Form 10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
|
|
|
þ |
|
Quarterly report under Section 13 or 15(d) of the Securities Exchange Act of 1934 |
For the quarterly period ended June 30, 2009.
|
|
|
o |
|
Transition report under Section 13 or 15(d) of the Securities Exchange Act of 1934 |
For the transition period from to .
Commission File Number 000-50309
Clearant, Inc.
(Exact name of registrant as specified in its charter)
|
|
|
Delaware
|
|
91-2190195 |
|
|
|
(State or other jurisdiction of incorporation)
|
|
(I.R.S. Employer Identification Number) |
1801 Avenue of the Stars, Suite 435
Los Angeles, California 90067
(Address of principal executive offices, including zip code)
(310) 479-4570
(Registrants telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File Required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such file). Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company.
|
|
|
|
|
|
|
Large accelerated filer o
|
|
Accelerated filer o
|
|
Non-accelerated filer o
|
|
Smaller reporting company þ |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes o No þ
As of August 13, 2009, there were 48,957,445 shares of registrants common stock, $0.0001 par
value, outstanding.
PART I FINANCIAL INFORMATION
ITEM 1. Financial Statements
CLEARANT, INC.
BALANCE SHEETS
(in thousands, except par value)
|
|
|
|
|
|
|
|
|
|
|
June 30, 2009 |
|
|
December 31, 2008 |
|
|
|
(Unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
104 |
|
|
$ |
265 |
|
Accounts receivable, net of allowances of
$81 and $91 at June 30, 2009 and December
31, 2008, respectively |
|
|
206 |
|
|
|
276 |
|
Inventory and inventory related
prepayments, net of reserve of $1,307 and
$1,315 at June 30, 2009 and December 31,
2008, respectively |
|
|
15 |
|
|
|
15 |
|
Prepaids and other |
|
|
114 |
|
|
|
62 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
439 |
|
|
|
618 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net of $166 and
$146 of accumulated depreciation at June
30, 2009 and December 31, 2008,
respectively |
|
|
24 |
|
|
|
44 |
|
Identifiable intangibles, net of $1,307
and $1,285 of accumulated amortization at
June 30, 2009 and December 31, 2008,
respectively |
|
|
986 |
|
|
|
970 |
|
Deposits and other assets |
|
|
84 |
|
|
|
85 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
1,533 |
|
|
$ |
1,717 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders Deficit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,131 |
|
|
$ |
1,070 |
|
Accrued liabilities |
|
|
923 |
|
|
|
736 |
|
Deferred revenue |
|
|
8 |
|
|
|
7 |
|
Bridge loans |
|
|
106 |
|
|
|
106 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
2,168 |
|
|
|
1,919 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible promissory note related
party, net of discount of $154 and $135 at
June 30, 2009 and December 31, 2008,
respectively |
|
|
1,133 |
|
|
|
758 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
3,301 |
|
|
|
2,677 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders deficit: |
|
|
|
|
|
|
|
|
Series A preferred stock ($0.0001 par
value; 50,000 shares authorized; 0 issued
and outstanding at June 30, 2009 and
December 31, 2008, respectively) |
|
|
|
|
|
|
|
|
Common stock ($0.0001 par value; 200,000
shares authorized; 48,957 and 48,957
issued and outstanding at June 30, 2009
and December 31, 2008, respectively) |
|
|
5 |
|
|
|
5 |
|
Additional paid-in-capital |
|
|
87,243 |
|
|
|
87,013 |
|
Accumulated deficit |
|
|
(89,016 |
) |
|
|
(87,978 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders deficit |
|
|
(1,768 |
) |
|
|
(960 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders deficit |
|
$ |
1,533 |
|
|
$ |
1,717 |
|
|
|
|
|
|
|
|
See accompanying notes to financial statements.
F-1
CLEARANT, INC.
STATEMENTS OF OPERATIONS
(in thousands, except for per share data)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Month Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing |
|
$ |
9 |
|
|
$ |
14 |
|
|
$ |
16 |
|
|
$ |
71 |
|
Direct distributions |
|
|
363 |
|
|
|
455 |
|
|
|
800 |
|
|
|
762 |
|
Fee for service |
|
|
24 |
|
|
|
27 |
|
|
|
48 |
|
|
|
36 |
|
Contract research and milestones |
|
|
6 |
|
|
|
8 |
|
|
|
12 |
|
|
|
100 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
402 |
|
|
|
504 |
|
|
|
876 |
|
|
|
969 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues |
|
|
204 |
|
|
|
289 |
|
|
|
463 |
|
|
|
502 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
198 |
|
|
|
215 |
|
|
|
413 |
|
|
|
467 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales, general and administrative |
|
|
687 |
|
|
|
690 |
|
|
|
1,358 |
|
|
|
1,502 |
|
Research and development |
|
|
|
|
|
|
2 |
|
|
|
|
|
|
|
5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
687 |
|
|
|
692 |
|
|
|
1,358 |
|
|
|
1,507 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(489 |
) |
|
|
(477 |
) |
|
|
(945 |
) |
|
|
(1,040 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income (expense) |
|
|
(51 |
) |
|
|
3 |
|
|
|
(93 |
) |
|
|
12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before provision (benefit) for income taxes |
|
|
(540 |
) |
|
|
(474 |
) |
|
|
(1,038 |
) |
|
|
(1,028 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision (benefit) for income taxes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(540 |
) |
|
$ |
(474 |
) |
|
$ |
(1,038 |
) |
|
$ |
(1,028 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.02 |
) |
|
$ |
(0.02 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of weighted average shares used in per
share calculation: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
48,957 |
|
|
|
48,957 |
|
|
|
48,957 |
|
|
|
48,957 |
|
See accompanying notes to financial statements.
F-2
CLEARANT, INC.
STATEMENTS OF CASH FLOWS
(in thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
|
2009 |
|
|
2008 |
|
Operating activities |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(1,038 |
) |
|
$ |
(1,028 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
41 |
|
|
|
89 |
|
Accretion of debt discount |
|
|
38 |
|
|
|
|
|
Stock-based compensation |
|
|
230 |
|
|
|
273 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
70 |
|
|
|
18 |
|
Inventory and inventory related prepayments |
|
|
|
|
|
|
(16 |
) |
Prepaids |
|
|
(52 |
) |
|
|
(56 |
) |
Accounts payable |
|
|
61 |
|
|
|
(40 |
) |
Accrued liabilities |
|
|
152 |
|
|
|
99 |
|
Deferred revenue |
|
|
1 |
|
|
|
(1 |
) |
Other assets and liabilities |
|
|
(4 |
) |
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(501 |
) |
|
|
(661 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investing activities |
|
|
|
|
|
|
|
|
Cost of identified intangibles |
|
|
(37 |
) |
|
|
(24 |
) |
Capital expenditures |
|
|
|
|
|
|
(15 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(37 |
) |
|
|
(39 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing activities |
|
|
|
|
|
|
|
|
Proceeds from convertible secured promissory note related party, net of
fees of $42 |
|
|
377 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
377 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in cash and cash equivalents |
|
|
(161 |
) |
|
|
(700 |
) |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, beginning of period |
|
|
265 |
|
|
|
1,062 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period |
|
$ |
104 |
|
|
$ |
362 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental Disclosure of Non-cash Financing Activities: |
|
|
|
|
|
|
|
|
Cash paid for interest |
|
$ |
56 |
|
|
$ |
|
|
See accompanying notes to financial statements.
F-3
CLEARANT, INC.
NOTES TO FINANCIAL STATEMENTS
(in thousands, except for share and per share data)
(Unaudited)
NOTE 1 BASIS OF PRESENTATION
Our accompanying unaudited interim financial statements have been prepared in accordance with U.S.
generally accepted accounting principles (GAAP) and reflect all adjustments, consisting solely of
normal recurring adjustments, needed to fairly present the financial results for these interim
periods. These financial statements include amounts that are based on managements best estimates
and judgments. These estimates may be adjusted as more information becomes available, and any
adjustment could be significant. The impact of any change in estimates is included in the
determination of earnings in the period in which the change in estimate is identified. The results
of operations for the three and six months ended June 30, 2009 are not necessarily indicative of
the results that may be expected for the entire 2009 fiscal year.
We have omitted footnote disclosures that would substantially duplicate the disclosures contained
in our audited financial statements and should be read in conjunction with the financial statements
for the fiscal years ended December 31, 2008 and 2007 and notes thereto in our Form 10-K dated
December 31, 2008, filed with the Securities and Exchange Commission (the SEC) on March 24, 2009.
NOTE 2 GOING CONCERN
The accompanying financial statements have been prepared on the basis that we will continue as a
going concern. We have incurred significant operating losses and negative cash flows from operating
activities since our inception. As of June 30, 2009, these conditions raised substantial doubt as
to our ability to continue as a going concern. In July 2008, we raised additional capital to
supplement our operations by entering into a $2,000 related party convertible secured promissory
note. Please see Note 6 Convertible Secured Promissory Note Related Party for further
discussion. The $2,000 related party convertible secured promissory note was scheduled to be
funded, net of fees of approximately $250, in tranches of: $400 on July 8, 2008; $400 on August 22,
2008 of which $252 was received on September 5, 2008, and $148 was received on October 1, 2008;
$600 scheduled on October 6, 2008 of which $68 was received on December 12, 2008, $50 was received
on January 8, 2009, $155 was received on February 26, 2009, $77 was received on March 12, 2009, $76
was received on May 4, 2009, and $60 was received on May 20, 2009; and $600 scheduled on
February 16, 2009 which has not yet been received. On February 20, 2009, we entered into a
1st amendment with CPI Investments, Inc. (CPI) extending the closing dates for the
amounts due on October 6, 2008 and February 16, 2009, to March 31, 2009 and April 30, 2009,
respectively. The extension of the closing date for the amount due on October 6, 2008 accounts for
payments previously made and required payments of $160 due February 20, 2009 (of which we received
$155 on February 26, 2009 and $5 on March 12, 2009), $100 due by March 10, 2009 (of which we
received $72 on March 12, 2009 and $28 on May 4, 2009) and $222 due before March 31, 2009 (of which
we received $48 on May 4, 2009 and $60 on May 20, 2009). The 1st amendment also gives us
the option to extend the initial maturity date of each promissory note to January 8, 2012. On
August 3, 2009, we entered into a 2nd amendment to the CPI Agreement. The
2nd amendment extends the closing dates for the third and fourth tranches of financing
from March 31, 2009 and April 30, 2009, respectively to August 3, 2009 and October 31, 2009 and
establishes a payment schedule for the third and fourth tranches of financing. The 2nd
amendment extending the closing date for the amount due on March 31, 2009 accounts for payments
previously made (see Note 6), and requires a payment of $114 on August 3, 2009, of which we
received $50 on August 5, 2009. The 2nd amendment extending the closing date for the
amount due on April 30, 2009 requires payments of $100 on August 15, 2009, $100 on August 31, 2009,
$200 on September 30, 2009, and $200 on October 31, 2009. The 2nd amendment also gives
us the option to extend the initial maturity date of each promissory note to three years from the
closing date of funding of the final tranche. There can be no assurance that we will receive any of
the remaining amounts due on the convertible secured promissory note. Regardless of whether we
receive the full amount of the remaining amounts, we will still require and continue to seek
additional capital to fund our ongoing operations. There can be no assurance that we will be
successful in our efforts to generate, increase, or maintain revenue or raise additional capital on
terms acceptable to us or that we will be able to continue as a going concern. The financial
statements do not include any adjustments relating to the recoverability of the carrying amount of
the recorded assets or the amount of liabilities that might result from the outcome of this
uncertainty.
F-4
NOTE 3 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Revenue Recognition and Deferred Revenue
We recognize revenue in accordance with the provisions of Staff Accounting Bulletin (SAB) No.
104, Revenue Recognition. Our revenue sources are direct distribution of Clearant
Process® sterile implants, and licensing fees and sterilization services to
customers who incorporate the Clearant Process® technology into their product
and manufacturing processes, which may include performance milestones and contract research
activities. We recognize direct distribution revenue upon the sourcing of tissue by a customer.
Licensing revenue is recognized when a customer distributes products incorporating the Clearant
Process® and revenue related to the sterilization service is recognized when
the service is substantially complete. We recognize revenue related to performance milestones and
contract research in accordance with Statement of Position (SOP) 81-1, Accounting for Performance
of Construction-Type and Certain Production-Type Contracts. Revenue related to a performance
milestone is recognized upon customer acceptance of the achievement of that milestone, as defined
in the respective agreements. Revenue related to contract research activities is recognized on a
percentage-of-completion basis. In the event cash is received in advance of service performed, we
will defer the related revenue recognition until the underlying performance milestone is achieved
and or the contract research activities commence. In the event advance cash payments are not
attributable to any performance milestone and or contract research activity, we will recognize the
underlying amounts into revenue on a straight-line basis over the term of the underlying agreement.
We include shipping charges in the gross invoice price to customers and classify the total amount
as revenue in accordance with Emerging Issues Task Force Issue (EITF) 00-10, Accounting for
Shipping and Handling Fees and Costs. Shipping costs are recorded as cost of revenues. We evaluate
the collectability of accounts receivable and provide a reserve for credit losses, as appropriate.
As of June 30, 2009 and December 31, 2008, we reserved for credit losses of $81 and $91,
respectively.
Cost of revenues
Cost of revenues consists of costs associated with direct distribution of Clearant
Process® sterile implants to a customer and with providing sterilization
services to customers. We had no inventory reserves recorded as cost of revenues during the three
and six months ended June 30, 2009 and 2008, respectively.
Use of Estimates
The preparation of financial statements in conformity with U.S. generally accepted accounting
principles requires management to make estimates and assumptions that affect the reported amounts
of assets and liabilities and the disclosure of contingent assets and liabilities at the date of
the financial statements and the reported amounts of revenue and expenses during the reporting
period. Actual results could differ from those estimates.
Cash Equivalents and Concentration of Credit Risk
We consider all highly liquid investments with an original maturity of three months or less to be
cash equivalents. Financial instruments that potentially subject us to a concentration of credit
risk consist of cash and cash equivalents, and accounts receivable. Cash is deposited with what we
believe are highly credited, quality financial institutions. The deposited cash may exceed FDIC
insured limits. For the six months ended June 30, 2009, three customers accounted for approximately
20% of revenues and three customers accounted for approximately 27% of accounts receivable.
Accounts Receivable and Allowance for Doubtful Accounts
Accounts receivable are recorded at the invoiced amount and do not bear interest. Provisions for
doubtful accounts are recorded in general and administrative expenses. The allowance for doubtful
accounts is based on the best estimate of the amount of probable credit losses in existing accounts
receivable. The allowance for doubtful accounts is determined based on historical write-off
experience, current customer information and other relevant data. Clearant reviews the allowance
for doubtful accounts monthly. Account balances are charged off against the
allowance when management believes it is probable the receivable will not be recovered. As of June
30, 2009 and December 31, 2008, the allowance for doubtful accounts was $81 and $91, respectively.
F-5
Inventory and Inventory Related Prepayments
Inventory is primarily comprised of implantable donor tissue treated with the Clearant
Process® and is valued at the lower of cost or market with cost determined
using the first-in, first-out method. Inventory is located at contracted tissue banks and on
consignment in hospitals. Inventory may be written down from time to time based on market
conditions or other factors. As of June 30, 2009 and December 31, 2008, we had an inventory and
inventory related prepayment reserve of $1,307 and $1,315, respectively.
In accordance with the terms of the Osprey Agreement (see Note 8 Commitments and Contingencies
below in the accompanying footnotes to the financial statements), we are required to make
prepayments. Upon receipt of the inventory, the prepayments will be reclassified as inventory until
distributed.
Property and Equipment
Property and equipment are stated at cost. Depreciation is provided using the straight-line method
based upon estimated useful lives of the assets, which are generally three to seven years.
Leasehold improvements are amortized over the estimated useful lives of the assets or related lease
terms, whichever is shorter. Repair and maintenance expenditures are charged to appropriate expense
accounts in the period incurred. During the three and six months ended June 30, 2009 and 2008, we
sold no property or equipment.
Fair Value Measurements
Effective January 1, 2008, we adopted Statement of Financial Accounting Standards (SFAS) No. 157,
Fair Value Measurements (SFAS 157), except as it applies to the nonfinancial assets and
nonfinancial liabilities subject to Financial Staff Position SFAS 157-2. SFAS 157 clarifies that
fair value is an exit price, representing the amount that would be received to sell an asset or
paid to transfer a liability in an orderly transaction between market participants. As such, fair
value is a market-based measurement that should be determined based on assumptions that market
participants would use in pricing an asset or a liability. As a basis for considering such
assumptions, SFAS 157 establishes a three-tier value hierarchy, which prioritizes the inputs used
in the valuation methodologies in measuring fair value:
Level 1 Observable inputs that reflect quoted prices (unadjusted) for identical assets or
liabilities in active markets.
Level 2 Include other inputs that are directly or indirectly observable in the marketplace.
Level 3 Unobservable inputs which are supported by little or no market activity.
The fair value hierarchy also requires an entity to maximize the use of observable inputs and
minimize the use of unobservable inputs when measuring fair value.
In accordance with SFAS 157, we measure our cash equivalents at fair value. Our cash equivalents
are classified within Level 1. Cash equivalents are valued primarily using quoted market prices
utilizing market observable inputs. At June 30, 2009, cash equivalents consisted of money market
funds measured at fair value on a recurring basis. Fair value of our money market funds was $81 and
$267 as of June 30, 2009 and 2008, respectively.
Long-Lived Assets
We review and evaluate our long-lived assets for impairment when events or changes in circumstances
indicate that the related carrying amounts may not be recoverable. An impairment loss is measured
as the amount by which the asset carrying value exceeds its fair value. Fair value is generally
determined using valuation techniques such as estimated future cash flows. An impairment is
considered to exist if total estimated future cash flows on an
undiscounted basis are less than the carrying amount of the asset. An impairment loss is measured
and recorded based on discounted estimated future cash flows. Assumptions underlying future cash
flow estimates are subject to risks and uncertainties. No impairment losses were recorded during
the three and six months ended June 30, 2009 and 2008.
F-6
Identifiable Intangibles
Certain costs associated with obtaining and licensing patents and trademarks are capitalized as
incurred and are amortized on a straight-line basis over the shorter of their estimated useful
lives or their legal lives of 17 to 20 years. Amortization of such costs begins once the patent or
trademark has been issued. We evaluate the recoverability of our patent costs and trademarks
quarterly based on estimated undiscounted future cash flows. In accordance with SFAS No. 144,
Accounting for the Impairment or Disposal of Long-Lived Assets, the carrying amount of a long-lived
asset is not recoverable if it exceeds the sum of the undiscounted cash flows expected to result
from the use and eventual disposition of the asset. Based upon our valuation assessments of our
patents, no impairment exists as of June 30, 2009 and December 31, 2008.
Research and Development Costs
Research and development costs are expensed as incurred.
Income Taxes
Income taxes are accounted for under SFAS No. 109, Accounting for Income Taxes (SFAS 109), using
the liability method. Under SFAS 109, deferred tax assets and liabilities are determined based on
differences between financial reporting and tax basis of assets and liabilities, and are measured
using the enacted tax rates and laws that are expected to be in effect when the differences
reverse. Valuation allowances are established when necessary to reduce deferred tax assets to the
amounts expected to be realized.
The significant components of the provision for income taxes for the periods ending June 30, 2009
and December 31, 2008 were $0 and $0, respectively, for the current state provision. There was no
state deferred or federal tax provision.
Due to our current net loss position, we have provided a valuation allowance in full on our net
deferred tax assets in accordance with SFAS 109 and in light of the uncertainty regarding ultimate
realization of the net deferred tax assets.
We adopted the provisions of FASB Interpretation No. 48, Accounting for Uncertainty in Income Taxes
(FIN 48), on January 1, 2007. FIN 48 prescribes a recognition threshold and measurement attribute
for the financial statement recognition and measurement of a tax position taken or expected to be
taken in a tax return. FIN 48 also provides guidance on derecognition, classification, interest and
penalties, accounting in interim periods, disclosure, and transition. Due to the fact that we have
substantial net operating loss carryforwards, adoption of FIN 48 had no impact on our beginning
retained earnings, balance sheets, or statements of operations.
Stock-Based Compensation
Stock-based compensation expense is recognized under SFAS No. 123(R), Share Based Payment (SFAS
123R), which requires the measurement and recognition of compensation expense for all share-based
payment awards to employees and directors based on estimated fair value. Stock-based compensation
expense for employees and directors for the three and six months ended June 30, 2009 were $115 and
$230, respectively, and $136 and $273 for the three and six months ended June 30, 2008,
respectively.
There were no options granted to employees and directors during the three and six months ended June
30, 2009 and 2008.
F-7
Options issued to consultants are being accounted for in accordance with the provisions of EITF
No. 96-18, Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring,
or in Conjunction with Selling, Goods or Services (EITF 96-18). There were no options granted to
consultants during the three and six months ended June 30, 2009 and 2008.
As stock-based compensation expense recognized for the six months ended June 30, 2009 and 2008 is
based on awards ultimately expected to vest, it has been reduced for estimated forfeitures which we
estimate to be approximately 7% and 9%, respectively. As of June 30, 2009 and 2008, stock-based
compensation expense has been reduced by estimated forfeitures not yet incurred of approximately $7
and $20, respectively.
Fair Value of Financial Instruments
Fair value of financial instruments are accounted for under FSP FAS 107-1 and APB 28-1, which
require that the carrying amounts reported in the balance sheet for financial instruments such as
cash, cash equivalents, accounts receivable, accounts payable and accrued liabilities to
approximate fair value because of the immediate or short-term maturity of these financial
instruments. Debt is estimated to approximate fair value based upon current market borrowing rates
for loans with similar terms and maturities.
Recent Accounting Pronouncements
In May 2009, the FASB issued SFAS No. 165, Subsequent Events (SFAS 165). SFAS No. 165 was issued
in order to establish principles and requirements for reviewing and reporting subsequent events and
requires disclosure of the date through which subsequent events are evaluated and whether the date
corresponds with the time at which the financial statements were available for issue (as defined)
or were issued. SFAS No. 165 is effective for interim reporting periods ending after June 15, 2009.
The adoption of SFAS No. 165 did not have a material impact on our financial position, results of
operations, and cash flows.
In June 2009, the FASB issued SFAS No. 168, The FASB Accounting Standards Codification and the
Hierarchy of Generally Accepted Accounting Principles (SFAS 168). SFAS 168 establishes the FASB
Accounting Standards Codification (Codification) as the single source of authoritative GAAP to be
applied by nongovernmental entities, except for the rules and interpretive releases of the SEC
under authority of federal securities laws, which are sources of authoritative GAAP for SEC
registrants. All guidance contained in the Codification carry equal level of authority. The
Codification does not change GAAP. SFAS 168 is effective for interim and annual periods ending on
or after September 15, 2009. The adoption of SFAS 168 is not expected to have any impact on our
results of operations and financial position.
NOTE 4 NET LOSS PER SHARE
We compute net loss per share in accordance with SFAS No. 128, Earnings Per Share (SFAS 128).
Under the provisions of SFAS 128, basic loss per share is computed by dividing net loss by the
weighted average number of common stock shares outstanding during the periods presented. Diluted
earnings would customarily include, if dilutive, potential common stock shares issuable upon the
exercise of stock options and warrants. The dilutive effect of outstanding stock options and
warrants is reflected in earnings per share in accordance with SFAS 128 by application of the
treasury stock method. For the periods presented, the computation of diluted loss per share equaled
basic loss per share as the inclusion of any dilutive instruments would have had an antidilutive
effect on the earnings per share calculation in the periods presented.
The following potential common shares have been excluded from the computation of diluted net loss
per share since their effect would have been antidilutive:
|
|
|
|
|
|
|
|
|
|
|
For the Six Months Ended June 30, |
|
|
|
2009 |
|
|
2008 |
|
Stock Options |
|
|
2,557,855 |
|
|
|
3,358,212 |
|
Warrants |
|
|
2,113,052 |
|
|
|
133,052 |
|
F-8
The following table sets forth the computation of basic and diluted net loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Month Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Basic and diluted net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to common stock |
|
$ |
(540 |
) |
|
$ |
(474 |
) |
|
$ |
(1,038 |
) |
|
$ |
(1,028 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common stock shares outstanding |
|
|
48,957 |
|
|
|
48,957 |
|
|
|
48,957 |
|
|
|
48,957 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted |
|
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.02 |
) |
|
$ |
(0.02 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
NOTE 5 INCOME TAXES
We file income tax returns in the U.S. federal jurisdiction, and various states and foreign
jurisdictions. With few exceptions, we are no longer subject to U.S. federal, state and local
income tax examinations by tax authorities for years before 2001.
We recognize accrued interest and penalties on unrecognized tax benefits in income tax expense. We
did not have any unrecognized tax benefits as of June 30, 2009 and 2008. As a result, we did not
recognize interest expense, and additionally, did not record any penalties during the six months
ended June 30, 2009 and 2008. We do not expect that the amounts of unrecognized tax benefits will
change significantly within the next 12 months.
NOTE 6 CONVERTIBLE SECURED PROMISSORY NOTE RELATED PARTY
On July 9, 2008, we entered into a Subscription and Purchase Agreement dated as of July 8, 2008
with CPI whereby CPI agreed to loan us the aggregate amount of $2,000 (the CPI Agreement). As
discussed below, CPI is currently in default of its funding obligations under the agreement as
amended.
The loan is payable, net of fees of approximately $250, in four tranches which consist of: (i) $400
which was funded on July 8, 2008; (ii) $400 of which $252 was funded on September 5, 2008, and $148
was funded on October 1, 2008; (iii) $600 scheduled to be funded on October 6, 2008 of which $68
was received on December 12, 2008, $50 was received on January 8, 2009, $155 was received on
February 26, 2009, $77 was received on March 12, 2009, $76 was received on May 4, 2009, and $60 was
received on May 20, 2009; and (iv) $600 scheduled to be funded which has not been received. On
February 20, 2009, we entered into a 1st amendment with CPI extending the closing dates
for the amounts due on October 6, 2008 and February 16, 2009, to March 31, 2009 and April 30, 2009,
respectively and establishing a new payment schedule for the October 6, 2008 tranche. The extension
of the closing date for the amount due on October 6, 2008 accounts for payments previously made,
and required payments due pursuant to the payment schedule set forth in the 1st
amendment, which consists of $160 due February 20, 2009 (of which we received $155 on February 26,
2009 and $5 on March 12, 2009), $100 due by March 10, 2009 (of which we received $72 on March 12,
2009 and $28 on May 4, 2009), and $222 due before March 31, 2009 (of which we received $48 of May
4, 2009 and $60 on May 20, 2009). The 1st amendment also gives us the option to extend
the initial maturity date of each promissory note to January 8, 2012. On August 3, 2009, we entered
into a 2nd amendment to the CPI Agreement. The 2nd amendment extends the
closing dates for the third and fourth tranches of financing from March 31, 2009 and April 30,
2009, respectively to August 3, 2009 and October 31, 2009 and establishes a payment schedule for
the third and fourth tranches of financing. The 2nd amendment extending the closing
date for the amount due on March 31, 2009 accounts for payments previously made, and requires a
payment of $114 on August 3, 2009, of which we received $50 on August 5, 2009. The 2nd
amendment extending the closing date for the amount due on April 30, 2009 requires payments of $100
on August 15, 2009, $100 on August 31, 2009, $200 on September 30, 2009, and $200 on October 31,
2009. The 2nd amendment also gives us the option to extend the initial maturity date of
each promissory note to three years from the closing date of funding of the final tranche. There
can be no assurance that we will receive any of the remaining amounts due on the convertible
secured promissory note. The principal amounts loaned have a 3-year term and will bear interest at
12% per year payable
monthly with no prepayment option. The loan is convertible into 18,181,818 shares of our restricted
common stock at a conversion price of $0.11. There was no beneficial conversion feature as
calculated under EITF 00-27, Application of Issue No. 98-5 to Certain Convertible Instruments,
(EITF 00-27).
F-9
According to APB Opinion No. 14, Accounting for Convertible Debt and Debt Issued with Stock
Purchase Warrants (APB 14), we allocated the proceeds received to the convertible debt and
warrants based upon relative fair value.
We allocated $63 to the warrants and $146 to the debt discount related to the financing fees which
are being amortized over the life of the debt. Interest expense recognized for the three and six
months ended June 30, 2009 was $51 and $93, respectively, and $0 and $0 for the three and six
months ended June 30, 2008, respectively.
Pursuant to the CPI Agreement, we granted CPI 2-year warrants to purchase (a) 4,500,000 shares of
common stock at a $0.30 exercise price, and (b) 200,000 shares of common stock at a $0.15 exercise
price, both vesting pro-rata upon funding of each tranche. We accounted for these warrants in
accordance with EITF Issue No. 00-19, Accounting for Derivative Financial Statements Indexed to,
and Potentially Settled in a Companys own stock, (EITF 00-19).
In addition, we also granted CPI one share of our Series A Preferred Stock, which votes together
with our common stock and has votes equal to 45,454,545 shares of common stock. Those votes will be
reduced by 2.5 votes for every 1 share of common stock into which the loan is converted. Provided
that CPI meets its funding obligations under the CPI Agreement, CPI will maintain its voting rights
throughout the term of the loan.
Under the terms of the CPI Agreement, CPI appointed 3 board members to our board of directors,
Michael Bartlett, Kenneth W. Davidson and Alan S. Blazei. Michael Bartlett also serves as the
president of CPI. CPI is a related party to the Company.
NOTE 7 STOCK-BASED AWARDS
Stock Options
A summary of activity under our 2000 Stock Option Plan (the 2000 Plan), 2005 Stock Option Plan
(the 2005 Plan), and Non-Plan Options as of December 31, 2008, and for the six months ended June
30, 2009 is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employees |
|
|
Non-Employees |
|
|
Total |
|
|
|
|
|
|
|
Exercise |
|
|
|
|
|
|
Exercise |
|
|
|
|
|
|
Exercise |
|
|
|
Shares |
|
|
Price |
|
|
Shares |
|
|
Price |
|
|
Shares |
|
|
Price |
|
Outstanding at December 31,
2008 |
|
|
2,585,000 |
|
|
$ |
0.35-$63.14 |
|
|
|
173,000 |
|
|
$ |
0.70-$57.68 |
|
|
|
2,758,000 |
|
|
$ |
0.35-$63.14 |
|
Granted |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
Exercised |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
Change in Status |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
Canceled |
|
|
200,000 |
|
|
$ |
0.45 |
|
|
|
|
|
|
$ |
|
|
|
|
200,000 |
|
|
$ |
0.45 |
|
Outstanding at June 30, 2009 |
|
|
2,385,000 |
|
|
$ |
0.35-$63.14 |
|
|
|
173,000 |
|
|
$ |
0.70-$57.68 |
|
|
|
2,558,000 |
|
|
$ |
0.35-$63.14 |
|
Of the 2,558,000 shares outstanding for the six-months ended June 30, 2009 and the 2,758,000 shares
outstanding for the year ended December 31, 2008, 2,010,000 and 2,210,000 were issued to officers
and directors, respectively.
As of June 30, 2009 and December 31, 2008, there were $624 and $861, respectively of total
unrecognized compensation costs related to non-vested share-based compensation arrangements granted
under the 2005 Plan. These costs are expected to be recognized over the weighted-average period of
2.0 and 2.3 years, respectively.
When options are exercised, our policy is to issue previously unissued shares of common stock to
satisfy share option exercises. As of June 30, 2009 and December 31, 2008, we had 7,873,723 and
7,673,723 shares of unissued shares reserved for issuance under the 2005 Plan, respectively.
F-10
NOTE 8 COMMITMENTS AND CONTINGENCIES
On September 27, 2006, we entered into a renewable two-year supply and distribution agreement (the
Osprey Agreement) with Osprey Biomedical Corp. (Osprey). Under the Osprey Agreement, Osprey
granted us exclusive rights to place current and future Osprey cervical and lumbar allografts
treated with the Clearant Process® in certain geographic territories with an
option for additional geographic territories. In exchange for the exclusive rights under the Osprey
Agreement, we were obligated to pay Osprey $500 as a prepayment for certain ordered products to be
delivered after October 1, 2006. This prepayment was due upon the earlier of the following:
(i) within three business days after we receive debt or equity financing of at least $1 million, or
(ii) October 31, 2006. In addition, we were required to make the following quarterly payments to be
applied to payments for ordered products: $650 by October 31, 2006; $750 by January 1, 2007; $850
by April 1, 2007; $1 million by July 1, 2007; $1.2 million by October 1, 2007; $1.3 million by
January 1, 2008; $1.5 million by April 1, 2008; and $1.75 million by July 1, 2008.
As of June 30, 2009, all tissue orders had not been delivered by Osprey and we have not made the
prepayments. In February 2007, we received notice from Osprey of its termination of the Osprey
Agreement, effective within thirty days from receipt of the notification if we did not timely cure
certain alleged payment defaults. The termination of the Osprey Agreement has resulted in the
discontinuation or disruption of the spinal bone implant supply, which has had a material adverse
impact on our ability to distribute spinal bone implants treated with the Clearant
Process®. In addition, the lack of supply of the ordered products has had a
material impact on our revenues and cash flows.
NOTE 8 SUBSEQUENT EVENTS
In accordance with SFAS 165, we evaluated subsequent events through the August 14, 2009 issuance
date of these financial statements. On August 3, 2009, we entered into a 2nd amendment
to the CPI Agreement. The 2nd amendment extends the closing dates for the third and
fourth tranches of financing from March 31, 2009 and April 30, 2009, respectively to August 3,
2009 and October 31, 2009 and establishes a payment schedule for the third and fourth tranches of
financing. The 2nd amendment extending the closing date for the amount due on March 31,
2009 accounts for payments previously made (see Note 6), and requires a payment of $114 on August
3, 2009, of which we received $50 on August 5, 2009. The 2nd amendment extending the
closing date for the amount due on April 30, 2009 requires payments of $100 on August 15, 2009,
$100 on August 31, 2009, $200 on September 30, 2009, and $200 on October 31, 2009. The
2nd amendment also gives us the option to extend the initial maturity date of each
promissory note to three years from the closing date of funding of the final tranche. There can be
no assurance that we will receive any of the remaining amounts due on the convertible secured
promissory note.
F-11
|
|
|
ITEM 2. |
|
Managements Discussion and Analysis of Financial Condition and Results of Operations |
The following discussion of our financial condition and results of operations should be read in
conjunction with our financial statements and the related notes, and the other financial
information included in this report. As used in this report, the terms Clearant, Company, we,
our, and like references mean Clearant, Inc., a Delaware corporation.
Forward-Looking Statements
The forward-looking comments contained in this report involve risks and uncertainties. Our actual
results may differ materially from those discussed here due to factors such as, among others,
limited operating history, difficulty in developing, exploiting and protecting proprietary
technologies, results of additional clinical studies, acceptance and success of our direct
distribution of allografts, intense competition and substantial regulation in the healthcare
industry. Additional factors that could cause or contribute to such differences can be found in the
following discussion and in the Risks Factors set forth in Item 1 of our Form 10-K dated
December 31, 2008, filed with the Securities and Exchange Commission on March 24, 2009 (the Form
10-K).
Overview
We acquire and develop our pathogen inactivation technology, the Clearant
Process® , and market it to producers of biological products, most notably
devitalized musculoskeletal tissue allograft implants (tissue).
We develop and market a proprietary pathogen inactivation technology that reduces the risk of
contamination to biological products by inactivating a broad range of pathogens. The Clearant
Process® is based on exposing a biological product to gamma-irradiation under
specialized, proprietary or patented conditions that deliver a predetermined amount of radiation to
inactivate a desired level of pathogens, thereby reducing the risk of contamination, while
preserving the functionality and integrity of the treated product. The Clearant
Process® is designed to:
|
|
|
Inactivate a broad range of known pathogens irrespective of size, origin or
structure; |
|
|
|
Achieve sterility, in some cases with margins of safety greater than that of a
medical device; |
|
|
|
Be used in either intermediate or final stages of production; |
|
|
|
Protect the mechanical and biological properties of the biological product being
treated; and |
|
|
|
Be applied to a product after it has been sealed into its final package. |
To date, we have entered into a total of ten agreements with customers to utilize the Clearant
Process® with their products. Of these agreements, six are licensing
agreements with tissue banks and one is an agreement with a manufacturer of recombinant protein
products, in return for milestone payments and royalties on end-product sales. Through June 30,
2009, four of these licensees have launched tissue products that were treated using the Clearant
Process®, but are not treating all of their tissue with the Clearant
Process®. Additionally, in September 2005, we launched a new sterilization
service (the Clearant Sterilization Service or Sterilization Service) which allows customers to
send ready for sterilization tissue to our facility near Chicago, Illinois to be irradiated under
Clearant Process® conditions by us. Through June 30, 2009, we have signed
four such Sterilization Service agreements with tissue banks. Many of the companies have not yet
implemented the Clearant Process®, and we cannot estimate when or if they
will do so.
Based on these license and Sterilization Service results, we implemented a plan to better market
and promote adoption of the Clearant Process®, which is to directly
distribute Clearant Process® sterile implants to our customers in order to
facilitate market penetration. We do not intend to continue to pursue the license and sterilization
agreements.
12
Results of Operations
Three Months Ended June 30, 2009 Compared to Three Months Ended June 30, 2008
Revenues
Our total revenue decreased by $102,000 or 20%, to $402,000 for the three months ended June 30,
2009, from $504,000 for the three months ended June 30, 2008.
Revenues from direct distribution of Clearant Process® sterile implants were
$363,000 and $455,000 during the three months ended June 30, 2009 and 2008, respectively. This is a
20% decrease over the quarter ending June 30, 2008. Direct distribution continues to be our primary
strategy of our growth plan.
Revenues from licensing activities decreased 36% to $9,000 for the three months ended June 30,
2009, from $14,000 for the three months ended June 30, 2008. Additionally revenues from fee for
service activities were $24,000 and $27,000 for the three months ended June 30, 2009 and June 30,
2008, respectively, as we continued to offer customers the opportunity to use our Sterilization
Service. These figures are consistent with our strategy of moving away from a royalty model and
aggressively targeting a direct distribution strategy. While we are continuing to service the
existing license and fee for service agreements, we are not actively pursuing new license or fee
for service agreements, and it is unlikely that there will be a near-term material growth in
licensing or fee for service revenue.
Revenues from contract research and milestones decreased to $6,000 in the three months ended June
30, 2009, from $8,000 for the three months ended June 30, 2008. The decrease is consistent with our
strategy of moving away from a royalty model and aggressively targeting a direct distribution
strategy.
Since 2006, we have changed our emphasis away from one-time, generally non-recurring research and
grant revenue to direct distribution of Clearant Process® sterile implants
and obtaining license and Sterilization Service customers. We expect to continue this strategy and
expect contract research and grant revenue to decrease. We expect these direct distribution,
license and sterilization revenue to be more characteristic of recurring revenue.
Cost of Revenues
Our total cost of revenues decreased by $85,000, or 30% to $204,000 for the three months ended June
30, 2009, from $289,000 for the three months ended June 30, 2008. This decrease is primarily
related to the decrease in direct distribution revenue for the three months ended June 30, 2009. We
expect that the costs associated with the direct distribution and sterilization services to
increase or decrease in conjunction with the revenue increases or decreases.
Sales, General and Administrative Expenses
Sales, general and administrative expenses decreased by $3,000 or 1%, to $687,000 for the three
months ended June 30, 2009, from $690,000 for the three months ended June 30, 2008.
The $3,000 decrease in sales, general and administrative expenses for the three months ended June
30, 2009, from the three months ended June 30, 2008, is consistent with our overall reduction in
expenses. Future sales and marketing expense increases or decreases will be affected by the
revenue, effort and timing required to provide Clearant Process® sterile
implants to the marketplace.
We incurred $115,000 in non-cash stock-based compensation expense for the three months ended June
30, 2009 compared to $136,000 for the three months ended June 30, 2008. The decrease primarily
relates to the resignation of two of our directors at the end of 2008.
13
Research and Development Expenses
Research and development expenses decreased 100% to $0 for the three months ended June 30, 2009,
from $2,000 for the three months ended June 30, 2008. This decrease was largely a result of reduced
research and development costs associated with the reduction of our research and development
personnel and related expenses. This was accomplished due to our shift in focus from research and
development to the commercialization of the Clearant Process®. We expect to
maintain minimal research and development costs in 2009, however we cannot make any assurances that
we will stay ahead of competition at these low levels of expenditures. From time-to-time we may
complement our in-house research and development with universities and third party research and
development consulting firms, which we believe provides a broader expertise in research and
development and allows us to maintain a low research and development headcount.
Other Income/Expense
For the three months ended June 30, 2009, we recognized $51,000 in net interest expense compared to
$3,000 in net interest income for the same three months last year. The increase in net interest
expense is due to interest recorded on the July 2008 related party convertible secured promissory
note. We had $104,000 cash on hand as of June 30, 2009, of which $81,000 was invested in short-term
conservative money market funds.
Six Months Ended June 30, 2009 Compared to Six Months Ended June 30, 2008
Revenues
Our total revenue decreased by $93,000 or 10%, to $876,000 for the six months ended June 30, 2009,
from $969,000 for the six months ended June 30, 2008.
Revenues from direct distribution of both Clearant Process® sterile implants
and non-Clearant Process® implants were $800,000 and $762,000 during the six
months ended June 30, 2009 and 2008, respectively. This is a 5% increase over the quarter ending
June 30, 2008. Direct distribution continues to be our primary strategy of our growth plan.
Revenues from licensing activities decreased 78% to $16,000 for the six months ended June 30, 2009,
from $71,000 for the six months ended June 30, 2008. The decrease is primarily related to the
addition of a new licensing customer in the first quarter of 2008 which triggered a one-time
initiation payment. Additionally revenues from fee for service activities were $48,000 and $36,000
for the six months ended June 30, 2009 and 2008, respectively, as we continued to offer customers
the opportunity to use our Sterilization Service. These figures are consistent with our strategy of
moving away from a royalty model and aggressively targeting a direct distribution strategy. While
we are continuing to service the existing license and fee for service agreements, we are not
actively pursuing new license or fee for service agreements, and it is unlikely that there will be
a near-term material growth in licensing or fee for service revenue.
Revenues from contract research, milestones and grants decreased to $12,000 in the six months ended
June 30, 2009, from $100,000 for the six months ended June 30, 2008. The decrease is primarily
related to the addition of a new licensing customer in the first quarter of 2008 which triggered a
milestone payment.
Since 2006, we have changed our emphasis away from one-time, generally non-recurring research and
grant revenue to direct distribution of Clearant Process® sterile implants
and obtaining license and Sterilization Service customers. We expect to continue this strategy and
expect contract research and grant revenue to decrease. We expect these direct distribution,
license and sterilization revenue to be more characteristic of recurring revenue. In addition, we
expect that the costs associated with the direct distribution and Sterilization Services to
increase in conjunction with the revenue increase.
Cost of Revenues
Our total cost of revenues decreased by $39,000, or 8% to $463,000 for the six months ended June
30, 2009, from $502,000 for the six months ended June 30, 2008. This decrease is primarily related
to the decrease in direct
distribution revenue for the six months ended June 30, 2009. We expect that the costs associated
with the direct distribution and sterilization services to increase or decrease in conjunction with
the revenue increases or decreases.
14
Sales, General and Administrative Expenses
Sales, general and administrative expenses decreased by $144,000 or 10%, to $1,358,000 for the six
months ended June 30, 2009, from $1,502,000 for the six months ended June 30, 2008.
The $144,000 decrease in sales, general and administrative expenses for the six months ended June
30, 2009, from the six months ended June 30, 2008, was principally due to the reduction in overall
expenses including legal fees, accounting fees, board fees, and investor relations. Future sales
and marketing expense increases or decreases will be affected by the revenue, effort and timing
required to provide Clearant Process® sterile implants to the marketplace.
We incurred $230,000 in non-cash stock-based compensation expense for the six months ended June 30,
2009 compared to $273,000 for the six months ended June 30, 2008. The decrease primarily relates to
the resignation of two of our directors at the end of 2008.
Research and Development Expenses
Research and development expenses decreased 100% to $0 for the six months ended June 30, 2009, from
$5,000 for the six months ended June 30, 2008. This decrease was largely a result of reduced
research and development costs associated with the reduction of our research and development
personnel and related expenses. This was accomplished by our shift in focus from research and
development to the commercialization of the Clearant Process®. We expect to
maintain minimal research and development costs in 2009, however we cannot make any assurances that
we will stay ahead of competition at these low levels of expenditures. From time-to-time we may
complement our in-house research and development with universities and third party research and
development consulting firms, which we believe, provides a broader expertise in research and
development and allows us to maintain a low research and development headcount.
Other Income/Expense
For the six months ended June 30, 2009, we recognized $93,000 in net interest expense compared to
$12,000 in net interest income for the same six months last year. The increase in net interest
expense is due to interest recorded on the July 2008 related party convertible secured promissory
note. We had $104,000 cash on hand as of June 30, 2009, of which $81,000 was invested in
short-term conservative money market funds.
Preferred Stock Dividend and Financing Costs
As of June 30, 2009 and 2008, there were 0 shares of preferred stock outstanding and no dividends,
respectively.
Liquidity and Capital Resources
The accompanying financial statements have been prepared on the basis that we will continue as a
going concern. We have incurred significant operating losses and negative cash flows from operating
activities since our inception. As of June 30, 2009, these conditions raised substantial doubt as
to our ability to continue as a going concern. We raised additional capital in 2008 to supplement
our operations including the capital raise that involved the issuance of a related party
convertible secured promissory note which to date has not been funded as agreed. There can be no
assurance that we will be successful in our efforts to generate, increase, or maintain revenue or
raise additional capital on terms acceptable to us or that we will be able to continue as a going
concern. The financial statements do not include any adjustments relating to the recoverability of
the carrying amount of the recorded assets or the amount of liabilities that might result from the
outcome of this uncertainty.
15
We expect to incur operating losses and negative cash flows for the foreseeable future. Our ability
to execute on our current business plan is dependent upon our ability to develop and market our
products, and, ultimately, to generate revenue.
Research and Development
For the coming year we plan to focus on generating revenue through our direct distribution revenue
model and will expend cash to facilitate that process. In the long term, we plan to re-initiate our
research and development spending surrounding blood plasma derivatives and recombinant products.
Direct Distribution Strategy
On November 28, 2006, we entered into a two-year supply agreement with a tissue bank for the supply
of Clearant Process® sports medicine implants. We have agreed to pay a
transfer fee for the sports medicine implants. The agreement shall automatically renew for
successive one-year terms unless either party terminates upon written notice to the other party.
This two-year supply agreement automatically renewed as of November 28, 2008.
On September 27, 2006, we entered into the Osprey Agreement described in Note 8 in the accompanying
footnotes to the financial statements. Under the Osprey Agreement, Osprey granted us exclusive
rights to place current and future Osprey cervical and lumbar allografts treated with the Clearant
Process® in certain geographic territories with an option for additional
geographic territories. In exchange for the exclusive rights under the Osprey Agreement, we were
obligated to pay Osprey $500 as a prepayment for certain ordered products to be delivered after
October 1, 2006. This prepayment was due upon the earlier of the following: (i) within three
business days after we receive debt or equity financing of at least $1 million, or (ii) October 31,
2006. In addition, we were required to make the following quarterly payments to be applied to
payments for ordered products: $650 by October 31, 2006; $750 by January 1, 2007; $850 by April 1,
2007; $1 million by July 1, 2007; $1.2 million by October 1, 2007; $1.3 million by January 1, 2008;
$1.5 million by April 1, 2008; and $1.75 million by July 1, 2008.
As of June 30, 2009, all tissue orders had not been delivered by Osprey and we have not made the
prepayments. In February 2007, we received notice from Osprey of its termination of the Osprey
Agreement, effective within thirty days from receipt of the notification if we did not timely cure
certain alleged payment defaults. The termination of the Osprey Agreement has resulted in the
discontinuation or disruption of the spinal bone implant supply, which has had a material adverse
impact on our ability to distribute spinal bone implants treated with the Clearant
Process®. In addition, the lack of supply of the ordered products has had a
material impact on our revenues and cash flows.
Our operating plan, this acquisition of inventory, higher levels of historic accounts receivable
and the related sales and marketing costs associated with the direct distribution strategy have had
an impact on our cash requirements, and have created the need for additional financing.
Limited Cash Availability
Net cash used in operating activities was $501,000 for the six months ended June 30, 2009, compared
to $661,000 for the six months ended June 30, 2008. During the six months ended June 30, 2009, cash
used in operations resulted from a $152,000 increase in accrued liabilities due to the financing of
insurance as well as the accrual of interest on the July 2008 related party convertible secured
promissory note. Non-cash adjustments to operating activities for the six months ended June 30,
2009, included depreciation and amortization expense of $41,000 and a non-cash charge of $230,000
for stock-based compensation.
Our net cash used in investing activities was $37,000 for the six months ended June 30, 2009
compared to net cash used of $39,000 for the six months ended June 30, 2008. Our investing
activities consisted primarily of patent-related intellectual property expenses and capital
expenditures.
We have financed our operations since inception primarily through the sale of shares of our stock
and convertible notes. Our net cash provided by financing activities was $377,000 for the six
months ended June 30, 2009, compared to net cash provided by financing activities of $0 for the six
months ended June 30, 2008. Cash provided
by financing activities for the six months ended June 30, 2009 consisted of the net proceeds from
the issuance of a related party convertible secured promissory note in conjunction with the capital
raise in 2008, leaving a balance of $104,000 in cash and cash equivalents at June 30, 2009.
16
Doubt About Our Ability To Continue As Going Concern
The accompanying financial statements have been prepared on the basis that we will continue as a
going concern. We have incurred significant operating losses and negative cash flows from operating
activities since our inception. As of December 31, 2008, these conditions raised substantial doubt
as to our ability to continue as a going concern.
In July 2008, we raised additional capital to supplement our operations by entering into a
$2,000,000 related party convertible secured promissory note with CPI Investments, Inc (CPI). As
a result of difficulties in the credit and financial markets, CPI has defaulted on its funding
obligations under the agreement as amended. CPI has represented that they are attempting to remedy
the default, but we have not yet received all of the required funds. The note was scheduled to be
funded, net of fees of approximately $250,000, in the following tranches:
|
|
|
$400,000 due and paid on July 8, 2008; |
|
|
|
$400,000 due on August 22, 2008, of which $252,000 was received on September 5,
2008, and $148,000 was received on October 1, 2008; |
|
|
|
$600,000 due on October 6, 2008, of which $68,000 was received on December 12,
2008, $50,000 was received on January 8, 2009, $155,000 was received on February 26,
2009, $77,000 was received on March 12, 2009, $76,000 was received on May 4, 2009, and
$60,000 was received on May 20, 2009; and |
|
|
|
$600,000 due on February 16, 2009, which has not been received. |
On February 20, 2009, we entered into a 1st amendment with CPI, extending the closing
dates for the amounts due on October 6, 2008 and February 16, 2009, to March 31, 2009 and April 30,
2009, respectively. The 1st amendment extending the closing date for the amounts due on
October 6, 2008 accounts for payments previously made, as discussed above, and requires the
following payments:
|
|
|
$160,000 due on February 20, 2009, of which we received $155,000 on February 26,
2009 and $5,000 on March 12, 2009, |
|
|
|
$100,000 due by March 10, 2009, of which we received $72,000 on March 12, 2009
and $28,000 on May 4, 2009; and |
|
|
|
$222,000 due before March 31, 2009, of which we received $48,000 on May 4, 2009
and $60,000 on May 20, 2009. |
The 1st amendment also gives us the option to extend the initial maturity date of each
promissory note to January 8, 2012. On August 3, 2009, we entered into a 2nd amendment
to the CPI Agreement. The 2nd amendment extends the closing dates for the amounts due
on March 31, 2009 and April 30, 2009 to July 15, 2009 and October 17, 2009, respectively. The
2nd amendment extending the closing date for the amounts due on March 31, 2009 accounts
for payments previously made, as discussed above, and requires the following payment:
|
|
|
$114,000 on August 3, 2009, of which we received $50,000 on August 5, 2009 |
17
The 2nd amendment extending the closing date amounts due on April 30, 2009 accounts for
payments previously made, as discussed above, and requires the following payment:
|
|
|
$100,000 on August 15, 2009, |
|
|
|
|
$100,000 on August 31, 2009, |
|
|
|
$200,000 on September 30, 2009, and |
|
|
|
$200,000 on October 31, 2009. |
The 2nd amendment also gives us the option to extend the initial maturity date of each
promissory note to three years from the closing date of funding of the final tranche.
There can be no assurance that we will receive any of the remaining amounts due on the convertible
secured promissory note. CPIs repeated and ongoing defaults under the original and amended
agreements have negatively impacted our financial position. If CPI fails to promptly fund the
remaining amounts due under the amended agreement, we may be forced to seek necessary funds from
any available sources, on terms which may be unfavorable or highly dilutive to our existing
stakeholders.
Regardless of whether we receive the full amount of the remaining amounts, we will still require
and continue to seek additional capital to fund our ongoing operations. There can be no assurance
that we will be successful in our efforts to generate, increase, or maintain revenue or raise
additional capital on terms acceptable to us or that we will be able to continue as a going
concern. The financial statements do not include any adjustments relating to the recoverability of
the carrying amount of the recorded assets or the amount of liabilities that might result from the
outcome of this uncertainty.
We have incurred significant operating losses and negative cash flows from operating activities,
and have limited available cash, which raises substantial doubt about our ability to continue as a
going concern. Our ability to continue as a going concern is dependent upon our ability to obtain
additional equity or debt financing, reduce expenditures, attain further operating efficiencies,
and, ultimately, to generate greater revenue.
Options for raising capital include issuing common stock, preferred stock, convertible stock,
warrants, or a combination of these equity securities. Equity financing may be supplemented with
additional debt financing for inventory, accounts receivable and working capital. We may also seek
to explore additional methods of raising funds, including joint ventures, licensing and other
arrangements.
We may not be successful in obtaining financing, and if funding is obtained it may be on terms
considered unfavorable to us, CPI or our existing shareholders. The inability or failure to raise
capital before our available cash is depleted will have a material adverse effect on our business
and may result in bankruptcy or discontinuation of operations.
As of June 30, 2009, we had cash on-hand of $104,000. Our ability to have sufficient capital
through the end of 2009 is dependent on successful settlement of vendor claims, and we will need to
raise additional capital prior to the end of 2009. Failure to raise additional capital and to reach
settlements with these vendors could result in the discontinuation of operations. Also, changes in
our business strategy, technology development or marketing plans or other events affecting our
operating plans and expenses may result in the expenditure of existing cash before that time. If
this occurs, our ability to meet our cash obligations as they become due and payable will depend on
our ability to sell securities, borrow funds or some combination thereof. We may not be successful
in raising necessary funds on acceptable terms, or at all.
18
Contractual Obligations and Commercial Commitments
We lease facilities and equipment under noncancelable operating leases with various expirations
through 2010. The future minimum lease payments under these leases and other contractual
obligations as of June 30, 2009 are as follows ($ in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due By Period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
More than 5 |
|
Contractual Obligations |
|
Total |
|
|
1 Year |
|
|
1-3 Years |
|
|
3-5 Years |
|
|
Years |
|
Operating Lease Obligations |
|
$ |
81 |
|
|
$ |
77 |
|
|
$ |
4 |
|
|
$ |
|
|
|
$ |
|
|
The forward-looking comments contained in the above discussion involve risks and uncertainties. Our
actual results may differ materially from those discussed here due to factors such as, among
others, limited operating history, difficulty in developing, exploiting and protecting proprietary
technologies, intense competition and substantial regulation in the healthcare industry. Additional
factors that could cause or contribute to such differences can be found under the Risk Factors
section in our Form 10-K.
Off-Balance Sheet Arrangements
Except for operating lease commitments, as of June 30, 2009, we had no off-balance sheet
arrangements.
Critical Accounting Policies and Estimates
The discussion and analysis of our financial condition and results of operations is based upon our
financial statements, which have been prepared in accordance with U.S. generally accepted
accounting principles . Generally accepted accounting principles require management to make
estimates, judgments and assumptions that affect the reported amounts of assets, liabilities,
revenues and expenses, and the disclosure of contingent assets and liabilities. We base our
estimates on experience and on various other assumptions that we believe to be reasonable under the
circumstances, the results of which form the basis for making judgments about the carrying values
of assets and liabilities that may not be readily apparent from other sources. Our actual results
may differ from those estimates.
We consider our critical accounting policies to be those that involve significant uncertainties,
require judgments or estimates that are more difficult for management to determine or that may
produce materially different results when using different assumptions. We consider the following
accounting policies to be critical:
Revenue Recognition and Deferred Revenue
We recognize revenue in accordance with the provisions of SAB No. 104, Revenue Recognition. Our
revenue sources are direct distribution of Clearant Process® sterile
implants, and licensing fees and Sterilization Services to customers who incorporate the Clearant
Process® technology into their product and manufacturing processes, which may
include performance milestones and contract research activities. We recognize direct distribution
revenue upon the sourcing of tissue by a customer. Licensing revenue is recognized when a customer
distributes products incorporating the Clearant Process® and revenue related
to the Sterilization Service is recognized when the service is substantially complete. We recognize
revenue related to performance milestones and contract research in accordance with Statement of
Positions (SOP) 81-1, Accounting for Performance of Construction-Type and Certain Production-Type
Contracts. Revenue related to a performance milestone is recognized upon customer acceptance of the
achievement of that milestone, as defined in the respective agreements. Revenue related to contract
research activities is recognized on a percentage-of-completion basis. In the event cash is
received in advance of service performed, we will defer the related revenue recognition until the
underlying performance milestone is achieved and or the contract research activities commence. In
the event advance cash payments are not attributable to any performance milestone and or contract
research activity, we will recognize the underlying amounts into revenue on a straight-line basis
over the term of the underlying agreement. We include shipping charges in the gross invoice price
to customers and classify the total amount as revenue in accordance with EITF 00-10, Accounting for
Shipping and Handling Fees and Costs. Shipping costs are recorded as cost of revenues. We evaluate
the collectability of accounts receivables and provide a reserve for credit losses, as appropriate.
As of June 30, 2009 and December 31, 2008, we reserved for credit losses of $81,000 and $91,000,
respectively.
19
Cost of Revenues
Cost of revenues consists of costs associated with direct distribution of Clearant
Process® sterile implants to a customer and with providing Sterilization
Services to customers. We had no inventory reserve recorded as cost of revenue during the three or
six months ended June 30, 2009 and 2008, respectively.
Inventory and Inventory Related Prepayments
Inventory is primarily comprised of implantable donor tissue treated with the Clearant
Process® and is valued at the lower of cost or market with cost determined
using the first-in, first-out method. Inventory is located at contracted tissue banks and on
consignment in hospitals. Inventory may be written down from time to time based on market
conditions or other factors. As of June 30, 2009 and December 31, 2008, we had an inventory and
inventory related prepayment reserve of $1,307,000 and $1,315,000, respectively.
In accordance with the terms of the Osprey Agreement (see Note 8 in the accompanying footnotes to
the financial statements), we are required to make prepayments. Upon receipt of the inventory, as
provided under the Osprey Agreement, the prepayments will be reclassified as inventory until
distributed.
Identifiable Intangibles
Certain costs associated with obtaining and licensing patents and trademarks are capitalized as
incurred and are amortized on a straight-line basis over the shorter of their estimated useful
lives or their legal lives of 17 to 20 years. Amortization of such costs begins once the patent or
trademark has been issued. We evaluate the recoverability of our patent costs and trademarks
quarterly based on estimated undiscounted future cash flows.
Research and Development Costs
Research and development costs are expensed as incurred.
Income Taxes
Income taxes are accounted for under SFAS 109, Accounting for Income Taxes, using the liability
method. Under SFAS 109, deferred tax assets and liabilities are determined based on differences
between financial reporting and tax basis of assets and liabilities, and are measured using the
enacted tax rates and laws that are expected to be in effect when the differences reverse.
Valuation allowances are established when necessary to reduce deferred tax assets to the amounts
expected to be realized.
We adopted the provisions of FASB Interpretation No. 48, Accounting for Uncertainty in Income Taxes
(FIN 48), on January 1, 2007. FIN 48 prescribes a recognition threshold and measurement attribute
for the financial statement recognition and measurement of a tax position taken or expected to be
taken in a tax return. FIN 48 also provides guidance on derecognition, classification, interest and
penalties, accounting in interim periods, disclosure, and transition. Due to the fact that we have
substantial net operating loss carryforwards, adoption of FIN 48 had no impact on our beginning
retained earnings, balance sheets, or statements of operations.
Stock-Based Compensation
Stock-based compensation expense is recognized under SFAS No. 123(R), Share Based Payment, which
requires the measurement and recognition of compensation expense for all share-based payment awards
to employees and directors based on estimated fair value. Stock-based compensation expense for
employees and directors for the three and six months ended June 30, 2009 were $115,000 and
$230,000, respectively, and $136,000 and $273,000 for the three and six months ended June 30, 2008,
respectively.
Fair Value of Financial Instruments
Fair
value of financial instruments are accounted for under FSP FAS 107-1
and APB 28-1, which require that the carrying amounts reported in the
balance sheet for financial instruments such as cash, cash
equivalents, accounts receivable, accounts payable and accrued
liabilities to approximate fair value because of the immediate or
short-term maturity of these financial instruments. Debt is estimated
to approximate fair value based upon current market borrowing rates
for loans with similar terms and maturities.
20
Legal Proceedings
From time to time, we may be involved in litigation relating to claims arising out of our
operations in the normal course of business.
Recent Accounting Pronouncements
In May 2009, the FASB issued SFAS No. 165, Subsequent Events (SFAS 165). SFAS No. 165 was issued
in order to establish principles and requirements for reviewing and reporting subsequent events and
requires disclosure of the date through which subsequent events are evaluated and whether the date
corresponds with the time at which the financial statements were available for issue (as defined)
or were issued. SFAS No. 165 is effective for interim reporting periods ending after June 15, 2009.
The adoption of SFAS No. 165 did not have a material impact on our financial position, results of
operations, and cash flows.
In June 2009, the FASB issued SFAS No. 168, The FASB Accounting Standards Codification and the
Hierarchy of Generally Accepted Accounting Principles (SFAS 168). SFAS 168 establishes the FASB
Accounting Standards Codification (Codification) as the single source of authoritative GAAP to be
applied by nongovernmental entities, except for the rules and interpretive releases of the SEC
under authority of federal securities laws, which are sources of authoritative GAAP for SEC
registrants. All guidance contained in the Codification carry equal level of authority. The
Codification does not change GAAP. SFAS 168 is effective for interim and annual periods ending on
or after September 15, 2009. The adoption of SFAS 168 is not expected to have any impact on our
results of operations and financial position.
ITEM 3. Quantitative and Qualitative Disclosures about Market Risk
Historically, we have invested our cash in short term commercial paper, certificates of deposit,
money market accounts and marketable securities. We consider any liquid investment with an original
maturity of three months or less when purchased to be cash equivalents. We adhere to an investment
policy which requires that all investments be investment grade quality and no more than ten percent
of our portfolio may be invested in any one security or with one institution.
ITEM 4. Controls and Procedures
We have evaluated, with the participation of our Chief Executive Officer and Chief Financial
Officer, the effectiveness of our system of disclosure controls and procedures as of the end of the
period covered by this report. Based on this evaluation our Chief Executive Officer and Chief
Financial Officer has determined that our disclosure controls and procedures are effective as of
the end of the period covered in this Quarterly Report on Form 10-Q (as defined in Rule 13(a)-15(e)
under the Exchange Act). There has been no change in our internal control over financial reporting
during our most recent fiscal quarter that has materially affected, or is reasonably likely to
materially affect, our internal control over financial reporting.
21
PART II OTHER INFORMATION
ITEM 6. Exhibits
|
|
|
Exhibit 3.1
|
|
Amended and Restated Certificate of Incorporation Clearant,
Inc., a Delaware corporation, incorporated by reference to
Exhibit 3.1 on our Current Report on Form 10-KSB filed with
the SEC on April 1, 2008. |
|
|
|
Exhibit 3.2
|
|
Bylaws of Clearant, Inc., A Delaware corporation,
incorporated by reference to our Proxy Statement on Form
DEF14A for our annual meeting of stockholders held on June
30, 2005, filed with the SEC on April 4, 2005. |
|
|
|
Exhibit 4.1
|
|
Specimen Common Stock Certificate, incorporated by reference
to Exhibit 4.2 on our Registration Statement on Form S-3,
filed with the SEC on November 23, 2005. |
|
|
|
Exhibit 10.1
|
|
Amendment No. 2 to Subscription and Purchase Agreement dated
August 3, 2009, by and between Clearant, Inc. and CPI
Investments, Inc., incorporated by reference to Exhibit 10.1
on our Current Report on Form 8-K filed with the SEC on
August 12, 2009. |
|
|
|
Exhibit 10.2
|
|
Exhibit A to Amendment No. 2 to Subscription and Purchase
Agreement, dated July 24, 2009, incorporated by reference to
Exhibit 10.2 on our Current Report on Form 8-K filed with the
SEC on August 12, 2009. |
|
|
|
Exhibit 31.1
|
|
Certification of Chief Executive Officer and Chief Financial
Officer pursuant to Section 302 of the Sarbanes-Oxley Act of
2002. |
|
|
|
Exhibit 32.1
|
|
Certification of Chief Executive Officer and Chief Financial
Officer pursuant to Section 906 of the Sarbanes-Oxley Act of
2002. |
22
CAUTIONARY STATEMENT CONCERNING FORWARD-LOOKING INFORMATION
This report contains forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995 with respect to the financial condition, results of operations,
business strategies, operating efficiencies or synergies, competitive positions, growth
opportunities for existing products, plans and objectives of management, markets for stock of
Clearant, Inc. and other matters. Statements in this report that are not historical facts are
forward-looking statements for the purpose of the safe harbor provided by Section 21E of the
Exchange Act and Section 27A of the Securities Act. Such forward-looking statements, including,
without limitation, those relating to the future business prospects, revenues and income of
Clearant, Inc., wherever they occur, are necessarily estimates reflecting the best judgment of the
senior management of Clearant, Inc. on the date on which they were made, or if no date is stated,
as of the date of this report. These forward-looking statements are subject to risks, uncertainties
and assumptions, including those described in the Risk Factors in our Form 10-K for the fiscal
year ended December 31, 2008, filed with the SEC on March 24, 2009 (the Form 10-K), that may
affect the operations, performance, development and results of our business. Because the factors
discussed in our Form 10-K and this report could cause actual results or outcomes to differ
materially from those expressed in any forward-looking statements made by us or on our behalf, you
should not place undue reliance on any such forward-looking statements. New factors emerge from
time to time, and it is not possible for us to predict which factors will arise. In addition, we
cannot assess the impact of each factor on our business or the extent to which any factor, or
combination of factors, may cause actual results to differ materially from those contained in any
forward-looking statements.
You should understand that the following important factors, in addition to those discussed in the
Risk Factors section of our Form 10-K, could affect our future results and could cause those
results to differ materially from those expressed in such forward-looking statements:
|
|
|
general economic conditions; |
|
|
|
the effectiveness of our planned advertising, marketing and promotional
campaigns; |
|
|
|
physician and patient acceptance of our products and services, including newly
introduced products; |
|
|
|
anticipated trends and conditions in the industry in which we operate, including
regulatory changes; |
|
|
|
our future capital needs and our ability to obtain financing; and |
|
|
|
other risks and uncertainties as may be detailed from time to time in our public
announcements and filings with the SEC. |
Although we believe that our expectations are reasonable, we cannot assure you that our
expectations will prove to be correct. Should any one or more of these risks or uncertainties
materialize, or should any underlying assumptions prove incorrect, actual results may vary
materially from those described in this quarterly report as anticipated, believed, estimated,
expected or intended.
Except to the extent required by law, we undertake no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information, future events or any other
reason. All subsequent forward-looking statements attributable to us or any person acting on our
behalf are expressly qualified in their entirety by the cautionary statements contained or referred
to herein. In light of these risks, uncertainties and assumptions, the forward-looking events
discussed in this report may not occur.
23
SIGNATURES
In accordance with the requirements of the Securities Exchange Act of 1934, the registrant has
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Date: August 14, 2009
|
|
|
|
|
|
By: |
/s/ Jon Garfield
|
|
|
|
Jon Garfield, Chief Executive Officer |
|
|
|
and Chief Financial Officer |
|
|
|
|
|
By: |
/s/ Susan Etzel
|
|
|
|
Susan Etzel, Chief Accounting Officer |
|
24
EXHIBIT INDEX
|
|
|
Exhibit No. |
|
Description |
Exhibit 31.1
|
|
Certification of Chief Executive Officer and Chief Financial
Officer pursuant to Section 302 of the Sarbanes-Oxley Act of
2002. |
|
|
|
Exhibit 32.1
|
|
Certification of Chief Executive Officer and Chief Financial
Officer pursuant to Section 906 of the Sarbanes-Oxley Act of
2002. |
25