Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its
novel and proprietary nanosecond pulsed field ablation (nsPFA™)
technology for the treatment of atrial fibrillation, today
announced financial results for the first quarter ended March 31,
2023.
Business Updates
- Announced the appointment of Gansevoort “Gan” Dunnington, MD,
as Chief Medical Officer, Cardiac Surgery; Dr. Dunnington is a key
opinion leading cardiothoracic surgeon pioneering novel
less-invasive technologies to improve the lives of patients with
atrial fibrillation.
- Completed a pre-submission meeting with the FDA to review the
regulatory requirements for the Company’s nsPFA surgical ablation
clamp as part of the standard Q-submission process; expect
continued engagement with FDA to finalize the regulatory path for
the device.
- Continued development across several preclinical studies for
the Company’s nsPFA cardiac ablation catheter device to support a
first-in-human feasibility study.
- 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.
- Announced decision to redeem all outstanding warrants from the
Company’s June 2022 Rights Offering; the exercise of warrants in
2023 represents an opportunity to raise up to an additional $15.0
million for the Company.
“In the first quarter we advanced our preclinical and regulatory
objectives for our two novel nsPFA devices, the surgical ablation
clamp and cardiac ablation catheter. Our preclinical evidence
continues to demonstrate differentiated benefits of nsPFA that we
believe can advance the treatment of atrial fibrillation,” said
Kevin Danahy, Chief Executive Officer of Pulse Biosciences. “We are
excited to expand our leadership team with the appointment of our
Chief Medical Officer, Dr. Gan Dunnington. He has been actively
involved with the preclinical studies of our nsPFA surgical
ablation clamp and shares our enthusiasm about the potential of the
technology. His continued contributions will be extremely valuable
as we advance clinical, regulatory, and potential commercialization
of the device.”
First 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 March 31, 2023,
were $9.6 million, compared to $17.7 million for the prior year
period. Non-GAAP cost and expenses for the three months ended March
31, 2023, were $8.3 million compared to $14.7 million in the prior
year period.
GAAP net loss for the three months ended March 31, 2023, was
($9.8) million compared to ($17.3) million for the three months
ended March 31, 2022. Non-GAAP net loss for the three months ended
March 31, 2023 was ($8.6) million compared to ($14.2) million for
the three months ended March 31, 2023.
Cash and cash equivalents totaled $54.1 million as of March 31,
2023, compared to $12.7 million as of March 31, 2022 and $61.1
million as of December 31, 2022. Cash used in the first quarter of
2023 was $7.2 million compared to $15.9 million in the same period
in the prior year and $8.0 million used in the fourth quarter of
2022. Cash used in the first quarter excludes $200 thousand of net
proceeds from the exercise of warrants.
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,
May 11, 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
nano-second pulses of electrical energy to non-thermally clear
cells while sparing adjacent non-cellular tissue. The Company is
actively pursuing the development of its nsPFA technology for use
in electrophysiology and the treatment of atrial fibrillation.
Visit pulsebiosciences.com to learn more.
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 performance and time-based options. 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, statements about the
Company’s redemption of warrants and other 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 and whether future clinical
studies will show the CellFX System is safe and effective to treat
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)
March 31,
December 31,
2023
2022
ASSETS
Current assets:
Cash and cash equivalents
$
54,098
$
61,139
Prepaid expenses and other current
assets
849
1,008
Total current assets
54,947
62,147
Property and equipment, net
1,865
1,961
Intangible assets, net
2,384
2,551
Goodwill
2,791
2,791
Right-of-use assets
7,869
8,062
Other assets
365
365
Total assets
$
70,221
$
77,877
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$
2,160
$
1,573
Accrued expenses
3,091
2,595
Deferred revenue
4
—
Lease liability, current
935
896
Related party note payable, current
801
917
Total current liabilities
6,991
5,981
Lease liability, less current
8,898
9,144
Related party note payable, less
current
65,000
65,000
Total liabilities
80,889
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 – 37,593 shares and
37,235 shares at March 31, 2023 and
December 31, 2022,
respectively
37
37
Additional paid-in capital
293,801
292,420
Accumulated other comprehensive income
(loss)
—
—
Accumulated deficit
(304,506
)
(294,705
)
Total stockholders’ deficit
(10,668
)
(2,248
)
Total liabilities and stockholders’
deficit
$
70,221
$
77,877
PULSE BIOSCIENCES,
INC.
Condensed Consolidated
Statements of Operations and Comprehensive Loss
(In thousands, except per
share amounts)
(Unaudited)
Three-Month Periods
Ended
March 31,
2023*
2022
Revenues:
Product revenues
$
—
$
444
Total revenues
—
444
Cost and expenses:
Cost of revenues
—
909
Research and development
5,829
6,769
Sales and marketing
—
5,541
General and administrative
3,733
4,498
Total cost and expenses
9,562
17,717
Loss from operations
(9,562
)
(17,273
)
Other income (expense):
Interest income (expense), net
(239
)
—
Total other income (expense)
(239
)
—
Net loss
(9,801
)
(17,273
)
Other comprehensive gain (loss):
Unrealized gain (loss) on
available-for-sale securities
—
—
Comprehensive loss
$
(9,801
)
$
(17,273
)
Net loss per share:
Basic and diluted net loss per share
$
(0.26
)
$
(0.58
)
Weighted average shares used to compute
net loss per common share — basic and diluted
37,390
29,745
Three-Month Periods
Ended
March 31,
Stock Based Compensation
Expense:
2023*
2022
Cost of revenues
$
—
$
90
Research and development
258
457
Sales and marketing
—
454
General and administrative
638
1,006
Total stock-based compensation expense
$
896
$
2,007
*For the three month period ended March 31, 2023, the Company
reclassified certain expenses as a result of the shift in focus
from dermatology to cardiology. The Company is no longer selling
the CellFX system into the dermatology market, and is therefore no
longer incurring Cost of Revenues. 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.
Going forward, the Company will evaluate the classification of
expenses as research and development or general and administrative
in accordance with ASC Topic 730, Research and Development.
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
March 31,
2023
2022
Reconciliation of GAAP to non-GAAP Cost
of revenues:
GAAP Cost of revenues
$
—
$
909
Less: Stock-based compensation expense
—
(90
)
Less: Depreciation and amortization
—
(5
)
Less: Restructuring
—
(19
)
Non-GAAP Cost of revenues
$
—
$
795
Reconciliation of GAAP to non-GAAP
Research and development:
GAAP Research and development
$
5,829
$
6,769
Less: Stock-based compensation expense
(258
)
(457
)
Less: Depreciation and amortization
(57
)
(59
)
Less: Restructuring
(38
)
(127
)
Non-GAAP Research and development
$
5,476
$
6,126
Reconciliation of GAAP to non-GAAP
Sales and marketing:
GAAP Sales and marketing
$
—
$
5,541
Less: Stock-based compensation expense
—
(454
)
Less: Depreciation and amortization
—
(13
)
Less: Restructuring
—
(546
)
Non-GAAP Sales and marketing
$
—
$
4,528
Reconciliation of GAAP to non-GAAP
General and administrative:
GAAP General and administrative
$
3,733
$
4,498
Less: Stock-based compensation expense
(638
)
(1,006
)
Less: Depreciation and amortization
(244
)
(249
)
Less: Restructuring
(12
)
(41
)
Non-GAAP General and administrative
$
2,839
$
3,202
Reconciliation of GAAP to non-GAAP Cost
and expenses:
GAAP Cost and expenses
$
9,562
$
17,717
Less: Stock-based compensation expense
(896
)
(2,007
)
Less: Depreciation and amortization
(301
)
(326
)
Less: Restructuring
(50
)
(733
)
Non-GAAP Cost and expenses
$
8,315
$
14,651
Reconciliation of GAAP to non-GAAP Net
loss:
GAAP Net loss
$
(9,801
)
$
(17,273
)
Add: Stock-based compensation expense
896
2,007
Add: Depreciation and amortization
301
326
Add: Restructuring
50
733
Non-GAAP Net loss
$
(8,554
)
$
(14,207
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230511005798/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 Sep 2024 to Oct 2024
Pulse Biosciences (NASDAQ:PLSE)
Historical Stock Chart
From Oct 2023 to Oct 2024