PLUS THERAPEUTICS, INC. - Quarter Report: 2008 June (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 June 30, 2008
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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 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
July 31, 2008, there were 26,394,349 shares of the registrant’s common stock
outstanding.
CYTORI
THERAPEUTICS, INC.
INDEX
Item 1. Financial
Statements
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CONSOLIDATED
CONDENSED BALANCE SHEETS
(UNAUDITED)
As
of
June
30, 2008
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As
of
December
31, 2007
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|||||||
Assets
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||||||||
Current
assets:
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||||||||
Cash
and cash equivalents
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$ | 5,328,000 | $ | 11,465,000 | ||||
Accounts
receivable, net of allowance for doubtful accounts of $62,000 and $1,000
in 2008 and
2007, respectively
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1,073,000 | 9,000 | ||||||
Inventories,
net
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932,000 | — | ||||||
Other
current assets
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741,000 | 764,000 | ||||||
Total
current assets
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8,074,000 | 12,238,000 | ||||||
Property
and equipment, net
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3,062,000 | 3,432,000 | ||||||
Investment
in joint venture
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352,000 | 369,000 | ||||||
Other
assets
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553,000 | 468,000 | ||||||
Intangibles,
net
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967,000 | 1,078,000 | ||||||
Goodwill
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3,922,000 | 3,922,000 | ||||||
Total
assets
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$ | 16,930,000 | $ | 21,507,000 | ||||
Liabilities
and Stockholders’ Deficit
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||||||||
Current
liabilities:
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||||||||
Accounts
payable and accrued expenses
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$ | 6,837,000 | $ | 7,349,000 | ||||
Current
portion of long-term obligations
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483,000 | 721,000 | ||||||
Total
current liabilities
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7,320,000 | 8,070,000 | ||||||
Deferred
revenues, related party
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17,974,000 | 18,748,000 | ||||||
Deferred
revenues
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2,379,000 | 2,379,000 | ||||||
Option
liability
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1,000,000 | 1,000,000 | ||||||
Long-term
deferred rent
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326,000 | 473,000 | ||||||
Long-term
obligations, less current portion
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129,000 | 237,000 | ||||||
Total
liabilities
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29,128,000 | 30,907,000 | ||||||
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 2008 and 2007
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— | — | ||||||
Common
stock, $0.001 par value; 95,000,000 shares authorized; 28,258,683 and
25,962,222 shares issued and 26,385,849 and 24,089,388 shares outstanding
in 2008 and 2007, respectively
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28,000 | 26,000 | ||||||
Additional
paid-in capital
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143,386,000 | 129,504,000 | ||||||
Accumulated
deficit
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(148,818,000 | ) | (132,132,000 | ) | ||||
Treasury
stock, at cost
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(6,794,000 | ) | (6,794,000 | ) | ||||
Amount
due from exercises of stock
options
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— | (4,000 | ) | |||||
Total
stockholders’ deficit
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(12,198,000 | ) | (9,400,000 | ) | ||||
Total
liabilities and stockholders’ deficit
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$ | 16,930,000 | $ | 21,507,000 |
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
June 30,
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For
the Six Months
Ended
June 30,
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|||||||||||||||
2008
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2007
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2008
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2007
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Product
revenues:
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||||||||||||||||
Related
party
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$ | 28,000 | $ | 512,000 | $ | 28,000 | $ | 792,000 | ||||||||
Third
party
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1,376,000 | — | 1,529,000 | — | ||||||||||||
1,404,000 | 512,000 | 1,557,000 | 792,000 | |||||||||||||
Cost
of product revenues
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675,000 | 197,000 | 735,000 | 422,000 | ||||||||||||
Gross
profit
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729,000 | 315,000 | 822,000 | 370,000 | ||||||||||||
Development
revenues:
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||||||||||||||||
Development,
related party
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— | 1,796,000 | 774,000 | 1,796,000 | ||||||||||||
Development
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— | 10,000 | — | 10,000 | ||||||||||||
Research
grant and other
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12,000 | 8,000 | 49,000 | 53,000 | ||||||||||||
12,000 | 1,814,000 | 823,000 | 1,859,000 | |||||||||||||
Operating
expenses:
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Research
and development
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5,034,000 | 4,393,000 | 9,998,000 | 9,390,000 | ||||||||||||
Sales
and marketing
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1,117,000 | 519,000 | 2,074,000 | 1,065,000 | ||||||||||||
General
and administrative
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3,162,000 | 3,433,000 | 6,272,000 | 6,599,000 | ||||||||||||
Change
in fair value of option liabilities
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(200,000 | ) | (100,000 | ) | — | 100,000 | ||||||||||
Total
operating expenses
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9,113,000 | 8,245,000 | 18,344,000 | 17,154,000 | ||||||||||||
Operating
loss
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(8,372,000 | ) | (6,116,000 | ) | (16,699,000 | ) | (14,925,000 | ) | ||||||||
Other
income (expense):
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||||||||||||||||
Gain
on sale of assets
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— | 1,858,000 | — | 1,858,000 | ||||||||||||
Interest
income
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38,000 | 348,000 | 114,000 | 545,000 | ||||||||||||
Interest
expense
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(18,000 | ) | (43,000 | ) | (41,000 | ) | (95,000 | ) | ||||||||
Other
expense, net
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(53,000 | ) | (52,000 | ) | (43,000 | ) | (54,000 | ) | ||||||||
Equity
gain (loss) from investment in joint venture
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(8,000 | ) | 9,000 | (17,000 | ) | 6,000 | ||||||||||
Total
other income (expense)
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(41,000 | ) | 2,120,000 | 13,000 | 2,260,000 | |||||||||||
Net
loss
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(8,413,000 | ) | (3,996,000 | ) | (16,686,000 | ) | (12,665,000 | ) | ||||||||
Other
comprehensive loss – unrealized holding loss
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— | — | — | (1,000 | ) | |||||||||||
Comprehensive
loss
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$ | (8,413,000 | ) | $ | (3,996,000 | ) | $ | (16,686,000 | ) | $ | (12,666,000 | ) | ||||
Basic
and diluted net loss per common share
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$ | (0.33 | ) | $ | (0.17 | ) | $ | (0.66 | ) | $ | (0.58 | ) | ||||
Basic
and diluted weighted average common shares
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25,819,980 | 23,497,375 | 25,131,317 | 21,790,048 | ||||||||||||
SEE NOTES
TO UNAUDITED CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
4
CYTORI THERAPEUTICS, INC.
CONSOLIDATED
CONDENSED STATEMENTS OF CASH FLOWS
(UNAUDITED)
For
the Six Months Ended June 30,
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||||||||
2008
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2007
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|||||||
Cash
flows from operating activities:
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||||||||
Net
loss
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$ | (16,686,000 | ) | $ | (12,665,000 | ) | ||
Adjustments
to reconcile net loss to net cash used in operating
activities:
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||||||||
Depreciation
and amortization
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777,000 | 843,000 | ||||||
Warranty
provision
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(22,000 | ) | (43,000 | ) | ||||
Increase
in allowance for doubtful accounts
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61,000 | 1,000 | ||||||
Change
in fair value of option liabilities
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— | 100,000 | ||||||
Stock-based
compensation expense
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1,199,000 | 1,155,000 | ||||||
Gain
on sale of assets
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— | (1,858,000 | ) | |||||
Equity
(gain) loss from investment in joint venture
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17,000 | (6,000 | ) | |||||
Increases
(decreases) in cash caused by changes in operating assets and
liabilities:
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||||||||
Accounts
receivable
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(1,125,000 | ) | 179,000 | |||||
Inventories
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(932,000 | ) | (22,000 | ) | ||||
Other
current assets
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23,000 | 145,000 | ||||||
Other
assets
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(85,000 | ) | 11,000 | |||||
Accounts
payable and accrued expenses
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(490,000 | ) | (913,000 | ) | ||||
Deferred
revenues, related party
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(774,000 | ) | (1,796,000 | ) | ||||
Deferred
revenues
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— | (10,000 | ) | |||||
Long-term
deferred rent
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(147,000 | ) | (130,000 | ) | ||||
Net
cash used in operating activities
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(18,184,000 | ) | (15,009,000 | ) | ||||
Cash
flows from investing activities:
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||||||||
Proceeds
from sale and maturity of short-term investments
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5,006,000 | 18,459,000 | ||||||
Purchases
of short-term investments
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(5,006,000 | ) | (18,280,000 | ) | ||||
Proceeds
from sale of assets
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— | 3,175,000 | ||||||
Costs
from sale of assets
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— | (109,000 | ) | |||||
Purchases
of property and equipment
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(296,000 | ) | (365,000 | ) | ||||
Net
cash provided by (used in) investing activities
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(296,000 | ) | 2,880,000 | |||||
Cash
flows from financing activities:
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||||||||
Principal
payments on long-term obligations
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(346,000 | ) | (774,000 | ) | ||||
Proceeds
from exercise of employee stock options
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689,000 | 908,000 | ||||||
Proceeds
from sale of common stock and warrants
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12,000,000 | 21,500,000 | ||||||
Costs
from sale of common stock
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— | (1,599,000 | ) | |||||
Proceeds
from sale of treasury stock
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— | 6,000,000 | ||||||
Net
cash provided by financing activities
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12,343,000 | 26,035,000 | ||||||
Net
increase (decrease) in cash and cash equivalents
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(6,137,000 | ) | 13,906,000 | |||||
Cash
and cash equivalents at beginning of period
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11,465,000 | 8,902,000 | ||||||
Cash
and cash equivalents at end of period
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$ | 5,328,000 | $ | 22,808,000 | ||||
Supplemental
disclosure of cash flows information:
|
||||||||
Cash
paid during period for:
|
||||||||
Interest
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$ | 44,000 | $ | 96,000 | ||||
Taxes
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— | 2,000 | ||||||
SEE NOTES
TO UNAUDITED CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
5
CYTORI THERAPEUTICS, INC.
NOTES
TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
JUNE
30, 2008
(UNAUDITED)
1.
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Basis
of Presentation
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Our
accompanying unaudited consolidated condensed financial statements as of June
30, 2008 and for the three and six months ended June 30, 2008 and 2007 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, 2007 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 and six
months ended June 30, 2008 are not necessarily indicative of the results that
may be expected for the year ending December 31, 2008. For further
information, refer to our consolidated financial statements for the year ended
December 31, 2007 and footnotes thereto which were included in our Annual Report
on Form 10-K, dated March 14, 2008.
2.
|
Use
of Estimates
|
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. Actual results
could differ from these estimates. 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.
Our most
significant estimates and critical accounting policies involve recognizing
revenue, evaluating goodwill for impairment, accounting for product line
dispositions, 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, and assessing
how to report our investment in Olympus-Cytori, Inc.
|
3.
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Liquidity
|
We
incurred losses of $8,413,000 and $16,686,000 for the three and six months ended
June 30, 2008 and $3,996,000 and $12,665,000 for the three and six months ended
June 30, 2007, respectively. We have an accumulated deficit of
$148,818,000 as of June 30, 2008. Additionally, we have used net cash of
$18,184,000 and $15,009,000 to fund our operating activities for the six months
ended June 30, 2008 and 2007, respectively. To date these operating losses
have been funded primarily from outside sources of invested
capital.
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. During the first
half of 2008, we initiated our commercialization activities while simultaneously
pursuing available financing sources to support operations and growth. Our
current efforts to raise capital have taken longer than we initially
anticipated. However, we announced on August 8, 2008, the raising of
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 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.
With this
recently completed private placement, we believe we have enough cash to fund
operations through at least the next six months, and we will continue to seek
additional cash through operating profits, 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
transaction and corporate partnership in the near-term. If such efforts
are not successful, we will need to significantly reduce or curtail
our research and development, clinical activities and other
operations, and
this would negatively affect our ability to achieve corporate growth
goals.
6
We expect to continue to utilize
our cash and cash equivalents to fund operations, including sales &
marketing efforts, clinical trials, pre-clinical activities, and further
research and development of products. Management
recognizes the need to generate positive
cash flows in future periods and to obtain additional capital from multiple
sources in order to
continue our operations as planned. Without this additional capital as
well as cash generated from sales and containment of operating costs, we will
not have adequate funding for sales & marketing
efforts, clinical
trials, further pre-clinical activities and product development required to
support successful commercialization. No assurance can be given
that we can generate sufficient revenue to cover operating costs or that
additional financing will be available to us and, if available, on terms
acceptable to us in the future.
Our
product sales, which commenced in the first quarter of 2008, are not currently
sufficient by themselves to provide long-term cash flow viability to the
Company. However, based on the results of our initial product launch in
the first half of this year combined with orders received and expected during
the remainder of the year and beyond, we believe our revenue generation
prospects will provide an increasingly significant contribution to our operating
cash flows.
Management
actively monitors current and projected costs as we progress into product
commercialization and sales in order to match projected expenditures to
available cash flow
(as noted above, the recent financing took longer than originally anticipated
due to current economic conditions and during that time management was
monitoring cash outflow). Cost containment
measures are currently being explored with the goal of reducing or eliminating
non-essential research and administrative expenditures as well as utilizing
manufacturing techniques and alternatives that can help generate production
economies of scale.
4.
|
Segment
Information
|
We manage
our business based on two distinct operating segments – (a) Regenerative cell
technology and (b) MacroPore Biosurgery.
Our
regenerative cell technology segment develops, manufactures and sells medical
technologies to enable the practice of regenerative medicine with an initial
focus on reconstructive surgery and cell banking. Our
commercialization model is based on the sale of Celution® Systems
and their related harvest and delivery instrumentation, and on generating
recurring revenues from single-use consumable sets utilized during each patient
procedure.
Our
MacroPore Biosurgery unit develops Thin Film bioresorbable implants for sale in
Japan through Senko Medical Trading Company or Senko, which has exclusive
distribution rights to these products in Japan. Also, until after the
second quarter of 2007, the MacroPore Biosurgery segment manufactured and
distributed the HYDROSORB™ family of spine and orthopedic implants.
We
measure the success of each operating segment based on operating profits and
losses and, additionally, in the case of the regenerative cell technology
segment, the achievement of key research objectives. In arriving at
our operating results for each segment, we use the same accounting policies as
those used for our consolidated company and as described throughout this
note. However, segment operating results exclude allocations of
company-wide general and administrative costs and changes in fair value of our
option liabilities.
During
the three and six months ended June 30, 2008, we had no significant activity in
the MacroPore Biosurgery operating segment as a result of sale in May 2007 to
Kensey Nash of the intellectual property rights and tangible assets related to
the spine and orthopedic bioresorbable implant product line.
Prior
year results presented below have been developed on the same basis as the
current year amounts. For all periods presented, we did not have any
intersegment transactions.
7
The
following tables provide information regarding the performance and assets of our
operating segments:
For
the three months
ended
June 30,
|
For
the six months
ended
June 30,
|
|||||||||||||||
2008
|
2007
|
2008
|
2007
|
|||||||||||||
Revenues:
|
||||||||||||||||
Regenerative
cell technology
|
$ | 1,416,000 | $ | 1,804,000 | $ | 2,380,000 | $ | 1,849,000 | ||||||||
MacroPore
Biosurgery
|
— | 522,000 | — | 802,000 | ||||||||||||
Total
revenues
|
$ | 1,416,000 | $ | 2,326,000 | $ | 2,380,000 | $ | 2,651,000 | ||||||||
Segment
operating income (losses):
|
||||||||||||||||
Regenerative
cell technology
|
$ | (5,352,000 | ) | $ | (3,014,000 | ) | $ | (10,321,000 | ) | $ | (8,364,000 | ) | ||||
MacroPore
Biosurgery
|
(58,000 | ) | 231,000 | (106,000 | ) | 138,000 | ||||||||||
General
and administrative expenses
|
(3,162,000 | ) | (3,433,000 | ) | (6,272,000 | ) | (6,599,000 | ) | ||||||||
Changes
in fair value of option liabilities
|
200,000 | 100,000 | — | (100,000 | ) | |||||||||||
Total
operating loss
|
$ | (8,372,000 | ) | $ | (6,116,000 | ) | $ | (16,699,000 | ) | $ | (14,925,000 | ) |
As
of June 30,
|
As
of December 31,
|
|||||||
2008
|
2007
|
|||||||
Assets:
|
||||||||
Regenerative
cell technology
|
$ | 13,399,000 | $ | 11,591,000 | ||||
MacroPore
Biosurgery
|
— | — | ||||||
Corporate
assets
|
3,531,000 | 9,916,000 | ||||||
Total
assets
|
$ | 16,930,000 | $ | 21,507,000 |
5.
|
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.
We
evaluate our investments in accordance with the provisions of Statement of
Financial Accounting Standards (“SFAS”) No. 115, “Accounting for Certain
Investments in Debt and Equity Securities.” Based on our intent, our
investment policies and our ability to liquidate debt securities, we classify
short-term investment securities within current assets. Available-for-sale
securities are carried at fair value, with unrealized gains and losses reported
as accumulated other comprehensive income (loss) within stockholders’ equity.
The amortized cost basis of debt securities is periodically adjusted for
amortization of premiums and accretion of discounts to maturity. Such
amortization is included as a component of interest income or interest expense.
The amortized cost basis of securities sold is based on the specific
identification method and all such realized gains and losses are recorded as a
component within other income (expense). We review the carrying
values of our investments and write down such investments to estimated fair
value by a charge to the statements of operations when the severity and duration
of a decline in the value of an investment is considered to be other than
temporary. The cost of securities sold or purchased is recorded on
the settlement date.
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 considered cash equivalents as of June
30, 2008.
6.
|
Summary
of Significant Accounting Policies
|
|
Inventories
|
Inventories
include the cost of material, labor, and overhead, and are stated at the lower
of average cost, determined on the first-in, first-out (FIFO) method, or
market. We periodically evaluate our on-hand stock and make
appropriate provisions for any stock deemed excess or obsolete. We
expense excess manufacturing costs, that is, costs resulting from lower than
“normal” production levels.
Our
inventory balance as of June 30, 2008 includes the cost of materials on hand as
of June 30, 2008 that we purchased on or after March 1, 2008. March
1, 2008 is considered our commercialization date based on completion of final
development activities associated with our Celution® 800/CRS
System products. All materials purchased prior to the
commercialization date were expensed as research and development expense during
the period they were purchased, of which $171,000 (with a net book value of
$0) was on hand as of June 30, 2008 to be utilized in future
manufacturing.
No
inventory provisions were recorded during the three and six month periods ended
June 30, 2008 and 2007.
8
Property
and Equipment
Property
and equipment is stated at cost, net of accumulated
depreciation. Depreciation expense is provided for on a straight-line
basis over the estimated useful lives of the assets, or the life of the lease
(as applicable), whichever is shorter, and range from three to five
years. When assets are sold or otherwise disposed of, the cost and
related accumulated depreciation are removed from the accounts and the resulting
gain or loss is included in operations. Maintenance and repairs are
charged to operations as incurred.
|
Revenue
Recognition
|
Product
Sales
Beginning
in March 2008, we began sales and shipments of our Celution® 800/CRS
System to the European and Asia-Pacific reconstructive surgery
market. Assuming all other applicable revenue recognition criteria
have been met, revenue for these product sales will generally 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 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”).
Before
the disposal of our bioresorbable spine and orthopedic product line in May 2007,
we sold our (non-Thin Film) MacroPore Biosurgery products to Medtronic, Inc., a
related party. We recognized revenue on product sales to Medtronic
upon shipment of ordered products to Medtronic, as title and risk of loss were
transferred at that point.
In May
2007, we sold to Kensey Nash our intellectual property rights and tangible
assets related to our bioresorbable spine and orthopedic product
line.
License/Distribution
Fees
If
separable under EITF Issue No. 00-21, “Revenue Arrangements with Multiple
Deliverables” (“EITF 00-21”), we recognize any upfront payments received from
license/distribution agreements as revenues over the period in which the
customer benefits from the license/distribution agreement.
To date,
we have not received any upfront license payments that are separable under EITF
00-21. Accordingly, such license revenues have been combined with
other elements, such as research and development activities, for purposes of
revenue recognition. For instance, we account for the license fees
and milestone payments under the Distribution Agreement with Senko as a single
unit of accounting. Similarly, we have attributed the upfront fees
received under the arrangements with Olympus Corporation, a related party (see
note 13), to a combined unit of accounting comprising a license we granted to
Olympus-Cytori, Inc., which we refer to as the Joint Venture or the JV, a
related party, as well as development services we agreed to perform for this
entity.
In the
first quarter of 2006, we granted Olympus an exclusive right to negotiate a
commercialization collaboration for the use of adipose stem and regenerative
cells for a specific therapeutic area outside of cardiovascular
disease. In exchange for this right, we received $1,500,000 from
Olympus, which is non-refundable but may be applied towards any definitive
commercial collaboration in the future. As part of this agreement,
Olympus will conduct market research and pilot clinical studies in collaboration
with us for the therapeutic area up to December 31, 2008 when this exclusive
right will terminate. The $1,500,000 payment was received in the
second quarter of 2006 and recorded as deferred revenues, related
party. The deferred revenues, related party will be recognized as
revenue either (i) in connection with other consideration received as part of a
definitive commercial collaboration in the future, or (ii) when the exclusive
negotiation period expires.
In the
third quarter of 2004, we entered into a Distribution Agreement with
Senko. Under this agreement, we granted to Senko an exclusive license
to sell and distribute certain Thin Film products in Japan and received a
$1,500,000 upfront license fee from them in return for this right. We
have recorded the $1,500,000 received as deferred revenues in the accompanying
consolidated condensed balance sheets. 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.
No
license/distribution fees (that would be considered separable under EITF 00-21)
have been recognized as revenues in the three and six month periods ended June
30, 2008 and 2007.
9
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 or the NIH. Revenue earned
under development agreements is classified as either research grant or
development revenues in our consolidated condensed statements of operations,
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 the
consolidated condensed 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 condensed statements
of operations.
We
received a total of $22,000,000 from Olympus and Olympus-Cytori, Inc. during
2005 in two separate but related transactions (see note
13). Approximately $4,689,000 of this amount related to common stock
that we issued, as well as two options we granted, to
Olympus. Moreover, during the first quarter of 2006, we received
$11,000,000 from the Joint Venture upon achieving the CE Mark on the
Celution®
600. The difference between the proceeds received and the fair values
of the common stock and option liability was recorded as deferred revenue, since
conceptually; the excess proceeds represent a prepayment for future
contributions and obligations of Cytori for the benefit of the Joint Venture,
rather than additional equity investment in Cytori. Considering the
$4,689,000 initially allocated to the common stock issued and the two options,
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. As noted above, the license and development services are
not separable under EITF 00-21. The recognition of this deferred
amount will require the 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 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.
We
established the R&D milestones based upon our development obligations to the
JV and the specific R&D support activities to be performed to achieve these
obligations. Our R&D milestones consist of the following primary
performance categories: product development, regulatory approvals,
and generally associated pre-clinical and clinical
trials. Within each category are milestones that take
substantive effort to complete and are critical pieces of the overall progress
towards completion of the next generation product, which we are obligated to
support within the agreements entered into with Olympus.
To
determine whether substantive effort was required to achieve the milestones, we
considered the external costs, required personnel and relevant skill levels, the
amount of time required to complete each milestone, and the interdependent
relationships between the milestones, in that the benefits associated with the
completion of one milestone generally support and contribute to the achievement
of the next.
Determination
of the relative values assigned to each milestone involved substantial
judgment. The assignment process was based on discussions with
persons responsible for the development process and the relative costs of
completing each milestone. We considered the costs of completing the
milestones in allocating the portion of the “deferred revenues, related party”
account balance to each milestone. Management believes that, while
the costs incurred in achieving the various milestones are subject to
estimation, due to the high correlation of such costs to outputs achieved, the
use of external contract research organization costs and internal labor costs as
the basis for the allocation process provides management the ability to
accurately and reasonably estimate such costs.
Of the
amounts received and deferred, we recognized development revenues of $0 and
$774,000 during the three and six month periods ended June 30, 2008,
respectively. We recognized $1,796,000 during the three and six month
periods ended June 30, 2007. All related development costs are
expensed as incurred and are included in research and development expense on the
consolidated condensed statements of operations.
10
In the
third quarter of 2004, we entered into a Distribution Agreement with
Senko. Under this agreement, 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 following defined research and
development milestones:
·
|
In
2004, we received a nonrefundable payment of $1,250,000 from Senko after
filing an initial regulatory application with the Japanese Ministry of
Health, Labour and Welfare or the MHLW, related to the Thin Film product
line. We initially recorded this payment as deferred revenues
of $1,250,000.
|
·
|
Upon
the achievement of commercialization (i.e., regulatory approval by the
MHLW), we will be entitled to an additional nonrefundable payment of
$250,000.
|
Of the
amounts received and deferred with respect to Senko, we did not recognize any
development revenues in the three and six months ended June 30, 2008,
respectively. We recognized $10,000 during the three and six month
periods ended June 30, 2007, respectively. As noted above, the
license and the milestone components of the Senko Distribution Agreement are
accounted for as a single unit of accounting. This single element
includes a $1,500,000 license fee which is partially refundable if it is
determined in good faith by the parties that Commercialization of the Products
is unobtainable, then 50% of the distribution rights fee will be returned to
Senko. We have recognized, and will continue to recognize, the
non-contingent fees allocated to this combined deliverable as we complete
performance obligations under the Distribution Agreement with
Senko. Accordingly, we expect to recognize approximately $1,129,000
(consisting of remaining $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 once commercialization is
achieved. We will not recognize the potentially refundable portion of
the fees until the right of refund expires.
7.
|
Inventories
|
|
Inventories
are carried at lower cost, which approximates average cost, determined on
the first-in, first-out (FIFO) method, or market. We had no
inventories as of December 31, 2007 as all materials purchased prior to
the commercialization date of March 1, 2008 were expensed as research and
development expense during the period they were
purchased.
|
|
Inventories
consisted of the following:
|
As
of
June
30, 2008
|
||||
Raw
materials
|
$ | 405,000 | ||
Work-in-progress
|
306,000 | |||
Finished
goods
|
221,000 | |||
Total
|
$ | 932,000 |
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 and six months ended June 30, 2008 and
2007, we had no impairment losses associated with our long-lived
assets.
9.
|
Share-Based
Compensation
|
Through
December 31, 2007, we used the “simplified method” to estimate the expected term
of our stock options, as outlined in SEC Staff Accounting Bulletin No.
107. Starting January 1, 2008, we calculated the expected term of our
stock options based on our historical data. The expected term is
calculated for and applied to all employee awards as a single group as we do not
expect (nor does historical data suggest) substantially different exercise or
post-vesting termination behavior amongst our employee
population. The fair value of each option awarded is estimated on the
date of grant using the Black-Scholes-Merton option valuation model utilizing
expected term based on our historical data. The Company will
periodically evaluate our historical data to assess the adequacy of the expected
term. The effect of this change on income from continuing operations
and net income is immaterial.
11
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.
We have
excluded all potentially dilutive securities from the calculation of diluted
loss per share attributable to common stockholders for the three and six months
ended June 30, 2008 and 2007, as their inclusion would be antidilutive.
Potentially dilutive common shares excluded from the calculations of diluted
loss per share were 7,985,949 for the three and six month periods ended June 30,
2008 and 8,161,043 for the three and six month periods ended June 30, 2007,
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 conducting pre-clinical development research, enrolling
patients, recruiting 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 June 30, 2008, 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 $8,426,000 ($4,100,000 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.
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.
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
agreement, which was amended and restated in September 2006 to better reflect
our business model, calls for various periodic payments until such time as we
begin commercial sales of any products utilizing the licensed
technology. Upon achieving commercial sales of products or services
covered by the UC license agreement, we will be required to pay variable earned
royalties based on the net sales of products sold. Minimum royalty
amounts will increase annually with a plateau in 2015. In addition,
there are certain due diligence milestones that are required to be reached as a
result of the agreement. Failure to fulfill these milestones may
result in a reduction of or loss of the specific rights to which the affected
milestone relates.
12
Additionally,
we are obligated to reimburse UC for patent prosecution and other legal costs on
any patent applications contemplated by the agreement. In particular,
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
will likely 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 231
Patent, and that all other inventorship issues shall be determined according to
the facts presented at trial. The trial was concluded in January 2008
and on June 9, 2008 the Court signed its final order which we received on June
12, 2008. The Court concluded that the University of Pittsburgh’s
assignors were the sole inventors of the 231 Patent. 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 and six months ended June 30, 2008, we expensed $73,000 and $240,000,
respectively, for legal fees related to this license. In the three
and six months ended June 30, 2007, we expensed $518,000 and $602,000,
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 June
30, 2008 of $1,763,000 is a reasonable estimate of our liability for the
expenses incurred through June 30, 2008.
13.
|
Transactions
with Olympus Corporation
|
Initial
Investment by Olympus Corporation in Cytori
In the
second quarter of 2005, we entered into a common stock purchase agreement with
Olympus in which we received $11,000,000 in cash proceeds.
Under
this agreement, we issued 1,100,000 shares of common stock to
Olympus. In addition, we also granted Olympus an immediately
exercisable option to acquire 2,200,000 shares of our common stock at $10 per
share, which expired on December 31, 2006. Before its expiration, we
accounted for this option as a liability in accordance with EITF 00-19,
“Accounting for Derivative Financial Instruments Indexed to, and Potentially
Settled in, a Company's Own Stock” because from the date of grant through the
expiration, we would have been required to deliver listed common stock to settle
the option shares upon exercise.
The
$11,000,000 in total proceeds we received in the second quarter of 2005 exceeded
the sum of (i) the market value of our stock as well as (ii) the fair value of
the option at the time we entered into the share purchase
agreement. The $7,811,000 difference between the proceeds received
and the fair values of our common stock and option liability was recorded as a
component of deferred revenues, related party in the accompanying consolidated
condensed balance sheet. This difference was recorded as deferred
revenue since, conceptually, the excess proceeds represent a prepayment for
future contributions and obligations of Cytori for the benefit of the Joint
Venture (see below), rather than an additional equity investment in
Cytori. We will recognize development revenue upon achievement of
related milestones, in accordance with proportional performance
methodology. If and as such revenues are recognized, deferred revenue
will be decreased (see note 6 under revenue recognition).
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. As part of this agreement, Olympus
will conduct market research and pilot clinical studies in collaboration with us
for the therapeutic area up to December 31, 2008 when this exclusive right will
terminate.
In August
2006, we received an additional $11,000,000 from Olympus for the issuance of
approximately 1,900,000 shares of our common stock at $5.75 per share under the
shelf registration statement filed in May 2006. The purchase price
was based on our closing price on August 9, 2006.
13
As of
June 30, 2008, Olympus holds approximately 11% 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
On
November 4, 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.
Under the
Joint Venture Agreements with Olympus:
·
|
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 regenerative cells residing in adipose 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
Celution®
600 in January 2006, we received an additional $11,000,000 development
milestone payment from the Joint
Venture.
|
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 June
30, 2008, the carrying value of our investment in the Joint Venture is
$352,000.
We are
under no obligation to provide additional funding to the Joint Venture, but may
choose to do so. We made no contributions to the Joint Venture during
the three and six months ended June 30, 2008 and 2007,
respectively.
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
November 4, 2005, the fair value of the Put was estimated to be
$1,500,000. At June 30, 2008 and December 31, 2007, the estimated
fair value of the Put was $1,000,000. 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:
June
30, 2008
|
December
31, 2007
|
November
4, 2005
|
||||||||||
Expected
volatility of
Cytori
|
61.00 | % | 60.00 | % | 63.20 | % | ||||||
Expected
volatility of the Joint Venture
|
61.00 | % | 60.00 | % | 69.10 | % | ||||||
Bankruptcy
recovery rate for
Cytori
|
21.00 | % | 21.00 | % | 21.00 | % | ||||||
Bankruptcy
threshold for
Cytori
|
$ | 8,925,000 | $ | 9,324,000 | $ | 10,780,000 | ||||||
Probability
of a change of control event for Cytori
|
2.56 | % | 2.17 | % | 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
|
3.99 | % | 4.04 | % | 4.66 | % |
14
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 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 may sell
such systems exclusively to us at a formula-based transfer price; we have
retained marketing rights to the second and all subsequent generation devices
for all therapeutic applications of adipose regenerative cells.
As part
of the various agreements with Olympus, we will be required, following
commercialization of the Joint Venture’s Celution® System
or Systems, to provide monthly forecasts to the Joint Venture specifying the
quantities of each category of devices that we intend to purchase over a rolling
six-month period. Although we are not subject to any minimum purchase
requirements, we are obliged to buy a minimum percentage of the products
forecasted by us in such reports. Since we can effectively control
the number of devices we will agree to purchase and because no commercial
devices have yet been developed to trigger the forecast requirement, we estimate
that the fair value of this guarantee is de minimis as of June 30,
2008.
In August
2007 we entered into a License and Royalty Agreement with the Joint
Venture. This Royalty Agreement provides us the ability 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 allows for the sale
of the Cytori system until such time as the Joint Venture’s products are
commercially available, subject to a reasonable royalty that will be payable to
the Joint Venture for all such sales. During the three and six month
periods ended June 30, 2008, in connection with our sales of our Celution® 800/CRS
System products to the European and Asia-Pacific reconstructive surgery market,
we incurred approximately $72,000 and $83,000, respectively, in royalty cost
related to our agreement with the Joint Venture. This cost is
included as a component of cost of product revenues in our consolidated
condensed statement of operations.
Deferred
revenues, related party
As of
June 30, 2008, the deferred revenues, related party account primarily consists
of the consideration we have received in exchange for contributions and
obligations that we have agreed to on behalf of Olympus and the Joint Venture
(less any amounts that we have recognized as revenues in accordance with our
revenue recognition policies set out in note 6). These contributions
include product development, regulatory approvals, and generally associated
pre-clinical and clinical trials to support the commercialization of the
Celution® System
platform. Our obligations also include maintaining the exclusive and
perpetual license to our device technology, including the Celution® System
platform and certain related intellectual property.
Pursuant
to EITF 00-21, we have concluded that the license and development services must
be accounted for as a single unit of accounting. Refer to note 6 for
a full description of our revenue recognition policy.
14. Fair Value
Measurements
On
January 1, 2008, we adopted certain provisions of SFAS No. 157, “Fair Value
Measurements” (“SFAS 157”). SFAS 157 provides a single definition of
fair value and a common framework for measuring fair value as well as new
disclosure requirements for fair value measurements used in financial
statements. SFAS 157 applies to reported balances that are required
or permitted to be measured at fair value under existing pronouncements;
accordingly, the standard does not require any new fair value measurements of
reported balances.
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. We do not expect the adoption of the SFAS 157 for
non-financial assets and liabilities to have a material impact on our
consolidated financial position or results of operations.
On
January 1, 2008, we also adopted SFAS No. 159, “The Fair Value Option for
Financial Assets and Financial Liabilities” (“SFAS 159”), which permits
companies to choose to measure many financial instruments and certain other
items at fair value. However, we have not elected to measure any
additional financial instruments or other items at fair value under the
provisions of this standard.
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:
15
· 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
|
|||||||||||||||
June 30, 2008
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Assets:
|
||||||||||||||||
Cash
equivalents
|
$ | 4,594,000 | $ | 4,594,000 | $ | — | $ | — | ||||||||
Liabilities:
|
||||||||||||||||
Put
option liability
|
$ | (1,000,000 | ) | $ | — | $ | — | $ | (1,000,000 | ) | ||||||
We use
quoted market prices to determine the fair value of our cash equivalents, which
consist of money market funds and other highly liquid, exchange-traded fixed
income and equity securities, 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, 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
|
Six
months ended
|
|||||||
Put
option liability
|
June
30, 2008
|
June
30, 2008
|
||||||
Beginning
balance
|
$ | (1,200,000 | ) | $ | (1,000,000 | ) | ||
Decrease
in fair value recognized in operating expenses
|
200,000 | — | ||||||
Ending
balance
|
$ | (1,000,000 | ) | $ | (1,000,000 | ) | ||
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 June
30, 2008.
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.
16
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, 2007.
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 our 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.
Overview
Liquidity
We
incurred losses of $8,413,000 and $16,686,000 for the three and six months ended
June 30, 2008 and $3,996,000 and $12,665,000 for the three and six months ended
June 30, 2007, respectively. We have an accumulated deficit of
$148,818,000 as of June 30, 2008. Additionally, we have used net cash of
$18,184,000 and $15,009,000 to fund our operating activities for the six months
ended June 30, 2008 and 2007, respectively.
To
date these operating losses have been funded primarily from outside sources of
invested capital.
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. During the first
half of 2008, we initiated our commercialization activities while simultaneously
pursuing available financing sources to support operations and growth. Our
current efforts to raise capital have taken longer than we initially
anticipated. However, we announced on August 8, 2008, the raising of
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 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.
17
With this
recently completed private placement, we believe we have enough cash to fund
operations through at least the next six months, and we will continue to seek
additional cash through operating profits, 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
transaction and corporate partnership in the near-term. If such efforts
are not successful, we will need to significantly reduce or curtail
our research and development, clinical activities and other
operations, and
this would negatively affect our ability to achieve corporate growth
goals.
We
expect to continue to utilize our cash and cash equivalents to fund operations,
including sales & marketing efforts, clinical trials, pre-clinical
activities, and further research and development of products.
Management recognizes the need to generate positive
cash flows in future periods and to obtain additional capital from multiple
sources in
order to continue our operations as planned. Without this additional
capital as well as cash generated from sales and containment of operating costs,
we will not have adequate funding for sales
& marketing efforts, clinical
trials, further pre-clinical activities and product development required to
support successful commercialization. No assurance
can be given that we can generate sufficient revenue to cover operating costs or
that additional financing will be available to us and, if available, on terms
acceptable to us in the future.
Our
product sales, which commenced in the first quarter of 2008, are not currently
sufficient by themselves to provide long-term cash flow viability to the
Company. However, based on the results of our initial product launch in
the first half of this year combined with orders received and expected during
the remainder of the year and beyond, we believe our revenue generation
prospects will provide an increasingly significant contribution to our operating
cash flows.
Management
actively monitors current and projected costs as we progress into product
commercialization and sales in order to match projected expenditures to
available cash flow
(as noted above, the recent financing took longer than originally anticipated
due to current economic conditions and during that time management was
monitoring cash outflow). Cost containment
measures are currently being explored with the goal of reducing or eliminating
non-essential research and administrative expenditures as well as utilizing
manufacturing techniques and alternatives that can help generate production
economies of scale.
Regenerative
Cell Technology
Cytori’s
goal is to become a global provider of medical technologies, specifically
designed for practicing regenerative medicine. Regenerative medicine describes
the emerging field that aims to repair or restore lost or damaged organ and cell
function. Our commercial activities are currently focused on cosmetic and
reconstructive surgery in Europe and Asia and stem and regenerative cell banking
(cell preservation). Our product pipeline is focused on new treatments for
cardiovascular disease, orthopedic damage, gastrointestinal disorders, pelvic
health conditions, and other medical applications.
The
foundation of Cytori’s business is the Celution® System
product platform. This family of products can process a patient’s own cells at
the bedside in real time. These cells are then delivered back to the patient,
where they’re needed, all during the same surgical procedure. The Celution® System
product platform consists of the Celution® Device,
related single-use consumables, reusable surgical instruments, and a proprietary
enzyme solution. The more therapeutic applications we develop for the cellular
output of the Celution® System
product family, the more opportunities we may have to offer our technology to
hospitals, clinics, and physicians.
The
Celution® 800 and
900 are bedside systems that separate stem and regenerative cells residing
naturally within adipose (fat) tissue. We introduced the Celution® 800/CRS
into the European and Asia-Pacific cosmetic and reconstructive surgery market in
the first quarter of 2008. In addition, commercialization efforts are ongoing
for the Celution® 900/MB
as part of our comprehensive cell banking (cryopreservation) product offering.
We believe these two markets offer the potential for revenue growth over the
next few years until new products come out of our development pipeline. This
product development pipeline includes applications for cardiovascular disease,
for which two clinical trials are presently underway in Europe, spinal disc
repair, gastrointestinal disorders, and pelvic health conditions.
Over the
next 12 months, we anticipate focusing on the following
initiatives:
·
|
Selling
additional StemSource®
Cell Banks to hospitals and companies around the
globe
|
·
|
Expanding
commercialization of the Celution®
800/CRS in Europe and Asia-Pacific into the European and Asia-Pacific
reconstructive surgery market
|
·
|
Completing
our post-marketing study in Europe with the Celution®
800/CRS for the reconstruction of breast tissue following partial
mastectomy to support expanded marketing efforts and
reimbursement
|
·
|
Advancing
our cardiovascular disease product pipeline through clinical
development
|
·
|
Seeking
strategic commercialization
partnerships
|
18
During
the first half of 2008, we introduced and received the first orders for
Celution® System
products, which were sold into the European and Asian reconstructive surgery
market. A broader launch is expected following the successful completion of at
least one breast reconstruction post-partial mastectomy post-marketing study
designed to provide Cytori with additional clinical data to support broad
physician adoption and reimbursement. Breast reconstruction is a niche market
that we are pursuing because there is a significant medical need for viable
reconstructive alternatives to partial mastectomy patients. This segment of the
reconstructive surgery market may also be effectively addressed with targeted
sales and distribution efforts.
There are
an estimated 370,000 patients in Europe diagnosed each year with breast cancer,
of which approximately 75% are eligible to undergo partial mastectomy. Based on
this figure and the survival rate for breast cancer patients, there are already
millions of women in Europe who have been treated for breast cancer, for which a
percentage could be eligible for partial mastectomy defect
reconstruction.
Reconstruction
of partial mastectomy defects using autologous fat grafting
augmented with adipose-derived stem and regenerative cells, processed
with the Celution® 600
System (an earlier generation of the Celution® 800
System), was reported in December 2007 to be safe and effective in a 21 patient,
investigator-initiated study in Japan. While more clinical trials
will be required, the study observed that combining adipose-derived stem and
regenerative cells with additional adipose tissue in order to fill the defect
area was safe and resulted in 79% patient satisfaction, with a statistically
significant improvement and maintenance of tissue thickness six months following
surgery. These results formed the basis for the design of our company-sponsored
post-marketing study in Europe, RESTORE II, which began in the second quarter of
2008.
The
Celution®
900-based StemSource® Cell
Bank was also launched this year. It is being commercialized to hospitals in
Japan, Korea, Taiwan, and Thailand through our partner Green Hospital Supply. In
addition, we are offering the StemSource® Cell
Bank to select companies and hospitals throughout the rest of the world. This
product is important as it allows us to capitalize near-term in a scalable
fashion on another application for the Celution® System
platform, the cryopreservation of cells, which is estimated to be a large,
untapped medical market. Additionally, Cytori will generate recurring
revenues each time a patient preserves his or her cells, which will require a
single-use consumable.
The most
technically advanced therapeutic application in our product development pipeline
is cardiovascular disease. We currently have two clinical trials underway
for adipose-derived stem and regenerative cells for the treatment of
cardiovascular disease, one targeting a chronic form of heart disease and the
other targeting heart attacks, an acute form of heart disease.
We
identified this market as a priority because we believe there is significant
need for new forms of cardiovascular disease treatment and because it represents
one of the largest global healthcare market opportunities. The American Heart
Association estimates that in the United States of America alone, there are
approximately 865,000 heart attacks each year and more than 13,000,000 people
suffer from coronary heart disease.
On June
24, 2008, the United States Patent & Trademark Office issued Patent No.
7,390,484, or the 484 patent, covering our Celution® System
technology. The 484 patent specifically protects Cytori's device
technology that processes adipose tissue to obtain a diverse and mixed
population of cells. Key claims are directed to a closed processing system for
tissue collection, filtration, concentration and a provision for aseptic
removal. Unlike Patent No. 6,777,231, which the Celution® System
does not practice, and which was recently the subject of an adverse court ruling
(see Part II, Item I, Legal Proceedings), the 484 patent is an important
component of our regenerative cell therapy intellectual property portfolio. The
484 patent describes a system for bringing to the patient’s bedside a mixed
population of cells including, but not limited to, fibroblasts, red blood cells,
white blood cells, smooth muscle cells, smooth muscle progenitor cells,
endothelial cells, endothelial progenitor cells, lymphatic cells, lymphatic
progenitor cells, as well as adult stem cells.
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.
|
19
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
June 30, 2008, the estimated fair value of the Put was
$1,000,000. 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.
In August
2007, we entered into a License and Royalty Agreement with the Joint Venture
which provides us the ability 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 allows for the sale
of the Cytori-developed Celution® System
platform until such time as the Joint Venture’s products are
commercially available for the same market served by 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 stem and 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. As part of this agreement, Olympus
will conduct market research and pilot clinical studies in collaboration with us
for the therapeutic area up to December 31, 2008 when this exclusive right will
terminate.
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.
MacroPore
Biosurgery
Spine and orthopedic
products
By
selling our spine and orthopedic surgical implant business to Kensey Nash
Corporation in the second quarter of 2007, we have completed our transition away
from the bioresorbable product line for which we were originally
founded.
Thin Film Japan Distribution
Agreement
In 2004,
we sold the majority of our Thin Film business to MAST. 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.
20
In the
third quarter of 2004, we entered into a Distribution Agreement with
Senko. 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
recorded as a component of deferred revenues. We did not recognize
any development revenues with respect to Senko during the three and six month
periods ended June 30, 2008. We recognized $10,000 for the three and
six month periods ended June 30, 2007.
Results
of Operations
Our
overall net loss for the three and six month periods ended June 30, 2008 was
$8,413,000 and $16,686,000, which was driven by $5,034,000 and $9,998,000 in
research and development expenses, $1,117,000 and $2,074,000 in sales and
marketing expenses, and $3,162,000 and $6,272,000 in general and administrative
expenses, respectively. This compares to a net loss for the three and six month
periods ended June 30, 2007 of $3,996,000 and $12,665,000, which was driven by
$4,393,000 and $9,390,000 in research and development expenses and $3,433,000
and $6,599,000 in general and administrative expenses, respectively. The net
loss for the six months ended June 30, 2008 reflects expenses related to
preparations for regenerative cell technology commercialization, including
build-out of our manufacturing capability, as well as costs associated with
clinical trials. The losses for these periods were offset in part by
the recognition of development revenue as well as recognition of revenue on the
first of our Celution® System
product sales. We currently expect our net operating loss for 2008
will be approximately $25,000,000.
Product
revenues
Product
revenues in 2008 relate to our regenerative cell technology segment and
consisted of revenues from our Celution® System
products. Product revenues in 2007 relate to our MacroPore Biosurgery
segment and consisted of revenues from our spine and orthopedic
products. The following table summarizes the components for the three
and six months ended June 30, 2008 and 2007:
For
the three months ended June 30,
|
For
the six months ended June 30,
|
|||||||||||||||
2008
|
2007
|
2008
|
2007
|
|||||||||||||
Regenerative cell
technology:
|
||||||||||||||||
Celution®
Systems
|
||||||||||||||||
Related
party
|
$ | 28,000 | $ | — | $ | 28,000 | $ | — | ||||||||
Third
party
|
1,376,000 | — | 1,529,000 | — | ||||||||||||
MacroPore
Biosurgery:
|
||||||||||||||||
Spine
and orthopedic products
|
— | 512,000 | — | 792,000 | ||||||||||||
Total
product revenues
|
$ | 1,404,000 | $ | 512,000 | $ | 1,557,000 | $ | 792,000 | ||||||||
%
attributable to Medtronic
|
— | 100.0 | % | — | 100.0% | % | ||||||||||
%
attributable to Olympus
|
2.0 | % | — | 1.8 | % | — |
Beginning
in March of 2008, we began sales and shipments of our Celution® 800/CRS
System to the European and Asia-Pacific reconstructive surgery
market. Assuming all other applicable revenue recognition criteria
have been met, revenue for these product sales will generally 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. Shipping and handling costs that are billed to our
customers are classified as revenue. As of June 30, 2008 we had open
sales orders of $767,000 and we had $113,000 of shipped product orders that did
not reach final destination. Revenue for these items is expected to
be recognized in the quarter ending September 30, 2008.
21
Spine and
orthopedic product revenues represent sales of bioresorbable implants used in
spine and orthopedic surgical procedures. We sold this line of
business to Kensey Nash in May 2007.
The future. We
expect to generate product revenues during 2008 related to our regenerative cell
therapy segment from the sale of our Celution® devices
and single-use consumables related to breast reconstructive surgery as well as
from our August 2007 commercialization agreement with Green Hospital Supply,
Inc. for regenerative cell banking in Japan. In addition, we expect
to generate revenues for regenerative cell banking in other countries in Asia
and Europe.
We expect
to have product revenues related to our MacroPore Biosurgery segment again if
commercialization of the Thin Film products in Japan occurs and we begin Thin
Film shipments to Senko.
Cost of product
revenues
Cost of
product revenues for 2008 relates to Celution® System
products in our regenerative cell technology segment and includes material,
manufacturing labor, overhead costs, and an inventory provision, if
applicable. Cost of product revenues for 2007 relates to spine and
orthopedic products in our MacroPore Biosurgery segment and includes material,
manufacturing labor, overhead costs, and an inventory provision, if
applicable. The following table summarizes the components of our cost
of revenues for the three and six months ended June 30, 2008 and
2007:
For
the three months ended June 30,
|
For
the six months ended June 30,
|
|||||||||||||||
2008
|
2007
|
2008
|
2007
|
|||||||||||||
Regenerative cell
technology:
|
||||||||||||||||
Cost
of product revenues
|
$ | 662,000 | $ | — | $ | 716,000 | $ | — | ||||||||
Share-based
compensation
|
13,000 | — | 19,000 | — | ||||||||||||
Total
regenerative cell technology
|
675,000 | — | 735,000 | — | ||||||||||||
MacroPore
Biosurgery:
|
||||||||||||||||
Cost
of product revenues
|
— | 188,000 | — | 403,000 | ||||||||||||
Share-based
compensation
|
— | 9,000 | — | 19,000 | ||||||||||||
Total
MacroPore Biosurgery
|
— | 197,000 | — | 422,000 | ||||||||||||
Total
cost of product revenues
|
$ | 675,000 | $ | 197,000 | $ | 735,000 | $ | 422,000 | ||||||||
Total
cost of product revenues as % of product revenues
|
48.1 | % | 38.5 | % | 47.2 | % | 53.3 | % | ||||||||
Regenerative
cell technology:
|
·
|
The
increase in cost of product revenues for the three and six months ended
June 30, 2008 as compared to the same periods in 2007 was due to
Celution®
System product sales for which revenue was recognized during the three and
six months ended June 30, 2008. Cost of sales included an
economic benefit of approximately $292,000 and $327,000, respectively,
related to material cost and labor/overhead previously expensed as
research and development prior to commercialization date of March 1, 2008
that was sold during the three and six months ended June 30,
2008.
|
|
·
|
Cost
of product revenues included approximately $13,000 and $19,000 of
share-based compensation expense for the three and six months ended June
30, 2008, respectively. For further details, see share-based
compensation discussion
below.
|
MacroPore
Biosurgery:
|
·
|
The
decrease in cost of product revenues for the three and six months ended
June 30, 2008 as compared to the same period in 2007 was due to a decrease
in production of MacroPore Biosurgery spine and orthopedic products,
followed by our sale of the product line in May
2007.
|
|
·
|
Cost
of product revenues included approximately $9,000 and $19,000 of
share-based compensation expense for the three and six months ended June
30, 2007, respectively. For further details, see share-based
compensation discussion below.
|
The future. We
expect to see a nominal decrease of gross profit margin for the regenerative
cell technology segment as the balance of production inventory on hand that was
previously expensed as research and development cost decreases. We expect to
incur costs related to our MacroPore products once commercialization is achieved
for our Japan Thin Film product line.
22
Development
revenues
The following table summarizes the
components of our development revenues for the three and six months ended June
30, 2008 and 2007:
For
the three months ended June 30,
|
For
the six months ended June 30,
|
|||||||||||||||
2008
|
2007
|
2008
|
2007
|
|||||||||||||
Regenerative cell
technology:
|
||||||||||||||||
Development
(Olympus)
|
$ | — | $ | 1,796,000 | $ | 774,000 | $ | 1,796,000 | ||||||||
Regenerative
cell storage services and other
|
12,000 | 8,000 | 49,000 | 53,000 | ||||||||||||
Total
regenerative cell technology
|
12,000 | 1,804,000 | 823,000 | 1,849,000 | ||||||||||||
MacroPore
Biosurgery:
|
||||||||||||||||
Development
(Senko)
|
— | 10,000 | — | 10,000 | ||||||||||||
Total
development revenues
|
$ | 12,000 | $ | 1,814,000 | $ | 823,000 | $ | 1,859,000 |
Regenerative
cell technology:
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
and six months ended June 30, 2008, we recognized $0 and $774,000 of revenue
associated with our arrangements with Olympus, respectively.
MacroPore
Biosurgery:
Under a
distribution agreement with Senko we are entitled to earn payments based on
achieving certain milestones. We did not recognize any revenue for
the three and six months ended June 30, 2008. We recognized $10,000
for the three and six months ended June 30, 2007.
The future. We
don’t expect to recognize additional development revenues from our regenerative
cell technology segment during the remainder of 2008, as the anticipated
completion for the next phase of our Joint Venture and other Olympus product
development performance obligations is 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 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 as the refund rights
associated with the license payment expire.
23
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 and six months ended June 30, 2008 and 2007:
For
the three months ended June 30,
|
For
the six months ended June 30,
|
|||||||||||||||
2008
|
2007
|
2008
|
2007
|
|||||||||||||
Regenerative cell
technology:
|
||||||||||||||||
Regenerative
cell technology
|
$ | 4,502,000 | $ | 2,837,000 | $ | 8,479,000 | $ | 6,073,000 | ||||||||
Development
milestone (Joint Venture)
|
371,000 | 1,329,000 | 1,213,000 | 2,834,000 | ||||||||||||
Share-based
compensation
|
161,000 | 175,000 | 301,000 | 327,000 | ||||||||||||
Total
regenerative cell technology
|
5,034,000 | 4,341,000 | 9,993,000 | 9,234,000 | ||||||||||||
MacroPore Biosurgery:
|
||||||||||||||||
Bioresorbable
polymer implants
|
— | 30,000 | 5,000 | 111,000 | ||||||||||||
Development
milestone (Senko)
|
— | 21,000 | — | 43,000 | ||||||||||||
Share-based
compensation
|
— | 1,000 | — | 2,000 | ||||||||||||
Total
MacroPore Biosurgery
|
— | 52,000 | 5,000 | 156,000 | ||||||||||||
Total
research and development expenses
|
$ | 5,034,000 | $ | 4,393,000 | $ | 9,998,000 | $ | 9,390,000 |
Regenerative
cell technology:
·
|
Regenerative
cell technology expenses relate to the development of a technology
platform that involves using adipose tissue as a source for 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 $176,000 and $310,000 for the three and six
months ended June 30, 2008, respectively, as compared to the same periods
in 2007 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. Professional services expense increased by $154,000
and $334,000 for the three and six months ended June 30, 2008,
respectively, as compared to the same periods in 2007. This was
due to increased use of consultants and temporary labor during the current
quarter. Pre-clinical and clinical study expense increased by
$488,000 and $277,000 for the three and six months ended June 30, 2008,
respectively as compared to the same periods in 2007. This
fluctuation was due primarily to a transition in focus from pre-clinical
studies to clinical studies. Expenses for supplies increased by
$193,000 and $377,000 for the three and six months ended June 30, 2008, as
compared to the same periods in 2007, primarily due to use of inventory
supplies for research purposes and purchases of production supplies prior
to the related product line
commercialization.
|
·
|
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 and six months ended June 30, 2008, costs associated with the
development of the device were $371,000 and $1,213,000,
respectively. For the three and six months ended June 30, 2007,
costs associated with the development of the device were $1,329,000 and
$2,834,000, respectively. The decrease in the costs related to
the Joint Venture with Olympus is primarily due to the completion of
pre-clinical milestone activities. The three months ended June
30, 2008 and 2007 expenses were composed of $176,000 and $828,000 in labor
and related benefits, $80,000 and $224,000 in consulting and other
professional services, $14,000 and $151,000 in supplies and $101,000 and
$126,000, respectively, in other miscellaneous expense. The six
months ended June 30, 2008 and 2007 expenses were composed of $660,000 and
$1,719,000 in labor and related benefits, $230,000 and $530,000 in
consulting and other professional services, $48,000 and $341,000 in
supplies and $275,000 and $244,000, respectively, in other miscellaneous
expense.
|
·
|
Share-based
compensation for the regenerative cell technology segment of research and
development was $161,000 and $301,000 for the three and six months ended
June 30, 2008, respectively. Share-based compensation for the
regenerative cell technology segment of research and development was
$175,000 and $327,000 for the three and six months ended June 30, 2007,
respectively. See share-based compensation discussion below for
more details.
|
24
MacroPore
Biosurgery:
.
·
|
Research
and development expenses for bioresorbable polymer implants substantially
decreased as of June 30, 2008. This was due to a redistribution
of labor resources from one business segment to the other, as well as to
termination of spine and orthopedics product research upon sale of that
product line in May 2007.
|
·
|
Under
a distribution agreement with Senko, we are responsible for the completion
of the initial regulatory application to the MHLW and commercialization of
the Thin Film product line in Japan. Commercialization occurs
when one or more Thin Film product registrations are completed with the
MHLW. During the three and six months ended June 30, 2007, we
incurred $21,000 and $43,000, respectively, of expenses related to this
regulatory and registration process. We did not incur any
expenses related to this regulatory and registration process for the three
and six months ended June 30, 2008.
|
·
|
Share-based
compensation for the MacroPore Biosurgery segment of research and
development for the three and six months ended June 30, 2007 was $1,000
and $2,000, respectively. There were no share-based
compensation expenses for the MacroPore Biosurgery segment of research and
development for the three and six months ended June 30,
2008. See share-based compensation discussion below for more
details.
|
The future. Our
strategy is to continue our research and development efforts in the regenerative
cell field and we anticipate expenditures in this area of research to total
approximately $22,000,000 to $24,000,000 in 2008 (see liquidity discussion in
the MD&A overview). We are working to develop therapies for
cardiovascular disease as well as new approaches for aesthetic and
reconstructive surgery, gastrointestinal disorders and spine and orthopedic
conditions. We are also developing a regenerative cell banking
platform for use in hospitals and clinics that will preserve harvested
regenerative cells for potential future use. The expenditures have
related and will continue to primarily relate to developing therapeutic
applications and conducting pre-clinical and clinical studies on adipose-derived
regenerative cells.
Sales and marketing
expenses
Sales and
marketing expenses include costs of marketing personnel, tradeshows, physician
training, and promotional activities and materials. Before the sale
of our spine and orthopedic implant product line in May 2007, Medtronic was
responsible for the distribution, marketing, and sales support of our spine and
orthopedic devices. The following table summarizes the components of
our sales and marketing expenses for the three and six months ended June 30,
2008 and 2007:
For
the three months ended June 30,
|
For
the six months ended June 30,
|
|||||||||||||||
2008
|
2007
|
2008
|
2007
|
|||||||||||||
Regenerative cell
technology:
|
||||||||||||||||
International
sales and marketing
|
$ | 975,000 | $ | 412,000 | $ | 1,808,000 | $ | 846,000 | ||||||||
Share-based
compensation
|
84,000 | 65,000 | 165,000 | 135,000 | ||||||||||||
Total
regenerative cell technology
|
1,059,000 | 477,000 | 1,973,000 | 981,000 | ||||||||||||
MacroPore Biosurgery:
|
||||||||||||||||
General
corporate marketing
|
— | 8,000 | — | 21,000 | ||||||||||||
International
sales and marketing
|
58,000 | 34,000 | 101,000 | 63,000 | ||||||||||||
Total
MacroPore Biosurgery
|
58,000 | 42,000 | 101,000 | 84,000 | ||||||||||||
Total
sales and marketing expenses
|
$ | 1,117,000 | $ | 519,000 | $ | 2,074,000 | $ | 1,065,000 |
Regenerative
Cell Technology:
·
|
The
increase in international sales and marketing expense for the three and
six months ended June 30, 2008 as compared to the same periods in 2007 was
mainly attributed to the increase in salary and related benefits expense
of $256,000 and $482,000, respectively, not including share-based
compensation, increase in travel related expenses of $82,000 and $139,000,
respectively, increase in printing, supplies, and postage of $50,000 and
$104,000, respectively, and increase in promotion expenses of $96,000 and
$55,000, respectively, which are due to our emphasis in seeking strategic
alliances and/or co-development partners for our regenerative cell
technology.
|
·
|
Share-based
compensation for the regenerative cell segment of sales and marketing for
the three and six months ended June 30, 2008 was $84,000 and $165,000,
respectively. Share-based compensation for the regenerative
cell segment of sales and marketing for the three and six months ended
June 30, 2007 was $65,000 and $135,000, respectively. See
share-based compensation discussion below for more
details.
|
25
MacroPore
Biosurgery:
·
|
General
corporate marketing expenditures relate to expenditures for maintaining
our corporate image and reputation within the research and surgical
communities relevant to bioresorbable
implants. Expenditures in this area declined to $0 in the
first half 2008 as we focused on our regenerative cell technology business
and exited from our spine and orthopedic implant
business.
|
·
|
International
sales and marketing expenditures relate to costs associated with
developing an international bioresorbable Thin Film distributor and
supporting a bioresorbable Thin Film sales office in
Japan.
|
The future. We
expect sales and marketing expenditures related to the regenerative cell
technology to increase as we continue to expand our pursuit of strategic
alliances and co-development partners, as well as market our Celution® System.
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
and six months ended June 30, 2008 and 2007:
For
the three months ended June 30,
|
For
the six months ended June 30,
|
|||||||||||||||
2008
|
2007
|
2008
|
2007
|
|||||||||||||
General
and administrative
|
$ | 2,775,000 | $ | 3,076,000 | $ | 5,558,000 | $ | 5,927,000 | ||||||||
Share-based
compensation
|
387,000 | 357,000 | 714,000 | 672,000 | ||||||||||||
Total
general and administrative expenses
|
$ | 3,162,000 | $ | 3,433,000 | $ | 6,272,000 | $ | 6,599,000 |
·
|
An
overall decrease (excluding stock-based compensation) occurred during the
three and six months ended June 30, 2008 as compared to the same periods
in 2007. This resulted primarily from a decrease in
professional services of $319,000 and $431,000, respectively, as compared
to the same periods in 2007. The decrease in professional
services was primarily due to a non-recurring fee of $322,000 incurred
during first quarter of 2007 related to our February 2007 sale of common
stock and an overall decrease in legal expense (see discussion below for
more detail).
|
·
|
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 and six months ended June 30, 2008, we expensed $73,000 and
$240,000, respectively, for legal fees related to this
license. In the same periods in 2007, we expensed $518,000 and
$602,000, respectively, for legal fees related to this
license. Our legal expenses related to this lawsuit and the
appeal will fluctuate depending upon the activity incurred during each
period.
|
·
|
Share-based
compensation related to general and administrative expense for the three
and six months ended June 30, 2008 was $387,000 and $714,000,
respectively. For the same periods in 2007, share-based
compensation related to general and administrative expense was $357,000
and $672,000, respectively. See share-based compensation
discussion below for more details.
|
The future. We
expect general and administrative expenses of approximately $10,000,000 to
$12,000,000 in 2008 and are focused on minimizing the ratio of these expenses to
research and development expenses.
26
Share-based compensation
expenses
The
following table summarizes the components of our share-based compensation for
the three and six months ended June 30, 2008 and 2007:
For
the three months ended June 30,
|
For
the six months ended June 30,
|
|||||||||||||||
2008
|
2007
|
2008
|
2007
|
|||||||||||||
Regenerative cell
technology:
|
||||||||||||||||
Cost
of product
revenues
|
$ | 13,000 | $ | — | $ | 19,000 | $ | — | ||||||||
Research
and development-related
|
161,000 | 175,000 | 301,000 | 327,000 | ||||||||||||
Sales
and marketing-related
|
84,000 | 65,000 | 165,000 | 135,000 | ||||||||||||
Total
regenerative cell technology
|
258,000 | 240,000 | 485,000 | 462,000 | ||||||||||||
MacroPore Biosurgery:
|
||||||||||||||||
Cost
of product
revenues
|
— | 9,000 | — | 19,000 | ||||||||||||
Research
and development – related
|
— | 1,000 | — | 2,000 | ||||||||||||
Total
MacroPore Biosurgery
|
— | 10,000 | — | 21,000 | ||||||||||||
General
and administrative-related
|
387,000 | 357,000 | 714,000 | 672,000 | ||||||||||||
Total
share-based compensation
|
$ | 645,000 | $ | 607,000 | $ | 1,199,000 | $ | 1,155,000 |
Most of
the expenses in the three and six month periods ended June 30, 2008 related to
the vesting of stock option awards to employees. 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.
During
the first quarter of 2007, we issued to our officers and directors stock options
to purchase up to 410,000 shares of our common stock, with a four-year vesting
for our officers and 24-month vesting for our directors. The grant date fair
value of option awards granted to our officers and directors was $3.82 and $3.70
per share, respectively. The resulting share-based compensation expense of
$1,480,000, net of estimated forfeitures, will be recognized as expense over the
respective vesting periods.
During
the second quarter of 2007, we made a company-wide option grant to our
non-executive employees to purchase up to 213,778 shares of our common stock,
subject to a four-year vesting schedule. The grant date fair value for the
awards was $3.66 per share. The resulting share-based compensation expense of
$739,000, net of estimated forfeitures, will be recognized as expense over the
respective vesting periods.
The future. We expect
to 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 June 30, 2008, the total compensation cost related
to non-vested stock options not yet recognized for all our plans is
approximately $4,720,000. These costs are expected to be recognized over a
weighted average period of 1.85 years.
Change in fair value of
option liabilities
The
following is a table summarizing the change in fair value of option liabilities
for the three and six months ended June 30, 2008 and 2007:
For
the three months ended June 30,
|
For
the six months ended June 30,
|
|||||||||||||||
2008
|
2007
|
2008
|
2007
|
|||||||||||||
Change
in fair value of put option liability
|
(200,000 | ) | (100,000 | ) | — | 100,000 |
·
|
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 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 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.
|
27
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:
June
30, 2008
|
December
31, 2007
|
November
4, 2005
|
||||||||||
Expected
volatility of
Cytori
|
61.00 | % | 60.00 | % | 63.20 | % | ||||||
Expected
volatility of the Joint Venture
|
61.00 | % | 60.00 | % | 69.10 | % | ||||||
Bankruptcy
recovery rate for
Cytori
|
21.00 | % | 21.00 | % | 21.00 | % | ||||||
Bankruptcy
threshold for
Cytori
|
$ | 8,925,000 | $ | 9,324,000 | $ | 10,780,000 | ||||||
Probability
of a change of control event for Cytori
|
2.56 | % | 2.17 | % | 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
|
3.99 | % | 4.04 | % | 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.
Gain on sale of
assets
Gain on
sale of assets was $1,858,000 for the three and six months ended June 30,
2007. There was no gain on sale of assets for the three and six
months ended June 30, 2008.
In May
2007, we sold to Kensey Nash our intellectual property rights and tangible
assets related to our spine and orthopedic bioresorbable implant product line, a
part of our MacroPore Biosurgery business. Excluded from the sale was
our Japan Thin Film product line. We received $3,175,000 in cash
related to the disposition. The assets comprising the spine and
orthopedic product line transferred to Kensey Nash were as follows:
Carrying
Value Prior to Disposition
|
||||
Inventory
|
$ | 94,000 | ||
Other
current assets
|
17,000 | |||
Assets
held for sale
|
436,000 | |||
Goodwill
|
465,000 | |||
$ | 1,012,000 |
We
incurred expenses of $109,000 in connection with the sale during the second
quarter of 2007. As part of the disposition agreement, we were
required to provide training to Kensey Nash representatives in all aspects of
the manufacturing process related to the transferred spine and orthopedic
product line, and to act in the capacity of a product manufacturer from the
point of sale through August 2007. Because of these additional
manufacturing requirements, we deferred $196,000 of the gain related to the
outstanding manufacturing requirements, and we recognized $1,858,000 as a gain
on sale in the statement of operations during the second quarter of
2007. These manufacturing requirements were completed in August as
planned, and the associated costs were classified against the deferred balance,
reducing it to zero. No further costs or adjustments relating to this
product line sale are anticipated.
The
revenues and expenses related to the spine and orthopedic product line
transferred to Kensey Nash for the three and six months ended June 30, 2008 and
2007 were as follows:
For
the three months ended June 30,
|
For
the six months ended June 30,
|
|||||||||||||||
2008
|
2007
|
2008
|
2007
|
|||||||||||||
Revenues
|
$ | — | $ | 512,000 | $ | — | $ | 792,000 | ||||||||
Cost
of product revenues
|
— | (197,000 | ) | — | (422,000 | ) | ||||||||||
Research
& development
|
— | (31,000 | ) | — | (113,000 | ) | ||||||||||
Sales
& marketing
|
— | (8,000 | ) | — | (21,000 | ) |
28
Financing
items
The
following table summarizes interest income, interest expense, and other income
and expense for the three and six months ended June 30, 2008 and
2007:
For
the three months ended June 30,
|
For
the nine months ended June 30,
|
|||||||||||||||
2008
|
2007
|
2008
|
2007
|
|||||||||||||
Interest
income
|
$ | 38,000 | $ | 348,000 | $ | 114,000 | $ | 545,000 | ||||||||
Interest
expense
|
(18,000 | ) | (43,000 | ) | (41,000 | ) | (95,000 | ) | ||||||||
Other
income (expense)
|
(53,000 | ) | (52,000 | ) | (43,000 | ) | (54,000 | ) | ||||||||
Total
|
$ | (33,000 | ) | $ | 253,000 | $ | 30,000 | $ | 396,000 |
·
|
Interest
income decreased for the three and six months ended June 30, 2008 as
compared to the same periods in 2007 due to a decrease in interest rates
and cash balance available for
investment.
|
·
|
Interest
expense decreased for the three and six months ended June 30, 2008 as
compared to the same periods in 2007 due to lower principal balances on
our long-term equipment-financed
borrowings.
|
·
|
The
changes in other income (expense) in the three and six months ended June
30, 2008 as compared to the same periods in 2007 resulted primarily from
changes in foreign currency exchange
rates.
|
The
future. Interest income earned in 2008 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
2008.
|
Equity gain
(loss) from investment in Joint
Venture
|
The
following table summarizes our equity gain or loss from investment in joint
venture for the three and six months ended June 30, 2008 and 2007:
For
the three months ended June 30,
|
For
the six months ended June
30,
|
|||||||||||||||
2008
|
2007
|
2008
|
2007
|
|||||||||||||
Equity
gain (loss) in investment
|
$ | (8,000 | ) | $ | 9,000 | $ | (17,000 | ) | $ | 6,000 |
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 two to three 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. Though we have no obligation to do so, we and Olympus plan
to jointly fund 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 June 30, 2008 and
December 31, 2007:
June
30,
|
December
31,
|
|||||||
2008
|
2007
|
|||||||
Cash
and cash equivalents
|
$ | 5,328,000 | $ | 11,465,000 | ||||
Current
assets
|
$ | 8,074,000 | $ | 12,238,000 | ||||
Current
liabilities
|
7,320,000 | 8,070,000 | ||||||
Working
capital
|
$ | 754,000 | $ | 4,168,000 |
29
In order
to provide greater financial flexibility and liquidity, and in view of the
substantial cash requirements of our regenerative cell business during its
development stage, we have an ongoing need to raise additional
capital. In the first quarter of 2007, we received net proceeds of
$19,901,000 from the sale of units consisting of 3,746,000 shares of common
stock and 1,873,000 common stock warrants (with an exercise price of $6.25 per
share) under a shelf registration statement. In the
second quarter of 2007, we received net proceeds of $6,000,000 from the sale of
1,000,000 shares of common stock to Green Hospital Supply, Inc. in a private
placement. Also, in the second quarter of 2007, we successfully
divested our spine and orthopedic product line to Kensey Nash for gross proceeds
of $3,175,000. In the first half of 2008, we received net proceeds of
$12,000,000 from the sale of 2,000,000 shares of unregistered common stock to
Green Hospital Supply, Inc. in a private placement. Additionally, we
announced on August 8, 2008, the raising of 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 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.
Our
product sales, which commenced in the first quarter of 2008, are not currently
sufficient by themselves to provide long-term cash flow viability to the
Company. However, based on the results of our initial product launch in
the first half of this year combined with orders received and expected during
the remainder of the year and beyond, we believe our revenue generation
prospects will provide an increasingly significant contribution to our operating
cash flows.
Management actively monitors
current and projected costs as we progress into product commercialization and
sales in order to match projected expenditures to available cash flow (as noted
in the above liquidity discussion in the MD&A Overview, the recent financing took
longer than originally anticipated due to current economic conditions and during
that time management was monitoring cash outflow). Cost containment
measures are currently being explored with the goal of reducing or eliminating
non-essential research and administrative expenditures as well as utilizing
manufacturing techniques and alternatives that can help generate production
economies of scale.
With
consideration of these endeavors as well as existing funds, additional capital
will need to be raised during 2008 through accessible sources of third party
financing, as well as an increase in our results of operations, to provide us
adequate cash to satisfy our working capital, capital expenditures, debt service
and other financial commitments at least through June 30, 2009 (see liquidity
discussion in the MD&A Overview).
We expect
to utilize our cash and cash equivalents to fund our operations, including
research and development of our products primarily, pre-clinical activities and
for clinical trials. However, we will be required to raise capital from
one or more sources in the near term to continue our operations as previously
conducted. We believe that without additional capital from accessible
sources of financing, as well as an increase in capital from operations, we do
not currently have adequate funding to complete the development, preclinical
activities and clinical trials required to bring our future products to
market. Therefore significant additional funding will be
required. No assurance can be made that such funding will be
available to us. If we are unsuccessful in our efforts to raise additional
funds through accessible sources of financing in the near term, we will be
required to significantly reduce or curtail research and development activities
and other operations. Management actively monitors cash expenditures and
projected expenditures as we operate and progress toward our goals of product
commercialization and sales in an effort to match projected expenditures to
available cash flow.
From
inception to June 30, 2008, 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,
|
·
|
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,
|
30
·
|
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,
|
·
|
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,
and
|
·
|
Receiving
$12,000,000 in net proceeds from a private placement to Green Hospital
Supply, Inc. during first half
2008.
|
We do not
expect significant capital expenditures during the remainder of
2008.
Any
excess funds are expected to be invested in short-term available-for-sale
investments.
Our cash
requirements for 2008 and beyond will depend on numerous factors, including the
resources we devote to developing and supporting our investigational cell
therapy products, market acceptance of any developed products, regulatory
approvals and other factors. We expect to incur research and
development expenses at high levels in our regenerative cell platform for an
extended period of time and have therefore pursued expansion of our cash
position through financing transactions where appropriate as well as actively
seeking co-development and marketing agreements, research grants, and licensing
agreements related to our regenerative cell technology platform.
The
following summarizes our contractual obligations and other commitments at June
30, 2008, and the effect such obligations could have on our liquidity and cash
flow in future periods:
Payments
due by period
|
||||||||||||||||||||
Contractual
Obligations
|
Total
|
Less
than 1
year
|
1
– 3 years
|
3
– 5 years
|
More
than
5
years
|
|||||||||||||||
Long-term
obligations
|
$ | 612,000 | $ | 483,000 | $ | 129,000 | $ | — | $ | — | ||||||||||
Interest
commitment on long-term obligations
|
40,000 | 35,000 | 5,000 | — | — | |||||||||||||||
Operating
lease obligations
|
3,252,000 | 1,617,000 | 1,554,000 | 57,000 | 24,000 | |||||||||||||||
Minimum
purchase requirements
|
2,820,000 | 1,120,000 | 1,700,000 | — | — | |||||||||||||||
Pre-clinical
research study obligations
|
281,000 | 281,000 | — | — | — | |||||||||||||||
Clinical
research study obligations
|
8,426,000 | 4,100,000 | 3,800,000 | 526,000 | — | |||||||||||||||
Total
|
$ | 15,431,000 | $ | 7,636,000 | $ | 7,188,000 | $ | 583,000 | $ | 24,000 |
We will
be required to raise capital from one or more sources in the near term to
fulfill the less than one year contractual obligations as presented in the above
table (see liquidity discussion in the MD&A overview).
Cash
(used in) provided by operating, investing, and financing activities for the six
months ended June 30, 2008 and 2007 is summarized as follows:
For the six months ended June 30,
|
||||||||
2008
|
2007
|
|||||||
Net
cash used in operating activities
|
$ | (18,184,000 | ) | $ | (15,009,000 | ) | ||
Net
cash provided by (used in) investing activities
|
(296,000 | ) | 2,880,000 | |||||
Net
cash provided by financing activities
|
12,343,000 | 26,035,000 |
31
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, other operational activities, and a comparatively small
amount of product sales generated an operating loss of $16,699,000 for the six
months ended June 30, 2008. The operating cash impact of this loss
was $18,184,000, after adjusting for the recognition of non-cash development
revenue of $774,000, the consideration of non-cash share-based compensation of
$1,199,000, other adjustments for material non-cash activities, such as
depreciation and amortization, changes in working capital due to timing of
product shipments (accounts receivable) and payment of liabilities.
Research
and development efforts, other operational activities, and a comparatively small
amount of product sales generated a $14,925,000 net loss for the six months
ended June 30, 2007. The cash impact of this loss was $15,009,000,
after adjusting for the recognition of non-cash development revenue of
$1,796,000, the consideration of non-cash share-based compensation of
$1,155,000, other adjustments including material non-cash activities, such as
depreciation and amortization, and 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 six months ended June 30, 2008 resulted
primarily from purchases of property and equipment.
Net cash
provided by investing activities for the six months ended June 30, 2007 resulted
primarily from proceeds from the sale of our spine and orthopedics bioresorbable
implant product line to Kensey Nash.
Capital
spending is essential to our product innovation initiatives and to maintaining
our operational capabilities. For the six months ended June 30, 2008
and 2007, we used cash to purchase $296,000 and $365,000, respectively, of
property and equipment, primarily to support the research and development of the
regenerative cell technology platform.
Financing
Activities
The net
cash provided by financing activities for the six months ended June 30, 2008
related mainly to the private issuance of 2,000,000 shares of unregistered
common stock to Green Hospital Supply, Inc. for $12,000,000.
The net
cash provided by financing activities for the six months ended June 30, 2007
related mainly to the issuance of 3,746,000 shares of our common stock and
1,873,000 common stock warrants in exchange for approximately $21,500,000
($19,901,000 net of direct offering costs) as well as the sale of 1,000,000
shares of treasury stock 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.
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. 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.
Inventories
Inventories include the cost of
material, labor, and overhead, and are stated at the lower of average cost,
determined on the first-in, first-out (FIFO) method, or market. We
periodically evaluate our on-hand stock and make appropriate provisions for any
stock deemed excess or obsolete. We expense excess manufacturing
costs, that is, costs resulting from lower than “normal” production
levels.
Our inventory balance as of June 30,
2008 represents cost of materials on hand as of June 30, 2008 that we purchased
on or after March 1, 2008. March 1, 2008 is considered our
commercialization date based on completion of final development activities
associated with our Celution® 800/CRS
System products. All materials purchased prior to the
commercialization date were included as research and development expense during
the period they were purchased.
No
inventory provisions were recorded during the first half of 2008 and
2007.
32
Revenue
Recognition
We derive
our revenue from a number of different sources, including but not limited
to:
·
|
Fees
for achieving certain defined milestones under research and/or development
arrangements.
|
·
|
Product
sales, and
|
·
|
Payments
under license or distribution
agreements.
|
A number
of our revenue generating arrangements are relatively simple in nature, meaning
that there is little judgment necessary with regard to the timing of when we
recognize revenues or how such revenues are presented in the financial
statements.
However,
we have also entered into more complex arrangements, including but not limited
to our contracts with Olympus, Senko, and the National Institutes of Health
(NIH). Moreover, some of our non-recurring transactions, such as our
disposition of the majority of our Thin Film business to MAST, contain elements
that relate to our revenue producing activities.
As a
result, some of our most critical accounting judgments relate to the
identification, timing, and presentation of revenue related activities. These
critical judgments are as follows:
Multiple-element
arrangements
Some of
our revenue generating arrangements contains a number of distinct revenue
streams, known as “elements.” For example, our Distribution Agreement
with Senko contains direct or indirect future revenue streams related
to:
·
|
A
distribution license fee (which was paid at the outset of the
arrangement),
|
·
|
Milestone
payments for achieving commercialization of the Thin Film product line in
Japan,
|
·
|
Training
for representatives of Senko,
|
·
|
Sales
of Thin Film products to Senko, and
|
·
|
Payments
in the nature of royalties on future product sales made by Senko to its
end customers.
|
Emerging
Issues Task Force Issue No. 00-21, “Revenue Arrangements with Multiple
Deliverables” (“EITF 00-21”), governs whether each of the above elements in the
arrangement should be accounted for individually, or whether the entire contract
should be treated as a single unit of accounting.
EITF
00-21 indicates that individual elements may be separately accounted for only
when:
·
|
The
delivered element has stand alone value to the
customer,
|
·
|
There
is objective evidence of the fair value of the remaining undelivered
elements, and
|
·
|
If
the arrangement contains a general right of return related to any products
delivered, delivery of the remaining goods and services is probable and
within the complete control of the
seller.
|
In the
case of the Senko Distribution Agreement, we determined that (a) the milestones
payments for achieving commercialization and (b) the future sale of Thin Film
products to Senko were “separable” elements. That is, each of these
elements, upon delivery, will have stand alone value to Senko and there will be
objective evidence of the fair value of any remaining undelivered elements at
that time. The arrangement does not contain any general right of
return, and so this point is not relevant to our analysis.
On the
other hand, we concluded that (a) the upfront distribution license fee, (b) the
revenues from training for representatives of Senko, and (c) the payments in the
form of royalties on future product sales are not separable elements under EITF
00-21.
33
In
arriving at our conclusions, we had to consider whether our customer, Senko,
would receive stand alone value from each delivered element. We also,
in some cases, had to look to third party evidence to support the fair value of
certain undelivered elements. Finally, we had to make assumptions
about how the non-separable elements of the arrangement are earned, particularly
the estimated period over which Senko will benefit from the arrangement (refer
to the “Recognition” discussion below for further background).
Similarly,
we have attributed the upfront fees received under the arrangements with Olympus
Corporation, a related party, to a combined unit of accounting comprising a
license we granted to the Joint Venture, Olympus-Cytori, Inc., a related party,
as well as development services we agreed to perform for this
entity. We concluded that the license and development services must
be accounted for as a single unit of accounting. In reaching this
conclusion, we determined that the license would not have stand alone value to
the Joint Venture. This is because Cytori is the only party that
could be reasonably expected to perform certain development contributions and
obligations, including product development assistance, certain agreed regulatory
filings and generally associated pre-clinical and clinical studies necessary for
the Joint Venture to derive value from the license.
Recognition
Besides
determining whether to account separately for components of a multiple-element
arrangement, we also use judgment in determining the appropriate accounting
period in which to recognize revenues that we believe (a) have been earned and
(b) are realizable. The following describes some of the recognition
issues we have considered during the reporting period.
·
|
Product
Revenues
|
o
|
Beginning
in March of 2008, we began sales and shipments of our Celution® 800/CRS
System to the European and Asia-Pacific reconstructive surgery
market. Assuming all other applicable revenue recognition
criteria have been met, revenue for these product sales will generally 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. Shipping and handling costs that
are billed to our customers are classified as revenue, in accordance with
Emerging Issues Task Force Issue No. 00-10, “Accounting for Shipping and
Handling Fees and Costs” (“EITF
00-10).
|
·
|
Upfront
License Fees/Milestones
|
o
|
As
part of the Senko Distribution Agreement, we received an upfront license
fee upon execution of the arrangement, which, as noted previously, was not
separable under EITF 00-21. Accordingly, the license has been
combined with the development (milestones) element to form a single
accounting unit. This single element of $3,000,000 in fees
includes $1,500,000, which is potentially refundable. We have
recognized, and will continue to recognize, the non-contingent fees
allocated to this combined element as revenues as we complete each of the
performance obligations associated with the milestones component of this
combined deliverable. Note that the timing of when we have
recognized revenues to date does not correspond with the cash we received
upon achieving certain milestones. For example, the first such
milestone payment for $1,250,000 became payable to us when we filed a
commercialization application with the Japanese regulatory
authorities. However, we determined that the payment received
was not commensurate with the level of effort expended, particularly when
compared with other steps we believe are necessary to commercialize the
Thin Film product line in Japan. Accordingly, we did not
recognize the entire $1,250,000 received as revenues, but instead all but
$371,000 of this amount is classified as deferred
revenues. Approximately $371,000 ($10,000 in 2007, $152,000 in
2006, $51,000 in 2005 and $158,000 in 2004) has been recognized to date as
development revenues based on our estimates of the level of effort
expended for completed milestones as compared with the total level of
effort we expect to incur under the arrangement to successfully achieve
regulatory approval of the Thin Film product line in
Japan. These estimates were subject to judgment and there may
be changes to these estimates as we continue to seek regulatory
approval. In fact there can be no assurance that
commercialization in Japan will ever be achieved, as we have yet to
receive approval from the MHLW.
|
34
o
|
We
also received upfront fees as part of the Olympus arrangements (although,
unlike in the Senko agreement, these fees were
non-refundable). Specifically, in exchange for an upfront fee,
we granted the Joint Venture an exclusive, perpetual license to certain of
our intellectual property and agreed to perform additional development
activities. This upfront fee has been recorded in the liability
account entitled deferred revenues, related party, on our consolidated
balance sheet. Similar to the Senko agreement, we expect to
recognize revenues from the combined license/development accounting unit
as we perform our obligations under the agreements, as this represents our
final obligation underlying the combined accounting
unit. Specifically, we have recognized revenues from the
license/development accounting unit using a “proportional performance”
methodology, resulting in the de-recognition of amounts recorded in the
deferred revenues, related party, account as we complete various
milestones underlying the development services. Proportional
performance methodology was elected due to the nature of our development
obligations and efforts in support of the Joint Venture with Olympus,
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. We established the R&D
milestones based upon our development obligations to the JV and the
specific R&D support activities to be performed to achieve these
obligations. Our R&D milestones consist of the following
primary performance categories: product development, regulatory
approvals, and generally associated pre-clinical and clinical
trials. Within each category are milestones that take
substantive effort to complete and are critical pieces of the overall
progress towards completion of the next generation product, which we are
obligated to support within the agreements entered into with
Olympus. To determine whether substantive effort was required
to achieve the milestones, we considered the external costs, required
personnel and relevant skill levels, the amount of time required to
complete each milestone, and the interdependent relationships between the
milestones, in that the benefits associated with the completion of one
milestone generally support and contribute to the achievement of the
next. Determination of the relative values assigned to each
milestone involved substantial judgment. The assignment process
was based on discussions with persons responsible for the development
process and the relative costs of completing each milestone. We
considered the costs of completing the milestones in allocating the
portion of the “deferred revenues, related party” account balance to each
milestone. Management believes that, while the costs incurred
in achieving the various milestones are subject to estimation, due to the
high correlation of such costs to outputs achieved, the use of external
contract research organization costs and internal labor costs as the basis
for the allocation process provides management the ability to accurately
and reasonably estimate such costs. The accounting policy
described above could result in revenues being recorded in an earlier
accounting period than had other judgments or assumptions been made by
us.
|
·
|
Government
Grants
|
o
|
We
are eligible to receive grants from the NIH related to our research on
adipose derived cell therapy to treat myocardial
infarctions. Revenues derived from reimbursement of direct
out-of-pocket expenses for research costs associated with grants are
recorded 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, the Company records 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 the consolidated statements of
operations. Additionally, research arrangements we have with
NIH, as well commercial enterprises such as Olympus and Senko, are
considered a key component of our central and ongoing
operations. Moreover, the government obtains rights under the
arrangement, in the same manner (but perhaps not to the same extent) as a
commercial customer that similarly contracts with us to perform research
activities. For instance, the government and any authorized
third parties may use our federally funded research and/or inventions
without payment of royalties to us. Accordingly, the inflows
from such arrangements are presented as revenues in the consolidated
statements of operations.
|
Our
policy is to recognize revenues under the NIH grant arrangement as the lesser of
(i) qualifying costs incurred (and not previously recognized), plus our
allowable grant fees for which we are entitled to funding or (ii) the amount
determined by comparing the outputs generated to date versus the total outputs
expected to be achieved under the research arrangement.
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 June 30, 2008. As required by SFAS 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. Moreover, this testing must be performed at a level of the
organization known as the reporting unit. A reporting unit is at
least the same level as a company’s operating segments, and sometimes even one
level lower. Our two reporting units are the same as our two
operating segments.
35
Specifically,
the process for testing goodwill for impairment under SFAS 142 involves the
following steps:
·
|
Company
assets and liabilities, including goodwill, are allocated to each
reporting unit for purposes of completing the goodwill impairment
test.
|
·
|
The
carrying value of each reporting unit – that is, the sum of all of the net
assets allocated to the reporting unit – is then compared to its fair
value.
|
·
|
If
the fair value of the reporting unit is lower than its carrying amount,
goodwill may be impaired – additional testing is
required.
|
The
application of the goodwill impairment test involves a substantial amount of
judgment. For instance, SFAS 142 requires that assets and liabilities
be assigned to a reporting unit if both of the following criteria are
met:
·
|
The
asset will be employed in or the liability relates to the operations of a
reporting unit.
|
·
|
The
asset or liability will be considered in determining the fair value of the
reporting unit.
|
We
developed mechanisms to assign company-wide assets like shared property and
equipment, as well as company-wide obligations such as borrowings under our GE
loan facility, to our two reporting units. In some cases, certain
assets were not allocable to either reporting unit and were left
unassigned.
We
estimated the fair value of our reporting units by using various estimation
techniques. For example in 2006, we estimated the fair value of our
MacroPore Biosurgery reporting unit based on an equal weighting of the market
values of comparable enterprises and discounted projections of estimated future
cash flows. Clearly, identifying comparable companies and estimating
future cash flows as well as appropriate discount rates involve
judgment. On the contrary, we estimated the fair value of our
regenerative cell reporting unit solely using an income approach, as – at that
time – we believed there were no comparable enterprises on which to base a
valuation. The assumptions underlying this valuation method involve a
substantial amount of judgment, particularly since our regenerative cell
business has yet to generate any revenues and does not have a commercially
viable product. The combined value of our goodwill is consistent with
the market’s valuation.
In 2007,
all goodwill that previously had been assigned to our MacroPore Biosurgery
reporting unit was derecognized as a result of our sale of our spine and
orthopedic product line to Kensey Nash. Accordingly, there was no
need to test this component of our business for goodwill impairment in
2007.
Also in
2007, we completed our goodwill impairment testing for our regenerative cell
technology reporting unit using a market-based approach. We concluded
that the fair value of this unit exceeded its carrying value, and that none of
our reported goodwill was impaired.
Again,
the manner in which we assigned assets, liabilities, and goodwill to our
reporting units, as well as how we determined the fair value of such reporting
units, involves significant uncertainties and estimates. The
judgments employed may have an effect on whether a goodwill impairment loss is
recognized.
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.
|
36
·
|
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 June 30, 2008 or for the three and six 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.
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 March
2007, the FASB ratified the consensus reached by the Emerging Issues Task Force
(EITF) on Issue No. 07-3, “Accounting for Nonrefundable Advance Payments for
Goods or Services Received for Use in Future Research and Development
Activities” (“EITF 07-3”). EITF 07-3 states that nonrefundable
advance payments for future research and development activities should be
deferred and capitalized. Such amounts should be recognized as an
expense as the goods are delivered or the related services are
performed. The guidance is effective for all periods beginning after
December 15, 2007, which we adopted effective January 1, 2008. The
adoption of EITF 07-3 did not have a significant effect on our consolidated
financial statements.
In
December 2007, the FASB issued 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. We do not believe that the adoption of SFAS 160
will have a significant effect on our consolidated financial
statements.
37
In
December 2007, the FASB issued 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. We do not believe that the adoption of SFAS
141R will have a significant effect on our consolidated financial
statements.
In
December 2007, the FASB ratified the consensus reached by the Emerging Issues
Task Force on 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. We are currently in
the process evaluating whether the adoption of EITF 07-1 will have a significant
effect on our consolidated financial statements.
In
March 2008, FASB issued SFAS No. 161, “Disclosures about Derivative
Instruments and Hedging Activities-an amendment of FASB Statement No. 133”
(“SFAS 161”). SFAS 161 expands the current disclosure requirements of SFAS
No. 133, “Accounting for Derivative Instruments and Hedging Activities,”
such that entities must now provide enhanced disclosures on a quarterly basis
regarding how and why the entity uses derivatives; how derivatives and related
hedged items are accounted for under SFAS No. 133 and how derivatives and
related hedged items affect the entity’s financial position, performance and
cash flows. Pursuant to the transition provisions of the Statement, the company
will adopt SFAS 161 in fiscal year 2009 and will present the required
disclosures in the prescribed format on a prospective basis. The adoption of
SFAS 161 will not impact the consolidated condensed financial statements as it
is disclosure-only in nature.
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 June 30, 2008, 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, 2007, 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 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.
38
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 June 30, 2008.
Changes
in Internal Control over Financial Reporting
There has
been no change in our internal control over financial reporting during the
quarter ended June 30, 2008 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 June 30, 2008, 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 will need to raise more
cash in the near future
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 will
be required to raise capital from one or more sources in the near term to
continue its operations as previously conducted. We believe that
without additional capital from accessible sources of financing, as well as an
increase in capital from our operations, we do not currently have adequate
funding to complete the development, pre-clinical
activities, clinical trials and marketing efforts required to
successfully bring its current and future products to
market. Therefore significant additional funding will be
required. 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. The inability to obtain sufficient
funds would require us to delay, scale back, or eliminate some or all of our
research or product development, manufacturing operations, clinical or
regulatory activities, or to out-license commercial rights to products or
technologies thus having a substantial negative effect on our results of
operations and financial condition.
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.
39
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. will continue to require
more money than its initial 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.
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.
40
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 products 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 intend 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.
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.
41
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
have just begun launching 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 obtain additional patents, maintain
trade secret protection, and operate without infringing on the proprietary
rights of third parties.
Our
recently 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.
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. We have been incurring substantial legal costs as
a result of the University of Pittsburgh lawsuit, and our president, Marc
Hedrick, is a named individual defendant in that lawsuit because he is one of
the inventors identified on the patent. As a named inventor on the
patent, Marc Hedrick is entitled to receive from the UC up to 7% of royalty
payments made by a licensee (us) to UC. This agreement was in place
prior to his employment with us.
42
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.
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.
43
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.
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.
44
We depend on a few key
officers
Our
performance is substantially dependent on the performance of our executive
officers and other key scientific 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.
Item 3. Defaults Upon Senior Securities
|
None
|
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 a 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. Additionally, we entered into a new lease during second quarter
of 2008 for a 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. For these
properties, we pay an aggregate of approximately $132,000 in rent per
month.
45
Staff
As of
June 30, 2008, we had 150 employees, including part-time and full-time
employees. These employees are comprised of 20 employees in
manufacturing, 72 employees in research and development, 17 employees in sales
and marketing and 41 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. A breakout by segment is as
follows:
Regenerative
Cell Technology
|
Corporate
|
Total
|
||||||||||
Manufacturing
|
20 | — | 20 | |||||||||
Research
& Development
|
72 | — | 72 | |||||||||
Sales
and Marketing
|
17 | — | 17 | |||||||||
General
& Administrative
|
— | 41 | 41 | |||||||||
Total
|
109 | 41 | 150 |
46
Item 6. Exhibits
10.29.1
|
Amendment
No. 1 to License/ Joint Development Agreement dated May 20, 2008, between
Olympus Corporation, Olympus-Cytori, Inc. and the Company (filed
herewith)
|
|
10.48.1
|
Amendment
No. 1 to Master Cell Banking and Cryopreservation Agreement, effective
June 4, 2008, by and between Green Hospital Supply, Inc. and Cytori
Therapeutics, Inc. (filed as Exhibit 10.48.1 to our Form 8-K Current
Report as filed on June 10, 2008 and incorporated by reference
herein)
|
|
10.51
|
Common
Stock Purchase Agreement, dated February 8, 2008, by and between Green
Hospital Supply, Inc. and Cytori
Therapeutics, Inc. (filed as Exhibit 10.51 to our Form 8-K Current Report
as filed on February 19, 2008 and incorporated by reference
herein).
|
|
10.51.1
|
Amendment
No. 1 to Common Stock Purchase Agreement, dated February 29, 2008, by and
between Green Hospital Supply, Inc. and Cytori Therapeutics, Inc. (filed
as Exhibit 10.51.1 to our Form 8-K Current Report as filed on February 29,
2008 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).
|
47
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, in San Diego, California, on August 11, 2008.
CYTORI
THERAPEUTICS, INC.
|
||
By:
|
/s/
Christopher J. Calhoun
|
|
Dated:
August 11, 2008
|
Christopher
J. Calhoun
|
|
Chief
Executive Officer
|
||
By:
|
/s/
Mark E. Saad
|
|
Dated:
August 11, 2008
|
Mark
E. Saad
|
|
Chief
Financial Officer
|
48