-----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, DMyCvMlVLlPaogXcwNk29WLFn9GA3wO6Prwvuzhg80ezt6RIzISAJiFVSI1CJD85 146ce8jt8/fY4AuV3YbOYA== 0001013606-04-000004.txt : 20040806 0001013606-04-000004.hdr.sgml : 20040806 20040806140905 ACCESSION NUMBER: 0001013606-04-000004 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20040630 ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20040806 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ENDOLOGIX INC /DE/ CENTRAL INDEX KEY: 0001013606 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 680328265 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-28440 FILM NUMBER: 04957356 BUSINESS ADDRESS: STREET 1: 13700 ALTON PARKWAY STREET 2: STE 160 CITY: IRVINE STATE: CA ZIP: 92618 BUSINESS PHONE: 9494579546 MAIL ADDRESS: STREET 1: 13900 ALTON PARKWAY STREET 2: SUITE 122 CITY: IRVINE STATE: CA ZIP: 92718 FORMER COMPANY: FORMER CONFORMED NAME: RADIANCE MEDICAL SYSTEMS INC /DE/ DATE OF NAME CHANGE: 19990122 FORMER COMPANY: FORMER CONFORMED NAME: CARDIOVASCULAR DYNAMICS INC DATE OF NAME CHANGE: 19960506 8-K 1 form8k2ndqtr.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) August 5, 2004

ENDOLOGIX, INC.


(Exact name of registrant as specified in its charter)



DELAWARE                   0-28440                    68-0328265


  (Stateor other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.)

13900 ALTON PARKWAY, SUITE 122
IRVINE, CA 92618


(Address of principal executive offices) (Zip Code)

Registrant's telephone number, including area code      (949) 595-7200


Item 7. FINANCIAL STATEMENTS AND EXHIBITS.

99.1 Press Release, dated August 5, 2004, issued by Endologix, Inc.

Item 12. DISCLOSURE OF RESULTS OF OPERATIONS AND FINANCIAL CONDITION.

On August 5, 2004, Endologix, Inc. announced financial results for the second quarter ended June 30, 2004. A copy of the press release making this announcement is attached hereto as Exhibit 99.1 and incorporated herein by reference. The press release shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933.

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, thereunto duly authorized.

 
 
Date: August 6, 2004 By:      /s/ David M. Richards           __________________________________________
           David M. Richards
           Chief Financial Officer

3


EXHIBIT INDEX

Exhibit 99.1   Earnings Release of Endologix, Inc. dated August 5, 2004  

4


EX-99 2 ex99-1.htm

Exhibit 99.1

{ENDOLOGIX, INC. LOGO}

PRESS RELEASE

DATE: August 5, 2004
CONTACT: David Richards, Chief Financial Officer, 949-595-7200
  www.endologix.com

Endologix, Inc.Reports

2nd Quarter 2004 Results

Irvine, CA — August 5, 2004 — Endologix, Inc., (NASDAQ: ELGX) today announced financial results for the secondquarter ended June 30, 2004.

Paul McCormick, Endologix’s President and CEO, said, “During the second quarter, we continued to make significant progress on the FDA’s review of our pre-market application (“PMA”) for the infrarenal Powerlink System for treating Abdominal Aortic Aneurysms. Moreover, we received and responded to the FDA’s letter following their in-depth review of our PMA. Based upon the FDA’s review thus far, and the strength of our clinical results, we continue to believe that we will receive FDA approval for our infrarenal Powerlink System in the second half of 2004.”

Total revenues for the second quarter of 2004 were 22% higher at $1,202,000, compared with $989,000 for the second quarter of 2003. The increase was due to higher product revenues for the second quarter of 2004 of $565,000, primarily from initial orders from our new European distributor, Edwards LifeSciences AG, and was partially offset by a decrease of $352,000 in license revenues from Guidant product licensing.

Total revenues for the first six months of 2004 were 6% lower at $2,022,000, compared with $2,151,000 for the same period of 2003. The increase in product revenue of $418,000 for the first six months of 2004 was due primarily from initial orders from our new European distributor, and was offset by a $547,000 decrease in license revenue from Guidant. We anticipate that Guidant license revenues will continue to decline.

Total operating expenses increased $319,000 for the second quarter of 2004 to $2,886,000, compared with $2,567,000 for the same period of 2003. The increase in sales and marketing staffing costs was related to higher staffing costs incurred in anticipation of a focused U.S. launch of our infrarenal Powerlink System in the second half of 2004 and accounted primarily for the increase in operating expenses during the second quarter of 2004.

Total operating expenses increased $683,000 for the first six months of 2004 to $5,500,000, compared with $4,817,000 for the same period of 2003. During the first six months of 2004, costs increased $435,000 for sales and marketing due primarily to staffing increases, as described above. General and administration costs increased $696,000 due mainly to a 2003 legal cost reimbursement of $468,000 under a lawsuit settlement, and 2004 consulting costs for review of our internal controls over financial reporting, as required under section 404 of the Sarbanes-Oxley Act. These cost increases were partially offset by a decrease in research and development costs for legacy radiation product clinical trials of $445,000.


Endologix, Inc. develops and manufactures minimally invasive treatments for vascular diseases. The Company’s Powerlink System is an endoluminal stent graft for treating abdominal aortic aneurysm (AAA). AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured abdominal aortic aneurysms is approximately 75%, making it the 13th leading cause of death in the United States. Additional information can be found on the Company’s Web site at www.endologix.com.

Except for historical information contained herein, this news release contains forward-looking statements, the accuracy of which are necessarily subject to risks and uncertainties, including reduction of Company revenue resulting from declines in sales of Guidant’s royalty-bearing products, and the unpredictability of clinical trials and regulatory approval, changes in future economic, competitive and market conditions, uncertainty of acceptance in the marketplace and future business decisions, adequacy of financial resources to support operations after December 31, 2005 and our ability to raise capital, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Endologix, and the risk factors and other matters set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2003, and other reports filed thereafter.


{ENDOLOGIX, INC. LOGO}

ENDOLOGIX, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)
(Unaudited)

Three Months Ended Six Months Ended
June 30, June 30,
2003
2004
2003
2004
Revenue:                    
  Product sales   $ 295   $ 860   $ 785   $ 1,203  
  License revenue    694    342    1,366    819  




Total revenues    989    1,202    2,151    2,022  
  Cost of product sales    108    415    365    658  




Gross profit    881    787    1,786    1,364  
Operating expenses:  
  Research, development and clinical    1,715    1,652    3,561    3,097  
  Marketing and sales    154    481    437    872  
  General and administrative    697    753    835    1,531  
  Minority Interest    1    --    (16 )  --  




Total operating expenses    2,567    2,886    4,817    5,500  




Loss from operations    (1,686 )  (2,099 )  (3,031 )  (4,136 )
Other income (expense):  
   Interest income    46    83    200    137  
  Gain (loss) on disposal of assets    (11 )  --    (8 )  3  
  Other expense    (2 )  (16 )  (4 )  (9 )




          Total other income    33    67    188    131  




Net loss    ($ 1,653 )  ($ 2,032 )  ($ 2,843 )  ($ 4,005 )




Basic and diluted net loss per share    ($ 0.07 )  ($ 0.06 )  ($ 0.12 )  ($ 0.13 )




Shares used in computing basic and  
    diluted net loss per share    23,915    31,717    23,981    30,495  





{ENDOLOGIX, INC. LOGO}

ENDOLOGIX, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)
(Unaudited)

December 31, June 30,
2003
2004
ASSETS            
  Cash, cash equivalents and marketable securities   $ 12,568   $ 21,398  
  Accounts receivable, net    239    505  
  Other receivables    656    442  
  Inventories    2,780    3,195  
  Other current assets    245    374  


      Total current assets    16,488    25,913  
Property and equipment, net    141    195  
Marketable securities    211    5,054  
Goodwill and other intangibles, net    18,136    17,433  
Other assets    367    28  


      Total Assets   $ 35,343   $ 48,624  


LIABILITIES AND STOCKHOLDERS' EQUITY   
Current liabilities   $ 1,468   $ 1,858  
Accrued compensation    --    88  


      Total liabilities    1,468    1,946  
Stockholders' equity    33,875    46,678  


      Total Liabilities and Stockholders' Equity   $ 35,343   $ 48,624  


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