NEOGENOMICS INC
For the period ended Dec 31, 2024. Filed Feb 18, 2025.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2024 · Filed Feb 18, 2025
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-K
For the fiscal year ended December 31, 2024
or
| ☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
|---|
For the transition period from _________ to __________
Commission File Number:001-35756
NEOGENOMICS, INC.
(Exact name of registrant as specified in its charter)
| Nevada | 74-2897368 |
|---|---|
| (State or other jurisdiction of incorporation or organization) | (IRS Employer Identification No.) |
9490 NeoGenomics Way, Fort Myers, FL 33912
(Address of principal executive offices, Zip code)
(239) 768-0600
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s): | Name of each exchange on which registered: |
|---|---|---|
| Common Stock, par value $0.001 per share | NEO | The Nasdaq Stock Market LLC |
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ☐
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ☐No ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☒ | Accelerated filer | ☐ |
|---|---|---|---|
| Non-accelerated filer | ☐ | Smaller Reporting Company | ☐ |
| Emerging Growth Company | ☐ | ||
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.☒
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act): ☐ Yes☒ No
As of June 30, 2024, the aggregate market value of the registrant’s common stock held by non-affiliates of the registrant was $1.3 billion, based on the closing price of the registrant’s common stock of $13.87 per share on June 30, 2024.
The number of shares outstanding of the registrant’s common stock, par value $0.001 per share, as of February 11, 2025:128,461,383.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the registrant’s Proxy Statement for its 2025 Annual Meeting of Stockholders are incorporated by reference into Part III of this Annual Report on Form 10-K.
NEOGENOMICS, INC.
FORM 10-K ANNUAL REPORT
For the Fiscal Year Ended December 31, 2024
Table of Contents
| Page | ||
|---|---|---|
| PART I | ||
| Item 1. | Business | 5 |
| Item 1A. | Risk Factors | 18 |
| Item 1B. | Unresolved Staff Comments | 40 |
| Item 1C. | Cybersecurity | 40 |
| Item 2. | Properties | 41 |
| Item 3. | Legal Proceedings | 41 |
| Item 4. | Mine Safety Disclosures | 41 |
| PART II | ||
| Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 42 |
| Item 6. | [RESERVED] | 43 |
| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 43 |
| Item 7A. | Quantitative and Qualitative Disclosures About Market Risk | 53 |
| Item 8. | Financial Statements and Supplementary Data | 54 |
| Item 9. | Changes in and Disagreements With Accountants on Accounting and Financial Disclosure | 89 |
| Item 9A. | Controls and Procedures | 89 |
| Item 9B. | Other Information | 91 |
| Item 9C. | Disclosure Regarding Foreign Jurisdictions That Prevent Inspections | 91 |
| PART III | ||
| Item 10. | Directors, Executive Officers and Corporate Governance | 91 |
| Item 11. | Executive Compensation | 91 |
| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 91 |
| Item 13. | Certain Relationships and Related Transactions, and Director Independence | 91 |
| Item 14. | Principal Accounting Fees and Services | 91 |
| PART IV | ||
| Item 15. | Exhibits and Financial Statement Schedules | 91 |
| SIGNATURES | 96 | |
| Table of Contents | NEOGENOMICS, INC. |
|---|
FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intends,” “may,” “plan,” “potential,” “project,” “will,” “would,” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements address various matters, including the Company’s strategy, future operations, future financial position, future revenues, changing reimbursement levels from government payers and private insurers, projected costs, prospects and plans, and objectives of management. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that could cause our actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the risks set forth below under “Risk Factors Summary” and “Risk Factors” in Part I, Item 1A in this Annual Report on Form 10-K as filed with the Securities and Exchange Commission (the “SEC”).
The forward-looking statements included in this Annual Report on Form 10-K speak only as of the date of this report, and the Company undertakes no obligation to update any forward-looking statement or statements to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time and it is not possible for management to predict all of such factors, nor can it assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.
Trademarks
The “NeoGenomics”, “Genoptix”, “Clarient”, “Inivata”, and “Trapelo” company names and certain logos have been trademarked with the United States Patent and Trademark Office. We have trademarked or have applications pending for the brand names NEO COMPREHENSIVE, NEO EXPAND, NEOLINK, NEOLAB, NEOACCESS, NEOTYPE, NEOSITE, CHART, COMPASS, eCOMPASS, FLEXREPORT, HEMEFISH, MULTIOMYX, NEOVUE, NEOHELIX, NEONET, NEOLYTX, NEOACCELERATE, NEOENGAGE, NEOPIXEL, NEONUCLEUS, NEOSEEK, NEOEXPLORE, NEOUNIVERSITY, PATHSITE, QUICKPATH, TAM-SEQ, INVISION, INVISIONSEQ, INVISIONFIRST, INVISIONFIRST-LUNG, INVISIONSCAN, PANTRACER, RADAR, and NEORADAR. We also have trademarked or have pending trademarks for the marketing slogans “SERVING PATIENTS, SAVING LIVES”, “TAKING CANCER PERSONALLY”, and “UNIVERSAL FUSION EXPRESSION”. Any other trademarks, registered marks and trade names appearing in this Annual Report on Form 10-K are the property of their respective holders.
| Table of Contents | NEOGENOMICS, INC. |
|---|
Glossary
Throughout this 2024 Form 10-K, we may use certain abbreviations, acronyms and terms which are described below:
| ACA | The Patient Protection and Affordable Care Act |
|---|---|
| ACLA | American Clinical Laboratory Association |
| AKS | Anti-Kickback Statute |
| CAP | College of American Pathologists |
| CDx | Companion Diagnostic |
| CGP | Comprehensive Genetic Profile |
| CLIA | Clinical Laboratory Improvement Amendments of 1988 |
| CMS | Centers for Medicare and Medicaid Services |
| CRO | Contract research organizations |
| DHS | Designated health services |
| FCA | The federal False Claims Act |
| FDA | U.S. Federal Drug Administration |
| FISH | Fluorescence In-Situ Hybridization |
| GAAP | U.S generally accepted accounting principles |
| GDPR | The European Union’s General Data Protection Regulation |
| HIPAA | The Health Insurance Portability and Accountability Act of 1996 |
| IHC | Immunohistochemistry |
| LDT | Laboratory developed tests |
| LIMS | Laboratory Information Management System |
| MolDx | Molecular Diagnostic Services Program |
| MRD | Minimal residual disease |
| NGS | Next-generation sequencing |
| OIG | The Office of Inspector General of the Department of Health and Human Services |
| PCR | Polymerase chain reaction |
| PHI | Protected health information |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.