Pulse Biosciences will host Third Quarter 2023 Financial Results
conference call at 9:00 am PT / 12:00 pm ET on Monday, November 13,
2023
Pulse Biosciences, Inc. (Nasdaq: PLSE), a company primarily
focused on leveraging its novel and proprietary CellFX Nanosecond
Pulsed Field Ablation (nsPFA) technology for the treatment of
atrial fibrillation, today announced financial results for the
third quarter ended September 30, 2023.
Recent Business Highlights
- Advanced feasibility and preclinical studies for the cardiac
ablation clamp and catheter programs, and expect to file an FDA
510(k) submission for the cardiac surgical clamp between December
and end of first quarter 2024 and to commence the initial, Pulse
Biosciences, first-in-human, CellFX nsPFA circumferential cardiac
ablation catheter procedure within a window of time commencing
between December 2023 and end of first quarter 2024
- Appointed renowned cardiothoracic surgeon Niv Ad, M.D., as
Chief Science Officer, Cardiac Surgery to lead the clinical
strategy and contribute to the development of the product
portfolio
- Presentation by electrophysiologist key opinion leader Dr.
Usman Siddiqui at the Global EP Summit 2023 featured the CellFX
nsPFA circumferential catheter system and detailed both the utility
of the novel energy modality and its potential impact on the
treatment of atrial fibrillation
- Completed treatment of 21 subjects in the thyroid clinical
feasibility study. Initial group was treated percutaneously with
initial parameters in June 2023 with evaluations at 30, 90, 180,
and 360 days post treatment. An additional group was started on
November 7, 2023 with the goal of optimizing treatment
parameters.
- Two poster presentations at the American Thyroid Association
2023 Annual Meeting suggest the percutaneous electrode delivery of
CellFX nsPFA may be a safe and effective method for treating benign
thyroid nodules, as supported by data from the first prospective
clinical feasibility study of the technology
“We made tremendous progress advancing our cardiac device
development in the third quarter. In the lab, our CellFX nsPFA
technology continues to demonstrate the potential to revolutionize
the treatment of atrial fibrillation. In the clinic, CellFX nsPFA
is demonstrating the ability to safely and effectively treat benign
thyroid nodules, and at the podium, we are pleased to be seeing
increasing external validation of our technology from KOLs at
various scientific meetings,” said Kevin Danahy, President and
Chief Executive Officer of Pulse Biosciences. “With the addition of
another renowned cardiothoracic surgeon, Dr. Niv Ad, to our
leadership team, we are on track to file a 510(k) submission for
clearance for our cardiac ablation clamp and initiate the cardiac
ablation catheter first-in-human study between December 2023 and
end of first quarter 2024.”
Third Quarter 2023 Results
Total GAAP cost and expenses, representing cost of revenues,
research and development, sales and marketing, and general and
administrative expenses, for the three months ended September 30,
2023, were $11.3 million compared to $18.0 million for the prior
year period. Non-GAAP cost and expenses for the three months ended
September 30, 2023, were $9.2 million compared to $16.8 million for
the prior year period. The decrease in costs and expenses compared
to the prior year period was driven by the prior headcount
reduction and restructuring and the $7.2 million inventory reserve
related to the dermatology business in the third quarter 2022,
partially offset by an increase in research and development
expenses to support advancement of our CellFX nsPFA cardiology
devices.
GAAP net loss for the three months ended September 30, 2023 was
($10.6) million compared to ($18.0) million for the three months
ended September 30, 2022. Non-GAAP net loss for the three months
ended September 30, 2023 was ($8.5) million compared to ($16.8)
million for the three months ended September 30, 2022.
Cash and cash equivalents totaled $50.4 million as of September
30, 2023, compared to $69.2 million as of September 30, 2022 and
$58.7 million as of June 30, 2023. Cash used in the third quarter
of 2023 was $8.7 million compared to $10.6 million in the same
period in the prior year and $10.0 million used in the second
quarter of 2023.
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,
November 13, 2023, beginning at 9:00am 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
Nanosecond Pulsed Field Ablation (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 CellFX nsPFA could have a profound positive impact on
healthcare for both patients and providers.
Pulse Biosciences, CellFX, Nano-Pulse Stimulation, NPS, 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, such as
advancement of its cardiac clamp through the appropriate FDA
regulatory path and possible initiation of a first-in-human safety
feasibility study of its CellFX nsPFA cardiac ablation catheter
system, statements concerning the Company’s future regulatory
strategies and possible government clearances and approvals,
statements concerning customer adoption and future use of the
CellFX System to address a range of conditions such as atrial
fibrillation and benign thyroid nodules, statements about the
Company’s future financing opportunities and operating expenses,
and Pulse Biosciences’ expectations, whether stated or implied,
regarding whether the Company’s CellFX nsPFA technology will become
a disruptive treatment option for treating cardiac arrhythmias,
benign thyroid nodules or any other medical condition and whether
future clinical studies will show the CellFX System is safe and
effective to treat atrial fibrillation, benign thyroid nodules 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)
September 30,
December 31,
2023
2022
ASSETS
Current assets:
Cash and cash equivalents
$
50,386
$
61,139
Prepaid expenses and other current
assets
1,237
1,008
Total current assets
51,623
62,147
Property and equipment, net
1,648
1,961
Intangible assets, net
2,052
2,551
Goodwill
2,791
2,791
Right-of-use assets
7,466
8,062
Other assets
365
365
Total assets
$
65,945
$
77,877
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$
1,412
$
1,573
Accrued expenses
3,004
2,595
Lease liability, current
1,016
896
Related party note payable, current
—
917
Total current liabilities
5,432
5,981
Lease liability, less current
8,368
9,144
Related party note payable, less
current
—
65,000
Total liabilities
13,800
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 – 54,991 shares and 37,235
shares at September 30, 2023 and December 31, 2022,
respectively
55
37
Additional paid-in capital
377,072
292,420
Accumulated other comprehensive income
(loss)
—
—
Accumulated deficit
(324,982
)
(294,705
)
Total stockholders’ equity (deficit)
52,145
(2,248
)
Total liabilities and stockholders’
equity
$
65,945
$
77,877
PULSE BIOSCIENCES,
INC.
Condensed Consolidated
Statements of Operations and Comprehensive Loss
(In thousands, except per
share amounts)
(Unaudited)
Three-Month Periods
Ended
Nine-Month Periods
Ended
September 30,
September 30,
2023*
2022
2023*
2022
Revenues:
Product revenues
$
—
$
—
$
—
$
709
Total revenues
—
—
—
709
Cost and expenses:
Cost of revenues
—
8,400
—
10,653
Research and development
7,472
4,517
19,998
16,744
Sales and marketing
—
2,020
—
11,251
General and administrative
3,780
3,088
11,043
11,373
Total cost and expenses
11,252
18,025
31,041
50,021
Loss from operations
(11,252
)
(18,025
)
(31,041
)
(49,312
)
Other income (expense):
Interest income (expense), net
686
(14
)
764
4
Total other income (expense)
686
(14
)
764
4
Net loss
(10,566
)
(18,039
)
(30,277
)
(49,308
)
Other comprehensive gain (loss):
Unrealized gain (loss) on
available-for-sale securities
—
—
—
—
Comprehensive loss
$
(10,566
)
$
(18,039
)
$
(30,277
)
$
(49,308
)
Net loss per share:
Basic and diluted net loss per share
$
(0.19
)
$
(0.49
)
$
(0.66
)
$
(1.50
)
Weighted average shares used to compute
net loss per common share — basic and diluted
54,923
37,158
45,672
32,825
Three-Month Periods
Ended
Nine-Month Periods
Ended
September 30,
September 30,
Stock Based Compensation
Expense:
2023*
2022
2023*
2022
Cost of revenues
$
—
$
24
$
—
$
204
Research and development
982
287
1,758
1,240
Sales and marketing
—
(44
)
—
772
General and administrative
816
456
2,079
2,227
Total stock-based compensation expense
$
1,798
$
723
$
3,837
$
4,443
*For the three and nine month periods
ended September 30, 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
Nine-Month Periods
Ended
September 30,
September 30,
2023
2022
2023
2022
Revenue by category:
Systems
$
—
0
%
$
—
—
$
—
0
%
$
576
81
%
Cycle units
—
0
%
—
—
—
0
%
133
19
%
Total revenue
$
—
0
%
$
—
—
$
—
0
%
$
709
100
%
Revenue by geography:
North America
$
—
0
%
$
—
—
$
—
0
%
$
526
74
%
Rest of World
—
0
%
—
—
—
0
%
183
26
%
Total revenue
$
—
0
%
$
—
—
$
—
0
%
$
709
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
Nine-Month Periods
Ended
September 30,
September 30,
2023
2022
2023
2022
Reconciliation of GAAP to non-GAAP Cost
of revenues:
GAAP Cost of revenues
$
—
$
8,400
$
—
$
10,653
Less: Stock-based compensation expense
—
(24
)
—
(204
)
Less: Depreciation and amortization
—
(5
)
—
(14
)
Less: Restructuring
—
(27
)
—
(43
)
Non-GAAP Cost of revenues
$
—
$
8,344
$
—
$
10,392
Reconciliation of GAAP to non-GAAP
Research and development:
GAAP Research and development
$
7,472
$
4,517
$
19,998
$
16,744
Less: Stock-based compensation expense
(982
)
(287
)
(1,758
)
(1,240
)
Less: Depreciation and amortization
(55
)
(75
)
(172
)
(203
)
Less: Restructuring
—
(54
)
(38
)
(177
)
Non-GAAP Research and development
$
6,435
$
4,101
$
18,030
$
15,124
Reconciliation of GAAP to non-GAAP
Sales and marketing:
GAAP Sales and marketing
$
—
$
2,020
$
—
$
11,251
Less: Stock-based compensation expense
—
44
—
(772
)
Less: Depreciation and amortization
—
(15
)
—
(43
)
Less: Restructuring
—
(95
)
—
(598
)
Non-GAAP Sales and marketing
$
—
$
1,954
$
—
$
9,838
Reconciliation of GAAP to non-GAAP
General and administrative:
GAAP General and administrative
$
3,780
$
3,088
$
11,043
$
11,373
Less: Stock-based compensation expense
(816
)
(456
)
(2,079
)
(2,227
)
Less: Depreciation and amortization
(242
)
(244
)
(730
)
(758
)
Less: Restructuring
—
(22
)
(5
)
(60
)
Non-GAAP General and administrative
$
2,722
$
2,366
$
8,229
$
8,328
Reconciliation of GAAP to non-GAAP Cost
and expenses:
GAAP Cost and expenses
$
11,252
$
18,025
$
31,041
$
50,021
Less: Stock-based compensation expense
(1,798
)
(723
)
(3,837
)
(4,443
)
Less: Depreciation and amortization
(297
)
(339
)
(902
)
(1,018
)
Less: Restructuring
—
(198
)
(43
)
(878
)
Non-GAAP Cost and expenses
$
9,157
$
16,765
$
26,259
$
43,682
Reconciliation of GAAP to non-GAAP Net
loss:
GAAP Net loss
$
(10,566
)
$
(18,039
)
$
(30,277
)
$
(49,308
)
Add: Stock-based compensation expense
1,798
723
3,837
4,443
Add: Depreciation and amortization
297
339
902
1,018
Add: Restructuring
—
198
43
878
Non-GAAP Net loss
$
(8,471
)
$
(16,779
)
$
(25,495
)
$
(42,969
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231113194475/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
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