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

TL;DR

<b>Nuwellis, Inc. has filed its 2023 annual report (10-K) detailing its financial performance and business operations.</b>

AI Summary

Nuwellis, Inc. (NUWE) filed a Annual Report (10-K) with the SEC on March 11, 2024. Nuwellis, Inc. filed its 2023 Form 10-K on March 11, 2024. The company was formerly known as CHF Solutions, Inc. and Sunshine Heart, Inc. Nuwellis, Inc. is incorporated in Delaware. The company's fiscal year ends on December 31. Nuwellis, Inc. is listed on the NASDAQ exchange.

Why It Matters

For investors and stakeholders tracking Nuwellis, Inc., this filing contains several important signals. This filing provides a comprehensive overview of Nuwellis's financial health, operational strategies, and risk factors for the fiscal year ending December 31, 2023. Investors and stakeholders can use this report to assess the company's performance, understand its market position, and evaluate potential risks and opportunities.

Risk Assessment

Risk Level: medium — Nuwellis, Inc. shows moderate risk based on this filing. The company's financial performance and ability to continue as a going concern are subject to significant risks, as indicated by the need for substantial financing and potential dilution from equity issuances.

Analyst Insight

Monitor Nuwellis's upcoming financial reports and strategic announcements for updates on revenue growth, cost management, and progress towards profitability.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-03-11 — Filing Date (Date of submission)
• 001-35312 — SEC File Number (SEC filing identifier)
• 0001506492 — Central Index Key (Company identifier)

Key Players & Entities

• Nuwellis, Inc. (company) — Filer name
• CHF Solutions, Inc. (company) — Former company name
• Sunshine Heart, Inc. (company) — Former company name
• NASDAQ (company) — Stock exchange
• DE (company) — State of incorporation
• Eden Prairie (company) — Business address city

FAQ

Industry Context

Nuwellis, Inc. operates in the electromedical and electrotherapeutic apparatus industry, focusing on medical devices.

Regulatory Implications

The company is subject to standard SEC reporting requirements for publicly traded companies, including the annual filing of Form 10-K.

What Investors Should Do

1. Review the full 10-K filing for detailed financial statements and management's discussion and analysis.
2. Analyze the risk factors section for potential challenges and uncertainties facing Nuwellis.
3. Compare Nuwellis's performance metrics with industry peers.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-03-11: Filing Date — Date the 10-K report was officially submitted to the SEC.

Year-Over-Year Comparison

This filing represents the annual 10-K for the fiscal year 2023, succeeding previous quarterly and annual filings.

Key Financial Figures

• $0.0001 — ich registered Common Stock, par value $0.0001 per share NUWE The Nasdaq Stock Mar
• $2.69 — the June 30, 2023 closing sale price of $2.69 per share) was approximately $ 5.0 mil
• $24,000 — for 8.3 days at a cost of approximately $24,000 15 , to which reimbursement will only c
• $15.2 million — uch penalties can cost a hospital up to $15.2 million annually. 17, 18, 19 Treatments for F
• $3,975 — is demonstrated a total cost savings of $3,975, or 14.4%, per patient when using ultra
• $60.2 billion — States, costing the nation an estimated $60.2 billion each year, with hospital costs accounti
• $1 billion — . heart failure market is approximately $1 billion 62 and that roughly 30% of its revenue

Filing Documents

• ef20015266_10k.htm (10-K) — 1962KB
• ef20015266_ex4-14.htm (EX-4.14) — 65KB
• ef20015266_ex21.htm (EX-21) — 2KB
• ef20015266_ex23-1.htm (EX-23.1) — 3KB
• ef20015266_ex31-1.htm (EX-31.1) — 11KB
• ef20015266_ex31-2.htm (EX-31.2) — 11KB
• ef20015266_ex32-1.htm (EX-32.1) — 4KB
• ef20015266_ex32-2.htm (EX-32.2) — 4KB
• ef20015266_ex97.htm (EX-97) — 47KB
• image-logo01.jpg (GRAPHIC) — 404KB
• image-logo02.jpg (GRAPHIC) — 403KB
• 0001140361-24-012644.txt (&nbsp;) — 9275KB
• nuwe-20231231.xsd (EX-101.SCH) — 49KB
• nuwe-20231231_cal.xml (EX-101.CAL) — 68KB
• nuwe-20231231_def.xml (EX-101.DEF) — 290KB
• nuwe-20231231_lab.xml (EX-101.LAB) — 798KB
• nuwe-20231231_pre.xml (EX-101.PRE) — 441KB
• ef20015266_10k_htm.xml (XML) — 936KB

Business

Business 4 Item 1A.

Risk Factors

Risk Factors 21 Item 1B. Unresolved Staff Comments 34 Item 1C. Cybersecurity 34 Item 2.

Properties

Properties 35 Item 3.

Legal Proceedings

Legal Proceedings 35 Item 4. Mine Safety Disclosures 35 PART II 36 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 36 Item 6. [Reserved] 36 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 36 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 45 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 45 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 66 Item 9A.

Controls and Procedures

Controls and Procedures 66 Item 9B. Other Information 67 Item 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 67 PART III 67 Item 10. Directors, Executive Officers and Corporate Governance 67 Item 11.

Executive Compensation

Executive Compensation 71 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 77 Item 13. Certain Relationships and Related Transactions, and Director Independence 78 Item 14. Principal Accountant Fees and Services 79 PART IV 80 Item 15. Exhibits and Financial Statement Schedules 80 Item 16 Form 10-K Summary 92

SIGNATURES

SIGNATURES 92 2 Table of Contents CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains forward-looking statements within the meaning of the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the "Securities Act" ), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act" ). These forward-looking statements relate to us, our business prospects and our results of operations and are subject to certain risks and uncertainties posed by many factors and events that could cause our actual business, prospects and results of operations to differ materially from those anticipated by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those described under the heading "Risk Factors" included in this Annual Report on Form 10-K. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this report. In some cases, you can identify forward-looking statements by the following words: "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "should," "will," "would" or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. We undertake no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise. Readers are urged to carefully review and consider the various disclosures made by us in this report and in our other reports filed with the U.S. Securities and Exchange Commission (the "SEC" ) that advise interested parties of the risks and factors that may affect our business. 3 Table of Contents PART I Item 1.

Business

Business Overview We are a medical technology company dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovative technology. The company is focused on developing, manufacturing, and commercializing medical devices used in ultrafiltration therapy, including the Aquadex FlexFlow and the Aquadex SmartFlow systems (collectively the "Aquadex System"). The Aquadex SmartFlow system is indicated for temporary (up to eight hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics. Fluid Overload Fluid overload, also known as hypervolemia, is a condition in which there is too much fluid in the blood, vital organs, and interstitial space, and generally refers to the expansion of the extracellular fluid volume. Although the body does need some amount of fluid to remain healthy, too much can cause an imbalance and damage to an individual's health. 1 The signs and symptoms of fluid overload are not always the same in each patient and may vary. However, possible signs and symptoms of fluid overload include pulmonary edema/pleural effusion, peripheral edema, anasarca (swelling of the skin) ascites, jugular vein distention and dyspnea. 2 Medical conditions or diseases where excess fluid accumulates in the body are heart failure, kidney failure, nephrotic syndrome, cirrhosis, or burn injuries/trauma. Individuals may also suffer from temporary fluid overload following certain surgical procedures, such as cardiac surgery, although fluid overload is the leading cause of death for critically ill patients in the ICU within 90 days of admission. 3 The diagnosis of fluid overload can be made through a variety of tests/exams such as a physical exam (weight, presence of pulmonary rales, and edema), blood chemistry, natriuretic peptides, liver enzymes, hemoglobin

View Full Filing

View this 10-K filing on SEC EDGAR