Fourth Quarter 2022 Preliminary Unaudited Financial Highlights
- Preliminary unaudited revenue of
$5.2 million , a 21% year-over-year increase; - Increased biologics and drug delivery revenue to
$2.3 million , a 37% year-over-year increase; - Increased functional neurosurgery products and services to
$2.3 million , a 7% year-over-year increase; - Cash burn of approximately
$3.0 million in the fourth quarter. The Company had approximately$37.5 million in cash, cash equivalents and short-term investments atDecember 31, 2022 .
Full Year 2022 Preliminary Unaudited Financial Highlights
- Achieved preliminary unaudited record revenue of
$20.6 million , a 26% year-over-year increase, versus most recent guidance of$21.0 -$22.0 million ; - Increased biologics and drug delivery revenue to
$9.1 million , a 34% year-over-year increase; - Increased functional neurosurgery products and services revenue to
$9.1 million , a 13% year-over-year increase; - Added multiple new biologics and drug delivery partners in the year to bring the total to more than 50 partners.
Business Outlook and Planned Value Creating Milestones
- The Company estimates revenue in 2023 to be between
$25.0 million and$27.0 million , representing growth between 22% and 31%; - Submission to the FDA of a Biologics License Application (BLA) by PTC Therapeutics for Upstaza™, using the ClearPoint SmartFlow® Cannula, for minimally invasive infusion of the gene therapy;
- Initiation of multiple pharmaceutical partner clinical trials globally;
- Expansion of the installed base to approximately 10 additional centers worldwide;
- Revenue growth from international customers driven by 8 active centers installed in the E.U. and
U.K. ; - Commercialization of the ClearPoint PRISM™ Neuro Laser Therapy System and expansion into limited market release centers;
- Completion of Phase 1 safety study in
Lund, Sweden , for the use of PRISM™ to treat brain lesions; - Up to 8 FDA submissions for new hardware and software products in our portfolio;
- Production of first devices at our new expanded manufacturing facility in
California .
“Our team made tremendous progress toward our four-pillar growth strategy in 2022 and finished the year with approximately 26% growth in revenue, driven by the 34% revenue growth in our biologics and drug delivery business, and 11 new centers installed worldwide,” commented
The preliminary unaudited financial results described in the press release are estimates only and subject to revision until we report our full financial results for the fourth quarter and full year 2022 during our upcoming earnings announcement.
About
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, 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 more than 65 sites in
Forward-Looking Statements
Statements in this press release covering preliminary financial results for completed periods and expected results in future periods, and statements 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, the size of total addressable markets or the market opportunity for the Company’s products and services, 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, global instability, supply chain disruptions, labor shortages, and macroeconomic and inflationary conditions; future revenue from sales of the Company’s ClearPoint Neuro Navigation System and other new products offered by the Company; the Company’s ability to market, commercialize and achieve broader market acceptance for the Company’s ClearPoint Neuro Navigation System and other new products offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of our products and services in their delivery of therapies; 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
Contact:Danilo D’Alessandro , Chief Financial Officer (888) 287-9109 info@clearpointneuro.comCaroline Corner , Investor Relations ir@clearpointneuro.com
Source:
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