Full Press Release Details
ClearPoint Neuro Reports Second Quarter 2021 Results
Record Case Volume Supported Clinically During the Quarter
SOLANA BEACH, CA, August 10, 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 second quarter ended June 30, 2021.
Second Quarter Highlights
Reported revenue of $3.4 million, a 38% year-over-year
Clinical team supported a record 249 cases, a
98% year-over- year increase;
Increased biologics and drug delivery revenue to
$1.4 million, a 19% year-over-year increase;
and drug delivery relationships bringing current count of active partners to approximately 35 from approximately 30 in
FDA clearance of the SmartFrame Array and performed first human cases.
continues to estimate total case volume supported to be in the range of 900 - 1000 for 2021; and
The Company continues to estimate revenue to be between $16.0
and $17.5 million for 2021.
"The ClearPoint Neuro team enjoyed multiple significant
successes in the 2021 second quarter, headlined by our record case volume result, which demonstrated a return to pre-pandemic levels
a quarter ahead of schedule," commented Joe Burnett, the Company's President and Chief Executive Officer. "Also encouraging
has been the resumption of clinical and pre-clinical activities by our biologics and drug delivery partners who have resumed lab-based
activities and enrollment in human clinical trials, which we believe puts the regulatory pathway for their therapies back on track. We
are currently working with more than 30 partners in the drug delivery space and expect to add additional partners in the second half
of 2021. Further, our development and production teams remain on track for all the programs we announced in February, which keeps our
planned timelines and key milestones on schedule. While we are monitoring the impact of the new Delta wave of COVID-19 cases, which has
again started to put pressure on elective procedures at several customer sites as hospital ICU beds fill up, we believe our biologics
and drug delivery business will make up for any potential impact in the second half and we continue to estimate that the range
of cases supported by our clinical team will be in a range of 900 - 1000, and that our revenues will be in a range of $16.0 - $17.5
Financial Results - Quarter Ended June 30, 2021
Total revenue was $3.4 million for the three months ended
June 30, 2021, and $2.5 million for the three months ended June 30, 2020, which represents an increase of $0.9 million, or 38%.
Functional neurosurgery navigation revenue, which consists
of disposable product commercial sales related to cases utilizing the ClearPoint system, increased 74% to $1.9 million for the three months
ended June 30, 2021, from $1.1 million for the same period in 2020. This increase reflects the resumption in the three months ended June
30, 2021, of elective surgical procedures, which were postponed or cancelled during the three months ended June 30, 2020, due to the effects
of the COVID-19 pandemic.
Biologics and drug delivery revenue, which includes sales
of disposable products and services related to customer-sponsored clinical trials utilizing our products, increased 19% to $1.4 million
for the three months ended June 30, 2021, from $1.2 million for the same period in 2020. This increase was due to an increase, during
the quarter ended June 30, 2021, relative to the same period in 2020, in biologic and drug delivery service revenue of $0.2 million, and
an increase in biologic and drug delivery product revenue of $0.04 million.
Capital equipment and software revenue, consisting of sales
of ClearPoint reusable hardware and software, and of related services, were $0.2 million for each of the three months ended June 30, 2021.
Revenue from this product line historically has varied from quarter to quarter, and overall, the Company believes that hospitals'
capital equipment acquisition activities remain at a low level, relative to the acquisition activity prior to the onset in 2020 of the
Gross margin for the three months ended June 30, 2021, was
67%, as compared with gross margin of 68% for the same period in 2020. This decrease in gross margin was due primarily to a decreased
contribution, during the three months ended June 30, 2021, as compared to the same period in 2020, from service revenue, which carries
a higher gross margin relative to product lines, substantially offset by an increased contribution from functional neurosurgery navigation
disposable product sales, which carry a higher gross margin relative to other product lines.
Research and development costs were $2.1 million for
the three months ended June 30, 2021, compared to $0.8 million for the same period in 2020, an increase of $1.3 million, or 161%.
The increase was due primarily to increases in personnel costs due to growth in headcount, and software development and product development
costs. Sales and marketing expenses were $1.6 million for the three months ended June 30, 2021, compared to $1.1 million for the same
period in 2020, an increase of $0.5 million, or 42%. This increase was due primarily to increases in marketing personnel costs resulting
from increases in headcount, and a commensurate increase in marketing activities including our expansion into Europe. General and administrative
expenses were $2.0 million for the three months ended June 30, 2021, compared to $1.2 million for the same period in 2020, an increase
of $0.8 million, or 63%. This increase was due primarily to increases in state franchise taxes, share-based compensation, occupancy costs,
insurance and professional fees related primarily to public company reporting.
At June 30, 2021, the Company had cash and cash equivalents
totaling $61.5 million as compared to $20.1 million at December 31, 2020, with the increase resulting primarily from the completion of
a public offering of its common stock in February 2021.
Teleconference Information
and analysts are invited to listen to a live broadcast review of the Company's 2021 second quarter on Tuesday, August 10, 2021 at 4:30
p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online here.
Investors and analysts who would like to participate in the conference call via telephone may do so at (877) 407-9034, or at (201) 493-6737
if calling from outside the U.S. or Canada and then entering conference
I.D. number 13721705.
For those who cannot access the live broadcast, a replay will
be available shortly after the completion of the call until September 10, 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 Relations" page.
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 sites in the United States, Canada, and Europe. ClearPoint Neuro is partnered with approximately
35 biologics/pharmaceutical companies and academic centers, providing solutions for direct CNS delivery of therapeutics in pre-clinical
studies and clinical trials worldwide. To date, more than 4,500 cases have been performed and supported by the Company's
field-based clinical specialist team, which offers support and services to our customers and partners. For more information, please visit
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 may cause the Company's actual
results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include
those relating to: the impact of the COVID-19 pandemic and the measures adopted to contain its spread; future revenue from sales of the
Company's ClearPoint Neuro Navigation System products; the Company's ability to market, commercialize and achieve broader
market acceptance for the Company's ClearPoint Neuro Navigation System products; and risks inherent in the research and development
of new products. More detailed information on these and additional factors that could affect the Company's actual results are described
in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2020, and
the Company's Quarterly Report on Form 10-Q for the three months ended March 31, 2021, both of which has been filed with the Securities
and Exchange Commission, and the Company's Quarterly Report on Form 10-Q for the three months ended June 30, 2021, which the Company
intends to file with the Securities and Exchange Commission on or before August 16, 2021.
Danilo D'Alessandro, Chief Financial Officer
Caroline Corner, Investor Relations
CLEARPOINT NEURO, INC.