Submitted Neurovascular Indication Marking
Important Step toward Addressing Stroke Market; Raised $19.8
Million to Fund Ongoing Innovation
Corindus Vascular Robotics, Inc. (NYSE American: CVRS), a
leading developer of precision vascular robotics, today reported
financial results for its fourth quarter and year ended December
31, 2018.
Recent Financial Highlights and Business
Accomplishments:
- Revenue totaled $4.7 million during the
fourth quarter and $10.8 million for the full year 2018, an
increase of 12% over the fourth quarter and full year of 2017;
- Sold 522 cassettes in the quarter, an
increase of 15% year-over-year;
- Successfully conducted the world’s
first in-human telerobotic coronary intervention using CorPath®
GRX;
- Dr. Tejas Patel, Chairman and Chief
Interventional Cardiologist of the Apex Heart Institute in India,
conducted five percutaneous coronary intervention (PCI) procedures
from a distance of approximately 20 miles;
- Success of the study paves the way to
begin commercial product development for use of the CorPath System
in remote interventions and potentially expand the Company’s
robotic platform to address stroke care;
- Expanded the company’s global footprint
to include multiple systems in India and the Middle East and one in
Singapore; preparing to launch programs in Japan and Australia; and
received an order in Q1 2019 for the first system to be installed
in Europe at the Clinique Pasteur in Toulouse, France;
- Submitted for premarket clearance with
the U.S. Food & Drug Administration (FDA) for neurovascular
intervention indication for CorPath GRX;
- Upon successful FDA clearance, CorPath
GRX would become the world’s first and only robotic platform
indicated for use in PCI, percutaneous vascular intervention (PVI)
and neurovascular intervention (NVI);
- Preparing to submit the next wave of
procedural automation in the technIQ™ Series to the FDA for
clearance, with plans to submit early 2019;
- Raised an aggregate amount of $19.8
million in gross proceeds in a private placement with a large
institutional investor and existing investors in Q1 2019; and,
- Advanced partnership discussions to
co-develop and commercialize a neurovascular robotic platform with
remote capabilities.
“2019 is poised to be another significant year for Corindus. The
successful completion of the world’s first-in-human remote robotic
PCI procedure in India in December represents an exciting milestone
for the future of our technology. Doctors around the world are
embracing the technology and its life-saving potential for patients
with limited access to care. Physicians increasingly understand
that building clinical knowledge and expertise in robotics is a
prerequisite to telerobotic intervention. As a result, we expect to
see continued positive momentum and have seen a shortening of the
sales cycle from initial discussion to installation of our robotic
platform. Through the expansion of existing programs in the U.S.,
increased utilization and the broadening of our global footprint,
we believe we are on the right path to serve patients and build
shareholder value,” said Mark Toland, President and Chief Executive
Officer.
“Moreover, we have advanced our neurovascular work and look
forward to receiving clearance from the FDA for the neurovascular
indication for the CorPath GRX. We believe our technology has the
potential to address the large unmet need and transform the
standard of care for stroke patients, where access is limited and
time to treatment is critical. We expect the private placement we
recently completed, along with the potential strategic partnership
we are pursuing to provide us with the added financial flexibility
to bring this indication to market,” added Toland.
Fourth Quarter 2018 Financial Results
Revenue for the fourth quarter of 2018 totaled $4.7 million,
compared to $4.2 million in the same period of the prior year.
During the quarter, Corindus installed six new CorPath GRX Systems
and one system upgrade, increasing the installed base of CorPath
GRX to 52 systems.
Gross profit for the fourth quarter of 2018 totaled $1.9
million, compared to $1.2 million in the same period of the prior
year.
Selling, general and administrative expenses totaled $6.6
million for the fourth quarter of 2018, compared to $7.2 million in
the fourth quarter of 2017.
Research and development expenses totaled $2.6 million for the
fourth quarter of 2018, compared to $2.0 million in the fourth
quarter of 2017.
Net loss totaled $7.4 million for the fourth quarter of 2018,
compared to a net loss of $8.0 million in the fourth quarter of
2017.
2018 Financial Results
Revenue for 2018 totaled $10.8 million compared to $9.7 million
in 2017.
Gross profit totaled $2.1 million in 2018 compared to $0.4
million in 2017.
Selling, general and administrative expenses totaled $27.3
million in 2018, compared to $24.8 million in 2017.
Research and development expenses were $8.8 million in 2018,
compared to $9.5 million in 2017.
Net loss was $35.0 million in 2018 compared to a net loss of
$34.1 million in 2017.
Liquidity
Cash and cash equivalents as of December 31, 2018 were $23.8
million. In Q1 2019, Corindus completed a private placement,
raising an aggregate amount of $19.8 million in gross proceeds.
Webcast and Conference Call Information
Management will host a conference call and webcast today
beginning at 4:30pm ET to discuss financial results and recent
business developments.
Investors interested in listening to the conference call may do
so by dialing (833) 286-5802 (for domestic callers) or (647)
689-4447 (for international callers), using Conference ID: 5572188.
To listen to a live webcast, please visit the "Investor Relations"
section of the Company’s website at: www.corindus.com.
Following the call, a replay will be available on the Investor
Relations section of the Company’s website.
About Corindus Vascular Robotics, Inc.
Corindus Vascular Robotics, Inc. is a global technology leader
in robotic-assisted vascular interventions. The Company’s CorPath®
platform is the first FDA-cleared medical device to bring robotic
precision to percutaneous coronary and vascular procedures. CorPath
GRX is the second-generation robotic-assisted technology offering
enhancements to the platform by adding important key upgrades that
increase precision, improve workflow, and extend the capabilities
and range of procedures that can be performed robotically. We are
focused on developing innovative robotic solutions to revolutionize
treatment of emergent conditions by providing specialized and
timely medical care to patients around the world. For additional
information, visit www.corindus.com, and follow @CorindusInc.
Forward Looking Statements
Statements made in this release that are not statements of
historical or current facts are "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements may involve known and unknown
risks, uncertainties and other factors that may cause the actual
results, performance or achievements of Corindus to be materially
different from historical results or from any future results or
projections expressed or implied by such forward-looking
statements. Accordingly, readers should not place undue reliance on
any forward-looking statements. In addition to statements that
explicitly describe such risks and uncertainties, readers are urged
to consider statements in the conditional or future tenses or that
includes terms such as "believes," "belief," "expects,"
"estimates," "intends," "anticipates" or "plans" to be uncertain
and forward-looking. Forward-looking statements may include
comments as to Corindus’ beliefs and expectations as to future
events and trends affecting its business and are necessarily
subject to uncertainties, many of which are outside Corindus’
control.
Examples of such statements include statements regarding or such
as:
- That the success of the world’s first
in-human telerobotic coronary intervention paves the way to begin
commercial product development for use of the CorPath System in
remote interventions and potentially expand the Company's robotic
platform to address stroke care;
- The ability to commercialize the
CorPath System for remote interventions;
- The launch of programs in Japan and
Australia and the placement of systems in Europe and the timing of
such placements;
- The clearance of and timing of our
planned neurovascular FDA submission;
- The planned submission of procedural
automation in the technIQTM Series and the timing of such
submission;
- Our ability to enter into a partnership
to co-develop and commercialize a neurovascular robotic platform
with remote capabilities;
- The shortening of the sales cycle;
- The advancement of our remote vascular
robotic technology;
- The potential for remote vascular
robotic technology to revolutionize treatment times for patients
suffering from stroke and heart attacks;
- Beginning to see traction in revenue
and utilization; and
- That the private placement we recently
completed, along with a potential strategic partnership, would
provide us with the added financial flexibility to bring this
indication to market.
Important factors that could cause actual results to differ
materially from those indicated by such forward-looking statements
are described in the sections titled "Risk Factors" in the
Company's filings with the Securities and Exchange Commission,
including its most recent Annual Report on Form 10-K and Quarterly
Reports on Form 10-Q, as well as reports on Form 8-K, including,
but not limited to the following: our ability to expand our
technology platform and achieve the advances necessary for
telestenting and remote procedures, including in humans; our
ability to expand our technology platform for use in other segments
of the vascular intervention market, including neurointerventional
and other more complex cardiac interventions; obtaining necessary
regulatory approvals for the use on humans and marketing of our
products in the United States and in other countries, including for
stroke and other neurovascular interventions; the rate of adoption
of our CorPath System and the rate of use of our cassettes; risks
associated with market acceptance, including pricing and
reimbursement; our ability to enforce our intellectual property
rights; our need for additional funds to support our operations;
our ability to manage expenses and cash flow; factors relating to
engineering, regulatory, manufacturing, sales and customer service
challenges; potential safety and regulatory issues that could slow
or suspend our sales; and the effect of credit, financial and
economic conditions on capital spending by our potential customers.
Forward looking statements speak only as of the date they are made.
Corindus undertakes no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise that occur after that date. More
information is available on Corindus' website at
http://www.corindus.com.
CORINDUS VASCULAR ROBOTICS, INC.
UNAUDITED CONSOLIDATED BALANCE SHEETS
(In thousands)
December 31, December 31, 2018 2017
Assets Current
Assets: Cash and cash equivalents $ 23,849 $ 17,458 Accounts
receivable 4,599 2,863 Inventories, net 2,508 2,103 Prepaid
expenses and other current assets 447 539
Total current assets 31,403 22,963 Property and equipment,
net 1,779 1,452 Deposits and other assets 343
151 Total assets $ 33,525 $ 24,566
Liabilities, preferred stock and
stockholders' (deficit) equity
Current Liabilities: Accounts payable $ 3,591 $ 2,416 Accrued
expenses 3,292 3,637 Customer deposits - 93 Deferred revenue 662
339 Current portion of capital lease obligation 56 49 Current
portion of long-term debt 1,011 - Total
current liabilities 8,612 6,534
Long-term Liabilities: Deferred revenue, net of current portion 285
342 Long-term capital lease obligation, net of current portion 46
102 Other liabilities 62 73 Long-term debt 10,774
- Total long-term liabilities 11,167
517 Total liabilities 19,779 7,051
Commitments and Contingencies Total preferred stock
22,952 -
Total stockholders' (deficit) equity
(9,206 ) 17,515
Total liabilities, preferred stock and
stockholders' (deficit) equity
$ 33,525 $ 24,566
CORINDUS VASCULAR ROBOTICS, INC.
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS (In thousands, except share and per share
amounts) Three Months Ended Year Ended December 31, December
31, 2018 2017 2018 2017 Revenue $ 4,673 $ 4,190 $ 10,781 $
9,650 Cost of revenue 2,759 2,990
8,673 9,265 Gross profit 1,914
1,200 2,108 385
Operating expenses: Research and development 2,599 1,971
8,769 9,517 Selling, general and administrative 6,603 7,211 27,300
24,777 Restructuring charge (3 ) - 346
- Total operating expense 9,199
9,182 36,415 34,294
Operating loss (7,285 ) (7,982 ) (34,307 ) (33,909 )
Other income (expense) Warrant revaluation 80 - 120 - Interest, net
(268 ) 11 (884 ) (208 ) Other, net 38 -
82 (6 ) Total other income (expense), net
(150 ) 11 (682 ) (214 )
Net loss $ (7,435 ) $ (7,971 ) $ (34,989 ) $ (34,123 )
Accretion of beneficial conversion feature of Series A preferred
stock (30 ) - (5,266 ) - Dividends on preferred stock (752 ) -
(2,388 ) - Net loss attributable to common stockholders $
(8,217 ) $ (7,971 ) $ (42,643 ) $ (34,123 ) Net loss per
share attributable to common stockholders--basic and diluted $
(0.04 ) $ (0.04 ) $ (0.22 ) $ (0.20 ) Weighted-average
common shares used in computing net loss per share attributable to
common stockholders--basic and diluted 191,468,420
188,560,378 189,619,507
173,925,450 Comprehensive loss: Net loss $ (7,435 ) $
(7,971 ) $ (34,989 ) $ (34,123 ) Comprehensive loss $ (7,435 ) $
(7,971 ) $ (34,989 ) $ (34,123 )
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version on businesswire.com: https://www.businesswire.com/news/home/20190312005834/en/
Media Contact:Matter for CorindusJessica
Wolter978-518-4536corindus@matternow.comwww.matternow.com
Investor Contact:Lisa WilsonIn-Site Communications, Inc.T:
917-543-9932ir@corindus.com
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