SAN DIEGO, CA--(Marketwire - Aug 9, 2011) - Cytori Therapeutics, Inc. (
"Our focus is on advancing our cardiovascular disease product pipeline and growing our hospital-based soft tissue business," said Christopher J. Calhoun, chief executive officer of Cytori. "Simultaneously we are pursuing nearer-term sales opportunities based on our existing product approvals, implementing a plan to achieve regional profitability, and reducing overall corporate burn."
The accomplishments since the end of the first quarter include:
Cardiovascular Product Development:
- Reported that Celution® demonstrated a sustained benefit in the APOLLO acute myocardial infarction trial at 18-months
- Applied for European marketing approval for no-option chronic myocardial ischemia indication-for-use based on the sustained benefit observed in the PRECISE trial
- Recently completed a pre-IDE meeting with the FDA, which we believe establishes a clear path toward initiating an IDE trial
Soft Tissue:
- Completed formal economic analysis in the U.K. and received a cost-effectiveness recommendation by the National Innovation Center, an important step in securing U.K. reimbursement
- Achieved key reimbursement objectives in France and Germany for expanding market access
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Focusing sales effort to emphasize hospital customers in the G5 and to strengthen senior management and board members
Mr. Calhoun added, "We remain on track for a decision on the chronic myocardial ischemia CE Mark application and expect more reportable developments related to European reimbursement."
Financials:
Product revenues for the second quarter of 2011 were a record $2.4 million, compared to $2.1 million in the second quarter of 2010, and $1.4 million in the first quarter of 2011. Gross profit was $1.3 million with a gross margin of 54% in the second quarter of 2011, compared to a gross profit of $1.2 million, with a gross margin of 58% for the same period in 2010.
Second quarter 2011 revenues include recognition of one StemSource® Cell Bank in Japan. In addition, Cytori is on track to complete installation of a Cell Bank in Hong Kong in the third quarter. Cytori expects revenues to continue to recover following a more challenging first quarter.
System and consumable shipments remained relatively flat while PureGraft™ shipments increased by 55% in the second quarter of 2011 compared to the first quarter of 2011. Cytori ended the second quarter of 2011 with 169 cumulative revenue generating units in the field. Also during the second quarter of 2011, the Company shipped 229 consumables, including 169 reorders and 1,309 PureGraft™ units. System and consumable order growth is impacted by limited regulatory indications, absence of reimbursement in regions where products are approved, and the above noted shift of resources toward hospital sales in Europe.
Net cash used in operating activities decreased to $9.0 million in the second quarter of 2011 from $10.5 million in the first quarter of 2011. Second quarter 2011 operating expenses of $5.7 million included a $5.2 million offset for non-cash items of change of the fair value of the warrant and option liabilities. Before any non-cash items, second quarter 2011 operating expenses were $10.9 million. This compares to total operating expenses before any non-cash items of $9.8 million in the first quarter of 2011.
Second quarter operating expenses supported the launch of the European pivotal acute heart attack trial (ADVANCE), commercial activities related to regenerative medicine applications such as reimbursement, and preparations for a U.S. clinical trial. Ongoing global and regional organizational improvements are expected to result in lower operating expenses and cash utilization in the second half of 2011.
Cytori ended the second quarter of 2011 with $33.2 million in cash and cash equivalents, plus $2.5 million in accounts receivable. Subsequent to the end of the quarter, Cytori raised $6.0 million in gross proceeds as part of a financing agreement.
Conference Call Information and Shareholder Letter
Cytori will host a management conference call at 5:00 p.m. Eastern Time today to further discuss these results. The live audio webcast of the conference call may be accessed under "Webcasts" in the Investor Relations section of Cytori's website (http://ir.cytoritx.com). The webcast will be available live and by replay two hours after the call and archived for one year. More details on our commercial and clinical progress are contained in the 'August 2011 Shareholder Letter' which is posted on the homepage of our investor relations website.
About Cytori
Cytori is a leader in cell therapy, providing patients and physicians around the world with medical technologies that harness the potential of adult regenerative cells from adipose tissue. The Celution® System family of medical devices and instruments is being sold into the European and Asian cosmetic and reconstructive surgery markets but is not yet available in the United States. Our StemSource® product line is sold globally for cell banking and research applications. Our PureGraft™ products are available in North America and Europe for fat grafting procedures. www.cytori.com
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, but not limited to, those regarding our belief in our ability to continue to accelerate sales and revenue growth, continue progress in development of our cardiovascular disease pipeline, continue progress in achieving expanded indications-for-use in Europe of Celution® System in chronic myocardial ischemia, achieve product reimbursement for breast reconstruction in Europe, address multiple therapeutic areas with our device, commence a U.S. chronic myocardial ischemia clinical study, launch the Celution® One system in Europe, and strengthen our global sales and marketing team, are all subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include, but are not limited to, risks related to our history of operating losses, the need for further financing and our ability to access the necessary additional capital for our business, the quality and effectiveness of our products, the effectiveness of our regulatory and sales and marketing programs, the quality and acceptance of our clinical data, dependence on third party performance and the risk of natural disasters and other occurrences that may disrupt the normal business cycles in areas of our global operations, as well as other risks and uncertainties described under the "Risk Factors" section in Cytori's Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
| CONSOLIDATED CONDENSED BALANCE SHEETS | |||||||||
| (UNAUDITED) | |||||||||
| As of June 30, 2011 | As of December 31, 2010 | ||||||||
| Assets | |||||||||
| Current assets: | |||||||||
| Cash and cash equivalents | $ | 33,229,000 | $ | 52,668,000 | |||||
| Accounts receivable, net of reserves of $349,000 and $306,000 in 2011 and 2010, respectively | 2,461,000 | 2,073,000 | |||||||
| Inventories, net | 3,891,000 | 3,378,000 | |||||||
| Other current assets | 849,000 | 834,000 | |||||||
| Total current assets | 40,430,000 | 58,953,000 | |||||||
| Property and equipment, net | 1,923,000 | 1,684,000 | |||||||
| Restricted cash and cash equivalents | 350,000 | 350,000 | |||||||
| Investment in joint venture | 357,000 | 459,000 | |||||||
| Other assets | 1,471,000 | 566,000 | |||||||
| Intangibles, net | 303,000 | 413,000 | |||||||
| Goodwill | 3,922,000 | 3,922,000 | |||||||
| Total assets | $ | 48,756,000 | $ | 66,347,000 | |||||
| Liabilities and Stockholders' Equity | |||||||||
| Current liabilities: | |||||||||
| Accounts payable and accrued expenses | $ | 6,857,000 | $ | 6,770,000 | |||||
| Current portion of long-term obligations | 8,755,000 | 6,453,000 | |||||||
| Total current liabilities | 15,612,000 | 13,223,000 | |||||||
| Deferred revenues, related party | 4,281,000 | 5,512,000 | |||||||
| Deferred revenues | 4,964,000 | 4,929,000 | |||||||
| Warrant liability | 2,809,000 | 4,987,000 | |||||||
| Option liability | 1,280,000 | 1,170,000 | |||||||
| Long-term deferred rent | 374,000 | 398,000 | |||||||
| Long-term obligations, net of discount, less current portion | 9,295,000 | 13,255,000 | |||||||
| Total liabilities | 38,615,000 | 43,474,000 | |||||||
| Commitments and contingencies | |||||||||
| Stockholders' equity: | |||||||||
| Preferred stock, $0.001 par value; 5,000,000 shares authorized; -0- shares issued and outstanding in 2011 and 2010 | -- | -- | |||||||
| 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 | 52,000 | 52,000 | |||||||
| Additional paid-in capital | 237,296,000 | 232,819,000 | |||||||
| Accumulated deficit | (227,207,000 | ) | (209,998,000 | ) | |||||
| Total stockholders' equity | 10,141,000 | 22,873,000 | |||||||
| Total liabilities and stockholders' equity | $ | 48,756,000 | $ | 66,347,000 | |||||
| CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||||||||||||||||
| (UNAUDITED) | |||||||||||||||||
| For the Three Months Ended June 30, |
For the Six Months Ended June 30, |
||||||||||||||||
| 2011 | 2010 | 2011 | 2010 | ||||||||||||||
| Product revenues: | |||||||||||||||||
| Related party | $ | -- | $ | -- | $ | -- | $ | 9,000 | |||||||||
| Third party | 2,411,000 | 2,091,000 | 3,773,000 | 4,347,000 | |||||||||||||
| 2,411,000 | 2,091,000 | 3,773,000 | 4,356,000 | ||||||||||||||
| Cost of product revenues | 1,109,000 | 883,000 | 1,950,000 | 1,813,000 | |||||||||||||
| Gross profit | 1,302,000 | 1,208,000 | 1,823,000 | 2,543,000 | |||||||||||||
| Development revenues: | |||||||||||||||||
| Development, related party | -- | -- | 1,231,000 | 2,122,000 | |||||||||||||
| Research grant and other | 11,000 | 7,000 | 15,000 | 28,000 | |||||||||||||
| 11,000 | 7,000 | 1,246,000 | 2,150,000 | ||||||||||||||
| Operating expenses: | |||||||||||||||||
| Research and development | 3,071,000 | 2,301,000 | 6,118,000 | 4,546,000 | |||||||||||||
| Sales and marketing | 3,716,000 | 2,425,000 | 6,942,000 | 4,424,000 | |||||||||||||
| General and administrative | 4,147,000 | 3,052,000 | 7,692,000 | 6,271,000 | |||||||||||||
| Change in fair value of warrant liability | (5,649,000 | ) | (1,461,000 | ) | (2,178,000 | ) | (3,628,000 | ) | |||||||||
| Change in fair value of option liability | 400,000 | (60,000 | ) | 110,000 | 200,000 | ||||||||||||
| Total operating expenses | 5,685,000 | 6,257,000 | 18,684,000 | 11,813,000 | |||||||||||||
| Operating loss | (4,372,000 | ) | (5,042,000 | ) | (15,615,000 | ) | (7,120,000 | ) | |||||||||
| Other income (expense): | |||||||||||||||||
| Interest income | 1,000 | 2,000 | 4,000 | 3,000 | |||||||||||||
| Interest expense | (696,000 | ) | (254,000 | ) | (1,434,000 | ) | (530,000 | ) | |||||||||
| Other expense, net | (15,000 | ) | (49,000 | ) | (62,000 | ) | (125,000 | ) | |||||||||
| Equity loss from investment in joint venture | (56,000 | ) | (34,000 | ) | (102,000 | ) | (55,000 | ) | |||||||||
| Total other income (expense) | (766,000 | ) | (335,000 | ) | (1,594,000 | ) | (707,000 | ) | |||||||||
| Net loss | $ | (5,138,000 | ) | $ | (5,377,000 | ) | $ | (17,209,000 | ) | $ | (7,827,000 | ) | |||||
| Basic and diluted net loss per common share | $ | (0.10 | ) | $ | (0.12 | ) | $ | (0.33 | ) | $ | (0.18 | ) | |||||
| Basic and diluted weighted average common shares | 52,411,642 | 45,295,965 | 52,204,348 | 43,772,219 | |||||||||||||
| CYTORI THERAPEUTICS, INC. | ||||||||||
| CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS | ||||||||||
| (UNAUDITED) | ||||||||||
| For the Six Months Ended June 30, | ||||||||||
| 2011 | 2010 | |||||||||
| Cash flows from operating activities: | ||||||||||
| Net loss | $ | (17,209,000 | ) | $ | (7,827,000 | ) | ||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||
| Depreciation and amortization | 400,000 | 553,000 | ||||||||
| Amortization of deferred financing costs and debt discount | 471,000 | 199,000 | ||||||||
| Provision for doubtful accounts | 235,000 | 567,000 | ||||||||
| Change in fair value of warrants | (2,178,000 | ) | (3,628,000 | ) | ||||||
| Change in fair value of option liabilities | 110,000 | 200,000 | ||||||||
| Share-based compensation expense | 1,721,000 | 1,468,000 | ||||||||
| Equity loss from investment in joint venture | 102,000 | 55,000 | ||||||||
| Increases (decreases) in cash caused by changes in operating assets and liabilities: | ||||||||||
| Accounts receivable | (623,000 | ) | (1,509,000 | ) | ||||||
| Inventories | (513,000 | ) | 34,000 | |||||||
| Other current assets | (15,000 | ) | 289,000 | |||||||
| Other assets | (905,000 | ) | -- | |||||||
| Accounts payable and accrued expenses | 92,000 | (227,000 | ) | |||||||
| Deferred revenues, related party | (1,231,000 | ) | (2,122,000 | ) | ||||||
| Deferred revenues | 35,000 | 47,000 | ||||||||
| Long-term deferred rent | (24,000 | ) | -- | |||||||
| Net cash used in operating activities | (19,532,000 | ) | (11,901,000 | ) | ||||||
| Cash flows from investing activities: | ||||||||||
| Purchases of property and equipment | (433,000 | ) | (348,000 | ) | ||||||
| Investment in joint venture | -- | (330,000 | ) | |||||||
| Net cash used in investing activities | (433,000 | ) | (678,000 | ) | ||||||
| Cash flows from financing activities: | ||||||||||
| Principal payments on long-term obligations | (2,230,000 | ) | (5,454,000 | ) | ||||||
| Proceeds from long term obligations | -- | 20,000,000 | ||||||||
| Debt issuance costs and loan fees | -- | (559,000 | ) | |||||||
| Proceeds from exercise of employee stock options and warrants | 2,756,000 | 7,042,000 | ||||||||
| Proceeds from sale of common stock and warrants | -- | 17,314,000 | ||||||||
| Costs from sale of common stock and warrants | -- | (518,000 | ) | |||||||
| Net cash provided by financing activities | 526,000 | 37,825,000 | ||||||||
| Net increase (decrease) in cash and cash equivalents | (19,439,000 | ) | 25,246,000 | |||||||
| Cash and cash equivalents at beginning of period | 52,668,000 | 12,854,000 | ||||||||
| Cash and cash equivalents at end of period | $ | 33,229,000 | $ | 38,100,000 | ||||||
Contact Information:
Contact:
Tom Baker
tbaker@cytori.com
+1.858.875.5258