding, the
terms on which we could obtain additional capital may be adversely affected. The
holders of these warrants might be expected to exercise them at a time when we
would, in all likelihood, be able to obtain any needed capital by a new offering
of securities on terms more favorable than those provided by these
warrants.
Failure
To Maintain Effective Internal Controls In Accordance With Section 404 Of
The Sarbanes-Oxley Act Could Have A Material Adverse Effect On Our Business And
Stock Price.
If we
fail to maintain adequacy of our internal controls in accordance with the
requirements of Section 404 of the Sarbanes-Oxley Act of 2002 and as such
standards are modified, supplemented or amended from time to time, we may not be
able to ensure that we can conclude on an ongoing basis that we have effective
internal controls over financial reporting in accordance with Section 404
of the Sarbanes-Oxley Act. Failure to achieve and maintain an
effective internal control environment could have a material adverse effect on
our stock price. During the
course of our testing of our internal controls, we may identify, and have to
disclose, material weaknesses or significant deficiencies in our internal
controls that will have to be remediated. Implementing any appropriate changes
to our internal controls may require specific compliance training of our
directors, officers and employees, entail substantial costs in order to modify
our existing accounting systems, and take a significant period of time to
complete. Such changes may not, however, be effective in maintaining the
adequacy of our internal controls, and any failure to maintain that adequacy, or
consequent inability to produce accurate financial statements on a timely basis,
could increase our operating costs and could materially impair our ability to
operate our business. In addition, investors’ perceptions that our internal
controls are inadequate or that we are unable to produce accurate financial
statements may negatively affect our stock price.
RISKS
RELATING TO THE COMPANY'S BUSINESS
If
the potential of stem cell therapy to treat serious disease is not realized, the
value of our stem cell collection, processing and storage and our development
programs could be significantly reduced.
The
potential of stem cell therapy to treat serious disease is currently being
explored. Stem cell therapy is not a commonly used procedure and it has not been
proven in clinical trials that stem cell therapy will be an effective treatment
for diseases other than those currently addressed by hematopoietic stem cell
transplants (hematopoietic stem cells are the stem cells from which all blood
cells are made). No stem cell products have been successfully developed and
commercialized to date, and none have received regulatory approval in the
United States or internationally. Stem cell therapy may be susceptible to
various risks, including undesirable and unintended side effects, unintended
immune system responses, inadequate therapeutic efficacy or other
characteristics that may prevent or limit its approval or commercial use. The
value of our stem cell collection, processing and storage and our development
programs could be significantly reduced if the use of stem cell therapy to treat
a wide-range of serious diseases is not proven effective in the near
future.
Because
the stem cell industry is subject to rapid technological and therapeutic
changes, our future success will materially depend on the viability of the
commercial use of stem cells for the treatment of disease.
Our
success materially depends on the development of therapeutic treatments and
cures for disease using stem cells. The broader medical and research environment
for such treatments and cures critically affects the utility of stem cells, the
services we offer to the public, and our future success. The value of stem cells
in the treatment of disease is subject to potentially revolutionary
technological, medical and therapeutic changes. However, future technological
and medical developments or improvements in conventional therapies could render
the use of stem cells and our services and equipment obsolete and unmarketable.
As a result, there can be no assurance that our services will provide
competitive advantages over other technologies. If technological or medical
developments arise that materially alter the commercial viability of our
technology or services, we may be forced to incur significant costs in replacing
or modifying equipment in which we have already made a substantial investment
prior to the end of its anticipated useful life. Alternatively, significant
advances may be made in other treatment methods or in disease prevention
techniques which could significantly reduce or entirely eliminate the need for
the services we provide. The materialization of any of these risks could have a
material adverse effect on our business, financial condition, our results of
operations or our ability to operate at all.
We
may be forced to undertake lengthy and costly efforts to build market acceptance
of our stem cell collection, processing and storage services, the success of
which is critical to our profitability. There can be no assurance that these
services will gain market acceptance. To date, only a minimal number of
collections have been performed at the collection centers in our
network.
Our
future success in the business of collecting, processing and storing adult stem
cells depends on the successful and continued market acceptance of this service.
Broad use and acceptance of our service requires marketing expenditures and
education and awareness of consumers and medical practitioners who, under
present law, must order stem cell collection on behalf of a potential customer.
The time and expense required to educate and build awareness of our services and
their potential benefits could significantly delay market acceptance and our
ultimate profitability. The successful commercialization of our services
will also require that we satisfactorily address the concerns of medical
practitioners in order to avoid potential resistance to recommendations for our
services and ultimately reach our potential consumers. No assurances can be
given that our business plan and marketing efforts will be successful, that we
will be able to commercialize our services, or that there will be market
acceptance of our services or clinical acceptance of our services by physicians
sufficient to generate any material revenues for us. To date, only a minimal
number of collections have been performed at the collection centers in our
network.
Ethical
and other concerns surrounding the use of stem cell therapy may increase the
regulation of or negatively impact the public perception of our stem cell
services, thereby reducing demand for our services.
The use
of embryonic stem cells for research and stem cell therapy has been the subject
of debate regarding related ethical, legal and social issues. Although our
business only utilizes adult stem cells and does not involve the more
controversial use of embryonic stem cells, the use of other types of human
stem cells for therapy could give rise to similar ethical, legal and social
issues as those associated with embryonic stem cells. Additionally, it is
possible that our business could be negatively impacted by any stigma associated
with the use of embryonic stem cells if the public fails to appreciate the
distinction between the use of adult versus embryonic stem cells. The commercial
success of our business will depend in part on public acceptance of the use of
stem cell therapy, in general, for the prevention or treatment of human
diseases. Public attitudes may be influenced by claims that stem cell therapy is
unsafe or unnecessary, and stem cell therapy may not gain the acceptance of
the public or the medical community. Public pressure or adverse events in the
field of stem cell therapy that may occur in the future also may result in
greater governmental regulation of our business creating increased expenses and
potential regulatory delays relating to the approval or licensing of any or all
of the processes and facilities involved in our stem cell banking services. In
the event that the use of stem cell therapy becomes the subject of adverse
commentary or publicity, our business could be adversely affected and the
market price for our common stock could be significantly harmed.
We
operate in a highly regulated environment, and our failure to comply with
applicable regulations, registrations and approvals would materially and
adversely affect our business.
Historically,
the FDA has not regulated banks that collect and store stem cells. More recent
changes, however, require establishments engaged in the recovery, processing,
storage, labeling, packaging or distribution of any Human Cells, Tissues, and
Cellular and Tissue-Based Products (HCT/Ps) or the screening or testing of a
cell tissue donor to register with the FDA. The registration requirement was
effective as of January 2004 and we are currently so registered. The FDA also
adopted rules in May 2005 that regulate current Good Tissues Practices (cGTP).
Certain of our operations, or operations of our contracted service providers,
are subject to these regulations, and there can be no assurance that we or
they will be able, or will have the resources, to comply or to remain in
compliance. Future FDA regulations could also adversely impact or limit our
ability to market or perform our services. In order to collect and store
blood stem cells we must conduct (or arrange for the conduct of) a variety of
laboratory tests which are regulated under the federal Clinical Laboratory
Improvement Amendments (CLIA). Any facility conducting regulated tests must
obtain a CLIA certificate of compliance and submit to regular
inspection.
Some
states require additional regulation and oversight of clinical laboratories
operating within their borders and some impose obligations on out-of-state
laboratories providing services to their residents. Many of the states in which
we, our strategic partners or members of our collection network engage in
collection, processing or storage activities have licensing requirements that
must be complied with. Additionally, there may be state regulations impacting
the use of blood products that would impact our business. We currently have a
biologics license from the State of California. We also have two provisional
licenses from the State of New York, which permit the Company’s California
facility to collect, process and store hematopoietic progenitor cells (“HPCs”)
collected from New York residents, and also permit the solicitation in New York
relating to the collection of HPCs. A third provisional license received in
January 2008, permits the California facility to collect, process, store and use
for medical research HPCs collected from New York residents. New
England Cryogenic Center, Inc., or NECC, the cryogenic laboratory with whom we
have formed a strategic alliance to provide additional processing and storage
capacity for consumers on the East Coast, to process and store for certain
research purposes; and PCT, the facility with whom we have formed a strategic
alliance to provide additional processing and storage capacity for commercial
purposes at the cGMP level at its California and New Jersey facilities,
have each represented to the Company that each has such licenses as are required
to perform the services provided for under their respective agreements with the
Company. Each such license is subject to certain limitations. There
can be no assurance that we, our strategic partners or members of our collection
center network will be able to obtain any necessary licenses required to conduct
business in any states, or maintain licenses that are required and obtained with
respect to such states, including California and New York. Certain licensing
requirements involve the need to hire medical directors and others with certain
training and technical backgrounds and there can be no assurance that such
individuals can be retained or will remain retained. We may also be
subject to state and federal privacy laws related to the protection of our
customers’ personal health information and state and federal laws related to the
security of such personal health information and other personal data to
which we would have access through the provision of our services. In
particular, we serve as a “business
associate” of
various health care providers in our collection center network who
are obligated to comply with privacy and security standards adopted under
the Health Insurance Portability and Accountability Act of 1996
(HIPAA). As a business associate, we incur certain regulatory obligations
which will be changing over the next year as a result of amendments to HIPAA
under the American Recovery and Reinvestment Act of 2009 (ARRA). Under
ARRA, our privacy and security compliance burden will increase, and we will be
subject to audit and enforcement by the federal government and in some
cases, enforcement by state authorities. We will also be obligated to
publicly disclose wrongful disclosures or losses of personal health information.
We may be required to spend substantial amounts of time and money to
comply with these requirements, any regulations and licensing requirements, as
well as any future legislative and regulatory initiatives. Failure to comply
with applicable regulatory requirements or delay in compliance may result in,
among other things, injunctions, operating restrictions, and civil fines and
criminal prosecution which would have a material adverse effect on the marketing
and sales of our services and impair our ability to operate profitably or
preclude our ability to operate at all in the future. NeoStem is in
the process of transferring its processing and storage operations to NECC and
PCT due to space constraints at its California facility. Any delay in
complying with licensing requirements applicable to such new processing and
storage facilities could have a material adverse impact on our
business.
Our
adult stem cell collection, processing and storage business was not contemplated
by many existing laws and regulations.
The
service that we provide is unique. It is not medical treatment, although it
involves medical procedures. It is not clinical research, although we have
entered the research and development arena relating to the VSEL technology and
additional research participation is part of our business plan. Our research
activities are subject to different regulations than our commercial
activities. Our adult stem cell collection, processing and storage
business was not contemplated by many of the regulations in the field in which
we operate and as a result, there is often considerable uncertainty when we
are analyzing the applicability of regulatory requirements. We have devoted
significant resources to ensuring compliance with those laws that we believe to
be applicable and when applicability of a law is in doubt, we have opted to
comply in order to minimize risk. It is possible, however, that
regulators may disagree with some of our interpretations of the law prompting
additional compliance requirements or even enforcement actions. Such enforcement
may have a material adverse effect on our operations or may require
re-structuring of our operations or impair our ability to operate
profitably.
Our
failure to comply with laws related to hazardous materials could materially harm
us.
We are
subject to state and federal laws regulating the proper disposal of biohazardous
material. Although we believe we are currently in compliance with all such
applicable laws, a violation of such laws, or the future enactment of more
stringent laws or regulations, could subject us to liability for noncompliance
and may require us to incur costs and/or otherwise have a material adverse
effect on our ability to do business.
Side
effects or limitations of the stem cell collection process or a failure in the
performance of our or our strategic partners’ cryopreservation storage facility
or systems could harm our business and reputation.
To the
extent a customer experiences adverse side effects from the stem cell collection
process, the quantities of stem cells collected through our process are
ultimately determined to be in inadequate therapeutic amounts, or our or our
strategic partners’ cryopreservation storage services are disrupted or
discontinued, or our ability to provide banked stem cells is impaired for any
reason, our business and operations could be adversely affected. Any equipment
failure that causes a material interruption or discontinuance in our or our
strategic partners’ cryopreservation storage of stem cell specimens could result
in stored specimens being damaged and unable to be utilized. Adverse side
effects of the collection process, limitations of the collection process (such
as whether the collection process produces a sufficient quantity of stem cells
for all future therapeutic applications) or specimen damage (including
contamination or loss in transit to us), could result in litigation against us
and reduced future revenue, as well as harm to our reputation. Our insurance may
not adequately compensate us for any losses that may occur due to any such
adverse side effects, limitations or failures in our or our strategic partners’
systems or interruptions in our or our strategic partners’ ability to maintain
proper, continued, cryopreservation storage services. Our and our strategic
partners’ systems and operations are vulnerable to damage or interruption from
fire, flood, equipment failure, break-ins, tornadoes and similar events for
which we do not have redundant systems or a formal disaster recovery plan and we
may not carry sufficient business interruption insurance to compensate us for
losses that may occur. Any claim of adverse side effects or limitations or
material disruption in our or our strategic partners’ ability to maintain
continued uninterrupted storage systems could have a material adverse effect on
our business, operating results and financial condition.
We
are dependent on existing relationships with third parties to conduct our
business.
Our
process of collecting stem cells involves the injection of a “mobilizing agent”
which causes the stem cells to leave the bone marrow and enter into the blood
stream. The injection of this mobilizing agent is an integral part of the
collection process. There is currently only one supplier of this mobilizing
agent, and we are currently dependent upon our relationship with such supplier
to maintain an adequate supply. Although we continue to explore alternative
methods of stem cell collection including the use of alternative mobilizing
agents, there can be no assurance that any such methods will prove to be
successful. In the event that our supplier is unable or unwilling to continue to
supply a mobilizing agent to us on commercially reasonable terms, and we are
unable to identify alternative methods or find substitute suppliers on
commercially reasonable terms, we may not be able to successfully
commercialize our business. We are also currently using only one outside
“apheresis” provider that also is the apheresis provider to certain of our
collection centers being operated by members of our network. “Apheresis” is the
process through which stem cells are extracted from a patient’s whole blood and
it is an integral part of our collection process. Although other third parties
could provide apheresis services, any disruption in the relationship with this
service would cause a delay in the delivery of our services. In order to
successfully commercialize our business, we will continue to depend upon our
relationship with such companies or we or the collection centers operated by
members of our network will need to develop internal capabilities to provide
this service and obtain appropriate licensure. See also “- Our new
research and development activities present additional risks” for additional risks
relating to our dependence on third parties for development of our VSEL
technology.
Our
success will depend in part on establishing and maintaining effective strategic
partnerships and collaborations, which may impose restrictions on our business
and subject us to additional regulation.
A key
aspect of our business strategy is to establish strategic relationships in order
to gain access to critical supplies, to expand or complement our research and
development or commercialization capabilities, or to reduce the cost of research
and development or commercializing services on our own. There can be no
assurance that we will enter into such relationships, that the arrangements will
be on favorable terms or that such relationships will be successful.
Relationships with licensed professionals such as physicians may be subject to
state and federal laws including fraud and abuse regulations restricting the
referral of business, prohibiting certain payments to physicians, or otherwise
limiting our options for structuring a relationship. If our services become
widely reimbursable by government or private insurers, we could be subject to
additional regulation and perhaps additional limitations on our ability to
structure relationships with physicians. Additionally, state regulators may
impose restrictions on the types of business relationships into which licensed
physicians or other licensed professionals may enter. Failure to comply with
applicable fraud and abuse regulations or other regulatory requirements could
result in civil fines, criminal prosecution or other sanctions. Even if we do
enter into these arrangements, we may not be able to maintain these
relationships or establish new ones in the future on acceptable terms.
Furthermore, these arrangements may require us to grant certain rights to third
parties, including exclusive rights or may have other terms that are burdensome
to us. If any of our partners terminate their relationship with us or fail to
perform their obligations in a timely manner, our research and development
activities or commercialization of our services may be substantially impaired or
delayed. If we fail to structure our relationships with physicians in accordance
with applicable fraud and abuse laws or other regulatory requirements it could
have a material adverse effect on our business.
We
are dependent upon our management, scientific and medical personnel and we may
face difficulties in attracting qualified employees or managing the growth of
our business.
Our
future performance and success are dependent upon the efforts and abilities of
our management, medical and scientific personnel. Furthermore, our future growth
will require hiring a significant number of qualified technical, medical,
scientific, commercial, business and administrative personnel. Accordingly,
recruiting and retaining such personnel in the future will be critical to our
success. If we are not able to attract and retain, on acceptable terms, the
qualified personnel necessary for the continued development of our business,
including those required in order for us to obtain and maintain appropriate
licensure, we may not be able to sustain our operations or achieve our business
objectives. Our failure to manage growth effectively could limit our ability to
achieve our commercialization and other goals relating to, and we may fail in
developing, our new business.
General
economic recession could negatively impact demand for our services.
Economic
recession, including attendant job loss, could negatively impact the demand for
our services.
Our
research and development activities present additional risks.
Our
research and development activities relating to the VSEL technology are subject
to many of the same risks as our adult stem cell collection, processing and
storage business, and there can be no assurance that we independently or through
collaborations will successfully develop, commercialize or market the VSEL
technology. Any sublicensing arrangements we may desire to enter into in
connection with the development of this technology are subject to the prior
approval of the University of Louisville and there can be no assurance they will
give such approvals although they may not unreasonably withhold their
approval. Further, we have development obligations under our
exclusive license agreement with the University of Louisville pursuant to which
we have licensed the VSEL technology. As we currently have minimal capacity to
conduct research and development activities, to assist in meeting such
development obligations we have entered into a sponsored research agreement with
the University of Louisville pursuant to which research services are being
provided and on which we are currently dependent on their performance in
developing the VSEL technology. Additional research projects are also being
pursued. We will, however, require additional research and development capacity
and access to funds to meet our obligations under the license agreement and
fully develop the VSEL technology and integrate it into our business, and expect
losses to increase as our research and development efforts
progress. We have applied for SBIR grants and also anticipate seeking
to obtain such funds through applications for other State and Federal grants,
grants abroad, direct investments into SCTI, strategic arrangements as well as
other funding sources to help offset all or a portion of these costs; however,
there can be no assurance that such funds will be received. We must also develop
increased internal research capability and sufficient laboratory facilities or
establish relationships to provide such research capability and facilities.
There can be no assurance that we will be able to establish and maintain such
relationships on commercially acceptable terms, if at all. Further, we must meet
payment and other obligations under the license and sponsored research
agreements. The license agreement requires the payment of certain license fees,
royalties and milestone payments, payments for patent filings and applications
and the use of due diligence in developing and commercializing the VSEL
technology. The sponsored research agreement requires periodic and milestone
payments. Our failure to meet financial or other obligations under the license
or sponsored research agreements in a timely manner could result in the loss of
some or all of our rights to proprietary technology (as an example, portions of
the license may be converted to a non-exclusive license or it can be terminated
entirely), and/or we could lose our right to have the University of Louisville
conduct research and development efforts.
The
commercial viability of our VSEL technology is subject to substantially the same
risks as our adult stem cell collection, processing and storage business, but it
may also depend upon the ability to successfully expand the number of VSELs
collected through our adult stem cell collection process into a therapeutically
viable amount as well as the utility of VSELs for therapeutic purposes. As the
number of VSELs which can be isolated from the adult peripheral blood collected
is relatively small, the ability to create a therapeutic quantity of VSELs from
a small number of cells may be essential to effectively using VSELs. There are
many biotechnology laboratories attempting to develop stem cell expansion
technology, but to date, stem cell expansion techniques are very inefficient and
typically the target cells stop dividing naturally, keeping the yield low. A
critical aspect of our adult stem cell collection and banking service relating
to the VSEL technology could therefore be the utilization of stem cell expansion
processes, and there can be no assurance that such technology will be
available.
Moreover,
stem cell collection and harvesting techniques are becoming the subject of new
and rapidly developing technologies and could undergo significant change in the
future. Rapid technological development could result in our VSEL technology
becoming obsolete prior to its successful integration into the process and
commercialization of our collection, processing and storage business. Successful
biotechnology development in general is highly uncertain and is dependent on
numerous factors, many of which are beyond our control. Technology that appears
promising in the early phases of development may fail to be successfully
commercialized for numerous reasons, including, but not limited to competing
technologies for the same indication.
We
believe that the VSEL technology is properly classified under the FDA’s HCT/P
regulatory paradigm and not as a medical device or as a biologic or
drug. There can be no assurance that the FDA would agree that this
category of regulatory classification applies to the VSEL technology, and the
reclassification of this technology could have adverse consequences for us and
make it more difficult or expensive for us to conduct this business by requiring
regulatory clearance, approval and/or compliance with additional regulatory
requirements.
If
we are unable to obtain future financing when needed, we may not be able to pay
fees relating to our licenses, patents or other intellectual property on a
timely basis or at all, which could result in a loss of any or all of our
intellectual property rights.
Our License Agreement with the
University of Louisville requires, and other license agreements to which we are
or may become a party in the future will or may require, us to pay license fees,
royalties and milestone payments and fees for patent filings and
applications. In addition, obtaining and maintaining patent
protection depends, in part, on our ability to pay the applicable filing and
maintenance fees. Our failure to meet financial obligations under our
license agreements in a timely manner or our non-payment or delay in payment of
our patent fees, could result in the loss of some or all of our rights to
proprietary technology or the inability to secure or enforce intellectual
property protection. The loss of any or all of our intellectual
property rights would limit our ability to develop and/or market our services,
which would materially adversely affect our business, financial condition and
results of operations.
Any
future acquisitions may expose us to additional risks.
We
continuously review acquisition prospects that would complement our current
business, increase the size and geographic scope of our operations or otherwise
offer revenue generating or other growth opportunities. In 2008 we
were actively involved in exploring, and continue to explore, acquisition
opportunities of revenue generating businesses, both domestically or abroad,
including businesses that are synergistic with or additive to our current
business. The financing for any of these acquisitions (including the
Merger and Share Exchange transactions) could dilute the interests of our
stockholders, result in an increase in our indebtedness or both. Acquisitions
may entail numerous risks, including:
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difficulties in
assimilating acquired operations, technologies or products, including the
loss of key employees from acquired
businesses;
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diversion
of management’s attention from our core
business;
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risks
of entering markets (including those overseas) in which we have limited or
no prior experience; and
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our
management team has limited experience in purchasing and integrating new
businesses.
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Our
failure to successfully complete the integration of any acquired business could
have a material adverse effect on our business, financial condition and
operating results. In addition, there can be no assurance that we will be able
to identify additional suitable acquisition candidates or consummate additional
acquisitions on favorable terms.
RISKS
RELATING TO COMPETITION
The
stem cell preservation market has and continues to become increasingly
competitive.
We may
face competition from companies with far greater financial, marketing, technical
and research resources, name recognition, distribution channels and market
presence than us, who are marketing or developing new services that are similar
to the services that are now being or may in the future be developed by us.
There can be no assurance that we will be able to compete
successfully.
For
example, in the established market for cord blood stem cell banking, the growth
in the number of families banking their newborn’s cord blood stem cells has
been accompanied by an increasing landscape of competitors. Our business, which
has been more recently developed, already faces competition from other
established operators of stem cell preservation businesses and providers of stem
cell storage services. We believe that certain of our competitors have
established stem cell banking services to process and store stem cells
collected from adipose tissue (fat tissue). This type of stem cell banking will
require partnering with cosmetic surgeons who perform liposuction
procedures. In addition, we believe the use of adult stem cells from
adipose tissue will require extensive clinical trials to prove the safety and
efficacy of such cells and the enzymatic process required to extract adult
stem cells from fat. From a technology perspective this ability to expand a
small number of stem cells could present a competitive alternative to stem cell
banking. The ability to create a therapeutic quantity of stem cells from a
small number of cells is essential to using embryonic stem cells and would
be desirable to treat patients who can only supply a small number of their own
stem cells. There are many biotechnology laboratories attempting to develop stem
cell expansion technology, but to date, stem cell expansion techniques are very
inefficient and typically the target cells stop dividing naturally, keeping the
yield low. This could also have an adverse effect on our ability to fully
utilize our VSEL technology, which will be dependent upon access to reliable
stem cell expansion technology. However, even though reliable stem cell
expansion technology may ease some of the limitations of the competitive
alternatives to our business, it would also allow us to utilize the VSEL
technology and also complement adult stem cell banking by allowing individuals
to extend the banking of an initial collection of cells for many
applications.
We also
understand that other technologies are being developed which claim the ability
to harvest stem cells through a variety of other techniques, such as turning
skin cells into cells that behave like embryonic stem cells or harvesting stem
cells from the pulp of baby teeth. No assurance can be given that such
technologies, or any other technologies, will not ultimately prove to be more
successful, have a faster rate of market penetration or have broader application
than ours. There can be no assurance that technological or medical breakthroughs
by our current or future competitors will not render the Company’s business of
stem cell preservation commercially or otherwise unappealing or obsolete. In
addition, the Company believes that one’s use of their own (autologous) stem
cells presents fewer risks and increases the therapeutic value of stem cell
therapy but the Company could nonetheless face competition from companies
seeking to promote the benefits of third party donors.
In the
event that we are not able to compete successfully with our current or potential
competitors, it may be difficult for us to grow our revenue and maintain our
existing business without incurring significant additional expenses to try to
refine our technology, services or approach to our business to better compete,
and even then there would be no guarantee of success.
We
may face competition in the future from established cord blood banks and some
hospitals.
Cord
blood banks such as ViaCord (a division of ViaCell International, a wholly-owned
subsidiary of PerkinElmer, Inc.) or Cryo-Cell International may be drawn to the
field of stem cell collection because their processing labs and storage
facilities can be used for processing adult stem cells from peripheral
blood and their customer lists may provide them with an easy access to the
market. We estimate that there are approximately 59 cord blood banks in the
United States, approximately 44 of which are autologous (donor and recipient are
the same) and approximately 15 of which are allogeneic (donor and recipient are
not the same). Hospitals that have transplant centers to serve cancer patients
may elect to provide some or all of the services that we provide. We estimate
that there are approximately 200 hospitals in the United States with stem cell
transplant centers. All of these competitors may have access to greater
financial resources. In addition, other established companies with greater
access to financial resources may enter our markets and compete with us. There
can be no assurance that we will be able to compete successfully.
RISKS
RELATING TO INTELLECTUAL PROPERTY
There
is significant uncertainty about the validity and permissible scope of patents
in the biotechnological industry. We may not be able to obtain patent
protection.
There can
be no assurance that the patent applications to which we hold rights will result
in the issuance of patents, or that any patents issued or licensed to our
company will not be challenged and held to be invalid or of a scope of coverage
that is different from what we believe the patent’s scope to be. Further, there
can be no assurance that any future patents related to these technologies will
ultimately provide adequate patent coverage for or protection of our present or
future technologies, products or processes. Our success will depend, in part, on
whether we can obtain patents to protect our own technologies; obtain licenses
to use the technologies of third parties if necessary, which may be protected by
patents; protect our trade secrets and know-how; and operate without infringing
the intellectual property and proprietary rights of others.
We
may be unable to protect our intellectual property from infringement by third
parties.
Despite
our efforts to protect our intellectual property, third parties may infringe or
misappropriate our intellectual property or may develop intellectual property
competitive to ours. Our competitors may independently develop similar
technology, duplicate our processes or services or design around our
intellectual property rights. As a result, we may have to litigate to enforce
and protect our intellectual property rights to determine their scope, validity
or enforceability. Intellectual property litigation is costly, time-consuming,
diverts the attention of management and technical personnel and could result in
substantial uncertainty regarding our future viability. The loss of intellectual
property protection or the inability to secure or enforce intellectual property
protection would limit our ability to develop and/or market our services in the
future. This would also likely have an adverse affect on the revenues
generated by any sale or license of such intellectual property.
Furthermore, any public announcements related to such litigation or regulatory
proceedings could adversely affect the price of our common stock.
Third
parties may claim that we infringe on their intellectual property.
We also
may be subject to costly litigation in the event our technology infringes upon
another party’s proprietary rights. Third parties may have, or may
eventually be issued, patents that would be infringed by our technology. Any of
these third parties could make a claim of infringement against us with respect
to our technology. We may also be subject to claims by third parties
for breach of copyright, trademark or license usage rights. An adverse
determination in any litigation of this type could require us to design around a
third party’s patent, license alternative technology from another party or
otherwise result in limitations in our ability to use the intellectual property
subject to such claims. Litigation and patent interference
proceedings could result in substantial expense to us and significant diversion
of efforts by our technical and management personnel. An adverse
determination in any such interference proceedings or in patent litigation to
which we may become a party could subject us to significant liabilities to third
parties or, as noted above, require us to seek licenses from third
parties. If required, the necessary licenses may not be available on
acceptable financial or other terms or at all. Adverse determinations
in a judicial or administrative proceeding or failure to obtain necessary
licenses could prevent us, in whole or in part, from commercializing our
products, which could have a material adverse effect on our business, financial
condition and results of operations.
RISKS RELATING TO THE MERGER
AND SHARE EXCHANGE
Risks relating to both the
Merger and the Share Exchange
The
consummation of the Merger and Share Exchange and related transactions are
contingent upon the satisfaction of certain closing conditions, and the failure
or delay in satisfying such closing conditions could result in increased costs
and enhanced expenditure of resources or a decline in NeoStem's stock
price.
The
transactions contemplated by the Agreement and Plan of Merger and the Share
Exchange Agreement are subject to the satisfaction of several closing
conditions. In order to consummate the Merger, the stockholders of
NeoStem must approve both the issuance of securities in connection with the
Merger and the amendment to NeoStem's amended and restated certificate of
incorporation to increase the number of authorized shares of Preferred Stock and
the CBH stockholders must approve the Merger and the Spin-off. In
addition, in order to consummate the Merger, the shares of NeoStem Common Stock
to be issued in connection with the Merger must be authorized for listing on the
NYSE Amex (or any other stock exchange on which shares of NeoStem Common Stock
are listed); approval by the relevant PRC and other governmental authorities of
NeoStem's acquisition of 51% ownership interest in Erye, as described above,
must be obtained; NeoStem must receive a re-affirmation of the fairness opinion
issued by vFinance; and other customary closing conditions set forth in the
Agreement and Plan of Merger must be satisfied. The Share Exchange
Agreement also contains various conditions to closing. There is no
guarantee that such approvals will be obtained or that such conditions will be
satisfied.
Any
failure to satisfy or delay in satisfying any condition to closing, could result
in increased costs as a result of additional efforts directed towards attempting
to consummate the transactions, as well as decreased operational performance
pending the outcome of the efforts directed at completion of the
transactions. Legal, accounting, and printing fees must be paid
whether or not the Merger or Share Exchange transactions are consummated, and
the amount of any or all of these fees may be enhanced if there is any failure
or delay in satisfying the closing conditions. Any such delays or
failures to satisfy conditions could materially adversely affect NeoStem’s
business, financial condition and results of operations. In addition,
a failure to complete the Merger and/or the Share Exchange, or a delay in
completing either or both transactions, could result in a decline of the market
price of NeoStem Common Stock to the extent that the relevant current market
price reflects a market assumption that either the Merger and/or the Share
Exchange will be completed.
NeoStem
will need substantial additional financing to fund operations of NeoStem, CBH
and Shandong following the Merger and Share Exchange, and if it is unable to
obtain future capital on acceptable terms or at all, the business operations of
the combined entity will be adversely affected.
None of NeoStem, CBH or the Shandong
Institute has sufficient capital to fund the operating plan for the business of
the combined company following the Merger and the Share Exchange. In
addition, NeoStem's cash requirements may increase significantly because of the
transaction costs relating to the Merger and the Share
Exchange. Although NeoStem expects to seek additional capital through
public or private financings, additional financing may not be available on
acceptable terms, or at all. If NeoStem is unable to obtain adequate
financing on a timely basis, or at all, it may be unable to operate the business
of the combined company following the Merger and the Share
Exchange.
Sales
of substantial amounts of NeoStem Common Stock in the open market, or the
availability of such shares for sale, could adversely affect the price of
NeoStem Common Stock and other securities, and certain currently outstanding
options and warrants will be repriced.
As of
March 27, 2009, 7,749,358 shares of NeoStem Common Stock were issued and
outstanding. Upon consummation of the Merger and the Share Exchange,
it is expected that approximately 25,982,367 shares of NeoStem Common Stock will
be outstanding. Immediately prior to the consummation of the Merger
and the Share Exchange, NeoStem intends to reprice currently outstanding options
and warrants to purchase an aggregate of approximately 3,077,283 shares of
NeoStem Common Stock pursuant to the terms of the Agreement and Plan of
Merger. It is currently anticipated that options to purchase an
aggregate of approximately 1,642,300 shares of NeoStem Common Stock with a
current range of exercise prices of $0.95 to $25.00 per share will be repriced
to a range of $0.80 to $6.8779 per share, and warrants to purchase an aggregate
of approximately 1,339,733 shares of NeoStem Common Stock with a current range
of exercise prices of $3.00 to $8.00 per share will repriced to a range of $2.00
to $3.68 per share. After giving effect to the repricing and the
consummation of the Merger and the Share Exchange, the following securities that
may be exercised for, or are convertible into, shares of NeoStem Common
Stock are currently anticipated to be outstanding:
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Stock
options to purchase 1,723,300 shares of NeoStem Common Stock at an
approximate weighted average exercise price of approximately $0.90 per
share.
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Warrants
to purchase 4,645,692 shares of NeoStem Common Stock at an approximate
weighted average exercise price of approximately $2.27 per
share.
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Class
A Warrants to purchase 635,000 shares of NeoStem Common Stock at an
exercise price of $2.8922 per share. The Class A Warrants were issued in
our public offering in August
2007.
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Class
B Warrants to purchase 2,400,000 shares of NeoStem Common Stock at an
exercise price of $0.80 per share. The Class B Warrants will be
issued in connection with the
Merger.
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Class
C Warrants to purchase up to 2,012,097 shares of NeoStem Common Stock at
an exercise price of $2.50 per share. The Class C Warrants may
be issued in connection with the
Merger.
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NeoStem
Series C Preferred Stock, convertible into up to 6,977,512 shares of
NeoStem Common Stock at a conversion price of $0.90 per
share. The NeoStem Series C Preferred Stock may be issued in
connection with the
Merger.
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The vast
majority of the outstanding shares of NeoStem Common Stock, as well as
substantially all the shares of NeoStem Common Stock that may be issued under
our outstanding options, warrants and Class A warrants, are or have the
contractual right to be registered or are otherwise not restricted from
trading.
Our
outstanding warrants may negatively affect our ability to raise additional
capital.
During
the terms of NeoStem's outstanding warrants and Class A Warrants, and the Class
B Warrants and Class C Warrants to be issued in connection with the Merger, the
holders thereof are given the opportunity to profit from a rise in the market
price of the NeoStem Common Stock. So long as these warrants are
outstanding, the terms on which we could obtain additional capital may be
adversely affected. The holders of these warrants might
be expected to exercise them at a time when NeoStem would, in all
likelihood, be able to obtain any needed capital by a new offering of securities
on terms more favorable than those provided by these warrants.
Risks Relating to the
Merger
Set forth
below are certain risk factors relating to the proposed Merger of which you
should be aware. More complete risk factors relating to the proposed Merger will
be included in the Proxy Statement/Registration Statement.
The
consummation of the transactions contemplated by the Merger Agreement is
dependent upon NeoStem's obtaining all relevant and necessary governmental
approvals from the relevant PRC government authorities.
Pursuant
to the Merger Agreement, NeoStem will acquire, indirectly through NeoStem's
ownership in Merger Sub, a 51% ownership interest in Erye, with EET owning the
remaining 49% ownership interest in Erye. NeoStem, Merger Sub and EET must enter
into a Joint Venture Agreement to govern the rights and obligations of NeoStem,
Merger Sub and EET with respect to their ownership in Erye. The Joint Venture
Agreement, together with the articles of incorporation of Erye, must be
delivered to the relevant PRC governmental organizations for inspection and
approval, and the closing of the transactions contemplated by the Merger
Agreement are contingent upon, among other things, obtaining all relevant and
necessary governmental approvals from the relevant PRC government authorities of
the Joint Venture Agreement, the articles of incorporation and the transactions
contemplated thereby. There can be no assurance that NeoStem will be able to
obtain all such relevant and necessary governmental approvals from the relevant
PRC government authorities on a timely basis or at all.
NeoStem
has incurred, and expects to continue to incur, significant costs and expenses
in connection with the proposed Merger. Any failure to obtain, or delay in
obtaining, the necessary PRC government approvals would prevent NeoStem from
being able to consummate, or delay the consummation of, the transactions
contemplated by the Merger Agreement, which could materially adversely affect
its business, financial condition and results of operations.
Following
the Merger, a substantial portion of NeoStem's assets will be located in the PRC
and a substantial portion of NeoStem's revenue will be derived from operations
in the PRC. Since this is one of NeoStem's first ventures into the Chinese
market, NeoStem's operations may be subject to additional risks and
uncertainties.
Because
NeoStem does not have any experience in doing business in the PRC, the Company’s
directors, officers, managers, and employees will be encountering for the first
time the economic, political, and legal climate that is unique to the PRC, which
may present risk and uncertainties to NeoStem's operations. Although in recent
years the PRC’s government has implemented measures emphasizing the use of
market forces for economic reform, the reduction of state ownership of
productive assets and the establishment of sound corporate governance in
business enterprises, a substantial portion of productive assets in the PRC is
still owned by the PRC’s government. In addition, the PRC’s government continues
to play a significant role in regulating industry development by imposing
industrial policies. It also exercises significant control over the PRC’s
economic growth through the allocation of resources, controlling payment of
foreign currency-denominated obligations, setting monetary policy and providing
preferential treatment to particular industries or companies.
There can
be no assurance that the PRC’s economic, political or legal systems will not
develop in a way that becomes detrimental to our business, results of operations
and prospects. NeoStem's activities may be materially and adversely affected by
changes in the PRC’s economic and social conditions and by changes in the
policies of the PRC’s government, such as measures to control inflation, changes
in the rates or method of taxation and the imposition of additional restrictions
on currency conversion.
Additional
factors that NeoStem may experience in connection with having operations in the
PRC that may adversely affect NeoStem's business and results of operations
include the following:
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NeoStem
may not be able to enforce or obtain a remedy under any material
agreements.
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PRC
restrictions on foreign investment could severely impair NeoStem's ability
to conduct its business or acquire or contract with other entities in the
future.
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Restrictions
on currency exchange may limit NeoStem's ability to use cash flow most
effectively or to repatriate our investment and fluctuations in currency
values could adversely affect operating
results.
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Cultural,
language and managerial differences may result in the reduction of our
overall performance.
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Political
instability in the PRC could harm NeoStem's
business.
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Risks Relating to the Share
Exchange
Set forth
below are certain risk factors relating to the proposed Share Exchange of which
you should be aware. More complete risk factors relating to the proposed Share
Exchange will be included in the Proxy Statement/Registration
Statement.
If
the government of the PRC determines that the arrangements that establish the
structure for operating the Shandong Business do not comply with PRC government
restrictions on foreign investment in the relevant industry, NeoStem may be
subject to severe consequences and penalties.
Pursuant
to the Share Exchange Agreement, NeoStem will acquire the HK Entity, which owns
the WFOE, and the WFOE seeks to obtain certain benefits from Shandong through
the VIE Documents. As a Delaware corporation, NeoStem is classified as a foreign
enterprise under PRC law, and the WFOE is classified as a foreign-invested
enterprise. Because various regulations in China currently restrict or prevent
foreign-invested entities from holding certain licenses and controlling
businesses in certain industries, NeoStem must rely on the contractual
relationships memorialized in the VIE Documents to obtain benefits from the
business, personnel, and financial affairs of Shandong.
The PRC
laws and regulations governing business entities are often vague and uncertain.
There is a particular lack of clarity in the PRC law applicable to the
arrangements establishing the operating structure. Despite the uncertain
application of PRC law, the structure of the WFOE, together with the contractual
arrangements under the VIE Documents, has been implemented successfully where
foreign-invested entities have participated in obtaining benefits from PRC
entities engaged in restricted businesses. However, PRC law is more vague on the
subject of utilizing such structure in the context of prohibited businesses in
which Shandong may engage. Given this lack of clarity in PRC law, if NeoStem is
found to be in violation of any existing or future PRC laws, regulations, and/or
circulars, the relevant regulatory authorities would have broad discretion in
dealing with such violation, including levying fines, confiscating NeoStem's
income, revoking business and/or operating licenses, requiring NeoStem to
restructure the relevant ownership structure or operations, and requiring
NeoStem to discontinue all or any portion of its operations in the PRC. Any of
these actions could cause significant disruption to NeoStem's business
operations and may materially and adversely affect NeoStem's business, financial
condition and results of operations. There can be no assurance that NeoStem will
not be found in violation of any current or future PRC laws, regulations, and/or
circulars.
The
WFOE’s contractual arrangements with Shandong and its equity owners as
memorialized in the VIE documents may not be as effective in obtaining
benefits from Shandong as direct ownership of Shandong.
NeoStem
intends to conduct substantially all of the Shandong Business in the PRC and
generate substantially all of its revenues from the Shandong Business vis-à-vis
the WFOE and Shandong, through contractual arrangements with Shandong and its
equity owners that provide NeoStem with certain benefits from Shandong. NeoStem
will depend on Shandong to hold and maintain certain licenses and other relevant
government approvals necessary for its business activities. Shandong also owns
certain assets relating to its business and operations, and employs the
personnel necessary to carry out such business and operations. NeoStem will have
no ownership interest in Shandong. The contractual arrangements as embodied in
the VIE Documents may not be as effective in providing NeoStem with benefits
from Shandong as direct ownership of Shandong. In addition, Shandong or its
equity owners may breach the contractual arrangements.
Employees
and/or officers of Shandong may encounter conflicts of interest between their
duties to NeoStem and to Shandong. There can be no assurance that when conflicts
of interest arise, the ultimate equity owners of Shandong will act completely in
NeoStem's interests or that conflicts of interest will be resolved in NeoStem's
favor. These ultimate equity owners could violate any applicable non-competition
or employment agreements or their legal duties by diverting business
opportunities from NeoStem to others. In any event, we would have to rely on
legal remedies under PRC law. These remedies may not always be effective in
vindicating our rights, particularly in light of the uncertainties of the PRC
legal system.
Following
the Share Exchange, a substantial portion of NeoStem's assets will be located in
the PRC and a substantial portion of NeoStem's revenue will be derived from
operations in the PRC. Since this is one of NeoStem's first ventures into the
Chinese market, NeoStem's operations may be subject to additional risks and
uncertainties.
See Risks
Relating to the Merger (above).
For
additional factors that NeoStem may experience in connection with having
operations in the PRC that may adversely affect NeoStem's business and results
of operations, see Risk Factors Relating to the Merger (above).
Risks
Related to the Joint Venture Agreement
Even
if Erye continues to be profitable, NeoStem will be entitled to receive only 6%
of the net profits of Erye for a three-year period commencing on the first day
of the fiscal quarter after the consummation of the Merger, which could
adversely affect NeoStem's results of operations.
Upon
consummation of the transactions contemplated by the Merger, NeoStem will own
51% of the ownership interests in Erye, and EET will own
the remaining 49% ownership interest. Pursuant to the terms and
conditions of the 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 NeoStem's 51% interest in Erye; and
(iii) 6% of the net profit will be distributed to NeoStem directly for NeoStem’s
operating expenses. There can be no assurance that Erye will continue
to be profitable following the consummation of the Merger, if at all, or that
NeoStem will ever receive any distributions from Erye whatsoever.
Many
terms of the Joint Venture Agreement, as well as the location of its operations,
limit NeoStem's ability to control major decisions of Erye, which could
adversely affect NeoStem's business.
Pursuant
to the Joint Venture Agreement, Erye's Board of Directors shall be comprised of
two individuals designated by EET and three individuals designated by NeoStem;
provided, that one of the positions designated by NeoStem shall be assumed by
the member of the NeoStem Board of Directors designated by
EET. Pursuant to the terms of the Joint Venture Agreement, the
affirmative vote of all of the Erye Board of Directors is required for several
major decisions of Erye including the amendment of the Joint Venture Agreement
or Articles of Association of Erye, the termination or dissolution of Erye,
increase or reduction of the registered capital of Erye and merger or spin-off
of Erye. Pursuant to the terms of the Joint Venture Agreement, the
affirmative vote of more than 75% of the Erye Board of Directors is required for
several major decisions of Erye, including, among others, the disposition of all
material assets of Erye, a change of more than 50% of the equity interest in
Erye, changes in more than 50% of the directors of Erye within any consecutive
24 month period, decisions on the material strategy and operation and
development of Erye and the entrance into related party transactions with Erye's
shareholders and their affiliates. In addition, since many of Erye's
officers will live outside the United States, it may be difficult for us to
exert control over the day-to-day operations of Erye.
Some
terms of the Joint Venture Agreement limit NeoStem's ability with respect to
future acquisitions of and investments in chemical drug manufacturing companies,
which could adversely affect NeoStem's business.
Pursuant
to the terms of the Joint Venture Agreement, prior to the investment by NeoStem
in any chemical drug manufacturing company that competes directly with the
business of Erye, NeoStem must obtain the consent from Erye. NeoStem also must
consult with Erye prior to introducing any new small molecule drug in China with
respect to whether it can be produced more cheaply or efficiently by Erye. There
can be no assurance that Erye will give its consent to NeoStem’s investment in
any chemical drug manufacturing company, which could adversely affect the
development of NeoStem's business.
The
income obtained by NeoStem as a shareholder of Erye from the relocation of Erye
will be transferred to EET, which could adversely affect NeoStem's results of
operations.
Pursuant
to the terms of the Joint Venture Agreement, after the relocation of Erye, the
old plant shall cease all its current business and all income in the form of
relocation compensation by the government, and total payments generated from any
lease or transfer to third party shall be vested in EET, which could adversely
affect NeoStem's results of operations.
RISKS
RELATING TO DOING BUSINESS IN CHINA
We are
beginning to pursue business opportunities in China in addition to those
contemplated by the Merger Agreement and the Share Exchange Agreement, and it is
expected that our business will develop an increasingly significant presence in
China. Please consult the “Business Overview” section of this Annual Report,
which contains a discussion of our agreement with PCT contemplating a plan for
the establishment of a stem cell processing, storage and manufacturing operation
in Beijing; a summary of our plans to create a new WFOE and one or more new
limited liability companies in China directed at our efforts to exercise control
over the proposed stem cell processing, storage and manufacturing operation and
related research and development activities; and a description of our license
agreement with Vincent Giampapa, M.D., F.A.C.S. pertaining to the China
territory. Because
China’s economy, laws, regulations and policies are different from those
typically found in the west and are continually changing, we will face risks
including those summarized below:
China
is a developing nation governed by a one party government and may be more
susceptible to political, economic, and social upheaval than other
nations.
China is
a developing country governed by a one-party government. China
is also a country with an extremely large population, widening income gaps
between rich and poor and between urban and rural residents, minority ethnic and
religious populations, and growing access to information about the different
social, economic, and political systems to be found in other
countries. China has also experienced extremely rapid economic
growth over the last decade, and its legal and regulatory systems have changed
rapidly to accommodate this growth. These conditions make China
unique and may make it susceptible to major structural
changes. Such changes could include a reversal of China’s
movement to encourage private economic activity; labor disruptions or other
organized protests; nationalization of private businesses; internal conflicts
between the police or military and the citizenry; and international political or
military conflict. If any of these events were to occur, it
could shut down China’s economy and cause us to temporarily or permanently cease
any operations in China.
The
PRC’s laws, regulations and policies, and changes to them, may limit the ability
of our operations in China to operate profitably, or may prevent our operations
in China from functioning at all.
Any
operations we pursue in China may be heavily regulated by many state, provincial
and local authorities. Any operations in China may be subject to the actions of
PRC government regulators such as the State Food and Drug Administration
(“SFDA”). Government regulations may have a material impact on
our operations in China, increase costs and prevent or delay our company in
licensing, manufacturing and marketing any products or services we may decide to
offer. Any research, development, testing, manufacturing or marketing
activities that we engage in may be subject to various governmental regulations
in China, including health and drug regulations. Government
regulations, among other things, cover the inspection of and controls over
testing, manufacturing, safety and environmental considerations, efficacy,
labeling, advertising, promotion, record keeping and sale and distribution of
pharmaceutical products. In the event we seek to license,
manufacture, sell or distribute any products or services, we might need the
proper approval from certain government agencies such as the
SFDA. The future growth and profitability of any operations in
China would be contingent on obtaining the requisite approvals. There is no
assurance that we will obtain such approvals.
In
addition, delays or rejections may be encountered based upon additional
government regulation from future legislation, administrative action or changes
in governmental policy and interpretation. Any marketing activities
we might engage in also may subject us to government regulations with respect to
the prices that we intend to charge or any other marketing and promotional
related activities. Government regulations may substantially
increase our costs for developing, licensing, manufacturing and marketing any
products or services, impacting negatively on our operation, revenue, income and
cash flow. There could be changes in government regulations
applicable to pharmaceutical industries, which changes may adversely affect our
business.
Because
we do not have any experience in doing business in the PRC, our directors,
officers, managers, and employees will be encountering for the first time the
economic, political, and legal climate that is unique to the PRC, which may
present risk and uncertainties to our operations. Although in recent
years the PRC’s government has implemented measures emphasizing the use of
market forces for economic reform, the reduction of state ownership of
productive assets and the establishment of sound corporate governance in
business enterprises, a substantial portion of productive assets in the PRC is
still owned by the PRC’s government. In addition, the PRC’s government continues
to play a significant role in regulating industry development by imposing
industrial policies. It also exercises significant control over the PRC’s
economic growth through the allocation of resources, controlling payment of
foreign currency-denominated obligations, setting monetary policy and providing
preferential treatment to particular industries or
companies. There can be no assurance that the PRC’s economic,
political or legal systems will not develop in a way that becomes detrimental to
our business, results of operations and prospects. Our activities may
be materially and adversely affected by changes in the PRC’s economic and social
conditions and by changes in the policies of the PRC’s government, such as
measures to control inflation, changes in the rates or method of taxation and
the imposition of additional restrictions on currency conversion.
If
political relations between China and the Unites States or Europe deteriorate,
it could cause a downturn in our financial condition; disruptions to our
operations; or a less receptive public response to the goods or services we may
offer.
The
relationship between China and the United States and Europe is subject to sudden
fluctuation and periodic tension. Relations may also be compromised
if the U.S. or Europe becomes a more vocal advocate of Taiwan or proceeds to
sell certain military weapons and technology to Taiwan. Changes in
political conditions in China and changes in the state of Sino-U.S. relations
and Sino-European relations are difficult to predict and could adversely affect
our operations or financial condition. In addition, because of our involvement
in the Chinese market, any deterioration in political relations might cause a
public perception in the United States or elsewhere that might cause the goods
or services we may offer to become less attractive. Because we are
not limited to any specific industry, there is no basis for investors in this
offering to evaluate the possible extent of any impact on our ultimate
operations if relations are strained between China and either the United States
or Europe.
We
may not be able to enforce our rights in China.
China’s
legal and judicial system may negatively impact foreign
investors. In 1982, the National People’s Congress amended the
Constitution of China to authorize foreign investment and guarantee the “lawful
rights and interests” of foreign investors in the
China. However, China’s system of laws in this area is not yet
comprehensive. The legal and judicial systems in the China are
still rudimentary, and enforcement of existing laws is
inconsistent. Many judges in China lack the depth of legal
training and experience that would be expected of a judge in a more developed
country. Because the China judiciary is relatively
inexperienced in enforcing the laws that do exist, anticipation of judicial
decision-making is more uncertain than would be expected in a more developed
country. It may be impossible to obtain swift and equitable
enforcement of laws that do exist, or to obtain enforcement of the judgment of
one court by a court of another jurisdiction. China’s legal
system is based on civil law, or written statutes; a decision by one judge does
not set a legal precedent that must be followed by judges in other
cases. In addition, the interpretation of Chinese laws may vary
to reflect domestic political changes.
PRC laws
and regulations that may govern our business operations in China are sometimes
vague and uncertain. There are substantial uncertainties
regarding the interpretation and application of PRC laws and regulations,
including but not limited to the laws and regulations governing our business and
the enforcement and performance of our contractual arrangements in the event of
the imposition of statutory liens, death, bankruptcy and criminal
proceedings. We will be required to comply with certain PRC laws and
regulations. These laws and regulations are sometimes vague and
may be subject to future changes, and their official interpretation and
enforcement may involve substantial uncertainty. The
effectiveness of newly enacted laws, regulations or amendments may be delayed,
resulting in detrimental reliance by foreign investors. New
laws and regulations that affect existing and proposed future businesses may
also be applied retroactively. We cannot predict what effect
the interpretation of existing or new PRC laws or regulations may have on our
business.
The laws of China are likely to govern
many of our material agreements. We cannot assure you that we will be
able to enforce our interests or our material agreements or that remedies will
be available outside of certain regions. For example, the system of
laws and the enforcement of existing laws in China may not be as certain in
implementation and interpretation as in the United States. The
Chinese judiciary is relatively inexperienced in enforcing corporate and
commercial law, leading to a higher than usual degree of uncertainty as to the
outcome of any litigation. The inability to enforce or obtain a
remedy under any of our future agreements may have a material adverse impact on
our operations.
If
China imposes restrictions to reduce inflation, future economic growth in China
could be severely curtailed, which could lead to a significant decrease in the
efficiency and/or profitability of our operations in China.
While the economy of China has
experienced rapid growth, this growth has been uneven among various sectors of
the economy and in different geographical areas of the country. Rapid
economic growth can lead to growth in the supply of money and rising
inflation. If prices for any products or services being developed in
China rise at a rate that is insufficient to compensate for the rise in the
costs of supplies, materials or labor, it may have an adverse effect on
profitability. In order to control inflation in the past, China has
imposed controls on bank credits, limits on loans for fixed assets and
restrictions on state bank lending. If similar restrictions are
imposed, it may lead to a slowing of economic growth. We cannot
predict with any certainty the degree to which our line of business will be
affected by any slow-down of economic growth.
Many
industries in China are subject to government regulations that limit or prohibit
foreign investments in such industries, which may limit our potential to control
certain businesses, acquire specific interests, or partake of particular
ventures.
The Chinese government has imposed
regulations in various industries, such as publishing, media, market research,
medical research (including the stem cell business) and social research
industries, that would limit foreign investors’ equity ownership or prohibit
foreign investments altogether in companies that operate in such
industries. As a result, the range of new business ventures or the
nature of investment opportunities available to us may be limited.
The
laws and regulations governing the stem cell therapy industry in China are
developing and subject to future changes. Future PRC laws may impose conditions
or requirements with which we may not be able to comply, which could materially
and adversely affect our business.
As the
stem cell therapy industry is at an early stage of development in China, new
laws and regulations may be adopted in the future to address new issues that
arise from time to time. As a result, substantial uncertainties exist regarding
the interpretation and implementation of current and any future PRC laws and
regulations applicable to the stem cell therapy industry. There is no way to
predict the content or scope of applicability of future Chinese stem cell
regulation. There can be no assurances that in the future the PRC government
authorities will not issue laws or regulations which may impose conditions or
requirements with which we may not be able to comply, which could materially and
adversely affect our business, financial condition and results of
operations.
The
import into China or export from China of technology relating to stem cell
therapy may be prohibited or restricted.
The
Ministry of Commerce (MOFCOM) and Ministry of Science and Technology of China
(MOST) jointly publish the Catalogue of Technologies the Export of which from
China is Prohibited or Restricted, and the Catalogue of Technologies the Import
of which into China Prohibited or Restricted. Stem cell related
technologies are not listed in the current versions of these catalogues, and
therefore their import or export should not be forbidden or require that
approval MOFCOM and MOST. However, these catalogues are subject to
revision and, as the PRC authorities develop policies concerning stem cell
technologies, it is possible that the categories would be amended or updated
should the Chinese government want to regulate the export or import of stem cell
related technologies to protect material state interests or for other
reasons. Should the catalogues be updated so as to bring any
activities of the planned stem cell processing, storage and manufacturing
operation in Beijing and related research and development activities under their
purview, any such limitations or restrictions imposed on the operations and
related activities could materially and adversely affect our business, financial
condition and results of operations.
If
China enacts regulations that reach a greater number of industry segments so as
to forbid or restrict foreign investment, our ability to consummate business
combinations or enter into business transactions could be severely
impaired.
Many of the rules and regulations
that companies face in China are not explicitly communicated. If new
laws or regulations forbid foreign investment in industries in which we want to
complete a business combination, the laws could severely impair our choice of
candidate pool of potential target businesses. Additionally, if the
relevant Chinese authorities find us or the target business with which we
ultimately complete a business combination to be in violation of any existing or
future Chinese laws or regulations, they would have broad discretion in dealing
with such a violation, including, without limitation:
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revoking
our business and other
licenses;
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requiring
that we restructure our ownership or operations;
and
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requiring
that we discontinue any portion or all of our
business.
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Additionally,
the business relationships we establish in China will be subject to PRC
interpretations of the applicability of PRC law to our particular business
arrangements.
Recent
changes in China’s currency policies may cause our ability to succeed in the
international markets to be diminished.
Historically, China “pegged” its
currency to the United States dollar. This meant that each unit of
Chinese currency had a set ratio for which it could be exchanged for United
States currency, as opposed to having a floating value like other countries’
currencies. Many countries argued that this system of keeping the
Chinese currency low when compared to other countries gave Chinese companies an
unfair price advantage over foreign companies. Due to mounting
pressure from outside countries, China recently reformed its economic policies
to establish a floating value. As a result of this policy reform,
Chinese-based operations may be adversely affected since the competitive
advantages that existed as a result of the former policies will
cease. We cannot assure you that our interests in China will be able
to compete effectively with the new policies in place.
Anti-inflation
measures may be ineffective or harm our ability to do business in
China.
In recent
years, the PRC government has instituted anti-inflationary measures to curb the
risk of an overheated economy characterized by debilitating
inflation. These measures have included devaluations of the
renminbi, restrictions on the availability of domestic credit, and limited
re-centralization of the approval process for some international
transactions. These austerity measures may not succeed in
slowing down the economy’s excessive expansion or control inflation, or they may
slow the economy below a healthy growth rate and lead to economic stagnation or
recession; in the worst-case scenario, the measures could slow the economy
without curbing inflation. The PRC government could adopt
additional measures to further combat inflation, including the establishment of
price freezes or moratoriums on certain projects or
transactions. Such measures could harm the economy generally
and hurt our business by limiting the income of our customers available to spend
on our services, by forcing us to lower our profit margins, and by limiting our
ability to obtain credit or other financing to pursue our expansion plans or
maintain our business.
The
uncertain legal environment in China could limit the legal protections available
to you and could adversely affect our ability to provide our services in
China.
Any WFOE structure we establish would
be subject to the uncertainties of applicable PRC law. WFOE’s are subject
generally to laws and regulations applicable to foreign investment in China and,
in particular, to laws applicable to wholly foreign-owned enterprises. The PRC
legal system is a civil law system based on written statutes. Unlike common law
systems, it is a system in which decided legal cases have little precedential
value. PRC laws, regulations and legal requirements governing economic matters
are evolving rapidly, and their interpretation and enforcement involve
uncertainties. These uncertainties could limit the legal protections available
to foreign investors and entities, including you and us, such as the right of
foreign-invested enterprises to hold licenses and permits. As the PRC legal
system matures, changes in its legislation or interpretation of its legislation
may adversely affect our ability to provide our services and any associated
products in China.
Regulations
relating to the transfer of state-owned property rights in enterprises may
increase the cost of any acquisitions or transactions, and may therefore impose
an additional administrative burden on us.
The legislation governing the
acquisition of a China state-owned company contains stringent governmental
regulations. The transfer of state-owned property rights in
enterprises must take place through a government approved “state-owned asset
exchange,” and the value of the transferred property rights must be evaluated by
those Chinese appraisal firms qualified to do “state-owned assets
evaluation.” The final price must not be less than 90.0% of the
appraisal price. Additionally, bidding/auction procedures are
essential in the event that there is more than one potential
transferee. In the case of an acquisition by foreign investors
of state-owned enterprises, the acquirer and the seller must make a resettlement
plan to properly resettle the employees, and the resettlement plan must be
approved by the Employees’ Representative Congress. The seller must
pay all unpaid wages and social welfare payments from the existing assets of the
target company to the employees. These regulations may adversely
affect our ability to acquire a state-owned business or assets.
In
the event that our future expansion creates a scenario where certain directors
and/or officers will live outside the United States and a significant portion of
our assets will be located outside the United States, investors may not be able
to enforce federal securities laws or their other legal rights.
Future expansion may require that many
of our directors and/or officers will reside outside of the United States, and a
substantial portion of our assets may be located outside of the United
States. As a result, it may be difficult, or in some cases not
possible, for investors in the United States to enforce their legal rights, to
effect service of process upon certain of our directors or officers or to
enforce judgments of United States courts predicated upon civil liabilities and
criminal penalties against our directors and officers pursuant to United States
laws.
Cultural,
language and managerial differences may result in the reduction of our overall
performance.
While
Chinese mergers and acquisitions are increasing in frequency, assimilating
cultural, language and managerial differences remains
problematic. Friction may result due to the consolidation of
management teams from different cultural backgrounds. In addition, errors
arising through language translations may cause miscommunications relating to
material information, which could adversely affect our business operations.
These factors may make the management of our operations in China more
difficult.
Political
instability in China could harm our business.
We
may target or have associations with businesses in China that have operations
associated with developing countries in Asia where political, economic and
social transition is taking place. Some Asian countries, including
China, have experienced political instability, expropriation or nationalization
of property, civil strife, strikes, acts of war and insurrections. Any of these
conditions occurring could disrupt or terminate our operations, causing our
operations to be curtailed or terminated in these areas or our operations to
decline and could cause us to incur additional costs.
Ethical
and other concerns surrounding the use of stem cell therapy may increase the
regulation of or negatively impact the public perception of our stem cell
services, thereby reducing demand for our services.
The use
of embryonic stem cells for research and stem cell therapy has been the subject
of debate regarding related ethical, legal and social issues. The Ministry of
Science and Technology and the Ministry of Health of the PRC issued “The Ethical
Guiding Principles for the Research of Human Embryonic Stem Cell” on December
24, 2003, which are formulated for the purpose of aligning the research of human
embryonic stem cell in the biomedical field in China with the ethical criterion
of life, ensuring the respect and observance of internationally recognized
ethical standards of life and the relevant provisions of our country, as well as
promoting the healthy development of the research on human embryonic stem cell.
According to the Ethical Guiding Principles, all those engaging in activities
concerning the research of human embryonic stem cell within the territory of PRC
shall abide by the present Guiding Principles, according to which, any research
on reproductive cloning is prohibited, and no human gamete, germ cell, embryo or
fetus tissues may be bought or sold. Although our business does not involve the
more controversial use of embryonic stem cells, the use of other types of human
stem cells for therapy could give rise to similar ethical, legal and social
issues as those associated with embryonic stem cells. Additionally, it is
possible that our business could be negatively impacted by any stigma associated
with the use of embryonic stem cells if the public fails to appreciate the
distinction between the use of adult versus embryonic stem cells. The commercial
success of our business will depend in part on public acceptance of the use of
stem cell therapy, in general, for the prevention or treatment of human
diseases. Public attitudes may be influenced by claims that stem cell therapy is
unsafe or unnecessary, and stem cell therapy may not gain the acceptance of the
public or the medical community. Public pressure or adverse events in the field
of stem cell therapy that may occur in the future also may result in greater
governmental regulation of our business creating increased expenses and
potential regulatory delays relating to the approval or licensing of any or all
of the processes and facilities involved in our stem cell banking services. In
the event that the use of stem cell therapy becomes the subject of adverse
commentary or publicity, our business could be adversely affected and the market
price for our common stock could be significantly harmed.
In
the event we consummate our plans to establish the stem cell processing, storage
and manufacturing operation in Beijing and related research and development
activities, and the government of the PRC determines that the arrangements that
establish any new WFOE structure implemented for conducting these operations do
not comply with PRC government restrictions on foreign investment in the
relevant industry, or if the structure is not compatible with PRC laws regarding
foreign investment generally, we may be subject to severe consequences and
penalties, and we may be precluded from launching any such new
operation.
As noted in the “Business Overview”
section of this Annual Report, we are planning the launch of a stem cell
processing, storage and manufacturing operation in Beijing as well as related
research and development activities. However, any such development would be
dependent upon our establishing a new WFOE and one or more new China-based
limited liability companies. Any such new WFOE would be classified as
a foreign-invested enterprise. Because various regulations in China currently
restrict or prevent foreign-invested entities from holding certain licenses and
controlling businesses in certain industries, we would be required to rely on
the contractual relationships memorialized in the relevant VIE Documents to
obtain benefits from the business, personnel, and financial affairs of any new
stem cell processing, storage and manufacturing operation in Beijing and related
research and development activities.
Our
ability to lease the premises for a new facility, to hire personnel, to purchase
lab equipment, to seek government grants, and to transfer certain of our
intellectual property and “know how” to a new facility, would all depend upon
the functionality of the VIE Documents and upon the application of PRC law to
the structure of any new WFOE. The PRC laws and regulations governing business
entities are often vague and uncertain. Despite the uncertainties associated
with the application of PRC law, a structure involving a WFOE, together with the
contractual arrangements under the VIE Documents, has been implemented
successfully where foreign-invested entities have participated in controlling
PRC entities engaged in “restricted businesses.” However, should a facility we
establish be deemed to engage in a “prohibited business,” there would be a
particular lack of clarity as to the application of PRC law. Given the lack of
clarity in PRC law, if we were to be found in violation of any existing or
future PRC laws, regulations, and/or circulars, the relevant regulatory
authorities would have broad discretion in dealing with such violation,
including levying fines, confiscating our income, revoking business and/or
operating licenses, requiring us to restructure the relevant ownership structure
or operations, and requiring us to discontinue all or any portion of our
operations in the PRC. Any of these actions could cause significant disruption
to our business operations and may materially and adversely affect our business,
financial condition and results of operations. There can be no assurance that we
will not be found in violation of any current or future PRC laws, regulations
and/or circulars.
As
we proceed to establish the stem cell processing, storage and manufacturing
operation in Beijing, any new WFOE’s contractual arrangements with the facility
and its equity owners, as memorialized in the VIE documents, may not be as
effective in providing benefits from the facility as direct ownership
of the facility.
In the event the stem cell processing,
storage and manufacturing operation and related research and development
activities is established, substantially all of the business, as well as
substantially all of our revenues from the operation, would be directed by means
of the WFOE, through contractual arrangements with the facility and its equity
owners and any other limited liability company set up in connection with these
activities that would provide us with benefits from the facility. We would
depend on the facility to enter into a lease agreement for the premises; hire
employees; purchase laboratory equipment; seek government funding; and hold
certain of our intellectual property and “know-how.” We would also depend on the
facility to maintain certain licenses and other relevant government approvals
necessary for its business and operations. We would have no direct ownership
interest in the facility. The contractual arrangements as embodied in the VIE
Documents may not be as effective in providing us benefits from such facility as
would direct ownership. In addition, the facility or its equity owners may
breach the contractual arrangements. We would similarly rely on any
other limited liability company set up in connection with the conduct of related
research and development activities.
Employees and/or officers of the
prospective processing and storage facility/laboratory may encounter conflicts
of interest between their duties to us and to the facility. There can be no
assurance that if conflicts of interest arise, the ultimate equity owners of the
facility will act completely in our interests or that conflicts of interest will
be resolved in our favor. These ultimate equity owners could violate any
applicable non-competition or employment agreements or their legal duties by
diverting business opportunities from us to others. In any event, we would have
to rely on legal remedies under PRC law. These remedies may not always be
effective in vindicating our rights, particularly in light of the uncertainties
of the PRC legal system.
If
we move forward with our plans to expand into China through the establishment of
any new WFOE and any new China-based limited liability company, we may need to
partly rely on distributions paid pursuant to the applicable contractual
relationships for certain of our cash needs. If these entities are unable to
remit to us sufficient distributions due to statutory or contractual
restrictions, our cash needs may not be met.
We anticipate that certain of our
cash needs may be met by means of the distributions to be paid pursuant to the
contractual relationships relevant to any new WFOE we may establish. That is,
our access to distributions from the planned stem cell processing, storage and
manufacturing operation in Beijing including related research and development
activities would be limited to our rights under contract. In the event we
proceeded with these plans, we would depend in part on receipt of these
distributions for paying cash distributions to our shareholders, servicing any
debt we may incur and paying our operating expenses. The payment of
distributions in China is subject to limitations. Regulations in the
PRC currently permit payment of dividends by PRC subsidiaries only out of
accumulated profits as determined in accordance with accounting standards and
regulations in China. In addition, if any of the relevant entities
incur any debt in the future, the instruments governing the debt may restrict
the respective entity’s ability to make distributions. In the event that
contractual rights, statutory enactments or PRC regulations delayed or prevented
our receipt of anticipated distributions, our operations may be materially
adversely affected.
PRC
regulation of loans and direct investment by offshore holding companies to PRC
entities may delay or prevent us from making loans or additional capital
contributions to any PRC operating subsidiaries and affiliated entities that we
may establish.
In the event that we establish a new
WFOE or any other PRC operating subsidiaries and affiliated entities, any loans
or additional capital contributions that we might make to such entities must
comply with PRC legal requirements relating to foreign debt registration and to
PRC companies’ “registered capital” and “total
investment.” “Registered capital” refers to the capital contributed
to or paid into a PRC company in cash or in kind, and “total investment” refers
to the amount of a company’s registered capital plus all external borrowings by
such company. The amounts of a PRC company’s registered capital and
total investment are set forth in the company’s constitutional documents and are
approved by the competent government authority in advance. Loans to such
companies cannot exceed the difference between such company’s registered capital
and total investment, unless the company has obtained the approval of the
appropriate government approval authority.
In the event we decide to establish
any PRC subsidiaries and then seek to finance such PRC subsidiaries by making
additional capital contributions, such additional contributions must be approved
by the government approval authority. We cannot assure you that we will be able
to obtain these government registrations or approvals on a timely basis, if at
all, with respect to future loans or additional capital contributions by us to
any subsidiaries or affiliates. If we fail to receive such registrations or
approvals, our ability to capitalize any PRC operations would be negatively
affected, which could adversely and materially affect the liquidity of any such
PRC subsidiaries and our ability to expand our business.
RISKS
RELATED TO SEC INFORMAL REQUEST
We
have received an informal request for documents in connection with an SEC
investigation of a third party matter
In connection with the SEC's investigation of a matter referred to as a matter
of a third party (the “Third Party”), we have received an informal request
from the SEC, dated December 23, 2008, for the voluntary production of documents
and information concerning the issuance, distribution, registration, purchase,
sale and/or offer to sell our securities from January 1, 2007 to the
present. The Third Party served as the lead underwriter of our public
offering that was consummated in August 2007. We are cooperating
fully with the SEC’s request. While there is no indication to date that we
are the target of an investigation and the letter stated that the
request should not be construed as an indication by the SEC or its staff that
any violation of the federal securities laws has occurred, nor should it be
considered a reflection upon any person, entity or security, there can be
no assurance that the SEC will not take any action against us. Any
determination by the SEC to take action against us could be costly and time
consuming, could divert the efforts and attention of our directors,
officers and employees from the operation of our business and could result in
sanctions against us, any or all of which could have a material adverse effect
on our business and operating results.
ITEM
1B. UNRESOLVED STAFF COMMENTS
Not
applicable.
ITEM
2. PROPERTIES
Effective
as of July 1, 2006, the Company entered into an agreement for the use of
space at 420 Lexington Avenue, New York, New York. This space
was subleased from an affiliate of Duncan Capital Group LLC (a former financial
advisor to and an investor in the Company) and DCI Master LDC (the lead investor
in the Company’s June 2006 private placement). Pursuant to the terms
of the Agreement, the Company was obligated to pay $7,500 monthly for the space,
including the use of various office services and utilities. The agreement is on
a month to month basis, subject to a thirty day prior written notice requirement
to terminate. The space serves as the Company’s principal executive offices. On
October 27, 2006, the Company amended this agreement to increase the
utilized space for an additional payment of $2,000 per month. In May
2007, the Board of Directors approved an amendment to this agreement whereby, in
exchange for a further increase in utilized space, the Company would pay on a
monthly basis (i) $10,000 in cash and (ii) shares of the Company’s restricted
Common Stock with a value of $5,000 based on the fair market value of the Common
Stock on the date of issuance. Commencing in August 2007, the parties
agreed this monthly fee of $15,000 would be paid in cash on a month to month
basis. In February 2008, the Company was advised that a portion of this sublet
space was no longer available. The Company agreed to utilize the
smaller space for a monthly fee of $9,000 beginning in March 2008, as it was
expected that many of our employees would be spending a majority of their time
in Long Island, New York, helping to launch the ProHealthcare collection
center. On September 24, 2008, the Company entered into a license
agreement with a provider of executive office space (the “Licensor”) to use
office space at 420 Lexington Avenue, Suite 300, New York, NY 10170
(the “New Office Lease”). The New Office Lease had an initial term
from October 1, 2008 through September 30, 2009 at a monthly cost of $10,000,
automatically renewing for successive one year terms unless 60 days’ prior
written notice was given by either party. Monthly charges upon
renewal were to be determined by Licensor. Beginning February 1,
2009, the Company had the right to terminate the New Office Lease provided,
among other things, that 60 days’ prior written notice was
given. Upon entering into the New Office Lease for office space at
Suite 300, the Company further reduced the amount of office space it was
utilizing at Suite 450 in the same building with a corresponding reduction in
the monthly fee to $3,500 which was paid through December 31, 2008.
NeoStem
believed the combined office space at Suite 300 and Suite 450 at 420 Lexington
Avenue, New York, NY, would be sufficient for its near term needs; however,
sufficient space was again becoming available at Suite 450 and therefore 60
days’ prior written notice was given to Licensor in December 2008 that the
Company would be terminating the lease at Suite 300 effective February 1,
2009. It is anticipated that the Company will enter into an agreement
for the lease of executive office space at Suite 450, 420 Lexington Avenue, New
York, NY 10170 with a lease term through June 2013. Rental
and utility payments are anticipated to be in the aggregate approximate monthly
amount of $20,100. To help defray the cost of the lease, the Company
will license to third parties the right to occupy certain of the offices in
Suite 450 and use certain business services. Such license payments
will total approximately $14,400 per month. The lease is expected to
be entered into pursuant to an assignment and assumption of the original lease
from the original lessor thereof, DCI Master LDC (the lead investor in the
Company’s June 2006 private placement) 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”). The Company will be credited with an
amount remaining as a security deposit with the landlord from such original
lessor (the “Security Deposit Credit”), be 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, such security deposit and payment of the Security Deposit
Credit to the Guarantor to be in the approximate aggregate amount of
$157,100. Pending the execution of the new lease, the Company
has been paying a fee of $2,500 per month to the landlord since January
2009. The Company believes this space should be sufficient for its
needs for the foreseeable future, although there can be no assurance that the
new lease will be entered into and the Company may then need to secure new
executive office space.
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 continues to occupy the space on a
month-to-month basis. This space was sufficient for the Company’s
past needs but the Company plans to close this facility by the end of the second
quarter of 2009 and transfer its processing and storage operations to state of
the art facilities operated by leaders in cell processing. It intends
to utilize NECC, with whom it entered into a Master Services agreement and a
first statement of work effective as of August 2007, to provide additional
processing and cryogenic storage to the Company at the NECC Facility in Newton,
Massachusetts, to process and store for certain research purposes, and to
utilize 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 addition, pursuant to NeoStem’s second statement of
work with NECC entered into in October 2008, NeoStem is currently paying $5,000
per month for the right to use shared laboratory space and certain
administrative space at the NECC Facility. NS California also leased
office space in Agoura Hills, California on a month-to-month basis from Symbion
Research International at a monthly rental of $1,687. Effective March
31, 2008, we canceled our space agreement with Symbion Research International.
We currently do not anticipate a continuing need for office space in
California. Rent for these facilities for the years ended December
31, 2008, 2007 and 2006, was approximately $202,000, $215,000 and $79,000,
respectively.
ITEM
3. LEGAL PROCEEDINGS
NeoStem
is not aware of any material pending legal proceedings against it.
In
connection with the SEC's investigation of a matter referred to as a
matter of a third party (the “Third Party”), NeoStem has received an informal
request from the SEC, dated December 23, 2008, for the voluntary production of
documents and information concerning the issuance, distribution, registration,
purchase, sale and/or offer to sell its securities from January 1, 2007 to the
present. The Third Party served as the lead underwriter of NeoStem's
public offering that was consummated in August 2007. NeoStem is
cooperating fully with the SEC’s request. The letter stated that the
request should not be construed as an indication by the SEC or its staff that
any violation of the federal securities laws has occurred, nor should it be
considered a reflection upon any person, entity or security. There is
no indication to date that NeoStem is the subject of an
investigation.
ITEM
4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
No
matters were submitted to a vote of the Company's stockholders during the fourth
quarter of 2008.
ITEM
5(a). MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER
MATTERS.
Our
Common Stock trades on the NYSE Amex (previously known as the American Stock
Exchange) under the symbol “NBS.” From August 31, 2006 to August 8,
2007, it traded on the OTC Bulletin Board under the symbol “NEOI” and from
July 24, 2003 to August 30, 2006 traded under the symbol
“PHSM.” The following table sets forth the high and low sales prices
and high and low bid prices (as applicable) of our Common Stock for each
quarterly period within the two most recent fiscal years, and for the current
year to date, as reported by the NYSE Amex, the American Stock Exchange and/or
NASDAQ Trading and Market Services (as applicable). On March 27,
2009, the closing sales price for our Common Stock was $0.94. Information set
forth in the table below reflects inter-dealer prices without retail mark-up,
mark-down, or commission, and may not necessarily represent actual
transactions.
2009
|
|
High
|
|
|
Low
|
|
First
Quarter (to March 27, 2009)
|
|
$ |
1.08 |
|
|
$ |
0.43 |
|
2008
|
|
High
|
|
|
Low
|
|
First
Quarter
|
|
$ |
2.24 |
|
|
$ |
1.18 |
|
Second
Quarter
|
|
|
1.48 |
|
|
|
0.41 |
|
Third
Quarter
|
|
|
1.80 |
|
|
|
0.70 |
|
Fourth
Quarter
|
|
|
2.15 |
|
|
|
0.41 |
|
2007
|
|
High
|
|
|
Low
|
|
First
Quarter
|
|
$ |
8.00 |
|
|
$ |
2.50 |
|
Second
Quarter
|
|
|
6.40 |
|
|
|
3.70 |
|
Third
Quarter
|
|
|
7.65 |
|
|
|
3.65 |
|
Fourth
Quarter
|
|
|
4.75 |
|
|
|
1.28 |
|
HOLDERS.
As of March 27, 2009, there were approximately 1,025 holders of record of the
Company's Common Stock (which does not include beneficial owners for whom
Cede & Co. or others act as nominees).
DIVIDENDS.
Holders of Common Stock are entitled to dividends when, as, and if declared by
the Board of Directors out of funds legally available therefor. We have not paid
any cash dividends on our Common Stock and, for the foreseeable future, intend
to retain future earnings, if any, to finance the operations, development and
expansion of our business. Future dividend policy is subject to the discretion
of the Board of Directors.
EQUITY
COMPENSATION PLAN INFORMATION
The following table gives information
about the Company’s Common Stock that may be issued upon the exercise of
options, warrants and rights under the Company’s 2003 Equity Participation Plan
as of December 31, 2008. This plan was the Company’s only equity
compensation plan in existence as of December 31, 2008.
Plan Category
|
|
(a)
Number
of Securities to be Issued Upon Exercise of Outstanding Options, Warrants and Rights
|
|
|
|
(b)
Weighted-Average
Exercise Price of Outstanding Options, Warrants and Rights
|
|
|
|
(c)
Number
of Securities Remaining Available For Future Issuance Under Equity
Compensation Plan (Excluding Securities Reflected In Column (a))
|
|
Equity
Compensation Plans Approved by Shareholders
|
|
|
1,725,300
|
|
|
$ |
3.96
|
|
|
|
36,298 |
|
Equity
Compensation Plans Not Approved by Shareholders
|
|
|
0
|
|
|
|
0
|
|
|
|
0
|
|
TOTAL
|
|
|
1,725,300 |
|
|
$ |
3.96 |
|
|
|
36,298 |
|
Previously reported on the Company’s Current Reports on Form 8-K
dated March 20, 2008, May 20, 2008, July 24, 2008, August 28, 2008, October 15,
2008 and November 26, 2008, respectively.
Not
applicable.
ITEM
5(c) REPURCHASES OF EQUITY SECURITIES
There
were no repurchases of equity securities by the Company or any affiliated
purchaser during the fourth quarter of the fiscal year ended December 31, 2008
as to which information is required to be furnished.
ITEM
6. SELECTED FINANCIAL DATA
The
selected statements of operations and balance sheet data set forth below are
derived from audited financial statements of the Company. The information set
forth below should be read in conjunction with the Company's audited
consolidated financial statements and notes thereto. See Item 8 "Financial
Statements and Supplementary Data" and Item 7 "Management's Discussion and
Analysis of Financial Condition and Results of Operations." The
requirement to provide geographical information for the operations of the
Company is not practical.
Statement of Operations:
($’000 except net
loss
per share which is stated in
$ and weighted average
number of shares)
|
|
Year
Ended
December
31,
2008
|
|
|
Year Ended
December 31,
2007
|
|
|
Year Ended
December 31,
2006
|
|
|
Year Ended
December 31,
2005
|
|
|
Year Ended
December 31,
2004
|
|
Earned
revenues
|
|
$ |
84 |
|
|
$ |
232 |
|
|
$ |
46 |
|
|
$ |
35 |
|
|
$ |
49 |
|
Direct
costs
|
|
|
32 |
|
|
|
25 |
|
|
|
22 |
|
|
|
25 |
|
|
|
34 |
|
Gross
profit
|
|
|
52 |
|
|
|
207 |
|
|
|
23 |
|
|
|
10 |
|
|
|
15 |
|
Operating
(loss)
|
|
|
(9,233 |
) |
|
|
(10,439
|
) |
|
|
(4,691
|
) |
|
|
(1,601
|
) |
|
|
(1,474
|
) |
Net
loss
|
|
|
(9,242 |
) |
|
|
(10,445
|
) |
|
|
(6,051
|
) |
|
|
(1,745
|
) |
|
|
(1,748
|
) |
Basic
and diluted earnings per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
(1.53 |
) |
|
|
(3.18
|
) |
|
|
(4.43
|
) |
|
|
(3.51
|
) |
|
|
(5.37
|
) |
Weighted
average number of shares outstanding
|
|
|
6,056,886 |
|
|
|
3,284,116 |
|
|
|
1,365,027 |
|
|
|
497,758 |
|
|
|
325,419 |
|
Balance Sheet Data:
$’000
|
|
As
of
December
31,
2008
|
|
|
As of
December 31,
2007
|
|
|
As of
December 31,
2006
|
|
|
As of
December 31,
2005
|
|
|
As of
December 31,
2004
|
|
Working
Capital (Deficiency)
|
|
$ |
(431 |
) |
|
$ |
1,931 |
|
|
$ |
(310 |
) |
|
$ |
(1,245 |
) |
|
$ |
(1,239 |
)
|
Total
Assets
|
|
|
1,824 |
|
|
|
3,775 |
|
|
|
1,195 |
|
|
|
643 |
|
|
|
99 |
|
Current
Liabilities
|
|
|
961 |
|
|
|
444 |
|
|
|
838 |
|
|
|
1,752 |
|
|
|
1,288 |
|
Long
Term Debt
|
|
|
— |
|
|
|
15 |
|
|
|
65 |
|
|
|
— |
|
|
|
— |
|
(Accumulated
Deficit)
|
|
|
(39,994 |
) |
|
|
(30,752 |
) |
|
|
(20,307 |
) |
|
|
(14,255 |
) |
|
|
(12,510 |
)
|
Total
Stockholders’ (Deficit)/ Equity
|
|
|
863 |
|
|
|
3,316 |
|
|
|
292 |
|
|
|
(1,818 |
) |
|
|
(1,932 |
)
|
ITEM
7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATION
The
following discussion and analysis highlights significant factors influencing
NeoStem’s financial condition and results of operations. It should be
read together with the audited consolidated financial statements and notes
thereto included in Item 8 of this report, and is qualified in its entirety by
reference thereto. This discussion contains forward-looking statements. Please
see “Caution Regarding Forward-Looking Statements” for a discussion of the
risks, uncertainties and assumptions relating to these statements.
OVERVIEW
NeoStem
is engaged in a platform business of operating a commercial autologous (donor
and recipient are the same) adult stem cell bank and is pioneering the
pre-disease collection, processing and long-term storage of stem cells from
adult donors that they can access for their own future medical treatment.
We are managing a network of adult stem cell collection centers in major
metropolitan areas of the United States. We have also entered the research and
development arenas, through the acquisition of a worldwide exclusive license to
an early-stage technology to identify and isolate rare stem cells from adult
human bone marrow, called VSEL (very small embryonic-like) stem cells. VSELs
have many physical characteristics typically found in embryonic stem cells,
including the ability to differentiate into specialized cells found in
substantially all the different types of cells and tissue that make up the body.
On January 19, 2006, we consummated the acquisition of the assets of NS
California, Inc., a California corporation (“NS California”) relating to NS
California’s business of collecting and storing adult stem cells.
Effective with the acquisition, the business of NS California became our
principal business, rather than our historic business of providing capital and
business guidance to companies in the healthcare and life science
industries. NeoStem provides adult stem cell processing, collection and
banking services with the goal of making stem cell collection and storage widely
available, so that the general population will have the opportunity to store
their own stem cells for future healthcare needs.
The adult
stem cell industry is a field independent of embryonic stem cell research which
NeoStem believes is more likely to be burdened by governmental, legal, ethical
and technical issues than adult stem cell research. Medical
researchers, scientists, medical institutions, physicians, pharmaceutical
companies and biotechnology companies are currently developing therapies for the
treatment of disease using adult stem cells. As these adult stem cell
therapies obtain necessary regulatory approvals and become standard of care,
patients will need a service to collect, process and bank their stem cells.
NeoStem intends to provide this service.
Initial
participants in our collection center network have been single physician
practices who opened collection centers in California, Pennsylvania and Nevada.
Revenues generated by these early adopters have not been significant and are not
expected to become significant. However, these centers have served as a platform
for the development of NeoStem’s business model and today NeoStem is focusing on
multi-physician and multi-specialty practices joining its network in major
metropolitan areas. Toward this end, NeoStem signed an agreement in
June 2008 for a New York City stem cell collection center to be opened by Bruce
Yaffe, M.D., Yaffe, Ruden and Associates, which facility became operational in
November 2008. In July 2008, NeoStem signed an agreement for a Santa Monica,
California based stem cell collection center to be opened by Stem Collect of
Santa Monica LLC at The Hall Center. This facility became operational
in the fall of 2008. Additionally, NeoStem signed an agreement with Celvida LLC
pursuant to which a Southern Florida stem cell collection center located in
Coral Gables, a suburb of Miami, became operational in September
2008. In March 2009, the Company signed an agreement to open a
collection center with the Giampapa Institute for Anti-Aging Medical Therapy in
Montclair, New Jersey.
During
2008, parallel to growing the platform business and the efforts we undertook in
that regard to establish a network of collection centers in certain major
metropolitan areas of the United States to drive growth, we recognized the need
to acquire a revenue generating business in the United States or abroad and
began exploring acquisition opportunities of revenue generating
businesses. In November 2008, NeoStem entered into the Merger
Agreement with CBH to acquire the 51% interest in Suzhou Erye Pharmaceuticals
Company Ltd., “Erye” a Sino-foreign
limited liability joint venture organized under the laws of the PRC, which has
been in business for more than 50 years and currently manufactures over 100
drugs on seven Good Manufacturing Practices (GMP) lines, including small
molecule drugs. Erye specializes in research and development, production and
sales of pharmaceutical products, as well as chemicals used in pharmaceutical
products. Also in November 2008, NeoStem entered into the Share Exchange
Agreement to obtain benefits from Shandong New Medicine Research Institute of
Integrated Traditional and Western Medicine Limited Liability Company, a China
limited liability company, which is engaged in the business of research,
development, popularization and transference of regenerative medicine technology
(except for those items for which it does not have special approval) in the
PRC. Subject to the fulfillment of various closing conditions
(including shareholder approval), the Merger and the Share Exchange are
currently anticipated to close near the end of the second quarter of
2009.
The
Company has engaged in various capital raising activities to pursue its business
opportunities, raising approximately $3,823,000 in 2006, $7,939,000 in 2007 and
$2,899,000 in 2008 through the sale of its Common Stock, warrants and
convertible promissory notes. These amounts include an aggregate of $250,000
raised from the private placement of the convertible promissory notes in the
Westpark private placement in January 2006, $2,079,000 raised from the
June 2006 private placement of shares of Common Stock and warrants to
purchase shares of Common Stock, an aggregate of $1,750,000 raised from the
additional private placement of shares of Common Stock and warrants to purchase
shares of Common Stock in rolling closings in the summer of 2006, an aggregate
of $2,500,000 (net proceeds of $2,320,000) raised in January and February
2007 from the private placement of units consisting of shares of Common Stock
and warrants to purchase shares of Common Stock, an aggregate of $6,350,000 (net
proceeds of $5,619,000) raised in August 2007 from the public offering of
1,270,000 units consisting of shares of Common Stock and warrants to purchase
shares of Common Stock, and an aggregate of $1,150,000, $1,000,000, $250,000 and
$500,000, raised in May 2008, September 2008, October 2008 and November 2008,
respectively, with total net proceeds of $2,899,000, from the additional private
placement of Common Stock and warrants to purchase Common
Stock. These capital raising activities enabled us to acquire the
business of NS California, pursue our business plan and grow our adult stem cell
collection and storage business, including expanding marketing and sales
activities, and explore acquisition opportunities. In October 2008
we were advised that we would receive Federal funding from the Department of
Defense to evaluate the potential use of adult stem cell therapy for wound
healing, and would be included in the Department of Defense Fiscal Year 2009
Appropriations Bill. Such funding is currently anticipated to be in
the approximate net amount of $681,000.
In
February and March 2009, in order to move forward certain research and
development activities, strategic relationships in various clinical and
therapeutic areas as well as to support activities related to the Merger
Agreement and Share Exchange Agreement, and other ongoing obligations of the
Company, the Company issued promissory notes (“RimAsia Notes”) totaling
$1,150,000 to RimAsia Capital Partners, L.P., a principal stock holder of the
Company, which notes bear interest at a rate equal to 10% per annum and mature
on October 31, 2009 except that they mature earlier in the case of an equity
financing by the Company that raises in excess of
$10,000,000.
The
acquisition of the VSEL technology was made through our acquisition of our
subsidiary Stem Cell Technologies, Inc. in a stock-for-stock
exchange. Although the funds obtained through the acquisition of SCTI
funded certain early obligations under NeoStem’s agreements relating to the VSEL
technology, substantial additional funds will be needed and additional research
and development capacity will be required to meet its development obligations
under the License Agreement and develop the VSEL
technology. NeoStem has applied for Small Business Innovation
Research (SBIR) grants and may also seek to obtain funds through applications
for other State and Federal grants, grants abroad, direct investments, strategic
arrangements as well as other funding sources to help offset all or a portion of
these costs. A portion of the proceeds from the RimAsia Notes are
being used to meet funding requirements of developing the VSEL
technology.
With
regard to the proposed Merger and Share Exchange, it is not anticipated that in
the next year either of these acquisitions will generate sufficient excess cash
flow to support NeoStem’s platform business and therefore the Company will also
need to raise substantial additional funds to fund its platform business and/or
acquire another revenue generating business. Additionally, even if either
or both of the acquisitions closes, the closings will likely not occur until the
end of the second quarter of 2009 and NeoStem will need to fund its platform
business as well as the large costs associated with the acquisition transactions
until such time. NeoStem’s history of losses and liquidity problems may
make it difficult to raise additional funding. There can be no assurance that
NeoStem will be able to obtain additional funding on terms acceptable to
NeoStem. Any equity financing may be dilutive to stockholders and debt
financing, if available, may involve significant restrictive
covenants.
The Company has begun other initiatives
to expand its operations into China including with respect to technology
licensing, establishment of stem cell processing and storage capabilities and
research and clinical development. It is taking steps to establish a
separate WFOE and one or more limited liability companies and put in place
separate VIE documents with respect to these activities. The Company
is exploring the possibility of these expansion activities being a substitute
for its moving forward with closing the transactions under the Share Exchange
Agreement.
CRITICAL
ACCOUNTING POLICIES
NeoStem’s
“Critical Accounting Policies” are as follows, and are also described in Note 2
to the audited consolidated financial statements and notes thereto, included in
Item 8 of this report:
Revenue
Recognition: In
the fourth quarter of 2006, NeoStem initiated the collection and banking of
autologous adult stem cells and the first collection center in its collection
center network opened. NeoStem recognizes revenue related to the collection and
cryopreservation of autologous adult stem cells when the cryopreservation
process is completed (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 advance payments. Start up fees that are
received from collection centers that seek to open collection centers (in
consideration of NeoStem establishing a service territory for the collection
center) are recognized after agreements are signed and the collection center has
been qualified by NeoStem’s credentialing committee.
Income Taxes and
Valuation Reserves: We are required to
estimate our income taxes in each of the jurisdictions in which we operate as
part of preparing our financial statements. This involves estimating the actual
current tax in addition to assessing temporary differences resulting from
differing treatments for tax and financial accounting purposes. These
differences, together with net operating loss carryforwards and tax credits, are
recorded as deferred tax assets or liabilities on our balance sheet. A judgment
must then be made of the likelihood that any deferred tax assets will be
realized from future taxable income. A valuation allowance may be required to
reduce deferred tax assets to the amount that is more likely than not to be
realized. In the event we determine that we may not be able to realize all or
part of our deferred tax asset in the future, or that new estimates indicate
that a previously recorded valuation allowance is no longer required, an
adjustment to the deferred tax asset is charged or credited to net income in the
period of such determination. Upon receipt of the proceeds from the last foreign
purchasers of the Company’s Common Stock in January 2000, Common Stock ownership
changed in excess of 50% during the three-year period then ended. At December
31, 2008, the Company had net operating loss carryforwards of approximately
$31,000,000 applicable to future Federal income taxes, approximately $24,000,000
applicable to New York State income taxes, approximately $2,000,000 applicable
to California income taxes and approximately $12,500,000 applicable to New York
City income taxes. Included in the Federal net operating loss carryforwards is
approximately $2,121,000 that has been limited by the ownership change. The tax
loss carryforwards expire at various dates through 2028. 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.
Goodwill: Goodwill represents the
excess of the purchase price over the fair value of the net assets acquired in a
business combination. The Company reviews recorded goodwill for potential
impairment annually or upon the occurrence of an impairment indicator. The
Company performed its annual impairment tests as of December 31, 2008 and
determined no impairment exists. The Company will perform its future annual
impairment as of the end of each fiscal year.
Intangible
Asset: SFAS No. 142 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 consists
of patents and rights associated with the Very Small Embryonic Like (“VSEL”)
Stem Cells which constitutes the principal assets acquired in the acquisition of
Stem Cells Technologies, Inc., have been assigned a useful life and are
amortized on a straight-line basis over a period of twenty years.
RECENT
ACCOUNTING PRONOUNCEMENTS
In September 2006, the Financial
Accounting Standards Board ("FASB") issued SFAS No. 157, "Fair Value
Measurements" ("SFAS No. 157"). SFAS No. 157 defines fair value, establishes a
framework for measuring fair value in accordance with U.S. GAAP, and expands
disclosures about fair value measurements. SFAS No. 157 does not require any new
fair value measurements; rather, it applies to other accounting pronouncements
that require or permit fair value measurements. In February 2008, the FASB
issued FASB Staff Position ("FSP") No. 157-2, "Effective Date of FASB Statement
No. 157" ("FSP No. 157-2"). FSP No. 157-2 delays the effective date of SFAS No.
157 for nonfinancial assets and nonfinancial liabilities, except for certain
items that are recognized or disclosed at fair value in the financial statements
on a recurring basis (at least annually). We were required to apply the
provisions of SFAS No. 157 to financial assets and liabilities prospectively as
of January 1, 2008. Its adoption did not materially impact our
results of operations or financial position. We will be required to apply the
provisions of SFAS No. 157 to nonfinancial assets and nonfinancial liabilities
as of January 1, 2009 and are currently evaluating the impact of the application
of SFAS No. 157 as it pertains to these items.
In
February 2007, the FASB issued SFAS No. 159, "The Fair Value Option for
Financial Assets and Financial Liabilities — including an amendment of FAS 115"
("SFAS No. 159"). SFAS No. 159 allows companies to choose, at specified election
dates, to measure eligible financial assets and liabilities at fair value that
are not otherwise required to be measured at fair value. Unrealized gains and
losses shall be reported on items for which the fair value option has been
elected in earnings at each subsequent reporting date. SFAS No. 159 also
establishes presentation and disclosure requirements. SFAS No. 159 was effective
for fiscal years beginning after January 1, 2008 and will be applied
prospectively. At the present time SFAS No. 159 has no impact on our
operations.
In June
2007, the FASB ratified EITF No. 07-03, “Accounting for Nonrefundable Advance
Payments for Goods or Services Received for Future Research and Development
Activities” (“EITF 07-03”). EITF 07-03 requires that nonrefundable advance
payments for goods or services that will be used or rendered for future research
and development activities be deferred and capitalized and recognized as an
expense as the goods are delivered or the related services are
performed. EITF 07-03 is effective, on a prospective basis, for
fiscal years beginning after December 15, 2007. At the present time
the adoption of EITF 07-03 does not have a material effect on the Company’s
operations or financial position.
In
October 2007, the Company adopted the provisions of SFAS No. 158, "Employers'
Accounting for Defined Benefit Pension and Other Postretirement Plans — an
amendment of FASB Statements No. 87, 88, 106, and 132 (R)" ("SFAS No. 158").
This standard requires recognition of the overfunded or underfunded status of
each plan as an asset or liability in the consolidated balance sheet with the
offsetting change in that funded status to accumulated other comprehensive
income. Upon adoption, this standard requires immediate recognition in
accumulated other comprehensive income of actuarial gains/losses and prior
service costs/benefits — both of which were previously unrecognized. Additional
minimum pension liabilities and related intangible assets are eliminated upon
adoption of the new standard. At the present time we do not have any defined
benefit pension plans and therefore the measurement date provisions of SFAS No.
158 will not have a material impact on our consolidated financial
statements.
In
December 2007, the FASB issued SFAS No. 141R, "Business Combinations" ("SFAS No.
141R"). SFAS No. 141R amends SFAS 141 and provides revised guidance for
recognizing and measuring identifiable assets and goodwill acquired, liabilities
assumed, and any noncontrolling interest in the acquiree. It also provides
disclosure requirements to enable users of the financial statements to evaluate
the nature and financial effects of the business combination. It is effective
for fiscal years beginning on or after December 15, 2008 and will be applied
prospectively. We are currently evaluating the impact of adopting SFAS No. 141R
on our current consolidated financial statements and how this may affect the
proposed Merger and Share Exchange transactions.
In
December 2007, the FASB issued SFAS No. 160, "Noncontrolling Interests in
Consolidated Financial Statements — an amendment of ARB No. 51" ("SFAS No.
160"). SFAS No. 160 requires that ownership interests in subsidiaries held by
parties other than the parent, and the amount of consolidated net income, be
clearly identified, labeled, and presented in the consolidated financial
statements. It also requires once a subsidiary is deconsolidated, any retained
noncontrolling equity investment in the former subsidiary be initially measured
at fair value. Sufficient disclosures are required to clearly identify and
distinguish between the interests of the parent and the interests of the
noncontrolling owners. It is effective for fiscal years beginning on or after
December 15, 2008 and requires retroactive adoption of the presentation and
disclosure requirements for existing minority interests. All other requirements
shall be applied prospectively. At the present time SFAS No. 160 has no impact
on our operations. We are currently evaluating the impact of adopting
SFAS No. 160 and how this may affect the proposed Merger and Share Exchange
transactions.
In
December 2007, the EITF reached a consensus on EITF No. 07-01, Accounting for
Collaborative Arrangements Related to the Development and Commercialization of
Intellectual Property (“EITF 07-01”). EITF 07-01 discusses the appropriate
income statement presentation and classification for the activities and payments
between the participants in arrangements related to the development and
commercialization of intellectual property. The sufficiency of disclosure
related to these arrangements is also specified. EITF 07-01 is effective for
fiscal years beginning after December 15, 2008. At the present time EITF No.
07-01 has no impact on our operations. However, based upon the nature of the
Company’s business, EITF 07-01 could have an impact on its financial position
and results of operations in future years.
In March
2008, the FASB issued SFAS No. 161, "Disclosures about Derivative Instruments
and Hedging Activities — an amendment of FASB Statement No. 133" ("SFAS No.
161"), which requires additional disclosures about objectives and strategies for
using derivative instruments, how the derivative instruments and related hedged
items are accounted for under SFAS No. 133, "Accounting for Derivative
Instruments and Hedging Activities," and related interpretations, and how the
derivative instruments and related hedged items affect our financial statements.
SFAS No. 161 also requires disclosures about credit risk-related contingent
features in derivative agreements. SFAS No. 161 is effective for fiscal years
and interim periods beginning after November 15, 2008 and will be applied
prospectively. We are currently evaluating the impact of adopting SFAS No. 161
on our consolidated financial statements.
In
April 2008, the FASB issued FASB Staff Position No. 142-3, "Determination of the
Useful Life of Intangible Assets" ("FSP 142-3"). FSP 142-3 amends the factors
that should be considered in developing renewal or extension assumptions that
are used to determine the useful life of a recognized intangible asset under
SFAS No. 142, "Goodwill and Other Intangible Assets," and requires enhanced
related disclosures. FSP 142-3 must be applied prospectively to all intangible
assets acquired as of and subsequent to fiscal years beginning after December
15, 2008. At the present time, FSP 142-3 has no impact on our
operations.
In
May 2008, the FASB issued Staff Position APB 14-1, "Accounting for Convertible
Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial
Cash Settlement)" ("APB 14-1") to clarify that convertible debt instruments that
may be settled in cash upon conversion (including partial cash settlement) are
not addressed by paragraph 12 of APB Opinion No. 14, "Accounting for Convertible
Debt and Debt Issued with Stock Purchase Warrants." Additionally, APB 14-1
specifies that issuers of such instruments should separately account for the
liability and equity components in a manner that will reflect the entity's
nonconvertible debt borrowing rate when interest cost is recognized in
subsequent periods. APB 14-1 is effective for NeoStem as of January 1,
2009. At the present time APB 14-1 has no impact on our
operations. We are evaluating the impact of adopting APB 14-1 on the
proposed Merger and Share Exchange transactions.
In June
2008, the FASB ratified EITF Issue No. 07-5, “Determining Whether an Instrument
(or an Embedded Feature) Is Indexed to an Entity’s Own Stock” (“EITF 07-5”). EITF 07-5
provides that an entity should use a two step approach to evaluate whether an
equity-linked financial instrument (or embedded feature) is indexed to its own
stock, including evaluating the instrument’s contingent exercise and settlement
provisions. It also clarifies the impact of foreign currency denominated strike
prices and market-based employee stock option valuation instruments on the
evaluation. EITF 07-5 is effective for fiscal years beginning after December 15,
2008. The Company is currently evaluating the potential impact, if any, the new
pronouncement will have on its consolidated financial statements.
In
June 2008, the FASB issued FSP EITF 03-6-1, “Determining Whether Instruments
Granted in Share-Based Payment Transactions Are Participating Securities.” This
FSP clarifies that all outstanding unvested share-based payment awards that
contain rights to non-forfeitable dividends participate in undistributed
earnings with common shareholders. Awards of this nature are considered
participating securities and the two-class method of computing basic and diluted
earnings per share must be applied. This FSP is effective for fiscal years
beginning after December 15, 2008. NeoStem is currently evaluating the potential
impact, if any, the new pronouncement will have on its consolidated financial
statements.
RESULTS
OF OPERATIONS
Years
Ended December 31, 2008 and December 31, 2007
For the
year ended December 31, 2008, total revenues were $83,500 compared to $232,000
for the year ended December 31, 2007. The revenues generated in the years ended
December 31, 2008 and 2007 were derived from a combination of revenues from the
collection of autologous adult stem cells, start up fees collected from
collection centers in NeoStem’s collection center network and additionally, for
the year ended December 31, 2007, recognition of fees received in prior years
from the sale of extended warranties and service contracts via the Internet,
which were deferred and recognized over the life of such contracts. For the year
ended December 31, 2008, NeoStem earned $52,500 relating to the collection and
storage of autologous adult stem cells and $31,000 of start up fees. For the
year ended December 31, 2007, NeoStem earned $41,000 from the collection and
storage of autologous adult stem cells and $189,000 from start up fees. The
reduction in start up fees from 2007 to 2008 was due primarily to reduced
activity in establishing collection centers and a concentration of the Company’s
efforts on recruiting clients into the existing network in the Greater New York
area, Southern California and Coral Gables, Florida. In addition, start up fees
have been reduced because the Company has more recently opted to help support
the launch of its new centers by waiving or reducing its start up
fees. NeoStem recognized revenues from the sale of extended
warranties and service contracts via the Internet of $1,700 for the year ended
December 31, 2007. Since NeoStem has not been in the business of
offering extended warranties since 2002 it was expected that this revenue source
would decline and the recognition of these revenues ended in March
2007.
Direct
costs are comprised of the cost of collecting autologous stem cells from clients
and, as it relates to the prior business of offering extended warranties, the
pro-rated cost of reinsurance purchased at the time an extended contract was
sold to underwrite the potential obligations associated with such warranties.
For the year ended December 31, 2008, the direct costs of collecting autologous
stem cells were $32,000. For the year ended December 31, 2007, the direct costs
of collecting autologous stem cells were $24,000 and $1,000 was associated with
the pro-rata cost of reinsurance purchased for associated extended
warranties.
Selling,
general and administration expenses for the year ended December 31, 2008 has
decreased by $1,360,000 or 13% over the year ended December 31, 2007, from
$10,646,000 to $9,285,000. The decrease in selling, general and administrative
expenses is primarily due to an overall decrease in operating expenses as the
Company made a concerted effort to reduce staff and trim expenses. In an effort
to preserve cash in 2008 and 2007, the Company continued to utilize common
stock, common stock options and warrants to pay for certain services. In 2008,
the Company incurred $3,890,000 of expense related to the use of various equity
instruments compared to 2007 when the Company incurred $4,590,000 of expense
from such use, an overall reduction of $729,000. Equity instruments have been
used for compensation purposes for management and other staff, consultants and
directors and to pay for investment banking fees, investor relations, marketing
expenses as well as other expenses. The compensatory element of the
vesting of stock options and common stock granted to staff and directors was
reduced by $1,462,000 in 2008 principally because the fair value of the options
and common stock vesting in 2008 was significantly lower in comparison to 2007.
The Company’s use of equity instruments to pay for investment banking fees,
investor relations, marketing expense as well as other expenses increased by
$589,000. Cash expenditures decreased $632,000, or 10%, when compared to 2007.
This decrease is the combination of an increase resulting from expenses and
activities associated with the proposed Merger with CBH and the proposed Share
Exchange with China StemCell Medical Holding Limited relating to Shandong, in
the amount of $806,000 and a reduction in operating expenses of $1,438,000. The
decrease in cash funded operating expenses was primarily related to a decrease
in legal expense of $630,000, investor relations expense of $312,000, consulting
fees of $213,000, salary and benefits of $109,000, travel and entertainment of
$108,000, validation expenses required for New York licensing of $60,000, the
conclusion of severance payments to a former staff member of $54,000, stock
exchange fees, filing fees and other related fees of $42,800, reduced attendance
at conferences of $29,500 and laboratory expenses of $14,000. These
decreases were offset by increases in marketing expenses of $34,200, accounting
fees of $18,000, research and development expenditures related to fees due the
University of Louisville in connection with our VSEL license of $50,000,
expenses for applying for scientific grants and other activities to support our
VSEL research of $18,000, and a variety of other expenses that resulted in a net
expense increase of $14,100.
Years
Ended December 31, 2007 and December 31, 2006
For the
year ended December 31, 2007, total revenues were $232,000 compared to $46,000
for the year ended December 31, 2006. The revenues generated in the years ended
December 31, 2007 and 2006 were derived from a combination of revenues from the
collection of autologous adult stem cells, start up fees collected from
collection centers in NeoStem’s collection center network and recognition of
fees received in prior years from the sale of extended warranties and service
contracts via the Internet, which were deferred and recognized over the life of
such contracts. For the year ended December 31, 2007, NeoStem earned $41,000
from the collection of autologous adult stem cells and $189,000 of start up
fees. For the year ended December 31, 2006, NeoStem earned $11,000 from the
collection of autologous adult stem cells and $10,000 from start up fees.
NeoStem recognized revenues from the sale of extended warranties and service
contracts via the Internet of $1,700 for the year ended December 31, 2007, as
compared to $25,000 for the year ended December 31, 2006. Since NeoStem has
not been in the business of offering extended warranties since 2002 it was
expected that this revenue source would decline and the recognition of these
revenues ended in March 2007.
Direct
costs are comprised of the cost of collecting autologous stem cells from clients
and the pro-rated cost of reinsurance purchased at the time an extended contract
was sold to underwrite the potential obligations associated with such
warranties. For the year ended December 31, 2007, the direct costs of collecting
autologous stem cells were $24,000 and $1,000 was associated with the pro-rata
cost of reinsurance purchased for associated extended warranties. For the year
ended December 31, 2006, the direct costs of collecting autologous stem cells
were $4,000 and $18,000 was associated with the pro-rata cost of reinsurance
purchased for associated extended warranties.
Selling,
general and administration expenses for the year ended December 31, 2007
increased by $5,931,000 or 126% over the year ended December 31, 2006, from
$4,715,000 to $10,646,000. The increase in selling, general and administrative
expenses was primarily due to increases in marketing efforts through the hiring
of staff, preparation of marketing materials, attending key marketing events and
retaining the services of specialized marketing consulting firms. However, a
substantial portion of the increase was due to the compensatory element of stock
options and stock awards granted under NeoStem’s 2003 Equity Participation Plan
to certain officers, employees and consultants to NeoStem, totaling $2,980,000
for the year, an increase in operating expenses of $2,147,000 over 2006. In
addition, and in order to conserve cash, NeoStem used common stock and common
stock purchase warrants as consideration for services. During 2007, NeoStem
issued common stock and common stock purchase warrants valued at $1,653,000 as
consideration for director fees, consulting fees, investor relations, marketing,
rent and marketing services, an increase of $1,432,000 over 2006. Cash
expenditures increased $2,352,000 over 2006. Increases in staff increased salary
and benefits by $1,078,000 over 2006; staff increases also increased travel and
entertainment expenses by $281,000, cash expenditures for rent by $73,000 and
telephone expense by $19,000 over 2006. For key, limited role, functions NeoStem
has utilized consultants to support staff efforts resulting in an increase in
cash expenditures for consulting expense of $183,000. Marketing efforts to
enlarge our collection center network and develop new markets increased
operating expenses by $324,000. NeoStem also sought to increase public and
investor awareness of the value of adult stem cells which resulted in increases
in investor relations expenses by $385,000 over 2006. In comparison to 2006,
legal expenses increased $57,000, accounting fees increased $44,000, stock
transfer fees increased $30,000, postage increased $25,000, bad debts increased
$20,000, depreciation and amortization increased $25,000, licensure expense
increased $49,000 and stock exchange fees increased $64,000. Such increases were
essentially offset by reductions in fees paid to investment bankers in 2006 of
$138,000 and settlement costs paid in 2006 of $189,000.
Interest
expense for the year ended December 31, 2007 was $22,000 as compared to
$1,371,000 for the year ended December 31, 2006, a decrease of $1,349,000. This
decrease was primarily as a result of the conversion of convertible promissory
notes issued in the Westpark private placement (through which NeoStem raised
$500,000 through the sale of convertible promissory notes and warrants in
December 2005 and January 2006 and in which Westpark Capital, Inc. acted as
placement agent). Substantially all of this debt was converted to common stock
in 2006 and the remaining $75,000 in principal balance outstanding was repaid in
January 2007.
LIQUIDITY
AND CAPITAL RESOURCES
General
At
December 31, 2008, NeoStem had a cash balance of $431,000 and a negative working
capital of $(431,000). NeoStem has met its immediate cash
requirements through offerings of Common Stock and warrants in 2008 which raised
an aggregate gross amount of $2,900,000. NeoStem generates revenues
from its adult stem cell collection activities. To date, NeoStem’s
revenues generated from such activities have not been significant and we had
minimal adult stem cell collection activity during 2008.
NeoStem
had been exploring acquisition opportunities of revenue generating businesses
and in November 2008 entered into the Merger Agreement with CBH to acquire the
51% ownership interest in Erye, which manufactures over 100 drugs on seven cGMP
lines and the Share Exchange Agreement with respect to Shandong which is engaged
in the business of research, development, popularization and transference of
regenerative medicine technology (except for those items for which it does not
have special approval) in the PRC. The Company has also begun other
initiatives to expand its operations into China including with respect to
technology licensing, establishment of stem cell processing and storage
capacities and research and clinical development. The Company has
incurred substantial expenses in connection with these China
activities. The acquisition transactions are not expected to close
before the second quarter of 2009 and in any event neither the acquisition
transactions nor the Company’s other initiatives in China are expected to
generate sufficient excess cash flow to support NeoStem’s platform business or
its initiatives in China in the near term. The Company is exploring
the possibility of its independent initiatives in China being a substitute for
its moving forward with closing the transactions under the Share Exchange
Agreement.
The Company currently intends to meet
its cash requirements in the near term through financing activities including an
equity offering in the second quarter 2009 in an amount anticipated to be no
less than $10 million. During the first quarter 2009, the Company issued
promissory notes to a principal stockholder of the Company which aggregated
$1,150,000 (see Note 14 to the audited consolidated financial statements and
related notes included in Item 8 of this report). In the event that this equity
offering is not successful, the Company would need to substantially reduce its
operating costs and would seek additional bridge financing until a future equity
offering could be accomplished.
Years
Ended December 31, 2008 and December 31, 2007
The
following chart represents the net funds provided by or used in operating,
financing and investment activities for each period indicated:
|
|
Year Ended
|
|
|
|
December
31, 2008
|
|
|
December
31, 2007
|
|
Cash
(used) in operating activities
|
|
$ |
(4,732,000 |
) |
|
$ |
(6,132,000 |
) |
Cash
provided/(used) in investing activities
|
|
$ |
(9,800 |
) |
|
$ |
153,000 |
|
Cash
provided by financing activities
|
|
$ |
2,869,000 |
|
|
$ |
7,847,000 |
|
At
December 31, 2008, NeoStem had a cash balance of $431,000, negative working
capital of $(431,000) and a stockholders’ equity of $863,200. NeoStem
incurred a net loss of $9,242,000 for the year ended December 31, 2008. Such
loss adjusted for non-cash items, including common stock, common stock option
and common stock purchase warrant issuances which were related to services
rendered of $3,890,000, depreciation and amortization of $116,000 and bad debt
expense of $22,000; increases in accounts payable, notes payable,
accrued liabilities reduced the cash required for operations and
increases in prepaid insurance expenses increased the use of
cash resulting in an overall increase of $482,000, resulted in cash
used in operations totaling $4,732,000 for the year ended December 31, 2008.
Accordingly, the large difference between operating loss and cash used in
operations was the result of a number of non-cash expenses charged to results of
operations. The negative working capital at December 31, 2008 is due primarily
to $423,000 in amounts due law firms and financial consultants engaged in
connection with the proposed Merger with CBH and the proposed Share Exchange
with China StemCell Medical Holding Limited relating to Shandong, and an accrued
bonus of $250,000 due our Chief Executive Officer who has deferred receipt of
such bonus in order to conserve NeoStem’s current cash.
To meet
its cash requirements for the year ended December 31, 2008, NeoStem relied on
offerings of common stock and warrants completed in each of May 2008, September
2008, October 2008 and November 2008 raising gross proceeds in the aggregate
amount of $2,900,000 and its existing cash balances. Under NeoStem’s
current business plan it is generating revenues from its platform business of
adult stem cell collection activities which to date have not been significant,
having had only nine collections during the year. NeoStem currently
intends to meet its cash requirements in the near term with the proceeds of the
RimAsia Notes and through financing activities, other collaborative arrangements
and government awards and anticipates that with the recent opening of key
collection centers and the Company’s initiatives in China, revenues may start to
increase in 2009.
On
November 2, 2008, NeoStem signed the Merger Agreement to acquire CBH and its 51%
interest in Suzhou Erye Pharmaceuticals Company Ltd., and the Share Exchange
Agreement to acquire China StemCell Medical Holding Limited and obtain
benefits from Shandong New Medicine Research Institute of Integrated Traditional
and Western Medicine Limited Liability Company. Erye is in the middle of
an expansion through relocation of its pharmaceutical manufacturing facility
which is planned to be completed over the next three years. To date this
activity has been self-funded by Erye and minority shareholders of Erye and it
is anticipated that they will continue to fund this project. In the event
Erye is unable to raise the remaining funds needed for the relocation of its
pharmaceutical manufacturing facility it could become incumbent upon NeoStem to
assist in this effort. To facilitate the financing of this relocation
project NeoStem has agreed to reinvest approximately 90% of its 51%
interest in Erye into the company for its relocation pursuant to Erye’s joint
venture agreement for a period of three years. In order to
maximize the potential of Shandong, a capital infusion into the company will
likely be needed to, among other things, build a laboratory and develop its
regenerative medicine business. In the event either or both of the acquisitions
do not close, NeoStem would also need to raise substantial additional funds to
fund its platform business and/or acquire a revenue generating business.
It is not anticipated that in the next year either of these acquisitions will
generate sufficient excess cash flow to support NeoStem’s platform business and
therefore the Company will also need to raise substantial additional funds to
fund its platform business and/or acquire another revenue generating
business. Additionally, even if either or both of the acquisitions closes,
the closings will likely not occur until the end of the second quarter of 2009
and NeoStem will need to fund its platform business as well as the large costs
associated with the acquisition transactions until such time. NeoStem’s
history of losses and liquidity problems may make it difficult to raise
additional funding. There can be no assurance that NeoStem will be able to
obtain additional funding on terms acceptable to NeoStem. Any equity financing
may be dilutive to stockholders and debt financing, if available, may involve
significant restrictive covenants.
In
November 2007, NeoStem acquired the exclusive, worldwide rights to very small
embryonic like (VSEL) technology developed by researchers at the University of
Louisville. These rights were acquired through NeoStem’s acquisition of Stem
Cell Technologies, Inc., the licensee to a license agreement (the “License
Agreement”) with the University of Louisville. Concurrent with acquiring these
rights, NeoStem entered into a sponsored research agreement (the "Sponsored
Research Agreement" or "SRA") with the University of Louisville Research
Foundation (“ULRF”) under which NeoStem will support 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 Graham Brown
Cancer Center at the University of Louisville. The term of the research is two
and one-half years and is expected to commence in April 2009. The License
Agreement requires the payment of certain license fees, royalties and milestone
payments, payments for patent filings and applications and the use of due
diligence in developing and commercializing the VSEL technology. The SRA
requires periodic and milestone payments. All payments required to be made to
date have been made.
Under the
License Agreement as amended in February 2009, NeoStem made in March 2009
payments of $66,000 in license issue fees and prepayment of patent costs and
will be responsible for additional patent-related costs. Thereafter, an annual
license maintenance fee of $10,000 will be required upon the issuance of a
licensed patent and royalties will be payable based upon the sale of certain
licensed products. Under the Sponsored Research Agreement, NeoStem agreed to
support the research as set forth in a research plan in an amount of $375,000.
Such costs are to be paid by NeoStem in accordance with a payment schedule which
sets forth the timing and condition of each such payment over the term of the
SRA, the first payment of $100,000 (for which there was originally a $50,000
credit) being due upon the commencement of the research. In October 2008, the
SRA was amended to provide for certain additional research to be conducted as
work preliminary to the first research aim under the SRA, for which
approximately one-half of the $50,000 credit was utilized to pay the
fee. Although certain early obligations under the Company’s
agreements relating to the VSEL technology were paid for with funds supplied by
the seller to SCTI prior to the acquisition, substantial additional funds will
be needed and additional research and development capacity will be required to
meet the Company’s development obligations under the License Agreement and
develop the VSEL technology. The Company has applied to the U.S.
Small Business Administration for Small Business Innovation Research (SBIR)
grants and may also seek to obtain funds through applications for other State
and Federal grants, grants abroad, direct investments, strategic arrangements as
well as other funding sources to help offset all or a portion of these
costs. A portion of the proceeds from the RimAsia Notes (described
above) are being used to meet funding requirements of developing the VSEL
technology. The Company is seeking to develop increased internal
research capability and sufficient laboratory facilities or establish
relationships to provide such research capability and
facilities. Toward this end, we have hired a Director of Stem Cell
Research and Laboratory Operations and arranged for research facilities at the
facility of a strategic partner. In addition to the research we are currently
funding at the University of Louisville, we are also in discussions relating to
other research to generate data relating to other clinical applications of
VSELs, including neural, cardiac and ophthalmic, to expand our research efforts
and maximize the value of this technology.
In
October 2008, NeoStem was advised that we would receive Federal funding from the
Department of Defense to evaluate the potential use of adult stem cell therapy
for wound healing. It is anticipated that this research and the
related funding will begin in 2009. The funds must be distributed to us by
October 2010 and the budget we can submit for the project must not exceed
$681,000. NeoStem continues to make application for awards through
the Small Business Innovative Research (SBIR) Program, although it has received
no notice of any SBIR award to date. It is anticipated that some of
the funds (if any) received from such appropriations and grants will fund
certain expenses of Company while the remaining portion will be paid to third
party researchers.
The
following table reflects a summary of NeoStem’s contractual cash obligations as
of December 31, 2008:
|
|
Payments due by period |
|
Contractual
Obligations
|
|
Total
|
|
|
Less than 1 year
|
|
|
1-3 years
|
|
|
3-5 years
|
|
|
More than
5 years
|
|
Capitalized lease
|
|
$ |
16,000 |
|
|
|
16,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Facility
lease
|
|
|
105,000 |
|
|
|
60,000 |
|
|
|
45,000 |
|
|
|
|
|
|
|
|
|
Minimum
royalties due University of Louisville
|
|
|
66,000 |
|
|
|
66,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Sponsored
research agreement – University of Louisville
|
|
|
325,000 |
|
|
|
150,000 |
|
|
|
100,000 |
|
|
|
75,000 |
|
|
|
|
|
Employment
agreements
|
|
|
316,000 |
|
|
|
316,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
828,000 |
|
|
$ |
608,000 |
|
|
$ |
145,000 |
|
|
$ |
75,000 |
|
|
$ |
— |
|
Years
Ended December 31, 2007 and December 31, 2006
The
following chart represents the net funds provided by or used in operating,
financing and investment activities for each period indicated:
|
|
Year Ended
|
|
|
|
December 31, 2007
|
|
|
December 31, 2006
|
|
Cash
(used) in operating activities
|
|
$ |
(6,132,000 |
) |
|
$ |
(3,639,000 |
) |
Cash
provided/(used) in investing activities
|
|
$ |
153,000 |
|
|
$ |
(43,000 |
) |
Cash
provided by financing activities
|
|
$ |
7,847,000 |
|
|
$ |
3,630,000 |
|
At
December 31, 2007, NeoStem had a cash balance of $2,304,000, working
capital of $1,931,000 and a stockholders’ equity of $3,316,000. NeoStem incurred
a net loss of $10,445,000 for the year ended December 31, 2007. Such
loss adjusted for non-cash items, including common stock, common stock option
and common stock purchase warrant issuances which were related to services
rendered of $4,590,000, and depreciation of $54,000 which was offset by cash
settlements of various accounts payable, notes payable and accrued liabilities
of $352,000, resulted in cash used in operations totaling $6,132,000 for the
year ended December 31, 2007. Accordingly, the large difference
between operating loss and cash used in operations was the result of a number of
non-cash expenses charged to results of operations.
To meet
its cash requirement for the year ended December 31, 2007, NeoStem relied on
proceeds from the sale of its securities resulting in net proceeds of $7,939,000
from the January 2007 private placement and the August 2007 public offering (as
described below).
In
January and February 2007, NeoStem raised an aggregate of $2,500,000
through the private placement of 250,000 units at a price of $10.00 per unit
(the “January 2007 private placement”). Each unit was comprised of two
shares of NeoStem’s Common Stock, one redeemable seven-year warrant to purchase
one share of Common Stock at a purchase price of $8.00 per share and one
non-redeemable seven-year warrant to purchase one share of Common Stock at a
purchase price of $8.00 per share. NeoStem issued an aggregate of 500,000 shares
of Common Stock, and warrants to purchase up to an aggregate of 500,000 shares
of Common Stock at an exercise price of $8.00 per share. Emerging Growth
Equities, Ltd (“EGE”), the placement agent for the January 2007 private
placement, received a cash fee equal to $171,275 and was entitled to expense
reimbursement not to exceed $50,000. NeoStem also issued to EGE redeemable seven
year warrants to purchase 34,255 shares of Common Stock at a purchase price of
$5.00 per share, redeemable seven-year warrants to purchase 17,127 shares of
Common Stock at a purchase price of $8.00 per share and non-redeemable
seven-year warrants to purchase 17,127 shares of Common Stock at a purchase
price of $8.00 per share. The net proceeds of this offering were approximately
$2,320,000.
In August
2007, NeoStem completed a sale of 1,270,000 units at a price of $5.00 per unit
pursuant to a best efforts public offering. A registration statement
on Form SB-2A (File No. 333-142923) relating to these units was filed with the
Securities and Exchange Commission and declared effective on July 16,
2007. Each unit consisted of one share of common stock and one-half
of a five year Class A warrant to purchase one-half a share of common stock at a
price of $6.00 per share. Thus, 1,000 units consisted of 1,000 shares
of common stock and Class A warrants to purchase 500 shares of common stock. The
aggregate number of shares of common stock included within the units was
1,270,000 and the aggregate number of Class A warrants included within the units
was 535,000. In connection with the public offering, NeoStem issued
five year warrants to purchase an aggregate of 95,250 shares of common stock at
$6.50 per share to the underwriters for the offering. After payment of
underwriting commissions and expenses and other costs of the offering, the
aggregate net proceeds to NeoStem were $5,579,000.
NeoStem
does not believe that its operations have been materially influenced by
inflation in the fiscal year ended December 31, 2008, a situation which is
expected to continue for the foreseeable future.
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
8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The financial statements and notes
thereto required to be filed under this Item are presented commencing on page
F-1 of this Annual Report on Form 10-K. Following is supplementary
financial information:
Selected
Quarterly Financial Data
$’000
(except
net loss per share which is stated in $)
|
|
Quarter
Ended
12/31/08
|
|
|
Quarter
Ended
9/30/08
|
|
|
Quarter
Ended
6/30/08
|
|
|
Quarter
Ended
3/31/08
|
|
|
Quarter
Ended
12/31/07
|
|
|
Quarter
Ended
9/30/07
|
|
|
Quarter
Ended
6/30/07
|
|
|
Quarter
Ended
3/31/07
|
|
Revenues
|
|
$ |
34 |
|
|
$ |
25 |
|
|
$ |
24 |
|
|
$ |
— |
|
|
$ |
157 |
|
|
$ |
13 |
|
|
$ |
6 |
|
|
$ |
56 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Direct
Costs
|
|
|
19 |
|
|
|
9 |
|
|
|
4 |
|
|
|
— |
|
|
|
15 |
|
|
|
7 |
|
|
|
2 |
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
profit
|
|
|
15 |
|
|
|
16 |
|
|
|
20 |
|
|
|
— |
|
|
|
142 |
|
|
|
6 |
|
|
|
4 |
|
|
|
55 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Loss
|
|
|
(2,431 |
) |
|
|
(1,919 |
) |
|
|
(2,360 |
) |
|
|
(2,524 |
) |
|
|
(2,342 |
) |
|
|
(4,322 |
) |
|
|
(1,957 |
) |
|
|
(1,818 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Loss
|
|
|
(2,431 |
) |
|
|
(1,922 |
) |
|
|
(2,362 |
) |
|
|
(2,527 |
) |
|
|
(2,343 |
) |
|
|
(4,328 |
) |
|
|
(1,958 |
) |
|
|
(1,816 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss per share (1)
|
|
|
(.33 |
) |
|
|
(.30 |
) |
|
|
(.43 |
) |
|
|
(.52 |
) |
|
|
(.51 |
) |
|
|
(1.26 |
) |
|
|
(.74 |
) |
|
|
(.73 |
) |
(1)
|
Earnings
per share are computed independently for each of the quarters
presented. Therefore, the sum of quarterly earnings per share
do not equal the total computed for the
year.
|
NeoStem,
Inc. and Subsidiaries
Table of
Contents
|
|
Page
|
Report
of Independent Registered Public Accounting Firm -
|
|
|
|
Holtz
Rubenstein Reminick LLP
|
|
F –
1
|
|
|
|
Financial
Statements:
|
|
|
|
|
|
|
Consolidated
Balance Sheets at December 31, 2008 and 2007
|
|
F –
2
|
|
|
|
|
|
Consolidated Statements
of Operations
|
|
|
|
Years
Ended December 31, 2008, 2007 and 2006
|
|
F –
3
|
|
|
|
|
|
Consolidated Statements
of Stockholders’ Equity/ (Deficit)
|
|
|
|
Years
Ended December 31, 2008, 2007 and 2006
|
|
F –
4 – F– 6
|
|
|
|
|
|
Consolidated Statements
of Cash Flows
|
|
|
|
Years
Ended December 31, 2008, 2007 and 2006
|
|
F
– 7 – F– 8
|
|
|
|
|
|
Notes
to Consolidated Financial Statements
|
|
F –
9 – F – 43
|
|
|
|
|
|
|
|
|
Report of Independent
Registered Public Accounting Firm
To the
Board of Directors and Stockholders
NeoStem,
Inc. and Subsidiaries
We have
audited the accompanying consolidated balance sheets of NeoStem, Inc. and
Subsidiaries as of December 31, 2008 and 2007 and the related consolidated
statements of operations, stockholders' equity/ (deficit) and cash flows for
each of the years in the three-year period ended December 31,
2008. These consolidated financial statements are the responsibility
of the Company's management. Our responsibility is to express an
opinion on these financial statements based on our audits.
We
conducted our audits in accordance with standards of the Public Company
Accounting Oversight Board (United States). Those standards require
that we plan and perform the audits to obtain reasonable assurance about whether
the financial statements are free of material misstatement. The
Company is not required to have, nor were we engaged to perform, audits of its
internal control over financial reporting. Our audits include consideration of
internal control over financial reporting as a basis for designing audit
procedures that are appropriate in the circumstances, but not for the purpose of
expressing an opinion on the effectiveness of the Company’s internal control
over financial reporting. Accordingly, we express no such opinion. An audit
includes examining, on a test basis, evidence supporting the amounts and
disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement
presentation. We believe that our audits provide a reasonable basis
for our opinion.
In our
opinion, the consolidated financial statements referred to above present fairly,
in all material respects, the financial position of NeoStem, Inc. and
Subsidiaries as of December 31, 2008 and 2007 and the results of their
operations and cash flows for each of the years in the three-year period ended
December 31, 2008 in conformity with accounting principles generally accepted in
the United States of America.
/s/ Holtz
Rubenstein Reminick LLP
Melville,
New York
March 31,
2009
NEOSTEM,
INC. AND SUBSIDIARIES
Consolidated
Balance Sheets
|
|
|
|
|
|
|
|
|
December
31,
|
|
|
|
2008
|
|
|
2007
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
430,786 |
|
|
$ |
2,304,227 |
|
Accounts
receivable, net of allowance for doubtful accounts of $0 and $19,500,
respectively
|
|
|
7,193 |
|
|
|
24,605 |
|
Prepaid
expenses and other current assets
|
|
|
92,444 |
|
|
|
46,248 |
|
Total
current assets
|
|
|
530,423 |
|
|
|
2,375,080 |
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net
|
|
|
99,490 |
|
|
|
164,122 |
|
Intangible
asset
|
|
|
633,789 |
|
|
|
669,000 |
|
Goodwill
|
|
|
558,169 |
|
|
|
558,169 |
|
Other
assets
|
|
|
2,445 |
|
|
|
8,778 |
|
|
|
$ |
1,824,316 |
|
|
$ |
3,775,149 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY/(DEFICIT)
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$ |
508,798 |
|
|
$ |
158,453 |
|
Accrued
liabilities
|
|
|
427,767 |
|
|
|
228,726 |
|
Unearned
revenues
|
|
|
9,849 |
|
|
|
2,902 |
|
Notes
payable – related party, current
|
|
|
— |
|
|
|
24,022 |
|
Note
payable – current
|
|
|
— |
|
|
|
4,720 |
|
Current
portion of capitalized lease obligation
|
|
|
14,726 |
|
|
|
25,406 |
|
Total
current liabilities
|
|
|
961,140 |
|
|
|
444,229 |
|
|
|
|
|
|
|
|
|
|
Capitalized
lease obligation, net of current portion
|
|
|
— |
|
|
|
14,726 |
|
|
|
|
|
|
|
|
|
|
COMMITMENTS
AND CONTINGENCIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’
equity:
|
|
|
|
|
|
|
|
|
Preferred
stock; authorized, 5,000,000 shares Series B
|
|
|
|
|
|
|
|
|
convertible
redeemable preferred stock, liquidation value, 1 share of common stock per
share, $.01 par value; authorized, 825,000 shares; issued and outstanding,
10,000 shares at December 31, 2008 and December 31, 2007
|
|
|
100 |
|
|
|
100 |
|
Common
stock, $.001 par value; authorized, 500,000,000 shares;
|
|
|
|
|
|
|
|
|
issued
and outstanding, 7,715,006 December 31, 2008
and
4,826,055 shares at December 31, 2007
|
|
|
7,715 |
|
|
|
4,826 |
|
Additional
paid-in capital
|
|
|
40,871,570 |
|
|
|
34,802,309 |
|
Unearned
compensation
|
|
|
(21,900 |
) |
|
|
(738,803 |
) |
Accumulated
deficit
|
|
|
(39,994,309 |
) |
|
|
(30,752,238 |
) |
Total
stockholders’ equity
|
|
|
863,176
|
|
|
|
3,316,194
|
|
|
|
$ |
1,824,316 |
|
|
$ |
3,775,149 |
|
The
accompanying notes are an integral part of these consolidated financial
statements
NEOSTEM,
INC. AND SUBSIDIARIES
Consolidated
Statements of Operations
|
|
Years
ended December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
$ |
83,541 |
|
|
$ |
231,664 |
|
|
$ |
45,724 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Direct
Costs
|
|
|
31,979 |
|
|
|
24,847 |
|
|
|
22,398 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
Profit |
|
|
51,562 |
|
|
|
206,817 |
|
|
|
23,326 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling,
General and Administrative
|
|
|
9,285,015 |
|
|
|
10,645,653 |
|
|
|
4,714,568 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Loss
|
|
|
(9,233,453 |
) |
|
|
(10,438,836 |
) |
|
|
(4,691,242 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
Income (Expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
Income
|
|
|
3,044 |
|
|
|
15,331 |
|
|
|
20,432 |
|
Interest
Expense – Series A mandatorily
|
|
|
|
|
|
|
|
|
|
|
|
|
Redeemable
convertible Preferred Stock
|
|
|
— |
|
|
|
— |
|
|
|
(9,934 |
) |
Interest
Expense
|
|
|
(11,662 |
) |
|
|
(21,968 |
) |
|
|
(1,370,656 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(8,618 |
) |
|
|
(6,637 |
) |
|
|
(1,360,158 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Loss
|
|
$ |
(9,242,071 |
) |
|
$ |
(10,445,473 |
) |
|
$ |
(6,051,400 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic loss per
share
|
|
$ |
(1.53 |
) |
|
$ |
(3.18 |
) |
|
$ |
(4.43 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding
|
|
|
6,056,886 |
|
|
|
3,284,116 |
|
|
|
1,365,027 |
|
The
accompanying notes are an integral part of these consolidated financial
statements
NEOSTEM,
INC. AND SUBSIDIARIES
|
|
Consolidated
Statements of Stockholders'
Equity/(Deficit)
|
|
|
Series
B Convertible Preferred Stock
|
|
Common
Stock
|
|
|
Unearned
|
|
|
Additional
Paid
|
|
|
Accumulated
|
|
|
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Shares
|
|
|
Amount
|
|
|
Compensation
|
|
|
in Capital
|
|
|
Deficit
|
|
|
Total
|
|
Balance
at December 31, 2005
|
|
|
10,000 |
|
|
$ |
100 |
|
|
|
7,054,400 |
|
|
$ |
7,050 |
|
|
|
|
|
$ |
12,430,577 |
|
|
$ |
(14,255,365 |
) |
|
$ |
(1,817,638 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustment
for reverse Common Stock split
|
|
|
|
|
|
|
|
|
|
|
(6,348,960 |
) |
|
|
(6,345 |
) |
|
|
|
|
|
6,345 |
|
|
|
|
|
|
|
— |
|
|