PLUS THERAPEUTICS, INC. - Quarter Report: 2009 March (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
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ý
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QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
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For
the quarterly period ended March 31, 2009
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OR
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o
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TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
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For
the transition period
from to
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Commission
file number 0-32501
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CYTORI
THERAPEUTICS, INC.
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(Exact
name of Registrant as Specified in Its
Charter)
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DELAWARE
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33-0827593
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(State
or Other Jurisdiction
of
Incorporation or Organization)
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(I.R.S.
Employer
Identification
No.)
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3020
CALLAN ROAD, SAN DIEGO, CALIFORNIA
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92121
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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: (858)
458-0900
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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 (“the Exchange Act”) 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
ý 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 files).
Yes
o 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. See definition of “large accelerated filer,” “accelerated
filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act (Check
one).
Large
Accelerated Filer o
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Accelerated
Filer ý
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Non-Accelerated
Filer o
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Smaller
reporting company o
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(Do
not check if a smaller reporting company)
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Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
Yes o No ý
As of
April 30, 2009, there were 34,088,915 shares of the registrant’s common stock
outstanding.
CYTORI
THERAPEUTICS, INC.
INDEX
CYTORI THERAPEUTICS, INC.
CONSOLIDATED
CONDENSED BALANCE SHEETS
(UNAUDITED)
As
of
March
31, 2009
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As
of
December
31, 2008
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|||||||
Assets
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||||||||
Current
assets:
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||||||||
Cash
and cash equivalents
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$ | 15,472,000 | $ | 12,611,000 | ||||
Accounts
receivable, net of allowance for doubtful accounts of $272,000 and
$122,000 in 2009 and 2008, respectively
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1,219,000 | 1,308,000 | ||||||
Inventories,
net
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1,851,000 | 2,143,000 | ||||||
Other
current assets
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1,158,000 | 1,163,000 | ||||||
Total
current assets
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19,700,000 | 17,225,000 | ||||||
Property
and equipment, net
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2,278,000 | 2,552,000 | ||||||
Investment
in joint venture
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308,000 | 324,000 | ||||||
Other
assets
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649,000 | 729,000 | ||||||
Intangibles,
net
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801,000 | 857,000 | ||||||
Goodwill
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3,922,000 | 3,922,000 | ||||||
Total
assets
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$ | 27,658,000 | $ | 25,609,000 | ||||
Liabilities
and Stockholders’ Deficit
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||||||||
Current
liabilities:
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||||||||
Accounts
payable and accrued expenses
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$ | 4,395,000 | $ | 5,088,000 | ||||
Current
portion of long-term obligations
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2,497,000 | 2,047,000 | ||||||
Total
current liabilities
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6,892,000 | 7,135,000 | ||||||
Deferred
revenues, related party
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16,474,000 | 16,474,000 | ||||||
Deferred
revenues
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2,464,000 | 2,445,000 | ||||||
Warrant
liability
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677,000 | — | ||||||
Option
liability
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2,270,000 | 2,060,000 | ||||||
Long-term
deferred rent
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84,000 | 168,000 | ||||||
Long-term
obligations, less current portion
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4,520,000 | 5,044,000 | ||||||
Total
liabilities
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33,381,000 | 33,326,000 | ||||||
Commitments
and contingencies
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||||||||
Stockholders’
deficit:
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||||||||
Preferred
stock, $0.001 par value; 5,000,000 shares authorized; -0- shares issued
and outstanding in 2009 and 2008
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— | — | ||||||
Common
stock, $0.001 par value; 95,000,000 shares authorized; 34,088,915 and
31,176,275 shares issued and 34,088,915 and 29,303,441 shares outstanding
in 2009 and 2008, respectively
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34,000 | 31,000 | ||||||
Additional
paid-in capital
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159,629,000 | 161,214,000 | ||||||
Accumulated
deficit
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(165,386,000 | ) | (162,168,000 | ) | ||||
Treasury
stock, at cost
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— | (6,794,000 | ) | |||||
Total
stockholders’ deficit
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(5,723,000 | ) | (7,717,000 | ) | ||||
Total
liabilities and stockholders’ deficit
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$ | 27,658,000 | $ | 25,609,000 |
SEE NOTES
TO UNAUDITED CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
3
CYTORI THERAPEUTICS, INC.
CONSOLIDATED
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
For
the Three Months Ended March 31,
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||||||||
2009
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2008
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|||||||
Product
revenues:
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||||||||
Related
party
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$ | 564,000 | $ | — | ||||
Third
party
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1,348,000 | 153,000 | ||||||
1,912,000 | 153,000 | |||||||
Cost
of product revenues
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1,087,000 | 60,000 | ||||||
Gross
profit
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825,000 | 93,000 | ||||||
Development
revenues:
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Development,
related party
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— | 774,000 | ||||||
Research
grants and other
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8,000 | 37,000 | ||||||
8,000 | 811,000 | |||||||
Operating
expenses:
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Research
and development
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3,468,000 | 4,963,000 | ||||||
Sales
and marketing
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1,286,000 | 958,000 | ||||||
General
and administrative
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2,494,000 | 3,111,000 | ||||||
Change
in fair value of warrants
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(1,021,000 | ) | — | |||||
Change
in fair value of option liability
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210,000 | 200,000 | ||||||
Total
operating expenses
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6,437,000 | 9,232,000 | ||||||
Operating
loss
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(5,604,000 | ) | (8,328,000 | ) | ||||
Other
income (expense):
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Interest
income
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14,000 | 76,000 | ||||||
Interest
expense
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(400,000 | ) | (23,000 | ) | ||||
Other
income (expense), net
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(92,000 | ) | 11,000 | |||||
Equity
loss from investment in joint venture
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(16,000 | ) | (9,000 | ) | ||||
Total
other income (expense), net
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(494,000 | ) | 55,000 | |||||
Net
loss
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$ | (6,098,000 | ) | $ | (8,273,000 | ) | ||
Basic
and diluted net loss per share
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$ | (0.20 | ) | $ | (0.34 | ) | ||
Basic
and diluted weighted average common shares
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30,266,169 | 24,442,655 |
SEE NOTES
TO UNAUDITED CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
4
CYTORI THERAPEUTICS, INC.
CONSOLIDATED
CONDENSED STATEMENTS OF CASH FLOWS
(UNAUDITED)
For
the Three Months Ended March 31,
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||||||||
2009
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2008
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Cash
flows from operating activities:
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Net
loss
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$ | (6,098,000 | ) | $ | (8,273,000 | ) | ||
Adjustments
to reconcile net loss to net cash used in operating
activities:
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Depreciation
and amortization
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346,000 | 392,000 | ||||||
Amortization
of deferred financing costs and debt discount
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199,000 | — | ||||||
Warranty
provision
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(11,000 | ) | (11,000 | ) | ||||
Provision
for doubtful accounts
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150,000 | 7,000 | ||||||
Change
in fair value of warrants
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(1,021,000 | ) | — | |||||
Change
in fair value of option liability
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210,000 | 200,000 | ||||||
Share-based
compensation expense
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643,000 | 554,000 | ||||||
Equity
loss from investment in joint venture
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16,000 | 9,000 | ||||||
Increases
(decreases) in cash caused by changes in operating assets and
liabilities:
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Accounts
receivable
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(61,000 | ) | (144,000 | ) | ||||
Inventories
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292,000 | (360,000 | ) | |||||
Other
current assets
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(18,000 | ) | (18,000 | ) | ||||
Other
assets
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26,000 | (39,000 | ) | |||||
Accounts
payable and accrued expenses
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(682,000 | ) | (631,000 | ) | ||||
Deferred
revenues, related party
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— | (774,000 | ) | |||||
Deferred
revenues
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19,000 | — | ||||||
Long-term
deferred rent
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(84,000 | ) | (74,000 | ) | ||||
Net
cash used in operating activities
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(6,074,000 | ) | (9,162,000 | ) | ||||
Cash
flows from investing activities:
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||||||||
Proceeds
from sale and maturity of short-term investments
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— | 2,239,000 | ||||||
Purchases
of short-term investments
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— | (2,239,000 | ) | |||||
Purchases
of property and equipment
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(9,000 | ) | (175,000 | ) | ||||
Net
cash used in investing activities
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(9,000 | ) | (175,000 | ) | ||||
Cash
flows from financing activities:
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||||||||
Principal
payments on long-term obligations
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(203,000 | ) | (173,000 | ) | ||||
Proceeds
from exercise of employee stock options
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3,000 | 55,000 | ||||||
Proceeds
from sale of common stock
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6,086,000 | 6,000,000 | ||||||
Costs
related to sale of common stock
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(875,000 | ) | — | |||||
Proceeds
from sale of treasury stock
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3,933,000 | — | ||||||
Net
cash provided by financing activities
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8,944,000 | 5,882,000 | ||||||
Net
increase (decrease) in cash and cash equivalents
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2,861,000 | (3,455,000 | ) | |||||
Cash
and cash equivalents at beginning of period
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12,611,000 | 11,465,000 | ||||||
Cash
and cash equivalents at end of period
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$ | 15,472,000 | $ | 8,010,000 | ||||
Supplemental
disclosure of cash flow information:
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Cash
paid during period for:
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||||||||
Interest
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$ | 205,000 | $ | 24,000 | ||||
SEE NOTES
TO UNAUDITED CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
5
CYTORI THERAPEUTICS, INC.
NOTES
TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
March
31, 2009
(UNAUDITED)
1.
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Basis
of Presentation
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Our
accompanying unaudited consolidated condensed financial statements as of March
31, 2009 and for the three months ended March 31, 2009 and 2008 have been
prepared in accordance with accounting principles generally accepted in the
United States of America for interim financial
information. Accordingly, they do not include all of the information
and footnotes required by accounting principles generally accepted in the United
States of America for annual financial statements. Our consolidated
condensed balance sheet at December 31, 2008 has been derived from the audited
financial statements at that date, but does not include all of the information
and footnotes required by accounting principles generally accepted in the United
States of America for complete financial statements. In the opinion
of management, all adjustments (consisting of normal recurring adjustments)
considered necessary for a fair presentation of the financial position and
results of operations of Cytori Therapeutics, Inc., and our subsidiaries (the
Company) have been included. Operating results for the three months
ended March 31, 2009 are not necessarily indicative of the results that may be
expected for the year ending December 31, 2009. These financial
statements should be read in conjunction with the consolidated financial
statements and notes therein included in our annual report on Form 10-K for the
year ended December 31, 2008.
2.
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Use
of Estimates
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The
preparation of consolidated condensed financial statements in conformity with
accounting principles generally accepted in the United States of America
requires management to make estimates and assumptions affecting the reported
amounts of assets and liabilities and 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. Our most
significant estimates and critical accounting policies involve recognizing
revenue, evaluating goodwill for impairment, valuing warrants, valuing our put
option arrangement with Olympus Corporation (Put option) (see notes 13 and 14),
determining the assumptions used in measuring share-based compensation expense,
valuing our deferred tax assets, assessing how to report our investment in
Olympus-Cytori, Inc., estimating our allowance for doubtful accounts and
valuation of inventory.
Actual
results could differ from these estimates. Current economic
conditions, including illiquid credit markets and volatile equity markets,
contribute to the inherent uncertainty of such
estimates. Management’s estimates and assumptions are reviewed
periodically, and the effects of revisions are reflected in the consolidated
condensed financial statements in the periods they are determined to be
necessary.
3.
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Liquidity
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We
incurred losses of $6,098,000 and $8,273,000 for the three months ended March
31, 2009 and 2008, respectively. We have an accumulated deficit of
$165,386,000 as of March 31, 2009. Additionally, we have used net cash of
$6,074,000 and $9,162,000 to fund our operating activities for three months
ended March 31, 2009 and 2008, respectively. To date these
operating losses have been funded primarily from outside sources of invested
capital.
During
2008, we initiated our commercialization activities while simultaneously
pursuing available financing sources to support operations and
growth. We have had, and continue to have, an ongoing need to raise
additional cash from outside sources to fund our operations. However,
our ability to raise capital has been adversely affected by current credit
conditions and the downturn in the financial markets and the global
economy. Accordingly, the combination of these facts raises
substantial doubt as to the Company’s ability to continue as a going
concern. The accompanying consolidated condensed financial statements
have been prepared assuming that the Company will continue as a going
concern. If we are unsuccessful in our efforts to raise outside
capital in the near term, we will be required to further reduce our research,
development, and administrative operations, including reduction of our employee
base, in order to offset the lack of available funding.
We are
pursuing financing opportunities in both the private and public debt and equity
markets as well as through strategic corporate partnerships. We have an
established history of raising capital through these platforms, and we are
currently involved in negotiations with multiple parties. In August 2008,
we raised approximately $17,000,000 in gross proceeds from a private placement
of 2,825,517 unregistered shares of common stock and 1,412,758 common stock
warrants (with an original exercise price of $8.50 per share) to a syndicate of
investors including Olympus Corporation, who acquired 1,000,000 unregistered
shares and 500,000 common stock warrants in exchange for $6,000,000 of the total
proceeds raised. In October 2008, we entered into a secured Loan
Agreement with General Electric Capital Corporation and Silicon Valley Bank
(“Lenders”) to borrow up to
6
$15,000,000. An
initial term loan of $7,500,000, less fees and expenses, was funded on October
14, 2008. We could not access the remaining $7,500,000 under this
facility as we were not able to meet certain financial prerequisites that had
been established by the Lenders. In March 2009, we raised
approximately $10,000,000 in gross proceeds from the sale to institutional
investors of a total of 4,771,174 shares of our common stock (the “Shares”) and
warrants to purchase up to a total of 6,679,644 additional shares of our common
stock (the “Warrants”) at a purchase price of $2.10 per unit, with each unit
consisting of one (1) Share and one and four-tenths (1.4) Warrants (with an
exercise price of $2.59 per share).
We expect
to continue to utilize our cash and cash equivalents to fund operations through
the next nine months, subject to minimum cash and cash liquidity requirements of
the Loan and Security Agreement with the Lenders, which requires that we
maintain at least three months of cash on hand to avoid an event of default
under the Loan and Security Agreement. We continue to seek additional
cash through product revenues, strategic collaborations, and future sales of
equity or debt securities. Although there can be no assurance given, we
hope to successfully complete one or more additional financing transactions or
corporate partnerships in the near-term. Without this additional capital,
current working capital, cash generated from sales and containment of costs will
not provide adequate funding for operations at their current levels. If such
efforts are not successful, we will need to further reduce or curtail operations
and this could negatively affect our ability to achieve corporate growth goals.
We have implemented an operating plan that reduces certain operations to
focus almost entirely on the supply of current products to existing or new
distribution channels. In addition, as part of this plan, there will be
minimal expenditures for ongoing scientific research, product development or
clinical research. This impacts research and development headcount,
external subcontractor expenditures, capital outlay and general and
administrative expenditures related to the supervision of such
activities. In parallel, we significantly reduced administrative
staff and salaries consistent with the overall reduction in scope of
operations. In aggregate, such reductions resulted in eliminations of
roles for the many of the Company’s current staff (our overall headcount
decreased to 85 employees as of March 31, 2009 as compared to 126 employees as
of December 31, 2008) and the deferral or elimination of most research and
development projects until such time that cash resources are available from
operations or outside sources to re-establish development and growth
plans. Management is currently reviewing contractual obligations related
to the pre-clinical and clinical commitments along with minimum purchase
requirements to include deferral of such commitments as part of this
plan.
4.
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Short-Term
Investments
|
We invest
excess cash in money market funds, highly liquid debt instruments of financial
institutions and corporations with strong credit ratings, and in United States
government obligations. We have established guidelines relative to
diversification and maturities that maintain safety and liquidity. These
guidelines are periodically reviewed and modified to take advantage of trends in
yields and interest rates. After considering current market
conditions, and in order to minimize our risk, management has elected to invest
all excess funds in money market funds and other highly liquid investments that
are appropriately classified as cash equivalents as of March 31, 2009 and
December 31, 2008.
5.
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Warrant
Liability
|
Effective
January 1, 2009 we adopted the provisions of Emerging Issues Task Force (“EITF”)
Issue No. 07-5, “Determining Whether an Instrument (or Embedded Feature) Is
Indexed to an Entity’s Own Stock” (“EITF 07-5”). EITF 07-5 applies to any
freestanding financial instruments or embedded features that have the
characteristics of a derivative, as defined by SFAS No. 133, “Accounting for
Derivative Instruments and Hedging Activities,” and to any freestanding
financial instruments that are potentially settled in an entity’s own common
stock. As a result of adopting EITF 07-5, original amount of 1,412,758 of our
issued and outstanding common stock purchase warrants previously classified as a
component of stockholders’ deficit are now presented as a liability. These
warrants had an original exercise price of $8.50 and expire in August 2013 (see
note 15 for warrant adjustments). As such, effective January 1, 2009
we reclassified the fair value of these common stock purchase warrants, which
have exercise price reset features, from equity to liability status as if these
warrants were treated as a derivative liability since their date of issue in
August 2008. On January 1, 2009, we reclassified from additional paid-in
capital, as a cumulative effect adjustment, $2.9 million to beginning
accumulated deficit and $1.7 million to a long-term warrant liability to
recognize the fair value of such warrants on such date. The fair value of these
common stock purchase warrants declined to $677,000 as of March 31, 2009. As
such, we recognized a $1.0 million gain from the change in fair value of these
warrants for the three months ended March 31, 2009.
These
common stock purchase warrants were initially issued in connection with our
August 2008 private placement of 2,825,517 unregistered shares of common stock
and 1,412,758 common stock warrants. The common stock purchase warrants were not
issued with the intent of effectively hedging any future cash flow, fair value
of any asset, liability or any net investment in a foreign operation. The
warrants do not qualify for hedge accounting, and as such, all future changes in
the fair value of these warrants will be recognized currently in earnings until
such time as the warrants are exercised or expire. These common stock purchase
warrants do not trade in an active securities market, and as such, we estimate
the fair value of these warrants using the Black-Scholes option pricing model
using the following assumptions:
7
As
of
March
31, 2009
|
As
of
December
31, 2008
|
|||||||
Expected
term
|
4.36
years
|
4.61
years
|
||||||
Common
stock market price
|
$ | 1.72 | $ | 3.61 | ||||
Risk-free
interest rate
|
1.67 | % | 1.55 | % | ||||
Expected
volatility
|
70.05 | % | 65.71 | % | ||||
Resulting
fair value (per warrant)
|
$ | 0.40 | $ | 1.20 |
Expected
volatility is based primarily on historical volatility. Historical volatility
was computed using daily pricing observations for recent periods that correspond
to the expected term of the warrants. We believe this method produces an
estimate that is representative of our expectations of future volatility over
the expected term of these warrants. We currently have no reason to believe
future volatility over the expected remaining life of these warrants is likely
to differ materially from historical volatility. The expected life is based on
the remaining term of the warrants. The risk-free interest rate is based on
five-year U.S. Treasury securities.
See note
14 for further discussion of fair value for these warrants.
6.
|
Revenue
Recognition
|
Product
Sales
We
recognize revenue from product sales when the following fundamental criteria are
met: (i) persuasive evidence of an arrangement exists, (ii) delivery has
occurred, (iii) the price to the customer is fixed or determinable and (iv)
collection of the resulting accounts receivable is reasonably
assured.
For all
sales, we use a binding purchase order or a signed agreement as evidence of an
arrangement. Revenue for these product sales will be recognized upon
delivery to the customer, as all risks and rewards of ownership have been
substantively transferred to the customer at that point. For
Celution® 800/CRS
System sales to customers who arrange for and manage the shipping process, we
recognize revenue upon shipment from our facilities. Shipping and
handling costs that are billed to our customers are classified as revenue, in
accordance with Emerging Issues Task Force (EITF) Issue No. 00-10, “Accounting
for Shipping and Handling Fees and Costs” (“EITF 00-10”). The
customer’s obligation to pay and the payment terms are set at the time of
delivery and are not dependent on the subsequent use or resale of our
product.
For those
sales that include multiple deliverables, we allocate revenue based on the
relative fair values of the individual components as determined in accordance
with EITF Issue No. 00-21, “Revenue Arrangements with Multiple Deliverables”
(“EITF 00-21”). When more than one element such as product
maintenance or technical support services are included in an arrangement, we
allocate revenue between the elements based on each element’s relative fair
value, provided that each element meets the criteria for treatment as a separate
unit of accounting. An item is considered a separate unit of
accounting if it has value to the customer on a standalone basis and there is
objective and reliable evidence of the fair value of the undelivered
items. Fair value is generally determined based upon the price
charged when the element is sold separately. In the absence of fair
value for a delivered element, we allocate revenue first to the fair value of
the undelivered elements and allocate the residual revenue to the delivered
elements. Fair values for undelivered elements are determined based
on vendor-specific objective evidence. Deferred service revenue is
recognized ratably over the period the services are provided. In the
absence of fair value for an undelivered element, the arrangement is accounted
for as a single unit of accounting, resulting in a deferral of revenue
recognition for delivered elements until all undelivered elements have been
fulfilled.
Concentration
of Significant Customers
For the
three months ended March 31, 2009, our sales were concentrated in two
distributors and one direct customer, which in aggregate comprised 72% of our
revenue recognized for the three months ended March 31,
2009. Asia-Pacific region accounted for 65% of our revenue recognized
for the three months ended March 31, 2009. Additionally, one
distributor and one end customer accounted for 70% of total outstanding accounts
receivable as of March 31, 2009. We continuously monitor the
creditworthiness of our distributors and believe our sales to diverse end
customers and to diverse geographies further serve to mitigate our exposure to
credit risk.
Research
and Development
We earn
revenue for performing tasks under research and development agreements with both
commercial enterprises, such as Olympus and Senko, and governmental agencies
like the National Institutes of Health (“NIH”). Revenue earned under
development agreements is classified as either research grant or development
revenues depending on the nature of the arrangement. Revenues derived
from reimbursement of direct out-of-pocket expenses for research costs
associated with grants are presented in compliance with EITF Issue No. 99-19,
“Reporting Revenue Gross as a Principal Versus Net as an Agent,” and
8
EITF
Issue No. 01-14, “Income Statement Characterization of Reimbursements Received
for “Out-of-Pocket” Expenses Incurred.” In accordance with the
criteria established by these EITF Issues, we record grant revenue for the gross
amount of the reimbursement. The costs associated with these
reimbursements are reflected as a component of research and development expense
in our consolidated statements of operations. Additionally, research
and development arrangements we have with commercial enterprises such as Olympus
and Senko are considered a key component of our central and ongoing
operations. Accordingly, when recognized, the inflows from such
arrangements are presented as revenues in our consolidated statements of
operations.
We
received substantial funds from Olympus and Olympus-Cytori, Inc. during 2005 and
2006. We recorded upfront fees totaling $28,311,000 as deferred
revenues, related party. In exchange for these proceeds, we agreed to
(a) provide Olympus-Cytori, Inc. an exclusive and perpetual license to our
therapeutic device technology, including the Celution® System platform and
certain related intellectual property, and (b) provide future development
contributions related to commercializing the Celution® System
platform. The license and development services are not separable
under EITF 00-21. The recognition of this deferred amount requires
achievement of service related milestones, under a proportional performance
methodology. If and as such revenues are recognized, deferred revenue
will be decreased. Proportional performance methodology was elected
due to the nature of our development obligations and efforts in support of the
Joint Venture (“JV”), including product development activities and regulatory
efforts to support the commercialization of the JV products. The application of
this methodology uses the achievement of R&D milestones as outputs of value
to the JV. We received up-front, non-refundable payments in
connection with these development obligations, which we have broken down into
specific R&D milestones that are definable and substantive in nature, and
which will result in value to the JV when achieved. Revenue will be
recognized as the above mentioned R&D milestones are
completed. Of the amounts received and deferred, we recognized
development revenues of $774,000 for the three months ended March 31,
2008. No similar revenue was recognized for the three months ended
March 31, 2009. All related development costs are expensed as
incurred and are included in research and development expense on the statement
of operations.
Under a
Distribution Agreement with Senko, we granted to Senko an exclusive license to
sell and distribute certain Thin Film products in Japan. We have also
earned or will be entitled to earn additional payments under the Distribution
Agreement based on achieving the defined research and development milestones.
There was no development revenue recognized during the three months ended March
31, 2009 and 2008.
7.
|
Inventories
|
|
Inventories
are carried at the lower of cost, which approximates average cost,
determined on the first-in, first-out (FIFO) method, or
market.
|
|
Inventories
consisted of the following:
|
March
31,
|
December
31,
|
|||||||
2009
|
2008
|
|||||||
Raw
materials
|
$ | 967,000 | $ | 712,000 | ||||
Work
in process
|
462,000 | 347,000 | ||||||
Finished
goods
|
422,000 | 1,084,000 | ||||||
$ | 1,851,000 | $ | 2,143,000 |
8.
|
Long-Lived
Assets
|
In
accordance with SFAS No. 144, “Accounting for Impairment or Disposal of
Long-Lived Assets,” we assess certain long-lived assets, such as property and
equipment and intangible assets other than goodwill, for potential impairment
when there is a change in circumstances that indicates carrying values of assets
may not be recoverable. Such long-lived assets are deemed to be
impaired when the undiscounted cash flows expected to be generated by the asset
(or asset group) are less than the asset’s carrying amount. Any
required impairment loss would be measured as the amount by which the asset’s
carrying value exceeds its fair value, and would be recorded as a reduction in
the carrying value of the related asset and a charge to operating
expense. During the three months ended March 31, 2009 and 2008, we
had no impairment losses associated with our long-lived assets.
9.
|
Share-Based
Compensation
|
During
the first quarter of 2009, we made a company-wide option grant to our
non-executive employees to purchase up to 249,250 shares of our common stock,
subject to a four-year graded vesting schedule. The grant date fair value of the
awards was $2.00 per share. Following the reduction of our workforce at
the end of the same quarter, 182,100 of these options remained
outstanding. The resulting share-based compensation expense of $364,200,
net of estimated forfeitures, will be recognized as expense over the employees’
respective service periods.
9
During
the first quarter of 2009, we issued to our officers and directors options to
purchase an aggregate of up to 585,000 shares of our common stock, with
four-year graded vesting for our officers and two-year graded vesting for our
directors. The grant date fair value of the awards granted to our officers and
directors was $2.70 per share. The resulting share-based compensation expense of
$1,579,500, net of estimated forfeitures, will be recognized as expense over the
respective service periods.
During
the first quarter of 2008, we issued to our officers and directors stock options
to purchase an aggregate of up to 450,000 shares of our common stock, with
four-year graded vesting for our officers and two-year graded vesting for our
directors. The grant date fair value of option awards granted to our officers
and directors was $2.73 per share. The resulting share-based compensation
expense of $1,230,000, net of estimated forfeitures, will be recognized as
expense over the respective service periods.
10.
|
Loss
per Share
|
We
compute loss per share based on the provisions of SFAS No. 128, “Earnings per
Share.” Basic per share data is computed by dividing net income or loss
applicable to common stockholders by the weighted average number of common
shares outstanding during the period. Diluted per share data is computed by
dividing net income or loss applicable to common stockholders by the weighted
average number of common shares outstanding during the period increased to
include, if dilutive, the number of additional common shares that would have
been outstanding as calculated using the treasury stock method. Potential common
shares were related entirely to outstanding but unexercised options and warrants
for all periods presented.
On
January 1, 2009, we adopted FSP No. EITF 03-6-1, “Determining Whether
Instruments Granted in Share-Based Payment Transactions Are Participating
Securities,” (FSP EITF 03-6-1). FSP EITF 03-6-1 states that unvested share-based
payment awards that contain nonforfeitable rights to dividends or dividend
equivalents (whether paid or unpaid) are participating securities and shall be
included in the computation of earnings per share pursuant to the two-class
method. The adoption of FSP EITF 03-6-1 did not have a material impact on our
financial statements.
We have
excluded all potentially dilutive securities from the calculation of diluted
loss per share attributable to common stockholders for the three months ended
March 31, 2009 and 2008, as their inclusion would be antidilutive. Potentially
dilutive common shares excluded from the calculations of diluted loss per share
were 16,983,686 and 8,248,870 for the three month periods ended March 31, 2009
and 2008, respectively.
11.
|
Commitments
and Contingencies
|
We have
entered into agreements, which have provisions for cancellation, with various
clinical research organizations for pre-clinical and clinical development
studies. Under the terms of these agreements, the vendors provide a variety of
services including, but not limited to, conducting pre-clinical development
research, recruiting and enrolling patients, monitoring studies, and data
analysis. Payments under these agreements typically include fees for services
and reimbursement of expenses. The timing of payments due under these agreements
is estimated based on current schedules of pre-clinical and clinical studies in
progress. As of March 31, 2009, we have pre-clinical research study
obligations of $281,000 (which are expected to be fully completed within a year)
and clinical research study obligations of $5,500,000 ($2,500,000 of which are
expected to be completed within a year).
We are
subject to various claims and contingencies related to legal
proceedings. Due to their nature, such legal proceedings involve
inherent uncertainties including, but not limited to, court rulings,
negotiations between affected parties, and governmental
actions. Management assesses the probability of loss for such
contingencies and accrues a liability and/or discloses the relevant
circumstances, as appropriate. Management believes that any liability
to us or other remedy that may arise as a result of currently pending legal
proceedings will not have a material adverse effect on our financial condition,
liquidity, or results of operations as a whole.
During
2008, we entered into a supply agreement with minimum purchase requirements
clause. As of March 31, 2009, we have minimum purchase obligations of
$2,125,000 ($1,169,000 of which are to be expected to complete within a
year).
Refer to
note 12 for a discussion of our commitments and contingencies related to our
interactions with the University of California.
Refer to
note 13 for a discussion of our commitments and contingencies related to our
transactions with Olympus, including (a) our obligation to the Joint Venture in
future periods and (b) certain put and call rights embedded in the arrangements
with Olympus.
10
12.
|
License
Agreement
|
On October 16, 2001, StemSource, Inc. entered into an exclusive worldwide license agreement with the Regents of the University of California or UC, licensing all of UC’s rights to certain pending patent applications being prosecuted by UC and (in part) by the University of Pittsburgh, for the life of these patents, with the right of sublicense. The exclusive license relates to an issued patent number 6,777,231, which we refer to as the ‘231 Patent, and various pending applications relating to adipose-derived stem cells. In November 2002, we acquired StemSource, and the license agreement was assigned to us.
The
University of Pittsburgh filed a lawsuit in the fourth quarter of 2004, naming
all of the inventors who had not assigned their ownership interest in the ‘231
Patent to the University of Pittsburgh. It was seeking a
determination that its assignors, rather than UC’s assignors, are the true
inventors of the ‘231 Patent. This lawsuit has subjected us to and
may continue to subject us to significant costs and expenses.
On August
9, 2007, the United States District Court, or the Court, granted the University
of Pittsburgh’s motion for Summary Judgment in part, determining that the
University of Pittsburgh’s assignors were properly named as inventors on the
‘231 Patent, and that all other inventorship issues shall be determined
according to the facts presented at trial. The Court’s decision
terminated UC’s rights to the ‘231 Patent. Upon review of the Court’s
findings, we believe that the Court’s decision was in error. The UC
assignors have agreed to appeal the decision and a Notice of Appeal was filed on
July 9, 2008. If the UC assignors’ appeal of the Court’s decision is
successful, UC’s rights to the ‘231 Patent should be reinstated.
We are
not named as a party to the lawsuit, but our president, Marc Hedrick, is one of
the inventors identified on the ‘231 Patent and therefore is a named individual
defendant. Due to our license obligations to UC relating to the ‘231
Patent and other UC patent applications, we have provided substantial financial
and other assistance to the defense of the lawsuit. Since our current products
and products under development do not practice the ‘231 Patent, our primary
ongoing business activities and product development pipeline should not be
affected by the Court’s decision. Although the ‘231 Patent is unrelated to our
current products and product pipeline, we believe that the ‘231 Patent and/or
the other technology licensed from UC may have long term potential to be useful
for future product developments, and so we have elected to support UC’s legal
efforts in the appeal of the Court’s final order.
During
the three months ended March 31, 2009 and 2008 we expensed $8,000 and $167,000,
respectively, for legal fees related to this license. These expenses
have been classified as general and administrative expense in the accompanying
financial statements. We believe that the amount accrued as of March
31, 2009 of $667,000 is a reasonable estimate of our liability for the expenses
incurred through March 31, 2009.
13.
|
Transactions
with Olympus Corporation
|
Initial
Investment by Olympus Corporation in Cytori
In 2005,
we entered into a common stock purchase agreement with Olympus in which we
received $11,000,000 in cash proceeds. We received an additional
$11,000,000 from Olympus in August 2006 for the issuance of approximately
1,900,000 shares of our common stock at $5.75 per share. We received
an additional $6,000,000 from Olympus in August 2008 for the issuance of
1,000,000 unregistered shares of our common stock at $6.00 per share and 500,000
common stock warrants (with an original exercise price of $8.50 per share, see
note 15) under a private placement offering.
As of
March 31, 2009, Olympus holds approximately 11.77% of our issued and outstanding
shares. Additionally, Olympus has a right to designate a director to
serve on our Board of Directors, which it has not yet exercised, though it has
from time to time utilized an observer to attend Company Board
meetings.
Formation
of the Olympus-Cytori Joint Venture
In 2005,
we entered into a joint venture and other related agreements (the “Joint Venture
Agreements”) with Olympus. The Joint Venture is owned equally by
Olympus and us. We have determined that the Joint Venture is a
variable interest entity or VIE, pursuant to Financial Accounting Standards
Board (FASB) Interpretation No. 46 (revised 2003), “Consolidation of Variable
Interest Entities - an interpretation of ARB No. 51” (“FIN 46R”), but that
Cytori is not the VIE’s primary beneficiary. Accordingly, we have
accounted for our interests in the Joint Venture using the equity method of
accounting, since we can exert significant influence over the Joint Venture’s
operations. At March 31, 2009, the carrying value of our investment
in the Joint Venture is $308,000. We are under no obligation to
provide additional funding to the Joint Venture, but may choose to do
so. We made no cash contributions to the Joint Venture during the
three months ended March 31, 2009 and 2008, respectively.
11
Put/Calls
and Guarantees
The
Shareholders’ Agreement between Cytori and Olympus provides that in certain
specified circumstances of insolvency or if we experience a change in control,
Olympus will have the rights to (i) repurchase our interests in the Joint
Venture at the fair value of such interests or (ii) sell its own interests in
the Joint Venture to Cytori at the higher of (a) $22,000,000 or (b) the Put’s
fair value.
At March
31, 2009 and December 31, 2008, the estimated fair value of the Put was
$2,270,000 and $2,060,000, respectively. Fluctuations in the Put
value are recorded in the consolidated condensed statements of operations as a
component of change in fair value of option liabilities. The estimated fair
value of the Put has been recorded as a long-term liability in the caption
option liability in our consolidated condensed balance sheets.
The
valuations of the Put were completed using an option pricing theory based
simulation analysis (i.e., a Monte Carlo simulation). The valuations
are based on assumptions as of the valuation date with regard to the market
value of Cytori and the estimated fair value of the Joint Venture, the expected
correlation between the values of Cytori and the Joint Venture, the expected
volatility of Cytori and the Joint Venture, the bankruptcy recovery rate for
Cytori, the bankruptcy threshold for Cytori, the probability of a change of
control event for Cytori, and the risk free interest rate.
The
following assumptions were employed in estimating the value of the
Put:
March
31, 2009
|
December
31, 2008
|
|||||||
Expected
volatility of
Cytori
|
70.00 | % | 68.00 | % | ||||
Expected
volatility of the Joint Venture
|
70.00 | % | 68.00 | % | ||||
Bankruptcy
recovery rate for
Cytori
|
21.00 | % | 21.00 | % | ||||
Bankruptcy
threshold for
Cytori
|
$ | 15,711,000 | $ | 16,740,000 | ||||
Probability
of a change of control event for Cytori
|
2.67 | % | 2.80 | % | ||||
Expected
correlation between fair values of Cytori and the Joint Venture in the
future
|
99.00 | % | 99.00 | % | ||||
Risk
free interest
rate
|
2.71 | % | 2.25 | % |
The Put
has no expiration date. Accordingly, we will continue to recognize a
liability for the Put and mark it to market each quarter until it is exercised
or until the arrangements with Olympus are amended.
14.
|
Fair
Value Measurements
|
SFAS 157 emphasizes that fair value is a market-based measurement, not an entity-specific measurement. Therefore, a fair value measurement should be determined based on the assumptions that market participants would use in pricing the asset or liability. SFAS 157 establishes a three-level hierarchy to prioritize the inputs used in the valuation techniques to derive fair values. The basis for fair value measurements for each level within the hierarchy is described below, with Level 1 having the highest priority and Level 3 having the lowest:
· Level 1:
Quoted prices in active markets for identical assets or
liabilities.
· Level 2:
Quoted prices for similar assets or liabilities in active markets; quoted prices
for identical or similar instruments in markets that are not active; and
model-derived valuations in which all significant inputs are observable in
active markets.
· Level 3:
Valuations derived from valuation techniques in which one or more significant
inputs are unobservable in active markets.
The
following table provides a summary of the recognized assets and liabilities that
we measure at fair value on a recurring basis:
Balance
as of
|
Basis
of Fair Value Measurements
|
|||||||||||||||
March
31, 2009
|
Level
1
|
Level
2
|
Level
3
|
|||||||||||||
Assets:
|
||||||||||||||||
Cash
equivalents
|
$ | 6,830,000 | $ | 6,830,000 | $ | — | $ | — | ||||||||
Liabilities:
|
||||||||||||||||
Put
option liability
|
$ | (2,270,000 | ) | $ | — | $ | — | $ | (2,270,000 | ) | ||||||
Warrant
liability
|
$ | (677,000 | ) | $ | — | $ | (677,000 | ) | $ | — | ||||||
We use
quoted market prices to determine the fair value of our cash equivalents, which
consist of money market funds and therefore these are classified in Level 1 of
the fair value hierarchy.
Our put
option liability (see note 13) is valued using an option pricing theory based
simulation analysis (i.e., a Monte Carlo simulation). Assumptions are made with
regard to the market value of Cytori and the estimated fair value of the Joint
Venture, the expected correlation between the values of Cytori and the Joint
Venture,
12
the
expected volatility of Cytori and the Joint Venture, the bankruptcy recovery
rate for Cytori, the bankruptcy threshold for Cytori, the probability of a
change of control event for Cytori, and the risk free interest
rate. Because some of the inputs to our valuation model are either
not observable quoted prices or are not derived principally from or corroborated
by observable market data by correlation or other means, the put option
liability is classified as Level 3 in the fair value hierarchy.
The
following table summarizes the change in our Level 3 put option liability
value:
Three
months ended
|
Year
ended
|
|||||||
Put
option liability
|
March
31, 2009
|
December
31, 2008
|
||||||
Beginning
balance
|
$ | (2,060,000 | ) | $ | (1,000,000 | ) | ||
Increase in
fair value recognized in operating expenses
|
(210,000 | ) | (1,060,000 | ) | ||||
Ending
balance
|
$ | (2,270,000 | ) | $ | (2,060,000 | ) | ||
Our
warrant liability is calculated utilizing the Black-Scholes option-pricing model
in which all significant inputs are observable in active markets, such as common
stock market price, volatility, and risk free rate, therefore the warrant
liability is classified as Level 2 in the fair value hierarchy. See note 5
for further discussion of fair value for these warrants.
No other
assets or liabilities are measured at fair value on a recurring basis, or have
been measured at fair value on a non-recurring basis subsequent to initial
recognition, on the accompanying consolidated condensed balance sheet as of
March 31, 2009.
15.
|
Stockholders’
Deficit
|
Common
Stock
On
February 8, 2008, we agreed to sell 2,000,000 shares of unregistered common
stock to Green Hospital Supply, Inc., a related party, for $12,000,000 cash, or
$6.00 per share in a private stock placement. On February 29, 2008,
we closed the first half of the private placement with Green Hospital Supply,
Inc. and received $6,000,000. We closed the second half of the
private placement on April 30, 2008 and received the second payment of
$6,000,000. As of March 31, 2009, Green Hospital Supply, Inc., a related party,
holds approximately 8.8% of our issued and outstanding shares.
On August
11, 2008, we raised approximately $17,000,000 in gross proceeds from a private
placement of 2,825,517 unregistered shares of common stock and 1,412,758 common
stock warrants (with an original exercise price of $8.50 per share) to a
syndicate of investors including Olympus Corporation, who acquired 1,000,000
unregistered shares and 500,000 common stock warrants in exchange for $6,000,000
of the total proceeds raised. Purchase price per unit was $6.00, with
each unit consisting of one (1) common stock share and a half (0.5) common stock
warrant. These warrants will not be exercisable until six months
after the date of issuance and will expire five years after the date the
warrants are first exercisable. Effective January 1, 2009, warrants issued
in August 2008 as part of our private placement of common stock are accounted
for in accordance with EITF Issue No. 07-5. EITF 07-5 provides
a framework for evaluating the terms of a particular instrument to determine
whether such instrument is considered a derivative financial
instrument. Under EITF 07-5, warrants issued in August 2008 as part
of our private placement of common stock are classified as a warrant liability
in our consolidated balance sheet. See note 5 – Warrant
Liability.
On March
10, 2009, we raised approximately $10,000,000 in gross proceeds from sale to
institutional investors of a total of 4,771,174 shares of our common stock (the
“Shares”) and warrants to purchase up to a total of 6,679,644 additional shares
of our common stock (the “Warrants”) at a purchase price of $2.10 per unit, with
each unit consisting of one (1) Share and one and four-tenths (1.4)
Warrants. The Warrants will not be exercisable until six months after
the date of issuance and will expire five years after the date the warrants are
first exercisable. The Warrants will have an exercise price of $2.59 per share,
which was the consolidated closing bid price of the Company's common stock on
March 9, 2009, as reported by NASDAQ. The Shares and the Warrants are
immediately separable and will be issued separately. We have
accounted for the Warrants as a component of stockholders’ deficit, consistent
with EITF 00-19, “Accounting for Derivative Financial Instruments Indexed to,
and Potentially Settled in, a Company’s Own Stock”. The Warrants must be
settled through a cash exercise whereby the warrant holder exchanges cash for
shares of Cytori common stock, unless the exercise occurs when the related
registration statement is not effective, in which case the warrant holder can
only exercise through the cashless exercise feature of the warrant
agreement.
Warrant
Adjustments
Our
issuance of the Warrants with an exercise price of $2.59 per share in connection
with our March 2009 equity offering, triggered an adjustment to the exercise
price and number of shares issuable under the warrants issued to investors in
our August 2008 private placement financing. As a result, the common
stock warrants issued on August 11, 2008, are currently exercisable for
1,679,503 shares of our common stock at an exercise price of $7.15 per
share.
13
Treasury
Stock
As part
of our equity offering on March 10, 2009, we sold our remaining 1,872,834 shares
of common stock from our treasury for $3,933,000 cash, or $2.10 per
share. The cost basis of the treasury stock sold was at a weighted
average purchase price, or $3.63 per share, resulting in a loss of $1.53 per
share, or $2,861,000 in aggregate, and was accounted for as a charge to
additional paid-in capital.
16.
|
Subsequent
Events
|
On May 7,
2009, we entered into a security purchase agreement with institutional investors
for the sale of a total of 1,864,783 unregistered shares of our common stock and
warrants to purchase up to a total of 3,263,380 unregistered share of our common
stock for approximately $4,252,000 in gross proceeds. Purchase price
per unit was $2.28, with each unit consisting of one (1) share of our common
stock and one and seventy five-hundredth (1.75) common stock
warrants. These warrants will have an exercise price of $2.62 per
share and a five year term after their date of issuance. The closing
is expected to take place on or about May 11, 2009.
Warrant
Adjustments
Our
issuance of shares and warrants in the May 7, 2009 offering is expected to
trigger an adjustment to the exercise price and number of shares issuable under
the warrants issued to investors in our August 2008 private placement
financing. Upon closing of our May 2009 transaction, the common stock
warrants issued on August 11, 2008, will be exercisable for 1,816,708 shares of
our common stock at an exercise price of $6.61 per share.
14
Item 2. Management’s Discussion and Analysis
of Financial Condition and Results of Operations
Our
Management’s Discussion and Analysis of Financial Condition and Results of
Operations (MD&A) includes the following sections:
·
|
Overview
that discusses our operating results and some of the trends that affect
our business.
|
·
|
Results
of Operations that includes a more detailed discussion of our revenue and
expenses.
|
·
|
Liquidity
and Capital Resources which discusses key aspects of our statements of
cash flows, changes in our financial position and our financial
commitments.
|
·
|
Significant
changes since our most recent Annual Report on Form 10-K in the Critical
Accounting Policies and Estimates that we believe are important to
understanding the assumptions and judgments underlying our financial
statements.
|
You
should read this MD&A in conjunction with the financial statements and
related notes in Item 1 and our Annual Report on Form 10-K for the fiscal
year ended December 31, 2008.
CAUTIONARY
STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This
report contains certain statements that may be deemed “forward-looking
statements” within the meaning of United States of America securities
laws. All statements, other than statements of historical fact, that
address activities, events or developments that we intend, expect, project,
believe or anticipate and similar expressions or future conditional verbs such a
will, should, would, could or may occur in the future are forward-looking
statements. Such statements are based upon certain assumptions and assessments
made by our management in light of their experience and their perception of
historical trends, current conditions, expected future developments and other
factors they believe to be appropriate.
These
statements include, without limitation, statements about our anticipated
expenditures, including those related to clinical research studies, and general
and administrative expenses; the potential size of the market for our
products, future development and/or expansion of our products
and therapies in our markets, ability to generate product
revenues or effectively manage our gross profit margins; our ability to obtain
regulatory clearance; expectations as to our future performance; the future
impact and ongoing appeal with respect to the ‘231 patent
litigation, the “Liquidity and Capital Resources” section of this
report, including our need for additional financing and the availability
thereof; and the potential enhancement of our cash position through development,
marketing, and licensing arrangements. Our actual results will
likely differ, perhaps materially, from those anticipated in these
forward-looking statements as a result of various factors, including: our need
and ability to raise additional cash, our joint ventures, risks associated
with laws or regulatory requirements applicable to us, market
conditions, product performance, unforeseen litigation, and competition within
the regenerative medicine field, to name a few. The forward-looking
statements included in this report are subject to a number of additional
material risks and uncertainties, including but not limited to the risks
described our filings with the Securities and Exchange Commission and under the
“Risk Factors” section in Part II below.
We encourage you to read our Risk
Factors descriptions carefully. We caution you not to place undue reliance
on the forward-looking statements contained in this report. These
statements, like all statements in this report, speak only as of the date of
this report (unless an earlier date is indicated) and we undertake no obligation
to update or revise the statements except as required by law. Such
forward-looking statements are not guarantees of future performance and actual
results will likely differ, perhaps materially, from those suggested by such
forward-looking statements.
Liquidity
We
incurred losses of $6,098,000 and
$8,273,000 for the three months ended March 31, 2009 and 2008,
respectively. We have an accumulated deficit of $165,386,000 as of
March 31, 2009. Additionally, we have used net cash of $6,074,000 and $9,162,000 to fund
our operating activities for three months ended March 31, 2009 and 2008,
respectively. To date these
operating losses have been funded primarily from outside sources of invested
capital.
During
2008, we initiated our commercialization activities while simultaneously
pursuing available financing sources to support operations and
growth. We have had, and continue to have, an ongoing need to raise
additional cash from outside sources to fund our operations. However,
our ability to raise capital has been adversely affected by current credit
conditions and the downturn in the financial markets and the global
economy. Accordingly, the combination of these facts raises
substantial doubt as to the Company’s ability to continue as a going
concern. The accompanying consolidated condensed financial statements
have been prepared assuming that the Company will continue as a going
concern. If we are unsuccessful in our efforts to raise outside
capital in the near term, we will be required to further reduce our research,
development, and administrative operations, including reduction of our employee
base, in order to offset the lack of available funding.
15
We are
pursuing financing opportunities in both the private and public debt and equity
markets as well as through strategic corporate partnerships. We have an
established history of raising capital through these platforms, and we are
currently involved in negotiations with multiple parties. In August 2008,
we raised approximately $17,000,000 in gross proceeds from a private placement
of 2,825,517 unregistered shares of common stock and 1,412,758 common stock
warrants (with an original exercise price of $8.50 per share) to a syndicate of
investors including Olympus Corporation, who acquired 1,000,000 unregistered
shares and 500,000 common stock warrants in exchange for $6,000,000 of the total
proceeds raised. In October 2008, we entered into a secured Loan
Agreement with General Electric Capital Corporation and Silicon Valley Bank
(“Lenders”) to borrow up to $15,000,000. An initial term loan of
$7,500,000, less fees and expenses, was funded on October 14,
2008. We could not access the remaining $7,500,000 under this
facility as we were not able to meet certain financial prerequisites that had
been established by the Lenders. In March 2009, we raised
approximately $10,000,000 in gross proceeds from the sale to institutional
investors of a total of 4,771,174 shares of our common stock and warrants to
purchase up to a total of 6,679,644 additional shares of our common with an
exercise price of $2.59 per share.
We expect
to continue to utilize our cash and cash equivalents to fund operations through
the next nine months, subject to minimum cash and cash liquidity requirements of
the Loan and Security Agreement with the Lenders, which requires that we
maintain at least three months of cash on hand to avoid an event of default
under the Loan and Security Agreement. We continue to seek additional
cash through product revenues, strategic collaborations, and future sales of
equity or debt securities. Although there can be no assurance given, we
hope to successfully complete one or more additional financing transactions and
corporate partnerships in the near-term. Without this additional capital,
current working capital, cash generated from sales and containment of costs will
not provide adequate funding for operations at their current levels. If such
efforts are not successful, we will need to further reduce or curtail operations
and this could negatively affect our ability to achieve corporate growth goals.
We have implemented an operating plan that reduces certain operations to
focus almost entirely on the supply of current products to existing or new
distribution channels. In addition, as part of this plan, there will be
minimal expenditures for ongoing scientific research, product development or
clinical research. This impacts research and development headcount,
external subcontractor expenditures, capital outlay and general and
administrative expenditures related to the supervision of such
activities. In parallel, we significantly reduced administrative
staff and salaries consistent with the overall reduction in scope of
operations. In aggregate, such reductions resulted in eliminations of
roles for the many of the Company’s current staff (our overall headcount
decreased to 85 employees as of March 31, 2009 as compared to 126 employees as
of December 31, 2008) and the deferral or elimination of most development
projects until such time that cash resources are available from operations or
outside sources to re-establish development and growth plans. Management
is currently reviewing contractual obligations related to the pre-clinical and
clinical commitments along with minimum purchase requirements to include
deferral of such commitments as part of this plan.
Overview
Cytori
Therapeutics, Inc. develops and globally commercializes regenerative medicine
technologies, which provide real-time, point-of-care access to clinical grade
regenerative cells. The Company’s main product is the Celution® System, the
first and only automated device that enables rapid extraction, concentration and
reinfusion of a patient’s adipose regenerative cells in a single surgical
procedure. Our technology is incorporated into two product families. The
Celution®-related products are sold throughout Europe and Asia primarily into
the cosmetic and reconstructive surgery market and are under evaluation by the
U.S. FDA. Our StemSource® products are sold globally for cell banking and
research applications. We are also developing additional clinical uses of our
technology for the treatment of multiple medical conditions, including
cardiovascular disease, urinary tract disorders and would related conditions. To
commercialize our technology, Cytori has partnered with global and regional
leaders in healthcare such as Olympus Corporation, GE Healthcare and Green
Hospital Supply.
Cytori is
working with multiple distributors to commercialize the Celution® into the
European cosmetic and reconstructive surgery market. The Celution® 800/CRS is
currently sold by GE Healthcare in select European countries. In order to
support future sales, expand claims, and seek reimbursement for the use of
the Celution® System
in post-partial mastectomy defect reconstruction, Cytori is conducting a 70
patient European post-marketing study, RESTORE-2. We have currently enrolled
more than 50% of the patients. Final results from this study are
expected to be reported in 2010, with initial data on a subset of patients who
have been followed for six months reported in late 2009. In the United
States, we are continuing to seek regulatory and marketing approval for the
Celution® 700 System family of products, the U.S. version of the device. We
expect to finalize our U.S. regulatory and clinical development strategy later
in 2009.
The
StemSource® Cell Bank products are being offered through our commercialization
partner Green Hospital Supply in Japan, Korea, Taiwan and Thailand. We believe
that continued growth in the cell bank business in 2009 within Asia Pacific will
be driven by hospitals where a device is already installed as part of an
investigator-initiated study, and where physicians are already familiar with the
use of the system and its benefits. In addition, GE Healthcare is
commercializing both the StemSource® Banking and research products in select
European countries and in North America. The commercialization
activities are performed predominantly by our distributors, however we continue
to serve in a consulting capacity to assist as needed in sales and
service.
In the
first quarter of 2009, we completed enrollment in our European heart attack
trial after the enrollment of the first cohort. Enrollment in our second
European trial, for chronic ischemia, is ongoing and should be complete in 2009.
Cardiovascular disease
16
represents
our most advanced product pipeline application. Once results are available, we
plan to either seek a co-development partner or pursue further development in a
measured way until such time as we have the adequate financial resources to
invest in pivotal European studies and U.S. clinical trials.
In
partnership with Olympus Corporation, we continued to work towards finalizing
the second commercial generation Celution® System. Currently, we
manufacture the first commercial generation Celution® System
and consumables at our corporate headquarters and provide all servicing for the
device through our regional offices.
During
the first quarter of 2009, we were granted several additional U.S. patents and
patent allowances, which cover various aspects of the Celution® System
technology and applications of the Celution® System
output. These developments further protect our proprietary rights and
competitive position.
In
addition to our increased investment in commercial activities, in the first
quarter of 2009 we implemented a reduction in preclinical research and
cardiovascular disease development expenses and are continually looking for ways
to reduce expenditures. Because we have passed the feasibility stage and are now
manufacturing commercial products, we have less reliance going forward on basic
and preclinical development activities. Preclinical research will continue at a
base level required to fulfill demands for potential partnerships, expanding
intellectual property, and supporting commercial activities.
Olympus
Partnership
On
November 4, 2005, we entered into a strategic development and manufacturing
joint venture agreement and other related agreements, which we refer to as the
JV Agreements, with Olympus Corporation. As part of the terms of the
JV Agreements, we formed a joint venture, Olympus-Cytori, Inc., which we refer
to as the Joint Venture, to develop and manufacture future generation devices
based on our Celution® System
platform.
Under the
Joint Venture Agreements:
·
|
Olympus
paid $30,000,000 for its 50% interest in the Joint
Venture. Moreover, Olympus simultaneously entered into a
License/Joint Development Agreement with the Joint Venture and us to
develop a second generation commercial system and manufacturing
capabilities.
|
·
|
We
licensed our device technology, including the Celution®
System platform and certain related intellectual property, to the Joint
Venture for use in future generation devices. These devices
will process and purify adult stem and regenerative cells residing in
adipose (fat) tissue for various therapeutic clinical
applications. In exchange for this license, we received a 50%
interest in the Joint Venture, as well as an initial $11,000,000 payment
from the Joint Venture; the source of this payment was the $30,000,000
contributed to the Joint Venture by Olympus. Moreover, upon
receipt of a CE mark for the first generation Celution®
System platform in January 2006, we received an additional $11,000,000
development milestone payment from the Joint
Venture.
|
Put/Calls and
Guarantees
The
Shareholders’ Agreement between Cytori and Olympus provides that in certain
specified circumstances of insolvency or if we experience a change in control,
Olympus will have the rights to (i) repurchase our interests in the Joint
Venture at the fair value of such interests or (ii) sell its own interests in
the Joint Venture to Cytori at the higher of (a) $22,000,000 or (b) the Put’s
fair value.
As of
March 31, 2009, the estimated fair value of the Put was
$2,270,000. Fluctuations in the estimated Put value are recorded in
the statements of operations as a component of change in fair value of option
liabilities. The estimated fair value of the Put has been recorded as a
long-term liability on the consolidated condensed balance sheets in the caption
option liability.
The Put
has no expiration date. Accordingly, we will continue to recognize a
liability for the Put and mark it to market each quarter until it is exercised
or until the arrangements with Olympus are amended.
Olympus-Cytori Joint
Venture
The Joint
Venture currently has exclusive access to our technology for the development,
manufacture, and supply of the devices (second generation and beyond) for all
therapeutic applications. Once a later generation Celution® System
is developed and approved by regulatory agencies, the Joint Venture would sell
such systems exclusively to us at a formula-based transfer price; we have
retained marketing rights to the second generation devices for all therapeutic
applications of adipose stem and regenerative cells.
We have
worked closely with Olympus’ team of scientists and engineers to design the
future generations Celution® System
so that it will contain certain product enhancements and can be manufactured in
a streamlined manner.
17
In August
2007, we entered into a License and Royalty Agreement with the Joint Venture
which allowed us to commercially launch the Celution® System
platform earlier than we could have otherwise done so under the terms of the
Joint Venture Agreements. The Royalty Agreement provides for the sale
of the Cytori-developed Celution® System
platform, including the Celution® 800/CRS
and Celution® 900/MB,
until such time as the Joint Venture’s products are commercially
available for the same market served by the Cytori platform, subject to a
reasonable royalty that will be payable to the Joint Venture for all such
sales.
We
account for our investment in the Joint Venture under the equity method of
accounting.
Other Related Party
Transactions
In a
separate agreement entered into on February 23, 2006, we granted Olympus an
exclusive right to negotiate a commercialization collaboration for the use of
adipose regenerative cells for a specific therapeutic area outside of
cardiovascular disease. In exchange for this right, we received a
$1,500,000 payment from Olympus, which was non-refundable but could be applied
towards a definitive commercial collaboration in the future. As part
of this agreement, Olympus would conduct market research and pilot clinical
studies in collaboration with us for the therapeutic area up to December 31,
2008 when this exclusive right expired. The $1,500,000 payment was
received in the second quarter of 2006 and recorded as deferred revenues,
related party. Accordingly, on December 31, 2008, we recognized
$1,500,000 as other development revenue and reduced our deferred revenues,
related party balance for the same amount.
On
February 8, 2008, we agreed to sell 2,000,000 shares of unregistered common
stock to Green Hospital Supply, Inc. for $12,000,000 cash, or $6.00 per share,
in a private stock placement. On February 29, 2008, we closed the
first half of the private placement with Green Hospital Supply, Inc. and
received $6,000,000. We closed the second half of the private
placement on April 30, 2008 and received the second payment of
$6,000,000.
In August
2008, we received an additional $6,000,000 from Olympus in a private placement
of 1,000,000 unregistered shares of our common stock and a warrant to purchase
an additional 500,000 shares of our common stock at an original exercise price
of $8.50 per share. The purchase price was $6.00 per unit (with each
unit consisting of one share and 50% warrant coverage). The warrant
is exercisable anytime after February 11, 2009 and will expire on August 11,
2013.
Thin Film Japan Distribution
Agreement
In 2004,
we sold the majority of our Thin Film business to MAST Biosurgery
AG. We retained all rights to Thin Film business in Japan (subject to
a purchase option of MAST, which expired in May 2007), and we received back from
MAST a license of all rights to Thin Film technologies in the spinal field,
exclusive at least until 2012, and the field of regenerative medicine,
non-exclusive on a perpetual basis.
In the
third quarter of 2004, we entered into a Distribution Agreement with Senko
Medical Trading Company. Under this agreement, we granted to Senko an
exclusive license to sell and distribute certain Thin Film products in
Japan. Specifically, the license covers Thin Film products with the
following indications: anti-adhesion; soft tissue support; and minimization of
the attachment of soft tissues. The Distribution Agreement with Senko
commences upon “commercialization.” Commercialization will occur when
one or more Thin Film product registrations are completed with the Japanese
Ministry of Health, Labour and Welfare, or MHLW. Following
commercialization, the Distribution Agreement has a duration of five years and
is renewable for an additional five years after reaching mutually agreed minimum
purchase guarantees.
We
received a $1,500,000 upfront license fee from Senko. We have
recorded the $1,500,000 received as a component of deferred revenues in the
accompanying consolidated condensed balance sheet. Half of the
license fee is refundable if the parties agree commercialization is not
achievable and a proportional amount is refundable if we terminate the
arrangement, other than for material breach by Senko, before three years
post-commercialization.
Under the
Distribution Agreement, we will also be entitled to earn additional payments
from Senko based on achieving defined milestones. On September 28,
2004, we notified Senko of completion of the initial regulatory application to
the MHLW for the Thin Film product. As a result, we became entitled
to a nonrefundable payment of $1,250,000, which we received in October 2004 and
had recorded as a component of deferred revenues. We did not
recognize any development revenues with respect to Senko during the three months
ended March 31, 2009 and 2008.
Results
of Operations
Our
overall net losses for the three months ended March 31, 2009 and 2008 were
$6,098,000 and $8,273,000, which was driven by $3,468,000 and $4,963,000 in
research and development expenses, $1,286,000 and $958,000 in sales and
marketing expenses, and $2,494,000 and $3,111,000 in general and administrative
expenses, respectively. The net loss for the three months ended March 31, 2009
18
reflects
expenses related to expansion and pursuit of distribution partners, research
efforts related to regenerative cell technology commercialization as well as
costs associated with clinical trials. The losses for these periods
were offset in part by the recognition of revenue on our Celution® System
product sales and Celution®
StemSource® Cell
Bank. We experienced minimal activity in the MacroPore operating
segment for the three months ended March 31, 2009 and 2008. We
currently expect our net operating loss for 2009 will be approximately
$18,000,000 to $20,000,000.
Product
revenues
Product
revenues consisted of revenues from our Celution® System
products and Celution®
StemSource® Cell
Bank.
The
following table summarizes the components for the three months ended March 31,
2009 and 2008:
For
the three months ended March 31,
|
||||||||
2009
|
2008
|
|||||||
Celution®
Systems
|
||||||||
Related
party
|
$ | 564,000 | $ | — | ||||
Third
party
|
1,348,000 | 153,000 | ||||||
Total
product
revenues
|
$ | 1,912,000 | $ | 153,000 | ||||
%
attributable to Green Hospital Supply, Inc.
|
29.5 | % | — |
Beginning
in March of 2008, we began sales and shipments of our Celution® 800/CRS
System to the European and Asia-Pacific reconstructive surgery
markets. Assuming all other applicable revenue recognition criteria
have been met, revenue for these product sales will be recognized upon delivery
to the customer, as all risks and rewards of ownership have been substantively
transferred to the customer at that point. For product sales to
customers who arrange for and manage all aspects of the shipping process, we
recognize revenue upon shipment from our facilities. For product
sales that include a combination of equipment, services, or other multiple
deliverables that will be provided in the future, we defer an estimate of the
fair value of those future deliverables from product revenue until such
deliverables have been provided or earned. Shipping and handling
costs that are billed to our customers are classified as revenue.
The future. We
expect to continue to generate regenerative cell technology product revenues
during 2009 from Celution® 800/CRS and consumable sales in Europe and we expect
to generate product revenues from StemSource® Cell Bank sales in Japan through
our distribution partner Green Hospital Supply, Inc. Additionally, we expect to
have Thin Film product revenues when commercialization of the Thin Film products
in Japan occurs and we begin Thin Film shipments to Senko, pending regulatory
approval.
Cost of product
revenues
Cost of
product revenues for 2009 and 2008 relate to Celution® System
products and a Celution®
StemSource® Cell
Bank and includes material, manufacturing labor, and overhead
costs. The following table summarizes the components of our cost of
revenues for the three months ended March 31, 2009 and 2008:
For
the three months ended March 31,
|
||||||||
2009
|
2008
|
|||||||
Cost
of product revenues
|
$ | 1,071,000 | $ | 54,000 | ||||
Share-based
compensation
|
16,000 | 6,000 | ||||||
Total
cost of product revenues
|
$ | 1,087,000 | $ | 60,000 | ||||
Total
cost of product revenues as % of product revenues
|
56.9 | % | 39.2 | % |
·
|
The
increase in cost of product revenues for the three months ended March 31,
2009 as compared to the same period in 2008 was due to increase in
Celution®
System product sales, for which initial revenue was recognized during the
three months ended March 31, 2008, as our commercialization date was March
1, 2008. We also recorded revenue for a StemSource® Cell Bank
that was installed in the first quarter of 2009. For the three
months ended March 31, 2008, cost of sales included an economic benefit of
approximately $35,000, related to inventory and labor/overhead previously
expensed as research and development prior to our commercialization date
of March 1, 2008. Cost of product revenues as a percentage of
product revenues was 56.9% and 39.2% for the three months ended March 31,
2009 and 2008, respectively. Some fluctuation in this
percentage is to be expected due to the product mix as well as mix of
distributor and direct sales comprising the revenue for the
period.
|
19
·
|
Cost
of product revenues included approximately $16,000 and $6,000 of
share-based compensation expense for the three months ended March 31, 2009
and 2008, respectively. For further details, see share-based
compensation discussion below.
|
The future. We
expect to see a nominal variation in our gross profit margin as the product mix
comprising revenues fluctuates. Additionally, we expect to incur
costs related to our MacroPore products if and when commercialization is
achieved for our Japan Thin Film product line.
Development
revenues
The following table summarizes the
components of our development revenues for the three months ended March 31, 2009
and 2008:
For
the three months ended March 31,
|
||||||||
2009
|
2008
|
|||||||
Development
(Olympus)
|
$ | — | $ | 774,000 | ||||
Research
grant
(NIH)
|
7,000 | — | ||||||
Regenerative
cell storage services and other
|
1,000 | 37,000 | ||||||
Total
development revenues
|
$ | 8,000 | $ | 811,000 |
We recognize deferred revenues, related
party, as development revenue when certain performance obligations are met
(i.e., using a proportional performance approach). During the three
months ended March 31, 2009 and 2008, we recognized $0 and $774,000 of revenue
associated with our arrangements with Olympus, respectively.
The
research grant revenue relates to our agreement with the National Institutes of
Health (“NIH”). Under this arrangement, the NIH reimburses us for
“qualifying expenditures” related to research on Adipose Tissue-Derived Cells
for Vascular Cell Therapy. To receive funds under the grant
arrangement, we are required to (i) demonstrate that we incurred “qualifying
expenses,” as defined in the grant agreement between the NIH and us, (ii)
maintain a system of controls, whereby we can accurately track and report all
expenditures related solely to research on Adipose Tissue-Derived Cells for
Vascular Therapy, and (iii) file appropriate forms and follow appropriate
protocols established by the NIH.
During
the three months ended March 31, 2009, we incurred $7,000 in qualified
expenditures. We recognized a total of $7,000 in revenues for the
three months ended March 31, 2009, which included allowable grant fees as well
as cost reimbursements.
The future. We
expect to recognize additional development revenues from our regenerative cell
technology segment during the remainder of 2009, as the anticipated completion
for the next phase of our Joint Venture and other Olympus product development
performance obligations is in 2009. If we are successful in achieving
certain milestone points related to these activities, we may recognize
approximately $1,200,000 in revenues in 2009. The exact timing of
when amounts will be reported in revenue will depend on internal factors (for
instance, our ability to complete certain contributions and obligations that we
have agreed to perform) as well as external considerations, including obtaining
certain regulatory clearances and/or approvals related to the Celution®
System. The cash for these contributions and obligations was received
when the agreement was signed and no further related cash payments will be made
to us.
We will
continue to recognize revenue from the Thin Film development work we are
performing on behalf of Senko, based on the relative fair value of the
milestones completed as compared to the total efforts expected to be necessary
to obtain regulatory clearance from the MHLW. We are still awaiting
regulatory clearance from the MHLW in order for initial commercialization to
occur. Accordingly, we expect to recognize approximately $1,129,000
(consisting of $879,000 in deferred revenues plus a non-refundable payment of
$250,000 to be received upon commercialization) in revenues associated with this
milestone arrangement if and when regulatory approval is
achieved. Moreover, we expect to recognize $500,000 per year
associated with deferred Senko license fees over a three-year period following
commercialization, if achieved, as the refund rights associated with the license
payment expire.
20
Research and development
expenses
Research
and development expenses include costs associated with the design, development,
testing and enhancement of our products, regulatory fees, the purchase of
laboratory supplies, pre-clinical studies and clinical studies. The
following table summarizes the components of our research and development
expenses for the three months ended March 31, 2009 and 2008:
For
the three months ended March 31,
|
||||||||
2009
|
2008
|
|||||||
General
research and development
|
$ | 2,564,000 | $ | 3,981,000 | ||||
Development
milestone (Joint Venture)
|
790,000 | 842,000 | ||||||
Share-based
compensation
|
114,000 | 140,000 | ||||||
Total
research and development expenses
|
$ | 3,468,000 | $ | 4,963,000 |
·
|
Research
and development expenses relate to the development of a technology
platform that involves using adipose tissue as a source of autologous
regenerative cells for therapeutic applications. These
expenses, in conjunction with our continued development efforts related to
our Celution®
System, result primarily from the broad expansion of our research and
development efforts enabled by the funding we received from Olympus in
2005 and 2006 and from other investors during the last few
years. Labor-related expenses, not including share-based
compensation, decreased by $456,000 for the three months ended March 31,
2009, as compared to the same period in 2008 primarily due to the decrease
in headcount for our research and development department as a result of
achievement of commercialization and transfer of employees from research
and development to the manufacturing department as well as reduction in
force implemented by management at the end first quarter of 2009 and third
quarter of 2008 in efforts to cut costs. Professional services
expense decreased by $304,000 for the three months ended March 31, 2009,
as compared to the same period in 2008. This was due to a
decreased use of consultants and temporary labor for the three months
ended March 31, 2009. Expenses for supplies decreased by
$542,000 for the three months ended March 31, 2009 as compared to the same
period in 2008, primarily due to purchases of production supplies in 2008
prior to the related product line commercialization, which occurred on
March 1, 2008.
|
·
|
Expenditures
related to the Joint Venture with Olympus, which are included in the
variation analysis above, include costs that are necessary to support the
commercialization of future generation devices based on our Celution® System. These
development activities, which began in November 2005, include performing
pre-clinical and clinical studies, seeking regulatory approval, and
performing product development related to therapeutic applications for
adipose regenerative cells for multiple large markets. For the
three months ended March 31, 2009 and 2008, costs associated with the
development of the device were $790,000 and $842,000,
respectively. The decrease in the costs related to the Joint
Venture with Olympus is primarily due to the completion of product
development milestone activities. The three months ended March 31, 2009
and 2008 expenses were composed of $266,000 and $484,000 in labor and
related benefits, $324,000 and $150,000 in consulting and other
professional services, $171,000 and $34,000 in supplies and $29,000 and
$174,000, respectively, in other miscellaneous
expense.
|
·
|
Share-based
compensation for research and development was $114,000 and $140,000 for
the three months ended March 31, 2009 and 2008,
respectively. See share-based compensation discussion below for
more details.
|
The future. Our
strategy is to substantially reduce our research and development expenditures in
2009 and we anticipate expenditures in this area to be well below the
expenditures in 2008 as we shift our focus toward manufacturing and sales (see
additional discussion regarding liquidity at the beginning of Item 2,
Management’s Discussion and Analysis of Financial Condition and Results of
Operations).
21
Sales and marketing
expenses
Sales and
marketing expenses include costs of marketing personnel, tradeshows, physician
training, and promotional activities and materials. The following
table summarizes the components of our sales and marketing expenses for the
three months ended March 31, 2009 and 2008:
For
the three months ended March 31,
|
||||||||
2009
|
2008
|
|||||||
International
sales and marketing
|
$ | 1,173,000 | $ | 878,000 | ||||
Share-based
compensation
|
113,000 | 80,000 | ||||||
Total
sales and marketing expenses
|
$ | 1,286,000 | $ | 958,000 |
·
|
The
increase in international sales and marketing expense for the three months
ended March 31, 2009 as compared to the same period in 2008 was mainly
attributed to the increase in salary and related benefits expense of
$228,000, not including share-based compensation, an increase in travel
related expenses of $38,000; and an increase in professional services of
$30,000, which are due to our emphasis in seeking strategic alliances
and/or co-development partners for our regenerative cell technology as
well as sales and marketing efforts related to our commercialization
activities.
|
·
|
Share-based
compensation for sales and marketing for the three months ended March 31,
2009 and 2008 was $113,000 and $80,000, respectively. See
share-based compensation discussion below for more
details.
|
The future. We
expect sales and marketing expenditures related to the regenerative cell
technology to be maintained at or near current levels as we continue to expand
our base of distribution partners, strategic alliances and co-development
partners, as well as market our Celution® System
and StemSource® Cell
Bank (see additional discussion regarding liquidity at the beginning of Item 2,
Management’s Discussion and Analysis of Financial Condition and Results of
Operations).
General and administrative
expenses
General
and administrative expenses include costs for administrative personnel, legal
and other professional expenses, and general corporate expenses. The
following table summarizes the general and administrative expenses for the three
months ended March 31, 2009 and 2008:
For
the three months ended March 31,
|
||||||||
2009
|
2008
|
|||||||
General
and administrative
|
$ | 2,094,000 | $ | 2,783,000 | ||||
Share-based
compensation
|
400,000 | 328,000 | ||||||
Total
general and administrative expenses
|
$ | 2,494,000 | $ | 3,111,000 |
·
|
A
decrease in general and administrative expenses (excluding share-based
compensation) occurred during the three months ended March 31, 2009 as
compared to the same period in 2008. This resulted primarily
from a decrease in salary and related benefits expense of $363,000, not
including share-based compensation, and a decrease in travel related
expenses of $183,000 for the three months ended March 31, 2009 as compared
to the same period in 2008. These decreases resulted from
management efforts to decrease costs, see additional discussion regarding
liquidity at the beginning of Item 2, Management’s Discussion and Analysis
of Financial Condition and Results of
Operations.
|
·
|
We
have incurred substantial legal expenses in connection with the University
of Pittsburgh’s lawsuit. Although we are not litigants and are
not responsible for any settlement costs, if we are not successful in
overturning the Court’s decision on the ‘231 Patent, our license rights to
the ‘231 Patent will be lost. Since our current products and
products under development do not practice the ‘231 Patent, our primary
ongoing business activities and product development pipeline should not be
affected by the Court’s decision. Although the ‘231 Patent is unrelated to
our current products and product pipeline, we believe that the ‘231 Patent
and/or the other technology licensed from UC may have long term potential
to be useful for future product developments, and so we have elected to
support UC’s legal efforts in the appeal of the Court’s final
order. The amended license agreement we signed with UC in the
third quarter of 2006 clarified that we are responsible for patent
prosecution and litigation costs related to this lawsuit. In
the three months ended March 31, 2009 and 2008, we expensed $8,000 and
$167,000, respectively, for legal fees related to this
license. Our legal expenses related to this lawsuit will
fluctuate depending upon the activity incurred during each
period.
|
22
·
|
Share-based
compensation expense related to general and administrative expense for the
three months ended March 31, 2009 and 2008 was $400,000 and $328,000,
respectively. See share-based compensation discussion below for
more details.
|
The future. We
expect general and administrative expenses to be further reduced in 2009
compared to the prior year as we are seeking ways to minimize these expenses
where possible (see additional discussion regarding liquidity at the beginning
of Item 2, Management’s Discussion and Analysis of Financial Condition and
Results of Operations).
Share-based compensation
expenses
The
following table summarizes the components of our share-based compensation
expenses for the three months ended March 31, 2009 and 2008:
For
the three months ended March 31,
|
||||||||
2009
|
2008
|
|||||||
Cost
of product
revenues
|
$ | 16,000 | $ | 6,000 | ||||
Research
and development-related
|
114,000 | 140,000 | ||||||
Sales
and marketing-related
|
113,000 | 80,000 | ||||||
General
and administrative-related
|
400,000 | 328,000 | ||||||
Total
share-based compensation
|
$ | 643,000 | $ | 554,000 |
Most of
the share-based compensation expenses in the three month ended March 31, 2009
and 2008 related to the vesting of stock option awards to
employees.
During
the first quarter of 2009, we made a company-wide option grant to our
non-executive employees to purchase up to 249,250 shares of our common stock,
subject to a four-year graded vesting schedule. The grant date fair value of the
awards was $2.00 per share. Following the reduction of our workforce at
the end of this quarter, 182,100 of these options remained
outstanding. The resulting share-based compensation expense of
$364,200, net of estimated forfeitures, will be recognized as expense over the
employees’ respective service periods.
During the first quarter of 2009, we
issued to our officers and directors options to purchase an aggregate of up to
585,000 shares of our common stock, with four-year graded vesting for our
officers and two-year graded vesting for our directors. The grant date fair
value of the awards granted to our officers and directors was $2.70 per share.
The resulting share-based compensation expense of $1,579,500, net of estimated
forfeitures, will be recognized as expense over the respective service
periods.
During
the first quarter of 2008, we issued to our officers and directors stock options
to purchase up to 450,000 shares of our common stock, with a four-year graded
vesting schedule for our officers and two-year graded vesting for our directors.
The grant date fair value of option awards granted to our officers and directors
was $2.73 per share. The resulting share-based compensation expense of
$1,230,000, net of estimated forfeitures, will be recognized as expense over the
respective service periods.
The future. We will
continue to grant options (which will result in an expense) to our employees
and, as appropriate, to non-employee service providers. In addition,
previously-granted options will continue to vest in accordance with their
original terms. As of March 31, 2009, the total compensation cost
related to non-vested stock options not yet recognized for all our plans is
approximately $4,525,000. These costs are expected to be recognized over a
weighted average period of 1.91 years.
23
Change in fair value of
warrant liability
The
following is a table summarizing the change in fair value of our warrant
liability for the three months ended March 31, 2009 and 2008:
For
the three months ended March 31,
|
||||||||
2009
|
2008
|
|||||||
Change
in fair value of warrant liability
|
$ | (1,021,000 | ) | $ | — |
·
|
In
August 2008, we issued common stock purchase warrants in connection with
our private placement of 2,825,517 unregistered shares of common stock and
1,412,758 common stock warrants. The common stock purchase warrants were
not issued with the intent of effectively hedging any future cash flow,
fair value of any asset, liability or any net investment in a foreign
operation. The warrants do not qualify for hedge accounting, and as such,
all future changes in the fair value of these warrants will be recognized
currently in earnings until such time as the warrants are exercised or
expire. These common stock purchase warrants do not trade in an active
securities market, and as such, we estimate the fair value of these
warrants using the Black-Scholes option pricing model using the following
assumptions:
|
As
of
March
31, 2009
|
As
of
December
31, 2008
|
|||||||
Expected
term
|
4.36
years
|
4.61
years
|
||||||
Common
stock market price
|
$ | 1.72 | $ | 3.61 | ||||
Risk-free
interest rate
|
1.67 | % | 1.55 | % | ||||
Expected
volatility
|
70.05 | % | 65.71 | % | ||||
Resulting
fair value (per warrant)
|
$ | 0.40 | $ | 1.20 |
Expected
volatility is based primarily on historical volatility. Historical volatility
was computed using daily pricing observations for recent periods that correspond
to the expected term of the warrants. We believe this method produces an
estimate that is representative of our expectations of future volatility over
the expected term of these warrants. We currently have no reason to believe
future volatility over the expected remaining life of these warrants is likely
to differ materially from historical volatility. The expected life is based on
the remaining term of the warrants. The risk-free interest rate is based on
five-year U.S. Treasury securities.
The future. Future
changes in the fair value of the warrant liability will be recognized
currently in earnings until such time as the warrants are exercised or
expire.
Change in fair value of
option liability
The
following is a table summarizing the change in fair value of our put option
liability for the three months ended March 31, 2009 and 2008:
For
the three months ended March 31,
|
||||||||
2009
|
2008
|
|||||||
Change
in fair value of option liability
|
$ | 210,000 | $ | 200,000 |
·
|
In
reference to the Joint Venture, the Shareholders’ Agreement between Cytori
and Olympus provides that in certain specified circumstances of insolvency
or if we experience a change in control, Olympus will have the right to
(i) repurchase our interests in the Joint Venture at the fair value of
such interests or (ii) sell its own interests in the Joint Venture to us
at the higher of (a) $22,000,000 or (b) the Put’s fair
value. The Put value has been classified as a
liability.
|
The
valuations of the Put were completed using an option pricing theory-based
simulation analysis (i.e., a Monte Carlo simulation). The valuations
are based on assumptions as of the valuation date with regard to the market
value of Cytori and the estimated fair value of the Joint Venture, the expected
correlation between the values of Cytori and the Joint Venture, the expected
volatility of Cytori and the Joint Venture, the bankruptcy recovery rate for
Cytori, the bankruptcy threshold for Cytori, the probability of a change of
control event for Cytori, and the risk-free interest rate.
24
The
following assumptions were employed in estimating the value of the
Put:
March
31, 2009
|
December
31, 2008
|
November
4, 2005
|
||||||||||
Expected
volatility of
Cytori
|
70.00 | % | 68.00 | % | 63.20 | % | ||||||
Expected
volatility of the Joint Venture
|
70.00 | % | 68.00 | % | 69.10 | % | ||||||
Bankruptcy
recovery rate for
Cytori
|
21.00 | % | 21.00 | % | 21.00 | % | ||||||
Bankruptcy
threshold for
Cytori
|
$ | 15,711,000 | $ | 16,740,000 | $ | 10,780,000 | ||||||
Probability
of a change of control event for Cytori
|
2.67 | % | 2.80 | % | 3.04 | % | ||||||
Expected
correlation between fair values of Cytori and the Joint Venture in the
future
|
99.00 | % | 99.00 | % | 99.00 | % | ||||||
Risk
free interest
rate
|
2.71 | % | 2.25 | % | 4.66 | % |
The future. The
Put has no expiration date. Accordingly, we will continue to
recognize a liability for the Put until it is exercised or until the
arrangements with Olympus are amended.
Financing
items
The
following table summarizes interest income, interest expense, and other income
and expense for the three months ended March 31, 2009 and 2008:
For
the three months ended March 31,
|
||||||||
2009
|
2008
|
|||||||
Interest
income
|
$ | 14,000 | $ | 76,000 | ||||
Interest
expense
|
(400,000 | ) | (23,000 | ) | ||||
Other
income (expense)
|
(92,000 | ) | 11,000 | |||||
Total
|
$ | (478,000 | ) | $ | 64,000 |
·
|
Interest
income decreased for the three months ended March 31, 2009 as compared to
the same period in 2008 due to a decrease in interest
rates.
|
·
|
Interest
expense increased for the three months ended March 31, 2009 as compared to
the same period in 2008 due to non-cash amortization of debt issuance
costs and debt discount associated with a new term loan. In
October 2008, we entered into a secured Loan Agreement with General
Electric Capital Corporation and Silicon Valley Bank (“Lenders”) to borrow
up to $15,000,000. An initial term loan of $7,500,000, less
fees and expenses, funded on October 14,
2008.
|
·
|
The
changes in other income (expense) in the three months ended March 31, 2009
as compared to the same period in 2008 resulted primarily from changes in
foreign currency exchange rates.
|
The
future. Interest income earned in the remainder of 2009
will be dependent on our levels of funds available for investment as well as
general economic conditions. Subject to our future financing
activities, we expect interest expense to remain relatively consistent during
the remainder of 2009.
|
Equity loss from
investment in Joint Venture
|
The
following table summarizes our equity loss from investment in joint venture for
the three months ended March 31, 2009 and 2008:
For
the three months ended March 31,
|
||||||||
2009
|
2008
|
|||||||
Equity
loss in investment
|
$ | (16,000 | ) | $ | (9,000 | ) |
The
activity relates entirely to our 50% equity interest in the Joint Venture, which
we account for using the equity method of accounting.
The future. We do
not expect to recognize significant losses from the activities of the Joint
Venture in the foreseeable future. Over the next one to two years,
the Joint Venture is expected to incur labor costs related to the development of
our second generation commercial system as well as general and administrative
expenses, offset by royalty and other revenue expected to be generated by
25
our
current Celution® 800/CRS and future generation devices. Though
we have no obligation to do so, we plan to contribute funding to the Joint
Venture to cover any costs should the Joint Venture deplete its cash
balance.
Liquidity
and Capital Resources
Short-term and long-term
liquidity
The
following is a summary of our key liquidity measures at March 31, 2009 and
December 31, 2008:
March
31,
|
December
31,
|
|||||||
2009
|
2008
|
|||||||
Cash
and cash equivalents
|
$ | 15,472,000 | $ | 12,611,000 | ||||
Current
assets
|
$ | 19,700,000 | $ | 17,225,000 | ||||
Current
liabilities
|
6,892,000 | 7,135,000 | ||||||
Working
capital
|
$ | 12,808,000 | $ | 10,090,000 |
In order
to continue the operations of our regenerative cell business at or near current
levels, we will need to raise additional capital in the near term.
During
2008, we initiated our commercialization activities while simultaneously
pursuing available financing sources to support operations and
growth. We have had, and continue to have, an ongoing need to raise
additional cash from outside sources to fund our operations. However,
our ability to raise capital has been adversely affected by current credit
conditions and the downturn in the financial markets and the global
economy. Accordingly, the combination of these facts raises
substantial doubt as to the Company’s ability to continue as a going
concern. The accompanying consolidated financial statements and
financial statement schedule have been prepared assuming that the Company will
continue as a going concern. If we are unsuccessful in our efforts to
raise outside capital in the near term, we will be required to further reduce
our research, development, and administrative operations, including reduction of
our employee base, in order to offset the lack of available
funding.
We are
pursuing financing opportunities in both the private and public debt and equity
markets as well as through strategic corporate partnerships. We have
an established history of raising capital through these platforms, and we are
currently involved in negotiations with multiple parties. In August
2008, we raised approximately $17,000,000 in gross proceeds from a private
placement of 2,825,517 unregistered shares of common stock and 1,412,758 common
stock warrants (with an original exercise price of $8.50 per share) to a
syndicate of investors including Olympus Corporation, who acquired 1,000,000
unregistered shares and 500,000 common stock warrants in exchange for $6,000,000
of the total proceeds raised. In October 2008, we entered into a
secured Loan agreement with General Electric Capital Corporation and Silicon
Valley Bank (“Lenders”) to borrow up to $15,000,000. An initial term
loan of $7,500,000, less fees and expenses, was funded on October 14,
2008. We could not access the remaining $7,500,000 under this
facility as we were not able to meet certain financial prerequisites that had
been established by the Lenders. In March 2009, we raised
approximately $10,000,000 in gross proceeds from sale to institutional investors
of a total of 4,771,174 shares of our common stock and warrants to purchase up
to a total of 6,679,644 additional shares of our common with an exercise price
of $2.59 per share.
We expect
to continue to utilize our cash and cash equivalents to fund operations through
the next nine months, subject to minimum cash and cash liquidity requirements of
the Loan and Security Agreement with the Lenders, which requires that we
maintain at least three months of cash on hand to avoid an event of default
under the Loan and Security Agreement. We continue to seek additional
cash through product revenues, strategic collaborations, and future sales of
equity or debt securities. Although there can be no assurance given, we
hope to successfully complete one or more additional financing transactions and
corporate partnerships in the near-term. Without this additional capital,
current working capital and cash generated from sales and containment of costs
will not provide adequate funding for operations at their current levels. If
such efforts are not successful, we will need to further reduce or curtail our
operations and this could negatively affect our ability to achieve corporate
growth goals. We have implemented an operating plan that reduces certain
operations to focus almost entirely on the supply of current products to
existing or new distribution channels. In addition, as part of this plan,
there will be minimal expenditures for ongoing scientific research, product
development or clinical research. This impacts research and development
headcount, external subcontractor expenditures, capital outlay and general and
administrative expenditures related to the supervision of such
activities. In parallel, we significantly reduced administrative
staff and salaries consistent with the overall reduction in scope of
operations. In aggregate, such reductions resulted in eliminations of
roles for the many of the Company’s current staff and the deferral or
elimination of most development projects until such time that cash resources are
available from operations or outside sources to re-establish development and
growth plans. Management is currently reviewing contractual obligations
related to the pre-clinical and clinical commitments along with minimum purchase
requirements to include deferral of such commitments as part of this
plan. Based on estimated annualized impact of reductions described
above, we believe that cash operating requirements in the near term may be
reduced to a range of $1.0 to $1.2 million per month.
26
From
inception to March 31, 2009, we have financed our operations primarily
by:
·
|
Issuing
stock in pre-IPO transactions, a 2000 initial public offering in Germany,
and stock option exercises,
|
·
|
Generating
revenues,
|
·
|
Selling
the bioresorbable implant CMF product line in September
2002,
|
·
|
Selling
the bioresorbable implant Thin Film product line (except for the territory
of Japan), in May 2004,
|
·
|
Licensing
distribution rights to Thin Film in Japan, in exchange for an upfront
license fee in July 2004 and an initial development milestone payment in
October 2004,
|
·
|
Obtaining
a modest amount of capital equipment long-term
financing,
|
·
|
Selling
1,100,000 shares of common stock to Olympus under an agreement which
closed in May 2005,
|
·
|
Receiving
upfront and milestone fees from our Joint Venture with Olympus, which was
entered into in November 2005,
|
·
|
Receiving
funds in exchange for granting Olympus an exclusive right to negotiate in
February 2006,
|
·
|
Receiving
$16,219,000 in net proceeds from a common stock sale under the shelf
registration statement in August
2006,
|
·
|
Receiving
$19,901,000 in net proceeds from the sale of common stock plus common
stock warrants under the shelf registration statement in February
2007,
|
·
|
Receiving
$6,000,000 in net proceeds from a private placement to Green Hospital
Supply, Inc. in April 2007, and
|
·
|
Receiving
gross proceeds of $3,175,000 from the sale of our bioresorbable spine and
orthopedic surgical implant product line to Kensey Nash in May
2007.
|
·
|
Receiving
$12,000,000 in net proceeds from a private placement to Green Hospital
Supply, Inc. during first half
2008.
|
·
|
Receiving
$17,000,000 in gross proceeds in August 2008 from a private placement of
2,825,517 unregistered shares of common stock and 1,412,758 common stock
warrants (with an original exercise price of $8.50 per share) to a
syndicate of investors including Olympus Corporation, who acquired
1,000,000 unregistered shares and 500,000 common stock warrants in
exchange for $6,000,000 of the total proceeds
raised.
|
·
|
Obtaining
a term loan of $7,500,000 from General Electric Capital Corporation and
Silicon Valley Bank (Lenders) in October
2008.
|
·
|
Receiving
approximately $10,000,000 in gross proceeds from sale to institutional
investors of a total of 4,771,174 shares of our common stock and warrants
to purchase up to a total of 6,679,644 additional shares of our common
with an exercise price of $2.59 per share in March
2009.
|
We do not
expect significant capital expenditures during the remainder of
2009.
Any
excess funds are expected to be retained as cash equivalents in money market
accounts.
Our cash
requirements for remainder of 2009 and beyond will depend on numerous factors,
including our successful restructuring of our operating plan and business
strategies as described above. Under our previous operating plan, we
would have expected to incur research and development expenses at high levels in
our regenerative cell platform for an extended period of time. Under
the new plan, we will seek to reduce these expenditures as much as
possible.
27
The
following summarizes our contractual obligations and other commitments at March
31, 2009, and the effect such obligations could have on our liquidity and cash
flow in future periods (see additional discussion regarding Liquidity at the
beginning of Item 2, Management’s Discussion and Analysis of Financial Condition
and Results of Operations):
Payments
due by period
|
||||||||||||||||||||
Contractual
Obligations
|
Total
|
Less
than 1
year
|
1
– 3 years
|
3
– 5 years
|
More
than
5
years
|
|||||||||||||||
Long-term
obligations
|
$ | 7,710,000 | $ | 2,497,000 | $ | 5,196,000 | $ | 17,000 | $ | — | ||||||||||
Interest
commitment on long-term obligations
|
1,171,000 | 678,000 | 488,000 | 5,000 | — | |||||||||||||||
Operating
lease obligations
|
2,268,000 | 1,674,000 | 526,000 | 66,000 | 2,000 | |||||||||||||||
Minimum
purchase requirements
|
2,125,000 | 1,169,000 | 956,000 | — | — | |||||||||||||||
Pre-clinical
research study obligations
|
281,000 | 281,000 | — | — | — | |||||||||||||||
Clinical
research study obligations
|
5,500,000 | 2,500,000 | 3,000,000 | — | — | |||||||||||||||
Total
|
$ | 19,055,000 | $ | 8,799,000 | $ | 10,166,000 | $ | 88,000 | $ | 2,000 |
Cash
(used in) provided by operating, investing, and financing activities for the
three months ended March 31, 2009 and 2008 is summarized as
follows:
For
the three months ended March 31,
|
||||||||
2009
|
2008
|
|||||||
Net
cash used in operating activities
|
$ | (6,074,000 | ) | $ | (9,162,000 | ) | ||
Net
cash used in investing activities
|
(9,000 | ) | (175,000 | ) | ||||
Net
cash provided by financing activities
|
8,944,000 | 5,882,000 |
Operating
activities
Net cash
used in operating activities for both periods presented resulted primarily from
expenditures related to our regenerative cell research and development
efforts.
Research
and development efforts and other operational activities, offset in part by
product sales, generated an operating loss of $6,098,000 for the three months
ended March 31, 2009. The operating cash impact of this loss was
$6,074,000, after adjusting for the consideration of non-cash share-based
compensation, other adjustments for material non-cash activities, such as
depreciation and amortization, change in fair value of option liabilities and
warrants, changes in working capital due to timing of product shipments
(accounts receivable) and payment of liabilities.
Research
and development efforts and other operational activities, offset in part by
product sales, generated an operating loss of $8,273,000 for the three months
ended March 31, 2008. The operating cash impact of this loss was
$9,162,000, after adjusting for the recognition of non-cash development revenue
of $774,000, the consideration of non-cash share-based compensation of $554,000,
other adjustments for material non-cash activities, such as depreciation and
amortization, change in fair value of option liabilities, changes in working
capital due to timing of product shipments (accounts receivable) and payment of
liabilities.
Investing
activities
Net cash
used in investing activities for the three months ended March 31, 2009 and 2008
resulted from purchases of property and equipment.
Financing
Activities
The net
cash provided by financing activities for the three months ended March 31, 2009
related primarily to an equity offering of approximately $10,000,000 in gross
proceeds to institutional investors for a total of 4,771,174 shares of our
common stock and warrants to purchase up to a total of 6,679,644 additional
shares of our common stock with an exercise price of $2.59 per
share.
The net
cash provided by financing activities for the three months ended March 31, 2008
related mainly to the private issuance of 1,000,000 shares of unregistered
common stock to Green Hospital Supply, Inc. for $6,000,000.
Critical
Accounting Policies and Significant Estimates
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires us to make estimates
and assumptions that affect the reported amounts of our assets, liabilities,
revenues, and expenses, and that affects our recognition and disclosure of
contingent assets and liabilities.
28
While our
estimates are based on assumptions we consider reasonable at the time they were
made, our actual results may differ from our estimates, perhaps
significantly. If results differ materially from our estimates, we
will make adjustments to our financial statements prospectively as we become
aware of the necessity for an adjustment.
We
believe it is important for you to understand our most critical accounting
policies as these are policies that require us to make our most significant
judgments and, as a result, could have the greatest impact on our future
financial results. Below are the key updates to our accounting
policies for the three months ended March 31, 2009. These accounting
policies should be read in conjunction with the accounting policies included in
our annual report on Form 10-K for the year ended December 31,
2008.
Warrant
Liability
Effective
January 1, 2009 we adopted the provisions of Emerging Issues Task Force (“EITF”)
Issue No. 07-5, “Determining Whether an Instrument (or Embedded Feature) Is
Indexed to an Entity’s Own Stock” (“EITF 07-5”). EITF 07-5 applies to any
freestanding financial instruments or embedded features that have the
characteristics of a derivative, as defined by SFAS No. 133, “Accounting for
Derivative Instruments and Hedging Activities,” and to any freestanding
financial instruments that are potentially settled in an entity’s own common
stock. As a result of adopting EITF 07-5, the original amount of 1,412,758 of
our issued and outstanding common stock purchase warrants previously classified
as a component of stockholders’ deficit are now presented as liabilities.. These
warrants had an original exercise price of $8.50 and expire in August 2013. (see
note 15 for warrant adjustments) As such, effective January 1, 2009 we
reclassified the fair value of these common stock purchase warrants, which have
exercise price reset features, from equity to liability status as if these
warrants were treated as a derivative liability since their date of issue in
August 2008. On January 1, 2009, we reclassified from additional paid-in
capital, as a cumulative effect adjustment, $2.9 million to beginning
accumulated deficit and $1.7 million to a long-term warrant liability to
recognize the fair value of such warrants on that date. The fair value of these
warrants declined to $677,000 as of March 31, 2009, and we recognized a $1.0
million gain from the change in fair value of warrants for the three months
ended March 31, 2009.
These
common stock purchase warrants were initially issued in connection with our
August 2008 private placement of 2,825,517 unregistered shares of common stock
and 1,412,758 common stock warrants. The common stock purchase warrants were not
issued with the intent of effectively hedging any future cash flow, fair value
of any asset, liability or any net investment in a foreign operation. The
warrants do not qualify for hedge accounting, and as such, all future changes in
their fair value will be recognized currently in earnings until such time as the
warrants are exercised or expire. These common stock purchase warrants do not
trade in an active securities market, and as such, we estimate their fair value
using the Black-Scholes option pricing model and the following
assumptions:
As
of
March
31, 2009
|
As
of
December
31, 2008
|
|||||||
Expected
term
|
4.36
years
|
4.61
years
|
||||||
Common
stock market price
|
$ | 1.72 | $ | 3.61 | ||||
Risk-free
interest rate
|
1.67 | % | 1.55 | % | ||||
Expected
volatility
|
70.05 | % | 65.71 | % | ||||
Resulting
fair value (per warrant)
|
$ | 0.40 | $ | 1.20 |
Expected
volatility is based primarily on historical volatility. Historical volatility
was computed using daily pricing observations for recent periods that correspond
to the expected term of the warrants. We believe this method produces an
estimate that is representative of our expectations of future volatility over
the expected term of these warrants. We currently have no reason to believe
future volatility over the expected remaining life of these warrants is likely
to differ materially from historical volatility. The expected life is based on
the remaining term of the warrants. The risk-free interest rate is based on
five-year U.S. Treasury securities.
Revenue
Recognition
Product
Sales
We
recognize revenue from product sales when the following fundamental criteria are
met: (i) persuasive evidence of an arrangement exists, (ii) delivery has
occurred, (iii) the price to the customer is fixed or determinable and (iv)
collection of the resulting accounts receivable is reasonably
assured.
For all
sales, we use a binding purchase order or a signed agreement as evidence of an
arrangement. Revenue for these product sales will be recognized upon
delivery to the customer, as all risks and rewards of ownership have been
substantively transferred to the customer at that point. For
Celution® 800/CRS
System sales to customers who arrange for and manage the shipping process, we
recognize revenue upon shipment from our facilities. Shipping and
handling costs that are billed to our customers are classified as revenue, in
accordance with Emerging Issues Task Force (EITF) Issue No. 00-10, “Accounting
for Shipping and Handling Fees and Costs” (“EITF 00-10”). The
customer’s obligation to pay and the payment terms are set at the time of
delivery and are not dependent on the
subsequent use or resale of our product.
29
For those
sales that include multiple deliverables, we allocate revenue based on the
relative fair values of the individual components as determined in accordance
with EITF Issue No. 00-21, “Revenue Arrangements with Multiple Deliverables”
(“EITF 00-21”). When more than one element such as product
maintenance or technical support services are included in an arrangement, we
allocate revenue between the elements based on each element’s relative fair
value, provided that each element meets the criteria for treatment as a separate
unit of accounting. An item is considered a separate unit of
accounting if it has value to the customer on a standalone basis and there is
objective and reliable evidence of the fair value of the undelivered
items. Fair value is generally determined based upon the price
charged when the element is sold separately. In the absence of fair
value for a delivered element, we allocate revenue first to the fair value of
the undelivered elements and allocate the residual revenue to the delivered
elements. Fair values for undelivered elements are determined based
on vendor-specific objective evidence. Deferred service revenue is
recognized ratably over the period the services are provided. In the
absence of fair value for an undelivered element, the arrangement is accounted
for as a single unit of accounting, resulting in a deferral of revenue
recognition for delivered elements until all undelivered elements have been
fulfilled.
Concentration
of Significant Customers
For the
three months ended March 31, 2009, our sales were concentrated in two
distributors and one direct customer, which in aggregate comprised 72% of our
revenue recognized for the three months ended March 31,
2009. Asia-Pacific region accounted for 65% of our revenue recognized
for the three months ended March 31, 2009. Additionally, one
distributor and one end customer accounted for 70% of total outstanding accounts
receivable as of March 31, 2009. We continuously monitor the
creditworthiness of our distributors and believe our sales to diverse end
customers and to diverse geographies further serve to mitigate our exposure to
credit risk.
Research
and Development
We earn
revenue for performing tasks under research and development agreements with both
commercial enterprises, such as Olympus and Senko, and governmental agencies
like the National Institutes of Health (“NIH”). Revenue earned under
development agreements is classified as either research grant or development
revenues depending on the nature of the arrangement. Revenues derived
from reimbursement of direct out-of-pocket expenses for research costs
associated with grants are presented in compliance with EITF Issue No. 99-19,
“Reporting Revenue Gross as a Principal Versus Net as an Agent,” and EITF Issue
No. 01-14, “Income Statement Characterization of Reimbursements Received for
“Out-of-Pocket” Expenses Incurred.” In accordance with the criteria
established by these EITF Issues, we record grant revenue for the gross amount
of the reimbursement. The costs associated with these reimbursements
are reflected as a component of research and development expense in our
consolidated statements of operations. Additionally, research and
development arrangements we have with commercial enterprises such as Olympus and
Senko are considered a key component of our central and ongoing
operations. Accordingly, when recognized, the inflows from such
arrangements are presented as revenues in our consolidated statements of
operations.
We
received substantial funds from Olympus and Olympus-Cytori, Inc. during 2005 and
2006. We recorded upfront fees totaling $28,311,000 as deferred
revenues, related party. In exchange for these proceeds, we agreed to
(a) provide Olympus-Cytori, Inc. an exclusive and perpetual license to our
therapeutic device technology, including the Celution® System platform and
certain related intellectual property, and (b) provide future development
contributions related to commercializing the Celution® System
platform. The license and development services are not separable
under EITF 00-21. The recognition of this deferred amount requires
achievement of service related milestones, under a proportional performance
methodology. If and as such revenues are recognized, deferred revenue
will be decreased. Proportional performance methodology was elected
due to the nature of our development obligations and efforts in support of the
Joint Venture (“JV”), including product development activities and regulatory
efforts to support the commercialization of the JV products. The application of
this methodology uses the achievement of R&D milestones as outputs of value
to the JV. We received up-front, non-refundable payments in
connection with these development obligations, which we have broken down into
specific R&D milestones that are definable and substantive in nature, and
which will result in value to the JV when achieved. Revenue will be
recognized as the above mentioned R&D milestones are
completed. Of the amounts received and deferred, we recognized
development revenues of $774,000 for the three months ended March 31,
2008. No similar revenue was recognized for the three months ended
March 31, 2009. All related development costs are expensed as
incurred and are included in research and development expense on the statement
of operations.
Under a
Distribution Agreement with Senko, we granted to Senko an exclusive license to
sell and distribute certain Thin Film products in Japan. We have also
earned or will be entitled to earn additional payments under the Distribution
Agreement based on achieving the defined research and development milestones.
There was no development revenue recognized during the three months ended March
31, 2009 and 2008.
30
Goodwill
Impairment Testing
In late
2002, we purchased StemSource, Inc. and recognized over $4,600,000 in goodwill
associated with the acquisition, of which $3,922,000 remains on our balance
sheet as of March 31, 2009. As required by Statement of Financial
Accounting Standard No. 142, “Goodwill and Other Intangible Assets” (“SFAS
142”), we must test this goodwill at least annually for impairment as well as
when an event occurs or circumstances change such that it is reasonably possible
that impairment may exist. The application of the goodwill impairment
test involves a substantial amount of judgment. The judgments
employed may have an effect on whether a goodwill impairment loss is
recognized.
In 2008,
we completed our goodwill impairment testing using a combination of an
income-based approach incorporating discounted projections of estimated future
cash flows and a market-based approach. We concluded that the fair
value of our main reporting unit exceeded its carrying value, and that none of
our reported goodwill was impaired.
Variable
Interest Entity (Olympus-Cytori Joint Venture)
FASB
Interpretation No. 46 (revised 2003), “Consolidation of Variable Interest
Entities - An Interpretation of ARB No. 51” (“FIN 46R”) requires a variable
interest entity, or VIE, to be consolidated by its primary
beneficiary. Evaluating whether an entity is a VIE and determining
its primary beneficiary involves significant judgment.
We
concluded that the Olympus-Cytori Joint Venture was a VIE based on the following
factors:
·
|
Under
FIN 46R, an entity is a VIE if it has insufficient equity to finance its
activities. We recognized that the initial cash contributed to
the Joint Venture formed by Olympus and Cytori ($30,000,000) would be
completely utilized by the first quarter of 2006. Moreover, it
was highly unlikely that the Joint Venture would be able to obtain the
necessary financing from third party lenders without additional
subordinated financial support – such as personal guarantees by one or
both of the Joint Venture stockholders. Accordingly, the Joint
Venture will require additional financial support from Olympus and Cytori
to finance its ongoing operations, indicating that the Joint Venture is a
VIE. We contributed $300,000 and $150,000 in the fourth quarter
of 2007 and first quarter of 2006, respectively, to fund the Joint
Venture’s ongoing operations.
|
·
|
Moreover,
Olympus has a contingent put option that would, in specified
circumstances, require Cytori to purchase Olympus’s interests in the Joint
Venture for a fixed amount of $22,000,000. Accordingly, Olympus
is protected in some circumstances from absorbing all expected losses in
the Joint Venture. Under FIN 46R, this means that Olympus may
not be an “at-risk” equity holder, although Olympus clearly has decision
rights over the operations of the Joint
Venture.
|
Because
the Joint Venture is undercapitalized, and because one of the Joint Venture’s
decision makers may be protected from losses, we have determined that the Joint
Venture is a VIE under FIN 46R.
As noted
previously, a VIE is consolidated by its primary beneficiary. The
primary beneficiary is defined in FIN 46R as the entity that would absorb the
majority of the VIE’s expected losses or be entitled to receive the majority of
the VIE’s residual returns (or both).
Significant
judgment was involved in determining the primary beneficiary of the Joint
Venture. Under FIN 46R, we believe that Olympus and Cytori are
“de facto agents” and, together, will absorb more than 50% of the Joint
Venture’s expected losses and residual returns. Ultimately, we
concluded that Olympus, and not Cytori, was the party most closely related with
the joint venture and, hence, its primary beneficiary. Our conclusion
was based on the following factors:
·
|
The
business operations of the Joint Venture will be most closely aligned to
those of Olympus (i.e., the manufacture of
devices).
|
·
|
Olympus
controls the Board of Directors, as well as the day-to-day operations of
the Joint Venture.
|
The
application of FIN 46R involves substantial judgment. Had we
consolidated the Joint Venture, though, there would be no effect on our net loss
or shareholders’ equity at March 31, 2009 or for the three months then
ended. However, certain balance sheet and income statement captions
would have been presented in a different manner. For instance, we
would not have presented a single line item entitled investment in joint venture
in our balance sheet but, instead, would have performed a line by line
consolidation of each of the Joint Venture’s accounts into our financial
statements.
31
Income
Taxes
Income
taxes are accounted for under the asset and liability
method. Deferred tax assets and liabilities are recognized for the
future tax consequences attributable to differences between the financial
statement carrying amounts of existing assets and liabilities and their
respective tax bases and operating loss and tax credit carry
forwards. Deferred tax assets and liabilities are measured using
enacted tax rates expected to apply to taxable income (loss) in the years in
which those temporary differences are expected to be recovered or
settled. Due to our history of loss, a full valuation allowance is
recognized against deferred tax assets.
In July
2006, FASB issued Interpretation No. 48, “Accounting for Uncertainty in
Income Taxes—An Interpretation of FASB Statement No. 109” (“FIN
48”). FIN 48 clarifies the accounting for uncertainty in income taxes
recognized in an entity’s financial statements in accordance with FASB Statement
No. 109, “Accounting for Income Taxes”, and prescribes a recognition
threshold and measurement attributes for financial statement disclosure of tax
positions taken or expected to be taken on a tax return. Under FIN 48, the
impact of an uncertain income tax position on the income tax return must be
recognized at the largest amount that is more-likely-than-not to be sustained
upon audit by the relevant taxing authority. An uncertain income tax
position will not be recognized if it has less than a 50% likelihood of being
sustained. Additionally, FIN 48 provides guidance on derecognition,
classification, interest and penalties, accounting in interim periods,
disclosure and transition.
Recent
Accounting Pronouncements
In February 2008, the FASB issued Staff
Position “Effective Date
of FASB Statement No. 157” (FSP No. 157-2), which delayed the adoption date
until January 1, 2009 for non-financial assets and liabilities that are measured
at fair value on a non-recurring basis, such as goodwill and identifiable
intangible assets. The adoption of SFAS 157 for non-financial assets and
liabilities did not have a material impact on our consolidated condensed
financial position or results of operations.
On
January 1, 2009, we adopted SFAS No. 160, “Noncontrolling Interests
in Consolidated Financial Statements - an Amendment of ARB No. 51” ("SFAS
160"). SFAS 160 establishes new accounting and reporting standards
for the noncontrolling interest in a subsidiary and for the deconsolidation of a
subsidiary. SFAS 160 is effective for annual periods beginning on or after
December 15, 2008. The adoption of SFAS 160 did not have a
significant effect on our consolidated condensed financial
statements.
On
January 1, 2009, we adopted SFAS No. 141 (revised 2007), “Business Combinations”
("SFAS 141R"). SFAS 141R retains the fundamental requirements of
Statement No. 141 to account for all business combinations using the acquisition
method (formerly the purchase method) and for an acquiring entity to be
identified in all business combinations. However, the new standard
requires the acquiring entity in a business combination to recognize all the
assets acquired and liabilities assumed in the transaction; establishes the
acquisition-date fair value as the measurement objective for all assets acquired
and liabilities assumed; and requires the acquirer to disclose the information
they need to evaluate and understand the nature and financial effect of the
business combination. SFAS 141R is effective for acquisitions made on
or after the first day of annual periods beginning on or after December 15,
2008. The adoption of SFAS 141R did not have a significant effect on
our consolidated condensed financial statements.
On
January 1, 2009, we adopted EITF Issue 07-1, “Accounting for Collaborative
Arrangements” (“EITF 07-1”). EITF 07-1 requires collaborators to
present the results of activities for which they act as the principal on a gross
basis and report any payments received from (made to) other collaborators based
on other applicable GAAP or, in the absence of other applicable GAAP, based on
analogy to authoritative accounting literature or a reasonable, rational, and
consistently applied accounting policy election. The guidance is
effective for fiscal years beginning after December 15, 2008. The
adoption of EITF 07-1 did not have a significant effect on our consolidated
condensed financial statements.
Effective
January 1, 2009, we adopted the provisions of Emerging Issues Task Force
(“EITF”) Issue No. 07-5, “Determining Whether an Instrument (or Embedded
Feature) Is Indexed to an Entity’s Own Stock” (“EITF 07-5”). EITF 07-5 applies
to any freestanding financial instruments or embedded features that have the
characteristics of a derivative, as defined by SFAS No. 133, “Accounting for
Derivative Instruments and Hedging Activities,” and to any freestanding
financial instruments that are potentially settled in an entity’s own common
stock. As a result of adopting EITF 07-5, the original amount of 1,412,758 of
our issued and outstanding common stock purchase warrants previously treated as
equity pursuant to the derivative treatment exemption were no longer afforded
equity treatment. These warrants had an original exercise price of $8.50 and
expire in August 2013. (see note 15 for warrant adjustments) As such, effective
January 1, 2009, we reclassified the fair value of these common stock purchase
warrants, which have exercise price reset features, from equity to liability
status as if these warrants were treated as a derivative liability since their
date of issue in August 2008. On January 1, 2009, we reclassified from
additional paid-in capital, as a cumulative effect adjustment, $2.9 million to
beginning accumulated deficit and $1.7 million to a long-term warrant liability
to recognize the fair value of such warrants on that date. The fair value of
these warrants declined to $677,000 as of March 31, 2009, and we recognized a
$1.0 million gain from the change in fair value of warrants for the three months
ended March 31, 2009.
In April
2008, the FASB issued FASB Staff Position (“FSP”) FAS 142-3, “Determination of
the Useful Life of Intangible Assets.” This FSP amends the
factors that should be considered in developing renewal or extension assumptions
used to determine
32
the
useful life of a recognized intangible asset under FASB Statement No. 142, Goodwill and Other Intangible
Assets. The intent of this FSP is to improve the consistency between the
useful life of a recognized intangible asset under Statement 142 and the period
of expected cash flows used to measure the fair value of the asset under FASB
Statement No. 141R, and other U.S. generally accepted accounting principles.
This FSP is effective for our interim and annual financial statements beginning
after November 15, 2008. The adoption of this FSP did not have a material impact
on our consolidated condensed financial statements.
On
January 1, 2009, we adopted FSP No. EITF 03-6-1, “Determining Whether
Instruments Granted in Share-Based Payment Transactions Are Participating
Securities,” (FSP EITF 03-6-1). FSP EITF 03-6-1 states that unvested share-based
payment awards that contain nonforfeitable rights to dividends or dividend
equivalents (whether paid or unpaid) are participating securities and shall be
included in the computation of earnings per share pursuant to the two-class
method. The adoption of FSP EITF 03-6-1 did not have a material impact on our
consolidated condensed financial statements.
In
November 2008, the FASB ratified EITF Issue No. 08-6, “Equity Method Investment
Accounting Considerations” (“EITF 08-6”). EITF 08-6 applies to all
investments accounted for under the equity method. It states that an
entity shall measure its equity investment initially at
cost. Contingent consideration should only be included in the initial
measurement of the equity method investment if it is required to be recognized
by specific authoritative guidance other than SFAS No. 141R. However,
if any equity method investment agreement involves a contingent consideration
arrangement in which the fair value of the investor’s share of the investee’s
net assets exceeds the investor’s initial cost, a liability should be
recognized. An equity method investor is required to recognize
other-than-temporary impairments of an equity method investment and shall
account for a share issuance by an investee as if the investor had sold a
proportionate share of its investment. Any gain or loss to the
investor resulting from an investee’s share issuance shall be recognized in
earnings. EITF 08-6 shall be effective in fiscal years beginning on or after
December 15, 2008, and interim periods within those fiscal years and shall be
applied prospectively. Adoption of EITF 08-6 did not have a material
impact on our consolidated condensed financial statements.
Item 3. Quantitative and Qualitative Disclosures about
Market Risk
We are
exposed to market risk related to fluctuations in foreign currency exchange
rates.
Interest
Rate Exposure
We are not subject to market risk due
to fluctuations in interest rates on our long-term obligations as they bear a
fixed rate of interest. Our exposure relates primarily to short-term
investments, including funds classified as cash equivalents. As of
March 31, 2009, all excess funds were invested in money market funds and other
highly liquid investments, therefore our interest rate exposure is not
considered to be material.
Foreign
Currency Exchange Rate Exposure
Our
exposure to market risk due to fluctuations in foreign currency exchange rates
relates primarily to our activities in Europe and Japan. Transaction
gains or losses resulting from cash balances and revenues have not been
significant in the past and we are not engaged in any hedging activity in the
Euro, the Yen or other currencies. Based on our cash balances and
revenues derived from markets other than the United States for the year ended
December 31, 2008, a hypothetical 10% adverse change in the Euro or Yen against
the U.S. dollar would not result in a material foreign currency exchange
loss. Consequently, we do not expect that reductions in the value of
such sales denominated in foreign currencies resulting from even a sudden or
significant fluctuation in foreign exchange rates would have a direct material
impact on our financial position, results of operations or cash
flows.
Notwithstanding
the foregoing, the indirect effect of fluctuations in interest rates and foreign
currency exchange rates could have a material adverse effect on our business,
financial condition and results of operations. For example, foreign
currency exchange rate fluctuations may affect international demand for our
products. In addition, interest rate fluctuations may affect our
customers’ buying patterns. Furthermore, interest rate and currency
exchange rate fluctuations may broadly influence the United States and foreign
economies resulting in a material adverse effect on our business, financial
condition and results of operations.
Under our
Japanese Thin Film agreement with Senko, we would receive payments in the nature
of royalties based on Senko’s net sales. Such sales and resulting
royalties would be Yen denominated.
Item 4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
We
maintain disclosure controls and procedures that are designed to ensure that
information required to be disclosed in our reports filed or furnished pursuant
to the Exchange Act is recorded, processed, summarized and reported within the
time periods specified in the Securities and Exchange Commission’s rules and
forms, and that such information is accumulated and communicated
33
to our
management, including our Chief Executive Officer and Chief Financial Officer,
as appropriate, to allow for timely decisions regarding required
disclosure. In designing and evaluating the disclosure controls and
procedures, management recognizes that any controls and procedures, no matter
how well designed and operated, can provide only reasonable assurance of
achieving the desired control objectives, and management necessarily is required
to apply its judgment in evaluating the cost-benefit relationship of possible
controls and procedures.
As
required by Rule 13a-15(b) under the Exchange Act, we carried out an evaluation,
under the supervision and with the participation of our management, including
our Chief Executive Officer and Chief Financial Officer, of the effectiveness of
the design and operation of our disclosure controls and procedures as of the end
of the period covered by this Quarterly Report of Form 10-Q. Based on
the foregoing, our Chief Executive Officer and Chief Financial Officer concluded
that our disclosure controls and procedures were effective and were operating at
a reasonable assurance level as of March 31, 2009.
Changes
in Internal Control over Financial Reporting
There has
been no change in our internal control over financial reporting during the
quarter ended March 31, 2009 that have materially affected, or are reasonably
likely to materially affect, our internal control over financial
reporting.
PART II. OTHER INFORMATION
Item
1. Legal
Proceedings
From time
to time, we have been involved in routine litigation incidental to the conduct
of our business. As of March 31, 2009, we were not a party to any material legal
proceeding. We are not formally a party to the University of
Pittsburgh patent litigation. However, we are responsible for
reimbursing certain related litigation costs. On June 12, 2008, we
received the Court’s final order concluding that the University of Pittsburgh’s
assignors were the sole inventors of the ‘231 Patent. The UC assignors are
appealing the Court’s decision and a Notice of Appeal was filed on July 9,
2008. Since our current products and products under development do not
practice the ‘231 Patent, our primary ongoing business activities and product
development pipeline should not be affected by the Court’s decision. Although
the ‘231 Patent is unrelated to our current products and product pipeline, we
believe that the ‘231 Patent and/or the other technology licensed from UC may
have long term potential to be useful for future product developments, and so we
have elected to support UC’s legal efforts in the appeal of the Court’s final
order.
Item 1A. Risk Factors
In
analyzing our company, you should consider carefully the following risk factors
together with all of the other information included in this quarterly report on
Form 10-Q. Factors that could adversely affect our business,
operating results, and financial condition, as well as adversely affect the
value of an investment in our common stock, include those discussed
below, as well as those discussed above in “Management’s Discussion and Analysis
of Financial Condition and Results of Operations” and elsewhere throughout this
quarterly report on Form 10-Q.
We are
subject to the following significant risks, among others:
We need to raise more cash
in the near term
We have
almost always had negative cash flows from operations. Our business
will continue to result in a substantial requirement for research and
development expenses for several years, during which we may not be able to bring
in sufficient cash and/or revenues to offset these expenses. We are
required to raise capital from one or more sources in the near term to continue
our operations at or close to the levels currently conducted. We
believe that without raising additional capital from accessible sources of
financing, as well as an increase in capital from our operations, we may not
have adequate funding to complete the development, pre-clinical
activities, clinical trials and marketing efforts required to
successfully bring our current and future products to market. In
addition, if we are not successful in raising additional cash we will be
required to negotiate with General Electric Capital Corporation (“GECC”) and
Silicon Valley Bank (“SVB”) to obtain an amendment to the cash liquidity
requirements of the Loan and Security Agreement dated October 14, 2008 (“Loan
Agreement”). If we are not successful in obtaining either the additional funding
or cash liquidity relief then we could be in default under the Loan Agreement.
If we are in default or if our senior secured lenders otherwise assert that
there has been an event of default, they may seek to accelerate our senior
secured loan and exercise their rights and remedies under the Loan Agreement,
including the sale of our property and other assets. In such event, we may
be forced to file a bankruptcy case or have an involuntary bankruptcy case filed
against us or otherwise liquidate our assets. Any of these events would
have a substantial and material adverse effect on our business, financial
condition, results of operations, the value of our common stock and warrants and
our ability to raise capital. There is no guarantee that adequate
funds will be available when needed from additional debt or equity financing,
arrangements with distribution partners, increased results of operations, or
from other sources, or on terms attractive to us. Although we entered
into a $15,000,000 loan facility with GECC and SVB in October 2008, we could not
access the remaining $7,500,000 under that facility as we were not able satisfy
certain financial conditions on or before December 12, 2008. The
inability to obtain
34
sufficient
additional funds in the near term would, at a minimum, require us to delay,
scale back, or eliminate some or all of our research or product development,
manufacturing operations, clinical or regulatory activities, which could have a
substantial negative effect on our results of operations and financial
condition.
Continued turmoil in the
economy could harm our business
Negative
trends in the general economy, including trends resulting from an actual or
perceived recession, tightening credit markets, increased cost of commodities,
including oil, actual or threatened military action by the United States and
threats of terrorist attacks in the United States and abroad, could cause a
reduction of investment in and available funding for companies in certain
industries, including ours. Our ability to raise capital has been and
may continue to be adversely affected by current credit conditions and the
downturn in the financial markets and the global economy.
We have never been
profitable on an operational basis and expect significant operating losses for
the next few years
We have
incurred net operating losses in each year since we started
business. As our focus on the Celution® System
platform and development of therapeutic applications for its cellular output has
increased, losses have resulted primarily from expenses associated with research
and development activities and general and administrative
expenses. While we are implementing cost reduction measures where
possible, we nonetheless expect to continue operating in a loss position on a
consolidated basis and that recurring operating expenses will be at high levels
for the next several years, in order to perform clinical trials, additional
pre-clinical research, product development, and marketing. As a
result of our historic losses, we have historically been, and continue to be,
reliant on raising outside capital to fund our operations as discussed in
the prior risk factor.
Our business strategy is
high-risk
We are
focusing our resources and efforts primarily on development of the Celution® System
family of products and the therapeutic applications of its cellular output,
which requires extensive cash needs for research and development
activities. This is a high-risk strategy because there is no
assurance that our products will ever become commercially viable (commercial
risk), that we will prevent other companies from depriving us of market share
and profit margins by selling products based on our inventions and developments
(legal risk), that we will successfully manage a company in a new area of
business (regenerative medicine) and on a different scale than we have operated
in the past (operational risk), that we will be able to achieve the desired
therapeutic results using stem and regenerative cells (scientific risk), or that
our cash resources will be adequate to develop our products until we become
profitable, if ever (financial risk). We are using our cash in one of
the riskiest industries in the economy (strategic risk). This may
make our stock an unsuitable investment for many investors.
We must keep our joint
venture with Olympus operating smoothly
Our
business cannot succeed on the currently anticipated timelines unless our Joint
Venture collaboration with Olympus goes well. We have given
Olympus-Cytori, Inc. an exclusive license to manufacture future generation
Celution® System
devices. If Olympus-Cytori, Inc. does not successfully develop and
manufacture these devices, we may not be able to commercialize any device or any
therapeutic products successfully into the market. In addition,
future disruption or breakup of our relationship would be extremely costly to
our reputation, in addition to causing many serious practical
problems.
We and
Olympus must overcome contractual and cultural barriers. Our
relationship is formally measured by a set of complex contracts, which have not
yet been tested in practice. In addition, many aspects of the
relationship will be non-contractual and must be worked out between the parties
and the responsible individuals. The Joint Venture is intended to
have a long life, and it is difficult to maintain cooperative relationships over
a long period of time in the face of various kinds of
change. Cultural differences, including language barrier to some
degree, may affect the efficiency of the relationship.
Olympus-Cytori,
Inc. is 50% owned by us and 50% owned by Olympus. By contract, each
side must consent before any of a wide variety of important business actions can
occur. This situation possesses a risk of potentially time-consuming
and difficult negotiations which could at some point delay the Joint Venture
from pursuing its business strategies.
Olympus
is entitled to designate the Joint Venture's chief executive officer and a
majority of its board of directors, which means that day-to-day decisions which
are not subject to a contractual veto will essentially be controlled by
Olympus. In addition, Olympus-Cytori, Inc. may require more money
than its current capitalization in order to complete development and production
of future generation devices. If we are unable to help provide future
financing for Olympus-Cytori, Inc., our relative equity interest in
Olympus-Cytori, Inc. may decrease.
Furthermore,
under a License/Joint Development Agreement among Olympus-Cytori, Inc., Olympus,
and us, Olympus will have a primary role in the development of Olympus-Cytori,
Inc.’s next generation devices. Although Olympus has extensive
experience in developing medical devices, this arrangement will result in a
reduction of our control over the development and manufacturing of the next
generation devices.
35
We have a limited operating
history; operating results and stock price can be volatile like many life
science companies
Our
prospects must be evaluated in light of the risks and difficulties frequently
encountered by emerging companies and particularly by such companies in rapidly
evolving and technologically advanced biotech and medical device
fields. Due to limited operating history and the transition from the
MacroPore biomaterials to the regenerative medicine business, comparisons of our
year-to-year operating results are not necessarily meaningful and the results
for any periods should not necessarily be relied upon as an indication of future
performance. All 2007 product revenues came from our spine and
orthopedics implant product line, which we sold in May 2007.
From time
to time, we have tried to update our investors’ expectations as to our operating
results by periodically announcing financial guidance. However, we
have in the past been forced to revise or withdraw such guidance due to lack of
visibility and predictability of product demand.
We are vulnerable to
competition and technological change, and also to physicians’
inertia
We
compete with many domestic and foreign companies in developing our technology
and products, including biotechnology, medical device, and pharmaceutical
companies. Many current and potential competitors have substantially
greater financial, technological, research and development, marketing, and
personnel resources. There is no assurance that our competitors will
not succeed in developing alternative products that are more effective, easier
to use, or more economical than those which we have developed or are in the
process of developing, or that would render our products obsolete and
non-competitive. In general, we may not be able to prevent others
from developing and marketing competitive products similar to ours or which
perform similar functions.
Competitors
may have greater experience in developing therapies or devices, conducting
clinical trials, obtaining regulatory clearances or approvals, manufacturing and
commercialization. It is possible that competitors may obtain patent
protection, approval, or clearance from the FDA or achieve commercialization
earlier than we can, any of which could have a substantial negative effect on
our business. Finally, Olympus and our other partners might pursue
parallel development of other technologies or products, which may result in a
partner developing additional products competitive with ours.
We
compete against cell-based therapies derived from alternate sources, such as
bone marrow, umbilical cord blood and potentially embryos. Doctors
historically are slow to adopt new technologies like ours, whatever the merits,
when older technologies continue to be supported by established
providers. Overcoming such inertia often requires very significant
marketing expenditures or definitive product performance and/or pricing
superiority.
We expect
physicians’ inertia and skepticism to also be a significant barrier as we
attempt to gain market penetration with our future products. We believe we will
need to finance lengthy time-consuming clinical studies (so as to provide
convincing evidence of the medical benefit) in order to overcome this inertia
and skepticism particularly in reconstructive surgery, cell preservation, the
cardiovascular area and many other indications.
Most potential applications
of our technology are pre-commercialization, which subjects us to development
and marketing risks
We are in
a relatively early stage of the path to commercialization with many of our
products. We believe that our long-term viability and growth will
depend in large part on our ability to develop commercial quality cell
processing devices and useful procedure-specific consumables, and to establish
the safety and efficacy of our therapies through clinical trials and
studies. With our Celution®
platform, we are pursuing new approaches for reconstructive surgery,
preservation of stem and regenerative cells for potential future use, therapies
for cardiovascular disease, gastrointestinal disorders and spine and orthopedic
conditions. There is no assurance that our development programs will
be successfully completed or that required regulatory clearances or approvals
will be obtained on a timely basis, if at all.
There is
no proven path for commercializing the Celution® System
platform in a way to earn a durable profit commensurate with the medical
benefit. Although we began to commercialize our reconstructive
surgery products in Europe and certain Asian markets, and our cell banking
products in Japan, Europe, and certain Asian markets in 2008, additional market
opportunities for our products and/or services are likely to be another two to
five years away.
Successful
development and market acceptance of our products is subject to developmental
risks, including failure of inventive imagination, ineffectiveness, lack of
safety, unreliability, failure to receive necessary regulatory clearances or
approvals, high commercial cost, preclusion or obsolescence resulting from third
parties’ proprietary rights or superior or equivalent products, competition from
copycat products, and general economic conditions affecting purchasing
patterns. There is no assurance that we or our partners will
successfully develop and commercialize our products, or that our competitors
will not develop competing technologies that are less expensive or
superior. Failure to successfully develop and market our products
would have a substantial negative effect on our results of operations and
financial condition.
36
The timing and amount of
Thin Film revenues from Senko are uncertain
The sole
remaining product line in our MacroPore Biosurgery segment is our Japan Thin
Film business. Our right to receive royalties from Senko, and to
recognize certain deferred revenues, depends on the timing of MHLW approval for
commercialization of the product in Japan. We have no control over
this timing and our previous expectations have not been met. Also,
even after commercialization, we will be dependent on Senko, our exclusive
distributor, to drive product sales in Japan.
There is
a risk that we could experience with Senko some of the same problems we
experienced in our previous relationship with Medtronic, which was the exclusive
distributor for our former bioresorbable spine and orthopedic implant product
line.
We have limited
manufacturing experience
We have
limited experience in manufacturing the Celution® System
platform or its consumables at a commercial level. With respect to
our Joint Venture, although Olympus is a highly capable and experienced
manufacturer of medical devices, there can be no guarantee that the
Olympus-Cytori Joint Venture will be able to successfully develop and
manufacture the next generation Celution® device
in a manner that is cost-effective or commercially viable, or that development
and manufacturing capabilities might not take much longer than currently
anticipated to be ready for the market.
Although
we have begun introduction of the Celution® 800 and
the Celution®
900-based StemSource® Cell
Bank in 2008, we cannot assure that we will be able to manufacture sufficient
numbers of such products to meet the demand, or that we will be able to overcome
unforeseen manufacturing difficulties for these sophisticated medical devices,
as we await the availability of the Joint Venture next generation Celution®
device.
In the
event that the Olympus-Cytori Joint Venture is not successful, Cytori may not
have the resources or ability to self-manufacture sufficient numbers of devices
and consumables to meet market demand, and this failure may substantially extend
the time it would take for us to bring a more advanced commercial device to
market. This makes us significantly dependant on the continued dedication and
skill of Olympus for the successful development of the next generation
Celution®
device.
We may not be able to
protect our proprietary rights
Our
success depends in part on whether we can maintain our existing patents, obtain
additional patents, maintain trade secret protection, and operate without
infringing on the proprietary rights of third parties.
Our
amended regenerative cell technology license agreement with the Regents of the
University of California, or the UC, contains certain developmental milestones,
which if not achieved could result in the loss of exclusivity or loss of the
license rights. The loss of such rights could impact our ability to develop
certain regenerative cell technology products. Also, our power as
licensee to successfully use these rights to exclude competitors from the market
is untested. In addition, further legal risk arises from a lawsuit
filed by the University of Pittsburgh in the United States District Court, or
the Court, naming all of the inventors who had not assigned their ownership
interest in Patent 6,777,231, which we refer to as the ‘231 Patent, to the
University of Pittsburgh, seeking a determination that its assignors, rather
than UC’s assignors, are the true inventors of ‘231 Patent. On June
12, 2008, we received the Court’s final order concluding that the University of
Pittsburgh’s assignors were the sole inventors of the ‘231 Patent, which
terminates UC’s rights to this patent unless the decision of the Court is
overturned. The UC assignors are appealing the Court’s decision and a
Notice of Appeal was filed on July 9, 2008. We are the exclusive,
worldwide licensee of the UC’s rights under this patent in humans, which relates
to adult stem cells isolated from adipose tissue that can differentiate into two
or more of a variety of cell types. If the UC assignors do not prevail on
appeal, our license rights to this patent will be permanently lost.
There can
be no assurance that any of our pending patent applications will be approved or
that we will develop additional proprietary products that are patentable. There
is also no assurance that any patents issued to us will provide us with
competitive advantages, will not be challenged by any third parties, or that the
patents of others will not prevent the commercialization of products
incorporating our technology. Furthermore, there can be no guarantee
that others will not independently develop similar products, duplicate any of
our products, or design around our patents.
Our
commercial success will also depend, in part, on our ability to avoid infringing
on patents issued to others. If we were judicially determined to be
infringing on any third-party patent, we could be required to pay damages, alter
our products or processes, obtain licenses, or cease certain
activities. If we are required in the future to obtain any licenses
from third parties for some of our products, there can be no guarantee that we
would be able to do so on commercially favorable terms, if at
all. U.S. patent applications are not immediately made public, so we
might be surprised by the grant to someone else of a patent on a technology we
are actively using. As noted above as to the University of Pittsburgh
lawsuit, even patents issued to us or our licensors might be judicially
determined to belong in full or in part to third parties.
37
Litigation,
which would result in substantial costs to us and diversion of effort on our
part, may be necessary to enforce or confirm the ownership of any patents issued
or licensed to us, or to determine the scope and validity of third-party
proprietary rights. If our competitors claim technology also claimed
by us and prepare and file patent applications in the United States of America,
we may have to participate in interference proceedings declared by the U.S.
Patent and Trademark Office or a foreign patent office to determine priority of
invention, which could result in substantial costs to and diversion of effort,
even if the eventual outcome is favorable to us. Any such litigation
or interference proceeding, regardless of outcome, could be expensive and
time-consuming.
In
addition to patents, which alone may not be able to protect the fundamentals of
our regenerative cell business, we also rely on unpatented trade secrets and
proprietary technological expertise. Our intended future cell-related
therapeutic products, such as consumables, are likely to fall largely into this
category. We rely, in part, on confidentiality agreements with our
partners, employees, advisors, vendors, and consultants to protect our trade
secrets and proprietary technological expertise. There can be no guarantee that
these agreements will not be breached, or that we will have adequate remedies
for any breach, or that our unpatented trade secrets and proprietary
technological expertise will not otherwise become known or be independently
discovered by competitors.
Failure
to obtain or maintain patent protection, or protect trade secrets, for any
reason (or third-party claims against our patents, trade secrets, or proprietary
rights, or our involvement in disputes over our patents, trade secrets, or
proprietary rights, including involvement in litigation), could have a
substantial negative effect on our results of operations and financial
condition.
We may not be able to
protect our intellectual property in countries outside the United
States
Intellectual
property law outside the United States is uncertain and in many countries is
currently undergoing review and revisions. The laws of some countries
do not protect our patent and other intellectual property rights to the same
extent as United States laws. This is particularly relevant to us as
we currently conduct most of our clinical trials outside of the United
States. Third parties may attempt to oppose the issuance of patents
to us in foreign countries by initiating opposition proceedings. Opposition
proceedings against any of our patent filings in a foreign country could have an
adverse effect on our corresponding patents that are issued or pending in the
U.S. It may be necessary or useful for us to participate in proceedings to
determine the validity of our patents or our competitors’ patents that have been
issued in countries other than the U.S. This could result in substantial costs,
divert our efforts and attention from other aspects of our business, and could
have a material adverse effect on our results of operations and financial
condition. We currently have pending patent applications in Europe, Australia,
Japan, Canada, China, Korea, and Singapore, among others.
We and Olympus-Cytori, Inc.
are subject to intensive FDA regulation
As newly
developed medical devices, Celution® System
family of products must receive regulatory clearances or approvals from the FDA
and, in many instances, from non-U.S. and state governments prior to their
sale. The Celution® System
family of products is subject to stringent government regulation in the United
States by the FDA under the Federal Food, Drug and Cosmetic Act. The
FDA regulates the design/development process, clinical testing, manufacture,
safety, labeling, sale, distribution, and promotion of medical devices and
drugs. Included among these regulations are pre-market clearance and
pre-market approval requirements, design control requirements, and the Quality
System Regulations/Good Manufacturing Practices. Other statutory and
regulatory requirements govern, among other things, establishment registration
and inspection, medical device listing, prohibitions against misbranding and
adulteration, labeling and post-market reporting.
The
regulatory process can be lengthy, expensive, and uncertain. Before
any new medical device may be introduced to the United States of America market,
the manufacturer generally must obtain FDA clearance or approval through either
the 510(k) pre-market notification process or the lengthier pre-market approval
application, or PMA, process. It generally takes from three to 12
months from submission to obtain 510(k) pre-market clearance, although it may
take longer. Approval of a PMA could take four or more years from the
time the process is initiated. The 510(k) and PMA processes can be
expensive, uncertain, and lengthy, and there is no guarantee of ultimate
clearance or approval. We expect that some of our future products
under development as well as Olympus-Cytori’s will be subject to the lengthier
PMA process. Securing FDA clearances and approvals may require the
submission of extensive clinical data and supporting information to the FDA, and
there can be no guarantee of ultimate clearance or approval. Failure
to comply with applicable requirements can result in application integrity
proceedings, fines, recalls or seizures of products, injunctions, civil
penalties, total or partial suspensions of production, withdrawals of existing
product approvals or clearances, refusals to approve or clear new applications
or notifications, and criminal prosecution.
Medical
devices are also subject to post-market reporting requirements for deaths or
serious injuries when the device may have caused or contributed to the death or
serious injury, and for certain device malfunctions that would be likely to
cause or contribute to a death or serious injury if the malfunction were to
recur. If safety or effectiveness problems occur after the product
reaches the market, the FDA may take steps to prevent or limit further marketing
of the product. Additionally, the FDA actively enforces regulations
prohibiting marketing and promotion of devices for indications or uses that have
not been cleared or approved by the FDA.
38
There can
be no guarantee that we will be able to obtain the necessary 510(k) clearances
or PMA approvals to market and manufacture our other products in the United
States of America for their intended use on a timely basis, if at
all. Delays in receipt of or failure to receive such clearances or
approvals, the loss of previously received clearances or approvals, or failure
to comply with existing or future regulatory requirements could have a
substantial negative effect on our results of operations and financial
condition.
To sell in international
markets, we will be subject to intensive regulation in foreign
countries
In
cooperation with our distribution partners, we intend to market our current and
future products both domestically and in many foreign markets. A number of risks
are inherent in international transactions. In order for us to market
our products in Europe, Canada, Japan and certain other non-U.S. jurisdictions,
we need to obtain and maintain required regulatory approvals or clearances and
must comply with extensive regulations regarding safety, manufacturing processes
and quality. For example, we still have not obtained regulatory
approval for our Thin Film products in Japan. These regulations,
including the requirements for approvals or clearances to market, may differ
from the FDA regulatory scheme. International sales also may be
limited or disrupted by political instability, price controls, trade
restrictions and changes in tariffs. Additionally, fluctuations in
currency exchange rates may adversely affect demand for our products by
increasing the price of our products in the currency of the countries in which
the products are sold.
There can
be no assurance that we will obtain regulatory approvals or clearances in all of
the countries where we intend to market our products, or that we will not incur
significant costs in obtaining or maintaining foreign regulatory approvals or
clearances, or that we will be able to successfully commercialize current or
future products in various foreign markets. Delays in receipt of
approvals or clearances to market our products in foreign countries, failure to
receive such approvals or clearances or the future loss of previously received
approvals or clearances could have a substantial negative effect on our results
of operations and financial condition.
Changing, New and/or
Emerging Government Regulations
Government
regulations can change without notice. Given that fact that Cytori operates in
various international markets, our access to such markets could change with
little to no warning due to a change in government regulations that suddenly
up-regulate our product(s) and create greater regulatory burden for our cell
therapy and cell banking technology products.
Due to
the fact that there are new and emerging cell therapy and cell banking
regulations that have recently been drafted and/or implemented in various
countries around the world, the application and subsequent implementation of
these new and emerging regulations have little to no precedence. Therefore, the
level of complexity and stringency is not known and may vary from country to
country, creating greater uncertainty for the international regulatory
process.
Health Insurance
Reimbursement Risks
New and
emerging cell therapy and cell banking technologies, such as those provided by
the Celution® System
family of products, may have difficulty or encounter significant delays in
obtaining health care reimbursement in some or all countries around the world
due to the novelty of our cell therapy and cell banking technology
and subsequent lack of existing reimbursement schemes / pathways. Therefore, the
creation of new reimbursement pathways may be complex and lengthy with no
assurances that such reimbursements will be successful. The lack of health
insurance reimbursement or reduced or minimal reimbursement pricing may have a
significant impact on our ability to successfully sell our cell therapy and cell
banking technology product(s) into a county or region.
Market Acceptance of New
Technology
New and
emerging cell therapy and cell banking technologies, such as those provided by
the Celution® System
family of products, may have difficulty or encounter significant delays in
obtaining market acceptance in some or all countries around the world due to the
novelty of our cell therapy and cell banking technologies. Therefore, the market
adoption of our cell therapy and cell banking technologies may be slow and
lengthy with no assurances that significant market adoption will be successful.
The lack of market adoption or reduced or minimal market adoption of our cell
therapy and cell banking technologies may have a significant impact on our
ability to successfully sell our product(s) into a country or
region.
We and/or the Joint Venture
have to maintain quality assurance certification and manufacturing
approvals
The
manufacture of our Celution® System
will be, and the manufacture of any future cell-related therapeutic products
would be, subject to periodic inspection by regulatory authorities and
distribution partners. The manufacture of devices and products for
human use is subject to regulation and inspection from time to time by the FDA
for compliance with the FDA’s Quality System Regulation, or QSR, requirements,
as well as equivalent requirements and inspections by state and non-U.S.
regulatory authorities. There can be no guarantee that the FDA or
other authorities will not, during the course of an inspection of existing or
new facilities, identify what they consider to be deficiencies in our compliance
with QSRs or other requirements and request, or seek remedial
action.
39
Failure
to comply with such regulations or a potential delay in attaining compliance may
adversely affect our manufacturing activities and could result in, among other
things, injunctions, civil penalties, FDA refusal to grant pre-market approvals
or clearances of future or pending product submissions, fines, recalls or
seizures of products, total or partial suspensions of production, and criminal
prosecution. There can be no assurance after such occurrences that we
will be able to obtain additional necessary regulatory approvals or clearances
on a timely basis, if at all. Delays in receipt of or failure to
receive such approvals or clearances, or the loss of previously received
approvals or clearances could have a substantial negative effect on our results
of operations and financial condition.
We depend on a few key
officers
Our
performance is substantially dependent on the performance of our executive
officers and other key scientific and sales staff, including Christopher J.
Calhoun, our Chief Executive Officer, and Marc Hedrick, MD, our
President. We rely upon them for strategic business decisions and
guidance. We believe that our future success in developing marketable products
and achieving a competitive position will depend in large part upon whether we
can attract and retain additional qualified management and scientific
personnel. Competition for such personnel is intense, and there can
be no assurance that we will be able to continue to attract and retain such
personnel. The loss of the services of one or more of our executive
officers or key scientific staff or the inability to attract and retain
additional personnel and develop expertise as needed could have a substantial
negative effect on our results of operations and financial
condition.
We may not have enough
product liability insurance
The
testing, manufacturing, marketing, and sale of our regenerative cell products
involve an inherent risk that product liability claims will be asserted against
us, our distribution partners, or licensees. There can be no
guarantee that our clinical trial and commercial product liability insurance is
adequate or will continue to be available in sufficient amounts or at an
acceptable cost, if at all. A product liability claim, product
recall, or other claim, as well as any claims for uninsured liabilities or in
excess of insured liabilities, could have a substantial negative effect on our
results of operations and financial condition. Also, well-publicized
claims could cause our stock to fall sharply, even before the merits of the
claims are decided by a court.
Our charter documents
contain anti-takeover provisions and we have adopted a Stockholder Rights Plan
to prevent hostile takeovers
Our
Amended and Restated Certificate of Incorporation and Bylaws contain certain
provisions that could prevent or delay the acquisition of the Company
by means of a tender offer, proxy contest, or otherwise. They could
discourage a third party from attempting to acquire control of Cytori, even if
such events would be beneficial to the interests of our
stockholders. Such provisions may have the effect of delaying,
deferring, or preventing a change of control of Cytori and consequently could
adversely affect the market price of our shares. Also, in 2003 we adopted a
Stockholder Rights Plan of the kind often referred to as a poison pill. The
purpose of the Stockholder Rights Plan is to prevent coercive takeover tactics
that may otherwise be utilized in takeover attempts. The existence of such a
rights plan may also prevent or delay a change in control of Cytori, and this
prevention or delay adversely affect the market price of our
shares.
We pay no
dividends
We have
never paid in the past, and currently do not intend to pay any cash dividends in
the foreseeable future.
Item 2. Unregistered Sales of Equity
Securities and Use of Proceeds
On
February 8, 2008, we agreed to sell 2,000,000 shares of unregistered common
stock to Green Hospital Supply, Inc. for $12,000,000 cash, or $6.00 per share in
a private stock placement. On February 29, 2008 we closed the first
half of the private placement with Green Hospital Supply, Inc. and received
$6,000,000 in exchange for 1,000,000 unregistered shares of Cytori common
stock. On April 30, 2008 we received the second $6,000,000 payment
from Green Hospital Supply, Inc. in exchange for 1,000,000 unregistered shares
of Cytori common stock.
On August
11, 2008, we raised approximately $17,000,000 in gross proceeds from a private
placement of 2,825,517 unregistered shares of common stock and 1,412,758 common
stock warrants (with an original exercise price of $8.50 per share) to a
syndicate of investors including Olympus Corporation, who acquired 1,000,000
unregistered shares and 500,000 common stock warrants in exchange for $6,000,000
of the total proceeds raised. Additional information regarding this
private placement was previously provided in a current report on Form 8-K filed
on August 8, 2008.
Item 3. Defaults Upon Senior
Securities
|
None
|
40
Item 4. Submission of Matters to a Vote of Security
Holders
|
None
|
Item 5. Other Information
Properties
We
currently lease 91,000 square feet located at 3020 and 3030 Callan Road, San
Diego, California. The related rent agreement bears rent at a rate of
$1.15 per square foot, with annual increases of 3%. The lease term is
57 months, commencing on October 1, 2005 and expiring on June 30,
2010. We also lease 4,027 square feet of office space located at 9-3
Otsuka 2-chome, Bunkyo-ku, Tokyo, Japan. The agreement provides for
rent at a rate of $4.38 per square foot, expiring on November 30,
2009. We also entered into a new lease during the second quarter of
2008 for 900 square feet of office space located at Via Gino Capponi n. 26,
Florence, Italy. The lease agreement provides for rent at a rate of
$2.63 per square foot, expiring on April 22, 2014. Additionally,
we’ve entered into several lease agreements for corporate housing for our
employees on international assignments. For these properties, we pay
an aggregate of approximately $145,000 in rent per month.
Staff
As of
March 31, 2009, we had 85 employees, including part-time and full-time
employees. These employees are comprised of 14 employees in
manufacturing, 33 employees in research and development, 15 employees in sales
and marketing and 23 employees in management and finance and
administration. From time to time, we also employ independent
contractors to support our operations. Our employees are not
represented by any collective bargaining unit and we have never experienced an
organized work stoppage.
41
Item 6. Exhibits
Exhibit
No.
|
Description
|
|
4.2
|
Form
of Warrant to Purchase Common Stock issued on March 13, 2009 pursuant to
the Subscription Agreement, dated March 9, 2009, by and among the Company
and the Purchasers identified on the signature pages thereto (filed as
Exhibit 4.2 to our current report on Form 8-K filed on March 10, 2009 and
incorporated by reference herein).
|
|
10.63
|
Subscription
Agreement, dated March 9, 2009 (filed as Exhibit 10.63 to our Form 8-K
Current Report as filed on March 10, 2009 and incorporated by reference
herein).
|
|
10.64
|
Placement
Agency Agreement, dated March 9, 2009, between Cytori Therapeutics, Inc.
and Piper Jaffray & Co. (filed as Exhibit 10.64 to our
Form 8-K Current Report as filed on March 10, 2009 and
incorporated by reference herein).
|
|
10.65
|
Securities
Purchase Agreement, dated May 7, 2009, by and among the Company and the
Purchasers identified on the signature pages thereto (filed as Exhibit
10.63 to our current report on Form 8-K filed on May 8, 2009 and
incorporated by reference herein).
|
|
10.66
|
Form
of Warrant to Purchase Common Stock to be issued pursuant to the
Securities Purchase Agreement, dated May 7, 2009, by and among the Company
and the Purchasers identified on the signature pages thereto (filed as
Exhibit 10.64 to our current report on Form 8-K filed on May 8, 2009 and
incorporated by reference herein).
|
|
10.67
|
Registration
Rights Agreement, dated May 7, 2009, by and among the Company and the
Purchasers identified on the signature pages thereto (filed as Exhibit
10.65 to our current report on Form 8-K filed on May 8, 2009 and
incorporated by reference herein).
|
|
31.1
|
Certification
of Principal Executive Officer Pursuant to Securities Exchange Act Rule
13a-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of
2002 (filed herewith).
|
|
31.2
|
Certification
of Principal Financial Officer Pursuant to Securities Exchange Act Rule
13a-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of
2002 (filed herewith).
|
|
32.1*
|
Certifications
Pursuant to 18 U.S.C. Section 1350/ Securities Exchange Act Rule
13a-14(b), as adopted pursuant to Section 906 of the Sarbanes - Oxley Act
of 2002 (filed herewith).
|
* These
certifications are being furnished solely to accompany this report pursuant to
18 U.S.C. 1350 and are not being filed for purposes of Section 18 of the
Securities and Exchange Act of 1934 and are not to be incorporated by reference
into any filing of the Company, whether made before or after the date hereof,
regardless of any general incorporation language in such filing.
42
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
CYTORI
THERAPEUTICS, INC.
|
||
By:
|
/s/
Christopher J. Calhoun
|
|
Dated:
May 11, 2009
|
Christopher
J. Calhoun
|
|
Chief
Executive Officer
|
||
By:
|
/s/
Mark E. Saad
|
|
Dated:
May 11, 2009
|
Mark
E. Saad
|
|
Chief
Financial Officer
|
43