EX-99.1 2 exhibit991_pressrelease.htm EXHIBIT 99.1 CYTORI PRESS RELEASE 11-4-2010 exhibit991_pressrelease.htm
EXHIBIT 99.1
LOGO

November 4, 2010

Cytori Reports Third Quarter & Nine Month 2010 Results

Cytori Therapeutics (NASDAQ:CYTX) reports third quarter and nine month 2010 financial results. Further details, including progress of the Company’s commercial activities and product development pipeline, are provided in the ‘November 2010 Shareholder Letter', which may be accessed at http://ir.cytoritx.com.
 
Recently, Cytori has executed the following milestones:
 
·  
Grew system installed-base in Europe, Asia and U.S., bringing cumulative revenue-generating units worldwide to 135;
 
·  
Shipped 221 consumables, including 162 consumable re-orders during the third quarter;
 
·  
Expanded European Celution® regulatory approval to include breast reconstruction and other medical indications such as treatment of Crohn’s fistulas;
 
·  
Received approval for and launched PureGraft™ into the U.S. and European plastic and reconstructive surgery markets;
 
·  
Finalized protocol and identified initial sites for ADVANCE, the Company’s pivotal European heart attack study, with enrollment anticipated to begin in the first quarter of 2011;
 
·  
Prepared Celution® pre-IDE applications, which will be submitted to FDA to initiate a U.S. soft tissue defect repair study; and
 
·  
Capitalized the Company through 2012 from a public offering, raising $19.3 million in net proceeds.
 
Financial Results
 
Product revenues were $1.5 million for the quarter and $5.9 million for the first nine months in 2010, compared to $1.4 million and $4.6 million for the same time periods, respectively, in 2009. Gross profit was $0.6 million for the third quarter and $3.1 million for the first nine months of 2010, compared to $0.6 million and $1.9 million for the same periods respectively in 2009.
 
Revenue growth for the first nine months of 2010 compared to the same period in 2009 is due in part to increased demand for the Celution® System for private pay cosmetic surgery procedures and the sale of a StemSource® Cell Bank in each of the first two quarters of 2010, compared to one StemSource® Bank sale in the period in 2009. There was no StemSource® Cell Bank sale in the third quarter of 2010. Decline in third quarter 2010 consumable orders reflects seasonality of cosmetic procedures in July and August.
 
Total operating expenses were $10.3 million and $22.1 million for the third quarter and first nine months of 2010, respectively, compared to $7.0 million and $21.7 million for the same periods in 2009. The increase in operating expenses in the third quarter of 2010 is due in part to a $1.8 million non-cash change in the fair value of the warrant liability.  Total operating expenses reflect an increase in sales and marketing and general administration activities that was partially offset by a decrease in research and development costs.
 
Cash and cash equivalents as of September 30, 2010 were $30.7 million. An additional $19.3 million in net proceeds were raised subsequent to the end of the quarter through a public offering of common stock.
 
Outlook
 
Cytori continues to expand the number of Celution® and StemSource® products in the field while simultaneously investing in growing system adoption, consumable usage, and broadening the market. With the recent expanded CE Mark, European sales activities will be focused increasingly on hospitals, where the new medical indications that the Celution® System received will facilitate penetration. The claims expansion coupled with the upcoming release of complete results from RESTORE 2 are expected to support our breast reconstruction reimbursement efforts in Europe. The recently approved PureGraft™ product will be marketed as a broad based fat grafting product to the private pay plastic surgery market. PureGraft™ users then provide an enhanced base of potential customers of the premium Celution® System.  The Asia Pacific sales activities will continue to focus on a mix of research and cosmetic surgery sales, while looking to grow into at least one new geographic region by early next year. The U.S. sales activities will continue to focus on penetrating the U.S. private pay autologous fat grafting market with PureGraft™ while continuing to generate StemSource® System sales for research and banking.
 
Conference Call & Shareholder Letter
 
Cytori will host a conference call and question and answer session at 5:00 PM Eastern Time today to further discuss these results. The audio webcast of the conference call may be accessed under "Webcasts" in the Investor Relations section of Cytori's website (www.cytori.com). The webcast will be available live and by replay two hours after the call and archived for 90 days.
 
Cautionary Statement Regarding Forward-Looking Statements

This press release and shareholder letter include 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, the expectation that expanded European regulatory approval for Celution® and release of complete results from RESTORE 2will facilitate reimbursement efforts, improve our ability to sell systems to hospitals and expand our market opportunity, our belief that we can fund operations through 2012, our expectation that the US and European launch of PureGraft™ may enhance our Celution® customer base 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, inherent risk and uncertainty in the protection of intellectual property rights, regulatory uncertainties regarding the collection and results of clinical data, uncertainties relating to the future success of our sales and marketing programs, dependence on third party performance, as well as other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Commission Filings on Forms 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.

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LOGO

CYTORI THERAPEUTICS, INC.
CONSOLIDATED CONDENSED BALANCE SHEETS
(UNAUDITED)
 
   
As of
September 30, 2010
   
As of
December 31, 2009
 
Assets
           
Current assets:
           
Cash and cash equivalents
  $ 30,729,000     $ 12,854,000  
Accounts receivable, net of allowance for doubtful accounts of $314,000 and $751,000 in 2010 and 2009, respectively
    1,664,000       1,631,000  
Inventories, net
    3,065,000       2,589,000  
Other current assets
    974,000       1,024,000  
                 
Total current assets
    36,432,000       18,098,000  
                 
Property and equipment, net
    1,172,000       1,314,000  
Restricted cash and cash equivalents
    350,000        
Investment in joint venture
    512,000       280,000  
Other assets
    520,000       500,000  
Intangibles, net
    469,000       635,000  
Goodwill
    3,922,000       3,922,000  
                 
Total assets
  $ 43,377,000     $ 24,749,000  
                 
Liabilities and Stockholders’ Equity (Deficit)
               
Current liabilities:
               
Accounts payable and accrued expenses
  $ 5,406,000     $ 5,478,000  
Current portion of long-term debt
    4,211,000       2,705,000  
                 
Total current liabilities
    9,617,000       8,183,000  
                 
Deferred revenues, related party
    5,512,000       7,634,000  
Deferred revenues
    2,417,000       2,388,000  
Warrant liability
    4,448,000       6,272,000  
Option liability
    1,320,000       1,140,000  
Long-term deferred rent
    302,000        
Long-term debt, less current portion
    15,243,000       2,790,000  
                 
Total liabilities
    38,859,000       28,407,000  
                 
Commitments and contingencies
               
Stockholders’ equity (deficit):
               
Preferred stock, $0.001 par value; 5,000,000 shares authorized; -0- shares issued and outstanding in 2010 and 2009
           
Common stock, $0.001 par value; 95,000,000 shares authorized; 45,909,194 and 40,039,259 shares issued and 45,909,194 and 40,039,259 shares outstanding in 2010 and 2009, respectively
    46,000       40,000  
Additional paid-in capital
    205,219,000       178,806,000  
Accumulated deficit
    (200,747,000 )     (182,504,000 )
                 
Total stockholders’ equity (deficit)
    4,518,000       (3,658,000 )
                 
Total liabilities and stockholders’ equity (deficit)
  $ 43,377,000     $ 24,749,000  


 
 

 

LOGO

 
CYTORI THERAPEUTICS, INC.
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)

   
For the Three Months
Ended September 30,
   
For the Nine Months
Ended September 30,
 
   
2010
   
2009
   
2010
   
2009
 
                         
Product revenues:
                       
    Related party
  $ 581,000     $ 9,000     $ 590,000     $ 582,000  
    Third party
    938,000       1,377,000       5,286,000       3,994,000  
      1,519,000       1,386,000       5,876,000       4,576,000  
                                 
Cost of product revenues
    920,000       782,000       2,733,000       2,645,000  
                                 
Gross profit
    599,000       604,000       3,143,000       1,931,000  
                                 
Development revenues:
                               
Development, related party
                2,122,000       7,250,000  
Research grant and other
    65,000       5,000       93,000       27,000  
      65,000       5,000       2,215,000       7,277,000  
Operating expenses:
                               
Research and development
    2,480,000       2,618,000       7,026,000       9,006,000  
Sales and marketing
    2,932,000       1,621,000       7,356,000       4,369,000  
General and administrative
    3,060,000       2,483,000       9,331,000       7,287,000  
Change in fair value of warrants
    1,803,000       446,000       (1,824,000 )     1,558,000  
Change in fair value of option liability
    (20,000 )     (140,000 )     180,000       (560,000 )
                                 
Total operating expenses
    10,255,000       7,028,000       22,069,000       21,660,000  
                                 
Operating loss
    (9,591,000 )     (6,419,000 )     (16,711,000 )     (12,452,000 )
                                 
Other income (expense):
                               
Interest income
    3,000       2,000       6,000       19,000  
Interest expense
    (759,000 )     (346,000 )     (1,288,000 )     (1,120,000 )
Other expense, net
    (27,000 )     (31,000 )     (152,000 )     (139,000 )
Equity loss from investment in joint venture
    (43,000 )     (8,000 )     (98,000 )     (35,000 )
                                 
Total other expense
    (826,000 )     (383,000 )     (1,532,000 )     (1,275,000 )
                                 
Net loss
  $ (10,417,000 )   $ (6,802,000 )   $ (18,243,000 )   $ (13,727,000 )
                                 
Basic and diluted net loss per common share
  $ (0.23 )   $ (0.18 )   $ (0.40 )   $ (0.39 )
                                 
Basic and diluted weighted average common shares
    45,905,580       37,176,165       45,185,774       34,893,303  
                                 



 
 

 
 
 
LOGO

CYTORI THERAPEUTICS, INC.
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
(UNAUDITED)

   
For the Nine Months Ended September 30,
 
   
2010
   
2009
 
Cash flows from operating activities:
           
Net loss
  $ (18,243,000 )   $ (13,727,000 )
Adjustments to reconcile net loss to net cash used in operating activities:
               
Depreciation and amortization
    772,000       1,279,000  
Amortization of deferred financing costs and debt discount
    449,000       559,000  
Warranty provision
          (23,000 )
Provision for doubtful accounts
    428,000       450,000  
Change in fair value of warrants
    (1,824,000 )     1,558,000  
Change in fair value of option liability
    180,000       (560,000 )
Share-based compensation expense
    2,294,000       1,991,000  
Equity loss from investment in joint venture
    98,000       35,000  
Increases (decreases) in cash caused by changes in operating assets and liabilities:
               
Accounts receivable
    (452,000 )     (997,000 )
Inventories
    (476,000 )     249,000  
Other current assets
    (104,000 )     (26,000 )
Other assets
    (64,000 )     49,000  
Accounts payable and accrued expenses
    (72,000 )     (1,066,000 )
Deferred revenues, related party
    (2,122,000 )     (7,250,000 )
Deferred revenues
    29,000       (33,000 )
Long-term deferred rent
    302,000       (168,000 )
                 
Net cash used in operating activities
    (18,805,000 )     (17,680,000 )
                 
Cash flows from investing activities:
               
Purchases of property and equipment
    (473,000 )     (100,000 )
Cash invested in restricted cash
    (350,000 )      
Investment in joint venture
    (330,000 )      
                 
Net cash used in investing activities
    (1,153,000 )     (100,000 )
                 
Cash flows from financing activities:
               
Principal payments on long-term debt
    (5,454,000 )     (1,419,000 )
Proceeds from long-term debt
    20,000,000        
Debt issuance costs and loan fees                                                                                                
    (559,000 )      
Proceeds from exercise of employee stock options and warrants
    7,050,000       71,000  
Proceeds from sale of common stock and warrants
    17,314,000       16,865,000  
Costs from sale of common stock and warrants
    (518,000 )     (1,141,000 )
Proceeds from sale of treasury stock
          3,933,000  
                 
Net cash provided by financing activities
    37,833,000       18,309,000  
                 
Net increase in cash and cash equivalents
    17,875,000       529,000  
                 
Cash and cash equivalents at beginning of period
    12,854,000       12,611,000  
                 
Cash and cash equivalents at end of period
  $ 30,729,000     $ 13,140,000