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TranS1 Inc. Reports Operating Results for the Third Quarter of 2009

GlobeNewswire
posted: 26 DAYS 23 HOURS AGO


 Highlights:

 Third quarter revenues increased 15% to $6.9 million

 729 TranS1 procedures performed globally in the quarter

 Gross margin was 80.2% for the quarter

 GAAP loss per share was $0.27 for the quarter

 Non-GAAP loss per share was $0.24 for the quarter

WILMINGTON, N.C., Oct. 29, 2009 (GLOBE NEWSWIRE) -- TranS1 Inc. (Nasdaq:TSON), a medical device company focused on designing, developing and marketing products that implement its proprietary minimally invasive surgical approach to treat degenerative disc disease and instability affecting the lower lumbar region of the spine, today announced its financial results for the third quarter ended September 30, 2009.

Revenues were $6.9 million in the third quarter of 2009, representing a 15% increase over revenues of $6.0 million in the third quarter of 2008. Gross margin was 80.2% in the third quarter of 2009 as compared to 83.2% in the third quarter of 2008. Gross margin in the third quarter included a non-recurring charge of approximately $125,000 related to inventory obsolescence. Excluding this charge, gross margin would have been 82.0%.

Operating expenses were $11.2 million in the third quarter of 2009 compared to $10.4 million in the third quarter of 2008. The increase in operating expenses is primarily attributable to an increase in sales and marketing costs as a result of the continued expansion of the direct sales force, increased commissions as a result of increased sales and increased spending for research and development.

Net loss was $5.6 million and $4.8 million for the quarters ended September 30, 2009 and 2008, respectively. GAAP net loss per common share was $0.27 in the third quarter of 2009 compared to a net loss per share of $0.23 in the third quarter of 2008.

For the quarters ended September 30, 2009 and 2008, on a non-GAAP basis adjusting for non-cash stock compensation expense, net loss per common share was $0.24 and $0.20, respectively.

Cash, cash-equivalents and investments were $61.3 million as of September 30, 2009.

"Our results this quarter were impacted by continuing uncertainty in the marketplace surrounding reimbursement for our AxiaLIF procedure, which we are addressing with increased education and support resources for our current and prospective surgeon users," said Rick Randall, President and CEO of TranS1. "We remain confident in our products, clinical benefits and prospects for future growth as the market for minimally invasive spine surgery continues to expand."

Conference Call

TranS1 will host a conference call today at 5:30 pm ET to discuss its third quarter financial results. To listen to the conference call on your telephone, please dial 888-298-3490 for domestic callers and 719-325-2174 for international callers approximately ten minutes prior to the start time. The call will be concurrently webcast. To access the live audio broadcast or the subsequent archived recording, visit the TranS1 website at www.trans1.com under the investor relations section.

Non-GAAP Measures

Management uses certain non-GAAP financial measures such as non-GAAP net loss and net loss per share, which exclude stock based compensation. This non-GAAP presentation is given in part to enhance the understanding of the company's historical financial performance and comparability between periods. The company believes that the non-GAAP presentation to exclude stock-based compensation is relevant and useful information that will be widely used by investors and analysts. Accordingly, the company is disclosing this information to permit additional analysis of the company's performance. These non-GAAP measures are not in accordance with, or an alternative for, GAAP, and may be different from non-GAAP measures used by other companies. Investors should consider these non-GAAP measures in addition to, and not as a substitute for, financial performance measures in accordance with GAAP. A reconciliation of the GAAP financial measures to the comparable non-GAAP financial measure is included below.

About TranS1 Inc.

TranS1 is a medical device company focused on designing, developing and marketing products that implement its proprietary minimally invasive surgical approach to treat degenerative disc disease and instability affecting the lower lumbar region of the spine. TranS1 currently markets two single-level fusion products, the AxiaLIF(R) and the AxiaLIF 360(TM), and a two-level fusion product, the AxiaLIF 2L(TM), in the US and Europe. TranS1 was founded in May 2000 and is headquartered in Wilmington, North Carolina. For more information, visit www.trans1.com.

Forward-Looking Statements

This press release includes forward-looking statements, the accuracy of which is necessarily subject to risks and uncertainties. These risks and uncertainties include, among other things, risks associated with the adoption of a new technology by spine surgeons, product development efforts, regulatory requirements, maintenance and prosecution of adequate intellectual property protection and other economic and competitive factors. These forward-looking statements are based on the company's expectations as of the date of this press release and the company undertakes no obligation to update information provided in this press release. For a discussion of risks and uncertainties associated with TranS1's business, please review the company's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2008.



                                TranS1 Inc.                            
                         Statements of Operations                     
                  (in thousands, except per share amounts)            
                              (Unaudited)                             
                                                                      
                                                                      
                              Three Months Ended    Nine Months Ended 
                                  Sept. 30,             Sept. 30,     
                            -------------------   -------------------
                              2009       2008       2009       2008  
                            --------   --------   --------   -------- 
 Revenue                    $  6,912   $  6,021   $ 23,528   $ 17,950 
 Cost of revenue               1,366      1,011      4,423      3,186 
                            --------   --------   --------   -------- 
 Gross profit                  5,546      5,010     19,105     14,764 
                            --------   --------   --------   -------- 
 Operating expenses:                                                  
 Research and development      1,362        910      5,047      3,241 
 Sales and marketing           8,126      7,782     26,219     20,680 
 General and                                                          
  administrative               1,683      1,671      5,714      5,563 
                            --------   --------   --------   -------- 
 Total operating expenses     11,171     10,363     36,980     29,484 
                            --------   --------   --------   -------- 
 Operating loss               (5,625)    (5,353)   (17,875)   (14,720)
 Interest income                  54        589        382      2,218 
                            --------   --------   --------   -------- 
 Net loss                   $ (5,571)  $ (4,764)  $(17,493)  $(12,502)
                            ========   ========   ========   ======== 
 
 Net loss per common share                                            
  - basic and diluted       $  (0.27)  $  (0.23)  $  (0.85)  $  (0.62)
                            ========   ========   ========   ======== 
 
 Weighted average common                                              
  shares outstanding -                                                
  basic and diluted           20,630     20,474     20,591     20,206 
                            ========   ========   ========   ======== 
                                                                      
 Stock-based compensation                                             
  is included in operating                                            
  expenses in the                                                     
  following categories:                                               
 Cost of revenue            $     19   $     18   $     56   $     45 
 Research and development         40         99        141        394 
 Sales and marketing             368        445      1,143      1,319 
 General and administrative      186        181        860        839 
                            --------   --------   --------   -------- 
                            $    613   $    743   $  2,200   $  2,597 
                            ========   ========   ========   ========


 Reconciliation of Quarterly Results                                  
 (in thousands, except per share amounts)                             
 (Unaudited)                                      2009         2008   
                                                --------     -------- 
                                                                      
 GAAP net loss                                  $ (5,571)    $ (4,764)
 Stock based compensation                            613          743 
                                                --------     -------- 
 Non-GAAP net loss                              $ (4,958)    $ (4,021)
                                                ========     ======== 
                                                                      
 Shares used in computing GAAP and non-GAAP                           
  loss per share                                  20,630       20,474 
                                                ========     ======== 
                                                                      
 Non-GAAP loss per share                        $  (0.24)    $  (0.20)
                                                ========     ======== 
                                                                      
 Reconciliation of Year-To-Date Results                               
 (in thousands, except per share amounts)                             
 (Unaudited)                                      2009         2008   
                                                --------     -------- 
                                                                      
 GAAP net loss                                  $(17,493)    $(12,502)
 Stock based compensation                          2,200        2,597 
                                                --------     -------- 
 Non-GAAP net loss                              $(15,293)    $ (9,905)
                                                ========     ======== 
                                                                      
 Shares used in computing GAAP and non-GAAP                           
  loss per share                                  20,591       20,206 
                                                ========     ======== 
                                                                      
 Non-GAAP loss per share                        $  (0.74)    $  (0.49)
                                                ========     ========


                                TranS1 Inc.                              
                              Balance Sheets                             
                              (in thousands)                             
                                (Unaudited)                              
                                                                      
                                               Sept. 30,     Dec. 31,
                                                  2009         2008 
                                               ---------    --------- 
 Assets                                                               
 Current assets:                                                     
   Cash and cash equivalents                   $  30,298    $  42,051 
   Short-term investments                         30,969       35,215 
   Accounts receivable, net                        4,168        4,812 
   Inventory                                       7,671        6,369 
   Prepaid expenses and other assets                 433          632 
                                               ---------    --------- 
     Total current assets                         73,539       89,079 
  Property and equipment, net                      1,281        1,412 
                                               ---------    --------- 
     Total assets                              $  74,820    $  90,491 
                                               =========    ========= 
                                                                      
  Liabilities and Stockholders' Equity                                
  Current liabilities:                                                
   Accounts payable                            $   2,655    $   2,896 
   Accrued expenses                                1,780        2,009 
                                               ---------    --------- 
     Total current liabilities                     4,435        4,905 
                                               ---------    --------- 

 Stockholders' equity                                                
   Common stock                                        2            2 
   Additional paid-in capital                    135,796      133,507 
   Accumulated other comprehensive income              3           -- 
   Accumulated deficit                           (65,416)     (47,923)
                                               ---------    --------- 
     Total stockholders' equity                   70,385       85,586 
                                               ---------    --------- 
     Total liabilities and stockholders'                              
      equity                                   $  74,820    $  90,491 
                                               =========    =========


                                 TranS1 Inc.                             
                          Statements of Cash Flows                       
                               (in thousands)                            
                                 (Unaudited)                             
                                                                      
                                                                      
                                                   Nine Months Ended  
                                                       Sept. 30,      
                                                 -------------------- 
                                                   2009        2008   
                                                 --------    -------- 
 Cash flows from operating activities:                                
 Net loss                                       $(17,493)   $(12,502)
  Adjustments to reconcile net loss to net                            
   cash used in operating activities                                  
     Depreciation                                     684         583 
     Stock-based compensation                       2,200       2,597 
     Allowance for excess and obsolete                                
      inventory                                       541         376 
     Provision for bad debts                           63          84 
     Changes in operating assets and                                  
      liabilities:                                                    
       (Increase) decrease in accounts                                
         receivable                                   581        (611)
       (Increase) decrease in inventory            (1,843)     (1,804)
       (Increase) decrease in prepaid expenses        199         196 
       Increase (decrease) in accounts payable       (241)        772 
       Increase (decrease) in accrued expenses       (229)        413 
                                                 --------    -------- 
  Net cash used in operating activities           (15,538)     (9,896)
                                                 --------    -------- 
  Cash flows from investing activities:                               
  Purchase of property and equipment                 (553)     (1,003)
  Purchases of investments                        (39,911)    (50,826)
  Sales and maturities of short-term investments   44,157      39,791 
                                                 --------    -------- 
  Net cash provided by (used in) investing                            
   activities                                       3,693     (12,038)
                                                 --------    -------- 
  Cash flows from financing activities:                               
  Proceeds from issuance of common stock               92         188 
                                                 --------    -------- 
  Net cash provided by (used in) financing                            
   activities                                          92         188 
                                                 --------    -------- 
  Net increase (decrease) in cash and cash                            
   equivalents                                    (11,753)    (21,746)
  Cash and cash equivalents, beginning of period   42,051      64,676 
                                                 --------    -------- 
  Cash and cash equivalents, end of period       $ 30,298    $ 42,930 
                                                 ========    ========
CONTACT:  TranS1 Inc.
          Investors:
          Michael Luetkemeyer, Chief Financial Officer
          910-332-1700

          Westwicke Partners
          Mark Klausner
          443-213-0501
          mark.klausner@westwicke.com
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