Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric
medicine company commercializing the CellFX® System powered by
Nano-Pulse Stimulation™ (NPS™) technology, today announced
financial results for the first quarter of 2022.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20220511005989/en/
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Company Updates
- Increased the overall CellFX System commercial session
utilization four week moving average1 during Q1 with decreasing
trend in early Q2 due to transition in commercial strategy.
- Appointed new commercial leadership and began initiation of the
CellFX System utilization program in May with nine commercial
clinics to establish commercial integration best practices.
Established program goal for each clinic of 40 commercial sessions
per month. Average monthly utilization of the nine participating
clinics during Q1 was 14 sessions per month.
- Generated first quarter 2022 revenue of $444 thousand.
- Completed one commercial sale of a CellFX System in the first
quarter of 2022.
- Transitioned 10 Controlled Launch Program participants to
commercial use in the first quarter totaling 39 commercial
conversions at the end of the first quarter. There are 20 clinics
remaining in the Controlled Launch program after a total of 11
clinics have opted out as of the end of Q1.
- Met with FDA regarding the Additional Information (AI) letter
response to the sebaceous hyperplasia 510(k). Provided additional
analysis of the clinical data following the meeting, at FDA’s
request, and anticipate further communication prior to any formal
response to the AI letter.
1 Utilization is measured as commercial sessions defined as
individual patient treatments, regardless of the number of lesions
treated, performed using CellFX Systems that have been purchased or
converted to commercial use from the controlled launch program.
“In the first quarter of 2022 we took steps to refocus our
CellFX dermatology efforts by bringing in new commercial
leadership. We have prioritized increasing CellFX System
utilization at a subset of our commercial clinics, with the goal of
developing commercial integration best practices that will drive
utilization across all clinics. While these best practices are
being established there will be a reduced focus on capital sales,”
said Darrin Uecker, President and CEO of Pulse Biosciences. “We
also continue to prioritize indication expansion for the CellFX
System and are actively working with FDA on this process.”
First Quarter 2022 Results
Revenue for the three months ended March 31, 2022 was $444
thousand. System revenue for the three months ended March 31, 2022
was $367 thousand. Cycle units revenue for the three months ended
March 31, 2022 was $77 thousand resulting from the purchase of
cycle units to be used with commercial systems. Total revenues of
$331 thousand were recognized on a non-cash basis resulting from
the Controlled Launch Participants opting to acquire CellFX Systems
during the quarter.
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, 2022
were $17.7 million, compared to $18.5 million for the prior year
period. Non-GAAP cost and expenses for the three months ended March
31, 2022 were $14.7 million, compared to $11.3 million for the same
period in the prior year. The year-over-year increase in non-GAAP
cost and expenses was primarily driven by the expansion of
commercial and operational infrastructure, including increased
headcount, to support commercialization activities. The first
quarter of 2022 also included a discrete restructuring charge of
$733 thousand, of which $706 thousand remains in accrued expenses
as of March 31, 2022.
GAAP net loss for the three months ended March 31, 2022 was
($17.3) million compared to ($18.6) million for the three months
ended March 31, 2021. Non-GAAP net loss for the three months ended
March 31, 2022 was ($14.2) million compared to ($11.4) million for
the three months ended March 31, 2021.
Cash, cash equivalents and investments totaled $12.7 million as
of March 31, 2022 compared to $59.9 million as of March 31, 2021
and $28.6 million as of December 31, 2021. Cash used in the first
quarter of 2022 totaled $15.9 million compared to $10.7 million
used in the same period in the prior year and $13.4 million used in
the fourth quarter of 2021.
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, 2022, 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
Nano-Pulse Stimulation technology delivers nano-second pulses of
electrical energy to non-thermally clear cells while sparing
adjacent non-cellular tissue. The CellFX® System is the first
commercial product to harness the distinctive advantages of NPS
technology to treat a variety of applications for which an optimal
solution remains unfulfilled. The initial commercial use of the
CellFX System is to address a range of dermatologic conditions that
share high demand among patients and practitioners for improved
dermatologic outcomes. Designed as a multi-application platform,
the CellFX System offers customer value with a utilization-based
revenue model. Visit pulsebiosciences.com to learn more.
To stay informed about the CellFX System, please visit
CellFX.com and sign-up for updates.
Pulse Biosciences, CellFX, Nano-Pulse Stimulation, NPS 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 Pulse Biosciences’ expectations regarding
the Company’s Controlled Launch program and the Company’s other
activities to develop and commercialize NPS technology to drive
growth, such as statements concerning the timing and prospects for
converting participants in the Controlled Launch into commercial
customers, statements concerning customer adoption and future use
of the CellFX System, and statements concerning the use of best
practices to drive utilization across clinics, statements about
market opportunities in aesthetic dermatology and in other areas of
medicine, statements about potential future regulatory clearances
and about expanding the CellFX System’s indications for use,
statements relating to the effectiveness of the Company’s NPS
technology and the CellFX System to improve patient outcomes,
statements relating to the Company’s current and planned future
clinical studies and its ability to execute these studies
successfully, statements about the Company’s pipeline of product
candidates and ability to pursue applications for NPS technology
outside of dermatology, statements relating to the impact of
COVID-19, statements concerning the impact of the Company’s recent
corporate restructuring on its operations, statements about the
Company’s rights offering or any other of its future financing
activities, and other future events. These forward-looking
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,
2022
2021
ASSETS
Current assets:
Cash and cash equivalents
$
12,676
$
28,614
Accounts Receivable
21
61
Inventory
7,487
5,824
Prepaid expenses and other current
assets
1,979
2,131
Total current assets
22,163
36,630
Property and equipment, net
2,554
2,462
Intangible assets, net
3,050
3,216
Goodwill
2,791
2,791
Right-of-use assets
8,611
8,785
Other assets
365
365
Total assets
$
39,534
$
54,249
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$
3,486
$
2,904
Accrued expenses
4,604
4,389
Deferred revenue
16
16
Lease liability, current
799
774
Note payable, current
—
436
Total current liabilities
8,905
8,519
Lease liability, less current
9,833
10,040
Total liabilities
18,738
18,559
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 – 29,802 shares and 29,716
shares at March 31, 2022 and December 31, 2021, respectively
29
29
Additional paid-in capital
274,240
271,861
Accumulated other comprehensive income
(loss)
—
—
Accumulated deficit
(253,473
)
(236,200
)
Total stockholders’ equity
20,796
35,690
Total liabilities and stockholders’
equity
$
39,534
$
54,249
PULSE BIOSCIENCES,
INC.
Condensed Consolidated
Statements of Operations and Comprehensive Loss
(In thousands, except per
share amounts)
(Unaudited)
Three-Month Periods
Ended
March 31,
2022
2021
Revenues:
Product revenues
$
444
$
—
Total revenues
444
—
Cost and expenses:
Cost of revenues
909
—
Research and development
6,769
9,063
Sales and marketing
5,541
4,146
General and administrative
4,498
5,316
Total cost and expenses
17,717
18,525
Loss from operations
(17,273
)
(18,525
)
Other income (expense):
Interest income (expense), net
—
(114
)
Total other income (expense)
—
(114
)
Net loss
(17,273
)
(18,639
)
Other comprehensive gain (loss):
Unrealized gain (loss) on
available-for-sale securities
—
1
Comprehensive loss
$
(17,273
)
$
(18,638
)
Net loss per share:
Basic and diluted net loss per share
$
(0.58
)
$
(0.71
)
Weighted average shares used to compute
net loss per common share — basic and diluted
29,745
26,072
Three-Month Periods
Ended
March 31,
Stock Based Compensation
Expense:
2022
2021
Cost of revenues
$
90
$
—
Research and development
457
3,166
Sales and marketing
454
1,761
General and administrative
1,006
2,038
Total stock-based compensation expense
$
2,007
$
6,965
PULSE BIOSCIENCES,
INC.
Consolidated Revenue Financial
Highlights
(In thousands)
(Unaudited)
Three-Month Periods
Ended
March 31,
2022
2021
Revenue by category:
Systems
$
367
83%
$
—
-
Cycle units
77
17%
—
-
Total revenue
$
444
100%
$
—
-
Revenue by geography:
North America
$
312
70%
$
—
-
Rest of World
132
30%
—
-
Total revenue
$
444
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
March 31,
2022
2021
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
$
6,769
$
9,063
Less: Stock-based compensation expense
(457
)
(3,166
)
Less: Depreciation and amortization
(59
)
(39
)
Less: Restructuring
(127
)
—
Non-GAAP Research and development
$
6,126
$
5,858
Reconciliation of GAAP to non-GAAP
Sales and marketing:
GAAP Sales and marketing
$
5,541
$
4,146
Less: Stock-based compensation expense
(454
)
(1,761
)
Less: Depreciation and amortization
(13
)
—
Less: Restructuring
(546
)
—
Non-GAAP Sales and marketing
$
4,528
$
2,385
Reconciliation of GAAP to non-GAAP
General and administrative:
GAAP General and administrative
$
4,498
$
5,316
Less: Stock-based compensation expense
(1,006
)
(2,038
)
Less: Depreciation and amortization
(249
)
(240
)
Less: Restructuring
(41
)
—
Non-GAAP General and administrative
$
3,202
$
3,038
Reconciliation of GAAP to non-GAAP Cost
and expenses:
GAAP Cost and expenses
$
17,717
$
18,525
Less: Stock-based compensation expense
(2,007
)
(6,965
)
Less: Depreciation and amortization
(326
)
(279
)
Less: Restructuring
(733
)
—
Non-GAAP Cost and expenses
$
14,651
$
11,281
Reconciliation of GAAP to non-GAAP Net
loss:
GAAP Net loss
$
(17,273
)
$
(18,639
)
Add: Stock-based compensation expense
2,007
6,965
Add: Depreciation and amortization
326
279
Add: Restructuring
733
—
Non-GAAP Net loss
$
(14,207
)
$
(11,395
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220511005989/en/
Investors: Pulse Biosciences Sandra Gardiner, EVP and CFO
510.241.1077 IR@pulsebiosciences.com or Gilmartin Group Philip Trip
Taylor 415.937.5406 philip@gilmartinir.com
Media: Tosk Communications Nadine D. Tosk 504.453.8344
nadinepr@gmail.com or press@pulsebiosciences.com
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