0000950170-22-013586.txt : 20220801 0000950170-22-013586.hdr.sgml : 20220801 20220801100921 ACCESSION NUMBER: 0000950170-22-013586 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20220801 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20220801 DATE AS OF CHANGE: 20220801 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Outset Medical, Inc. CENTRAL INDEX KEY: 0001484612 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 200514392 STATE OF INCORPORATION: DE FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39513 FILM NUMBER: 221123168 BUSINESS ADDRESS: STREET 1: 3052 ORCHARD DRIVE CITY: SAN JOSE STATE: CA ZIP: 95134 BUSINESS PHONE: 669-231-8200 MAIL ADDRESS: STREET 1: 3052 ORCHARD DRIVE CITY: SAN JOSE STATE: CA ZIP: 95134 FORMER COMPANY: FORMER CONFORMED NAME: Home Dialysis Plus, Ltd. DATE OF NAME CHANGE: 20100219 8-K 1 om-20220801.htm 8-K 8-K
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 1, 2022

 

Outset Medical, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-39513

20-0514392

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

 

 

 

3052 Orchard Dr.,

San Jose, California

 

95134

(Address of Principal Executive Offices)

 

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (669) 231-8200

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock, $0.001 par value per share

 

OM

 

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 

 

Item 2.02 Result of Operations and Financial Condition.

 

On August 1, 2022, Outset Medical, Inc. (the “Company”) issued a press release and will hold its second quarter 2022 earnings conference call announcing the Company’s financial results for the quarter ended June 30, 2022, as well as full year 2022 guidance. A copy of the press release is furnished herewith as Exhibit 99.1 and incorporated into this Item 2.02 by reference.

 

The information contained in this Item 2.02 and Exhibit 99.1 hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended (the "Securities Act"), or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 8.01 Other Events.

 

As previously disclosed, on June 13, 2022, the Company announced its implementation of a shipment hold on the distribution of its Tablo Hemodialysis System for home use pending the Food and Drug Administration’s (“FDA”) review and clearance of a 510(k) application the Company submitted for changes made since the device’s original March 2020 clearance.

 

On August 1, 2022, the Company also announced that the FDA has cleared its 510(k) application of Tablo for patient use in the home and that the Company has resumed shipments of Tablo for home use.

 

Forward-Looking Statements

 

This report and the exhibit attached hereto contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. 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 projected revenues and gross margin. 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 report and the exhibit attached hereto can be found in the Risk Factors section of the Company’s public filings with the Securities and Exchange Commission (“SEC”), including its 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.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit

Number

 

Description

99.1

 

Press Release entitled “Outset Medical Resumes Shipment of Tablo Systems for Home Use, Reports Second Quarter 2022 Financial Results and Provides 2022 Guidance” dated August 1, 2022

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

 

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 

Outset Medical, Inc.

 

 

 

 

 

Date: August 1, 2022

 

By:

/s/Nabeel Ahmed

 

 

 

Nabeel Ahmed

 

 

 

Chief Financial Officer

 

 

 EX-99.1 2 om-ex99_1.htm EX-99.1 EX-99.1

Exhibit 99.1

 

Outset Medical Resumes Shipment of Tablo Systems for Home Use,

Reports Second Quarter 2022 Financial Results and Provides 2022 Guidance



Investor Webcast and Conference Call Scheduled for 5:00 p.m. EST
 

 

San Jose, CA – August 1, 2022 – 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 announced clearance by the Food and Drug Administration of its previously disclosed 510(k) submission and resumption of Tablo® Hemodialysis System shipments for home use.

 

The Company also reported financial results for the second quarter ended June 30, 2022 and provided financial guidance for 2022. Revenue for the second quarter totaled $25.1 million, in line with guidance provided on June 13, 2022. Gross margin for the second quarter was 15.1%, compared to 4.2% in the second quarter of 2021 and 14.5% in the first quarter of 2022.

 

“We are pleased to begin supporting new patients in the home again and helping them achieve autonomy and control over where and when they dialyze,” said Leslie Trigg, Chair and Chief Executive Officer. “As we look to the second half of the year, we see no change in underlying demand for Tablo. However, we have reflected in our guidance the staffing and inflationary pressures our provider customers are facing, as well as the work we need to do to regain commercial momentum following release of the Tablo ship hold.”

 

Second Quarter 2022 Financial Results

Revenue for the second quarter of 2022 was $25.1 million, compared to $25.2 million in the second quarter of 2021. Product revenue for the second quarter of 2022 was $19.6 million, representing a decrease of 4.9% compared to $20.6 million in the second quarter of 2021. Service and other revenue for the second quarter of 2022 was $5.4 million, representing an increase of 18.5% compared to $4.6 million in the second quarter of 2021.

 

Total gross profit for the second quarter of 2022 was $3.8 million, compared to $1.1 million for the second quarter of 2021. Total gross margin for the second quarter of 2022 was 15.1%, compared to 4.2% in the second quarter of 2021. On a non-GAAP basis, gross margin for the second quarter of 2022 improved to 15.9% from 4.4% in the second quarter of 2021. Product gross profit for the second quarter of 2022 was $1.9 million, compared to ($1.4) million of product gross loss in the second quarter of 2021. Product gross margin for the second quarter of 2022 was 9.7%, compared to (7.0)% in the second quarter of 2021. Service and other gross profit for the second quarter of 2022 was $1.9 million, compared to $2.5 million of service and other gross profit in the second quarter of 2021. Service and other gross margin for the second quarter of 2022 was 34.6%, compared to 54.5% in the second quarter of 2021.

 

Operating expenses for the second quarter of 2022 were $47.5 million, including research and development (R&D) expenses of $13.5 million, sales and marketing (S&M) expenses of $23.2 million, and general and administrative (G&A) expenses of $10.8 million. This compared to operating expenses of $31.0 million, including R&D expenses of $8.0 million, S&M expenses of $13.2 million, and G&A expenses of $9.7 million in the second quarter of 2021.

 

Excluding stock-based compensation expense, non-GAAP operating expenses for the second quarter of 2022 were $40.3 million, including R&D expenses of $11.7 million, S&M expenses of $20.3 million, and G&A expenses of $8.2 million.

 

Second quarter 2022 net loss was ($43.8) million, or ($0.92) per share, compared to net loss of ($30.2) million, or ($0.66) per share, for the same period in 2021. On a non-GAAP basis, net loss for the second quarter of 2022 was ($36.4) million, or ($0.77) per share, compared to non-GAAP net loss of ($26.3) million, or ($0.57) per share for the same period in 2021.

 

Total cash, including restricted cash, cash equivalents and short-term investments, was $295.4 million as of June 30, 2022.

 

Full Year 2022 Financial Guidance

Outset now projects revenue for 2022 of $105 million to $110 million, which represents 2% to 7% growth over 2021.

 

 

 

Webcast and Conference Call Details

Outset will host a conference call today, August 1, 2022, at 2:00 p.m. PT / 5:00 p.m. ET to provide a business update and discuss its second quarter 2022 financial results. The dial-in numbers are 877-451-6152 for domestic callers and 201-389-0879 for international callers. The conference ID is 13731999. 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 impact of the COVID-19 pandemic and other macroeconomic factors on the Company 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.

 

 

 

 

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

 

 

 

 

Outset Medical, Inc.

Condensed Statements of Operations

(in thousands, except per share amounts)

(unaudited)

 

 

 

Three Months Ended

 

 

 

Six Months Ended

 

 

 

 

June 30,

 

 

 

June 30,

 

 

 

 

2022

 

 

 

2021

 

 

 

2022

 

 

 

2021

 

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product revenue

 

$

19,621

 

 

 

$

20,628

 

 

 

$

45,285

 

 

 

$

38,838

 

 

Service and other revenue

 

 

5,436

 

 

 

 

4,588

 

 

 

 

10,322

 

 

 

 

9,294

 

 

Total revenue

 

 

25,057

 

 

 

 

25,216

 

 

 

 

55,607

 

 

 

 

48,132

 

 

Cost of revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product revenue (2)

 

 

17,718

 

 

 

 

22,077

 

 

 

 

40,828

 

 

 

 

42,654

 

 

Cost of service and other revenue

 

 

3,557

 

 

 

 

2,087

 

 

 

 

6,555

 

 

 

 

4,137

 

 

Total cost of revenue

 

 

21,275

 

 

 

 

24,164

 

 

 

 

47,383

 

 

 

 

46,791

 

 

Gross profit (1)

 

 

3,782

 

 

 

 

1,052

 

 

 

 

8,224

 

 

 

 

1,341

 

 

Gross margin (1)

 

 

15.1

 

%

 

 

4.2

 

%

 

 

14.8

 

%

 

 

2.8

 

%

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development (2)

 

 

13,521

 

 

 

 

8,032

 

 

 

 

24,352

 

 

 

 

15,602

 

 

Sales and marketing (2)

 

 

23,198

 

 

 

 

13,204

 

 

 

 

43,575

 

 

 

 

26,353

 

 

General and administrative (2)

 

 

10,784

 

 

 

 

9,722

 

 

 

 

20,493

 

 

 

 

18,968

 

 

Total operating expenses

 

 

47,503

 

 

 

 

30,958

 

 

 

 

88,420

 

 

 

 

60,923

 

 

Loss from operations

 

 

(43,721

)

 

 

 

(29,906

)

 

 

 

(80,196

)

 

 

 

(59,582

)

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income and other income, net

 

 

459

 

 

 

 

164

 

 

 

 

579

 

 

 

 

276

 

 

Interest expense

 

 

(481

)

 

 

 

(431

)

 

 

 

(903

)

 

 

 

(853

)

 

Loss before provision for income taxes

 

 

(43,743

)

 

 

 

(30,173

)

 

 

 

(80,520

)

 

 

 

(60,159

)

 

Provision for income taxes

 

 

96

 

 

 

 

35

 

 

 

 

211

 

 

 

 

74

 

 

Net loss

 

$

(43,839

)

 

 

$

(30,208

)

 

 

$

(80,731

)

 

 

$

(60,233

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$

(0.92

)

 

 

$

(0.66

)

 

 

$

(1.69

)

 

 

$

(1.36

)

 

Shares used in computing net loss per share, basic and diluted

 

 

47,882

 

 

 

 

45,680

 

 

 

 

47,686

 

 

 

 

44,228

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1)  Gross profit and gross margin by source consisted of the following:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

 

Six Months Ended

 

 

 

 

June 30,

 

 

 

June 30,

 

 

 

 

2022

 

 

 

2021

 

 

 

2022

 

 

 

2021

 

 

Gross profit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product revenue

 

$

1,903

 

 

 

$

(1,449

)

 

 

$

4,457

 

 

 

$

(3,816

)

 

Service and other revenue

 

 

1,879

 

 

 

 

2,501

 

 

 

 

3,767

 

 

 

 

5,157

 

 

Total gross profit

 

$

3,782

 

 

 

$

1,052

 

 

 

$

8,224

 

 

 

$

1,341

 

 

Gross margin

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product revenue

 

 

9.7

 

%

 

 

(7.0

)

%

 

 

9.8

 

%

 

 

(9.8

)

%

Service and other revenue

 

 

34.6

 

%

 

 

54.5

 

%

 

 

36.5

 

%

 

 

55.5

 

%

Total gross margin

 

 

15.1

 

%

 

 

4.2

 

%

 

 

14.8

 

%

 

 

2.8

 

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(2)  Include stock-based compensation expense as follows:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

 

Six Months Ended

 

 

 

 

June 30,

 

 

 

June 30,

 

 

 

 

2022

 

 

 

2021

 

 

 

2022

 

 

 

2021

 

 

Cost of revenue

 

$

190

 

 

 

$

62

 

 

 

$

283

 

 

 

$

137

 

 

Research and development

 

 

1,808

 

 

 

 

643

 

 

 

 

2,966

 

 

 

 

1,808

 

 

Sales and marketing

 

 

2,864

 

 

 

 

1,052

 

 

 

 

4,570

 

 

 

 

2,794

 

 

General and administrative

 

 

2,552

 

 

 

 

2,180

 

 

 

 

4,601

 

 

 

 

5,050

 

 

Total stock-based compensation expense

 

$

7,414

 

 

 

$

3,937

 

 

 

$

12,420

 

 

 

$

9,789

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Outset Medical, Inc.

Condensed Balance Sheets

(in thousands, except per share amounts)

 

 

 

June 30,

 

 

December 31,

 

 

 

2022

 

 

2021

 

 

 

(Unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

75,497

 

 

$

182,348

 

Short-term investments

 

 

186,565

 

 

 

157,140

 

Accounts receivable, net

 

 

24,627

 

 

 

25,600

 

Inventories

 

 

53,689

 

 

 

39,185

 

Prepaid expenses and other current assets

 

 

5,399

 

 

 

5,529

 

Total current assets

 

 

345,777

 

 

 

409,802

 

Restricted cash

 

 

33,311

 

 

 

33,311

 

Property and equipment, net

 

 

15,245

 

 

 

12,964

 

Operating lease right-of-use assets

 

 

6,687

 

 

 

7,231

 

Other assets

 

 

216

 

 

 

156

 

Total assets

 

$

401,236

 

 

$

463,464

 

Liabilities and stockholders' equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

2,753

 

 

$

1,763

 

Accrued compensation and related benefits

 

 

15,795

 

 

 

24,948

 

Accrued expenses and other current liabilities

 

 

23,261

 

 

 

13,789

 

Accrued warranty liability

 

 

3,444

 

 

 

3,704

 

Deferred revenue, current

 

 

7,752

 

 

 

6,340

 

Operating lease liabilities, current

 

 

1,235

 

 

 

1,151

 

Term loan, current

 

 

1,000

 

 

 

—

 

Total current liabilities

 

 

55,240

 

 

 

51,695

 

Accrued interest, noncurrent

 

 

960

 

 

 

721

 

Deferred revenue, noncurrent

 

 

205

 

 

 

312

 

Operating lease liabilities, noncurrent

 

 

6,261

 

 

 

6,893

 

Term loan, noncurrent

 

 

28,806

 

 

 

29,762

 

Total liabilities

 

 

91,472

 

 

 

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 June 30, 2022 and December 31, 2021

 

 

—

 

 

 

—

 

Common stock, $0.001 par value; 300,000 shares authorized as of June 30, 2022 and December 31, 2021; 47,997 and 47,241 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively

 

 

48

 

 

 

47

 

Additional paid-in capital

 

 

1,017,396

 

 

 

1,000,212

 

Accumulated other comprehensive loss

 

 

(955

)

 

 

(184

)

Accumulated deficit

 

 

(706,725

)

 

 

(625,994

)

Total stockholders' equity

 

 

309,764

 

 

 

374,081

 

Total liabilities and stockholders' equity

 

$

401,236

 

 

$

463,464

 

 

 

 

 

Outset Medical, Inc.

Condensed Statements of Cash Flows

(in thousands)

(unaudited)

 

 

 

Six Months Ended June 30,

 

 

 

2022

 

 

2021

 

Net cash used in operating activities

 

$

(76,910

)

 

$

(69,457

)

Net cash used in investing activities

 

 

(34,706

)

 

 

(104,267

)

Net cash provided by financing activities

 

 

4,765

 

 

 

153,026

 

Net decrease in cash, cash equivalents and restricted cash

 

 

(106,851

)

 

 

(20,698

)

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)

 

$

108,808

 

 

$

307,585

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(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):

 

 

 

 

 

June 30,

 

 

 

2022

 

 

2021

 

Cash and cash equivalents

 

$

75,497

 

 

$

274,274

 

Restricted cash

 

 

33,311

 

 

 

33,311

 

Total cash, cash equivalents and restricted cash*

 

$

108,808

 

 

$

307,585

 

 

 

 

 

 

 

 

* The total cash, including restricted cash, cash equivalents and investment securities as of June 30, 2022 was $295.4 million; compared to $429.5 million as of June 30, 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

 

 

 

Six Months Ended

 

 

 

 

June 30,

 

 

 

June 30,

 

 

 

 

2022

 

 

 

2021

 

 

 

2022

 

 

 

2021

 

 

GAAP net loss per share, diluted

 

$

(0.92

)

 

 

$

(0.66

)

 

 

$

(1.69

)

 

 

$

(1.36

)

 

Stock-based compensation expense

 

 

0.15

 

 

 

 

0.09

 

 

 

 

0.26

 

 

 

 

0.22

 

 

Non-GAAP net loss per share, diluted

 

$

(0.77

)

 

 

$

(0.57

)

 

 

$

(1.43

)

 

 

$

(1.14

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Reconciliation between GAAP and non-GAAP net loss:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

 

Six Months Ended

 

 

 

 

June 30,

 

 

 

June 30,

 

 

 

 

2022

 

 

 

2021

 

 

 

2022

 

 

 

2021

 

 

GAAP net loss, diluted

 

$

(43,839

)

 

 

$

(30,208

)

 

 

$

(80,731

)

 

 

$

(60,233

)

 

Stock-based compensation expense

 

 

7,414

 

 

 

 

3,937

 

 

 

 

12,420

 

 

 

 

9,789

 

 

Non-GAAP net loss, diluted

 

$

(36,425

)

 

 

$

(26,271

)

 

 

$

(68,311

)

 

 

$

(50,444

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Reconciliation between GAAP and non-GAAP results of operations:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

 

Six Months Ended

 

 

 

 

June 30,

 

 

 

June 30,

 

 

 

 

2022

 

 

 

2021

 

 

 

2022

 

 

 

2021

 

 

GAAP gross profit

 

$

3,782

 

 

 

$

1,052

 

 

 

$

8,224

 

 

 

$

1,341

 

 

Stock-based compensation expense

 

 

190

 

 

 

 

62

 

 

 

 

283

 

 

 

 

137

 

 

Non-GAAP gross profit

 

$

3,972

 

 

 

$

1,114

 

 

 

$

8,507

 

 

 

$

1,478

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP gross margin

 

 

15.1

 

%

 

 

4.2

 

%

 

 

14.8

 

%

 

 

2.8

 

%

Stock-based compensation expense

 

 

0.8

 

 

 

 

0.2

 

 

 

 

0.5

 

 

 

 

0.3

 

 

Non-GAAP gross margin

 

 

15.9

 

%

 

 

4.4

 

%

 

 

15.3

 

%

 

 

3.1

 

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP research and development expense

 

$

13,521

 

 

 

$

8,032

 

 

 

$

24,352

 

 

 

$

15,602

 

 

Stock-based compensation expense

 

 

(1,808

)

 

 

 

(643

)

 

 

 

(2,966

)

 

 

 

(1,808

)

 

Non-GAAP research and development expense

 

$

11,713

 

 

 

$

7,389

 

 

 

$

21,386

 

 

 

$

13,794

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP sales and marketing expense

 

$

23,198

 

 

 

$

13,204

 

 

 

$

43,575

 

 

 

$

26,353

 

 

Stock-based compensation expense

 

 

(2,864

)

 

 

 

(1,052

)

 

 

 

(4,570

)

 

 

 

(2,794

)

 

Non-GAAP sales and marketing expense

 

$

20,334

 

 

 

$

12,152

 

 

 

$

39,005

 

 

 

$

23,559

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP general and administrative expense

 

$

10,784

 

 

 

$

9,722

 

 

 

$

20,493

 

 

 

$

18,968

 

 

Stock-based compensation expense

 

 

(2,552

)

 

 

 

(2,180

)

 

 

 

(4,601

)

 

 

 

(5,050

)

 

Non-GAAP general and administrative expense

 

$

8,232

 

 

 

$

7,542

 

 

 

$

15,892

 

 

 

$

13,918

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP total operating expense

 

$

47,503

 

 

 

$

30,958

 

 

 

$

88,420

 

 

 

$

60,923

 

 

Stock-based compensation expense

 

 

(7,224

)

 

 

 

(3,875

)

 

 

 

(12,137

)

 

 

 

(9,652

)

 

Non-GAAP total operating expense

 

$

40,279

 

 

 

$

27,083

 

 

 

$

76,283

 

 

 

$

51,271

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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