Nuo Therapeutics, Inc. - Annual Report: 2006 (Form 10-K)
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, 2006
OR
o TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d)
OF
THE
SECURITIES EXCHANGE ACT OF 1934
For
the
transition period from ____________ to__________
Commission
file number
001-32518
——————
CYTOMEDIX,
INC.
(Exact
Name of Registrant
as Specified in Its Charter)
Delaware
|
|
23-3011702
|
(State
or Other Jurisdiction of
Incorporation
or Organization)
|
|
(IRS
Employer
Identification
No.)
|
416
Hungerford Drive, Suite 330
Rockville,
MD 20850
(Address
of Principal Executive Offices) (Zip Code)
(240)
499-2680
(Registrant’s
Telephone Number, Including Area Code)
——————
Securities
registered under Section 12(b) of the Exchange Act: None
Securities
registered under Section 12(g) of the Exchange Act:
Common
Stock, par value $.0001
(Title
of
class)
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined
in
Rule 405 of the Securities Act. Yes ¨ No x
Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or Section 15(d) of the Act. Yes ¨ No x
Indicate
by check mark whether the registrant (1) has filed all reports required to
be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements
for
the past 90 days. Yes x No ¨
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. ¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of “accelerated
filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check
one):
|
Large
Accelerated Filer ¨
|
|
Accelerated
Filer x
|
|
Non-Accelerated
Filer ¨
|
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes ¨ No x
The
aggregate market value of the voting stock (Common stock) held by non-affiliates
of the registrant as of the close of business on June 30, 2006 was approximately
$84 million based on the closing sale price of the Common stock on the American
Stock Exchange on that date. The registrant does not have any non-voting common
equity.
APPLICABLE
ONLY TO ISSUERS INVOLVED IN BANKRUPTCY PROCEEDINGS
DURING
THE PRECEDING FIVE YEARS
Indicate
by check mark whether the registrant has filed all documents and reports
required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange
Act
of 1934 subsequent to the distribution of securities under a plan confirmed
by a
court. Yes ý No ¨
APPLICABLE
ONLY TO CORPORATE REGISTRANTS
Indicate
the number of shares outstanding of each of the registrant’s classes of common
stock, as of the latest practicable date. 28,998,248 shares of Common stock,
par
value $.0001, outstanding as of February 15, 2007.
DOCUMENTS
INCORPORATED BY REFERENCE
None.
CYTOMEDIX,
INC.
TABLE
OF CONTENTS
Page
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PART
I
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Item
1.
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Business
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1
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Item
1A.
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Risk
Factors
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10
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Item
1B.
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Unresolved
Staff Comments
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14
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Item
2
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Properties
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14
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Item
3.
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Legal
Proceedings
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14
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Item
4.
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Submission
of Matters to a Vote of Security Holders
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14
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PART
II
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|||
Item
5.
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Market
for Registrant’s Common Equity, Related Stockholder Matters
and
Issuer Purchases of Equity Securities
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16
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Item
6.
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Selected
Financial Data
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17
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Item
7.
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
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17
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Item
7A.
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Quantitative
and Qualitative Disclosures About Market Risk
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23
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Item
8.
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Financial
Statements and Supplementary Data
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24
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Item
9.
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Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosure
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52
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Item
9A.
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Controls
and Procedures
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52
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Item
9B.
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Other
Information
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54
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PART
III
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|||
Item
10.
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Directors,
Executive Officers and Corporate Governance
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55
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Item
11.
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Executive
Compensation
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57
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Item
12.
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Security
Ownership of Certain Beneficial Owners and Management
and
Related Stockholder Matters
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62
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Item
13.
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Certain
Relationships and Related Transactions, and Director
Independence
|
63
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Item
14.
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Principal
Accounting Fees and Services
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64
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PART
IV
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|||
Item
15.
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Exhibits
and Financial Statement Schedules
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64
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Signatures
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65
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Exhibit
Index
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66
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PART
I
ITEM
1. BUSINESS
The
terms
"Cytomedix," and "Company," as used in this annual report, refer to Cytomedix,
Inc.
You
are
cautioned that this Form 10-K contains "forward-looking statements" within
the
meaning of the Private Securities Litigation Reform Act of 1995. When the words
"believes," "plans," "anticipates", "will likely result," "will continue,"
"projects," "expects," and similar expressions are used in this Form 10-K,
they
are intended to identify "forward-looking statements," and such statements
are
subject to certain risks and uncertainties which could cause actual results
to
differ materially from those projected. Furthermore, the Company’s plans,
strategies, objectives, expectations and intentions are subject to change at
any
time at the discretion of management and the Board of Directors.
These
forward-looking statements speak only as of the date this report is filed.
The
Company does not intend to update the forward-looking statements contained
in
this report, so as to reflect events or circumstances after the date hereof
or
to reflect the occurrence of unanticipated events, except as may occur as part
of its ongoing periodic reports filed with the SEC.
GENERAL
DEVELOPMENT OF THE BUSINESS
Informatix
Holdings, Inc. was incorporated in Delaware in 1998. In 1999, an unrelated
Arkansas corporation, Autologous Wound Therapy, Inc. ("AWT"), merged with and
into Informatix Holdings, Inc. and the name of the surviving corporation was
changed to Autologous Wound Therapy, Inc. In 2000, AWT changed its name to
Cytomedix, Inc. The principal offices are located in Rockville, Maryland.
In
2001,
the Company filed bankruptcy under Chapter 11 of the United States Bankruptcy
Code, after which Cytomedix was authorized to continue to conduct its business
as debtor and debtor-in-possession. A new board of directors was elected which
then appointed a new management team. New management immediately began
formulating a plan of reorganization that would enable the Company to reorganize
and emerge quickly from Chapter 11 in order to preserve its value as a going
concern. The Company emerged from bankruptcy in 2002 under a Plan of
Reorganization. At that time, all of the Company’s securities or other claims
against or equity interest in the Company were canceled and of no further force
or effect. Holders of certain claims or securities were entitled to receive
new
securities from Cytomedix in exchange for their claims or equity interests
prior
to bankruptcy. All known and allowed claims and equity interests have been
satisfied and resolved as of the filing of this form 10-K.
FINANCIAL
INFORMATION ABOUT SEGMENTS AND GEOGRAPHIC REGIONS
Cytomedix
has only one operating segment and operates only in the United States. See
Item
8, Financial Statements and Supplementary Data.
DESCRIPTION
OF THE BUSINESS
Overview
Cytomedix
is a biotechnology company that develops and licenses autologous
cellular therapies (i.e., therapies using the patient’s own body products),
including Cytomedix’s proprietary AutoloGel™ Process to produce a platelet rich
plasma gel (“AutoloGel™”) for the treatment of wounds. To create AutoloGel™, the
patient’s own platelets and plasma are separated through centrifugation and
combined with several reagents. This process releases multiple growth factors
from the platelets, creates a fibrin matrix scaffold, and forms a gel that
is
topically applied to a wound (under the direction of a physician). Upon topical
application, the Company believes that AutoloGel™ initiates a reaction that
closely mimics the body’s natural healing process.
Company-sponsored
studies indicate increased healing for AutoloGelTM
as
compared to enhanced traditional treatments as well as competing treatments
for
the treatment of diabetic foot ulcers, the Company’s initial focus within its
target market.
Multiple
growth factor therapies have not been widely used in the traditional commercial
setting because such therapies have generally not been available or widely
known
by clinicians. Until a few years ago, the autologous process of securing
multiple growth factors from a patient’s blood products was, substantially, an
exclusive treatment available through outpatient wound care centers affiliated
with Curative Health Services (“Curative”). In January 2001, the Company
purchased certain technology, assets and intellectual property rights associated
with autologous multiple growth factor therapies from Curative and has since
refined the product to a more marketable state.
1
Market
Cytomedix’s
primary target market is the multi-billion dollar, chronic, non-healing wound
market. Such wounds typically arise from one of three etiologies: diabetic
foot
ulcers, venous leg ulcers, and pressure ulcers. The following table lists the
prevalence of these wound types:
Incidence
of Chronic Wounds in the U.S.
(number
of wounds in millions)
Source:
Advanced Wound Management: Healing and Restoring Lives;
Advanced
Medical Technology Association (AdvaMed), June 2006
|
|
U.S.
|
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|||
Diabetic
Foot
Ulcers
|
|
1.5
|
|
Venous
Leg Ulcers
|
2.5
|
||
Pressure
Ulcers
|
2.0
|
||
Totals
|
6.0
|
The
prevalence of chronic wounds in the U.S. is linked directly to increased aging
demographics, vascular diseases, venous insufficiency, and excessive pressure
and diabetic neuropathy. The prevalence of worldwide chronic wounds is estimated
to be 18 million (6).
Diabetic
Foot Ulcers
According
to the American Diabetes Association (“ADA”)(1), there are approximately 20.8
million people with diabetes in the U.S., or 7% of the total population. It
is
estimated that 15-20% of these people with diabetes will develop a foot ulcer
in
their lifetime and that 14-24% of diabetic foot ulcers result in amputation.(2)
Over 82,000 amputations per year have been documented.(3) Estimated amputation
costs are between $20,000 and $60,000 per procedure (4), implying an aggregate
cost of between $1.6 billion and $4.9 billion per year. The chances of a second
amputation within 3-5 years may be as high as 50%, with a 5 year post-amputation
mortality rate of 39-68%.(5)
Venous
Stasis Leg Ulcers
Venous
leg ulcers are the most frequently occurring type of chronic wound. The
prevalence rises dramatically with age, increasing to 1% of the population
over
age 60. It is estimated that treatment costs total between $2.5 to $3.5 billion
annually and a loss of 2 million workdays per year. (4)
Pressure
Ulcers
Over
2.0
million pressure ulcers occur each year with an annual cost greater than $1.3
billion. One study indicates that nearly 15% of hospitalized patients age 65
or
older developed a pressure ulcer during a 5-day or longer stay. Furthermore,
up
to one-fifth of all home health service visits involve care of a pressure ulcer,
and more than one-third of people with spinal cord injuries develop pressure
ulcers. (4)
References
(1) www.diabetes.org,
2006
(2) H.R
3203 Submitted to the House of Representatives, Sept 30, 2003
(3) National
Diabetes Statistics, National Diabetes Information Clearinghouse, National
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH,
2004
(4) Advanced
Wound Management: Healing and Restoring Lives; Advanced Medical Technology
Association (AdvaMed); June 2006
(5) Reiber
GE, Boyko EJ, Smith DG: Lower Extremity Foot Ulcers and Amputations in Diabetes.
In Diabetes in America. 2nd ed., National Institutes of Health, NIDDK, NIH
Pub
No. 95-1468, 1995.
(6) Growth
Factors:
Indications, Products, and Markets; Kalorama Publications; October
2003
2
Strategy
The
Company has developed a three-pronged strategy to leverage its intellectual
property and capitalize on the market for its AutoloGel™:
·
|
Obtain
broad reimbursement from third-party
payers
|
·
|
Enforce
rights under the Company’s patents
|
·
|
Target
the non-reimbursement sensitive
market
|
In
order
to increase the prospects for securing broad reimbursement as well as enhance
the sales and marketing efforts, the Company completed a well-controlled,
prospective clinical trial and submitted a 510(k) Premarket Notification to
the
FDA.
Clinical
Trial and FDA Clearance
In
2005,
the Company completed its prospective, randomized, blinded, controlled,
multi-center clinical trial designed to prove the efficacy and safety of its
AutoloGel™ System (see discussion in this section under “Government Approval”)
for the treatment of non-healing diabetic foot ulcers. The audited results
yielded 40 patients who met the trial protocol. Analysis of the size of wounds
in the study shows that 35 out of the 40 patients (88%) had wounds that were
less than or equal to 7 square centimeters in area and 2 cubic centimeters
in
volume. For these most common wound sizes in the study, the healing rate of
the
AutoloGel™ group was 81.3% and that for the control group was 42.1%. The
difference of 39.2% between these groups is clearly statistically significant,
with a p-value of 0.036. Within the full cohort of the 40 patients, 68.4% of
the
patients treated with AutoloGel™ achieved full wound closure versus 42.9% of
those patients treated in the control group. The difference of 25.5% between
the
healing rate of the AutoloGel™ group versus the control group is approaching
statistical significance with a p-value of 0.125. The Company believes that
the
healing rates of AutoloGel™ at 81.3% for the most common wound sizes in the
study and 68.4% for all wound sizes appear to be better than any other wound
care products cleared by the FDA and covered by Medicare reimbursement with
which the Company is familiar, although this comparison is not as reliable
as a
head-to-head study. The control group patients were not on placebo; rather,
they
were treated using a saline gel cleared by the FDA for wound treatment. If
the
control group patients healed at the originally anticipated rate of 20-30%
for
standard treatments for diabetic foot ulcers, the difference between the healing
rates in the AutoloGel™ group versus the control group would have been even more
strongly statistically significant.
These
data reflect the results following an independent audit of the data by a former
FDA official responsible for Bio-Research Monitoring. During the audit,
Cytomedix discovered that some patients originally included in the trial had
not
met the inclusion criteria or were not provided treatment according to the
study
protocol. This audit was conducted at the request of Cytomedix when preliminary
data were inconsistent with independent and Company retrospective
studies.
Based
on
the audited results of the trial, and other data compiled by the Company, in
late January 2006 Cytomedix submitted a Premarket Notification (“510(k)”) to the
FDA seeking clearance of its AutoloGel™ System for diabetic foot ulcers and
other indications. While AutoloGel™ is regulated by FDA under the Medical Device
Amendments of the Food, Drug and Cosmetic Act, the FDA Center for Biologics
Evaluation and Research (“CBER”) has the jurisdiction for reviewing such
products. FDA assigned CBER as the primary center that reviewed and approved
the
Investigational Device Exemption (“IDE”) under which this clinical trial was
conducted. On October 13, 2006, the FDA denied Cytomedix’s claim that AutoloGel™
is substantially equivalent to predicate devices, as asserted in the 510(k),
and
delivered to Cytomedix a Non-Substantial Equivalence (“NSE”) determination
letter.
Based
on
the information contained in the NSE determination letter and conversations
with
the FDA, the Company believes that the primary grounds for rejecting the claim
of substantial equivalence concern the use of bovine thrombin which is used
to
activate the platelet rich plasma (“PRP”) in the AutoloGel™ System. Bovine
thrombin is a clotting agent derived from cows that has been used extensively
on
humans in surgery and other medical applications to stop bleeding. It is also
used along with platelet gel therapy products that have been cleared by FDA
for
use in surgery. However, CBER cites published articles that contend that bovine
thrombin creates antibodies that may decrease a patient’s Factor V count (a
clotting agent naturally found within blood) which could cause a bleeding
tendency. The analysis and clinical interpretation of the data in Cytomedix’s
submission to the FDA had concluded that the data from the clinical trial does
not demonstrate this complication. No statistically or clinically significant
differences were noted between the PRP gel and control from baseline to endpoint
laboratory shifts in hematology, clotting factors, and Factor V tests.
Additionally, no clinically important changes in clotting factors that would
cause concern about the effect of the PRP gel or control on Factor V activity
were found during an independent medical expert review of the medical records,
including clinical lab test data and concomitant medications.
3
FDA
also
raised concerns relating to the clinical trial and the number of protocol
violations which resulted in a lack of statistical significance in the results
of the “intent-to-treat” patient cohort and the subset analysis that showed full
statistical significance in the results for 88% of the wounds which represented
the per protocol majority wound group within the trial. The Company believed
that, during face-to-face meetings with the FDA and in subsequent formal
responses to FDA questions, it had addressed these concerns to the FDA’s
satisfaction, although they were still listed in the NSE letter from the
FDA.
The
Company disagrees with the decision as expressed in the NSE determination letter
and, in response to an offer made by the FDA, appealed the decision via an
informal review with officials in the Office of the Center Director for CBER.
The written appeal was submitted to the FDA in late December 2006 and then
a
face-to-face meeting was held in late January 2007 between Cytomedix, its
outside experts, and various FDA personnel involved in the review process.
Cytomedix presented additional expert analysis of the safety data gathered
during the clinical trial, in particular that data relating to the use of bovine
thrombin. In addition, Cytomedix clarified the grounds on which it is seeking
marketing clearance for AutoloGel and argued the appropriateness of a reversal
of the FDA’s original decision. A decision from the FDA regarding the Company’s
appeal is pending.
The
Company currently sells commercially AutoloGel™ process components, the
AutoloGel™ Component Kit and Process Centrifuge for use in wound care and
autologous wound therapy performed under the physicians’ practice of medicine
doctrine. This approach represents the practice currently prevalent in the
platelet gel therapy industry, both in the treatment of chronic wounds as well
as the use of platelet gel therapies in the operating room in fields such as
orthopedic and cardiovascular surgery. However, without FDA clearance, the
Company’s ability to make claims for the AutoloGel™ System regarding its use to
treat or heal wounds is limited. The Company believes this is a significant
barrier to broad clinical and market acceptance of the Company’s product. It is
also possible that at some point the FDA may require companies to conduct
clinical trials on all specific clinical therapies and uses for which their
products can be used, whether or not they make a specific labeled claim to
that
effect. Further, it is also possible that FDA could require companies to stop
marketing platelet gel therapies until FDA clearance or approval for specific
wound healing claims is obtained.
Third-Party
Reimbursement
The
Company believes the full market potential of AutoloGel™ cannot be achieved
without broad third-party reimbursement from Medicare and commercial insurers.
The Company has initiated efforts to obtain Medicare reimbursement through
the
Center for Medicare and Medicaid Services (“CMS”). This process involves three
tracks which can be pursued simultaneously:
§ |
Coverage
- Coverage requires a determination by CMS that AutoloGel™ is “reasonable
and necessary.” A National Non-Coverage Decision, issued in 1992 and
amended in 2003, broadly disallows Medicare coverage for Autologous
Blood-Derived Products for Chronic Non-Healing Wounds. This decision
currently applies to AutoloGel™. The primary basis cited for this
non-coverage decision was a lack of specific evidence. The Company
is
planning to meet with CMS to discuss a reconsideration of that decision
based on data from the controlled clinical trial and other recent
evidence.
|
§ |
Coding
- Coding involves identifying an existing code or codes which aptly
describe the AutoloGel™ System, or applying for new coding or modification
of the definitions of existing coding to properly describe the Company’s
offering. The Company is evaluating the Healthcare Common Procedure
Coding
System (“HCPCS”) codes, obtained through CMS and Current Procedural
Terminology (“CPT”) codes, obtained through the American Medical
Association, to determine the optimal reimbursement pathway for
AutoloGel™.
|
§ |
Payment
- Payment involves the establishment of a fee schedule associated
with the
Company’s product vis a vis the applicable
codes.
|
The
Company has had the results of its clinical trial published in a peer-reviewed
journal. The article, entitled “A Prospective, Randomized, Controlled Trial of
Autologous Platelet-Rich Plasma Gel for the Treatment of Diabetic Foot Ulcers,”
was published, as the feature article in the June 2006 issue of Ostomy/Wound
Management (“OWM”). OWM is the premiere journal for information on wound care
and the related, overlapping fields of skin care, ostomy care, incontinence
care, and nutrition, and is the only peer-reviewed, multidisciplinary
publication specifically targeted to the advanced wound care practitioner.
The
Company believes that publication in peer-reviewed journals is generally
regarded as a necessary precursor to a favorable reimbursement decision from
CMS
and also is an important step toward building broad clinical awareness and
acceptance of AutoloGel™. The Company plans to present the results of its
clinical trial and other recent evidence as support for its reimbursement
pursuits with CMS. Additionally, Cytomedix requisitioned a pharmaco-economic
study to evaluate the cost effectiveness of the AutoloGel™ System. Such studies
are performed to present scientific, demographic and economic information to
justify to CMS and other payor organizations that a particular product and
therapy is clinically safe and effective and cost effective with respect to
its
alternatives. Preliminary results of the pharmaco-economic study suggest a
favorable comparison of AutoloGel™ over competing treatments in both clinical
and cost effectiveness. The final report should be available sometime in the
first quarter of 2007 and would also be provided to CMS.
4
While
not
an official precondition for a reimbursement code, the Company believes that
securing Food and Drug Administration (“FDA”) clearance of the AutoloGel™ System
for specific clinical indications, such as for the treatment of non-healing
diabetic foot ulcers, will be heavily weighed by CMS when making its decision.
Should the Company’s appeal to the FDA ultimately prove unsuccessful, the
Company would need to analyze the ultimate nature of the FDA’s determination and
the potential impact on the efforts to secure CMS reimbursement for the
AutoloGel™ System and components.
While
commercial insurers are not required to follow CMS reimbursement decisions,
the
Company believes they generally weigh heavily the position taken by CMS.
Therefore, the results of the Company’s efforts with CMS could likely influence
the degree of success the Company achieves in securing reimbursement from other
third-party payers such as commercial insurers.
Should
the Company be successful in its efforts to obtain reimbursement, third-party
payors, including CMS, would permit payment for the AutoloGel™ System for use in
certain types of chronic wounds. If this is accomplished, AutoloGel™ could then
be positioned as a reimbursed alternative treatment for the estimated 6.0
million chronic wounds that occur each year in the United States.
In
general, to raise the scientific awareness of the use of AutoloGel™, posters and
oral presentations of the clinical trial results have been presented at multiple
scientific/medical meetings including: American Diabetes Association, American
Podiatric Medical Association, and the Clinical Symposium on Advances in Skin
and Wound Care.
Patents
and Licensing
The
Company has initiated a broad based patent and licensing strategy intended
to
(i) enforce the rights under the Company’s patents in order to ensure that
Cytomedix shareholders derive economic benefit from the Company’s intellectual
property, and (ii) assist the Company in establishing a dominant market position
for the AutoloGel™ System within the market for autologous growth factor
products used for the treatment of chronic wounds. In 2005 and 2006, the Company
identified and successfully pursued numerous companies, both small and large,
that market products similar to AutoloGel™, that the Company believed were
infringing or inducing infringement of its intellectual property rights.
Settlements have been achieved and licenses have been granted to these companies
resulting in a royalty stream for Cytomedix.
The
primary license agreements are listed below:
Licensee
|
Date
of Agreement |
Date
of Expiration
(4) |
Initial
Licensing
Fee
|
On-going Royalty Percentage
(2) |
|||||||||
DePuy
Spine, Inc. (1)
|
3/19/2001
|
11/24/2009
|
$
|
750,000
|
6.5%
|
|
|||||||
|
3/4/2005
|
||||||||||||
Medtronic,
Inc.
|
5/1/2005
|
11/24/2009
|
$
|
680,000
|
7.5%
on disposables
|
||||||||
|
1.5%
on hardware
|
||||||||||||
Harvest
Technologies, Inc.
|
6/30/2005
|
11/24/2009
|
$
|
500,000
|
7.5%
on disposables
|
||||||||
|
1.5%
on hardware
|
||||||||||||
Perfusion
Partners, Inc.
|
6/26/2005
|
11/24/2009
|
$
|
250,000
|
(3)
|
10.0%
|
|
||||||
COBE
Cardiovascular, Inc.
|
10/7/2005
|
11/24/2009
|
$
|
45,000
|
7.5%
on disposables
|
||||||||
|
1.5%
on hardware
|
||||||||||||
SafeBlood
Technologies, Inc.
|
10/12/2005
|
11/24/2009
|
$
|
50,000
|
(3)
|
8.0%
to 9.0%
|
|
||||||
Biomet
Biologics, Inc. (5)
|
5/19/2006
|
11/24/2009
|
$
|
2,600,000
|
none
|
||||||||
CellMedix,
Inc.
|
11/28/2006
|
11/24/2009
|
$
|
30,000
|
9.5%
|
|
(1) Cytomedix
has two license agreements with DePuy Spine, Inc.. The original license
agreement was dated March 19, 2001, amended March 3, 2005, and provides for
the
use of applications under Cytomedix patents in the fields of diagnostic and
therapeutic spinal, neurosurgery and orthopedic surgery. The second license
agreement is dated March 4, 2005, and applies to all fields not covered in
the
original license agreement as amended.
(2) Certain
minimum royalties may apply to certain agreements and other royalty percentages
may apply to future products covered under selected license
agreements.
(3) Some
of
these amounts are payable over a period of time as defined in executed notes
payable to Cytomedix.
(4) These
dates reflect the expiration of the license in the U.S., which coincides with
the expiration of the Knighton Patent in the U.S. In some cases, the licensing
agreements applicable to territories outside the U.S. extend to the expiration
of the patents in the respective foreign countries.
5
(5) The
Settlement and License Agreement with Biomet Biologics, Inc. (“Biomet”) called
for a $2.6 million payout from Biomet to Cytomedix. This payout took the form
of
$1.4 million payable upon execution of the agreement and $100,000 payable at
the
end of each of 12 consecutive quarters beginning with the quarter ending
September 2006. These payments are not tied to any performance commitments
by
Cytomedix and are not dependent on Biomet sales.
The
Company’s ongoing patent enforcement strategy is being conducted on a full
contingency basis by the law firms Fitch, Even, Tabin & Flannery and Robert
F. Coleman and Associates, both based in Chicago, Illinois.
The
Company expects to incur “Cost of royalties” (consisting of royalty expense and
contingent legal fees) in the range of 30-50% of on-going royalty revenues
relating to these and future settlements.
The
Company intends to press forward aggressively in other instances of infringement
with aggressive legal and business actions to defend its intellectual property
and, where possible, arrive at equitable settlements with
infringers.
Non-Reimbursement
Sensitive Market
The
Company is also working to penetrate the segment of the national market that
is
not sensitive to direct reimbursement for the Company’s product. This includes
capitated environments such as long-term acute care facilities, health
maintenance organizations, home health agencies, as well as government agencies,
(e.g. the Veterans Administration).
The
Company is addressing various parts of this market via distributors, independent
sales representatives, and internal sales representatives.
Sales
and Marketing
Given
the
Company’s status with respect to marketing clearance for its AutoloGel™ System,
Cytomedix continues to maintain a limited sales and marketing infrastructure
for
the AutoloGel™ Component Kit and Process Centrifuge. The Company predominately
distributes its products through a network of commission-based internal and
independent sales representatives. At December 31, 2006, the Company was
represented by three internal and one independent sales representative,
servicing approximately a dozen states. The Company expects to expand this
representation in 2007.
Suppliers
The
Company outsources manufacturing for all the components of the
AutoloGelTM
process.
While the Company utilizes single suppliers for several components of
AutoloGelTM,
such
components are readily available on the open market and therefore the Company
believes that no dependencies exist from its current sourcing practices. The
one
exception is a reagent, bovine thrombin, available exclusively through King
Pharmaceuticals.
Competition
Wound
care products can be categorized into 3 general areas: passive, interactive,
and
active.
· |
Passive
products -- such as gauze and bandages, cover the wound to protect
it.
|
· |
Interactive
products -- attempt to optimize the wound environment so it is more
conducive for the body to enact the innate healing process. The wound
care
world recognizes that moist wound healing is more effective for cellular
growth than dry wound healing, however excessive moisture can be
detrimental to healing. In addition, wounds need to be free of infection,
have adequate perfusion and tissue oxygenation, and reduced pressure.
There are hundreds of wound dressings on the market, some provide
a
long-term moist wound environment, others absorb large amounts of
exudates, and some provide topical antimicrobial agents. In addition,
there are multiple devices that attempt to assist with creating the
optimal wound environment. However, as a whole, none of them are
positioned to actively direct cellular
growth.
|
· |
Active
wound products -- directly stimulate cellular growth and migration
in the
wound area. Growth factor products, such as AutoloGel™, are a predominant
product in this category. Science has documented that multiple growth
factors cause cellular growth and migration to actively grow granulation
tissue, capillaries, and epithelium. Tissue engineered grafts could
also
fall into this category because they contain live cells and secondarily,
may have some growth factors in the
tissue.
|
Thus,
when identifying competitors, each product can be categorized in the above
breakdown. Passive products are not a competitor for AutoloGel™. While some of
the interactive products can be competitors, others can be complimentary to
AutoloGel™. The other active products could be categorized as the major
competitors.
6
The
major
competitors are other platelet gel companies, many of whom have licensing
agreements with Cytomedix. To date, these companies are selling platelet gel
mostly into the surgical market for dental, plastic, orthopedic, and general
surgery purposes but may also try to sell into the wound care market. When
compared to the other platelet gel companies, Cytomedix’s AutoloGel™ System has
the smallest, most portable centrifuge with the fastest spin time (1.5 minutes
compared to 13-20 minutes). This makes it possible to use in a greater variety
of health care settings, i.e. hospital, outpatient clinics, physicians offices,
or long term care, long term acute care, and home health settings. In addition,
it is a user-friendly system so multiple health care providers can process
the
gel, rather than specialty technicians. Competitors’ systems generally require a
larger blood draw, more detailed processing steps, and a longer spin time.
While
competitors claim a larger growth factor and platelet count than at baseline,
no
studies exist that prove this is efficacious. To date, Cytomedix’s AutoloGel™
System is the only platelet gel system that has completed a prospective,
randomized, controlled trial in humans. The Company believes this trial
demonstrated both the safety and efficacy of the AutoloGel™ System.
Regranex,
a prescription cream marketed by Ethicon, a division of Johnson & Johnson,
Inc. ("J&J"), contains a single recombinant growth factor. Having been
introduced after lengthy clinical trials several years ago, its revenues, based
on the Company’s best estimate, have grown significantly. Cytomedix perceives
the single growth factor Regranex as a less effective method of healing chronic
wounds in comparison with autologous multiple growth factors. While Cytomedix
acknowledges the success of the Regranex product in the marketplace, an
excellent opportunity exists to capture market share from this product once
reimbursement is available for AutoloGel™. A recent CMS (Medicare) decision
disallowed coverage for Regranex because it is self-administered.
The
tissue-engineered products have changed extensively lately. Smith and Nephew,
the manufacturer of Dermagraft, has taken the product off the market recently
and has subsequently sold the technology to Advanced BioHealing. Ortec
International, Inc.is continuing to conduct clinical trials on its product
Orcel. Apligraf, manufactured by Organogenesis, is the only tissue engineered
product on the market at this time.
The
major
competitor in the interactive area is a device called Vacuum Assisted Closure
(“V.A.C.”) system produced by Kinetic Concepts, Inc. (“KCI”). During the year
ended December 31, 2005, KCI worldwide revenues due to V.A.C. sales and rentals
were reported as $908 million. Several of the sites that have used the V.A.C.
system have now tried AutoloGel™. It has been reported to the Company by several
of these sites that AutoloGel™ was very competitive with the V.A.C. and may even
be better in both clinical and cost effectiveness. This, however, was based
on
individual case reports and experience of physicians rather than any rigorous
comparative studies. Yet the V.A.C's established position is substantially
CMS
reimbursed, which provides for a substantial current economic competitive
advantage.
Intellectual
Property Rights
Cytomedix
regards its patents, trademarks, trade secrets, and other intellectual property
(collectively, the “Intellectual Property Assets”) as critical to its success.
Cytomedix relies on a combination of patents, trademarks, and trade secret
and
copyright laws, as well as confidentiality procedures, contractual provisions,
and other similar measures, to establish and protect its Intellectual Property
Assets. Cytomedix has in the past several years filed numerous patent
applications worldwide seeking protection of its technologies. Cytomedix owns
eight U.S. patents (including U.S. Patent No. 5,165,938 (the “Knighton Patent”)
and U.S. Patent No. 6,303,112 (the “Worden Patent”)), various corresponding
foreign patents, and various trademarks. Cytomedix has received, filed, or
is in
the process of filing trademarks for the names “Cytomedix,” “AutoloGel”, and a
few variants thereof. In addition, Cytomedix has numerous pending trademark
applications and foreign patent applications involving enriched platelet wound
healant, platelet derived wound healant, angiogenic peptides, and
anti-inflammatory peptides.
To
prevent disclosure of its trade secrets, Cytomedix restricts access to its
proprietary information. All of its employees, consultants, and other persons
with access to Cytomedix's proprietary information execute confidentiality
agreements with Cytomedix. Cytomedix has also pursued litigation against those
persons believed to be infringing on the Company's Intellectual Property Assets
seeking both damages and injunctive relief.
Despite
these efforts, Cytomedix may not be able to prevent misappropriation of its
technology or deter others from developing similar technology in the future.
Furthermore, policing the unauthorized use of its Intellectual Property Assets
is difficult. Litigation necessary to enforce Cytomedix's Intellectual Property
Assets could result in substantial costs and diversion of
resources.
The
Company is party to certain royalty agreements relating to its intellectual
property under which it pays certain fees. See Note 5 to the Financial
Statements.
7
Government
Regulation
Devices
that the Company manufactures and distributes are subject to regulations by
the
Food and Drug Administration, including record-keeping requirements, good
manufacturing practices and mandatory reporting of certain adverse experiences
resulting from use of the devices, and certain state agencies. Labeling and
promotional activities are also subject to regulation by the FDA and the Federal
Trade Commission, in certain circumstances. Current FDA enforcement policy
prohibits the marketing of approved medical devices for unapproved uses and
the
agency scrutinizes the labeling and advertising of medical devices to ensure
that unapproved uses are not promoted.
Before
a
new medical device can be introduced to the market, the manufacturer must
generally obtain FDA clearance or approval. In the United States, medical
devices are classified into one of three classes - Class I, II or III. The
controls applied by the FDA to the different classifications are those believed
by the FDA to be necessary to provide reasonable assurance that the device
is
safe and effective. Class I devices are non-critical products that FDA believes
can be adequately regulated by “general controls” that include provisions
relating to labeling, manufacturer registration, defect notification, records
and reports, and good manufacturing practices (“GMP”) based on the FDA’s Quality
Systems Regulations. Most Class I devices are exempt from pre-market
notification and some are also exempt from GMP requirements. Class II devices
are products for which the general controls of Class I devices, by themselves,
are not sufficient to assure safety and effectiveness and, therefore, require
special controls. Additional special controls for Class II devices include
performance standards, post-market surveillance patient registries, and the
use
of FDA guidelines. Standards may include both design and performance
requirements. Class III devices have the most restrictive controls and require
pre-market approval by the FDA. Generally, Class III devices are limited to
life-sustaining, life-supporting or implantable devices. The FDA inspects
medical device manufacturers and has a broad authority to order recalls of
medical devices, to seize non-complying medical devices, and to criminally
prosecute violators.
Section
510(k) of the Federal Food, Drug and Cosmetic Act requires individuals or
companies manufacturing most medical devices intended for human use to file
a
notice with the FDA at least ninety days before intending to introduce the
device into the market. This notice, commonly referred to as a 510(k), must
identify the type of classified device into which the product falls, the class
of that type, and a specific product already being marketed or cleared by FDA
and to which the product is “substantially equivalent.” In some instances, the
510(k) must include data from human clinical studies in order to establish
“substantial equivalence.” The FDA must agree with the claim of “substantial
equivalence” before the device can be marketed. The statutory time frame for
clearance of a 510(k) is 90 days, though it often takes longer.
If
a
product is Class III and does not qualify for the 510(k) process, then the
FDA
must approve a pre-market approval (“PMA”) application before marketing can
begin. PMA applications must demonstrate, among other factors, that the device
in question is safe and effective. Obtaining a PMA application approval can
sometimes take several years, depending upon the complexity of the issues
involved with the device. The statutory time frame for the review of a PMA
by
the FDA is 180 days and many devices are reviewed and approved within that
time
frame or within a few months afterward. Marketing approval based on a PMA is
generally a longer process than the 510(k) clearance process that is typically
obtained in comparatively less time.
Government
Approval
Cytomedix
has sought to ensure compliance with the FDA regulations and policies for
medical devices and, specifically, platelet gel therapies.
The
Company currently markets the AutoloGel™ Process Centrifuge,the AutoloGel™
Component Kit, and certain commercially available reagents (i.e. calcium
chloride, ascorbic acid, and bovine thrombin). Each component is a
legally-marketed product that either has been cleared by FDA for marketing
or is
exempt from pre-market notification and clearance. The AutoloGel™ Centrifuge,
when used with the AutoloGel™ Component Kit and certain reagents, form the basis
for the AutoloGel process and are used for wound care and for treating chronic
wound, including diabetic ulcers, at the physician’s discretion. The Federal
Food, Drug and Cosmetic Act does not authorize the FDA to limit or interfere
with the “physician's practice of medicine” and use of legally-marketed devices
for any condition or disease within a legitimate doctor-patient relationship
as
long as no specific claims are made for the product.
In
2003,
the Company conceptualized marketing an AutoloGel™ System, consisting of a
centrifuge, a component kit, and reagents, for specific indications such as
diabetic, pressure, and venous ulcers.
During
2003, the Company made a business decision to undertake a prospective,
randomized, blinded, controlled trial for the AutoloGel™ System. The objective
of the trial was to demonstrate safety and efficacy of the AutoloGel™ System for
treating diabetic foot ulcers to the scientific and reimbursement community,
as
well as to the FDA in order to obtain the agency’s marketing clearance of the
AutoloGel™ System. In making this decision, the Company subjected itself to
increased FDA oversight and its regulations governing the investigational use
of
medical devices, codified at 21 C.F.R. Part 812. To this end, the Company
submitted an “Investigational Device Exemption” (“IDE”) application to the FDA
under these rules and obtained approval on March 5, 2004, thus allowing the
Company to begin its clinical trial.
8
Once
the
study was completed and clinical results analyzed, the Company submitted a
510(k) requesting FDA’s clearance of the AutoloGel™ System in January 2006, as
discussed above, under the caption Clinical
Trial and FDA Clearance.
Fraud
and Abuse Laws
The
Company may also be indirectly subject to federal and state physician self
referral laws. Federal physician self-referral legislation (commonly known
as
the “Stark Law”) prohibits, subject to certain exceptions, physician referrals
of Medicare and Medicaid patients to an entity providing certain “designated
health services” if the physician or an immediate family member has any
financial relationship with the entity. A person who engages in a scheme to
circumvent the Stark Law's referral prohibition may be fined up to $100,000
for
each such arrangement or scheme. The penalties for violating the Stark Law
also
include civil monetary penalties of up to $15,000 per referral and possible
exclusion from federal health care programs such as Medicare and Medicaid.
The
Stark Law also prohibits the entity receiving the referral from billing any
good
or service furnished pursuant to an unlawful referral, and any person collecting
any amounts in connection with an unlawful referral is obligated to refund
such
amounts. Various states have corollary laws to the Stark Law, including laws
that require physicians to disclose any financial interest they may have with
a
health care provider to their patients when referring patients to that provider.
Both the scope and exception for such laws vary from state to
state.
The
Company may also be subject to federal and state anti-kickback laws. Section
1128B (b) of the Social Security Act, commonly referred to as the Anti-Kickback
Law, prohibits persons from knowingly and willfully soliciting, receiving,
offering or providing remuneration, directly or indirectly, to induce either
the
referral of an individual, or the furnishing, recommending, or arranging for
a
good or service, for which payment may be made under a federal health care
program such as Medicare and Medicaid. The Anti-Kickback Law is broad, and
it
prohibits many arrangements and practices that are otherwise lawful in
businesses outside of the health care industry. The U.S. Department of Health
and Human Services (“DHHS”) has issued regulations, commonly known as safe
harbors that set forth certain provisions which, if fully met, will assure
health care providers and other parties that they will not be prosecuted under
the federal Anti-Kickback Law. Although full compliance with these provisions
ensures against prosecution under the Anti-Kickback Law, the failure of a
transaction or arrangement to fit within a specific safe harbor does not
necessarily mean that the transaction or arrangement is illegal or that
prosecution under the federal Anti-Kickback Law will be pursued. The penalties
for violating the Anti-Kickback Law include imprisonment for up to five years,
fines of up to $250,000 per violation for individuals and up to $500,000 per
violation for companies and possible exclusion from federal health care
programs. Many states have adopted laws similar to the federal Anti-Kickback
Law, and some of these state prohibitions apply to patients for health care
services reimbursed by any source, not only federal health care programs such
as
Medicare and Medicaid.
In
addition, there are two other health care fraud laws to which the Company may
be
subject, one which prohibits knowingly and willfully executing or attempting
to
execute a scheme or artifice to defraud any health care benefit program,
including private payers (“fraud on a health benefit plan”) and one which
prohibits knowingly and willfully falsifying, concealing or covering up a
material fact or making any materially false, fictitious or fraudulent statement
or representation in connection with the delivery of or payment for health
care
benefits, items or services. These laws apply to any health benefit plan, not
just Medicare and Medicaid.
The
Company may also be subject to other laws which prohibit submitting claims
for
payment or causing such claims to be submitted that are false. Violation of
these false claims statutes may lead to civil money penalties, criminal fines
and imprisonment, and/or exclusion from participation in Medicare, Medicaid
and
other federally funded state health programs. These statutes include the federal
False Claims Act, which prohibits the knowing filing of a false claim (or
causing the submission of a false claim) or the knowing use of false statements
to obtain payment from the U.S. federal government. When an entity is determined
to have violated the False Claims Act, it must pay three times the actual
damages sustained by the government, plus mandatory civil penalties of between
$5,500 and $11,000 for each separate false claim. Suits filed under the False
Claims Act can be brought by an individual on behalf of the government (a “qui
tam action”). Such individuals (known as “qui tam relators”) may share in the
amounts paid by the entity to the government in fines or settlement. In addition
certain states have enacted laws modeled after the False Claims Act. “Qui tam”
actions have increased significantly in recent years causing greater numbers
of
health care companies to have to defend false claim actions, pay fines or be
excluded from the Medicare, Medicaid or other federal or state health care
programs as a result of an investigation arising out of such
action.
Several
states also have referral, fee splitting and other similar laws that may
restrict the payment or receipt of remuneration in connection with the purchase
or rental of medical equipment and supplies. State laws vary in scope and have
been infrequently interpreted by courts and regulatory agencies, but may apply
to all health care products and services, regardless of whether Medicaid or
Medicare funds are involved.
9
Research
and Development
The
Company is currently focusing its limited resources on broadly commercializing
AutoloGelTM.
It
therefore expends only very minor amounts on research and development activities
(“R&D”). The Company currently focuses its R&D activities on the
improvement of its current product offering, but, in the future, intends to
develop the technology underlying its broader patent portfolio.
Employees
At
December 31, 2006, the Company had twelve full-time employees. These include
three executive officers, Dr. Kshitij Mohan as Chief Executive Officer, Mr.
Andrew S. Maslan as Chief Financial Officer and Ms. Carelyn P. Fylling as Vice
President of Professional Services. The remaining personnel consist of sales
and
marketing, clinical, accounting, and regulatory professionals.
AVAILABLE
INFORMATION
Cytomedix
files periodic reports and all amendments thereto pursuant to Section 13(a)
or
15(d) of the Securities and Exchange Act of 1934. These reports are available,
free of charge, through the Company’s website at www.cytomedix.com.
ITEM
1A. RISK FACTORS
Cytomedix
cautions the readers not to place undue reliance on any forward-looking
statements, which are based on certain assumptions and expectations that may
or
may not be valid or actually occur. The risk factors that follow may cause
actual results to differ materially from those expressed or implied by any
forward-looking statement. The risks described below are not to be deemed an
exhaustive list of all potential risks.
The
FDA Denied the Company’s Claims in its 510(k) Pre-Market Notification and the
Company’s Appeal May Not Be Successful
The
FDA
denied the Company’s claims in its 510(k). The Company has appealed this
decision and currently awaits a final ruling from the FDA. There is no assurance
that the Company’s efforts to have the original decision reversed or amended to
the Company’s satisfaction will be successful. A lack of FDA clearance may make
it more difficult to obtain reimbursement codes and/or adversely affect the
Company’s ability to implement a significant portion of its business plan.
Specifically, the Company may be unable to obtain a significant share of the
chronic wound care market. Even with FDA clearance, the Company can provide
no
assurance that it will be able to obtain Medicare or other third party
reimbursement.
The
Company Has Limited Sources of Working Capital
Because
the Company was in bankruptcy in 2002, the Company will not be able to obtain
debt financing. All working capital required to implement the Company’s business
plan will be provided by funds obtained through offerings of its equity
securities, and revenues generated by the Company. No assurance can be given
that the Company will have revenues sufficient to support and sustain its
operations through 2007.
If
the
Company does not have sufficient working capital and is unable to generate
revenues or raise additional funds, the following may occur: delaying the
completion of the Company’s current business plan or significantly reducing the
scope of the business plan; delaying some of its development and clinical or
marketing testing; delaying its plans to pursue government regulatory and
reimbursement approval and/or clearance for its wound treatment technologies;
postponing the hiring of new personnel; or, in an extreme situation, ceasing
operations.
The
Company Has a History of Losses
The
Company has a history of losses, is not currently profitable, and expects to
incur substantial losses and negative operating cash flows for the foreseeable
future. The Company may never achieve or maintain profitability. The Company
will need to generate significant revenues to achieve and maintain
profitability. The Company cannot guarantee that it will be able to generate
these revenues, and it may never achieve profitability.
10
The
Company Has a Short Operating History and Limited Operating
Experience
The
Company must be evaluated in light of the uncertainties and complexities
affecting an early stage biotechnology company. The Company has only recently
begun to implement its current business plan. Thus, the Company has a very
limited operating history. Continued operating losses, together with the risks
associated with the Company’s ability to gain new customers for its product
offerings may have a material adverse effect on the Company’s liquidity. The
Company may also be forced to respond to unforeseen difficulties, such as
decreasing demand for its products and services, regulatory requirements and
unanticipated market pressures.
Since
emerging from bankruptcy and continuing through today, the Company is developing
a business model that includes protecting its patent position, addressing its
third-party reimbursement issues, and developing a sales and marketing program.
There can be no assurance that its business model in its current form can
accomplish the Company’s stated goals.
The
Company’s Intellectual Property Assets Are Critical to Its
Success
The
Company regards its patents, trademarks, trade secrets, and other intellectual
property assets as critical to its success. The Company relies on a combination
of patents, trademarks, and trade secret and copyright laws, as well as
confidentiality procedures, contractual provisions, and other similar measures,
to establish and protect its intellectual property. The Company attempts to
prevent disclosure of its trade secrets by restricting access to sensitive
information and requiring employees, consultants, and other persons with access
to the Company’s sensitive information to sign confidentiality agreements.
Despite these efforts, the Company may not be able to prevent misappropriation
of its technology or deter others from developing similar technology in the
future. Furthermore, policing the unauthorized use of its intellectual property
assets is difficult and expensive. Litigation has been necessary in the past
and
may likely be necessary in the future in order to protect the Company’s
intellectual property assets. Litigation could result in substantial costs
and
diversion of resources. The Company cannot guarantee that it will be successful
in any litigation matter relating to its intellectual property assets.
Continuing litigation or other challenges could result in one or more of its
patents being declared invalid. In such a case, any royalty revenues from the
affected patents would be adversely affected although the Company may still
be
able to continue to develop and market its products.
The
Company’s patent covering the specific gel formulation that is applied as part
of the AutoloGel™ System (the “Worden Patent”) expires no earlier than February
2019. The Company’s U.S. Knighton Patent (which is the subject of license
agreements between the Company and Medtronic, Inc., DePuy Spine, Inc., Biomet
Biologics, Inc., COBE Cardiovascular, Inc., and Harvest Technologies
Corporation, among others) expires in November 2009. The Company is pursuing
a
strategy to obtain FDA clearance and CMS reimbursement, but there can be no
assurance that the Company will be able to establish such a significantly
increased share of the wound care market prior to the expiration of the U.S.
Knighton Patent in 2009, after which the Company may be more vulnerable to
competitive factors because third parties will not then need a license from
the
Company to perform the methods claimed in the Knighton Patent.
The
AutoloGel™ Components are Subject to Governmental
Regulation
The
Company’s success is also impacted by factors outside of the Company’s control.
The Company’s current therapies may be subject to extensive regulation by
numerous governmental authorities in the United States, both federal and state,
and in foreign countries by various regulatory agencies.
Specifically,
the Company’s devices are subject to regulation by the FDA and state regulatory
agencies. The FDA regulates drugs, medical devices and biologics that move
in
interstate commerce and requires that such products receive pre-marketing
approval based on evidence of safety and efficacy. The regulations of government
health ministries in foreign countries are analogous to those of the FDA in
both
application and scope. In addition, any change in current regulatory
interpretations by, or positions of, state regulatory officials where the
AutoloGel™ process is practiced could materially and adversely affect the
Company’s ability to sell products in those states.
The
FDA
could require the Company to stop selling the components used to prepare
AutoloGel™ until it obtains clearance or approval of a specific wound healing
claim. While the Company believes that all of said components are legally
marketed, the FDA could take the position that the Company cannot market the
AutoloGel™ Component Kit or Process Centrifuge for wound healing until the
Company has a specific approval or clearance to do so from the FDA.
Further,
as the Company expands and offers additional products in the United States
and
in foreign countries, approval from the FDA and comparable foreign regulatory
authorities prior to introduction of any such products into the market may
be
required. The Company has no assurance that it will be able to obtain all
necessary approvals from the FDA or comparable regulatory authorities in foreign
countries for these products. Failure to obtain the required approvals would
have a material adverse impact on the Company’s business and financial
condition.
11
Compliance
with FDA and other governmental requirements imposes significant costs and
expenses. Further, the Company’s failure to comply with these requirements could
result in sanctions, limitations on promotional or other business activities,
or
other adverse effects on the Company’s business. Further, recent efforts to
control healthcare costs could negatively effect demand for the Company’s
products and services.
The
Company Could Be Adversely Affected if Customers Cannot Obtain
Reimbursement
The
AutoloGel™ Component Kit and Process Centrifuge are marketed to healthcare
providers. Some of these providers, in turn, seek reimbursement from third-party
payers such as Medicare, Medicaid, and other private insurers. Many foreign
countries also have comprehensive government managed healthcare programs that
provide reimbursement for healthcare products. Under such healthcare systems,
reimbursement is often a determining factor in predicting a product’s success,
with some physicians and patients strongly favoring only those products for
which they will be reimbursed.
In
order
to achieve a viable reimbursement pathway for the AutoloGel™ process components,
the Company has conducted a prospective, randomized, blinded, controlled,
multi-site clinical trial as approved by the FDA to provide the necessary data
as required by CMS, formerly known as the Healthcare Financing Agency. In
addition, the 2003 CMS non-coverage decision for “Autologous Blood-Derived
Products for the Treatment of Chronic Wounds”, which builds on the 1992 HCFA
ruling may have to be dismissed or a carve-out would need to be created in
order
to make national coverage by Medicare possible. The Company cannot assure that
its efforts in this area will be successful and therefore, a significant
obstacle to broad third-party reimbursement may remain. Further, even if the
Non-Coverage Decision is reversed, the Company cannot guarantee that third-party
payers will elect to reimburse treatments using the Company’s products or
processes or, if such reimbursement is approved, that the level of reimbursement
granted will be sufficient to cover the cost of the product or process to the
physician or to the patient.
Healthcare
providers’ inability to obtain third-party reimbursement for the treatment could
have an adverse effect on the Company’s success.
Royalty
Revenues Are Unpredictable
While
the
Company currently has several primary licensing agreements that are expected
to
generate on-going royalty revenues, the Company cannot currently reasonably
predict the magnitude of those revenues. Because Cytomedix’s licensing
activities are recent, it is premature to predict the resulting royalty streams
from these licensing agreements. Furthermore, royalty streams from these
agreements are entirely dependent on the sales of its licensees and are
therefore outside the control of Cytomedix. Past levels of royalty revenues
from
these agreements are not necessarily an indication of future
activity.
The
Success of the AutoloGel™ System Is Dependent on Acceptance by the Medical
Community
The
commercial success of the Company’s products and processes will depend upon the
medical community and patients accepting the therapies as safe and effective.
If
the medical community and patients do not ultimately accept the therapies as
safe and effective, the Company’s ability to sell the products and processes
will be materially and adversely affected. While acceptance by the medical
community may be fostered by broad evaluation via peer-reviewed literature,
the
Company may not have the resources to facilitate sufficient
publication.
The
Company May Be Unable to Attract and Retain Key
Personnel
The
future success of the Company depends on the ability to attract, retain and
motivate highly skilled management, including sales representatives. The Company
has retained a team of highly qualified officers and consultants, but the
Company cannot provide assurance that it will be able to successfully integrate
these officers and consultants into its operations, retain all of them, or
be
successful in recruiting additional personnel as needed. The Company’s inability
to do so will materially and adversely affect the business prospects, operating
results and financial condition.
The
Company’s ability to maintain and provide additional services to its existing
customers depends upon its ability to hire and retain business development
and
scientific and technical personnel with the skills necessary to keep pace with
continuing changes in cellular therapy technologies. Competition for such
personnel is intense; the Company competes with pharmaceutical, biotechnology
and healthcare companies. The Company’s inability to hire additional qualified
personnel may lead to higher recruiting, relocation and compensation costs
for
such personnel. These increased costs may reduce the Company’s profit margins or
make hiring new personnel impractical.
12
Legislative
and Administrative Action May Have an Adverse Effect on the
Company
Political,
economic and regulatory influences are subjecting the health care industry
in
the United States to fundamental change. The Company cannot predict what other
legislation relating to its business or to the health care industry may be
enacted, including legislation relating to third-party reimbursement, or what
effect such legislation may have on the Company’s business, prospects, operating
results and financial condition. The Company expects federal and state
legislators to continue to review and assess alternative health care delivery
and payment systems and possibly adopt legislation affecting fundamental changes
in the health care delivery system. Such laws may contain provisions that may
change the operating environment for its targeted customers including hospitals
and managed care organizations.
Health
care industry participants may react to such legislation by curtailing or
deferring expenditures and initiatives, including those relating to the
Company’s products. Future legislation could result in modifications to the
existing public and private health care insurance systems that would have a
material adverse effect on the reimbursement policies discussed
above.
The
Company Could Be Affected by Malpractice Claims
Providing
medical care entails an inherent risk of professional malpractice and other
claims. The Company does not control or direct the practice of medicine by
physicians or health care providers who use the products and does not assume
responsibility for compliance with regulatory and other requirements directly
applicable to physicians. The Company cannot guarantee that claims, suits or
complaints relating to the use of the AutoloGel™ components and treatment
administered by physicians will not be asserted against the Company in the
future.
The
production, marketing and sale, and use of the AutoloGel™ Component Kit and
Process Centrifuge entail risks that product liability claims will be asserted
against the Company. These risks cannot be eliminated, and the Company could
be
held liable for any damages that result from adverse reactions or infectious
disease transmission. Such liability could materially and adversely affect
the
Company’s business, prospects, operating results and financial
condition.
The
Company currently maintains professional and product liability insurance
coverage, but the Company cannot give assurance that the coverage limits of
this
insurance would be adequate to protect against all potential claims. The Company
cannot guarantee that it will be able to obtain or maintain professional and
product liability insurance in the future on acceptable terms or with adequate
coverage against potential liabilities.
AutoloGel™
Has
Existing Competition in the Marketplace
In
the
market for biotechnology products, the Company faces competition from
pharmaceutical companies, biopharmaceutical companies and other competitors.
Other companies have developed or are developing products that may be in direct
competition with the AutoloGel™ process. Biotechnology development projects are
characterized by intense competition. Thus, the Company cannot assure any
investor that it will be the first to the market with any newly developed
products or that it will successfully be able to market these products. If
the
Company is not able to participate and compete in the cellular therapy market,
the Company’s financial condition will be materially and adversely affected. The
Company cannot guarantee that it will be able to compete effectively against
such companies in the future. Many of these companies have substantially greater
capital resources, larger marketing staffs and more experience in
commercializing products. Recently developed technologies, or technologies
that
may be developed in the future, may be the basis for developments that will
compete with the Company’s products.
Risks
Related to the Company’s Common Stock
The
average daily trading volume in Cytomedix Common stock is relatively low. As
long as this condition continues, it could be difficult or impossible to sell
a
significant number of shares of Common stock at any particular time at the
market prices prevailing immediately before such shares are offered. In
addition, sales of substantial amounts of Common stock could lower the
prevailing market price of the Company’s Common stock. This would limit or
perhaps prevent the Company’s ability to raise capital through the sale of
securities. Additionally, the Company has significant numbers of outstanding
warrants and options that, if exercised and sold, could put additional downward
pressure on the Common stock price.
The
Company is Subject to Anti-Takeover Provisions and Laws.
Provisions
in Cytomedix’s Restated Certificate of Incorporation and Restated Bylaws and
applicable provisions of the Delaware General Corporation Law may make it more
difficult for a third party to acquire control of the Company without the
approval of the board of directors. These provisions may make it more difficult
or expensive for a third party to acquire a majority of the Company’s
outstanding voting Common stock or delay, prevent or deter a merger,
acquisition, tender offer or proxy contest, which may negatively affect the
Common stock price.
13
Purchases
of the Company’s Common Stock Are Subject to the SEC's Penny Stock
Rules.
Generally,
any non-NASDAQ equity security that has a market price of less than $5.00 per
share is defined as a Penny Stock. Penny Stocks are subject to special rules
and
regulations under the Securities Exchange Act of 1934. These rules require
additional disclosure by broker-dealers in connection with any trades involving
Penny Stock. Cytomedix Common stock is currently defined as a Penny Stock,
and
the Company is uncertain if the market price of its common stock will ever
be
above $5.00 per share. As a result of its characterization as a Penny Stock,
the
market liquidity for the Company’s Common stock may be adversely affected by the
Penny Stock rules and regulations. This could restrict an investor's ability
to
sell the common stock in a secondary market. The rules governing Penny Stock
require the delivery, prior to any Penny Stock transaction, of a disclosure
schedule explaining the Penny Stock market and the risks associated therewith,
and impose various sales practice requirements on broker-dealers who sell Penny
Stocks to persons other than established customers and accredited investors
(generally defined as an investor with a net worth in excess of $1,000,000
or
annual income exceeding $200,000, $300,000 together with a spouse). For these
types of transactions, the broker-dealer must make a special suitability
determination for the purchaser and have received the purchaser's written
consent to the transaction prior to sale. The broker-dealer also must disclose
the commissions payable to the broker-dealer, current bid and offer quotations
for the Penny Stock and, if the broker-dealer is the sole market-maker, the
broker-dealer must disclose this fact and the broker-dealer's presumed control
over the market. Such information must be provided to the customer orally or
in
writing prior to effecting the transaction and in writing before or with the
customer confirmation. Monthly statements must be sent disclosing recent price
information for the Penny Stock held in the account and information on the
limited market in Penny Stock. The additional burdens imposed on broker-dealers
may discourage them from effecting transactions in the Company’s Common stock,
which could severely limit the liquidity of the Common stock and the ability
of
shareholders to sell the Common stock in the secondary market.
ITEM
1B. UNRESOLVED STAFF COMMENTS
None.
ITEM
2. PROPERTIES
The
Company does not own any real property and does not intend to invest in any
real
property.
The
Company’s principal executive offices are located in Rockville, Maryland.
Cytomedix occupies facilities consisting of 3,100 square feet under an operating
lease expiring July 31, 2008, subject to an early termination option available
to Cytomedix. See Note 16 to the Financial Statements.
ITEM
3. LEGAL PROCEEDINGS
At
present, the Company is not engaged in or the subject of any legal
proceedings.
ITEM
4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
The
Company held its annual meeting of shareholders on November 3, 2006, at the
Company’s offices in Rockville, Maryland. At the meeting, the shareholders
re-elected James S. Benson, David P. Crews, Arun K. Deva, David F. Drohan,
Mark
T. McLoughlin, and Kshitij Mohan as Directors to hold office until the next
annual meeting of shareholders and until their successors are duly elected.
A
summary of votes cast follows below:
14
NOMINEE
|
VOTES
FOR
|
VOTES
WITHHELD
|
|
ABSTENTIONS*
|
||||||
James
S. Benson
|
21,816,240
|
196,940
|
—
|
|||||||
David
P. Crews
|
21,815,308
|
197,872
|
—
|
|||||||
Arun
K. Deva
|
21,810,640
|
202,540
|
—
|
|||||||
David
F. Drohan
|
21,815,308
|
197,872
|
—
|
|||||||
Mark
T. McLoughlin
|
21,816,240
|
196,940
|
—
|
|||||||
Dr.
Kshitj Mohan
|
21,794,443
|
218,737
|
—
|
* Pursuant
to the terms of the Proxy Statement, proxies received were voted, unless
authority was withheld, in favor of the election of the six
nominees.
Shareholders
also voted to ratify the appointment of L J Soldinger Associates, LLC as the
Company’s independent registered accountant for the fiscal year ending December
31, 2006 with 21,969,431 votes for, 24,235 votes against, and 19,514
abstentions.
Shareholders
also voted to ratify an amendment to the Long-Term Incentive Plan making Awards
available representing up to 5,000,000 shares of Common stock with 6,056,251
votes for, 2,401,658 votes against, and 86,838 abstentions.
Further
information regarding the meeting and the proposals submitted to a vote of
the
shareholders may be found in the Company’s definitive proxy statement filed with
the Securities and Exchange Commission on September 22, 2006.
15
PART
II
ITEM
5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER
PURCHASES OF EQUITY SECURITES
Since
June 2005, the Company’s Common stock has been listed on the American Stock
Exchange under the symbol GTF. Prior to this listing the Company’s Common stock
was traded in the Over-the-Counter (“OTC”) market and quoted on the OTC bulletin
board under the symbol CYME. Set forth below are the high and low closing sale
prices for the Common stock for each quarter since the quarter beginning January
1, 2004, as reported by NASDAQ and AMEX as appropriate. The prices prior to
June
30, 2005 are over-the-counter market quotations and reflect inter-dealer prices,
without retail mark-up, mark-down or commission and may not represent actual
transactions.
Quarter
ended
|
High
|
Low
|
|||||
December
31, 2006
|
$
|
2.76
|
$
|
0.91
|
|||
September
30, 2006
|
$
|
3.34
|
$
|
2.60
|
|||
June
30, 2006
|
$
|
3.20
|
$
|
2.25
|
|||
March
31, 2006
|
$
|
2.90
|
$
|
2.23
|
|||
December
31, 2005
|
$
|
3.36
|
$
|
2.01
|
|||
September
30, 2005
|
$
|
6.85
|
$
|
1.68
|
|||
June
30, 2005
|
$
|
5.07
|
$
|
3.12
|
|||
March
31, 2005
|
$
|
3.50
|
$
|
2.35
|
There
were approximately 658 shareholders of record of Common stock as of February
15,
2007.
Cytomedix
did not pay dividends to holders of Common stock in 2006 or 2005. The Company
is
prohibited from declaring dividends on Common stock if any dividends are due
on
shares of Series A, B, or C Convertible Preferred stock. If there are no unpaid
dividends on shares of Series A, B, or C Convertible Preferred stock, any
decision to pay cash dividends on Common stock will depend on the Company’s
ability to generate earnings, need for capital, and overall financial condition,
and other factors the Board deems relevant. Cytomedix does not anticipate paying
cash dividends on Common stock in the foreseeable future, but instead will
retain any earnings for reinvestment in the business.
RECENT
SALES OF UNREGISTERED SECURITIES
The
Company issued 1,062,500 shares of Common stock during the fourth quarter of
2006. The following table lists the sources of and the proceeds from those
issuances:
Source
|
#
of Shares
|
Total
Exercise
Price
|
||||||
Exercise
of unit offering warrants
|
287,500
|
$
|
431,250
|
|||||
Exercise
of other warrants (1)
|
775,000
|
$
|
775,000
|
|||||
Totals
|
1,062,500
|
$
|
1,206,250
|
(1) |
These
warrants reflect consultant warrants held by one party. Upon exercise,
the
Company accepted $75,000 in cash and a Negotiable Term Promissory
Note and
related Security Agreement (the “Note”). The Note, which was amended in
February 2007, provides for the remaining exercise proceeds to be
delivered to the Company in installment payments ending on April
30, 2007.
The Note bears interest on the outstanding balance at 6% per year.
As of
February 15, 2007, the maker of the Note was current in making all
required principal and interest payments and the principal balance
remaining was $426,250.
|
The
Company has used the cash proceeds from these issuances for general corporate
purposes. All shares were issued in private offerings exempt from registration
pursuant to Section 4(2) of the Securities Act.
See
Note
11 to the Financial Statements for further information on the Company’s capital
structure.
16
PERFORMANCE
GRAPH
Below
is
a line graph comparing total cumulative return on an investment of $100 invested
on January 27, 2003 in: (i) the Company’s Common Stock, (ii) an industry index,
namely the AMEX Biotechnology Index, and (iii) a broad market index, namely
the
Russell Microcap Index. All values assume reinvestment of the full amount of
all
dividends, where applicable, and are calculated as of the last trading day
of
each fiscal year.
Comparison
of 47 Month Cumulative Total ReturnAmong Cytomedix, Inc., Amex Biotechnology
Index,
and
Russell Microcap Index
ITEM
6. SELECTED FINANCIAL DATA
2006
|
2005
|
2004
|
2003
|
2002*
|
||||||||||||
Revenues
|
$
|
1,948,155
|
$
|
1,514,425
|
$
|
1,145,591
|
$
|
1,086,923
|
$
|
666,183
|
||||||
Loss
from operations
|
$
|
(4,159,264
|
)
|
$
|
(7,446,134
|
)
|
$
|
(8,188,360
|
)
|
$
|
(4,131,705
|
)
|
$
|
(2,018,465
|
)
|
|
Net
loss
|
$
|
(2,262,956
|
)
|
$
|
(6,503,485
|
)
|
$
|
(8,139,326
|
)
|
$
|
(4,124,889
|
)
|
$
|
(2,016,961
|
)
|
|
Basic
and diluted net loss per common
share
|
$
|
(0.08
|
)
|
$
|
(0.27
|
)
|
$
|
(0.62
|
)
|
$
|
(0.37
|
)
|
$
|
(0.22
|
)
|
|
Total
assets
|
$
|
10,233,774
|
$
|
7,877,917
|
$
|
8,186,472
|
$
|
5,740,920
|
$
|
6,153,709
|
||||||
Long-term
obligations and redeemable preferred
stock
|
$
|
376,520
|
$
|
263,787
|
$
|
356,630
|
$
|
438,081
|
$
|
519,507
|
||||||
Cash
dividends declared per common share
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
* On
July
1, 2002, the Company emerged from bankruptcy under a plan of reorganization.
The
2002 periodic information included in the table above reflects results of the
six months ended December 31, 2002.
ITEM
7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF
OPERATIONS
Management's
Discussion and Analysis and other parts of this report contain forward-looking
statements that involve risks and uncertainties. All forward-looking statements
included in this report are based on information available to the Company on
the
date hereof, and the Company assumes no obligation to update any such
forward-looking statements. The following should be read in conjunction with
the
audited financial statements and the notes thereto included elsewhere
herein.
17
In
2006,
Cytomedix submitted its 510(k) to, received a denial from, and prepared its
appeal to the FDA for specific indications for its AutoloGelTM
System.
The Company realized a 29% increase in revenues driven by increased licensing
royalties. The Company also realized a 65% reduction to net loss driven by
a
major patent litigation settlement agreement as well as reduced equity-based
compensation and clinical trial related expenses and the increased royalty
revenues noted above. Following is a discussion of Cytomedix’s Results of
Operations for the years ended December 31, 2006, 2005, and 2004. This
discussion should be read together with the audited financial statements and
notes thereto contained in Item 8 of this document.
COMPARATIVE
RESULTS OF OPERATIONS FOR THE YEARS ENDED DECEMBER 31, 2006 AND
2005
Revenues
Revenues
rose $434,000 (29%) to $1,948,000 comparing the year ended December 31, 2006,
to
the same period last year. Revenues are normally generated from two sources:
the
sale of disposable kits and reagents and royalties received from licensing
activities. In the third quarter of 2006, the Company also recognized $117,000
in revenue related to comprehensive wound services provided for a government
agency under a limited term contract. This service revenue is not expected
to
continue. The
increase was attributable to increased royalties of $496,000 and increased
sales
of $117,000 related to the services mentioned above, partially offset by a
$179,000 decrease in product sales. Increases in royalties were due to six
new
license agreements entered into during 2005. Product sales decreased primarily
due to decreased sales to nursing homes, government agencies, and Medicaid
customers.
Gross
Profit
Gross
profit rose $300,000 (47%) to $934,000 comparing the year ended December 31,
2006, to the same period last year. For the same periods, gross margins rose
to
48% from 42%.
The
increase in gross profits is primarily attributable to the licensing agreements
entered into after March 31, 2005 which carry a greater gross margin than
previously existing licensing agreements.
Royalties
from the licensing agreements with DePuy Spine, Inc., inclusive of the
amortization of deferred revenue associated with the initial deposit of
$750,000, generates a gross margin of approximately 20%. The Company expects
gross margins generated from all other licensing agreements to be in the range
of 50-70%.
Operating
Expenses
Operating
expenses fell $2,986,000 (37%) to $5,093,000 comparing the year ended December
31, 2006, to the same period last year. The Company relies heavily on the use
of
equity-based compensation to various employees, consultants and other parties
that provide services to the Company. Due to the magnitude of this non-cash
expense, the exhibits below highlight the impact of this equity-based
compensation on the Company’s operating expenses. These exhibits present the
Company’s operating expenses in accordance with generally accepted accounting
principles (“GAAP”), the amount of equity-based compensation expense included in
the respective line items, and then the operating expenses without the
equity-based compensation, which is not in accordance with GAAP (“NON-GAAP”).
The following exhibit is presented as an additional tool to evaluate the
Company’s operating expenditures between years:
18
Operating
Expense Information Not in Conformity with Generally Accepted Accounting
Principles
Year
Ended December 31,
2006
|
Year
Ended December 31,
2005
|
||||||||||||||||||
GAAP
AS
REPORTED
|
NET
EQUITY
BASED
COMPENSATION
|
NON-GAAP
OPERATING
EXPENSES
WITHOUT
EQUITY
BASED
COMPENSATION
|
GAAP
AS
REPORTED
|
NET
EQUITY
BASED
COMPENSATION
|
NON-GAAP
OPERATING
EXPENSES
WITHOUT
EQUITY
BASED
COMPENSATION
|
||||||||||||||
Salaries
and wages
|
$
|
2,190,737
|
$
|
(692,250
|
)
|
$
|
1,498,487
|
$
|
2,970,036
|
$
|
(1,352,448
|
)
|
$
|
1,617,588
|
|||||
Consulting
expenses
|
180,157
|
(8,344
|
)
|
171,813
|
145,739
|
(29,444
|
)
|
116,295
|
|||||||||||
Consulting
expenses - related party
|
35,000
|
—
|
35,000
|
185,764
|
(77,764
|
)
|
108,000
|
||||||||||||
Professional
fees
|
763,912
|
—
|
763,912
|
1,018,779
|
—
|
1,018,779
|
|||||||||||||
Royalty
expenses - related party
|
75,000
|
—
|
75,000
|
75,000
|
—
|
75,000
|
|||||||||||||
Clinical
trial related expenses
|
62,052
|
—
|
62,052
|
1,588,916
|
—
|
1,588,916
|
|||||||||||||
General
and administrative expenses
|
1,785,976
|
(502,330
|
)
|
1,283,646
|
2,095,001
|
(556,999
|
)
|
1,538,002
|
|||||||||||
Total
operating expenses
|
$
|
5,092,834
|
$
|
(1,202,924
|
)
|
$
|
3,889,910
|
$
|
8,079,235
|
$
|
(2,016,655
|
)
|
$
|
6,062,580
|
Salaries
and Wages
Salaries
and wages fell $779,000 (26%) to $2,191,000 comparing the year ended December
31, 2006, to the same period last year. The decrease was primarily due to lower
non-cash equity-based compensation ($660,000) and fewer employees.
Consulting
and Related Party Consulting Expenses
Consulting
and related party consulting expenses fell $116,000 (35%) to $215,000 comparing
the year ended December 31, 2006, to the same period last year. The decrease
was
primarily due to lower non-cash equity-based compensation ($99,000) and the
overall reduction in use of outside consultants.
Professional
Fees
Professional
fees fell $255,000 (25%) to $764,000 comparing the year ended December 31,
2006,
to the same period last year. Professional fees consist primarily of legal
and
accounting services.
The
decrease was primarily due to decreases in patent litigation related
expenditures ($315,000) due to the successful completion of several patent
infringement actions in 2005, decreases in fees to securities and general
counsel attorneys ($90,000) due primarily to reduced current period activity
related to the Company’s listing on the American Stock Exchange, and decreases
in accounting fees ($55,000), partially offset by increases in audit fees
($75,000) driven by compliance with Section 404 of the Sarbanes-Oxley Act and
increased attorneys fees ($175,000) related to the appeal of the FDA’s decision
regarding the Company’s 510(k) Premarket Notification for AutoloGelTM
System.
Clinical
Trial Related Expenses
Clinical
trial related expenses fell $1,527,000 (96%) to $62,000 comparing the year
ended
December 31, 2006, to the same period last year. The Company completed the
active phase of the trial in 2005 and in the first two quarters of 2006 incurred
only limited expenses associated with the close out of the trial.
General
and Administrative Expenses
General
and administrative expenses fell $309,000 (15%) to $1,786,000 comparing the
year
ended December 31, 2006, to the same period last year. The decrease was due
primarily to decreases in travel related expenditures ($163,000), AMEX filing
fees ($52,000), investor services ($43,000), and depreciation of fixed assets
($35,000), partially offset by increases in marketing related activities
($30,000).
Other
Income/Expenses
Other
income rose $954,000 (101%) to $1,896,000 comparing the year ended December
31,
2006, to the same period last year.
The
increase was primarily due to increased interest income ($143,000) as a result
of higher interest rates and larger cash balances, increased patent settlement
income ($600,000, net), and a one time charge ($228,000) in 2005 recorded for
the issuance of 65,000 shares of the Company’s Common stock in return for a full
settlement and release of all claims from a lawsuit brought against the Company
relating to its emergence from bankruptcy.
19
COMPARATIVE
RESULTS OF OPERATIONS FOR THE YEARS ENDED DECEMBER 31, 2005 AND
2004
Revenues
Revenues
rose $369,000 (32%) to $1,514,000 comparing the year ended December 31, 2005
to
the same period in 2004. Revenues are normally generated from two sources:
the
sale of disposable kits and reagents and royalties received from licensing
activities.
The
increase in revenue is attributable to increased royalties of $547,000 from
five
new licensing agreements entered into during 2005, primarily those with
Medtronic, Inc. and Harvest Technologies, Inc., entered into during the second
quarter. This increase was partially offset by a $178,000 decrease in AutoloGel™
kit sales. AutoloGel™ kit sales decreased due to reduced sales to two large
nursing home customers and difficulty qualifying patients for commercial
insurance reimbursement, partially offset by an increase in sales to the
non-reimbursement sensitive market.
Gross
Profit
Gross
profit rose $199,000 (46%) to $633,000 comparing the year ended December 31,
2005 to the same period in 2004. For the same periods, gross margins rose to
42%
from 38%.
The
increase in gross profit is primarily attributable to the Medtronic and Harvest
licensing agreements which carry a greater gross margin than previously existing
licensing agreements. This increase in gross profit was partially offset by
a
decrease in gross profit from AutoloGel™ kit sales. This decrease was primarily
attributable to increased costs for educational treatments used in an effort
to
penetrate more profitable segments of the market, as well as the write-off
of
obsolete inventory.
The
DePuy
royalties, inclusive of the amortization of deferred revenue associated with
the
initial deposit of $750,000, generates a gross margin of approximately 20%.
The
Company expects gross margins generated from all other licensing agreements
to
be in the range of 50-70%.
Operating
Expenses
Operating
expenses fell $543,000 (6%) to $8,079,000 comparing the year ended December
31,
2005 to the same period in 2004. The Company relies heavily on the use of
equity-based compensation to various employees, consultants and other parties
that provide services to the Company. Due to the magnitude of this non-cash
expense, the following exhibit highlights the impact of this equity-based
compensation on the Company’s operating expenses. The exhibit below presents the
Company’s operating expenses in accordance with generally accepted accounting
principles (“GAAP”) and presents the amount of equity-based compensation expense
included in the respective line items and then reflects the operating expenses
without the equity-based compensation, which is not in accordance with GAAP
(“NON-GAAP”). The following exhibit is presented to provide an additional tool
to evaluate the Company’s operating expenditures between years:
Operating
Expense Information Not In Conformity With Generally Accepted Accounting
Principles
Year
Ended December 31, 2005
|
Year
Ended December 31, 2004
|
||||||||||||||||||
ACCOUNT
|
GAAP AS
REPORTED |
NET EQUITY
BASED |
|
NON-GAAP OPERATING |
GAAP AS
REPORTED |
NET EQUITY
BASED |
NON-GAAP OPERATINGEXPENSES
WITHOUT
|
||||||||||||
Salaries
and wages
|
$
|
2,970,036
|
$
|
(1,352,448
|
)
|
$
|
1,617,588
|
$
|
1,769,170
|
$
|
(578,492
|
)
|
$
|
1,190,678
|
|||||
Consulting
expenses
|
145,739
|
(29,444
|
)
|
116,295
|
1,023,255
|
(837,975
|
)
|
185,280
|
|||||||||||
Consulting
expenses - related party
|
185,764
|
(77,764
|
)
|
108,000
|
789,189
|
(529,085
|
)
|
260,104
|
|||||||||||
Professional
fees
|
1,018,779
|
—
|
1,018,779
|
867,928
|
(10,250
|
)
|
857,678
|
||||||||||||
Royalty
expenses - related party
|
75,000
|
—
|
75,000
|
75,000
|
—
|
75,000
|
|||||||||||||
Clinical
trial related expenses
|
1,588,916
|
—
|
1,588,916
|
1,385,120
|
—
|
1,385,120
|
|||||||||||||
General
and administrative expenses
|
2,095,001
|
(556,999
|
)
|
1,538,002
|
2,712,462
|
(1,141,454
|
)
|
1,571,008
|
|||||||||||
Total
operating expenses
|
$
|
8,079,235
|
$
|
(2,016,655
|
)
|
$
|
6,062,580
|
$
|
8,622,124
|
$
|
(3,097,256
|
)
|
$
|
5,524,868
|
20
Salaries
and Wages
Salaries
and wages rose $1,201,000 (68%) to $2,970,000 comparing the year ended December
31, 2005 to the same period in 2004.
The
increase was primarily due to increased non-cash equity-based compensation,
primarily a result of $798,000 related to the revaluation and expense associated
with the change in terms to existing options, pursuant to the separation
agreement with the Company’s former CFO dated July 15, 2005, and increased bonus
accrual ($216,000). The remainder of the increase is due to additional
employees, and severance costs for the former CFO.
Consulting
and Related Party Consulting Expenses
Consulting
and related party consulting expenses fell $1,481,000 (82%) to $332,000
comparing the year ended December 31, 2005 to the same period in
2004.
The
decrease was primarily due to a $1,260,000 decrease in non-cash equity-based
compensation. The remaining change was due to decreases in other compensation
and expenses relating to these consultants. During 2004, the Company relied
upon
the issuance of stock options and warrants to attract and retain senior level
consultants to assist in all phases of its operations. This included strategic
planning, financing related support, governmental support and lobbying, and
on-going managerial support. Most of these activities were significantly
curtailed or eliminated in 2005.
Professional
Fees
Professional
fees rose $151,000 (17%) to $1,019,000 comparing the year ended December 31,
2005 to the same period in 2004. Professional fees consist primarily of legal
and accounting services.
The
increase was primarily due to increased patent litigation related expenditures
and auditing/accounting fees, partially offset by decreases in fees to
securities and general counsel attorneys.
Clinical
Trial Related Expenses
Clinical
trial related expenses rose $204,000 (15%) to $1,589,000 comparing the year
ended December 31, 2005 to the same period in 2004. During 2005, the trials
were
in the active treatment phase.
The
increase was primarily due to greater expenditures ($268,000) for the various
clinical sites participating in the trials and higher fees from its contract
research organization and for consultants, partially offset by reduced costs
for
equipment and supplies.
General
and Administrative Expenses
General
and administrative expenses fell $617,000 (23%) to $2,095,000 comparing the
year
ended December 31, 2005 to the same period in 2004.
The
decrease was primarily due to a decrease in non-cash equity-based compensation
for the board of directors and outside service providers
($619,000).
Other
Income/Expenses
Other
income rose $894,000 (1,822%) to $943,000 comparing the year ended December
31,
2005 to the same period in 2004.
The
increase was primarily attributable to patent litigation settlements (net of
related costs) in the amount of $1,047,000, with a lesser impact from higher
interest income. These increases were partially offset by expenses ($227,500)
recorded for the issuance of 65,000 shares of the Company’s Common stock in
return for a full settlement and release of all claims from a lawsuit brought
against the Company in its emergence from bankruptcy.
21
MODIFIED
EBITDA INFORMATION NOT IN CONFORMITY WITH GENERALLY ACCEPTED ACCOUNTING
PRINCIPLES
Throughout
this report, the Company has presented income statement items in conformity
with
GAAP, except where otherwise noted. Given the magnitude of the non-cash
expenses, the Company utilizes a modified EBITDA (earnings before income taxes,
depreciation and amortization and other non-cash items) to evaluate and monitor
the results of operations. Although EBITDA is a NON-GAAP financial measure,
the
Company believes that this information will allow for an additional
clarification of the Company’s performance and provides the readers of the
Company’s financial statements an additional tool to evaluate the comparative
performance of the Company. Following, is a reconciliation of the comparative
net (loss) to Common shareholders to modified EBITDA utilized by the
Company:
Year
Ended
December
31,
|
||||||||||
2006
|
2005
|
|
2004
|
|
||||||
Net
loss to common stockholders,
|
||||||||||
as
stated (GAAP)
|
$
|
(2,299,317
|
)
|
$
|
(6,588,387
|
)
|
$
|
(11,259,187
|
)
|
|
Adjustments
to reconcile net loss
|
||||||||||
to
common stockholders to EBITDA:
|
||||||||||
Preferred
dividends
|
36,361
|
84,902
|
319,861
|
|||||||
Series
C Preferred stock dividend
|
||||||||||
attributable
to below market
|
||||||||||
beneficial
conversion features
|
—
|
—
|
2,800,000
|
|||||||
Depreciation
and amortization
|
197,194
|
224,274
|
218,954
|
|||||||
Stock-based
compensation
|
1,202,924
|
2,016,655
|
3,097,256
|
|||||||
Other
expense (1)
|
—
|
262,500
|
—
|
|||||||
MODIFIED
EBITDA – NON-GAAP
|
$
|
(862,838
|
)
|
$
|
(4,000,056
|
)
|
$
|
(4,823,116
|
)
|
(1) |
Consists
of 65,000 shares of the Company’s Common stock (market value $227,500)
issued in return for a full settlement and release of all claims
from a
lawsuit brought against the Company in its emergence from bankruptcy
and
8,673 shares of the Company’s Common stock (market value $35,000) issued
for executive search fees.
|
CONTRACTUAL
OBLIGATIONS
The
Company had the following contractual obligations as of December 31,
2006:
Payments
Due by Period
|
||||||||||||||||
Contractual
Obligations
|
Total
|
Less
than 1 Year
|
1-3
Years
|
|
4-5
Years
|
More
than 5 Years
|
||||||||||
Operating
Leases
|
$
|
103,027
|
$
|
64,658
|
$
|
38,369
|
$
|
—
|
$
|
—
|
||||||
Other
Liabilities (1)
|
329,000
|
144,000
|
185,000
|
—
|
—
|
|||||||||||
Total
|
$
|
432,027
|
$
|
208,658
|
$
|
223,369
|
$
|
—
|
$
|
—
|
___________
(1)
Amounts less than one year are included in the "Accounts
payable and accrued expenses" line of the Balance Sheet.
LIQUIDITY
AND CAPITAL RESOURCES
In
the years ended December 31, 2006, 2005, and 2004, the Company's operating
revenues did not cover the costs of its operations. The cash position of the
Company at December 31, 2006 was $4,662,000. The Company believes that it will
have adequate cash on hand to fund operations for the year ending December
31,
2007. However, additional cash may be required if operating revenues do not
materialize, the cost of operations increases, or if the Company’s efforts to
appeal the FDA’s NSE determination letter prove unsuccessful and a change in
strategy requires significant short-term funding.
22
The
Company has no material commitments for capital expenditures.
Because
the Company was in bankruptcy in 2002, the Company may not be able to obtain
debt financing. All working capital required to implement the Company’s business
plan will be provided by funds obtained through offerings of its equity
securities, and revenues generated by the Company.
PROSPECTS
FOR THE FUTURE
Cytomedix’s
success is directly dependent on the success of AutoloGel™, and the Company
believes that AutoloGel™ has a reasonable chance for success in the marketplace.
First and foremost, the Company believes that, based on the results of the
Company’s clinical trial and other historical data as well as the preliminary
results of a pharmaco-economic study, AutoloGel™ has higher healing rates for
diabetic foot ulcers and is more cost effective than most other wound
treatments. The Company owns the patents on the process for utilizing platelet
gel for wound healing, the basis of its license agreements, through 2009 and
for
the specific formulation of AutoloGel™, which provides several competitive
advantages, through 2019.
However,
Cytomedix is currently facing a regulatory hurdle. Specifically, it is seeking
a
reversal, or acceptable amendment, to the FDA’s NSE determination letter. If the
Company is successful in this effort, then its current strategic plan remains
completely in tact. If efforts are unsuccessful, the Company would likely
implement one or more contingent strategies. These contingent strategies are
currently being evaluated and refined.
Although
it is premature to narrow these strategies, they are currently being considered
independently and in combinations. Each strategy offers its own unique set
of
opportunities and challenges.
Significant
challenges still exist in implementing the Company’s plans; whether FDA
clearance is obtained and the Company pursues its current strategy, or the
Company pursues an alternative strategic plan. Management continues to focus
its
efforts on leveraging the strength of its intellectual property and successes
to
date.
ITEM
7A. QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The
Company does not enter into financial instruments for speculation or trading
purposes. In accordance with the Company’s investment policy, cash is to be
invested in bank and institutional money market funds, or in T-Bills or
short-term T-Notes. At December 31, 2006, the Company’s cash balance of
approximately $4.7 million was maintained primarily in bank and institutional
money market accounts. These accounts are sensitive to changes in the general
level of interest rates. Based on the Company’s cash balances at December 31,
2006, a 100 basis point increase or decrease in interest rates would have an
approximately $47,000 impact on the Company’s annual interest income and net
loss. Actual changes in rates may differ from the hypothetical assumption used
in computing this exposure.
23
ITEM
8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the
Board of Directors and Shareholders
Cytomedix,
Inc.
Rockville,
Maryland
We
have
audited the accompanying balance sheets of Cytomedix, Inc. as of December
31,
2006 and 2005, and the related statements of operations, stockholders' equity,
and cash flows for each of the years in the three-year period ended December
31,
2006. These 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 the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that
we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. 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 financial statements referred to above present fairly, in all
material respects, the financial position of' Cytomedix, Inc. as of December
31,
2006 and 2005 and its results of operations, changes in stockholders' equity
and
its cash flows for each of the years in the three-year period ended December
31,
2006 in conformity with. accounting principles generally accepted in the
United
States of America.
We
have
also audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United Sates), the effectiveness of Cytomedix, Inc. internal
control over financial reporting as of December 31, 2006, based on criteria
established in Internal Control - Integrated Framework issued by the Committee
of Sponsoring Organizations of the Treadway Commission (COSO), and our report
dated February 23, 2007 expressed an unqualified opinion on management's
assessment of internal control over financial reporting and an adverse opinion
on the effectiveness of internal control over financial reporting.
L
J
SOLDINGER ASSOCIATES, LLC
Deer
Park, Illinois, USA
February
23, 2007
24
CYTOMEDIX,
INC.
Balance
Sheets
December
31, 2006 |
December
31, 2005 |
||||||
ASSETS
|
|||||||
Current
assets
|
|||||||
Cash
|
$
|
4,662,199
|
$
|
3,123,927
|
|||
Accounts
and royalties receivable, net
|
548,269
|
430,167
|
|||||
Patent
settlements receivable, current portion
|
437,112
|
15,562
|
|||||
Prepaid
expenses, inventory, and other current assets
|
155,356
|
222,187
|
|||||
Total
current assets
|
5,802,936
|
3,791,843
|
|||||
|
|||||||
Patent
settlements receivable
|
574,072
|
31,962
|
|||||
Property
and equipment, net
|
11,759
|
74,594
|
|||||
Patents,
net
|
1,823,384
|
1,957,895
|
|||||
Goodwill
|
2,021,623
|
2,021,623
|
|||||
Total
assets
|
$
|
10,233,774
|
$
|
7,877,917
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
Current
liabilities
|
|||||||
Accounts
payable and accrued expenses
|
$
|
1,208,077
|
$
|
1,109,860
|
|||
Deferred
revenues, current portion
|
99,900
|
89,900
|
|||||
Dividends
payable on Series A, Series B and Series C preferred stock
|
18,236
|
28,142
|
|||||
Total
current liabilities
|
1,326,213
|
1,227,902
|
|||||
Deferred
revenues
|
191,475
|
263,745
|
|||||
Other
liabilities
|
185,000
|
—
|
|||||
Total
liabilities
|
1,702,688
|
1,491,647
|
|||||
Commitments
and contingencies
|
|||||||
Stockholders'
equity
|
|||||||
Series
A Convertible preferred stock; $.0001 par value, authorized
5,000,000
|
|||||||
shares;
2006 and 2005 issued and outstanding - 365,970 and 347,856
shares,
|
|||||||
respectively,
liquidation preference of $365,970 and $347,856,
respectively
|
37
|
34
|
|||||
Series
B Convertible preferred stock; $.0001 par value, authorized 5,000,000
|
|||||||
shares;
2006 and 2005 issued and outstanding - 83,431 and 84,604
shares,
|
|||||||
respectively,
liquidation preference of $83,431 and $84,604,
respectively
|
8
|
8
|
|||||
Series
C Convertible preferred stock; $.0001 par value, authorized
1,000,000
|
|||||||
shares;
2006 and 2005 issued and outstanding - 0.0 shares
|
—
|
—
|
|||||
Common
stock; $.0001 par value, authorized 65,000,000 shares; 2006 and
2005
|
|||||||
issued
and outstanding - 28,987,670 and 26,158,778 shares,
respectively
|
2,899
|
2,617
|
|||||
Subscriptions
receivable
|
(620,000
|
)
|
—
|
||||
Additional
paid-in capital
|
35,779,380
|
30,954,333
|
|||||
Deferred
compensation
|
—
|
(238,801
|
)
|
||||
Accumulated
deficit
|
(26,631,238
|
)
|
(24,331,921
|
)
|
|||
Total
stockholders' equity
|
8,531,086
|
6,386,270
|
|||||
Total
liabilities and stockholders' equity
|
$
|
10,233,774
|
$
|
7,877,917
|
The
accompanying notes are an integral part of these financial
statements.
25
CYTOMEDIX,
INC.
Statements
of Operations
Year
Ended December
31, |
||||||||||
2006
|
2005
|
2004
|
||||||||
Revenues
|
||||||||||
Sales
|
$
|
204,525
|
$
|
266,876
|
$
|
444,932
|
||||
Royalties
|
1,743,630
|
1,247,549
|
700,659
|
|||||||
Total
revenues
|
1,948,155
|
1,514,425
|
1,145,591
|
|||||||
Cost
of revenues
|
||||||||||
Cost
of sales
|
94,258
|
115,956
|
140,247
|
|||||||
Cost
of royalties
|
920,327
|
765,368
|
571,580
|
|||||||
Total
cost of revenues
|
1,014,585
|
881,324
|
711,827
|
|||||||
Gross
profit
|
933,570
|
633,101
|
433,764
|
|||||||
Operating
expenses
|
||||||||||
Salaries
and wages
|
2,190,737
|
2,970,036
|
1,769,170
|
|||||||
Consulting
expenses
|
180,157
|
145,739
|
1,023,255
|
|||||||
Consulting
expenses - related party
|
35,000
|
185,764
|
789,189
|
|||||||
Professional
fees
|
763,912
|
1,018,779
|
867,928
|
|||||||
Royalty
expenses - related party
|
75,000
|
75,000
|
75,000
|
|||||||
Clinical
trial related expenses
|
62,052
|
1,588,916
|
1,385,120
|
|||||||
General
and administrative expenses
|
1,785,976
|
2,095,001
|
2,712,462
|
|||||||
Total
operating expenses
|
5,092,834
|
8,079,235
|
8,622,124
|
|||||||
Loss
from operations
|
(4,159,264
|
)
|
(7,446,134
|
)
|
(8,188,360
|
)
|
||||
Other
income (expenses)
|
||||||||||
Interest
income (expense), net
|
244,595
|
101,564
|
54,049
|
|||||||
Contract
settlement and other gain (expense)
|
4,406
|
(206,159
|
)
|
(5,015
|
)
|
|||||
Patent
litigation settlements, net
|
1,647,307
|
1,047,244
|
--
|
|||||||
Total
other income (expenses)
|
1,896,308
|
942,649
|
49,034
|
|||||||
Loss
before provision for income taxes
|
(2,262,956
|
)
|
(6,503,485
|
)
|
(8,139,326
|
)
|
||||
Income
tax provision
|
—
|
—
|
—
|
|||||||
Net
loss
|
(2,262,956
|
)
|
(6,503,485
|
)
|
(8,139,326
|
)
|
||||
Preferred
dividend on:
|
||||||||||
Series
A preferred stock
|
29,052
|
43,769
|
122,740
|
|||||||
Series
B preferred stock
|
7,131
|
18,882
|
117,926
|
|||||||
Series
C preferred stock
|
178
|
22,251
|
2,879,195
|
|||||||
Net
loss to common stockholders
|
$
|
(2,299,317
|
)
|
$
|
(6,588,387
|
)
|
$
|
(11,259,187
|
)
|
|
Loss
per common share —
|
||||||||||
Basic
and diluted
|
$
|
(0.08
|
)
|
$
|
(0.27
|
)
|
$
|
(0.62
|
)
|
|
Weighted
average shares outstanding —
|
||||||||||
Basic
and diluted
|
27,470,781
|
24,428,653
|
18,085,769
|
The
accompanying notes are an integral part of these financial
statements.
26
CYTOMEDIX,
INC.
Statements
of Stockholders’ Equity
Common
Stock
|
Series
A Preferred
|
Series
B Preferred
|
Series
C Preferred
|
|
|
|||||||||||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Additional Paid-in |
Deferred Compensation |
Subscriptions Receivable |
Accumulated Deficit |
Total Stockholders |
||||||||||||||||||||||||||||
Balance
at December 31, 2003
|
13,211,453
|
$
|
1,323
|
1,475,471
|
$
|
147
|
1,514,862
|
$
|
151
|
—
|
$
|
—
|
$
|
12,378,878
|
$
|
(1,438,070
|
)
|
$
|
—
|
$
|
(6,484,347
|
)
|
$
|
4,458,082
|
||||||||||||||||
Private
placement of 4,500,000 common shares
with warrants, net of direct commissions
and expensese
|
4,500,000
|
450
|
—
|
—
|
—
|
—
|
—
|
—
|
4,011,175
|
—
|
(2,312,500
|
)
|
—
|
1,699,125
|
||||||||||||||||||||||||||
Private
placement of 280 shares of Series
C Convertible Preferred stock with
warrants, net of direct commissions and
expensese
|
—
|
—
|
—
|
—
|
—
|
—
|
280
|
—
|
2,474,193
|
—
|
—
|
—
|
2,474,193
|
|||||||||||||||||||||||||||
Beneficial
conversion feature recorded as
a preferred stock dividend related to
the Series C stock
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2,800,000
|
—
|
—
|
—
|
2,800,000
|
|||||||||||||||||||||||||||
Receipt
of subscriptions
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1,501,908
|
—
|
1,501,908
|
|||||||||||||||||||||||||||
Interest
earned on subscriptions
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(21,007
|
)
|
—
|
(21,007
|
)
|
|||||||||||||||||||||||||
Common
stock issued upon conversion of Series
A stock
|
5,999
|
1
|
(17,999
|
)
|
(2
|
)
|
—
|
—
|
—
|
—
|
1
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||||||
Common
stock issued upon conversion of Series
B stock
|
88,736
|
9
|
—
|
—
|
(250,212
|
)
|
(25
|
)
|
—
|
—
|
16
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||||||
Common
stock issued upon conversion of Series
C stock
|
1,960,500
|
196
|
—
|
—
|
—
|
—
|
(196
|
)
|
—
|
—
|
—
|
—
|
—
|
196
|
||||||||||||||||||||||||||
Dividend
issued on Series A and Series
B stock
|
—
|
—
|
118,312
|
12
|
122,392
|
12
|
—
|
—
|
240,679
|
—
|
—
|
—
|
240,703
|
|||||||||||||||||||||||||||
Common
stock issued upon exercise of Class
A warrants
|
659,418
|
66
|
—
|
—
|
—
|
—
|
—
|
—
|
659,352
|
—
|
—
|
—
|
659,418
|
|||||||||||||||||||||||||||
Common
stock issued upon cashless exercise of
268,945 Class A warrants
|
93,500
|
9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(9
|
)
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||||||
Common
stock issued upon exercise of Class
B warrants
|
51,898
|
5
|
—
|
—
|
—
|
—
|
—
|
—
|
77,842
|
—
|
—
|
—
|
77,847
|
|||||||||||||||||||||||||||
Common
stock issued upon exercise of Class
C-1 warrants
|
99,500
|
10
|
—
|
—
|
—
|
—
|
—
|
—
|
149,240
|
—
|
—
|
—
|
149,250
|
|||||||||||||||||||||||||||
Common
stock issued upon exercise of Class
C-2 warrants
|
85,000
|
8
|
—
|
—
|
—
|
—
|
—
|
—
|
127,491
|
—
|
—
|
—
|
127,499
|
|||||||||||||||||||||||||||
Common
stock issued upon exercise of employee
stock options
|
55,000
|
5
|
—
|
—
|
—
|
—
|
—
|
—
|
82,495
|
—
|
—
|
—
|
82,500
|
|||||||||||||||||||||||||||
Common
stock issued upon exercise of other
warrants
|
517,455
|
52
|
—
|
—
|
—
|
—
|
—
|
—
|
542,403
|
—
|
—
|
—
|
542,455
|
|||||||||||||||||||||||||||
Common
stock issued upon cashless exercise of
292,397 other warrants
|
160,078
|
16
|
—
|
—
|
—
|
—
|
—
|
—
|
(21
|
)
|
—
|
—
|
—
|
(5
|
)
|
|||||||||||||||||||||||||
Common
stock issued in lieu of cash for commissions
earned in private placement
|
12,300
|
1
|
—
|
—
|
—
|
—
|
—
|
—
|
15,374
|
—
|
—
|
—
|
15,375
|
|||||||||||||||||||||||||||
Record
other legal and accounting expenses associated
with the private placements
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(67,234
|
)
|
—
|
—
|
—
|
(67,234
|
)
|
|||||||||||||||||||||||||
Options
issued and issuable to Dr.
Kshitij Mohan per his employment agreement
dated April 20, 2004
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
740,000
|
(740,000
|
)
|
—
|
—
|
—
|
||||||||||||||||||||||||||
Revaluation
of options issued to BDR, Inc. in
connection with consulting services agreement
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
244,459
|
(244,459
|
)
|
—
|
—
|
—
|
||||||||||||||||||||||||||
Warrants
issued in connection with a general
business consulting contract with
Nadine C. Smith dated April 2003
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
647,300
|
(647,300
|
)
|
—
|
—
|
—
|
||||||||||||||||||||||||||
Options
issued and issuable to Carmen
Group in connection with a services
contract dated October 1, 2003
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
84,440
|
(84,440
|
)
|
—
|
—
|
—
|
||||||||||||||||||||||||||
Warrants
issued to Burnham-Hill in March
2004
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
111,430
|
(111,430
|
)
|
—
|
—
|
—
|
||||||||||||||||||||||||||
Termination
options issued to Mark
E. Cline and Nadine C. Smith
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
319,938
|
(319,938
|
)
|
—
|
—
|
—
|
||||||||||||||||||||||||||
Other
options issued
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
34,646
|
(34,646
|
)
|
—
|
—
|
—
|
||||||||||||||||||||||||||
Amortization
of deferred compensation related
to options and warrants issued for
services rendered by—
|
||||||||||||||||||||||||||||||||||||||||
Related
parties
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
787,550
|
—
|
vv
|
787,550
|
|||||||||||||||||||||||||||
Terminated
parties
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
319,938
|
—
|
—
|
319,938
|
|||||||||||||||||||||||||||
Other
parties
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1,945,007
|
—
|
—
|
1,945,007
|
|||||||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(11,259,187
|
)
|
(11,259,187
|
)
|
|||||||||||||||||||||||||
Balance
at December 31, 2004
|
21,500,837
|
$
|
2,151
|
1,575,784
|
$
|
157
|
1,387,042
|
$
|
138
|
84
|
$
|
—
|
$
|
25,674,088
|
$
|
(567,788
|
)
|
$
|
(831,599
|
)
|
$
|
(17,743,534
|
)
|
$
|
6,533,613
|
The
accompanying notes are an integral part of
these financial statements.
27
CYTOMEDIX,
INC.
Statements
of Stockholders’ Equity
Common
Stock
|
Series
A Preferred
|
Series
B Preferred
|
Series
C Preferred
|
|||||||||||||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Additional Paid-in |
Deferred Compensation |
Subscriptions Receivable |
Accumulated Deficit |
Total Stockholders |
||||||||||||||||||||||||||||
Receipt
of subscriptions
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
832,465
|
—
|
832,465
|
|||||||||||||||||||||||||||
Interest
earned on subscriptions
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(866
|
)
|
—
|
(866
|
)
|
|||||||||||||||||||||||||
Common
stock issued upon conversion of Series
A stock
|
418,219
|
42
|
(1,253,046
|
)
|
(125
|
)
|
—
|
—
|
—
|
—
|
83
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||||||
Common
stock issued upon conversion of Series
B stock
|
435,380
|
44
|
—
|
—
|
(1,308,773
|
)
|
(131
|
)
|
—
|
—
|
87
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||||||
Common
stock issued upon conversion of Series
C stock
|
839,500
|
84
|
—
|
—
|
—
|
—
|
(84
|
)
|
—
|
(84
|
)
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||||||
Dividend
issued on Series A and Series B stock
(paid in Common stock on those preferred
shares converted during the year)
|
27,871
|
3
|
25,118
|
2
|
6,335
|
1
|
—
|
—
|
166,061
|
—
|
—
|
—
|
166,067
|
|||||||||||||||||||||||||||
Common
stock issued upon exercise of Class
A warrants
|
42,500
|
4
|
—
|
—
|
—
|
—
|
—
|
—
|
42,496
|
—
|
—
|
—
|
42,500
|
|||||||||||||||||||||||||||
Common
stock issued upon exercise of Class
B warrants
|
449,233
|
45
|
—
|
—
|
—
|
—
|
—
|
—
|
673,805
|
—
|
—
|
—
|
673,850
|
|||||||||||||||||||||||||||
Common
stock issued upon cashless exercise of 94,171, Class B
warrants
|
57,775
|
6
|
—
|
—
|
—
|
—
|
—
|
—
|
(6
|
)
|
—
|
—
|
—
|
—
|
||||||||||||||||||||||||||
Common
stock issued upon exercise of Class
C-1 warrants
|
462,900
|
46
|
—
|
—
|
—
|
—
|
—
|
—
|
694,304
|
—
|
—
|
—
|
694,350
|
|||||||||||||||||||||||||||
Common
stock issued upon exercise of Class
C-2 warrants
|
478,700
|
48
|
—
|
—
|
—
|
—
|
—
|
—
|
718,002
|
—
|
—
|
—
|
718,050
|
|||||||||||||||||||||||||||
Common
stock issued upon exercise of Long-term
Incentive Plan options
|
252,000
|
25
|
—
|
—
|
—
|
—
|
—
|
—
|
367,475
|
—
|
—
|
—
|
367,500
|
|||||||||||||||||||||||||||
Common
stock issued upon exercise of Unit
Offering warrants
|
250,000
|
25
|
—
|
—
|
—
|
—
|
—
|
—
|
374,975
|
—
|
—
|
—
|
375,000
|
|||||||||||||||||||||||||||
Common
stock issued upon exercise of other
warrants
|
202,975
|
20
|
—
|
—
|
—
|
—
|
—
|
—
|
327,955
|
—
|
—
|
—
|
327,975
|
|||||||||||||||||||||||||||
Common
stock issued upon cashless exercise of
958,732 other warrants
|
667,215
|
67
|
—
|
—
|
—
|
—
|
—
|
—
|
(67
|
)
|
—
|
—
|
—
|
—
|
||||||||||||||||||||||||||
Common
stock issued for settlement of bankruptcy-related
lawsuit
|
65,000
|
6
|
—
|
—
|
—
|
—
|
—
|
—
|
227,494
|
—
|
—
|
—
|
227,500
|
|||||||||||||||||||||||||||
Common
stock issued in lieu of cash for fees
earned by executive recruiters
|
8,673
|
1
|
—
|
—
|
—
|
—
|
—
|
—
|
34,999
|
—
|
—
|
—
|
35,000
|
|||||||||||||||||||||||||||
Options
granted under the Long-Term Incentive
Plan to Management, Board of Directors,
and Advisors
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
377,669
|
(377,669
|
)
|
—
|
—
|
—
|
||||||||||||||||||||||||||
Revaluation
of options issued to William
Allender in connection with severance
agreement
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
798,262
|
(798,262
|
)
|
—
|
—
|
—
|
||||||||||||||||||||||||||
Warrants
granted to consultants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
476,735
|
(476,735
|
)
|
—
|
—
|
—
|
||||||||||||||||||||||||||
Amortization
of deferred compensation related
to options and warrants issued for
services rendered by—
|
||||||||||||||||||||||||||||||||||||||||
Related
parties
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1,615,533
|
—
|
—
|
1,615,533
|
|||||||||||||||||||||||||||
Other
parties
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
366,120
|
—
|
—
|
366,120
|
|||||||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(6,588,387
|
)
|
(6,588,387
|
)
|
|||||||||||||||||||||||||
Balance
at December 31, 2005
|
26,158,778
|
$
|
2,617
|
347,856
|
$
|
34
|
84,604
|
$
|
8
|
—
|
$
|
—
|
$
|
30,954,333
|
$
|
(238,801
|
)
|
$
|
—
|
$
|
(24,331,921
|
)
|
$
|
6,386,270
|
The
accompanying notes are an integral part of
these financial statements.
28
CYTOMEDIX,
INC.
Statements
of Stockholders’ Equity
Common
Stock
|
Series
A Preferred
|
Series
B Preferred
|
Series
C Preferred
|
|||||||||||||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Additional Paid-in |
Deferred Compensation |
Subscriptions Receivable |
Accumulated Deficit |
Total Stockholders |
||||||||||||||||||||||||||||
Correction
of share balance
|
—
|
—
|
(9,115
|
)
|
—
|
743
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||||||||
Reclassification
pursuant to adoption of SFAS
No. 123R
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(238,801
|
)
|
238,801
|
—
|
—
|
—
|
||||||||||||||||||||||||||
Common
stock issued upon conversion of Series
A stock
|
303
|
—
|
(909
|
)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||||||||
Common
stock issued upon conversion of Series
B stock
|
3,003
|
—
|
—
|
—
|
(9,010
|
)
|
(1
|
)
|
—
|
—
|
1
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||||||
Dividend
issued on Series A and Series B stock
|
—
|
—
|
28,138
|
3
|
7,094
|
1
|
—
|
—
|
35,228
|
—
|
—
|
—
|
35,232
|
|||||||||||||||||||||||||||
Common
stock issued upon exercise of Class
B warrants
|
22,500
|
2
|
—
|
—
|
—
|
—
|
—
|
—
|
33,748
|
—
|
—
|
—
|
33,750
|
|||||||||||||||||||||||||||
Common
stock issued upon exercise of Class
C-1 warrants
|
548,900
|
55
|
—
|
—
|
—
|
—
|
—
|
—
|
823,295
|
—
|
—
|
—
|
823,350
|
|||||||||||||||||||||||||||
Common
stock issued upon exercise of Class
C-2 warrants
|
21,750
|
2
|
—
|
—
|
—
|
—
|
—
|
—
|
32,623
|
—
|
—
|
—
|
32,625
|
|||||||||||||||||||||||||||
Common
stock issued upon exercise of Long-term
Incentive Plan options
|
79,200
|
8
|
—
|
—
|
—
|
—
|
—
|
—
|
118,792
|
—
|
—
|
—
|
118,800
|
|||||||||||||||||||||||||||
Common
stock issued upon exercise of Unit
Offering warrants
|
1,355,166
|
135
|
—
|
—
|
—
|
—
|
—
|
—
|
2,032,615
|
—
|
—
|
—
|
2,032,750
|
|||||||||||||||||||||||||||
Common
stock issued upon exercise of other
warrants
|
23,070
|
2
|
—
|
—
|
—
|
—
|
—
|
—
|
23,068
|
—
|
—
|
—
|
23,070
|
|||||||||||||||||||||||||||
Common
stock to be released upon full payment
of other warrants exercised
|
775,000
|
78
|
—
|
—
|
—
|
—
|
—
|
—
|
774,922
|
—
|
(697,500
|
)
|
—
|
77,500
|
||||||||||||||||||||||||||
Collections
on subscriptions receivable
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
77,500
|
—
|
77,500
|
|||||||||||||||||||||||||||
Expiration
of Series C-1 and Unit
Offering warrants, payable at $0.01
per called warrant not exercised
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(13,368
|
)
|
—
|
—
|
—
|
(13,368
|
)
|
|||||||||||||||||||||||||
Stock-based
compensation related to options
and warrants issued for services
rendered by—
|
||||||||||||||||||||||||||||||||||||||||
Employees
and Directors
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1,073,130
|
—
|
—
|
—
|
1,073,130
|
|||||||||||||||||||||||||||
Other
parties
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
129,794
|
—
|
—
|
—
|
129,794
|
|||||||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(2,299,317
|
)
|
(2,299,317
|
)
|
|||||||||||||||||||||||||
Balance
at December 31, 2006
|
28,987,670
|
$
|
2,899
|
365,970
|
$
|
37
|
83,431
|
$
|
8
|
—
|
$
|
—
|
$
|
35,779,380
|
$
|
—
|
$
|
(620,000
|
)
|
$
|
(26,631,238
|
)
|
$
|
8,531,086
|
The
accompanying notes are an integral part of these financial
statements.
29
CYTOMEDIX,
INC.
Statements
of Cash Flows
Year
Ended December
31, |
||||||||||
2006
|
2005
|
2004
|
||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||
Net
loss
|
$
|
(2,262,956
|
)
|
$
|
(6,503,485
|
)
|
$
|
(8,139,326
|
)
|
|
Adjustments
to reconcile net loss to net cash used in
|
||||||||||
operating
activities:
|
||||||||||
Depreciation
and amortization
|
197,194
|
224,274
|
218,954
|
|||||||
Stock-based
compensation - consultants and other
|
129,794
|
455,565
|
2,518,764
|
|||||||
Stock-based
compensation - employees and directors
|
1,073,130
|
1,526,088
|
578,492
|
|||||||
Stock
issued for contract settlement
|
—
|
227,500
|
—
|
|||||||
Stock
issued for consulting services
|
—
|
35,000
|
—
|
|||||||
(Gain)
Loss on disposal of assets
|
(4,348
|
)
|
(16,609
|
)
|
4,655
|
|||||
Interest
earned on stock subscriptions outstanding
|
—
|
(866
|
)
|
(21,008
|
)
|
|||||
Change
in current assets
|
(472,821
|
)
|
(78,305
|
)
|
(193,210
|
)
|
||||
Change
in patent settlements receivable
|
(542,110
|
)
|
(31,962
|
)
|
—
|
|||||
Change
in accounts payable and accrued expenses
|
98,217
|
94,678
|
400,752
|
|||||||
Change
in deferred revenues
|
(62,270
|
)
|
(84,138
|
)
|
(81,448
|
)
|
||||
Change
in other liabilities
|
185,000
|
—
|
—
|
|||||||
Net
cash used in operating activities
|
(1,661,170
|
)
|
(4,152,260
|
)
|
(4,713,375
|
)
|
||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||
Purchase
of equipment
|
—
|
—
|
(56,563
|
)
|
||||||
Proceeds
from sale of equipment
|
4,500
|
38,775
|
—
|
|||||||
(Increase)
Decrease in restricted cash
|
—
|
21,375
|
(600
|
)
|
||||||
Net
cash provided by (used in) investing activities
|
4,500
|
60,150
|
(57,163
|
)
|
||||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||
Proceeds
from sale of common and preferred stock, net
|
—
|
832,465
|
5,608,188
|
|||||||
Repayment
of note payable
|
—
|
—
|
(13,066
|
)
|
||||||
Proceeds
from option and warrant exercises
|
3,219,345
|
3,199,227
|
1,638,965
|
|||||||
Payment
for expiration of called warrants
|
(13,368
|
)
|
—
|
—
|
||||||
Dividends
paid
|
(11,035
|
)
|
(90,589
|
)
|
—
|
|||||
Net
cash provided by financing activities
|
3,194,942
|
3,941,103
|
7,234,087
|
|||||||
Net
increase (decrease) in cash
|
1,538,272
|
(151,007
|
)
|
2,463,549
|
||||||
Cash,
beginning of period
|
3,123,927
|
3,274,934
|
811,385
|
|||||||
Cash,
end of period
|
$
|
4,662,199
|
$
|
3,123,927
|
$
|
3,274,934
|
The
accompanying notes are an integral part of these financial
statements.
30
CYTOMEDIX,
INC.
Notes
to Financial Statements
NOTE
1 - DESCRIPTION OF THE BUSINESS
Cytomedix
is a biotechnology company that develops and licenses autologous
cellular therapies (i.e., therapies using the patient’s own body products),
including Cytomedix’s proprietary process to produce a platelet rich plasma gel
(“AutoloGel™”) for the treatment of wounds. To create AutoloGel™, the patient’s
own platelets and plasma are separated through centrifugation and combined
with
several reagents. This process releases multiple growth factors from the
platelets, creates a fibrin matrix scaffold, and forms a gel that is topically
applied to a wound (under the direction of a physician). Upon topical
application, the Company believes that AutoloGel™ initiates a reaction that
closely mimics the body’s natural healing process. Cytomedix sells its products
primarily to health care providers in the United States and licenses its patents
to medical device and product suppliers in the United States. The Company was
incorporated in the State of Delaware on April 29, 1998, and has its
headquarters in Rockville, Maryland.
NOTE
2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis
of Presentation
The
Company's financial statements are prepared on the accrual basis of accounting
in accordance with accounting principles generally accepted in the United States
of America. Certain financial information is based on fresh-start accounting
utilized upon the Company’s emergence from bankruptcy in July 2002.
Use
of Estimates
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the amounts reported in the financial
statements and the accompanying notes. Actual results could differ from those
estimates.
Concentration
of Risk
Approximately
$1.5 million, $1.1 million and $0.7 million, or 77%, 76% and 61% of the
Company’s revenue in the years ended December 31, 2006, 2005 and 2004
respectively, were generated from royalties from three, three and one licensees,
respectively. Should any of these licensees experience a significant decrease
in
the sales of products covered by its license agreement with Cytomedix, there
may
be a material adverse effect on Cytomedix’s results of future
operations.
As
of
December 31, 2006 and 2005, the Company maintained approximately $225,000 and
$340,000 respectively, in financial institutions in excess of Federal Deposit
Insurance Corporation (“FDIC”) insurance. In addition, $3,973,000 and $2,323,000
held in money market accounts at brokerage firms were in excess of the $500,000
Securitites Investor Protection Corporation (“SIPC”) coverage as of December 31,
2006 and 2005, respectively. These amounts not covered by SIPC were insured
by
the Company’s brokerage firm through the Customer Asset Protection Company
(“CAPCO”).
The Company currently has one product that is presently marketed. Significant changes in technology could lead to new products or services that compete with the product offered by the Company. These changes could materially affect the price of the Company’s product or render it obsolete.
The
Company outsources manufacturing for all the components of its offerings. While
the Company utilizes single suppliers for several components of the AutoloGel
offering, such components are readily available on the open market and therefore
no dependency exists. The one exception is a reagent, bovine thrombin, available
exclusively through King Pharmaceuticals.
31
CYTOMEDIX,
INC.
Notes
to Financial Statements
Cash
Equivalents
The
Company considers all highly liquid instruments purchased with an original
maturity of three months or less to be cash equivalents.
Accounts
and Royalties Receivable
Cytomedix
generates accounts receivable from the sale of its products. Cytomedix provides
for a reserve against receivables for estimated losses that may result from
a
customer’s inability or unwillingness to pay. The allowance for doubtful
accounts is estimated primarily based upon historical write-off percentages,
known problem accounts, and current economic conditions. Accounts are written
off against the allowance for doubtful accounts when the Company determines
that
amounts are not collectable. Recoveries of previously written-off accounts
are
recorded when collected.
Royalties
receivable represent current royalties earned on sales of covered product by
licensees.
Inventory
Inventory
is stated at the lower of cost or net realizable value. Cost is determined
on a
first-in-first-out (FIFO) basis. The Company's primary product is a kit that
is
composed of multiple items that expire at different periods with the earliest
item in the kit being the determining factor in its classification as a salable
item. Kits with expired components are segregated and used for demonstration
purposes only; the Company maintains a full reserve on these kits.
Property
and Equipment
Property
and equipment is stated at cost less accumulated depreciation and is
depreciated, using the straight-line method, over their estimated useful lives
ranging from three to seven years. Maintenance and repairs are charged to
operations as incurred. When assets are sold, or otherwise disposed of, the
cost
and related accumulated depreciation are removed from the accounts and any
gain
or loss is included in other income and expense.
Intangible
Assets
The
Company capitalizes the costs of purchased and internally developed patents.
This cost is amortized via the straight-line method over the remaining life
of
the patents.
The
Company accounts for finite-lived intangibles under SFAS No. 144, “Accounting
for the Impairment or Disposal of Long-Lived Assets,” and therefore reviews the
recoverability of long-lived and finite-lived intangible assets when
circumstances indicate that the carrying amount of assets may not be
recoverable.
The
Company follows the guidance of SFAS No. 142, “Goodwill and Other Intangible
Assets,” with regard to its indefinite-lived intangibles. SFAS No. 142 requires
that goodwill be assessed at least annually for impairment by applying a fair
value based test. This evaluation has been independently performed for 2006,
2005 and 2004 and is generally based on various analyses including cash flow
projections. In the event these analyses indicate an impairment, the Company
would record an impairment loss, if any, based on the fair value of the
assets.
No
impairment of intangible assets was recorded in 2006, 2005 or 2004.
Income
Taxes
Deferred
income taxes reflect the net tax effects of net operating loss carryforwards
and
temporary differences between the carrying amounts of assets and liabilities
for
financial reporting purposes and the amounts used for income tax purposes,
using
enacted tax rates in effect for the year in which the differences are expected
to reverse. A full valuation allowance has been established, reducing deferred
tax assets to zero, as management has determined that realization of this
benefit is not assured.
32
CYTOMEDIX,
INC.
Notes
to Financial Statements
Revenue
Recognition
The
Company recognizes revenue in accordance with SEC Staff Accounting Bulletin
No.
101, “Revenue Recognition in Financial Statements” (“SAB 101”), as amended. SAB
101 requires that four basic criteria must be met before revenue can be
recognized: (1) persuasive evidence of an arrangement exists; (2) delivery
has
occurred or services rendered; (3) consideration is fixed and determinable;
and
(4) collectibility is reasonably assured.
Revenue
from the sale of the Company’s products to distributors and caregivers is
recognized upon delivery. Revenue from the sale of the Company’s products to
patients is recognized upon use of the product on the patient or acknowledgement
from a patient's insurer authorizing treatment, whichever is later.
Revenue
from the licensing of patents (royalty revenue) is generally recognized as
products are sold by licensees. Certain up-front license fees are amortized
over
the life of the license agreement. Lump sum payments, considered by the Company
to be discharges of past obligations, are reflected net of their associated
costs as “Patent litigation settlements, net” in the Statements of Operations.
Such amounts are recorded at their present value. The Company records revenue
and settlement income related to its agreement with Perfusion Partners
Associates, Inc. (“PPAI”) on the cash basis due to PPAI’s recent emergence from
bankruptcy.
Stock-Based
Compensation
The
Company adopted SFAS No. 123R, “Share-Based Payment,” as of January 1, 2006,
using the modified prospective application. Under this method, all equity-based
compensation awarded after the adoption date has been determined under the
fair
value provisions of SFAS No. 123R. Additionally, for all equity-based
compensation awarded prior to the adoption date, compensation for the portion
of
awards for which the requisite service is performed after the adoption date
is
recognized as service is rendered.
The
Company’s policy is to issue new shares of its Common stock when employees
exercise options awarded under its Long-Term Incentive Plan. See Note 12 to
the
Financial Statements.
As
permitted under SFAS No. 123, the Company applied the intrinsic value method
of
accounting prescribed by Accounting Principles Board (“APB”) Opinion No. 25,
“Accounting for Stock Issued to Employees,” and related interpretations, in
accounting for its stock-based grants to employees and directors in 2005 and
2004. Under the “intrinsic value” method, an option’s value is the excess of the
market price of the underlying stock on the date of grant over the exercise
price of the option. No value is attributed to the option if its exercise price
is greater than the stock’s market price. Had the Company continued to use the
intrinsic value provisions under APB Opinion No. 25, employee and director
stock-based compensation would have been $115,833, net of income taxes, for
the
year ended December 31, 2006. The change increased reported net loss and
basic and diluted loss per share for the year ended December 31, 2006 by
$957,297 and $0.03, respectively. The change had no effect on the Company’s cash
flow from operating, investing or financing activities.
Under
the
fair value method prescribed by SFAS 123R, the Company recorded $1,073,130,
net
of income taxes, in employee and director stock-based compensation for the
year
ended December 31, 2006. Had compensation expense for the years ended December
31, 2005 and 2004 been determined under the fair value provisions of SFAS No.
123 as amended by SFAS No. 148, “Accounting for Stock-Based Compensation -
Transition and Disclosure, an amendment of FASB Statement No. 123,” the
Company’s net loss and net loss per share to Common shareholders would have
differed as follows:
33
CYTOMEDIX,
INC.
Notes
to Financial Statements
2005
|
2004
|
||||||
Net
loss to common stockholders, as reported
|
$
|
(6,588,387
|
)
|
$
|
(11,259,187
|
)
|
|
Add:
|
|||||||
Stock-based
employee compensation
|
|||||||
expense
included in reported net loss
|
|||||||
determined
under APB No. 25,
|
|||||||
net
of related tax effects
|
698,380
|
258,464
|
|||||
Deduct:
|
|||||||
Stock-based
employee compensation
|
|||||||
expense
determined under fair value
|
|||||||
based
method for all awards,
|
|||||||
net
of related tax effects
|
(2,139,046
|
)
|
(793,792
|
)
|
|||
Pro
forma net loss
|
$
|
(8,029,053
|
)
|
$
|
(11,794,515
|
)
|
|
Loss
per share:
|
|||||||
Basic
and diluted - as reported
|
$
|
(0.27
|
)
|
$
|
(0.62
|
)
|
|
Basic
and diluted - pro forma
|
$
|
(0.33
|
)
|
$
|
(0.65
|
)
|
These
pro
forma amounts may not be representative of future disclosures since the
estimated fair value of stock options would be amortized to expense over the
vesting period and additional options may be issued in future
years.
The
fair
value of each option award is estimated on the date of grant using the
Black-Scholes option valuation model. The weighted-average assumptions used
in
the model are summarized in the following table:
2006
|
2005
|
2004
|
||||||||
Risk
free rate
|
4.73
|
%
|
4.40
|
%
|
3.90
|
%
|
||||
Expected
years until exercise
|
10.0
|
8.1
|
9.3
|
|||||||
Expected
stock volatility
|
113
|
%
|
114
|
%
|
100
|
%
|
||||
Dividend
yield
|
—
|
—
|
—
|
Expected
volatilities are based on historical volatility of the Company’s stock. The
Company uses historical data to estimate option exercise and employee
termination within the valuation model. The expected years until exercise
represents the period of time that options are expected to be outstanding.
The
risk-free rate for periods within the contractual life of the option is based
on
the U.S. Treasury yield curve in effect at the time of grant. The Company
estimated that the dividend rate on its Common stock will be zero.
Loss
Per Share
Loss
per
share is calculated in accordance with SFAS No. 128, “Earnings Per Share.” Basic
loss per share is computed based upon the weighted average number of shares
of
Common stock outstanding for the period and excludes any potential dilution.
Diluted earnings per share reflects potential dilution from the exercise of
securities into Common stock. Outstanding options and warrants to purchase
Common stock are not included in the computation of diluted earnings per share
because the effect of these instruments would be anti-dilutive (i.e. would
reduce the loss per share).
34
CYTOMEDIX,
INC.
Notes
to Financial Statements
The
Common shares potentially issuable upon the exercise of these instruments,
were
as follows at December 31:
2006
|
2005
|
2004
|
||||||||
Options
|
3,202,377
|
2,782,077
|
2,516,577
|
|||||||
Warrants
|
4,745,301
|
8,528,988
|
11,253,200
|
|||||||
Series
A Preferred Stock
|
121,990
|
115,580
|
525,261
|
|||||||
Series
B Preferred Stock
|
27,810
|
28,458
|
462,347
|
|||||||
Series
C Preferred Stock
|
—
|
—
|
839,000
|
|||||||
8,097,478
|
11,455,103
|
15,596,385
|
Fair
Value of Financial Instruments
The
carrying value of current assets and liabilities approximates fair value due
to
their relatively short maturities.
Reclassifications
Certain
reclassifications have been made to conform prior year's data to the current
presentation. These reclassifications had no effect on reported
earnings.
Registration
Payment Arrangements
The
Company is party to a registration rights agreement and a related warrant
agreement with one of its former consultants. The registration rights agreement
provides for liquidated damages, at the discretion of the warrantholder, in
the
event that the registration statement relating to the shares underlying the
warrants becomes ineffective. The Company’s obligations under this agreement run
through the earlier of April 1, 2012 or two years after the exercise of the
related warrants. At the discretion of the warrantholder, the liquidated damages
may take the form of cash or additional shares of the Company’s Common stock. As
of December 31, 2006, the Company has estimated the maximum undiscounted
liquidated damages at $171,000. However, pursuant to FASB Staff Position No.
EITF 00-19-2, which the Company adopted in the fourth quarter of 2006, the
Company has determined that it is unlikely that circumstances allowing for
the
aforementioned liquidated damages would arise, and therefore no contingent
liability has been recorded.
Recent
Accounting Pronouncements
In
July
2006, the FASB issued Interpretation No. 48 (“FIN 48”), “Accounting
for Uncertainty in Income Taxes, an interpretation of FASB Statement
No. 109,” which seeks to reduce the diversity in practice associated with
the accounting and reporting for uncertainty in income tax positions. This
Interpretation prescribes a comprehensive model for the financial statement
recognition, measurement, presentation and disclosure of uncertain tax positions
taken or expected to be taken in income tax returns. FIN 48 is effective
for fiscal years beginning after December 15, 2006 and the Company will
adopt the new requirements in its fiscal first quarter of 2007. The Company
does
not expect the adoption of this statement in fiscal year 2007 to have a material
impact on the Company’s financial position or results of operations
In
September 2006, the FASB issued Statement of Financial Accounting Standards
(“SFAS”) 157, “Fair Value Measurements” (“SFAS 157”), which provides guidance on
measuring the fair value of assets and liabilities. SFAS 157 will apply to
other
accounting pronouncements that require or permit assets or liabilities to be
measured at fair value but does not expand the use of fair value to any new
circumstances. This standard will also require additional disclosures in both
annual and quarterly reports. SFAS 157 will be effective for financial
statements issued for fiscal years beginning after November 15, 2007. The
Company is currently determining the effect, if any, the adoption of SFAS 157
will have on its financial statements.
In
September 2006, the SEC staff issued Staff Accounting
Bulletin No. 108, “Considering the Effects of Prior Year Misstatements
when Quantifying Misstatements in Current Year Financial Statements”
(“SAB 108”). The intent of SAB 108 is to reduce diversity in practice
for the method companies use to quantify financial statement misstatements,
including the effect of prior year uncorrected errors. SAB 108 establishes
an approach that requires quantification of financial statement errors using
both an income statement and a cumulative balance sheet approach. SAB 108
is effective for fiscal years beginning after November 15, 2006, and the
Company will adopt the new requirements in 2007. The adoption of SAB 108 is
not currently expected to have a significant impact on the Company’s financial
statements.
35
CYTOMEDIX,
INC.
Notes
to Financial Statements
NOTE
3 - WORKING CAPITAL
The
Company’s operating revenues do not cover the costs of its operations. The cash
position of the Company at December 31, 2006 was approximately $4.7 million.
The
Company believes that it will have adequate cash on hand to fund operations
for
the year ending December 31, 2007. However, additional cash may be required
if
operating revenues do not materialize, the cost of operations increases, or
if
the Company’s efforts to appeal the FDA’s NSE determination letter prove
unsuccessful and a change in strategy requires significant short-term
funding.
The
Company has no material commitments for capital expenditures.
Because
the Company was in bankruptcy in 2002, the Company may not be able to obtain
debt financing. All working capital required to implement the Company’s business
plan will be provided by funds obtained through offerings of its equity
securities, and revenues generated by the Company.
NOTE
4 - LICENSING AGREEMENTS
During
2006 and 2005, the Company entered into several separate settlement and license
Agreements. Under the terms of the respective agreements, payments of
approximately $4,905,000 were due to the Company for the discharge of past
obligations or as upfront fees. Additionally, certain licensees are required
to
pay on-going royalties on defined classes of sales.
Patent
settlements are one-time, non-recurring transactions. Amounts related to these
settlements that are payable to the Company over time are reflected as “Patent
settlements receivable, current portion” and “Patent settlements receivable” on
the Balance Sheet for their current and long-term portions respectively.
Associated costs, consisting of royalty and contingent legal fees payable upon
the collection of such receivables, are reflected in “Accounts payable and
accrued expenses” and “Other liabilities” on the Balance Sheet, for their
current and long-term portions, respectively. Income related to the settlement
of past obligations, net of associated costs, are reflected as “Patent
litigation settlements, net” on the Statements of Operations as
follows:
2006
|
2005
|
2004
|
||||||||
Income
|
$
|
2,479,000
|
$
|
1,388,000
|
$
|
—
|
||||
Costs
|
(832,000
|
)
|
(341,000
|
)
|
—
|
|||||
Net
settlement income
|
$
|
1,647,000
|
$
|
1,047,000
|
$
|
—
|
Due
to
PPAI’s recent emergence from bankruptcy, the Company records incomes when
payments are received from PPAI. As of December 31, 2006, the Company had
received and recorded $139,000 of the agreed $250,000 settlement for past
obligations from PPAI.
Royalties
earned after the effective dates of these agreements and amortization of
deferred revenue from up front fees, together with the related costs, are
included in the Statements of Operations as “Royalties” and “Cost of royalties,”
respectively.
Since
2003, the Company has incurred expenses of $690,000 (excluding royalty and
contingent legal fees) for patent enforcement actions. Of this amount,$1,000,
$479,000, and $197,000 were incurred during 2006, 2005 and 2004, respectively.
These fees have primarily been included in Professional fees. The Company’s
patent enforcement strategy is being conducted on a full contingency
basis.
The
Company’s primary license agreements, based on its ownership of the “Knighton
Patent” (US Patent No. 5,165,938), are listed below:
36
CYTOMEDIX,
INC.
Notes
to Financial Statements
Licensee
|
Date
of
Agreement
|
Date
of
Expiration
(4)
|
Initial
Licensing
Fee
|
On-going Royalty Percentage
(2) |
||||||||||
DePuy
Spine, Inc. (1)
|
3/19/2001
|
11/24/2009
|
$
|
750,000
|
6.5%
|
|
||||||||
3/4/2005
|
||||||||||||||
Medtronic,
Inc.
|
5/1/2005
|
11/24/2009
|
$
|
680,000
|
7.5%
on disposables
|
|||||||||
|
1.5%
on hardware
|
|||||||||||||
Harvest
Technologies, Inc.
|
6/30/2005
|
11/24/2009
|
$
|
500,000
|
7.5%
on disposables
|
|||||||||
|
1.5%
on hardware
|
|||||||||||||
Perfusion
Partners, Inc.
|
6/26/2005
|
11/24/2009
|
$
|
$
250,000
|
(3)
|
10.0%
|
|
|||||||
COBE
Cardiovascular, Inc.
|
10/7/2005
|
11/24/2009
|
$
|
45,000
|
7.5%
on disposables
|
|||||||||
|
1.5%
on hardware
|
|||||||||||||
SafeBlood
Technologies, Inc.
|
10/12/2005
|
11/24/2009
|
$
|
$
50,000
|
(3)
|
8.0%
to 9.0%
|
|
|||||||
|
||||||||||||||
Biomet
Biologics, Inc. (5)
|
5/19/2006
|
11/24/2009
|
$
|
2,600,000
|
none
|
|||||||||
|
||||||||||||||
CellMedix,
Inc.
|
11/28/2006
|
11/24/2009
|
$
|
30,000
|
9.5%
|
|
(1) Cytomedix
has two license agreements with DePuy Spine, Inc. The original license agreement
was dated March 19, 2001, amended March 3, 2005, and provides for the use of
applications under Cytomedix patents in the fields of diagnostic and therapeutic
spinal, neurosurgery and orthopedic surgery. The second license agreement is
dated March 4, 2005 and applies to all fields not covered in the original
license agreement as amended.
(2) Certain
minimum royalties may apply to certain agreements and other royalty percentages
may apply to future products covered under selected license
agreements.
(3) Some
of
these amounts are payable over a period of time as defined in executed notes
payable to Cytomedix.
(4) These
dates reflect the expiration of the license in the U.S., which coincides with
the expiration of the Knighton Patent in the U.S. In some cases, the licensing
agreements applicable to territories outside the U.S. extend to the expiration
of the patents in the respective foreign countries.
(5) The
Settlement and License Agreement with Biomet Biologics, Inc. (“Biomet”) called
for a $2.6 million payout from Biomet to Cytomedix. This payout took the form
of
$1.4 million payable upon execution of the agreement and $100,000 payable at
the
end of each of 12 consecutive quarters beginning with the quarter ending
September 2006. These payments are not tied to any performance commitments
by
Cytomedix and are not dependent on Biomet sales.
NOTE
5 - ROYALTY AGREEMENTS
The
Company is party to a Royalty Agreement with Curative Health Services, Inc.
Under this agreement as amended, Curative is to receive 92% of licensing
receipts from DePuy Spine, Inc. (a division of Johnson & Johnson, Inc.) and
10% of the total other amounts received by the Company in connection with
upfront, milestone and other similar payments relating to the Knighton
Patent.
The
Company is also party to a Royalty Agreement with Mr. Charles Worden. The
primary terms of this agreement are discussed in Note 15 - Related Party
Transactions.
37
CYTOMEDIX,
INC.
Notes
to Financial Statements
NOTE
6 - RECEIVABLES
Accounts
and royalties receivable, net consisted of the following at December
31:
2006
|
2005
|
||||||
Trade
receivables
|
$
|
168,477
|
$
|
197,982
|
|||
Royalty
receivables
|
491,250
|
304,250
|
|||||
Other
receivables
|
25,393
|
17,828
|
|||||
685,120
|
520,060
|
||||||
Less
allowance for doubtful accounts
|
(136,851
|
)
|
(89,893
|
)
|
|||
$
|
548,269
|
$
|
430,167
|
Bad
debt expense was approximately $62,000 for each of the years ended December
31,
2006 and 2005.
Patent
settlements are one-time, non-recurring transactions. Patent settlements
receivable consist of amounts owed to the Company for the discharge of past
obligations pursuant to settlement and licensing agreements with various
licensees. The amounts are reflected at their net present value using discount
rates between 8.00% and 8.25%. The current portions are due within one year
and
long-term portion are due at various periods through June 2009.
NOTE
7 - PREPAID EXPENSES, INVENTORY, AND OTHER CURRENT ASSETS
Prepaid
expenses, other current assets and inventory consisted of the following at
December 31:
2006
|
2005
|
||||||
Prepaid
insurance
|
$
|
131,406
|
$
|
117,880
|
|||
Prepaid
fees and rent
|
12,113
|
67,266
|
|||||
Travel
advances
|
—
|
5,655
|
|||||
Deposits
|
3,190
|
3,811
|
|||||
Inventory
|
8,647
|
27,575
|
|||||
$
|
155,356
|
$
|
222,187
|
38
CYTOMEDIX,
INC.
Notes
to Financial Statements
NOTE
8 - PROPERTY AND EQUIPMENT
Property
and equipment consisted of the following at December 31:
2006
|
2005
|
||||||
Medical
equipment
|
$
|
279,660
|
$
|
281,610
|
|||
Office
equipment
|
74,559
|
74,559
|
|||||
354,219
|
356,169
|
||||||
Less
accumulated depreciation
|
(342,460
|
)
|
(281,575
|
)
|
|||
$
|
11,759
|
$
|
74,594
|
Depreciation
expense was approximately $63,000, $98,000, and $93,000 for the years ended
December 31, 2006, 2005, and 2004, respectively.
NOTE
9 - INTANGIBLE ASSETS
Cytomedix
owns eight U.S. patents (including U.S. Patent No. 5,165,938 (the “Knighton
Patent”) and U.S. Patent No. 6,303,112 (the “Worden Patent”), various
corresponding foreign patents, and various trademarks. The Knighton Patent
and
Worden Patent expire in November 2009 and February 2019,
respectively.
Patents
and related accumulated amortization at December 31 was as
follows:
2006
|
2005
|
||||||
Patents
|
$
|
2,400,000
|
$
|
2,400,000
|
|||
Less
accumulated amortization
|
(576,616
|
)
|
(442,105
|
)
|
|||
$
|
1,823,384
|
$
|
1,957,895
|
Amortization
expense was approximately $135,000 for the year ended December 31, 2006 and
$126,000 for each of the years ended December 31, 2005 and 2004. The Company
is
amortizing the patents over the remaining lives of the patents and the Company
expects amortization expense to be approximately $151,000 in each of the next
five years.
Goodwill
represents the excess reorganization value over the amounts allocable to
identifiable assets upon the Company’s emergence from bankruptcy in
2002.
39
CYTOMEDIX,
INC.
Notes
to Financial Statements
NOTE
10 - INCOME TAXES
Income
tax (expense) benefit for the years ended December 31, 2006, 2005 and 2004
consisted of the following:
2006
|
2005
|
2004
|
||||||||
Current:
|
||||||||||
Federal
|
$
|
—
|
$
|
—
|
$
|
—
|
||||
State
|
—
|
—
|
—
|
|||||||
Deferred:
|
||||||||||
Federal
|
459,000
|
784,000
|
1,138,000
|
|||||||
State
|
98,000
|
133,000
|
182,000
|
|||||||
Net
operating loss carryforward
|
389,000
|
1,794,000
|
1,815,000
|
|||||||
Valuation
allowance
|
(946,000
|
)
|
(2,711,000
|
)
|
(3,135,000
|
)
|
||||
Total
income tax (expense) benefit
|
$
|
—
|
$
|
—
|
$
|
—
|
Significant
components of Cytomedix’s deferred tax assets and liabilities consisted of the
following at December 31:
2006
|
2005
|
||||||
Deferred
tax assets:
|
|||||||
Stock-based
compensation
|
$
|
3,071,000
|
$
|
2,564,000
|
|||
Other
|
166,000
|
158,000
|
|||||
Total
deferred tax assets
|
3,237,000
|
2,722,000
|
|||||
Deferred
tax liabilities:
|
|||||||
Amortization
of patents
|
(594,000
|
)
|
(631,000
|
)
|
|||
Other
|
(16,000
|
)
|
(21,000
|
)
|
|||
Net
deferred tax assets
|
2,627,000
|
2,070,000
|
|||||
Net
operating loss carryforwards
|
7,903,000
|
7,514,000
|
|||||
10,530,000
|
9,584,000
|
||||||
Less
valuation allowance
|
(10,530,000
|
)
|
(9,584,000
|
)
|
|||
Total
deferred tax assets
|
$
|
—
|
$
|
—
|
40
CYTOMEDIX,
INC.
Notes
to Financial Statements
The
following table presents a reconciliation between the U.S. federal statutory
income tax rate and the Company's effective tax rate:
2006
|
2005
|
2004
|
||||||||
U.S.
Federal statutory income tax
|
35.0%
|
|
35.0%
|
|
35.0%
|
|
||||
State
and local income tax benefits
|
6.6%
|
|
7.2%
|
|
2.5%
|
|
||||
Other
|
(1.7%)
|
|
(0.4%)
|
|
1.1%
|
|
||||
Nondeductible
expenses
|
(0.1%)
|
|
(0.1%)
|
|
(0.1%)
|
|
||||
Valuation
allowance for deferred
|
||||||||||
income
tax assets
|
(39.8%)
|
|
(41.7%)
|
|
(38.5%)
|
|
||||
Effective
income tax rate
|
(0.0%)
|
|
0.0%
|
|
0.0%
|
|
The
Company had loss carryforwards of approximately $21,578,000 as of December
31,
2006 that may be offset against future taxable income. The carryforwards will
expire between 2021 and 2026. Utilization of these carryforwards may be subject
to annual limitations based upon previous significant changes in stock
ownership. Management has determined that realization of this benefit is not
assured and accordingly has established a valuation allowance of $10,530,000
and
$9,584,000 at December 31, 2006 and 2005, respectively.
NOTE
11 - CAPITAL STOCK
The
Company has several classes of stock as described below.
Common
Stock
Common
stock has a par value of $.0001 per share and is limited to a maximum of
65,000,000 shares. It is subordinate to both Series A Convertible Preferred
stock and Series B Convertible Preferred stock and to all other classes and
series of equity securities of the Company which by their terms rank senior
to
it, in the event of a liquidation, dissolution, or winding up of the Company
or
with regard to any other rights, privileges or preferences. Each share of Common
stock represents the right to one vote. Holders of Common stock are entitled
to
receive dividends as may be declared by the Board of Directors, subject to
the
limitations in the terms of the Series A and B Convertible Preferred stock
described below.
Series
A Convertible Preferred Stock
Series
A
Convertible Preferred stock (“Series A”) has a par value of $.0001 per share and
is limited to a maximum of 5,000,000 shares. It has a stated liquidation
preference of $1.00 per share and preference over and rank senior to (i) Series
B Convertible Preferred stock, (ii) Common stock, and (iii) all other classes
and series of equity securities of the Company which by its terms do not rank
senior to the Series A stock. The Series A contains a negative covenant
prohibiting the Company from granting any security interest in the Company's
patents and/or future royalty streams ("Intellectual Property"). The holders
of
record of shares are entitled to receive cumulative dividends at the rate of
8%
of the stated liquidation preference amount per share per annum, payable
quarterly in arrears. These dividends are prior and in preference to any
declaration or payment of any distribution on any outstanding shares of Common
stock or any other equity securities of the Company ranking junior as to the
payment of dividends. Dividends are to be paid in shares of Series A or, in
the
sole discretion of the Board of Directors, in cash. Each share of Series A
stock
shall entitle the holder thereof to vote on all matters voted on by holders
of
Common stock of the Company voting together as a single class with the other
shares entitled to vote.
Each
share of Series A stock may be converted into Common stock at a conversion
rate
equal to 90% of the twenty-day average closing price of the Company’s Common
stock, but in no case shall this price be less than $3.00 per
share.
The
Company may redeem Series A stock for cash at a price per share equal to 104%
of
the liquidation preference amount plus all accrued but unpaid dividends, by
providing proper notice of not less than 10 days nor more than 60 days prior
to
a redemption date set by the Company.
41
CYTOMEDIX,
INC.
Notes
to Financial Statements
Series
B Convertible Preferred Stock
Series
B
Convertible Preferred stock (“Series B”) has a par value of $.0001 per share and
is limited to a maximum of 5,000,000 shares. It has a stated liquidation
preference of $1.00 per share, is subordinate to the Series A stock, and has
preference over and ranks senior to (i) common stock, and (ii) all other classes
and series of equity securities of the Company which by its terms do not rank
senior to the Series B stock. The Series B contains a negative covenant
prohibiting the Company from granting any security interest in the Company's
patents and/or future royalty streams ("Intellectual Property"). The holders
of
record of shares are entitled to receive cumulative dividends at the rate of
8%
of the stated liquidation preference amount per share per annum, payable
quarterly in arrears. These dividends are prior and in preference to any
declaration or payment of any distribution on any outstanding shares of Common
stock or any other equity securities of the Company ranking junior as to the
payment of dividends. Dividends are to be paid in shares of Series B or, in
the
sole discretion of the Board of Directors, in cash. Each share of Series B
stock
shall entitle the holder thereof to vote on all matters voted on by holders
of
Common stock of the Company voting together as a single class with the other
shares entitled to vote.
Each
share of Series B stock may be converted into Common stock at a conversion
rate
equal to 90% of the twenty-day average closing price of the Company’s Common
stock, but in no case shall this price be less than $3.00 per
share.
The
Company may redeem Series B stock for cash at a price per share equal to 103%
of
the liquidation preference amount plus all accrued but unpaid dividends, by
providing proper notice of not less than 10 days nor more than 60 days prior
to
a redemption date set by the Company.
Series
C Convertible Preferred Stock
Series
C
Convertible Preferred stock (“Series C”) has a par value of $.0001 per share and
is limited to a maximum of 1,000 shares. It has a stated liquidation preference
of $10,000 per share, and ranks junior to the Series A regarding distributions
upon liquidation of the Company. Series C stock ranks junior to the Series
B
solely with respect to the priority security interest in the Company's
Intellectual Property. The shares accrued dividends at 6% of the stated
liquidation preference amount from the date of issuance and increased to 8%
commencing on September 25, 2005, are payable annually in cash or shares of
Common stock at the option of the Company. The Series C stock ranks pari passu
with Series A and Series B with respect to payment of dividends. As of December
31, 2006 and 2005, no Series C remained outstanding.
Warrants
and Options
The
Company had the following outstanding warrants and options at December
31:
Equity
Instrument
|
2006
|
2005
|
|||||
A
and B Warrants (1)
|
—
|
22,500
|
|||||
C-1
Warrants (2)
|
—
|
815,900
|
|||||
C-2
Warrants (2)
|
855,000
|
876,750
|
|||||
D
Warrants (3)
|
304,033
|
—
|
|||||
Unit
Warrants (4)
|
1,825,000
|
4,250,000
|
|||||
Other
warrants (5)
|
1,761,268
|
2,563,838
|
|||||
Options
issued under the Long-Term
Incentive Plan (6)
|
3,202,377
|
2,782,077
|
(1) These
warrants were issued in connection with the $800,000 raised while the Company
was a debtor in possession and the $2.8 million raised upon the Company’s
emergence from bankruptcy. As of December 31, 2006, all class A and class B
warrants have been exercised or have expired.
42
CYTOMEDIX,
INC.
Notes
to Financial Statements
(2) These
warrants were issued in connection with the Series C stock offering and are
voluntarily exercisable at $1.50 per share, provided that the exercise does
not
result in the holder owning in excess of 9.999% of the outstanding shares of
the
Company's Common stock, and expire on March 25, 2009. They provide for a
cashless exercise at the option of the warrantholder provided that (i) the
per
share market price of one share of Common stock is greater than the warrant
price and (ii) a registration statement for the resale of warrant stock is
not
in effect. As of December 31, 2006 all class C-1 warrants have been exercised
or
have expired. The Company has the option to call up to 100% of the C-2 warrants
commencing July 29, 2007, provided that the Company's Common stock must have
been trading at a closing price greater than $3.00 for 10 consecutive trading
days prior to the call notice and a registration statement is then in effect
and
has been effective without lapse for a period of 60 consecutive days and trading
in the Company's stock shall not have been suspended. The Company, upon calling
the warrant and the expiration of 20 days without action by the warrant holder,
will remit to the holder of the warrant $.01 per called warrant and issue a
new
warrant representing the number of warrants not subject to the
call.
(3) These
warrants were issued in exchange for the voluntary exercise of Outstanding
Warrants during the offer period ending May 1, 2006 and are voluntarily
exercisable at $3.50 per share, provided that the exercise does not result
in
the holder owning in excess of 9.9% of the outstanding shares of the Company's
Common stock, and expire on May 1, 2011. The Company may call up to one hundred
percent (100%) of the class D warrants, provided that the Company’s Common stock
must have been trading at a closing price greater than $4.50 for a period of
at
least ten (10) consecutive trading days prior to the date of delivery of the
Call Notice, provided that the Registration Statement is then in effect and
trading in the Common stock shall not have been suspended by the Securities
and
Exchange commission or the securities exchange or quotation system on which
the
Common stock is then listed or traded.
(4)
These
warrants were issued in connection with the Unit offering (discussed later
in
this footnote), have a five year term, and are voluntarily exercisable at $1.50
per share, provided that the exercise does not result in the holder owning
in
excess of 9.999% of the outstanding shares of the Company's Common stock, and
expire on March 31, 2009. They provide for a cashless exercise at the option
of
the warrant provided that (i) the per share market price of one share of Common
stock is greater than the warrant price and (ii) a registration statement for
the resale of warrant stock is not in effect.
(5) These
warrants were issued to placement agents, consultants, and other professional
service providers in exchange for services provided. They have terms ranging
from 5 to 10 years with various expiration dates through February 24, 2014
and
exercise prices ranging from $1.00 to $6.00. The vesting period typically does
not exceed the service period. They are voluntarily exercisable once vested.
There is no call provision associated with these warrants.
(6) These
options were issued under the Company’s shareholder approved Long-Term Incentive
Plan. See Note 12 for a full discussion regarding these options.
Activity
The
Company issued 2,828,892 shares of Common stock during 2006. The following
table
lists the sources of and the proceeds from those issuances:
Source
|
#
of Shares
|
Total
Exercise
Price
|
|||||
Conversion
of series A convertible preferred shares
|
303
|
$
|
—
|
||||
Conversion
of series B convertible preferred shares
|
3,003
|
$
|
—
|
||||
Exercise
of class B warrants
|
22,500
|
$
|
33,750
|
||||
Exercise
of series C-1 warrants
|
548,900
|
$
|
823,350
|
||||
Exercise
of series C-2 warrants
|
21,750
|
$
|
32,625
|
||||
Exercise
of unit offering warrants
|
1,355,166
|
$
|
2,032,750
|
||||
Exercise
of options issued under the Long-Term
Incentive Plan
|
79,200
|
$
|
118,800
|
||||
Exercise
of other warrants (1)
|
798,070
|
$
|
798,070
|
||||
Totals
|
2,828,892
|
$
|
3,839,345
|
(1) Proceeds
include $620,000 in the form of a note receivable. See discussion
below.
43
CYTOMEDIX,
INC.
Notes
to Financial Statements
The
Company issued 4,657,941 shares of Common stock during 2005. The following
table
lists the sources of and the proceeds from those issuances:
Source
|
#
of Shares
|
Total
Exercise
Price
|
|||||
Conversion
of series A convertible preferred shares (1)
|
431,528
|
—
|
|||||
Conversion
of series B convertible preferred shares (1)
|
449,942
|
—
|
|||||
Conversion
of series C convertible preferred shares
|
839,500
|
—
|
|||||
Exercise
of class A warrants
|
42,500
|
$
|
42,500
|
||||
Exercise
of class B warrants (2)
|
507,008
|
$
|
673,851
|
||||
Exercise
of class C-1 warrants
|
462,900
|
$
|
694,350
|
||||
Exercise
of class C-2 warrants
|
478,700
|
$
|
689,925
|
||||
Exercise
of unit offering warrants
|
250,000
|
$
|
375,000
|
||||
Exercise
of options issued under the Long-Term
Incentive Plan (3)
|
252,000
|
$
|
367,500
|
||||
Exercise
of other warrants (2)
|
870,190
|
$
|
356,101
|
||||
Other
issuances
|
73,673
|
—
|
|||||
Totals
|
4,657,941
|
$
|
3,199,227
|
(1) Includes,
but is not limited to, the immediate conversion to Common stock of certain
dividends paid in preferred stock.
(2) Includes
Common stock issued pursuant to cashless exercise provisions.
(3) The
issuance of these shares were registered by the Company’s S-8 filed on November
1, 2004.
The
Company has used the cash proceeds from these issuances for general corporate
purposes. The issuance of shares under the Company's Long-Term Incentive Plan
were registered by the Company's S-8 filed on November 1, 2004. All other shares
were issued in private offerings exempt from registration pursuant to Section
4(2) of the Securities Act.
In
2006,
the Company granted 500,000 options to purchase the Company’s Common stock with
exercise prices ranging from $1.50 to $4.89. These options were granted to
employees and board members under the Long-Term Incentive Plan (see Note
12).
On
October 1, 2006, FEQ Investments, Inc. (“FEQI”) exercised 775,000 consultant
warrants and simultaneously entered into a Negotiable Term Promissory Note
and
related Security Agreement (the “Note”) with the Company in the amount of
$697,500. The exercise price for these options was $1 per share or a total
of
$775,000. The Note provides for the exercise proceeds to be delivered to the
Company in installment payments ending on February 15, 2007. The Note bears
interest on the outstanding balance at 6% per year. The Company holds the stock
certificate resulting from the exercise as collateral. The outstanding principal
balance of $620,000 at December 31, 2006, is reflected as an offset to
Stockholder’s equity on the Balance Sheet. See Note 18 to the Financial
Statements.
On
August
30, 2006, as required by the Certificate of Designation filed with the Delaware
Secretary of State, the Company declared a stock dividend on its Series A and
B
Convertible Preferred shares. This dividend resulted in issuance of 27,869
and
7,036 shares of Series A and B Convertible Preferred stock, respectively, and
the issuance of 109 shares of Common stock, in lieu of preferred shares, to
prior holders of Series A and B Convertible Preferred shares that were converted
to Common stock prior to the payment of the preferred dividends.
On
July
31, 2006, the Company’s common stock closed above $3.00 on the American Stock
Exchange for the tenth consecutive trading day. As authorized by Section 8
of
the Series C-1 Warrants and the Unit Offering Warrants, Cytomedix issued a
Call
Notice to call all warrants that were eligible and remained outstanding. As
a
result of an amendment to the terms of the warrant, which was accepted by a
majority of the warrantholders, the exercise period was extended, giving the
warrantholders until October 20, 2006 to exercise their warrants. The total
number of warrants called was 1,605,734 at an exercise price of $1.50 per
warrant. Upon expiration of the exercise period on October 20, 2006, 268,900
warrants had been exercised resulting in proceeds of approximately $403,000
to
the Company. The remaining 1,336,834 unexercised warrants expired and were
cancelled by the Company. Per the terms of the warrant agreements, the Company
remitted $0.01 for each expired warrant, or approximately $13,000 in the
aggregate.
44
CYTOMEDIX,
INC.
Notes
to Financial Statements
In
May
2006, the Company paid a cash dividend on Series C Convertible Preferred shares
at the rate of six percent per annum, amounting to $11,000. The dividends were
calculated based on the number of days the shareholder held the Series C
Convertible Preferred shares prior to conversion.
In
2005,
the Company granted 732,500 options to purchase the Company’s Common stock with
exercise prices ranging from $1.15 to $6.00. These options were granted to
employees, board members, and professional service providers. Of these, 517,500
were granted under the Long-Term Incentive Plan. The remaining 215,000 grants
were as follows:
· |
On
March 7, 2005, the Company granted to Kol Bio-Medical Instruments,
Inc. a
warrant to purchase 60,000 shares of the Company’s Common stock at an
exercise price of $2.48. These options vest one year from the date
of
grant and expire in five years.
|
· |
On
April 18, 2005, the Company granted to Crystal Research Associates,
LLC a
warrant to purchase 125,000 shares of the Company’s Common stock at an
exercise price of $3.14. These options vested immediately and expire
in
five years.
|
· |
On
August 29, 2005, the Company granted to The Wall Street Group, Inc.
a
warrant to purchase 30,000 shares of the Company’s Common stock at an
exercise price of $6.00. These options vested over a one year period
and
expire in five years.
|
On
July
15, 2005, the Company entered into a Separation Agreement and Release with
William L. Allender. Under said Separation Agreement, Mr. Allender agreed to
provide consulting services to the Company as needed and to provide for a smooth
transition to his successor. The Company agreed to extend the expiration date
of
Mr. Allender’s options to purchase Common stock and to allow cashless exercise
of said options as part of his severance package. The extension of the
expiration date of the options resulted in the Company recording approximately
$798,000 of compensation expense in 2005.
In
June
2005, the Company paid a cash dividend on Series C Convertible Preferred shares
at the rate of six percent per annum, amounting to approximately $91,000. The
dividends were calculated based on the number of days the shareholder held
the
Series C Convertible Preferred shares prior to conversion.
On
June
30, 2005, as required by the Certificate of Designation filed with the Delaware
Secretary of State, the Company declared a stock dividend on its Series A and
B
Convertible Preferred shares. This dividend resulted in the issuance of 25,685
and 6,323 shares of Series A and B Convertible Preferred shares respectively,
and the issuance of 27,249 shares of Common stock as a result of the automatic
conversion of preferred shares issued as dividends to prior holders of Series
A
and B Convertible Preferred shares who had already converted to Common stock
prior to the payment of the preferred dividends (see footnote 1 to the above
table).
On
June
29, 2004, the Company entered into a termination agreement with Mark Cline
that
granted him 150,000, five year stock purchase warrants to purchase the Company's
Common stock at $1.50 per share in exchange for all previously issued and vested
stock options granted to him plus other considerations. On that date, the
warrants were valued at $204,000 and the Company recorded deferred compensation
of that amount. Subsequently, the Company amortized the entire $204,000,
recording the expense to wages and salaries in 2004.
On
April
20, 2004, the Company awarded to Dr. Kshitij Mohan 1,000,000, ten year options
to purchase the Company’s Common stock for $1.50 per share as part of the two
year contract between Dr. Mohan and the Company to accept the position as Chief
Executive Officer. At the date of the award, the fair market value was $2.24
per
share. In accordance with APB 25, the Company recorded deferred compensation
of
$740,000 at that date and amortized approximately $370,000 and $258,000 in
2005
and 2004, respectively, recording the expense to wages and salaries. The Company
would have recorded $112,000 in 2006 under APB 25.
On
January 2, 2004, the Company entered into a termination agreement with Kent
Smith that granted him 175,000 warrants to purchase the Company's Common stock
at $1.50 per share in exchange for all previously issued and vested stock
options granted to him plus other considerations. The warrants vested
immediately and expire in three years. The options that were cancelled under
the
agreement totaled 569,621 of which 403,080 were fully vested. On that date,
the
warrants were valued at $115,938 and the Company recorded deferred compensation
in that amount. Subsequently, the Company amortized the entire $115,938 to
compensation expense in 2004.
45
CYTOMEDIX,
INC.
Notes
to Financial Statements
At
December 31, the following amounts were accrued for dividends
payable:
2006
|
2005
|
||||||
Series
A Preferred Stock
|
$
|
14,786
|
$
|
13,872
|
|||
Series
B Preferred Stock
|
3,450
|
3,413
|
|||||
Series
C Preferred Stock
|
—
|
10,857
|
|||||
$
|
18,236
|
$
|
28,142
|
No
dividends were declared or paid on the Company’s Common stock in any of the
periods discussed in this report.
Offerings
In
March
2004, the Company entered into a Series C Convertible Preferred Stock Purchase
Agreement with several accredited investors providing for the sale and issuance
of $2.8 million of Series C Convertible Preferred stock (“Series C”)
representing 280 shares, at $10,000 per share, of preferred stock which are
convertible into 2.8 million shares of Common stock. For each Series C share,
the Company issued Series C-1 and Series C-2 warrants allowing the holders
thereof to purchase an aggregate of approximately 2.8 million shares of Common
stock at an exercise price of $1.50 per share. The characteristics and relative
rights of the Series C stock and the basic terms of the C-1 and C-2 warrants
are
discussed earlier in this footnote. Pursuant to a registration rights agreement,
the Company subsequently registered the resale of the Common stock issuable
upon
conversion of the Series C Convertible Preferred stock and the Common stock
issuable upon exercise of the Series C-1 and Series C-2 warrants. The Company
received proceeds from this placement, net of commissions and expenses of
$325,807, of $2,474,193. In addition to the commissions, the placement agent
also received five-year warrants to purchase 280,000 shares of the Company's
Common stock at an exercise price of $1.00 per share and was awarded a six-month
consulting agreement for future financing services in return for compensation
of
$5,000 per month and additional warrants to purchase 100,000 shares of Common
stock at an exercise price of $1.00 per share.
The
Company’s stock price on March 26, 2004 was $2.06; consequently, pursuant to the
requirements of EITF 98-5 “Accounting for Convertible Securities with Beneficial
Conversion Features or Contingently Adjustable Conversion Ratios” (“EITF 98-5”),
as amended by EITF 00-27 “Application of Issue 98-5 to Certain Convertible
Instruments”, the issuance of the Series C stock, which are convertible
initially at $1.00 per share at any time, resulted in a beneficial conversion
feature (the difference between the market price and the conversion price)
recorded as a preferred stock dividend in the amount of $2,800,000.
Simultaneous
with the Series C placement, the Company commenced a separate private placement
in which the Company offered for sale 4,500 units at $1,000 per unit (the “Unit
Offering”), in return for a total of $4,500,000, consisting of cash and
negotiable subscription promissory notes receivable. Each unit consists of
1,000
shares of Common stock and a five-year warrant (the “unit warrants”) to purchase
an additional 1,000 shares at $1.50 per share. The characteristics and relative
rights of the Common stock and the basic terms of the unit warrants are
discussed earlier in this footnote. As compensation for their services, certain
broker-dealers received cash commissions in the amount of 10% of the gross
proceeds. The Company incurred $38,825 of professional fees related to this
placement which have been netted against the proceeds. At December 31, 2004,
the
Company had subscriptions receivable of $825,000 plus accrued interest, all
of
which was received in 2005.
On
May 1,
2006, the Company completed a Class D Warrant Offer whereby, for each $7.50
of
Outstanding Warrants exercised by warrantholders during the offer period, the
Company issued one Class D Warrant which the holder may exercise for one share
of Cytomedix Common Stock at an exercise price of $3.50. These Class D Warrants
have a five year term and are callable at the Company’s discretion if the
closing price of the Company’s Common Stock is at least $4.50 for 10 consecutive
trading days and certain other conditions are met. Through this offer, the
Company received exercises of Outstanding Warrants totaling approximately
$2,280,000 and issued 304,033 Class D Warrants. These Class D Warrants carry
piggyback registration rights whereby the Company must include the shares
underlying these Class D Warrants on any registration statement filed by the
Company after the closing of the Offering.
46
CYTOMEDIX,
INC.
Notes
to Financial Statements
NOTE
12 - LONG-TERM INCENTIVE PLAN
Cytomedix
has a shareholder-approved, Long-Term Incentive Plan (“LTIP”) that permits
incentive awards of options, SARs, restricted stock awards, phantom stock
awards, performance unit awards, dividend equivalent awards and other
stock-based awards. Cytomedix may issue up to 5,000,000 shares of stock under
this LTIP. At December 31, 2006, 1,411,423 shares were available for future
grants. Of all options granted through December 31, 2006, 386,200 had been
exercised and 3,202,377 remained outstanding. Option terms are set by the Board
of Directors for each option grant, and generally vest immediately upon grant
or
over a period of time ranging up to three years, are exercisable in whole or
installments, and expire ten years from the date of grant. These options expire
at various dates through October 11, 2016.
A
summary
of the status of Cytomedix’s LTIP at December 31, 2004, 2005 and 2006, and
changes during the periods then ended, is presented in the tables
below:
Number
of Shares |
Weighted Average |
||||||
Balance
at December 31, 2003
|
1,840,698
|
$
|
1.50
|
||||
Granted
|
1,480,000
|
$
|
1.52
|
||||
Cancelled
|
(749,121
|
)
|
$
|
1.48
|
|||
Exercised
|
(55,000
|
)
|
$
|
1.50
|
|||
Balance
at December 31, 2004
|
2,516,577
|
$
|
1.51
|
||||
Granted
|
517,500
|
$
|
1.52
|
||||
Cancelled
|
—
|
—
|
|||||
Exercised
|
(252,000
|
)
|
$
|
1.46
|
|||
Balance
at December 31, 2005
|
2,782,077
|
$
|
1.68
|
||||
Granted
|
500,000
|
$
|
2.25
|
||||
Cancelled
|
(500
|
)
|
$
|
1.90
|
|||
Exercised
|
(79,200
|
)
|
$
|
1.50
|
|||
Balance
at December 31, 2006
|
3,202,377
|
$
|
1.82
|
47
CYTOMEDIX,
INC.
Notes
to Financial Statements
A
summary
of option activity under the LTIP as of December 31, 2006, and changes during
the year then ended is presented below:
Options
|
|
Shares
|
Weighted-Average
Exercise Price
|
Weighted-Average
Remaining Contractual Term
|
Aggregate
Intrinsic Value
|
||||||||
Outstanding
at January 1, 2006
|
2,782,077
|
$
|
1.68
|
||||||||||
Granted
|
500,000
|
$
|
2.25
|
||||||||||
Exercised
|
(79,200
|
)
|
$
|
1.50
|
|||||||||
Forfeited
or expired
|
(500
|
)
|
$
|
1.90
|
|||||||||
Outstanding
at December 31, 2006
|
3,202,377
|
$
|
1.82
|
7.3
|
$
|
0
|
|||||||
Exercisable
at December 31, 2006
|
2,944,046
|
$
|
1.71
|
7.1
|
$
|
0
|
The
following table summarizes information about stock options outstanding as of
December 31, 2006:
Options
Outstanding
|
Options
Exercisable
|
|||||||||||||||
Range
of Exercise |
Number
of Outstanding |
Weighted
Average
|
Weighted
Average
|
Number Exercisable |
Weighted Average |
|||||||||||
$1.15
- $1.50
|
2,384,877
|
6.7
|
$
|
1.49
|
2,384,877
|
$
|
1.49
|
|||||||||
$2.06
- $2.73
|
645,000
|
9.2
|
$
|
2.42
|
476,668
|
$
|
2.37
|
|||||||||
$3.14
- $6.00
|
172,500
|
8.5
|
$
|
4.08
|
82,501
|
$
|
4.09
|
The
weighted-average grant-date fair value of stock options granted under the LTIP
during the years 2006, 2005, and 2004 was $2.33, $2.74, and $1.46, respectively.
The total intrinsic value of stock options exercised under the LTIP during
the
fiscal years ended December 31, 2006, 2005, and 2004, was $126,000, $916,000,
and $36,000, respectively.
As
of
December 31, 2006, there was $655,170 of total unrecognized compensation cost
related to nonvested stock options granted under the LTIP. That cost is expected
to be recognized over a weighted-average period of 1.7 years. The total fair
value of stock options granted under the LTIP that vested during the fiscal
years ended December 31, 2006, 2005, and 2004, was $1,421,000, $1,459,000,
and
$1,475,000, respectively.
On
July
15, 2005, the Company entered into a Separation Agreement and Release with
William L. Allender. Under said Separation Agreement, Mr. Allender agreed to
provide consulting services to the Company as needed. The Company agreed to
extend the contractual life of 150,000 fully vested options to purchase Common
stock held by Mr. Allender's and to allow cashless exercise of said options
as
part of his severance package. As a result of that modification, the Company
recognized additional compensation expense of $798,000 for the fiscal year
ended
December 31, 2005.
48
CYTOMEDIX,
INC.
Notes
to Financial Statements
NOTE
13 - DEFERRED COMPENSATION
The
components of deferred compensation for the options granted are as follows
at
December 31, 2005:
Beginning
balance
|
$
|
567,788
|
||
Deferred
compensation recorded
|
1,652,666
|
|||
Amortization
of stock-based compensation
|
(1,981,653
|
)
|
||
$
|
238,801
|
Due
to
the adoption of FAS123R on January 1, 2006, the above balance was re-classified
to “Additional paid-in capital”.
NOTE
14 - SUPPLEMENTAL CASH FLOW DISCLOSURES - NON-CASH
TRANSACTIONS
Non-cash
transactions for years ended December 31 include:
2006
|
2005
|
2004
|
||||||||
Commissions
paid in stock
|
$
|
—
|
$
|
—
|
$
|
15,374
|
||||
Accrued
dividends on 6% preferred stock
|
—
|
—
|
79,195
|
|||||||
Accrued
dividends on 8% preferred stock
|
36,361
|
84,902
|
240,665
|
|||||||
Beneficial
conversion feature of Series C
|
||||||||||
Preferred
stock recorded as preferred
|
||||||||||
stock
dividend
|
—
|
—
|
2,800,000
|
|||||||
Stock
issued for executive recruitment fees
|
—
|
35,000
|
—
|
|||||||
Stock
issued for contract litigation settlement
|
—
|
227,500
|
—
|
|||||||
Preferred
dividends paid by issuance of stock
|
35,232
|
166,063
|
240,704
|
|||||||
Note
received for Common stock issued on
|
||||||||||
warrant
exercise
|
620,000
|
—
|
—
|
Cash
paid
for interest and taxes was $0 in 2006, 2005, and 2004,
respectively.
NOTE
15 - RELATED PARTY TRANSACTIONS
BDR,
Inc.
(“BDR”) is a consulting firm owned solely by Jimmy D. Swink, Jr. The Company
entered into a consulting agreement with BDR, dated July 11, 2002. Under this
agreement, the Company granted BDR stock options representing the right to
purchase 300,000 shares of the Company’s Common stock at $1.50 per share (the
fair market value on the date of grant). Additionally, in February 2004, the
Company issued 10-year warrants to purchase an additional 200,000 shares of
Common stock at $1.50 to BDR, in connection with the consulting agreement.
All
such options and warrants are fully vested as of December 31, 2006. Pursuant
to
extensions, this consulting agreement expired on August 31, 2006. Under the
consulting agreement, BDR received compensation totaling $35,000, $186,000,
and
$412,000 (of which $0, $78,000, and $289,000 was equity-based compensation
valued in accordance with SFAS123) for services rendered in the years ended
2006, 2005, and 2004, respectively.
In
1999,
the founder and then sole stockholder of the Company, Charles Worden, and the
Company entered into an agreement where the Company was to pay Mr. Worden a
royalty. Mr. Worden and the Company entered into a substitute royalty agreement
with court approval on November 14, 2001, which superseded the agreement dated
October 29, 1999. The Company agreed to pay Mr. Worden a royalty of five percent
of the gross profit from the sale, licensing or other exploitation of the Worden
Patent. The royalty payment during any calendar year was limited to $600,000.
The Company was to pay Mr. Worden a minimum royalty of $6,250 per month in
advance. For the years ended December 31, 2006, 2005 and 2004, the total royalty
expense was $75,000 per year. The Company granted a security interest and lien
in the Worden Patent. In addition, the Company granted a reversionary interest
in the patent if the Company discontinues substantially all efforts to
commercialize the Worden Patent.
49
CYTOMEDIX,
INC.
Notes
to Financial Statements
The
Carmen Group, Inc. was engaged during the second quarter of 2003 as a business
consultant to strategically position and represent the Company before the
federal government. A former director of the Company, Mr. Robert Burkett, was
also a senior consultant with the Carmen Group, Inc. during the term of the
agreement. Effective October 1, 2003, a formal agreement was signed with the
Carmen Group, Inc. for a period of one year to provide services for the Company
for a flat fee of $15,000 per month plus expenses. Additionally, the agreement
stipulated that the Company would issue to the Carmen Group, Inc. an option
to
purchase 100,000 shares immediately exercisable at $1.25 with an additional
100,000 shares being issuable one year from the date of agreement at an exercise
price of $2.00. In 2004, the Carmen Group provided services to the Company
amounting to $377,000, which included $240,000 of stock-based compensation.
The
Company did not incur any expenses in 2005 or 2006 relating to this agreement
as
this agreement expired September 30, 2004, and was neither renewed nor
extended.
NOTE
16 - OPERATING LEASES
The
Company leases its office space under an operating lease expiring in July 2008,
with future minimum lease payments as indicated in the table
below:
Years
ending December 31:
|
||||
2007
|
$
|
64,658
|
||
2008
|
38,369
|
|||
Thereafter
|
—
|
|||
Total
future minimum lease payments
|
$
|
103,027
|
For
the
years ended December 31, 2006, 2005 and 2004, the Company incurred rent expense
of approximately $63,000, $44,000 and $32,000, respectively.
NOTE
17 - COMMITMENTS AND CONTINGENCIES
Under
the
Company’s plan of reorganization upon emergence from bankruptcy in July 2002,
the pre-bankruptcy Series A Preferred stock and the dividends accrued thereon
that existed prior to emergence from bankruptcy are exchanged into one share
of
new Common stock for every five shares of pre-bankruptcy Series A Preferred
shares held as of the date of emergence from bankruptcy. This exchange is
contingent on the successor Company’s attaining aggregate gross revenues for
four consecutive quarters of at least $10,000,000 prior to July 2009 and would
result in the issuance of approximately 350,000 shares of Common
stock.
Under
a
distributor agreement, title passes when invoiced product is received by the
distributor or its designee in acceptable condition. Cytomedix recognizes
revenue when shipped and does not reserve for defective merchandise.
Historically, returns for defective merchandise from all customers have been
negligible.
NOTE
18 - SUBSEQUENT EVENTS
In
January 2007, the Board of Directors authorized the grant of certain stock
options under the Long-Term Incentive Plan to board members for their upcoming
service in 2007. These options have an exercise price of $1.10, vest in equal
monthly installments through December 2007, and expire ten years from the date
of grant.
In
February 2007, the terms of the Note from FEQ Investments were amended to
accelerate a portion of the principal payments and extend the remainder. As
amended, the final installment payment is due by April 30, 2007. All other
terms
of the Note remain unchanged and in full force and effect.
50
CYTOMEDIX,
INC.
Notes
to Financial Statements
NOTE
19 - QUARTERLY FINANCIAL DATA (UNAUDITED)
First Quarter |
Second Quarter |
Third Quarter |
Fourth Quarter |
||||||||||
2006
|
|||||||||||||
Revenues
|
$
|
485,537
|
$
|
411,324
|
$
|
574,091
|
$
|
477,203
|
|||||
Gross
profit
|
$
|
221,975
|
$
|
188,038
|
$
|
350,773
|
$
|
172,784
|
|||||
Net
income (loss)
|
$
|
(1,214,998
|
)
|
$
|
801,155
|
$
|
(1,032,850
|
)
|
$
|
(816,263
|
)
|
||
Income
(loss) per common share--
|
|||||||||||||
Basic
|
$
|
(0.05
|
)
|
$
|
0.03
|
$
|
(0.04
|
)
|
$
|
(0.03
|
)
|
||
Diluted
|
$
|
(0.05
|
)
|
$
|
0.02
|
$
|
(0.04
|
)
|
$
|
(0.03
|
)
|
||
2005
|
|||||||||||||
Revenues
|
$
|
271,174
|
$
|
305,129
|
$
|
446,384
|
$
|
491,738
|
|||||
Gross
profit
|
$
|
116,733
|
$
|
101,123
|
$
|
251,102
|
$
|
164,143
|
|||||
Net
loss
|
$
|
(2,096,729
|
)
|
$
|
(1,269,514
|
)
|
$
|
(2,281,948
|
)
|
$
|
(855,294
|
)
|
|
Loss
per common share--
|
|||||||||||||
Basic
and diluted
|
$
|
(0.10
|
)
|
$
|
(0.05
|
)
|
$
|
(0.09
|
)
|
$
|
(0.03
|
)
|
51
ITEM
9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
None.
ITEM
9A. CONTROLS AND PROCEDURES
Conclusion
Regarding the Effectiveness of Disclosure Controls and
Procedures
Under
the
supervision and with the participation of management, including the Chief
Executive Officer (“CEO”) and Chief Financial Officer (“CFO”), the Company
conducted an evaluation of its disclosure controls and procedures, as such
term
is defined under Rule 13a-15(e) promulgated under the Securities Exchange Act
of
1934, as amended (the “Exchange Act”) as of December 31, 2006. Based on this
evaluation, its CEO and CFO concluded the Company's disclosure controls are
not effective.
Management’s
Report on Internal Control over Financial Reporting
The
Company’s management is responsible for establishing and maintaining adequate
internal control over financial reporting, as such term is defined in Exchange
Act Rule 13a-15(f). Under the supervision and with the participation of its
management, including the CEO and CFO, the Company conducted an evaluation
of
the effectiveness of its internal control over financial reporting based on
the
framework in Internal Control—Integrated Framework issued by the Committee of
Sponsoring Organizations of the Treadway Commission. Based on this evaluation
under the framework in Internal Control—Integrated Framework, management
concluded that the Company’s internal control over financial reporting was
not effective as of December 31, 2006.
Two
material weaknesses were noted based on evidence of errors in application
of
controls over financial disclosures and in recording stock-based compensation
expense. The financial statement disclosure errors related primarily to SFAS109,
Accounting
for Income Taxes,
and the
recently adopted SFAS123R, Share-Based
Payment.
While a
disclosure checklist was utilized for year-end reporting, certain disclosures
were not included or properly prepared. Errors were also noted in the recording
of stock-based compensation related to one set of option grants.
Management
is in the process of evaluating these issues and will take remedial action
in
2007.
Management’s
assessment of the effectiveness of internal control over financial reporting
as
of December 31, 2006, has been audited by L J Soldinger Associates, LLC, an
independent registered public accounting firm, as stated in their report as
set
forth on the following page.
Changes
in Internal Control over Financial Reporting
The
Company made the following changes in its internal controls over financial
reporting during the quarterly period ended December 31, 2006, that have
materially affected, or are reasonably likely to materially affect, its internal
control over financial reporting:
§ |
Created
formal documentation of internal control structure and testing of
key
internal controls
|
§ |
Implemented
system of mandatory signatures to evidence preparation and review
of items
that encompass certain key controls
|
§ |
Formalized
a company-wide authority matrix regarding contracts, purchasing,
and
invoice approval
|
§ |
Developed
checklists to be used at certain regular meetings to ensure comprehensive
discussion of internal controls
|
52
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the
Board of Directors and
Shareholders
of Cytomedix, Inc.
We
have
audited management's assessment, included in the accompanying section Item
9A.
Control and Procedures, that Cytomedix, Inc. did not maintain effective internal
control over financial reporting as of December 31, 2006, based on criteria
established in Internal Control-Integrated Framework issued by the Committee
of
Sponsoring Organizations of the Treadway Commission (COSO). Cytomedix, Inc.'s
management is responsible for maintaining effective internal control over
financial reporting and for its assessment of the effectiveness of internal
control over financial reporting. Our responsibility is to express an opinion
on
management's assessment and an opinion on the effectiveness of the company's
internal control over financial reporting based on our audit.
We
conducted our audit in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that
we plan
and perform the audit to obtain reasonable assurance about whether effective
internal control over financial reporting was maintained in all material
respects. Our audit included obtaining an understanding of internal control
over
financial reporting, evaluating management's assessment, testing and evaluating
the design and operating effectiveness of internal control, and performing
such
other procedures as we considered necessary in the circumstances. We believe
that our audit provides a reasonable basis for our opinion.
A
company's internal control over financial reporting is a process designed
to
provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles. A company's internal control
over
financial reporting includes those policies and procedures that (1) pertain
to
the maintenance of records that, in reasonable detail, accurately and fairly
reflect the transactions and dispositions of the assets of the company; (2)
provide reasonable assurance that transactions are recorded as necessary
to
permit preparation of financial statements in accordance with generally accepted
accounting principles, and that receipts and expenditures of the company
are
being made only in accordance with authorizations of management and directors
of
the company; and (3) provide reasonable assurance regarding prevention or
timely
detection of unauthorized acquisition, use, or disposition of the company's
assets that could have a material effect on the financial
statements.
Because
of its inherent limitations, internal control over financial reporting may
not
prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may
become
inadequate because of changes in conditions, or that the degree of compliance
with the policies or procedures may deteriorate.
A
material weakness is a control deficiency, or combination of control
deficiencies, that results in more than a remote likelihood that a material
misstatement of the annual or interim financial statements will not be prevented
or detected. The following two material weaknesses have been identified and
included in management's assessment. The material weaknesses were based on
evidence of errors in application of controls over financial disclosures
and in
recording stock-based compensation expense. The financial statement disclosure
errors related primarily to SFAS 109, Accounting for Income Taxes, and the
recently adopted SFAS 123R, Share-Based Payment. While a disclosure checklist
was utilized for year-end reporting, certain required disclosures were not
included or properly prepared. Errors were also noted in the calculation
and
recording of stock-based compensation related to one set of option
grants.
These
material weaknesses were considered in determining the nature, timing, and
extent of audit tests applied in our audit of the 2006 financial statements,
and
this report does not affect our report dated February 23, 2007 on those
financial statements.
In
our
opinion based on our audit, management's assessment that Cytomedix, Inc.
did not
maintain effective
internal
control over financial reporting as of December 31, 2006, is fairly stated,
in
all material respects, based on criteria established in Internal
Control-Integrated Framework issued by the Committee of Sponsoring Organizations
of the Treadway Commission (COSO). Also, in our opinion, because of the effect
of the material weakness described above on the achievement of the objectives
of
the control criteria, Cytomedix, Inc. has not maintained effective internal
control over financial reporting as of December 31, 2006 based on criteria
established in Internal Control-Integrated Framework issued by the Committee
of
Sponsoring Organizations of the Treadway Commission (COSO).
We
have
also audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), the balance sheets and the related statements
of operations, stockholders' equity and cash flows of Cytomedix, Inc., and
our
report dated February 23, 2007 expressed an unqualified opinion.
L
J
SOLDINGER ASSOCIATES LLC
Deer
Park, Illinois, USA
February
23, 2007
53
ITEM
9B. OTHER INFORMATION
None.
54
PART
III
ITEM
10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The
Company’s directors, executive officers and significant employees are listed
below:
Name
|
Age
|
Date
of Election or
Appointment |
Position(s)
with the Company
|
|||
James
S. Benson
|
|
67
|
|
November
1, 2004
|
|
Director
|
David
P. Crews
|
44
|
September
28, 2001
|
Director
|
|||
Arun
K. Deva
|
62
|
November
23, 2004
|
Director
|
|||
David
F. Drohan
|
68
|
July
12, 2004
|
Director
|
|||
Mark
T. McLoughlin
|
51
|
June
7, 2004
|
Director
|
|||
Kshitij
Mohan
|
61
|
April
20, 2004
|
Chairman
of the Board
|
|||
Chief
Executive Officer
|
||||||
Andrew
S. Maslan
|
37
|
August
15, 2005
|
Chief
Financial Officer
|
|||
Carelyn
P. Fylling
|
59
|
December
1, 2001
|
Vice
President of Professional
Services
|
JAMES
S. BENSON
has
served as a Director since November 1, 2004. Mr. Benson has over 25 years of
experience in the healthcare industry, and also serves as a director of
Cryolife, Inc. Recently, he retired from the Advanced Medical Device Association
(AdvaMed) where he served as executive vice president for technical and
regulatory affairs. Prior to that, he held numerous senior positions at the
FDA
over a twenty year period. He retired from the FDA as director of the Center
for
Devices and Radiological Health (CDRH). Earlier, he served as deputy
commissioner of the FDA, and also as its commissioner for a one-year period.
During his tenure with the FDA, Mr. Benson worked closely with other Federal
agencies and worked with Congress to craft and create various pieces of
legislation including "The Food and Drug Modernization Act of 1997", "The
Biomaterials Access Act of 1998" and "The Medical Device User Fee and
Modernization Act of 2002". Mr. Benson earned a B.S. degree in civil engineering
from the University of Maryland and a M.S. degree in nuclear engineering from
the Georgia Institute of Technology.
DAVID
P. CREWS
has
served as a Director since his election through the consent solicitation that
became effective on September 28, 2001. Mr. Crews is executive vice president
of
Crews and Associates, Inc., a brokerage house located in Little Rock, Arkansas,
founded by his father. Mr. Crews has worked at Crews & Associates for more
than 22 years, specializing in the fixed income markets. He is a former partner
of All American Leasing, a municipal finance firm, and also serves as vice
president, secretary, and treasurer of CHASC, Inc., an entity that acquired
Smith Capital Management (an investment advisory firm). Mr. Crews is also a
Board Member of Pure Energy Group, Inc. (an oil and gas company).
ARUN
K. DEVA
has
served as a Director since November 23, 2004. Mr. Deva is the founder and
President of Deva & Associates, P.C., a Rockville, Maryland based mid-size
accounting and consulting firm that provides accounting, auditing, litigation
support, due diligence, cost-benefit analysis and other financial consulting
services to many Federal agencies and corporations. He is also the founder
and
President of CPAMoneyWatch.com, LLC, a web based business services provider
offering online accounting and business solutions to small and mid-sized
businesses. Prior to establishing Deva & Associates in 1991, Mr. Deva was a
partner at Touche Ross & Co. (now Deloitte & Touche). He has served as a
management consultant for several public and private companies with a focus
on
financial restructurings, negotiations with lenders and creditors, financial
reporting and disclosures, and filings with the Securities and Exchange
Commission. Mr. Deva is a member of the American Institute of Certified Public
Accountants, Maryland Association of Certified Public Accountants and
Association of Government Accountants. He was appointed to the Maryland Banking
Board by the Governor of Maryland for a six-year term ending in 2008. Mr. Deva
earned his Bachelor of Commerce degree in accounting from St. Xavier's College
in India and a Masters of Business Administration degree in Finance from Indiana
University, Bloomington, Indiana.
DAVID
F. DROHAN
has
served as a Director since July 12, 2004. Mr. Drohan recently retired from
Baxter Healthcare Corporation where he served as Senior Vice President and
President of Baxter's medication delivery business, a position he held since
May
2001. In this capacity, he had direct general management responsibility for
the
development and worldwide marketing of intravenous products, drug-delivery
and
automated distribution systems, as well as anesthesia, critical care and
oncology products representing $4 billion in combined annual sales. He joined
Baxter in 1965 as a territory manager in New York and throughout the years
has
held a succession of senior positions. Prior to joining Baxter, Mr. Drohan
worked for Proctor & Gamble. He is currently a director of Cytomedix, Inc.
as well as a director of Pharmedium Health Care Corp. He is a trustee of Parents
Project Muscular Dystrophy and a director of the Baxter Credit Union. He earned
his bachelor's degree in industrial relations from Manhattan College, New York.
55
MARK
T. McLOUGHLIN
has
served as a Director since June 7, 2004. Mr. McLoughlin currently serves as
Sr.
Vice President, Chief Marketing Officer - International for Cardinal Health,
Inc., one of the world's largest health care manufacturing and distribution
companies. In this capacity, he has strategic responsibility for the entire
International Marketing organization for Cardinal Health based in Geneva
Switzerland. Prior to joining Cardinal, he was vice president of commercial
operations for Norwood Abbey Ltd., an Australian-based medical technology
company. Earlier, he was President of North American operations for Ion Beam
Application, Inc., a Belgium-based global medical technology company. His
executive career experience also includes Mallinckrodt, as well as positions
with other healthcare companies.
DR.
KSHITIJ MOHAN
was
appointed as Chief Executive Officer on April 20, 2004 and has served as a
Director since May 7, 2004 and Board Chairman since July 12, 2005. Prior to
assuming his positions in the Company, Dr. Mohan served as Chief Executive
officer of International Remote Imaging Systems, Inc., the predecessor company
of IRIS International. Previously, he was the Chief Regulatory and Technology
Strategist for the Law Firm of King and Spalding, Senior Vice-President and
Chief Technology Officer for Boston Scientific Corporation, and Corporate
Vice-President of Baxter International, responsible for all corporate research
and technical services and was a member of the Baxter operating management
team.
Prior to entering the private sector, Dr. Mohan served in various capacities
within the U.S. Food and Drug Administration, including leading the science
and
technology programs and the office of product evaluation and approval of medical
devices and between 1979 - 1983 served in the White House Office of Management
and Budget with responsibilities for the national R & D policies, programs
of the National Science Foundation and NASA's Aeronautical and Space Research
and Technology programs. Dr Mohan has been widely published in the field of
health policies, regulations and Applied Physics and served on numerous Boards
including the Corporate Advisory Boards of the Schools of Engineering at
Dartmouth College and the University of California at Riverside. Dr. Mohan
earned a PH.D. degree in Physics from Georgetown University, a M.S. degree
in
Physics from the University of Colorado and a B.Sc., First Class Honors, Patna
University, Patna, India.
ANDREW
S. MASLAN
joined
the company as corporate controller on July 1, 2005, and became our Chief
Financial Officer on August 15, 2005. Mr. Maslan most recently served as
controller for BioReliance Corporation based in Rockville, Maryland, which
was
acquired by Invitrogen (Nasdaq: IVGN) in February 2004. Earlier, he held
positions with two other Rockville, Maryland-based companies, serving as a
principal with GlobeTraders, Inc., and senior accountant for Providence
Laboratory Associates. Mr. Maslan began his professional career serving as
an
auditor with KPMG Peat Marwick, and is a certified public accountant licensed
in
the state of Maryland.
CARELYN
P. FYLLING, RN, MSN,
has
served as the Company's Vice President of Professional Services since December
2001. Ms. Fylling was director of training and program development at the
International Diabetes Center in Minneapolis, Minnesota. She also has served
on
the national Board of Directors of the American Diabetes Association and
numerous national committees of the American Diabetes Association. Ms. Fylling
received the prestigious Ames Award for Outstanding Educator in the Field of
Diabetes. Subsequently, she joined Curative Health Services and helped the
company grow from three employees to over 650 employees. During her 13 years
at
Curative, Ms. Fylling helped to design the national wound database, developed
clinical protocols, conducted outcome studies, trained physicians and nurses
in
comprehensive wound management, wrote scientific articles and abstracts,
assisted in clinical trials and marketing, and developed an Internet-based
online wound care training program for health professionals. Subsequently,
she
provided independent consulting and outsourcing services to the health care
industry through Fylling Associates, LLC, which she wholly owns, and through
Strategic Partners, LLC, in which she held a partnership interest.
Audit
Committee
At
a
meeting of the Board of Directors in December 2004, the Board formed an Audit
Committee. Mr. Arun K. Deva serves as chairman of the Audit Committee and is
the
audit committee financial expert. The Board has determined that Mr. Deva is
“independent” as defined by section 121(A) of the listing standards of the
American Stock Exchange and Item 7(d)(3)(iv) of Schedule 14A of the Securites
Exchange Act of 1934. Other members of the Audit Committee are Messrs. David
P.
Crews and David F. Drohan.
56
Code
of Conduct and Ethics
In
April 2005, the Board approved a Code of Conduct and Ethics applicable to all
directors, officers and employees which complies with Section 807 of the
American Stock Exchange Corporate Governance Requirements and with the
definition of a "code of ethics" as set forth in Item 406 of SEC Regulation
S-K.
A copy of this Code of Conduct is available at the Company’s website at
www.cytomedix.com ,and is available at no charge by contacting the Company
at
it’s headquarters as listed on the cover page of this report.
Section
16(a) Beneficial Ownership Reporting Compliance
Section
16(a) of the Act requires officers, directors and persons who own more than
ten
percent of a registered class of equity securities to, within specified time
periods, file certain reports of ownership and changes in ownership with the
SEC. The Company is not aware of any failure to file initial statements of
beneficial ownership of securities (Forms 3) or change in beneficial ownership
reports or report transactions (Forms 4) in a timely manner during the fiscal
year ended December 31, 2006, by any of the current directors or executive
officers.
ITEM
11. EXECUTIVE COMPENSATION
During
2006, the Company had the following executive officers: Kshitij Mohan, CEO;
Andrew S. Maslan, Chief Financial Officer; Carelyn P. Fylling, Vice President
of
Professional Services.
Compensation
Discussion and Analysis
The
Compensation Committee has responsibility for reviewing and making
recommendations to the Board of Directors with respect to the Company’s overall
executive compensation policy, including such items as (i) the annual base
salary, annual bonus, and annual and long-term equity-based or other incentives
of each corporate officer, including the CEO; (ii) corporate goals and
objectives relevant to each executive officer’s compensation, evaluate each
executive officer's performance in light of those goals and objectives, and
recommend each executive officer's compensation level based on this evaluation,
which recommendation will be subject to approval by the full Board; and (iii)
any other matter, such as severance agreements, change in control agreements,
or
special or supplemental executive benefits, within the Committee's
authority:
The
overall compensation policy, which is applicable to the Cytomedix executive
officers, is to position the aggregate of the compensation components at a
level
commensurate with the Company’s size and performance relative to similar
companies. The Compensation Committee seeks to make compensation decisions
consistent with the long-term growth and performance objectives of the Company.
The Compensation Committee implements its compensation policy in a manner
designed to maximize shareholder benefit by aligning the interests of employees
with the interests of shareholders through the award of stock options and
motivating executive officers by rewarding them based on
performance.
The
Company is committed to providing a competitive pay program that is fair,
non-discriminatory, and attractive to quality personnel. Further, the Cytomedix
pay program is structured to achieve motivation of its employees and efficient
performance. Accordingly, Cytomedix has structured its pay program to achieve
these goals through an appropriate mix of cash and equity-based compensation
as
well as productivity-based awards.
The
Company’s executive compensation program currently consists primarily of salary,
annual peformance bonuses and incentive awards in the form of stock options
under the Company’s Long-Term Incentive Plan. The Compensation Committee
believes that stock options awarded under the Cytomedix Long-Term Incentive
Plan
provide the most useful incentive to encourage executive officers and other
employees to maximize productivity and efficiency because the value of such
options relates to the Company’s stock price. Awards under the Long-Term
Incentive Plan have the effect of more closely aligning the interests of the
Company’s employees with its shareholders, while at the same time offering an
attractive vehicle for the recruitment, retention, and compensation of
employees.
The
CEO’s
annual performance bonus is dependent on his performance against pre-determined
management business objectives (“MBO’s”). The MBO’s in effect for the CEO’s most
recently completed employment year related to the following general
areas:
§ |
Patents
and Licensing
|
o |
Resolution
of actual and potential infringement
matters
|
o |
Development
and implementation of utilization
strategies
|
§ |
Product
Development
|
o |
Completion
of clinical trial and submission of preliminary
results
|
o |
Development
and implementation of regulatory
strategy
|
o |
Completion
of a pharmaco-economic study
|
o |
Development
of a strategy for submission to the Center of Medicare and Medicaid
Services
|
§ |
Sales
and Marketing
|
o |
Finalize
potential sales contracts and further development of independent
slaes
representative network
|
§ |
Financial
Performance
|
o |
Increase
gross revenues
|
o |
Secure
additional financing, if necessary
|
o |
Further
development of strategic plan
|
57
While
based generally on the CEO’s merit and performance and considering his
contribution to Cytomedix’s success, the specific performance criteria are set
by the Compensation Committee and approved by the Board of Directors on an
annual basis to reflect an appropriate balance of the Company’s short-term and
long-term goals.
Goals
and
objectives for other executive officers are designed to facilitate the
achievement of the overarching Company goals reflected in the CEO’s
MBO’s.
Summary
Compensation and Grants
Summary
Compensation Table for the year ended December 31,
2006
Name
and Principal Position
|
Year
|
Salary
|
Bonus
|
Option
Awards
|
All
Other Compensation
|
Total
|
||||||||||||||
Kshitij
Mohan
|
(1) |
2006
|
$
|
323,549
|
$
|
150,000
|
$
|
311,503
|
$
|
25,619
|
$
|
810,671
|
||||||||
Chief
Executive Officer
|
||||||||||||||||||||
(Effective
April 1, 2004)
|
||||||||||||||||||||
Andrew
S. Maslan
|
(2) |
2006
|
148,500
|
27,700
|
160,304
|
844
|
337,348
|
|||||||||||||
Chief
Financial Officer
|
||||||||||||||||||||
(Effective
August 16, 2005)
|
||||||||||||||||||||
Carelyn
P. Fylling
|
(3) |
2006
|
136,500
|
—
|
15,059
|
169
|
151,728
|
|||||||||||||
VP
Professional Services
|
(1) Upon
acceptance of the position of Chief Executive Officer, Dr. Mohan was awarded
1,000,000 ten-year options to purchase the Company’s Common stock for $1.50.
Under the terms of his employment agreement, 500,000 options vested immediately,
250,000 vested in April 2005 and the remaining options will vest in April 2006.
Also, pursuant to this agreement, upon reaching the first and second anniversary
dates of his agreement, Dr. Mohan received 100,000 ten-year options at $1.50.
Amounts in the All Other Compensation column consist of $25,000 that Dr. Mohan
received as a “perk package and $619 in company paid life insurance premiums for
Dr. Mohan’s benefit.
(2) Pursuant
to his employment agreement as amended, in 2005 Mr. Maslan was granted 60,000
ten-year options to purchase shares of the Company’s Common stock at an exercise
price of $5.07 per share and, in 2006 Mr. Maslan was granted 40,000 and 50,000
ten-year options to purchase shares of the Company’s Common stock at exercise
prices of $2.23 and $2.75 per share, respectively. Options vest at intervals
through October 2009. Amounts in the All Other Compensation column consist
of
$844 in company paid life insurance premiums for Mr. Maslan’s
benefit.
(3) In
2006,
Ms. Fylling was granted 20,000 ten-year options to purchase shares of Common
stock at $2.40. Amounts in the All Other Compensation column consist of $169
in
company paid life insurance premiums for Ms. Fylling’s benefit.
58
Grants
of Plan-Based Awards in 2006
Name
|
Grant
Date
|
Date
Board Took Action to Grant Award
|
Option
Awards: Number of Securites Underlying Options
|
Exercise
Price of Option Awards
|
Grant
Date Fair Value of Option Awards
|
|||||||||||
Kshitij
Mohan
|
8/17/2006
|
4/19/2004
|
100,000
|
$
|
1.50
|
$
|
207,700
|
|||||||||
Andrew
S. Maslan
|
3/17/2006
|
3/17/2006
|
40,000
|
$
|
2.23
|
$
|
94,800
|
|||||||||
|
10/11/2006
|
10/11/2006
|
50,000
|
$
|
2.73
|
$
|
127,000
|
|||||||||
Carelyn
P. Fylling
|
1/12/2006
|
1/12/2006
|
20,000
|
$
|
2.40
|
$
|
45,200
|
Narrative
Disclosure to Summary Compensation and Grants
The
Company has the following employment agreements with its executive
officers:
Kshitij
Mohan: On April 20, 2004, the Company entered into an employment
contract with Dr. Kshitij Mohan to serve as Chief Executive Officer. The
employment contract had an initial term of two years. The term is automatically
extended by one year increments on each anniversary of the effective date unless
the contract is otherwise terminated in accordance with its provisions. As
an
inducement to enter this agreement, Dr. Mohan received 1,000,000 ten-year stock
options at an exercise price of $1.50 per share. Of these options, 500,000
became immediately exercisable with the remaining 250,000 becoming exercisable
on the first anniversary of the agreement, and the remaining 250,000 becoming
exercisable on the second anniversary. Dr. Mohan’s base salary for the first
contract year was $275,000, increasing by at least 10% on each anniversary
of
the agreement. At December 31, 2006, Dr. Mohan’s annual base salary was
$332,750. Pursuant to this agreement, Dr. Mohan was entitled to and received
100,000 options upon each of the first and second anniversary dates of this
agreement. These options had a ten-year term and an exercise price of $1.50
per
share. Additionally, in each of the first and second years of this agreement,
Dr. Mohan received $150,000 cash bonus upon the achievement of performance
criteria agreed upon by Dr. Mohan and the Board of Directors. In employment
years ending April 20, 2007 and beyond, Dr. Mohan is eligible for an annual
bonus at the discretion of the Board of Directors, upon the achievement of
mutually agreed-upon performance criteria. Dr. Mohan also receives a guaranteed
“perk package” of $25,000 to be paid at the beginning of each year under the
term of this agreement.
Andrew
Maslan:
On June
3, 2005, the Company entered into an employment agreement with Mr. Andrew S.
Maslan to serve as Corporate Controller. Employment was at will, with certain
notification provisions. Mr. Maslan’s base salary was $135,000, subject to
review at the end of the first calendar year. Mr. Maslan’s annual target bonus
percentage was 20%, depending on the achievement of performance criteria. Mr.
Maslan was also granted 60,000 ten-year options to purchase shares of the
Company’s Common stock at an exercise price of $5.07. In October 2006, this
agreement was amended to increase Mr. Maslan’s annual base salary to $155,000
and target bonus percentage to 25% and provided for the grant of an additional
50,000 10-year options to purchase the Company’s stock at a price of $2.73 per
share. Additional grants of options or increases to base salary may be
considered annually, as of the anniversary date of the amended agreement, or
in
the ordinary course of business at the discretion of the CEO and Board of
Directors.
Carelyn
Fylling:
On
September 4, 2002, the Company entered into an employment agreement with Ms.
Carelyn P. Fylling to serve as Vice President of Professional Services. The
term
was for a period of one year, renewable on the first anniversary for a period
of
two years and in one year increments thereafter. Under the agreement, Ms.
Fylling's base salary was $130,000, subject to increase upon review by the
Board
at the end of each calendar year. Stock options and annual bonus are at the
discretion of the Board. Other benefits are in accordance with Company
policy.
59
Outstanding
Equity Awards at December 31, 2006
Option
Awards
|
||||||||||||||
Name
|
Number
of Securities Underlying Unexercised Options
Exercisable
(1)
|
Number
of Securities Underlying Unexercised Options
Unexercisable
|
Option
Exercise Price
|
Option
Expiration Date
|
||||||||||
Kshitij
Mohan
|
990,000
|
—
|
$
|
1.50
|
4/20/2014
|
|||||||||
100,000
|
—
|
$
|
1.50
|
6/6/2015
|
||||||||||
100,000
|
—
|
$
|
1.50
|
8/17/2016
|
||||||||||
Andrew
S. Maslan
|
30,000
|
30,000
|
(2)
|
$
|
5.07
|
1/11/2016
|
||||||||
13,334
|
26,666
|
(3)
|
$
|
2.23
|
3/16/2016
|
|||||||||
|
—
|
50,000
|
(4)
|
$
|
2.73
|
10/11/2016
|
||||||||
Carelyn
P. Fylling
|
250,000
|
—
|
$
|
1.50
|
8/7/2012
|
|||||||||
19,077
|
—
|
$
|
1.25
|
10/21/2013
|
||||||||||
|
—
|
20,000
|
(5)
|
$
|
2.40
|
1/11/2016
|
(1) |
All
options are fully vested.
|
(2) |
Options
vest as follows: 15,000 on 7/1/2007, 15,000 on
7/1/2008
|
(3) |
Options
vest as follows: 13,333 on 3/17/2007, 13,333 on
3/17/2008
|
(4) |
Options
vest as follows: 16,667 on 10/11/2007, 16,667 on 10/11/2008, 16,666
on
10/11/2009
|
(5) |
Options
vest as follows: 6,667 on 1/12/2007, 6,667 on 1/12/2008, 6,666 on
1/12/2009
|
Potential
Payments Upon Termination or Change-in-Control
The
following table presents potential payments to executive officers upon
termination or a change-in-control event as defined by their respective
employment agreements, based on assumptions as if the event took place on
December 31, 2006.
Name
/ Reason
for Termination
|
Base
Salary
|
Discretionary
Bonus
|
||||||
Kshitij
Mohan
|
||||||||
Disability
|
(1) |
305,021
|
170,536
|
|||||
Change
of Control
|
(2) |
665,500
|
488,200
|
|||||
Not
for Cause
|
(3) |
665,500
|
658,736
|
|||||
Death
|
(4) |
—
|
—
|
|||||
Voluntary
by Dr. Mohan
|
(5) |
—
|
—
|
|||||
Andrew
S. Maslan
|
||||||||
Not
for Cause
|
(6) |
77,500
|
—
|
|||||
Carelyn
P. Fylling
|
||||||||
Disability
|
(7) |
125,125
|
—
|
|||||
Death
|
(8) |
—
|
—
|
|||||
Not
for Cause
|
(9) |
68,250
|
—
|
|||||
Involuntary
Termination by
Ms. Fylling for Good
Reason
|
(10) |
125,125
|
—
|
|||||
Change
of Control
|
(11) |
68,250
|
—
|
|||||
Voluntary
by Ms. Fylling
|
(12) |
37,538
|
—
|
60
(1) |
Base
salary will be paid over a period of 11 months, less net amounts
received
under Company sponsored long-term disability insurance. Discretionary
bonus was estimated based on pro-rata portion (based on current employment
year) and targeted $150,000 annual cash bonus and 100,000 annual
option
grant. All unexercised options granted to Dr. Mohan will remain
exercisable through their original expiration
date.
|
(2) |
Base
salary will be paid over a period of 24 months. Discretionary bonus
is due
within 30 days of change-in-control and is equal to two years bonus
estimated based on targeted $150,000 annual cash bonus and 100,000
annual
option grant. All unexercised options granted to Dr. Mohan will remain
exercisable through their original expiration
date.
|
(3) |
Base
salary will be paid over a period of 24 months. Discretionary bonus
is due
within 30 days of change-in-control and is equal to pro-rata portion
(based on current employment year) plus two years bonus estimated
based on
targeted $150,000 annual cash bonus and 100,000 annual option grant.
All
unexercised options granted to Dr. Mohan will remain exercisable
through
their original expiration date.
|
(4) |
All
unexercised options granted to Dr. Mohan will remain exercisable
through
their original expiration date.
|
(5) |
If
Dr. Mohan provides 30 days prior written notice to facilitate transition,
then all unexercised options granted to Dr. Mohan will remain exercisable
through their original expiration date. Otherwise, unexercised options
granted to Dr. Mohan will expire three months after
termination.
|
(6) |
Base
salary will be paid over a period of 6 months. Unvested options will
continue to vest for a period of six months from
termination.
|
(7) |
Base
salary will be paid over a period of 11 months, less net amounts
received
under Company sponsored long-term disability insurance. Prorated
bonus and
incentive compensation based on the then-applicable bonus plan/long-term
incentive compensation program (based on current employment
year).
|
(8) |
Base
salary through end of month in which death occurs, plus prorated
bonus and
incentive compensation based on the then-applicable bonus plan/long-term
incentive compensation program (based on current employment year).
All
vested stock options become property of the executive's
estate.
|
(9) |
Lump
sum severance payment equal to six months of base salary. Prorated
bonus
and incentive compensation based on the then-applicable bonus
plan/long-term incentive compensation program (based on current employment
year). The exercise date of all stock options shall be extended for
twelve
months following the date of
termination.
|
(10) |
Lump
sum severance payment equal to eleven months of base salary. Prorated
bonus and incentive compensation based on the then-applicable bonus
plan/long-term incentive compensation program (based on current employment
year). The exercise date of all stock options shall be extended for
twelve
months following the date of
termination.
|
(11) |
All
issued and unvested stock options become immediately fully vested
and
exercisable. Lump sum severance payment equal to six months of base
salary. Prorated bonus and incentive compensation based on the
then-applicable bonus plan/long-term incentive compensation program
(based
on current employment year). The exercise date of all stock options
shall
be extended for twelve months following the date of
termination.
|
(12) |
Ms.
Fylling's employment may be terminated voluntarily (i) upon written
consent of Ms. Fylling and the Company, or (ii) upon sixty days'
written
notice by Ms. Fylling. If voluntarily terminated pursuant to (i),
Ms.
Fylling agrees to stay in the employ of the Company for three months,
in
which she will receive 110% of her base salary. If voluntarily terminated
pursuant to (ii), the Company may accelerate the termination date
by
paying the base salary for such sixty day period in a lump
sum.
|
Compensation
of Directors
For
service during 2006, each non-employee director was entitled to and received
options to purchase 30,000 shares of the Company’s Common stock; each committee
chair was entitled to and received options to purchase 10,000 shares of the
Company’s Common stock; each non-employee director was entitled to and received
$500 for his participation in each telephonic meeting of the Board or a
Committee and $1,000 for his participation in each in-person meeting of the
Board or a Committee.
Director
Compensation in 2006
Name
|
Fees
Earned or Paid in Cash
|
Option
Awards (1)
|
Total
|
|||||||
James
S. Benson
|
$
|
7,000
|
$
|
84,640
|
$
|
91,640
|
||||
David
P. Crews
|
$
|
8,000
|
$
|
63,480
|
$
|
71,480
|
||||
Arun
K. Deva
|
$
|
9,000
|
$
|
84,640
|
$
|
93,640
|
||||
David
F. Drohan
|
$
|
7,000
|
$
|
63,480
|
$
|
70,480
|
||||
Mark
T. McLoughlin
|
$
|
6,500
|
$
|
84,640
|
$
|
91,140
|
(1) |
At
December 31, 2006, the following number of stock options remained
unexercised by non-employee directors as follows: Benson - 110,000,
Crews
- 290,000, Deva - 110,000, Drohan - 90,000, McLoughlin -
110,000
|
61
Compensation
Committee Report
The
Compensation Committee has reviewed and discussed the Compensation Discussion
and Analysis section of this item 11 with management, and, based on that review
and discussion, recommended to the Board of Directors that said Compensation
Discussion and Analysis be included in this annual report on form
10-K.
Submitted
by Compensation Committee
Mark
T.
McLoughlin (Chairman)
David
P.
Crews
David
F.
Drohan
ITEM
12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED
STOCKHOLDER MATTERS
The
Company maintains a Long-Term Incentive Plan approved by a majority of
shareholders that authorizes awards representing up to 5,000,000 shares of
Common stock.
EQUITY
COMPENSATION PLAN INFORMATION AS OF DECEMBER 31,
2006
Plan
category
|
Number
of securities to be issued upon exercise of outstanding options,
warrants,
and rights
|
Weighted
average exercise price of outstanding options, warrants, and
rights
|
Number
of securities remaining available for future
issuance
|
|||||||
(a)
|
(b)
|
(c)
|
||||||||
Equity
compensation plans approved by security holders
|
3,202,377
|
$
|
1.82
|
1,411,423
|
||||||
Equity
compensation plans not approved by security holders
|
0
|
--
|
0
|
|||||||
Total
|
3,202,377
|
$
|
1.82
|
1,411,423
|
As
of
December 31, 2006, 386,200 shares of common stock have been issued upon exercise
of options granted pursuant to the Long Term Incentive Plan.
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS
In
reliance upon statements filed with the SEC under Section 13(d) or 13(g) of
the
Secutities Exchange Act of 1934 (unless the Company knew or had reason to know
such statements are not accurate or complete), the following persons are known
to Cytomedix to be the beneficial owner of more than five percent of Cytomedix’s
voting securities as of February 15, 2007, as indicated below:
Title
of Class
|
Name
and Address of Beneficial Owner
|
Amount
and Nature of Beneficial Ownership
|
Percent
of Class
|
||||||||
Common
Stock
|
David
E. Jorden
|
2,487,800
|
(1)
|
8.5
|
%
|
||||||
600
Travis, Suite 3700
|
|||||||||||
Houston,
Texas 77002
|
(1) Includes
167,000 shares issuable upon exercise of warrants. Pursuant to the terms of
the
warrants, the reporting person cannot exercise such warrants if the exercise
would result in the reporting person being the “beneficial owner” of more than
9.999% of the outstanding stock within the meaning of Rule 13d-1 under the
Securities Exchange Act of 1934.
62
SECURITY
OWNERSHIP OF MANAGEMENT
The
following table sets forth the number and percentage of shares of all classes
of
stock that as of February 15, 2007 are deemed to be beneficially owned by each
director and executive officer of the Company and by all directors and executive
officers as a group:
Title
of Class
|
Name
of
Beneficial
Owner
|
Amount
and Nature of Beneficial Ownership (1)
|
Percent
of
Class
(1)
|
||||||||
Common
Stock
|
James
S. Benson
|
150,000
|
(2)
|
*
|
|||||||
|
|||||||||||
Common
Stock
|
David
P. Crews
|
1,021,623
|
(3)
|
3.4
|
%
|
||||||
|
|||||||||||
Common
Stock
|
Arun
K. Deva
|
150,000
|
(4)
|
*
|
|||||||
|
|||||||||||
Common
Stock
|
David
F. Drohan
|
122,000
|
(5)
|
*
|
|||||||
|
|||||||||||
Common
Stock
|
Carelyn
P. Fylling
|
293,375
|
(6)
|
*
|
|||||||
|
|||||||||||
Common
Stock
|
Andrew
S. Maslan
|
154,000
|
(7)
|
*
|
|||||||
|
|||||||||||
Common
Stock
|
Mark
T. McLoughlin
|
150,000
|
(8)
|
*
|
|||||||
|
|||||||||||
Common
Stock
|
Kshitij
Mohan
|
1,200,000
|
(9)
|
4.0
|
%
|
||||||
|
|||||||||||
Common
Stock
|
Group
consisting of Benson, Crews, Deva, Drohan, Fylling, Maslan, McLoughlin,
and Mohan
|
3,240,998
|
9.6
|
%
|
* Less
than
1%.
(1) For
purposes of determining the amount of securities beneficially owned, share
amounts include all Common stock owned outright plus all convertible shares,
warrants, and options exercisable for Common stock. The Percent of Class for
Common stock is
based on the number of shares of the Company’s Common stock outstanding as of
February 15, 2007. Shares of Common stock issuable upon conversion of
convertible notes, or the exercise of options or warrants currently exercisable,
or exercisable within 60 days after the preparation of this table, are deemed
outstanding for the purpose of computing the percentage ownership of the person
holding such options or warrants, but are not deemed outstanding for computing
the percentage ownership of any other persons.
(2) Consists
of 150,000 shares Mr. Benson may acquire upon the exercise of stock
options.
(3) Consists
of 684,871 shares owned as trustee for David Paul Crews Revocable Trust, 16,752
shares owned by children, and 320,000 shares Mr. Crews may acquire upon the
exercise of stock options.
(4) Consists
of 150,000 shares Mr. Deva may acquire upon the exercise of stock
options.
(5) Consists
of 2,000 shares directly owned by Mr. Drohan and 120,000 shares Mr. Drohan
may
acquire upon the exercise of stock options.
(6) Consists
of 4,298 shares directly owned by Ms. Fylling and 289,077 shares Ms. Fylling
may
acquire upon the exercise of stock options.
(7) Consists
of 4,000 shares directly owned by Mr. Maslan and 150,000 shares Mr. Maslan
may
acquire upon the exercise of stock options.
(8) Consists
of 150,000 shares Mr. McLoughlin may acquire upon the exercise of stock
options.
(9) Consists
of 10,000 shares directly owned by Dr. Mohan and 1,190,000 shares Dr. Mohan
may
acquire upon the exercise of stock options.
ITEM
13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE
The
Company was not involved in any transactions with related persons, as defined
in
Item 404 of Regulation S-K, since January 1, 2006, nor are there any such
proposed transactions, that exceed $120,000.
The
Company has the following directors: James S. Benson, David P. Crews, Arun
K.
Deva, David F. Drohan, Mark T. McLoughlin, and Kshitij Mohan. Each of these
directors is independent as defined by Section 121(A) of the listing standards
of the American Stock Exchange, with the exception of Dr. Mohan, who, in
addition to serving as the Chairman of the Board, is also the Company’s Chief
Executive Officer. Dr. Mohan does not serve on the Audit, Nominating and
Governance, or Compensation Committees.
63
ITEM
14. PRINCIPAL ACCOUNTING FEES AND SERVICES
The
following table presents fees for professional services rendered by L J
Soldinger Associates LLC for the fiscal years 2006 and 2005:
Services
Performed
|
2006
|
2005
|
|||||
Audit
Fees (1)
|
$
|
340,000
|
$
|
200,000
|
|||
Audit-Related
Fees (2)
|
2,000
|
30,000
|
|||||
Tax
Fees (3)
|
19,000
|
15,000
|
|||||
All
Other Fees (4)
|
—
|
—
|
|||||
Total
Fees
|
$
|
361,000
|
$
|
245,000
|
(1) Audit
fees represent fees billed for professional services provided in connection
with
the audit of the Company’s annual financial statements, reviews of its quarterly
financial statements, audit services provided in connection with statutory
and
regulatory filings for those years and audit services provided in connection
with securities registration and/or other issues resulting from that process.
In
2006, audit fees also includes services rendered for audits of management’s
assessment of the effectiveness of internal controls over financial reporting
and the effectiveness of internal control over financial reporting.
(2) Audit-related
fees represent fees billed primarily for assurance and related services
reasonably related to securities registration and/or other issues resulting
from
that process.
(3) Tax
fees
principally represent fees billed for tax preparation, tax advice and tax
planning services.
(4) All
other
fees principally would include fees billed for products and services provided
by
the accountant, other than the services reported under the three captions
above.
Pursuant
to its charter, the Audit Committee must pre-approve audit services and
permitted non-audit services (including the fees and terms thereof) to be
performed for the Company by its independent auditor. In 2005 and 2006, all
such
services were pre-approved by the Audit Committee.
PART
IV
ITEM
15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a)
|
1.
|
Financial
Statements
|
The
following financial statements of Cytomedix, Inc. are included in Item
8:
Report of Independent Registered Public Accounting Firm | 24 | |
Balance Sheets | 25 | |
Statements of Operations | 26 | |
Statements of Stockholders’ Equity | 27 | |
Statements of Cash Flows | 30 | |
Notes to Financial Statements | 31 |
2.
|
Schedule
II—Valuation and Qualifying
Accounts
|
See
Footnotes to Financial Statements in Item 8 of this report.
(b)
|
Exhibits
|
For
a
list of exhibits filed with this Form 10-K, refer to the Exhibit Index beginning
on page 66.
64
SIGNATURES
In
accordance with Section 13 or 15(d) of the Exchange Act, the registrant caused
this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
CYTOMEDIX,
INC.
By:
/s/Kshitij Mohan
Kshitij
Mohan, CEO and Chairman of the Board of Directors
Date:
February 26,
2007
|
In
accordance with the Exchange Act, this report has been signed below by the
following persons on behalf of the registrant and in the capacities and on
the
dates indicated.
By:
/s/Kshitij Mohan
Kshitij
Mohan, CEO and Chairman of the Board of Directors
Date:
February 26, 2007
/s/Andrew
S. Maslan
Andrew
S. Maslan, Chief Financial Officer
and
Chief Accounting Officer
Date:
February 26, 2007
/s/David
P. Crews
David
P. Crews, Director
Date:
February 26, 2007
/s/Arun
K. Deva
Arun
K. Deva, Director
Date:
February 26, 2007
/s/David
F. Drohan
David
F. Drohan, Director
Date:
February 26,
2007
|
Signed
originals of this written statement have been provided to Cytomedix, Inc. and
will be retained by Cytomedix, Inc. and furnished to the Securities and Exchange
Commission or its staff upon request.
65
EXHIBIT
INDEX
2.1 | First Amended Plan of Reorganization with All Technical Amendments (Previously filed on June 28, 2002, on Form 8-K, File No. 000-28443). | |
2.2 | Amended and Restated Official Exhibits to the First Amended Plan of Reorganization of Cytomedix, Inc. with All Technical Amendments (Previously filed on May 10, 2004, on Form 10-QSB for the quarter ended March 31, 2004, File No. 000-28443). | |
3.1 | Restated Certificate of Incorporation of Cytomedix, Inc. (Previously filed on November 7, 2002, on Form 10-QSB for quarter ended June 30, 2001, File No. 000-28443). | |
3.2 | Amendment to Restated Certificate of Incorporation of Cytomedix, Inc. (Previously filed on November 15, 2004, on Form 10-QSB for quarter ended September 30, 2004, File No. 000-28443). | |
3.3 | Restated Bylaws of Cytomedix, Inc. (Previously filed on November 7, 2002, on Form 10-QSB for quarter ended June 30, 2001, File No. 000-28443). | |
4.1 | Amended and Restated Certificate of Designation of the Relative Rights and Preferences of Series A Preferred, Series B Preferred and common stock of Cytomedix, Inc. (Previously filed on March 31, 2004, on Form 10-KSB for year ended December 31, 2003, File No. 000-28443). | |
4.2 | Form of Class A Warrant issued to New Investors and DIP Lenders (Previously filed on December 5, 2002, on Form 10-QSB for quarter ended September 30, 2001, File No. 000-28443). | |
4.3 | Form of Class B Warrant issued to New Investors and DIP Lenders (Previously filed on December 5, 2002, on Form 10-QSB for quarter ended September 30, 2001, File No. 000-28443). | |
4.4 | Form of Series C-1 Warrant to Purchase Shares of common stock of Cytomedix, Inc. (Previously filed on March 29, 2004 on Form 8-K, File No. 000-28443.) | |
4.5 | Form of Series C-2 Warrant to Purchase Shares of common stock of Cytomedix, Inc. (Previously filed on March 29, 2004 on Form 8-K, File No. 000-28443). | |
4.6 | Certificate of Designation of the Relative Rights and Preferences of the Series C Convertible Stock of Cytomedix, Inc. as filed with the Delaware Secretary of State on March 25, 2004 (Previously filed on March 29, 2004 on Form 8-K, File No. 000-28443). | |
4.7 | Form of warrant issued to investors in the 2004 Unit Offering (Previously filed on May 11, 2004, on Form SB-2, File No. 333-115364). | |
4.8 | Form of Class D Warrant to Purchase Shares of Common Stock of Cytomedix, Inc. (Previously filed on May 2, 2005, on Form 8-K, File No. 001-32518). | |
4.9 | Form of Registration Rights Agreement between Cytomedix, Inc., and Class D Warrantholders (Previously filed on May 2, 2005, on Form 8-K, File No. 001-32518). | |
10.1 | Royalty Agreement, dated as of December 26, 2000, by and between Cytomedix, Inc. and Curative Health Services, Inc. (Previously filed on January 17, 2001, on Form 8-K, File No. 000-28443). | |
10.2 | First Amendment to Royalty Agreement, dated as of April 20, 2001, by and between Cytomedix, Inc. and Curative Health Services, Inc. (Previously filed on May 25, 2001, on SB-2/A, File No. 333-55818). | |
10.3 | Second Amendment to Royalty Agreement, dated as of December 5, 2002, by and between Cytomedix, Inc. and Curative Health Services, Inc. (Previously filed on March 31, 2003, on Form 10-KSB for year ended December 31, 2002, File No. 000-28443). | |
10.4 | Cytomedix, Inc. Long-Term Incentive Plan. | |
10.5 | License Agreement dated March 21, 2001, by and between Cytomedix, Inc. and DePuy AcroMed, Inc. (Previously filed on April 16, 2001, on Form 10-KSB for year ended December 31, 2000, File No. 000-28443). |
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10.6 | Amendment dated March 3, 2005, to the License Agreement by and between Cytomedix, Inc. and DePuy Spine, Inc. (f/k/a DePuy Acromed, Inc.) (Previously filed on March 31, 2005, on Form 10-KSB for year ended December 31, 2004, File No. 000-28443). | |
10.7 | Second License Agreement dated March 3, 2005, to the License Agreement by and between Cytomedix, Inc. and DePuy Spine, Inc. (f/k/a DePuy Acromed, Inc.) (Previously filed on March 31, 2005, on Form 10-KSB for year ended December 31, 2004, File No. 000-28443). | |
10.8 | Settlement and License Agreement dated May 1, 2005 by and between Cytomedix, Inc. and Medtronic, Inc. (Previously filed on May 10, 2005, on Form 8-K, File No. 000-28443). | |
10.9 | Settlement Agreement and License Agreement dated May 23, 2005, by and between Cytomedix, Inc., and Harvest Technologies Corporation (Previously filed on May 27, 2005, on Form 8-K, File No. 000-28443). | |
10.10 | Settlement and License Agreement dated June 26, 2005, by and between Cytomedix, Inc., and Perfusion Partners and Associates Inc. (Previously filed on August 15, 2005, on Form 10-QSB for the quarter ended June 20, 2005, File No. 000-28443). | |
10.11 | License Agreement dated October 7, 2005, by and between Cytomedix, Inc., and COBE Cardiovascular, Inc. (Previously filed on October 11, 2005, on Form 8-K, File No. 000-28443). | |
10.12 | Settlement and License Agreement dated October 12, 2005, by and between Cytomedix, Inc., and SafeBlood Technologies, Inc. (Previously filed on November 9, 2005, on Form 10-QSB, File No. 000-28443). | |
10.13 | Employment Agreement with Ms. Carelyn P. Fylling (Previously filed on December 5, 2002, on Form 10-QSB for quarter ended September 30, 2001, File No. 000-28443). | |
10.14 | Employment Agreement with Mr. William L. Allender (Previously filed on March 31, 2004, on Form 10-KSB for year ended December 31, 2003, File No. 000-28443). | |
10.15 | Addendum to Employment Agreement with Mr. William L. Allender (Previously filed on November 15, 2004, on Form 10-QSB for quarter ended September 30, 2004, File No. 000-28443). | |
10.16 | Separation Agreement and Release dated July 15, 2005, by and between Cytomedix, Inc., and William L. Allender (Previously filed on August 15, 2005, on Form 10-QSB for the quarter ended June 30, 2005, File No. 000-28443). | |
10.17 | Employment Agreement with Kshitij Mohan, Ph.D., dated April 20, 2004 (Previously filed on May 7, 2004, on Form 8-K, File No. 00028443). | |
10.18 | Termination Agreement between Cytomedix, Inc., and Kshitij Mohan, dated April 20, 2004 (Previously filed on May 7, 2004, on Form 8-K, File No. 000-28443). | |
10.19 | Employment Agreement dated June 3, 2005, by and between Cytomedix, Inc., and Andrew Maslan (Previously filed on June 20, 2005, on Form 8-K, File No. 000-28443). | |
10.20 | Distributor Agreement dated October 31, 2005 by and between Cytomedix, Inc. and National Wound Therapies, LLC. (Previously filed on March 23, 2006, on Form 10-KSB, File No. 001-32518). | |
10.21 | Settlement and License Agreement dated May 19, 2006, between Cytomedix, Inc., and Biomet Biologics, Inc. (Previously filed on August 9, 2006, on Form 10-Q, File No. 001-32518). | |
10.22 | First Addendum to Letter Agreement dated October 4, 2006, between Cytomedix, Inc., and Andrew Maslan (Previously filed on November 1, 2006 on Form 10-Q, File No. 001-32518). | |
20.1 | Definitive Proxy Statement (Previously filed on September 22, 2006, File No. 001-32518). | |
23.1 | Consent of LJ Soldinger Associates, LLC. | |
31.1 | Certification of Chief Executive Officer of Cytomedix, Inc., pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
31.2 | Certification of Chief Financial Officer of Cytomedix, Inc., pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
32.1 | Certificate of Chief Executive Officer of Cytomedix, Inc., pursuant to 18 U.S.C.ss.1350. | |
32.2 | Certificate of Chief Financial Officer of Cytomedix, Inc., pursuant to 18 U.S.C.ss.1350. |
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