Outset Medical, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Outset Medical, Inc. has filed its 2023 10-K report detailing its financial performance and business operations.</b>

AI Summary

Outset Medical, Inc. (OM) filed a Annual Report (10-K) with the SEC on February 21, 2024. Outset Medical, Inc. filed its 2023 Form 10-K on February 21, 2024. The filing covers the fiscal year ending December 31, 2023. The company's principal business address is 3052 Orchard Drive, San Jose, CA 95134. Outset Medical, Inc. was formerly known as Home Dialysis Plus, Ltd. before a name change on February 19, 2010. The company operates in the Electromedical & Electrotherapeutic Apparatus industry (SIC 3845).

Why It Matters

For investors and stakeholders tracking Outset Medical, Inc., this filing contains several important signals. The 10-K filing provides a comprehensive overview of the company's financial health, operational activities, and strategic direction for the fiscal year 2023, which is crucial for investors to assess the company's performance and future prospects. This filing includes detailed financial statements, risk factors, and executive compensation, offering transparency into the company's management and potential challenges, enabling informed investment decisions.

Risk Assessment

Risk Level: — Outset Medical, Inc. shows moderate risk based on this filing. The company's financial performance and future outlook are subject to various risks, including market competition and operational challenges, as detailed in the 10-K filing.

Analyst Insight

Review the detailed financial statements and risk factors in the 10-K to understand Outset Medical's current financial position and potential future challenges.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reported period)
• 2024-02-21 — Filing Date (Date of submission)
• 3845 — SIC Code (Industry classification)
• 001-39513 — SEC File Number (Company's SEC filing number)

Key Players & Entities

• Outset Medical, Inc. (company) — Filer
• Home Dialysis Plus, Ltd. (company) — Former company name
• 3052 Orchard Drive, San Jose, CA 95134 (company) — Business address
• 2023-12-31 (date) — Fiscal year end
• 2024-02-21 (date) — Filing date

FAQ

Industry Context

Outset Medical operates within the Electromedical & Electrotherapeutic Apparatus industry, focusing on medical devices.

Regulatory Implications

The company is subject to SEC regulations for public filings, including the annual 10-K report.

What Investors Should Do

1. Analyze the revenue and profitability trends for fiscal year 2023.
2. Assess the company's debt structure and liquidity position.
3. Evaluate the identified risk factors and their potential impact on future operations.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
• 2024-02-21: Filing Date — Date the 10-K was officially submitted to the SEC.

Year-Over-Year Comparison

This is the 2023 Form 10-K filing, providing updated financial and operational information compared to previous filings.

Key Financial Figures

• $0.001 — ch registered Common Stock, par value $0.001 per share OM The Nasdaq Stock Marke

Filing Documents

• om-20231231.htm (10-K) — 2991KB
• om-ex10_4.htm (EX-10.4) — 169KB
• om-ex10_11.htm (EX-10.11) — 106KB
• om-ex10_12.htm (EX-10.12) — 104KB
• om-ex10_25.htm (EX-10.25) — 99KB
• om-ex23_1.htm (EX-23.1) — 3KB
• om-ex31_1.htm (EX-31.1) — 15KB
• om-ex31_2.htm (EX-31.2) — 15KB
• om-ex32_1.htm (EX-32.1) — 14KB
• om-ex97_1.htm (EX-97.1) — 25KB
• img17345289_0.jpg (GRAPHIC) — 9KB
• img265557197_0.jpg (GRAPHIC) — 728KB
• img265557197_1.jpg (GRAPHIC) — 64KB
• 0000950170-24-018093.txt (&nbsp;) — 14405KB
• om-20231231.xsd (EX-101.SCH) — 1780KB
• om-20231231_htm.xml (XML) — 2063KB

Business

Business 3 Item 1A.

Risk Factors

Risk Factors 21 Item 1B. Unresolved Staff Comments 60 Item 1C. Cybersecurity 60 Item 2.

Properties

Properties 63 Item 3.

Legal Proceedings

Legal Proceedings 63 Item 4. Mine Safety Disclosures 63 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 64 Item 6. [ Reserved ] 65 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 66 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 75 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 76 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 103 Item 9A.

Controls and Procedures

Controls and Procedures 103 Item 9B. Other Information 103 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 103 PART III Item 10. Directors, Executive Officers and Corporate Governance 105 Item 11.

Executive Compensation

Executive Compensation 105 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 105 Item 13. Certain Relationships and Related Transactions, and Director Independence 105 Item 14. Principal Accounting Fees and Services 105 PART IV Item 15. Exhibits, Financial Statement Schedules 106 Item 16 Form 10-K Summary 106 i SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K (this Annual Report) contains forward-looking statements within the meaning of the federal securities laws. All statements other than statements of historical fact contained in this Annual Report are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "should," "expects," "plans," "anticipates," "could," "intends," "target," "projects," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. These forward-looking statements include, but are not limited to, statements about: our future results of operations and financial position, including our expectations and projections regarding our revenues and revenue growth rate, cost of revenues, operating expenses, gross margin, capital expenditures, cash position, cash burn and our ability to achieve and maintain future profitability; our business strategy, plans and objectives of management; key factors we believe affect our performance, including our beliefs about the opportunities presented by these factors, our ability to successfully address each of these factors and the anticipated impacts of these factors on our business, financial condition and result of operations; our expectations regarding the market sizes and growth potential for Tablo, including our estimates of annual spending on dialysis and the number of people affected by kidney failure in the United States, and the total addressable market opportunities for Tablo in the

B usiness

Item 1. B usiness. Our Company Outset is a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis. We believe the Tablo Hemodialysis System (Tablo) represents a significant technological advancement that transforms the dialysis experience for patients and operationally simplifies it for providers. We designed Tablo from the ground up to be a single enterprise solution that can be utilized across the continuum of care, allowing dialysis to be delivered anytime, anywhere and by virtually anyone. Tablo is currently cleared by the U.S. Food and Drug Administration (FDA) for use in the hospital, clinic or home setting. Our technology is designed to elevate the dialysis experience for patients, and help providers overcome traditional care delivery challenges. Our focus on flexibility, ease of use and user experience translates to meaningfully reduced training times and fixed infrastructure requirements. Requiring only an electrical outlet and tap water to operate, Tablo frees patients and providers from the burdensome infrastructure required to operate traditional dialysis machines. The integration of water purification and on-demand dialysate production in a single 35-inch compact console enables Tablo to serve as a dialysis clinic on wheels. Tablo leverages cloud technology, making it possible for providers to monitor devices and treatments remotely, perform patient and population analytics and automate clinical recordkeeping. With a simple-to-use touchscreen interface, two-way wireless data transmission and a proprietary data analytics platform, Tablo is a new holistic approach to dialysis care. Unlike traditional hemodialysis machines, which have limited clinical versatility across care settings, Tablo can be used seamlessly across multiple care settings and a wide range of clinical applications. We have generated meaningful evidence to demonstrate that providers can realize significant operational effi

View Full Filing

View this 10-K filing on SEC EDGAR