ClearPoint Neuro Reports Fourth Quarter and Full Year 2023 Preliminary Revenue Results and Guidance for Full Year 2024 Revenue
January 08 2024 - 4:05PM
ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global
therapy-enabling platform company providing navigation and delivery
to the brain, today announced preliminary, unaudited financial
results for its fourth quarter and full year ended December 31,
2023. These preliminary unaudited financial results are
management’s estimates and are subject to revision in the course of
completing annual audit processes. Audited results for 2023 will be
publicly reported by the Company later in the first quarter of
2024, prior to a Form 10-K filing for the year with full financial
statements.
Fourth Quarter 2023 Preliminary
Unaudited Financial Highlights
- Preliminary
unaudited revenue of approximately $6.8 million, a 32%
year-over-year increase;
- Increased biologics and drug delivery
revenue to approximately $4.1 million, a 76% year-over-year
increase; and
- Cash burn of approximately $1.2 million
in the fourth quarter. The Company had approximately $23.1 million
in cash and cash equivalents at December 31, 2023.
Full Year 2023 Preliminary Unaudited
Financial Highlights
- Achieved
preliminary unaudited record revenue of approximately $24 million,
a 17% year-over-year increase, versus most recent guidance of $23 -
$25 million; and
- Increased biologics
and drug delivery revenue to approximately $13.6 million, a 49%
year-over-year increase.
Business Outlook and Planned Value
Creating Milestones
- The Company
estimates revenue in 2024 to be between $28 million and $32
million, representing growth between 17% and 33%;
- Achieve FDA clearance and launch
SmartFrame OR for navigation and first revenue in the operating
room;
- Launch full market release of the
ClearPoint PRISM® Neuro Laser Therapy System;
- Launch and deploy ClearPoint 2.2
Software with embedded ClearPoint Maestro® and 1.2 Array Software
with parallel trajectory tumor planning application to the
installed base;
- Win first purchase orders for GLP ready
pre-clinical services;
- Prototype demonstration of next
generation software application for AI predictive modeling to
pharma partners;
- Continue global expansion to achieve
100 ClearPoint sites by 2025; and
- Demonstrate operating leverage with
expenses increasing less than revenue growth.
“We are thrilled with our fourth quarter performance delivering
record revenue of $6.8 million, reflecting 32% growth, while
meaningfully reducing our cash burn and gaining commitments for
multiple new ClearPoint installations,” commented Joe Burnett,
President and CEO at ClearPoint Neuro.
“In 2024, we look forward to several new product introductions
reflecting success with the strategic investments we have made to
expand our leadership position, including the SmartFrame OR for our
entrance into the operating room; the full market release of the
PRISM laser therapy system; the integration of ClearPoint Maestro
into our navigation software; and the expansion of our pre-clinical
biologics and drug delivery services including GLP readiness. These
represent four new potential revenue streams that we plan to add to
our base business throughout the year.”
Management will be available for meetings in San Francisco
during the J.P. Morgan Healthcare Conference from January 8-11,
2024.
About ClearPoint Neuro
ClearPoint Neuro is a device, cell, and gene therapy-enabling
company offering precise navigation to the brain and spine. The
Company uniquely provides both established clinical products as
well as pre-clinical development services for controlled drug and
device delivery. The Company’s flagship product, the ClearPoint
Neuro Navigation System, has FDA clearance and is CE-marked.
ClearPoint Neuro is engaged with healthcare and research centers in
North America, Europe, Asia, and South America. The Company is also
partnered with the most innovative pharmaceutical/biotech
companies, academic centers, and contract research organizations,
providing solutions for direct CNS delivery of therapeutics in
pre-clinical studies and clinical trials worldwide. To date,
thousands of procedures have been performed and supported by the
Company’s field-based clinical specialist team, which offers
support and services to our customers and partners worldwide. For
more information, please visit www.clearpointneuro.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the context of the federal securities laws, including the Company’s
expectation for revenues, operating expenses, the adequacy of cash
and cash equivalent balances to support operations and meet future
obligations, the future market of its products and services, and
other performance and results. These forward-looking statements are
based on management’s current expectations and are subject to the
risks inherent in the business, which 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: global and political instability,
supply chain disruptions, labor shortages, and macroeconomic and
inflationary conditions; future revenue from sales of the Company’s
products and services; the Company’s ability to market,
commercialize and achieve broader market acceptance for new
products and services offered by the Company; the ability of our
biologics and drug delivery partners to achieve commercial success,
including their use of the Company’s products and services in their
delivery of therapies; the Company’s expectations, projections and
estimates regarding expenses, future revenue, capital requirements,
and the availability of and the need for additional financing; the
Company’s ability to obtain additional funding to support its
research and development programs; the ability of the Company to
manage the growth of its business; the Company’s ability to attract
and retain its key employees; and risks inherent in the research,
development, and regulatory approval 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, 2022, and the Company’s Quarterly Report on Form
10-Q for the three months ended September 30, 2023, both of which
have been filed with the Securities and Exchange Commission, and
the Company’s Annual Report on Form 10-K for the year ended
December 31, 2023, which the Company intends to file with the
Securities and Exchange Commission on or before March 31, 2024. The
Company does not assume any obligation to update these
forward-looking statements.
Contact:
Danilo D’Alessandro, Chief Financial Officer
(888) 287-9109
ir@clearpointneuro.com
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