Avinger, Inc. (NASDAQ:AVGR) (the “Company”), a leading developer of
innovative treatments for peripheral artery disease (“PAD”), today
reported results for the third quarter ended September 30, 2016.
Third Quarter and Recent Highlights
- Revenue of $5.3 million, a 95% increase compared to the third
quarter of 2015
- Added 17 Lumivascular™ accounts, expanding the installed base
of the Company's Lumivascular platform to 143 accounts
- Completed a public offering of common stock which resulted in
net proceeds of $31.5M
- Established national sales agreements with HealthTrust
Purchasing Group and the U.S. Department of Veterans Affairs
- Launched upgraded Lightbox L250 imaging console and began
shipments of Pantheris® with enhanced plaque cutting
capability
- Received expanded FDA indications for Pantheris as a diagnostic
imaging device
“We are very pleased with our sales execution this quarter,
which reflects the proactive changes made to the sales
organization, as well as our recent success in signing contracts
with large healthcare providers,” said Jeff Soinski, Avinger’s
president and CEO. “Additionally, we closed a significant financing
this quarter which allows us to continue to focus on driving
adoption of our Lumivascular technology.”
Dr. John B. Simpson, Avinger's founder and executive chairman,
stated, “In addition to ramping our revenues, we also have
increased and upgraded our product offerings, and have made good
progress on our R&D pipeline with regulatory filings planned in
upcoming quarters. Our new catheters and Lightbox reflect our
continued focus on responding to physician feedback, and our
planned future products should allow us to better treat patients
with more complex lesions in more tortuous locations, smaller
vessels below the knee and eventually in the coronary
arteries.”
Third Quarter 2016 Financial Results
Total revenue was $5.3 million for the third quarter ended
September 30, 2016, a 95% increase from the third quarter of 2015
and a 14% increase from the second quarter of 2016. Revenue related
to Lightbox imaging consoles was $1.4 million, a 65% increase
compared to the third quarter of 2015 and a 43% increase from the
second quarter of 2016. Revenue from disposable devices was $3.9
million, a 110% increase compared to the third quarter of 2015 and
a 5% increase from the second quarter of 2016. Revenue results
reflect the second full quarter of Pantheris sales following FDA
clearance on March 1, 2016 as well as continued strong adoption of
the Lumivascular platform by new hospital customers.
Gross margin for the third quarter of 2016 was 30%, down from
36% in the comparable quarter of 2015 and increased from 22% in the
second quarter of 2016. The year-over-year decrease was primarily
attributable to the growth of the Company’s manufacturing
infrastructure associated with the commercial launch of Pantheris
and a higher proportion of Lumivascular accounts participating in
the Company’s placement-to-purchase and rental programs, and the
improvement compared to the second quarter of 2016 related
primarily to reduced warranty costs and the higher gross margin
associated with revenues related to Lightbox imaging consoles.
Operating expenses for the third quarter of 2016 were $13.0
million, compared to $10.8 million in the third quarter of 2015.
This growth was primarily attributable to expansion of the
Company’s commercial organization and marketing expenses associated
with the launch of Pantheris.
Loss from operations for the third quarter of 2016 was $11.4
million, compared to $9.9 million for the third quarter of 2015,
and net loss for the third quarter of 2016 was $13.0 million,
compared to $13.3 million for the third quarter of 2015. Loss per
share for the third quarter of 2016 was $0.73, compared to $1.08
for the third quarter of 2015. The decreased loss per share
primarily reflects the issuance of 9.9 million shares in the
Company’s follow-on public offering which closed on August 16,
2016.
Adjusted EBITDA, a non-GAAP measure, was a loss of $9.3 million
for the third quarter of 2016, compared to a loss of $8.3 million
for the third quarter of 2015.
Cash and cash equivalents totaled $43.3 million as of September
30, 2016, compared to $43.1 million as of December 31, 2015.
2016 OutlookThe Company has narrowed its
expected range for 2016 revenues to $20 million to $21 million,
representing year-over-year growth ranging from 87% to 96%. This
compares to the previous range of $19 million to $23 million.
Net loss per share for 2016 is projected to be $(3.28) to
$(3.46), which reflects the increased weighted-average share count
of 16.5 million. This is compared to the previous guidance of
$(4.35) to $(4.55).
Consistent with the Company’s previous guidance, Adjusted
EBITDA, a non-GAAP measure, for 2016 is projected to be a loss of
$40 million to $43 million.
No reconciliation of the Company’s 2016 Adjusted EBITDA
guidance, which excludes estimates for stock-based compensation
expense, depreciation and amortization, is included in the
financial schedules attached to this press release. The Company is
not able to accurately forecast the excluded items at the level of
precision that would be required to be included in the most
directly comparable GAAP financial measure without unreasonable
efforts.
Conference Call Avinger will hold a conference
call today, November 3, 2016 at 1:30pm PT/4:30pm ET to discuss its
third quarter 2016 financial results. Individuals may listen to the
call by dialing (844) 776-7820 for domestic callers or (661)
378-9536 for international callers and referencing Conference ID:
96290958. To listen to a live webcast, please visit the investor
relations section of Avinger's website at: www.avinger.com.
A replay of the call will be available beginning November 3,
2016 at 4:30pm PT/7:30pm ET through 4:30pm PT/7:30pm ET on
November 4, 2016. To access the replay, dial (855) 859-2056 or
(404) 537-3406 and reference Conference ID: 96290958. The webcast
will also be available on Avinger's website for one year following
the completion of the call.
About Avinger, Inc. Avinger, Inc. is a
commercial-stage medical device company that designs, manufactures
and sells image-guided, catheter-based systems for the treatment of
patients with peripheral artery disease (PAD). PAD is characterized
by a build-up of plaque in the arteries that supply blood to the
legs and feet. The company’s mission is to dramatically improve the
treatment of vascular disease through the introduction of products
based on its Lumivascular platform, the only intravascular
image-guided system of therapeutic catheters available in this
market. Avinger’s current Lumivascular products include the
Lightbox imaging console, the Ocelot family of catheters, which are
designed to penetrate total arterial blockages, known as chronic
total occlusions, or CTOs, and Pantheris, the first-ever
image-guided atherectomy device, designed to precisely remove
arterial plaque in PAD patients. For more information, please visit
www.avinger.com.
Forward-Looking StatementsThis news release
contains forward-looking statements within the meaning of Section
27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934 and the Private Securities Litigation Reform
Act of 1995. These forward-looking statements include statements
regarding the long-term outlook for the adoption of Lumivascular
technology, future regulatory filings and product offerings, the
use of Lumivascular technology in more complex lesions and in the
coronary arteries, expectations for growth, and financial and
operating guidance. Such statements are based on current
assumptions that involve risks and uncertainties that could cause
actual outcomes and results to differ materially. These risks and
uncertainties, many of which are beyond our control, include our
dependency on a limited number of products; ability to demonstrate
the benefits of our lumivascular platform; the resource
requirements related to Pantheris; the outcome of clinical trial
results; potential exposure to third-party product liability and
intellectual property litigation; lack of long-term data
demonstrating the safety and efficacy of our lumivascular platform
products; reliance on third-party vendors; dependency on physician
adoption; reliance on key personnel; and requirements to obtain
regulatory approval to commercialize our products; as well as the
other risks described in the section entitled “Risk Factors” and
elsewhere in our second quarter Form 10-Q filing made with the
Securities and Exchange Commission on August 5, 2016. These
forward-looking statements speak only as of the date hereof and
should not be unduly relied upon. Avinger disclaims any obligation
to update these forward-looking statements.
Use of Non-GAAP Financial Measures
To supplement our condensed financial statements prepared in
accordance with U.S. generally accepted accounting principles
(GAAP), we also provide Adjusted EBITDA in this release. Management
of the company believes that Adjusted EBITDA, considered together
with GAAP financial information, provides useful information for
investors by excluding stock-based compensation expense,
depreciation and amortization, which are not indicative of the
company's core operating performance. Reconciliations of Adjusted
EBITDA used in this release to the most directly comparable GAAP
measures for the respective periods can be found in the
reconciliation of GAAP to non-GAAP financial information
immediately following the financial tables. We use Adjusted EBITDA
for financial and operational decision-making purposes and as a
means to evaluate period-to-period comparisons. We believe that
Adjusted EBITDA provides useful information about our operating
results, enhance the overall understanding of past financial
performance and future prospects and allow for greater transparency
with respect to key metrics used by management in its financial and
operational decision making. Non-GAAP financial measures have
limitations as analytical tools, are likely different than those
provided by other companies in our industry and should not be
considered in isolation or as a substitute for our financial
results prepared in accordance with GAAP.
Avinger,
Inc. |
|
|
|
Statements of
Operations Data |
|
|
|
(in thousands,
except per share data) |
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
|
|
|
|
|
September 30, |
|
September 30, |
|
|
|
|
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
Revenues |
|
$ |
5,316 |
|
|
$ |
2,721 |
|
|
$ |
14,535 |
|
|
$ |
7,856 |
|
|
|
|
Cost of
revenues |
|
|
3,742 |
|
|
|
1,750 |
|
|
|
10,747 |
|
|
|
4,672 |
|
|
|
|
|
Gross
profit |
|
|
1,574 |
|
|
|
971 |
|
|
|
3,788 |
|
|
|
3,184 |
|
|
|
|
|
|
|
|
|
30 |
% |
|
|
36 |
% |
|
|
26 |
% |
|
|
41 |
% |
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
3,591 |
|
|
|
3,955 |
|
|
|
11,505 |
|
|
|
11,766 |
|
|
|
|
|
Selling, general and administrative |
|
|
9,414 |
|
|
|
6,892 |
|
|
|
31,036 |
|
|
|
19,802 |
|
|
|
|
|
|
Total operating
expenses |
|
|
13,005 |
|
|
|
10,847 |
|
|
|
42,541 |
|
|
|
31,568 |
|
|
|
|
Loss from
operations |
|
|
(11,431 |
) |
|
|
(9,876 |
) |
|
|
(38,753 |
) |
|
|
(28,384 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income |
|
|
27 |
|
|
|
11 |
|
|
|
88 |
|
|
|
23 |
|
|
|
|
Interest
expense |
|
|
(1,553 |
) |
|
|
(1,334 |
) |
|
|
(3,959 |
) |
|
|
(4,002 |
) |
|
|
|
Other
income (expense), net |
|
|
(12 |
) |
|
|
(2,058 |
) |
|
|
(7 |
) |
|
|
(1,525 |
) |
|
|
|
Loss before
provision for income taxes |
|
|
(12,969 |
) |
|
|
(13,257 |
) |
|
|
(42,631 |
) |
|
|
(33,888 |
) |
|
|
|
Provision
for income taxes |
|
|
- |
|
|
|
(7 |
) |
|
|
- |
|
|
|
- |
|
|
|
|
Net loss
and comprehensive loss |
|
|
(12,969 |
) |
|
|
(13,250 |
) |
|
|
(42,631 |
) |
|
|
(33,888 |
) |
|
|
|
Adjustment
to net loss resulting from convertible preferred stock
modification |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(2,384 |
) |
|
|
|
Net loss
and comprehensive loss attributable to common stockholders |
|
$ |
(12,969 |
) |
|
$ |
(13,250 |
) |
|
$ |
(42,631 |
) |
|
$ |
(36,272 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
attributable to common stockholders per share, basic and
diluted |
|
$ |
(0.73 |
) |
|
$ |
(1.08 |
) |
|
$ |
(2.97 |
) |
|
$ |
(3.32 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average common shares used to |
|
|
|
|
|
|
|
|
|
|
|
|
compute net
loss per share, basic and diluted |
|
|
17,694 |
|
|
|
12,280 |
|
|
|
14,378 |
|
|
|
10,935 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Avinger,
Inc. |
|
Balance Sheets
Data |
|
(in
thousands) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30, |
|
December
31, |
|
|
|
|
|
|
2016 |
|
|
|
2015 |
|
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
43,281 |
|
|
$ |
43,059 |
|
|
|
|
Accounts
receivable, net |
|
|
4,693 |
|
|
|
2,060 |
|
|
|
|
Inventories |
|
|
7,080 |
|
|
|
5,405 |
|
|
|
|
Prepaid
expenses and other current assets |
|
|
773 |
|
|
|
533 |
|
|
|
Total
current assets |
|
|
55,827 |
|
|
|
51,057 |
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
4,401 |
|
|
|
2,822 |
|
|
Other assets |
|
|
211 |
|
|
|
225 |
|
|
|
Total
assets |
|
$ |
60,439 |
|
|
$ |
54,104 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
1,326 |
|
|
$ |
1,113 |
|
|
|
|
Accrued
compensation |
|
|
2,823 |
|
|
|
3,083 |
|
|
|
|
Accrued
expenses and other current liabilities |
|
|
2,822 |
|
|
|
3,285 |
|
|
|
Total
current liabilities |
|
|
6,971 |
|
|
|
7,481 |
|
|
|
|
|
|
|
|
|
|
Borrowings |
|
|
40,713 |
|
|
|
29,565 |
|
|
Other long-term liabilities |
|
|
840 |
|
|
|
1,469 |
|
|
|
|
Total
liabilities |
|
|
48,524 |
|
|
|
38,515 |
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred
stock |
|
|
- |
|
|
|
- |
|
|
|
Common
stock |
|
|
23 |
|
|
|
13 |
|
|
|
Additional
paid-in capital |
|
|
250,784 |
|
|
|
211,837 |
|
|
|
Accumulated
deficit |
|
|
(238,892 |
) |
|
|
(196,261 |
) |
|
|
|
Total stockholders’
equity |
|
|
11,915 |
|
|
|
15,589 |
|
|
|
|
Total liabilities and
stockholders’ equity |
|
$ |
60,439 |
|
|
$ |
54,104 |
|
|
|
|
|
|
|
|
|
|
Avinger,
Inc. |
Adjusted
EBITDA |
(in
thousands) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
|
|
September 30, |
|
September 30, |
|
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
Loss from
operations |
$ |
(11,431 |
) |
|
$ |
(9,876 |
) |
|
$ |
(38,753 |
) |
|
$ |
(28,384 |
) |
Add:
Stock-based compensation |
|
1,712 |
|
|
|
1,211 |
|
|
|
5,301 |
|
|
|
3,691 |
|
Add:
Depreciation and amortization |
|
404 |
|
|
|
320 |
|
|
|
1,095 |
|
|
|
960 |
|
|
Adjusted
EBITDA |
$ |
(9,315 |
) |
|
$ |
(8,345 |
) |
|
$ |
(32,357 |
) |
|
$ |
(23,733 |
) |
|
|
|
INVESTOR CONTACT
Matt Ferguson
Avinger, Inc.
(650) 241-7917
ir@avinger.com
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