ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global
device, cell, and gene therapy-enabling company offering precise
navigation to the brain and spine, today announced financial
results for its fourth quarter and full-year ended
December 31, 2023.
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 of Irvine manufacturing facility; and
- Cash burn of $1.2 million in the fourth
quarter, bringing cash and cash equivalents to $23.1 million as of
December 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 new Carlsbad 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 $6.8 million, over 30% topline
growth, and a reduction in our quarterly cash burn to only $1.2
million, our lowest since 2020,” commented Joe Burnett, President
and CEO at ClearPoint Neuro. “In just the first two months of 2024
we have already achieved some key strategic milestones including
multiple FDA clearances and first-in-human procedures, first
shipments to EU countries from our new Carlsbad facility and under
EU-MDR certification, publication of key validation papers in
peer-reviewed journals supporting both our navigation software and
laser therapy system, and activation of more new clinical customers
in the first quarter than in all of 2023.
“As a result,” continued Burnett, “we have been able to complete
an important equity offering of approximately $15 million which
solidifies our balance sheet for our pharma partners and will allow
us to retire our entire outstanding debt in the next 12 months. It
was very encouraging to perform this capital raise alongside many
other biotech companies in the past few weeks, highlighting renewed
investment into this important and exciting gene and cell therapy
space. We continue to look with confidence at 2024 and reaffirm our
2024 revenue guidance to be in the range of $28.0 million - $32.0
million.”
Financial Results - Year Ended
December 31, 2023
Total revenue was $24.0 million and $20.6
million for the years ended December 31, 2023 and 2022,
respectively.
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 $13.6 million for the year ended
December 31, 2023, from $9.1 million for the same period in
2022. This increase is attributable to a $6.0 million increase in
service revenue related to new preclinical studies and services
entered into with our partners for the year ended December 31,
2023, compared to the same period in 2022, partially offset by a
$1.5 million decrease in product revenue.
Functional neurosurgery navigation and therapy
revenue which primarily consists of disposable product commercial
sales related to cases utilizing the ClearPoint system, decreased
7% to $8.5 million during the year ended December 31, 2023,
from $9.1 million for the same period in 2022. The decrease is
driven by lower service revenue of $0.6 million as a result of
pausing a co-development program with one of our Brain Computer
Interface partners for the year ended December 31, 2023,
compared to the same period in 2022.
Capital equipment and software revenue,
consisting of sales of ClearPoint reusable hardware and software,
and of related services, decreased 21% to $1.8 million for the year
ended December 31, 2023, from $2.3 million for the same period
in 2022, due primarily to a decrease in the placements of
ClearPoint capital and software.
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 $36.1 million for the
full year 2023, compared with $29.9 million for 2022. The increase
was mainly driven by an increase in personnel-related expenses,
including share-based compensation, as we increased headcount to
fund the expansion of the research and development, clinical, and
support organizations, as well as an increase in the allowance for
credit losses.
Financial Results – Quarter Ended
December 31, 2023
Total revenue was $6.8 million for the three
months ended December 31, 2023, and $5.2 million for the three
months ended December 31, 2022, which represents an increase
of $1.6 million, or 32%.
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 $4.1 million for the three months ended
December 31, 2023, from $2.3 million for the same period in
2022. This increase is attributable to a $1.8 million increase in
service revenue, partially offset by a slight decrease in product
revenue.
Functional neurosurgery navigation and therapy
revenue decreased 11% to $2.0 million for the three months ended
December 31, 2023, from $2.3 million for the same period in
2022. The decrease was driven by lower service revenue.
Capital equipment and software revenue,
consisting of sales of ClearPoint reusable hardware and software,
and of related services, increased 23% to $0.7 million for the
three months ended December 31, 2023, from $0.6 million for
the same period in 2022.
Gross margin for the three months ended
December 31, 2023, was 59%, as compared to a gross margin of
64% for the three months ended December 31, 2022. The decrease
in gross margin was due primarily 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.
Operating expenses for the fourth quarter of
2023 were $8.7 million, compared to $7.8 million for the fourth
quarter of 2022. The increase was mainly driven by the increase in
headcount across the organization and share-based compensation as
well as an increase in the allowance for credit losses.
At December 31, 2023, the Company had cash
and cash equivalents and short-term investments totaling $23.1
million compared to $37.5 million at December 31, 2022, with
the decrease resulting primarily from the use of cash in operating
activities of $13.7 million.
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
Tuesday, March 12, 2024 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=198rn5GM.
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 April 12,
2024, 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 is a device, cell, and gene
therapy-enabling company offering precise navigation to the brain
and spine. The Company uniquely provides both established clinical
products as well as pre-clinical development services for
controlled drug and device delivery. The Company’s flagship
product, the ClearPoint Neuro Navigation System, has FDA clearance
and is CE-marked. ClearPoint Neuro is engaged with healthcare and
research centers in North America, Europe, Asia, and South America.
The Company is also partnered with the most innovative
pharmaceutical/biotech 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, thousands of 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
worldwide. 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 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 December 31, 2022, and the Company’s Quarterly
Report on Form 10-Q for the three months ended September 30, 2023,
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, 2023, which the Company intends to file
with the Securities and Exchange Commission on or before March 31,
2024. The Company does not assume any obligation to update these
forward-looking statements.
CLEARPOINT NEURO, INC.Consolidated
Statements of Operations(Dollars in thousands,
except for share and per share data) |
|
Years Ended December 31, |
|
|
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 |
|
|
|
|
|
|
|
|
|
CLEARPOINT NEURO, INC.Consolidated Balance
Sheets(Dollars in thousands, except for share and
per share data) |
|
December 31, |
|
|
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, $0.01 par value; 25,000,000 shares authorized at
December 31, 2023 and 2022; none issued and outstanding at
December 31, 2023 and 2022 |
|
— |
|
|
|
— |
|
Common stock, $0.01 par value; 90,000,000 shares authorized at
December 31, 2023 and 200,000,000 shares authorized at
December 31, 2022; 24,652,729 and 24,578,983 shares issued and
outstanding at December 31, 2023 and 2022, respectively |
|
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 |
|
|
|
|
|
|
|
|
|
CLEARPOINT NEURO, INC.Consolidated
Statements of Cash Flows(Dollars in
thousands) |
|
Years Ended December 31, |
|
|
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
ClearPoint Neuro (NASDAQ:CLPT)
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