ORTHOPEDIATRICS CORP
For the period ended Dec 31, 2024. Filed Mar 5, 2025.
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FY2024 · Filed Mar 5, 2025
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-K
[Mark One]
☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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 001-38242
(Exact name of registrant as specified in its charter)
| Delaware | 26-1761833 |
|---|---|
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification Number) |
| 2850 Frontier DriveWarsaw, Indiana | 46582 |
|---|---|
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (574)268-6379
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, $0.00025 par value per share | KIDS | Nasdaq Global Market |
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 Section 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 to Section 7(a)(2)(B) of the Securities 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☒
The aggregate market value of the registrant's common stock held by non-affiliates of the registrant was approximately $263.4 million as of the last business day of the registrant's most recently completed second fiscal quarter (June 30, 2024), based upon the closing sale price for the registrant's common stock on that day as reported by the Nasdaq Global Market. Shares of common stock held by each officer and director of the registrant and by each person who owns 10 percent or more of outstanding common stock on June 30, 2024 have been excluded in that such persons may be deemed to be affiliates. This determination of affiliate status is not necessarily conclusive for other purposes.
As of March 1, 2025, the registrant had 24,286,590 outstanding shares of common stock, $0.00025 par value per share.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the registrant’s definitive proxy statement for its 2025 Annual Meeting of Stockholders are incorporated by reference into Part III of this Form 10-K.
| Statement Regarding Forward-Looking Statements | 6 | |
|---|---|---|
| Risk Factor Summary | 7 | |
| PART I | ||
| Item 1. | Business | 8 |
| Item 1A. | Risk Factors | 32 |
| Item 1B. | Unresolved Staff Comments | 71 |
| Item 1C. | Cybersecurity | 71 |
| Item 2. | Properties | 72 |
| Item 3. | Legal Proceedings | 72 |
| Item 4. | Mine Safety Disclosures | 72 |
| PART II | ||
| Item 5. | Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 73 |
| Item 6. | [Reserved] | 74 |
| Item 7. | Management's Discussion and Analysis of Financial Condition and Results of Operations | 75 |
| Item 7A. | Quantitative and Qualitative Disclosure about Market Risk | 85 |
| Item 8. | Financial Statements and Supplementary Data | 86 |
| Item 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 123 |
| Item 9A. | Controls and Procedures | 123 |
| Item 9B. | Other Information | 124 |
| Item 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 124 |
| PART III | ||
| Item 10. | Directors, Executive Officers and Corporate Governance | 125 |
| Item 11. | Executive Compensation | 125 |
| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 125 |
| Item 13. | Certain Relationships, Related Transactions and Director Independence | 125 |
| Item 14. | Principal Accountant Fees and Services | 125 |
| PART IV | ||
| Item 15. | Exhibits and Financial Statement Schedules | 126 |
Glossary of Acronyms and Defined Terms
| ACL | Anterior cruciate ligament |
|---|---|
| ApiFix | The combination of ApiFix, Ltd and ApiFix, Inc., which were acquired by the Company on April 1, 2020 |
| Approved Body | An approved body under UK medical Device Regulations |
| Band-Lok | Band-Lok, LLC, which sold certain intellectual property assets to the Company on June 10, 2020 |
| Boston O&P | Boston Brace International, Inc., which was acquired by the Company on January 5, 2024 |
| CE Mark | Conformite Europeene Mark used for medical devices in the EEA; a product with such a mark is referred to herein as a "CE-Marked" product. |
| CME | Continuing medical education |
| CMS | Centers for Medicare and Medicaid Services |
| Company | OrthoPediatrics Corp. |
| Convertible Notes | $50 million of 4.75% Convertible Senior Notes due 2030 that were sold to Braidwell Transaction Holdings LLC – Series 10 on August 5, 2024 |
| DHHS | U.S. Department of Health and Human Services |
| EEA | European Economic Area |
| EU | European Union |
| Exchange Act | U.S. Securities Exchange Act of 1934 |
| FDA | U.S. Food and Drug Administration |
| FDASIA | Food and Drug Administration Safety and Innovation Act |
| FDCA | Federal Food, Drug and Cosmetic Act |
| FERA | Fraud Enforcement Recovery Act of 2009 |
| Foundation | The Foundation for Advancing Pediatric Orthopedics |
| GAAP | U.S. Generally Accepted Accounting Principles |
| GDPR | EU General Data Protection Regulation |
| HCP | Healthcare providers |
| HDE | Humanitarian Device Exemption under FDA regulation |
| HIPAA | Health Insurance Portability and Accountability Act of 1996 |
| IPO | Company’s initial public offering of its common stock on October 11, 2017 |
| IRB | Institutional Review Board utilized by the FDA |
| LLD | Limb length discrepancies |
| Loan Agreement | Fourth Amended and Restated Loan and Security Agreement with Squadron Capital LLC (terminated effective as of December 29, 2023), which provided the Company with a $50.0 million revolving credit facility |
| MDD | Medical Devices Directive |
| MD Ortho or MDO | MD Orthopaedics, which was acquired by the Company on April 1, 2022 |
| MDR | EU’s Medical Device Regulation |
| MHRA | Medicines and Healthcare products Regulatory Agency of the United Kingdom |
| MidCap Credit Agreement | Credit, Security and Guaranty Agreement with MidCap Financial Trust, asamended from time to time, which provided the company with a $50 million line of credit and a $30 million term loan. Terminated August 5, 2024. |
| MPFL | Medial petellofemoral ligament |
| O&P | Orthotic and prosthetic |
| Orthex | Orthex, LLC, which was acquired by the Company on June 4, 2019 |
| Pega Medical or Pega | Pega Medical Inc., which was acquired by the Company on July 1, 2022 |
| PMA | Premarket Approval Application with the FDA |
| PNP | Pediatric Nailing Platform |
|---|---|
| POD | Physician-owned distributorships |
| POSNA | Pediatric Orthopaedic Society of North America |
| QSR | FDA’s Quality System Regulation |
| RSV | Respiratory Syncytial Virus, a respiratory virus commonly impacting children |
| SEC | United States Securities and Exchange Commission |
| Squadron | Squadron Capital LLC, which is the Company’s largest investor |
| Structure Medical | Structure Medical, LLC |
| Telos | Telos Partners, LLC, which was acquired by the Company on March 9, 2020 |
| Term Loan Agreement | Credit Agreement and Guaranty with Braidwell LP which provides the Company with an initial $25 million and access to a delayed draw term loan facility for an additional $25 million. |
| UK or United Kingdom | The United Kingdom of Great Britain and Northern Ireland |
| UKCA Mark | UK Conformity Assessed marking is a new UK product marking that is used for goods being placed on the market in Great Britain (England, Wales and Scotland) |
| Vilex | Vilex in Tennessee, Inc., which was acquired by the Company on June 4, 2019 and substantially all its assets were sold on December 31, 2019 to a wholly-owned subsidiary of Squadron Capital, LLC |
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