-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, MXUBDis52saBQhKMLMbe+8oWTQKWXlxijHZoF+5FdIhUkk90A6YMIcoJHQUSEPOI sBWjfqcc/XXBZZ6+3nZLhw== 0001095981-08-000032.txt : 20080808 0001095981-08-000032.hdr.sgml : 20080808 20080808085004 ACCESSION NUMBER: 0001095981-08-000032 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080808 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080808 DATE AS OF CHANGE: 20080808 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CYTORI THERAPEUTICS, INC. CENTRAL INDEX KEY: 0001095981 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 330827593 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-32501 FILM NUMBER: 081000489 BUSINESS ADDRESS: STREET 1: 3020 CALLAN ROAD CITY: SAN DIEGO STATE: CA ZIP: 92121 BUSINESS PHONE: 8584580900 MAIL ADDRESS: STREET 1: 3020 CALLAN ROAD CITY: SAN DIEGO STATE: CA ZIP: 92121 FORMER COMPANY: FORMER CONFORMED NAME: MACROPORE INC DATE OF NAME CHANGE: 20010320 8-K 1 cytori_8k08082008q2earnings.htm CYTORI THERAPEUTICS FORM 8-K FILED 08-08-2008 Q2 EARNINGS cytori_8k08082008q2earnings.htm


SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

Form 8-K

Current Report 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  August 8, 2008


CYTORI THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
 

Delaware
000-32501
33-0827593
(State or Other Jurisdiction of Incorporation)
(Commission File
Number)
(I.R.S. Employer Identification Number)

3020 Callan Road, San Diego, California 92121
(Address of principal executive offices, with zip code)

(858) 458-0900
(Registrant's telephone number, including area code)

n/a
(Former name or former address, if changed since last report)


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
 
   o
    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
   o
    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
   o
    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
   o
    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))



 
 

Item 2.02                      Results of Operations and Financial Condition
 
On August 8, 2008, Cytori Therapeutics, Inc. issued a press release announcing its financial results for the second quarter ended June 30, 2008. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

The information disclosed under this Item 2.02 in this report, including 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.
 

Item 9.01                      Financial Statements and Exhibits

(d)           Exhibits
 
Exhibit No.                                     Description
99.1                                      Cytori Therapeutics, Inc. Press Release, dated August 8, 2008*

*    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.


 
2


SIGNATURES


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 hereunto duly authorized.


   CYTORI THERAPEUTICS, INC.
   
 Date:  August 8, 2008  By:  /s/ Mark E. Saad                 
      Mark E. Saad
      Chief Financial Officer



 
 
 

 
 
 
 
 
 
3

 
EX-99.1 2 exhibit991_pressrelease.htm EXHIBIT 99.1 CYTORI PRESS RELEASE 08-08-2008 Q2 EARNINGS exhibit991_pressrelease.htm
Exhibit 99.1

 
Cytori Reports Second Quarter Financial Results;
Strong Growth in Product Orders and Celution® Revenue

 
San Diego, CA, August 8, 2008 - -- Cytori Therapeutics (NASDAQ:CYTX) reports financial results for the quarter ended June 30, 2008.
 
During the second quarter, there was continued demand for Cytori’s Celution® System in Europe and Asia among plastic and reconstructive surgeons. System sales in the first half of 2008 accomplished the Company’s initial goal of installing devices at key surgical centers and with luminary surgeons. Cytori anticipates significant revenue growth for the remainder of 2008, resulting from StemSource® Cell Bank orders and Celution System and related consumable sales into the European and Asia Pacific cosmetic and reconstructive surgery market. We received our first two purchase commitments for StemSource® Cell Banks during the third quarter. Based on current visibility, Cytori reaffirms its $10 to $12 million revenue guidance for 2008.
 
Product revenue increased to $1.4 million in the second quarter of 2008 from $153,000 in the first quarter of 2008. Because this is the first year Cytori is recognizing Celution System-based product revenues, the second quarter of 2007 is not a comparable period. Cytori’s second quarter product revenue related entirely to Cytori’s cosmetic and reconstructive surgery (CRS) business, which includes the Celution System, related single procedure consumables, surgical instruments, and a proprietary enzyme solution. Cytori also received orders late in the second quarter for an additional $880,000 in CRS related products, which will be shipped and likely recognized in the third quarter. Subsequent to the end of the second quarter, Cytori entered purchase commitments for two StemSource Cell Banks for an aggregate purchase price in excess of $2.5 million. The Company expects these banks to be installed in the second half of 2008.
 
Total operating expenses for the quarter ended June 30, 2008 were $9.1 million compared to $8.2 million in the same period in 2007. The increase in operating expenses was due in part to increased sales and marketing to support commercialization activity offset by a decline in general and administrative expenses. Cytori ended the second quarter of 2008 with cash and cash equivalents and accounts receivable of $6.4 million.  The Company will receive an additional $17 million in gross proceeds from the sale of 2.83 million unregistered shares to Olympus Corporation and select institutional investors from agreements entered into on August 7 and 8, 2008.
 
 
Year-to-Date Highlights
 
Cytori achieved progress across multiple areas of its business during and subsequent to the end of the second quarter, which will support its near-term commercialization activities and product development pipeline.
 
CRS Business: Cytori initiated its Celution® System post-marketing study in Europe, RESTORE II, for breast reconstruction following partial mastectomy during the second quarter. The RESTORE II study will enroll up to 70 patients and is intended to support reimbursement and to provide additional clinical data. Patient enrollment has started, and several patients have already been enrolled at clinical trial centers. In addition, the Company was informed that enrollment in an independent investigator-initiated Celution System study in Japan for breast augmentation was completed. Early results from the first three patients show that an increase in breast volume was maintained at three months. Cytori was also invited by Nagasaki University to participate in a research consortium investigating cell-enhanced reconstruction in HIV therapy-induced facial wasting, a potentially new and promising application for the Celution System.
 
StemSource®: Cytori entered into its first two purchase commitments during the third quarter for StemSource Cell Banks. Our first sale was to a leading tissue and cell banking company in Europe, BioHellenika. Our second purchase commitment is in the form of a binding letter of intent with a medical group in Singapore. Cytori has also recently expanded its commercialization partnership with Green Hospital Supply, who will market the cell banking product in Korea, Taiwan and Thailand, in addition to Japan.

 
 

 

Intellectual property: Cytori was issued a key patent in June 2008, which Cytori believes provides market protection for commercialization of the Celution System in the United States. The newly issued patent specifically protects Cytori's device technology that processes adipose tissue to obtain a diverse and mixed population of cells. The Company’s intellectual property position was bolstered by its receipt of a Notice of Allowance in July 2008 from the U.S. Patent & Trademark Office for a patent application that covers methods of creating a cell-enhanced graft using a closed system to process adipose-derived stem and regenerative cells. This patent is expected to specifically protect Cytori's Celution System-based devices and methods essential in novel cosmetic and reconstructive surgery procedures.
 
Product Pipeline: Cytori continued to enroll patients in the Company’s chronic heart disease and heart attack clinical trials in Europe. To accelerate enrollment, the Company is working to open additional trial centers. In addition, Cytori formed a collaboration with the Fraunhofer Institute for Cell Therapy and Immunology to develop adipose-derived stem and regenerative cell-based treatments for ischemic stroke. The Fraunhofer Society is expected to commit $425,000 over two years in support of Cytori's already planned research and development. The goal of the collaboration is to advance adipose-derived stem and regenerative cells into clinical trials for ischemic stroke.
 
Management Discussion
 
Cytori's management will host a conference call at 10:00 a.m. Eastern Daylight Time today to discuss these results. The audio webcast of the conference call may be accessed under "Events & Webcasts" in the Investor Relations section of the Company's website at www.cytoritx.com. The webcast will be available live and by replay two hours after the call on the company's website and archived for 90 days. A telephone replay will be available for one week. To access the replay, please call +1 (303) 590-3000 (PIN: 11116771#).
 
About Cytori

Cytori’s (NASDAQ: CYTX) goal is to be the global leader in regenerative medicine. The company is dedicated to providing patients with new options for reconstructive surgery, developing treatments for cardiovascular disease, and banking patients' adult stem and regenerative cells. The Celution® 800 System is being introduced in Europe and Asia Pacific into the reconstructive surgery market while the Celution® 900 System is being commercialized globally for cryopreserving a patient's own stem and regenerative cells. Clinical trials are ongoing in cardiovascular disease and planned for spinal disc degeneration, gastrointestinal disorders, and other unmet medical needs. www.cytoritx.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 are 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, statements regarding (a) securing sufficient operating capital, (b) the need for further financing, (c) our history of operating losses, (d) our anticipated revenue growth from StemSource Cell Bank orders, (e) our revenue guidance for 2008, (f) protection of our intellectual property rights, (g) our collaboration with the Fraunhofer Society and the related clinical trials, and other risks and uncertainties described under the "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.
 
###
 

 

 

Consolidated Condensed Balance Sheets
(Unaudited)

 
   
As of
June 30, 2008
   
As of
December 31, 2007
 
             
Assets
           
Current assets:
           
Cash and cash equivalents
  $ 5,328,000     $ 11,465,000  
Accounts receivable, net of allowance for doubtful accounts of $62,000 and $1,000 in 2008 and 2007, respectively
    1,073,000       9,000  
Inventories, net
    932,000        
Other current assets
    741,000       764,000  
                 
Total current assets
    8,074,000       12,238,000  
                 
Property and equipment, net
    3,062,000       3,432,000  
Investment in joint venture
    352,000       369,000  
Other assets
    553,000       468,000  
Intangibles, net
    967,000       1,078,000  
Goodwill
    3,922,000       3,922,000  
                 
Total assets
  $ 16,930,000     $ 21,507,000  
                 
Liabilities and Stockholders’ Deficit
               
Current liabilities:
               
Accounts payable and accrued expenses
  $ 6,837,000     $ 7,349,000  
Current portion of long-term obligations
    483,000       721,000  
                 
Total current liabilities
    7,320,000       8,070,000  
                 
Deferred revenues, related party
    17,974,000       18,748,000  
Deferred revenues
    2,379,000       2,379,000  
Option liability
    1,000,000       1,000,000  
Long-term deferred rent
    326,000       473,000  
Long-term obligations, less current portion
    129,000       237,000  
                 
Total liabilities
    29,128,000       30,907,000  
                 
Commitments and contingencies
               
Stockholders’ deficit:
               
Preferred stock, $0.001 par value; 5,000,000 shares authorized; -0- shares issued and outstanding in 2008 and 2007
           
Common stock, $0.001 par value; 95,000,000 shares authorized; 28,258,683 and 25,962,222 shares issued and 26,385,849 and 24,089,388 shares outstanding in 2008 and 2007, respectively
    28,000       26,000  
Additional paid-in capital
    143,386,000       129,504,000  
Accumulated deficit
    (148,818,000 )     (132,132,000 )
Treasury stock, at cost
    (6,794,000 )     (6,794,000 )
Amount due from exercises of stock options                                                                                                     
          (4,000 )
                 
Total stockholders’ deficit
    (12,198,000 )     (9,400,000 )
                 
Total liabilities and stockholders’ deficit
  $ 16,930,000     $ 21,507,000  
 

 

 

Consolidated Condensed Statements of Operations
(Unaudited)
 
   
For the Three Months
Ended June 30,
   
For the Six Months
Ended June 30,
 
   
2008
   
2007
   
2008
   
2007
 
                         
Product revenues:
                       
    Related party
  $ 28,000     $ 512,000     $ 28,000     $ 792,000  
    Third party
    1,376,000             1,529,000        
      1,404,000       512,000       1,557,000       792,000  
                                 
Cost of product revenues
    675,000       197,000       735,000       422,000  
                                 
Gross profit
    729,000       315,000       822,000       370,000  
                                 
Development revenues:
                               
Development, related party
          1,796,000       774,000       1,796,000  
Development
          10,000             10,000  
Research grant and other
    12,000       8,000       49,000       53,000  
      12,000       1,814,000       823,000       1,859,000  
Operating expenses:
                               
Research and development
    5,034,000       4,393,000       9,998,000       9,390,000  
Sales and marketing
    1,117,000       519,000       2,074,000       1,065,000  
General and administrative
    3,162,000       3,433,000       6,272,000       6,599,000  
Change in fair value of option liabilities
    (200,000 )     (100,000 )           100,000  
                                 
Total operating expenses
    9,113,000       8,245,000       18,344,000       17,154,000  
                                 
Operating loss
    (8,372,000 )     (6,116,000 )     (16,699,000 )     (14,925,000 )
                                 
Other income (expense):
                               
Gain on sale of assets
          1,858,000             1,858,000  
Interest income
    38,000       348,000       114,000       545,000  
Interest expense
    (18,000 )     (43,000 )     (41,000 )     (95,000 )
Other expense, net
    (53,000 )     (52,000 )     (43,000 )     (54,000 )
Equity gain (loss) from investment in joint venture
    (8,000 )     9,000       (17,000 )     6,000  
                                 
Total other income (expense)
    (41,000 )     2,120,000       13,000       2,260,000  
                                 
Net loss
    (8,413,000 )     (3,996,000 )     (16,686,000 )     (12,665,000 )
                                 
Other comprehensive loss – unrealized holding loss
                      (1,000 )
                                 
Comprehensive loss
  $ (8,413,000 )   $ (3,996,000 )   $ (16,686,000 )   $ (12,666,000 )
                                 
Basic and diluted net loss per common share
  $ (0.33 )   $ (0.17 )   $ (0.66 )   $ (0.58 )
                                 
Basic and diluted weighted average common shares
    25,819,980       23,497,375       25,131,317       21,790,048  
                                 
 

 
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