NeuroPace Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>NeuroPace Inc. has officially filed its comprehensive 2023 annual report (10-K) detailing its financial performance and operational status as of December 31, 2023.</b>

AI Summary

NeuroPace Inc (NPCE) filed a Annual Report (10-K) with the SEC on March 5, 2024. NeuroPace Inc. reported its 2023 fiscal year results, filing its annual 10-K report on March 5, 2024. The company's fiscal year concluded on December 31, 2023. The filing covers the period from January 1, 2023, to December 31, 2023. NeuroPace Inc. is categorized under SIC code 3841 for Surgical & Medical Instruments & Apparatus. The company's principal business address is located at 455 N. Bernardo Avenue, Mountain View, CA.

Why It Matters

For investors and stakeholders tracking NeuroPace Inc, this filing contains several important signals. This 10-K filing provides investors and stakeholders with the company's official audited financial statements and management's discussion and analysis for the full fiscal year 2023, enabling a thorough assessment of its performance and strategic direction. As a medical device company specializing in neurostimulation, the detailed disclosures within the 10-K are crucial for understanding NeuroPace's market position, regulatory compliance, and future growth prospects in the epilepsy treatment sector.

Risk Assessment

Risk Level: medium — NeuroPace Inc shows moderate risk based on this filing. The company operates in the highly regulated medical device industry, facing risks related to product development, clinical trials, regulatory approvals, and market adoption, which are detailed in the 10-K filing.

Analyst Insight

Review the detailed financial statements and risk factors in the 10-K to assess NeuroPace's financial health and strategic outlook for 2024.

Key Numbers

• 2023-12-31 — Fiscal Year End (The end date of the reporting period.)
• 2024-03-05 — Filing Date (Date the 10-K report was filed.)
• 2023-01-01 — Reporting Period Start (Beginning of the fiscal year covered by the report.)

Key Players & Entities

• NeuroPace Inc. (company) — Filer of the 10-K report.
• 455 N. Bernardo Avenue (location) — Business and mailing address.
• Mountain View, CA (location) — City and state of the company's address.
• 3841 (industry_code) — Standard Industrial Classification code for Surgical & Medical Instruments & Apparatus.

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The company is subject to extensive regulation by the FDA and other global health authorities, which can impact product development, manufacturing, marketing, and sales.
• Market Adoption and Competition [high — market]: Successful commercialization depends on market acceptance of its RNS System and competition from existing and emerging therapies for epilepsy.
• Need for Future Financing [medium — financial]: The company has a history of operating losses and may require additional capital to fund its operations and growth strategies.
• Manufacturing and Supply Chain Risks [medium — operational]: Disruptions in manufacturing or the supply chain for critical components could adversely affect product availability and revenue.

Key Dates

• 2024-03-05: 10-K Filing — Official annual report for fiscal year 2023.

Key Financial Figures

• $0.001 — ange on which registered Common Stock, $0.001 par value per share NPCE Nasdaq Global
• $4.49 — million, based on the closing price of $4.49 for shares of the registrant's common s
• $27 billion — we believe represents an approximately $27 billion total addressable market. While we are
• $1.1 billion — ore market opportunity of approximately $1.1 billion for initial RNS System implants, and we

Filing Documents

• npce-20231231.htm (10-K) — 1687KB
• exhibit42-descriptionofsec.htm (EX-4.2) — 25KB
• exhibit1012-irinaridleytra.htm (EX-10.12) — 65KB
• exhibit1016-microsystemste.htm (EX-10.16) — 188KB
• exhibit1019-greatbatchfirs.htm (EX-10.19) — 13KB
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• exhibit231-consentofpricew.htm (EX-23.1) — 2KB
• exhibit311-certificationsf.htm (EX-31.1) — 11KB
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• exhibit321-certificationsf.htm (EX-32.1) — 7KB
• exhibit97-incentivecompens.htm (EX-97) — 38KB
• npce-20231231_g1.jpg (GRAPHIC) — 42KB
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• 0001528287-24-000005.txt (&nbsp;) — 74690KB
• npce-20231231.xsd (EX-101.SCH) — 44KB
• npce-20231231_cal.xml (EX-101.CAL) — 73KB
• npce-20231231_def.xml (EX-101.DEF) — 211KB
• npce-20231231_lab.xml (EX-101.LAB) — 745KB
• npce-20231231_pre.xml (EX-101.PRE) — 454KB
• npce-20231231_htm.xml (XML) — 790KB

Business

Business 7 Item 1A.

Risk Factors

Risk Factors 47 Item 1B. Unresolved Staff Comments 98

C

Item 1 C . Cybersecurity 99 Item 2.

Properties

Properties 100 Item 3.

Legal Proceedings

Legal Proceedings 100 Item 4. Mine Safety Disclosures 100 Part II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 101 Item 6. [Reserved] 101 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 102 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 112 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 112 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 141 Item 9A.

Controls and Procedures

Controls and Procedures 142 Item 9B. Other Information 142 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 143 Part III Item 10. Directors, Executive Officers and Corporate Governance 144 Item 11.

Executive Compensation

Executive Compensation 145 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 145 Item 13. Certain Relationships and Related Transactions, and Director Independence 145 Item 14. Principal Account ant Fees and Services 145 Part IV Item 15. Exhibit and Financial Statement Schedules 146 Item 16. Form 10–K Summary 150

Signatures

Signatures 151 SPECIAL NOTE ABOUT FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, about us and our industry that involve substantial risks and uncertainties. All statements regarding future events, results or other matters contained in this report, including statements regarding our future results of operations and financial condition, business strategy, and plans and objectives of management for future operations, are forward-looking statements. In some cases, forward-looking statements may be identified by words such as "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," or "would," or the negative of these words or other similar terms or expressions. These forward-looking statements include, but are not limited to, statements concerning the following: our expected future growth; the size and growth potential of the markets for our products, and our ability to serve those markets; our ability to accurately forecast demand for our products; the rate and degree of market acceptance of our products; coverage and reimbursement for procedures performed using our products, including pre-implant evaluations, implant procedures, and follow-up care; the performance of third parties in connection with the manufacturing and development of our products, including single-source suppliers; regulatory developments in the United States and in any foreign countries in which we may seek to do business; our ability to retain regulatory approval for our products or obtain regulatory approval for updates to our products, or new products or indications in the United States and in any foreign countries in which we may seek to do business; our research and development for existing products and new products;

Business

Item 1. Business. Overview We are a medical device company focused on transforming the lives of people living with epilepsy by reducing or eliminating the occurrence of debilitating seizures. Our novel and differentiated RNS System is the first and only commercially available, brain-responsive neuromodulation system that delivers personalized, real-time treatment at the seizure source. By continuously monitoring and analyzing the brain's electrical activity, recognizing patient-specific abnormal electrical patterns, and responding in real time with imperceptible electrical pulses to prevent seizures, our RNS System is programmed by clinicians to deliver the precise amount of therapy when and where it is needed and provides exceptional clinical outcomes with approximately three minutes of stimulation on average per day. Our RNS System is also the only commercially available device that records continuous brain activity data and allows clinicians to monitor patients not only in person, but also remotely, providing them the data they need to make more informed treatment decisions, thus optimizing patient care. We believe the therapeutic advantages of our RNS System, combined with the insights obtained from our extensive brain data set, offer a significant leap forward in epilepsy treatment. As of December 31, 2023, over 5,000 patients have received our RNS System. We believe our compelling body of long-term clinical data, demonstrating continuous improvement in outcomes over time, will support the continued adoption of our RNS System among the approximately 575,000 adults in the United States with drug-resistant focal epilepsy. We continue seeking indication expansion to, over time, cover the entire approximately 1.2 million drug-resistant epilepsy patients in the United States and may additionally seek to expand our operations to reach the approximately 16.5 million drug-resistant epilepsy patients globally. Epilepsy is a devastating chronic disorder characterized

View Full Filing

View this 10-K filing on SEC EDGAR