Unassociated Document
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of
Report (Date of earliest event reported): June 30, 2010
BACTERIN INTERNATIONAL
HOLDINGS, INC.
(Exact
Name of Registrant as Specified in Charter)
Delaware
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333-158426
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20-5313323
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(State
or other jurisdiction
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(Commission
File Number)
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(IRS
Employer)
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of
incorporation)
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Identification
No.)
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600
Cruiser Lane
Belgrade,
Montana
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59714
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(Address
of principal executive offices)
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(Zip
Code)
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Registrant’s
telephone number, including area code: (406) 388-0480
K-Kitz,
Inc.
1630
Integrity Drive East, Columbus, Ohio
43209
(Former
Name or Former Address, if Changed Since Last Report)
Copies
to:
Greenberg
Traurig, LLP
The Tabor
Center
1200
Seventeenth Street, Suite 2400
Denver,
Colorado 80123
Tel.:
(303) 572-6586
Fax:
(303) 572-6540
Attn: C.
Ben Huber, Esq.
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
o
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
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o
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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o
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
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o
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Pre-commencement
communications pursuant to Rule 13e-4 (c) under the Exchange Act (17 CFR
240.13e-4(c))
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CURRENT
REPORT ON FORM 8-K
K-KITZ,
INC.
June
30, 2010
TABLE
OF CONTENTS
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Page
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Item
1.01
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Entry
into a Material Definitive Agreement
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1
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Item
2.01.
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Completion
of Acquisition or Disposition of Assets
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5
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Item
3.02.
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Unregistered
Sales of Equity Securities
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45
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Item
5.01.
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Changes
in Control of Registrant
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46
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Item
5.02.
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Departure
of Directors or Certain Officers; Election of Directors; Appointment of
Certain Officers; Compensatory Arrangements of Certain
Officers
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46
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Item
5.03.
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Amendments
to Articles of Incorporation or Bylaws; Change in Fiscal
Year
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47
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Item
9.01.
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Financial
Statements and Exhibits
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47
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Items
1.01 Entry into a Material Definitive Agreement.
Summary
On June
30, 2010, we completed a reverse merger transaction (the “Reverse Merger”), in
which we caused Bacterin International, Inc., a Nevada corporation (“Bacterin”
or the “Company”), to be merged with and into KB Merger Sub, Inc., a Nevada
corporation and our newly-created, wholly-owned subsidiary (“Merger
Sub”). The reverse merger was consummated under Nevada corporate law
pursuant to an Agreement and Plan of Merger, dated as of June 30, 2010 (the
“Merger Agreement”), as discussed below. Concurrently with the
closing of the Reverse Merger, we also completed a private placement of common
stock and warrants to purchase common stock to accredited investors, and
received gross proceeds of approximately $7,508,000 at the closing of the
private placement.
As a
result of the Reverse Merger, we are now engaged, through Bacterin, in the
business of biomaterials research, development, and
commercialization. Bacterin is expanding its intellectual property
base and has successfully leveraged its technical expertise and knowledge of
biofilms into multiple product areas. Bacterin is well positioned for future
growth through established partnerships with major medical device manufacturers
and provider networks, as well as through its own in-house sales force and its
ongoing Bacterin product development of innovative tissue constructs and
bioactive coated devices. Revenues for Bacterin come from product
manufacturing, sales, distribution, licensing agreements and
grants.
Before
the Reverse Merger, our corporate name was K-Kitz, Inc., and our trading symbol
was KKTZ.OB. On June 29, 2010, we changed our corporate name to
“Bacterin International Holdings, Inc.” which name change became effective
for trading purposes on July 1, 2010. We intend to request a trading
symbol change to correspond with our name change at the appropriate time and in
accordance with FINRA policies that went into effect June 1, 2010. Accordingly,
our trading symbol will remain KKTZ.OB until such time as we move to another
market or otherwise can effect a trading symbol change through FINRA. As a result
of the Reverse Merger, consummated pursuant to the Merger Agreement, Bacterin
became our wholly-owned subsidiary, with the former stockholders of Bacterin
acquiring 28,257,287 shares of our common stock, representing approximately 96%
of our outstanding common stock prior to taking into account the issuance of any
shares pursuant to the private placement.
Concurrently
with the closing of the Reverse Merger, we completed an initial closing of a
private placement to selected qualified investors of shares of our common stock
at a purchase price of $1.60 per share and detachable warrants to purchase
one-quarter share of our common stock (at an exercise price of $2.50 per
share). In total, we sold 4,934,534 shares of our common stock and
warrants to purchase 1,233,634 shares of common stock as part of this initial
closing, and may sell up to an additional 6,268,472 shares of our common stock
and warrants to purchase 1,567,118 shares of common stock to investors that
participated in the initial closing, management and certain note holders until
July 30, 2010, when the offering period expires. We received gross
proceeds of $7,508,329 in consideration for the sale of the shares of common
stock and warrants, which consisted of (i) $4,026,000 in cash from investors in
the private placement and (ii) $3,482,329 from note holders in an earlier
Bacterin bridge financing who converted into the private placement at a discount
to the purchase price and received warrants with a discounted exercise price, as
described below.
In order
to fund Bacterin’s working capital and capital expenditures during the months
prior to the Reverse Merger and during the offering period, Bacterin and certain
placement agents conducted two bridge financings of approximately $5,250,000 in
aggregate principal amount of convertible notes and warrants, of which
$3,400,000 plus $82,329 in interest accrued thereon was converted into the
private placement (at a discount to the per share purchase price).
Concurrently
with the closing of the Reverse Merger and the private placement, we repurchased
4,319,404 shares of our common stock from one of our stockholders for aggregate
consideration of $100, as well as certain other good and valuable consideration,
and immediately thereafter cancelled those shares.
The
Reverse Merger
General
At the
closing of the Reverse Merger, the former stockholders of Bacterin received
shares of our common stock for all of the outstanding shares of common stock of
Bacterin held by them. As a result, at the closing of the Reverse
Merger, we issued an aggregate of 28,257,287 shares of our common stock to the
former stockholders of Bacterin. The shares issued to Bacterin’s
former stockholders represent approximately 96% of our outstanding shares of
common stock, exclusive of 4,934,534 shares of common stock issued in the
initial closing of the private placement, or approximately 82% of our
outstanding shares of common stock, inclusive of such shares issued in the
initial closing of the private placement. The consideration issued in
the Reverse Merger was determined as a result of arm’s-length negotiations
between us and Bacterin.
Immediately
prior to the closing of the Reverse Merger, the former stockholders of Bacterin
and the note holders who participated in an earlier bridge financing conducted
by Bacterin also held outstanding stock options and warrants to purchase shares
of common stock of Bacterin. Pursuant to the Merger Agreement, we
have agreed to issue shares of our common stock upon the exercise of these stock
options and warrants in lieu of shares of Bacterin’s common stock previously
issuable thereunder, and, based upon the ratio used to determine the number of
shares issuable to Bacterin stockholders in connection with the Reverse Merger,
we are obligated upon the exercise of those stock options and warrants to issue
4,213,196 shares and 4,879,075 shares of our common stock,
respectively.
To the
extent any of Bacterin’s former stockholders elect to exercise any dissenters’
rights in connection with the Reverse Merger, we will be obligated to purchase
any such dissenter’s shares of Bacterin common stock for “fair value” as
determined immediately prior to the Reverse Merger, all in accordance with
Nevada law. In addition, we will also be obligated to issue
additional shares of our common stock to the non-dissenting Bacterin
stockholders such that the non-dissenting stockholders would have held
approximately 96% of our outstanding shares of common stock immediately upon
consummation of the Reverse Merger, exclusive of any shares of our common stock
issued in the private placement. Certain of Bacterin’s former
stockholders, who held approximately 743,940 shares of Bacterin common stock in
the aggregate, provided proper notice to perfect their ability to exercise
dissenters’ rights (or 371,970 shares of our common stock that they will receive
in the Reverse Merger if they ultimately elect not to exercise such
rights).
Changes
Resulting from the Reverse Merger
We intend
to carry on Bacterin’s biomaterials business as our sole line of business. We
have relocated our executive offices to those of Bacterin at 600 Cruiser Lane,
Belgrade, Montana 59714. Our new telephone number is (406) 388-0480,
fax number is (406) 388-1354, and corporate website is www.bacterin.com. The
contents of our website are not part of this current report.
Our
pre-Reverse Merger stockholders will not be required to exchange their existing
K-Kitz, Inc., stock certificates for new certificates of Bacterin Holdings
International, Inc., since the OTC Bulletin Board will consider our existing
stock certificates as constituting “good delivery” in securities transactions
subsequent to the Reverse Merger. The Nasdaq Capital Market, where we intend to
apply to list our common stock for trading as soon as reasonably practicable,
will also consider the submission of existing stock certificates as “good
delivery.” We cannot be certain that we will receive approval to list our common
stock on the Nasdaq Capital Market.
Change
of Board Composition and Executive Officers
Prior to
the closing of the Reverse Merger and private placement, our board of directors
was composed only of Jennifer Jarvis and Michael Funtjar. On June 30, 2010,
concurrently with such transactions, Ms. Jarvis and Mr. Funtjar expanded the
size of the board of directors to five members, and appointed Guy S. Cook,
Mitchell Godfrey, and Kent Swanson to fill the vacancies created
thereby. The new directors then accepted the resignations of Ms.
Jarvis and Mr. Funtjar and appointed Ken Calligar and Daniel Frank to fill the
two vacancies created by their resignations. Upon their appointment,
the new directors further expanded the size of the board of directors to six
members, and appointed Gary Simon to fill the vacancy created
thereby.
Mr. Cook,
Mr. Godfrey and Mr. Swanson are all former Bacterin directors. Mr.
Swanson, Mr. Calligar, Mr. Frank and Mr. Simon are independent of management.
All directors will hold office until the next annual meeting of stockholders and
the election and qualification of their successors.
Prior to
the closing of the Reverse Merger and private placement, Ms. Jarvis was our
President, Chief Executive Officer, and Chief Financial Officer and Mr. Funtjar
was our Secretary and Chief Operating Officer. Ms. Jarvis and Mr.
Funtjar resigned from all of those offices effective June 30, 2010.
On June
30, 2010, our board of directors named the following persons as our new
executive officers: Guy S. Cook - Chairman of the Board, Chief Executive Officer
and President; Mitchell Godfrey - Secretary and Treasurer; and John P. Gandolfo
- Interim Chief Financial Officer. These individuals held those same
positions with Bacterin, our wholly-owned subsidiary through which we conduct
our business, prior to the Reverse Merger and will continue to carry on in the
same capacities with Bacterin, as will Darrel Holmes - Executive Vice President
of Medical Devices and Jesus Hernandez - Executive Vice President of
Biologics. Mr. Gandolfo joined Bacterin as its interim Chief
Financial Officer, effective June 4, 2010, and filled this position full time
commencing on July 6, 2010. Officers are elected annually by our
board of directors and serve at the discretion of our board.
We have
assumed all of such officers’ current employment agreements (including
intellectual property ownership provisions and restrictive covenants relating to
confidential information) and they have agreed to such
assumption. See “Directors and Executive Officers - Employment
Agreements” for the terms of those agreements.
The
disclosure set forth under “Directors and Executive Officers” in Item 2.01 of
this current report is incorporated herein in its entirety by
reference.
Change
of Stockholder Control
Except as
described above under “Change of Board Composition and Executive Officers,” no
arrangements or understandings exist among our present or former controlling
stockholders with respect to the election of persons to our board of directors
and, to our knowledge, no other arrangements exist that might result in a change
of control of our company. Further, as a result of our repurchase of shares from
an existing stockholder and the issuance of 28,257,287 shares of common stock to
the former stockholders of Bacterin, a change of stockholder control has
occurred. Prior to the repurchase and the closing of the Reverse
Merger, Jennifer Jarvis beneficially owned 82% of our outstanding shares of
common stock. After these transactions, the former stockholders of Bacterin own
approximately 96% of our outstanding shares of common stock, exclusive of shares
of common stock acquired in the private placement through purchase or conversion
or approximately 82% of our outstanding shares of common stock, inclusive of
such shares of common stock acquired in the private placement through purchase
or conversion. We are continuing as a “smaller reporting company,” as defined
under the Securities Exchange Act of 1934, as amended, following the exchange
transaction.
The
disclosure set forth under “Security Ownership of Certain Beneficial Owners and
Management” in Item 2.01 of this current report is incorporated herein in its
entirety by reference.
Accounting
Treatment
In
accordance with Statement of Financial Accounting Standards No. 141, “Business
Combinations,” and the assumptions and adjustments described in the accompanying
notes to the unaudited pro forma combined condensed financial statements,
Bacterin is considered the accounting acquiror in the Reverse Merger. Because
Bacterin’s former stockholders as a group retained or received the larger
portion of the voting rights in the combined entity and Bacterin’s senior
management represents all of the senior management of the combined entity,
Bacterin was considered the acquiror for accounting purposes and will account
for the exchange transaction as a reverse acquisition. The acquisition will be
accounted for as the recapitalization of Bacterin since, at the time of the
acquisition, we were a company with minimal assets and liabilities.
Consequently, the assets and liabilities and the historical operations that will
be reflected in the consolidated financial statements will be those of Bacterin
and will be recorded at the historical cost basis of Bacterin.
Amendments
to Articles of Incorporation and Bylaws
In
connection with the Reverse Merger, our board of directors and stockholders have
approved and we filed on June 29, 2010, an amendment to our certificate of
incorporation with the Secretary of State of the State of Delaware to change our
name to Bacterin International Holdings, Inc.
Prior to
the Reverse Merger, we amended our by-laws to permit us to set the size of our
board of directors from between one and nine directors.
Bacterin
International Equity Incentive Plan
We
recently adopted the Bacterin International Equity Incentive Plan, which became
effective prior to the Reverse Merger, under which 6,000,000 shares of our
common stock are reserved for issuance as equity awards. The purpose
of this plan is two-fold. First, in connection with the Reverse
Merger, we are substituting each equity award granted under the Bacterin
International, Inc. 2004 Stock Incentive Plan, as most recently amended
effective April 1, 2009, with a substantially similar equity award granted under
our new plan (subject to proportionate adjustments to reflect the ratios used in
consummating the Reverse Merger). Accordingly, of the 6,000,000
shares of our common stock that are reserved for issuance as awards under this
plan, 4,213,196 have been or will be issued as substitute awards, leaving an
additional 1,786,804 shares for issuance thereunder, representing approximately
13.3%, 9.3% and 4%, respectively, of the fully-diluted shares of our common
stock immediately following the Reverse Merger and the private
placement. Second, the shares of stock remaining available for
issuance under this plan will be used for attracting and retaining employees,
management, directors and outside consultants, who will be granted awards at
fair market value from time to time under the guidance and approval of our
compensation committee or such other group as is vested by our board with the
power to administer the plan, and in accordance with the terms of such equity
incentive plan. See “Directors and Executive Officers - Incentive
Compensation Plans.”
The
Private Placement
Concurrently
with the closing of the Reverse Merger, we completed the sale of 4,934,534
shares of our common stock and warrants to purchase an additional 1,233,634
shares of our common stock in a private placement to accredited investors in
reliance upon the exemption from registration provided by Section 4(2) of the
Securities Act of 1933, as amended, and Regulation D promulgated
thereunder. We sold each share and warrant for an aggregate price of
$1.60 per share pursuant to the terms of a subscription agreement executed and
delivered by each investor on or before the closing of the private
placement. Each warrant entitles the holder to purchase one-quarter
share of our common stock at an exercise price of $2.50 per share for a period
of five years from the date of the closing on their subscription. The
form of private placement subscription agreement is filed as Exhibit 10.1 to
this report. Certain Bacterin note holders also participated in the
private placement by converting certain debt into shares of our common stock and
warrants; however, the conversion of their debt was effected at a 10% discount
to the price per share at which investors purchased securities in such private
placement, being $1.44 per share, and the exercise price of the warrants they
received also carried a 10% discount to the exercise price of the warrants
received by new investors in such private placement, being $2.25 per
share.
We
received gross proceeds from the private placement of $7,508,329 from both
purchases of our common stock and warrants and conversions by existing
convertible note holders into such securities. Placement agents
received an aggregate of $322,080 in cash fees in connection with the private
placement and reimbursements of their out-of-pocket expenses. In
addition, the placement agents received 67,686 shares of our common stock and
warrants to purchase 251,625 shares of our common stock at an exercise price of
$1.60 per share.
After the
closing of the Reverse Merger and the private placement, we had outstanding
34,440,103 shares of common stock. In addition, we are obligated to
issue 4,213,196 shares of common stock upon the exercise of stock options held
by former holders of Bacterin options, 4,879,075 shares of common stock upon the
exercise of warrants held by former holders of Bacterin warrants, and 1,485,259
shares of common stock upon the exercise of warrants received by investors,
including converting note holders and placement agents in our private
placement.
Following
the initial closing, the private placement will remain open until July 30, 2010,
subject to the earlier termination at the election of us and the placement
agent. During this time period, we may close on additional
subscriptions and bridge note conversions under the private placement; provided,
however, that the only persons who may participate in the private placement
pursuant to any subsequent closings after the initial closing are (i) investors
or note holders who participated in the initial closing, (ii) members of our
management, and (iii) holders of our convertible bridge notes, regardless if
they participated in the initial closing, so long as the amount raised in the
private placement then meets the conditions for it to constitute a “Qualified
Offering” under the terms of such notes.
Lock-Up
Agreements
All
shares of common stock issued in the Reverse Merger to the former holders of
shares in Bacterin will be considered “restricted securities” under U.S. federal
securities laws and may not be resold pursuant to Rule 144 for a period of one
year after the filing of this report. Each of the former Bacterin
stockholders who served as directors or executive officers of Bacterin as of the
closing of the Reverse Merger or who have joined as members of our Board of
Directors concurrently with the consummation of the Reverse Merger
(collectively, “Management”), have executed one-year a lock-up agreement with us
which provide that their shares, including any shares that are now owned or are
subsequently acquired by them, will not be, directly or indirectly, publicly
sold, subject to a contract for sale or otherwise transferred for a period of 12
months following the Reverse Merger and the private placement; provided,
however, that (a) the restrictions set forth in such lock-up agreement will not
apply to any securities acquired by Management in the private placement and (b)
Guy Cook is permitted to hypothecate, pledge and grant a security interest in up
to 5,000,000 of his existing shares received from us in connection with the
Reverse Merger as collateral for borrowed funds used to acquire securities in
the private placement and, if such collateral is executed against, shall be
permitted to assign and transfer such shares to the secured party free of any
restrictions set forth therein.
Registration
Rights
We have
agreed to use our best efforts to file a shelf registration statement on Form
S-1 with the U.S. Securities and Exchange Commission (“SEC”) covering the resale
of all shares of common stock and all shares of common stock underlying the
warrants issued in connection with the private placement (as well as up to
1,177,196 shares of our common stock held by certain of our stockholders at the
time of the closing of the Reverse Merger and the shares underlying the
placement agents’ warrants) on or before the date which is 90 days after the
closing date and to use our best efforts to have such shelf registration
statement declared effective by the SEC as soon as practicable thereafter, but
in any event not later than 150 days after the closing date (or 180 days after
the closing date in the event of a full review of the registration statement by
the SEC). We are also obligated to respond to any SEC comments within
a stipulated period of time after receiving any such comments and to maintain
the effectiveness of the shelf registration statement from the effective date
through the earlier of (a) the date on which all the investors in the private
placement have completed the sales or distribution described in the registration
statement relating thereto or, if earlier, until all securities covered by the
registration rights agreement may be sold by the investors in the private
placement under Rule 144(b)(1), and (b) the date that is 18 months following the
private placement closing date. In the event the shelf registration
statement is not filed with, or declared effective by, the SEC on or prior to
the dates set forth above, or we fail to timely satisfy our reporting
requirements, each investor in the private placement will receive cash
liquidated damages equal to 1% of the purchase price for the shares of common
stock and warrants acquired in the private placement for each month (or portion
thereof) that the registration statement is not so filed or effective, or has
failed to timely file required reports, provided that the aggregate payment as a
result of the registration default will in no event exceed 12% of the purchase
price for the shares of common stock and warrants.
Item 2.01. Completion of Acquisition or
Disposition of Assets.
Information
concerning the principal terms of the Reverse Merger and our business is set
forth below.
The
Reverse Merger
On June
30, 2010, we entered into the Merger Agreement with Bacterin and closed the
Reverse Merger. At such time, Bacterin became our wholly-owned
subsidiary and we discontinued our prior business of distributing emergency
preparedness kits.
Pursuant
to the Merger Agreement, at closing, the former stockholders of Bacterin
received an aggregate of 28,257,287 shares of our common stock, representing
approximately 96% of our outstanding shares of common stock, exclusive of shares
of common stock sold in the concurrent private placement, or approximately 82%
inclusive of such shares. Immediately prior to the closing of the
exchange transaction, Bacterin had outstanding a total of approximately
56,514,573 shares of common stock, plus stock options to purchase 8,777,492
shares of common stock and warrants to purchase 10,164,739 shares of common
stock. In exchange for the shares we issued to the former Bacterin
stockholders, we acquired 100% of the outstanding shares of common stock of
Bacterin. The consideration issued in the Reverse Merger was determined as a
result of arm’s-length negotiations between the parties.
Pursuant
to the Merger Agreement, we also agreed to issue shares of our common stock upon
the exercise of Bacterin’s stock options and warrants in lieu of shares of
Bacterin common stock previously issuable thereunder, and, based upon the ratio
used to determine the number of shares issuable to Bacterin stockholders in
connection with the Reverse Merger, we are obligated upon the exercise of those
stock options and warrants to issue 4,213,196 shares and 4,879,075 shares of our
common stock, respectively.
To the
extent any of Bacterin’s former stockholders elect to exercise any dissenters’
rights in connection with the Reverse Merger, we will be obligated to purchase
any such dissenter’s shares of Bacterin common stock for “fair value” as
determined immediately prior to the Reverse Merger, all in accordance with
Nevada law. In addition, we will also be obligated to issue
additional shares of our common stock to the non-dissenting Bacterin
stockholders such that the non-dissenting stockholders would have held
approximately 96% of our outstanding shares of common stock immediately upon
consummation of the Reverse Merger, exclusive of any shares of our common stock
issued in the private placement. Certain of Bacterin’s former
stockholders, who held approximately 743,940 shares of Bacterin common stock in
the aggregate, provided proper notice to perfect their ability to exercise
dissenters’ rights (or 371,970 shares of our common stock that they will receive
in the Reverse Merger if they ultimately elect not to exercise such
rights).
Following
the Reverse Merger, we succeeded to the biomaterials research, development, and
commercialization business of Bacterin as our sole line of business, which will
be conducted through our new, wholly-owned subsidiary, Bacterin International,
Inc. See “Description of Business” below. Prior to the
Reverse Merger, there were no material relationships between us and Bacterin,
between Bacterin and our respective affiliates, directors or officers, or
between any associates of Bacterin or our respective officers or directors. All
of our pre-Reverse Merger liabilities were settled prior to
closing.
Description
of Our Company and Predecessor
We were
incorporated in the State of Delaware on August 8, 2006. We were
formed to design, assemble, market and sell emergency preparedness kits and
supplies to school systems, municipalities, businesses and other
customers. On November 12, 2009, we completed our initial public
offering of 1,000,000 shares of common stock to the public pursuant to a
registration statement on Form S-1 that we filed with the SEC and was declared
effective on September 29, 2009.
Description
of Business
Unless
the context otherwise requires, “we,” “our,” “us” and similar expressions used
in this Description of Business section refer to Bacterin prior to the closing
of the Reverse Merger on June 30, 2010, and Bacterin International Holdings,
Inc., f/k/a K-Kitz, Inc., as successor to the business of Bacterin,
following the closing of the Reverse Merger transaction.
Overview
of Our Business
We
develop, manufacture and market biologics products to domestic and international
markets through our biologics division and are a leader in the field of
biomaterials research, device development and commercialization. Our
proprietary methods optimize the growth factors in human allografts to create
the ideal stem cell scaffold and promote bone and other tissue
growth. These products are used in a variety of applications
including enhancing fusion in spine surgery, relief of back pain with a facet
joint stabilization, promotion of bone growth in foot and ankle surgery,
promotion of skull healing following neurosurgery and cartilage regeneration in
knee and other joint surgeries.
Our
medical devices division develops medical devices intended for use in several
diverse clinical areas including orthopedic, plastic, and cardiovascular
surgery. Our background and expertise is in the research, testing, and
development of coatings for medical devices, particularly antimicrobial-based
coatings. Such coatings contain active agents and provide our
products with several potential advantages over traditional medical devices.
They offer a means of protecting the surface of a medical device from
contamination by pathogenic organisms, thereby minimizing the potential for
infection. Other coatings can serve as a reserve for local delivery
of active agents, enhancing a variety of biological functions such as bone
growth and pain management.
In
addition to the manufacture and sales of coated medical devices, the medical
devices division works with our biologics division to produce and distribute
OsteoSelect® DBM putty, an osteoinductive product used by surgeons as a bone
void filler in the extremities and pelvis. DBM putty is considered a
combination product by regulatory agencies – both a tissue and a medical
device.
The
medical devices division also develops custom surgical instrument kits for use
with allografts processed by our biologics division. These kits offer
state-of-the-art instrumentation that is designed based upon the needs and
inputs of surgeons who desire to use the most minimally invasive techniques. The
instrumentation is intended to be an optimal delivery system for the proper
placement of our proprietary allografts. Objectives of allograft use
include pain relief, aid in the regeneration of tissue, and to provide a
scaffold for bone fusion in spinal and sports medicine procedures.
The
medical devices division actively develops intellectual property associated with
our devices and coating platforms, for the purposes of protecting our
Bacterin-branded devices and for use in alliance projects.
The
manufacturing and operations of the biologics and medical devices divisions are
organized separately while products from both are marketed through several
channels including private label arrangements, independent distributors, joint
development projects and our direct sales network, which we began to implement
in the last half of 2009. The focus of our efforts and the use of the
proceeds from prior financings and the private placement have been used, and
will continue to be used, to, among other things, expand this direct sales
network and our production capacity. To date, we have established 13
regions with a regional vice-president in charge of all activities within the
region and have hired and trained 24 sales representatives. Our goal is to have
four to five sales representatives in each region.
Our
headquarters, laboratory and manufacturing facilities are located at 600 Cruiser
Lane, Belgrade, Montana 59714. Our telephone number is (406) 388-0480
and our fax number is (406) 388-0422. We also maintain an office at
8310 S. Valley Highway, No. 300, Englewood, Colorado 80112, and have sales
employees located across the United States.
We began
operations in 1998 as a sole proprietorship founded by Guy Cook, our President
and Chief Executive Officer, as a spinout of the internationally acclaimed
Center for Biofilm Engineering at Montana State University (the
“CBE”). Mr. Cook is an expert in microbial testing methods and has
been recognized by the U.S. Food and Drug Administration (“FDA”), industry, and
academia for his contributions to the development of bioactive
coatings. This sole proprietorship was eventually incorporated as
“Bacterin, Inc.” in the state of Montana in January 2000 to further Mr. Cook’s
work. In March 2004, Bacterin, Inc.’s stockholders completed the
terms of a share exchange agreement with a company called Oil & Gas Seekers,
Inc., a Nevada corporation (“OGS”), which subsequently changed its name to
“Bacterin International, Inc.”, to effectively become a publicly-traded
corporation. As a result of this transaction, the stockholders of
Bacterin, Inc., became stockholders of us, and Bacterin, Inc., became our
wholly-owned subsidiary. At the end of 2004, management concluded that this
transaction was problematic and did not deliver the expected
result. Based on this determination, we entered into an agreement in
2005 to amend the terms of the exchange transaction with the former majority
stockholder of OGS. In May 2005, we merged Bacterin, Inc., up and
into us.
Leveraging
off the “state of the art” research and development activities ongoing at the
CBE in biofilm technology, we began as a biomaterials testing laboratory and
have systematically expanded our strategic vision towards the development of
Bacterin-labeled medical devices. Our revenues were historically
derived from testing services and milestone payments from collaborative product
development agreements with various “blue chip” medical
manufacturers. Today, however, we generate revenue from a number of
revenue sources including the following: license fees and royalties from
collaborative product development efforts with medical device manufacturers;
sales from products developed and manufactured by us under our own label;
products manufactured by us under private labels for other device distributing
companies; and contract revenue from analytical testing and development services
provided to medical device manufacturer clients, which tailor our coating
process to the client’s specific product/medical application.
During
2008, we reached an important transition point in our history. Most
of our business endeavors prior to that time had been devoted to developing our
products with revenue generated from a variety of limited sources, including
testing, government grants and unsubstantial product sales. In 2008,
however, revenue from product sales either under our name or “private label”
became our primary source of revenue.
On June
18, 2010, we were contacted by a scientific advisor of a major participant in
the medical device industry to inquire about what a potential buy-out price
might be for us. This individual has recommended that the
industry participant should consider acquiring us. In response
to his inquiry, we informed him that we believed $600 million was an
appropriate buy-out price. There have been no further discussions
since such time. This offer and our response does not suggest, and no
one should infer therefrom, that we are being or will be acquired, or that $600
million is a reasonable valuation of our company.
Industry
and Market Overview
The
orthopedic biomaterials market consists of materials that are organic, inorganic
or synthetic in nature. These materials are implanted or applied in or near the
indicated bone to facilitate healing, encourage bone tissue augmentation,
compensate in areas where bone tissue is depleted and restore structure to allow
for repair. Orthopedic biomaterials are capable of producing specific biological
action or regenerative responses that are beyond what is observed in normal
healing. These materials are often used as substitutes to autograft materials,
which are taken from a harvest site in the patient to patch or repair the
wounded or unhealthy site.
Bone is a
biologically active tissue and may or may not regenerate depending on the
condition of the patient. The damage may be significant enough that a
scaffold to help regenerate the surgical site may be necessary. In
2009, the orthopedic biomaterials market was valued at almost $3.5 billion. This
market is expected to grow at a CAGR of 8.9% by 2016. (Idata Research Inc.
2010, U.S. Market for Orthopedic Biomaterials).
Products
and Services
We have
developed and currently manufacture and sell several human tissue-based
products, primarily allografts, into the medical marketplace through our
biologics division. In addition, we also manufacture and sell,
directly under our own name, indirectly through distributors and pursuant to
private label arrangements, various coating and surgical drain products through
our medical devices division.
Biologics
Division
Our
biologics products include OsteoSponge®, OsteoSponge® SC, OsteoWrap®,
OsteoLock®, BacFast® and OsteoSelect®, as well as certain other allograft
products which are briefly described below:
|
·
|
OsteoSponge®
is a form of demineralized bone matrix made from 100% human bone. Derived
from trabecular (cancellous) bone, OsteoSponge® provides a natural
scaffold for cellular in-growth and exposes bone-forming proteins to the
healing environment. The malleable properties of OsteoSponge®
enable it to conform to, and fill, most defects. Upon
compressing the allograft, OsteoSponge® springs back to completely fill
the void. Its unique mechanical and biological properties make
OsteoSponge® an ideal bone graft for use in various orthopedic practices
including spine, neurology, cranial/maxillofacial, trauma,
plastic/reconstruction and general procedures where new bone growth is
needed.
|
|
·
|
OsteoSponge®
SC is a form of OsteoSponge® designed to be used in joint
surgery. Bacterin has shown, in goat studies, the ability to
re-generate cartilage in joint repair and believes that this product has
the potential to significantly change the standard of care in human joint
surgery. We have received permission from the FDA to market
this product as a subchondral bone void filler and are currently marketing
it as such. Surgeons are using the product and we are beginning
trials to establish the ability to market it as a cartilage re-generation
scaffold. These trials are likely to take two years and we will
likely publish preliminary results of the study at six months and one
year. There can be no assurance that these trials will be
successful or lead to any FDA action. Part of the proceeds of
the private placement will be used to fund this clinical
trial.
|
|
·
|
OsteoWrap® is
100% human cortical bone demineralized through a proprietary process to
make the graft flexible while maintaining allograft
integrity. This product has various applications in orthopedic,
neurological, trauma, oral/maxillofacial and reconstructive
procedures. OsteoWrap® can wrap around non-union fractures to
assist with fusion, can act as a biologic plate or can be used in
conjunction with a hardware plate system. Additionally, this
product provides the surgeon with superior handling characteristics as the
allograft can be easily sized using surgical scissors or a scalpel, and
will withhold sutures or staples for
fixation.
|
|
·
|
OsteoLock®
and BacFast® are facet stabilization dowels made from human
bone. The shape of our facet stabilization dowel is engineered
to maximize osteoconductivity and surface area contact, as well as provide
stability to prevent migration from the surgical site. BacFast®
HD, having the same design as OsteoLock®, is optimized through our
proprietary demineralization technology. This technology
increases the surface area of the outer collagen matrix of the graft while
exposing native bone morphogenic proteins (BMPs) and growth
factors. Because of the hyper-demineralization technology,
BacFast® HD has osteoinductive properties, as well as being
osteoconductive. OsteoLock® and BacFast® can be used to augment
spinal procedures, or as a stand-alone procedure for mild spinal
conditions. While this product is currently in production and
use, Bacterin is initiating clinical studies to further support its
effectiveness and some of the proceeds of the private placement will be
used to fund these clinical trials. There can be no assurance
of the success of these trials.
|
|
·
|
OsteoSelect® DBM
putty is engineered with the surgeon in mind. With outstanding
handling characteristics, OsteoSelect® can be easily molded into any shape
and compressed into bony voids. Taking the design a step further, Bacterin
has validated a low-dose, low-temperature gamma sterilization process to
provide maximum osteoinductive potential while still affording device
level sterility. Every production batch of OsteoSelect® is
tested for its bone growth characteristics allowing us to make that unique
marketing claim.
|
In
addition, we make and sell (i) sports allografts which are processed
specifically for anterior and posterior cruciate ligament repairs, anterior
cruciate ligament reconstruction and meniscal repair, (ii) milled allografts
which are comprised of cortical bone milled to desired shapes and dimensions,
also called milled spinal allografts, and (iii) traditional allografts for
multi-disciplinary applications including orthopedics, neurology, podiatry,
oral/maxillofacial, genitourinary and plastic/reconstructive.
We are
hoping to be able to expand our product definition for certain of our products
to claim cartilage regeneration capability. Over the past few months,
approximately 15 patients thus far have undergone knee, foot or ankle surgery
for the purposes of the trial to make such claims. We plan to have
200 patients in the trial by year end. Thus far, the first patients
were operated on 6 months ago and, in all cases, no adverse events were
reported. We are 5 to 7 months away from reaching an anecdotal
threshold at which point we hope that our findings can be presented to the
sports medicine and orthopedic repair community.
Medical
Device Products
Our
medical devices division researches, tests and develops coatings for medical
devices, particularly antimicrobial-based coatings. Such coatings
contain active agents and provide our products with several potential advantages
over traditional medical devices. They offer a means of protecting the surface
of a medical device from contamination by pathogenic organisms, thereby
minimizing the potential for infection. Other coatings can serve as a
reserve for local delivery of active agents, enhancing a variety of biological
functions such as bone growth and pain management. This division produces and
distributes OsteoSelect® DBM putty, an osteoinductive product used by surgeons
as a bone void filler in the extremities and pelvis. DBM putty is
considered a combination product by regulatory agencies – both a tissue and a
medical device.
Our
medical devices division also develops custom surgical instrument kits for use
with allografts processed by our biologics division. These kits offer
state-of-the-art instrumentation that is designed based upon the needs and
inputs of surgeons who desire to use the most minimally invasive techniques. The
instrumentation is intended to be an optimal delivery system for the proper
placement of our proprietary allografts. Objectives of allograft use
include pain relief, aid in the regeneration of tissue, and to provide a
scaffold for bone fusion in spinal and sports medicine procedures. We
currently sell a surgical drain series called Via™, which is used to drain
exudate from a surgical site. Building upon the Via™ platform,
Bacterin plans on releasing a second generation product called the Elutia®
surgical drains which will be performance enhanced via an antimicrobial coating
to help reduce the incidence of surgical site infection.
Our wound
drain product is gaining attention at the VA Hospitals. At the end of
last month, we received notice that the Brook Army Medical Hospital in Texas, a
level 1 trauma facility, will begin using our wound drain product system
wide. This hospital currently reports that over fifty percent (50%)
of post operative infections occur due to an uncoated wound drain that it is
currently using. We are hopeful that over the next several months,
our wound drain product will be distributed throughout the VA Hospital
system. Our wound drain products sell into hospitals for $40 and cost
us approximately $6 to produce. We believe that the ultimate size of
the market for wound drains is $80 million per year. We continue to
build our pipeline of products for antimicrobial coated medical devices with one
approval expected in Q3 2010, and another by Q2 2011. These product
revenues are not reflected in our current sales forecasts.
Technology
and Intellectual Property
Patents
Our
patent efforts have been, and will continue to be, primarily focused in two key
areas:
|
·
|
The
delivery of bioactive agents impregnated into or onto metals, polymers or
tissues which, when activated by bodily fluids, release the agent into the
surrounding environment; and
|
|
·
|
The
development of innovative and novel, engineered tissue implants or
constructs which employ acellular tissue and processes, and enhanced
demineralized bone matrix products.
|
The
following table summarizes our current patent portfolio, including patents
covering technology licensed by us for use or inclusion in certain of our
products:
Title
|
Business
Purpose
|
First
Inventor
|
Serial
or Patent
Number
|
Date
Filed
or Granted
|
Status
|
1.
Pending U.S. Applications
|
MEDICAL
DEVICE INCLUDING A BIOACTIVE IN A NON-IONIC AND AN IONIC FORM AND METHODS
OF PREPARATION THEREOF
|
This
application arose out of a now defunct project. We retained rights as the
technology may prove useful in the future. The patent describes the
modification of elution profiles via active agent equilibration; it is
potentially applicable to many coated products.
|
Mike
Johnson
|
11/864,360
|
9/28/2007
|
Undergoing
further examination
|
ANTIMICROBIAL
COATING FOR INHIBITION OF BACTERIAL ADHESION AND BIOFILM
FORMATION
|
This
application relates to the coating used for the Elutia® wound drain and for the
Bard BioBloc coating on their HemoStar hemodialysis catheter. The efficacy
period can be varied according to the desired outcome; the coating has
shown in vitro efficacy for between 7 and 21 days.
|
Guy
Cook
|
10/891,885
|
7/15/2004
|
Non-final
Office Action mailed 9/15/09; response submitted
12/15/09
|
PROCESS
FOR DEMINERALIZATION OF BONE MATRIX WITH PRESERVATION OF NATURAL GROWTH
FACTORS
|
This
application is intended to protect OsteoSponge®, a core product produced
by our Biologics division. OsteoSponge® is a novel form of
demineralized bone matrix which provides a natural scaffold for cellular
growth and exposes bone growth inducing proteins to the healing
environment.
|
Nancy
J. Shelby
|
12/130,384
|
5/30/2008
|
First
examination: November 2010 (estimated)
|
2.
Pending Foreign Applications
|
|
|
|
|
MEDICAL
DEVICE INCLUDING A BIOACTIVE IN A NON-IONIC AND AN IONIC FORM AND METHODS
OF PREPARATION THEREOF
|
This
application arose out of a now defunct project. We retained rights as the
technology may prove useful in the future. The patent describes the
modification of elution profiles via active agent equilibration and is
potentially applicable to many coated products.
|
Mike
Johnson
|
PCT/US2007/079924
|
9/28/2007
|
Preliminary
Report on Patentability generated 3/13/09
|
Title
|
Business
Purpose
|
First
Inventor
|
Serial
or Patent
Number
|
Date
Filed
or Granted
|
Status
|
2.
Pending Foreign Applications
|
ANTIMICROBIAL
COATING FOR INHIBITION OF BACTERIAL ADHESION AND BIOFILM
FORMATION
|
This
application relates to the coating used for the Elutia® wound drain and for the
Bard BioBloc coating on their HemoStar hemodialysis catheter. The efficacy
period can be varied according to the desired outcome; the coating has
shown in vitro efficacy for between 7 and 21 days.
|
Guy
Cook
|
PCT/US2005/015162
|
4/28/2005
|
Entered
National Phase in: Europe, Australia, Canada, Japan
|
PROCESS
FOR DEMINERALIZATION OF BONE MATRIX WITH PRESERVATION OF NATURAL GROWTH
FACTORS
|
This
application is intended to protect OsteoSponge®, a core product produced
by our Biologics division. OsteoSponge® is a novel form of
demineralized bone matrix which provides a natural scaffold for cellular
growth and exposes bone growth inducing proteins to the healing
environment.
|
Nancy
J. Shelby
|
PCT/US2008/006942
|
6/2/2008
|
Entered
national Phase in: Europe, Canada, Mexico, Korea
|
AN
ELASTOMERIC ARTICLE INCORPORATED WITH A BROAD SPECTRUM
ANTIMICROBIAL
|
This
application was generated as a means of protecting the technology used for
a forthcoming product. We have observed long term (over 30 days) in vitro
efficacy with this technology.
|
Benjamin
P. Luchsinger
|
PCT/US2009/005103
|
9/11/2009
|
Awaiting
International Search Report (this application will enter the US through
PCT)
|
3.
In-Licensed Intellectual Property
|
|
|
|
|
SWOLLEN
DEMINERALIZED BONE PARTICLES, FLOWABLE OSTEOGENIC COMPOSITION CONTAINING
SAME AND USE OF THE COMPOSITION IN THE REPAIR OF OSSEOUS
DEFECTS
|
This
patent protects OsteoSelect®, Bacterin’s DBM putty.
OsteoSelect® has
exceptional handling characteristics and can easily be molded into any
shape and compressed into bony voids. Bacterin employs a low-dose,
low-temperature sterilization process to provide maximum osteoinductive
potential while maintaining device-level sterility.
|
Simon
Bogdansky
|
5,284,655
|
2/8/1994
|
Granted
|
FLOWABLE
DEMINERALIZED BONE PWDER COMPOSITION AND ITS USE IN BONE
REPAIR
|
This
patent protects OsteoSelect®, Bacterin’s DBM putty.
OsteoSelect® has
exceptional handling characteristics and can easily be molded into any
shape and compressed into bony voids. Bacterin employs a low-dose,
low-temperature sterilization process to provide maximum osteoinductive
potential while maintaining device-level sterility.
|
Robert
K. O’Leary
|
5,290,558
|
3/1/1994
|
Granted
|
Management
believes our patent filings and patent position will facilitate growth and
enhance our proprietary core competencies, enabling us to protect and expand
revenue growth and stockholder value in the future. We expect that
additional patent applications will be filed and prosecuted as inventions are
discovered, technological improvements and processes are developed and specific
applications are identified. The status of individual patents and patent
jurisdiction is maintained in our internal records. We anticipate,
however, that there may be instances in which we enter into collaborative
research and development agreements with medical device companies under such
terms that the medical device company may or will retain a right to make future
patent filings arising from such cooperative development agreement. In such
instances, we will attempt to protect our overall patent use rights by
agreements which limit the right of the collaborative party to an exclusive
right only as it pertains to the field of use, as defined by the applicable
project’s scope of work. In this manner, we anticipate that we will receive
future benefit and use of such intellectual property outside the field of use,
as defined by any given scope of work. There can be no assurance that
we will be able to obtain final approval of any patents.
Trademarks
We
believe in the superiority of our technology and products. As a
result, we have invested in the development and protection of the names of our
products in order to drive consumer awareness and loyalty to the
brand. To protect this investment, we have registered, and continue
to seek registration, of these trademarks and continuously monitor and
aggressively pursue users of names and marks that potentially infringe upon our
registered trademarks. We currently own registered trademarks to the
following brand names of certain of our products: OsteoSponge®,
OsteoWrap®, OsteoLock®, BacFast®, OsteoSelect®, and Elutia®. We
recently sued Allosource for infringing our OsteoSponge® trademark by marketing
their competitive allograft product under the name “AlloSponge.” See
“Description of Business - Legal Proceedings.”
Trade
Secrets
To
safeguard our proprietary knowledge and technology, we rely heavily upon trade
secret protection and non-disclosure/confidentiality agreements with employees,
consultants and third party collaboration partners with access to our
confidential information. There can be no assurance, however, that these
measures will adequately protect against the unauthorized disclosure or use of
confidential information, or that third parties will not be able to
independently develop similar technology. Additionally, there can be no
assurance that any agreements concerning confidentiality and non-disclosure will
not be breached, or if breached, that we will have an adequate remedy to protect
us against losses. Although we believe our proprietary technology has value,
because of rapid technological changes in the medical industry, we also believe
that proprietary protection is of less significance than factors such as the
intrinsic knowledge and experience of our management, advisory board,
consultants and personnel and their ability to identify unmet market needs and
to create, invent, develop and market innovative and differentiated new medical
devices.
Donor
Procurement
We
implemented our biologics division, among other reasons, to secure and process
our own tissue, which posed initial challenges and associated operational
disadvantages. At the time we embarked on this plan, we lacked donor
sources, manufacturing capabilities, and distribution channels. We
also lacked the vertical integration of an in-house tissue processing laboratory
and were thus constrained by sub-contracting tissue processing to outside
processors. These same sub-contractors are essentially suppliers of their own
tissue to the marketplace and are hence ultimately our
competitors. We have since successfully secured rights of first
refusal of human tissue with multiple recovery agencies. Concurrent with this
initiative, we also sought to secure future allograft production capability by
constructing our own tissue processing facility. We have now begun
efforts to expand our network for donor tissue in anticipation of increased
production and believe that this effort, along with our current network of
procurement agencies, will be sufficient to supply enough donors to meet the
forecasted revenue volume through 2011 and beyond. We expect to be
able to continue to build the network for donor tissue as the needs
arise.
Sales
and Marketing
We are
committed to building our direct sales channel into the primary method of
distributing our products. We have promoted three regional vice presidents to
the role of executive vice-president to lead the North, South and West thirds of
the United States and established 13 regions with a regional vice president in
charge of all activities within the region. We have hired and trained
24 sales representatives toward a near term goal of establishing four to five
sales representatives in each region. While we expect that the cost of this
initiative will likely result in a net loss from operations in 2010, it is our
expectation that this investment in the direct sales network will lead to higher
revenue in 2010 and beyond, as well as profitability in 2011 and
beyond. No assurance can be given that these efforts will be
successful.
After 7
months of testing by Broadlane, Inc., the largest operator of healthcare supply
chains in the United States, and its clients, we were accepted in May 2010 as an
authorized vendor in its group purchasing program, which enables Broadlane’s
customers to purchase products from us. Broadlane manages
approximately $10 billion in contract volume with over 6,000 medical facilities
and 33,000 physician practices in its network. In June 2010,
Broadlane issued a newsletter to its entire network showcasing and introducing
Bacterin to all of its hospitals, independent delivery networks, ambulatory care
and surgery centers. As a result of this contract, our sales force
can now proceed to sell our products to this expansive network of
doctors. During the first month of our contract with Broadlane, we
anticipate that five percent (5%) of our revenues will be attributed to new
sales out of the Broadlane network. We have already received our
first order from Tenet Hospitals, which runs over 40 hospitals, and Advocates in
Illinois, which manages approximately 25 hospitals. We expect to have
our best month ever in June 2010 and our best quarter ever in the second quarter
of 2010.
We also
market our products through “private label” agreements whereby we package our
products under another company’s name and they are responsible for the sale and
distribution of the product. Additionally, we market our products
through independent distributors who then sell to their customer
base. In both of these channels, we provide our customer with a
discount off our list price. We have experienced a decline in revenue
from these channels and expect that these channels will continue to represent a
smaller portion of our overall revenue as our direct distribution channel
grows.
Within
the medical devices division, our marketing strategy is to develop product
development alliances with multinational medical device companies at the same
time as we develop our own new products in fields or applications outside of the
rights of our collaborative partners. We have implemented this
strategy and are pursuing contract opportunities with other medical device
companies.
We also
have a physician compensation program that compensates physicians as employees
for referring our products to other surgeons and medical care providers with
whom they do not have a disqualifying “financial relationship” under applicable
laws. Physician employees, at our direction, refer us to other
physicians and are paid a commission on all revenue generated by the referred
physicians’ use of our products. Although we have been advised by
counsel that this program complies with the Stark laws and applicable
anti-kickback regulations, there can be no assurance that there will not be
additional regulations adopted which could have an impact on this
program. We have also established procedures that are designed to
prevent abuses involving these physician employees and others with whom they
have financial relationships.
Summary
Financial Targets
The
following table sets forth certain of our summary financial targets for the
years ending December 31, 2010 through December 31, 2012, which give pro forma
effect to our receipt of gross proceeds of $4,026,000 from the private placement
and the conversion of $3,482,329 in outstanding principal owed under certain
convertible bridge notes into shares of our common stock, as described
herein. These targets are based on our current business plan and
incorporate estimates and assumptions regarding circumstances and events that
have not yet taken place and which are subject to various uncertainties inherent
in formulating these targets. Although management believes that the
assumptions used to create these targets are reasonable, they are necessarily
speculative, and we cannot guarantee that these targets will be
met. See “Risk Factors” for a discussion of risks and uncertainties
that could have a material impact on our ability to achieve the targeted results
set forth below. Actual results will likely vary significantly from
those set forth in the table and variations may be material and
adverse.
|
|
2010
|
|
|
2011
|
|
|
2012
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$ |
20,550,729 |
|
|
$ |
67,391,153 |
|
|
$ |
124,197,777 |
|
Cost
of Goods Sold
|
|
|
4,160,411 |
|
|
|
13,651,082 |
|
|
|
25,036,930 |
|
Gross
Profit
|
|
|
16,390,317 |
|
|
|
53,740,071 |
|
|
|
99,160,847 |
|
Expenses
|
|
|
21,702,013 |
|
|
|
39,845,754 |
|
|
|
56,145,501 |
|
Net
Income Before Tax
|
|
|
(5,311,696 |
) |
|
|
13,894,317 |
|
|
|
43,015,346 |
|
Income
Taxes
|
|
|
- |
|
|
|
- |
|
|
|
(17,206,138 |
) |
Net
Income
|
|
$ |
(5,311,696 |
) |
|
$ |
13,894,317 |
|
|
$ |
25,809,208 |
|
Earnings
per Share
|
|
$ |
(0.13 |
) |
|
$ |
0.31 |
|
|
$ |
0.57 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EBITDA
|
|
|
(2,686,448 |
) |
|
|
15,203,804 |
|
|
|
44,923,934 |
|
EBITDA
per share
|
|
$ |
0.06 |
|
|
$ |
0.34 |
|
|
$ |
1.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fully
Diluted Shares
|
|
|
41,373,020 |
|
|
|
45,017,632 |
|
|
|
45,017,632 |
|
Growth
Strategy
After
multiple years of product development, we believe that our technology has been
largely market tested, and since 2009, we have been transitioning our focus to
appropriately market and distribute our products. We have spent
months preparing the business to capitalize on our core markets, as well as new
market opportunities. In particular, we have diversified our supply
of donor tissue, expanded our production capabilities, developed the
infrastructure of what we believe will grow into a formidable sales force,
refined the message to our market and started gathering proof points on how to
scale our revenue in these markets.
We began
implementing a direct sales network in July 2009. As of December 31,
2009, we had 7 regional vice presidents and 21 sales
representatives. Currently, we have 3 executive vice presidents, 7
regional vice presidents, and 24 sales representatives. Our goal is
to grow this sales force to 3 executive vice presidents, 13-15 regional vice
presidents, and 52 sales representatives. We strive to hire sales
representatives with deep industry experience and pre-existing
contacts. In addition, we plan to utilize small independent sales
representatives with entrenched physician relationships. We expect
revenue to move towards 50% by employed sales representatives and 50% by
independent sales representatives.
We are
working on developing and implementing a high-level, national effort to present
our products as a value proposition to hospital chains, insurers and other
purchasing organizations. To this end, we have already entered into
agreements with Banner Hospitals, the Hospital for Special Surgery, Broadlane (a
purchasing organization for 1,200 hospitals and other medical facilities), and
Access Mediquip (a national purchasing organization for ambulatory surgery
centers). We anticipate that these agreements will pave the way for
our sales representatives to call on physicians, as the hospital process will
already be approved.
Competition
Because
the orthopedic biomaterials market overlaps with a number of medical fields –
spine, trauma, joint reconstruction, sports medicine, pharmaceuticals and
biotechnology – fragmentation is to be expected. However, there is one clear
leader in the market: Medtronic held 27.1% of the market in
2009. Medtronic’s lead is based on the strength of their Infuse®
growth factor product. However, the growth potential of this product
has been affected by some negative media attention regarding off-label usage and
adverse events with specific indications.
Beyond
Medtronic, the orthopedic biomaterials market is comprised of a great number of
players, each offering a multitude of products. It is expected that several new
products will emerge over the coming years. These assumptions are based on the
advance of technology and the clinical promise of regenerative therapies such as
stem cells and bone marrow concentration.
Specific
competitors in the orthopedic biomaterials markets are: Medtronic , DePuy,
Synthes, Arthrex, Smith & Nephew, Nuvasive, OrthoFix, Biomet,
Osteotech, Orthovita, MTF, Stryker, RTI, AlloSource, Lifenet
Health, Integra, ConMed/Linvatec, Wright, Exactech, ArthroCare, Harvest,
and Arteriocyte. (Idata Research Inc. 2010, U.S. Market for Orthopedic
Biomaterials).
Government
Regulation
We
produce human allografts that are regulated and comply with all the criteria
under both 361 and 351 of the Public Health Service Act. Compliance
is determined by the FDA during the inspection of our facility. To
date, we have successfully completed all of our FDA inspections. We
are registered with the FDA as a manufacturer of human cellular and tissue
products (HCT/Ps) as well as medical devices. We are an accredited
member of the American Association of Tissue Banks in good
standing. We meet all licensing requirements for the distribution of
HCT/Ps in the States of Florida, California, Maryland and New
York. We cannot predict the impact of future regulations on either us
or our customers.
Human
Tissue
Our human
tissue products, which are sold through our biologics division, have been
regulated by the FDA since 1993. In May 2005, three new, comprehensive
regulations went into effect that address manufacturing activities associated
with HCT/Ps. The first requires that companies that produce and distribute
HCT/Ps register with the FDA. The second provides criteria that must be met for
donors to be eligible to donate tissues and is referred to as the “Donor
Eligibility” rule. The third rule governs the processing and distribution of the
tissues and is often referred to as the “Current Good Tissue Practices” rule.
Together, they are designed to ensure that sound, high quality practices are
followed to reduce the risk of tissue contamination and of communicable disease
transmission to recipients. Our HCT/P products such as OsteoSponge®
are regulated by the Center for Biologics Evaluation and
Research. Our OsteoSponge® and OsteoWrap® products are regulated as a
HCT/P as determined by the Tissue Reference Group and regulated solely under
Section 361 of the Public Health Service Act and 21 CFR Part 1271.
Medical
Devices
Because
our medical devices incorporate coating technologies, they are subject to
regulation by the FDA. These medical devices require the approval of
the FDA prior to sale within the United States. The manufacturers and
licensees who use our coating technology in their medical devices will have the
burden of demonstrating the safety and efficacy of the medical devices, a burden
which we will assist such manufacturers and licensees in demonstrating to the
extent our coating technologies are at issue. Sales of medical
devices using our coating technology in the European Union will require the CE
Mark certification and sales of such medical devices in Canada will require
approval from the Medical Device Bureau of Canada.
Within
the United States, the FDA process requires that a pre-market notification (a
“510(k) Submission”) be made to the FDA to demonstrate that the medical device
is safe and effective and is substantially equivalent to a legally marketed
device that is not subject to pre-market approval. Applicants must
compare the device to one or more similar devices that are commercially
available in the U.S. (known as the “predicate device”), and make and support a
claim of substantial equivalency to such predicate device. Support
for such claims must include descriptive data and, when necessary, performance
data. In some cases, data from clinical trials must also be submitted
in support of a 510(k) Submission. The FDA must then issue an order
finding substantial equivalency before the devices may be commercially
distributed in the U.S. This process can take anywhere from three
months to two or three years, and can be extremely expensive. The
Center for Devices and Radiological Health regulates medical devices, including
our OsteoSelect® DBM putty.
ISO
Certification
In March
2010, we announced that we had received certification from the International
Organization for Standardization (“ISO”) for fulfilling the requirements of ISO
13485:2003. The Geneva based International Organization for
Standardization is the world’s largest developer and publisher of International
Standards. ISO 13485:2003 specifies requirements for a quality
management system. To obtain ISO 13485:2003 certification, an organization must
demonstrate its ability to provide medical devices that consistently meet
applicable customer and regulatory requirements. The primary objective of ISO
13485:2003 is to facilitate harmonized medical device regulatory requirements
for quality management systems. All requirements of ISO 13485:2003 are specific
to organizations providing medical devices, regardless of the type or size of
the organization. The certification assures our customers and
partners of our commitment to quality, and in the quality of our innovative
products and processes. Additionally, we believe that the ISO
13485:2003 certification offers new markets and business opportunities for our
products in the global marketplace.
Employees
As of
June 30, 2010, we had 80 full-time employees, of whom 31 were in product
development, 38 in sales and marketing, and 11 in administrative. In
addition, we make use of a varying number of temporary employees and outsourced
services to manage normal business cycles. None of these employees is
covered by a collective bargaining agreement and our management considers
relations with employees and services partners to be good.
Facilities
We lease
approximately 16,000 square feet in a building located at 600 Cruiser Lane,
Belgrade, Montana 59714. In addition to our corporate headquarters,
this space also includes a clean room, fully equipped diagnostics laboratory,
microbiology laboratory and testing laboratory. We lease the building
under a ten-year operating lease which runs through October 2013 and has a
monthly lease payment of $10,000. The lease also has a ten-year
renewal option.
In
November 2007, we purchased a 14,000 square foot facility at 664 Cruiser Lane,
Belgrade, Montana 59714. This building is an FDA registered facility
with 5 “Class 1,000” clean rooms and currently houses our medical device
coatings operations. The validated manufacturing areas and laboratory
facilities located in this facility provide processing and testing space to
manufacture medical devices pursuant to FDA, GMP regulations, and ISO
13485:2003. We expect this facility to meet all of our regulatory
requirements for the manufacture of future Bacterin-label products, including
our surgical drains (Via™ and Elutia®), as well as production requirements for
coated medical devices from our medical device partners. The facility
is registered with the FDA for device design, device manufacture, and contract
manufacture, as well as for screening, testing, storing, and distributing
biological tissues.
We also
lease office space in Englewood, Colorado, where certain of our administrative
and sales functions are housed.
Legal
Proceedings
In
November 2009, we were served a complaint in connection with the following court
action filed in Utah state court: Yanaki and Activatek v. Cook and
Bacterin International, Inc., case number 090912772. This
action involves the plaintiff’s attempt to sell shares of our common stock to a
third party in a private sale and claims, as its primary allegation, tortuous
interference with the sales contract. We believe this lawsuit is
without merit and we are conducting a vigorous defense.
We
initiated an arbitration proceeding in Bozeman, Montana to collect a large
account receivable from OrthoPro, LLC under a Private Label Distribution
Agreement. OrthoPro has made a counterclaim in that arbitration
which, in our judgment, is without merit. We plan to vigorously
pursue the recovery of all amounts owed and to defend against the
counterclaim.
As a
result of our policy to aggressively defend our intellectual property rights, we
recently filed and served a complaint in a lawsuit styled Bacterin International, Inc. v.
Allosource in the Federal District Court for the District of
Colorado. Our complaint is based on Allosource’s infringement of our
OsteoSponge® trademark through Allosource’s use of the name
“AlloSponge.” Allosource has generally denied all allegations and has
filed a counterclaim to cancel the federal registration for
OsteoSponge®. We believe the counterclaim has no merit and we intend
to aggressively pursue our infringement claims.
We have
recently received notice from legal counsel for minSURG International, Inc.
(“minSURG”) of minSURG’s recently issued U.S. Patent No. 7,708,761, entitled
“Spinal Plug for a Minimally Invasive Facet Joint Fusion System” (the “minSURG
Patent”) alleging infringement or inducement of infringement by us of the
minSURG Patent. We are early into the process of evaluating the validity of the
minSURG Patent and its relevance to our dowel products and their use in
minimally invasive facet surgeries. Regardless of the outcome of this
analysis, we do not anticipate this notice to have a material impact on our
overall sales or operating results.
Risk
Factors
Our
business involves significant risks and uncertainties, many of which are beyond
our control, and any investment in our common stock involves a high degree of
risk. Discussed below are many of the material risk factors faced by us that may
have an impact on our future results.
Risks
Related to Our Business and Our Industry
Our
products are relatively new and long-term results are incomplete, thus, the
future of our business still remains uncertain.
Many of
our current products are relatively new and have been in use for a relatively
short period of time. See “Description of Business - Products and
Services.” The results of the use of these products will be monitored
for many years. While preliminary results have been good, there can
be no assurance that some of these products will perform well over longer
periods of time. Future product issues may expose us to legal
actions, removal of regulatory approvals or products being pulled from
use. If we become subject to product or general liability or errors
and omissions claims, they could be time-consuming and costly. The U.S. Food and
Drug Administration (the “FDA”) and foreign regulatory authorities may impose
significant restrictions on the use or marketing of our products or impose
additional requirements. Later discovery of previously unknown
problems with any of these products or their manufacture may result in further
restrictions, including withdrawal of the product from the
market. Any such restrictions or withdrawals could materially affect
our ability to execute our business plan. In addition, governmental
authorities could seize our inventory of products, or force us to recall any
product already in the market if we fail to comply with FDA or other
governmental regulations.
Many
competitive products exist and more will be developed, and we may not be able to
successfully compete because we are smaller and have fewer financial
resources.
Our
business is in a very competitive and evolving field. Rapid new
developments in this field have occurred over the past few years, and are
expected to continue to occur. Other companies already have competing
products available or about to be available or may develop products to compete
with ours. Many of these products may have short regulatory
timeframes and our competitors, many with more substantial development
resources, may be able to develop competing products that are equal to or better
than ours. This may make our products obsolete or undesirable by
comparison and reduce our revenue. Our success will depend, in large
part, on our ability to maintain a competitive position concerning our
intellectual property, and to develop new technologies and new applications for
our technologies. Many of our competitors have substantially greater
financial and technical resources, as well as greater production and marketing
capabilities, than us.
The
medical community and the general public may perceive synthetic materials and
growth factors as safer, which could have a material adverse effect on our
business.
Members
of the medical community and the general public may perceive synthetic materials
and growth factors as safer than allograft-based bone tissue
products. Our products may be incapable of competing successfully
with synthetic bone graft substitutes and growth factors developed and
commercialized by others, which could have a material adverse effect on our
business, financial condition and results of operations.
We
are highly dependent on the availability of human donors; any disruptions could
cause our customers to seek alternative providers or technologies.
We are
highly dependent on our ability to obtain donor cadavers as the raw material for
many of our products. The availability of acceptable donors is
relatively limited and we compete with many other companies for this limited
availability. The availability of donors is also impacted by
regulatory changes, general public opinion of the donor process and our
reputation for our handling of the donor process. In addition, due to
seasonal changes in the mortality rates, some scarce tissues are at times in
short supply. Any disruption in the supply of this crucial raw
material could have significant consequences for our revenue, operating results
and continued operations. See “Description of Business - Donor
Procurement.”
We
will need to continue to innovate and develop new products to be desirable to
our customers.
The
markets for our products and services are characterized by rapid technological
change, frequent new introductions, changes in customers’ demands and evolving
industry standards. Accordingly, we will need to continue to innovate
and develop additional products. These efforts can be costly, subject
to long development and regulatory delays and may not result in products
approved for sale. These costs may hurt operating results and may
require additional capital. If additional capital is not available,
we may be forced to curtail development activities. In addition, any
failure on our behalf to react to changing market conditions could create an
opportunity for other market participants to capture a critical share of the
market within a short period of time.
Our
success will depend on our ability to engage and retain qualified technical
personnel who are difficult to attract.
Our
success will depend on our ability to attract and retain qualified technical
personnel to assist in research and development, testing, product
implementation, low-scale production and technical
support. Competition for qualified technical personnel is intense,
and we may encounter difficulty in engaging and retaining qualified personnel
needed to implement our growth plan. The demand for such personnel is
high and the supply of qualified technical personnel is limited. A
significant increase in the wages paid by competing employers could result in a
reduction of our technical work force and increases in the wage rates that we
must pay or both. If either of these events were to occur, our cost
structure could increase and our growth potential could be
impaired.
Loss
of key members of our management who we need to succeed could adversely affect
our business.
We are
highly dependent on the services of Guy Cook, our President and Chief Executive
Officer, and other key members of our management team and the loss of his or any
of their services could have an adverse effect on our future
operations. See “Management.” We do not currently maintain
a key-man life insurance policy insuring the life of Mr. Cook or any other
member of our management team.
We
are highly dependent on the continued availability of our facilities and would
be harmed if they were unavailable for any prolonged period of
time.
Any
failure in the physical infrastructure of our facilities or services could lead
to significant costs and disruptions that could reduce our revenues and harm our
business reputation and financial results. We are highly reliant on
our Belgrade, Montana facilities. See “Description of Business -
Facilities.” Any natural or man-made event that impacts our ability
to utilize these facilities could have a significant impact on our operating
results, reputation and ability to continue operations. The
regulatory process for approval of facilities is time-consuming and our ability
to rebuild facilities would take a considerable amount of time and expense and
cause a significant disruption in service to our customers. Further,
the FDA or some other regulatory agency could identify deficiencies in future
inspections of our facilities or our supplies that could disrupt our business,
reducing profitability. We carry business interruption insurance to
help in these instances, but it may not cover all costs or our standing in the
market.
We
will be required to invest in facilities and equipment on a continuing basis,
which will put pressure on us to finance these investments.
We have
invested, and intend to continue to invest, in facilities and state-of-the-art
equipment in order to increase, expand or update our capabilities and
facilities. See “Description of Business -
Facilities.” Changes in technology or sales growth beyond currently
established production capabilities, which we anticipate, will require further
investment. However, there can be no assurance that we will generate
sufficient funds from operations to maintain our existing facilities and
equipment or to finance any required capital investments or that other sources
of funding will be available. Additionally, there can be no guarantee
that any future expansion will not negatively affect earnings.
Future
revenue will depend on our ability to develop new sales channels and there can
be no assurance that these efforts will result in significant
sales.
We are in
the process of developing sales channels for our products but there can be no
assurance that these channels can be developed or that we will be successful in
selling our products. We currently sell our products through direct
sales by our employees, through distributor relationships and through “private
label” arrangements with other companies. We are engaging in a major
initiative to build and further expand our direct sales force. See
“Description of Business - Sales and Marketing.” This effort will
have significant costs that will be incurred prior to the generation of revenue
sufficient to cover these costs. The costs incurred for these efforts
may impact our operating results and there can be no assurance of their
effectiveness. Many of our competitors have well-developed sales
channels and it may be difficult for us to break through these competitors to
take market share. If we are unable to develop these sales channels,
we may not be able to grow revenue or maintain our current level of revenue
generation.
Our
physician compensation program could be adversely impacted by new regulation,
which could impact our current competitive strengths.
Our
physician compensation program compensates physicians as employees for referring
our products to other surgeons and medical care providers with whom they do not
have a disqualifying “financial relationship” under applicable
laws. Physician employees, at our direction, refer us to other
physicians and are paid a commission on all revenue generated by the referred
physicians’ use of our products. This program was vetted by counsel
for compliance with the Stark laws and anti-kickback
regulations. However, there can be no assurance that there will not
be additional regulations adopted which could have an impact on this
program. We have also established procedures that are designed to
prevent abuses involving these physician employees and others with whom they
have financial relationships.
There
may be fluctuations in our operating results, which will impact our stock
price.
Significant
annual and quarterly fluctuations in our results of operations may be caused by,
among other factors, our volume of revenues, the timing of new product or
service announcements, releases by us and our competitors in the marketplace of
new products or services, and general economic conditions. There can
be no assurance that the level of revenues and profits, if any, achieved by us
in any particular fiscal period will not be significantly lower than in other
comparable fiscal periods. Our expense levels are based, in part, on
our expectations as to future revenues. As a result, if future
revenues are below expectations, net income or loss may be disproportionately
affected by a reduction in revenues, as any corresponding reduction in expenses
may not be proportionate to the reduction in revenues.
We
are dependent on the ability of our licensees and development partners for
obtaining regulatory approvals and market acceptance of their products, for
which we may have no control.
A large
part of our success will depend on our ability, or that of our licensees, to
obtain timely regulatory approval for products employing our
technology. Moreover, our success will also depend on whether, and
how quickly, our licensees gain market acceptance of products incorporating our
technology, compared to competitors using competing technologies.
Negative
publicity concerning methods of human tissue recovery and screening of donor
tissue in the industry in which we operate may reduce demand for our allografts
and impact the supply of available donor tissue.
Media
reports or other negative publicity concerning both improper methods of tissue
recovery from donors and disease transmission from donated tissue may limit
widespread acceptance of our allografts. Unfavorable reports of
improper or illegal tissue recovery practices, both in the United States and
internationally, as well as incidents of improperly processed tissue leading to
transmission of disease, may broadly affect the rate of future tissue donation
and market acceptance of allograft technologies. Potential patients
may not be able to distinguish our allografts, technologies and the tissue
recovery and the processing procedures from those of our competitors or others
engaged in tissue recovery. In addition, families of potential donors
may become reluctant to agree to donate tissue to for-profit tissue
processors.
Our
revenues will depend upon prompt and adequate reimbursement from public and
private insurers and national health systems.
Political,
economic and regulatory influences are subjecting the healthcare industry in the
United States to fundamental change. The ability of hospitals to pay
fees for allograft bone tissue products depends in part on the extent to which
reimbursement for the costs of such materials and related treatments will
continue to be available from governmental health administration authorities,
private health coverage insurers and other organizations. We may have
difficulty gaining market acceptance for our products if government and
third-party payors do not provide adequate coverage and
reimbursement. Major third-party payors of hospital services and
hospital outpatient services, including Medicare, Medicaid and private
healthcare insurers, annually revise their payment methodologies, which can
result in stricter standards for reimbursement of hospital charges for certain
medical procedures or the elimination of reimbursement. Further,
Medicare, Medicaid and private healthcare insurer cutbacks could create downward
price pressure on our products.
Our
operating results will be harmed if we are unable to effectively manage and
sustain our future growth.
We might
not be able to manage our future growth efficiently or
profitably. Our business is unproven on a large scale and actual
revenue and operating margins, or revenue and margin growth, may be less than
expected. If we are unable to scale our production capabilities
efficiently, we may fail to achieve expected operating margins, which would have
a material and adverse effect on our operating results. Growth may
also stress our ability to adequately manage our operations, quality of
products, safety and regulatory compliance. If growth significantly
decreases our reserves, we may be required to obtain additional financing, which
may increase our indebtedness or result in dilution to our
stockholders. Further, there can be no assurance that we would be
able to obtain any additional financing.
Future
business combinations may be difficult to integrate and cause our attention to
be diverted.
We may
pursue various business combinations with other companies or acquisitions of
additional product lines. There can be no assurance that such
acquisitions will be available at all, or on terms acceptable to
us. These may require additional financing which may increase our
indebtedness or outstanding shares, resulting in dilution to
stockholders. The inability to obtain such future financing may
inhibit our growth and operating results. Integration of acquisitions or
additional products can be time consuming, difficult and expensive and may
significantly impact operating results. We may sell some or all of
our product lines to other companies or may agree to combine with another
company. Selling some of our product lines may inhibit our
ability to generate positive operating results going forward.
Acquisitions
that we consummate could disrupt our business and harm our financial
condition.
In the
future, we may evaluate potential strategic acquisitions of complementary
businesses, products or technologies. We may not be able to identify
appropriate acquisition candidates or successfully negotiate, finance or
integrate any businesses, products or technologies that we
acquire. Furthermore, the integration of any acquisition may divert
management’s time and resources from our core business. While we,
from time to time, evaluate potential acquisitions of businesses, products and
technologies, and anticipate continuing to make these evaluations, we have no
present understandings, commitments or agreements with respect to any
acquisitions.
We
may be subject to future product liability litigation that could be expensive
and may not be adequate in a catastrophic situation.
Although
we are not currently subject to any product liability proceedings, we may incur
material liabilities relating to product liability claims in the future,
including product liability claims arising out of the usage of our
products.
We
may implement a product recall or voluntary market withdrawal due to product
defects or product enhancements and modifications, which would significantly
increase our costs.
The
manufacturing and marketing of our biologic products, medical devices and
coating technologies involves an inherent risk that our products may prove to be
defective. In that event, we may voluntarily implement a recall or
market withdrawal or may be required to do so by a regulatory
authority. A recall of one of our products, or a similar product
manufactured by another manufacturer, could impair sales of the products we
market as a result of confusion concerning the scope of the recall or as a
result of the damage to our reputation for quality and safety.
Risks
Related to the Regulatory Environment in which We Operate
U.S.
governmental regulation could restrict the use of our products or our
procurement of tissue.
In the
United States, the procurement and transplantation of allograft bone tissue is
subject to federal law pursuant to the National Organ Transplant Act (“NOTA”), a
criminal statute which prohibits the purchase and sale of human organs used in
human transplantation, including bone and related tissue, for “valuable
consideration.” NOTA permits reasonable payments associated with the removal,
transportation, processing, preservation, quality control, implantation and
storage of human bone tissue. We provide services in all of these areas in the
United States, with the exception of removal and implantation, and receive
payments for all such services. We make payments to certain of our clients and
tissue banks for their services related to recovering allograft bone tissue on
our behalf. If NOTA is interpreted or enforced in a manner which prevents us
from receiving payment for services we render or which prevents us from paying
tissue banks or certain of our clients for the services they render for us, our
business could be materially and adversely affected.
We are
engaged through our marketing employees, independent sales agents and sales
representatives in ongoing efforts designed to educate the medical community as
to the benefits of our products, and we intend to continue our educational
activities. Although we believe that NOTA permits payments in connection with
these educational efforts as reasonable payments associated with the processing,
transportation and implantation of our products, payments in connection with
such education efforts are not exempt from NOTA’s restrictions and our inability
to make such payments in connection with our education efforts may prevent us
from paying our sales representatives for their education efforts and could
adversely affect our business and prospects. No federal agency or court has
determined whether NOTA is, or will be, applicable to every allograft bone
tissue-based material which our processing technologies may generate. Assuming
that NOTA applies to our processing of allograft bone tissue, we believe that we
comply with NOTA, but there can be no assurance that more restrictive
interpretations of, or amendments to, NOTA will not be adopted in the future
which would call into question one or more aspects of our method of
operations.
Our
business is subject to continuing regulatory compliance by the FDA and other
authorities.
As a
manufacturer and marketer of medical devices, we are subject to extensive
regulation by the FDA and the Center for Medicare Services of the U.S.
Department of Health and Human Services and other federal governmental agencies
and, in some jurisdictions, by state and foreign governmental
authorities. These regulations govern the introduction of new medical
devices, the observance of certain standards with respect to the design,
manufacture, testing, labeling, promotion and sales of the devices, the
maintenance of certain records, the ability to track devices, the reporting of
potential product defects, the import and export of devices and other
matters. We are facing an increasing amount of scrutiny and
compliance costs as more states are implementing regulations governing medical
devices, pharmaceuticals and/or biologics which affect many of our
products.
Medical
devices that incorporate coatings technology are subject to FDA regulation and
compliance. Generally, any medical device manufacturer that wishes to
incorporate our coatings technology into its products will be responsible for
obtaining FDA approval for the medical devices it intends to market; we will
assist in the 510(k) filing submitted by licensees. The FDA process
can take several months to several years in the United States. The
time required to obtain approval for international sales may be longer or
shorter, depending on the laws of the particular country. There can
be no assurance that our licensees will be able to obtain FDA or international
approval on a timely basis. The FDA may also require the more
extensive PMA process for certain products. Approval or clearance may
place substantial restrictions on the indications for which the product may be
marketed or to whom it may be marketed, warnings that may be required to
accompany the product or additional restrictions placed on the sale and/or use
of the product. Changes in regulations or adoption of new regulations
could also cause delays in obtaining product approval. In addition,
regulatory approval is subject to continuing compliance with regulatory
standards, and product approval is subject to withdrawal if a licensee fails to
comply with standards, or if an unforeseen event should occur concerning a
product. Significant delays in obtaining product approval could have
a significantly detrimental impact on our business. See “Description
of Business - Government Regulation.”
Human
tissues intended for transplantation have been regulated by the FDA since 1993.
In May 2005, three new comprehensive regulations went into effect that address
manufacturing activities associated with human cells, tissues and cellular and
tissue-based products (HCT/Ps). The first requires that companies that produce
and distribute HCT/Ps register with the FDA. The second provides criteria that
must be met for donors to be eligible to donate tissues and is referred to as
the “Donor Eligibility” rule. The third rule governs the processing and
distribution of the tissues and is often referred to as the “Current Good Tissue
Practices” rule. Together they are designed to ensure that sound, high quality
practices are followed to reduce the risk of tissue contamination and of
communicable disease transmission to recipients. See “Description of
Business - Government Regulation.”
The “Good
Tissue Practices” rule covers all stages of allograft processing, from
procurement of tissue to distribution of final allografts. These
regulations increased regulatory scrutiny within the industry in which we
operate and have lead to increased enforcement action which affects the conduct
of our business. In addition, these regulations can increase the cost
of tissue recovery activities.
Other
regulatory entities include state agencies with statutes covering tissue
banking. Regulations issued by Florida, New York, California and
Maryland will be particularly relevant to our business. Most states
do not currently have tissue banking regulations. However, recent
incidents of allograft related infections in the industry may stimulate the
development of regulation in other states. It is possible that others
may make allegations against us or against donor recovery groups or tissue banks
about non-compliance with applicable FDA regulations or other relevant statutes
or regulations. Allegations like these could cause regulators or
other authorities to take investigative or other action, or could cause negative
publicity for our business and the industry in which we operate.
Our
products may be subject to regulation in the EU as well should we enter that
market. In the European Union (“EU”), regulations, if applicable,
differ from one EU member state to the next. Because of the absence
of a harmonized regulatory framework and the proposed regulation for advanced
therapy medicinal products in the EU, as well as for other countries, the
approval process for human derived cell or tissue based medical products may be
extensive, lengthy, expensive and unpredictable. Among others, some
of our products may be subject to European Union member states’ regulations that
govern the donation, procurement, testing, coding, traceability, processing,
preservation, storage, and distribution of human tissues and cells and cellular
or tissue-based products. Some EU member states have their own tissue
banking regulations.
Clinical
trials can be long, expensive and ultimately uncertain.
Clinical
trials are required to develop products, gain market acceptance and obtain
510(k) certifications from the FDA. We have several clinical trials
planned and will likely undertake future trials. These trials often
take two years to execute and are subject to factors within and outside of our
control. The outcome of these trials is uncertain and may have a
significant impact on the success of our current and future products and future
profits.
The
commencement or completion of any of our clinical trials may be delayed or
halted for numerous reasons, including, but not limited to, a regulatory body
placing clinical trials on hold, patients not enrolling in clinical trials at
the rate we expect, patients experiencing adverse side effects, third party
contractors failing to perform in accordance with our anticipated schedule or
consistent with good clinical practices, inclusive or negative interim trial
results or our inability to obtain sufficient quantities of raw materials to
produce our products. Our development costs will increase if we have
material delays in our clinical trials or if we need to perform more or larger
clinical trials than planned. If this occurs, our financial results
and the commercial prospects for our products will be harmed and our prospects
for profitability will be harmed.
Product
pricing (and, therefore, profitability) is subject to regulatory
control.
The
pricing and profitability of our products may become subject to control by the
government and other third-party payors. The continuing efforts of
governmental and other third-party payors to contain or reduce the cost of
healthcare through various means may adversely affect our ability to
successfully commercialize our products. In most foreign markets, the
pricing and/or profitability of certain diagnostics and prescription
pharmaceuticals are subject to governmental control. In the United
States, we expect that there will continue to be federal and state proposals to
implement similar governmental control. Changes in prices, including
any mandated pricing, could impact our revenue and financial
performance. See “Description of Business - Government
Regulation.”
Risks
Related to Our Intellectual Property
Our
success will depend on our ability to protect our intellectual property
rights.
Our
success will depend, to a large extent, on our ability to successfully obtain
and maintain patents, prevent misappropriation or infringement of intellectual
property, maintain trade secret protection, and conduct operations without
violating or infringing on the intellectual property rights of third
parties. See “Description of Business - Technology and Intellectual
Property.” There can be no assurance that our patented and
patent-pending technology will provide us with a competitive advantage, that we
will be able to develop or acquire additional technology that is patentable, or
that third parties will not develop and offer technologies which are similar to
ours. Moreover, we can provide no assurance that confidentiality
agreements, trade secrecy agreements or similar agreements intended to protect
unpatented technology will provide the intended
protection. Intellectual property litigation is extremely expensive
and time-consuming, and it is often difficult, if not impossible, to predict the
outcome of such litigation. A failure by us to protect our
intellectual property could have a materially adverse effect on our business and
operating results and our ability to successfully compete in this
industry.
We
may not be able to obtain or protect our proprietary rights relating to our
products.
We may
not be able to obtain, maintain and protect certain proprietary rights necessary
for the development and commercialization of our products or product
candidates. Our
commercial success will depend in part on obtaining and maintaining patent
protection on our products and successfully defending these patents against
third-party challenges. Our ability to commercialize our products
will also depend in part on the patent positions of third parties, including
those of our competitors. The patent positions of pharmaceutical and
biotechnology companies can be highly uncertain and involve complex legal and
factual questions. Accordingly, we cannot predict with certainty the
scope and breadth of patent claims that may be afforded to other companies’
patents. We could incur substantial costs in litigation if we are
required to defend against patent suits brought by third parties, or if we
initiate suits to protect our patent rights.
Future
protection for our proprietary rights is uncertain.
The
degree of future protection for our proprietary rights is uncertain. We cannot
ensure that:
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·
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we
were the first to make the inventions covered by each of our patent
applications;
|
|
·
|
we
were the first to file patent applications for these
inventions;
|
|
·
|
others
will not independently develop similar or alternative technologies or
duplicate any of our technologies;
|
|
·
|
any
of our pending patent applications will result in issued
patents;
|
|
·
|
any
of our issued patents or those of our licensors will be valid and
enforceable;
|
|
·
|
any
patents issued to us or our collaborators will provide a basis for
commercially viable products or will provide us with any competitive
advantages or will not be challenged by third
parties;
|
|
·
|
we
will develop additional proprietary technologies that are patentable;
or
|
|
·
|
the
patents of others will not have a material adverse effect on our business
rights and measures we rely on to protect the intellectual property
underlying our products may not be adequate to prevent third parties from
using our technology, all of which could harm our ability to compete in
the market.
|
Our
success depends on our ability to avoid infringing on the intellectual property
rights of third parties.
Our
commercial success depends in part on our ability and the ability of our
collaborators to avoid infringing patents and proprietary rights of third
parties. Third parties may accuse us or our collaborators of
employing their proprietary technology in our products, or in the materials or
processes used to research or develop our products, without
authorization. Any legal action against our collaborators or us
claiming damages and/or seeking to stop our commercial activities relating to
the affected products, materials and processes could, in addition to subjecting
us to potential liability for damages, require our collaborators or us to obtain
a license to continue to utilize the affected materials or processes or to
manufacture or market the affected products. We cannot predict
whether we or our collaborators would prevail in any of these actions or whether
any license required under any of these patents would be made available on
commercially reasonable terms, if at all. If we are unable to obtain
such a license, we or our collaborators may be unable to continue to utilize the
affected materials or processes or manufacture or market the affected products
or we may be obligated by a court to pay substantial royalties and/or other
damages to the patent holder. Even if we are able to obtain such a
license, the terms of such a license could substantially reduce the commercial
value of the affected product or products and impair our prospects for
profitability. Accordingly, we cannot predict whether or to what
extent the commercial value of the affected product or products or our prospects
for profitability may be harmed as a result of any of the liabilities discussed
above. Furthermore, infringement and other intellectual property
claims, with or without merit, can be expensive and time-consuming to litigate
and can divert management’s attention from our core business. We may
be unable to obtain and enforce intellectual property rights to adequately
protect our products and related intellectual property.
Others
may claim an ownership interest in our intellectual property.
A
third-party may claim an ownership interest in one or more of our patents or
intellectual property. While we believe we own 100% of the right,
title and interest in the patents for which we have applied and our other
intellectual property, including that which we license from third parties, we
cannot guarantee that a third-party will not, at some time, assert a claim or an
interest in any of such patents or intellectual property. We are
presently unaware of any claims or assertions by third-parties with respect to
its patents or intellectual property, except that, as a defense to a lawsuit we
brought against Allograft for infringement of our OsteoSponge® trademark,
Allograft has counterclaimed in an attempt to invalidate such mark. A
successful challenge or claim by a third party to our patents or intellectual
property could have a significant adverse effect on our prospects.
The
result of litigation may result in financial loss and/or impact our ability to
sell our products going forward.
We will
vigorously defend any future intellectual property litigation that may arise but
there can be no assurance that we will prevail in these matters. An
unfavorable judgment may result in a financial burden on us. An
unfavorable judgment may also result in restrictions on our ability to sell
certain products and therefore may impact future operating results.
Because we became public through a
reverse merger, we may not be able to attract the attention of major brokerage
firms.
Additional
risks are associated with our becoming public through a reverse merger. For
example, security analysts of major brokerage firms may not provide coverage of
us since there is no incentive to brokerage firms to recommend the purchase of
our common stock. We cannot assure you that brokerage firms will want to conduct
any public offerings on our behalf in the future.
If
we do not timely file and have declared effective the registration statement
required pursuant to our private placement, we will be required to pay
liquidated damages.
As part
of our private placement, we entered into a registration rights agreement. Under
this agreement, we are obligated to file a registration statement providing for
the resale of the shares of common stock acquired in the private placement and
underlying the warrants. Pursuant to the agreement, we agreed to file and have
declared effective the registration statement by a certain date. If we do not
meet this timeline, we must pay liquidated damages in the amount equal to 1% of
the aggregate investment amount per month, subject to a maximum limit of 12% of
the aggregate investment amount.
If
and when our registration statement becomes effective, a significant number of
shares of common stock will be eligible for sale, which could depress the market
price of our common stock.
Following
the effective date of the registration statement, a significant number of our
shares of common stock will become eligible for sale in the public market, which
could harm the market price of the stock. Further, shares may be offered from
time to time in the open market pursuant to Rule 144, and these sales may have a
depressive effect as well. In general, a person who has held restricted shares
for a period of six months may, upon filing a notification with the SEC on Form
144, sell our common stock into the market, subject to certain
limitations.
To
the extent any of Bacterin’s former stockholders elect to exercise any
dissenters rights in connection with the Reverse Merger, we are obligated to
issue additional shares of our common stock to the non-dissenting Bacterin
stockholders.
To the
extent any of Bacterin’s former stockholders elect to exercise any dissenters’
rights in connection with the Reverse Merger, we are obligated to purchase any
such dissenter’s shares of Bacterin common stock for “fair value” as determined
immediately prior to the Reverse Merger, all in accordance with Nevada
law. In addition, we would also be obligated to issue additional
shares of our common stock to the non-dissenting Bacterin stockholders such that
the non-dissenting stockholders would have held approximately 96% of our
outstanding shares of common stock immediately upon consummation of the Reverse
Merger, exclusive of any shares of our common stock issued in the private
placement. Certain of Bacterin’s former stockholders, who held
approximately 743,940 shares of Bacterin common stock in the aggregate, provided
proper notice to perfect their ability to exercise dissenters’ rights (or
371,970 shares of our common stock that they will receive in the Reverse Merger
if they ultimately elect not to exercise such rights).
There
has been no active public trading market for our common stock.
There is
currently no active public market for our common stock. An active trading market
may not develop or, if developed, may not be sustained. The lack of an active
market may impair your ability to sell your shares of common stock at the time
you wish to sell them or at a price that you consider reasonable. The lack of an
active market may also reduce the market value and increase the volatility of
your shares of common stock. An inactive market may also impair our ability to
raise capital by selling shares of common stock and may impair our ability to
acquire other companies or assets by using shares of our common stock as
consideration.
The
market price of our common stock has been and will likely continue to be highly
volatile, as is the stock market in general, and the market for OTC Bulletin
Board quoted stocks, in particular. Some of the factors that may materially
affect the market price of our common stock are beyond our control, such as
changes in financial estimates by industry and securities analysts, conditions
or trends in the industry in which we operate or sales of our common stock.
These factors may materially adversely affect the market price of our common
stock, regardless of our performance. In addition, the public stock markets have
experienced extreme price and trading volume volatility. This volatility has
significantly affected the market prices of securities of many companies for
reasons frequently unrelated to the operating performance of the specific
companies. These broad market fluctuations may adversely affect the market price
of our common stock.
Our
stockholders may experience significant dilution if future equity offerings are
used to fund operations or acquire complementary businesses.
If our
future operations or acquisitions are financed through the issuance of equity
securities, our stockholders could experience significant dilution. In addition,
securities issued in connection with future financing activities or potential
acquisitions may have rights and preferences senior to the rights and
preferences of our common stock. We also have established an equity incentive
plan for our management and employees. We expect to grant options to purchase
shares of our common stock to our directors, employees and consultants and we
will grant additional options in the future. The issuance of shares of our
common stock upon the exercise of these options may result in dilution to our
stockholders.
Our
current management can exert significant influence over us and make decisions
that are not in the best interests of all stockholders.
Our
executive officers and directors beneficially own as a group approximately
43.12% of our outstanding shares of common stock. As a result, these
stockholders will be able to assert significant influence over all matters
requiring stockholder approval, including the election and removal of directors
and any change in control. In particular, this concentration of ownership of our
outstanding shares of common stock could have the effect of delaying or
preventing a change in control, or otherwise discouraging or preventing a
potential acquirer from attempting to obtain control. This, in turn, could have
a negative effect on the market price of our common stock. It could also prevent
our stockholders from realizing a premium over the market prices for their
shares of common stock. Moreover, the interests of the owners of this
concentration of ownership may not always coincide with our interests or the
interests of other stockholders and, accordingly, could cause us to enter into
transactions or agreements that we would not otherwise consider.
Our
common stock is considered “penny stock” and may be difficult to
sell.
The SEC
has adopted Rule 3a51-1, which establishes the definition of a "penny stock" for
the purposes relevant to us, as any equity security that has a market price of
less than $5.00 per share or with an exercise price of less than $5.00 per
share, subject to certain exceptions. The market price of our common
stock is less than $5.00 per share and therefore may be designated as a “penny
stock” according to SEC rules. For any transaction involving a penny
stock, unless exempt, Rule 15g-9 requires:
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·
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that
a broker or dealer approve a person's account for transactions in penny
stocks; and
|
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·
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that
the broker or dealer receives from the investor a written agreement to the
transaction, setting forth the identity and quantity of the penny stock to
be purchased.
|
In order
to approve a person's account for transactions in penny stocks, the broker or
dealer must:
|
·
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obtain
financial information and investment experience objectives of the person;
and
|
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·
|
make
a reasonable determination that the transactions in penny stocks are
suitable for that person and the person has sufficient knowledge and
experience in financial matters to be capable of evaluating the risks of
transactions in penny stocks.
|
The
broker or dealer must also deliver, prior to any transaction in a penny stock, a
disclosure schedule prescribed by the SEC relating to the penny stock market,
which, in highlight form:
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·
|
sets
forth the basis on which the broker or dealer made the suitability
determination; and
|
|
·
|
that
the broker or dealer received a signed, written agreement from the
investor prior to the transaction.
|
Disclosure
also has to be made about the risks of investing in penny stocks in both public
offerings and in secondary trading and about the commissions payable to both the
broker-dealer and the registered representative, current quotations for the
securities and the rights and remedies available to an investor in cases of
fraud in penny stock transactions. Finally, monthly statements have
to be sent disclosing recent price information for the penny stock held in the
account and information on the limited market in penny stocks.
Generally,
brokers may be less willing to execute transactions in securities subject to the
"penny stock" rules. This may make it more difficult for investors to
dispose of our Common Stock and cause a decline in the market value of our
stock. In addition, since the Common Stock is currently traded on the
OTC Bulletin Board, investors may find it difficult to obtain accurate
quotations of the Common Stock and may experience a lack of buyers to purchase
such stock or a lack of market makers to support the stock price.
We
currently intend to retain our future earnings to support operations and to
finance expansion and, therefore, we do not anticipate paying any cash dividends
on our common stock in the foreseeable future.
We
intend to apply for trading our common stock on Nasdaq, although we may not
satisfy its eligibility criteria for listing or will ever be listed on
Nasdaq.
We intend
to apply to list our common stock for trading on the Nasdaq Capital Market as
soon as reasonable practicable. No assurance can be given that we
will satisfy the eligibility criteria or other initial listing requirements, or
that our shares of common stock will ever be listed on Nasdaq or another
national securities exchange.
We
could issue “blank check” preferred stock without stockholder approval with the
effect of diluting then current stockholder interests and impairing their voting
rights, and provisions in our charter documents and under Delaware law could
discourage a takeover that stockholders may consider favorable.
Our
certificate of incorporation provides for the authorization to issue up to
5,000,000 shares of “blank check” preferred stock with designations, rights and
preferences as may be determined from time to time by our board of directors.
Our board of directors is empowered, without stockholder approval, to issue a
series of preferred stock with dividend, liquidation, conversion, voting or
other rights which could dilute the interest of, or impair the voting power of,
our common stockholders. The issuance of a series of preferred stock could be
used as a method of discouraging, delaying or preventing a change in control.
For example, it would be possible for our board of directors to issue preferred
stock with voting or other rights or preferences that could impede the success
of any attempt to change control of our company. In addition, advanced notice is
required prior to stockholder proposals.
Cautionary
Language Regarding Forward-Looking Statements and Industry Data
This
current report contains “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995 that involve risks and
uncertainties, many of which are beyond our control. Our actual results could
differ materially and adversely from those anticipated in such forward-looking
statements as a result of certain factors, including those set forth above and
elsewhere in this report. Important factors that may cause actual results to
differ from these forward-looking statements include, but are not limited to,
for example:
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adverse
economic conditions,
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inability
to raise sufficient additional capital to operate our
business,
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unexpected
costs, lower than expected sales and revenues, and operating
deficits,
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adverse
results of any legal proceedings,
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Inability
to enter into acceptable relationships with one or more of our suppliers
for key biomaterial supplies and the failure of such suppliers to deliver
acceptable quality and quantity of such supplies on a cost-effective
basis,
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the
volatility of our operating results and financial
condition,
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●
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inability
to attract or retain qualified senior management personnel, including
sales and marketing personnel
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Inability
to achieve anticipated product sales, and
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other
specific risks that may be referred to in this current
report.
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All
statements, other than statements of historical facts, included in this current
report regarding our strategy, future operations, financial position, estimated
revenue or losses, projected costs, prospects and plans and objectives of
management are forward-looking statements. When used in this current report, the
words “will,” “may,” “believe,” “anticipate,” “intend,” “estimate,” “expect,”
“project,” “plan” and similar expressions are intended to identify
forward-looking statements, although not all forward-looking statements contain
such identifying words. All forward-looking statements speak only as of the date
of this report. We undertake no obligation to update any forward-looking
statements or other information contained herein. Stockholders and potential
investors should not place undue reliance on these forward-looking statements.
Although we believe that our plans, intentions and expectations reflected in or
suggested by the forward-looking statements in this report are reasonable, we
cannot assure stockholders and potential investors that these plans, intentions
or expectations will be achieved. We disclose important factors that could cause
our actual results to differ materially from expectations under “Risk Factors”
and elsewhere in this current report. These cautionary statements qualify all
forward-looking statements attributable to us or persons acting on our
behalf.
Information
regarding market and industry statistics contained in this current report is
included based on information available to us that we believe is accurate. It is
generally based on academic and other publications that are not produced for
purposes of securities offerings or economic analysis. Forecasts and other
forward-looking information obtained from these sources are subject to the same
qualifications and the additional uncertainties accompanying any estimates of
future market size, revenue and market acceptance of products and
services. Except as required by U.S. federal securities laws, we have
no obligation to update forward-looking information to reflect actual results or
changes in assumptions or other factors that could affect those statements. See
“Risk Factors” for a more detailed discussion of risks and uncertainties that
may have an impact on our future results.
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
You
should read the following discussion of our financial condition and results of
operations in conjunction with our financial statements and related notes set
forth in Item 9.01 of this report. Unless the context otherwise
requires, “we,” “our,” “us” and similar expressions used in this Management’s
Discussion and Analysis of Financial Condition and Results of Operation section
refer to Bacterin prior to the closing of the Reverse Merger on June 30, 2010,
and Bacterin International Holdings, Inc., f/k/a K-Kitz, Inc., as successor to
the business of Bacterin, following the closing of the Reverse Merger
transaction.
Overview
We
develop, manufacture and market biologics products to domestic and international
markets through our biologics division and are a leader in the field
of biomaterials research, device development and
commercialization. Our proprietary methods optimize the growth
factors in human allografts to create the ideal stem cell scaffold and promote
bone and other tissue growth. These products are used in a variety of
applications including enhancing fusion in spine surgery, relief of back pain
with a facet joint stabilization, promotion of bone growth in foot and ankle
surgery, promotion of skull healing following neurosurgery and cartilage
regeneration in knee and other joint surgeries.
Our
medical devices division develops medical devices intended for use in several
diverse clinical areas including orthopedic, plastic, and cardiovascular
surgery. Our background and expertise is in the research, testing, and
development of coatings for medical devices, particularly antimicrobial-based
coatings. Such coatings contain active agents and provide our
products with several potential advantages over traditional medical devices.
They offer a means of protecting the surface of a medical device from
contamination by pathogenic organisms, thereby minimizing the potential for
infection. Other coatings can serve as a reserve for local delivery
of active agents, enhancing a variety of biological functions such as bone
growth and pain management.
The
manufacturing and operations of the biologics and device divisions are organized
separately while products from both are marketed through several channels
including private label arrangements, independent distributors, joint
development projects and our direct sales network which we began to implement in
the last half of 2009. To date, we have established 13 regions with a
regional vice-president in charge of all activities within the region and have
hired and trained 24 sales representatives. Our customers are located
worldwide, with approximately 91% of our sales being derived from customers
located in the United States. Our headquarters, laboratory and
manufacturing facilities are located in Belgrade, Montana.
Revenue
Model
We
generate revenue from a variety of sources, including the following: license
fees and royalties from collaborative product development efforts with medical
device manufacturers; sales from products developed and manufactured by us under
our own label; products manufactured by us under private labels for other device
distributing companies; and contract revenue from analytical testing and
development services provided to medical device manufacturer clients, which
tailor our coating process to the client’s specific product/medical
application. In order for us to recognize revenue from these sources,
the following criteria generally must be met:
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we
have entered into a legally binding agreement with the customer for the
product or services;
|
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·
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the
products or services have been delivered by
us;
|
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·
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our
fee for providing the products or services is fixed and determinable;
and
|
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·
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our
fee is actually collectible.
|
We record
revenue net of any applicable sales, use, or excise taxes. If our
arrangement with the customer includes a right of acceptance or a right to
cancel, revenue is recognized when our products or services are accepted or when
the right to cancel has expired. We sell to certain customers
under consignment arrangements. Under these arrangements, revenue is
recorded on the date of sale. Revenue for research and development
services provided by us is recognized based upon our meeting certain performance
standards, such as incurring qualifying costs, as set forth in the specific
arrangement governing the provision of such services.
Results
of Operations
Comparison
of Three Months Ended March 31, 2010 and 2009
The
following table sets forth key components of our results of operations during
the three months ended March 31, 2010 and 2009, both in dollars and as a
percentage of our revenue. The acquisition of Bacterin International
Holdings, Inc. f/k/a K-Kitz, Inc. by Bacterin through the Reverse Merger
occurred after March 31, 2010. The combined presentation below refers
to that of Bacterin International Holdings, Inc. f/k/a K-Kitz, Inc. and
Bacterin.
|
|
Unaudited Three Months Ended March
31,
|
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2010
|
|
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2009
|
|
|
|
|
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|
%
of
|
|
|
|
|
|
%
of
|
|
|
|
Amount
|
|
|
Revenue
|
|
|
Amount
|
|
|
Revenue
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
Tissue
sales
|
|
$ |
2,707,124 |
|
|
|
98.93
|
% |
|
$ |
1,984,676 |
|
|
|
94.58
|
% |
Royalties and
other
|
|
|
29,309 |
|
|
|
1.07
|
% |
|
|
113,765 |
|
|
|
5.42
|
% |
Total
Revenue
|
|
|
2,736,433 |
|
|
|
100.00
|
% |
|
|
2,098,441 |
|
|
|
100.00
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of tissue sales
|
|
|
604,622 |
|
|
|
22.10
|
% |
|
|
483,640 |
|
|
|
23.05
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
Profit
|
|
|
2,131,811 |
|
|
|
77.90
|
% |
|
|
1,614,801 |
|
|
|
76.95
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and
administrative
|
|
|
816,700 |
|
|
|
29.85
|
% |
|
|
405,145 |
|
|
|
19.31
|
% |
Selling and
marketing
|
|
|
701,879 |
|
|
|
25.65
|
% |
|
|
224,312 |
|
|
|
10.69
|
% |
Depreciation
|
|
|
152,502 |
|
|
|
5.57
|
% |
|
|
163,575 |
|
|
|
7.80
|
% |
Compensation
expense
|
|
|
1,483,871 |
|
|
|
54.23
|
% |
|
|
720,446 |
|
|
|
34.33
|
% |
Total Operating
Expenses
|
|
|
3,154,952 |
|
|
|
115.29
|
% |
|
|
1,513,478 |
|
|
|
72.12
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income
from Operations
|
|
|
(1,023,141
|
) |
|
|
-37.39
|
% |
|
|
101,323 |
|
|
|
4.83
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
Income (Expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
|
(625,797
|
) |
|
|
-22.87
|
% |
|
|
(96,161
|
) |
|
|
-4.58
|
% |
Other
|
|
|
5,924 |
|
|
|
0.22
|
% |
|
|
10,868 |
|
|
|
0.52
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
Other Income (Expense)
|
|
|
(619,873
|
) |
|
|
-22.65
|
% |
|
|
(85,293
|
) |
|
|
-4.06
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Income Before Benefit (Provision)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
for Income
Taxes
|
|
|
(1,643,014
|
) |
|
|
-60.04
|
% |
|
|
16,030 |
|
|
|
0.76
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Benefit
(Provision) for Income Taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
|
|
|
- |
|
|
|
0.00
|
% |
|
|
- |
|
|
|
0.00
|
% |
Deferred
|
|
|
- |
|
|
|
0.00
|
% |
|
|
- |
|
|
|
0.00
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Income
|
|
$ |
(1,643,014 |
) |
|
|
-60.04
|
% |
|
$ |
16,030 |
|
|
|
0.76
|
% |
Total
revenue for the three months ended March 31, 2010 increased by 30.4% to
$2,736,433 compared to $2,098,441 in the three months ended March 31,
2009. The increase related primarily to the implementation of a
direct sales force effort in July 2009. Prior to that time, we
utilized a distributor model with a limited direct sales force.
Costs
of Revenue
Costs of
revenue consist primarily of tissue and device manufacturing
costs. Costs of revenue increased by 25.0%, or $120,982, to $604,622
for the three months ended March 31, 2010, from $483,640 for the three months
ended March 31, 2009. Cost of revenue increase was the result of
increased sales and a write-off of approximately $64,000 of
obsolete inventory. Our gross profit margin increased
slightly to 77.9% for the three months ended March 31, 2010 compared to 76.95%
for the three months ended March 31, 2009.
Operating
Expenses
Operating
expenses include general and administrative expenses, selling and marketing
expenses, depreciation, and compensation costs, including incentive
compensation and non cash stock based compensation. Operating expenses
increased 108.5%,
or $1,641,474,
to $3,154,952
for the three months ended March 31, 2010 from $1,513,478
for the three months ended March 31, 2009.
General
and Administrative
General
and administrative expenses consist principally of employee related costs and
corporate expenses for legal, accounting and other professional fees
as well as occupancy costs. General and administrative expenses increased
101.6%%, or $411,555 to $816,700, for the three months ended March 31, 2010
compared to the three months ended March 31, 2009. The increase is largely
associated with one-time legal and professional fees incurred throughout the
transactions described in this report.
Selling
and Marketing
Selling
and marketing expenses exclude sales based compensation expense and primarily
consist of costs for trade shows, sales conventions and meetings, travel
expenses, advertising and other sales and marketing related
costs. Selling and marketing expenses increased 212.9%, or $477,567,
to $701,879 for the three months ended March 31,2010 from $224,312 for the first
quarter of 2009. As a percentage of revenue, selling and marketing
expenses increased to 25.65% in the first quarter of 2010 from 10.69% in the
comparable period of the prior year. The increases were primarily the
result of increased travel costs associated with the larger sales force and a
substantial increase in marketing and advertising activities in
2010.
Depreciation
Depreciation
expense consists of depreciation of long-lived property and equipment.
Depreciation expenses decreased 6.8%, to $152,502 for the three months ended
March 31, 2010 from $163,575 for the three months ended March 31, 2009.
This decrease was a result of certain assets becoming fully
depreciated.
Compensation
expense
Compensation
expense consists of payroll and related expenses and includes non-cash based
stock compensation expense. Compensation expense increased 106% or
$763,425, to $1,483,871 for the three months ended March 31,2010 from $720,446
in the comparable period of the prior year. This increase was
primarily due to our implementation of a direct sales effort in 2009 which
substantially increased the sales force headcount. In addition, we
granted more stock options to employees than the prior year. As a
percentage of revenues, compensation expense in the first quarter of 2010 was
54.23% of revenues compared to 34.33% in the prior year.
Interest
Expense
Interest
expense is from our notes payable and convertible debt instruments.
Interest expense for the three months ended March 31, 2010 increased 550.8%
to $625,797 as
compared to $96,161 for the three months ended March 31, 2009. This
increase was a direct result of the interest expense associated with the
increase in convertible notes payable.
Comparison
of Twelve Months Ended December 31, 2009 and December 31, 2008
The
following table sets forth key components of our results of operations during
the twelve months ended December 31, 2009 and 2008, both in actual dollars and
as a percentage of our revenue. The acquisition of Bacterin
International Holdings, Inc. f/k/a K-Kitz, Inc. by Bacterin through the Reverse
Merger occurred after March 31, 2010. The combined presentation below
refers to that of Bacterin International Holdings, Inc. f/k/a K-Kitz, Inc. and
Bacterin.
|
|
Twelve Months Ended December
31,
|
|
|
|
2009
|
|
|
2008
|
|
|
|
|
|
|
%
of
|
|
|
|
|
|
%
of
|
|
|
|
Amount
|
|
|
Revenue
|
|
|
Amount
|
|
|
Revenue
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
Tissue
sales
|
|
$ |
7,101,357 |
|
|
|
96.05
|
% |
|
$ |
8,031,611 |
|
|
|
97.80
|
% |
Royalties and
other
|
|
|
292,136 |
|
|
|
3.95
|
% |
|
|
180,848 |
|
|
|
2.20
|
% |
Total
Revenue
|
|
|
7,393,493 |
|
|
|
100.00
|
% |
|
|
8,212,459 |
|
|
|
100.00
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of tissue sales
|
|
|
2,318,142 |
|
|
|
31.35
|
% |
|
|
1,522,658 |
|
|
|
18.54
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
Profit
|
|
|
5,075,351 |
|
|
|
68.65
|
% |
|
|
6,689,801 |
|
|
|
81.46
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and
administrative
|
|
|
2,218,162 |
|
|
|
30.00
|
% |
|
|
2,053,797 |
|
|
|
25.01
|
% |
Selling and
marketing
|
|
|
1,281,932 |
|
|
|
17.34
|
% |
|
|
429,170 |
|
|
|
5.23
|
% |
Depreciation
|
|
|
661,847 |
|
|
|
8.95
|
% |
|
|
646,846 |
|
|
|
7.88
|
% |
Research and
development
|
|
|
- |
|
|
|
0.00
|
% |
|
|
288,091 |
|
|
|
3.51
|
% |
Compensation
expense
|
|
|
4,535,964 |
|
|
|
61.35
|
% |
|
|
2,157,450 |
|
|
|
26.27
|
% |
Total Operating
Expenses
|
|
|
8,697,905 |
|
|
|
117.64
|
% |
|
|
5,575,354 |
|
|
|
67.89
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income
from Operations
|
|
|
(3,622,554
|
) |
|
|
-49.00
|
% |
|
|
1,114,447 |
|
|
|
13.57
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
Income (Expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
|
(513,934
|
) |
|
|
-6.95
|
% |
|
|
(1,374,360
|
) |
|
|
-16.74
|
% |
Other
|
|
|
10,746 |
|
|
|
0.15
|
% |
|
|
20,601 |
|
|
|
0.25
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
Other Income (Expense)
|
|
|
(503,188
|
) |
|
|
-6.81
|
% |
|
|
(1,353,759
|
) |
|
|
-16.48
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Income Before Benefit (Provision)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
for Income
Taxes
|
|
|
(4,125,742
|
) |
|
|
-55.80
|
% |
|
|
(239,312
|
) |
|
|
-2.91
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Benefit
(Provision) for Income Taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
|
|
|
- |
|
|
|
0.00
|
% |
|
|
- |
|
|
|
0.00
|
% |
Deferred
|
|
|
- |
|
|
|
0.00
|
% |
|
|
- |
|
|
|
0.00
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Income
|
|
$ |
(4,125,742 |
) |
|
|
-55.80
|
% |
|
$ |
(239,312 |
) |
|
|
-2.91
|
% |
Revenue
in 2009 and 2008 was comprised solely of tissue and device
sales. Total revenue decreased by 11.3% year-over-year at $7,393,493
in 2009, compared to $8,212,459 in 2008. The decrease was largely the result of
transitioning the sales model from a distributorship model with a limited direct
sales force to a direct sales force model. In addition, during 2009,
we terminated an agreement with a distributor customer with annual sales of
approximately $3,000,000 as part of our transition to a direct sales force
model.
Our
largest single customer accounted for 12% and 37% of total consolidated revenues
for the years ended 2009 and 2008, respectively. Our relationship
with the customer is governed by a contract between the two parties which
identifies prices for the services to be rendered and payments to be made by the
customer to us. The contract expires in February 2011.
Costs
of Revenue
Costs of
revenue consist primarily of tissue and device manufacturing
costs. Costs of revenue increased by 52.2%%, or $795,484, to
$2,318,142 for the year ended December 31, 2009, from $1,522,658 for the year
ended December 31, 2008. Cost of revenue increase was the result
of increased costs associated with our higher sales and a product mix shift
which resulted in higher sales of products with higher costs.
Operating
Expenses
Operating
expenses include general and administrative expenses, selling and marketing
expenses, depreciation, research and development expenses, and compensation
costs, including incentive compensation. Operating expenses increased
56.0%, or $3,122,151 for the year ended December 31, 2009 compared to the
year ended December 31, 2008.
General
and Administrative
General
and administrative expenses consist principally of employee related costs and
corporate expenses for legal, accounting and other professional fees
as well as occupancy costs. General and administrative expenses increased
8%, or $164,365 to $2,218,162, for the twelve months ended December 31, 2009
compared to 2008. The increase is largely associated with increased legal
and professional fees incurred between the two periods. As a
percentage of revenues, general and administrative expenses were 30.0% in 2009
compared to 25.01% in 2008.
Selling
and Marketing
Selling
and marketing expenses exclude sales based compensation expense and primarily
consist of costs for trade shows, sales conventions and meetings, travel
expenses, advertising and other sales and marketing related costs. Selling
and marketing expenses increased 198.7%, or $852,762, to $1,281,932 for the
twelve months ended December 31, 2009 from $429,170 for 2008. As a
percentage of revenue, selling and marketing expenses increased to 17.34% in
2009 from 5.23% in the prior year. The increases were primarily the
result of increased travel costs associated with the larger sales force and a
substantial increase in marketing and advertising activities in 2009 as part of
our switch to a direct sales force model from a distributorship
model.
Depreciation
Depreciation
expense consists of depreciation of long-lived property and equipment.
Depreciation expense remained relatively unchanged increasing to $661,847 in
2009 from $646,846 in 2008.
Research and
Development
Research
and development expenses consist primarily of costs for product research and
development and department related expenses. Research and development
expenses were $288,091 in 2008. In 2009, we did not incur any
research and development expenses as we focused our efforts on the
implementation of our direct sales force model.
Compensation
expense
Compensation
expense consists of payroll and related expenses and includes non-cash stock
compensation expense. Compensation expense increased 110.2% or
$2,378,514, to $4,535,964 for 2009 from $2,157,450 in the comparable year period
for 2008. This increase was primarily due to our implementation of a
direct sales effort in 2009 which substantially increased the sales force
headcount. In addition, we granted more stock options to employees in
2009 than in the prior year. As a percentage of revenues,
compensation expense in 2009 was 61.35% compared to 26.27% in the prior
year.
Interest
Expense
Interest
expense is from our promissory notes and convertible debt
instruments. Interest expense for the year ended December 31, 2009
decreased 62.61%, or $860,426, as compared to the year ended December 31,
2008. This decrease was a result of lower debt balances during the
year.
Liquidity
and Capital Resources
Since our
inception, we have historically financed our operations through operating cash
flows, as well as the private placement of equity securities and debt, and other
debt transactions. Most recently, on June 30, 2010, we raised
approximately $7,508,329 through a private placement of equity securities and
conversion of a portion of a bridge loan financing. At December 31,
2009, we had $1,368,573 of cash and cash equivalents and accounts
receivables. In the
first quarter of 2010, we received proceeds of $2,695,000 in connection with
an unsecured convertible bridge loan financing. In
addition, we have access to credit lines secured by certain of our accounts
receivable balances.
Net cash
used in operating activities for the year ended December 31, 2009 was
$3,671,596. This was primarily related to cash used to fund our
operations as well as an increase of accounts receivable of approximately
$739,000 and an increase in our inventory balance of approximately
$851,000. For the twelve months ended December 31, 2008, net cash
provided by operating activities was $502,008 due to a lower net loss compared
to 2009.
Net cash
provided by financing activities was $3,436,991 and $545,169 for the years ended
December 31, 2009 and 2008, respectively. The net cash provided from
financing activities during 2009 was $1,950,000 from the sale and issuance of
common stock and $1,000,000 from releases on certain restrictions on
cash. The cash receipts were partially offset from the payment of
notes payable in the amount of $942,562. Net cash provided from
financing in 2008 included $1,000,000 in proceeds from notes payable, $2,340,000
from issuance of convertible notes payable and $1,278,514 from the sale and
issuance of common stock. The cash inflows were partially offset by
the payments of $3,073,345 for long-term debt, stockholder notes and capital
leases.
Off
Balance Sheet Arrangements
We do not
have any off balance sheet arrangements that have or are reasonably likely to
have a current or future effect on our financial condition, changes in financial
condition, revenues or expenses, results of operations, liquidity or capital
expenditures or capital resources that are material to an investor in our
shares.
Cash
Requirements
We
believe that our cash on hand from our recent private placement of equity
securities and from operations will be sufficient to meet our anticipated cash
requirements through December 31, 2010. If we do not meet our
revenue objectives over that period, we may need to sell additional equity
securities, which could result in dilution to our stockholders, or seek
additional loans. The incurrence of indebtedness would result in
increased debt service obligations and could require us to agree to operating
and financial covenants that would restrict our operations. Financing may not be
available in amounts or on terms acceptable to us, if at all. Any
failure by us to raise additional funds on terms favorable to us, or at all,
could limit our ability to expand our business operations and could harm our
overall business prospects.
Security
Ownership of Certain Beneficial Owners and Management
The
following table sets forth information regarding the beneficial ownership of our
common stock as of June 30, 2010, by (a) each person who is known by us to
beneficially own 5% or more of our common stock, (b) each of our directors and
executive officers, and (c) all of our directors and executive officers as a
group.
Name (1)
|
|
Number of
Shares
Beneficially
Owned (2)
|
|
|
Percentage of
Shares
Beneficially
Owned
(3)
|
|
5% or
Greater Stockholder:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Guy
S. Cook
|
|
|
13,180,189 |
(4) |
|
|
38.11 |
% |
|
|
|
|
|
|
|
|
|
Executive
Officers and Directors:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Guy
S. Cook
|
|
|
13,180,189 |
|
|
|
38.11 |
% |
|
|
|
|
|
|
|
|
|
Mitchell
Godfrey
|
|
|
810,248 |
(5) |
|
|
2.34 |
% |
|
|
|
|
|
|
|
|
|
Kent
Swanson
|
|
|
408,716 |
(6) |
|
|
1.18 |
% |
|
|
|
|
|
|
|
|
|
Ken
Calligar
|
|
|
50,000 |
|
|
|
* |
% |
|
|
|
|
|
|
|
|
|
Gary
Simon
|
|
|
117,188 |
(7) |
|
|
* |
% |
|
|
|
|
|
|
|
|
|
Daniel
Frank
|
|
|
85.938 |
(8) |
|
|
* |
% |
|
|
|
|
|
|
|
|
|
John
P. Gandolfo
|
|
|
0 |
|
|
|
* |
% |
|
|
|
|
|
|
|
|
|
Jesus
Hernandez
|
|
|
535,680 |
(9) |
|
|
1.53 |
% |
|
|
|
|
|
|
|
|
|
Darrel
Holmes
|
|
|
99,556 |
(10) |
|
|
* |
% |
|
|
|
|
|
|
|
|
|
All
executive officers and directors as a group (9 persons)
|
|
|
15,287,514 |
|
|
|
43.12 |
% |
|
*
Less than 1% of outstanding shares of common
stock.
|
|
(1)
|
The
address of each person is c/o Bacterin International, Inc., 600 Cruiser
Lane, Belgrade Montana 59714.
|
|
(2)
|
Unless
otherwise indicated, includes shares owned by a spouse, minor children and
relatives sharing the same home, as well as entities owned or controlled
by the named person. Also includes shares if the named person has the
right to acquire those shares within 60 days after June 30, 2010, by the
exercise or conversion of any warrant, stock option or convertible
preferred stock. Unless otherwise noted, shares are owned of record and
beneficially by the named person.
|
|
(3)
|
The
calculation in this column is based upon 34,440,103 shares of common stock
outstanding on June 30, 2010. The shares of common stock underlying
warrants and stock options are deemed outstanding for purposes of
computing the percentage of the person holding them, but are not deemed
outstanding for the purpose of computing the percentage of any other
person.
|
|
(4)
|
Includes
(a) 19,200 shares of our common stock issuable to Sue Cook, Mr. Cook’s
spouse and our head of human resources, upon the exercise of stock options
previously granted by Bacterin under its 2004 Stock Incentive Plan, (b)
484,375 shares of common stock acquired in the private placement that
occurred concurrently with the Reverse Merger, and (c) warrants to
purchase 121,094 shares of our common stock which were also acquired in
such private placement.
|
|
(5)
|
Includes
144,000 shares of our common stock issuable to Mr. Godfrey upon the
exercise of stock options previously granted by Bacterin under its 2004
Stock Incentive Plan.
|
|
(6)
|
Includes
67,049 shares of our common stock issuable to Mr. Swanson upon the
exercise of warrants previously issued to Mr. Swanson in connection with
his conversion of certain debt.
|
|
(7)
|
Includes
(a) 93,750 shares of common stock acquired in the private placement that
occurred concurrently with the Reverse Merger, and (b) warrants to
purchase 23,438 shares of our common stock which were also acquired in
such private placement, all of which are held indirectly through an entity
that Mr. Simon controls.
|
|
(8)
|
Includes
(a) 68,750 shares of common stock acquired in the private placement that
occurred concurrently with the Reverse Merger, and (b) warrants to
purchase 17,188 shares of our common stock which were also acquired in
such private placement.
|
|
(9)
|
Represents
shares of our common stock issuable to Mr. Hernandez upon the exercise of
stock options previously granted by Bacterin under its 2004 Stock
Incentive Plan.
|
|
(10)
|
Includes
89,556 shares of our common stock issuable to Mr. Holmes upon the exercise
of stock options previously granted by Bacterin under its 2004 Stock
Incentive Plan.
|
Directors
and Executive Officers
Executive
Officers and Directors
The
names, ages and positions of our executive officers and directors as of June 30,
2010, are as follows:
Name
|
|
Age
|
|
Position
|
|
|
|
|
|
Guy
Cook
|
|
45
|
|
Chairman
of the Board, Chief Executive Officer, President and Chief Scientific
Officer
|
Mitchell
T. Godfrey
|
|
64
|
|
Director,
Secretary and Treasurer
|
Kent
Swanson
|
|
65
|
|
Director
|
Ken
Calligar
|
|
53
|
|
Director
|
Daniel
Frank
|
|
53
|
|
Director
|
Gary
Simon
|
|
49
|
|
Director
|
John
P. Gandolfo
|
|
49
|
|
Interim
Chief Financial Officer
|
Jesus
Hernandez
|
|
54
|
|
Vice
President of Biologics
|
Darrel
Holmes
|
|
57
|
|
Vice
President of Medical
Devices
|
The
principal occupations for the past five years (and, in some instances, for prior
years) of each of our executive officers and directors are as
follows. All of such persons joined our company in the same positions
that they held in Bacterin at the closing of the Reverse Merger on June 30,
2010.
Guy Cook, Chairman of the Board,
Chief Executive Officer, President and Chief Scientific Officer, is
considered an international expert in biofilm science and its application. He is
widely published and has been invited to speak at many prominent biofilm
conferences, including the “Anti-Infective Materials” Seminar in Tokyo and the
FDA-CDRH Antimicrobial Device Efficacy Testing Seminar. Mr. Cook started his
career as a product specialist in the Image Analysis Department for Laboratory
Equipment Company in Chicago. He later became President of Delta Resources in
Crystal Lake, Illinois, which specialized in developing customized image
analysis solutions for the academic community. In 1996, he moved to Montana and
worked as a Confocal Microscopist for the Center for Biofilm Engineering at the
Montana State University where he developed several proprietary testing models
for the medical device industry. Mr. Cook attended the University of Indiana and
received Bachelor of Science degrees in Finance and Economics.
Mitchell T. Godfrey, Director,
Secretary and Treasurer, has been involved over the past 25 years in a
number of private enterprises, including consulting for and participation in
firms in the manufacturing, medical devices, nuclear, service and animal health
industries. Mr. Godfrey graduated from the University of Utah in 1968
with Bachelor of Science degrees in psychology and mathematics. He served as a
Lieutenant in the U.S. Navy for a period of four years in the
1960s. Upon his return from overseas duty, he served as a director of
the Utah Vietnam Agent Orange Program. He currently is the Chairman of the
Montana based Crow Creek Falls Conservation Group and has been actively involved
in many other organizations. Mr. Godfrey joined us in October 2003 as
our Chief Financial Officer until December 2007, when his primary responsibility
was changed to investor relations.
Kent Swanson, Director, was
with Accenture for over 32 years, retiring from the firm in 2001 as a Senior
Partner. He held global leadership and management positions in a wide
range of industries and geographies. From 2001 to 2008, he was the
Board Chair of ALN Medical Management; providing outsourced services for
clinic-based physician practices. Also from 2001 to 2008, he was
Board Chair for Boys Hope Girls Hope of Colorado, a charitable organization
providing a home and scholarshiped education for disadvantaged children with
significant capabilities and promise. From 2002 to 2009, he was a
Board member, Audit Committee member and Compensation Committee Chair for MPC
Computers. Mr. Swanson graduated with distinction from the University
of Minnesota earning an M.S. in Business and received an M.B.A. from the
University of Chicago in 1969.
Ken Calligar, Director, has
over 25 years of executive level experience in the financial
industry. In July 2008, he founded Convertible Capital, an
investment banking firm, specializing in highly tailored capital raising and
advisory work, where he serves as the managing director. Prior to
Convertible Capital, from May 2005 to July 2008, he was a managing director with
Jefferies & Co. where he ran the equity-linked Capital Markets
Group. He has also held managing positions in convertible
securities groups at H&Q, Chase, Painewebber, and UBS. Ken has
solid experience in deal structuring, M&A, and raising capital in both
equity and debt markets.
Daniel Frank, Director, joined
Fidelity Investments in 1979 as an analyst, worked with Peter Lynch on the
Magellan Fund and in 1982 was given sole portfolio responsibility for the
Fidelity Special Situations Fund which he launched and grew to over $800
million. Danny left Fidelity after 14 years in 1996, ranked by
Barrons as one of the top 100 portfolio managers. Danny then became
Managing Director of the Soros Chatterjee Fund where he invested in public and
private health care companies. He was also managing director of ACI
Capital and, most recently, the managing director of Cerberus Capital management
responsible for running a $300 million healthcare fund. Danny has
severed on several public and private healthcare company boards including
I-Stat, Aton Pharmaceuticals from 2006 to 2010, Reva Medical from 2006 to
present, Molecular Insight Pharmaceuticals from 2003 to present, and Biosphere
Medical (as board observer) from 2008 to 2010.
Gary Simon, Director, is a
managing member of UVE Partners, LLC, which he co-founded in
2000. UVE Partners is a fund focused on realizing long term
appreciation from investments in listed small and micro cap companies with
capitalizations of $500 million, or less. Prior to UVE Partners, Gary
was Senior Vice President of Barington Capital Group, a full-service investment
banking firm. During the 1990s he served as Chief Financial Officer
of Concord Camera Corp and Multi-Media Tutorial Services, both NASDAQ traded
companies. Gary began his career at Ernst & Young where he served as a
Senior Manager in the Corporate Finance Group, providing mergers and
acquisitions advisory services to small and medium sized companies and as a
Senior Accountant providing auditing and advisory services to emerging growth
companies. Gary received his MBA in finance from New York
University.
John P. Gandolfo, Chief Financial
Officer, joined Bacterin as its interim Chief Financial Officer on a
part-time basis, effective June 4, 2010, and filled this position full time
commencing on July 6, 2010. Mr. Gandolfo has 25 years of experience
as chief financial officer of rapidly growing private and publicly held
companies with a primary focus in the life sciences, healthcare and medical
device areas. Mr. Gandolfo has had direct responsibility over capital
raising, including four public offerings, financial management, mergers and
acquisition transactions and SEC reporting throughout his professional
career. Prior to joining Bacterin, Mr. Gandolfo served as the Chief
Financial Officer for Progenitor Cell Therapy LLC, a leading manufacturer of
stem cell therapies. Prior to joining Progenitor, Mr. Gandolfo served
as the Chief Financial Officer for Power Medical Interventions, Inc., a publicly
held developer and manufacturer of computerized surgical stapling and cutter
systems, from January 2007 to January 2009. Prior to joining PMI,
Mr. Gandolfo was the Chief Financial Officer of Bioject Medical
Technologies, Inc., a publicly held supplier of needle-free drug delivery
systems to the pharmaceutical and biotechnology industries, from September 2001
to May 2006, and served on the Bioject’s Board of Directors from September 2006
through May 2007. Prior to joining Bioject, Mr. Gandolfo was the Chief
Financial Officer of Capital Access Network, Inc., a privately held
specialty finance company, from 2000 through September 2001, and
Xceed, Inc., a publicly held Internet consulting firm, from 1999 to 2000.
From 1994 to 1999, Mr. Gandolfo was Chief Financial Officer and Chief
Operating Officer of Impath, Inc., a publicly held, cancer-focused
healthcare information company. From 1987 through 1994, he was Chief Financial
Officer of Medical Resources, Inc., a publicly held manager of diagnostic
imaging centers throughout the United States. A graduate of Rutgers
University, Mr. Gandolfo is a certified public accountant (inactive status)
who began his professional career at Price Waterhouse.
Jesus Hernandez, Vice President of
Biologics, began his career as the Director of the Organ and Tissue Bank
at University of California, Irvine Medical Center. He has over 20 years of
organ and tissue banking experience, including having served as Chief Operating
Officer and Chief Executive Officer for two national tissue
banks. Mr. Hernandez served as the Chief Operating Officer of Bone
Bank Allografts from November 1997 to April 2005. He has been an
advisor for various committees including the United Network for Organ Sharing,
Association of Organ Procurement Organizations, North American Transplant
Coordinators Organization, American Association of Tissue Banks and served as a
board member of the World Children’s Transplant Fund. Mr. Hernandez graduated
from the University of California, Irvine. Mr. Hernandez has served
in his current position since April 2005.
Darrel Holmes, Vice President of
Medical Devices, joined Bacterin in 2003 as Director of Operations. Mr.
Holmes started his career as chemist and later Director of Operations for ICL
Scientific. He later worked for Hycor Medical as the Director of Manufacturing,
and then as Director of Operations at Stratagene Cloning Systems. Mr. Holmes
moved to Montana and became the President of Big Spring Water in Bozeman. He
holds several certificates including Environmental Inspector with the
Environmental Assessment Association and is a Hazardous Materials Specialist.
Mr. Holmes attended California State University at Long Beach and graduated with
a Bachelor’s Degree in Biology. He has over 25 years of Technical Operations
experience in the medical device and diagnostics industries.
Scientific
Advisory Board
Our
Scientific Advisory Board assists us with issues relating to the clinical
development and exploitation of our coating and biologic
technologies. As our needs evolve, members with required areas of
interest and expertise are added. The members of our Scientific Advisory Board
are compensated with stock options and shares of common stock under our equity
incentive plan.
Steven Scott MD, is
currently the Chairman of our Scientific Advisory Board and a member of the
American Academy of Orthopaedic Surgeons, the Musculoskeletal Tumor Society and
the Pediatric Society Orthopaedic of North America. Dr. Scott
maintains an active orthopaedic practice in Salt Lake City and has special
expertise in the use of Ilizarov External Fixation, pediatric orthopaedics, bone
graft technology, and orthopedic oncology. Dr. Scott has authored
many scientific publications, has presented at numerous national conferences and
has a patent pending. He received his BA from Linfield College summa
cum laude and attended medical school at the University of
Colorado. He completed his orthopaedic training at the University of
Utah and the Mayo Clinic; he holds a clinical appointment within the Department
of Orthopaedics at University of Utah and received an M.B.A. through the
University of Utah.
Board
Composition and Terms of Office
The
composition of our board of directors, and any future audit committee,
compensation committee, and nominations and governance committee, will be
subject to the corporate governance provisions of our primary trading market,
including rules relating to the independence of directors. All
directors hold office until the next annual meeting of stockholders and the
election and qualification of their successors. Officers are elected
annually by the board of directors and serve at the discretion of the
board.
We have
not previously had an audit committee, compensation committee or nominations and
governance committee. Later in 2010, our board of directors expects to create
such committees, in compliance with established corporate governance
requirements.
Audit
Committee. We
plan to establish an audit committee of the board of directors. Gary
Simon is expected to chair this committee upon its establishment. The
audit committee’s duties would be to recommend to the board of directors the
engagement of independent auditors to audit our financial statements and to
review our accounting and auditing principles. The audit committee would review
the scope, timing and fees for the annual audit and the results of audit
examinations performed by the internal auditors and independent public
accountants, including their recommendations to improve the system of accounting
and internal controls. The audit committee would at all times be composed
exclusively of directors who are, in the opinion of the board of directors, free
from any relationship which would interfere with the exercise of independent
judgment as a committee member and who possess an understanding of financial
statements and generally accepted accounting principles.
Compensation
Committee. We
plan to establish a compensation committee of the board of
directors. Ken Calligar is expected to chair this committee upon its
establishment. The compensation committee would review and approve
our salary and benefits policies, including compensation of executive officers.
The compensation committee would also administer our equity incentive plan, and
recommend and approve awards, including grants of stock options and restricted
stock, under that plan.
Nominations and
Governance Committee. We plan to establish a nominations and governance
committee of the board of directors. Daniel Frank is expected to
chair this committee upon its establishment. The purpose of the
nominations and governance committee would be to select, or recommend for our
entire board’s selection, the individuals to stand for election as directors at
the annual meeting of stockholders and to oversee the selection and composition
of committees of our board. The nominations and governance committee’s duties
would also include considering the adequacy of our corporate governance and
overseeing and approving management continuity planning processes.
Nominations
to the Board of Directors
Our
directors take a critical role in guiding our strategic direction and oversee
the management of our company. Board candidates are considered based
upon various criteria, such as their broad-based business and professional
skills and experiences, a global business and social perspective, concern for
the long-term interests of the stockholders, diversity, and personal integrity
and judgment.
In
addition, directors must have time available to devote to board activities and
to enhance their knowledge in the growing business. Accordingly, we
seek to attract and retain highly qualified directors who have sufficient time
to attend to their substantial duties and responsibilities.
Indebtedness
of Directors and Executive Officers
We have a
note receivable from Guy Cook, our Chairman, Chief Executive Officer and
President, in the principal amount of $72,178, which bears interest at the prime
rate of interest and is secured by certain shares of our common stock owned by
Mr. Cook.
We have a
promissory note due to Mitchell T. Godfrey, our director and our Secretary and
Treasurer, in the principal amount of $83,090, which bears interest at 6% per
annum with an unspecified maturity date.
Family
Relationships
There are
no family relationships among our new directors and executive officers and any
former or proposed directors or executive officers.
Legal
Proceedings
As of the
date of this current report, there are no material proceedings pending or
threatened to which any of our directors, executive officers, affiliates or
stockholders is or would be a party adverse to us.
The table
below summarizes the compensation earned for services rendered to Bacterin
International Holdings, Inc. f/ka/ K-Kitz, Inc. and Bacterin International, Inc.
in all capacities, for the fiscal years indicated, by its Chief Executive
Officer and two most highly-compensated officers other than the Chief Executive
Officer.
Name
and
Principal
Position
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-Equity
Incentive
Plan
Compensation
|
|
|
Change
in
Pension
Value
and
Nonqualified
Deferred
Compensation
Earnings
|
|
|
|
|
|
|
|
Guy
S. Cook(1)
|
|
2009
|
|
$ |
230,750 |
|
|
$ |
-- |
|
|
$ |
40,000 |
(2) |
|
$ |
-- |
|
|
$ |
-- |
|
|
$ |
-- |
|
|
$ |
34,897 |
(2) |
|
$ |
305,647 |
|
Chairman
of the Board and
Chief
Executive Officer
|
|
2008
|
|
|
249,210 |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
23,783 |
|
|
|
272,993 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jesus
Hernandez(1)
|
|
2009
|
|
|
236,153 |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
12,743 |
|
|
|
248,896 |
|
EVP
- Biologics
|
|
2008
|
|
|
197,308 |
|
|
|
27,500 |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
66,983 |
|
|
|
236,791 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Darrel
Holmes(1)
|
|
2009
|
|
|
100,000 |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
15,744 |
|
|
|
115,744 |
|
EVP
- Medical Devices
|
|
2008
|
|
|
57,115 |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
9,040 |
|
|
|
66,155 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jennifer
Jarvis
|
|
2009
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
Former
Director, Chief
Executive
Officer, President
and
Chief Financial Officer(3)
|
|
2008
|
|
|
45,000 |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
45,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
_______________
|
(1)
|
Each
of Mr. Cook, Mr. Hernandez and Mr. Holmes received this compensation in
connection with their service to Bacterin, our wholly-owned subsidiary
through which we now operate our
business.
|
|
(2)
|
Mr.
Cook received 25,000 shares of common stock of Bacterin (as adjusted to
reflect the ratio used to determine the number of shares issuable to
Bacterin stockholders in connection with the Reverse Merger) and is
entitled to $10,000, each as of December 31, 2009, for his service on
Bacterin’s board of directors for fiscal year 2009, though payment of the
$10,000 has been deferred indefinitely. Although this
consideration reflects Bacterin’s past board compensation policy, it does
not reflect our current board compensation policy, which is discussed
below.
|
|
(3)
|
Ms.
Jarvis resigned from her position as a director and our Chief Executive
Officer, President and Chief Financial Officer, effective June 30,
2010.
|
The
aggregate amount of benefits in each of the years indicated did not exceed the
lesser of $50,000 or 10% of the compensation of any named officer.
We do not
currently have any employment agreements with our executive officers and do not
intend to enter into any such agreements in the near
term. We intend to keep the current employment agreements
between Bacterin, our wholly-owned subsidiary through which we now conduct our
business, and Guy Cook, Mitchell Godfrey, John P. Gandolfo, Jesus Hernandez and
Darrel Holmes. The employment agreements are set forth in Item 9.01
of this report. The employment agreements require each of the executives
to perform such duties as are customarily performed by one holding their
positions, which are President and Chief Executive Officer, Secretary and
Treasurer, Interim Chief Financial Officer, Executive Vice President - Biologics
Division and Executive Vice President - Medical Devices Division,
respectively. The employment agreements for each of the above
officers are for an indefinite term and provide that each of Messrs. Cook,
Godfrey, Gandolfo, Hernandez and Holmes receive a fixed annual base salary
during the term of the employment agreement. In addition, each
executive is entitled to (a) receive certain cash bonuses as set forth in their
respective employment agreements or as may be determined in the future by our
compensation committee of our board of directors (or the entire board until such
committee has been established) and (b) participate in our equity incentive
plan.
The
employment agreements are essentially terminable at will by reference to the
termination procedures set forth in Bacterin’s employee manual but also provide
for termination of an executive’s employment without any further obligation of
our company upon the disability of the executive for a period of 30 days or more
during any calendar year.
The
employment agreements also contain covenants (a) restricting the executive from
engaging in any activity competitive with our business during the term of the
employment agreement, (b) prohibiting the executive from disclosing confidential
information regarding our company, and (c) requiring that all intellectual
property developed by the executive and relating to our business constitutes our
sole and exclusive property. The officers also entered into lock-up
agreements restricting the sale of their shares of our common stock over an
initial period of time following the closing of the private
placement.
Bacterin
International Equity Incentive Plan
Prior to
the consummation of the Reverse Merger, we adopted and ratified the Bacterin
International Equity Incentive Plan. The following is a summary of
the material terms of that plan.
The
purpose of the incentive compensation plan is to enable us to attract, retain
and motivate key employees, directors and, on occasion, independent consultants,
by providing them with stock options and restricted stock
grants. Stock options granted under the incentive compensation plan
may be either incentive stock options to employees, as defined in Section 422A
of the Internal Revenue Code of 1986, or non-qualified stock
options. The plan is currently administered by our board of directors
but will be administered by our compensation committee once such committee has
been established. The administrator of the plan has the power to
determine the terms of any stock options granted under the incentive plan,
including the exercise price, the number of shares subject to the stock option
and conditions of exercise. Stock options granted under the incentive
plan are generally not transferable, vest in installments and are exercisable
during the lifetime of the optionee only by such optionee. The
exercise price of all incentive stock options granted under the incentive plan
must be at least equal to the fair market value of the shares of common stock on
the date of the grant. The specific terms of each stock option grant
will be reflected in a written stock option agreement.
Also, in
connection with the Reverse Merger, we are substituting each equity award
granted under the Bacterin International, Inc. 2004 Stock Incentive Plan, as
most recently amended effective April 1, 2009, with a substantially similar
equity award granted under our new plan; provided, that the number of shares
which may be purchased under such substitute options and the exercise prices
therefor reflect proportional adjustments required to be made to account for the
ratio used in determining the number of shares issuable to Bacterin stockholders
in connection with the Reverse Merger.
There are
6,000,000 shares of our common stock authorized to be issued under the plan,
representing approximately 17.4% of our outstanding common stock or 13.3% on a
fully-diluted basis. As of June 30, 2010, we had outstanding options
to purchase 4,213,196 shares granted to employees and executives (at exercise
prices ranging from $0.104 to $2.60 per share), leaving an additional 1,786,804
available for issuance thereunder. The outstanding options reflect
substitute options to be granted to former holders of Bacterin options issued
under its 2004 Stock Incentive Plan, as amended.
Except
for the Equity Incentive Plan discussed above, we have not had a stock option
plan or other similar incentive compensation plan for officers, directors and
employees, and no stock options, restricted stock or stock appreciation rights
grants were granted or were outstanding at any time prior to the Reverse
Merger.
Outstanding
Equity Awards at Fiscal Year-End (December 31, 2009)
|
|
|
|
|
|
Number
of Securities
Underlying
Unexercised
Options
|
|
|
Equity
Incentive
Plan
Awards:
Number
of Securities
Underlying
Unexercised
Unearned
|
|
|
Option
Exercise
|
|
|
Option
Expiration
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Guy
Cook
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
Jesus
Hernandez(1)
|
|
|
480,000 |
|
|
|
-- |
|
|
|
-- |
|
|
$ |
1.396 |
|
|
10/10/16
|
|
Jesus
Hernandez(1)
|
|
|
55,680 |
|
|
|
-- |
|
|
|
-- |
|
|
$ |
1.667 |
|
|
5/19/15
|
|
Darrrel
Holmes(2)
|
|
|
43,200 |
|
|
|
|
|
|
|
|
|
|
$ |
0.104 |
|
|
10/9/13
|
|
Darrrel
Holmes(2)
|
|
|
28,800 |
|
|
|
|
|
|
|
|
|
|
$ |
1.396 |
|
|
10/9/16
|
|
Darrrel
Holmes(2)
|
|
|
17,556 |
|
|
|
|
|
|
|
54,444 |
|
|
$ |
1.563 |
|
|
12/29/18
|
|
_______________
|
(1)
|
In
connection with the Reverse Merger, Mr. Hernandez will receive substitute
options to purchase 535,680 shares of our common stock under the Bacterin
International Equity Incentive Plan in replacement of his current options
to purchase 1,000,000 shares of Bacterin’s common stock at $0.67 per share
and 116,000 shares at $0.80 per share under Bacterin’s 2004 Stock
Incentive Plan, as amended. The change in the number of option
shares and exercise price reflects proportional adjustments required to be
made to reflect the ratio used to determine the number of shares issuable
to Bacterin stockholders in connection with the Reverse
Merger.
|
|
(2)
|
In
connection with the Reverse Merger, Mr. Holmes will receive substitute
options to purchase an aggregate of 144,000 shares of our common stock
under the Bacterin International Equity Incentive Plan in replacement of
his current options to purchase 90,000 shares of Bacterin’s common stock
at $0.05 per share, 60,000 shares at $0.67 per share, and 150,000 shares
at $0.75 per share under Bacterin’s 2004 Stock Incentive Plan, as
amended. The change in the number of option shares and exercise
price reflects proportional adjustments required to be made to reflect the
ratio used to determine the number of shares issuable to Bacterin
stockholders in connection with the Reverse Merger. 11,244 of
the unvested options vest on December 29, 2010, 14,400 vest on
December 29, 2011, 14,400 vest on December 29, 2012, and 14,400 vest on
December 29, 2013.
|
Potential
Payments Upon Termination or Change-in-Control
SEC
regulations state that we must disclose information regarding agreements, plans
or arrangements that provide for payments or benefits to our named executive
officers in connection with any termination of employment or change in control
of the company. We currently have no employment agreements with any of our named
executive officers, nor any compensatory plans or arrangements that provide for
any payments or benefits upon the resignation, retirement or any other
termination of any of our named executive officers, as the result of a change in
control, or from a change in any named executive officer’s responsibilities
following a change in control.
Director
Compensation
|
|
Fees
Earned
or
Paid in
Cash(1)
|
|
|
|
|
|
|
|
|
Non-Equity
Incentive
Plan
Compensation
|
|
|
Change
in Pension
Value
and Nonqualified
Deferred
Compensation
Earnings
|
|
|
|
|
|
|
|
Mitch
Godfrey
|
|
$ |
10,000 |
|
|
$ |
40,000 |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
$ |
50,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Kent
Swanson
|
|
$ |
10,000 |
|
|
$ |
40,000 |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
$ |
50,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Steve
Warnecke(3)
|
|
$ |
10,000 |
|
|
$ |
40,000 |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
$ |
50,000 |
|
_______________
(1)
|
Each
of Bacterin’s directors, regardless of management affiliation, earned
$10,000 for their service on Bacterin’s board of directors during 2009
although payment of such amount has been indefinitely
deferred.
|
(2)
|
Each
of Bacterin’s directors, regardless of management affiliation, received
50,000 shares of common stock as of December 31, 2009, for their service
on Bacterin’s board of directors during
2009.
|
(3)
|
Mr.
Warnecke resigned as a director effective May 22,
2010.
|
We are
currently re-evaluating our director compensation policies and intend to adopt
new ones shortly. We expect that such new policies will, among other
things, entitle each non-management director to receive participation fees for
attendance at regular and special meetings of our board of directors and stock
options granted under our Bacterin International Equity Incentive Plan, to
purchase shares of our common stock with an exercise price equal to the fair
market value of such stock on the date of grant. Our board of directors will
review director compensation annually and adjust it according to prevailing
market conditions and good business practices.
Compensation
Committee Interlocks and Insider Participation
No
interlocking relationship exists between our board of directors and the board of
directors or compensation committee of any other company, nor has any
interlocking relationship existed in the past.
Certain
Relationships and Transactions
Guy Cook,
our President and Chief Executive Officer, serves as a board member of West
Coast Tissue Services and American Donor Services. Both of these
entities recover tissue from donors. We reimburse them for their
recovery fees, which are comprised primarily of labor costs. The
aggregate amount of all payments we and our subsidiaries made to these entities
since January 1, 2008 is $575,297.27 to West Coast Tissue Services, and
$1,654,352.00 to American Donor Services. This relationship benefits
us, and thus Mr. Cook, as these entities provide us with donors, thus insuring
that we have a pipeline of current and future donors, which is necessary to our
success. Mr. Cook’s wife performs the bookkeeping and accounting for
American Donor Services. She was paid $60,126 in 2009 for her
services, but received no compensation in 2006-2008 or 2010 for her
services.
Concurrently
with the closing of the Reverse Merger and the private placement, we repurchased
and cancelled, 4,319,404 shares of our common stock from Jennifer Jarvis, our
former director, chief executive officer and chief financial officer, for
aggregate consideration of $100 and certain other good and valuable
consideration.
Although
we have not adopted a Code of Ethics at this time, we rely on our board to
review related party transactions on an ongoing basis to prevent conflicts of
interest. Our board reviews a transaction in light of the affiliations of the
director, officer or employee and the affiliations of such person’s immediate
family. Transactions are presented to our board for approval before they are
entered into or, if this is not possible, for ratification after the transaction
has occurred. If our board finds that a conflict of interest exists, then it
will determine the appropriate remedial action, if any. Our board approves or
ratifies a transaction if it determines that the transaction is consistent with
the best interests of our company. These policies and procedures are
not evidenced in writing.
Director
Independence
During
the year ended December 31, 2009, we did not have any independent directors on
our board. We evaluate independence by the standards for director
independence established by applicable laws, rules, and listing standards
including, without limitation, the standards for independent directors
established by the NASDAQ stock market.
Subject
to some exceptions, these standards generally provide that a director will not
be independent if:
|
·
|
the
director is, or in the past three years has been, an employee of
ours;
|
|
·
|
a
member of the director's immediate family is, or in the past three years
has been, an executive officer of
ours;
|
|
·
|
the
director or a member of the director's immediate family has received more
than $120,000 per year in direct compensation from us other than for
service as a director (or for a family member, as a non-executive
employee);
|
|
·
|
the
director or a member of the director's immediate family is, or in the past
three years has been, employed in a professional capacity by our
independent public accountants, or has worked for such firm in any
capacity on our audit;
|
|
·
|
the
director or a member of the director's immediate family is, or in the past
three years has been, employed as an executive officer of a company where
one of our executive officers serves on the compensation committee;
or
|
|
·
|
the
director or a member of the director's immediate family is an executive
officer of a company that makes payments to, or receives payments from, us
in an amount which, in any twelve-month period during the past three
years, exceeds the greater of $1,000,000 or two percent of that other
company's consolidated gross
revenues.
|
Description
of Securities
Common
Stock
The
holders of our common stock are entitled to one vote per share. Our
certificate of incorporation does not provide for cumulative
voting. The holders of our common stock are entitled to receive
ratably such dividends, if any, as may be declared by our board of directors out
of legally available funds. However, the current policy of our board of
directors is to retain earnings, if any, for our operation and
expansion. Upon our liquidation, dissolution or winding-up, the
holders of our common stock are entitled to share ratably in all of our assets
which are legally available for distribution, after payment of or provision for
all liabilities and the preferences of any then outstanding shares of preferred
stock. The holders of our common stock have no preemptive,
subscription, redemption or conversion rights. All issued and
outstanding shares of our common stock are, and the common stock reserved for
issuance upon exercise of the warrants will be, when issued, fully-paid and
non-assessable.
Preferred
Stock
Our
certificate of incorporation authorizes the issuance of up to 5,000,000 shares
of “blank check” preferred stock with designations, rights and preferences as
may be determined from time to time by our board of directors. We
have not designated or issued any shares of our preferred stock to
date.
Warrants
We issued
warrants to purchase approximately 1,485,259 shares of our common stock in the
initial closing of the private placement, including warrants to purchase 251,625
shares of our common stock that was issued to the placement
agents. Each warrant acquired in the private placement entitles the
holder thereof to purchase shares of our common stock at an exercise price of
$2.50 per share from the date of issuance until the fifth anniversary thereof;
provided, that note holders who converted debt in the private placement,
received warrants with an exercise price of $2.25 per share and the placement
agents received warrants with an exercise price of $1.60 per share.
In
addition, subject to adjustment for the ratio used to determine the number of
shares issuable to Bacterin stockholders in connection with the Reverse Merger,
we have assumed Bacterin’s obligations under its outstanding warrants
immediately prior to the Reverse Merger and are in the process of issuing
substitute warrants. As a result of such assumption and issuance of
substitute warrants, we also have warrants outstanding to purchase approximately
4,879,075 shares of our common stock. The exercise prices of these
warrants range from $2.08 to $2.60 and commence expiring in March 2014 through
December 2019.
Adjustments. All
of our outstanding warrants contain provisions that protect the holders thereof
against dilution by adjustment of the number of shares for which the warrants
are exercisable as well as the exercise price to purchase such shares in certain
events, such as stock dividends, stock splits, mergers and other similar
events.
In
addition, the warrants that were issued in connection with our recent bridge
financings provide that, in the event that we issue any shares of our common
stock (or securities convertible into or exercisable or exchangeable for shares
of common stock) for an effective price of less than $1.60 per share of common
stock, except (i) securities which are issued pursuant to the bridge financings,
(ii) shares of our common stock or options to purchase such shares issued to
employees, consultants, officers or directors in accordance with stock plans
approved by the board of directors, and shares of common stock issuable under
options or warrants that are outstanding as of the date of the closing of the
bridge financings or issued in the future pursuant to the our equity incentive
plan up to a total of 6,000,000 shares, and (iii) shares of our common stock
issued pursuant to a stock dividend, split or other similar transaction, the
exercise price of each warrant shall be adjusted downward on a “full-ratchet”
basis, i.e., to the lowest price per share at which our stock was issued or
deemed issued, regardless of how many shares were issued at such
price. The holder of a Warrant will not possess any rights as a
stockholder of our company unless and until he exercises the
Warrant.
Cashless
Exercise. The warrants issued in connection with our recent
bridge financings and the private placement contain “cashless” exercise
provisions. In a “cashless” exercise, a warrant is exchanged for a
lesser number of shares because a portion of the shares is used to pay the
exercise price.
Stockholder
Rights. The warrants do not confer upon holders any voting or
any other rights as a stockholder of our company.
The
foregoing discussion of our warrants, to the extent it relates to the warrants
issued in the private placement, is qualified entirely by reference to the
composite form of the warrant used in such private placement and included as an
exhibit to this current report.
We have
agreed to use our best efforts to file a shelf registration statement on Form
S-1 with the SEC covering the resale of all shares of common stock and all
shares of common stock underlying the warrants issued in connection with the
private placement (as well as up to 1,177,196 shares of our common stock held by
certain of our stockholders at the time of the closing of the Reverse Merger and
the shares underlying the placement agents’ warrants) on or before the date
which is 90 days after the closing date and use our best efforts to have such
shelf registration statement declared effective by the SEC as soon as
practicable thereafter, but in any event not later than 150 days after the
closing date (or 180 days after the closing date in the event of a full review
of the registration statement by the SEC). We are also obligated to
respond to any SEC comments within a stipulated period of time after receiving
any such comments and to maintain the effectiveness of the shelf registration
statement from the effective date through the earlier of (a) the date on which
all the investors in the private placement have completed the sales or
distribution described in the registration statement relating thereto or, if
earlier until all securities covered by the registration rights agreement may be
sold by the investors in the private placement under Rule 144(b)(1) and (b) the
date that is eighteen (18) months anniversary of the sale of the
securities. In the event the shelf registration statement is not
filed with, or declared effective by, the SEC on or prior to the dates set forth
above, or we fail to timely satisfy our reporting requirements, each investor in
the private placement will receive cash liquidated damages equal to 1% of the
purchase price for the shares of common stock and warrants acquired in the
private placement for each month (or portion thereof) that the registration
statement is not so filed or effective, or has failed to timely file required
reports, provided that the aggregate payment as a result of the registration
default will in no event exceed 12% of the purchase price for the shares of
common stock and warrants. We will bear the expenses in connection
with the registration of these shares (exclusive of any underwriting discounts
and commissions, if any).
If, at
any time or from time to time after the date of the effectiveness of the
registration statement, we determine good faith, following consultation with
legal counsel, that (i) it would be detrimental to us and our stockholders for
resales of the registered securities to be made pursuant to a registration
statement due to the existence of a material development or potential material
development involving us that we would be obligated to disclose in a
registration statement, which disclosure would be premature or otherwise
inadvisable at such time or would have a material adverse effect upon us and our
stockholders, or (ii) such material development or potential material
development involving us would adversely affect or require premature disclosure
of the filing of a registration by us of any class of our equity securities,
then we have the right to suspend offers and sales of the registered securities
pursuant to a registration statement for a period of not more than 30 calendar
days in any 12 month period, but only if we reasonably conclude, after
consultation with outside legal counsel, that the failure to suspend the use of
the registration statement would create a material liability or violation under
applicable securities laws or regulations.
Lock-Up
Agreements
All
shares of common stock issued in the Reverse Merger to the former holders of
shares in Bacterin will be considered “restricted securities” under U.S. federal
securities laws and may not be resold pursuant to Rule 144 for a period of one
year after the filing of this report. Each of the former Bacterin
stockholders who served as directors or executive officers of Bacterin as of the
closing of the Reverse Merger or who have joined as members of our Board of
Directors concurrently with the consummation of the Reverse Merger
(collectively, “Management”), have executed one-year a lock-up agreement with us
which provide that their shares, including any shares that are now owned or are
subsequently acquired by them, will not be, directly or indirectly, publicly
sold, subject to a contract for sale or otherwise transferred for a period of 12
months following the Reverse Merger and the private placement; provided,
however, that (a) the restrictions set forth in such lock-up agreement will not
apply to any securities acquired by Management in the private placement and (b)
Guy Cook is permitted to hypothecate, pledge and grant a security interest in up
to 5,000,000 of his existing shares received from us in connection with the
Reverse Merger as collateral for borrowed funds used to acquire securities in
the private placement and, if such collateral is executed against, shall be
permitted to assign and transfer such shares to the secured party free of any
restrictions set forth therein.
Other
Rights To Acquire Our Common Stock
We are
contractually obligated to issue shares of our common stock to one of our
stockholders as follows:
|
·
|
if,
after seven months from the closing of the Reverse Merger and the private
placement, our common stock is publicly trading at an average daily
closing price of $1.60 per share for the 30 days immediately preceding the
last day of such seven month period, we must issue to such stockholder
375,000 shares of our common stock;
|
|
·
|
if,
after 13 months from the closing of the Reverse Merger and the private
placement, our common stock is publicly trading at an average daily
closing price of $1.60 per share for the 30 days immediately preceding the
last day of such thirteen month period, we must issue to such stockholder
375,000 additional shares of our common stock;
and
|
|
·
|
if,
after 13 months from the closing of the Reverse Merger and the private
placement, our common stock is publicly trading at an average daily
closing price of $2.40 per share for the 30 days immediately preceding the
last day of such thirteen month period, we must issue to such stockholder
375,000 additional shares of our common stock (which shares, for the sake
of clarification, shall be in addition to the shares to be issued pursuant
to the second bullet point above).
|
Market
Price and Dividends on Common Equity and Related Stockholder
Matters
Trading
Information
Our
common stock will trade in the over-the-counter market and will be quoted on the
OTC Bulletin Board under the trading symbol KKTZ.OB until such time as we have
received a new symbol. The trading market for our common stock has been
extremely limited and sporadic.
We intend
to apply to list our common stock for trading on the Nasdaq Capital Market as
soon as reasonably practicable. No assurance can be given that we
will satisfy the initial listing requirements, or that our shares of common
stock will ever be listed on Nasdaq or another national securities
exchange.
The
warrants will not be registered or listed for trading.
Our
current transfer agent and registrar for our common stock is Globex Transfer,
LLC, Deltona, Florida. We will serve as warrant agent for the
Warrants.
Holders
of Record
As of
June 30, 2010, there were approximately 324 holders of record of our common
stock.
Dividends
We have
not paid any dividends on our common stock and we do not intend to pay any
dividends on our common stock in the foreseeable future.
Indemnification
of Directors and Officers
Our
certificate of incorporation provides that no director of the company will be
personally liable to the company or our stockholders for monetary damages for
breach of fiduciary duty as a director, except for liability (i) for any breach
of the director’s duty of loyalty to the company or our stockholders, (ii) for
acts or omissions not in good faith or which involve intentional misconduct or a
knowing violation of law, (iii) for the improper declaration of dividends or
redemption of shares of capital stock in violation of Delaware law, or (iv) for
any transaction from which the director derived an improper personal
benefit.
We have
been advised that it is the position of the SEC that insofar as the foregoing
provisions may be invoked to disclaim liability for damages arising under the
Securities Act of 1933, as amended, that such provisions are against public
policy as expressed in the Securities Act and are therefore
unenforceable.
Reverse
Merger. On
June 30, 2010, at the closing of the Reverse Merger, we issued an aggregate of
28,257,287 shares of our common stock to the former stockholders of Bacterin.
The shares of our common stock issued to former holders of Bacterin’s common
stock in connection with the exchange transaction were exempt from registration
under Section 4(2) of the Securities Act of 1933 as a sale by an issuer not
involving a public offering and under Regulation D promulgated pursuant to the
Securities Act of 1933. These shares of common stock were not registered under
the Securities Act, or the securities laws of any state, and were offered and
sold in reliance on the exemption from registration afforded by Section 4(2) and
Regulation D (Rule 506) under the Securities Act and corresponding provisions of
state securities laws, which exempts transactions by an issuer not involving any
public offering. Such securities may not be offered or sold in the
United States absent registration or an applicable exemption from the
registration requirements and certificates evidencing such shares contain or,
upon issuance will contain, a legend stating the same.
Private
Placement. Concurrently with the closing of the Reverse Merger, we
completed the initial closing of a private placement to certain institutional
investors and accredited individuals of shares of our common stock and warrants
to purchase additional shares of our common stock. We sold each share
and warrant for an aggregate price of $1.60 per share pursuant to the terms of a
subscription agreement executed and delivered by each investor on or before the
closing of the private placement. Each warrant entitles the holder to
purchase one-quarter share of our common stock at an exercise price of $2.50 per
share for a period of five years from the date of the closing on their
subscription. The form of private placement subscription agreement is
filed as Exhibit 10.1 to this report. Certain Bacterin note holders
also participated in the private placement by converting certain debt into
shares of our common stock and warrants; however, the conversion of their debt
was effected at a 10% discount to the price per share at which investors
purchased securities in such private placement, being $1.44 per share, and the
exercise price of the warrants they received also carried a 10% discount to the
exercise price of the warrants received by new investors in such private
placement, being $2.25 per share. In total, we sold 4,934,534 shares
of our common stock and warrants to purchase an aggregate of up to 1,233,634
shares of common stock, including the conversion of debt in the private
placement by note holders and excluding warrants issued to the placement agent.
We received gross proceeds of $7,508,329, including from the conversion of debt,
in consideration for the sale of the shares and warrants.
The
shares of common stock and warrants issued in the private placement were exempt
from registration under Section 4(2) of the Securities Act of 1933 as a sale by
an issuer not involving a public offering and under Regulation D promulgated
pursuant to the Securities Act of 1933, as amended. The shares of common stock
and warrants were not registered under the Securities Act, or the securities
laws of any state, and were offered and sold in reliance on the exemption from
registration afforded by Section 4(2) and Regulation D (Rule 506) under the
Securities Act and corresponding provisions of state securities laws, which
exempts transactions by an issuer not involving any public offering. Such
securities may not be offered or sold in the United States absent registration
or an applicable exemption from the registration requirements and certificates
evidencing such securities contain a legend stating the same.
Transaction Fees
and Use of Proceeds. We have assumed Bacterin’s agreement to
pay the lead placement agent, Middlebury Securities, LLC, and any sub-placement
agents, in total, (i) a cash fee equal to 8% of the aggregate gross cash
proceeds received in the private placement, (ii) warrants to purchase that
number of shares of our common stock equal to 10% of the shares of common stock
purchased in the private placement, at an exercise price of $1.60 per share, and
(iii) shares of our common stock equal to 2% of the shares of common stock
purchased in the private placement for cash and acquired through the conversion
of $1,250,000 in convertible debt. Except as set forth above, no
commission was paid to the placement agents for sales of shares of our common
stock or warrants upon the conversion of the debt held by note holders from
Bacterin’s bridge financings. Additionally, we paid auditing fees of
approximately $86,000, and legal fees for us, Bacterin and the investors in the
Reverse Merger and private placement of approximately $340,000.
The net
proceeds will be used to pay certain of our debts and provide additional working
capital for us. Specifically, the net proceeds of the private
placement will be used by us to support sales and marketing, purchase
bio-materials and other product components, fund research and development,
reduce existing trade payables and other liabilities, repay notes payable, pay
the costs associated with the Reverse Merger and the private placement
(including the future costs of registering the Company’s common shares under the
Securities Act and on-going public company costs) and for working capital and
general corporate purposes.
The
amount of our actual expenditures will depend upon numerous factors, including
the pace with which we can commercially deploy our products. Actual
expenditures may vary substantially and we may find it necessary or advisable to
reallocate the net proceeds for other purposes. Pending application
of the net proceeds as described above, we intend to invest the net proceeds of
from the private placement in short-term, interest-bearing
securities.
Item
5.01. Changes in Control of Registrant.
The
information set forth above in Items 1.01 and 2.01 of this report is
incorporated herein by reference in its entirety.
The
information set forth above in Items 1.01 and 2.01 of this report is
incorporated herein by reference in its entirety.
Item
5.03. Amendments to Articles of Incorporation or Bylaws; Change in
Fiscal Year.
The information set forth above in
Items 1.01 and 2.01 of this report is incorporated herein by reference in its
entirety.
(a) Financial
Statements of Businesses Acquired.
The
financial statements of Bacterin for the 12 months ended December 31, 2009 and
2008 and for the three months ended March 31, 2010 and 2009 (unaudited) are
incorporated herein by reference to Exhibits 99.1 and 99.2, respectively, to
this current report.
(b) Pro
Forma Financial Information.
Our
unaudited pro forma condensed combined financial statements as of and for the
three months ended March 31, 2010 and the 12 months ended December 31, 2009 are
incorporated herein by reference to Exhibit 99.3 to this report, and are based
on the historical financial statements of our company and Bacterin after giving
effect to the Reverse Merger. The unaudited pro forma combined condensed balance
sheet as of March 31, 2010 is presented to give effect to the Reverse Merger as
if it occurred on April 1, 2010. The unaudited pro forma combined condensed
statement of operations of our company and Bacterin for the three months ended
March 31, 2010 and the 12 months ended December 31, 2009 are presented as if the
combination had taken place on April 1, 2010.
Reclassifications
have been made to the company’s historical financial statements to conform to
Bacterin’s historical financial statement presentation.
The
unaudited pro forma combined condensed financial statements should be read in
conjunction with “Management’s Discussion and Analysis of Financial Condition
and Results of Operations” set forth under Item 2.01 of this current report,
which disclosure is incorporated herein by reference, and the historical
consolidated financial statements and accompanying notes of our company and
Bacterin. The unaudited pro forma combined condensed financial statements are
not intended to represent or be indicative of our consolidated results of
operations or financial condition that would have been reported had the Reverse
Merger been completed as of the dates presented, and should not be taken as
representative of the future consolidated results of operations or financial
condition of our company.
(d) Exhibits.
The
exhibits listed in the following Exhibit Index are filed as part of this current
report.
|
|
Description
|
|
|
|
2.1*
|
|
Agreement
and Plan of Merger, dated as of June 30, 2010, by and among K-Kitz, Inc.,
KB Merger Sub, Inc. and Bacterin International, Inc.
|
|
|
|
3.1*
|
|
Certificate
of Incorporation, including all amendments to date
|
|
|
|
3.2(a)
|
|
Amendment
No. 1 to Bylaws, dated May 24, 2010
|
|
|
|
3.2(b)**
|
|
Bylaws,
including all amendments to date except the amendment set forth at Exhibit
3.2(a) hereto
|
|
|
|
4.1*
|
|
Form
of Warrant to Purchase Common Stock.
|
|
|
|
10.1*
|
|
Form
of Private Placement Subscription Agreement to purchase Shares and
Warrants.
|
|
|
|
10.2
|
|
Form
of Registration Rights Agreement
|
|
|
|
10.3
|
|
Form
of Management Lock-Up Agreement for the officers and directors of Bacterin
International Holdings, Inc. and Bacterin International,
Inc.
|
|
|
|
10.4
|
|
Form
of Indemnification Agreement for the officers and directors of Bacterin
International Holdings, Inc. and Bacterin International,
Inc.
|
|
|
|
10.5
|
|
Bacterin
International Equity Incentive Plan.
|
|
|
|
10.6
|
|
Guy
Cook Employment Agreement
|
|
|
|
10.7
|
|
Mitchell
Godfrey Employment Agreement
|
|
|
|
10.8 |
|
John
Gandolfo Employment Agreement
|
|
|
|
10.9
|
|
Jesus
Hernandez Employment Agreement
|
|
|
|
10.10
|
|
Darrel
Holmes Employment Agreement
|
|
|
|
21.1
|
|
Subsidiaries
of Bacterin, Inc.
|
|
|
|
99.1
|
|
Financial
statements of Bacterin International, Inc. as of and for the 12 months
ended December 31, 2009 and 2008.
|
|
|
|
99.2
|
|
Financial
statements of Bacterin International, Inc. as of and for the three months
ended March 31, 2010 and 2009 (unaudited).
|
|
|
|
99.3
|
|
Unaudited
pro forma condensed combined financial statements of K-Kitz, Inc. and
Bacterin International, Inc. as of and for the three months ended March
31, 2010 and the 12 months ended December 31,
2009.
|
________________
* Incorporated
herein by reference to the exhibits included with Form 8-K dated June 30, 2010,
filed with the SEC on June 30, 2010.
** Incorporated
herein by reference to the exhibits included with Registration Statement on Form
S-1 (No. 333-158426), declared effective by the U.S. Securities and Exchange
Commission on September 29, 2009.
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
Date:
July 7, 2010
|
BACTERIN
INTERNATIONAL HOLDINGS, INC.
|
|
|
|
|
By:
|
/s/
Guy S. Cook
|
|
|
Guy
S. Cook
|
|
|
President
and Chief Executive
Officer
|