2023 Full Year and Fourth Quarter Highlights
- Reported fourth quarter 2023 revenue of
$6.8 million , a 32% year-over-year increase compared with the fourth quarter of 2022; - Reported revenue of
$24.0 million for the full year 2023, an increase of 17% over 2022 and representing the ninth consecutive year of growth; - Increased biologics and drug delivery revenue to
$13.6 million for the full year 2023, a 49% increase over 2022; - Completed Certification of
Carlsbad development and manufacturing facility and shut down ofIrvine manufacturing facility; and - Cash burn of
$1.2 million in the fourth quarter, bringing cash and cash equivalents to$23.1 million as ofDecember 31, 2023 .
2024 Operational Highlights
- Six new hospital customers already added since the beginning of the year;
- Received 510(k) clearance for Smartframe OR™ Stereotactic System;
- First-in-Human cases performed using ClearPoint 2.2 Software and ClearPoint Array 1.2
Parallel Trajectory Software ; - First product approved under European MDR and products shipped to
Europe from newCarlsbad development and manufacturing facility; - Validation Papers for ClearPoint Maestro and ClearPoint PRISM products published in peer-reviewed journals;
- Completed a public offering of common stock, resulting in gross proceeds of approximately
$15 million ; and - Reaffirming 2024 revenue guidance to be between
$28.0 million and$32.0 million .
Business Outlook
“We are pleased to confirm our fourth quarter 2023 performance which included record revenue of
“As a result,” continued Burnett, “we have been able to complete an important equity offering of approximately
Financial Results - Year Ended
Total revenue was
Biologics and drug delivery revenue, which include sales of disposable products and services related to customer-sponsored preclinical and clinical trials utilizing our products, increased 49% to
Functional neurosurgery navigation and therapy revenue which primarily consists of disposable product commercial sales related to cases utilizing the ClearPoint system, decreased 7% to
Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software, and of related services, decreased 21% to
The Company achieved a gross margin of 57% on its sales for 2023, compared to a gross margin of 66% for 2022. This decrease in gross margin was primarily due to an increase in biologics and drug delivery preclinical services, which, to date, have had a lower margin than in prior years, as we launch new services and increase our presence in this space. Increased costs related to the transition to the new manufacturing facility also contributed to the decrease in gross margin compared to the prior year.
Operating expenses were
Financial Results – Quarter Ended
Total revenue was
Biologics and drug delivery revenue, which includes sales of disposable products and services related to customer-sponsored preclinical and clinical trials utilizing our products, increased 76% to
Functional neurosurgery navigation and therapy revenue decreased 11% to
Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software, and of related services, increased 23% to
Gross margin for the three months ended
Operating expenses for the fourth quarter of 2023 were
At
Teleconference Information
Investors and analysts are invited to listen to a live broadcast review of the Company's fourth quarter and full year 2023 on
For those who cannot access the live broadcast, a replay will be available shortly after the completion of the call until
About
Forward-Looking Statements
Statements in this press release and in the teleconference referenced above 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, the Company’s expectation for revenues, operating expenses, the adequacy of cash and cash equivalent balances to support operations and meet future obligations, 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. 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
Consolidated Statements of Operations (Dollars in thousands, except for share and per share data) | |||||||
Years Ended | |||||||
2023 | 2022 | ||||||
Revenue: | |||||||
Product revenue | $ | 10,603 | $ | 12,789 | |||
Service and other revenue | 13,352 | 7,762 | |||||
Total revenue | 23,955 | 20,551 | |||||
Cost of revenue | 10,341 | 7,020 | |||||
Gross profit | 13,614 | 13,531 | |||||
Research and development costs | 11,709 | 10,894 | |||||
Sales and marketing expenses | 12,595 | 9,358 | |||||
General and administrative expenses | 11,756 | 9,611 | |||||
Operating loss | (22,446 | ) | (16,332 | ) | |||
Other income (expense): | |||||||
Other expense, net | (29 | ) | (22 | ) | |||
Interest income (expense), net | 386 | (81 | ) | ||||
Net loss | $ | (22,089 | ) | $ | (16,435 | ) | |
Net loss per share attributable to common stockholders: | |||||||
Basic and diluted | $ | (0.90 | ) | $ | (0.68 | ) | |
Weighted average shares outstanding: | |||||||
Basic and diluted | 24,605,212 | 24,181,854 | |||||
Consolidated Balance Sheets (Dollars in thousands, except for share and per share data) | |||||||
2023 | 2022 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 23,140 | $ | 27,615 | |||
Short-term investments | — | 9,874 | |||||
Accounts receivable, net | 3,211 | 2,665 | |||||
Inventory, net | 7,911 | 9,303 | |||||
Prepaid expenses and other current assets | 1,910 | 1,723 | |||||
Total current assets | 36,172 | 51,180 | |||||
Property and equipment, net | 1,389 | 806 | |||||
Operating lease rights of use | 3,564 | 1,895 | |||||
Software license inventory | 386 | 450 | |||||
Licensing rights | 1,041 | 1,028 | |||||
Other assets | 109 | 131 | |||||
Total assets | $ | 42,661 | $ | 55,490 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 393 | $ | 272 | |||
Accrued compensation | 2,947 | 2,824 | |||||
Other accrued liabilities | 1,053 | 2,065 | |||||
Operating lease liabilities, current portion | 424 | 561 | |||||
Deferred product and service revenue, current portion | 2,613 | 1,066 | |||||
Total current liabilities | 7,430 | 6,788 | |||||
Operating lease liabilities, net of current portion | 3,568 | 1,532 | |||||
Deferred product and service revenue, net of current portion | 541 | 390 | |||||
2020 senior secured convertible note payable, net | 9,949 | 9,893 | |||||
Total liabilities | 21,488 | 18,603 | |||||
Commitments and contingencies | |||||||
Stockholders’ equity: | |||||||
Preferred stock, | — | — | |||||
Common stock, | 247 | 246 | |||||
Additional paid-in capital | 193,382 | 187,008 | |||||
Accumulated deficit | (172,456 | ) | (150,367 | ) | |||
Total stockholders’ equity | 21,173 | 36,887 | |||||
Total liabilities and stockholders’ equity | $ | 42,661 | $ | 55,490 | |||
Consolidated Statements of Cash Flows (Dollars in thousands) | |||||||
Years Ended | |||||||
2023 | 2022 | ||||||
Cash flows from operating activities: | |||||||
Net loss | $ | (22,089 | ) | $ | (16,435 | ) | |
Adjustments to reconcile net loss to net cash flows from operating activities: | |||||||
Allowance for credit losses (recoveries) | 1,258 | (117 | ) | ||||
Depreciation and amortization | 626 | 244 | |||||
Share-based compensation | 6,079 | 4,126 | |||||
Amortization of debt issuance costs and original issue discounts | 57 | 55 | |||||
Amortization of lease right of use assets, net of accretion in lease liabilities | 831 | 533 | |||||
Accretion of discounts on short-term investments | (126 | ) | (284 | ) | |||
Increase (decrease) in cash resulting from changes in: | |||||||
Accounts receivable | (1,804 | ) | (211 | ) | |||
Inventory, net | 1,246 | (4,421 | ) | ||||
Prepaid expenses and other current assets | (113 | ) | (1,216 | ) | |||
Other assets | 22 | (6 | ) | ||||
Accounts payable and accrued expenses | (649 | ) | 1,591 | ||||
Lease liability | (755 | ) | (541 | ) | |||
Deferred revenue | 1,697 | 515 | |||||
Net cash flows from operating activities | (13,720 | ) | (16,167 | ) | |||
Cash flows from investing activities: | |||||||
Purchases of property and equipment | (717 | ) | (253 | ) | |||
Acquisition of licensing rights | (334 | ) | (893 | ) | |||
Purchase of short-term investments | — | (21,590 | ) | ||||
Proceeds from maturities of short-term investments | 10,000 | 12,000 | |||||
Net cash flows from investing activities | 8,949 | (10,736 | ) | ||||
Cash flows from financing activities: | |||||||
Proceeds from stock option and warrant exercises | — | 268 | |||||
Proceeds from issuance of common stock under employee stock purchase plan | 506 | 477 | |||||
Payments for taxes related to net share settlement of equity awards | (210 | ) | (336 | ) | |||
Net cash flows from financing activities | 296 | 409 | |||||
Net change in cash and cash equivalents | (4,475 | ) | (26,494 | ) | |||
Cash and cash equivalents, beginning of year | 27,615 | 54,109 | |||||
Cash and cash equivalents, end of year | $ | 23,140 | $ | 27,615 | |||
SUPPLEMENTAL CASH FLOW INFORMATION | |||||||
Cash paid for: | |||||||
Income taxes | $ | — | $ | — | |||
Interest | $ | 743 | $ | 523 |
Contact:Danilo D’Alessandro , Chief Financial Officer (888) 287-9109 ext. 3 ir@clearpointneuro.com
Source:
2024 GlobeNewswire, Inc., source