FEMASYS INC. 2023 Annual Report (10-K)

TL;DR

<b>Femasys Inc. filed its 2023 10-K annual report detailing its financial performance and business operations for the fiscal year ending December 31, 2023.</b>

AI Summary

FEMASYS INC (FEMY) filed a Annual Report (10-K) with the SEC on March 28, 2024. Femasys Inc. filed its 2023 10-K report on March 28, 2024, for the fiscal year ending December 31, 2023. The company is incorporated in Delaware and operates in the Surgical & Medical Instruments & Apparatus industry. Its principal business address is located in Suwanee, Georgia. The filing covers the period from January 1, 2023, to December 31, 2023. The report was filed under the Securities Exchange Act of 1934.

Why It Matters

For investors and stakeholders tracking FEMASYS INC, this filing contains several important signals. This 10-K filing provides a comprehensive overview of Femasys Inc.'s financial health, operational performance, and strategic positioning for the fiscal year 2023, which is crucial for investors to assess the company's value and future prospects. Understanding the details within this report allows stakeholders to evaluate the company's compliance with regulatory requirements and its adherence to accounting standards, ensuring transparency and accountability.

Risk Assessment

Risk Level: medium — FEMASYS INC shows moderate risk based on this filing. The company's financial performance and future outlook are subject to the inherent risks and uncertainties of the medical device industry, including market competition, regulatory approvals, and technological advancements, as detailed in its 10-K filing.

Analyst Insight

Investors should review the detailed financial statements and risk factors outlined in the 10-K to make informed investment decisions regarding Femasys Inc.

Key Numbers

• 20231231 — Fiscal Year End (Fiscal year end date)
• 20240328 — Filing Date (Date the 10-K was filed)
• 30024 — ZIP Code (Business address ZIP code)
• 770-500-3910 — Business Phone (Business phone number)

Key Players & Entities

• FEMASYS INC. (company) — Filer name
• 0001140361-24-016230 (filing_id) — Accession number
• 20231231 (date) — Conformed period of report
• 20240328 (date) — Filed as of date
• 3841 (industry_code) — Standard Industrial Classification
• DE (state) — State of incorporation
• GA (state) — Business address state
• 001-40492 (filing_id) — SEC file number

FAQ

Industry Context

Femasys Inc. operates within the Surgical & Medical Instruments & Apparatus industry, a sector characterized by innovation, regulatory oversight, and competitive dynamics.

Regulatory Implications

The company is subject to regulations governing medical devices, including those from the FDA and potentially international bodies, impacting product development, manufacturing, and marketing.

What Investors Should Do

1. Analyze the detailed financial statements for revenue, net income, and cash flow.
2. Review the risk factors section for potential challenges and uncertainties facing the company.
3. Examine any disclosures regarding executive compensation and corporate governance.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
• 2024-03-28: Filing Date — Date the 10-K was officially submitted to the SEC.

Year-Over-Year Comparison

This filing represents the annual 10-K report for the fiscal year 2023, providing a comprehensive update compared to previous filings.

Key Financial Figures

• $0.001 — ich registered Common stock, par value $0.001 FEMY NASDAQ Capital Market Securi

Filing Documents

• ef20015354_10k.htm (10-K) — 2283KB
• ef20015354_ex23-1.htm (EX-23.1) — 4KB
• ef20015354_ex31-1.htm (EX-31.1) — 8KB
• ef20015354_ex31-2.htm (EX-31.2) — 8KB
• ef20015354_ex32-1.htm (EX-32.1) — 5KB
• ef20015354_ex32-2.htm (EX-32.2) — 5KB
• ef20015354_ex97-1.htm (EX-97.1) — 47KB
• image00001.jpg (GRAPHIC) — 2KB
• image00002.jpg (GRAPHIC) — 2KB
• image00003.jpg (GRAPHIC) — 24KB
• image00004.jpg (GRAPHIC) — 26KB
• image00005.jpg (GRAPHIC) — 2KB
• 0001140361-24-016230.txt (&nbsp;) — 10986KB
• femy-20231231.xsd (EX-101.SCH) — 82KB
• femy-20231231_cal.xml (EX-101.CAL) — 92KB
• femy-20231231_def.xml (EX-101.DEF) — 349KB
• femy-20231231_lab.xml (EX-101.LAB) — 1020KB
• femy-20231231_pre.xml (EX-101.PRE) — 618KB
• ef20015354_10k_htm.xml (XML) — 1656KB

Forward-Looking Statements

Forward-Looking Statements 1 PART I 5 Item 1.

Business

Business 5 Item 1A.

Risk Factors

Risk Factors 29 Item 1B. Unresolved Staff Comments 73 Item 2.

Properties

Properties 74 Item 3.

Legal Proceedings

Legal Proceedings 74 Item 4. Mine Safety Disclosures 74 PART II 74 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 74 Item 6. [Reserved] 75 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 75 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 84 Item 8.

Financial Statements

Financial Statements 85 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 118 Item 9A.

Controls and Procedures

Controls and Procedures 118 Item 9B. Other Information 119 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 119 PART III 119 Item 10. Directors, Executive Officers, and Corporate Governance 119 Item 11.

Executive Compensation

Executive Compensation 119 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 119 Item 13. Certain Relationships and Related Transactions, and Director Independence 119 Item 14. Principal Accounting Fees and Services 119 PART IV 120 Item 15. Exhibits, Financial Statement Schedules 120 Item 16. Form 10-K Summary 122

Signatures

Signatures 123 Table of Contents SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains forward-looking statements. All statements other than statements of historical facts contained in this Annual Report on Form 10-K are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning: our ability to develop and advance our current product candidate and programs into, and successfully initiate and complete, clinical trials; the ability of our clinical trials to demonstrate safety and effectiveness of our product candidate and other positive results; our ability to enroll subjects in the clinical trial for our product candidate in order to advance the development thereof on a timely basis; our ability to successfully initiate and grow the commercial launch of FemaSeed; our ability to obtain additional financing to fund the clinical development and commercialization of our product candidate and products and fund our operations; estimates regarding the total addressable market for our products and product candidate; competitive companies and technologies in our industry; our ability to obtain U.S. Food and Drug Administration (FDA) approval for our permanent birth control system, ability to expand sales of our women-specific medical products and develop and commercialize additional products; our ability to obtain regulatory approvals for and commercialize our product candidate, or the effect of delays in obtaining regulatory authorizations and commercialize; our business model and strategic plans for our p

View Full Filing

View this 10-K filing on SEC EDGAR