Attached files
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| 8-K - CYTORI THERAPEUTICS FORM 8-K - PLUS THERAPEUTICS, INC. | cytori8k_080812.htm |
| EX-99.2 - EXHIBIT 99.2 CYTORI PRESS RELEASE - PLUS THERAPEUTICS, INC. | exhibit992_pressrelease.htm |
August 8, 2012
Cytori Provides Business Update and Reports Second Quarter and First Half 2012 Results
SAN DIEGO--During the second quarter and first half of 2012, Cytori Therapeutics (NASDAQ: CYTX) made key advancements in its cardiac cell therapy pipeline, achieved important commercial and regulatory milestones, carefully managed its financial resources and remained on plan to achieve $9 million in revenue for the year. The Company has achieved or made measurable progress in the following milestones, year-to-date:
Clinical Pipeline
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Received approval from the FDA to begin the U.S. ATHENA IDE trial for chronic myocardial ischemia in refractory heart failure patients. Patient screening is active and the first patient is expected to be treated shortly;
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Published positive six month outcomes from the APOLLO heart attack trial in the Journal of the American College of Cardiology;
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Commercial Business
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Expanded Celution® CE Mark certification to include broader wound healing and ischemia related indications-for-use;
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Received regulatory approval for Celution® in Russia and Croatia and obtained multiple additional Puregraft® approvals worldwide;
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Applied for formal approval of the Celution® System for breast reconstruction from the Medical Technology Assessment Committee in the U.K;
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Published positive 12 month outcomes from the RESTORE 2 trial in the European Journal of Surgical Oncology;
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Advanced negotiations to expand our Celution® CE Mark into cardiovascular and ischemic indications;
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Operations & Financial Performance
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Reduced net cash used in operating activities in the first half of 2012 compared to the first half of 2011, with related reductions in sales, general and administrative expenses;
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Received a U.S. composition patent for soft tissue defects and a U.S. device patent for accelerating the healing of wounds;
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Made tangible progress in several of our active partnership opportunities;
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“Our cardiovascular disease pipeline progressed in the first half of 2012,” said Christopher J. Calhoun, chief executive officer for Cytori Therapeutics. “In the U.S., our refractory heart failure trial (ATHENA) is actively screening patients, our EU acute heart attack trial (ADVANCE) protocol has been revised and is back in front of key regulators, and progress has been made in leveraging our cardiovascular clinical data to expand our European market access. We are also broadening our global footprint of approvals and indications-for-use, which directly expands our access to new markets and presents commercial opportunities which can be addressed with existing resources. Lastly, we continued to improve operations by lowering our quarterly cash utilization rate, while maintaining our investment in clinical development and remaining on plan to achieve 2012 revenue guidance.”
Financial Results
Total revenues were $4.4 million and $5.9 million for the second quarter and first half of 2012, respectively, which includes $2.4 million in development revenue recognized in the second quarter of 2012. This compares to $2.4 million and $5.0 million for the same periods of 2011, respectively, which includes $1.2 million in development revenue recognized in the first quarter of 2011.
Product revenues were $1.9 million and $3.4 million for the second quarter and first half of 2012, compared with $2.4 million and $3.8 million for the same periods in 2011. Gross profit was $0.9 million and $1.5 million for the second quarter and first half of 2012, compared to $1.3 million and $1.8 million for the second quarter and first half of 2011, respectively. As previously reported, product sales will be weighted toward the second half of 2012, due in part to realizing the impact of new country approvals and expanded indications-for-use mentioned above.
Research and development expenses remained relatively stable at $3.2 million and $6.0 million for the second quarter and first half of 2012, compared to the same periods in 2011. In contrast, sales, general and administrative expenses were reduced to $6.4 million and $12.7 million in the second quarter and first half of 2012, a decrease of 19% and 13%, respectively, compared to the same periods in 2011. This improvement was achieved in part by targeted reductions in headcount and external consulting costs.
Net loss was $7.9 million, or ($0.13) per share, and $17.2 million, or ($0.30) per share, for the second quarter and first half of 2012, respectively. This compares to $5.1 million, or ($0.10) per share, and $17.2 million, or ($0.33) per share for the second quarter and first half of 2011, respectively. Net loss for the second quarter and first half of 2011 includes non-cash credit of $5.2 million and $2.1 million respectively related to the change in the fair value of warrant and option liabilities compared to non-cash expense of $0.7 million and $0.6 million for the same periods in 2012. At the end of the second quarter of 2012, Cytori had $25.8 million in cash and cash equivalents and $2.0 million in accounts receivable, net of reserves.
Management Conference Call Webcast and Shareholder Letter Information
Cytori will host a management conference call at 5:00 p.m. Eastern Time today to further discuss the company’s progress. The webcast will be available live and by replay two hours after the call and may be accessed under "Webcasts" in the Investor Relations section (http://ir.cytori.com) of Cytori's website. If you are unable to access the webcast, you may dial in to the call at +1.866.791.6247, Passcode: 4549443. More details on our business are contained in the ‘August 2012 Shareholder Letter' posted on the homepage of our Investor Relations website.
About Cytori
Cytori Therapeutics is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and repair soft tissue defects. Our scientific data suggest ADRCs improve blood flow, moderate the immune response and keep tissue at risk of dying alive. As a result, we believe these cells can be applied across multiple “ischemic” conditions. These therapies are made available to the physician and patient at the point-of-care by Cytori’s proprietary technologies and products, including the Celution® system product family. 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 as the successful initiation of the ATHENA clinical trial of the Company’s Celution® system for chronic myocardial ischemia, our efforts to expand our CE Mark, achieve our revenue projection for 2012, and execute a commercialization partnership agreement. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks include clinical and regulatory uncertainties, such as those associated with the ATHENA clinical trial, including risks in the collection and results of clinical data, final clinical outcomes, dependence on third party performance, performance and acceptance of our products in the marketplace, and other risks and uncertainties described under "Risk Factors" in Cytori's Securities and Exchange Commission Filings. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
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Contact:
Investors Media
Tom Baker Megan McCormick
tbaker@cytori.com mmccormick@cytori.com
+1.858.875.5258 +1.858.875.5279
CYTORI THERAPEUTICS, INC.
CONSOLIDATED CONDENSED BALANCE SHEETS
(UNAUDITED)
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As of June 30, 2012
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As of December 31, 2011
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Assets
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||||||||
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Current assets:
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||||||||
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Cash and cash equivalents
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$ | 25,771,000 | $ | 36,922,000 | ||||
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Accounts receivable, net of reserves of $220,000 and of $474,000 in 2012 and 2011, respectively
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1,983,000 | 2,260,000 | ||||||
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Inventories, net
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3,108,000 | 3,318,000 | ||||||
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Other current assets
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1,115,000 | 837,000 | ||||||
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Total current assets
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31,977,000 | 43,337,000 | ||||||
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Property and equipment, net
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2,255,000 | 1,711,000 | ||||||
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Restricted cash and cash equivalents
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350,000 | 350,000 | ||||||
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Investment in joint venture
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164,000 | 250,000 | ||||||
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Other assets
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1,755,000 | 1,772,000 | ||||||
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Intangibles, net
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81,000 | 192,000 | ||||||
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Goodwill
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3,922,000 | 3,922,000 | ||||||
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Total assets
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$ | 40,504,000 | $ | 51,534,000 | ||||
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Liabilities and Stockholders’ Equity (Deficit)
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Current liabilities:
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Accounts payable and accrued expenses
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$ | 5,066,000 | $ | 5,334,000 | ||||
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Current portion of long-term obligations
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7,338,000 | 2,487,000 | ||||||
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Total current liabilities
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12,404,000 | 7,821,000 | ||||||
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Deferred revenues, related party
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1,107,000 | 3,520,000 | ||||||
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Deferred revenues
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5,296,000 | 5,244,000 | ||||||
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Warrant liability
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1,008,000 | 627,000 | ||||||
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Option liability
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2,100,000 | 1,910,000 | ||||||
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Long-term deferred rent
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600,000 | 504,000 | ||||||
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Long-term obligations, net of discount, less current portion
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17,441,000 | 21,962,000 | ||||||
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Total liabilities
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39,956,000 | 41,588,000 | ||||||
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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 2012 and 2011
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— | — | ||||||
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Common stock, $0.001 par value; 95,000,000 shares authorized; 58,706,856 and 56,594,683 shares issued and outstanding in 2012 and 2011, respectively
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59,000 | 57,000 | ||||||
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Additional paid-in capital
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260,146,000 | 252,338,000 | ||||||
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Accumulated deficit
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(259,657,000 | ) | (242,449,000 | ) | ||||
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Total stockholders’ equity
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548,000 | 9,946,000 | ||||||
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Total liabilities and stockholders’ equity
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$ | 40,504,000 | $ | 51,534,000 | ||||
CYTORI THERAPEUTICS, INC.
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(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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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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$ | 1,947,000 | $ | 2,411,000 | $ | 3,427,000 | $ | 3,773,000 | ||||||||
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Cost of product revenues
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1,032,000 | 1,109,000 | 1,885,000 | 1,950,000 | ||||||||||||
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Gross profit
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915,000 | 1,302,000 | 1,542,000 | 1,823,000 | ||||||||||||
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Development revenues:
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Development, related party
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2,413,000 | — | 2,413,000 | 1,231,000 | ||||||||||||
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Research grant and other
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16,000 | 11,000 | 19,000 | 15,000 | ||||||||||||
| 2,429,000 | 11,000 | 2,432,000 | 1,246,000 | |||||||||||||
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Operating expenses:
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Research and development
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3,224,000 | 3,071,000 | 6,060,000 | 6,118,000 | ||||||||||||
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Sales and marketing
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2,581,000 | 3,716,000 | 4,956,000 | 6,942,000 | ||||||||||||
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General and administrative
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3,788,000 | 4,147,000 | 7,712,000 | 7,692,000 | ||||||||||||
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Change in fair value of warrant liability
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251,000 | (5,649,000 | ) | 381,000 | (2,178,000 | ) | ||||||||||
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Change in fair value of option liability
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460,000 | 400,000 | 190,000 | 110,000 | ||||||||||||
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Total operating expenses
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10,304,000 | 5,685,000 | 19,299,000 | 18,684,000 | ||||||||||||
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Operating loss
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(6,960,000 | ) | (4,372,000 | ) | (15,325,000 | ) | (15,615,000 | ) | ||||||||
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Other income (expense):
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Interest income
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1,000 | 1,000 | 2,000 | 4,000 | ||||||||||||
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Interest expense
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(860,000 | ) | (696,000 | ) | (1,726,000 | ) | (1,434,000 | ) | ||||||||
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Other income (expense), net
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(27,000 | ) | (15,000 | ) | (73,000 | ) | (62,000 | ) | ||||||||
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Equity loss from investment in joint venture
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(37,000 | ) | (56,000 | ) | (86,000 | ) | (102,000 | ) | ||||||||
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Total other income (expense)
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(923,000 | ) | (766,000 | ) | (1,883,000 | ) | (1,594,000 | ) | ||||||||
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Net loss
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$ | (7,883,000 | ) | $ | (5,138,000 | ) | $ | (17,208,000 | ) | $ | (17,209,000 | ) | ||||
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Basic and diluted net loss per common share
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$ | (0.13 | ) | $ | (0.10 | ) | $ | (0.30 | ) | $ | (0.33 | ) | ||||
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Basic and diluted weighted average common shares
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58,676,092 | 52,411,642 | 58,080,541 | 52,204,348 | ||||||||||||
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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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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$ | (17,208,000 | ) | $ | (17,209,000 | ) | ||
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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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453,000 | 400,000 | ||||||
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Amortization of deferred financing costs and debt discount
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470,000 | 471,000 | ||||||
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Provision for doubtful accounts
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19,000 | 235,000 | ||||||
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Change in fair value of warrants
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381,000 | (2,178,000 | ) | |||||
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Change in fair value of option liabilities
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190,000 | 110,000 | ||||||
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Share-based compensation expense
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1,977,000 | 1,721,000 | ||||||
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Equity loss from investment in joint venture
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86,000 | 102,000 | ||||||
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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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258,000 | (623,000 | ) | |||||
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Inventories
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210,000 | (513,000 | ) | |||||
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Other current assets
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(278,000 | ) | (15,000 | ) | ||||
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Other assets
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17,000 | (905,000 | ) | |||||
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Accounts payable and accrued expenses
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(268,000 | ) | 92,000 | |||||
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Deferred revenues, related party
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(2,413,000 | ) | (1,231,000 | ) | ||||
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Deferred revenues
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52,000 | 35,000 | ||||||
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Long-term deferred rent
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96,000 | (24,000 | ) | |||||
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Net cash used in operating activities
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(15,958,000 | ) | (19,532,000 | ) | ||||
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Cash flows from investing activities:
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Purchases of property and equipment
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(886,000 | ) | (433,000 | ) | ||||
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Net cash used in investing activities
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(886,000 | ) | (433,000 | ) | ||||
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Cash flows from financing activities:
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Principal payments on long-term obligations
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(140,000 | ) | (2,230,000 | ) | ||||
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Proceeds from exercise of employee stock options
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951,000 | 2,756,000 | ||||||
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Proceeds from sale of common stock
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4,946,000 | — | ||||||
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Costs from sale of common stock
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(64,000 | ) | — | |||||
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Net cash provided by financing activities
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5,693,000 | 526,000 | ||||||
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Net decrease in cash and cash equivalents
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(11,151,000 | ) | (19,439,000 | ) | ||||
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Cash and cash equivalents at beginning of period
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36,922,000 | 52,668,000 | ||||||
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Cash and cash equivalents at end of period
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$ | 25,771,000 | $ | 33,229,000 | ||||