INTEGRA LIFESCIENCES HOLDINGS CORP
For the period ended Dec 31, 2024. Filed Feb 25, 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 25, 2025
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-K
(Mark One)
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 NO.000-26224
INTEGRA LIFESCIENCES HOLDINGS CORP ORATION
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
| Delaware | 51-0317849 | ||
|---|---|---|---|
| (STATE OR OTHER JURISDICTION OFINCORPORATION OR ORGANIZATION) | (I.R.S. EMPLOYERIDENTIFICATION NO.) | ||
| 1100 Campus Road | 08540 | ||
| Princeton | , | New Jersey | (ZIP CODE) |
| (ADDRESS OF PRINCIPAL EXECUTIVE OFFICES) | |||
REGISTRANT’S TELEPHONE NUMBER, INCLUDING AREA CODE: (609)275-0500
SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT:
| Title of Each Class | Trading Symbol | Name of Exchange on Which Registered |
|---|---|---|
| Common Stock, Par Value $.01 Per Share | IART | Nasdaq Global Select 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 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, a 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 if the registrant has elected not to use the extended transition period for complying with any new 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 Exchange Act). Yes☐ No☒
As of June 28, 2024, the aggregate market value of the registrant’s common stock held by non-affiliates was approxim ately $2,189.1 million based upon the closing sales price of the registrant’s common stock on The Nasdaq Global Select Market on such date. The number of shares of the registrant’s Common Stock, $0.01 par value, outstanding as of February 24, 2025 was 77,218,920.
DOCUMENTS INCORPORATED BY REFERENCE:
Certain portions of the registrant’s definitive proxy statement relating to its scheduled May 9, 2025 Annual Meeting of Stockholders, which will be filed with the Securities and Exchange Commission, are incorporated by reference in Part III of this Annual Report on Form 10-K.
TABLE OF CONTENTS
| Page | |
|---|---|
| PART I | |
| Item 1. Business | 6 |
| Item 1A. Risk Factors | 20 |
| Item 1B. Unresolved Staff Comments | 34 |
| Item 1C. Cybersecurity | 35 |
| Item 2. Properties | 36 |
| Item 3. Legal Proceedings | 36 |
| Item 4. Mine Safety Disclosures | 36 |
| PART II | |
| Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 37 |
| Item 6. [Reserved] | 38 |
| Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations | 38 |
| Item 7A. Quantitative and Qualitative Disclosures About Market Risk | 54 |
| Item 8. Financial Statements and Supplementary Data | 55 |
| Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosures | 55 |
| Item 9A. Controls and Procedures | 56 |
| Item 9B. Other Information | 56 |
| Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 56 |
| PART III | |
| Item 10. Directors, Executive Officers and Corporate Governance | 57 |
| Item 11. Executive Compensation | 57 |
| Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 57 |
| Item 13. Certain Relationships, Related Transactions, and Director Independence | 57 |
| Item 14. Principal Accountant Fees and Services | 57 |
| PART IV | |
| Item 15. Exhibits and Financial Statements Schedule | 57 |
| SIGNATURES | 63 |
Unless otherwise stated or the context otherwise indicates, all references in this Annual Report on Form 10-K to “Integra LifeSciences,” “Integra,” “the Company,” “we,” “our,” and “us” refer to Integra LifeSciences Holdings Corporation, a Delaware corporation and its consolidated subsidiaries.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
We have made statements in this report, including statements under “Business” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” that constitute forward-looking statements within the meaning 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 are subject to a number of risks, uncertainties and assumptions about us including, among other things:
the on-going and possible future effects of global challenges, including macroeconomic uncertainties, such as supply chain disruptions, inflation, bank failures, high interest rates and availability of capital markets, geopolitical uncertainty and instability, the spread or escalation of wars and other armed conflict, other economic disruptions and U.S. and global recession concerns, on our customers and suppliers, and on our business, financial condition, results of operations and cash flows;
general economic and business conditions, both domestically and in our international markets, including the effect of the continuing worldwide macroeconomic uncertainty and increasing trade regulations and tariffs;
our expectations and estimates concerning future financial performance, financing plans and the impact of competition;
trends in our business;
demand for our products, particularly capital equipment;
our ability to produce and deliver products in sufficient quantities to meet sales demands;
our failure to comply with the substantial regulation related to quality standards applicable to our manufacturing and quality processes could have an adverse effect on our business, financial condition, or results of operations;
our ability to remediate all matters identified in the United States Food and Drug Administration (the “FDA”) observations and warning letters that we received or may receive;
the ongoing and possible future effects of supply chain constraints, including the availability of critical raw materials and components, as well as cost inflation in materials, packaging and transportation;
our expectations concerning our ongoing restructuring, integration and manufacturing transfer and expansion activities;
existing and future regulations affecting our business, and enforcement of those regulations;
conducting business internationally;
our ability to obtain additional debt and equity financing to fund capital expenditures, working capital requirements and acquisitions;
physicians’ willingness to adopt our recently launched and planned products, third-party payors’ willingness to provide or continue reimbursement for any of our products and our ability to secure regulatory approval for products in development;
initiatives launched by our competitors;
our ability to protect our intellectual property, including trade secrets;
our ability to complete acquisitions, integrate operations post-acquisition and maintain relationships with customers of acquired entities;
the ability to successfully manage ongoing organizational and strategic changes, including our ability to attract, motivate and retain key employees and maintain engagement and efficiency in remote work environments;
trends relating to our financial condition or results of operations, including the impact of interest rate and foreign currency exchange fluctuations;
the effect of any future public health crises, including the timing, scope and effect of U.S. and international governmental, regulatory, fiscal, monetary and public health responses to such crises; and
other risk factors described in Item 1A. “Risk Factors” in this Annual Report on Form 10-K.
Forward-looking statements can be identified by forward-looking words such as “believe,” “may,” “could,” “might,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “seek,” “plan,” “expect,” “should,” “would,” “expect,” “target,” “pursue,” “forecast,” “hope” and similar expressions in this Annual Report on Form 10K. Forward-looking statements in this Annual Report on Form 10-K include, but are not limited to, statements regarding our five-pillar growth strategy; our hope to secure approval for DuraSorb in 2026; our business strategy and plans, including plans to deliver future innovation both within the ENT business and across other CSS technology platforms; our expectations regarding the operationalization of the Braintree facility and the timing thereof. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance, or achievements expressed or implied by such forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, these forward-looking statements represent our estimates and assumptions only as of the date of this report. Except as required by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Factors that could cause or contribute to differences in our future financial results include the cautionary statements set forth herein and in our other filings with the Securities and Exchange Commission, including those set forth under “Risk Factors” set forth in Part I, Item 1A of this Annual Report on Form 10-K. We qualify all of our forward-looking statements by these cautionary statements.
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