Nuvectra Corporation (NASDAQ:NVTR), a neurostimulation medical
device company, today announced financial results for the third
quarter ended September 30, 2017.
Highlights
- Record consolidated revenues of $7.6 million
- Virtis™ CE Mark approval anticipated in Q1 2018. On track for
FDA approval with an anticipated commercial launch in the U.S. in
the back half of 2018
- Entered into amended development agreement for the directStim
DBS system in conjunction with Aleva Neurotherapeutics’ recent $13
million Series D financing
- Completed $12.5 million draw of its Second Tranche Term B
loan
Scott Drees, CEO, said, “I am encouraged with
our results this quarter, specifically our U.S. Algovita sales
activity, highlighted by 25% sequential quarter over quarter
growth. With respect to our MRI progress, we have received FDA
feedback and are evaluating our responses to the Agency.
Additionally, we are accelerating our Algovita post-market clinical
activities with a goal of initiating study sites in the fourth
quarter for our four-arm clinical study. We also remain highly
focused on our Virtis European and U.S. regulatory approvals and
ultimate commercialization expected in 2018.”
Third Quarter Financial
Results
Total revenue in the third quarter of 2017 was $7.6
million, a 102% increase from $3.8 million in the third quarter of
2016. Gross profit in the third quarter of 2017 was $3.5 million,
or 45.5% gross margin, a change from $2.1 million, or 56.8% gross
margin, in the third quarter of 2016. The decrease in gross margin
was primarily due to the shift in mix, due to the growth in our
Algovita product line, which has lower margins than our other
product lines, partially offset by an increase in Algovita margins
year over year.
Operating expenses in the third quarter of 2017
were $14.5 million, a 30% increase from $11.1 million in the third
quarter of 2016. This increase primarily reflects investments in
scaling the Company’s sales and marketing team and corporate
infrastructure.
Net loss for the third quarter of 2017 was
$(11.6) million or $(1.09) per share, compared with a net loss of
$(9.5) million, or $(0.92) per share, for the third quarter of
2016.
Total cash and cash equivalents were $37.5
million as of September 30, 2017. On September 28, 2017, the
Company completed the draw of its Second Tranche Term B loan in the
amount of $12.5 million.
Conference Call Information
Nuvectra will hold a conference call today,
Wednesday, November 1, 2017, at 4:30pm ET to discuss the results.
The dial-in numbers are (844) 882-7830 for domestic callers and
(574) 990-9704 for international callers. The conference ID is
95424626. A live webcast of the conference call will be
available on the investor relations section of the Company’s
website at http://investors.nuvectramed.com/.
A replay of the call will be available starting
on November 1, 2017 through November 8, 2017. To access the replay,
dial (855) 859-2056 for domestic callers and (404) 537-3406 for
international callers and enter access code 95424626. The webcast
will be available in the investor relations section of the
Company’s website for 90 days following the completion of the
call.
About Nuvectra Corporation
NuvectraTM is a neurostimulation company committed
to helping physicians improve the lives of people with chronic
conditions. The Algovita® Spinal Cord Stimulation (SCS) System is
our first commercial offering and is CE marked and FDA approved for
the treatment of chronic intractable pain of the trunk and/or
limbs. Our innovative technology platform also has capabilities
under development to support other indications such as sacral
neuromodulation (SNM) for the treatment of overactive bladder, and
deep brain stimulation (DBS) for the treatment of Parkinson’s
Disease. In addition, our NeuroNexus subsidiary designs,
manufactures and markets leading-edge neural-interface technologies
for the neuroscience clinical research market. Visit the Nuvectra
website at www.nuvectramed.com.
Cautionary Note Regarding
Forward-Looking Statements
This press release contains "forward-looking
statements," including statements we make regarding the outlook
for Nuvectra as an independent publicly-traded company.
Forward-looking statements are based only on our current beliefs,
expectations and assumptions regarding the future of our business,
future plans and strategies, projections, anticipated events and
trends, the economy and other future conditions, and therefore they
are subject to inherent uncertainties, risks and changes in
circumstances that are difficult to predict and may be outside of
our control. Our actual performance may differ materially from
those indicated in the forward-looking statements. Therefore, you
should not rely on any of these forward-looking statements. Any
forward-looking statement made by us is based only on information
currently available to us and speaks only as of the date on which
it is made. Important factors that could cause our actual
results to differ materially from those indicated in the
forward-looking statements include: (i) our ability to successfully
commercialize Algovita and to develop, complete and commercialize
enhancements or improvements to Algovita; (ii) our ability to
successfully compete with our current SCS competitors and the
ability of our U.S. sales representatives to successfully establish
market share and acceptance of Algovita, (iii) the uncertainty of
obtaining regulatory approvals in the United States and Europe for
our Virtis SNM system, (iv) our ability to successfully launch and
commercialize the Virtis SNM system if it receives regulatory
approval (v) our ability to demonstrate the features, perceived
benefits and capabilities of Algovita to physicians and patients in
competition with similar products already well established and sold
in the SCS market; (vi) our ability to anticipate and satisfy
customer needs and preferences and to develop, introduce and
commercialize new products or advancements and improvements to
Algovita in order to successfully meet our customers’ expectations;
(vii) the outcome of our development plans for our neurostimulation
technology platform, including our ability to identify additional
indications or conditions for which we may develop neurostimulation
medical devices or therapies and seek regulatory approval thereof;
(viii) our ability to identify business development and growth
opportunities and to successfully execute on our strategy,
including our ability to seek and develop strategic partnerships
with third parties to, among other things, fund clinical and
development costs for new product offerings; (ix) the performance
by our development partners, including Aleva
Neurotherapeutics, S.A., of their obligations under their
agreements with us; (x) the scope of protection for our
intellectual property rights covering Algovita and other products
using our neurostimulation technology platform, along with any
product enhancements or improvements; (xi) our ability to
successfully build, attract and maintain an effective commercial
infrastructure and qualified sales force in the United States;
(xii) our compliance with all regulatory and legal requirements
regarding implantable medical devices and interactions with
healthcare professionals; (xiii) any product recalls, or the
receipt of any warning letters, mandatory corrections or fines from
any governmental or regulatory agency; (xiv) our ability to satisfy
the conditions and covenants, including trailing six month revenue
milestones, of our Credit Facility; and (xv) our ability to raise
capital through means other than or in addition to the Credit
Facility should it become necessary to do so, through a public
offering of our common stock, private equity or debt financings,
strategic partnerships, or other sources. Please see the section
entitled “Risk Factors” in Nuvectra’s Annual Report on Form 10-K
and in our other quarterly and periodic filings for a description
of these and other risks and uncertainties. We undertake no
obligation to publicly update any forward-looking statement,
whether written or oral, that may be made from time to time,
whether as a result of new information, future developments or
otherwise.
Nuvectra
CorporationCONDENSED CONSOLIDATED BALANCE
SHEETS—Unaudited(in thousands except share and per
share data)
|
|
As of |
|
|
|
September 30,
2017 |
|
|
December 30,2016 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
37,531 |
|
|
$ |
63,710 |
|
Trade
accounts receivable, net of allowance for doubtful accounts of $429
in fiscal 2017 and $10 in fiscal 2016 |
|
|
6,675 |
|
|
|
3,177 |
|
Inventories |
|
|
3,010 |
|
|
|
5,233 |
|
Prepaid
expenses and other current assets |
|
|
1,201 |
|
|
|
443 |
|
Total
current assets |
|
|
48,417 |
|
|
|
72,563 |
|
Property, plant and
equipment, net |
|
|
6,227 |
|
|
|
6,317 |
|
Intangible assets,
net |
|
|
1,499 |
|
|
|
1,714 |
|
Goodwill |
|
|
38,182 |
|
|
|
38,182 |
|
Other long-term
assets |
|
|
245 |
|
|
|
526 |
|
Total
assets |
|
$ |
94,570 |
|
|
$ |
119,302 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
2,147 |
|
|
$ |
9,928 |
|
Accrued
liabilities |
|
|
4,975 |
|
|
|
3,355 |
|
Accrued
compensation |
|
|
4,061 |
|
|
|
2,757 |
|
Short-term debt |
|
|
5,500 |
|
|
|
— |
|
Total
current liabilities |
|
|
16,683 |
|
|
|
16,040 |
|
Other long-term
liabilities |
|
|
916 |
|
|
|
940 |
|
Long-term debt,
net |
|
|
20,907 |
|
|
|
13,744 |
|
Total
liabilities |
|
|
38,506 |
|
|
|
30,724 |
|
|
|
|
|
|
|
|
|
|
Stockholders’
equity: |
|
|
|
|
|
|
|
|
Common
stock, $0.001 par value, 100,000,000 shares authorized; 10,745,653
and 10,319,627 shares issued and outstanding in fiscal 2017 and
fiscal 2016, respectively |
|
|
11 |
|
|
|
10 |
|
Additional paid-in capital |
|
|
125,287 |
|
|
|
121,806 |
|
Accumulated other comprehensive loss |
|
|
— |
|
|
|
(2 |
) |
Accumulated deficit |
|
|
(69,234 |
) |
|
|
(33,236 |
) |
Total
stockholders’ equity |
|
|
56,064 |
|
|
|
88,578 |
|
|
|
|
|
|
|
|
|
|
Total
liabilities and stockholders’ equity |
|
$ |
94,570 |
|
|
$ |
119,302 |
|
Nuvectra
CorporationCONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONSAND COMPREHENSIVE LOSS —
Unaudited(in thousands except per share
data)
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, 2017 |
|
|
September 30, 2016 |
|
|
September 30, 2017 |
|
|
September 30, 2016 |
|
|
Sales: |
|
|
|
|
|
|
|
|
Product |
$ |
7,431 |
|
|
$ |
2,603 |
|
|
$ |
18,684 |
|
|
$ |
6,044 |
|
|
Service |
|
186 |
|
|
|
1,163 |
|
|
|
1,196 |
|
|
|
2,338 |
|
|
Total
sales |
|
7,617 |
|
|
|
3,766 |
|
|
|
19,880 |
|
|
|
8,382 |
|
|
Cost of sales: |
|
|
|
|
|
|
|
|
Product |
|
4,019 |
|
|
|
1,144 |
|
|
|
9,393 |
|
|
|
2,872 |
|
|
Service |
|
132 |
|
|
|
484 |
|
|
|
708 |
|
|
|
1,074 |
|
|
Total
cost of sales |
|
4,151 |
|
|
|
1,628 |
|
|
|
10,101 |
|
|
|
3,946 |
|
|
Gross
profit |
|
3,466 |
|
|
|
2,138 |
|
|
|
9,779 |
|
|
|
4,436 |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Selling,
general and administrative expenses |
|
11,358 |
|
|
|
8,006 |
|
|
|
33,349 |
|
|
|
18,185 |
|
|
Research,
development and engineering costs, net |
|
3,136 |
|
|
|
3,114 |
|
|
|
10,730 |
|
|
|
10,097 |
|
|
Other
operating expenses |
|
— |
|
|
|
7 |
|
|
|
— |
|
|
|
476 |
|
|
Total
operating expenses |
|
14,494 |
|
|
|
11,127 |
|
|
|
44,079 |
|
|
|
28,758 |
|
|
Operating
loss |
|
(11,028 |
) |
|
|
(8,989 |
) |
|
|
(34,300 |
) |
|
|
(24,322 |
) |
|
Interest expense,
net |
|
422 |
|
|
|
455 |
|
|
|
1,190 |
|
|
|
978 |
|
|
Other expense, net |
|
179 |
|
|
|
6 |
|
|
|
499 |
|
|
|
53 |
|
|
Loss
before provision for income taxes |
|
(11,629 |
) |
|
|
(9,450 |
) |
|
|
(35,989 |
) |
|
|
(25,353 |
) |
|
Provision for income
taxes |
|
9 |
|
|
|
— |
|
|
|
9 |
|
|
|
— |
|
|
Net
loss |
$ |
(11,638 |
) |
|
$ |
(9,450 |
) |
|
$ |
(35,998 |
) |
|
$ |
(25,353 |
) |
|
|
|
|
|
|
|
|
|
|
Other comprehensive
gain: |
|
|
|
|
|
|
|
|
Unrealized holding gain on investments arising during
period |
|
— |
|
|
|
— |
|
|
|
2 |
|
|
|
— |
|
|
Other comprehensive
gain |
|
— |
|
|
|
— |
|
|
|
2 |
|
|
|
— |
|
|
Comprehensive loss |
$ |
(11,638 |
) |
|
$ |
(9,450 |
) |
|
$ |
(35,996 |
) |
|
$ |
(25,353 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share |
$ |
(1.09 |
) |
|
$ |
(0.92 |
) |
|
$ |
(3.43 |
) |
|
$ |
(2.47 |
) |
|
Basic and diluted
weighted average shares outstanding |
|
10,697 |
|
|
|
10,279 |
|
|
|
10,497 |
|
|
|
10,268 |
|
|
Company Contacts:Nuvectra
CorporationWalter Berger, COO & CFO(214)
474-3102wberger@nuvectramed.com
Investor Contacts:The Ruth
GroupZack Kubow / Brian Johnston(646)
536-7020/7028investors@nuvectramed.com
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