Full Press Release Details
ClearPoint Neuro Reports Fourth Quarter and Full-Year
Company Reports Record Revenues
IRVINE, CA, March 4, 2021 - ClearPoint Neuro,
Inc. (Nasdaq: CLPT) (the "Company"), a global therapy-enabling platform company providing navigation and delivery to
the brain, today announced financial results for its fourth quarter and full-year ended December 31, 2020.
2020 Full Year and Fourth Quarter Highlights
"Our goal throughout the last 12 months was to exit the COVID-19 pandemic
in a stronger position than we started, and I believe we are doing just that," commented Joe Burnett, President and CEO of
ClearPoint Neuro. "Despite still dealing with COVID-related closures and postponements, we are stronger than we have ever
been as it relates to our strategy, our partners, our portfolio, and our pipeline of potential new customers. We now have a strong
balance sheet to match, which will allow our talented team to relentlessly execute on our strategy. We are proud of the growth
we showed in 2020, particularly in our biologics and drug delivery business, and most importantly, proud of the close to 700 patients
we helped treat throughout the year, in spite of the COVID-19 pandemic.
"As we continue to see closures and postponements related to ICU bed
capacity due to the COVID-19 pandemic, we are not yet in a position to give a forecast for 2021," continued Burnett. "We
are, however, very encouraged that hospitals that have been closed to elective procedures for several months in states such as
Massachusetts, California, Texas, Arizona, Oklahoma and Kansas, have started to schedule patients for March and April, and we expect
to return to pre-COVID procedure volume in the second half of 2021."
Financial Results - Year Ended December
Total revenues were approximately $12.8 million and $11.2 million for the
years ended December 31, 2020 and 2019, respectively.
Functional neurosurgery navigation and therapy revenues, which consist of
disposable product commercial sales related to cases utilizing the ClearPoint system and related services, decreased 12% to $6.3
million for 2020 from $7.1 million for 2019. This decrease primarily reflects the continuing effects of the COVID-19 pandemic.
Although vaccinations to combat the COVID-19 virus have commenced, and elective surgical procedures that were postponed or cancelled
at the outset of the pandemic have resumed, such resumption is at volumes that have not yet reached pre-pandemic activity.
Biologics and drug delivery revenue, which include sales of services related
to customer-sponsored clinical trials utilizing the ClearPoint system and of related disposable products, increased 109% to $5.0
million for 2020, from $2.4 million for 2019. This increase was due primarily to an increase from 2019 to 2020 of approximately
$2.7 million, or 302%, in biologics and drug delivery services.
Capital equipment revenue, consisting of sales of ClearPoint reusable hardware
and software, and of related services, decreased 10% to $1.5 million for 2020, as compared with $1.7 million for 2019. While revenues
from this product line historically have varied from quarter to quarter, the Company believes that many hospitals have postponed
capital equipment acquisition activities due to the COVID-19 pandemic.
The Company achieved a gross margin of 71% on its sales for 2020, compared
to a gross margin of 65% for 2019. This increase was due primarily to a shift in the mix of revenues by line of business that resulted
in service revenues, which bear higher gross margins in comparison to other product lines, representing a greater contribution
to total sales for 2020, relative to 2019.
Research and development costs were $4.7 million for 2020, compared to $2.8
million in 2019, an increase of 67%, resulting primarily from cost increases in compensation, collaborative research, and intellectual
property, including amortization of acquired license rights. Sales and marketing expenses were $5.4 million for 2020, compared
to $4.8 million for the same period in 2019, an increase of 13%, resulting primarily from an increase in base compensation costs,
attributable primarily to headcount increases in the Company's clinical and marketing teams, that were partially offset by
decreases in travel costs and incentive-based compensation. General and administrative expenses were $5.3 million for 2020, compared
to $4.3 million for 2019, an increase of 22%, resulting primarily from increases in compensation, consisting primarily of stock-based
compensation and officer transition costs, occupancy costs and legal fees.
Financial Results - Three Months Ended December 31, 2020
Total revenues were approximately $3.7 million and $3.2 million for the
three months ended December 31, 2020 and 2019, respectively.
Functional neurosurgery navigation and therapy product and service revenues
decreased 5% to $1.6 million for the fourth quarter of 2020 from $1.7 million for the same period in 2019, due primarily to the
previously mentioned continuing effects of the COVID-19 pandemic.
Biologics and drug delivery revenue increased 40% to $1.5 million for the
fourth quarter of 2020, from $1.1 million for the same period in 2019, due primarily to an increase in biologics and drug delivery
services of approximately 81% from the fourth quarter of 2019 to the same period of 2020.
Capital equipment product and related service revenue increased 41% to $0.6
million for the fourth quarter of 2020, as compared with $0.4 million for the same period in 2019, due primarily to an increase
in systems placement in the fourth quarter of 2020, relative to the same period in 2019.
The Company realized a gross margin of 61% on its sales for the fourth quarter
of 2020, compared to a gross margin of 69% for the same period in 2019, due primarily to a one-time, year-to-date reclassification
of certain costs, previously classified during 2020 as operating expenses, as cost of revenues.
Research and development costs were $1.8 million for the fourth quarter
of 2020, compared to $0.8 million for the same period in 2019, an increase of 120%, resulting primarily from cost increases in
compensation, collaborative research, and intellectual property, including amortization of acquired license rights. Sales and marketing
expenses were $1.5 million for the fourth quarter of each of 2020 and 2019, due primarily to decreases in travel costs and incentive-based
compensation being substantially offset by increases in compensation costs due to headcount increases in the Company's clinical
and marketing teams. General and administrative expenses were $1.3 million for the fourth quarter of each of 2020 and 2019, resulting
primarily from increases in compensation costs, occupancy costs and legal fees being offset by the one-time reclassification of
costs mentioned above.
At December 31, 2020, the Company had cash and cash equivalents totaling
approximately $20.1 million, resulting primarily from the issuance of senior secured convertible notes in January and December
2020 in the aggregate amount of $25 million, which resulted in net proceeds to the Company totaling approximately $24.3 million.
From the proceeds of the January 2020 note issuance, the Company repaid and retired notes issued in 2010 having an aggregate principal
amount of approximately $2.8 million and accrued interest of approximately $0.9 million at the date of repayment.
Teleconference Information
Investors and analysts are invited to listen to a
live broadcast review of the Company's 2020 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 online here or by visiting the Company's website
at www.clearpointneuro.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 the U.S. or Canada.
For those who cannot access the live broadcast, a
replay will be available shortly after the completion of the call until April 3, 2021 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.clearpointneuro.com on the "Investor
About ClearPoint Neuro
ClearPoint Neuro's mission is to improve and
restore quality of life to patients and their families by enabling therapies for the most complex neurological disorders with
pinpoint accuracy. Applications of the Company's current product portfolio include deep-brain stimulation, laser ablation,
biopsy, neuro-aspiration, and delivery of drugs, biologics, and gene therapy to the brain. The ClearPoint Neuro Navigation System
has FDA clearance, is CE-marked, and is installed in over 60 active clinical sites in the United States, Canada, and Europe. The
Company's SmartFlow cannula is being used in partnership or evaluation with 25 individual biologics and
drug delivery companies in various stages from preclinical research to late-stage regulatory trials. To date, more than 4,000
cases have been performed and supported by the Company's field-based clinical specialist team which offers support and services
for our partners. For more information, please visit www.clearpointneuro.com.
Forward-Looking Statements
Statements herein concerning the Company's plans,
growth and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding
the Company's future events, developments and future performance, as well as management's expectations, beliefs, plans, estimates
or projections relating to the future, are forward-looking statements within the meaning of these laws. Uncertainties and risks