0001415889-14-001046.txt : 20140401 0001415889-14-001046.hdr.sgml : 20140401 20140401163044 ACCESSION NUMBER: 0001415889-14-001046 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20140327 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20140401 DATE AS OF CHANGE: 20140401 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Echo Therapeutics, Inc. CENTRAL INDEX KEY: 0001031927 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 411649949 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-35218 FILM NUMBER: 14734615 BUSINESS ADDRESS: STREET 1: 8 PENN CENTER STREET 2: 1628 JFK BLVD, SUITE 300 CITY: PHILADELPHIA STATE: PA ZIP: 19103 BUSINESS PHONE: 215-717-4100 MAIL ADDRESS: STREET 1: 8 PENN CENTER STREET 2: 1628 JFK BLVD, SUITE 300 CITY: PHILADELPHIA STATE: PA ZIP: 19103 FORMER COMPANY: FORMER CONFORMED NAME: SONTRA MEDICAL CORP DATE OF NAME CHANGE: 20020702 FORMER COMPANY: FORMER CONFORMED NAME: CHOICETEL COMMUNICATIONS INC/MN/ DATE OF NAME CHANGE: 20020701 FORMER COMPANY: FORMER CONFORMED NAME: SONTRA MEDICAL CORP DATE OF NAME CHANGE: 20020701 8-K 1 ecte8kapr12014.htm ecte8kapr12014.htm


UNITED STATES
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 27, 2014
 
Echo Therapeutics, Inc.
 (Exact name of Company as specified in its charter)
 
         
Delaware
 
000-23017
 
41-1649949
(State or other jurisdiction
of Incorporation)
 
(Commission File Number)
 
(I.R.S. Employer
Identification No.)
   
8 Penn Center
1628 JFK Blvd., Suite 300
Philadelphia, PA
 
 
 
19103
(Address of principal executive offices)
 
(Zip Code)

Company’s telephone number, including area code: (215) 717-4100

 
 (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 Company under any of the following provisions (see General Instruction A.2. below):
 
[  ]
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
[  ]
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
[  ]
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
[  ]
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 March 27, 2014, Echo Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the year ended December 31, 2013.  A copy of the press release is attached as Exhibit 99.1 to this report. 

The information furnished pursuant to Item 2.02 of this report, including Exhibit 99.1 hereto, shall not be considered “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of such section, nor shall it be incorporated by reference into future filings by the Company under the Securities Act of 1933, as amended, or under the Securities Exchange Act of 1934, as amended, unless the Company expressly sets forth in such future filing that such information is to be considered “filed” or incorporated by reference therein.
 
Item 9.01.   Financial Statements and Exhibits.
 
The Exhibits listed in the Exhibit Index immediately preceding such Exhibits are filed with or incorporated by reference in this report. 

 
 

 

SIGNATURES
 
              Pursuant to the requirements of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
                                                                                   
 
ECHO THERAPEUTICS, INC.
 
 
Dated: April 1, 2014
By:  /s/  Robert F. Doman
 
Robert F. Doman
 
 
Executive Chairman and Interim CEO
 
 
 
 

 
 
EXHIBIT INDEX

Exhibit No.
 
Description
     
99.1
 
Press Release issued by the Company on March 27, 2014.
EX-99.1 2 ex99-1.htm PRESS RELEASE ISSUED BY THE COMPANY ON MARCH 27, 2014 ex99-1.htm
Exhibit 99.1



 
Echo Therapeutics, Inc. Announces 2013 Financial Results
 
 
Company to Host Conference Call Today, March 27, 2014 at 9:00 AM ET
 
Philadelphia, PA – March 27, 2014 – Echo Therapeutics, Inc. (Nasdaq: ECTE), a medical device company developing its Symphony® CGM System as a non-invasive, wireless continuous glucose monitoring system, today announced financial results for the year ended December 31, 2013.  Echo’s Annual Report on Form 10-K, as filed with the SEC, will be available by visiting the Investors section of Echo’s website at www.echotx.com on March 28, 2014 after the close of the financial markets.
 
Recent Corporate Highlights:

·
In November 2013, Echo completed its multi-center clinical trial of the Symphony CGM System in post-surgical patients in hospital critical care units. Data collected from the study was presented at the International Symposium on Intensive Care and Emergency Medicine (ISICEM) in Brussels in March 2014.
·
In January 2014, Echo submitted data from the study, along with other additional documentation, to their notified body in a Technical File to support their CE Mark application to potentially obtain marketing approval for the Symphony CGM System in Europe.
·
Echo entered into a strategic collaboration agreement with Medical Technologies Innovation Asia (MTIA), Ltd., Hong Kong, for a license arrangement and equity investment in Echo in December 2013. Under the terms of the License, Development and Commercialization Agreement between MTIA and Echo, Echo granted MTIA rights to develop, manufacture, market and distribute Echo's Symphony CGM System on an exclusive basis for the Chinese market, including the Peoples' Republic of China, Hong Kong, Macau and Taiwan.
·
As part of a restructuring plan, Echo implemented a number of substantial cost reduction measures that did not diminish its ability to execute on its short-term objectives. As a result of these initiatives, 4th quarter cash usage decreased by approximately 39% from the average quarterly cash usage experienced during the first three quarters of 2013.
·
Echo hired Thomas Bishop, an accomplished product development executive, as Vice President of Product Development in January 2014. Mr. Bishop is leading the execution of Echo’s product roadmap strategy.

“We made tangible progress during 2013 and we achieved some important milestones, including the clinical validation of the Symphony CGM System,” said Robert F. Doman, Echo’s Executive Chairman and Interim CEO. “With our experienced management team, along with the cash infusion associated with the MTIA agreement, we can now focus on the continued, accelerated pace of Symphony’s development finalization necessary for the European market launch and the FDA regulatory trial.”
 
Fourth Quarter 2013 Financial Results

Echo’s net loss for the fourth quarter of 2013 was $3.9 million, or ($0.36) per share, compared to $1.9 million, or ($0.48) per share, for the fourth quarter of 2012. The operating loss for the fourth quarter of 2013 was $3.1 million compared to $4.7 million for the fourth quarter of 2012.  Research and development expenses were $1.3 million for the fourth quarter of 2013 compared to $2.9 million for the fourth quarter of 2012. Selling, general and administrative expenses were $1.8 million for the fourth quarter of 2013 compared to $1.7 million for the fourth quarter of 2012.

 
-1-

 
 
Fiscal Year 2013 Financial Results

For fiscal year 2013, the Company was principally involved with the product development and clinical studies of its Symphony CGM System. Echo's net loss for fiscal year 2013 was $19.4 million, or ($2.33) per share, compared to $12.3 million, or ($3.12) per share during 2012.  The operating loss for the year ended December 31, 2013 was $19.6 million compared to $15.0 million for the year ended December 31, 2012.  Research and development expenses were $11.3 million for the year ended December 31, 2013 compared to $8.7 million for the year ended December 31, 2012.  The increase in research and development expenses was primarily related to increased engineering and design expenses incurred with outside contractors and personnel relating to Symphony development.  Selling, general and administrative expenses were $8.4 million during 2013 compared to $6.4 million in 2012.   The increase in selling, general and administrative expenses was primarily due to increased personnel costs, legal costs, and expenses related to prelaunch marketing and manufacturing activities.  Echo reported a cash balance of approximately $8.1 million as of December 31, 2013. 
 
Conference Call

Management will host a conference call today starting at 9:00 AM ET.  To listen and/or participate in the call, please dial (877) 737-7051 and reference Echo Therapeutics and passcode 2657537 or pre-register for the call at http://bit.ly/1ge4TQk.  The archived audiocast will be available for fourteen days following the call by visiting the Events section of Echo's website at www.echotx.com.
 
About Echo Therapeutics

Echo Therapeutics is developing the Symphony CGM System as a non-invasive, wireless, continuous glucose monitoring system for use initially in the critical care setting. A significant longer-term opportunity may also exist for Symphony to be used in the hospital beyond the critical care setting, as well as in patients with diabetes in the outpatient setting. Echo has also developed its needle-free skin preparation device, the Prelude® SkinPrep System, as a platform technology to enhance delivery of topical pharmaceuticals.

Cautionary Statement Regarding Forward Looking Statements

The statements in this press release that are not historical facts, including the statement about its conference call, may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Echo's clinical studies, the safety and efficacy of Echo's Symphony CGM System, the failure of future development and preliminary marketing efforts related to Echo's Symphony CGM System, Echo's ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Echo's and its partners' ability to develop, market and sell the Symphony CGM System, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to its Symphony CGM System. These and other risks and uncertainties are identified and described in more detail in Echo's filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the year ended December 31, 2012, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Echo undertakes no obligation to publicly update or revise any forward-looking statements.

For More Information:
Christine H. Olimpio
Director, Investor Relations and Corporate Communications
(215) 717-4104

Connect With Us:
- Visit our website at www.echotx.com
- Follow us on Twitter at www.twitter.com/echotx
- Join us on Facebook at www.facebook.com/echotx
 
-2-

 
 
Echo Therapeutics, Inc.
 
Condensed Consolidated Balance Sheets
 
   
December 31,
2013
   
December 31,
2012
 
ASSETS
           
Current Assets:
           
Cash and cash equivalents
  $ 8,055,385     $ 3,747,210  
Other current assets
    1,319,713       1,451,093  
Total current assets
    9,375,098       5,198,303  
Net property and equipment (including assets under capitalized leases)
    1,495,807       1,638,395  
Other Assets:
               
Intangible assets, net of accumulated amortization
    9,625,000       9,625,000  
Deferred financing costs
    2,581,324       3,549,328  
Restricted cash, deposits and other assets
    12,066       10,566  
Total other assets
    12,218,390       13,184,894  
Total assets
  $ 23,089,295     $ 20,021,592  
                 
LIABILITIES AND STOCKHOLDERS' EQUITY
               
Current Liabilities:
               
Accounts payable
  $ 1,036,320     $ 2,319,219  
Deferred revenue from licensing agreements
    76,428       90,228  
Derivative warrant liability
    1,119,155       5,585,141  
Accrued expenses and other liabilities
    1,412,468       1,583,975  
Total current liabilities
    3,644,371       9,578,563  
Deferred revenue, net of current portion
    76,428       212,423  
Total liabilities
    3,720,799       9,790,986  
Commitments
               
Stockholders' Equity:
               
Convertible preferred stock, Series C,D & E
    27,496       30,160  
Common stock
    117,764       44,374  
Additional paid-in capital
    132,192,648       104,058,087  
Accumulated deficit
    (112,969,412 )     (93,902,015 )
Total stockholders' equity
    19,368,496       10,230,606  
Total liabilities and stockholders' equity
  $ 23,089,295     $ 20,021,592  
                 

 
-3-

 
Condensed Consolidated Statements of Operations
 
 
   
Quarter Ended
December 31,
   
Year Ended
December 31,
 
   
2013
   
2012
   
2013
   
2012
 
Licensing revenue
  $ (40,071 )   $ (87,662 )   $ 27,600     $ 5,119  
Total revenues
    (40,071 )     (87,662 )     27,600       5,119  
                                 
Operating Expenses:
                               
Research and development
    1,304,054       2,939,293       11,298,931       8,670,710  
Selling, general and administrative
    1,774,931       1,672,104       8,365,137       6,374,429  
Total operating expenses
    3,078,985       4,611,397       19,664,068       15,045,139  
Loss from operations
    (3,119,056 )     (4,699,059 )     (19,636,468 )     (15,040,020 )
                                 
Other Income (Expense):
                               
Interest expense, net
    (241,574 )     (415,135 )     (3,896,915 )     (499,392 )
Debt financing costs
    -       (295,000 )     -       (455,000 )
Loss on disposals of assets
    -       -       -       (21,272 )
Gain (loss) on revaluation of derivative warrant liability
    (140,000 )     3,482,395       4,465,986       3,683,676  
Other income (expense), net
    (381,574 )     (2,772,260 )     569,071       2,708,012  
Net loss
    (3,500,630 )     (1,926,799 )     (19,067,397 )     (12,332,008 )
Deemed dividend on beneficial conversion feature of
    Convertible preferred stock
    (371,140 )     -       (371,140 )     -  
Net loss applicable to common shareholders
  $ (3,871,770 )   $ (1,926,799 )   $ (19,438,537 )   $ (12,332,008 )
Net loss per common share, basic and diluted
  $ (0.36 )   $ (0.48 )   $ (2.33 )   $ (3.12 )
Basic and diluted weighted average common shares outstanding
    10,698,450       4,042,635       8,359,837       3,955,046  
 
(Reflects 1-for-10 reverse stock split, effective June 7, 2013)
 
###
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