Full Press Release Details
ClearPoint Neuro Reports Fourth Quarter and Full-Year
Company Reports Record Revenues
SOLANA BEACH, CA, March 1, 2022 - 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, 2021.
2021 Full Year and Fourth Quarter Highlights
"We are excited to close the books on a successful,
yet unpredictable 2021, as we overcame elective procedure disruptions and supply chain issues to reach record levels for case volume and
revenue," commented Joe Burnett, President and CEO at ClearPoint Neuro. "Our company has made progress across all four of
our growth pillars in the past year which I believe shows that our strategy has set a strong foundation which we will continue to build
on in the years ahead."
"Pillar One: Biologics and Drug Delivery
Pillar Two: Functional Neurosurgery Navigation for Deep-Brain
Stimulation and Brain-Computer Interfaces (BCI)
Pillar Three: Therapy and Access Products
Pillar Four: Achieve Global Scale
"Our balance sheet remains strong with more than $54
million in cash and equivalents on hand to fund operations for years to come. We continue to expect revenue in 2022 in the range of $20
to $22 million. During 2021, we also hired several highly accomplished new team members who will help accelerate execution of our four-pillar
Financial Results - Year Ended December 31, 2021
Total revenues were approximately $16.3 million and $12.8
million for the years ended December 31, 2021 and 2020, respectively.
Functional neurosurgery navigation and therapy revenue increased
30% to $8.1 million during the year ended December 31, 2021 from $6.2 million for the same period in 2020. This increase reflects the
resumption in 2021 of elective surgery procedures, which were postponed or cancelled during 2020 due to the effects of the COVID-19 pandemic.
Biologics and drug delivery revenue, which include sales of
disposable products and services related to customer-sponsored clinical trials utilizing our products, increased 31% to $6.8 million for
the year ended December 31, 2021, from $5.2 million for the same period in 2020.
Capital equipment and software revenue stayed relatively consistent
at $1.4 million for the years 2021 and 2020.
The Company achieved a gross margin of 69% on its sales for
2021, compared to a gross margin of 71% for 2020. This decrease in gross margin was due primarily to an increase in overhead allocated
to costs of sales in 2021 as compared to 2020.
Operating expenses were $24.7 million for the full year 2021,
compared to $15.3 million for 2020. The increase was mainly driven by an increase in personnel-related expenses as we increased headcount
to fund the expansion of the research and development, clinical and support organizations.
Financial Results - Three Months Ended December
Total revenue was $4.3 million for the three months ended
December 31, 2021 and $3.7 million for the three months ended December 31, 2020, which represents an increase of $0.6 million or 15%.
Functional neurosurgery navigation revenue increased 37% to
$2.1 million for the fourth quarter of 2021 from $1.6 million for the same period in 2020.
Biologics and drug delivery revenue increased 10% to $1.7
million for the fourth quarter of 2021, from $1.5 million for the same period in 2020.
Capital equipment product and related service revenue decreased
28% to $0.5 million for the fourth quarter of 2021, as compared with $0.6 million for the same period in 2020.
The Company realized a gross margin of 77% on its sales for
the fourth quarter of 2021, compared to a gross margin of 61% for the same period in 2020, due primarily to a one-time reclassification
of certain costs, previously classified as operating expenses to cost of revenues performed in Q4 2020 and due to lower excess and obsolete
inventory reserves taken in the fourth quarter of 2021.
Operating expenses for the fourth quarter of 2021 were $7.3
million, compared to $4.5 million for the fourth quarter of 2020. The increase was mainly driven by the increase in headcount and the
increased investments in research and development.
On December 31, 2021, the Company had cash and cash equivalents
totaling $54.1 million as compared to $20.1 million on December 31, 2020, with the increase resulting primarily from the completion of
a public offering of the Company's common stock in February 2021.
Teleconference Information
Investors and analysts are invited to listen
to a live broadcast review of the Company's fourth quarter and full year 2021 financial results on Tuesday, March 1, 2022 at 4:30 p.m.
Eastern time (1:30 p.m. Pacific time) which may be accessed online here: https://themediaframe.com/mediaframe/webcast.html?webcastid=ZSukJDu1.
Investors and analysts who would like to participate in the conference call via telephone may do so at (877) 407-9034, or at (201) 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 Thursday, March 31, 2022 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 website at www.clearpointneuro.com, on the "Investor Relations" page.
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, 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 approximately 60 active sites in the United States, Canada, and Europe. ClearPoint Neuro is partnered with approximately
40 biologics/pharmaceutical companies and academic centers, providing solutions for direct CNS delivery of therapeutics in pre-clinical
studies and clinical trials worldwide. To date, more than 5,000 cases 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
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;
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 December 31, 2020, and the Company's Quarterly Report on Form 10-Q for the three months ended
September 30, 2021, 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, 2021, which the
Company intends to file with the Securities and Exchange Commission on or before March 31, 2022.
Danilo D'Alessandro, Chief Financial Officer
Caroline Corner, Investor Relations
CLEARPOINT NEURO, INC.
Consolidated Balance Sheets
(Dollars in thousands, except for per share data)
| December 31, | ||||||||
| 2021 | 2020 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 54,109 | $ | 20,099 | ||||
| Accounts receivable, net | 2,337 | 1,881 | ||||||
| Inventory, net | 4,938 | 3,238 | ||||||
| Prepaid expenses and other current assets | 508 | 244 | ||||||
| Total current assets | 61,892 | 25,462 | ||||||
| Property and equipment, net | 539 | 319 | ||||||
| Operating lease rights of use | 2,241 | 2,736 | ||||||
| Software license inventory | 519 | 589 | ||||||
| Licensing rights | 265 | 353 | ||||||
| Other assets | 125 | 59 | ||||||
| Total assets | $ | 65,581 | $ | 29,518 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 427 | $ | 300 | ||||
| Accrued compensation | 2,604 | 1,595 | ||||||
| Other accrued liabilities | 537 | 349 | ||||||
| Operating lease liabilities, current portion | 507 | 394 | ||||||
| Deferred product and service revenue, current portion | 678 | 562 | ||||||
| Total current liabilities | 4,753 | 3,200 | ||||||
| Operating lease liabilities, net of current portion | 1,939 | 2,446 | ||||||
| Deferred product and service revenue, net of current portion | 264 | 215 | ||||||
| 2020 senior secured convertible notes payable, net | 9,838 | 21,280 | ||||||
| Total liabilities | 16,794 | 27,141 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.01 par value; 25,000,000 shares authorized at December 31, 2021 and 2020; none issued and outstanding at December 31, 2021 and 2020 | - | - | ||||||
| Common stock, $0.01 par value; 200,000,000 shares authorized at December 31, 2021 and 2020; 23,665,991 and 17,047,584 shares issued and outstanding at December 31, 2021 and 2020, respectively | 237 | 170 | ||||||
| Additional paid-in capital | 182,482 | 121,729 | ||||||
| Accumulated deficit | (133,932 | ) | (119,522 | ) | ||||
| Total stockholders' equity | 48,787 | 2,377 | ||||||
| Total liabilities and stockholders' equity | $ | 65,581 | $ | 29,518 |
CLEARPOINT NEURO, INC.
Consolidated Statements of Operations