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 second
quarter ended June 30, 2023.
Second Quarter Highlights
- Reported record
quarterly revenue of $6.0 million, a 14% year-over-year
increase;
- Increased biologics and drug delivery
revenue to $3.4 million, a 40% year-over-year increase;
- Announced an example of
a milestone-based biologics and drug delivery agreement
whereby ClearPoint would earn cash compensation based on the
successful progression of a drug candidate through the clinical and
regulatory process;
- Installed multiple new PRISM laser
therapy units and continued the limited market release in the
U.S.;
- Completed construction on the
manufacturing clean room at the Carlsbad, California facility;
- Cash and cash equivalents totaled $26.5
million as of June 30, 2023.
Business Outlook
The Company reaffirms its full year 2023 revenue
outlook of between $25.0 and $27.0 million.“We are pleased with our
result for the second quarter as we have returned to double-digit
growth and delivered record revenue stemming primarily from the
launch of new services in the biologics and drug delivery space
which grew more than 40%,” commented Joe Burnett, President and CEO
at ClearPoint Neuro. “As we look ahead to the second half of 2023,
we expect to demonstrate progress toward our continued growth and
scale by 1) accelerating revenue growth; 2) adding meaningful
strategic and milestone-based biologics and drug delivery
agreements; 3) expanding our PRISM limited market release to
multiple new centers; 4) executing as many as five FDA submissions
directly or through partnerships for new products; and 5)
completing the qualification of our new manufacturing clean room
facility in Carlsbad, California and producing sellable product. We
believe these milestones will contribute to a reduction in
operational cash burn compared to the first half of 2023 with
continued revenue growth in biologics and drug delivery being the
primary driver.”
Financial Results – Quarter Ended
June 30, 2023
Total revenue was $6.0 million for the three
months ended June 30, 2023, and $5.2 million for the three
months ended June 30, 2022, which represents an increase of
$0.8 million, or 14%.
Functional neurosurgery navigation and therapy
revenue, remained relatively consistent at $2.2 million for the
three months ended June 30, 2023 and 2022.
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 40% to $3.4 million for the three months ended
June 30, 2023, from $2.4 million for the same period in 2022.
This increase is attributable to a $1.8 million increase in service
revenue, partially offset by $0.9 million decrease in product
revenue.
Capital equipment and software revenue,
consisting of sales of ClearPoint reusable hardware and software,
and of related services, decreased 38% to $0.4 million for the
three months ended June 30, 2023, from $0.6 million for the
same period in 2022 as a result of fewer placements of ClearPoint
capital and software.
Gross margin for the three months ended
June 30, 2023, was 53%, as compared to a gross margin of 63%
for the three months ended June 30, 2022. The 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 product sales as we launch new services and increase
our presence in this space. Increased costs related to the
transition to the new manufacturing facility have also contributed
to the decrease in gross margin.
Operating expenses for the second quarter of
2023 were $10.3 million, compared to $7.5 million for the second
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 product development costs.
At June 30, 2023, the Company had cash and
cash equivalents and short-term investments totaling $26.5 million
as compared to $37.5 million at December 31, 2022, with the
decrease resulting primarily from the use of cash in operating
activities of $10.8 million.
Teleconference Information
Investors and analysts are invited to listen to a live broadcast
review of the Company's 2023 second quarter on Tuesday,
August 8, 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=n0kx7ZK0.
Investors and analysts who would like to participate in the
conference call via telephone may do so at (888) 437-3179, or at
(862) 298-0702 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 September
7, 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 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 over 65 sites in North America, Europe, and South
America. ClearPoint Neuro is partnered with more than 50
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, more than 6,000 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 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, 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;
risks inherent in the research and development, and regulatory
approval of new products; and risks in the process of developing
and establishing manufacturing operations in a new facility. 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 March 31, 2023, both
of which have been filed with the Securities and Exchange
Commission, and the Company’s Quarterly Report on Form 10-Q for the
three months ended June 30, 2023, which the Company intends to
file with the Securities and Exchange Commission on or before
August 14, 2023.
|
CLEARPOINT NEURO, INC.Consolidated
Statements of
Operations(Unaudited)(Dollars in
thousands, except for per share data) |
|
|
For The Three Months
EndedJune 30, |
|
|
2023 |
|
|
|
2022 |
|
Revenue: |
|
|
|
Product revenue |
$ |
2,337 |
|
|
$ |
3,457 |
|
Service and other revenue |
|
3,613 |
|
|
|
1,743 |
|
Total revenue |
|
5,950 |
|
|
|
5,200 |
|
Cost of revenue |
|
2,824 |
|
|
|
1,945 |
|
Gross profit |
|
3,126 |
|
|
|
3,255 |
|
Research and development
costs |
|
3,605 |
|
|
|
2,411 |
|
Sales and marketing
expenses |
|
3,474 |
|
|
|
2,387 |
|
General and administrative
expenses |
|
3,178 |
|
|
|
2,661 |
|
Operating loss |
|
(7,131 |
) |
|
|
(4,204 |
) |
Other expense: |
|
|
|
Other expense, net |
|
(2 |
) |
|
|
(8 |
) |
Interest income (expense), net |
|
81 |
|
|
|
(91 |
) |
Net loss |
$ |
(7,052 |
) |
|
$ |
(4,303 |
) |
Net loss per share
attributable to common stockholders: |
|
|
|
Basic and diluted |
$ |
(0.29 |
) |
|
$ |
(0.18 |
) |
Weighted average shares used
in computing net loss per share: |
|
|
|
Basic and diluted |
|
24,583,712 |
|
|
|
23,985,577 |
|
|
For The Six Months
EndedJune 30, |
|
|
2023 |
|
|
|
2022 |
|
Revenue: |
|
|
|
Product revenue |
$ |
4,967 |
|
|
$ |
6,620 |
|
Service and other revenue |
|
6,416 |
|
|
|
3,611 |
|
Total revenue |
|
11,383 |
|
|
|
10,231 |
|
Cost of revenue |
|
5,055 |
|
|
|
3,746 |
|
Gross profit |
|
6,328 |
|
|
|
6,485 |
|
Research and development
costs |
|
6,628 |
|
|
|
5,312 |
|
Sales and marketing
expenses |
|
6,407 |
|
|
|
4,404 |
|
General and administrative
expenses |
|
6,136 |
|
|
|
4,837 |
|
Operating loss |
|
(12,843 |
) |
|
|
(8,068 |
) |
Other expense: |
|
|
|
Other (expense) income, net |
|
(13 |
) |
|
|
3 |
|
Interest income (expense), net |
|
195 |
|
|
|
(197 |
) |
Net loss |
$ |
(12,661 |
) |
|
$ |
(8,262 |
) |
Net loss per share
attributable to common stockholders: |
|
|
|
Basic and diluted |
$ |
(0.52 |
) |
|
$ |
(0.35 |
) |
Weighted average shares used
in computing net loss per share: |
|
|
|
Basic and diluted |
|
24,583,439 |
|
|
|
23,834,847 |
|
|
CLEARPOINT NEURO, INC.Consolidated Balance
Sheets(Dollars in thousands, except for per share
data) |
|
|
June 30,2023 |
|
December 31,2022 |
|
(Unaudited) |
|
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
26,464 |
|
|
$ |
27,615 |
|
Short-term investments, at amortized cost |
|
— |
|
|
|
9,874 |
|
Accounts receivable, net |
|
2,799 |
|
|
|
2,665 |
|
Inventory, net |
|
9,204 |
|
|
|
9,303 |
|
Prepaid expenses and other current assets |
|
2,244 |
|
|
|
1,723 |
|
Total current assets |
|
40,711 |
|
|
|
51,180 |
|
Property and equipment,
net |
|
1,360 |
|
|
|
806 |
|
Operating lease, right-of-use
assets |
|
3,956 |
|
|
|
1,895 |
|
Software license
inventory |
|
407 |
|
|
|
450 |
|
Licensing rights |
|
1,051 |
|
|
|
1,028 |
|
Other assets |
|
156 |
|
|
|
131 |
|
Total assets |
$ |
47,641 |
|
|
$ |
55,490 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
1,273 |
|
|
$ |
272 |
|
Accrued compensation |
|
2,339 |
|
|
|
2,824 |
|
Other accrued liabilities |
|
1,373 |
|
|
|
2,065 |
|
Operating lease liabilities, current portion |
|
493 |
|
|
|
561 |
|
Deferred product and service revenue, current portion |
|
724 |
|
|
|
1,066 |
|
Total current liabilities |
|
6,202 |
|
|
|
6,788 |
|
Operating lease liabilities,
net of current portion |
|
3,855 |
|
|
|
1,532 |
|
Deferred product and service
revenue, net of current portion |
|
253 |
|
|
|
390 |
|
2020 senior secured
convertible note payable, net |
|
9,921 |
|
|
|
9,893 |
|
Total liabilities |
|
20,231 |
|
|
|
18,603 |
|
Commitments and
contingencies |
|
|
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.01 par value; 25,000,000 shares authorized;
none issued and outstanding at June 30, 2023 and
December 31, 2022 |
|
— |
|
|
|
— |
|
Common stock, $0.01 par value; 90,000,000 shares authorized at
June 30, 2023 and 200,000,000 shares authorized at
December 31, 2022; 24,627,674 shares issued and outstanding at
June 30, 2023; and 24,578,983 issued and outstanding at
December 31, 2022 |
|
246 |
|
|
|
246 |
|
Additional paid-in capital |
|
190,192 |
|
|
|
187,008 |
|
Accumulated deficit |
|
(163,028 |
) |
|
|
(150,367 |
) |
Total stockholders’ equity |
|
27,410 |
|
|
|
36,887 |
|
Total liabilities and stockholders’ equity |
$ |
47,641 |
|
|
$ |
55,490 |
|
|
CLEARPOINT NEURO, INC.Consolidated
Statements of Cash
Flows(Unaudited)(Dollars in
thousands) |
|
|
For The Six Months
EndedJune 30, |
|
|
2023 |
|
|
|
2022 |
|
Cash flows from operating
activities: |
|
|
|
Net loss |
$ |
(12,661 |
) |
|
$ |
(8,262 |
) |
Adjustments to reconcile net loss to net cash flows from operating
activities: |
|
|
|
Allowance for credit losses (recoveries) |
|
454 |
|
|
|
(10 |
) |
Depreciation and amortization |
|
285 |
|
|
|
187 |
|
Share-based compensation |
|
2,952 |
|
|
|
1,779 |
|
Amortization of debt issuance costs and original issue
discounts |
|
28 |
|
|
|
27 |
|
Amortization of lease right-of-use, net of accretion in lease
liabilities |
|
325 |
|
|
|
267 |
|
Accretion of discounts on short-term investments |
|
(126 |
) |
|
|
(23 |
) |
Increase (decrease) in cash resulting from changes in: |
|
|
|
Accounts receivable |
|
(588 |
) |
|
|
(1,001 |
) |
Inventory, net |
|
94 |
|
|
|
(1,786 |
) |
Prepaid expenses and other current assets |
|
(438 |
) |
|
|
(1,010 |
) |
Other assets |
|
(25 |
) |
|
|
30 |
|
Accounts payable and accrued expenses |
|
(282 |
) |
|
|
679 |
|
Lease liabilities |
|
(293 |
) |
|
|
(261 |
) |
Deferred revenue |
|
(480 |
) |
|
|
134 |
|
Net cash flows from operating
activities |
|
(10,755 |
) |
|
|
(9,250 |
) |
Cash flows from investing
activities: |
|
|
|
Purchases of property and equipment |
|
(461 |
) |
|
|
(145 |
) |
Acquisition of licensing rights |
|
(167 |
) |
|
|
(116 |
) |
Purchase of short-term investments |
|
— |
|
|
|
(21,590 |
) |
Proceeds from maturities of short-term investments |
|
10,000 |
|
|
|
— |
|
Net cash flows from investing activities |
|
9,372 |
|
|
|
(21,851 |
) |
Cash flows from financing activities: |
|
|
|
Proceeds from stock option and warrant exercises |
|
— |
|
|
|
256 |
|
Payments for taxes related to net share settlement of equity
awards |
|
(82 |
) |
|
|
— |
|
Proceeds from issuance of common stock under employee stock
purchase plan |
|
314 |
|
|
|
260 |
|
Net cash flows from financing
activities |
|
232 |
|
|
|
516 |
|
Net change in cash and cash
equivalents |
|
(1,151 |
) |
|
|
(30,585 |
) |
Cash and cash equivalents,
beginning of period |
|
27,615 |
|
|
|
54,109 |
|
Cash and cash equivalents, end
of period |
$ |
26,464 |
|
|
$ |
23,524 |
|
|
|
|
|
SUPPLEMENTAL CASH FLOW
INFORMATION |
|
|
|
Cash paid for: |
|
|
|
Income taxes |
$ |
— |
|
|
$ |
— |
|
Interest |
$ |
369 |
|
|
$ |
207 |
|
Contact:
Danilo D’Alessandro, Chief Financial Officer
(949) 900-6833
info@clearpointneuro.com
Caroline Corner, Investor Relations
ir@clearpointneuro.com
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