EnteroMedics Reports First Quarter 2013 Financial Results

EnteroMedics Reports First Quarter 2013 Financial Results 
Company to Host Conference Call Today, May 1, 2013, at 11:00 AM ET 
ST. PAUL, MN -- (Marketwired) -- 05/01/13 --  EnteroMedics Inc.
(NASDAQ: ETRM), the developer of medical devices using neuroblocking
technology to treat obesity, metabolic diseases and other
gastrointestinal disorders, today announced financial results for the
three months ended March 31, 2013.  
For the three months ended March 31, 2013, the Company reported a net
loss of $6.6 million, or $0.14 per share. Research and development
expenses were $2.7 million and general and administrative expenses
were $3.6 million. Operating expenses were primarily associated with
the cost of supporting multiple ongoing clinical trials, including
the ReCharge Study, the Company's international commercialization
efforts, and the continued development of VBLOC(R) vagal blocking
therapy delivered through the Company's Maestro(R) Rechargeable
System. On March 31, 2013, the Company's cash, cash equivalents,
restricted cash and short-term investments totaled $29.6 million. 
"EnteroMedics remains well funded to support our regulatory efforts
for commercialization of the Maestro ReChargeable System in the
United States, with a PMA application on track to be submitted to the
Food and Drug Administration in the second quarter of 2013," said
Greg S. Lea, Senior Vice President, Chief Financial Officer and Chief
Operating Officer. Mr. Lea noted: "In addition to our focus on US
regulatory milestones, we continue to advance our ex-US strategy by
pursuing reimbursement in Australia and applying to strengthen our CE
Mark in Europe to include diabetes and hypertension. Our current
cash, which includes a financing completed in the first quarter,
gives us the necessary resources to execute on these pivotal
regulatory and commercialization activities into 2014."  
Conference Call Details 
The first quarter conference call may be accessed by dialing (877)
280-7473 (U.S. and Canada) or (707) 287-9370 (international), and
entering passcode 41536010. A replay of the call will be available
from May 1, 2013 at 2:00 PM Eastern Time through July 29, 2013 at
11:59 PM Eastern Time by dialing (855) 859-2056 (U.S. and Canada) or
(404) 537-3406 (international) and entering
 passcode 41536010.  
To access the live webcast, visit the events page of the investor
relations section of EnteroMedics' website at www.enteromedics.com. A
replay of the webcast will be available immediately after the
conference call.  
About EnteroMedics Inc.  
EnteroMedics is a medical device company focused on the development
and commercialization of its neuroscience based technology to treat
obesity and metabolic diseases. EnteroMedics' proprietary technology,
VBLOC(R) vagal blocking therapy, delivered by a pacemaker-like device
called the Maestro(R) Rechargeable System, is designed to
intermittently block the vagus nerves using high-frequency,
low-energy, electrical impulses. VBLOC allows people with obesity to
take a positive path towards weight loss, addressing the lifelong
challenge of obesity and its comorbidities without sacrificing
wellbeing or comfort. EnteroMedics' Maestro Rechargeable System has
received CE Mark and is listed on the Australian Register of
Therapeutic Goods.  
Forward-Looking Safe Harbor Statement:  
This press release contains forward-looking statements about
EnteroMedics Inc. Our actual results could differ materially from
those discussed due to known and unknown risks, uncertainties and
other factors including our limited history of operations; our losses
since inception and for the foreseeable future; our lack of
commercial regulatory approval for our Maestro(R) System for the
treatment of obesity in the United States or in any foreign market
other than Australia and the European Community; our preliminary
findings from our EMPOWER(TM) and ReCharge pivotal trials; our
ability to comply with the Nasdaq continued listing requirements; our
ability to commercialize our Maestro System; our dependence on third
parties to initiate and perform our clinical trials; the need to
obtain regulatory approval for any modifications to our Maestro
System; physician adoption of our Maestro System and VBLOC(R) vagal
blocking therapy; our ability to obtain third party coding, coverage
or payment levels; ongoing regulatory compliance; our dependence on
third party manufacturers and suppliers; the successful development
of our sales and marketing capabilities; our ability to raise
additional capital when needed; international commercialization and
operation; our ability to attract and retain management and other
personnel and to manage our growth effectively; potential product
liability claims; potential healthcare fraud and abuse claims;
healthcare legislative reform; and our ability to obtain and maintain
intellectual property protection for our technology and products.
These and additional risks and uncertainties are described more fully
in the Company's filings with the Securities and Exchange Commission,
particularly those factors identified as "risk factors" in the annual
report on Form 10-K filed March 7, 2013. We are providing this
information as of the date of this press release and do not undertake
any obligation to update any forward-looking statements contained in
this document as a result of new information, future events or
otherwise.  
Caution - Investigational device. Limited by Federal (United States)
law to investigational use.  
The implantation procedure and usage of the Maestro(R) System carry
some risks, such as the risks generally associated with laparoscopic
procedures and those related to treatment as described in the
ReCharge clinical trial informed consent.  
(See attached tables) 


 
                                                                            
                             ENTEROMEDICS INC.                              
                       (A Development Stage Company)                        
        Condensed Consolidated Statements of Operations (unaudited)         
                   (in thousands, except per share data)                    
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                     Three Months Ended     
                                                          March 31,         
                                                 -------------------------- 
                                                     2013          2012     
                                                 ------------  ------------ 
                                                                            
Sales                                            $          -  $        123 
Cost of goods sold                                          -            85 
                                                 ------------  ------------ 
    Gross profit                                            -            38 
                                                 ============  ============ 
                                                                            
Operating expenses:                                                         
  Research and
 development                              2,733         2,710 
  Selling, general and administrative                   3,586         2,814 
                                                 ------------  ------------ 
    Total operating expenses                            6,319         5,524 
                                                 ------------  ------------ 
                                                                            
Operating loss                                         (6,319)       (5,486)
Other income (expense), net                              (262)         (147)
                                                 ------------  ------------ 
    Net loss                                     $     (6,581) $     (5,633)
                                                 ============  ============ 
                                                                            
  Net loss per share - basic and diluted         $      (0.14) $      (0.15)
                                                 ============  ============ 
                                                                            
                                                                            
  Shares used to compute basic and diluted net                              
   loss per share                                      46,896        36,757 
                                                 ============  ============ 
                                                                            
                                                                            
                                                                            
                              ENTEROMEDICS INC.                             
                        (A Development Stage Company)                       
              Condensed Consolidated Balance Sheets (unaudited)             
                               (in thousands)                               
                                                                            
                                                                            
                                                   March 31,    December 31,
                                                      2013          2012    
                                                 ------------- -------------
                     ASSETS                                                 
Cash, cash equivalents and short-term                                       
 investments                                     $      29,395 $      22,309
Restricted cash                                            200           200
Inventory                                                1,336         1,271
Prepaid expenses and other current assets                  603           624
Property and equipment, net                                592           610
Other assets                                             1,097         1,082
                                                 ------------- -------------
    Total assets                                 $      33,223 $      26,096
                                                 ============= =============
                                                                            
      LIABILITIES AND STOCKHOLDERS' EQUITY                                  
Liabilities:                                                                
  Accounts payable                               $         449 $         341
  Debt                                                   9,735         9,684
  Other liabilities                                      4,336         4,196
                                                 ------------- -------------
    Total liabilities                                   14,520        14,221
Stockholders' equity                                    18,703        11,875
                                                 ------------- -------------
    Total liabilities and stockholders' equity   $      33,223 $      26,096
                                                 ============= =============

  
Contact:
EnteroMedics Inc.
Greg S. Lea
(651) 789-2860
ir@enteromedics.com 
 
 
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