Endologix, Inc. (the “Company”) (NASDAQ: ELGX), a developer and
marketer of innovative treatments for aortic disorders, today
announced financial results for the third quarter ended
September 30, 2018.
“While there is still significant work to be done, our third
quarter results reflect the Company’s commitment to realizing the
full potential of our recently announced strategic plan, with the
ultimate goal of restoring credibility with customers and building
value for stockholders. Our revenue came in slightly above the
pre-announced range, and we also demonstrated gross margin
expansion and operating expense discipline during the quarter.
These results were largely driven by recent process improvements,
giving us confidence in our ability to achieve our 2018 financial
targets,” commented John Onopchenko, Chief Executive Officer of
Endologix, Inc. “Additionally, we continue to make progress toward
our clinical development and regulatory milestones and to educate
customers and investigators around the world on the clinical
benefits of AFX2, Ovation®, Alto®, and Nellix® in the treatment of
AAA.”
Financial Results
Global revenue in the third quarter of 2018 was $34.8 million, a
24.4% decrease from $46.0 million in the third quarter of 2017.
U.S. revenue in the third quarter of 2018 was $25.7 million, a
16.8% decrease from U.S. revenue of $30.9 million in the third
quarter of 2017. International revenue was $9.1 million, a 40.1%
decrease from International revenue of $15.1 million in the third
quarter of 2017. On a constant currency basis, third quarter 2018
International revenue decreased 39.6% over the third quarter of
2017.
Gross profit was $22.6 million in the third quarter of 2018,
which represents a gross margin of 65.1%. This compares to a gross
profit of $29.1 million, or a gross margin of 63.3%, in the third
quarter of 2017.
Total operating expenses of $38.5 million in the third quarter
of 2018 was flat when compared to the third quarter of 2017.
Excluding restructuring charges of $2.9 million in the third
quarter of 2018 and $0.1 million in the third quarter of 2017,
operating expense decreased 7.1% versus the third quarter of
2017.
Net loss for the third quarter of 2018 was $10.1 million, or
$(0.12) per share, compared to a net loss of $14.3 million, or
$(0.17) per share, a year ago. The net loss includes a $5.0 million
favorable fair market valuation of our Nellix contingent
consideration and an $8.3 million favorable change in derivative
related to the Deerfield credit facility. Adjusted Net Loss
(non-GAAP measure, defined below) totaled $13.0 million, compared
to an Adjusted Net Loss of $9.3 million for the third quarter of
2017. Adjusted EBITDA (non-GAAP measure, defined below) loss
totaled $9.3 million for the third quarter of 2018, compared to
Adjusted EBITDA loss of $4.3 million for the third quarter of
2017.
Total cash, cash equivalents, and restricted cash were $42.4
million as of September 30, 2018, and the Company had $10.0
million outstanding under the Deerfield revolving credit
facility.
Financial Guidance
As previously disclosed at its Investor Meeting in October, the
Company continues to anticipate 2018 revenue in the range of $150
million to $155 million. The Company now expects 2018 GAAP loss per
share to be in the range of $(0.91) to $(0.87), compared to the
previous range of $(1.12) to $(1.04). These loss per share numbers
contemplate the impact of restructuring charges in the second half
of the fiscal year but exclude the impact of any future changes in
fair value of contingent consideration or derivative
liabilities.
Furthermore, the Company continues to expect 2019 revenue of at
least $140 million, while operating expenses are anticipated to be
in the range of $130 million to $140 million.
Conference Call Information
Endologix's management will host a conference call today at 4:30
p.m. ET (1:30 p.m. PT) to discuss its third quarter 2018
results.
To participate in the conference call, dial 877-270-2148
(domestic) or 412-902-6510 (international) and refer to the
passcode 13684321.
This conference call will also be webcast and can be accessed
from the “Investors” section of the Company’s website at
www.endologix.com. The webcast replay
of the call will be available at the same site approximately one
hour after the end of the call.
A recording of the call will also be available from 7:30 p.m. ET
on Thursday, November 1, 2018, until 11:59 p.m. ET on Thursday,
November 8, 2018. To hear this recording, dial 844-512-2921
(domestic) or 412-317-6671 (international) and enter the passcode
13684321.
About Endologix, Inc.
Endologix, Inc. develops and manufactures minimally
invasive treatments for aortic disorders. The Company's focus is in
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 an 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. For more information,
visit 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. The Ovation Alto® System is only approved as an
investigational device and is not currently approved in any
market.
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 Endologix’s success in restoring credibility
with customers and building value for stockholders; Endologix’s
confidence in its ability to achieve its 2018 financial targets;
implementation of Endologix’s strategic and commercial execution
plans; Endologix’s progress toward its clinical development and
regulatory milestones; improvement in reducing operating expenses;
key strategic initiatives including educating physicians on the
clinical benefits of Endologix’s product offerings; prospects for
Endologix’s pipeline products, including Ovation Alto and Nellix;
positioning Endologix for profitable growth; Endologix’s 2018
revenue guidance and its anticipated 2018 GAAP loss per share; and
Endologix’s 2019 revenue guidance and its anticipated 2019
operating expense, 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, 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
and maintaining regulatory approval for Endologix's products,
Endologix’s ability to protect its intellectual property rights and
proprietary technologies, and other economic, business, competitive
and regulatory factors. The forward-looking statements contained in
this press release 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, 2017, and its Quarterly Reports on Form 10-Q for
the quarters ended March 31, 2018, June 30, 2018, and
September 30, 2018 (once it is filed) 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)" and (2) “Adjusted EBITDA" 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. These
measures, when used in conjunction with related GAAP financial
measures, provide investors with an additional financial analytical
framework that may be useful in assessing the Company’s financial
condition and results of operations. 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. Furthermore, these measures
are not intended to be liquidity measures. Other companies,
including other companies in the Company’s industry, may not use
these measures or may calculate these measures differently than the
Company does, limiting their usefulness as comparative
measures.
"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 (to the
extent relevant in a particular reporting period): (i) the fair
value adjustment to the Nellix® acquisition 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) inventory step-up amortization; and (ix)
loss on extinguishment of debt; and (x) fair value adjustment of
derivative liabilities. Endologix intends to calculate "Adjusted
Net Income (Loss)" in a consistent manner from period to
period.
In the three and nine months ended September 30, 2018 and
2017, 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) restructuring and other transition costs; (v) loss on
extinguishment of debt; and (vi) fair value adjustment of
derivative liabilities.
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.
Exhibit 99.1 ENDOLOGIX, INC. CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS Unaudited (In
thousands, except per share amounts) Three
Months Ended Nine Months Ended September 30,
September 30, 2018 2017 2018
2017 Revenue U.S. $ 25,699 $ 30,877 $ 85,060 $ 93,672
International 9,057 15,109 36,720 43,482
Total Revenue 34,756 45,986 121,780
137,154 Cost of goods sold 12,129 16,879
41,223 47,181 Gross profit $ 22,627 $ 29,107
$ 80,557 $ 89,973 Operating expenses: Research
and development 5,037 5,277 16,780 16,541 Clinical and regulatory
affairs 3,208 3,211 10,507 9,786 Marketing and sales 17,072 21,536
59,913 71,217 General and administrative 10,330 8,332 34,721 25,109
Restructuring costs 2,899 98 3,132 235
Total operating expenses 38,546 38,454 125,053
122,888 Loss from operations (15,919 ) (9,347 ) (44,496 )
(32,915 ) Other income (expense) (7,336 ) (5,664 ) (19,321 )
(15,514 ) Change in fair value of contingent consideration related
to acquisition 5,000 800 4,300 3,400 Change in fair value of
derivative liabilities 8,305 — 8,305 — Loss on debt extinguishment
— — (2,270 ) (6,512 ) Total other income (expense)
5,969 (4,864 ) (8,986 ) (18,626 ) Net loss before income tax
expense $ (9,950 ) $ (14,211 ) $ (53,482 ) $ (51,541 ) Income tax
expense (166 ) (62 ) (277 ) (338 ) Net loss $ (10,116 ) $ (14,273 )
$ (53,759 ) $ (51,879 ) Other comprehensive income (loss) foreign
currency translation 32 232 (647 ) 1,369
Comprehensive loss $ (10,084 ) $ (14,041 ) $ (54,406 ) $ (50,510 )
Basic and diluted net loss per share $ (0.12 ) $ (0.17 ) $
(0.64 ) $ (0.62 ) Shares used in computing basic and diluted net
loss per share 85,226 83,496 84,487 83,225
Exhibit 99.1
Non-GAAP Reconciliations:
Three Months Ended Nine Months Ended September
30, September 30, 2018 2017
2018 2017 Net Loss to Adjusted Net Loss: Net
loss $ (10,116 ) $ (14,273 ) $ (53,759 ) $ (51,879 ) Fair value
adjustment to Nellix contingent consideration liability (5,000 )
(800 ) (4,300 ) (3,400 ) Interest expense 7,225 6,021 18,895 16,119
Foreign currency (gain) loss 133 (354 ) 464 (560 ) Restructuring
and other transition costs 3,071 98 3,304 629 Loss on
extinguishment of debt — — 2,270 6,512 Fair value adjustment of
derivative liabilities (8,305 ) — (8,305 ) —
(1)
Adjusted Net Loss $ (12,992 ) $ (9,308 ) $ (41,431 ) $ (32,579
)
Adjusted Net Loss to Adjusted EBITDA: Adjusted
Net Loss $ (12,992 ) $ (9,308 ) $ (41,431 ) $ (32,579 ) Income
tax expense 166 62 277 338 Depreciation and amortization expense
1,988 2,287 5,919 6,934 Stock-based compensation expense 1,525
2,613 8,811 8,801
(2) Adjusted
EBITDA $ (9,313 ) $ (4,346 ) $ (26,424 ) $ (16,506 )
Exhibit 99.1
ENDOLOGIX, INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
Unaudited
(In thousands)
September 30, December 31, 2018
2017 ASSETS Current assets: Cash and cash equivalents
$ 38,271 $ 57,991 Restricted cash 4,143 2,608 Accounts receivable,
net allowance for doubtful accounts of $869 and $470, respectively.
22,756 32,294 Other receivables 75 418 Inventories 42,254 45,153
Prepaid expenses and other current assets 2,606 4,670
Total current assets 110,105 143,134 Property and
equipment, net 16,895 19,212 Goodwill 120,872 120,927 Intangibles,
net 77,312 80,403 Deposits and other assets 1,147 1,371
Total assets $ 326,331 $ 365,047
LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities:
Accounts payable $ 11,340 $ 12,351 Accrued payroll 14,260 15,054
Accrued expenses and other current liabilities 17,364 16,002
Current portion of debt 18,036 17,202 Revolving line of credit
10,000 21 Total current liabilities 71,000
60,630 Deferred income taxes 201 201 Deferred rent 7,761
7,724 Derivative liabilities 8,216 — Other liabilities 1,920 3,877
Contingently issuable common stock 5,000 9,300 Debt 189,090
208,253 Total liabilities 283,188 289,985
Commitments and contingencies Stockholders’ equity:
Convertible preferred stock, $0.001 par
value; 5,000,000 shares authorized. No shares issuedand
outstanding.
— —
Common stock, $0.001 par value;
170,000,000 and 135,000,000 shares authorized,
respectively.85,891,011 and 83,855,824 shares issued, respectively.
85,465,426 and 83,643,585 sharesoutstanding, respectively.
86 84 Treasury stock, at cost, 425,585 and 212,239 shares,
respectively. (4,026 ) (2,942 ) Additional paid-in capital 618,155
594,586 Accumulated deficit (573,760 ) (520,001 ) Accumulated other
comprehensive income 2,688 3,335 Total stockholders’
equity 43,143 75,062 Total liabilities and
stockholders’ equity $ 326,331 $ 365,047
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INVESTOR:Endologix, Inc.Vaseem Mahboob, CFO(949) 595-7200
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