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 fourth quarter and full year of 2021.
Company Updates
- Implemented changes to commercial leadership, salesforce and
strategy, to focus on increasing commercial clinic utilization and
over near-term reducing emphasis on new system sales.
- Appointed two medical technology industry veterans to
commercial leadership positions; Kevin Danahy to the newly created
role of Chief Commercial Officer and Joe Talarico as Vice-President
of North American Sales.
- Initiated operating expense reduction programs, including
workforce reductions, expected to lower costs by approximately 20%
from the current run rate, resulting in expected 2022 operating
expenses in line with 2021.
- Achieved fourth quarter 2021 revenue of $844 thousand and full
year 2021 revenue of $1.4 million.
- Completed the first three commercial sales of CellFX Systems,
two in the fourth quarter of 2021 and one in the first quarter of
2022.
- Transitioned 17 Controlled Launch Program participants to
commercial use in the fourth quarter and expect an additional 10
participants to transition in the first quarter, resulting in 39
total commercial conversions at the end of the first quarter.
- 20 clinics remain in the Controlled Launch program after a
total of 11 clinics have opted out at the end of Q1.
- FDA meeting expected in Q2 2022 to discuss Additional
Information letter regarding the sebaceous hyperplasia 510(k).
“2021 included a number of milestones for Pulse Biosciences,
including regulatory approvals in the U.S., Europe, Canada and
Australia, onboarding 70 Controlled Launch Program participants,
the transition of 29 clinics to commercial use, and sales of our
first two commercial CellFX Systems,” said Darrin Uecker, President
and CEO of Pulse Biosciences. “In 2022, our focus is on increasing
utilization at commercial clinics to develop CellFX reference
centers for the benign lesion market under new commercial
leadership. At the same time, we will remain focused on expanding
the CellFX System’s indications for use in dermatology and
beyond.”
Fourth Quarter 2021 Results
Revenue for the three months ended December 31, 2021 was $844
thousand. System revenue for the three months ended December 31,
2021 was $699 thousand, with approximately $600 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 December 31, 2021 was $145 thousand
resulting from the purchase of cycle units to be used with
commercial systems.
Total GAAP gross loss* for the three months ended December 31,
2021 was ($0.4) million. Excluding non-cash expenses for
stock-based compensation and depreciation and amortization,
non-GAAP gross loss for the three months ended December 31, 2021
was ($0.3) million. Following the transition 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 December 31, 2021 were $15.0
million, compared to $13.8 million for the prior year period.
Non-GAAP operating expenses for the three months ended December 31,
2021 were $11.2 million, compared to $11.1 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 offset by uncapitalized
manufacturing operations costs now recorded in cost of revenue.
GAAP net loss for the three months ended December 31, 2021 was
($15.4) million compared to ($13.8) million for the three months
ended December 31, 2020. Non-GAAP net loss for the three months
ended December 31, 2021, was ($11.5) million compared to ($11.1)
million for the three months ended December 31, 2020.
Full Year 2021 Results
Revenue for the full year of 2021 was $1.4 million. System
revenue for the full year of 2021 was $1.2 million including $1.1
million recognized on a non-cash basis resulting from the
Controlled Launch Participants opting to acquire CellFX Systems.
Cycle units revenue for the full year of 2021 was $229 thousand
resulting from the purchase of cycle units to be used with
commercial systems.
Total GAAP gross loss* for the full year of 2021 was ($0.6)
million. Excluding non-cash expenses for stock-based compensation
and depreciation and amortization, non-GAAP gross loss for the full
year of 2021 was ($0.4) million. Following the transition 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 full year of 2021 were $62.5 million, compared to
$50.0 million for 2020. Non-GAAP operating expenses for the full
year of 2021 were $46.9 million, compared to $38.8 million for the
same period in 2020. The year-over-year increase in operating
expenses was driven by the expansion of commercial and operational
infrastructure, including increased headcount, to support
commercialization activities and investments to expand use of the
CellFX System outside dermatology.
GAAP net loss for the full year of 2021 was ($63.7) million
compared to ($49.9) million for 2020. Non-GAAP net loss for the
full year of 2021, was ($47.9) million compared to ($38.7) million
for 2020.
Cash, cash equivalents and investments totaled $28.6 million as
of December 31, 2021 compared to $20.5 million as of December 31,
2020 and $42.0 million as of September 30, 2021. Cash used in the
fourth quarter of 2021 totaled $13.4 million compared to $9.2
million used in the same period in the prior year and $13.8 million
used in the third quarter of 2021. Excluding net proceeds from
equity offerings, cash used in the full year of 2021 totaled $52.9
compared to $34.9 million used in 2020.
* 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,
March 31, 2022, 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 Company’s Controlled Launch program and the Company’s other
activities to develop and commercialize NPS technology to drive
growth, such as statements about the timing and prospects for
converting KOLs participating in the Controlled Launch into
commercial customers, statements concerning customer adoption and
future use of the CellFX System, 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 in
dermatology, 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 on Company operating
expenses caused by the corporate restructuring announced today, and
other future events; our restructuring activities, including
workforce and expense reductions, for example, may be unexpectedly
disruptive to our operations and reputation, unexpectedly costly,
and could result in unforeseen material delays in our new product
development programs and commercialization efforts. 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)
December 31,
December 31,
2021
2020
ASSETS
Current assets:
Cash and cash equivalents
$
28,614
$
12,463
Investments
—
8,012
Accounts Receivable
61
—
Inventory
5,824
—
Prepaid expenses and other current
assets
2,131
1,864
Total current assets
36,630
22,339
Property and equipment, net
2,462
2,478
Intangible assets, net
3,216
3,882
Goodwill
2,791
2,791
Right-of-use assets
8,785
9,438
Other assets
365
365
Total assets
$
54,249
$
41,293
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$
2,904
$
1,717
Accrued expenses
4,389
5,326
Deferred revenue
16
—
Lease liability, current
774
542
Note payable, current
436
—
Total current liabilities
8,519
7,585
Lease liability, less current
10,040
10,814
Total liabilities
18,559
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 – 29,716 shares and 25,550
shares at December 31, 2021 and December 31, 2020, respectively
29
25
Additional paid-in capital
271,861
195,410
Accumulated other comprehensive income
(loss)
—
(1
)
Accumulated deficit
(236,200
)
(172,540
)
Total stockholders’ equity
35,690
22,894
Total liabilities and stockholders’
equity
$
54,249
$
41,293
PULSE BIOSCIENCES,
INC.
Condensed Consolidated
Statements of Operations and Comprehensive Loss
(In thousands, except per
share amounts)
(Unaudited)
Three-Month Periods
Ended
Twelve-Month Periods
Ended
December 31,
December 31,
2021
2020*
2021
2020*
Revenues:
Product revenues
$
844
$
—
$
1,418
$
—
Total revenues
844
—
1,418
—
Cost and expenses:
Cost of revenues
1,241
—
1,968
—
Research and development
5,658
7,425
28,640
26,444
Sales and marketing
4,054
2,330
14,751
7,256
General and administrative
5,301
4,001
19,073
16,265
Total cost and expenses
16,254
13,756
64,432
49,965
Loss from operations
(15,410
)
(13,756
)
(63,014
)
(49,965
)
Other income (expense):
Interest income (expense), net
(6
)
6
(646
)
114
Total other income (expense)
(6
)
6
(646
)
114
Net loss
(15,416
)
(13,750
)
(63,660
)
(49,851
)
Other comprehensive gain (loss):
Unrealized gain (loss) on
available-for-sale securities
—
(2
)
1
(5
)
Comprehensive loss
$
(15,416
)
$
(13,752
)
$
(63,659
)
$
(49,856
)
Net loss per share:
Basic and diluted net loss per share
$
(0.52
)
$
(0.54
)
$
(2.28
)
$
(2.14
)
Weighted average shares used to compute
net loss per common share — basic and diluted
29,637
25,360
27,964
23,248
Three-Month Periods
Ended
Twelve-Month Periods
Ended
December 31,
December 31,
Stock Based Compensation
Expense:
2021
2020*
2021
2020*
Cost of revenues
$
92
$
—
$
129
$
—
Research and development
625
1,056
5,211
4,013
Sales and marketing
423
285
2,749
1,187
General and administrative
2,471
1,048
6,512
4,875
Total stock-based compensation expense
$
3,611
$
2,389
$
14,601
$
10,075
*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
Twelve-Month Periods
Ended
December 31,
December 31,
2021
2020
2021
2020
Revenue by category:
Systems
$
699
83%
$
—
-
$
1,189
84%
$
—
-
Cycle units
145
17%
—
-
229
16%
—
-
Total revenue
$
844
100%
$
—
-
$
1,418
100%
$
—
-
Revenue by geography:
North America
$
777
92%
$
—
-
$
1,182
83%
$
—
-
Rest of World
67
8%
—
-
236
17%
—
-
Total revenue
$
844
100%
$
—
-
$
1,418
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
Twelve-Month Periods
Ended
December 31,
December 31,
2021
2020
2021
2020
Reconciliation of GAAP to non-GAAP Cost
of revenues:
GAAP Cost of revenues
$
1,241
$
—
$
1,968
$
—
Less: Stock-based compensation expense
(92
)
—
(129
)
—
Less: Depreciation and amortization
(3
)
—
(6
)
—
Non-GAAP Cost of revenues
$
1,146
$
—
$
1,833
$
—
Reconciliation of GAAP to non-GAAP
Research and development:
GAAP Research and development
$
5,658
$
7,425
$
28,640
$
26,444
Less: Stock-based compensation expense
(625
)
(1,056
)
(5,211
)
(4,013
)
Less: Depreciation and amortization
(45
)
(39
)
(168
)
(162
)
Non-GAAP Research and development
$
4,988
$
6,330
$
23,261
$
22,269
Reconciliation of GAAP to non-GAAP
Sales and marketing:
GAAP Sales and marketing
$
4,054
$
2,330
$
14,751
$
7,256
Less: Stock-based compensation expense
(423
)
(285
)
(2,749
)
(1,187
)
Less: Depreciation and amortization
(5
)
—
(5
)
—
Non-GAAP Sales and marketing
$
3,626
$
2,045
$
11,997
$
6,069
Reconciliation of GAAP to non-GAAP
General and administrative:
GAAP General and administrative
$
5,301
$
4,001
$
19,073
$
16,265
Less: Stock-based compensation expense
(2,471
)
(1,048
)
(6,512
)
(4,875
)
Less: Depreciation and amortization
(244
)
(247
)
(966
)
(933
)
Non-GAAP General and administrative
$
2,586
$
2,706
$
11,595
$
10,457
Reconciliation of GAAP to non-GAAP Cost
and expenses:
GAAP Cost and expenses
$
16,254
$
13,756
$
64,432
$
49,965
Less: Stock-based compensation expense
(3,611
)
(2,389
)
(14,601
)
(10,075
)
Less: Depreciation and amortization
(297
)
(286
)
(1,145
)
(1,095
)
Non-GAAP Cost and expenses
$
12,346
$
11,081
$
48,686
$
38,795
Reconciliation of GAAP to non-GAAP Net
loss:
GAAP Net loss
$
(15,416
)
$
(13,750
)
$
(63,660
)
$
(49,851
)
Add: Stock-based compensation expense
3,611
2,389
14,601
10,075
Add: Depreciation and amortization
297
286
1,145
1,095
Non-GAAP Net loss
$
(11,508
)
$
(11,075
)
$
(47,914
)
$
(38,681
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220331005960/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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