Revenue Grows 33.3% to $30.6 million, Gross
Margin expands 13.2 percentage points to 14.5%
Year-over-Year
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 first quarter ended March 31,
2022.
Recent Highlights
- Recorded net revenue of $30.6 million in the first quarter of
2022, a 33.3% increase compared to $22.9 million in the first
quarter of 2021 and an 8.5% increase compared to $28.2 million in
the fourth quarter of 2021
- Achieved gross margin for the first quarter of 2022 of 14.5%,
compared to 1.3% in the first quarter of 2021 and 11.8% in the
fourth quarter of 2021
- Shipped record number of Tablo consoles for Home patients,
reflecting continued momentum in health care providers establishing
Home programs
- Presented three data sets at the National Kidney Foundation
Spring Clinical Meeting highlighting the advantages of Tablo and
potential cost benefits of earlier peritoneal to home hemodialysis
conversion
- Appointed business leader Dale E. Jones to Board of
Directors
“The first quarter of 2022 was marked by strong revenue growth
and gross margin expansion, which resulted from the momentum we see
among both acute care customers and providers expanding access to
Tablo at Home,” said Leslie Trigg, Chair and Chief Executive
Officer. “As interest for Tablo accelerates across all market
segments, we continued to expand gross margins, invest in
innovation, and deliver consistent and predictable financial and
operational results, increasing our confidence for sustained strong
performance through 2022 and beyond.”
First Quarter 2022 Financial Results
Revenue for the first quarter of 2022 was $30.6 million,
representing an increase of 33.3% compared to $22.9 million in the
first quarter of 2021. Product revenue for the first quarter of
2022 was $25.7 million, representing an increase of 40.9% compared
to $18.2 million in the first quarter of 2021. Service and other
revenue for the first quarter of 2022 was $4.9 million,
representing an increase of 3.8% compared to $4.7 million in the
first quarter of 2021.
Total gross profit for the first quarter of 2022 was $4.4
million, compared to a gross profit of $0.3 million for the first
quarter of 2021. Total gross margin for the first quarter of 2022
was 14.5%, compared to 1.3% in the first quarter of 2021. On a
non-GAAP basis, gross margin for the first quarter of 2022 improved
to 14.8% from 1.6% in the first quarter of 2021. Product gross
profit for the first quarter of 2022 was $2.6 million, compared to
($2.4) million of product gross loss in the first quarter of 2021.
Product gross margin for the first quarter of 2022 was 10.0%,
compared to (13.0)% in the first quarter of 2021. Service and other
gross profit for the first quarter of 2022 was $1.9 million,
compared to $2.7 million of service and other gross profit in the
first quarter of 2021. Service and other gross margin for the first
quarter of 2022 was 38.6%, compared to 56.4% in the first quarter
of 2021.
Operating expenses for the first quarter of 2022 were $40.9
million, including research and development (R&D) expenses of
$10.8 million, sales and marketing (S&M) expenses of $20.4
million, and general and administrative (G&A) expenses of $9.7
million. This compared to operating expenses of $30.0 million,
including R&D expenses of $7.6 million, S&M expenses of
$13.1 million, and G&A expenses of $9.2 million in the first
quarter of 2021.
Excluding stock-based compensation expense, non-GAAP operating
expenses for the first quarter of 2022 were $36.0 million,
including R&D expenses of $9.7 million, S&M expenses of
$18.7 million, and G&A expenses of $7.7 million.
First quarter 2022 net loss was ($36.9) million, or ($0.78) per
share, compared to net loss of ($30.0) million, or ($0.70) per
share, for the same period in 2021. On a non-GAAP basis, net loss
for the first quarter of 2022 was ($31.9) million, or ($0.67) per
share, compared to non-GAAP net loss of ($24.2) million, or ($0.56)
per share for the same period in 2021.
Total cash, including restricted cash, cash equivalents and
short-term investments, was $335.6 million as of March 31,
2022.
Full Year 2022 Financial Guidance
Outset now projects revenue for the full year 2022 to range from
$144 million to $150 million, which represents approximately 40% to
46% growth over the Company’s fiscal year 2021 revenue. This
compares to prior 2022 revenue guidance of $142 million to $150
million.
Webcast and Conference Call Details
Outset will host a conference call today, May 4, 2022, at 2:00
p.m. PT / 5:00 p.m. ET to discuss its first quarter 2022 financial
results. The dial-in numbers are (833) 614-1409 for domestic
callers and (914) 987-7130 for international callers. The
conference ID is 4094889. 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
March 31,
2022
2021
Revenue:
Product revenue
$
25,664
$
18,210
Service and other revenue
4,886
4,706
Total revenue
30,550
22,916
Cost of revenue:
Cost of product revenue (2)
23,110
20,577
Cost of service and other revenue
2,998
2,050
Total cost of revenue
26,108
22,627
Gross profit (1)
4,442
289
Gross margin (1)
14.5
%
1.3
%
Operating expenses:
Research and development (2)
10,831
7,570
Sales and marketing (2)
20,377
13,149
General and administrative (2)
9,709
9,246
Total operating expenses
40,917
29,965
Loss from operations
(36,475
)
(29,676
)
Other income (expense):
Interest income and other income, net
120
112
Interest expense
(422
)
(422
)
Loss before provision for income taxes
(36,777
)
(29,986
)
Provision for income taxes
115
39
Net loss
$
(36,892
)
$
(30,025
)
Net loss per share, basic and diluted
$
(0.78
)
$
(0.70
)
Shares used in computing net loss per
share, basic and diluted
47,487
42,760
(1) Gross profit and gross margin by
source consisted of the following:
Three Months Ended
March 31,
2022
2021
Gross profit
Product revenue
$
2,554
$
(2,367
)
Service and other revenue
1,888
2,656
Total gross profit
$
4,442
$
289
Gross margin
Product revenue
10.0
%
(13.0
)
%
Service and other revenue
38.6
%
56.4
%
Total gross margin
14.5
%
1.3
%
(2) Include stock-based compensation
expense as follows:
Three Months Ended
March 31,
2022
2021
Cost of revenue
$
93
$
75
Research and development
1,158
1,165
Sales and marketing
1,706
1,742
General and administrative
2,049
2,870
Total stock-based compensation expense
$
5,006
$
5,852
Outset Medical, Inc.
Condensed Balance
Sheets
(in thousands, except per share
amounts)
March 31,
December 31,
2022
2021
(Unaudited)
Assets
Current assets:
Cash and cash equivalents
$
114,346
$
182,348
Short-term investments
187,921
157,140
Accounts receivable, net
26,899
25,600
Inventories
42,873
39,185
Prepaid expenses and other current
assets
5,387
5,529
Total current assets
377,426
409,802
Restricted cash
33,311
33,311
Property and equipment, net
13,882
12,964
Operating lease right-of-use assets
6,962
7,231
Other assets
161
156
Total assets
$
431,742
$
463,464
Liabilities and stockholders'
equity
Current liabilities:
Accounts payable
$
5,149
$
1,763
Accrued compensation and related
benefits
13,478
24,948
Accrued expenses and other current
liabilities
18,610
13,789
Accrued warranty liability
3,628
3,704
Deferred revenue, current
6,833
6,340
Operating lease liabilities, current
1,192
1,151
Total current liabilities
48,890
51,695
Accrued interest, noncurrent
840
721
Deferred revenue, noncurrent
194
312
Operating lease liabilities,
noncurrent
6,581
6,893
Term loan, noncurrent
29,784
29,762
Total liabilities
86,289
89,383
Commitments and contingencies
Stockholders' equity:
Preferred stock, $0.001 par value; 5,000
shares authorized, and no shares issued and outstanding as of March
31, 2022 and December 31, 2021
—
—
Common stock, $0.001 par value; 300,000
shares authorized as of March 31, 2022 and December 31, 2021;
47,712 and 47,241 shares issued and outstanding as of March 31,
2022 and December 31, 2021, respectively
48
47
Additional paid-in capital
1,008,940
1,000,212
Accumulated other comprehensive loss
(649
)
(184
)
Accumulated deficit
(662,886
)
(625,994
)
Total stockholders' equity
345,453
374,081
Total liabilities and stockholders'
equity
$
431,742
$
463,464
Outset Medical, Inc.
Condensed Statements of Cash
Flows
(in thousands)
(unaudited)
Three Months Ended March
31,
2022
2021
Net cash used in operating activities
$
(38,335
)
$
(38,616
)
Net cash used in investing activities
(33,390
)
(6,807
)
Net cash provided by financing
activities
3,723
2,218
Net decrease in cash, cash equivalents and
restricted cash
(68,002
)
(43,205
)
Cash, cash equivalents and restricted cash
at beginning of the period
215,659
328,283
Cash, cash equivalents and restricted cash
at end of the period (1)
$
147,657
$
285,078
(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):
March 31,
2022
2021
Cash and cash equivalents
$
114,346
$
251,767
Restricted cash
33,311
33,311
Total cash, cash equivalents and
restricted cash*
$
147,657
$
285,078
* The total cash, including restricted
cash, cash equivalents and investment securities as of March 31,
2022 was $335.6 million; compared to $310.8 million as of March 31,
2021.
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:
Three Months Ended
March 31,
2022
2021
GAAP net loss per share, diluted
$
(0.78
)
$
(0.70
)
Stock-based compensation expense
0.11
0.14
Non-GAAP net loss per share, diluted
$
(0.67
)
$
(0.56
)
Reconciliation between GAAP and
non-GAAP net loss:
Three Months Ended
March 31,
2022
2021
GAAP net loss, diluted
$
(36,892
)
$
(30,025
)
Stock-based compensation expense
5,006
5,852
Non-GAAP net loss, diluted
$
(31,886
)
$
(24,173
)
Reconciliation between GAAP and
non-GAAP results of operations:
Three Months Ended
March 31,
2022
2021
GAAP gross profit
$
4,442
$
289
Stock-based compensation expense
93
75
Non-GAAP gross profit
$
4,535
$
364
GAAP gross margin
14.5
%
1.3
%
Stock-based compensation expense
0.3
0.3
Non-GAAP gross margin
14.8
%
1.6
%
GAAP research and development
expense
$
10,831
$
7,570
Stock-based compensation expense
(1,158
)
(1,165
)
Non-GAAP research and development
expense
$
9,673
$
6,405
GAAP sales and marketing
expense
$
20,377
$
13,149
Stock-based compensation expense
(1,706
)
(1,742
)
Non-GAAP sales and marketing expense
$
18,671
$
11,407
GAAP general and administrative
expense
$
9,709
$
9,246
Stock-based compensation expense
(2,049
)
(2,870
)
Non-GAAP general and administrative
expense
$
7,660
$
6,376
GAAP total operating expense
$
40,917
$
29,965
Stock-based compensation expense
(4,913
)
(5,777
)
Non-GAAP total operating expense
$
36,004
$
24,188
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220504005776/en/
Investor Contact Jim Mazzola Outset Medical 858-342-8272
jmazzola@outsetmedical.com
Lynn Lewis or Brian Johnston Gilmartin Group
investors@outsetmedical.com
Media Contact Nicole Shannon Director, Marketing
Communications for Outset Medical nshannon@outsetmedical.com
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