Delaware
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001-34375
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33-0827593
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(State or Other Jurisdiction of Incorporation)
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(Commission File
Number)
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(I.R.S. Employer Identification Number)
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□
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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□
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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□
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Exhibit No.
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Description
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99.1
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Cytori Therapeutics, Inc. Press Release, dated March 7, 2013 *
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*
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Exhibit 99.1 hereto is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as expressly set forth in such filing.
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CYTORI THERAPEUTICS, INC.
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Date: March 7, 2013
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By: /s/ Mark E. Saad
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Mark E. Saad
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Chief Financial Officer
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·
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Initiated enrollment in the ATHENA U.S. refractory heart failure trial; all six centers are actively screening patients, enrollment is on track to be complete mid-summer
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·
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Awarded contract with BARDA, a division of the U.S. Health and Human Services, worth up to $106 million to develop a novel cell-based treatment of thermal burns combined with radiation injury
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·
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Obtained Class I device clearance in Japan, opening the Japanese market and increasing fourth quarter revenues
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·
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Opened EU vascular market with CE Mark claims for intravascular delivery (Intravase®)
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·
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Expanded CE Mark claims for multiple indications including cryptoglandular fistulae and tissue ischemia
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·
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Amended and resumed enrollment in the ADVANCE European heart attack trial
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·
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Achieved $9.1 million in product and contract revenue, including a record $4.3 million in the fourth quarter
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·
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Grew Celution® and StemSource® System shipments by 46% year-over-year
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·
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Increased patent portfolio year-over-year by 36% with the issuance of 15 patents worldwide, bringing the total number of global patents to 57 with 75 additional applications under review
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·
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Recruited Steven Kesten, M.D., as Executive Vice President and Chief Medical Officer
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·
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Raised $21.4 million in net proceeds from public offering of shares, including $2.8 million in net proceeds in January 2013 from the exercise of the full over-allotment option
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·
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Total product and contract revenues grew 14% year-over-year, with $4.4 million coming from Japan
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·
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System shipments grew 46% year-over-year, due mostly to the Class I device clearance in Japan in September 2012
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·
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Puregraft® sales grew 46% in 2012 during which time more than 5,000 units were shipped
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·
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Demonstrated leverage of commercial infrastructure as fourth quarter gross profit of $2.6 million exceeded sales and marketing expenses of $2.1 million
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Complete enrollment in the ATHENA trial in mid-summer; six month data in the first half of 2014
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Achieve proof-of-concept under the first option of the BARDA contract, which will qualify Cytori for up to $56 million in additional development funding
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Publish the 18 month outcomes from the PRECISE European refractory heart failure trial
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Continue to strengthen the Company’s patent position
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Increase product and contract revenue by at least 65% (at least $15 million) in 2013
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As of December 31,
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||||||||
2012
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2011
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|||||||
Assets
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||||||||
Current assets:
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||||||||
Cash and cash equivalents
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$ | 25,717,000 | $ | 36,922,000 | ||||
Accounts receivable, net of reserves of $278,000 and of $474,000 in 2012 and 2011, respectively
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3,926,000 | 2,260,000 | ||||||
Inventories, net
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3,175,000 | 3,318,000 | ||||||
Other current assets
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1,161,000 | 837,000 | ||||||
Total current assets
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33,979,000 | 43,337,000 | ||||||
Property and equipment, net
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2,174,000 | 1,711,000 | ||||||
Restricted cash and cash equivalents
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350,000 | 350,000 | ||||||
Investment in joint venture
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85,000 | 250,000 | ||||||
Other assets
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2,740,000 | 1,772,000 | ||||||
Intangibles, net
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— | 192,000 | ||||||
Goodwill
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3,922,000 | 3,922,000 | ||||||
Total assets
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$ | 43,250,000 | $ | 51,534,000 | ||||
Liabilities and Stockholders’ Equity (Deficit)
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||||||||
Current liabilities:
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||||||||
Accounts payable and accrued expenses
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$ | 7,411,000 | $ | 5,334,000 | ||||
Current portion of long-term obligations
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9,784,000 | 2,487,000 | ||||||
Warrant liability, current
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418,000 | — | ||||||
Total current liabilities
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17,613,000 | 7,821,000 | ||||||
Deferred revenues, related party
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638,000 | 3,520,000 | ||||||
Deferred revenues
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2,635,000 | 5,244,000 | ||||||
Warrant liability, long-term
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— | 627,000 | ||||||
Option liability
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2,250,000 | 1,910,000 | ||||||
Long-term deferred rent
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756,000 | 504,000 | ||||||
Long-term obligations, net of discount, less current portion
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12,903,000 | 21,962,000 | ||||||
Total liabilities
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36,795,000 | 41,588,000 | ||||||
Commitments and contingencies
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||||||||
Stockholders’ equity (deficit):
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||||||||
Preferred stock, $0.001 par value; 5,000,000 shares authorized; -0- shares issued and outstanding in 2012 and 2011
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— | — | ||||||
Common stock, $0.001 par value; 95,000,000 shares authorized; 65,914,050 and 56,594,683 shares issued and outstanding in 2012 and 2011, respectively
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66,000 | 57,000 | ||||||
Additional paid-in capital
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281,117,000 | 252,338,000 | ||||||
Accumulated deficit
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(274,728,000 | ) | (242,449,000 | ) | ||||
Total stockholders’ equity
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6,455,000 | 9,946,000 | ||||||
Total liabilities and stockholders’ equity
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$ | 43,250,000 | $ | 51,534,000 |
For the Three Months
Ended December 31,
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For the Twelve Months
Ended December 31,
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|||||||||||||||
2012
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2011
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2012
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2011
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Product revenues
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$ | 3,967,000 | $ | 2,076,000 | $ | 8,709,000 | $ | 7,983,000 | ||||||||
Cost of product revenues
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1,412,000 | 944,000 | 4,000,000 | 3,837,000 | ||||||||||||
Gross profit
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2,555,000 | 1,132,000 | 4,709,000 | 4,146,000 | ||||||||||||
Development revenues:
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Development, related party
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469,000 | 761,000 | 2,882,000 | 1,992,000 | ||||||||||||
Development
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2,529,000 | — | 2,529,000 | — | ||||||||||||
Government contract and other
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360,000 | 1,000 | 381,000 | 21,000 | ||||||||||||
3,358,000 | 762,000 | 5,792,000 | 2,013,000 | |||||||||||||
Operating expenses:
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Research and development
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4,013,000 | 1,956,000 | 13,628,000 | 10,904,000 | ||||||||||||
Sales and marketing
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2,081,000 | 3,000,000 | 9,488,000 | 13,560,000 | ||||||||||||
General and administrative
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4,183,000 | 3,498,000 | 15,672,000 | 14,727,000 | ||||||||||||
Change in fair value of warrant liability
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(1,453,000 | ) | (646,000 | ) | (209,000 | ) | (4,360,000 | ) | ||||||||
Change in fair value of option liability
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(150,000 | ) | 60,000 | 340,000 | 740,000 | |||||||||||
Total operating expenses
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8,674,000 | 7,868,000 | 38,919,000 | 35,571,000 | ||||||||||||
Operating loss
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(2,761,000 | ) | (5,974,000 | ) | (28,418,000 | ) | (29,412,000 | ) | ||||||||
Other income (expense):
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||||||||||||||||
Interest income
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1,000 | 3,000 | 4,000 | 9,000 | ||||||||||||
Interest expense
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(804,000 | ) | (861,000 | ) | (3,386,000 | ) | (2,784,000 | ) | ||||||||
Other income (expense), net
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(223,000 | ) | (18,000 | ) | (314,000 | ) | (55,000 | ) | ||||||||
Equity loss from investment in joint venture
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(36,000 | ) | (56,000 | ) | (165,000 | ) | (209,000 | ) | ||||||||
Total other income (expense)
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(1,062,000 | ) | (932,000 | ) | (3,861,000 | ) | (3,039,000 | ) | ||||||||
Net loss
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$ | (3,823,000 | ) | $ | (6,906,000 | ) | $ | (32,279,000 | ) | $ | (32,451,000 | ) | ||||
Basic and diluted net loss per common share
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$ | (0.06 | ) | $ | (0.12 | ) | $ | (0.55 | ) | $ | (0.61 | ) | ||||
Basic and diluted weighted average common shares
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59,581,607 | 55,664,792 | 58,679,687 | 53,504,030 | ||||||||||||
For the Years Ended December 31,
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||||||||
2012
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2011
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|||||||
Cash flows from operating activities:
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||||||||
Net loss
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$ | (32,279,000 | ) | $ | (32,451,000 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities:
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||||||||
Depreciation and amortization
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933,000 | 855,000 | ||||||
Amortization of deferred financing costs and debt discount
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930,000 | 711,000 | ||||||
Increase in allowance for doubtful accounts
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144,000 | 483,000 | ||||||
Change in fair value of warrants
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(209,000 | ) | (4,360,000 | ) | ||||
Change in fair value of option liability
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340,000 | 740,000 | ||||||
Stock-based compensation
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3,904,000 | 3,316,000 | ||||||
Equity loss from investment in joint venture
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165,000 | 209,000 | ||||||
Increases (decreases) in cash caused by changes in operating assets and liabilities:
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||||||||
Accounts receivable
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(1,810,000 | ) | (670,000 | ) | ||||
Inventories
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143,000 | 60,000 | ||||||
Other current assets
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(324,000 | ) | (3,000 | ) | ||||
Other assets
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(74,000 | ) | (1,206,000 | ) | ||||
Accounts payable and accrued expenses
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1,183,000 | (1,436,000 | ) | |||||
Deferred revenues, related party
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(2,882,000 | ) | (1,992,000 | ) | ||||
Deferred revenues
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(2,609,000 | ) | 315,000 | |||||
Long-term deferred rent
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252,000 | 106,000 | ||||||
Net cash used in operating activities
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(32,193,000 | ) | (35,323,000 | ) | ||||
Cash flows from investing activities:
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||||||||
Purchases of property and equipment
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(1,204,000 | ) | (560,000 | ) | ||||
Net cash used in investing activities
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(1,204,000 | ) | (560,000 | ) | ||||
Cash flows from financing activities:
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||||||||
Principal payments on long-term obligations
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(2,692,000 | ) | (4,529,000 | ) | ||||
Proceeds from long-term obligations
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— | 9,444,000 | ||||||
Debt issuance costs and loan fees
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— | (719,000 | ) | |||||
Proceeds from exercise of employee stock options and warrants and stock purchase plan
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1,413,000 | 2,849,000 | ||||||
Proceeds from sale of common stock
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24,953,000 | 13,286,000 | ||||||
Costs from sale of common stock
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(1,482,000 | ) | (194,000 | ) | ||||
Net cash provided by financing activities
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22,192,000 | 20,137,000 | ||||||
Net (decrease) increase in cash and cash equivalents
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(11,205,000 | ) | (15,746,000 | ) | ||||
Cash and cash equivalents at beginning of year
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36,922,000 | 52,668,000 | ||||||
Cash and cash equivalents at end of year
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$ | 25,717,000 | $ | 36,922,000 |