BioSpace Collaborative

Academic/Biomedical Research
News & Jobs
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  C2C Services & Suppliers™
Europe
Asia

DIVERSITY

PROFILES
Company Profiles

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Research Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
Get Our Industry eNewsletter FREE email:    
   

EnteroMedics (ETRMD) Reports Second Quarter 2012 Financial Results


8/7/2012 9:50:48 AM

ST. PAUL, MN--(Marketwire - August 07, 2012) - 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 and six months ended June 30, 2012.

For the three months ended June 30, 2012, the Company reported a net loss of $4.9 million, or $0.13 per share, including research and development expenses of $2.2 million and general and administrative expenses of $2.5 million. For the six months ended June 30, 2012, the Company reported a net loss of $10.6 million, or $0.28 per share. Operating expenses were primarily associated with the cost of supporting the Company's multiple ongoing clinical trials, including the ReCharge Study, international commercialization efforts, and the continued development of VBLOC® vagal blocking therapy delivered through the Company's Maestro® Rechargeable System. On June 30, 2012, the Company's cash, cash equivalents, restricted cash and short-term investments totaled $27.8 million.

"Taking the initial tranche of $10.0 million from the $20.0 million growth capital loan combined with the $5.0 million equity offering and the $3.6 million added to the balance sheet from warrant exercises through mid-July of this year significantly strengthens our long range capital plan," said Greg S. Lea, Senior Vice President and Chief Financial Officer. "Our cash and investments of $27.8 million at the end of June puts us in a comfortable position to reach beyond key clinical and regulatory milestones for the U.S. market, including a Premarket Approval application with the Food and Drug Administration, which we anticipate submitting in the first half of 2013 with the data from the ReCharge Study pivotal trial."

Conference Call Details

The conference call may be accessed by dialing (877) 280-7473 (U.S. and Canada) or (707) 287-9370 (international), and entering passcode 11943595. A replay of the call will be available from August 7, 2012 at 2:00 PM Eastern Time through December 7, 2012 at 11:59 PM Eastern Time by dialing (855) 859-2056 (U.S. and Canada) or (404) 537-3406 (international) and entering passcode 11943595.

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 Maestro® Rechargeable (RC) System

The Maestro RC System delivers VBLOC® vagal blocking therapy via two small electrodes that are laparoscopically implanted and placed in contact with the trunks of the vagus nerve just above the junction between the esophagus and the stomach. The Maestro RC System is powered by an internal, rechargeable battery. The battery is recharged via an external mobile charger and transmit coil that the patient uses for a short time each week. The Maestro RC System has received CE Mark and has been listed on the Australian Register of Therapeutic Goods.

About VBLOC® Therapy

EnteroMedics developed VBLOC® vagal blocking therapy to offer bariatric surgeons and their patients a less invasive alternative to existing surgical weight loss procedures that may present significant risks and alter digestive system anatomy, lifestyle and food choices. VBLOC® Therapy is delivered via the Maestro® System through laparoscopically implanted leads to intermittently block the vagus nerves using high-frequency, low-energy electrical impulses. VBLOC® Therapy is designed to target the multiple digestive functions under control of the vagus nerves and to affect the perception of hunger and fullness.

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® vagal blocking therapy, delivered by a pacemaker-like device called the Maestro® 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 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® 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™ pivotal trial; 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® 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 15, 2012. 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® 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   Six Months Ended  
                                          June 30,            June 30,      
                                     ------------------  ------------------ 
                                       2012      2011      2012      2011   
                                     --------  --------  --------  -------- 
                                                                            
Sales                                $    188  $      -  $    312  $      - 
Cost of goods sold                        146         -       232         - 
                                     --------  --------  --------  -------- 
    Gross profit                           42         -        80         - 
                                     --------  --------  --------  -------- 
                                                                            
Operating expenses:                                                         
  Research and development              2,230     3,315     4,940     6,104 
  Selling, general and                                                      
   administrative                       2,542     2,066     5,356     4,134 
                                     --------  --------  --------  -------- 
    Total operating expenses            4,772     5,381    10,296    10,238 
                                     --------  --------  --------  -------- 
                                                                            
Operating loss                         (4,730)   (5,381)  (10,216)  (10,238)
  Other income (expense), net            (224)     (176)     (371)     (405)
                                     --------  --------  --------  -------- 
    Net loss                         $ (4,954) $ (5,557) $(10,587) $(10,643)
                                     ========  ========  ========  ======== 
                                                                            
  Net loss per share - basic and                                            
   diluted                           $  (0.13) $  (0.20) $  (0.28) $  (0.38)
                                     ========  ========  ========  ======== 
                                                                            
  Shares used to compute basic and                                          
   diluted net loss per share          38,668    27,893    37,712    27,893 
                                     ========  ========  ========  ======== 
                                                                            
                                                                            
                                                                            
                                                                            
                              ENTEROMEDICS INC.                             
                        (A Development Stage Company)                       
              Condensed Consolidated Balance Sheets (unaudited)             
                               (in thousands)                               
                                                                            
                                                                            
                                                     June 30,   December 31,
                                                       2012         2011    
                                                   ------------ ------------
                                   ASSETS                                   
Cash, cash equivalents and short-term investments  $     27,552 $     29,493
Restricted cash                                             200          200
Inventory                                                 1,088        1,069
Prepaid expenses and other current assets                   652          805
Property and equipment, net                                 650          630
Other assets                                                382          289
                                                   ------------ ------------
    Total assets                                   $     30,524 $     32,486
                                                   ============ ============
                                                                            
                    LIABILITIES AND STOCKHOLDERS' EQUITY                    
Liabilities:                                                                
  Accounts payable                                 $         99 $        434
  Debt                                                    9,584        5,188
  Other liabilities                                       3,649        6,823
                                                   ------------ ------------
    Total liabilities                                    13,332       12,445
Stockholders' equity                                     17,192       20,041
                                                   ------------ ------------
    Total liabilities and stockholders' equity     $     30,524 $     32,486
                                                   ============ ============

Contact:
EnteroMedics Inc.
Greg S. Lea
(651) 789-2860
Email Contact


Read at BioSpace.com


   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES
 

//-->