Pulse Biosciences, Inc. (Nasdaq: PLSE), a company primarily
focused on leveraging its novel and proprietary Nanosecond Pulsed
Field Ablation (nsPFA) technology for the treatment of atrial
fibrillation, today announced financial results for the second
quarter ended June 30, 2023.
Business Updates
- Demonstrated that an nsPFA cardiac clamp can consistently
perform transmural ablations in cardiac muscle up to approximately
25 millimeters thick in 1.25 seconds in preclinical studies.
- Demonstrated that an nsPFA cardiac ablation catheter can
consistently perform circumferential ablations of targeted
pulmonary veins in a single shot in approximately 5 seconds in
preclinical studies.
- Three abstracts highlighting the results of preclinical studies
using an nsPFA cardiac ablation catheter device were presented by
physician collaborators at the Annual Heart Rhythm Society
Meeting.
- Achieved positive patient tolerance, safety and tissue response
in a first-in-human feasibility study of nsPFA delivery for the
ablation of benign thyroid nodules.
- Entered into a $65 million private placement stock purchase
agreement with Robert Duggan, the Company’s Executive Chairman,
effectively canceling all indebtedness owed by the Company to Mr.
Duggan.
- Further strengthened the balance sheet with gross proceeds of
$14.6 million in the second quarter through the exercise of
warrants from the Company’s June 2022 Rights Offering.
“We are encouraged by the preclinical results we have achieved
with the nsPFA cardiac clamp and catheter products. Our novel
devices, combined with our unique mechanism of action, are
demonstrating the potential to advance the standard of care for the
treatment of atrial fibrillation. Additionally, we view the
preliminary findings in our first-in-human feasibility study using
our proprietary nsPFA surgical end-effector to ablate benign
thyroid nodules as a significant validation of our engineering and
the potential for nsPFA to deliver safe and effective human tissue
ablation in surgery,” said Kevin Danahy, Chief Executive Officer of
Pulse Biosciences. “Looking ahead, we remain focused on gaining
clearance for a cardiac ablation clamp and advancing the catheter
toward first-in-human studies.”
Second 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 June 30, 2023,
were $10.2 million compared to $14.3 million for the prior year
period. Non-GAAP cost and expenses for the three months ended June
30, 2023, were $8.8 million compared to $12.2 million for the prior
year period. The decrease in operating expenses compared to the
prior year period was driven by the prior headcount reduction and
restructuring.
GAAP net loss for the three months ended June 30, 2023 was
($9.9) million compared to ($14.0) million for the three months
ended June 30, 2022. Non-GAAP net loss for the three months ended
June 30, 2023, was ($8.5) million compared to ($11.9) million for
the three months ended June 30, 2022.
Cash and cash equivalents totaled $58.7 million as of June 30,
2023, compared to $14.8 million as of June 30, 2022 and $54.1
million as of March 31, 2023. Cash used in the second quarter of
2023 was $10.0 million compared to $12.8 million in the same period
in the prior year and $7.2 million used in the first quarter of
2023. The increase of second quarter cash usage was primarily due
to the timing of certain nonrecurring payments. In the second
quarter of 2023, the Company received $14.6 million in gross
proceeds from the exercise of warrants issued in its June 2022
rights offering.
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,
August 10, 2023, 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
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 nsPFA technology for use in the
treatment of atrial fibrillation and in a select few other markets
where 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 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 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 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)
June 30,
December 31,
2023
2022
ASSETS
Current assets:
Cash and cash equivalents
$
58,747
$
61,139
Prepaid expenses and other current
assets
1,211
1,008
Total current assets
59,958
62,147
Property and equipment, net
1,755
1,961
Intangible assets, net
2,218
2,551
Goodwill
2,791
2,791
Right-of-use assets
7,670
8,062
Other assets
365
365
Total assets
$
74,757
$
77,877
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$
1,794
$
1,573
Accrued expenses
2,844
2,595
Lease liability, current
975
896
Related party note payable, current
—
917
Total current liabilities
5,613
5,981
Lease liability, less current
8,644
9,144
Related party note payable, less
current
—
65,000
Total liabilities
14,257
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 – 54,771 shares and 37,235
shares at June 30, 2023 and December 31, 2022, respectively
55
37
Additional paid-in capital
374,861
292,420
Accumulated other comprehensive income
(loss)
—
—
Accumulated deficit
(314,416
)
(294,705
)
Total stockholders’ (deficit) equity
60,500
(2,248
)
Total liabilities and stockholders’
equity
$
74,757
$
77,877
PULSE BIOSCIENCES,
INC.
Condensed Consolidated
Statements of Operations and Comprehensive Loss
(In thousands, except per
share amounts)
(Unaudited)
Three-Month Periods
Ended
Six-Month Periods
Ended
June 30,
June 30,
2023*
2022
2023*
2022
Revenues:
Product revenues
$
—
$
265
$
—
$
709
Total revenues
—
265
—
709
Cost and expenses:
Cost of revenues
—
1,344
—
2,253
Research and development
6,697
5,458
12,526
12,227
Sales and marketing
—
3,690
—
9,231
General and administrative
3,530
3,787
7,263
8,285
Total cost and expenses
10,227
14,279
19,789
31,996
Loss from operations
(10,227
)
(14,014
)
(19,789
)
(31,287
)
Other income:
Interest income, net
317
18
78
18
Total other income
317
18
78
18
Net loss
(9,910
)
(13,996
)
(19,711
)
(31,269
)
Other comprehensive gain:
Unrealized gain on available-for-sale
securities
—
—
—
—
Comprehensive loss
$
(9,910
)
$
(13,996
)
$
(19,711
)
$
(31,269
)
Net loss per share:
Basic and diluted net loss per share
$
(0.22
)
$
(0.44
)
$
(0.48
)
$
(1.02
)
Weighted average shares used to compute
net loss per common share — basic and diluted
44,512
31,492
40,970
30,623
Three-Month Periods
Ended
Six-Month Periods
Ended
June 30,
June 30,
Stock Based Compensation
Expense:
2023*
2022
2023*
2022
Cost of revenues
$
—
$
90
$
—
$
180
Research and development
518
496
776
953
Sales and marketing
—
362
—
816
General and administrative
625
765
1,263
1,771
Total stock-based compensation expense
$
1,143
$
1,713
$
2,039
$
3,720
*For the three- and six-month periods
ended June 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
Six-Month Periods
Ended
June 30,
June 30,
2023
2022
2023
2022
Revenue by category:
Systems
$
—
0
%
$
209
79
%
$
—
0
%
$
576
81
%
Cycle units
—
0
%
56
21
%
—
0
%
133
19
%
Total revenue
$
—
0
%
$
265
100
%
$
—
0
%
$
709
100
%
Revenue by geography:
North America
$
—
0
%
$
214
81
%
$
—
0
%
$
526
74
%
Rest of World
—
0
%
51
19
%
—
0
%
183
26
%
Total revenue
$
—
0
%
$
265
100
%
$
—
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
Six-Month Periods
Ended
June 30,
June 30,
2023
2022
2023
2022
Reconciliation of GAAP to non-GAAP Cost
of revenues:
GAAP Cost of revenues
$
—
$
1,344
$
—
$
2,253
Less: Stock-based compensation expense
—
(90
)
—
(180
)
Less: Depreciation and amortization
—
(5
)
—
(10
)
Less: Restructuring
—
—
—
(19
)
Non-GAAP Cost of revenues
$
—
$
1,249
$
—
$
2,044
Reconciliation of GAAP to non-GAAP
Research and development:
GAAP Research and development
$
6,697
$
5,458
$
12,526
$
12,227
Less: Stock-based compensation expense
(518
)
(496
)
(776
)
(953
)
Less: Depreciation and amortization
(59
)
(70
)
(117
)
(129
)
Less: Restructuring
—
—
(38
)
(127
)
Non-GAAP Research and development
$
6,120
$
4,892
$
11,595
$
11,018
Reconciliation of GAAP to non-GAAP
Sales and marketing:
GAAP Sales and marketing
$
—
$
3,690
$
—
$
9,231
Less: Stock-based compensation expense
—
(362
)
—
(816
)
Less: Depreciation and amortization
—
(15
)
—
(28
)
Less: Restructuring
—
—
—
(546
)
Non-GAAP Sales and marketing
$
—
$
3,313
$
—
$
7,841
Reconciliation of GAAP to non-GAAP
General and administrative:
GAAP General and administrative
$
3,530
$
3,787
$
7,263
$
8,285
Less: Stock-based compensation expense
(625
)
(765
)
(1,263
)
(1,771
)
Less: Depreciation and amortization
(244
)
(263
)
(488
)
(513
)
Less: Restructuring
(7
)
—
(19
)
(41
)
Non-GAAP General and administrative
$
2,654
$
2,759
$
5,493
$
5,960
Reconciliation of GAAP to non-GAAP Cost
and expenses:
GAAP Cost and expenses
$
10,227
$
14,279
$
19,789
$
31,996
Less: Stock-based compensation expense
(1,143
)
(1,713
)
(2,039
)
(3,720
)
Less: Depreciation and amortization
(303
)
(353
)
(605
)
(680
)
Less: Restructuring
(7
)
—
(57
)
(733
)
Non-GAAP Cost and expenses
$
8,774
$
12,213
$
17,088
$
26,863
Reconciliation of GAAP to non-GAAP Net
loss:
GAAP Net loss
$
(9,910
)
$
(13,996
)
$
(19,711
)
$
(31,269
)
Add: Stock-based compensation expense
1,143
1,713
2,039
3,720
Add: Depreciation and amortization
303
353
605
680
Add: Restructuring
7
—
57
733
Non-GAAP Net loss
$
(8,457
)
$
(11,930
)
$
(17,010
)
$
(26,136
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230810910916/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)
Historical Stock Chart
From Jul 2024 to Aug 2024
Pulse Biosciences (NASDAQ:PLSE)
Historical Stock Chart
From Aug 2023 to Aug 2024