Record Annual Revenue of $102.6 Million;
105% Year-over-Year Growth
Outset Medical, Inc. (Nasdaq: OM) (“Outset” or the “Company”), a
medical technology company pioneering a first-of-its-kind
technology to reduce the cost and complexity of dialysis, today
reported financial results for the fourth quarter and full year
ended December 31, 2021. The Company also announced that Leslie
Trigg has been appointed Chair of the Board of Directors in
addition to her ongoing role as President and Chief Executive
Officer.
Recent Highlights
- Recorded net revenue of $28.2 million in the fourth quarter of
2021, a 63.2% increase compared to $17.2 million in the fourth
quarter of 2020, and $102.6 million for the full year of 2021,
representing an increase of 105.5% compared to $49.9 million for
2020
- Achieved gross margin for the fourth quarter of 2021 of 11.8%,
compared to 2.4% in the fourth quarter of 2020
- Signed agreements with 7 of the 8 largest national health
systems and one-third of the largest 100 regional health
systems
- Granted 510(k) clearance from the Food and Drug Administration
(FDA) for Tablo® Hemodialysis System cartridge, enabling full
production in Mexico
- Received the first-ever approval for the Transitional Add-on
Payment Adjustment for New and Innovative Equipment and Supplies
(TPNIES) program from the Centers for Medicare & Medicaid
Services (CMS), which deemed Tablo® a substantial clinical
improvement over the incumbent home hemodialysis device
- Released its inaugural Environmental, Social, and Governance
(ESG) report highlighting the Company’s ESG-related programs,
priorities, goals, and performance
- Leslie Trigg appointed Chair in addition to her ongoing role as
Chief Executive Officer. Former Chairman D. Keith Grossman
continues to serve on the board and has been appointed Lead
Independent Director
“Our entire team contributed to an exceptional 2021, driving
record revenue growth, meaningful progress toward our long-term
gross margin goal and excellent visibility into 2022,” said Leslie
Trigg, Chair and Chief Executive Officer. “Our established
relationships with 7 of the 8 largest national health systems and
one-third of the largest 100 regional health systems puts us in a
strong position for growth this year in both the acute and home
settings.”
“On behalf of the Outset Board of Directors, I am pleased to
announce Leslie’s appointment to the additional role of Board
Chair,” said D. Keith Grossman, Lead Independent Director. “We look
forward to continuing to support Leslie and the entire team as
Outset continues to transform the dialysis industry.”
Fourth Quarter 2021 Financial Results
Revenue for the fourth quarter of 2021 was $28.2 million,
representing an increase of 63.2% compared to $17.2 million in the
fourth quarter of 2020. Product revenue for the fourth quarter of
2021 was $23.7 million, representing an increase of 79.5% compared
to $13.2 million in the fourth quarter of 2020. Service and other
revenue for the fourth quarter of 2021 was $4.5 million,
representing an increase of 10.6% compared to $4.1 million in the
fourth quarter of 2020.
Total gross profit for the fourth quarter of 2021 was $3.3
million, compared to a gross loss of $0.4 million for the fourth
quarter of 2020. Total gross margin for the fourth quarter of 2021
was 11.8%, compared to 2.4% in the fourth quarter of 2020. On a
non-GAAP basis, gross margin for the fourth quarter of 2021
improved to 12% from 2.8% in the fourth quarter of 2020. Product
gross profit for the fourth quarter of 2021 was $2.2 million,
compared to ($1.7) million of product gross loss in the fourth
quarter of 2020. Product gross margin for the fourth quarter of
2021 was 9.3%, compared to (13.2)% in the fourth quarter of 2020.
Service and other gross profit for the fourth quarter of 2021 was
$1.1 million, compared to $2.2 million of service and other gross
profit in the fourth quarter of 2020. Service and other gross
margin for the fourth quarter of 2021 was 25.1%, compared to 53.0%
in the fourth quarter of 2020.
Operating expenses for the fourth quarter of 2021 were $44.1
million, including research and development (R&D) expenses of
$11.4 million, sales and marketing (S&M) expenses of $23.0
million, and general and administrative (G&A) expenses of $9.7
million. This compared to operating expenses of $32.0 million,
including R&D expenses of $7.8 million, S&M expenses of
$15.2 million, and G&A expenses of $9.1 million in the fourth
quarter of 2020.
Excluding stock-based compensation expense, non-GAAP operating
expenses for the fourth quarter of 2021 were $39.4 million,
including R&D expenses of $10.2 million, S&M expenses of
$21.1 million, and G&A expenses of $8.1 million.
Fourth quarter 2021 net loss was ($41.2) million, or ($0.87) per
share, compared to net loss of ($32.0) million, or ($0.75) per
share, for the same period in 2020. On a non-GAAP basis, net loss
for the fourth quarter of 2021 was ($36.4) million, or ($0.77) per
share, compared to non-GAAP net loss of ($25.8) million, or ($0.60)
per share for the same period in 2020.
Full Year 2021 Financial Results
Revenue for the full year of 2021 was $102.6 million,
representing an increase of 105.5% compared to $49.9 million for
2020. Product revenue for the full year of 2021 was $84.3 million,
representing an increase of 112.8% compared to $39.6 million for
2020. Service and other revenue for the full year of 2021 was $18.3
million, representing an increase of 77.2% compared to $10.3
million for 2020.
Total gross profit for the full year of 2021 was $7.6 million,
compared to a gross loss of ($13.0) million for 2020. Total gross
margin for the full year of 2021 was 7.4%, compared to (26.1)% in
2020. Product gross loss for the full year of 2021 was ($0.3)
million, compared to ($17.4) million of product gross loss in 2020.
Product gross margin for the full year of 2021 was (0.4)%, compared
to (44.0)% in 2020. Service and other gross profit for the full
year of 2021 was $7.9 million, compared to $4.4 million of service
and other gross profit in 2020. Service and other gross margin for
the full year of 2021 was 43.4%, compared to 42.5% in 2020.
Operating expenses for the full year of 2021 were $138.1
million, including R&D expenses of $36.7 million, S&M
expenses of $65.1 million, and G&A expenses of $36.3 million.
This compared to operating expenses of $104.4 million, including
R&D expenses of $28.9 million, S&M expenses of $45.1
million, and G&A expenses of $30.5 million for 2020.
Excluding stock-based compensation expense, non-GAAP operating
expenses for the full year of 2021 were $121.0 million, including
R&D expenses of $32.9 million, S&M expenses of $59.2
million, and G&A expenses of $28.8 million.
Full year 2021 net loss attributable to common stockholders was
($131.9) million, or ($2.89) per share, compared to a net loss
attributable to common stockholders of ($79.3) million, or ($4.85)
per share, for 2020. On a non-GAAP basis, net loss for the full
year of 2021 was ($114.5) million, or ($2.51) per share, compared
to a non-GAAP net loss of ($57.9) million, or ($3.54) per share for
2020.
Total cash, including restricted cash, cash equivalents and
short-term investments, was $372.8 million as of December 31,
2021.
Full Year 2022 Financial Guidance
Outset projects revenue for the full year 2022 to range from
$142 million to $150 million, which represents approximately 38% to
46% growth over the Company’s fiscal year 2021 revenue.
Webcast and Conference Call Details
Outset will host a conference call today, February 16, 2022, at
2:00 p.m. PT / 5:00 p.m. ET to discuss its fourth quarter and full
year 2021 financial results. The dial-in numbers are (833) 614-1409
for domestic callers and (914) 987-7130 for international callers.
The conference ID is 6892802. A live webcast of the conference call
will be available on the Investor Relations section of the
Company's website at https://investors.outsetmedical.com. The
webcast will be archived on the website following the completion of
the call.
Use of Non-GAAP Financial Measures
The Company may report non‐GAAP results for gross profit/loss,
gross margin, operating expenses, operating margins, net
income/loss, basic and diluted net income/loss per share, other
income/loss, and cash flows. These non-GAAP financial measures are
in addition to, and not a substitute for, or superior to, financial
measures calculated in accordance with GAAP. The Company’s
financial measures under GAAP include stock-based compensation
expense, as listed in the itemized reconciliations between GAAP and
non‐GAAP financial measures included in this press release.
Management has excluded the effects of this non-cash expense item
in non‐GAAP measures to assist investors in analyzing and assessing
past and future operating performance and period-to-period
comparisons. There are limitations related to the use of non-GAAP
financial measures because they are not prepared in accordance with
GAAP, may exclude significant expenses required by GAAP to be
recognized in the Company’s financial statements, and may not be
comparable to non-GAAP financial measures used by other companies.
The Company encourages investors to carefully consider its results
under GAAP, as well as its supplemental non‐GAAP information and
the reconciliation between these presentations, to more fully
understand its business. Reconciliations between GAAP and non‐GAAP
results are presented in the Appendix A of this press release.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. All statements other than statements of historical fact
are forward-looking statements. Forward-looking statements are
based on management’s current assumptions and expectations of
future events and trends, which affect or may affect the Company’s
business, strategy, operations or financial performance, and actual
results and other events may differ materially from those expressed
or implied in such statements due to numerous risks and
uncertainties. Forward-looking statements include, but are not
limited to, statements about the Company’s possible or assumed
future results of operations and financial position, including
expectations regarding projected revenues (including sales into the
home market and such sales as a percentage of revenues), gross
margin, operating expenses, capital expenditures, profitability and
outlook; statements regarding the Company’s overall business
strategy, plans and objectives of management; the Company’s
expectations regarding the market sizes and growth potential for
Tablo and the total addressable market opportunities for Tablo;
continued execution of the Company’s initiatives designed to reduce
the cost of producing and shipping Tablo devices and its ability to
achieve projected cost reductions at the level or within the
timeframe estimated; the Company’s expectations with respect to
anticipated benefits of the TPNIES approval, as well as the
Company’s expectations regarding the continuing impact of the
COVID-19 pandemic on the Company and its operations as well as the
impact on its customers and suppliers. Forward-looking statements
are inherently subject to risks and uncertainties, some of which
cannot be predicted or quantified. Factors that could cause actual
results or other events to differ materially from those
contemplated in this press release can be found in the Risk Factors
section of Outset’s public filings with the Securities and Exchange
Commission, including Outset’s latest annual and quarterly reports.
Because forward-looking statements are inherently subject to risks
and uncertainties, you should not rely on these forward-looking
statements as predictions of future events. These forward-looking
statements speak only as of their date and, except to the extent
required by law, the Company undertakes no obligation to update
these statements, whether as a result of any new information,
future developments or otherwise.
About Outset Medical, Inc.
Outset is a medical technology company pioneering a
first-of-its-kind technology to reduce the cost and complexity of
dialysis. The Tablo® Hemodialysis System, FDA cleared for use from
the hospital to the home, represents a significant technological
advancement that transforms the dialysis experience for patients
and operationally simplifies it for providers. Tablo serves as a
single enterprise solution that can be utilized across the
continuum of care, allowing dialysis to be delivered anytime,
anywhere and by anyone. The integration of water purification and
on-demand dialysate production enables Tablo to serve as a dialysis
clinic on wheels, with 2-way wireless data transmission and a
proprietary data analytics platform powering a new holistic
approach to dialysis care. Tablo is a registered trademark of
Outset Medical, Inc.
Outset Medical, Inc.
Condensed Statements of
Operations
(in thousands, except per share
amounts)
(unaudited)
Three Months Ended
Years Ended
December 31,
December 31,
2021
2020
2021
2020
Revenue:
Product revenue
$
23,650
$
13,177
$
84,312
$
39,612
Service and other revenue
4,502
4,070
18,290
10,323
Total revenue
28,152
17,247
102,602
49,935
Cost of revenue:
Cost of product revenue (2)
21,459
14,917
84,639
57,035
Cost of service and other revenue
3,372
1,913
10,355
5,937
Total cost of revenue
24,831
16,830
94,994
62,972
Gross profit (1)
3,321
417
7,608
(13,037
)
Gross margin (1)
11.8
%
2.4
%
7.4
%
(26.1
)
%
Operating expenses:
Research and development (2)
11,410
7,784
36,741
28,850
Sales and marketing (2)
22,991
15,198
65,070
45,068
General and administrative (2)
9,719
9,050
36,316
30,512
Total operating expenses
44,120
32,032
138,127
104,430
Loss from operations
(40,799
)
(31,615
)
(130,519
)
(117,467
)
Other income (expense):
Interest income and other income, net
123
2
498
526
Interest expense
(431
)
(430
)
(1,715
)
(2,891
)
Change in fair value of redeemable
convertible preferred stock warrant liability
—
—
—
(93
)
Loss on extinguishment of term loan
—
—
—
(1,567
)
Loss before provision for income taxes
(41,107
)
(32,043
)
(131,736
)
(121,492
)
Provision for income taxes
125
—
199
—
Net loss
$
(41,232
)
$
(32,043
)
$
(131,935
)
$
(121,492
)
Net loss attributable to common
stockholders, basic and diluted (3)
$
(41,232
)
$
(32,043
)
$
(131,935
)
$
(79,324
)
Net loss per share attributable to common
stockholders, basic and diluted
$
(0.87
)
$
(0.75
)
$
(2.89
)
$
(4.85
)
Weighted-average shares used in computing
net loss per share attributable to common stockholders, basic and
diluted
47,169
42,715
45,589
16,358
(1) Gross profit and gross margin by
source consisted of the following:
Three Months Ended
Years Ended
December 31,
December 31,
2021
2020
2021
2020
Gross profit
Product revenue
$
2,191
$
(1,740
)
$
(327
)
$
(17,423
)
Service and other revenue
1,130
2,157
7,935
4,386
Total gross profit
$
3,321
$
417
$
7,608
$
(13,037
)
Gross margin
Product revenue
9.3
%
(13.2
)
%
(0.4
)
%
(44.0
)
%
Service and other revenue
25.1
%
53.0
%
43.4
%
42.5
%
Total gross margin
11.8
%
2.4
%
7.4
%
(26.1
)
%
(2) Include stock-based compensation
expenses as follows:
Three Months Ended
Years Ended
December 31,
December 31,
2021
2020
2021
2020
Cost of revenue
$
68
$
74
$
269
$
255
Research and development
1,241
1,289
3,809
4,615
Sales and marketing
1,896
1,595
5,897
4,423
General and administrative
1,587
3,310
7,470
12,146
Total stock-based compensation
expenses
$
4,792
$
6,268
$
17,445
$
21,439
(3) A reconciliation of the net loss to
net loss attributable to common stockholders is as follows:
Three Months Ended
Years Ended
December 31,
December 31,
2021
2020
2021
2020
Net loss
$
(41,232
)
$
(32,043
)
$
(131,935
)
$
(121,492
)
Adjustment to redemption value on
redeemable convertible preferred stock
—
—
—
(362
)
Deemed dividend on settlement of accrued
dividend*
—
—
—
42,530
Net loss attributable to common
stockholders, basic and diluted
$
(41,232
)
$
(32,043
)
$
(131,935
)
$
(79,324
)
* Deemed dividend on settlement of accrued
dividend arose as a result of the terms and conditions associated
with the Company's redeemable convertible preferred stock
outstanding prior to the Company's initial public offering ("IPO").
These terms and conditions were described in the Company's previous
SEC filings, including the 424(b) prospectus filed on September 16,
2020 in connection with the IPO.
Outset Medical, Inc.
Condensed Balance
Sheets
(in thousands, except per share
amounts)
December 31,
December 31,
2021
2020
(Unaudited)
Assets
Current assets:
Cash and cash equivalents
$
182,348
$
294,972
Short-term investments
157,140
19,898
Accounts receivable, net
25,600
6,468
Inventories
39,185
18,384
Prepaid expenses and other current
assets
5,529
6,189
Total current assets
409,802
345,911
Restricted cash
33,311
33,311
Property and equipment, net
12,964
14,998
Operating lease right-of-use assets
7,231
8,253
Other assets
156
1,356
Total assets
$
463,464
$
403,829
Liabilities and stockholders'
equity
Current liabilities:
Accounts payable
$
1,763
$
4,948
Accrued compensation and related
benefits
24,948
16,845
Accrued expenses and other current
liabilities
13,789
7,903
Accrued warranty liability
3,704
2,913
Deferred revenue, current
6,340
3,201
Operating lease liabilities, current
1,151
882
Total current liabilities
51,695
36,692
Accrued interest, noncurrent
721
240
Deferred revenue, noncurrent
312
570
Operating lease liabilities,
noncurrent
6,893
8,044
Term loan, noncurrent
29,762
29,674
Total liabilities
89,383
75,220
Commitments and contingencies
Stockholders' equity:
Preferred stock, $0.001 par value; 5,000
shares authorized, and no shares issued and outstanding as of
December 31, 2021 and 2020
—
—
Common stock, $0.001 par value; 300,000
shares authorized as of December 31, 2021 and 2020; 47,241 and
42,722 shares issued and outstanding as of December 31, 2021 and
2020, respectively
47
43
Additional paid-in capital
1,000,212
822,624
Accumulated other comprehensive (loss)
income
(184
)
1
Accumulated deficit
(625,994
)
(494,059
)
Total stockholders' equity
374,081
328,609
Total liabilities and stockholders'
equity
$
463,464
$
403,829
Outset Medical, Inc.
Condensed Statements of Cash
Flows
(in thousands)
(unaudited)
Years Ended December
31,
2021
2020
Net cash used in operating activities
$
(130,264
)
$
(99,015
)
Net cash provided by (used in) investing
activities
(142,507
)
3,947
Net cash provided by financing
activities
160,147
385,682
Net (decrease) increase in cash, cash
equivalents and restricted cash
(112,624
)
290,614
Cash, cash equivalents and restricted cash
at beginning of the period
328,283
37,669
Cash, cash equivalents and restricted cash
at end of the period (1)
$
215,659
$
328,283
(1) The following table provides a
reconciliation of cash, cash equivalents and restricted cash
reported within the accompanying condensed balance sheets that sum
to the total of the amounts shown in the accompanying condensed
statements of cash flows (in thousands):
December 31,
2021
2020
Cash and cash equivalents
$
182,348
$
294,972
Restricted cash
33,311
33,311
Total cash, cash equivalents and
restricted cash*
$
215,659
$
328,283
* The total cash, including restricted
cash, cash equivalents and investment securities as of December 31,
2021 was $372.8 million; compared to $348.2 million as of December
31, 2020.
Appendix A
Outset Medical, Inc.
Results of Operations –
Non-GAAP
(in thousands, except per share
amounts)
(unaudited)
Reconciliation between GAAP and
non-GAAP net loss per share attributable to common
stockholders:
Three Months Ended
Years Ended
December 31,
December 31,
2021
2020
2021
2020
GAAP net loss per share to common
stockholders, diluted
$
(0.87
)
$
(0.75
)
$
(2.89
)
$
(4.85
)
Stock-based compensation expense
0.10
0.15
0.38
1.31
Non-GAAP net loss per share to common
stockholders, diluted
$
(0.77
)
$
(0.60
)
$
(2.51
)
$
(3.54
)
Reconciliation between GAAP and
non-GAAP net loss attributable to common stockholders:
Three Months Ended
Years Ended
December 31,
December 31,
2021
2020
2021
2020
GAAP net loss attributable to common
stockholders, diluted
$
(41,232
)
$
(32,043
)
$
(131,935
)
$
(79,324
)
Stock-based compensation expense
4,792
6,268
17,445
21,439
Non-GAAP net loss per share attributable
to common stockholders, diluted
$
(36,440
)
$
(25,775
)
$
(114,490
)
$
(57,885
)
Reconciliation between GAAP and
non-GAAP results of operations:
Three Months Ended
Years Ended
December 31,
December 31,
2021
2020
2021
2020
GAAP gross profit
$
3,321
$
417
$
7,608
$
(13,037
)
Stock-based compensation expense
68
74
269
255
Non-GAAP gross profit
$
3,389
$
491
$
7,877
$
(12,782
)
GAAP gross margin
11.8
%
2.4
%
7.4
%
(26.1
)
%
Stock-based compensation expense
0.2
0.4
0.3
0.5
Non-GAAP gross margin
12.0
%
2.8
%
7.7
%
(25.6
)
%
GAAP research and development
expense
$
11,410
$
7,784
$
36,741
$
28,850
Stock-based compensation expense
(1,241
)
(1,289
)
(3,809
)
(4,615
)
Non-GAAP research and development
expense
$
10,169
$
6,495
$
32,932
$
24,235
GAAP sales and marketing
expense
$
22,991
$
15,198
$
65,070
$
45,068
Stock-based compensation expense
(1,896
)
(1,595
)
(5,897
)
(4,423
)
Non-GAAP sales and marketing expense
$
21,095
$
13,603
$
59,173
$
40,645
GAAP general and administrative
expense
$
9,719
$
9,050
$
36,316
$
30,512
Stock-based compensation expense
(1,587
)
(3,310
)
(7,470
)
(12,146
)
Non-GAAP general and administrative
expense
$
8,132
$
5,740
$
28,846
$
18,366
GAAP total operating expense
$
44,120
$
32,032
$
138,127
$
104,430
Stock-based compensation expense
(4,724
)
(6,194
)
(17,176
)
(21,184
)
Non-GAAP total operating expense
$
39,396
$
25,838
$
120,951
$
83,246
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220216005752/en/
Investor Contact Jim Mazzola Outset Medical 858-342-8272
jmazzola@outsetmedical.com
Brian Johnston (332) 895-3222 Gilmartin Group
investors@outsetmedical.com
Media Contact Nicole Shannon Director, Marketing
Communications for Outset Medical nshannon@outsetmedical.com
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