ClearPoint Neuro Reports Fourth Quarter and Full-Year 2022 Results
ClearPoint Neuro, Inc. (Nasdaq: CLPT) reported record revenues for the year ended December 31, 2022. The company achieved $20.6 million in total revenue, representing a 26% increase from 2021, marking the eighth consecutive year of growth. Q4 revenue was $5.2 million, a 21% year-over-year increase. Biologics and drug delivery revenue increased by 34% to $9.1 million for the full year. However, while gross margin was 66%, it decreased from 68% in 2021 due to rising indirect labor costs. The company ended 2022 with $37.5 million in cash and short-term investments. ClearPoint expects continued growth of 20% in 2023.
- Total revenue increased by 26% to $20.6 million for 2022.
- Fourth quarter revenue grew by 21% to $5.2 million.
- Biologics and drug delivery revenue rose 34% to $9.1 million.
- Added multiple new biologics and drug delivery partners, totaling over 50.
- Firm expects revenue growth of more than 20% in 2023.
- Gross margin decreased to 66% from 68% in 2021.
- Operating expenses rose to $29.9 million from $24.5 million.
Company Reports Record Revenues
SOLANA BEACH, Calif., March 01, 2023 (GLOBE NEWSWIRE) -- 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, 2022.
2022 Full Year and Fourth Quarter Highlights
- Reported fourth quarter 2022 revenue of
$5.2 million , a21% year-over-year increase compared with the fourth quarter of 2021; - Reported revenue of
$20.6 million for the full year 2022, an increase of26% over 2021 and representing the eighth consecutive year of growth; - Increased biologics and drug delivery revenue to
$9.1 million for the full year 2022, a34% increase over 2021; - Added multiple new biologics and drug delivery partners in the quarter to bring the total to more than 50; and
- Cash and short-term investments totaled
$37.5 million as of December 31, 2022.
Business Outlook
“We are pleased with our performance in 2022, growing revenue
Financial Results - Year Ended December 31, 2022
Total revenue was
Functional neurosurgery navigation and therapy revenue increased to
Biologics and drug delivery revenue, which include sales of disposable products and services related to customer-sponsored pre-clinical and clinical trials utilizing our products, increased
Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software, and of related services, increased
The Company achieved a gross margin of
Operating expenses were
Financial Results – Quarter Ended December 31, 2022
Total revenue was
Functional neurosurgery navigation and therapy revenue increased
Biologics and drug delivery revenue, which includes sales of disposable products and services related to customer-sponsored pre-clinical and clinical trials utilizing our products, increased
Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software, and of related services, increased
Gross margin for the three months ended December 31, 2022, was
Operating expenses for the fourth quarter of 2022 were
At December 31, 2022, the Company had cash and cash equivalents and short-term investments totaling
Teleconference Information
Investors and analysts are invited to listen to a live broadcast review of the Company's fourth quarter and full year 2022 on Wednesday, March 1, 2023 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time), which may be accessed online here: https://event.choruscall.com/mediaframe/webcast.html?webcastid=KFYSIHDo. Investors and analysts who would like to participate in the conference call via telephone may do so at (877) 407-9034, or at (202) 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 March 31, 2023, 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 Investor Relations website at https://ir.clearpointneuro.com/.
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, 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 North America, Europe, and South America. ClearPoint Neuro is partnered with more than 50 biologics/pharmaceutical 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, more than 5,000 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. For more information, please visit www.clearpointneuro.com.
Forward-Looking Statements
Statements in this press release and in the teleconference referenced above concerning the Company’s revenue expectations, plans, growth and strategies may be 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 December 31, 2021, and the Company’s Quarterly Report on Form 10-Q for the three months ended September 30, 2022, 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, 2022, which the Company intends to file with the Securities and Exchange Commission on or before March 31, 2023.
CLEARPOINT NEURO, INC.
Consolidated Statements of Operations
(Dollars in thousands, except for per share data)
Years Ended December 31, | ||||||||
2022 | 2021 | |||||||
Revenue: | ||||||||
Product revenue | $ | 12,789 | $ | 11,913 | ||||
Service and other revenue | 7,762 | 4,386 | ||||||
Total revenue | 20,551 | 16,299 | ||||||
Cost of revenue | 7,020 | 5,176 | ||||||
Gross profit | 13,531 | 11,123 | ||||||
Research and development costs | 10,894 | 9,281 | ||||||
Sales and marketing expenses | 9,358 | 7,217 | ||||||
General and administrative expenses | 9,611 | 7,999 | ||||||
Operating loss | (16,332 | ) | (13,374 | ) | ||||
Other income (expense): | ||||||||
Other expense, net | (22 | ) | (63 | ) | ||||
Interest expense, net | (81 | ) | (973 | ) | ||||
Net loss | $ | (16,435 | ) | $ | (14,410 | ) | ||
Net loss per share attributable to common stockholders: | ||||||||
Basic and diluted | $ | (0.68 | ) | $ | (0.69 | ) | ||
Weighted average shares outstanding: | ||||||||
Basic and diluted | 24,181,854 | 20,734,236 | ||||||
CLEARPOINT NEURO, INC.
Consolidated Balance Sheets
(Dollars in thousands, except for per share data)
December 31, | ||||||||
2022 | 2021 | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 27,615 | $ | 54,109 | ||||
Short-term investments | 9,874 | — | ||||||
Accounts receivable, net | 2,665 | 2,337 | ||||||
Inventory, net | 9,303 | 4,938 | ||||||
Prepaid expenses and other current assets | 1,723 | 508 | ||||||
Total current assets | 51,180 | 61,892 | ||||||
Property and equipment, net | 806 | 539 | ||||||
Operating lease rights of use | 1,895 | 2,241 | ||||||
Software license inventory | 450 | 519 | ||||||
Licensing rights | 1,028 | 265 | ||||||
Other assets | 131 | 125 | ||||||
Total assets | $ | 55,490 | $ | 65,581 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 272 | $ | 427 | ||||
Accrued compensation | 2,824 | 2,604 | ||||||
Other accrued liabilities | 2,065 | 537 | ||||||
Operating lease liabilities, current portion | 561 | 507 | ||||||
Deferred product and service revenue, current portion | 1,066 | 678 | ||||||
Total current liabilities | 6,788 | 4,753 | ||||||
Operating lease liabilities, net of current portion | 1,532 | 1,939 | ||||||
Deferred product and service revenue, net of current portion | 390 | 264 | ||||||
2020 senior secured convertible note payable, net | 9,893 | 9,838 | ||||||
Total liabilities | 18,603 | 16,794 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ equity: | ||||||||
Preferred stock, | — | — | ||||||
Common stock, | 246 | 237 | ||||||
Additional paid-in capital | 187,008 | 182,482 | ||||||
Accumulated deficit | (150,367 | ) | (133,932 | ) | ||||
Total stockholders’ equity | 36,887 | 48,787 | ||||||
Total liabilities and stockholders’ equity | $ | 55,490 | $ | 65,581 | ||||
CLEARPOINT NEURO, INC.
Consolidated Statements of Cash Flows
(Dollars in thousands)
Years Ended December 31, | ||||||||
2022 | 2021 | |||||||
Cash flows from operating activities: | ||||||||
Net loss | $ | (16,435 | ) | $ | (14,410 | ) | ||
Adjustments to reconcile net loss to net cash flows from operating activities: | ||||||||
Allowance for doubtful accounts | (117 | ) | 202 | |||||
Depreciation and amortization | 244 | 159 | ||||||
Share-based compensation | 4,126 | 2,078 | ||||||
Payment-in-kind interest | — | 325 | ||||||
Amortization of debt issuance costs and original issue discounts | 55 | 100 | ||||||
Amortization of lease right of use assets, net of accretion in lease liabilities | 533 | 533 | ||||||
Accretion of discounts on short-term investments | (284 | ) | — | |||||
Increase (decrease) in cash resulting from changes in: | ||||||||
Accounts receivable | (211 | ) | (658 | ) | ||||
Inventory, net | (4,421 | ) | (1,714 | ) | ||||
Prepaid expenses and other current assets | (1,216 | ) | (264 | ) | ||||
Other assets | (6 | ) | (66 | ) | ||||
Accounts payable and accrued expenses | 1,591 | 1,285 | ||||||
Lease liability | (541 | ) | (432 | ) | ||||
Deferred revenue | 515 | 165 | ||||||
Net cash flows from operating activities | (16,167 | ) | (12,697 | ) | ||||
Cash flows from investing activities: | ||||||||
Purchases of property and equipment | (253 | ) | (168 | ) | ||||
Acquisition of licensing rights | (893 | ) | — | |||||
Purchase of short-term investments | (21,590 | ) | — | |||||
Proceeds from maturities of short-term investments | 12,000 | — | ||||||
Net cash flows from investing activities | (10,736 | ) | (168 | ) | ||||
Cash flows from financing activities: | ||||||||
Proceeds from public offering of common stock, net of offering costs | — | 46,785 | ||||||
Proceeds from stock option and warrant exercises | 268 | 465 | ||||||
Proceeds from issuance of common stock under employee stock purchase plan | 477 | 224 | ||||||
Payments for taxes related to net share settlement of equity awards | (336 | ) | (599 | ) | ||||
Net cash flows from financing activities | 409 | 46,875 | ||||||
Net change in cash and cash equivalents | (26,494 | ) | 34,010 | |||||
Cash and cash equivalents, beginning of year | 54,109 | 20,099 | ||||||
Cash and cash equivalents, end of year | $ | 27,615 | $ | 54,109 | ||||
SUPPLEMENTAL CASH FLOW INFORMATION | ||||||||
Cash paid for: | ||||||||
Income taxes | $ | — | $ | — | ||||
Interest | $ | 523 | $ | 597 | ||||
FAQ
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