Outset Medical Reports First Quarter 2022 Financial Results
Revenue Grows 33.3% to
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
First Quarter 2022 Financial Results
Revenue for the first quarter of 2022 was
Total gross profit for the first quarter of 2022 was
Operating expenses for the first quarter of 2022 were
Excluding stock-based compensation expense, non-GAAP operating expenses for the first quarter of 2022 were
First quarter 2022 net loss was
Total cash, including restricted cash, cash equivalents and short-term investments, was
Full Year 2022 Financial Guidance
Outset now projects revenue for the full year 2022 to range from
Webcast and Conference Call Details
Outset will host a conference call today,
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
About
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
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Condensed Statements of Operations |
||||||||||
(in thousands, except per share amounts) |
||||||||||
(unaudited) |
||||||||||
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||||||
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Three Months Ended |
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||||||
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||||||
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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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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(1) Gross profit and gross margin by source consisted of the following: |
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|
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Three Months Ended |
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|
||||||
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|
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 |
|
% |
|
|
|
|
|
|
|
|
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(2) Include stock-based compensation expense as follows: |
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|
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Three Months Ended |
|
|
||||||
|
|
|
|
|
||||||
|
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Condensed Balance Sheets |
||||||||
(in thousands, except per share amounts) |
||||||||
|
|
|
|
|
|
|
||
|
|
2022 |
|
|
2021 |
|
||
|
|
(Unaudited) |
|
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|
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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, |
|
|
— |
|
|
|
— |
|
Common stock, |
|
|
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 |
|
|
||||||||
Condensed Statements of Cash Flows |
||||||||
(in thousands) |
||||||||
(unaudited) |
||||||||
|
|
Three Months Ended |
|
|||||
|
|
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): |
|
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|
|
|||||||
|
|
|
|
|||||
|
|
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 |
|
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|
Appendix A |
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|
||||||||||
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 |
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|
||||||
|
|
|
|
|
||||||
|
|
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 |
|
|
||||||
|
|
|
|
|
||||||
|
|
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 |
|
|
||||||
|
|
|
|
|
||||||
|
|
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
858-342-8272
jmazzola@outsetmedical.com
investors@outsetmedical.com
Media Contact
Director,
nshannon@outsetmedical.com
Source: