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

TL;DR

<b>Exagen Inc. has filed its annual 10-K report for the fiscal year ended December 31, 2023, providing a comprehensive overview of its financial performance and business operations.</b>

AI Summary

EXAGEN INC. (XGN) filed a Annual Report (10-K) with the SEC on March 18, 2024. Exagen Inc. filed its 10-K report for the fiscal year ending December 31, 2023. The filing covers the period from January 1, 2023, to December 31, 2023. The company's principal business address is 1261 Liberty Way, Vista, CA 92081. Exagen Inc. was formerly known as Exagen Diagnostics Inc. until December 30, 2003. The report details financial information and business operations for the fiscal year 2023.

Why It Matters

For investors and stakeholders tracking EXAGEN INC., this filing contains several important signals. This 10-K filing provides investors and stakeholders with detailed financial statements, risk factors, and management's discussion and analysis for the fiscal year 2023, enabling informed investment decisions. The report highlights potential concentration risks related to Medicare and Medicare Advantage, as well as specific products like AVISECTD, which could impact future revenue streams.

Risk Assessment

Risk Level: medium — EXAGEN INC. shows moderate risk based on this filing. The company faces medium risk due to potential customer and product concentration, particularly with Medicare and AVISECTD, which could lead to significant revenue fluctuations if these sources are negatively impacted.

Analyst Insight

Investors should closely examine the revenue breakdown and risk factors related to customer and product concentration in the 10-K filing to assess potential impacts on Exagen's future financial performance.

Key Numbers

• 2023-12-31 — Fiscal Year End (CONFORMED PERIOD OF REPORT)
• 2024-03-18 — Filing Date (AS OF DATE)
• 2023-01-01 — Reporting Period Start Date (2023-01-01)
• 2023-12-31 — Reporting Period End Date (2023-12-31)

Key Players & Entities

• EXAGEN INC. (company) — COMPANY CONFORMED NAME
• 0001274737 (company) — CENTRAL INDEX KEY
• 8071 (company) — STANDARD INDUSTRIAL CLASSIFICATION
• DE (company) — STATE OF INCORPORATION
• 1261 LIBERTY WAY (company) — BUSINESS ADDRESS STREET 1
• VISTA (company) — BUSINESS ADDRESS CITY
• CA (company) — BUSINESS ADDRESS STATE
• 92081 (company) — BUSINESS ADDRESS ZIP

FAQ

Risk Factors

• Customer Concentration Risk [medium — market]: The company faces risks due to concentration of revenue and accounts receivable from Medicare and Medicare Advantage, which could impact financial results if these programs change or are reduced.
• Product Concentration Risk [medium — market]: Revenue is significantly derived from specific products like AVISECTD, creating a risk if demand for these products declines or if competition increases.
• Supplier Concentration Risk [low — market]: The company relies on two suppliers for certain components, posing a risk if these suppliers face disruptions or increase prices.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-03-18: Filing Date — Date the 10-K report was officially filed with the SEC.

Key Financial Figures

• $0.001 — ich registered Common Stock, par value $0.001 per share XGN The Nasdaq Global Market
• $2.90 — on stock on the Nasdaq Global Market of $2.90 per share. Total shares of common stoc
• $7.5 b — tal addressable market of approximately $7.5 billion, based on the current Medicare al
• $9.2 b — SE testing products to be approximately $9.2 billion, based on estimated patient popul

Filing Documents

• exdx-20231231.htm (10-K) — 1589KB
• xgn-descriptionofsecurities.htm (EX-4.8) — 24KB
• ex231-2023bdoconsent.htm (EX-23.1) — 2KB
• xgn311-123123.htm (EX-31.1) — 12KB
• xgn312-123123.htm (EX-31.2) — 12KB
• xgn321-123123.htm (EX-32.1) — 8KB
• exdx-20231231_g1.jpg (GRAPHIC) — 29KB
• exdx-20231231_g2.jpg (GRAPHIC) — 228KB
• exdx-20231231_g3.jpg (GRAPHIC) — 338KB
• 0001274737-24-000022.txt (&nbsp;) — 9125KB
• exdx-20231231.xsd (EX-101.SCH) — 47KB
• exdx-20231231_cal.xml (EX-101.CAL) — 87KB
• exdx-20231231_def.xml (EX-101.DEF) — 202KB
• exdx-20231231_lab.xml (EX-101.LAB) — 646KB
• exdx-20231231_pre.xml (EX-101.PRE) — 437KB
• exdx-20231231_htm.xml (XML) — 970KB

Business

Item 1. Business. 2

Risk Factors

Item 1A. Risk Factors. 32

Unresolved Staff Comments

Item 1B. Unresolved Staff Comments. 68

Cybersecurity

Item 1C. Cybersecurity . 68

Properties

Item 2. Properties. 71

Legal Proceedings

Item 3. Legal Proceedings. 71

Mine Safety Disclosures

Item 4. Mine Safety Disclosures. 71 Part II

Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. 72

[Reserved]

Item 6. [Reserved]. 72

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

Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations. 73

Quantitative and Qualitative Disclosures About Market Risk

Item 7A. Quantitative and Qualitative Disclosures About Market Risk. 83

Financial Statements and Supplementary Data

Item 8. Financial Statements and Supplementary Data. 83

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. 83

Controls and Procedures

Item 9A. Controls and Procedures. 83

Other Information

Item 9B. Other Information. 85

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. 85 Part III

Directors, Executive Officers and Corporate Governance

Item 10. Directors, Executive Officers and Corporate Governance. 86

Executive Compensation

Item 11. Executive Compensation. 86

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

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. 86

Certain Relationships and Related Transactions, and Director Independence

Item 13. Certain Relationships and Related Transactions, and Director Independence. 86

Principal Accountant Fees and Services

Item 14. Principal Accountant Fees and Services. 86 Part IV

Exhibits and Financial Statement Schedules

Item 15. Exhibits and Financial Statement Schedules. 87

Form 10-K Summary

Item 16. Form 10-K Summary. 87

Financial Statements

Financial Statements F-1 Part I

Forward-Looking Statements and Market Data

Forward-Looking Statements and Market Data This Annual Report on Form 10-K (the Annual Report), contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act). All statements other than statements of historical facts contained in this Annual Report, including statements regarding our future results of operations and financial position, business strategy, current and future product offerings, reimbursement and coverage, the expected benefits from our commercial arrangements with third parties, research and development costs, timing and likelihood of success and plans and objectives of management for future operations, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. This Annual Report also contains estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. In some cases, you can identify forward-looking statements by terms such as "believe," "may," "will," "should," "predict," "goal," "strategy," "potentially," "estimate," "continue," "anticipate," "intend," "could," "would," "project," "plan," "expect," "seek," and similar expressions that convey uncertainty of future events or outcomes, are intended to identify forward-looking statements. The forward-looking statements in this Annual Report are only predicti

Business

Item 1. Business. Company Overview Exagen exists to provide clarity in autoimmune disease decision making with the goal of improving patients' clinical outcomes. We have developed and are commercializing a portfolio of innovative testing products, under our AVISE brand, which allow for the differential diagnosis, prognosis and monitoring of complex autoimmune and autoimmune-related diseases. We believe our strong focus and extensive background in the field of rheumatology, combined with our commitment to exceptional customer service and support, position us well to respond to the needs of rheumatologists and the patients they serve. We commercially launched our lead testing product, AVISE CTD, in 2012. AVISE CTD enables differential diagnosis for patients presenting with symptoms indicative of a wide variety of connective tissue diseases (CTDs) and other related diseases with overlapping symptoms. The comprehensive nature of AVISE CTD allows for the testing of a number of relevant biomarkers in one convenient blood draw (as opposed to testing serially for individual biomarkers, which adds time and cost to the diagnostic process). We believe AVISE CTD may provide clinical utility for more than 41 million individuals in the United States, encompassing patients with conditions like systemic lupus erythematosus (SLE); rheumatoid arthritis (RA); Sjgren's syndrome, antiphospholipid syndrome (APS); other autoimmune-related diseases, such as autoimmune thyroid; and disorders that mimic these diseases, such as fibromyalgia. There is an unmet need to add clarity for rheumatologists in their CTD clinical evaluations. As a result, we believe there is a significant market opportunity for our tests, which enable the differential diagnosis of these diseases, particularly, for potentially life-threatening diseases such as SLE. Included in AVISE CTD is our proprietary AVISE Lupus test, which enables the diagnosis of SLE based on levels of erythrocyte bound C4d (EC4d) and B cell

View Full Filing

View this 10-K filing on SEC EDGAR