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 third quarter of 2021.
Recent Highlights
- Achieved third quarter 2021 revenue of $574 thousand,
representing 12 Controlled Launch Program participants opting to
acquire their CellFX Systems and transition to commercial use
- Onboarded 68 CellFX System Controlled Launch Program
participants to date and anticipate the remaining to be onboarded
in Q4 to complete program enrollment across the U.S., Europe and
Canada
- Completed enrollment of 150 patients in an FDA IDE approved
pivotal comparison study to assess the treatment of cutaneous
non-genital warts using the CellFX System, the corresponding 510(k)
submission is on track to be completed in the first half of
2022
- Completed enrollment of 30 patients as part of a feasibility
study to assess the treatment of basal cell carcinoma using the
CellFX System, on track for tissue analysis to be completed in Q1
2022
- Strengthened the executive leadership team with the appointment
of Mitchell E. Levinson as Chief Strategy Officer, to spearhead the
Company’s multi-specialty expansion efforts to leverage NPS
technology, the CellFX platform and CellFX CloudConnect in
applications outside of dermatology
- Appointed healthcare industry executive Laureen DeBuono to its
Board of Directors
“We made important progress across the business in the third
quarter resulting in our first quarter of revenue as the initial
Controlled Launch Program participants elected to purchase their
CellFX Systems and Cycle Units for commercial use,” said Darrin
Uecker, President and CEO of Pulse Biosciences. “On the clinical
front we continue to prioritize studies to support regulatory
submissions to expand the CellFX System’s indications for use in
dermatology. At the same time, we are pleased about the
investigational preclinical work being done with NPS across other
medical specialties. We are laying a foundation to drive value
creation and maximize the full potential of the CellFX
platform.”
Third Quarter 2021 Results
Revenue for the three months ended September 30, 2021 was $574
thousand. System revenue for the three months ended September 30,
2021 was $490 thousand recognized on a non-cash basis resulting
from the Controlled Launch Participants opting to acquire CellFX
Systems. Cycle units revenue for the three months ended September
30, 2021 was $84 thousand resulting from the purchase of initial
cycle units to be used with commercial systems.
Total GAAP gross loss* for the three months ended September 30,
2021 was ($0.2) million. Excluding non-cash expenses for
stock-based compensation and depreciation and amortization,
non-GAAP gross loss for the three months ended September 30, 2021
was ($0.1) million. As the business transitioned to commercial
operations in the third quarter of 2021, all uncapitalized
manufacturing operations costs are now recorded in cost of revenue.
Prior to commercialization, these costs were recorded in research
and development expenses.
Total GAAP operating expenses representing research and
development, sales and marketing and general and administrative
expenses for the three months ended September 30, 2021 were $14.1
million, compared to $12.9 million for the prior year period.
Non-GAAP operating expenses for the three months ended September
30, 2021 were $12.3 million, compared to $10.0 million for the same
period in the prior year. The year-over-year increase in operating
expenses was primarily driven by the expansion of commercial and
operational infrastructure, including increased headcount, to
support commercialization activities.
GAAP net loss for the three months ended September 30, 2021 was
($14.3) million compared to ($12.9) million for the three months
ended September 30, 2020. Non-GAAP net loss for the three months
ended September 30, 2021, was ($12.4) million compared to ($10.0)
million for the three months ended September 30, 2020.
Cash, cash equivalents and investments totaled $42.0 million as
of September 30, 2021 compared to $47.4 million as of June 30,
2021. Cash used in the third quarter of 2021 totaled $13.8 million
excluding net proceeds received in the June 2021 private placement.
This compares with $8.3 million used in the same period in the
prior year and $15.0 million used in the second quarter of
2021.
* Gross loss is calculated as total revenues less cost of
revenues.
Reconciliations of GAAP to non-GAAP operating 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 15, 2021, beginning at 1:30pm PT. Investors interested in
listening to the conference call may do so by dialing
1-877-705-6003 for domestic callers or 1-201-493-6725 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. 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 operating 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
operating expenses and net loss measures. Depreciation and
amortization are non-cash charges to current operations.
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 benefits of the Company’s Controlled Launch program and
commercialization of the CellFX System to drive growth, including
the timing for onboarding KOLs, broader commercial launch and
future regulatory clearances, 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, the timing for
completion of such studies, and the ability of the Company to
execute such studies, as well as the anticipated results of any
such studies, statements relating to the Company’s pipeline of
product candidates, market opportunities and commercial launch
plans, including the market for aesthetic dermatologic procedures,
and statements relating to the impact of COVID-19 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,
2021
2020
ASSETS
Current assets:
Cash and cash equivalents
$
41,991
$
12,463
Investments
—
8,012
Accounts Receivable
72
—
Inventory
4,281
—
Prepaid expenses and other current
assets
2,866
1,864
Total current assets
49,210
22,339
Property and equipment, net
2,446
2,478
Intangible assets, net
3,382
3,882
Goodwill
2,791
2,791
Right-of-use assets
8,954
9,438
Other assets
365
365
Total assets
$
67,148
$
41,293
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$
2,706
$
1,717
Accrued expenses
4,971
5,326
Deferred revenue
7
—
Lease liability, current
749
542
Note payable, current
1,086
—
Total current liabilities
9,519
7,585
Lease liability, less current
10,242
10,814
Total liabilities
19,761
18,399
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 – 29,631 shares and 25,550
shares at September 30, 2021 and December 31, 2020,
respectively
29
25
Additional paid-in capital
268,142
195,410
Accumulated other comprehensive income
(loss)
—
(1
)
Accumulated deficit
(220,784
)
(172,540
)
Total stockholders’ equity
47,387
22,894
Total liabilities and stockholders’
equity
$
67,148
$
41,293
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,
2021
2020*
2021
2020*
Revenues:
Product revenues
$
574
$
—
$
574
$
—
Total revenues
574
—
574
—
Cost and expenses:
Cost of revenues
727
—
727
—
Research and development
6,460
6,968
22,982
19,019
Sales and marketing
3,404
1,746
10,697
4,926
General and administrative
4,256
4,191
13,772
12,264
Total cost and expenses
14,847
12,905
48,178
36,209
Loss from operations
(14,273
)
(12,905
)
(47,604
)
(36,209
)
Other income (expense):
Interest income (expense), net
(9
)
9
(640
)
108
Total other income (expense)
(9
)
9
(640
)
108
Net loss
(14,282
)
(12,896
)
(48,244
)
(36,101
)
Other comprehensive gain (loss):
Unrealized gain (loss) on
available-for-sale securities
—
1
1
(3
)
Comprehensive loss
$
(14,282
)
$
(12,895
)
$
(48,243
)
$
(36,104
)
Net loss per share:
Basic and diluted net loss per share
$
(0.48
)
$
(0.51
)
$
(1.76
)
$
(1.60
)
Weighted average shares used to compute
net loss per common share — basic and diluted
29,612
25,223
27,400
22,540
Three-Month Periods
Ended
Nine-Month Periods
Ended
September 30,
September 30,
Stock Based Compensation
Expense:
2021
2020*
2021
2020*
Cost of revenues
$
37
$
—
$
37
$
—
Research and development
418
1,183
4,586
2,957
Sales and marketing
65
312
2,326
903
General and administrative
1,057
1,154
4,041
3,826
Total stock-based compensation expense
$
1,577
$
2,649
$
10,990
$
7,686
*Certain 2020 amounts have been
reclassified to conform to the current period presentation. Sales
and marketing expenses have been reclassified out of general and
administrative and presented as a separate line item. Amortization
of intangible assets are reclassified to general and administrative
expenses.
PULSE BIOSCIENCES,
INC.
Consolidated Revenue Financial
Highlights
(In thousands)
(Unaudited)
Three-Month Periods
Ended
Nine-Month Periods
Ended
September 30,
September 30,
2021
2020
2021
2020
Revenue by category:
Systems
$
490
85%
$
—
-
$
490
85%
$
—
-
Cycle units
84
15%
—
-
84
15%
—
-
Total revenue
$
574
100%
$
—
-
$
574
100%
$
—
-
Revenue by geography:
North America
$
405
71%
$
—
-
$
405
71%
$
—
-
Rest of World
169
29%
—
-
169
29%
—
-
Total revenue
$
574
100%
$
—
-
$
574
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,
2021
2020
2021
2020
Reconciliation of GAAP to non-GAAP Cost
of revenues:
GAAP Cost of revenues
$
727
$
—
$
727
$
—
Add: Stock-based compensation expense
(37
)
—
(37
)
—
Add: Depreciation and amortization
(3
)
—
(3
)
—
Non-GAAP Cost of revenues
$
687
$
—
$
687
$
—
Reconciliation of GAAP to non-GAAP
Research and development:
GAAP Research and development
$
6,460
$
6,968
$
22,982
$
19,019
Less: Stock-based compensation expense
(418
)
(1,183
)
(4,586
)
(2,957
)
Less: Depreciation and amortization
(43
)
(41
)
(123
)
(123
)
Non-GAAP Research and development
$
5,999
$
5,744
$
18,273
$
15,939
Reconciliation of GAAP to non-GAAP
Sales and marketing:
GAAP Sales and marketing
$
3,404
$
1,746
$
10,697
$
4,926
Less: Stock-based compensation expense
(65
)
(312
)
(2,326
)
(903
)
Non-GAAP Sales and marketing
$
3,339
$
1,434
$
8,371
$
4,023
Reconciliation of GAAP to non-GAAP
General and administrative:
GAAP General and administrative
$
4,256
$
4,191
$
13,772
$
12,264
Less: Stock-based compensation expense
(1,057
)
(1,154
)
(4,041
)
(3,826
)
Less: Depreciation and amortization
(241
)
(223
)
(722
)
(686
)
Non-GAAP General and administrative
$
2,958
$
2,814
$
9,009
$
7,752
Reconciliation of GAAP to non-GAAP Cost
and expenses:
GAAP Cost and expenses
$
14,847
$
12,905
$
48,178
$
36,209
Less: Stock-based compensation expense
(1,577
)
(2,649
)
(10,990
)
(7,686
)
Less: Depreciation and amortization
(287
)
(264
)
(848
)
(809
)
Non-GAAP Cost and expenses
$
12,983
$
9,992
$
36,340
$
27,714
Reconciliation of GAAP to non-GAAP Net
loss:
GAAP Net loss
$
(14,282
)
$
(12,896
)
$
(48,244
)
$
(36,101
)
Add: Stock-based compensation expense
1,577
2,649
10,990
7,686
Add: Depreciation and amortization
287
264
848
809
Non-GAAP Net loss
$
(12,418
)
$
(9,983
)
$
(36,406
)
$
(27,606
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211115006190/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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