8-K
0001484612false00014846122024-11-062024-11-06

 

 

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): November 6, 2024

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 November 6, 2024, Outset Medical, Inc. (the “Company”) issued a press release and will hold its third quarter 2024 earnings conference call announcing the Company’s financial results for the quarter ended September 30, 2024, as well as updated financial guidance for 2024 revenue and non-GAAP gross margin. A copy of the press release is furnished herewith as Exhibit 99.1 and incorporated herein 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.

 

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 possible or assumed future results of operations and financial position, including expectations regarding projected revenues, gross margin, operating expenses, capital expenditures, cash burn, cash position, profitability and outlook; statements regarding the anticipated impacts and benefits of the Company’s cost reduction actions, initiatives to optimize the commercial organization and restructurings; 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 expand gross margins; the Company’s ability to respond to and resolve any reports, observations or other actions by the Food and Drug Administration or other regulators in a timely and effective manner; as well as the Company’s expectations regarding the impact of macroeconomic factors on the Company, 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 the Company’s public filings with the Securities and Exchange Commission, 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 Reports Third Quarter 2024 Financial Results” dated November 6, 2024

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: November 6, 2024

By:

/s/Nabeel Ahmed

Nabeel Ahmed

Chief Financial Officer

 

 


EX-99.1

Exhibit 99.1

 

Outset Medical Reports Third Quarter 2024 Financial Results

San Jose, CA – November 6, 2024 – 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 third quarter ended September 30, 2024.

“During the quarter, we made significant progress, achieving sequential revenue growth, expanding the Tablo footprint in both the acute and home care settings, boosting gross margin compared to last year and reaching a record level of recurring revenue,” said Leslie Trigg, Chair and Chief Executive Officer. “Meanwhile, we continued implementing our sales transformation, which is showing promising early results and is poised to significantly enhance our growth with acute-care providers.”

Third Quarter 2024 Financial Results

Revenue for the third quarter of $28.7 million increased 5% compared to $27.4 million in the second quarter and declined 6% from $30.4 million in the third quarter of 2023. Product revenue of $20.3 million rose 6% from $19.2 million in the second quarter and declined 14% from $23.5 million in the third quarter of 2023. Service and other revenue was $8.4 million, roughly even with $8.2 million in the second quarter and an increase of 22% compared to $6.8 million in the third quarter of 2023. Recurring revenue from the sale of Tablo cartridges and service reached $21 million, an increase of 4% from the second quarter and 17% as compared to the prior-year period.

Total gross profit of $9.8 million was even with the second quarter and up 37% from $7.2 million for the third quarter of 2023. Total gross margin of 34.3% declined 1.4 percentage points from 35.7% in the second quarter and rose nearly 11 percentage points compared to 23.6% in the third quarter of 2023. On a non-GAAP basis, gross margin of 36.4% declined less than 1 percentage point from 37.3% in the second quarter and rose nearly 11 percentage points from 25.6% in the third quarter of 2023. Product gross profit of $8.8 million increased 1% from $8.7 million in the second quarter and 31% compared to $6.7 million in the third quarter of 2023. Product gross margin of 43.2% declined 1.9 percentage points from 45.1% in the second quarter and increased nearly 15 percentage points from 28.4% in the third quarter of 2023. Service and other gross profit of $1.0 million was roughly even with the second quarter and doubled from $0.5 million in the third quarter of 2023. Service and other gross margin of 12.5% declined 1.1 percentage points compared to 13.6% in the second quarter and increased 5.7 percentage points from 6.8% in the third quarter of 2023.

Operating expenses of $33.7 million declined nearly 17% from the second quarter and 36% from the prior-year period. Research and development (R&D) expenses were $8.1 million, sales and marketing (S&M) expenses were $15.4 million, and general and administrative (G&A) expenses were $10.1 million. This compared to operating expenses of $52.6 million in the third quarter of 2023, including R&D expenses of $16.1 million, S&M expenses of $24.7 million, and G&A expenses of $11.8 million.

Excluding stock-based compensation expense and severance and related charges, net of adjustments to compensation accrual, non-GAAP operating expenses were $26.5 million, including R&D expenses of $6.6 million, S&M expenses of $13.6 million, and G&A expenses of $6.3 million.

Net loss was $27.9 million, or $(0.55) per share, compared to net loss of $46.2 million, or $(0.93) per share, for the same period in 2023. On a non-GAAP basis, net loss was $20.2 million, or $(0.39) per share, compared to non-GAAP net loss of $35.3 million, or $(0.71) per share for the same period in 2023.

Total cash, including restricted cash, cash equivalents and short-term investments, was $179.0 million as of September 30, 2024.

Full Year 2024 Financial Guidance

Outset increased 2024 revenue guidance to approximately $112 million from prior guidance of approximately $110 million, and non-GAAP gross margin guidance to the mid-30% range from the low-to-mid 30% range.

Webcast and Conference Call Details

Outset will host a conference call today, November 6, 2024, at 2:00 p.m. PT / 5:00 p.m. ET to discuss its third quarter 2024 financial results. Those interested in listening to the conference call may do so by registering online. Once registered, participants will receive dial-in numbers and a unique pin to join the call. Participants are encouraged to register more than 15 minutes before the start of the call. 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. As listed in the itemized reconciliations between GAAP and non-GAAP financial measures included in this press release, the Company’s GAAP financial measures include stock-based compensation expense, as well as severance and related charges net of the reversal of compensation accruals for impacted employees. Stock-based compensation is a non-cash expense, and severance and related charges arise outside the ordinary course of continuing operations and are not reflective of the Company's current operating performance. As such, management has excluded the effects of these items 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, gross margin, operating expenses, capital expenditures, cash burn, cash position, profitability and outlook; statements regarding the anticipated impacts and benefits of the Company’s cost reduction actions, initiatives to optimize the commercial organization and restructurings; 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 expand gross margins; the Company’s ability to respond to and resolve any reports, observations or other actions by the Food and Drug Administration or other regulators in a timely and effective manner; as well as the Company’s expectations regarding the impact of macroeconomic factors on the Company, 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 the Company’s public filings with the Securities and Exchange Commission, 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.

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

 


 

Investor Relations

jmazzola@outsetmedical.com

 

 


 

Outset Medical, Inc.

Condensed Statements of Operations

(in thousands, except per share amounts)

(unaudited)

 

 

 

Three Months Ended

 

 

 

Nine Months Ended

 

 

 

 

September 30,

 

 

 

September 30,

 

 

 

 

2024

 

 

 

2023

 

 

 

2024

 

 

 

2023

 

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product revenue

 

$

20,305

 

 

 

$

23,531

 

 

 

$

59,971

 

 

 

$

80,640

 

 

Service and other revenue

 

 

8,361

 

 

 

 

6,831

 

 

 

 

24,251

 

 

 

 

19,229

 

 

Total revenue

 

 

28,666

 

 

 

 

30,362

 

 

 

 

84,222

 

 

 

 

99,869

 

 

Cost of revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product revenue (2)

 

 

11,532

 

 

 

 

16,837

 

 

 

 

34,680

 

 

 

 

59,866

 

 

Cost of service and other revenue

 

 

7,314

 

 

 

 

6,368

 

 

 

 

21,725

 

 

 

 

18,715

 

 

Total cost of revenue

 

 

18,846

 

 

 

 

23,205

 

 

 

 

56,405

 

 

 

 

78,581

 

 

Gross profit (1)

 

 

9,820

 

 

 

 

7,157

 

 

 

 

27,817

 

 

 

 

21,288

 

 

Gross margin (1)

 

 

34.3

 

%

 

 

23.6

 

%

 

 

33.0

 

%

 

 

21.3

 

%

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development (2)

 

 

8,139

 

 

 

 

16,076

 

 

 

 

30,508

 

 

 

 

44,775

 

 

Sales and marketing (2)

 

 

15,417

 

 

 

 

24,720

 

 

 

 

54,593

 

 

 

 

74,038

 

 

General and administrative (2)

 

 

10,103

 

 

 

 

11,815

 

 

 

 

34,231

 

 

 

 

34,892

 

 

Total operating expenses

 

 

33,659

 

 

 

 

52,611

 

 

 

 

119,332

 

 

 

 

153,705

 

 

Loss from operations

 

 

(23,839

)

 

 

 

(45,454

)

 

 

 

(91,515

)

 

 

 

(132,417

)

 

Interest income and other income, net

 

 

2,149

 

 

 

 

2,573

 

 

 

 

7,718

 

 

 

 

7,889

 

 

Interest expense

 

 

(6,068

)

 

 

 

(3,213

)

 

 

 

(18,046

)

 

 

 

(9,258

)

 

Loss before provision for income taxes

 

 

(27,758

)

 

 

 

(46,094

)

 

 

 

(101,843

)

 

 

 

(133,786

)

 

Provision for income taxes

 

 

182

 

 

 

 

86

 

 

 

 

495

 

 

 

 

411

 

 

Net loss

 

$

(27,940

)

 

 

$

(46,180

)

 

 

$

(102,338

)

 

 

$

(134,197

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$

(0.55

)

 

 

$

(0.93

)

 

 

$

(1.98

)

 

 

$

(2.72

)

 

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

 

 

50,501

 

 

 

 

49,913

 

 

 

 

51,685

 

 

 

 

49,364

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

 

Nine Months Ended

 

 

 

 

September 30,

 

 

 

September 30,

 

 

 

 

2024

 

 

 

2023

 

 

 

2024

 

 

 

2023

 

 

Gross profit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product revenue

 

$

8,773

 

 

 

$

6,694

 

 

 

$

25,291

 

 

 

$

20,774

 

 

Service and other revenue

 

 

1,047

 

 

 

 

463

 

 

 

 

2,526

 

 

 

 

514

 

 

Total gross profit

 

$

9,820

 

 

 

$

7,157

 

 

 

$

27,817

 

 

 

$

21,288

 

 

Gross margin

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product revenue

 

 

43.2

 

%

 

 

28.4

 

%

 

 

42.2

 

%

 

 

25.8

 

%

Service and other revenue

 

 

12.5

 

%

 

 

6.8

 

%

 

 

10.4

 

%

 

 

2.7

 

%

Total gross margin

 

 

34.3

 

%

 

 

23.6

 

%

 

 

33.0

 

%

 

 

21.3

 

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(2)  Include stock-based compensation expense and severance and related charges, net as follows:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

 

Nine Months Ended

 

 

Stock-based compensation expense

 

September 30,

 

 

 

September 30,

 

 

 

 

2024

 

 

 

2023

 

 

 

2024

 

 

 

2023

 

 

Cost of revenue

 

$

296

 

 

 

$

620

 

 

 

$

1,092

 

 

 

$

1,381

 

 

Research and development

 

 

1,400

 

 

 

 

2,793

 

 

 

 

6,025

 

 

 

 

8,232

 

 

Sales and marketing

 

 

945

 

 

 

 

3,765

 

 

 

 

4,898

 

 

 

 

9,908

 

 

General and administrative

 

 

3,747

 

 

 

 

3,715

 

 

 

 

12,396

 

 

 

 

10,015

 

 

Total stock-based compensation expense

 

$

6,388

 

 

 

$

10,893

 

 

 

$

24,411

 

 

 

$

29,536

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

 

Nine Months Ended

 

 

Severance and related charges, net*

 

September 30,

 

 

 

September 30,

 

 

 

 

2024

 

 

 

2023

 

 

 

2024

 

 

 

2023

 

 

Cost of revenue

 

$

317

 

 

 

$

 

 

 

$

518

 

 

 

$

 

 

Research and development

 

 

161

 

 

 

 

 

 

 

 

1,124

 

 

 

 

 

 

Sales and marketing

 

 

873

 

 

 

 

 

 

 

 

1,765

 

 

 

 

 

 

General and administrative

 

 

20

 

 

 

 

 

 

 

 

390

 

 

 

 

 

 

Total severance and related charges, net

 

$

1,371

 

 

 

$

 

 

 

$

3,797

 

 

 

$

 

 

* Net of adjustments to compensation accrual

 

 

 

 

 

 

 

 


 

Outset Medical, Inc.

Condensed Balance Sheets

(in thousands, except per share amounts)

 

 

 

September 30,

 

 

December 31,

 

 

 

2024

 

 

2023

 

 

 

(Unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

33,287

 

 

$

68,509

 

Short-term investments

 

 

142,346

 

 

 

134,815

 

Accounts receivable, net

 

 

34,259

 

 

 

32,980

 

Inventories

 

 

61,436

 

 

 

49,215

 

Prepaid expenses and other current assets

 

 

3,945

 

 

 

5,700

 

Total current assets

 

 

275,273

 

 

 

291,219

 

Restricted cash

 

 

3,329

 

 

 

3,329

 

Property and equipment, net

 

 

9,492

 

 

 

13,273

 

Operating lease right-of-use assets

 

 

4,312

 

 

 

5,375

 

Other assets

 

 

484

 

 

 

605

 

Total assets

 

$

292,890

 

 

$

313,801

 

Liabilities and stockholders' equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

4,295

 

 

$

5,827

 

Accrued compensation and related benefits

 

 

14,719

 

 

 

19,005

 

Accrued expenses and other current liabilities

 

 

6,749

 

 

 

13,459

 

Accrued warranty liability

 

 

2,156

 

 

 

3,712

 

Deferred revenue, current

 

 

12,766

 

 

 

11,727

 

Operating lease liabilities, current

 

 

1,745

 

 

 

1,593

 

Total current liabilities

 

 

42,430

 

 

 

55,323

 

Accrued interest

 

 

2,222

 

 

 

896

 

Deferred revenue

 

 

77

 

 

 

101

 

Operating lease liabilities

 

 

3,157

 

 

 

4,482

 

Term loans

 

 

197,182

 

 

 

130,113

 

Total liabilities

 

 

245,068

 

 

 

190,915

 

Commitments and contingencies

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

Preferred stock, $0.001 par value; 5,000 shares authorized, and no shares issued and outstanding as of September 30, 2024 and December 31, 2023

 

 

 

 

 

 

Common stock, $0.001 par value; 300,000 shares authorized as of September 30, 2024 and December 31, 2023; 52,538 and 50,317 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively

 

 

52

 

 

 

50

 

Additional paid-in capital

 

 

1,111,503

 

 

 

1,084,515

 

Accumulated other comprehensive income

 

 

352

 

 

 

68

 

Accumulated deficit

 

 

(1,064,085

)

 

 

(961,747

)

Total stockholders' equity

 

 

47,822

 

 

 

122,886

 

Total liabilities and stockholders' equity

 

$

292,890

 

 

$

313,801

 

 

 


 

Outset Medical, Inc.

Condensed Statements of Cash Flows

(in thousands)

(unaudited)

 

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

Net cash used in operating activities

 

$

(99,815

)

 

$

(106,931

)

Net cash (used in) provided by investing activities

 

 

(4,215

)

 

 

59,601

 

Net cash provided by financing activities

 

 

68,808

 

 

 

10,423

 

Net decrease in cash, cash equivalents and restricted cash

 

 

(35,222

)

 

 

(36,907

)

Cash, cash equivalents and restricted cash at beginning of the period

 

 

71,838

 

 

 

76,533

 

Cash, cash equivalents and restricted cash at end of the period (1)

 

$

36,616

 

 

$

39,626

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(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):

 

 

 

 

 

September 30,

 

 

2024

 

 

2023

 

Cash and cash equivalents

 

$

33,287

 

 

$

36,297

 

Restricted cash

 

 

3,329

 

 

 

3,329

 

Total cash, cash equivalents and restricted cash*

 

$

36,616

 

 

$

39,626

 

 

 

 

 

 

 

 

* The total cash, including restricted cash, cash equivalents and investment securities as of September 30, 2024 was $179.0 million; compared to $197.3 million as of September 30, 2023.

 

 

 

 

 


 

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

 

 

 

Nine Months Ended

 

 

 

 

September 30,

 

 

 

September 30,

 

 

 

2024

 

 

 

2023

 

 

 

2024

 

 

 

2023

 

 

GAAP net loss per share, diluted

 

$

(0.55

)

 

 

$

(0.93

)

 

 

$

(1.98

)

 

 

$

(2.72

)

 

Stock-based compensation expense

 

 

0.13

 

 

 

 

0.22

 

 

 

 

0.47

 

 

 

 

0.60

 

 

Severance and related charges, net

 

 

0.03

 

 

 

 

 

 

 

 

0.07

 

 

 

 

 

 

Non-GAAP net loss per share, diluted

 

$

(0.39

)

 

 

$

(0.71

)

 

 

$

(1.44

)

 

 

$

(2.12

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Reconciliation between GAAP and non-GAAP net loss:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

 

Nine Months Ended

 

 

 

 

September 30,

 

 

 

September 30,

 

 

 

 

2024

 

 

 

2023

 

 

 

2024

 

 

 

2023

 

 

GAAP net loss, diluted

 

$

(27,940

)

 

 

$

(46,180

)

 

 

$

(102,338

)

 

 

$

(134,197

)

 

Stock-based compensation expense

 

 

6,388

 

 

 

 

10,893

 

 

 

 

24,411

 

 

 

 

29,536

 

 

Severance and related charges, net

 

 

1,371

 

 

 

 

 

 

 

 

3,797

 

 

 

 

 

 

Non-GAAP net loss, diluted

 

$

(20,181

)

 

 

$

(35,287

)

 

 

$

(74,130

)

 

 

$

(104,661

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Reconciliation between GAAP and non-GAAP results of operations:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

 

Nine Months Ended

 

 

 

 

September 30,

 

 

 

September 30,

 

 

 

2024

 

 

 

2023

 

 

 

2024

 

 

 

2023

 

 

GAAP gross profit

 

$

9,820

 

 

 

$

7,157

 

 

 

$

27,817

 

 

 

$

21,288

 

 

Stock-based compensation expense

 

 

296

 

 

 

 

620

 

 

 

 

1,092

 

 

 

 

1,381

 

 

Severance and related charges, net

 

 

317

 

 

 

 

 

 

 

 

518

 

 

 

 

 

 

Non-GAAP gross profit

 

$

10,433

 

 

 

$

7,777

 

 

 

$

29,427

 

 

 

$

22,669

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP gross margin

 

 

34.3

 

%

 

 

23.6

 

%

 

 

33.0

 

%

 

 

21.3

 

%

Stock-based compensation expense

 

 

1.0

 

 

 

 

2.0

 

 

 

 

1.3

 

 

 

 

1.4

 

 

Severance and related charges, net

 

 

1.1

 

 

 

 

 

 

 

 

0.6

 

 

 

 

 

 

Non-GAAP gross margin

 

 

36.4

 

%

 

 

25.6

 

%

 

 

34.9

 

%

 

 

22.7

 

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP research and development expense

 

$

8,139

 

 

 

$

16,076

 

 

 

$

30,508

 

 

 

$

44,775

 

 

Stock-based compensation expense

 

 

(1,400

)

 

 

 

(2,793

)

 

 

 

(6,025

)

 

 

 

(8,232

)

 

Severance and related charges, net

 

 

(161

)

 

 

 

 

 

 

 

(1,124

)

 

 

 

 

 

Non-GAAP research and development expense

 

$

6,578

 

 

 

$

13,283

 

 

 

$

23,359

 

 

 

$

36,543

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP sales and marketing expense

 

$

15,417

 

 

 

$

24,720

 

 

 

$

54,593

 

 

 

$

74,038

 

 

Stock-based compensation expense

 

 

(945

)

 

 

 

(3,765

)

 

 

 

(4,898

)

 

 

 

(9,908

)

 

Severance and related charges, net

 

 

(873

)

 

 

 

 

 

 

 

(1,765

)

 

 

 

 

 

Non-GAAP sales and marketing expense

 

$

13,599

 

 

 

$

20,955

 

 

 

$

47,930

 

 

 

$

64,130

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP general and administrative expense

 

$

10,103

 

 

 

$

11,815

 

 

 

$

34,231

 

 

 

$

34,892

 

 

Stock-based compensation expense

 

 

(3,747

)

 

 

 

(3,715

)

 

 

 

(12,396

)

 

 

 

(10,015

)

 

Severance and related charges, net

 

 

(20

)

 

 

 

 

 

 

 

(390

)

 

 

 

 

 

Non-GAAP general and administrative expense

 

$

6,336

 

 

 

$

8,100

 

 

 

$

21,445

 

 

 

$

24,877

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP total operating expense

 

$

33,659

 

 

 

$

52,611

 

 

 

$

119,332

 

 

 

$

153,705

 

 

Stock-based compensation expense

 

 

(6,092

)

 

 

 

(10,273

)

 

 

 

(23,319

)

 

 

 

(28,155

)

 

Severance and related charges, net

 

 

(1,054

)

 

 

 

 

 

 

 

(3,279

)

 

 

 

 

 

Non-GAAP total operating expense

 

$

26,513

 

 

 

$

42,338

 

 

 

$

92,734

 

 

 

$

125,550