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 first quarter ended March 31, 2024.
First Quarter Highlights
- Reported quarterly revenue of $7.6 million, a 41%
year-over-year increase;
- Increased biologics and drug delivery revenue to $4.3 million,
a 61% year-over-year increase;
- Partner PTC Therapeutics submitted first-ever neuro gene
therapy BLA to the FDA;
- Received 510(k) clearance for SmartFrame OR™ Stereotactic
System to support expansion into the Operating Room and performed
first clinical cases;
- Activated eight new hospital customers in the first quarter, a
new Company record for a quarter and bringing our total number of
global centers to over 80 sites;
- Operational cash burn reduced to $3.8 million, a 32%
year-over-year decrease;
- Completed a public offering of common stock, resulting in net
proceeds of approximately $16.2 million;
- Cash and cash equivalents totaled $35.4 million as of
March 31, 2024.
“Our ClearPoint Neuro team enjoyed the best
operating performance in our Company’s history, with contributions
coming from all four of our growth pillars,” commented Joe Burnett,
President and CEO at ClearPoint Neuro. “Overall, the company
achieved record revenue of $7.6 million or 41% growth, led by 61%
growth in biologics and drug delivery revenue, and 255% growth in
capital sales and service, which were also both new records. We
were thrilled to see not only over 60% growth in the core biologics
business, but to see many of our partners progress from a
regulatory standpoint including the first neuro gene therapy BLA
ever submitted to the FDA, and first patient enrolled in multiple
partner IDE trials since the start of the year.”
“Our device business activated eight new sites
in the quarter,” continued Burnett, “which was our fastest
activation period ever. For perspective, historically our Company
would activate about eight new customers in a calendar year, and
here we activated eight in the first quarter alone, with a very
healthy funnel of additional activations expected this year. These
new sites are going through training and are expected to support
our case volume and disposable revenue growth starting in the
second quarter, both using our legacy MRI guided navigation system
as well as our new FDA cleared Operating Room Navigation system,
the SmartFrame OR, for which we initiated a limited market release
in Q1 and successfully performed our initial clinical cases. We
have also placed multiple new Prism laser therapy systems and so
far this year released a new software version to improve workflow
and performance. We also achieved FDA clearance of a key ancillary
bone anchor which will facilitate laser applicators being placed
not only with ClearPoint navigation, but with other common
operating room navigation and robotic systems. ClearPoint Neuro’s
first quarter accomplishments were achieved while keeping our
operating expenses relatively flat year over year and reducing our
operational cash burn by more than 30%. Our successful capital
raise of $16.2 million in net proceeds not only brought new
institutional investors into our Company, but also solidified our
balance sheet with $35.4 million in cash and cash equivalents at
the end of the quarter. The team is excited to have started 2024
off strong with many more important milestones expected this
year.”
Business Outlook
The Company reaffirms its full year 2024 revenue
outlook of between $28.0 and $32.0 million.
Financial Results – Quarter Ended
March 31, 2024
Total revenue was $7.6 million for the three
months ended March 31, 2024, and $5.4 million for the three
months ended March 31, 2023, which represents an increase of
$2.2 million, or 41%.
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 61% to $4.3 million for the three months ended
March 31, 2024, from $2.7 million for the same period in
2023.
Functional neurosurgery navigation and therapy
revenue, decreased 18% to $1.9 million for the three months ended
March 31, 2024, from $2.4 million for the same period in 2023.
The decrease is driven primarily by lower service revenue of $0.5
million as a result of pausing a co-development program with one of
our Brain Computer Interface partners.
Capital equipment and software revenue,
consisting of sales of ClearPoint reusable hardware and software,
and of related services, increased 255% to $1.4 million for the
three months ended March 31, 2024, from $0.4 million for the
same period in 2023 due to a large increase in the placements of
ClearPoint navigation capital and software and Prism laser
units.
Gross margin for the three months ended
March 31, 2024, was 59%, in line with gross margin of 59% for
the three months ended March 31, 2023.
Operating expenses for the first quarter of 2024
were $8.8 million, compared to $8.9 million for the first quarter
of 2023. The decrease was mainly driven by lower product
development costs and bad debt expense, partially offset by higher
sales and marketing personnel expense.
At March 31, 2024, the Company had cash and
cash equivalents totaling $35.4 million as compared to $23.1
million at December 31, 2023, with the increase resulting from
the net proceeds from the public offering of common stock of $16.2
million, partially offset by the use of cash in operating
activities of $3.8 million.
Teleconference Information
Investors and analysts are invited to listen to a live broadcast
review of the Company's 2024 first quarter on Tuesday, May 7,
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=8hsthhLn.
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 June 7,
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 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, 2023, which has been filed with the Securities
and Exchange Commission, and the Company’s Quarterly Report on Form
10-Q for the three months ended March 31, 2024, which the
Company intends to file with the Securities and Exchange Commission
on or before May 15, 2024. The Company does not assume any
obligation to update these forward-looking statements.
CLEARPOINT NEURO, INC.Consolidated
Statements of
Operations(Unaudited)(in
thousands, except for share and per share data) |
|
For The Three Months
EndedMarch 31, |
|
|
2024 |
|
|
|
2023 |
|
Revenue: |
|
|
|
Product revenue |
$ |
3,635 |
|
|
$ |
2,630 |
|
Service and other revenue |
|
4,004 |
|
|
|
2,803 |
|
Total revenue |
|
7,639 |
|
|
|
5,433 |
|
Cost of revenue |
|
3,114 |
|
|
|
2,231 |
|
Gross profit |
|
4,525 |
|
|
|
3,202 |
|
Research and development
costs |
|
2,625 |
|
|
|
3,023 |
|
Sales and marketing
expenses |
|
3,290 |
|
|
|
2,933 |
|
General and administrative
expenses |
|
2,841 |
|
|
|
2,958 |
|
Operating loss |
|
(4,231 |
) |
|
|
(5,712 |
) |
Other expense: |
|
|
|
Other expense, net |
|
(26 |
) |
|
|
(11 |
) |
Interest income, net |
|
111 |
|
|
|
114 |
|
Net loss |
$ |
(4,146 |
) |
|
$ |
(5,609 |
) |
Net loss per share
attributable to common stockholders: |
|
|
|
Basic and diluted |
$ |
(0.16 |
) |
|
$ |
(0.23 |
) |
Weighted average shares used
in computing net loss per share: |
|
|
|
Basic and diluted |
|
25,452,096 |
|
|
|
24,583,163 |
|
CLEARPOINT NEURO, INC.Consolidated Balance
Sheets(in thousands, except for share and per
share data) |
|
March 31,2024 |
|
December 31,2023 |
|
(Unaudited) |
|
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
35,353 |
|
|
$ |
23,140 |
|
Accounts receivable, net |
|
2,511 |
|
|
|
3,211 |
|
Inventory, net |
|
7,960 |
|
|
|
7,911 |
|
Prepaid expenses and other current assets |
|
1,746 |
|
|
|
1,910 |
|
Total current assets |
|
47,570 |
|
|
|
36,172 |
|
Property and equipment,
net |
|
1,347 |
|
|
|
1,389 |
|
Operating lease, right-of-use
assets |
|
3,447 |
|
|
|
3,564 |
|
Software license
inventory |
|
237 |
|
|
|
386 |
|
Licensing rights |
|
887 |
|
|
|
1,041 |
|
Other assets |
|
149 |
|
|
|
109 |
|
Total assets |
$ |
53,637 |
|
|
$ |
42,661 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
844 |
|
|
$ |
393 |
|
Accrued compensation |
|
1,634 |
|
|
|
2,947 |
|
Other accrued liabilities |
|
986 |
|
|
|
1,053 |
|
Operating lease liabilities, current portion |
|
497 |
|
|
|
424 |
|
Deferred product and service revenue, current portion |
|
1,232 |
|
|
|
2,613 |
|
2020 senior secured convertible note payable, net |
|
9,964 |
|
|
|
— |
|
Total current liabilities |
|
15,157 |
|
|
|
7,430 |
|
Operating lease liabilities,
net of current portion |
|
3,438 |
|
|
|
3,568 |
|
Deferred product and service
revenue, net of current portion |
|
458 |
|
|
|
541 |
|
2020 senior secured
convertible note payable, net |
|
— |
|
|
|
9,949 |
|
Total liabilities |
|
19,053 |
|
|
|
21,488 |
|
Commitments and
contingencies |
|
|
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.01 par value; 25,000,000 shares authorized;
none issued and outstanding at March 31, 2024 and
December 31, 2023 |
|
— |
|
|
|
— |
|
Common stock, $0.01 par value; 90,000,000 shares authorized at
March 31, 2024 and December 31, 2023; 27,416,345 shares
issued and outstanding at March 31, 2024; and 24,652,729
issued and outstanding at December 31, 2023 |
|
274 |
|
|
|
247 |
|
Additional paid-in capital |
|
210,912 |
|
|
|
193,382 |
|
Accumulated deficit |
|
(176,602 |
) |
|
|
(172,456 |
) |
Total stockholders’ equity |
|
34,584 |
|
|
|
21,173 |
|
Total liabilities and stockholders’ equity |
$ |
53,637 |
|
|
$ |
42,661 |
|
CLEARPOINT NEURO, INC.Consolidated
Statements of Cash
Flows(Unaudited)(in
thousands) |
|
For The Three Months
EndedMarch 31, |
|
|
2024 |
|
|
|
2023 |
|
Cash flows from operating
activities: |
|
|
|
Net loss |
$ |
(4,146 |
) |
|
$ |
(5,609 |
) |
Adjustments to reconcile net loss to net cash flows from operating
activities: |
|
|
|
Allowance for credit losses (recoveries) |
|
(146 |
) |
|
|
171 |
|
Depreciation and amortization |
|
243 |
|
|
|
129 |
|
Share-based compensation |
|
1,504 |
|
|
|
1,307 |
|
Amortization of debt issuance costs and original issue
discounts |
|
15 |
|
|
|
14 |
|
Amortization of lease right-of-use, net of accretion in lease
liabilities |
|
231 |
|
|
|
142 |
|
Accretion of discounts on short-term investments |
|
— |
|
|
|
(69 |
) |
Increase (decrease) in cash resulting from changes in: |
|
|
|
Accounts receivable |
|
846 |
|
|
|
(184 |
) |
Inventory, net |
|
53 |
|
|
|
(578 |
) |
Prepaid expenses and other current assets |
|
165 |
|
|
|
(42 |
) |
Other assets |
|
(39 |
) |
|
|
— |
|
Accounts payable and accrued expenses |
|
(931 |
) |
|
|
(959 |
) |
Lease liabilities |
|
(171 |
) |
|
|
(146 |
) |
Deferred revenue |
|
(1,464 |
) |
|
|
144 |
|
Net cash flows from operating
activities |
|
(3,840 |
) |
|
|
(5,680 |
) |
Cash flows from investing
activities: |
|
|
|
Purchases of property and equipment |
|
— |
|
|
|
(138 |
) |
Net cash flows from investing
activities |
|
— |
|
|
|
(138 |
) |
Cash flows from financing
activities: |
|
|
|
Proceeds from public offering of common stock, net of offering
costs |
|
16,183 |
|
|
|
— |
|
Proceeds from stock option exercises |
|
21 |
|
|
|
— |
|
Payments for taxes related to net share settlement of equity
awards |
|
(151 |
) |
|
|
(5 |
) |
Net cash flows from financing
activities |
|
16,053 |
|
|
|
(5 |
) |
Net change in cash and cash
equivalents |
|
12,213 |
|
|
|
(5,823 |
) |
Cash and cash equivalents,
beginning of period |
|
23,140 |
|
|
|
27,615 |
|
Cash and cash equivalents, end
of period |
$ |
35,353 |
|
|
$ |
21,792 |
|
|
|
|
|
SUPPLEMENTAL CASH FLOW
INFORMATION |
|
|
|
Cash paid for: |
|
|
|
Income taxes |
$ |
— |
|
|
$ |
— |
|
Interest |
$ |
185 |
|
|
$ |
179 |
|
Contact:
Media Contact:
Jacqueline Keller, Vice President of Marketing
(888) 287-9109 ext. 4
info@clearpointneuro.com
Investor Relations:
Danilo D’Alessandro, Chief Financial Officer
(888) 287-9109 ext. 3
ir@clearpointneuro.com
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