Endologix
Feb 22, 2017

Endologix Reports Results for the Fourth Quarter and Full Year 2016

IRVINE, Calif., Feb. 22, 2017 (GLOBE NEWSWIRE) -- Endologix, Inc. (NASDAQ:ELGX), developer and marketer of innovative treatments for aortic disorders, today announced financial results for the three and twelve months ended December 31, 2016.

John McDermott, Endologix Chief Executive Officer, said, "In 2016, we successfully completed the TriVascular integration, advanced our strategic initiatives, and remain well positioned to execute on our long-term growth strategy. Looking forward, we have several opportunities to build value and enhance our position in the global aortic market. We anticipate CE Mark approval for Ovation Alto and Nellix ChEVAS in 2017, further expanding the number of AAA patients that can be treated with our innovative technologies. We also have several clinical milestones anticipated over the coming year, including presentation of the LUCY data and initiation of U.S. IDE clinical trials for Ovation Alto and Nellix ChEVAS. We also remain on track to submit the Nellix two-year IDE results and updated IFU to the FDA in the second quarter, which will be a key milestone towards Nellix FDA approval."

Financial Results

As a result of its merger with TriVascular Technologies, Inc. completed on February 3, 2016, Endologix's GAAP results ("as reported") include TriVascular's results from that date forward. In addition to reporting GAAP results, Endologix is providing a comparison to combined financial results, which combine standalone Endologix and TriVascular results for the fourth quarter of 2015 and year ended December 31, 2015 in their entirety.

Global revenue in the fourth quarter of 2016 was $47.5 million, a 21% increase from $39.2 million in the fourth quarter of 2015 and a 3% decrease from combined revenue of $49.0 million in the fourth quarter of 2015. For the year ended December 31, 2016, global revenue was $192.9 million, a 26% increase from $153.6 million for the year ended December 31, 2015 and a 1% increase from combined revenue of $190.6 million for the year ended December 31, 2015.

U.S. revenue in the fourth quarter of 2016 was $33.7 million, a 27% increase as reported and a 1% decrease from combined U.S. revenue of $33.9 million in the fourth quarter 2015. International revenue was $13.8 million, an 8% increase as reported and a 9% decrease from combined international revenue of $15.1 million in the fourth quarter of 2015. On constant currency basis, fourth quarter 2016 international revenue increased 10% as reported and decreased 7% on a combined basis.

Gross profit was $29.5 million in the fourth quarter of 2016, which represents a gross margin of 62%, compared to a gross margin of 60% as reported and 61% on a combined basis in the fourth quarter of 2015. Gross profit was $123.8 million for the year ended December 31, 2016, representing a gross margin of 64%. This compares to a gross margin of 66% as reported and 65% on a combined basis for the year ended December 31, 2015. Fourth quarter and year ended December 31, 2016 gross profit was negatively impacted by $0.6 million and $10.5 million related to purchase price accounting for inventory and intangible assets acquired by Endologix in the TriVascular merger. Excluding this impact, fourth quarter 2016 gross margin was 63% and year ended December 31, 2016 was 70%.

Total operating expenses were $51.7 million in the fourth quarter of 2016, compared to $45.5 million as reported and $66.5 million on a combined basis in the fourth quarter of 2015. Fourth quarter 2016 operating expenses included $2.4 million for expenses related to restructuring and contract termination and fourth quarter 2015 included $5.1 million for business acquisition expenses. Excluding these items, operating expenses in the fourth quarter of 2016 as compared to combined operating expenses in the fourth quarter of 2015 were lower by $12.2 million, or 20%, driven by synergy savings resulting from the TriVascular merger. For the year ending December 31, 2016, total research & development expenses were 16% lower and total selling, general and administrative expenses were 11% lower as compared to combined reported expenses for the year ending December 31, 2015.

Net loss for the fourth quarter of 2016 was $24.9 million, or $(0.30) per share, compared with net loss of $15.3 million, or $(0.22) per share, and combined net loss of $32.6 million for the fourth quarter of 2015. Endologix reported a negative Adjusted EBITDA (non-GAAP and defined below) for the fourth quarter of 2016 of $13.2 million, compared with a combined negative Adjusted EBITDA for the fourth quarter of 2015 of $25.7 million.

For the year ended December 31, 2016, Endologix reported a net loss of $154.7 million, or $(1.91) per share, compared with net loss of $50.4 million, or $(0.75) per share, and combined net loss of $111.8 million for the year ended December 31, 2015. Endologix reported a negative Adjusted EBITDA for the year ended December 31, 2016 of $41.4 million, compared with a combined negative Adjusted EBITDA for the year ended December 31, 2015 of $78.4 million.

Total cash, cash equivalents, restricted cash and marketable securities were $49.1 million as of December 31, 2016, compared to $177.3 million as of December 31, 2015. During the fourth quarter of 2016, the Company used $1.0 million for merger and restructure related expenses.

Financial Guidance

Endologix anticipates 2017 revenue to be in the range of $193 million to $200 million, representing reported growth of 0% to 4% compared to 2016 and constant currency growth of 2% to 5%. Endologix anticipates 2017 GAAP loss per share of $(0.70) to $(0.76) per share.

Conference Call Information

Endologix's management will host a conference call today to discuss these topics beginning at 5:00 P.M. Eastern time (2:00 P.M. Pacific time). To participate via telephone please call (877) 407-0789 from the U.S. or 1-(201)-689-8562 from outside the U.S. A telephone replay will be available for seven days following the completion of the call by dialing (844) 512-2921 from the U.S. or 1-(412)-317-6671 from outside the U.S., and entering pin number 13655149. The conference call will be broadcast live over the Internet at www.endologix.com. After the live webcast, a webcast replay of the call and a transcript of the call will be available online from the investor relations page of Endologix's website through February 22, 2018.

About Endologix

Endologix, Inc. develops and manufactures minimally invasive treatments for aortic disorders. The Company's focus is endovascular stent grafts for the treatment of abdominal aortic aneurysms (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 AAA is approximately 80%, making it a leading cause of death in the U.S. Additional information can be found on Endologix's website at www.endologix.com.

The Nellix® EndoVascular Aneurysm Sealing System has obtained CE Mark in the EU and is only approved as an investigational device in the United States.

Cautions Regarding Forward-Looking Statements

Except for historical information contained herein, this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  These forward-looking statements generally can be identified by the use of words such as "anticipate," "expect," "could," "may," "will," "believe," "estimate," "forecast," "goal," "project," "continue," "outlook," "guidance," "future," other words of similar meaning and the use of future dates. Forward-looking statements used in this press release include, but are not limited to, statements regarding the status of Endologix's post-merger integration of TriVascular's businesses and operations, anticipated growth opportunities for Endologix's existing products and potential future products, the progress and results of clinical trials, Endologix's ability to obtain regulatory approval of its existing products and potential future products, Endologix's ability to increase revenue through sales of its existing products and potential future products, and 2017 financial guidance, the accuracy of which are necessarily subject to risks and uncertainties that may cause Endologix's actual results to differ materially and adversely from the statements contained herein.  Some of the potential risks and uncertainties that could cause actual results to differ materially and adversely from anticipated results include Endologix's ability to integrate the businesses and operations of, and to realize the expected benefits of its merger with, TriVascular, continued market acceptance, endorsement and use of Endologix's products, the success of clinical trials relating to Endologix's products, product research and development efforts, uncertainty in the process of obtaining regulatory approval for Endologix's products, risks associated with international operations, including currency exchange rate fluctuations, Endologix's ability to protect its intellectual property rights and proprietary technologies, and other economic, business, competitive and regulatory factors. Undue reliance should not be placed the forward-looking statements contained in this press release, which speak only as of the date of this press release. Endologix undertakes no obligation to update any forward- looking statements contained in this press release to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to Endologix's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2015, for more detailed information regarding these risks and uncertainties and other factors that may cause actual results to differ materially from those expressed or implied.

Discussion of Non-GAAP Financial Measures

Endologix's management believes that the non-GAAP measures of (1) "Adjusted Net Income (Loss)", (2) "Adjusted EBITDA"  and (3) "Combined Financial Results" enhance an investor's overall understanding of Endologix's financial and operating performance and its future prospects by (i) being more reflective of core operating performance and (ii) being more comparable with financial results over various periods. Endologix's management uses these financial measures for strategic decision making, forecasting future financial results, and evaluating current period financial and operating performance. The presentation of non-GAAP financial information is not intended to be considered in isolation or as a substitute for, or superior to, the financial information prepared and presented in accordance with GAAP.

"GAAP" is generally accepted accounting principles in the United States.

Adjusted Net Income (Loss) Definition:

(1) "Adjusted Net Income (Loss)" is a non-GAAP measure defined by Endologix as net income (loss) under GAAP, excluding: (i) the fair value adjustment to the Nellix acquisition contingent consideration; (ii) interest expense; (iii) foreign currency (gains) or losses; (iv) legal settlement costs; (v) contract termination and business acquisition expenses; (vi) business development expenses, including licensing costs related to research and development activities; (vii) restructuring and other transition costs; (viii) fair value adjustment of derivative liabilities; and (ix) inventory step-up amortization.

In the three and twelve months ended December 31, 2016, this GAAP adjustment to net loss specifically represents: (i) the fair value adjustment to Nellix contingent consideration liability; (ii) interest expense; (iii) foreign currency (gains) or losses; (iv) legal settlement costs; (v) contract termination and business acquisition expenses; (vi) business development expenses, including licensing costs related to research and development activities; (vii) restructuring and other transition costs; (viii) fair value adjustment of derivative liabilities; and (ix) inventory step-up amortization.

In the three and twelve months ended December 31, 2015, this GAAP adjustment to net loss specifically represents: (i) the fair value adjustment to the Nellix contingent consideration liability; (ii) interest expense from the Company's convertible debt; and (iii) foreign currency (gains) or losses; and (iv) business development expenses; and (v) contract termination and business acquisition expenses.

In future periods, Adjusted Net Income (Loss) will continue to exclude: (i) the fair value adjustments to the Nellix contingent consideration liability; (ii) interest expense from the Company's convertible debt; (iii) foreign currency (gains) or losses; (iv) legal settlement costs; (v) contract termination and business acquisition expenses; (vi) business development expenses; (vii) restructuring and other transition costs; (viii) fair value adjustment of derivative liabilities; (ix) inventory step-up amortization; and (x) other non-recurring expenses or income, as described by Endologix.

Adjusted EBITDA Definition:

(2) "Adjusted EBITDA" is a non-GAAP measure defined by Endologix as "Adjusted Net Income (Loss)" excluding income tax (benefit) expense, depreciation and amortization expense, and stock-based compensation expense.

Combined Financial Results Definition:

(3) "Combined Financial Results" are non-GAAP measures defined by Endologix as Endologix's financial results combined with TriVascular's financial results.


ENDOLOGIX, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Unaudited
(In thousands, except per share amounts)
    
 Three Months Ended Twelve Months Ended
 December 31, December 31,
 2016 2015 2016 2015
Revenue       
U.S.$33,654  $26,403  $136,111  $107,228 
International13,809  12,829  56,814  46,384 
Total Revenue47,463  39,232  192,925  153,612 
Cost of goods sold
18,002  15,515  69,133  51,821 
Gross profit $29,461  $23,717  $123,792  $101,791 
Operating expenses:
       
Research and development8,541  8,738  32,337  26,421 
Clinical and regulatory affairs4,551   4,415  16,215  15,418 
Marketing and sales25,010  19,110  107,759  78,213 
General and administrative11,175  8,149  41,044  29,581 
Restructuring costs
2,481    11,093   
Contract termination and business acquisition expenses
(88) 5,071  5,768   5,071 
Settlement costs
    4,650   
Total operating expenses
51,670  45,483  218,866  154,704 
Loss from operations(22,209) (21,766) (95,074) (52,913)
Other income (expense)(5,538) (3,139) (17,774) (6,748)
Change in fair value of contingent consideration
related to acquisition
2,600  100  2,500  (100)
Change in fair value of derivative liabilities
    (43,831)  
Total other expense
(2,938) (3,039) (59,105) (6,848)
Net loss before income tax expense
$(25,147) $(24,805) $(154,179) $(59,761)
Income tax benefit (expense)222  9,512  (498) 9,337 
Net loss$(24,925) $(15,293) $(154,677) $(50,424)
Other comprehensive income (loss) foreign currency translation$(89) $(555) $978  $(1,762)
Comprehensive loss$(25,014) $(15,848) $(153,699) $(52,186)
Basic and diluted net loss per share$(0.30) $(0.22) $(1.91) $(0.75)
Shares used in computing basic and diluted net loss per share82,686  67,976  80,976  67,671 


Non-GAAP Reconciliations:       
        
 Three Months Ended  Twelve Months Ended
 December 31, December 31,
 2016 2015 2016 2015
Net Loss to Adjusted Net Loss       
Net loss$(24,926) $(15,293) $(154,677) $(50,424)
Fair value adjustment to Nellix contingent consideration liability(2,600) (100) (2,500) 100 
Interest expense4,160  3,016  15,841  7,476 
Foreign currency (gain) loss1,274   89  2,112  (504)
Settlement costs    4,650   
Contract termination and business acquisition expenses(88) 5,071  5,768  5,071 
Business development expenses1,000  1,866  1,000  2,500 
Restructuring and other transition costs
2,907    12,414   
Fair value adjustment of derivative liabilities    43,831   
Inventory step-up amortization     8,238   
(1) Adjusted Net Loss$ (18,273) $(5,351) $(63,323) $(35,781)
        
Adjusted Net Loss to Adjusted EBITDA:       
Adjusted Net Loss$(18,273) $(5,351) $(63,323) $(35,781)
Income tax (benefit) expense(222) (9,512) 498  (9,337)
Depreciation and amortization2,618  1,325  9,149  5,886 
Stock-based compensation2,645  2,086  12,286   9,255 
(2) Adjusted EBITDA$(13,232) $(11,452) $(41,390) $(29,977)


         
 Three Months Ended December 31, 2015 Twelve Months Ended December 31, 2015
 Endologix
Standalone
TriVascular
Standalone
(3) Combined
Financial
Results
 Endologix
Standalone
TriVascular
Standalone
(3) Combined
Financial
Results
Revenue:       
US$26,403 $7,461 $33,864  $107,228 $26,475 $133,703 
International12,829 2,319 15,148  46,384 10,518 56,902 
Total Revenue39,232 9,780 49,012   153,612 36,993 190,605 
Cost of goods sold15,515 3,746 19,261  51,821 14,317 66,138 
Gross profit$23,717 $6,034 $29,751  $101,791 $22,676 $124,467 
Operating expenses:       
Research and development8,738 2,150  10,888  26,421 9,161 35,582 
Clinical and regulatory affairs4,415 1,826 6,241  15,418 7,132 22,550 
Marketing and sales19,110 10,933 30,043  78,213 40,121 118,334 
General and administrative8,149 6,156 14,305  29,581 19,069 48,650 
Contract termination and business acquisition expenses5,071  5,071  5,071  5,071 
Total operating expenses45,483 21,065 66,548  154,704 75,483 230,187 
Loss from operations(21,766)(15,031 )(36,797) (52,913)(52,807)(105,720)
Total other income (expense)(3,039)(2,303)(5,342) (6,848)(8,419)(15,267)
Net loss before income tax benefit (expense)$(24,805)$(17,334)$(42,139) $(59,761)$(61,226)$(120,987)
Income tax benefit (expense)9,512 (6)9,506  9,337 (185)9,152 
Net loss$(15,293)$(17,340)$(32,633) $(50,424)$(61,411)$(111,835)


    
    
 Three Months Ended Twelve Months Ended
 Dec. 31, 2015 Dec. 31, 2015
Combined Net Loss to Combined Adjusted Net Loss:   
Combined Net Loss$(32,633) $(111,835)
Fair value adjustment to Nellix contingent consideration liability(100) 100 
Interest expense5,276  15,624 
Foreign currency (gain) loss89   (504)
Contract termination and business acquisition expenses5,071  5,071 
Business development expenses1,866  2,500 
(3) Combined Adjusted Net Loss$(20,431) $(89,044)
    
Combined Adjusted Net Loss to Combined Adjusted EBITDA:   
Combined Adjusted Net Loss$(20,431) $(89,044)
Income tax (benefit) expense(9,506) (9,152)
Depreciation and amortization1,576  6,499 
Stock-based compensation2,638  13,275 
(3) Combined Adjusted EBITDA$(25,723) $(78,422)

 

ENDOLOGIX, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
Unaudited
(In thousands)
 
  
 December 31,
 2016 2015
ASSETS   
Current assets:   
Cash and cash equivalents$26,120  $124,553 
Restricted cash2,001   
Marketable securities20,988   52,768 
Accounts receivable, net of allowance for doubtful accounts of $1,037 and $226, respectively34,430  28,531 
Other receivables1,787  375 
Inventories41,160  27,860 
Prepaid expenses and other current assets3,359  2,325 
Total current assets129,845  236,412 
Property and equipment, net23,265  23,355 
Goodwill120,711  28,685 
Intangibles, net84,511  42,118 
Deposits and other assets1,352  480 
Total assets$359,684  $331,050 
    
LIABILITIES AND STOCKHOLDERS' EQUITY   
Current liabilities:   
Accounts payable$13,237  $17,549 
Accrued payroll19,997  13,030 
Accrued expenses and other current liabilities11,668  5,576 
Contingently issuable common stock  14,700 
Total current liabilities44,902  50,855 
Deferred income taxes879  879 
Deferred rent7,949  8,051 
Other liabilities3,783  210 
Contingently issuable common stock12,200   
Convertible notes177,178  167,748 
Total liabilities 246,891  227,743 
Commitments and contingencies   
Stockholders' equity:   
Convertible preferred stock, $0.001 par value; 5,000,000 shares authorized.  No shares issued and outstanding.   
Common stock, $0.001 par value; 135,000,000 and 100,000,000 shares authorized, respectively. 82,986,244 and 68,235,179 shares issued, respectively. 82,774,005 and 68,034,386 shares outstanding, respectively.83   68 
Additional paid-in capital567,765  404,462 
Accumulated deficit(453,601) (298,924)
Treasury stock, at cost, 212,239 and 200,793 shares, respectively.(2,942) (2,809)
Accumulated other comprehensive income1,488  510 
Total stockholders' equity112,793  103,307 
Total liabilities and stockholders' equity$359,684  $331,050 
COMPANY CONTACTS:

Endologix, Inc.

John McDermott, CEO

Vaseem Mahboob, CFO

(949) 595-7200

www.endologix.com



INVESTOR CONTACTS:

The Ruth Group

Zack Kubow (646) 536-7020

Nick Laudico (646) 536-7030

Source: Endologix

News Provided by Acquire Media