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Outset Medical Reports Fourth Quarter and Full Year 2020 Financial Results

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Outset Medical, Inc. (Nasdaq: OM) (“Outset”), a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis, today reported financial results for the fourth quarter and full year ended December 31, 2020.

Recent Highlights

  • Recorded net revenue of $17.2 million in the fourth quarter and $49.9 million for the full year of 2020, representing 143% and 231% increases respectively, over the corresponding periods of 2019
  • Achieved GAAP gross margin of 2.4% for the fourth quarter of 2020, compared to (39.2%) in the fourth quarter of 2019
  • Manufactured the first Tablo consoles at Outset’s facility in Tijuana, Mexico during the first quarter 2021
  • Appointed health care industry veteran and digital health expert Karen Drexler to the Board of Directors

“In the fourth quarter our team continued to outperform while building a solid foundation for growth through 2021 and beyond,” said Leslie Trigg, President and Chief Executive Officer. “We expanded our customer base, deepened our relationships with top health systems, and continued to deliver an exceptional Tablo home experience for patients and their caregivers. More recently, we manufactured the first Tablo consoles at our new facility in Mexico, one quarter ahead of schedule, marking a milestone achievement for a key strategic initiative.”

Fourth Quarter 2020 Financial Results

Revenue for the fourth quarter of 2020 was $17.2 million, representing an increase of 143% compared to $7.1 million in the fourth quarter of 2019. Product revenue for the fourth quarter of 2020 was $13.2 million, representing an increase of 111% compared to $6.2 million in the fourth quarter of 2019. Service and other revenue for the fourth quarter of 2020 was $4.1 million, representing an increase of 387% compared to $0.8 million in the fourth quarter of 2019.

Total gross profit for the fourth quarter of 2020 was $0.4 million, compared to a gross loss of ($2.8) million for the fourth quarter of 2019. Total gross margin for the fourth quarter of 2020 was 2.4%, compared to (39.2%) in the fourth quarter of 2019. Product gross loss for the fourth quarter of 2020 was ($1.7) million, compared to ($2.0) million of product gross loss in the fourth quarter of 2019. Product gross margin for the fourth quarter of 2020 was (13.2%), compared to (31.4%) in the fourth quarter of 2019. Service and other gross profit for the fourth quarter of 2020 was $2.2 million, compared to ($0.8) million of service and other gross loss in the fourth quarter of 2019. Service and other gross margin for the fourth quarter of 2020 was 53.0%, compared to (97.5%) in the fourth quarter of 2019.

Operating expenses for the fourth quarter of 2020 were $32.0 million, including research and development (R&D) expenses of $7.8 million, sales and marketing (S&M) expenses of $15.2 million, and general and administrative (G&A) expenses of $9.1 million. This compared to operating expenses of $15.8 million, including R&D expenses of $6.6 million, S&M expenses of $6.9 million, and G&A expenses of $2.3 million in the fourth quarter of 2019.

Excluding stock-based compensation expense, non-GAAP operating expenses for the fourth quarter of 2020 were $25.8 million, including R&D expenses of $6.5 million, S&M expenses of $13.6 million, and G&A expenses of $5.7 million.

Fourth quarter 2020 net loss was ($32.0) million, or ($0.75) per share, compared to a net loss of ($19.4) million, or ($21.18) per share, for the same period in 2019. On a non-GAAP basis, net loss for the fourth quarter of 2020 was ($25.8) million, or ($0.60) per share, compared to a non-GAAP net loss of ($19.2) million, or ($20.91) per share for the same period in 2019.

Full Year 2020 Financial Results

Revenue for the full year of 2020 was $49.9 million, representing an increase of 231% compared to $15.1 million for 2019. Product revenue for the full year of 2020 was $39.6 million, representing an increase of 188% compared to $13.8 million for 2019. Service and other revenue for the full year of 2020 was $10.3 million, representing an increase of 677% compared to $1.3 million for 2019.

Total gross loss for the full year of 2020 was ($13.0) million, compared to a gross loss of ($17.8) million for 2019. Total gross margin for the full year of 2020 was (26.1%), compared to (118.1%) in 2019. Product gross loss for the full year of 2020 was ($17.4) million, compared to ($13.4) million of product gross loss in 2019. Product gross margin for the full year of 2020 was (44.0%), compared to (97.6%) in 2019. Service and other gross profit for the full year of 2020 was $4.4 million, compared to ($4.4) million of service and other gross loss in 2019. Service and other gross margin for the full year of 2020 was 42.5%, compared to (330.4%) in 2019.

Operating expenses for the full year of 2020 were $104.4 million, including R&D expenses of $28.9 million, S&M expenses of $45.1 million, and G&A expenses of $30.5 million. This compared to operating expenses of $52.5 million, including R&D expenses of $23.3 million, S&M expenses of $20.3 million, and G&A expenses of $8.9 million for 2019.

Excluding stock-based compensation expense, non-GAAP operating expenses for the full year of 2020 were $83.2 million, including R&D expenses of $24.2 million, S&M expenses of $40.6 million, and G&A expenses of $18.4 million.

Full year 2020 net loss attributable to common stockholders was ($79.3) million, or ($4.85) per share, compared to a net loss attributable to common stockholders of ($85.5) million, or ($99.58) per share, for 2019. On a non-GAAP basis, net loss for the full year of 2020 was ($57.9) million, or ($3.54) per share, compared to a non-GAAP net loss of ($84.6) million, or ($98.55) per share for 2019.

Total cash, including restricted cash, cash equivalents and short-term investments, was $348.2 million as of December 31, 2020, compared to $70.8 million as of December 31, 2019.

Full Year 2021 Financial Guidance

Outset projects revenue for the full year 2021 to range from $89 million to $94 million, which represents approximately 78 to 88% growth over the company’s fiscal year 2020 revenue.

First Quarter 2021 Financial Guidance

Outset projects revenue for the first quarter 2021 to range from $21 million to $22 million, which represents approximately 192 to 206% growth over the company’s first quarter 2020 revenue.

Webcast and Conference Call Details

Outset will host a conference call today, March 9, 2021, at 2:00 p.m. PT / 5:00 p.m. ET to discuss its fourth quarter and full year 2020 financial results. The dial-in numbers are (833) 614-1409 for domestic callers and (914) 987-7130 for international callers. The conference ID is 8495745. 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 flow. 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, profitability and outlook, statements regarding the Company’s overall business strategy, plans and objectives of management, 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 424(B)(4) filed on December 3, 2020 in connection with the company’s secondary public offering. 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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31,

 

 

 

Years Ended December 31,

 

 

 

 

2020

 

 

 

2019

 

 

 

2020

 

 

 

2019

 

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product revenue

 

$

13,177

 

 

 

$

6,249

 

 

 

$

39,612

 

 

 

$

13,750

 

 

Service and other revenue

 

 

4,070

 

 

 

 

836

 

 

 

 

10,323

 

 

 

 

1,328

 

 

Total revenue

 

 

17,247

 

 

 

 

7,085

 

 

 

 

49,935

 

 

 

 

15,078

 

 

Cost of revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product revenue (1)

 

 

14,917

 

 

 

 

8,214

 

 

 

 

57,035

 

 

 

 

27,164

 

 

Cost of service and other revenue

 

 

1,913

 

 

 

 

1,651

 

 

 

 

5,937

 

 

 

 

5,716

 

 

Total cost of revenue

 

 

16,830

 

 

 

 

9,865

 

 

 

 

62,972

 

 

 

 

32,880

 

 

Gross profit

 

 

417

 

 

 

 

(2,780

)

 

 

 

(13,037

)

 

 

 

(17,802

)

 

Gross margin

 

 

2.4

 

%

 

 

(39.2

)

%

 

 

(26.1

)

%

 

 

(118.1

)

%

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development (1)

 

 

7,784

 

 

 

 

6,629

 

 

 

 

28,850

 

 

 

 

23,327

 

 

Sales and marketing (1)

 

 

15,198

 

 

 

 

6,883

 

 

 

 

45,068

 

 

 

 

20,259

 

 

General and administrative (1)

 

 

9,050

 

 

 

 

2,278

 

 

 

 

30,512

 

 

 

 

8,919

 

 

Total operating expenses

 

 

32,032

 

 

 

 

15,790

 

 

 

 

104,430

 

 

 

 

52,505

 

 

Loss from operations

 

 

(31,615

)

 

 

 

(18,570

)

 

 

 

(117,467

)

 

 

 

(70,307

)

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income and other income, net

 

 

2

 

 

 

 

374

 

 

 

 

526

 

 

 

 

2,485

 

 

Interest expense

 

 

(430

)

 

 

 

(1,020

)

 

 

 

(2,891

)

 

 

 

(4,257

)

 

Change in fair value of redeemable convertible preferred stock warrant liability

 

 

—

 

 

 

 

(230

)

 

 

 

(93

)

 

 

 

3,800

 

 

Loss on extinguishment of term loan

 

 

—

 

 

 

 

—

 

 

 

 

(1,567

)

 

 

 

—

 

 

Loss before provision for income taxes

 

 

(32,043

)

 

 

 

(19,446

)

 

 

 

(121,492

)

 

 

 

(68,279

)

 

Provision for income taxes

 

 

—

 

 

 

 

—

 

 

 

 

—

 

 

 

 

20

 

 

Net loss

 

$

(32,043

)

 

 

$

(19,446

)

 

 

$

(121,492

)

 

 

$

(68,299

)

 

Net loss attributable to common stockholders, basic and diluted

 

$

(32,043

)

 

 

$

(19,446

)

 

 

$

(79,324

)

 

 

$

(85,461

)

 

Net loss per share attributable to common stockholders, basic and diluted

 

$

(0.75

)

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Outset Medical, Inc.

NASDAQ:OM

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About OM

outset is a pioneering medical technology company that always puts the patient before the machine. our human-centered model is designed to dramatically improve not only the care experience – for patients, families, providers and physicians alike – but also cost-efficiencies for providers. and to achieve this goal, we brought together the most dedicated, creative minds from dialysis with the most dedicated, creative minds from other healthcare fields, in the belief that cross-fertilization – along with hard work – is the surest path to invention. because we believe a dialysis machine should be as easy to use as an everyday consumer product, tablo was designed with simplicity in mind. one example is tablo’s touchscreen display, which offers step-by-step pictures and conversational instructions that make it hard to mess up no matter how new a patient, or caregiver, may be to dialysis. and with simplicity comes speed. we’ve set out to give people their time back. tablo dramatically reduces