Second Quarter Highlights
- Reported record quarterly revenue of
$5.2 million , a 52% year-over-year increase; - Partner PTC Therapeutics received a positive opinion for its gene therapy treatment Upstaza™. from the European Medicines Agency’s Committee for Medicinal Products for Human Use. Upstaza, which was granted full marketing authorization by the
European Commission inJuly 2022 , will be administered with the Company’s SmartFlow® Neuro Cannula; - Increased biologics and drug delivery revenue to
$2.4 million , a 73% year-over-year increase; - Added multiple new biologics and drug delivery partners in the quarter to bring the total to more than 45;
- Installed four additional systems in the quarter bringing the total to 8 new installations year-to-date;
- Achieved Medical Device Single Audit Program (MDSAP) certification paving the way for additional international regulatory submissions in support of pharmaceutical partners; and
- Cash and short-term investments totaled
$45.1 million as ofJune 30, 2022 .
Business Outlook
- The Company reaffirms its full year 2022 revenue outlook of between
$21.0 and$22.0 million .
“The ClearPoint Neuro Team has continued to execute against our four-pillar growth strategy in the second quarter,” commented
Particularly of note, the
At present, we are reaffirming our prior guidance of revenue between
Financial Results – Quarter Ended
Total revenue was
Functional neurosurgery navigation and therapy revenue, increased 17% to
Biologics and drug delivery revenue, which includes sales of disposable products and services related to customer-sponsored clinical trials utilizing our products, increased 73% to
Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software, and of related services, increased 282% to
Gross margin for the three months ended
Operating expenses for the second quarter of 2022 were
At
Teleconference Information
Investors and analysts are invited to listen to a live broadcast review of the Company's 2022 second quarter on
For those who cannot access the live broadcast, a replay will be available shortly after the completion of the call until
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, 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
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, 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; 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 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
Consolidated Statements of Operations
(Unaudited)
(Dollars in thousands, except for per share data)
For The Three Months Ended | |||||||
2022 | 2021 | ||||||
Revenue: | |||||||
Product revenue | $ | 3,457 | $ | 2,363 | |||
Service and other revenue | 1,743 | 1,050 | |||||
Total revenue | 5,200 | 3,413 | |||||
Cost of revenue | 1,943 | 1,139 | |||||
Gross profit | 3,257 | 2,274 | |||||
Research and development costs | 2,284 | 2,109 | |||||
Sales and marketing expenses | 2,187 | 1,590 | |||||
General and administrative expenses | 2,990 | 1,982 | |||||
Operating loss | (4,204 | ) | (3,407 | ) | |||
Other expense: | |||||||
Other expense, net | (8 | ) | (96 | ) | |||
Interest expense, net | (91 | ) | (240 | ) | |||
Net loss | $ | (4,303 | ) | $ | (3,743 | ) | |
Net loss per share attributable to common stockholders: | |||||||
Basic and diluted | $ | (0.18 | ) | $ | (0.17 | ) | |
Weighted average shares used in computing net loss per share: | |||||||
Basic and diluted | 23,985,577 | 21,523,393 |
For The Six Months Ended | |||||||
2022 | 2021 | ||||||
Revenue: | |||||||
Product revenue | $ | 6,620 | $ | 5,525 | |||
Service and other revenue | 3,611 | 1,918 | |||||
Total revenue | 10,231 | 7,443 | |||||
Cost of revenue | 3,728 | 2,555 | |||||
Gross profit | 6,503 | 4,888 | |||||
Research and development costs | 4,817 | 3,673 | |||||
Sales and marketing expenses | 4,032 | 3,165 | |||||
General and administrative expenses | 5,722 | 3,638 | |||||
Operating loss | (8,068 | ) | (5,588 | ) | |||
Other expense: | |||||||
Other income (expense), net | 3 | (122 | ) | ||||
Interest expense, net | (197 | ) | (571 | ) | |||
Net loss | $ | (8,262 | ) | $ | (6,281 | ) | |
Net loss per share attributable to common stockholders: | |||||||
Basic and diluted | $ | (0.35 | ) | $ | (0.31 | ) | |
Weighted average shares used in computing net loss per share: | |||||||
Basic and diluted | 23,834,847 | 20,195,488 |
Consolidated Balance Sheets
(Dollars in thousands, except for per share data)
2022 | 2021 | ||||||
(Unaudited) | |||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 23,524 | $ | 54,109 | |||
Short-term investments | 21,613 | — | |||||
Accounts receivable, net | 3,348 | 2,337 | |||||
Inventory, net | 6,639 | 4,938 | |||||
Prepaid expenses and other current assets | 1,517 | 508 | |||||
Total current assets | 56,641 | 61,892 | |||||
Property and equipment, net | 689 | 539 | |||||
Operating lease rights of use | 1,992 | 2,241 | |||||
Software license inventory | 504 | 519 | |||||
Licensing rights | 320 | 265 | |||||
Other assets | 94 | 125 | |||||
Total assets | $ | 60,240 | $ | 65,581 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 1,592 | $ | 427 | |||
Accrued compensation | 1,814 | 2,604 | |||||
Other accrued liabilities | 870 | 537 | |||||
Operating lease liabilities, current portion | 532 | 507 | |||||
Deferred product and service revenue, current portion | 675 | 678 | |||||
Total current liabilities | 5,483 | 4,753 | |||||
Operating lease liabilities, net of current portion | 1,671 | 1,939 | |||||
Deferred product and service revenue, net of current portion | 401 | 264 | |||||
2020 senior secured convertible notes payable, net | 9,865 | 9,838 | |||||
Total liabilities | 17,420 | 16,794 | |||||
Commitments and contingencies | |||||||
Stockholders’ equity: | |||||||
Preferred stock, | — | — | |||||
Common stock, | 245 | 237 | |||||
Additional paid-in capital | 184,769 | 182,482 | |||||
Accumulated deficit | (142,194 | ) | (133,932 | ) | |||
Total stockholders’ equity | 42,820 | 48,787 | |||||
Total liabilities and stockholders’ equity | $ | 60,240 | $ | 65,581 |
Consolidated Statements of Cash Flows
(Unaudited)
(Dollars in thousands)
For The Six Months Ended | |||||||
2022 | 2021 | ||||||
Cash flows from operating activities: | |||||||
Net loss | $ | (8,262 | ) | $ | (6,281 | ) | |
Adjustments to reconcile net loss to net cash flows from operating activities: | |||||||
Allowance for doubtful accounts | (10 | ) | 92 | ||||
Depreciation and amortization | 187 | 62 | |||||
Share-based compensation | 1,779 | 567 | |||||
Payment-in-kind interest | — | 189 | |||||
Amortization of debt issuance costs and original issue discounts | 27 | 54 | |||||
Amortization of lease rights of use, net of accretion in lease liabilities | 267 | 267 | |||||
Accretion of discounts on short-term investments | (23 | ) | — | ||||
Increase (decrease) in cash resulting from changes in: | |||||||
Accounts receivable | (1,001 | ) | (617 | ) | |||
Inventory, net | (1,786 | ) | (304 | ) | |||
Prepaid expenses and other current assets | (1,010 | ) | (760 | ) | |||
Other assets | 30 | (93 | ) | ||||
Accounts payable and accrued expenses | 679 | 1,312 | |||||
Lease liabilities | (261 | ) | (195 | ) | |||
Deferred revenue | 134 | (142 | ) | ||||
Net cash flows from operating activities | (9,250 | ) | (5,849 | ) | |||
Cash flows from investing activities: | |||||||
Purchases of property and equipment | (145 | ) | (5 | ) | |||
Acquisition of licensing rights | (116 | ) | — | ||||
Purchase of short-term investments | (21,590 | ) | — | ||||
Net cash flows from investing activities | (21,851 | ) | (5 | ) | |||
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 | 256 | 494 | |||||
Proceeds from issuance of common stock under employee stock purchase plan | 260 | — | |||||
Net cash flows from financing activities | 516 | 47,279 | |||||
Net change in cash and cash equivalents | (30,585 | ) | 41,425 | ||||
Cash and cash equivalents, beginning of period | 54,109 | 20,099 | |||||
Cash and cash equivalents, end of period | $ | 23,524 | $ | 61,524 | |||
SUPPLEMENTAL CASH FLOW INFORMATION | |||||||
Cash paid for: | |||||||
Income taxes | $ | — | $ | — | |||
Interest | $ | 207 | $ | 353 |
Contact:Danilo D’Alessandro , Chief Financial Officer (949) 900-6833 info@clearpointneuro.comCaroline Corner , Investor Relations ir@clearpointneuro.com
Source:
2022 GlobeNewswire, Inc., source