Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its
novel and proprietary CellFX® Nanosecond Pulsed Field Ablation™
(nsPFA™) technology, today announced business updates and financial
results for the fourth quarter and full year ended December 31,
2023.
Recent Business Highlights
CellFX nsPFA Percutaneous Electrode (End-effector of the
proprietary designed and engineered CellFX nsPFA energy delivery
system)
- Received U.S. FDA 510(k) clearance for use in non-cardiac soft
tissue ablation.
- Completed enrollment in the 30-patient first-in-human clinical
trial on the treatment of benign thyroid nodules and principal
investigator Dr. Stefano Spiezia presented the groundbreaking
positive clinical data at the North American Society for
Interventional Thyroidology 2024.
CellFX nsPFA 360° Cardiac Catheter (End-effector of the
proprietary designed and engineered CellFX nsPFA energy delivery
system)
- Completed 60-Day post-procedure evaluations of the initial
patients treated in the catheter first-in-human feasibility study;
the remaps demonstrated exceptional lesion quality, exceeding
clinicians’ expectations.
- Dr. Vivek Reddy showcased the first-in-human cases in a podium
presentation at the 29th Annual AF Symposium which was well
received by colleagues in the audience.
CellFX nsPFA Cardiac Clamp (End-effector of the
proprietary designed and engineered CellFX nsPFA energy delivery
system)
- Filed FDA 510(k) submission in December 2023, and is continuing
discussions with FDA.
Announcement of Rights Offering & Universal Shelf
Filing
- The Company’s Board of Directors has approved plans to initiate
a rights offering, pending U.S. Securities and Exchange Commission
(SEC) approval of a registration statement that is expected to be
filed next week, as detailed in the Company’s press release issued
earlier today titled, Pulse Biosciences Announces Plans to Initiate
a Rights Offering
- Consistent with the Company’s prior rights offerings, the units
of stock and warrants will only be offered to existing stockholders
as of a predetermined and to be announced record date, to be
announced once the registration statement becomes effective.
Additional details on the rights offering can be found in the
Company’s press release issued earlier today.
- To fund its future operations, the Company has filed a
preliminary registration statement with the SEC to establish a
universal shelf pursuant to which, once it is effective, the
Company may, from time to time, sell up to an aggregate of $50
million worth of its common stock, preferred stock, depositary
shares, warrants, debt securities, or units over the three year
life of the universal shelf.
“In 2023 the Pulse Biosciences team executed on the development
of our portfolio of CellFX nsPFA devices. This progress has led to
significant milestones like the FDA clearance of the CellFX nsPFA
Percutaneous Electrode System, exceptional clinical results in the
60 day remaps of our first patients treated in the CellFX nsPFA
360° Cardiac Catheter first-in-human feasibility study, and the
510(k) submission of our CellFX nsPFA Cardiac Clamp,” said Kevin
Danahy, President and Chief Executive Officer of Pulse
Biosciences.
Fourth Quarter 2023 Financial Results
Total GAAP costs and expenses, representing cost of revenues,
research and development, sales and marketing, and general and
administrative expenses, for the three months ended December 31,
2023, were $12.5 million compared to $8.7 million for the prior
year period. The increase in GAAP costs and expenses was primarily
driven by an increase in non-cash stock-based compensation expense
which was $3.3 million for the three months ended December 31, 2023
compared to $0.7 million for the prior year period. The remaining
increase in costs and expenses compared to the prior year was
driven by an increase in research and development expenses to
support the development of the CellFX nsPFA product portfolio.
Non-GAAP costs and expenses for the three months ended December 31,
2023, were $8.9 million compared to $7.7 million for the prior year
period.
GAAP net loss for the three months ended December 31, 2023 was
($11.9) million compared to ($9.2) million for the three months
ended December 31, 2022. Non-GAAP net loss for the three months
ended December 31, 2023 was ($8.3) million compared to ($8.1)
million for the three months ended December 31, 2022.
Full Year 2023 Financial Results
Total GAAP costs and expenses, representing cost of revenues,
research and development, sales and marketing and general and
administrative expenses, for the full year of 2023 were $43.6
million, compared to $58.8 million in 2022. Non-GAAP costs and
expenses for the full year of 2023 were $35.1 million compared to
$51.3 million in the prior year. The decrease in costs and expenses
compared to the prior year period was primarily driven by
optimizing headcount and streamlining and focusing resources on
advancing the development of the CellFX nsPFA product
portfolio.
GAAP net loss for the full year of 2023 was ($42.2) million
compared to ($58.5) million for 2022. Non-GAAP net loss for 2023
was ($33.8) million compared to ($51.1) million in 2022.
Cash and cash equivalents totaled $44.4 million as of December
31, 2023, compared to $61.1 million as of December 31, 2022 and
$50.4 million as of September 30, 2023. Cash used in the fourth
quarter of 2023 was $6.9 million compared to $8.0 million in the
same period in the prior year and $8.7 million used in the third
quarter of 2023. Excluding net proceeds from financing, cash used
in the full year of 2023 totaled $32.8 compared to $47.3 million
used in 2022.
Reconciliations of GAAP to non-GAAP cost and expenses and net
loss have been provided in the tables following the financial
statements in this press release. An explanation of these measures
is also included below under the heading “Non-GAAP Financial
Measures.”
Webcast and Conference Call Information
Pulse Biosciences’ management will host a conference call today,
March 28, 2024, beginning at 1:30pm PT. Investors interested in
listening to the conference call may do so by dialing
1-877-704-4453 for domestic callers or 1-201-389-0920 for
international callers. A live and recorded webcast of the event
will be available at https://investors.pulsebiosciences.com/.
About Pulse Biosciences®
Pulse Biosciences is a novel bioelectric medicine company
committed to health innovation that has the potential to improve
the quality of life for patients. The Company’s proprietary CellFX®
nsPFA™ technology delivers nanosecond pulses of electrical energy
to non-thermally clear cells while sparing adjacent noncellular
tissue. The Company is actively pursuing the development of its
CellFX nsPFA technology for use in the treatment of atrial
fibrillation and in a select few other markets where it could have
a profound positive impact on healthcare for both patients and
providers.
Pulse Biosciences, CellFX, Nano-Pulse Stimulation, NPS, nsPFA,
CellFX nsPFA and the stylized logos are among the trademarks and/or
registered trademarks of Pulse Biosciences, Inc. in the United
States and other countries.
Non-GAAP Financial Measures
In this press release, in order to supplement the Company’s
condensed consolidated financial statements presented in accordance
with Generally Accepted Accounting Principles, or GAAP, management
has disclosed certain non-GAAP financial measures for the statement
of operations. The Company believes that an evaluation of its
ongoing operations (and comparisons of its current operations with
historical and future operations) would be difficult if the
disclosure of its financial results were limited to financial
measures prepared in accordance with GAAP. As a result, the Company
is disclosing certain non-GAAP results in order to supplement
investors’ and other readers’ understanding and assessment of the
Company’s financial performance. Company management uses these
measurements as aids in monitoring the Company’s ongoing financial
performance from quarter to quarter, and year to year, on a regular
basis and for financial and operational decision-making. Non-GAAP
adjustments include stock-based compensation, depreciation and
amortization and restructuring charges. From time to time in the
future, there may be other items that the Company may exclude if
the Company believes that doing so is consistent with the goal of
providing useful information to management and investors. The
Company has provided a reconciliation of each non-GAAP financial
measure used in this earnings release to the most directly
comparable GAAP financial measure. Investors are cautioned that
there are a number of limitations associated with the use of
non-GAAP financial measures as analytical tools. Investors are
encouraged to review these reconciliations, and not to rely on any
single financial measure to evaluate the Company’s business.
Non-GAAP financial measures used by the Company may be
calculated differently from, and therefore may not be comparable
to, similarly titled measures used by other companies, which could
reduce the usefulness of the Company’s non-GAAP financial measures
as tools for comparison. Investors and other readers are encouraged
to review the related GAAP financial measures and the
reconciliation of non-GAAP measures to their most directly
comparable GAAP measures set forth below and should consider
non-GAAP measures only as a supplement to, not as a substitute for
or as a superior measure to, measures of financial performance
prepared in accordance with GAAP. Non-GAAP financial measures in
this earnings release exclude the following:
Non-cash expenses for stock-based compensation. The
Company has excluded the effect of stock-based compensation
expenses in calculating the Company’s non-GAAP cost and expenses
and net loss measures. Although stock-based compensation is a key
incentive offered to employees, the Company continues to evaluate
its business performance excluding stock-based compensation
expenses. The Company records stock-based compensation expense
related to grants of time-based and performance-based options, such
as options that vest as a result of the Company’s market
capitalization. Depending upon the size, timing and terms of the
grants, as well as the probability of achievement of
performance-based awards, this expense may vary significantly but
will recur in future periods. The Company believes that excluding
stock-based compensation better allows for comparisons from period
to period.
Depreciation and amortization. The Company has excluded
depreciation and amortization expense in calculating its non-GAAP
cost and expenses and net loss measures. Depreciation and
amortization are non-cash charges to current operations.
Restructuring charges. The Company has excluded
restructuring charges in calculating its non-GAAP cost and expenses
and net loss measures. Restructuring programs involve discrete
initiatives designed to improve operating efficiencies and include
employee termination, contract termination, and other exit costs
associated with the restructuring program. The Company believes
that excluding discrete restructuring charges allows for better
comparisons from period to period.
Forward-Looking Statements
All statements in this press release that are not historical are
forward-looking statements, including, among other things,
statements relating to the effectiveness of the Company’s CellFX
nsPFA technology and CellFX System to non-thermally clear cells
while sparing adjacent non-cellular tissue, statements concerning
the Company’s expected product development efforts and plans to
sell products commercially, such as its plans to demonstrate
advantages of its CellFX nsPFA Percutaneous Electrode over current
treatment options, statements concerning the Company’s future
fundraising efforts and whether those efforts will allow the
Company to continue current operations as planned, statements
concerning market opportunities, customer adoption and future use
of the CellFX System to address a range of conditions such as
atrial fibrillation, statements concerning early clinical successes
and whether they are predictive of the safety and efficacy of any
medical device such as the CellFX nsPFA 360° Cardiac Catheter,
Pulse Biosciences’ expectations, whether stated or implied,
regarding whether the Company’s CellFX nsPFA technology will become
a disruptive and durable treatment option for treating atrial
fibrillation or any other medical condition, and other future
events. These statements are not historical facts but rather are
based on Pulse Biosciences’ current expectations, estimates, and
projections regarding Pulse Biosciences’ business, operations and
other similar or related factors. Words such as “may,” “will,”
“could,” “would,” “should,” “anticipate,” “predict,” “potential,”
“continue,” “expects,” “intends,” “plans,” “projects,” “believes,”
“estimates,” and other similar or related expressions are used to
identify these forward-looking statements, although not all
forward-looking statements contain these words. You should not
place undue reliance on forward-looking statements because they
involve known and unknown risks, uncertainties, and assumptions
that are difficult or impossible to predict and, in some cases,
beyond Pulse Biosciences’ control. Actual results may differ
materially from those in the forward-looking statements as a result
of a number of factors, including those described in Pulse
Biosciences’ filings with the Securities and Exchange Commission.
Pulse Biosciences undertakes no obligation to revise or update
information in this release to reflect events or circumstances in
the future, even if new information becomes available.
PULSE BIOSCIENCES,
INC.
Condensed Consolidated Balance
Sheets
(In thousands, except per
share amounts)
(Unaudited)
December 31,
December 31,
2023
2022
ASSETS
Current assets:
Cash and cash equivalents
$
44,365
$
61,139
Prepaid expenses and other current
assets
963
1,008
Total current assets
45,328
62,147
Property and equipment, net
1,528
1,961
Intangible assets, net
1,886
2,551
Goodwill
2,791
2,791
Right-of-use assets
7,256
8,062
Other assets
365
365
Total assets
$
59,154
$
77,877
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$
1,836
$
1,573
Accrued expenses
3,814
2,595
Lease liability, current
1,058
896
Related party note payable, current
—
917
Total current liabilities
6,708
5,981
Lease liability, less current
8,086
9,144
Related party note payable, less
current
—
65,000
Total liabilities
14,794
80,125
Stockholders’ equity:
Preferred stock, $0.001 par value;
authorized – 50,000 shares; no shares issued and outstanding
—
—
Common stock, $0.001 par value: authorized
– 500,000 shares; issued and outstanding – 55,144 shares and 37,235
shares at December 31, 2023 and December 31, 2022, respectively
55
37
Additional paid-in capital
381,220
292,420
Accumulated other comprehensive income
(loss)
—
—
Accumulated deficit
(336,915
)
(294,705
)
Total stockholders’ equity (deficit)
44,360
(2,248
)
Total liabilities and stockholders’
equity
$
59,154
$
77,877
PULSE BIOSCIENCES,
INC.
Condensed Consolidated
Statements of Operations and Comprehensive Loss
(In thousands, except per
share amounts)
(Unaudited)
Three-Month Periods
Ended
Twelve-Month Periods
Ended
December 31,
December 31,
2023
2022
2023
2022
Revenues:
Product revenues
$
—
$
(9
)
$
—
$
700
Total revenues
—
(9
)
—
700
Cost and expenses:
Cost of revenues
—
1,291
—
11,944
Research and development
7,799
4,095
27,797
20,839
Sales and marketing
—
768
—
12,019
General and administrative
4,734
2,582
15,777
13,955
Total cost and expenses
12,533
8,736
43,574
58,757
Loss from operations
(12,533
)
(8,745
)
(43,574
)
(58,057
)
Other income (expense):
Interest income (expense), net
600
(452
)
1,364
(448
)
Total other income (expense)
600
(452
)
1,364
(448
)
Net loss
(11,933
)
(9,197
)
(42,210
)
(58,505
)
Other comprehensive gain:
Unrealized gain on available-for-sale
securities
—
—
—
—
Comprehensive loss
$
(11,933
)
$
(9,197
)
$
(42,210
)
$
(58,505
)
Net loss per share:
Basic and diluted net loss per share
$
(0.22
)
$
(0.25
)
$
(0.88
)
$
(1.72
)
Weighted average shares used to compute
net loss per common share — basic and diluted
55,058
37,229
48,038
33,935
Three-Month Periods
Ended
Twelve-Month Periods
Ended
December 31,
December 31,
Stock Based Compensation
Expense:
2023
2022
2023
2022
Cost of revenues
$
—
$
13
$
—
$
217
Research and development
1,733
323
3,491
1,563
Sales and marketing
—
(39
)
—
733
General and administrative
1,611
451
3,690
2,678
Total stock-based compensation expense
$
3,344
$
748
$
7,181
$
5,191
*For the three and twelve month periods
ended December 31, 2023, the Company reclassified certain expenses
as a result of the shift in focus from dermatology to cardiology.
Expenses previously included in Cost of Revenues are now recorded
as a part of Research and Development, and expenses previously
included in Sales and Marketing are now recorded as a part of
General and Administrative.
PULSE BIOSCIENCES,
INC.
Consolidated Revenue Financial
Highlights
(In thousands)
(Unaudited)
Three-Month Periods
Ended
Twelve-Month Periods
Ended
December 31,
December 31,
2023
2022
2023
2022
Revenue by category:
Systems
$
—
0
%
$
(16
)
0
%
$
—
0
%
$
560
80
%
Cycle units
—
0
%
7
0
%
—
0
%
140
20
%
Total revenue
$
—
0
%
$
(9
)
-
$
—
0
%
$
700
100
%
Revenue by geography:
North America
$
—
0
%
$
(9
)
0
%
$
—
0
%
$
517
74
%
Rest of World
—
0
%
—
0
%
—
0
%
183
26
%
Total revenue
$
—
0
%
$
(9
)
-
$
—
0
%
$
700
100
%
Reconciliation of GAAP to
Non-GAAP Financial Measures
The following table presents the
reconciliation of non-GAAP financial measures to the most directly
comparable GAAP financial measures:
(In thousands)
(Unaudited)
Three-Month Periods
Ended
Twelve-Month Periods
Ended
December 31,
December 31,
2023
2022
2023
2022
Reconciliation of GAAP to non-GAAP Cost
of revenues:
GAAP Cost of revenues
$
—
$
1,291
$
—
$
11,944
Less: Stock-based compensation expense
—
(13
)
—
(217
)
Less: Depreciation and amortization
—
(3
)
—
(18
)
Less: Restructuring
—
—
—
(43
)
Non-GAAP Cost of revenues
$
—
$
1,275
$
—
$
11,666
Reconciliation of GAAP to non-GAAP
Research and development:
GAAP Research and development
$
7,799
$
4,095
$
27,797
$
20,839
Less: Stock-based compensation expense
(1,733
)
(323
)
(3,491
)
(1,563
)
Less: Depreciation and amortization
(54
)
(78
)
(226
)
(281
)
Less: Restructuring
—
—
(38
)
(177
)
Non-GAAP Research and development
$
6,012
$
3,694
$
24,042
$
18,818
Reconciliation of GAAP to non-GAAP
Sales and marketing:
GAAP Sales and marketing
$
—
$
768
$
—
$
12,019
Less: Stock-based compensation expense
—
39
—
(733
)
Less: Depreciation and amortization
—
(10
)
—
(53
)
Less: Restructuring
—
—
—
(598
)
Non-GAAP Sales and marketing
$
—
$
797
$
—
$
10,635
Reconciliation of GAAP to non-GAAP
General and administrative:
GAAP General and administrative
$
4,734
$
2,582
$
15,777
$
13,955
Less: Stock-based compensation expense
(1,611
)
(451
)
(3,690
)
(2,678
)
Less: Depreciation and amortization
(250
)
(245
)
(980
)
(1,003
)
Less: Restructuring
—
—
(5
)
(60
)
Non-GAAP General and administrative
$
2,873
$
1,886
$
11,102
$
10,214
Reconciliation of GAAP to non-GAAP Cost
and expenses:
GAAP Cost and expenses
$
12,533
$
8,736
$
43,574
$
58,757
Less: Stock-based compensation expense
(3,344
)
(748
)
(7,181
)
(5,191
)
Less: Depreciation and amortization
(304
)
(336
)
(1,206
)
(1,355
)
Less: Restructuring
—
—
(43
)
(878
)
Non-GAAP Cost and expenses
$
8,885
$
7,652
$
35,144
$
51,333
Reconciliation of GAAP to non-GAAP Net
loss:
GAAP Net loss
$
(11,933
)
$
(9,197
)
$
(42,210
)
$
(58,505
)
Add: Stock-based compensation expense
3,344
748
7,181
5,191
Add: Depreciation and amortization
304
336
1,206
1,355
Add: Restructuring
—
—
43
878
Non-GAAP Net loss
$
(8,285
)
$
(8,113
)
$
(33,780
)
$
(51,081
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240328549098/en/
Investor Contacts: Pulse Biosciences Kevin Danahy,
President and CEO 510.241.1077 IR@pulsebiosciences.com or Gilmartin
Group Philip Trip Taylor 415.937.5406 philip@gilmartinir.com
Pulse Biosciences (NASDAQ:PLSE)
Gráfica de Acción Histórica
De Abr 2024 a May 2024
Pulse Biosciences (NASDAQ:PLSE)
Gráfica de Acción Histórica
De May 2023 a May 2024