UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
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(Mark One)
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x
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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, 2011
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OR
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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 001-34375
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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 x No o
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
Yes o No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definition of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act (Check one).
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Large Accelerated Filer o
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Accelerated Filer x
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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 x
As of July 29, 2011, there were 53,796,488 shares of the registrant’s common stock outstanding.
CYTORI THERAPEUTICS, INC.
INDEX
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PART I
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FINANCIAL INFORMATION
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Item 1.
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Financial Statements
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3
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4
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5
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6
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Item 2.
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17
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Item 3.
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29
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Item 4.
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30
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PART II
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OTHER INFORMATION
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Item 1.
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30
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Item 1A.
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30
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Item 2.
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38
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Item 3.
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38
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Item 4.
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38
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Item 5.
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38
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Item 6.
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39
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PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
CYTORI THERAPEUTICS, INC.
CONSOLIDATED CONDENSED BALANCE SHEETS
(UNAUDITED)
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As of June 30,
2011
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As of December 31,
2010
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Assets
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Current assets:
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Cash and cash equivalents
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$ | 33,229,000 | $ | 52,668,000 | ||||
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Accounts receivable, net of reserves of $349,000 and $306,000 in 2011 and 2010, respectively
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2,461,000 | 2,073,000 | ||||||
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Inventories, net
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3,891,000 | 3,378,000 | ||||||
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Other current assets
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849,000 | 834,000 | ||||||
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Total current assets
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40,430,000 | 58,953,000 | ||||||
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Property and equipment, net
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1,923,000 | 1,684,000 | ||||||
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Restricted cash and cash equivalents
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350,000 | 350,000 | ||||||
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Investment in joint venture
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357,000 | 459,000 | ||||||
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Other assets
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1,471,000 | 566,000 | ||||||
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Intangibles, net
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303,000 | 413,000 | ||||||
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Goodwill
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3,922,000 | 3,922,000 | ||||||
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Total assets
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$ | 48,756,000 | $ | 66,347,000 | ||||
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Liabilities and Stockholders’ Equity
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Current liabilities:
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Accounts payable and accrued expenses
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$ | 6,857,000 | $ | 6,770,000 | ||||
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Current portion of long-term obligations
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8,755,000 | 6,453,000 | ||||||
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Total current liabilities
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15,612,000 | 13,223,000 | ||||||
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Deferred revenues, related party
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4,281,000 | 5,512,000 | ||||||
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Deferred revenues
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4,964,000 | 4,929,000 | ||||||
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Warrant liability
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2,809,000 | 4,987,000 | ||||||
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Option liability
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1,280,000 | 1,170,000 | ||||||
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Long-term deferred rent
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374,000 | 398,000 | ||||||
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Long-term obligations, net of discount, less current portion
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9,295,000 | 13,255,000 | ||||||
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Total liabilities
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38,615,000 | 43,474,000 | ||||||
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Commitments and contingencies
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Stockholders’ equity:
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Preferred stock, $0.001 par value; 5,000,000 shares authorized; -0- shares issued and outstanding in 2011 and 2010
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- | - | ||||||
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Common stock, $0.001 par value; 95,000,000 shares authorized; 52,470,226 and 51,955,265 shares issued and 52,470,226 and 51,955,265 shares outstanding in 2011 and 2010, respectively
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52,000 | 52,000 | ||||||
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Additional paid-in capital
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237,296,000 | 232,819,000 | ||||||
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Accumulated deficit
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(227,207,000 | ) | (209,998,000 | ) | ||||
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Total stockholders’ equity
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10,141,000 | 22,873,000 | ||||||
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Total liabilities and stockholders’ equity
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$ | 48,756,000 | $ | 66,347,000 | ||||
SEE NOTES TO UNAUDITED CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
CYTORI THERAPEUTICS, INC.
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
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For the Three Months
Ended June 30,
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For the Six Months
Ended June 30,
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2011
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2010
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2011
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2010
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Product revenues:
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Related party
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$ | — | $ | — | $ | — | $ | 9,000 | ||||||||
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Third party
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2,411,000 | 2,091,000 | 3,773,000 | 4,347,000 | ||||||||||||
| 2,411,000 | 2,091,000 | 3,773,000 | 4,356,000 | |||||||||||||
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Cost of product revenues
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1,109,000 | 883,000 | 1,950,000 | 1,813,000 | ||||||||||||
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Gross profit
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1,302,000 | 1,208,000 | 1,823,000 | 2,543,000 | ||||||||||||
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Development revenues:
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Development, related party
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— | — | 1,231,000 | 2,122,000 | ||||||||||||
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Research grant and other
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11,000 | 7,000 | 15,000 | 28,000 | ||||||||||||
| 11,000 | 7,000 | 1,246,000 | 2,150,000 | |||||||||||||
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Operating expenses:
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Research and development
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3,071,000 | 2,301,000 | 6,118,000 | 4,546,000 | ||||||||||||
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Sales and marketing
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3,716,000 | 2,425,000 | 6,942,000 | 4,424,000 | ||||||||||||
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General and administrative
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4,147,000 | 3,052,000 | 7,692,000 | 6,271,000 | ||||||||||||
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Change in fair value of warrant liability
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(5,649,000 | ) | (1,461,000 | ) | (2,178,000 | ) | (3,628,000 | ) | ||||||||
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Change in fair value of option liability
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400,000 | (60,000 | ) | 110,000 | 200,000 | |||||||||||
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Total operating expenses
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5,685,000 | 6,257,000 | 18,684,000 | 11,813,000 | ||||||||||||
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Operating loss
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(4,372,000 | ) | (5,042,000 | ) | (15,615,000 | ) | (7,120,000 | ) | ||||||||
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Other income (expense):
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Interest income
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1,000 | 2,000 | 4,000 | 3,000 | ||||||||||||
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Interest expense
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(696,000 | ) | (254,000 | ) | (1,434,000 | ) | (530,000 | ) | ||||||||
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Other income (expense), net
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(15,000 | ) | (49,000 | ) | (62,000 | ) | (125,000 | ) | ||||||||
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Equity loss from investment in joint venture
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(56,000 | ) | (34,000 | ) | (102,000 | ) | (55,000 | ) | ||||||||
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Total other income (expense)
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(766,000 | ) | (335,000 | ) | (1,594,000 | ) | (707,000 | ) | ||||||||
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Net loss
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$ | (5,138,000 | ) | $ | (5,377,000 | ) | $ | (17,209,000 | ) | $ | (7,827,000 | ) | ||||
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Basic and diluted net loss per common share
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$ | (0.10 | ) | $ | (0.12 | ) | $ | (0.33 | ) | $ | (0.18 | ) | ||||
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Basic and diluted weighted average common shares
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52,411,642 | 45,295,965 | 52,204,348 | 43,772,219 | ||||||||||||
SEE NOTES TO UNAUDITED CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
CYTORI THERAPEUTICS, INC.
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
(UNAUDITED)
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For the Six Months Ended June 30,
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2011
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2010
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Cash flows from operating activities:
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Net loss
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$ | (17,209,000 | ) | $ | (7,827,000 | ) | ||
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Adjustments to reconcile net loss to net cash used in operating activities:
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Depreciation and amortization
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400,000 | 553,000 | ||||||
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Amortization of deferred financing costs and debt discount
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471,000 | 199,000 | ||||||
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Provision for doubtful accounts
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235,000 | 567,000 | ||||||
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Change in fair value of warrants
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(2,178,000 | ) | (3,628,000 | ) | ||||
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Change in fair value of option liabilities
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110,000 | 200,000 | ||||||
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Share-based compensation expense
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1,721,000 | 1,468,000 | ||||||
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Equity loss from investment in joint venture
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102,000 | 55,000 | ||||||
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Increases (decreases) in cash caused by changes in operating assets and liabilities:
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Accounts receivable
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(623,000 | ) | (1,509,000 | ) | ||||
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Inventories
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(513,000 | ) | 34,000 | |||||
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Other current assets
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(15,000 | ) | 289,000 | |||||
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Other assets
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(905,000 | ) | — | |||||
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Accounts payable and accrued expenses
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92,000 | (227,000 | ) | |||||
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Deferred revenues, related party
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(1,231,000 | ) | (2,122,000 | ) | ||||
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Deferred revenues
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35,000 | 47,000 | ||||||
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Long-term deferred rent
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(24,000 | ) | — | |||||
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Net cash used in operating activities
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(19,532,000 | ) | (11,901,000 | ) | ||||
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Cash flows from investing activities:
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Purchases of property and equipment
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(433,000 | ) | (348,000 | ) | ||||
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Investment in joint venture
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— | (330,000 | ) | |||||
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Net cash used in investing activities
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(433,000 | ) | (678,000 | ) | ||||
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Cash flows from financing activities:
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Principal payments on long-term obligations
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(2,230,000 | ) | (5,454,000 | ) | ||||
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Proceeds from long term obligations
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— | 20,000,000 | ||||||
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Debt issuance costs and loan fees
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— | (559,000 | ) | |||||
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Proceeds from exercise of employee stock options and warrants
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2,756,000 | 7,042,000 | ||||||
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Proceeds from sale of common stock and warrants
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— | 17,314,000 | ||||||
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Costs from sale of common stock and warrants
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— | (518,000 | ) | |||||
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Net cash provided by financing activities
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526,000 | 37,825,000 | ||||||
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Net increase (decrease) in cash and cash equivalents
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(19,439,000 | ) | 25,246,000 | |||||
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Cash and cash equivalents at beginning of period
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52,668,000 | 12,854,000 | ||||||
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Cash and cash equivalents at end of period
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$ | 33,229,000 | $ | 38,100,000 | ||||
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Supplemental disclosure of cash flows information:
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Cash paid during period for:
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Interest
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$ | 989,000 | $ | 287,000 | ||||
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Final payment fee on long-term debt
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— | 205,000 | ||||||
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Supplemental schedule of non-cash investing and financing activities:
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Fair value of warrants allocated to additional paid in capital
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$ | — | $ | 279,000 | ||||
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Capital equipment lease
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94,000 | |||||||
SEE NOTES TO UNAUDITED CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
CYTORI THERAPEUTICS, INC.
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
June 30, 2011
(UNAUDITED)
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1. Basis of Presentation
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Our accompanying unaudited consolidated condensed financial statements as of June 30, 2011 and for the three and six months ended June 30, 2011 and 2010 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, 2010 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, 2011 are not necessarily indicative of the results that may be expected for the year ending December 31, 2011. These financial statements should be read in conjunction with the consolidated financial statements and notes therein included in our annual report on Form 10-K for the year ended December 31, 2010.
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2. Use of Estimates
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The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions affecting the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expenses during the reporting period. Our most significant estimates and critical accounting policies involve recognizing revenue, evaluating goodwill for impairment, valuing our put option arrangement with Olympus Corporation, valuing warrants, determining the assumptions used in measuring share-based compensation expense,
valuing our deferred tax assets, assessing how to report our investment in Olympus-Cytori, Inc., and valuing allowances for doubtful accounts and inventories.
Actual results could differ from these estimates. Current economic conditions, including illiquid credit markets and volatile equity markets, contribute to the inherent uncertainty of such estimates. Management’s estimates and assumptions are reviewed periodically, and the effects of revisions are reflected in the consolidated financial statements in the periods they are determined to be necessary.
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3. Capital Availability
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We incurred net losses of $5,138,000 and $17,209,000 for the three and six months ended June 30, 2011 and $5,377,000 and $7,827,000 for the three and six months ended June 30, 2010, respectively. We have an accumulated deficit of $227,207,000 as of June 30, 2011. Additionally, we have used net cash of $19,532,000 and $11,901,000 to fund our operating activities for the six months ended June 30, 2011 and 2010, respectively. To date these operating losses have been funded primarily from outside sources of invested or borrowed capital.
Management recognizes the need to generate positive cash flows in future periods and/or to obtain additional capital from various sources. In the continued absence of positive cash flows from operations, 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.
During 2011 and 2010, we expanded our commercialization activities while simultaneously pursuing available financing sources to support operations and growth. We have had, and we may continue to have, an ongoing need to raise additional cash from outside sources to fund our operations. If we cannot do so when required, we would need to reduce our research, development, and administrative operations, including reductions of our employee base, in order to offset lack of available funding. We continue to evaluate available financing opportunities as part of our normal course of business. See note 19 for additional information on capital raised subsequent to June 30,
2011.
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4. Recently Adopted Accounting Pronouncements
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In October 2009, the FASB issued an update to the revenue recognition topic of the Codification. The update addresses the accounting for multiple-deliverable arrangements to enable vendors to account for products or services (deliverables) separately rather than as a combined unit. This guidance establishes a selling price hierarchy for determining the selling price of a deliverable, which is based on: (a) vendor-specific objective evidence; (b) third-party evidence; or (c) estimates. This guidance also eliminates the residual method of allocation and requires that arrangement consideration be allocated at the inception of the arrangement to all deliverables using the relative selling price method. In
addition, this guidance significantly expands required disclosures related to a vendor’s multiple-deliverable revenue arrangements. The update 2009-13 is effective prospectively for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010 and early adoption is permitted. The adoption of this standard did not have a material impact on our consolidated condensed financial statements.
In April 2010, the FASB issued additional guidance for revenue recognition to provide criteria that should be met for determining whether the milestone method of revenue recognition is appropriate. A vendor can recognize as revenue, in its entirety, consideration that is contingent upon achievement of a milestone in the period in which the milestone is achieved only if the milestone meets all criteria to be considered substantive. The guidance for milestone method of revenue recognition is effective on a prospective basis for milestones achieved in fiscal years, and interim periods within those years, beginning on or after June 15, 2010. The adoption of this standard did not have a material impact on our
consolidated condensed financial statements.
In January 2010, the FASB issued an update which provides guidance to improve disclosures about fair value measurements. This guidance amends previous guidance on fair value measurements to add new requirements for disclosures about transfers into and out of Levels 1 and 2 and separate disclosures about purchases, sales, issuances, and settlements relating to Level 3 measurement on a gross basis rather than on a net basis as previously required. This update also clarifies existing fair value disclosures about the level of disaggregation and about inputs and valuation techniques used to measure fair value. This guidance is effective for annual and interim periods beginning after December 15, 2009, except
for the requirement to provide the Level 3 activities of purchases, sales, issuances, and settlements on a gross basis, which will be effective for annual and interim periods beginning after December 15, 2010. Early application is permitted and, in the period of initial adoption, entities are not required to provide the amended disclosures for any previous periods presented for comparative purposes. This update did not have a material impact on our consolidated condensed financial statements.
In March 2010, the FASB issued an update to clarify that an employee share-based payment award with an exercise price denominated in the currency of a market in which a substantial portion of the equity securities trades should not be considered to contain a condition that is not a market, performance, or service condition. Therefore, an entity would not classify an award with such a feature as a liability if it otherwise qualifies as equity. Affected entities are required to record a cumulative catch-up adjustment for all awards outstanding as of the beginning of the annual period in which the guidance is adopted. This update did not have a material impact on our consolidated condensed financial
statements.
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5. Short-Term Investments
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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 to maintain safety and liquidity. These guidelines are periodically reviewed and modified to take advantage of trends in yields and interest rates. After considering current market conditions, and in order to minimize our risk, management has elected to invest all excess funds in money market funds and other highly liquid investments that are appropriately classified as cash equivalents as of June 30, 2011 and December 31,
2010.
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6. Restricted Cash and Cash Equivalents
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Restricted cash consists of cash and cash equivalents held in a letter of credit account pursuant to a lease agreement entered into on April 2, 2010 for leasing of property at 3020 and 3030 Callan Road, San Diego, California. The lease agreement required us to execute a letter of credit for $350,000 naming the landlord as a beneficiary. The letter of credit was issued in July 2010 and required us to maintain $350,000 as restricted cash for the duration of the lease, which expires October 31, 2015.
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7. Warrant Liability
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We account for certain common stock purchase warrants with exercise price reset features in accordance with the applicable FASB guidance. Under this guidance, warrants with these reset features are accounted for as fair value liabilities, with changes in fair value now included in net earnings (loss).
The fair value of the liability associated with the warrants with this reset feature decreased to $2,809,000 as of June 30, 2011, which resulted in a $5,649,000 and $2,178,000 gain from the change in fair value of warrants for the three and six months ended June 30, 2011, respectively.
Since these warrants do not qualify for hedge accounting, all future changes in the fair value of the warrants will be recognized currently in earnings until such time as the warrants are exercised or expire. These warrants are not traded in an active securities market, and as such, we estimated the fair value of these warrants using the Black-Scholes option pricing model using the following assumptions:
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As of
June 30, 2011
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As of
December 31, 2010
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|||||||
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Expected term
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2.12 years
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2.61 years
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||||||
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Common stock market price
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$
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4.79
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$
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5.19
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||||
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Risk-free interest rate
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0.45
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%
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0.82
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%
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||||
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Expected volatility
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66.51
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%
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86.03
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%
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||||
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Resulting fair value (per warrant)
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$
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1.46
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$
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2.50
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||||
Expected volatility is based primarily on historical volatility. Historical volatility was computed using daily pricing observations for recent periods that correspond to the expected term of the warrants. We believe this method produces an estimate that is representative of our expectations of future volatility over the expected term of these warrants. We currently have no reason to believe future volatility over the expected remaining life of these warrants is likely to differ materially from historical volatility. The expected life is based on the remaining term of the warrants. The risk-free interest rate is the interest rate for treasury constant maturity instruments published by the Federal Reserve Board that
is closest to the expected term of the warrants.
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8. Long-term Debt
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On June 11, 2010, we entered into an Amended and Restated Loan and Security Agreement with General Electric Capital Corporation (GECC), Silicon Valley Bank (SVB) and Oxford Finance Corporation (together, the “Lenders”), pursuant to which the Lenders agreed to make a term loan in an aggregate principal amount of up to $20.0 million (Term Loan), subject to the terms and conditions set forth in the Term Loan. On June 14, 2010, the Lenders funded a Term Loan in the principal amount of $20.0 million. The Term Loan accrues interest at a fixed rate of 9.87% per annum. We are required to make monthly payments of interest-only, through March 1, 2011, and are required to
repay the principal amount of the Term Loan over a period of twenty-seven (27) consecutive equal monthly installments of principal plus accrued interest, commencing on April 1, 2011. At maturity of the Term Loan, we will also make a final payment equal to 5% ($1,000,000) of the Term Loan. We may incur additional fees if we elect to prepay the Term Loan. In connection with the Term Loan, on June 11, 2010, we issued to the Lenders warrants to purchase up to an aggregate of 101,266 shares of our common stock at an exercise price of $3.95 per share. These warrants are immediately exercisable and will expire on June 11, 2017.
The Term Loan amended and restated the Original Term Loan, of which an aggregate balance of approximately $4.1 million remained outstanding along with a prorated final payment fee of $205,000. The net proceeds of the Term Loan, after payment of lender fees and expenses and the refinancing of the Original Term Loan, were approximately $15.3 million.
We accounted for this amendment to the Original Term Loan as debt modification since the terms of the amended Term Loan and the Original Term Loan were not substantially different and as present value of cash flows of the modified instrument (using a net method of comparing the present value of cash flows related to the lowest common principal balance between the old and the new loans) was within 10% of the original debt instrument. Accordingly, the fees associated with the amended Term Loan of $354,000 and the existing unamortized debt discount from the Original Term Loan of $242,000 will be amortized as an adjustment of interest expense over the remaining term of the Term Loan using the effective
interest method.
We allocated the aggregate proceeds of the Term Loan between the warrants and the debt obligations based on their relative fair values. The fair value of the warrants issued to the Lenders is calculated utilizing the Black-Scholes option-pricing model. We are amortizing the relative fair value of the warrants as a discount of $279,000 over the term of the loan using the effective interest method, with an effective interest rate of 14.78%. If the maturity of the debt is accelerated due to an event of default, then the amortization would be accelerated. The Term Loan is collateralized by the tangible assets of the company, and we were in compliance with our financial and non-financial covenants as of June
30, 2011.
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9. Revenue Recognition
|
Product Sales
We recognize revenue from product sales when the following fundamental criteria are met: (i) persuasive evidence of an arrangement exists, (ii) delivery has occurred, (iii) the price to the customer is fixed or determinable and (iv) collection of the resulting accounts receivable is reasonably assured.
For all sales, we use a binding purchase order or a signed agreement as evidence of an arrangement. Revenue for these product sales is recognized upon delivery to the customer, as all risks and rewards of ownership have been substantively transferred to the customer at that point. For 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. The customer’s obligation to pay and the payment terms are set at the time of delivery and are not dependent on the subsequent use or resale of our products.
For sales prior to January 1, 2011 that included multiple deliverables, we allocated revenue based on the relative fair values of the individual components. When more than one element such as product maintenance or technical support services were included in an arrangement, we allocated revenue between the elements based on each element’s relative fair value, provided that each element met the criteria for treatment as a separate unit of accounting (an item is considered a separate unit of accounting if it has value to the customer on a standalone basis and there is objective and reliable evidence of the fair value of the undelivered items). Fair value is generally determined based upon
the price charged when the element is sold separately. In the absence of fair value for a delivered element, we allocated revenue first to the fair value of the undelivered elements and allocated the residual revenue to the delivered elements. Fair values for undelivered elements were determined based on vendor-specific objective evidence as well as market participant quotes for similar services. In the absence of fair value for an undelivered element, the arrangement was accounted for as a single unit of accounting, resulting in a deferral of revenue recognition for delivered elements until all undelivered elements have been fulfilled. Deferred service revenue is recognized ratably over the period the services are provided.
Beginning in 2011, for sales that include multiple deliverables, such as sales of our StemSource® Cell Bank, we account for products or services (deliverables) separately rather than as a combined unit. Stem cell banks typically consist of a complex array of equipment and services, including one or more StemSource® devices, a cryogenic freezer, measuring and monitoring equipment, and a database patient tracking system. In addition, we provide installation and training services concurrent with the installation of the bank as well as web hosting, technical and maintenance services, generally for a period of up to one year, subsequent to the date of sale. The FASB guidance of the
Codification establishes a selling price hierarchy for determining the selling price of a deliverable, which is based on: (a) vendor-specific objective evidence (“VSOE”); (b) third-party evidence (“TPE”); or (c) management estimates. This guidance also eliminates the residual method of allocation and requires that arrangement consideration be allocated at the inception of the arrangement to all deliverables using the relative selling price method. For our cell bank sales, we establish selling prices for our undelivered future services based on vendor-specific quotes for comparable services when available. In the absence of VSOE, we use competitor’s products or services considered largely interchangeable with our own or management best estimates for our undelivered elements. Because our cell banks are not considered
functional and of standalone value to the customer until all equipment has been delivered and installation and training has occurred, the completion of these activities is the earliest point at which we can recognize any revenue for these transactions. The combination of the equipment, installation, and training activities therefore constitutes the primary unit of accounting, while future services such as web hosting and ongoing maintenance are deferred and recognized into income during the year following the installation. There would have been no material impact to our financial statements in 2010 had we applied this guidance retrospectively. The units of accounting we attribute to our cell bank sales have not changed from our prior methodology, and the pattern and timing of revenue recognition is not affected by the new guidance.
Concentration of Significant Customers
For the six months ended June 30, 2011, our sales were concentrated in one direct customer, which comprised 29% of our revenue recognized for the six months ended June 30, 2011. Our Asia-Pacific and North America region sales accounted for 71% of our revenue recognized for the six months ended June 30, 2011. Additionally, one direct customer accounted for 40% of total outstanding accounts receivable as of June 30, 2011.
For the six months ended June 30, 2010, our sales were concentrated in two direct customers, which in aggregate comprised 32% of our revenue recognized for the six months ended June 30, 2010. Our Asia-Pacific and North America region sales accounted for 87% of our revenue recognized for the six months ended June 30, 2010. Additionally, one distributor and two direct customers accounted for 37% of total outstanding accounts receivable as of June 30, 2010.
Research and Development
We earn revenue for performing tasks under research and development agreements with both commercial enterprises, such as Olympus and Senko, and governmental agencies like the National Institutes of Health (“NIH”). Revenue earned under development agreements is classified as either research grant or development revenues depending on the nature of the arrangement. Revenues derived from reimbursement of direct out-of-pocket expenses for research costs associated with grants are recorded as research grant and other within development revenues. Research grant revenue is recorded at the gross amount of the reimbursement. The costs associated with these reimbursements
are reflected as a component of research and development expense in our 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 statements of operations.
We received funds from Olympus and Olympus-Cytori, Inc. during 2005 and 2006. We recorded upfront fees totaling $28,311,000 as deferred revenues, related party. In exchange for these proceeds, we agreed to (a) provide Olympus-Cytori, Inc. an exclusive and perpetual license to our Celution® System device technology and certain related intellectual property, and (b) provide future development contributions related to commercializing the Celution® System platform. The license and development services are not separable and as a result the recognition of this deferred amount requires achievement of service related milestones, under a proportional performance
methodology. If and as such revenues are recognized, deferred revenue will be decreased. Proportional performance methodology was elected due to the nature of our development obligations and efforts in support of the Joint Venture (“JV”), including product development activities and regulatory efforts to support the commercialization of the JV products. The application of this methodology uses the achievement of R&D milestones as outputs of value to the JV. We received up-front, non-refundable payments in connection with these development obligations, which we have broken down into specific R&D milestones that are definable and substantive in nature, and which will result in value to the JV when achieved. As our research and development efforts progress, we periodically evaluate, and modify if necessary, the
milestone points in our proportional performance model to ensure that revenue recognition accurately reflects our best estimate of substantive value deliverable to the JV. Revenue will be recognized as the above mentioned R&D milestones are completed. Of the amounts received and deferred, we recognized development revenues of $0 and $1,231,000 for the three and six months ended June 30, 2011, respectively. During 2010, we recognized revenues of $0 and $2,122,000 for the three and six months ended June 30, 2010, respectively. All related development costs are expensed as incurred and are included in research and development expense on our statements of operations.
Under a Distribution Agreement with Senko, we granted to Senko an exclusive license to sell and distribute certain Thin Film products in Japan. We have also earned or will be entitled to earn additional payments under the Distribution Agreement based on achieving certain defined and substantive research and development milestones.
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, 2011 or 2010, respectively.
|
10. Inventories
|
Inventories are carried at the lower of cost or market, determined on the first-in, first-out (FIFO) method.
Inventories consisted of the following:
|
June 30,
2011 |
December 31,
2010 |
|||||||
|
Raw materials
|
$
|
2,294,000
|
$
|
2,311,000
|
||||
|
Work in process
|
652,000
|
410,000
|
||||||
|
Finished goods
|
945,000
|
657,000
|
||||||
|
$
|
3,891,000
|
$
|
3,378,000
|
|||||
|
11. 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, 2011 and 2010, we had no impairment losses associated with our long-lived assets.
|
12. Share-Based Compensation
|
During the first quarter of 2011, we issued to our directors, executive officers and certain non-executive employees options to purchase an aggregate of up to 692,500 shares of our common stock, with four-year vesting for our officers and employees and two-year vesting for our directors. The grant date fair value of the awards granted to our officers and employees was $3.46 and to our directors was $3.15 per share. The resulting share-based compensation expense of $2,375,000, net of estimated forfeitures, will be recognized as expense over the respective vesting periods.
We granted 246,225 performance-based restricted stock awards under the 2004 Equity Incentive Plan in February 2011. The awards provide employees until January 1, 2012 to achieve certain performance goals established by the Compensation Committee. The performance goals are weighted based on the following achievements: obtaining certain FDA clearance or approval (40%), achieving a targeted revenue increase for the fiscal year ended December 31, 2011 (20%), and entering into a major collaboration for development and/or commercialization of the Company’s products (40%). To the extent that any of the performance goals are partially achieved, the Compensation Committee maintains the discretion to continue
the vesting of all or a portion of the awards following January 1, 2012. Once earned, the awards will remain unvested until January 1, 2013. Termination of employment prior to vesting will result in the forfeiture of any earned (as well as unearned) awards. No compensation expense was recognized related to these awards during the three and six months ended June 30, 2011 because the performance criteria have not been met, nor has the Compensation Committee exercised its discretion in determining if partial awards will be granted. The following table summarizes activity with respect to such awards during the three and six months ended June 30, 2011:
|
Shares
|
Weighted Average Grant Date Fair Value
|
|||||||
|
Outstanding at January 1, 2011
|
0
|
|||||||
|
Granted
|
246,225
|
$
|
5.82
|
|||||
|
Vested
|
0
|
|||||||
|
Cancelled / Forfeited
|
0
|
|||||||
|
Outstanding at June 30, 2011
|
246,225
|
$
|
5.82
|
|||||
|
Vested at June 30, 2011
|
0
|
|||||||
During the first quarter of 2010, we issued to our directors, executive officers and certain non-executive employees options to purchase an aggregate of up to 1,155,000 shares of our common stock, with four-year vesting for our officers and employees and two-year vesting for our directors. The grant date fair value of the awards granted to our officers and employees was $4.07 and to our directors was $4.16 per share. The resulting share-based compensation expense of $4,713,000, net of estimated forfeitures, will be recognized as expense over the respective vesting periods.
|
13. Loss 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, including unvested performance-based restricted stock, from the calculation of diluted loss per share attributable to common stockholders for the three and six months ended June 30, 2011 and 2010, as their inclusion would be antidilutive. Potentially dilutive common shares excluded from the calculations of diluted loss per share were 19,196,482 for the three and six month periods ended June 30, 2011 and 18,821,894 for the three and six month periods ended June 30, 2010, respectively.
|
14. Commitments and Contingencies
|
We have entered into agreements, which have provisions for cancellation, with various clinical research organizations for pre-clinical and clinical development studies. Under the terms of these agreements, the vendors provide a variety of services including, but not limited to, conducting pre-clinical and clinical development research, recruiting and enrolling patients, monitoring studies, and data analysis. Payments under these agreements typically include fees for services and reimbursement of expenses. The timing of payments due under these agreements is estimated based on current schedules of pre-clinical and clinical studies in progress. As of June 30, 2011, we have pre-clinical research study
obligations of $90,000 (which are expected to be fully completed within a year) and clinical research study obligations of $12,400,000 ($3,000,000 of which are expected to be completed within a year).
We are subject to various claims and contingencies related to legal proceedings. Due to their nature, such legal proceedings involve inherent uncertainties including, but not limited to, court rulings, negotiations between affected parties, and governmental actions. Management assesses the probability of loss for such contingencies and accrues a liability and/or discloses the relevant circumstances, as appropriate. Management believes that any liability to us or other remedy that may arise as a result of currently pending legal proceedings will not have a material adverse effect on our financial condition, liquidity, or results of operations as a whole.
During 2008, we entered into a supply agreement with minimum purchase requirements clause. As of June 30, 2011, we have remaining minimum purchase obligations of $425,000, all of which is expected to be completed within a year.
During 2010, we entered into lease of 60,118 square feet at 3020 and 3030 Callan Road, San Diego, California. The related lease agreement bears monthly rent at a rate of $1.75 per square foot, with annual increase of $0.05 per square foot. The lease term is 64 months, commencing on July 1, 2010 and expiring on October 31, 2015. Additionally, we’ve entered into several lease agreements for international office locations and corporate housing for our employees on international assignments. As of June 30, 2011, we have remaining lease obligations of $6,284,000 ($1,650,000 of which are expected to be completed within a year).
Refer to note 15 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.
|
15. Transactions with Olympus Corporation
|
Initial Investment by Olympus Corporation in Cytori
In 2005, we entered into a common stock purchase agreement with Olympus in which we received $11,000,000 in cash proceeds. We received an additional $11,000,000 from Olympus in August 2006 for the issuance of approximately 1,900,000 shares of our common stock at $5.75 per share. We received an additional $6,000,000 from Olympus in August 2008 for the issuance of 1,000,000 unregistered shares of our common stock at $6.00 per share and 500,000 common stock warrants (with an original exercise price of $8.50 per share) under a private placement offering.
As of June 30, 2011, Olympus holds approximately 7.65% of our issued and outstanding shares. Additionally, Olympus has a right, which it has not yet exercised, to designate a director to serve on our Board of Directors.
Formation of the Olympus-Cytori Joint Venture
In 2005, we entered into a joint venture and other related agreements (the “Joint Venture Agreements”) with Olympus. The Joint Venture is owned equally by Olympus and us. We have determined that the Joint Venture is a variable interest entity or VIE, 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, 2011, the carrying value of our investment in the Joint Venture is $357,000. We are under no obligation to provide additional funding to the
Joint Venture, but may choose to do so. We made no cash contributions to the Joint Venture during the three and six months ended June 30, 2011. We contributed $330,000 during the three and six months ended June 30, 2010.
Put/Calls and Guarantees
The Shareholders’ Agreement between Cytori and Olympus provides that in certain specified circumstances of our 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 (the “Put”) at the higher of (a) $22,000,000 or (b) the Put’s fair value.
At June 30, 2011 and December 31, 2010, the estimated fair value of the Put was $1,280,000 and $1,170,000, respectively. Fluctuations in the Put value are recorded in the consolidated condensed statements of operations as a component of change in fair value of option liabilities. The estimated fair value of the Put has been recorded as a long-term liability in the caption option liability in our consolidated condensed balance sheets.
The valuations of the Put were completed using an option pricing theory based simulation analysis (i.e., a Monte Carlo simulation). The valuations are based on assumptions as of the valuation date with regard to the market value of Cytori and the estimated fair value of the Joint Venture, the expected correlation between the values of Cytori and the Joint Venture, the expected volatility of Cytori and the Joint Venture, the bankruptcy recovery rate for Cytori, the bankruptcy threshold for Cytori, the probability of a change of control event for Cytori, and the risk free interest rate.
The following assumptions were employed in estimating the value of the Put:
|
June 30,
2011
|
December 31,
2010
|
|||||||
|
Expected volatility of Cytori
|
73.40
|
%
|
73.00
|
%
|
||||
|
Expected volatility of the Joint Venture
|
73.40
|
%
|
73.00
|
%
|
||||
|
Bankruptcy recovery rate for Cytori
|
28.00
|
%
|
28.00
|
%
|
||||
|
Bankruptcy threshold for Cytori
|
$
|
7,801,000
|
$
|
5,842,000
|
||||
|
Probability of a change of control event for Cytori
|
3.28
|
%
|
3.43
|
%
|
||||
|
Expected correlation between fair values of Cytori and the Joint Venture in the future
|
99.00
|
%
|
99.00
|
%
|
||||
|
Risk free interest rate
|
3.18
|
%
|
3.30
|
%
|
||||
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.
|
16. Fair Value Measurements
|
Fair value measurements are market-based measurements, not entity-specific measurements. Therefore, fair value measurements are determined based on the assumptions that market participants would use in pricing the asset or liability. We follow 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:
· 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, 2011
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
|
Assets:
|
||||||||||||||||
|
Cash equivalents
|
$
|
27,806,000
|
$
|
27,806,000
|
$
|
—
|
$
|
—
|
||||||||
|
Liabilities:
|
||||||||||||||||
|
Put option liability
|
$
|
(1,280,000
|
)
|
$
|
—
|
$
|
—
|
$
|
(1,280,000
|
)
|
||||||
|
Warrant liability
|
$
|
(2,809,000
|
)
|
$
|
—
|
$
|
(2,809,000
|
)
|
$
|
—
|
||||||
|
Balance as of
|
Basis of Fair Value Measurements
|
|||||||||||||||
|
December 31, 2010
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
|
Assets:
|
||||||||||||||||
|
Cash equivalents
|
$
|
39,807,000
|
$
|
39,807,000
|
$
|
—
|
$
|
—
|
||||||||
|
Liabilities:
|
||||||||||||||||
|
Put option liability
|
$
|
(1,170,000
|
)
|
$
|
—
|
$
|
—
|
$
|
(1,170,000
|
)
|
||||||
|
Warrant liability
|
$
|
(4,987,000
|
)
|
$
|
—
|
$
|
(4,987,000
|
)
|
$
|
—
|
||||||
We use quoted market prices to determine the fair value of our cash equivalents, which consist of money market funds and therefore these are classified in Level 1 of the fair value hierarchy.
We value our put liability (see note 15) 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:
|
Put option liability
|
Six months ended
June 30, 2011 |
Three months ended
June 30, 2011 |
||||||
|
Beginning balance
|
$ | (1,170,000 | ) | $ | (880,000 | ) | ||
|
Decrease (increase) in fair value recognized in operating expenses
|
(110,000 | ) | (400,000 | ) | ||||
|
Ending balance
|
$ | (1,280,000 | ) | $ | (1,280,000 | ) | ||
|
Put option liability
|
Six months ended
June 30, 2010 |
Three months ended
June 30, 2010 |
||||||
|
Beginning balance
|
$ | (1,140,000 | ) | $ | (1,400,000 | ) | ||
|
Decrease (increase) in fair value recognized in operating expenses
|
(200,000 | ) | 60,000 | |||||
|
Ending balance
|
$ | (1,340,000 | ) | $ | (1,340,000 | ) | ||
Common stock purchase warrants issued in connection with our August 2008 private equity placement do not trade in an active securities market, and as such, we estimate the fair value of these warrants using the Black-Scholes option pricing model in which all significant inputs are observable in active markets, such as common stock market price, volatility, and risk free rate; therefore the warrant liability is classified as Level 2 in the fair value hierarchy. See note 7 for further discussion of fair value for these warrants.
No other assets or liabilities are measured at fair value on a recurring basis, or have been measured at fair value on a non-recurring basis subsequent to initial recognition, on the accompanying consolidated condensed balance sheet as of June 30, 2011.
|
17. Fair Value
|
Financial Instruments
We disclose fair value information about all financial instruments, whether or not recognized in the balance sheet, for which it is practicable to estimate fair value. The disclosures of estimated fair value of financial instruments at June 30, 2011 and December 31, 2010, were determined using available market information and appropriate valuation methods. Considerable judgment is necessary to interpret market data and develop estimated fair value. The use of different market assumptions or estimation methods may have a material effect on the estimated fair value amounts.
The carrying amounts for cash and cash equivalents, accounts receivable, inventories, other current assets, accounts payable, accrued expenses and other liabilities approximate fair value due to the short-term nature of these instruments.
We utilize quoted market prices to estimate the fair value of our fixed rate debt, when available. If quoted market prices are not available, we calculate the fair value of our fixed rate debt based on a currently available market rate assuming the loans are outstanding through maturity and considering the collateral. In determining the current market rate for fixed rate debt, a market spread is added to the quoted yields on federal government treasury securities with similar terms to the debt.
At June 30, 2011 and December 31, 2010, the aggregate fair value and the carrying value of the Company’s fixed rate debt were as follows:
|
June 30, 2011
|
December 31, 2010
|
|||||||||||||||
|
Fair Value
|
Carrying
Value
|
Fair Value
|
Carrying
Value
|
|||||||||||||
|
Fixed rate debt
|
$ | 18,057,000 | $ | 17,926,000 | $ | 19,782,000 | $ | 19,679,000 | ||||||||
Carrying value includes $852,000 and $1,321,000 of debt discount as of June 30, 2011 and December 31, 2010, respectively.
Nonfinancial Assets and Liabilities
We apply fair value techniques on a non-recurring basis associated with: (1) valuing potential impairment losses related to goodwill which are accounted for pursuant to the authoritative guidance for intangibles—goodwill and other; and (2) valuing potential impairment losses related to long-lived assets which are accounted for pursuant to the authoritative guidance for property, plant and equipment.
All of our goodwill is associated with regenerative cell technology, and we determine the fair value of this reporting unit based on a combination of inputs including the market capitalization of the Company, as well as Level 3 inputs such as discounted cash flows which are not observable from the market, directly or indirectly. We conduct our goodwill impairment analysis annually as of November 30 each year, or upon the occurrence of certain triggering events. No such triggering events occurred during the three and six months ended June 30, 2011. Historically, the fair value has significantly exceeded the carrying value.
We test for the impairment of our long-lived assets when triggering events occur and such impairment, if any, is measured at fair value. The inputs for fair value of our long lived assets would be based on Level 3 inputs as data used for such fair value calculations would be based on discounted cash flows using market place participant assumptions. No triggering events occurred during the three and six months ended June 30, 2011.
|
18. Stockholders’ Equity
|
Common Stock
On June 19, 2009, we entered into a common stock purchase agreement with Seaside 88, LP relating to the offering and sale of a total of up to 7,150,000 shares of our common stock. The agreement required us to issue and Seaside to buy 275,000 shares of our common stock once every two weeks, subject to the satisfaction of customary closing conditions. Upon completion of our scheduled closings pursuant to the agreement with Seaside 88, LP in June 2010, we raised approximately $30,172,000 in aggregate gross proceeds from this transaction from the sale of 7,150,000 shares of our common stock between June 2009 and June 2010, of which $17,314,000 in
gross proceeds from the sale of 3,300,000 shares was raised during 2010. We have accounted for each of the completed closings as a component of stockholders’ equity.
In October 2010, we entered into an underwriting agreement with Jefferies & Company, relating to the issuance and sale of 4,600,000 shares of our common stock. This price to the public in this offering was $4.50 per share and the underwriter agreed to purchase the shares from us at a price of $4.23 per share. The transaction was completed on October 13, 2010, raising approximately $20,700,000 in gross proceeds before deducting underwriting discounts and commissions and other offering expenses payable by us.
On December 13, 2010 we raised $10,000,000 in gross proceeds from a sale of 1,428,571 shares of unregistered common stock to Astellas Pharma Inc. for $7.00 per share in a private stock placement. Pursuant to the terms of the purchase agreement, we granted Astellas Pharma Inc. a two year right of first refusal to enter into a development and commercialization collaboration with us regarding the use of our technology, on a worldwide basis, for the treatment of liver conditions. In addition, we have agreed to use reasonable efforts to file a registration statement with the Securities and Exchange Commission to register the shares of common stock for resale upon the request of Astellas Pharma
Inc. We also granted Astellas Pharma Inc. a non-voting observer seat on our Board of Directors and the right to designate a representative member to our Scientific Advisory Board. The $10,000,000 in total proceeds we received exceeded the market value of our stock at the completion of the purchase agreement. The $2,526,000 difference between the proceeds received and the fair market values of our common stock was recorded as a component of deferred revenues in the accompanying balance sheets. This difference was recorded as deferred revenue since, conceptually, the excess proceeds represent a value paid by Astellas Pharma Inc. attributable to the scientific advisory board seat, the non-voting observer seat on our Board of Directors, and the two year right of first refusal to enter into a development and commercialization
collaboration with us regarding the use of our technology, on a worldwide basis, for the treatment of liver conditions, rather than an additional equity investment in Cytori. The recognition of this deferred amount is expected to occur upon the earlier of the expiration of the two year period or the termination of the agreement.
Warrant Adjustments
Our closings with Seaside 88, LP through June 7, 2010, our October 2010 offering of 4,600,000 shares of our common stock and our December 2010 sale of 1,428,571 shares of our common stock triggered an adjustment to the exercise price and number of shares issuable under the warrants issued to investors in our August 2008 private placement financing. As a result, as of June 30, 2011, the common stock warrants issued on August 11, 2008 are currently exercisable for 1,924,160 shares of our common stock at an exercise price of $6.02 per share.
Other Related Party Transactions
As of June 30, 2011 and December 31, 2010, Green Hospital Supply, Inc., our distribution partner in Japan and a related party, was a beneficial owner of more than five percent of our outstanding shares of common stock.
During the three and six months ended June 30, 2011, we incurred approximately $34,000 and $62,000, respectively, and $64,000 and $120,000 during the three and six months ended June 30, 2010, respectively, in royalty costs in connection with our sales of our Celution® 800/CRS System products to the European and Asia-Pacific reconstructive surgery market, pursuant to our License and Royalty Agreement with the Olympus -Cytori, Inc. joint venture. As of June 30, 2011 and December 31, 2010, Olympus Corporation was a beneficial owner of more than five percent of our outstanding shares of common stock.
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19. Subsequent Events
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We have evaluated events after the balance sheet date of June 30, 2011 and up to the date we filed this report.
On July 11, 2011, we entered into a common stock purchase agreement with Seaside 88, LP relating to the offering and sale of a total of up to 6,326,262 shares of our common stock. The agreement requires us to issue and Seaside to buy 1,326,262 shares of our common stock at an initial closing and 250,000 shares of our common stock once every two weeks, commencing 30 days after the initial closing, for up to an additional 20 closings, subject to the satisfaction of customary closing conditions. At an initial closing, the offering price was $4.52, which equaled to 88% of our common stock’s volume-weighted average trading prices, or VWAP, during the ten-day trading period immediately prior to the
initial closing date, raising approximately $6,000,000 in gross proceeds. At subsequent closings, the offering price will equal 90.25% of our common stock’s volume-weighted average trading prices during the ten-day trading period immediately prior to each subsequent closing date.
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:
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·
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Overview that discusses our operating results and some of the trends that affect our business.
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·
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Results of Operations that includes a more detailed discussion of our revenue and expenses.
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Liquidity and Capital Resources which discusses key aspects of our statements of cash flows, changes in our financial position and our financial commitments.
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·
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Significant changes since our most recent Annual Report on Form 10-K in the Critical Accounting Policies and Significant Estimates that we believe are important to understanding the assumptions and judgments underlying our financial statements.
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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, 2010.
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 as 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, our 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 “Liquidity and Capital Resources” section of this report, including our potential 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
Cytori develops, manufactures, and commercializes innovative medical devices, which enable physicians to practice regenerative medicine and cell therapy worldwide. We have invested more than $200 million into the design and development of our core device, the Celution® System. This device offers patients real-time access to the stem and regenerative cells residing naturally within their own adipose (fat) tissue. These stem and regenerative cells may potentially be used across multiple diseases or conditions resulting from a lack of blood supply (ischemia). Two areas where we are concentrating our efforts include: 1) soft tissue enhancement and defect repair; and 2) cardiovascular disease.
The primary business model is based on the sale of our systems and single-use cartridges, which generate recurring revenues on a per-procedure, single-use basis. Cytori is actively selling three product lines:
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·
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The Celution® family, which is approved in Europe with a CE Mark designation. The approved indications for use include processing of adipose tissue to extract stem and progenitor cells for the re-implantation into the same patient for breast reconstruction, aesthetic body contouring, and treatment of certain wounds related to Crohn’s fistulas.
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·
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The StemSource® family of laboratory equipment, which is available worldwide for use in research and stem cell banking.
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The PureGraft™ family of products, which are approved in the U.S. and Europe for the preparation of autologous fat grafts for use in aesthetic body contouring.
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Cytori’s commercial strategy is to focus primarily on selling our approved products into the reconstructive surgery market in Europe and Asia Pacific. Our products are also sold into the European and Asia Pacific cosmetic surgery market. We believe these areas can be successfully penetrated more quickly as we simultaneously work to develop our other target markets. Future sales will be driven by garnering coverage by government and private payors in Europe for breast reconstruction and capitalizing and facilitating growing visibility for autologous fat grafting.
We believe it is strategically valuable to invest a significant portion of our research and development efforts and resources into seeking Celution® System indications-for-use in cardiovascular disease worldwide. We have completed two European clinical trials, one for chronic myocardial ischemia and one for acute myocardial infarction. Based on the outcome from the PRECISE study, we are seeking an indication-for-use in Europe for no-option chronic myocardial ischemia patients. If we were to receive an indication-for-use in these no-option patients, we would begin offering the device to select European hospitals which would involve a related investment in sales and marketing activities. A multi-center pivotal
trial investigating the use of the device and its cell output as a treatment for heart attacks in Europe is currently enrolling. In the U.S., we are seeking to initiate a Pre-Market Approval (PMA) study of the Celution® System for cardiovascular disease, initially for chronic myocardial ischemia.
We also offer two ancillary product lines. Our PureGraft™ product line for autologous fat grafting is complementary to our cosmetic and reconstructive surgery business. The StemSource® offering is strategically important as it is being used by researchers to develop therapeutic applications we have neither the resources nor bandwidth to pursue. Alternatively, the product is being sold as lab equipment which may be integrated into a comprehensive cell or tissue bank at the customer’s facility or for the purposes of research. Over time, we anticipate these products will represent a smaller percentage of our overall revenues.
For the remainder of 2011, we will continue to seek various expanded regulatory and marketing approvals of the Celution® System family of products in the United States, Europe and Asia Pacific. In the U.S. we are pursuing three parallel strategies, which include the aforementioned goal of commencing a U.S. cardiac PMA study, a trial for soft-tissue repair, and several class II 510(K) applications. We are also anticipating European approval for and launch of the next-generation Celution® System, Celution® One, which has been designed and will be manufactured by the Olympus-Cytori Joint Venture. This version of the system is tailored for the hospital market and offers faster processing times with a
greater cell yield. We are also seeking to register or gain market approval for our products in various emerging markets, including Asia and South America.
Olympus Partnership
On November 4, 2005, we entered into a strategic development and manufacturing joint venture agreement and other related agreements with Olympus. As part of the terms of the JV Agreements, we formed a joint venture, Olympus-Cytori, Inc. (Joint Venture), to develop and manufacture future generation devices based on our Celution ® System platform.
Under the Joint Venture Agreements:
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·
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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.
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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.
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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 (the “Put”) at the higher of (a) $22,000,000 or (b) the Put’s fair value.
As of June 30, 2011, the estimated fair value of the Put was $1,280,000. Fluctuations in the estimated Put value are recorded in the statements of operations as a component of change in fair value of option liability. 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 Celution ® System device technology for the development, manufacture, and supply of such systems to us. Once a second generation Celution® System is developed and approved by regulatory agencies, the Joint Venture will exclusively supply us with these systems at a formula-based transfer price. We have retained all marketing rights (subject to our various distribution agreements) to sell the Celution ® System 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 of the Celution ® System so that it will contain certain product enhancements and that 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 us to manufacture the Cytori-developed Celution ® System platform, including the Celution ® 800/CRS, until such time as the Joint Venture’s products are commercially available for the same market served by the Cytori platform,
subject to a reasonable royalty that will be payable to the Joint Venture for all such sales.
We account for our investment in the Joint Venture under the equity method of accounting.
Other Related Party Transactions
In August 2008, we received $6,000,000 from Olympus in a private placement of 1,000,000 unregistered shares of our common stock and a warrant to purchase an additional 500,000 shares of our common stock at an original exercise price of $8.50 per share. The purchase price was $6.00 per unit (with each unit consisting of one share and 50% warrant coverage). The warrant is exercisable anytime after February 11, 2009 and will expire on August 11, 2013.
Thin Film Japan Distribution Agreement
In 2004, we sold the majority of our Thin Film business to MAST Biosurgery AG (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.
In the third quarter of 2004, we entered into a Distribution Agreement with Senko Medical Trading Company (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 months ended June 30, 2011 or 2010. To date we have recognized a total of $371,000 in development revenues (all of which was recognized prior to 2008) related to
this agreement.
Results of Operations
Our overall net losses for the three and six months ended June 30, 2011 were $5,138,000 and $17,209,000 as compared to the losses for the three and six months ended June 30, 2010 were $5,377,000 and $7,827,000, respectively. The fluctuation in the losses for the three and six months ended June 30, 2011 as compared to the losses for the three and six months ended June 30, 2010 is primarily due to the non-cash fair value estimates of our warrant liability, recognition of non-cash development revenue of $1,231,000 during first quarter of 2011 as compared to recognition of non-cash development revenue of $2,122,000 of during first quarter of 2010, offset by an increase in operating expenses and interest
expense.
Product revenues consisted of revenues primarily from our Celution ® System products and StemSource ® Cell Banks.
The following table summarizes the components for the three and six months ended June 30, 2011 and 2010:
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For the three months
ended June 30,
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For the six months
ended June 30,
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2011
|
2010
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2011
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2010
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Related party
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$ | — | $ | — | $ | — | $ | 9,000 | ||||||||
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Third party
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2,411,000 | 2,091,000 | 3,773,000 | 4,347,000 | ||||||||||||
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Total product revenues
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$ | 2,411,000 | $ | 2,091,000 | $ | 3,773,000 | $ | 4,356,000 | ||||||||
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% attributable to Green Hospital Supply, Inc.
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— | — | — | 0.2 | % | |||||||||||
Beginning in March of 2008, we began sales and shipments of our Celution ® 800/CRS System to the European and Asia-Pacific reconstructive surgery markets and during 2010 we began sales of our PureGraft™ System in the United States and Europe. Assuming all other applicable revenue recognition criteria have been met, revenue for these product sales is 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. Beginning in 2011, for product sales that include a combination of equipment, services, or other multiple deliverables that will be provided in the future, we defer an estimate based on relative selling price method for those future deliverables from product revenue until such deliverables have been provided or earned. Shipping and handling costs that are billed to our customers are classified as revenue.
Our product sales in the current year were significantly impacted by the major earthquake, tsunami and the aftermath that occurred in Japan in March. A significant portion of our customer base is located in Japan and thus the natural disaster affected our sales during the three and six months ended June 30, 2011.
The future. We expect product sales in Japan to improve as the country recovers from the March disaster. We expect to continue to generate product revenues from Celution® 800/CRS and consumable sales in Europe and we expect to continue to generate product revenues from StemSource® Cell Bank sales and Celution® System translational medical sales in Japan through direct sales and through our distribution partner Green Hospital Supply, from StemSource® banking and research products in the United States and elsewhere through direct sales and through our distribution partner GE Healthcare, and we also expect to generate
PureGraft™ System sales in the US and Europe. Additionally, we expect to have Thin Film product revenues, pending regulatory approval, when 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 relate primarily to Celution ® System products and StemSource ® Cell Banks and includes material, manufacturing labor, and overhead costs. The following table summarizes the components of our cost of revenues for the three and six months ended June 30, 2011 and 2010:
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For the three months
ended June 30,
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For the six months
ended June 30,
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2011
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2010
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2011
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2010
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Cost of product revenues
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$ | 1,092,000 | $ | 869,000 | $ | 1,916,000 | $ | 1,784,000 | ||||||||
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Share-based compensation
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17,000 | 14,000 | 34,000 | 29,000 | ||||||||||||
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Total cost of product revenues
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$ | 1,109,000 | $ | 883,000 | $ | 1,950,000 | $ | 1,813,000 | ||||||||
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Total cost of product revenues as % of product revenues
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46.0 | % | 42.2 | % | 51.7 | % | 41.6 | % | ||||||||
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Cost of product revenues as a percentage of product revenues was 46.0% and 51.7% for the three and six months ended June 30, 2011 and 42.2% and 41.6% for the three and six months ended June 30, 2010, respectively. Fluctuation in this percentage is to be expected due to the product mix, distributor and direct sales mix, and overhead allocation.
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The future. We expect to continue to see variation in our gross profit margin as the product mix comprising revenues fluctuates. Additionally, we expect to incur costs related to our MacroPore products if and when commercialization is achieved for our Japan Thin Film product line.
Development revenues
The following table summarizes the components of our development revenues for the three and six months ended June 30, 2011 and 2010:
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For the three months
ended June 30,
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For the six months
ended June 30,
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2011
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2010
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2011
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2010
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Development (Olympus)
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$ | — | $ | — | $ | 1,231,000 | $ | 2,122,000 | ||||||||
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Research grant and other
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11,000 | 7,000 | 15,000 | 28,000 | ||||||||||||
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Total
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$ | 11,000 | $ | 7,000 | $ | 1,246,000 | $ | 2,150,000 | ||||||||
We recognize deferred revenues, related party, as development revenue when certain performance obligations are met (i.e., using a proportional performance approach). During the quarter ended March 31, 2011, we recognized $1,231,000 of revenue associated with our arrangements with Olympus as a result of achieving a product development milestone related to the preproduction development of the next-generation Celution® One System. During the quarter ended March 31, 2010, we recognized $2,122,000 of revenue associated with our arrangements with Olympus as a result of achieving two milestones, one in product development, and one clinical milestone related to the assessment of trial outcomes at
6 months in one of our cardiac trials.
The future: We may recognize additional development revenues during 2011, as the anticipated completion for the next milestone of our Joint Venture and other Olympus performance obligations is in 2011. If we are successful in completing these activities, we may recognize approximately $200,000 in development revenues during second half of 2011. The exact timing of when amounts will be reported in revenue will depend on internal factors (for instance, our ability to complete certain contributions and obligations that we have agreed to perform) as well as external considerations, including obtaining certain regulatory clearances
and/or approvals related to the Celution® System. The cash for these contributions and obligations was received when the agreement was signed and no further related cash payments will be made to us.
We will continue to recognize revenue from the Thin Film development work we are performing on behalf of Senko, based on the relative fair value of the milestones completed as compared to the total efforts expected to be necessary to obtain regulatory clearance from the MHLW. We are still awaiting regulatory clearance from the MHLW in order for initial commercialization to occur. Accordingly, we expect to recognize approximately $1,129,000 (consisting of $879,000 in deferred revenues plus a non-refundable payment of $250,000 to be received upon commercialization) in revenues associated with this milestone arrangement if and when regulatory approval is achieved. Moreover, we expect to
recognize $500,000 per year associated with deferred Senko license fees over a three-year period following commercialization, if achieved, as the refund rights associated with the license payment expire.
Research and development expenses
Research and development expenses include costs associated with the design, development, testing and enhancement of our products, regulatory fees, the purchase of laboratory supplies, pre-clinical studies and clinical studies. The following table summarizes the components of our research and development expenses for the three and six months ended June 30, 2011 and 2010:
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For the three months
ended June 30,
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For the six months
ended June 30,
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2011
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2010
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2011
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2010
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General research and development
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$ | 2,633,000 | $ | 1,760,000 | $ | 5,205,000 | $ | 3,459,000 | ||||||||
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Development milestone (Joint Venture)
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324,000 | 436,000 | 680,000 | 864,000 | ||||||||||||
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Share-based compensation
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114,000 | 105,000 | 233,000 | 223,000 | ||||||||||||
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Total research and development expenses
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$ | 3,071,000 | $ | 2,301,000 | $ | 6,118,000 | $ | 4,546,000 | ||||||||
Research and development expenses relate to the development of a technology platform that involves using adipose tissue as a source of autologous regenerative cells for therapeutic applications. These expenses, in conjunction with 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.
The increase in research and development expenses for the three and six months ended June 30, 2011 as compared to the same periods in 2010 is primarily due to the initiation of our ADVANCE cardiac trial in Europe.
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, including the next generation 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 stem and regenerative cells for multiple large markets. The following table summarizes the components of our Joint Venture expenses for the three and six months
ended June 30, 2011, and 2010:
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For the three months
ended June 30,
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For the six months
ended June 30,
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|
2011
|
2010
|
2011
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2010
|
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Labor and related benefits
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$ | 100,000 | $ | 295,000 | $ | 309,000 | $ | 560,000 | ||||||||
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Consulting and other professional services
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214,000 | 122,000 | 356,000 | 277,000 | ||||||||||||
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Supplies
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— | — | — | 1,000 | ||||||||||||
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Other miscellaneous
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10,000 | 19,000 | 15,000 | 26,000 | ||||||||||||
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Total
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$ | 324,000 | $ | 436,000 | $ | 680,000 | $ | 864,000 | ||||||||
The future. We expect research and development expenditures to remain relatively stable through the remainder of 2011.
Sales and marketing expenses
Sales and marketing expenses include costs of marketing personnel, tradeshows, physician training, and promotional activities and materials. The following table summarizes the components of our sales and marketing expenses for the three and six months ended June 30, 2011 and 2010:
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For the three months
ended June 30,
|
For the six months
ended June 30,
|
|||||||||||||||
|
2011
|
2010
|
2011
|
2010
|
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International sales and marketing
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$ | 3,467,000 | $ | 2,237,000 | $ | 6,446,000 | $ | 4,046,000 | ||||||||
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Share-based compensation
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249,000 | 188,000 | 496,000 | 378,000 | ||||||||||||
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Total sales and marketing expenses
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$ | 3,716,000 | $ | 2,425,000 | $ | 6,942,000 | $ | 4,424,000 | ||||||||
The increase in sales and marketing expense for the three and six months ended June 30, 2011 as compared to the same period in 2010 was mainly attributed to the increase in salary and related benefits expense (excluding share-based compensation) of $803,000 and $1,463,000, an increase in travel related expenses of $162,000 and $263,000, and an increase in professional services of $125,000 and $277,000, respectively, which are due to our emphasis in seeking strategic alliances and/or co-development partners.
The future. We expect a reduction in sales and marketing expense during the remainder of 2011, as our core sales and marketing infrastructure has been built and we are emphasizing efficiencies.
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, 2011 and 2010:
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For the three months
ended June 30,
|
For the six months
ended June 30,
|
|||||||||||||||
|
2011
|
2010
|
2011
|
2010
|
|||||||||||||
|
General and administrative
|
$ | 3,687,000 | $ | 2,657,000 | $ | 6,734,000 | $ | 5,433,000 | ||||||||
|
Share-based compensation
|
460,000 | 395,000 | 958,000 | 838,000 | ||||||||||||
|
Total general and administrative expenses
|
$ | 4,147,000 | $ | 3,052,000 | $ | 7,692,000 | $ | 6,271,000 | ||||||||
The increase in general and administrative expenses (excluding share-based compensation) for the three and six months ended June 30, 2011 as compared to the same periods in 2010 was due primarily due to an increase in professional services (such as consulting and compliance expenses) of $635,000 and $940,000, and an increase in salary and related benefits expense (excluding share-based compensation) of $207,000 and $357,000, respectively.
The future. We expect general and administrative expenses to remain stable though the remainder of 2011.
Share-based compensation expenses
Stock-based compensation expenses include charges related to options issued to employees, directors and non-employees. We measure stock-based compensation expense based on the grant-date fair value of any awards granted to our employees. Such expense is recognized over the period of time that employees provide service to us and earn all rights to the awards.
The following table summarizes the components of our share-based compensation expenses for the three and six months ended June 30, 2011 and 2010:
|
For the three months
ended June 30,
|
For the six months
ended June 30,
|
|||||||||||||||
|
2011
|
2010
|
2011
|
2010
|
|||||||||||||
|
Cost of product revenues
|
$ | 17,000 | $ | 14,000 | $ | 34,000 | $ | 29,000 | ||||||||
|
Research and development-related
|
114,000 | 105,000 | 233,000 | 223,000 | ||||||||||||
|
Sales and marketing-related
|
249,000 | 188,000 | 496,000 | 378,000 | ||||||||||||
|
General and administrative-related
|
460,000 | 395,000 | 958,000 | 838,000 | ||||||||||||
|
Total share-based compensation
|
$ | 840,000 | $ | 702,000 | $ | 1,721,000 | $ | 1,468,000 | ||||||||
Most of the share-based compensation expenses in the three and six months ended June 30, 2011 and 2010 related to the vesting of stock option awards to employees.
During the first quarter of 2011, we issued to our directors, executive officers and certain non-executive employees options to purchase an aggregate of up to 692,500 shares of our common stock, with four-year vesting for our officers and employees and two-year vesting for our directors. The grant date fair value of the awards granted to our officers and employees was $3.46 and to our directors was $3.15 per share. The resulting share-based compensation expense of $2,375,000, net of estimated forfeitures, will be recognized as expense over the respective vesting periods.
We granted 246,225 performance-based restricted stock awards under the 2004 Equity Incentive Plan in February 2011. The awards provide employees until January 1, 2012 to achieve certain performance goals established by the Compensation Committee. The performance goals are weighted based on the following achievements: obtaining certain FDA clearance or approval (40%), achieving a targeted revenue increase for the fiscal year ended December 31, 2011 (20%), and entering into a major collaboration for development and/or commercialization of the Company’s products (40%). To the extent that any of the performance goals are partially achieved, the Compensation Committee maintains the discretion to continue
the vesting of all or a portion of the awards following January 1, 2012. Once earned, the awards will remain unvested until January 1, 2013. Termination of employment prior to vesting will result in the forfeiture of any earned (as well as unearned) awards. No compensation expense was recognized related to these awards during the three and six months ended June 30, 2011 because the performance criteria have not been met, nor has the Compensation Committee exercised its discretion in determining if partial awards will be granted. The following table summarizes activity with respect to such awards during the six months ended June 30, 2011:
|
Options
|
Weighted
Average Grant-
Date Fair Value
|
|||||||
|
Outstanding at January 1, 2011
|
0 | |||||||
|
Granted
|
246,225 | $ | 5.82 | |||||
|
Vested
|
0 | |||||||
|
Cancelled/forfeited
|
0 | |||||||
|
Outstanding at June 30, 2011
|
246,225 | $ | 5.82 | |||||
|
Vested at June 30, 2011
|
0 | |||||||
During the first quarter of 2010, we issued to our directors, executive officers and certain non-executive employees options to purchase an aggregate of up to 1,155,000 shares of our common stock, with four-year vesting for our officers and employees and two-year vesting for our directors. The grant date fair value of the awards granted to our officers and employees was $4.07 and to our directors was $4.16 per share. The resulting share-based compensation expense of $4,713,000, 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, directors, 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, 2011, the total compensation cost related to non-vested stock options not yet recognized for all our plans is approximately $8,485,000. These costs are expected to be recognized over a weighted average period of 1.81 years.
Change in fair value of warrant liability
The following is a table summarizing the change in fair value of our warrant liability for the three and six months ended June 30, 2011 and 2010:
|
For the three months
ended June 30,
|
For the six months
ended June 30,
|
|||||||||||||||
|
2011
|
2010
|
2011
|
2010
|
|||||||||||||
|
Change in fair value of warrant liability
|
$ | (5,649,000 | ) | $ | (1,461,000 | ) | $ | (2,178,000 | ) | $ | (3,628,000 | ) | ||||
The future . Future changes in the fair value of the warrant liability will be recognized currently in earnings until such time as the warrants are exercised or expire.
Change in fair value of option liability
The following is a table summarizing the change in fair value of our put option liability for the three and six months ended June 30, 2011 and 2010:
|
For the three months
ended June 30,
|
For the six months ended
June 30,
|
|||||||||||||||
|
2011
|
2010
|
2011
|
2010
|
|||||||||||||
|
Change in fair value of put option liability
|
$ | 400,000 | $ | (60,000 | ) | $ | 110,000 | $ | 200,000 | |||||||
The future . The Put has no expiration date. Accordingly, we will continue to recognize a liability for the Put until it is exercised or until the arrangements with Olympus are amended.
Financing items
The following table summarizes interest income, interest expense, and other income and expense for the three and six months ended June 30, 2011 and 2010:
|
For the three months ended
June 30,
|
For the six months ended
June 30,
|
|||||||||||||||
|
2011
|
2010
|
2011
|
2010
|
|||||||||||||
|
Interest income
|
$ | 1,000 | $ | 2,000 | $ | 4,000 | $ | 3,000 | ||||||||
|
Interest expense
|
(696,000 | ) | (254,000 | ) | (1,434,000 | ) | (530,000 | ) | ||||||||
|
Other income (expense)
|
(15,000 | ) | (49,000 | ) | (62,000 | ) | (125,000 | ) | ||||||||
|
Total
|
$ | (710,000 | ) | $ | (301,000 | ) | $ | (1,492,000 | ) | $ | (652,000 | ) | ||||
|
·
|
Interest income remained comparable for the three and six months ended June 30, 2011 as compared to the same period in 2010.
|
|
·
|
Interest expense increased for the three and six months ended June 30, 2011 as compared to the same period in 2010 due to cash interest and non-cash amortization of debt issuance costs and debt discount for our $20.0 million term loan. During the second quarter of 2010, we entered into an Amended and Restated Loan and Security Agreement, pursuant to which the lenders funded a term loan in the amount of $20.0 million on June 14, 2010, and which refinanced the remaining balance of the term loan from 2008.
|
|
·
|
The changes in other income (expense) in the three and six months ended June 30, 2011 as compared to the same period in 2010 resulted primarily from changes in foreign currency exchange rates.
|
The future. Interest income earned in the remainder of 2011 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 for the remainder of 2011 to increase as we continue to pay interest on the $20.0 million term loan that funded in June 2010.
Equity loss from investment in Joint Venture
The following table summarizes our equity loss from investment in joint venture for the three and six months ended June 30, 2011 and 2010:
|
For the three months ended
June 30,
|
For the six months ended
June 30,
|
|||||||||||||||
|
2011
|
2010
|
2011
|
2010
|
|||||||||||||
|
Equity loss in investment
|
$ | (56,000 | ) | $ | (34,000 | ) | $ | (102,000 | ) | $ | (55,000 | ) | ||||
The losses relate entirely to our 50% equity interest in the Joint Venture, which we account for using the equity method of accounting.
The future . We do not expect to recognize significant losses from the activities of the Joint Venture in the foreseeable future. Over the next one to two years, the Joint Venture is expected to incur labor costs related to the development of our second generation commercial system as well as general and administrative expenses, offset by royalty and other revenue expected to be generated by our current Celution® 800/CRS and future generation devices. Though we have no obligation to do so, we plan to contribute funding to the Joint Venture to cover any costs should the Joint Venture deplete its cash balance.
Liquidity and Capital Resources
Short-term and long-term liquidity
The following is a summary of our key liquidity measures at June 30, 2011 and December 31, 2010:
|
June 30,
2011 |
December 31,
2010 |
|||||||
|
Cash and cash equivalents
|
$ | 33,229,000 | $ | 52,668,000 | ||||
|
Current assets
|
$ | 40,430,000 | $ | 58,953,000 | ||||
|
Current liabilities
|
15,612,000 | 13,223,000 | ||||||
|
Working capital
|
$ | 24,818,000 | $ | 45,730,000 | ||||
We incurred net losses of $5,138,000 and $17,209,000 for the three and six months ended June 30, 2011 and 5,377,000 and $7,827,000 for the three and six months ended June 30, 2010, respectively. We have an accumulated deficit of $227,207,000 as of June 30, 2011. Additionally, we have used net cash of $19,532,000 and $11,901,000 to fund our operating activities for the six months ended June 30, 2011 and 2010, respectively. To date these operating losses have been funded primarily from outside sources of invested or borrowed capital.
Management recognizes the need to generate positive cash flows in future periods and/or to obtain additional capital from various sources. In the continued absence of positive cash flows from operations, 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.
During 2011 and 2010, we expanded our commercialization activities while simultaneously pursuing available financing sources to support operations and growth. We have had, and continue to have, an ongoing need to raise additional cash from outside sources to fund our operations. If we cannot do so, we would be required to reduce our research, development, and administrative operations, including reductions of our employee base, in order to offset lack of available funding. We continue to evaluate available financing opportunities as part of our normal course of business.
The following summarizes our contractual obligations and other commitments at June 30, 2011, 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
|
$ | 18,901,000 | $ | 8,917,000 | $ | 9,943,000 | $ | 41,000 | $ | — | ||||||||||
|
Interest commitment on long-term obligations
|
1,898,000 | 1,394,000 | 500,000 | 4,000 | — | |||||||||||||||
|
Operating lease obligations
|
6,284,000 | 1,650,000 | 2,770,000 | 1,864,000 | — | |||||||||||||||
|
Minimum purchase requirements
|
425,000 | 425,000 | — | — | — | |||||||||||||||
|
Pre-clinical research study obligations
|
90,000 | 90,000 | — | — | — | |||||||||||||||
|
Clinical research study obligations
|
12,400,000 | 3,000,000 | 9,400,000 | — | — | |||||||||||||||
|
Total
|
$ | 39,998,000 | $ | 15,476,000 | $ | 22,613,000 | $ | 1,909,000 | $ | — | ||||||||||
Cash (used in) provided by operating, investing, and financing activities for the six months ended June 30, 2011 and 2010 is summarized as follows:
|
For the six months ended June 30,
|
||||||||
|
2011
|
2010
|
|||||||
|
Net cash used in operating activities
|
$ | (19,532,000 | ) | $ | (11,901,000 | ) | ||
|
Net cash used in investing activities
|
(433,000 | ) | (678,000 | ) | ||||
|
Net cash provided by financing activities
|
526,000 | 37,825,000 | ||||||
Operating activities
Operational activities, inclusive of research and development, sales and marketing, and general and administrative efforts, offset in part by product sales, generated an operating loss of $15,615,000 for the six months ended June 30, 2011. The operating cash impact of this loss was $19,532,000, after adjusting for the recognition of non-cash development revenue of $1,231,000, the consideration of non-cash share-based compensation, other adjustments for material non-cash activities, such as depreciation and amortization, change in fair value of option liabilities and warrants, changes in working capital due to timing of product shipments (accounts receivable) and payment of
liabilities.
Operational activities, inclusive of research and development, sales and marketing, and general and administrative efforts, offset in part by product sales, generated an operating loss of $7,120,000 for the six months ended June 30, 2010. The operating cash impact of this loss was $11,901,000, after adjusting for the recognition of non-cash development revenue of $2,122,000, the consideration of non-cash share-based compensation, other adjustments for material non-cash activities, such as depreciation and amortization, change in fair value of option liabilities and warrants, changes in working capital due to timing of product shipments (accounts receivable) and payment of liabilities.
Investing activities
Net cash used in investing activities for the six months ended June 30, 2011 resulted from cash outflow for purchases of property and equipment.
Net cash used in investing activities for the six months ended June 30, 2010 resulted from cash outflow for investment in joint venture and purchases of property and equipment.
Financing Activities
The net cash provided by financing activities for the six months ended June 30, 2011 related to proceeds from exercise of warrants and employee stock options of $2,756,000 offset by the principal payments on long-term obligations of $2,230,000.
The net cash provided by financing activities for the six months ended June 30, 2010 related primarily to a sale of 3,300,000 shares for approximately $17,314,000 in gross proceeds in connection with common stock purchase agreement with Seaside entered into on June 19, 2009 and proceeds from exercise of warrants and employee stock options of $7,042,000. Additionally, in June 2010, we obtained a term loan in the amount of $20,000,000, less fees and expenses, which was used in part to refinance the remaining balance of the term loan entered into with GECC and SVB on October 14, 2008.
Critical Accounting Policies and Significant Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires us to make estimates and assumptions that affect the reported amounts of our assets, liabilities, revenues and expenses, and that affect 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 our policies that require us to make our most significant judgments and, as a result, could have the greatest impact on our future financial results.
Warrant Liability
Effective January 1, 2009, we changed our method of accounting for certain common stock purchase warrants with exercise price reset features due to the adoption of a new accounting standard. These warrants were issued in connection with our August 2008 private placement of 2,825,517 unregistered shares of common stock and 1,412,758 common stock warrants. The warrants had an original exercise price of $8.50 and expire in August 2013. Under the new standard, these warrants previously recognized in stockholders’ equity (deficit) are now accounted for as fair value liabilities, with changes in fair value included in net earnings (loss).
Revenue Recognition
Product Sales
See Notes to Consolidated Condensed Financial Statements included elsewhere herein for disclosure and discussion of revenue recognition.
Research and Development
We earn revenue for performing tasks under research and development agreements with both commercial enterprises, such as Olympus and Senko, and governmental agencies like the National Institutes of Health (“NIH”). Revenue earned under development agreements is classified as either research grant or development revenues depending on the nature of the arrangement. Revenues derived from reimbursement of direct out-of-pocket expenses for research costs associated with grants are recorded as research grant and other within development revenues. Research grant revenue is recorded at the gross amount of the reimbursement. The costs associated with these reimbursements
are reflected as a component of research and development expense in our 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 statements of operations.
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, 2011. We test this goodwill at least annually, as of November 30, for impairment as well as when an event occurs or circumstances change such that it is reasonably possible that impairment may exist. The application of the goodwill impairment test involves a substantial amount of judgment. The judgments employed may have an effect on whether a goodwill impairment loss is recognized.
No impairment triggering events occurred during the three and six months ended June 30, 2011 that would require us to perform an impairment test.
Variable Interest Entity (Olympus-Cytori Joint Venture)
A variable interest entity, or VIE, must 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:
|
·
|
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. In fact, we contributed $330,000, $300,000 and $150,000 in 2010, 2009, and 2008, respectively.
|
|
·
|
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, and as such, 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.
As noted previously, a VIE is consolidated by its primary beneficiary. The primary beneficiary is defined 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. 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, and therefore has the primary power to direct activities that could significantly impact economic performance.
|
Had we consolidated the Joint Venture, though, there would be no effect on our net loss or shareholders’ equity at June 30, 2011 or for the period 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 our deferred tax assets.
See Notes to Consolidated Condensed Financial Statements included elsewhere herein for disclosure and discussion of new accounting standards.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
We are exposed to market risk related to fluctuations in interest rates and 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, 2011, 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 currently 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 three and six months ended June 30, 2011, a hypothetical 10% adverse change in the Euro or Yen against the U.S. dollar are not expected to 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, which 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.
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, 2011.
There has been no change in our internal control over financial reporting during the quarter ended June 30, 2011 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, 2011, we were not a party to any material legal proceeding.
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 may need to raise more cash in the 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 likely be required to raise capital from one or more sources in the future to continue funding our operations to profitability. We do not currently believe that our cash balance and the revenues from our operations will be sufficient to fund the development and marketing efforts required to reach profitability without raising additional capital from accessible sources of financing in the
future. In addition, our Amended and Restated Loan and Security Agreement with General Electric Capital Corporation, Silicon Valley Bank and Oxford Finance Corporation requires us to maintain certain minimum cash requirements, and if our cash reserves fall below those minimum requirements, then we could be in default under our loan agreement and subject to potential adverse remedies by the lenders, which would have a substantial and material adverse effect on our business, financial condition, results of operations, the value of our common stock and warrants and our ability to raise capital. There is no guarantee that adequate funds will be available when needed from additional debt or equity financing, arrangements with development and commercialization partners, increased results of operations, or from other sources, or on terms attractive to us. Our
inability to obtain sufficient additional funds in the future would, at a minimum, require us to delay, scale back, or eliminate some or all of our research or product development, manufacturing operations, clinical or regulatory activities, which could have a substantial negative effect on our results of operations and financial condition.
Continued turmoil in the economy could harm our business
Negative trends in the general economy, including trends resulting from an actual or perceived recession, tightening credit markets, increased cost of commodities, including oil, actual or threatened military action by the United States and threats of terrorist attacks in the United States and abroad, could cause a reduction of investment in and available funding for companies in certain industries, including ours. Our ability to raise capital has been and may in the future be adversely affected by downturns in current credit conditions, financial markets and the global economy.
We have never been profitable on an operational basis and expect significant operating losses for the next few years
We have incurred net operating losses in each year since we started business. As our focus on the Celution ® System platform and development of therapeutic applications for its cellular output has increased, losses have resulted primarily from expenses associated with research and development activities and general and administrative expenses. While we work continuously to implement 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 been, and are likely to continue to be, reliant on raising outside capital to fund our operations as discussed in the prior risk factor.
Our business strategy is high-risk
We are focusing our resources and efforts primarily on development of the Celution ® System family of products and the therapeutic applications of its cellular output, which requires extensive cash needs for research, development, and commercialization 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.
Our business depends in part on keeping our Joint Venture collaboration with Olympus operating smoothly and efficiently. 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 these devices 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. Although our relationship is formally measured by a set of complex contracts, many aspects of the relationship will be non-contractual and must be worked out between the parties and the responsible individuals. The Joint Venture is intended to have a long life, and it is difficult to maintain cooperative relationships over a long period of time in the face of various kinds of change. Cultural differences, including language barrier to some degree, may affect the efficiency of the relationship.
Olympus-Cytori, Inc. is 50% owned by us and 50% owned by Olympus. By contract, each side must consent before any of a wide variety of important business actions can occur. This situation possesses a risk of potentially time-consuming and difficult negotiations which could at some point delay the Joint Venture from pursuing its business strategies.
Olympus is entitled to designate the Joint Venture's chief executive officer and a majority of its board of directors, which means that day-to-day decisions which are not subject to a contractual veto will essentially be controlled by Olympus. In addition, Olympus-Cytori, Inc. may require more money than its current capitalization in order to complete development and production of future generation devices. If we are unable to help provide future financing for Olympus-Cytori, Inc., our relative equity interest in Olympus-Cytori, Inc. may decrease.
Furthermore, under a License/Joint Development Agreement among Olympus-Cytori, Inc., Olympus, and us, Olympus will have a primary role in the development of Olympus-Cytori, Inc.’s next generation devices. Although Olympus has extensive experience in developing medical devices, this arrangement will result in a reduction of our control over the development and manufacturing of the next generation devices.
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. From time to time, we have tried to update our investors’ expectations as to our operating results by periodically announcing financial guidance. However, we have in the past been forced to revise or withdraw such guidance due to lack of visibility and predictability of product demand.
We are vulnerable to competition and technological change, and also to physicians’ inertia
We compete with many domestic and foreign companies in developing our technology and products, including biotechnology, medical device, and pharmaceutical companies. Many current and potential competitors have substantially greater financial, technological, research and development, marketing, and personnel resources. There is no assurance that our competitors will not succeed in developing alternative products that are more effective, easier to use, or more economical than those which we have developed or are in the process of developing, or that would render our products obsolete and non-competitive. In general, we may not be able to prevent others from developing and marketing
competitive products similar to ours or which perform similar functions.
Competitors may have greater experience in developing therapies or devices, conducting clinical trials, obtaining regulatory clearances or approvals, manufacturing and commercialization. It is possible that competitors may obtain patent protection, approval, or clearance from the FDA or achieve commercialization earlier than we can, any of which could have a substantial negative effect on our business. Finally, Olympus and our other partners might pursue parallel development of other technologies or products, which may result in a partner developing additional products competitive with ours.
We compete against cell-based therapies derived from alternate sources, such as bone marrow, umbilical cord blood and potentially embryos. Doctors historically are slow to adopt new technologies like ours, whatever the merits, when older technologies continue to be supported by established providers. Overcoming such inertia often requires very significant marketing expenditures or definitive product performance and/or pricing superiority.
We expect physicians’ inertia and skepticism to also be a significant barrier as we attempt to gain market penetration with our future products. We believe we will need to finance lengthy time-consuming clinical studies (so as to provide convincing evidence of the medical benefit) in order to overcome this inertia and skepticism particularly in reconstructive surgery, cell preservation, the cardiovascular area and many other indications.
Most potential applications of our technology are pre-commercialization, which subjects us to development and marketing risks
We are in a relatively early stage of the path to commercialization with many of our products. We believe that our long-term viability and growth will depend in large part on our ability to develop commercial quality cell processing devices and useful procedure-specific consumables, and to establish the safety and efficacy of our therapies through clinical trials and studies. With our Celution ® System platform, we are pursuing new approaches for reconstructive surgery, preservation of stem and regenerative cells for potential future use, therapies for cardiovascular disease, gastrointestinal disorders and spine and orthopedic
conditions. There is no assurance that our development programs will be successfully completed or that required regulatory clearances or approvals will be obtained on a timely basis, if at all.
There is no proven path for commercializing the Celution ® System platform in a way to earn a durable profit commensurate with the medical benefit. Although we began to commercialize our reconstructive surgery products in Europe and certain Asian markets, and our cell banking products in Japan, Europe, and certain Asian markets in 2008, additional market opportunities for many of our products and/or services are likely to be another two to four 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.
Future clinical trial results may differ significantly from our expectations
While our early clinical trial results so far have been very positive, and we have proceeded incrementally in the our these clinical trials in an effort to gauge the risks of proceeding with larger and more expensive trials, we cannot guarantee that we will not experience negative results in these larger and much more expensive clinical trials, such as the new ADVANCE acute heart attack trial in Europe. Poor results in our clinical trials could result in substantial delays in commercialization, substantial negative effects on the perception of our products, and substantial additional costs. These risks are increased by our reliance on third parties in the performance of many of the clinical trial
functions, including the clinical investigators, hospitals, and other third party service providers.
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.
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 ® System in a manner that is cost-effective or commercially viable, or that development and manufacturing capabilities might not take much longer than currently anticipated to be ready for the market.
Although we have begun introduction of the Celution ® 800 and the StemSource ® 900-based 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 ® System.
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 ® System.
We may not be able to protect our proprietary rights
Our success depends in part on whether we can maintain our existing patents, obtain additional patents, maintain trade secret protection, and operate without infringing on the proprietary rights of third parties.
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 not become the subject of a re-examination, 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 and in the case of 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, 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.
Successful challenges to our patents through oppositions, reexamination proceedings or interference proceedings could result in a loss of patent rights in the relevant jurisdiction. If we are unsuccessful in actions we bring against the patents of other parties and it is determined that we infringe the patents of third-parties, we may be subject to litigation, or otherwise prevented from commercializing potential products in the relevant jurisdiction, or may be required to obtain licenses to those patents or develop or obtain alternative technologies, any of which could harm our business. Furthermore, if such challenges to our patent rights are not resolved in our favor, we could be delayed or prevented from
entering into new collaborations or from commercializing certain products, which could adversely affect our business and results of operations.
Competitors or third parties may infringe our patents. We may be required to file patent infringement claims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that a patent of ours is not valid or is unenforceable, or that the third party’s technology does not in fact infringe upon our patents. An adverse determination of any litigation or defense proceedings could put one or more of our patents at risk of being invalidated or interpreted narrowly and could put our related pending patent applications at risk of not issuing. Litigation may fail and, even if successful, may result in substantial costs and be a distraction to our management. We may not be
able to prevent misappropriation of our proprietary rights, particularly in countries outside the U.S. where patent rights may be more difficult to enforce. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential or sensitive information could be compromised by disclosure in the event of litigation. In addition, during the course of litigation there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock.
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. Some of our intended future cell-related therapeutic products may fit 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.
Our amended regenerative cell technology license agreement with the Regents of the University of California (UC) which includes issued U.S. patent number 7,470,537, 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.
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 most of our current commercial product sales and clinical trials are 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 United States. 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 FDA regulation
As newly developed medical devices, the 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 U.S. 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 for their intended use on a timely basis, if at all. Delays in receipt of or failure to receive such clearances or approvals, the loss of previously received clearances or approvals, or failure to comply with existing or future regulatory requirements could have a substantial negative effect on our results of operations and financial condition.
To sell in international markets, we will be subject to 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 the 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.
Anticipated or unanticipated changes in the way or manner in which the FDA regulates products or classes/groups of products can delay, further burden, or alleviate regulatory pathways that were once available to other products. There are no guarantees that such changes in FDA’s approach to the regulatory process will not deleteriously affect some or all of our products or product applications.
We do not know if the current FDA proposed changes to the 510(k) system will have any material effect on any of our current or future 510(k) applications.
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.
Concentration of Sales/ Effects of Japan Crisis
We have a significant concentration of sales in Japan, the United States, and Europe given our early stage of commercialization. As a result of this regional concentration of sales, changes in the regulatory environment in these countries, or any other countries in which we have a significant concentration of sales, could adversely impact our sales. If the government of any of these countries significantly curtailed or prohibited the sale of our products, our revenues would be adversely affected. Recently, the earthquake, tsunami and subsequent problems affecting nuclear power plants in Japan have dramatically impacted Japan’s manufacturing capacity and business activities. The long term
effect of these issues is still uncertain. While we expect that the situation will stabilize and improve, if it does not, these circumstances could have a materially negative affect our revenues and profitability since our new Celution ® One device is manufactured in Japan, and a substantial portion of our sales have come from Japan.
Global Operations Expose Us To Additional Risk And Uncertainties.
We have operations in a number of regions around the world, including the United States, Japan, and Europe. Our global operations may be subject to risks that may limit our ability to operate our business. We sell our products globally, which exposes us to a number of risks that can arise from international trade transactions, local business practices and cultural considerations, including:
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political unrest, terrorism and economic or financial instability;
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nationalization programs that may be implemented by foreign governments;
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import-export regulations;
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difficulties in enforcing agreements and collecting receivables;
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difficulties in ensuring compliance with the laws and regulations of multiple jurisdictions;
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changes in labor practices, including wage inflation, labor unrest and unionization policies;
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longer payment cycles by international customers;
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currency exchange fluctuations;
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disruptions of service from utilities or telecommunications providers, including electricity shortages;
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difficulties in staffing foreign branches and subsidiaries and in managing an expatriate workforce, and differing employment practices and labor issues;
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potentially adverse tax consequences;
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We also face risks associated with currency exchange and convertibility, inflation and repatriation of earnings as a result of our foreign operations. We are also vulnerable to appreciation or depreciation of foreign currencies against the U.S. dollar. Although we have significant operations in Asia, a substantial portion of transactions are denominated in U.S. dollars. As appreciation against the U.S. dollar increases, it will result in an increase in the cost of our business expenses in abroad. Further, downward fluctuations in the value of foreign currencies relative to the U.S. dollar may make our products less price competitive than local solutions. From time to time, we may engage in currency hedging
activities, but such activities may not be able to limit the risks of currency fluctuations.
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.
We depend on a few key officers
Our performance is substantially dependent on the performance of our executive officers and other key scientific and sales staff, including Christopher J. Calhoun, our Chief Executive Officer, and Marc Hedrick, MD, our President. We rely upon them for strategic business decisions and guidance. We believe that our future success in developing marketable products and achieving a competitive position will depend in large part upon whether we can attract and retain additional qualified management and scientific personnel. Competition for such personnel is intense, and there can be no assurance that we will be able to continue to attract and retain such personnel. The loss of the services
of one or more of our executive officers or key scientific staff or the inability to attract and retain additional personnel and develop expertise as needed could have a substantial negative effect on our results of operations and financial condition.
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 Cytori 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 cash dividends 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
None
Item 3. Defaults Upon Senior Securities
None
Item 4. (Reserved)
Item 5. Other Information
Properties
We currently lease 60,118 square feet at 3020 and 3030 Callan Road, San Diego, California. The related lease agreement bears monthly rent at a rate of $1.75 per square foot, with annual increase of $0.05 per square foot. The lease term is 64 months, commencing on July 1, 2010 and expiring on October 31, 2015. In connection with this lease, we received a four month rent abatement period and an allowance for leasehold improvements of approximately $300,000. Additionally, we’ve entered into several lease agreements for international office locations and corporate housing for our employees on international assignments. For these properties, we pay an aggregate
of approximately $151,000 in rent per month.
Staff
As of June 30, 2011, we had 137 employees, including part-time and full-time employees. These employees are comprised of 19 employees in manufacturing, 44 employees in research and development, 42employees in sales and marketing and 32 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.
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Exhibit No.
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Description
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10.77
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Form Notice and Restricted Stock Award Agreement for grants of performance-based restricted stock awards under the 2004 Equity Incentive Plan (filed as Exhibit 10.1 to our current report on Form 8-K filed on March 4, 2011 and incorporated by reference herein)
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10.78
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Form of Common Stock Purchase Agreement by and between Cytori Therapeutics, Inc. and Seaside 88, LP, dated July 11, 2011 (filed as Exhibit 10.78 to our current report on Form 8-K filed on July 12, 2011 and incorporated by reference herein)
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First Amendment to Amended and Restated Loan and Security Agreement, dated June 23, 2011, by and among the Company, Oxford Finance LLC, the other lenders party hereto and General Electric Capital Corporation (filed herewith)
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1.1
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Underwriting Agreement, dated October 8, 2010, between Cytori Therapeutics, Inc. and Jefferies & Company (filed as Exhibit 1.1 to our Form 8-K Current Report as filed on October 8, 2010 and incorporated by reference herein).
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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).
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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).
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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).
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101.INS
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XBRL Instance Document
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101.SCH
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XBRL Schema Document
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101.CAL
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XBRL Calculation Linkbase Document
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101.LAB
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XBRL Label Linkbase Document
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101.PRE
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XBRL Presentation Linkbase Document
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* These certifications are being furnished solely to accompany this report pursuant to 18 U.S.C. 1350 and are not being filed for purposes of Section 18 of the Securities and Exchange Act of 1934 and are not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
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.
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CYTORI THERAPEUTICS, INC.
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By:
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/s/ Christopher J. Calhoun
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Dated: August 9, 2011
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Christopher J. Calhoun
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Chief Executive Officer
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By:
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/s/ Mark E. Saad
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Dated: August 9, 2011
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Mark E. Saad
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Chief Financial Officer
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39
EXHIBIT 10.79
FIRST AMENDMENT TO AMENDED AND RESTATED LOAN AND SECURITY AGREEMENT
THIS FIRST AMENDMENT TO AMENDED AND RESTATED LOAN AND SECURITY AGREEMENT (this “Amendment”), dated as of June 23, 2011, by and among CYTORI THERAPEUTICS, INC., a Delaware corporation (“Borrower”), OXFORD FINANCE LLC (as successor in interest to Oxford Finance Corporation) (“Oxford”), as a Lender (as defined below), the other Lenders party hereto and GENERAL ELECTRIC CAPITAL CORPORATION, a Delaware corporation, in its capacities as agent (the “Agent”) and a Lender.
W I T N E S S E T H:
WHEREAS, Borrower, the lenders signatory thereto from time to time (each a “Lender” and, collectively, the “Lenders”) and Agent are parties to that certain Amended and Restated Loan and Security Agreement, dated as of June 11, 2010 (as amended, supplemented, replaced and otherwise modified from time to time, the “Loan Agreement”; capitalized terms used herein have the meanings given to them in the Loan Agreement except as otherwise expressly defined herein), pursuant to which Lenders and Agent have agreed to provide to Borrower certain loans in accordance with the terms and conditions thereof;
WHEREAS, Borrower, Lenders and Agent desire to amend certain provisions of the Loan Agreement as provided herein and subject to the terms and conditions set forth herein;
NOW, THEREFORE, in consideration of the premises, the covenants and agreements contained herein, and other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, Borrower, Lenders and Agent hereby agree as follows:
1. AMENDMENTS TO LOAN AGREEMENT. Subject to the terms and conditions of this Amendment, including, without limitation, Section 3 of this Amendment, the Loan Agreement is hereby amended as of the First Amendment Effective Date (as defined below) as follows:
(a) Section 10.1, Assignment, of the Loan Agreement is hereby amended by deleting such section in its entirety and by inserting, in lieu thereof, the following:
“10.1 Assignment.
(a) Subject to the terms of this Section 10.1, each Lender shall have the right to sell, transfer or assign, at any time or times, all or a portion of its rights and obligations hereunder and under the other Debt Documents, its Commitment, its Term Loan or any portion thereof or interest therein, including any Lender’s rights, title, interests, remedies, powers or duties thereunder, provided, however, that any such sale, transfer or assignment shall: (i) except in the case of a sale, transfer or assignment to a Qualified Assignee (as defined below), require the prior written consent of Agent and the Required Lenders (which consent shall not be unreasonably withheld, conditioned or delayed); (ii) require the execution of an assignment agreement in form and substance reasonably satisfactory to, and acknowledged by, Agent (an “Assignment Agreement”); (iii) be conditioned on such assignee Lender representing to the assigning Lender and Agent that it is purchasing the applicable Commitment and/or Term Loan to be assigned to it for its own account, for investment purposes and not with a view to the distribution thereof; (iv) be in an aggregate amount of not less than $1,000,000, unless such assignment is made to an existing Lender or an affiliate of an existing Lender or is of the assignor’s (together with its affiliates’) entire interest of the Term Loan or is made with the prior written consent of Agent; and (v) include a payment to Agent of an assignment fee of $3,500 (unless otherwise agreed by Agent). In the case of an assignment by a Lender under this Section 10.1(a), the assignee shall have, to the extent of such assignment, the same rights, benefits and obligations as all other Lenders hereunder. The assigning Lender shall be relieved of its obligations hereunder with respect to its Commitment and Term Loan, as applicable, or assigned portion thereof from and after the date of such assignment. Borrower hereby acknowledges and agrees that any assignment shall give rise to a direct obligation of Borrower to the assignee and that the assignee shall be considered to be a “Lender”. In the event any Lender assigns or otherwise transfers all or any part of the Commitments and Obligations, upon the assignee’s or the assignor’s request, Agent shall request that Borrower execute new Notes in exchange for the Notes, if any, being assigned. Agent may amend Schedule A to this Agreement to reflect assignments made in accordance with this Section.
As used herein, “Qualified Assignee” means (a) any Lender and any affiliate of any Lender and (b) any commercial bank, savings and loan association or savings bank or any other entity which is an “accredited investor” (as defined in Regulation D under the Securities Act) which extends credit or buys loans as one of its businesses, including insurance companies, mutual funds, lease financing companies and commercial finance companies, in each case, which has a rating of BBB or higher from S&P and a rating of Baa2 or higher from Moody's at the date that it becomes a Lender, and in each case of clauses (a) and (b), which, through its applicable lending office, is capable of lending to Borrower without the imposition of any withholding or similar taxes; provided that (i) no person proposed to become a Lender after the Closing Date and determined by Agent to be acting in the capacity of a vulture fund or distressed debt purchaser shall be a Qualified Assignee, (ii) no person or Affiliate of such person proposed to become a Lender after the Closing Date and that holds any subordinated debt or stock issued by any Loan Party or its Affiliates shall be a Qualified Assignee and (iii) no person proposed to become a Lender after the Closing Date and that is a direct business competitor of a Loan Party shall be a Qualified Assignee so long as no Default or Event of Default exists at the time of the proposed assignment.
(b) In addition to the other rights provided in this Section 10.1, each Lender may, without notice to or consent from Agent or any Loan Party, sell participations to one or more persons or entities in or to all or a portion of its rights under the Debt Documents (including all of its rights with respect to the Term Loans); provided, however, that, whether as a result of any term of any Debt Document or of such participation, (i) no such participant shall have a commitment, or be deemed to have made an offer to commit, to make any Term Loan hereunder, and, no such participant shall be liable for any obligation of such Lender hereunder and which Lender shall remain expressly liable for all obligations of such Lender hereunder (in being expressly acknowledged and agreed that such Lender shall remain primarily liable for the obligations of such Lender hereunder regardless of any such participation), (ii) such Lender’s rights and obligations, and the rights and obligations of the Loan Parties and the Agent and other Lenders towards such Lender, under any Debt Document shall remain unchanged and each other party hereto shall continue to deal solely with such Lender, which shall remain the holder of the Obligations and which Lender shall remain expressly liable for all obligations of such Lender hereunder (in being expressly acknowledged and agreed that such Lender shall remain primarily liable for the obligations of such Lender hereunder regardless of any such participation), and in no case shall a participant have the right to enforce any of the terms of any Debt Document, and (iii) the consent of such participant shall not be required (either directly, as a restraint on such Lender’s ability to consent hereunder or otherwise) for any amendments, waivers or consents with respect to any Debt Document or to exercise or refrain from exercising any powers or rights such Lender may have under or in respect of the Debt Documents (including the right to enforce or direct enforcement of the Obligations), except for those described in clauses (ii), (iii) and (viii) of subsection 10.8(c) hereof.
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(c) In addition to the other rights provided in this Section 10.1, each Lender may, with prior written notice to the Agent, sell, transfer or assign to a Securitization Entity (and such Securitization Entity may, with prior written notice to the Agent, sell, transfer or assign to another Securitization Entity), at any time or times, all or a portion of its rights hereunder and under the other Debt Documents, its Term Loans or any portion thereof or interest therein; provided, however, that, (i) no such Securitization Entity shall have a commitment, or be deemed to have made an offer to commit, to make any Term Loan hereunder, and none shall be liable for any obligation of such Lender hereunder, (ii) such Lender’s obligations (including, without limitation, indemnity and funding obligations) under the Debt Documents shall remain unchanged, and (iii) the other parties hereto shall continue to deal solely with such Lender as servicer of the Securitization Entity until such time as such other parties receive a written notice from the Securitization Entity indicating that another person or entity will act as servicer for the Securitization Entity (at which time such other parties hereto shall be entitled to deal solely with such subsequent servicer) and such other parties hereto shall be fully entitled to rely on such written notice and shall have no liability for relying on such notice or for taking any action or omitting to take any action in reliance upon such notice.
As used herein, “Securitization Entity” means a special purpose funding vehicle that is a direct or indirect subsidiary of a Lender that is created solely for the purpose of such Lender obtaining funding secured by assets including all or any part of such Lender’s interests in this Agreement or any other Debt Document, or selling ownership interests therein, and that engages in no material activities other than in connection with the financing or securitization of loans or financial assets.
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(d) In addition to the other rights provided in this Section 10.1, each Lender and each Securitization Entity may grant a security interest in, or otherwise assign as collateral, all or a portion of its rights hereunder and under the other Debt Documents, its Term Loans or any portion thereof or interest therein, whether now owned or hereafter acquired (including rights to payments of principal or interest on the Term Loans), to (i) any federal reserve bank (pursuant to Regulation A of the Federal Reserve Board), without notice to the Agent or (ii) any holder of, or agent or trustee for the benefit of the holders of, such Lender’s or Securitization Entity’s debt obligations or equity securities by written notice to the Agent; provided, however, that (x) no such holder, agent or trustee, whether because of such grant or assignment or any foreclosure thereon (unless such foreclosure is made through an assignment in accordance with clause (a) above), shall be entitled to any rights of such Lender or Securitization Entity hereunder and no such Lender or Securitization Entity shall be relieved of any of its obligations hereunder, and (y) such grant or assignment shall not affect, and the Lender shall remain expressly liable for, all obligations of such Lender hereunder (it being expressly acknowledged and agreed that such Lender shall remain primarily liable for the obligations of such Lender hereunder regardless of any such grant or assignment).”
(b) Section 10.8, Entire Agreement; Amendments, Waivers, of the Loan Agreement is hereby amended by deleting subsections (b) and (c) in their entirety and by inserting, in lieu thereof, the following subsections (b) and (c), respectively:
“(b) No amendment, modification, termination or waiver of any provision of this Agreement or any other Debt Document, or any consent to any departure by Borrower therefrom, shall in any event be effective unless the same shall be in writing and signed by Agent, Borrower and Lenders having more than (x) 60% of the aggregate Commitments of all Lenders or (y) if such Commitments have expired or been terminated, 60% of the aggregate outstanding principal amount of the Term Loan (the “Requisite Lenders”); provided, however, that so long as a party that is a Lender hereunder on the Closing Date does not assign any portion of its Commitment or Term Loan (other than an assignment to any affiliate of such Lender), the “Requisite Lenders” shall include such Lender. Except as set forth in clause (c) below, all such amendments, modifications, terminations or waivers requiring the consent of any Lenders shall require the written consent of Requisite Lenders.”
“(c) No amendment, modification, termination or waiver of any provision of this Agreement or any other Debt Document shall, unless in writing and signed by Borrower, Agent and each Lender directly affected thereby: (i) increase or decrease any Commitment of any Lender or increase or decrease the Total Commitment (which shall be deemed to affect all Lenders), (ii) reduce the principal of or rate of interest on any Obligation or the amount of any fees payable hereunder (other than waiving the imposition of the Default Rate), (iii) postpone the date fixed for or waive any payment of principal of or interest on the Term Loan, or any fees hereunder, (iv) release all or substantially all of the Collateral, or consent to a transfer of all or substantially all of the Intellectual Property, in each case, except as otherwise expressly permitted in the Debt Documents (which shall be deemed to affect all Lenders), (v) subordinate the Lien on all or substantially all of the Collateral granted in favor of the Agent securing the Obligations (which shall be deemed to affect all Lenders), (vi) release a Loan Party from, or consent to a Loan Party’s assignment or delegation of, such Loan Party’s obligations hereunder and under the other Debt Documents or any Guarantor from its guaranty of the Obligations (which shall be deemed to affect all Lenders), (vii) amend, modify, terminate or waive Section 8.4, 9.7 or 10.8(b) or (c) or (viii) amend or modify the definition of “Requisite Lenders”.”
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(c) Section 10.8, Entire Agreement; Amendments, Waivers, of the Loan Agreement is hereby further amended by deleting subsection (e) in its entirety and by inserting, in lieu thereof, the following subsection (e):
“(e) Each Lender hereby consents to the release by Agent of any Lien held by the Agent for the benefit of itself and the Lenders in any or all of the Collateral to secure the Obligations upon (i) the occurrence of any Permitted Disposition pursuant to Section 7.3 and (ii) the termination of the Commitments and the payment and satisfaction in full of the Obligations.”
2. COSTS AND EXPENSES. Notwithstanding Section 10.5 of the Loan Agreement, Oxford Finance, LLC absolutely and unconditionally agrees to reimburse Agent and Borrower for all reasonable fees, costs and expenses incurred by Agent and Borrower in connection with this Amendment or otherwise related to the Debt Documents or the transactions contemplated hereby and thereby, including, without limitation, reasonable legal fees and costs (and without duplication, the allocated cost of in-house legal counsel), professional and consultant fees, recording fees, search fees and filing fees.
3. CONDITIONS TO EFFECTIVENESS. This Amendment shall become effective as of the date (the “First Amendment Effective Date”) upon which Agent shall notify Borrower in writing that each of the conditions specified below have been satisfied as determined in Agent’s sole discretion:
(a) Agent shall have received one or more counterparts of this Amendment, duly executed, completed and delivered by Agent, each Lender and each Loan Party;
(b) After giving effect to this Amendment, no Default or Event of Default shall have occurred and be continuing;
(c) Agent and Borrower shall have received payment of all unpaid fees and expenses described in Section 2 hereof; and
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(d) Agent shall have received all other documents and instruments as Agent or any Lender may reasonably deem necessary or appropriate to effectuate the intent and purpose of this Amendment.
4. NO OTHER AMENDMENTS.
(a) Except for the amendments set forth in Section 1 of this Amendment, the Loan Agreement and the other Debt Documents shall remain unchanged and in full force and effect. Nothing in this Amendment is intended, or shall be construed, to constitute a novation or an accord and satisfaction of any Loan Party’s Obligations under or in connection with the Loan Agreement and any other Debt Document or to modify, affect or impair the perfection or continuity of Agent’s security interest in, (on behalf of itself and Lenders) security titles to or other liens on any Collateral for the Obligations.
5. REPRESENTATIONS AND WARRANTIES. Each Loan Party hereby represents and warrants to Lenders as follows:
(a) Representations and Warranties. Each Loan Party hereby represents and warrants that, after giving effect to this Amendment, each of such Loan Party’s representations and warranties contained in the Debt Documents is true and correct in all material respects on and as of the date hereof, except for any representation and warranty that relates by its terms only to a specified date (in which case, it shall be true in all material respects on and as of such date).
(b) Binding Effect of Documents. This Amendment and the other Debt Documents have been duly executed and delivered to Agent and Lenders by such Loan Party and are in full force and effect, as modified hereby.
(c) No Conflict, Etc. Except as described in the note to Item 8 in Section D on Schedule B to the Loan Agreement, the execution, delivery and performance of this Amendment by such Loan Party will not violate any law, rule, regulation or order or contractual obligation or organizational document of such Loan Party and will not result in, or require, the creation or imposition of any lien, claim or encumbrance of any kind on any of its properties or revenues.
6. ADVICE OF COUNSEL. Each of the parties represents to each other party hereto that it has discussed this Amendment with its counsel.
7. SEVERABILITY OF PROVISIONS. In case any provision of or obligation under this Amendment shall be invalid, illegal or unenforceable in any applicable jurisdiction, the validity, legality and enforceability of the remaining provisions or obligations, or of such provision or obligation in any other jurisdiction, shall not in any way be affected or impaired thereby.
8. COUNTERPARTS. This Amendment may be executed in multiple counterparts, each of which shall be deemed to be an original and all of which when taken together shall constitute one and the same instrument. Delivery of an executed signature page of this Amendment by facsimile transmission or electronic transmission shall be as effective as delivery of a manually executed counterpart hereof.
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9. GOVERNING LAW. THIS AMENDMENT SHALL BE GOVERNED BY, AND CONSTRUED IN ACCORDANCE WITH, THE INTERNAL LAWS OF THE STATE OF NEW YORK APPLICABLE TO CONTRACTS MADE AND PERFORMED IN SUCH STATE WITHOUT REGARD TO THE PRINCIPLES THEREOF REGARDING CONFLICTS OF LAWS.
10. ENTIRE AGREEMENT. The Loan Agreement and the other Debt Documents as and when amended through this Amendment embodies the entire agreement between the parties hereto relating to the subject matter thereof and supersedes all prior agreements, representations and understandings, if any, relating to the subject matter thereof.
11. NO STRICT CONSTRUCTION, ETC. The parties hereto have participated jointly in the negotiation and drafting of this Amendment. In the event an ambiguity or question of intent or interpretation arises, this Amendment shall be construed as if drafted jointly by the parties hereto and no presumption or burden of proof shall arise favoring or disfavoring any party by virtue of the authorship of any provisions of this Amendment. Time is of the essence for this Amendment.
[Signature Page to Follow]
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IN WITNESS WHEREOF, the parties hereto have caused this First Amendment to Amended and Restated Loan and Security Agreement to be duly executed and delivered as of the day and year specified at the beginning hereof.
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BORROWER:
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| CYTORI THERAPEUTICS, INC. | |||
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By:
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/s/ Marc H. Hedrick | |
| Name: | Marc H. Hedrick | ||
| Title: | President | ||
| AGENT AND LENDERS: | |||
| GENERAL ELECTRIC CAPITAL CORPORATION, as Agent and Lender | |||
| By: | /s/ R. Hanes Whiteley | ||
| Name: | R. Hanes Whiteley | ||
| Title: | Duly Authorized Signatory | ||
| OXFORD FINANCE LLC (as successor in interest to Oxford Finance Corporation), as Lender | |||
| By: | /s/ John G. Henderson | ||
| Name: | John G. Henderson | ||
| Title: | Vice President & General Counsel | ||
| SILICON VALLEY BANK, as Lender | |||
| By: | /s/ R. Michael White | ||
| Name: | R. Michael White | ||
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Title:
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SRM | ||
EXHIBIT 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
I, Christopher J. Calhoun, certify that:
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1.
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I have reviewed this quarterly report on Form 10-Q of Cytori Therapeutics, Inc.;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements and other financial information included in this report fairly present in all material respects the financial condition, results of operations, and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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(a)
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designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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(b)
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designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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(c)
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evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report- based on such evaluation; and
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(d)
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disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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5.
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The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
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(a)
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all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize, and report financial information; and
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(b)
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any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Date: August 9, 2011
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/s/ Christopher J. Calhoun
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Christopher J. Calhoun,
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Chief Executive Officer
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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
I, Mark E. Saad, certify that:
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1.
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I have reviewed this quarterly report on Form 10-Q of Cytori Therapeutics, Inc.;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements and other financial information included in this report fairly present in all material respects the financial condition, results of operations, and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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(a)
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designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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(b)
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designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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(c)
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evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report- based on such evaluation; and
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(d)
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disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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5.
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The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
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(a)
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all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize, and report financial information; and
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(b)
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any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Date: August 9, 2011
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/s/ Mark E. Saad
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Mark E. Saad
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Chief Financial Officer
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EXHIBIT 32.1
CERTIFICATION 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
In connection with the Quarterly Report on Form 10-Q of Cytori Therapeutics, Inc. for the quarterly period ended June 30, 2011 as filed with the Securities and Exchange Commission on the date hereof, Christopher J. Calhoun, as Chief Executive Officer of Cytori Therapeutics, Inc., and Mark E. Saad, as Chief Financial Officer of Cytori Therapeutics, Inc., each hereby certifies, respectively, that:
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1.
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The Form 10-Q report of Cytori Therapeutics, Inc. that this certification accompanies fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934.
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By:
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/s/ Christopher J. Calhoun
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Dated: August 9, 2011
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Christopher J. Calhoun
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Chief Executive Officer
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By:
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/s/ Mark E. Saad
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Dated: August 9, 2011
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Mark E. Saad
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Chief Financial Officer
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