Full Press Release Details
MRI Interventions Reports 36% Increase
in Fourth Quarter Revenue
and Record Quarterly ClearPoint Cases
Quarter Cash Burn from Operations Reduced to $600,000
IRVINE, CA, March 11, 2019 - MRI Interventions,
Inc. (OTCQB: MRIC) (the "Company") today announced financial results for its fourth fiscal quarter and full year ended
Fourth Quarter 2018 Highlights
Joe Burnett, President and Chief Executive
Officer of MRI Interventions, Inc., said, "We produced a record fourth quarter including 36% growth in total revenue, a record
188 ClearPoint cases, a record $1.6 million in functional neurosurgery revenue and a 70% gross margin while reducing cash used
in operations to $600,000. These results reflect diligent focus on our four-pillar growth strategy by our entire team and set the
stage for an even more exciting year ahead. This is reflected in our 2019 expectations, which call for 800 to 850 cases using our
ClearPoint system and revenue of $9.5 to $10.5 million.
"In pillar one, functional neurosurgery,
we again reported record case volumes and record revenue in the quarter. We also commenced evaluation at five new ClearPoint sites
and increased the number of sites using our multiple procedures per day protocol to seven. The increase in case volume reflected
resolution in late 2018 of the FDA actions that affected third-party providers in the laser ablation space and overall momentum
for ClearPoint guided procedures. We also received FDA clearance in November for our ClearPoint 2.0 next-generation software platform
and expect it will be available for purchase by all new and existing ClearPoint customers in the first half of 2019.
"In biologics and drug delivery, our
second pillar, we are supporting multiple new gene therapy trials using a variety of combinations of our products and clinical
support services. This includes commencement of services under our expanded agreement with Voyager as part of its Phase 2 and 3
VY-AADC clinical trial.
"In pillar three, therapy, we announced
an agreement with CLS to co-develop hardware, disposables and software to make the ClearPoint platform work together with the FDA-cleared
Tranberg Therma Therapy System in a single, coordinated and efficient workflow. We believe that adding laser therapy to our portfolio
has the potential to turn our lowest revenue and margin procedure into our highest. We also received clearance for our ClearPoint
PURSUIT Neuro Aspiration System designed in collaboration with the Mayo Clinic. The PURSUIT device allows surgeons to identify
an aspiration target using real-time MRI guidance and monitor the aspiration during surgery of the ventricular system or cerebrum.
Musick, Irvine, California 92618 949.900.6833
"And in pillar four, gaining global scale,
we entered into a distribution agreement with CLS for the distribution in the U.S. and Canada of its laser ablation system for
non-neuro applications.
"We believe these outcomes demonstrate
the success of our efforts to transform our company into a full-line neuro and spine therapy company, with products and partnerships
for navigation, laser ablation, deep-brain stimulation, aspiration, gene therapy and more. We are excited to continue these efforts
in 2019 and expect noteworthy increases in both cases and revenue as we continue to advance our initiatives."
The Company announced that it has raised its
2019 revenue expectation to be in a range of $9.5 to $10.5 million, representing year-over-year growth of 30% to 42%. The Company
expects ClearPoint case volume to show similar growth in reaching an estimated range of 800 to 850 cases across its product portfolio.
Financial Results - Three Months
Ended December 31, 2018
Functional neurosurgery revenue, which consists
of disposable product sales and services related to cases utilizing the ClearPoint system, increased 21% to $1.6 million for the
three months ended December 31, 2018, from $1.3 million for the same period in 2017. The increase was primarily due to an increase
in ClearPoint case volume.
Biologics and drug delivery revenue, which
include sales of disposable products and services related to customer-sponsored clinical trials and services, increased 1,029%
to $469,000 for the three months ended December 31, 2018, from $42,000 for the same period in 2017.
Capital equipment and related service revenue,
consisting of sales of ClearPoint reusable hardware and software and related services, decreased to $174,000 for the three months
ended December 31, 2018, from $290,000 for the same period in 2017, due primarily to a decrease in sales of ClearPoint systems,
which, as previously noted, historically have varied from quarter to quarter. The decrease in systems sales was partially offset
by a 79% increase in capital equipment-related service revenues for the three months ended December 31, 2018 from the same period
Gross margin for the three months ended December
31, 2018 improved to 70% from 61% in the same period in 2017, due primarily to favorable product mix of higher margin disposable
products and services.
Research and development costs were $481,000
for three months ended December 31, 2018, compared to $582,000 for the same period in 2017, a decrease of 17%. Sales and marketing
expenses were $879,000 for the three months ended December 31, 2018, compared to $1.0 million for the same period in 2017, a decrease
of 13%. General and administrative expenses were $1.2 million for the three months ended December 31, 2018, compared to $1.3 million
for the same period in 2017, a decrease of 4%.
Financial Results - Year Ended
Functional neurosurgery revenue decreased 2%
to $5.4 million from $5.5 million in 2017. The decrease was due primarily to two factors: (a) FDA actions taken in early 2018 that
adversely affected third-party providers in the laser ablation space until resolutions were accepted by the FDA in the 2018 fourth
quarter; and (b) a third-party provider introduced a new deep brain stimulation system that did not have approval for use in the
MRI suite for most of 2018, which was resolved in the 2018 third quarter. In spite of these factors, cases continued to climb year-over-year,
to 670 cases in 2018, compared with 629 in 2017.
Biologics and drug delivery revenue increased
177% to $1.1 million for 2018, from $405,000 in 2017. This increase was due primarily to the commencement of additional services
during 2018, and to an increase in biologics and drug delivery product sales.
Capital equipment and related service revenue
decreased to $813,000 for 2018, from $1.5 million in 2017, due primarily to a decrease in sales of ClearPoint systems, which, as
previously noted, historically have varied from quarter to quarter. The decrease in systems sales was partially offset by a 12%
increase in capital equipment-related service revenues for the year ended December 31, 2018, as compared to 2017.
Gross margin for the year ended December 31,
2018 improved to 67% from 61% in 2017. The increase was due primarily to increased contribution from higher margin disposables
and services revenue.
Research and development costs were $2.3 million
in 2018, compared to $2.8 million in 2017, a decrease of $504,000, or 18%. Sales and marketing expenses were $3.5 million for the
year ended December 31, 2018, compared to $4.0 million in 2017, a decrease of $424,000, or 11%. General and administrative expenses
were $4.3 million for 2018, compared to $4.0 million for in 2017, an increase of $279,000, or 7%.
Teleconference Information
Investors and analysts are invited to listen
to a live broadcast review of the Company's 2018 fourth quarter and full year financial results today at 4:30 p.m. Eastern
time (1:30 p.m. Pacific time) that may be accessed by visiting the Company's website at www.mriinterventions.com
and selecting "Investors" / "News" / "IR Calendar." Investors and analysts who would like
to participate in the conference call may do so via telephone at (877) 407-9034, or at (201) 493-6737 if calling from outside
For those who cannot access the live broadcast,
a replay will be available shortly after the completion of the call until March 25, 2019 by calling (877) 660-6853, or (201) 612-7415
if calling from outside the U.S. or Canada, and then entering conference I.D. number 413671. An online archive of the broadcast
will be available on the Company's website at www.mriinterventions.com, on the "Investor Relations" page.
About MRI Interventions, Inc.
Building on the imaging power of magnetic resonance
imaging ("MRI"), MRI Interventions is creating innovative platforms for performing the next generation of minimally
invasive surgical procedures in the brain. The ClearPoint Neuro Navigation System, which has received 510(k) clearance and is CE
marked, utilizes a hospital's existing diagnostic or intraoperative MRI suite to enable a range of minimally invasive procedures
in the brain. For more information, please visit www.mriinterventions.com.
Forward-Looking Statements