-----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, AkEIRvPUs410d9tNaISn+946CaKjZX79WL/rCrOWAhtbHcO/N76u/Ovk0zc9CTo7 iOgRBGuzrHTQArUaNVU/Rw== 0001095981-07-000016.txt : 20070402 0001095981-07-000016.hdr.sgml : 20070402 20070330184822 ACCESSION NUMBER: 0001095981-07-000016 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20070330 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070402 DATE AS OF CHANGE: 20070330 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: 07735139 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_8k03302007.htm CYTORI THERAPEUTICS FORM 8-K 03-30-2007 Cytori Therapeutics Form 8-K 03-30-2007

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): March 30, 2007


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 Conditions

A press release was issued by Cytori Therapeutucs, Inc. on March 30, 2007 reporting financial results for the quarter and twelve months ended December 31, 2006. A copy of the press release is attached hereto as Exhibit 99.1.

Item 9.01    Financial Statements and Exhibits

(c) Exhibits

Exhibit 99.1    Press release issued by Cytori Therapeutics, Inc. on March 30, 2007, reported financial results for the quarter and twelve months ended December 31, 2006.
 
 
 
 
 
 
 
 
 
 
 
 

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:  March 30, 2007  By:  /s/ Christopher J. Calhoun  
      Christopher J. Calhoun
      Chief Executive Officer



 
 
 

 
 
 
 
 
 
3
 
 EX-99.1 2 ex99-1.htm CYTORI THERAPEUTICS PRESS RELEASE ISSUED MARCH 30, 2007 Cytori Therapeutics Press Release issued March 30, 2007
 
EXHIBIT 99.1

Cytori Reports 2006 Fourth Quarter and Year-End Results;
Reviews 2006 Progress and Provides 2007 Outlook


March 30, 2007, San Diego, Calif. - Cytori Therapeutics (NASDAQ: CYTX; Frankfurt: XMPA) reports financial results for the quarter and year ended December 31, 2006, reviews 2006 progress, and provides 2007 outlook.

“In 2006 we made significant strides toward commercializing the Celution™ System in early 2008,” said Christopher J. Calhoun, chief executive officer for Cytori. “This included the first clinical experience for the Celution™ System as part of a breast reconstruction safety and feasibility study, attaining key regulatory milestones and adding critical design components to tailor the Celution™ System to reconstructive surgery.

“In addition, we laid extensive groundwork to start two cardiovascular disease clinical trials. This included the completion of important preclinical research that helped us design and implement controlled, randomized dose-escalation studies. Our PRECISE chronic heart disease trial began enrollment in January 2007 and our APOLLO acute heart attack trial is expected to receive approval and begin enrolling patients next quarter.”

2007 Outlook

“Our major 2007 initiatives are to prepare for commercialization, execute strategic partnerships and advance our cardiovascular products through clinical development,” added Mr. Calhoun. “We believe the buildup to our 2008 product launch can significantly increase Cytori’s intrinsic value as we get closer to generating regenerative medicine product revenues.”

Cytori anticipates achieving the following milestones in 2007:
 
·  
Initiate the APOLLO heart attack safety and feasibility trial
 
·  
Announce the outcome of the investigator-initiated breast reconstruction safety and feasibility study in Japan using the Celution™ System
 
·  
Initiate a multi-center breast reconstruction efficacy trial in Europe in patients who underwent partial-mastectomy
 
·  
Expand the Celution™ System distribution network for reconstructive surgery
 
·  
Build out internal Celution™ System manufacturing capabilities to meet anticipated product demand in early 2008;
 
·  
Pursue commercialization partners for the Celution™ System in select therapeutic areas; and
 
·  
Enter a commercialization or out licensing agreement for adipose stem cell banking.
 

Financials

Cash, cash equivalents and short term investments were $12.9 million as of December 31, 2006. Subsequent to the end of the year, Cytori raised $20 million from an equity offering and entered into an agreement to raise $6 million as part of a strategic equity agreement with Green Hospital Supply, Inc.

Total development revenues for the quarter and year ended December 31, 2006 were $5.2 million and $6.5 million, respectively, compared to $235,000 and $371,000, respectively for the same period in 2005. The increase in development revenues in the fourth quarter and full year 2006 is due to the recognition of deferred revenue related to the Olympus-Cytori Joint Venture by achieving certain regulatory, preclinical development and Celution™ System development milestones. Product revenues from our non-core biomaterials products for the quarter and year ended December 31, 2006 were $363,000 and $1.5 million, respectively, compared to $858,000 and $5.6 million for 2005.


Research and development expenses for the quarter and year ended December 31, 2006 were $5.2 million and $22.0 million, respectively, compared to $4.9 million and $15.5 million, respectively, for the same periods in 2005. The increase in R&D for the full year 2006 is attributed to additional preclinical studies, preparations for upcoming clinical trials, increased Celution™ System development expenses to attain regulatory approvals, and internal scale-up for manufacturing of devices and consumables for clinical trials.

General and administrative expenses for the quarter and year ended December 31, 2006 were $2.5 million and $12.5 million, respectively, compared to $2.2 million and $10.2 million respectively for the same periods in 2005. Net loss for the quarter and year ended December 31, 2006 was $1.9 million, or $(0.10) per common share, and $25.4 million, or $(1.53) per common share. This compares to a net loss of $14.4 million, or $(0.96) per common share and $26.5 million, or $(1.80) per common share, for the same periods in 2005.

Conference Call Information

The management of Cytori Therapeutics will host a conference call today at 10:00 a.m. Eastern Daylight Time (EDT) or 4:00 p.m. Central European Summer Time (CEST). The conference call will be webcast live and may be accessed under "Events & Webcasts" in the Investor Relations section of the Company's website at http://www.cytoritx.com. The archived version of the webcast will be available two hours after the call on the company's website and accessible for 14 days. A telephone replay will be available for one week. To access the replay, please call +1 (303) 590-3000 (PIN: 11086131#).

1
Cytori Therapeutics

Cytori Therapeutics is developing and seeks to commercialize stem and regenerative cell therapies for cardiovascular disease, reconstructive surgery and many other serious chronic, and life threatening conditions. To provide these therapies, physicians remove a small amount of a patient's fat, also known as adipose tissue, and run it through Cytori's Celution™ System. This System quickly separates and concentrates stem and regenerative cells from adipose tissue so they may be quickly administered back to the patient about an hour later. This system will dramatically improve the way in which personalized cell-based therapies can be delivered to patients. www.cytoritx.com

Cautionary Statement Regarding Forward-Looking Statements 

This press release includes forward-looking statements regarding events, trends and prospects of our business, 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 our history of operating losses, the need for further financing, regulatory uncertainties, dependence on performance of third parties, and other risks and uncertainties described (under the heading "Risk Factors") in Cytori Therapeutics' Form 10-K annual report for the year ended December 31, 2006. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.

###
 
2


Consolidated Balance Sheets
 
   
As of December 31,
  
   
2006
  
2005
  
           
Assets
          
Current assets:
          
Cash and cash equivalents
  
$
8,902,000
  
$
8,007,000
  
Short-term investments, available-for-sale
    
3,976,000
    
7,838,000
  
Accounts receivable, net of allowance for doubtful accounts of $2,000 and $9,000 in 2006 and 2005, respectively
    
225,000
    
816,000
  
Inventories, net
    
164,000
    
258,000
  
Other current assets
    
711,000
    
621,000
  
               
Total current assets
    
13,978,000
    
17,540,000
  
               
Property and equipment held for sale, net
    
457,000
    
—
  
Property and equipment, net
    
4,242,000
    
4,260,000
  
Investment in joint venture
    
76,000
    
—
  
Other assets
    
428,000
    
458,000
  
Intangibles, net
    
1,300,000
    
1,521,000
  
Goodwill
    
4,387,000
    
4,387,000
  
               
Total assets
  
$
24,868,000
  
$
28,166,000
  
               
Liabilities and Stockholders’ Deficit
              
Current liabilities:
              
Accounts payable and accrued expenses
  
$
5,587,000
  
$
6,129,000
  
Current portion of long-term obligations
    
999,000
    
952,000
  
               
Total current liabilities
    
6,586,000
    
7,081,000
  
               
Deferred revenues, related party
    
23,906,000
    
17,311,000
  
Deferred revenues
    
2,389,000
    
2,541,000
  
Option liabilities
    
900,000
    
5,331,000
  
Long-term deferred rent
    
741,000
    
573,000
  
Long-term obligations, less current portion
    
1,159,000
    
1,558,000
  
               
Total liabilities
    
35,681,000
    
34,395,000
  
               
Commitments and contingencies
              
Stockholders’ deficit:
              
Preferred stock, $0.001 par value; 5,000,000 shares authorized; -0- shares issued and outstanding in 2006 and 2005
    
—
    
—
  
Common stock, $0.001 par value; 95,000,000 shares authorized; 21,612,243 and 18,194,283 shares issued and 18,739,409 and 15,321,449 shares outstanding in 2006 and 2005, respectively
    
22,000
    
18,000
  
Additional paid-in capital
    
103,053,000
    
82,196,000
  
Accumulated deficit
    
(103,460,000
)
  
(78,013,000
)
Treasury stock, at cost
    
(10,414,000
)
  
(10,414,000
)
Accumulated other comprehensive income (loss)
    
1,000
    
(16,000
)
Amount due from exercises of stock options
    
(15,000
)
  
—
  
               
Total stockholders’ deficit
    
(10,813,000
)
  
(6,229,000
)
               
Total liabilities and stockholders’ deficit
  
$
24,868,000
  
$
28,166,000
  

3
Income Statement

   
For the Years Ended December 31,
  
   
2006
  
2005
  
2004
  
               
Product revenues:
              
Sales to related party
  
$
1,451,000
  
$
5,634,000
  
$
4,085,000
  
Sales to third parties
    
—
    
—
    
2,237,000
  
                     
     
1,451,000
    
5,634,000
    
6,322,000
  
                     
Cost of product revenues
    
1,634,000
    
3,154,000
    
3,384,000
  
                     
Gross profit (loss)
    
(183,000
)
  
2,480,000
    
2,938,000
  
                     
Development revenues:
                    
Development, related party
    
5,905,000
    
—
    
—
  
Development
    
152,000
    
51,000
    
158,000
  
Research grants and other
    
419,000
    
320,000
    
338,000
  
                     
     
6,476,000
    
371,000
    
496,000
  
Operating expenses:
                    
Research and development
    
21,977,000
    
15,450,000
    
10,384,000
  
Sales and marketing
    
2,055,000
    
1,547,000
    
2,413,000
  
General and administrative
    
12,547,000
    
10,208,000
    
6,551,000
  
Change in fair value of option liabilities
    
(4,431,000
)
  
3,645,000
    
—
  
Restructuring charge
    
—
    
—
    
107,000
  
Equipment impairment charge
    
—
    
—
    
42,000
  
                     
Total operating expenses
    
32,148,000
    
30,850,000
    
19,497,000
  
                     
Operating loss
    
(25,855,000
)
  
(27,999,000
)
  
(16,063,000
)
                     
Other income (expense):
                    
Gain on sale of assets
    
—
    
5,526,000
    
—
  
Gain on sale of assets, related party
    
—
    
—
    
13,883,000
  
Interest income
    
708,000
    
299,000
    
252,000
  
Interest expense
    
(199,000
)
  
(137,000
)
  
(177,000
)
Other income (expense), net
    
(27,000
)
  
(55,000
)
  
15,000
  
Equity loss from investment in joint venture
    
(74,000
)
  
(4,172,000
)
  
—
  
                     
Total other income, net
    
408,000
    
1,461,000
    
13,973,000
  
                     
Net loss
    
(25,447,000
)
  
(26,538,000
)
  
(2,090,000
)
                     
Other comprehensive income (loss) - unrealized holding income (loss)
    
17,000
    
16,000
    
(58,000
)
                     
Comprehensive loss
  
$
(25,430,000
)
$
(26,522,000
)
$
(2,148,000
)
                     
Basic and diluted net loss per common share
  
$
(1.53
)
$
(1.80
)
$
(0.15
)
                     
Basic and diluted weighted average common shares
    
16,603,550
    
14,704,281
    
13,932,390
  
 
 
4 
 
 
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