Orthofix Medical Inc
For the period ended Dec 31, 2024. Filed Feb 25, 2025.
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FY2024 · Filed Feb 25, 2025
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Notes to the Consolidated Financial Statements
- Business and basis of presentation
Description of the Business
Orthofix Medical Inc. (the "Company" or "Orthofix") is a global medical technology company headquartered in Lewisville, Texas. By providing medical technologies that heal musculoskeletal pathologies, the Company delivers exceptional experiences and life-changing solutions to patients around the world. Orthofix offers a comprehensive portfolio of spinal hardware, bone growth therapies, specialized orthopedic solutions, biologics, and enabling technologies, including the 7D FLASH navigation system.
Basis of Presentation
The consolidated financial statements include the financial statements of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions are eliminated in consolidation. Information on our accounting policies and methods used in the preparation of our consolidated financial statements are included, where applicable, in the respective footnotes that follow.
| Footnote | Footnote Reference |
|---|---|
| Business and basis of presentation | 1 |
| Significant accounting policies | 2 |
| Recently adopted accounting standards and recently issued accounting pronouncements | 3 |
| Mergers and acquisitions | 4 |
| Inventories | 5 |
| Property, plant, and equipment | 6 |
| Intangible assets | 7 |
| Goodwill | 8 |
| Leases | 9 |
| Other current liabilities | 10 |
| Indebtedness | 11 |
| Fair value measurements and investments | 12 |
| Commitments and contingencies | 13 |
| Shareholders' equity | 14 |
| Revenue recognition and accounts receivable | 15 |
| Business segment information | 16 |
| Acquisition-related amortization and remeasurement | 17 |
| Share-based compensation | 18 |
| Defined contribution plans and deferred compensation | 19 |
| Income taxes | 20 |
| Earnings per share | 21 |
| Subsequent events | 22 |
Changes in Presentation of Consolidated Financial Statements
Certain prior year balances have been reclassified in the consolidated financial statements to conform to current period presentation.
- Significant accounting policies
The preparation of financial statements in conformity with United States generally accepted accounting principles ("U.S. GAAP") requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, the Company evaluates these estimates, including those related to contractual allowances, allowances for expected credit losses, inventories, valuation of intangible assets, goodwill, fair value measurements (including fair value measurements associated with business combinations and/or asset acquisitions), litigation and contingent liabilities, income taxes, and share-based compensation. Estimates are based on historical experience, future expectations, and other relevant assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates.
The following is a discussion of accounting policies and methods used in the consolidated financial statements that are not presented within other footnotes.
Market risk
In the ordinary course of business, the Company is exposed to the impact of changes in interest rates and foreign currency fluctuations. The Company’s objective is to limit the impact of such movements on earnings and cash flows. In order to achieve this objective, the Company seeks to balance its non-U.S. Dollar denominated income and expenditures.
The financial statements for operations outside the U.S. are generally maintained in each subsidiary's respective local currency. All foreign currency denominated balance sheet accounts, except shareholders’ equity, are translated to U.S. Dollars at year end exchange rates, and revenue and expense items are translated at average exchange rates prevailing during the year. Gains and losses resulting from the translation of foreign currency are recorded in the accumulated other comprehensive income (loss) component of shareholders’ equity. Transactional foreign currency gains and losses, including those generated from intercompany operations, are included in other income (expense), net and was a loss of $4.4 million, a gain of $1.6 million, and a loss of $3.3 million for the years ended December 31,2024, 2023, and 2022, respectively.
Financial instruments and concentration of credit risk
Financial instruments that could subject the Company to a concentration of credit risk consist primarily of cash, cash equivalents, and accounts receivable. Generally, cash is held at large financial institutions. The Company performs ongoing credit evaluations of customers, generally does not require collateral, and maintains a reserve for expected credit losses. The Company believes that a concentration of credit risk related to accounts receivable is limited because customers are geographically dispersed and end users are diversified.
Cash, cash equivalents, and restricted cash
The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents.
In November 2023, following the termination of the Second Amended and Restated Credit Agreement with JPMorgan Chase Bank, N.A., as Administrative Agent, and certain lender parties thereto, Bank of America required collateral of approximately $4.7 million of the Company’s cash as a banking service obligation, which was classified as restricted cash as of December 31, 2023. In March 2024, the Company entered into a Security Agreement with Bank of America to reduce the required collateral to $2.5 million.
Investing activities that did not result in cash receipts or cash payments during the years ended December 31,2024, 2023, and 2022 consisted of the following, which were not included within cash from investing activities in the Company’s consolidated statements of cash flows:
| (U.S. Dollars, in thousands) | 2024 | 2023 | 2022 |
|---|---|---|---|
| Supplemental disclosure of cash flow information: | |||
| Noncash investing activities: | |||
| Changes in accrued purchases of property, plant, and equipment | $(3,040) | $— | $— |
| Intangible assets acquired in asset acquisitions | — | — | 2,000 |
Research and development costs, including collaborative arrangements
Expenditures for research and development are expensed as incurred. Expenditures related to the Company’s collaborative arrangement with MTF Biologics ("MTF") are expensed based on the terms of the related agreement. The Company recognized $0.3 million, $0.8 million, and less than $0.1 million in research and development expense for the years ended December 31,2024, 2023, and 2022, respectively, related to this arrangement.
- Recently adopted accounting standards and recently issued accounting pronouncements
Recently Adopted Accounting Standards
Adoption of Accounting Standards Update ("ASU") 2021-08, Accounting for Contract Assets and Contract Liabilities with Contracts with Customers
In October 2021, the Financial Accounting Standards Board ("FASB") issued ASU 2021-08, which aims to address diversity in practice and inconsistency related to the accounting for acquired revenue contracts with customers in a business combination. The amendments require that an entity recognize and measure contract assets and contract liabilities acquired in a business combination in accordance with Topic 606, Revenue from Contracts with Customers. Adoption of this standard resulted in the recognition of $2.2 million in contract liabilities associated with acquired revenue contracts as a result of the Company’s merger with SeaSpine, which closed on January 5, 2023.
Adoption of ASU 2022-03 - Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions
In June 2022, the FASB issued ASU 2022-03, which clarifies the guidance in Topic 820, Fair Value Measurement, when measuring the fair value of an equity security subject to contractual restrictions that prohibit the sale and to introduce new disclosure requirements. The Company adopted this standard effective January 1, 2024, on a prospective basis. Adoption of this standard did not have a material impact to the Company's consolidated balance sheet, statements of operations, or cash flows, but did modify the Company's disclosures related to certain investments. Refer to Note 12 for the Company's updated disclosures on investments in equity securities subject to capital sale restrictions.
Adoption of ASU 2023-07 - Improvements to Reportable Segment Disclosures
In November 2023, the FASB issued ASU 2023-07, which enhances and improves disclosures about operating segment revenues, measures of profit/loss, and expenses to enable investors to better understand an entity's overall performance and assess potential future cash flows. The amendment requires that an entity disclose (i) significant expenses that are regularly provided to the Chief Operating Decision Maker ("CODM"), (ii) other segment items by reportable segment including a description of its composition, (iii) all annual disclosures required by Topic 280, Reporting Measures of Segment Profit or Loss, in interim periods, (iv) additional measures of a segment's profit or loss used by the CODM in assessing segment performance and allocation of resources, and (v) the title and position of the CODM and an explanation of how the CODM uses the reported measure(s) of segment profit or loss. The Company adopted this standard effective January 1, 2024, on a prospective basis. Refer to Note 16 for the Company's updated business segment disclosures.
Recently Issued Accounting Pronouncements
| Topic | Description of Guidance | Effective Date | Status of Company's Evaluation |
|---|---|---|---|
| Disclosure Improvements - Codification Amendments in Response to the SEC's Disclosure Update and Simplification Initiative (ASU 2023-06) | Adds interim and annual disclosure requirements to a variety of subtopics in the Accounting Standards Codification, including those focusing on accounting changes, earnings per share, debt, and repurchase agreements. The guidance will be applied prospectively. The effective date will be the date when the SEC's removal of the related disclosure requirement becomes effective, with early adoption prohibited. | Various | The Company is currently evaluating the impact this ASU may have on its consolidated financial statements. |
| Improvements to Income Tax Disclosures (ASU 2023-09) | Enhances the transparency and decision-making usefulness of income tax disclosures to better assess how an entity’s operations and related tax risks and tax planning and operational opportunities affect its tax rate and prospects for future cash flows. The amendments are to be applied prospectively, but retrospective application is permitted. | January 1, 2025 | The Company is currently evaluating the impact this ASU may have on its consolidated financial statements. |
| Disaggregation of Income Statement Expenses (ASU 2024-03) | Improve financial reporting by requiring that public business entities disclose additional information about specific expense categories in the note to the financial statements at interim and annual reporting periods. The amendments are to be applied prospectively to financial statements issued and retrospectively to all prior periods presented in the financial statements. | January 1, 2027 | The Company is currently evaluating the impact this ASU may have on its consolidated financial statements. |
Other recently issued ASUs, excluding those ASUs which have already been disclosed as adopted or described above, were assessed and determined not applicable, or are expected to have minimal impact on the Company's consolidated financial statements.
- Mergers and acquisitions
Merger with SeaSpine
On January 5, 2023, the Company and SeaSpine completed an all-stock merger of equals (the "Merger") to create a global medical technology company that provides medical technologies that heal musculoskeletal pathologies, and delivers exceptional experiences and life-changing solutions to patients around the world. As a result of the Merger, each share of SeaSpine common stock issued and outstanding immediately prior to the closing of the Merger was converted into the right to receive 0.4163 shares of Orthofix common stock.
The Company finalized its valuation of assets acquired and liabilities assumed during the fourth quarter of 2023. Certain acquired assets and liabilities assumed were valued utilizing Level 3 inputs and assumptions.
| (U.S. Dollars, in thousands) | Final Acquisition Date Fair Value | Assigned Useful Life |
|---|---|---|
| Assets acquired: | ||
| Current assets | ||
| Cash and cash equivalents | $29,419 | |
| Accounts receivable, net | 35,313 | |
| Inventories | 132,636 | |
| Prepaid expenses and other current assets | 4,590 | |
| Total current assets | 201,958 | |
| Property, plant, and equipment, net | 68,863 | |
| Customer relationships | 33,100 | 13 years |
| Developed technology | 47,200 | 6 - 8 years |
| In-process research and development ("IPR&D") | 5,750 | Indefinite |
| Other long-term assets | 20,501 | |
| Total identifiable assets acquired | $377,372 | |
| Liabilities assumed: | ||
| Current liabilities | ||
| Accounts payable | $21,602 | |
| Other current liabilities | 43,521 | |
| Total current liabilities | 65,123 | |
| Long-term borrowings under SeaSpine credit facility | 26,298 | |
| Other long-term liabilities | 32,823 | |
| Total liabilities assumed | 124,244 | |
| Net identifiable assets acquired | $253,128 | |
| Total fair value of consideration transferred | 376,745 | |
| Residual goodwill | $123,617 | |
The Company didnot recognize any direct acquisition-related costs, which exclude integration-related activities, during the year ended December 31, 2024, however, the Company recognized $9.9 million in such costs that were expensed during the year ended December 31, 2023. These costs are included in the consolidated statements of operations and comprehensive loss, primarily within general and administrative expenses. The Company's results of operations included $294.0 million of net sales from SeaSpine for the year ended December 31, 2024, and a net loss attributable to SeaSpine of $63.4 million for the year ended December 31, 2024. The Company's results of operations included $258.9 million of net sales from SeaSpine for the year ended December 31, 2023, and a net loss attributable to SeaSpine of $84.0 million for the year ended December 31, 2023.
Due to the consummation of the Merger occurring on January 5, 2023, all SeaSpine financial results for fiscal year 2023, except for the first four days of January, were included in the Company's condensed consolidated statement of operations and comprehensive loss. Therefore, the Company did not prepare unaudited pro forma financial information for the year ended December 31, 2023 or 2024, on the basis that the Merger was completed on January 1, 2023.
Integration and Restructuring Activities
The Company has incurred significant integration and restructuring costs in connection with the Merger. The following table summarizes integration costs incurred for the year ended December 31, 2024, and 2023.
| For the Year Ended December 31, | ||
|---|---|---|
| (U.S. Dollars, in millions) | 2024 | 2023 |
| Compensation-related integration costs | $4.0 | $17.7 |
| International spine restructuring | 0.5 | 1.3 |
| Fee paid to financial advisor to the Merger | — | 5.5 |
| Professional fees / consulting fees | 2.1 | 5.8 |
| Product rationalization charges | 9.7 | 6.0 |
| Other costs | 1.5 | 1.4 |
| Total | $17.8 | $37.7 |
After the consummation of the Merger, the Company approved and initiated certain restructuring activities to streamline costs and to better align talent with operational needs, including review of the Company's international spine business. As reported in the prior year, the Company expected to incur total pre-tax expenses of approximately $18.2 million associated with restructuring activities, which were recognized in operating expenses and resulted in accrued liabilities of $7.0 million as of December 31, 2023. The Company paid all remaining liabilities related to these activities in 2024, which primarily related to severance and retention payments.
- Inventories
Inventories are valued at the lower of cost or estimated net realizable value, after provision for excess, obsolete, or impaired items, which is reviewed and updated on a periodic basis by management. With respect to the Company’s manufacturing facilities in Texas and California, for inventory procured or produced internally or through contract manufacturing arrangements, standard cost, which approximates actual cost on the first-in, first-out ("FIFO") method, is used to value inventory. With respect to the Company’s manufacturing facilities in Italy, for inventory procured or produced internally or through contract manufacturing arrangements, weighted-average, which approximates actual cost on the first-in, first-out ("FIFO") method, is used to value inventory. Standard costs are reviewed by management, at least annually or more often, in the event circumstances indicate a change in cost has occurred.
Work-in-process and finished products include material, labor, and production overhead costs. Field and consignment inventory, which represents immediately saleable finished products inventory that is in the possession of the Company’s independent sales representatives or located at third-party customers, such as hospitals, is included within finished products.
| December 31, | ||
|---|---|---|
| (U.S. Dollars, in thousands) | 2024 | 2023 |
| Raw materials | $27,180 | $28,390 |
| Work-in-process | 56,920 | 53,510 |
| Finished products | 105,352 | 140,266 |
| Inventories | $189,452 | $222,166 |
The Company adjusts the value of its inventory to the extent management determines that the cost cannot be recovered due to obsolescence or other factors. To make these determinations, management uses estimates of future demand for each product to determine the appropriate inventory reserves and to make corresponding adjustments to the carrying value of these inventories to reflect the lower of cost or estimated net realizable value.
- Property, plant, and equipment
Property, plant, and equipment is stated at cost or estimated fair value when acquired as part of a business combination, less accumulated depreciation. Costs include all expenditures necessary to place the asset in service, generally including freight and sales and use taxes. Property, plant, and equipment also includes instrumentation, which is generally used to facilitate the implantation of the Company’s products.
The useful lives of these assets are generally as follows:
| Years | |
| Buildings | 25 to 33 |
|---|---|
| Plant and equipment | 1 to 10 |
| Instrumentation | 3 to 4 |
| Computer software | 3 to 7 |
| Furniture and fixtures | 4 to 8 |
The Company evaluates the useful lives of these assets on an annual basis. Depreciation is computed on a straight-line basis over the useful lives of the assets. Depreciation of leasehold improvements is computed over the shorter of the lease term or the useful life of the asset. Total depreciation expense was $41.1 million, $34.2 million, and $19.6 million for the years ended December 31, 2024, 2023, and 2022, respectively.
Expenditures for maintenance and repairs and minor renewals and improvements, which do not extend the lives of the respective assets, are expensed as incurred. All other expenditures for renewals and improvements are capitalized. The assets and related accumulated depreciation are adjusted for property retirements and disposals, with the resulting gain or loss included in earnings. Fully depreciated assets remain in the accounts until retired from service.
| December 31, | ||
|---|---|---|
| (U.S. Dollars, in thousands) | 2024 | 2023 |
| Cost | ||
| Buildings | $3,874 | $4,103 |
| Plant and equipment | 76,481 | 70,252 |
| Instrumentation | 176,387 | 154,192 |
| Computer software | 41,396 | 43,040 |
| Furniture and fixtures | 9,832 | 11,010 |
| Construction in progress | 22,693 | 41,751 |
| Finance lease assets | 21,383 | 23,337 |
| Property, plant, and equipment, gross | 352,046 | 347,685 |
| Accumulated depreciation | (212,242) | (188,625) |
| Property, plant, and equipment, net | $139,804 | $159,060 |
The Company capitalizes system development costs related to internal-use software during the application development stage. Costs related to preliminary project activities and post-implementation activities are expensed as incurred. Internal-use software is amortized on a straight-line basis over its estimated useful life, which generally ranges from three toseven years.
Long-lived assets are evaluated for impairment annually or whenever events or changes in circumstances have occurred that would indicate impairment. For purposes of the evaluation, the Company groups its long-lived assets with other assets and liabilities at the lowest level of identifiable cash flows if the asset does not generate cash flows independent of other assets and liabilities. If the carrying value of the asset or asset group exceeds the undiscounted cash flows expected to result from the use and eventual disposition of the asset group, the Company will write the carrying value down to fair value in the period identified.
The Company generally determines fair value of long-lived assets as the present value of estimated future cash flows. In determining the estimated future cash flows associated with the assets, the Company uses estimates and assumptions about future revenue contributions, cost structures, and remaining useful lives of the asset group. The use of alternative assumptions, including estimated cash flows, discount rates, and alternative estimated remaining useful lives could result in different calculations of impairment.
- Intangible assets
Intangible assets are recorded at cost, or when acquired as a part of a business combination, at estimated fair value, less accumulated amortization. These assets are amortized on a straight-line basis over the useful lives of the assets, which the Company believes is consistent with the pattern of economic benefit provided by the assets.
| December 31, | |||
|---|---|---|---|
| (U.S. Dollars, in thousands) | Weighted Average Amortization Period | 2024 | 2023 |
| Cost | |||
| Developed technology | 7.9 years | $92,686 | $92,416 |
| Patents | 10.0 years | 38,329 | 43,262 |
| IPR&D | Indefinite | 4,116 | 4,674 |
| Customer relationships | 12.5 years | 49,145 | 49,197 |
| License and other | 9.7 years | 18,359 | 24,584 |
| Trademarks—finite lived | 10.0 years | 1,735 | 1,797 |
| 9.7 years | 204,370 | 215,930 | |
| Accumulated amortization | |||
| Developed technology | $(40,813) | $(28,898) | |
| Patents | (35,918) | (40,494) | |
| Customer relationships | (17,044) | (11,988) | |
| License and other | (10,892) | (16,240) | |
| Trademarks—finite lived | (900) | (820) | |
| (105,567) | (98,440) | ||
| Intangible assets, net | $98,803 | $117,490 | |
Acquired IPR&D represents the fair value assigned to acquired research and development assets that have not reached technological feasibility. In a business combination, the fair value assigned to acquired IPR&D is determined by estimating the remaining costs to develop the acquired technology into commercially viable products, estimating the resulting revenues from the projects, and discounting the net cash flows to present value. The revenue and cost projections used to value acquired IPR&D are, as applicable, reduced based on the probability of success of developing the asset. Additionally, estimated revenues consider the relevant market sizes and growth factors, expected trends in technology, and the nature and expected timing of new product introductions by the Company and its competitors. The rates utilized to discount the net cash flows to their present value are commensurate with the stage of development of the project and uncertainties in the economic estimates used in the projections. Any future costs to further develop the IPR&D subsequent to acquisition are recorded to research and development expense as incurred.
IPR&D assets are considered to be indefinite-lived assets until the completion or abandonment of the associated research and development efforts. During the period the assets are considered indefinite-lived, they are not amortized but tested for impairment. Impairment testing is performed at least annually or when a triggering event occurs that could indicate a potential impairment. If and when development is complete, which generally occurs when regulatory approval to market a product is obtained, the associated assets are reclassified to developed technology and are amortized over an assigned useful life that best reflects the economic benefits provided by these assets.
Amortization expense for intangible assets was $19.0 million, $18.9 million, and $9.4 million for the years ended December 31, 2024, December 31, 2023, and 2022, respectively. Future amortization expense for intangible assets is estimated as follows:
| (U.S. Dollars, in thousands) | Amortization |
|---|---|
| 2025 | $19,859 |
| 2026 | 18,780 |
| 2027 | 18,418 |
| 2028 | 15,043 |
| 2029 | 7,139 |
| Thereafter | 15,448 |
| Total finite-lived intangible assets, net | $94,687 |
| Indefinite-lived intangible assets | 4,116 |
| Intangible assets, net | $98,803 |
- Goodwill
The Company tests goodwill at least annually for impairment. The Company tests more frequently if indicators are present or changes in circumstances suggest that impairment may exist. These indicators include, among others, declines in sales, earnings, or cash flows, or the development of a material adverse change in the business climate. The Company assesses goodwill for impairment at the reporting unit level, which is defined as an operating segment or one level below an operating segment.
The following table presents the net carrying value of goodwill as of December 31, 2024, and 2023, and a rollforward of such balances from December 31, 2023, by reportable unit:
| (U.S. Dollars, in thousands) | Balance as of December 31, 2023 | Impairment | Currency translation adjustment | Balance as of December 31, 2024 |
|---|---|---|---|---|
| Global Spine - Gross | $194,934 | $— | $— | $194,934 |
| Global Spine - Accumulated Impairment Loss | — | — | — | $— |
| Global Spine - Net | $194,934 | $— | $— | $194,934 |
| Global Orthopedics - Gross | $11,477 | $— | $(712) | $10,765 |
| Global Orthopedics - Accumulated Impairment Loss | (11,477) | — | 712 | $(10,765) |
| Global Orthopedics - Net | $— | $— | $— | $— |
| Goodwill, net of accumulated impairment losses | $194,934 | $— | $— | $194,934 |
In the fourth quarter of 2022, the Company performed a qualitative assessment for its annual goodwill impairment analysis, which did not result in an impairment charge. This qualitative analysis considered all relevant factors specific to the reporting units, including macroeconomic conditions, industry and market considerations, overall financial performance, and relevant entity-specific events.
In the third quarter of 2023, the Company announced the termination of its former President and Chief Executive Officer, former Chief Financial Officer, and former Chief Legal Officer, from their respective roles. Immediately following the announcement, the Company’s market capitalization decreased by approximately 30%, indicating that an impairment may exist. As a result, the Company performed an interim quantitative assessment of its goodwill as of September 30, 2023. The Company estimated the fair value of each reporting unit using a weighted average of the fair value derived from both an income approach and a market approach (all Level 3 fair value measurements). Upon performing its assessment, the Company determined its Global Spine reporting unit's fair value exceed its carrying value of net assets as of September 30, 2023.
In the fourth quarter of 2023, the Company performed a qualitative assessment for its annual goodwill impairment analysis, which did not result in an impairment charge. This qualitative analysis considered all relevant factors specific to the reporting units, including macroeconomic conditions, industry and market considerations, overall financial performance, and relevant entity-specific events.
In the fourth quarter of 2024, the Company performed a quantitative assessment for its annual goodwill impairment analysis, which did not result in an impairment charge. Upon performing the assessment, the Company determined the Global Spine reporting unit's fair value exceeded its carrying value and concluded there wereno indicators of impairment.
- Leases
The Company determines if a contractual arrangement qualifies as a lease at inception. The Company’s leases primarily relate to facilities, vehicles, and equipment. Lease assets represent the Company’s right to use an underlying asset for the lease term, while lease liabilities represent the obligation to make lease payments arising from the lease. Lease assets and liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company’s incremental borrowing rate is used as a discount rate, based on the information available at the commencement date, in determining the present value of lease payments. Lease assets also include the impact of any prepayments made and are reduced by the impact of any lease incentives.
The Company does not recognize lease liabilities or lease assets on the balance sheet for short-term leases (leases with a lease term of twelve months or less as of the commencement date). Rather, any short-term lease payments are recognized as an expense on a straight-line basis over the lease term. The current period short-term lease expense reasonably reflects the Company's short-term lease commitments.
For all classifications of leases, the Company combines lease and non-lease components to account for them as a single lease component. Variable lease payments are excluded from the lease liability and recognized in the period in which the obligation is incurred. Additionally, lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise the option.
A summary of the Company’s lease portfolio as of December 31, 2024, and 2023, is presented in the table below:
| (U.S. Dollars, in thousands, except lease term and discount rate) · Classification · December 31, 2024 · December 31, 2023 | |||||
|---|---|---|---|---|---|
| Assets | |||||
| Operating leases | Other long-term assets | $17,238 | $19,869 | ||
| Finance leases | Property, plant and equipment, net | 15,386 | 16,345 | ||
| Total lease assets | $32,624 | $36,214 | |||
| Liabilities | |||||
| Current | |||||
| Operating leases | Other current liabilities | $4,023 | $3,477 | ||
| Finance leases | Current portion of finance lease liability | 755 | 708 | ||
| Long-term | |||||
| Operating leases | Other long-term liabilities | 14,084 | 17,125 | ||
| Finance leases | Long-term portion of finance lease liability | 17,835 | 18,532 | ||
| Total lease liabilities | $36,697 | $39,842 | |||
| Weighted Average Remaining Lease Term | |||||
| Operating leases | 5.4 years | 6.2 years | |||
| Finance leases | 15.6 years | 16.6 years | |||
| Weighted Average Discount Rate | |||||
| Operating leases | 7.6% | 7.3% | |||
| Finance leases | 4.4% | 4.4% | |||
The components of lease costs were as follows:
| (U.S. Dollars, in thousands) | For the Year Ended December 31, 2024 | For the Year Ended December 31, 2023 | For the Year Ended December 31, 2022 |
|---|---|---|---|
| Finance lease costs: | |||
| Amortization of right-of-use assets | $1,014 | $1,013 | $1,238 |
| Interest on finance lease liabilities | 832 | 857 | 890 |
| Operating lease costs | 5,257 | 5,015 | 2,126 |
| Short-term lease costs | 249 | 313 | 152 |
| Variable lease costs | 1,796 | 1,883 | 932 |
| Total lease costs | $9,148 | $9,081 | $5,338 |
Supplemental cash flow information related to leases was as follows:
| (U.S. Dollars, in thousands) | For the Year Ended December 31, 2024 | For the Year Ended December 31, 2023 | For the Year Ended December 31, 2022 |
|---|---|---|---|
| Cash paid for amounts included in the measurement of lease liabilities | |||
| Operating cash flows from operating leases | $8,917 | $7,682 | $3,805 |
| Operating cash flows from finance leases | 831 | 857 | 885 |
| Financing cash flows from finance leases | 706 | 652 | 2,594 |
| Right-of-use assets obtained in exchange for lease obligations | |||
| Operating leases | 1,449 | 16,688 | 5,603 |
| Finance leases | 55 | — | — |
A summary of the Company’s remaining lease liabilities as of December 31, 2024, is included below:
| (U.S. Dollars, in thousands) | OperatingLeases | FinanceLeases |
|---|---|---|
| 2025 | $5,185 | $1,553 |
| 2026 | 5,006 | 1,581 |
| 2027 | 3,651 | 1,612 |
| 2028 | 1,841 | 1,643 |
| 2029 | 1,636 | 1,662 |
| Thereafter | 5,116 | 17,740 |
| Total undiscounted value of lease liabilities | 22,435 | 25,791 |
| Less: Interest | (4,328) | (7,201) |
| Present value of lease liabilities | $18,107 | $18,590 |
| Current portion of lease liabilities | $4,023 | $755 |
| Long-term portion of lease liabilities | 14,084 | 17,835 |
| Total lease liabilities | $18,107 | $18,590 |
- Other current liabilities
| December 31, | ||
|---|---|---|
| (U.S. Dollars, in thousands) | 2024 | 2023 |
| Accrued expenses | $11,391 | $12,189 |
| Salaries, bonuses, employee commissions, and related taxes payable | 43,899 | 38,826 |
| Accrued distributor commissions | 23,064 | 22,602 |
| Accrued litigation and investigation costs | 11,891 | 12,077 |
| Short-term operating lease liability | 4,023 | 3,477 |
| Non-income taxes payable | 8,414 | 7,585 |
| Contingent consideration short-term | 7,100 | 1,000 |
| Other payables | 9,288 | 7,152 |
| Other current liabilities | $119,070 | $104,908 |
- Indebtedness
The carrying values of the Company’s outstanding debt obligations as of December 31, 2024, and 2023, were as follows:
| December 31, | ||
|---|---|---|
| (U.S. Dollars, in thousands) | 2024 | 2023 |
| Outstanding Term Loans | ||
| Principal amount | $160,000 | $100,000 |
| Unamortized original debt discount | (2,327) | (4,331) |
| Unamortized debt issuance costs and lenders fees | (658) | (1,312) |
| Total indebtedness from outstanding term loans | 157,015 | 94,357 |
| Revolving Credit Facilities | ||
| Principal amount outstanding | — | — |
| Total indebtedness outstanding | $157,015 | $94,357 |
| Current portion of long-term debt | $— | $1,250 |
| Long-term debt | 157,015 | 93,107 |
| Total indebtedness outstanding | $157,015 | $94,357 |
The Company paid cash related to interest of $16.9 million, $5.8 million, and $1.4 million for the years ended December 31, 2024, 2023, and 2022, respectively.
Credit Agreement
On November 7, 2024, the Company, as borrower, and its U.S. subsidiaries entered into a $275.0 million secured credit agreement (the "Credit Agreement") with Oxford Finance LLC, as administrative agent and as collateral agent ("Oxford") and certain lenders party thereto, including Oxford, K2 HealthVentures LLC, and HSBC Ventures USA Inc. Certain of the Company’s foreign subsidiaries joined the Credit Agreement as guarantors shortly after the signing date. The Credit Agreement provides for a $160.0 million senior secured term loan (the "Initial Term Loan"), and a $65.0 million senior secured delayed draw term loan facility (the "Term B Loan"). Draws under the Term B Loan are at the Company’s option from January 1, 2025 through June 30, 2026, subject to, among other conditions, the Company’s continuing compliance with a pro-forma total debt-to-EBITDA leverage ratio of less than 4.0x. EBITDA is a non-GAAP financial measure which represents earnings before interest income (expense), income taxes, depreciation, amortization, and other negotiated addbacks and adjustments. In addition, at Oxford's discretion, an additional $50.0 million of draw capacity is available to the Company, through January 1, 2029 (the "Term C Loan" and, together with the Term B Loan, the "Delayed Draw Term Loans" and collectively with the Initial Term Loan, the "Credit Facilities"). The Initial Term Loan and Delayed Draw Term Loans, to the extent ultimately drawn, will each mature in November 2029, following an interest-only payment period ending December 2028, and monthly amortization of principal and accrued interest between January 2029 and November 2029.
The Credit Facilities are secured by a perfected first priority lien, or the equivalent security interest in each applicable jurisdiction, on substantially all of the assets of the Company and the applicable guarantors (subject to customary carveouts), including their respective U.S. intellectual property assets.
Borrowings under the Credit Facilities bear interest at a percentage rate equal to the greater of 8.75% or 5.75% plus the one-month term SOFR rate. A facility fee equal to 1.5% of each applicable funded loan tranche is due at the time of funding of such respective tranche, and a 0.5% unused line fee is payable annually on the Term B Loan.
The Credit Agreement contains customary affirmative and negative covenants, including limitations on the Company’s and its subsidiaries’ ability to incur additional debt, grant or permit additional liens, make certain investments and acquisitions, merge or consolidate with others, dispose of certain assets, pay dividends and distributions, pay subordinated indebtedness, and enter into affiliate transactions, as well as financial covenants that the Company (i) possess at least $45.0 million of unrestricted cash at the time the Initial Term Loan is funded and thereafter maintain $15.0 million of unrestricted cash in U.S.-based accounts, and (ii) maintain a maximum total debt-to-EBITDA leverage ratio no greater than 4.0x during the term of the facility.
In conjunction with obtaining the Credit Agreement, the Company paid $1.2 million in debt issuance costs. These costs have been allocated amongst each of the Initial Term Loan, Term B Loan, and Term C Loan and are being amortized over the term of the Credit Agreement. Capitalized debt issuance costs attributable to the Term B Loan and Term C Loan are included in other long-term assets, net of accumulated amortization, whereas capitalized debt issuance costs associated with the Initial Term Loan are recognized as a direct reduction of the outstanding indebtedness. As of December 31, 2024, and December 31, 2023, debt issuance costs associated with all credit facilities, net of accumulated amortization, were $1.1 million and $1.9 million, respectively. Debt issuance costs amortized or expensed totaled $4.4 million, $1.3 million, and $0.4 million for each of the years ended December 31, 2024, 2023, and 2022, respectively.
As of the effective date of the Credit Agreement, the Company had $125.0 million in principal amount of borrowings outstanding under the Company's prior financing agreement with Blue Torch Finance LLC. In connection with entering into the Credit Agreement, the Company repaid in full all amounts outstanding and terminated all commitments under such prior financing agreement.
Prior Financing Agreement
On November 6, 2023, the Company, as borrower, and certain subsidiaries of the Company as guarantors, entered into a Financing Agreement (the "Financing Agreement") with Blue Torch Finance LLC, as administrative agent and collateral agent (the "Agent"), and certain lenders party thereto. The Financing Agreement provided for a $100.0 million senior secured term loan (the "Blue Torch Initial Term Loan"), a $25.0 million senior secured delayed draw term loan facility (the "Delayed Draw Term Loan") which, subject to certain conditions specified in the Financing Agreement, was available to be drawn on or prior to March 30, 2024, and a $25.0 million senior secured revolving credit facility (the "Revolving Credit Facility," and together with the Blue Torch Initial Term Loan and the Delayed Draw Term Loan, the "Blue Torch Credit Facilities"), each of which were scheduled to mature on November 6, 2027. In connection with entering into the Financing Agreement, the Company repaid in full amounts outstanding and terminated all commitments under the Company’s prior $175 million senior secured revolving credit facility evidenced by that certain Second Amended and Restated Credit Agreement, dated as of October 25, 2019, among the Company, certain subsidiaries of the Company as borrowers and guarantors, JPMorgan Chase Bank, N.A., as administrative agent, and the lenders party thereto (as amended, supplemented or otherwise modified, the "JPMorgan Credit Agreement"). The Blue Torch Initial Term Loan was fully funded on the effective date of November 6, 2023. As of December 31, 2023, the Company hadnot made any borrowings under the Delayed Draw Term Loan or the Revolving Credit Facility. However, on January 10, 2024, the Company borrowed $15.0 million under the Revolving Credit Facility, which was fully repaid as of the effective date of the Credit Agreement.
Borrowings under the Financing Agreement were used for, among other things, the repayment in full of the JPMorgan Credit Agreement, working capital and other general corporate purposes of the Company. Borrowings under the Blue Torch Credit Facilities bore interest at a floating rate, which was, at the Company’s option, either the three-month SOFR rate (subject to a floor of 3.00% and a credit spread adjustment of 0.26161%) (the "Adjusted Term SOFR Rate") plus an applicable margin of 7.25%, or a base rate plus an applicable margin of 6.25%. A revolving unused line fee of 2.00% was payable monthly in arrears based on the average amount of the undrawn portion of each lender’s revolving credit commitments under the Revolving Credit Facility for the preceding month. A delayed draw unused fee equal to the Adjusted Term SOFR Rate plus a margin of 1.00% was payable monthly in arrears based on the average amount of the undrawn portion of each lender’s delayed draw term loan commitments in respect of the Delayed Draw Term Loan for the preceding month.
Certain of the Company’s existing and future material subsidiaries (collectively, the "Guarantors") were required to guarantee the repayment of the Company’s obligations under the Financing Agreement. The obligations of the Company and each of the Guarantors with respect to the Financing Agreement were secured by a pledge of substantially all assets of the Company and each of the Guarantors, including, without limitation, accounts receivables, deposit accounts, intellectual property, investment property, inventory, equipment and equity interests in their respective subsidiaries.
JPMorgan Credit Agreement
As disclosed above, on October 25, 2019, the Company, and certain of its wholly-owned subsidiaries (collectively with the Company, the "Borrowers"), as borrowers, and certain material subsidiaries of the Company as guarantors, entered into the JPMorgan Credit Agreement. The JPMorgan Credit Agreement provided for a $300.0 million secured revolving credit facility, amending and restating the revolving credit facility that previously existed with such lenders. The JPMorgan Credit Agreement had a maturity date of October 25, 2024. On March 1, 2023, the JPMorgan Credit Agreement was amended to replace London Inter-Bank Offered Rate ("LIBOR")-based pricing with Secured Overnight Financing Rate ("SOFR")-based pricing.
On June 13, 2023, the Company entered into a Limited Consent, Limited Waiver and Second Amendment to the Original Credit Agreement (the "Consent and Amendment"). Under the terms of the Consent and Amendment, the parties agreed to reduce the size of the secured revolving credit facility, off of which certain fees were based, from $300.0 million to $175.0 million, and to increase the applicable interest rate in certain circumstances.
On January 3, 2023, the Company borrowed $30.0 million for working capital purposes, including to fund certain Merger-related expenses, under the JPMorgan Credit Agreement. Subsequently, the Company borrowed an additional $49.0 million to fund working capital needs whereby, as of the effective date of the Financing Agreement, the Company had $79.0 million in principal amount of borrowings outstanding under the JPMorgan Credit Agreement. In connection with entering into the Financing Agreement, the Company repaid in full all amounts outstanding and terminated all commitments under the JPMorgan Credit Agreement.
Italian Line of Credit
The Company has an unused available Italian line of credit of €5.5 million ($5.7 million and $6.1 million) at December 31, 2024, and 2023, respectively. This unsecured line of credit provides the Company the option to borrow amounts in Italy at interest rates determined at the time of borrowing.
- Fair value measurements and investments
Fair value is defined as the price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Non-financial assets and liabilities of the Company measured at fair value include any long-lived assets that are impaired in a currently reported period or equity securities measured at observable prices in orderly transactions. The authoritative guidance also describes three levels of inputs that may be used to measure fair value:
| Level 1: | quoted prices in active markets for identical assets and liabilities |
|---|---|
| Level 2: | observable inputs other than quoted prices in active markets for identical assets and liabilities |
| Level 3: | unobservable inputs in which there is little or no market data available, which require the reporting entity to develop its own assumptions |
The Company’s financial instruments include cash equivalents, accounts receivable, accounts payable, long-term secured debt, available for sale debt securities, equity securities, contingent consideration, and deferred compensation plan liabilities. The carrying value of cash equivalents, accounts receivable, and accounts payable approximate fair value due to the short-term maturities of these instruments. The Company’s secured term loan carries a floating rate of interest; therefore, the carrying value of long-term debt is considered to approximate the fair value.
The Company’s available for sale debt securities, equity securities, contingent consideration, and deferred compensation plan liabilities are, or in some cases, were the only financial instruments recorded at fair value on a recurring basis as follows:
| (U.S. Dollars, in thousands) | Level 1 | Level 2 | Level 3 | BalanceDecember 31,2024 |
|---|---|---|---|---|
| Assets | ||||
| Neo Medical convertible loan agreement | $— | $— | $— | $— |
| Neo Medical preferred equity securities | — | — | — | — |
| Other investments | — | — | — | — |
| Total | $— | $— | $— | $— |
| Liabilities | ||||
| Lattus contingent consideration | $— | $— | $(15,400) | $(15,400) |
| Deferred compensation plan | — | (1,703) | — | (1,703) |
| Total | $— | $(1,703) | $(15,400) | $(17,103) |
| (U.S. Dollars, in thousands) | Level 1 | Level 2 | Level 3 | BalanceDecember 31,2023 |
|---|---|---|---|---|
| Assets | ||||
| Neo Medical convertible loan agreement | $— | $— | $6,760 | $6,760 |
| Neo Medical preferred equity securities | — | 4,951 | — | 4,951 |
| Bone Biologics equity securities | — | — | — | — |
| Other investments | — | — | 1,309 | 1,309 |
| Total | $— | $4,951 | $8,069 | $13,020 |
| Liabilities | ||||
| Lattus contingent consideration | $— | $— | $(8,500) | $(8,500) |
| Deferred compensation plan | — | (1,674) | — | (1,674) |
| Total | $— | $(1,674) | $(8,500) | $(10,174) |
The fair value of the Company’s deferred compensation plan liabilities is determined based on inputs that are readily available in public markets or that can be derived from information available in publicly quoted markets; therefore, the Company has categorized this liability as a Level 2 financial instrument.
Neo Medical Convertible Loan Agreements and Equity Investment
On October 1, 2020, the Company purchased shares of Neo Medical’s preferred stock for consideration of $5.0 million and entered into a Convertible Loan Agreement (the "Convertible Loan") pursuant to which Orthofix loaned Neo Medical CHF 4.6 million, or $5.0 million at the date of issuance.
In April 2024, the Company converted the Convertible Loan into shares of Neo Medical preferred equity securities. The preferred equity securities were recorded in other long-term assets and were considered an investment that did not have a readily determinable fair value. As such, the Company measured this investment at cost, less any impairment, plus or minus changes resulting from observable price changes in orderly transactions for identical or similar investments of the same issuer.
On November 14, 2024, the Company sold and transferred all shares of Neo Medical's preferred equity securities for CHF 6.6 million, or $7.4 million. The Company recorded a realized loss of $5.8 million as a result of the sale, recognized within other expense, net.
The table below presents a reconciliation of the carrying value of the Company’s investment in Neo Medical preferred equity securities for the years ended December 31, 2024, and 2023:
| (U.S. Dollars, in thousands) | 2024 | 2023 |
|---|---|---|
| Fair value of Neo Medical preferred equity securities at January 1 | $4,951 | $6,084 |
| Conversion of loan into preferred equity securities | 8,224 | — |
| Foreign currency remeasurement recognized in other income, net | — | 388 |
| Unrealized loss recognized in other expense, net | — | (1,521) |
| Sale of preferred equity securities | (7,396) | — |
| Realized loss recognized in other expense, net | (5,779) | — |
| Fair value of Neo Medical preferred equity securities at December 31 | $— | $4,951 |
| Cumulative unrealized gain (loss) on Neo Medical preferred equity securities | $— | $(720) |
Prior to conversion, the Convertible Loan was recorded at fair value, with applicable interest recorded in interest income. The fair value of the Convertible Loan was based upon significant unobservable inputs, including the use of option-pricing models, Monte Carlo simulations for certain periods, and a probability-weighted discounted cash flows model, requiring the Company to develop its own assumptions. Therefore, the Company had categorized this asset as a Level 3 financial asset.
Some of the more significant unobservable inputs used in the fair value measurement of the Convertible Loan included applicable discount rates, implied volatility, the likelihood and projected timing of repayment or conversion, and projected cash flows in support of the estimated enterprise value of Neo Medical. Holding other inputs constant, changes in these assumptions could have resulted in a significant change in the fair value of the Convertible Loan. If the amortized cost of the Convertible Loan exceeds its estimated fair value, the security is deemed to be impaired, and must be evaluated for the recognition of credit losses. Impairment resulting from credit losses is recognized within the statement of income, while impairment resulting from other factors is recognized within other comprehensive income (loss).
The following table provides a reconciliation of the beginning and ending balances of the Convertible Loan, measured at fair value using significant unobservable inputs (Level 3):
| (U.S. Dollars, in thousands) | 2024 | 2023 |
|---|---|---|
| Fair value of Neo Medical Convertible Loans at January 1 | $6,760 | $7,140 |
| Gains (losses) recognized in other comprehensive income (loss) | 1,671 | (1,233) |
| Interest recognized in interest income, net | 162 | 496 |
| Foreign currency remeasurement recognized in other income (expense), net | (629) | 617 |
| Expected credit loss recognized in other income (expense), net | 260 | (260) |
| Conversion into preferred equity securities | (8,224) | — |
| Fair value of Neo Medical Convertible Loans at December 31 | $— | $6,760 |
| Contractual value of Neo Medical Convertible Loans at December 31 | $— | $7,020 |
| Allowance for credit loss recognized in other expense, net | — | (260) |
| Amortized cost basis of Neo Medical Convertible Loans at December 31 | $— | $6,760 |
Bone Biologics Equity Securities
Until August of 2022, the Company held an investment in common stock of Bone Biologics Inc. ("Bone Biologics"), a developer of orthobiologic products. Bone Biologics’ common stock is actively traded on the NASDAQ (ticker BBLG). The Company concluded the investment represented a Level 1 fair value measurement subsequent to the public offering as the common shares subsequently had quoted prices in active markets for identical assets. As such, the Company recorded the investment at fair value, with changes in fair value recorded within other income (expense), net, subsequent to the public offering.
The following table presents the changes in fair value recognized for each of the years ended December 31,2024, 2023, and 2022:
| (U.S. Dollars, in thousands) | 2024 | 2023 | 2022 |
|---|---|---|---|
| Bone Biologics equity securities at January 1 | $— | $— | $309 |
| Fair value adjustments and impairments recognized in other expense, net | — | — | (183) |
| Proceeds from the disposition of equity securities | — | — | (126) |
| Bone Biologics equity securities at December 31 | $— | $— | $— |
Other investments
Other investments represent other assets and investments recorded at fair value that are not deemed to be material for disclosure on an individual basis. The fair value of these assets is based upon significant unobservable inputs, such as probability-weighted discounted cash flows models, requiring the Company to develop its own assumptions. Therefore, the Company has categorized these assets as Level 3 financial assets. This balance is classified within other current assets as of December 31, 2024, and was fully impaired as of such date, and was classified in other long-term assets as of December 31, 2023.
Lattus Contingent Consideration
In connection with the Merger, the Company assumed a contingent consideration obligation under a purchase agreement between SeaSpine and Lattus Spine LLC ("Lattus") executed in December 2022. Under the terms of the agreement, the Company may be required to make installment payments at certain dates based on future net sales of certain products (the "Lateral Products").
The estimated fair value of the Lattus contingent consideration is determined using a Monte Carlo simulation and a discounted cash flow model requiring significant inputs which are not observable in the market. The significant inputs include assumptions related to the timing and probability of certain product launch dates, estimated future sales of Lateral Products, revenue risk-adjusted discount rate, revenue volatility, and discount rates matched to the timing of payments. The following table provides a reconciliation of the beginning and ending balances for the Lattus contingent consideration measured at estimated fair value using significant unobservable inputs (Level 3):
| (U.S. Dollars, in thousands) | 2024 | 2023 |
|---|---|---|
| Lattus contingent consideration estimated fair value at January 1 | $8,500 | $11,200 |
| Change in fair value recognized in acquisition-related amortization and remeasurement | 6,900 | (2,700) |
| Lattus contingent consideration estimated fair value at December 31 | $15,400 | $8,500 |
The following table provides quantitative information related to certain key assumptions utilized within the valuation as of December 31, 2024:
| (U.S. Dollars, in thousands) · Fair Value as of December 31, 2024 · Unobservable inputs · Estimate | ||||
|---|---|---|---|---|
| Lattus Contingent Consideration | $15,400 | Counterparty discount rate | 10.9% | |
| Revenue risk-adjusted discount rate | 7.6% - 7.8% | |||
- Commitments and contingencies
Contingencies policy
The Company records accruals for certain outstanding legal proceedings, investigations, or claims when it is probable that a liability has been incurred and the amount of the loss can be reasonably estimated. The Company evaluates developments in legal proceedings, investigations, and claims that could affect the amount of any accrual, as well as any developments that would make a loss contingency both probable and reasonably estimable on a quarterly basis. When a loss contingency is not both probable and reasonably estimable, the Company does not accrue the loss. However, if the loss (or an additional loss in excess of the accrual) is at least a reasonable possibility and material, then the Company discloses a reasonable estimate of the possible loss or range of loss, if such reasonable estimate can be made. If the Company cannot make a reasonable estimate of the possible loss, or range of loss, then that is disclosed. In addition, legal fees and other directly related costs are expensed as incurred.
In addition to the matters described in the paragraphs below, in the normal course of its business, the Company is involved in various lawsuits from time to time and may be subject to certain other contingencies. The Company believes any losses related to these matters are individually and collectively immaterial as to a possible loss and range of loss.
Arbitration claims with former executives
In September 2023, the Company’s Board of Directors (the "Board") terminated the employment of Keith Valentine, John Bostjancic, and Patrick Keran, who had served respectively as the Company’s President and Chief Executive Officer, Chief Financial Officer, and Chief Legal Officer. The Board’s decision followed an investigation conducted by independent outside legal counsel and directed and overseen by the Company’s independent directors. As a result of the investigation, the Board determined that each of these executives engaged in repeated inappropriate and offensive conduct that violated multiple code of conduct requirements and was inconsistent with the Company’s values and culture. The Company notified each of Messrs. Valentine, Bostjancic, and Keran that their respective terminations were being made for "Cause," as defined in applicable employment-related agreements (including each executive’s respective Change in Control and Severance Agreement, dated June 19, 2023). The Company also notified each of Messrs. Valentine, Bostjancic, and Keran that it did not believe it was required to make any further payments to them, other than payment of salary through September 12, 2023. The Board also requested that Mr. Valentine resign as a director, which he did in October 2023.
In January 2024, the Company received written notices of arbitration claims from counsel to Messrs. Valentine, Bostjancic, and Keran. Each of the arbitration claims asserts that the respective former executive was wrongfully terminated for "Cause" because the former executive’s conduct did not meet the contractually applicable definition of "Cause." The claims seek relief for, among other things, alleged breach of contract, defamation, false light invasion of privacy, deceit, as well as indemnification and advancement for attorneys’ fees. Thethree former executives seek severance payments, as well as the value of forfeited equity grants under applicable change in control and severance agreements and further damages as a result of purported defamatory statements. In addition, in September 2024, Messrs. Valentine, Bostjancic and Keran filed an action in California State Court against former director and interim CEO Catherine Burzik and current director Wayne Burris, seeking relief for, among other things, alleged defamation, false light invasion of privacy, intentional misrepresentation, false promise, and tortious interference with contract.
The Company disagrees with the allegations contained in the arbitration demands and in the action against Ms. Burzik and Mr. Burris, and intends to vigorously defend the asserted claims. Due in part to the preliminary nature of this matter, the Company currently cannot reasonably estimate a possible loss, or range of loss, that may arise from these claims.
Securities class action complaints
On August 21, 2024, a securities class action complaint captioned Bernal v. Orthofix Medical Inc., et al., Case No. 24-cv-00690, was filed in the United States District Court for the Eastern District of Texas (the "Bernal Complaint"). The plaintiff, a purported Company shareholder, alleges through the complaint violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, and SEC Rule 10b-5 promulgated thereunder, and names as defendants the Company and the following former Company directors and officers: Jon Serbousek (former director and former President and Chief Executive Officer), Keith Valentine (former director and former President and Chief Executive Officer), John Bostjancic (former Chief Financial Officer), and Patrick Keran (former Chief Legal Officer). The complaint alleges that the Company made, and the named former directors and officers caused the Company to make, materially false and misleading statements between October 11, 2022 and September 12, 2023 that, according to the complaint, falsely assured the market regarding Messrs. Valentine, Bostjancic and Keran’s respective commitments to, among other things, ethical and legal standards and corporate responsibility.
On September 6, 2024, a securities class action complaint captioned O’Hara v. Orthofix Medical Inc., et al., Case No. 24-cv-01593, was filed in the United States District Court for the Southern District of California (the "O’Hara Complaint"). The plaintiff, a purported former shareholder of SeaSpine at the time of the Merger, alleges through the complaint violations of Sections 11, 12 and 15 of the Securities Act of 1933, and names most of the same defendants as the Bernal Complaint, as well as certain additional current and/or former Company directors and officers. The complaint makes similar assertions to the Bernal complaint, and alleges that the Company’s registration statement on Form S-4 filed in 2022 in connection with the Merger, as well as related written and oral offering materials, contained untrue statements of material fact and material omissions, including, among other things, with respect to the effectiveness of the Company’s internal controls. On November 26, 2024, the O’Hara Complaint was transferred to the Eastern District of Texas, and on December 11, 2024, the O’Hara Complaint was consolidated with the Bernal Complaint.
On October 28, 2024, a derivative shareholder complaint was filed against certain of the Company's current and former officers and directors alleging derivative liability for the allegations made in the two complaints noted above. On December 18, 2024, a second derivative shareholder complaint was filed with the same allegations made in the first derivative shareholder complaint. A motion to consolidate the two derivative shareholder complaints is pending.
The Company disagrees with the legal claims asserted in these complaints and intends to defend them vigorously. Due in part to the preliminary nature of these three matters, the Company currently cannot reasonably estimate a possible loss, or range of loss, that may arise from the respective complaints.
Commitments
As a result of the Merger, the Company became party to agreements with certain distributor partners that provide the Company with an option to purchase, and an option for those partners to require the Company to purchase, the distribution business of those partners at specified future dates. At such time, the Company or distributor may (in certain cases, subject to satisfying certain conditions) submit written notice to the other of its intention to exercise its rights and initiate or require the purchase. Upon receipt of the written notice, the Company and the distributor will work in good faith to consummate the purchase. Under certain of these agreements, the purchase price would be paid in shares of the Company's common stock, whereas for others, the purchase price can be paid in cash or shares, at the Company's option. Based on the closing price of the Company's common stock as of December 31, 2024, assuming the options under all the relevant agreements were exercised, the estimated total number of shares the Company would issue under these agreements was approximately 0.2 million shares for agreements that must be settled in shares of the Company's stock. The Company has received notification from one such distributor, who has notified the Company of its decision to exercise its buyout option. The Company is currently in negotiations with this distributor in regard to the consummation of the potential acquisition.
Italian Medical Device Payback ("IMDP")
In 2015, the Italian Parliament introduced rules for entities that supply goods and services to the Italian National Healthcare System. A key provision of the law is a ‘payback’ measure, requiring medical device companies in Italy to make payments to the Italian government if medical device expenditures exceed regional maximum ceilings. Companies are required to make payments equal to a percentage of expenditures exceeding maximum regional caps.
In the third quarter of 2022, the Italian Ministry of Health provided guidelines to the Italian regions and provinces on seeking payback of expenditure overruns relating to the 2015 through 2018 calendar years. Since receiving the guidelines, several regions and provinces have requested payment from affected medical device companies, including the Company. The Company has taken legal action to dispute the legality of such measures. In July 2024, the Italian Constitutional Court issued two judgments following public hearings on the matter held in May 2024. These judgments (i) declared the payback system itself as constitutionally legitimate and (ii) extended previously communicated reductions in the payback liability for certain fiscal years to all medical device companies, regardless of whether or not they had waived their legal claims on the matter.
The Company accounts for the estimated cost of the IMDP as sales, general, and administrative expense and periodically reassesses the liability based upon current facts and circumstances. As a result, the Company recorded expenses of $1.4 million, $1.3 million, and $1.2 million for the years ended December 31, 2024, 2023, and 2022, respectively, as a result of certain temporary relief provided by the Italian National Healthcare System in response to the COVID-19 pandemic. As of December 31, 2024, the Company has accrued $8.2 million related to the IMDP, which it has classified within other long-term liabilities; however, the actual liability could be higher or lower than the amount accrued once all legal proceedings are resolved and upon further clarification of the IMDP by the Italian authorities for more recent fiscal years.
- Shareholders’ equity
Dividends
The Company has not historically paid dividends to holders of its common stock. Certain subsidiaries of the Company have restrictions on their ability to pay dividends in certain circumstances pursuant to the Credit Agreement. In the event that the Company decides to pay a dividend to holders of its common stock in the future with dividends received from its subsidiaries, the Company may, based on prevailing rates of taxation, be required to pay additional withholding and income tax on such amounts received from its subsidiaries.
Accumulated Other Comprehensive Income (Loss)
Accumulated other comprehensive income (loss) is comprised of foreign currency translation adjustments and unrealized gains (losses) on available for sale debt securities. The Company’s policy is to release income tax effects related to items recognized within accumulated other comprehensive income (loss) using a portfolio approach. The components of and changes in accumulated other comprehensive income (loss) are as follows:
| (U.S. Dollars, in thousands) | CurrencyTranslationAdjustments | Neo Medical Convertible Loans | Other Investments | Accumulated OtherComprehensiveIncome (Loss) |
|---|---|---|---|---|
| Balance at December 31, 2021 | $(711) | $711 | $— | $— |
| Other comprehensive income (loss) | (1,771) | 294 | 101 | (1,376) |
| Income taxes | — | — | — | — |
| Balance at December 31, 2022 | $(2,482) | $1,005 | $101 | $(1,376) |
| Other comprehensive income (loss) | 1,417 | (1,233) | (101) | 83 |
| Income taxes | — | — | — | — |
| Balance at December 31, 2023 | $(1,065) | $(228) | $— | $(1,293) |
| Other comprehensive income (loss) | (3,009) | 1,671 | — | (1,338) |
| Income taxes | — | — | — | — |
| Reclassification adjustment to: | ||||
| Other expense, net | — | (1,671) | — | (1,671) |
| Balance at December 31, 2024 | $(4,074) | $(228) | $— | $(4,302) |
- Revenue recognition and accounts receivable
Revenue Recognition
The Company accounts for a contract when there is (i) approval and commitment from both parties, (ii) the rights of the parties are identified, (iii) payment terms are identified, (iv) the contract has commercial substance, (v) and collectability of consideration is probable. The Company’s contracts may contain one or more performance obligations. If a contract contains more than one performance obligation, the Company allocates the total transaction price to each of the performance obligations based upon the observable standalone selling price of the promised goods or services underlying each performance obligation. The Company recognizes revenue when control of the promised goods or services is transferred to the customer, which typically occurs at a point in time upon shipment, delivery, or utilization, in an amount that reflects the consideration which the Company expects to be entitled to in exchange for the promised goods or services. The consideration for goods or services reflects any fixed amount stated per the contract and estimates for any variable consideration, such as discounts, to the extent that is it probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is resolved.
The following sections discuss the Company’s revenue recognition policies by significant product category:
Bone Growth Therapies
Bone Growth Therapies revenue is largely attributable to the U.S. and is comprised of third-party payor transactions and wholesale revenue.
The largest portion of Bone Growth Therapies revenue is derived from third-party payors. This includes commercial insurance carriers, health maintenance organizations, preferred provider organizations, and governmental payors, such as Medicare. Revenue is recognized when the product is fitted to and accepted by the patient and all applicable documents required by the third-party payor have been obtained. Amounts paid by third-party payors are generally based on fixed or allowable reimbursement rates. These revenues are recorded at the expected or preauthorized reimbursement rates, net of any contractual allowances or adjustments. Certain billings are subject to review by the third-party payors and may be subject to adjustment.
Wholesale revenue is related to the sale of the Company’s bone growth stimulators directly to durable medical equipment suppliers. Wholesale revenues are typically recognized upon shipment and receipt of a confirming purchase order, which is when the customer obtains control of the promised goods.
Biologics revenue is largely attributable to the U.S. and is mostly processed from within the Company’s Irvine facility. In addition, the Company has a long-standing collaborative arrangement with MTF that provides exclusive global marketing rights to MTF’s Trinity and FiberFuse product families. Per the terms of the agreement, MTF sources the tissue, processes it to create the allografts, packages, and delivers the tissue to the customer. The Company receives marketing fees from MTF based on sales of products covered under the collaborative arrangement. MTF is considered the principal in these arrangements; therefore, the Company recognizes marketing service fees on a net basis within net sales upon shipment of the product to the customer and receipt of a confirming purchase order.
Spinal Implants and Global Orthopedics
Spinal Implants and Global Orthopedics products are distributed world-wide, with U.S. sales largely comprised of commercial sales and international sales derived from both commercial sales and stocking distributor arrangements.
Commercial revenue is largely related to the sale of the Company’s Spinal Implants and Global Orthopedics products to hospital customers. The customer obtains control and revenues are recognized when these products have been utilized and a confirming purchase order has been received from the hospital.
Other revenues within the Spinal Implants and Global Orthopedics product categories are derived from stocking distributors, who purchase the Company’s products and then re-sell them directly to customers, such as hospitals. For stocking distributor arrangements, it is the Company’s policy to recognize revenue upon shipment and receipt of a confirming purchase order, which is when the distributor obtains control of the promised goods. The transaction price for revenue recognition is estimated based upon the Company’s historical collection experience with the stocking distributor.
Product Sales and Marketing Service Fees
The table below presents net sales, which includes product sales and marketing service fees, for each of the years ended December 31, 2024, 2023, and 2022.
| For the year ended December 31, | |||
|---|---|---|---|
| (U.S. Dollars, in thousands) | 2024 | 2023 | 2022 |
| Product sales | $747,783 | $693,345 | $405,437 |
| Marketing service fees | 51,708 | 53,296 | 55,276 |
| Net sales | $799,491 | $746,641 | $460,713 |
Marketing service fees are received from MTF based on total sales of biologics tissues and relate solely to the Biologics product category within the Global Spine reporting segment, whereas product sales primarily consist of the sale of Bone Growth Therapies, Spinal Implants, non-MTF sourced Biologics, Enabling Technologies, and Global Orthopedics products. Marketing service fees received from MTF were $51.7 million, or approximately 31% of total Biologics revenues, for the year ended December 31, 2024. As MTF is the single supplier for certain allografts in the Company’s Biologics portfolio, derived from deceased donors for their bone grafts and living donors for their amnion grafts, any event or circumstance that would impact MTF’s continued access to donors or the Company’s ability to market these tissues may adversely impact the Company’s financial results.
Revenues exclude any value added or other local taxes, intercompany sales, and trade discounts. Shipping and handling costs for products shipped to customers are included in cost of sales, and were $9.9 million, $9.5 million, and $4.2 million for the years ended December 31, 2024, 2023, and 2022, respectively.
Accounts receivable and related allowances
Payment terms vary by the type and location of the Company’s customers and the products or services offered. The term between invoicing and when payment is due is generally not significant.
The Company’s allowance for expected credit losses represents the portion of the receivable’s amortized cost basis that an entity does not expect to collect over the receivable’s contractual life, considering past events, current conditions, and reasonable and supportable forecasts of future economic conditions.
The process for estimating the ultimate collection of accounts receivable involves certain assumptions and judgments. The determination of the contractual life of accounts receivable, the aging of outstanding receivables, as well as the historical collections, write-offs, and payor reimbursement experience over the estimated contractual lives of such receivables, are integral parts of the estimation process related to reserves for expected credit losses and the establishment of contractual allowances. Accounts receivable are analyzed on a quarterly basis to assess the adequacy of both reserves for expected credit losses and contractual allowances. Revisions in allowances for expected credit loss estimates are recorded as an adjustment to bad debt expense within sales, general, and administrative expenses. Revisions to contractual allowances are recorded as an adjustment to net sales. These estimates are periodically tested against actual collection or adjustment experience. In addition, the Company analyzes its receivables by geography and by customer type, where appropriate, in developing estimates for expected credit losses.
The following table provides the detail of changes in the Company’s allowance for expected credit losses for the years ended December 31, 2024, and 2023:
| For the year ended December 31, | ||
|---|---|---|
| (U.S. Dollars, in thousands) | 2024 | 2023 |
| Allowance for expected credit losses beginning balance | $7,130 | $6,419 |
| Addition resulting from the Merger with SeaSpine | — | 137 |
| Current period provision for expected credit losses | 1,999 | 820 |
| Write-offs charged against the allowance and other | (1,451) | (381) |
| Effect of changes in foreign exchange rates | (260) | 135 |
| Allowance for expected credit losses ending balance | $7,418 | $7,130 |
The Company will generally sell receivables from certain Italian public hospitals each year to accelerate cash collections. During 2024, 2023, and 2022, the Company sold €7.9 million, €9.2 million, and €9.2 million ($8.5 million, $10.0 million, and $9.6 million) of receivables, respectively. The related fees for 2024, 2023, and 2022, were $0.3 million, $0.4 million, and $0.3 million, respectively, which were recorded as interest expense. Accounts receivables sold without recourse are removed from the balance sheet at the time of sale.
- Business segment information
The Company's operations are managed throughtwo reporting segments: Global Spine and Global Orthopedics. These reporting segments represent the operating segments for which the President and Chief Executive Officer, who is also the CODM, reviews financial information and makes resource allocation decisions among businesses. The primary metric used by the CODM in managing the Company is adjusted earnings before interest, tax, depreciation, and amortization ("adjusted EBITDA", a non-GAAP financial measure). Adjusted EBITDA represents earnings before interest income (expense), income taxes, depreciation, and amortization, and excludes the impact of share-based compensation, gains and losses related to changes in foreign exchange rates, charges related to the SeaSpine merger and other strategic investments, acquisition-related fair value adjustments, gains and/or losses on investments, litigation and investigation charges, charges related to initial compliance with regulations set forth by the European Union Medical Device Regulation, and succession charges.
Corporate activities are comprised of operating expenses not directly identifiable within the two reporting segments, such as human resources, finance, legal, and information technology functions. The Company neither discretely allocates assets, other than goodwill, to its operating segments nor evaluates the operating segments using discrete asset information.
The Global Spine reporting segment offers two primary product categories: (i) Bone Growth Therapies and (ii) Spinal Implants, Biologics, and Enabling Technologies.
The Bone Growth Therapies product category manufactures, distributes, sells, and provides support services for market-leading devices used adjunctively in high-risk spinal fusion procedures and to treat both nonunion and acute fractures in the orthopedic space. These Class III medical devices are indicated as an adjunctive, noninvasive treatment to improve fusion success rates in the cervical and lumbar spine as well as a therapeutic treatment for non-spine acute and nonunion fractures. This product category uses distributors and a direct sales channel to sell its devices to hospitals, healthcare providers, and patients, in the U.S.
Spinal Implants, Biologics, and Enabling Technologies comprises (i) a broad portfolio of spine fixation and motion preservation implant products used in surgical procedures of the spine, (ii) one of the most comprehensive biologics portfolios in both the demineralized bone matrix and cellular allograft market segments, and (iii) image-guided surgical solutions to facilitate degenerative, minimally invasive, and complex surgical procedures. Spinal Implants, Biologics, and Enabling Technologies products are sold through a network of distributors and sales representatives to hospitals and healthcare providers on a global basis for Spinal Implants and Enabling Technologies, and primarily within the U.S. for Biologics.
The Global Orthopedics reporting segment offers products and solutions for limb deformity correction and complex limb reconstruction with a focus on use in trauma, adult and pediatric limb reconstruction, and foot and ankle procedures. This reporting segment specializes in the design, development, and marketing of external and internal fixation orthopedic products that are coupled with enabling digital technologies to serve the complete patient treatment pathway. We sell these products through a global network of distributors and sales representatives to hospitals, healthcare organizations, and healthcare providers.
The table below presents net sales by major product category by reporting segment:
| Year Ended December 31, | ||||||
|---|---|---|---|---|---|---|
| 2024 | 2023 | 2022 | ||||
| (U.S. Dollars, in thousands) | Net Sales | Percent ofTotal NetSales | Net Sales | Percent ofTotal NetSales | Net Sales | Percent ofTotal NetSales |
| Bone Growth Therapies | $233,405 | 29.2% | $212,530 | 28.5% | $187,247 | 40.7% |
| Spinal Implants, Biologics, and Enabling Technologies | 441,909 | 55.3% | 418,789 | 56.1% | 165,927 | 36.0% |
| Global Spine | 675,314 | 84.5% | 631,319 | 84.6% | 353,174 | 76.7% |
| Global Orthopedics | 124,177 | 15.5% | 115,322 | 15.4% | 107,539 | 23.3% |
| Net sales | $799,491 | 100.0% | $746,641 | 100.0% | $460,713 | 100.0% |
The following table presents adjusted EBITDA, the primary metric used in managing the Company, by reporting segment:
| (U.S. Dollars, in thousands) · Global Spine · Global Orthopedics · Total | ||||
|---|---|---|---|---|
| Segment revenues | $675,314 | $124,177 | $799,491 | |
| Less: | ||||
| Non-GAAP Cost of sales | 183,064 | 48,638 | 231,702 | |
| Non-GAAP Sales, general, and administrative | 368,817 | 70,185 | 439,002 | |
| Non-GAAP Research and development | 58,262 | 13,154 | 71,416 | |
| Other segment benefits | (22) | (54) | (76) | |
| Add: | ||||
| Non-GAAP Depreciation, amortization, and share-based compensation expense | 42,193 | 12,367 | 54,560 | |
| Segment Adjusted EBITDA | $107,386 | $4,621 | $112,007 | |
| Reconciling items: | ||||
| Corporate operating expenses | $44,591 | |||
| Interest expense, net | 29,631 | |||
| Depreciation and amortization | 60,061 | |||
| Share-based compensation expense | 32,455 | |||
| Foreign exchange impact | 4,395 | |||
| SeaSpine merger-related costs | 14,485 | |||
| Strategic investments | 910 | |||
| Acquisition-related fair value adjustments | 19,088 | |||
| Interest and loss on investments | 5,120 | |||
| Litigation and investigation costs | 15,770 | |||
| Succession charges | 9,376 | |||
| Medical device regulation | — | |||
| Business interruption - COVID-19 | — | |||
| Loss before income taxes | $(123,875) | |||
| (U.S. Dollars, in thousands) · Global Spine · Global Orthopedics · Total | ||||
|---|---|---|---|---|
| Segment Revenues | $631,319 | $115,322 | $746,641 | |
| Less: | ||||
| Non-GAAP Cost of sales | 166,885 | 47,928 | 214,813 | |
| Non-GAAP Sales, general, and administrative | 355,827 | 67,815 | 423,642 | |
| Non-GAAP Research and development | 56,512 | 10,726 | 67,238 | |
| Other segment expenses (benefits) | 45 | (82) | (37) | |
| Add: | ||||
| Non-GAAP Depreciation, amortization, and share-based compensation expense | 39,065 | 11,507 | 50,572 | |
| Segment Adjusted EBITDA | $91,115 | $442 | $91,557 | |
| Reconciling items: | ||||
| Corporate operating expenses | $45,272 | |||
| Interest expense, net | 8,631 | |||
| Depreciation and amortization | 53,063 | |||
| Share-based compensation expense | 35,707 | |||
| Foreign exchange impact | (1,581) | |||
| SeaSpine merger-related costs | 36,577 | |||
| Strategic investments | 2,272 | |||
| Acquisition-related fair value adjustments | 33,393 | |||
| Interest and loss on investments | 1,781 | |||
| Litigation and investigation costs | 14,453 | |||
| Succession charges | 1,176 | |||
| Medical device regulation | 9,492 | |||
| Business interruption - COVID-19 | — | |||
| Loss before income taxes | $(148,679) | |||
| (U.S. Dollars, in thousands) · Global Spine · Global Orthopedics · Total | ||||
|---|---|---|---|---|
| Segment Revenues | $353,174 | $107,539 | $460,713 | |
| Less: | ||||
| Non-GAAP Cost of sales | 74,573 | 44,784 | 119,357 | |
| Non-GAAP Sales, general, and administrative | 204,840 | 56,760 | 261,600 | |
| Non-GAAP Research and development | 29,220 | 8,364 | 37,584 | |
| Other segment benefits | (183) | (49) | (232) | |
| Add: | ||||
| Non-GAAP Depreciation, amortization, and share-based compensation expense | 17,969 | 7,587 | 25,556 | |
| Segment Adjusted EBITDA | $62,693 | $5,267 | $67,960 | |
| Reconciling items: | ||||
| Corporate operating expenses | $19,406 | |||
| Interest expense, net | 1,288 | |||
| Depreciation and amortization | 29,019 | |||
| Share-based compensation expense | 18,443 | |||
| Foreign exchange impact | 3,291 | |||
| SeaSpine merger-related costs | 11,902 | |||
| Strategic investments | 4,018 | |||
| Acquisition-related fair value adjustments | (15,595) | |||
| Interest and loss on investments | 187 | |||
| Litigation and investigation costs | 803 | |||
| Succession charges | 147 | |||
| Medical device regulation | 10,370 | |||
| Business interruption - COVID-19 | 2,387 | |||
| Loss before income taxes | $(17,706) | |||
The following table presents depreciation and amortization by reporting segment:
| Year Ended December 31, | |||
|---|---|---|---|
| (U.S. Dollars, in thousands) | 2024 | 2023 | 2022 |
| Global Spine | $49,507 | $41,213 | $18,213 |
| Global Orthopedics | 7,748 | 7,158 | 6,696 |
| Corporate | 2,806 | 4,692 | 4,110 |
| Total | $60,061 | $53,063 | $29,019 |
Geographical information
The table below presents net sales by geographic destination for each reporting segment and for the consolidated Company:
| Year Ended December 31, | |||
|---|---|---|---|
| (U.S. Dollars, in thousands) | 2024 | 2023 | 2022 |
| Global Spine | |||
| U.S. | $639,196 | $591,937 | $332,846 |
| International | 36,118 | 39,382 | 20,328 |
| Total Global Spine | 675,314 | 631,319 | 353,174 |
| Global Orthopedics | |||
| U.S. | $33,620 | $28,892 | $25,997 |
| International | 90,557 | 86,430 | 81,542 |
| Total Global Orthopedics | 124,177 | 115,322 | 107,539 |
| Consolidated | |||
| U.S. | $672,816 | $620,829 | $358,843 |
| International | 126,675 | 125,812 | 101,870 |
| Net sales | $799,491 | $746,641 | $460,713 |
The following data includes net sales by geographic destination:
| Year Ended December 31, | |||
|---|---|---|---|
| (U.S. Dollars, in thousands) | 2024 | 2023 | 2022 |
| U.S. | $672,816 | $620,829 | $358,843 |
| Italy | 21,001 | 20,060 | 19,098 |
| Germany | 9,004 | 11,467 | 11,569 |
| United Kingdom | 11,183 | 10,910 | 10,171 |
| France | 13,385 | 11,096 | 10,377 |
| Brazil | 5,707 | 6,452 | 5,668 |
| Others | 66,395 | 65,827 | 44,987 |
| Net sales | $799,491 | $746,641 | $460,713 |
The following data includes property, plant, and equipment by geographic area:
| (U.S. Dollars, in thousands) | 2024 | 2023 |
|---|---|---|
| U.S. | $125,541 | $142,727 |
| Italy | 9,472 | 10,187 |
| Germany | 1,904 | 3,030 |
| Others | 2,887 | 3,116 |
| Total | $139,804 | $159,060 |
- Acquisition-related amortization and remeasurement
Acquisition-related amortization and remeasurement consists of (i) the remeasurement of any related contingent consideration arrangement, (ii) amortization related to intangible assets acquired through business combinations or asset acquisitions, and (iii) recognized costs associated with acquired IPR&D assets, which are recognized immediately upon acquisition. Componentsof acquisition-related amortization and remeasurement for the years ended December 31, 2024, 2023, and 2022, respectively, are as follows:
| Year Ended December 31, | |||
|---|---|---|---|
| (U.S. Dollars, in thousands) | 2024 | 2023 | 2022 |
| Changes in fair value of contingent consideration | $6,900 | $(2,700) | $(17,200) |
| Amortization of acquired intangibles | 17,436 | 17,408 | 8,196 |
| Acquired IPR&D | — | 49 | 1,600 |
| Total | $24,336 | $14,757 | $(7,404) |
Lattus Contingent Consideration
In connection with the Merger, the Company assumed a contingent consideration obligation under a purchase agreement between SeaSpine and Lattus executed in December 2022. Under the terms of the agreement, the Company may be required to make installment payments at certain dates based on future net sales of Lateral Products. For additional information regarding this contingent consideration liability, see Note 12.
Spinal Kinetics Contingent Consideration
The Company recognized a contingent consideration obligation in connection with the acquisition of Spinal Kinetics in 2018. The fair value of the last contingent milestone payment, attributable to a revenue-based milestone, was concluded to be zero as the Company did not achieve the milestone prior to April 30, 2023, the end of the measurement period for achieving such milestone, which resulted in a decrease in fair value recognized within acquisition-related amortization and remeasurement of $17.2 million for the year ended December 31, 2022.
Legion Innovations, LLC Asset Acquisition
On December 29, 2022, the Company entered into a technology assignment and royalty agreement with Legion Innovations, LLC, a U.S.-based medical device technology company, whereby the Company acquired intellectual property rights to certain assets. As consideration, the Company agreed to pay $0.2 million in January 2023, with additional payments contingent upon reaching future commercialization and revenue-based milestones. The Company accounted for this transaction as an asset acquisition. As the transaction was classified as an asset acquisition, the value of the consideration associated with the contingent milestones will be recognized at the time that applicable contingencies are resolved and consideration is paid or becomes payable. The $0.2 million initial payment was accrued as of December 31, 2022, and was recognized as acquired IPR&D costs, which was then immediately expensed.
IGEA S.p.A Asset Acquisition
In April 2021, the Company entered into an Exclusive License and Distribution Agreement (the "License Agreement") with IGEA S.p.A ("IGEA"), an Italian manufacturer and distributor of bone and cartilage stimulation systems. As consideration for the License Agreement, the Company agreed to pay up to $4.0 million, with certain payments contingent upon reaching an FDA milestone. Of this amount, $0.5 million was paid in 2021, which was recognized as acquired IPR&D costs within acquisition-related amortization and remeasurement. The Company accounted for this transaction as an asset acquisition. As the transaction was classified as an asset acquisition, the value of the consideration associated with the contingent milestones are recognized at the time that applicable contingencies are resolved and consideration is paid or becomes payable. The License Agreement also includes certain minimum purchase requirements.
In May 2022, the Company achieved FDA approval pertaining to the acquired technology, triggering a contingent consideration milestone obligation of $3.5 million. Of this amount, $1.5 million was paid in 2022, $1.0 million was paid in 2023, and $1.0 million was paid in 2024.
- Share-based compensation
At December 31, 2024, and 2023, the Company had stock option and award plans, and a stock purchase plan.
Merger with SeaSpine
Pursuantto the Merger Agreement, the equity awards of SeaSpine (including stock options and restricted stock units) outstanding as of immediately prior to the closing of the Merger were converted into equity awards denominated in shares of Orthofix common stock. The Company issued options to purchase 1.9 million shares of Orthofix common stock and 0.5 million shares of time-based vesting restricted stock in connection with the conversion of such awards. The estimated fair value of the portion of the SeaSpine equity awards for which the required service period had been completed at the time of the closing of the Merger was treated as purchase consideration. The remaining estimated fair value is recorded as compensation expense over the remainder of the service period associated with the awards.
In addition, as part of the Merger, the Board determined to treat the transaction as a "Change in Control" under applicable agreements and equity plans. Thus, in January 2023, all outstanding and previously granted performance-based and market-based restricted stock units became time-based restricted stock units with the performance goals deemed achieved at the target level of 100%.
2012 Long Term Incentive Plan
The Board adopted the Amended and Restated 2012 Long-Term Incentive Plan (the "2012 LTIP") on April 23, 2018, which was subsequently approved by shareholder ratification. The 2012 LTIP provides for the grant of options to purchase shares of the Company’s common stock, stock awards (including restricted stock, unrestricted stock, and stock units), stock appreciation rights, performance-based awards, and other equity-based awards. All of the Company’s employees and the employees of the Company’s subsidiaries and affiliates are eligible and may receive awards under the 2012 LTIP. In addition, the Company’s non-employee directors, consultants, and advisors who perform services for the Company and its subsidiaries and affiliates may receive awards under the 2012 LTIP. Awards granted under the 2012 LTIP expire no later thanten years after the date of grant. At December 31, 2024, the Company reserves a total of 16.3 million shares of common stock for issuance pursuant to the 2012 LTIP, subject to certain adjustments set forth in the 2012 LTIP. At December 31, 2024, there were 1.7 million options outstanding under the 2012 LTIP, of which 1.2 million were exercisable. In addition, there were 1.4 million restricted stock units outstanding, some of which contain performance-based vesting conditions, under the 2012 LTIP as of December 31, 2024.
SeaSpine 2015 Plan
Pursuant to the Merger Agreement, the Company assumed awards outstanding under the SeaSpine Holdings Corporation Amended and Restated 2015 Incentive Award Plan Award Plan (the "SeaSpine 2015 Plan"). The SeaSpine 2015 Plan provides for the grant of options to purchase shares of the Company’s common stock, stock awards (including restricted stock, unrestricted stock, and stock units), stock appreciation rights, performance-based awards and other equity-based awards. All of the Company’s employees and the employees of the Company’s subsidiaries and affiliates are eligible and may receive awards under the SeaSpine 2015 Plan. In addition, the Company’s non-employee directors, consultants, and advisors who perform services for the Company and its subsidiaries and affiliates may receive awards under the SeaSpine 2015 Plan. At December 31, 2024, the Company reserves a total of 3.0 million shares of common stock for issuance pursuant to the SeaSpine 2015 Plan, subject to certain adjustments set forth in the SeaSpine 2015 Plan. At December 31, 2024, there were 0.7 million options outstanding under the SeaSpine 2015 Plan, of which 0.5 million were exercisable. In addition, there were 0.4 million restricted stock units outstanding, some of which contain performance-based vesting conditions, under the SeaSpine 2015 Plan as of December 31, 2024.
Inducement Plans
As an inducement to accept employment, the Company has periodically granted inducement awards to new employees and has also assumed inducement awards that were granted by SeaSpine prior to the Merger. During 2024, new employees were granted options to acquire up to 0.9 million shares of common stock and awarded 1.1 million restricted stock units, some of which contain performance-based vesting conditions. Under all inducement plans, as of December 31, 2024, there were 1.6 million options outstanding, of which 0.5 million were exercisable, and 1.2 million unvested restricted stock units outstanding, some of which contain performance-based vesting conditions.
Stock Purchase Plan
The Second Amended and Restated Stock Purchase Plan, as Amended (the "Stock Purchase Plan") provides for the issuance of shares of the Company’s common stock to eligible employees and directors of the Company and its subsidiaries that elect to participate in the plan and acquire shares of common stock through payroll deductions (including executive officers).
During each purchase period, eligible employees may designate between 1% and 25%of their compensation to be deducted for the purchase of common stock under the plan (or such other percentage in order to comply with regulations applicable to employees domiciled in or resident of a member state of the European Union). For eligible directors, the designated percentage will be applied to an amount equal to his or her director compensation paid in cash for the current plan period. The purchase price of the shares underthe plan is equal to 85% of the fair market value on the first day of the plan period or, if lower, on the last day of the plan period.
Due to the compensatory nature of such plan, the Company records the related share-based compensation expense in the consolidated statement of operations. Compensation expense is estimated using the Black-Scholes valuation model, with such value recognized as expense over the plan period. As of December 31, 2024, the aggregate number of shares reserved for issuance under the Stock Purchase Plan is 4.9 million. As of December 31, 2024, a total of 3.4 million shares had been issued pursuant to the Stock Purchase Plan.
Share-Based Compensation Expense
Share-based compensation expense is recorded in the same line of the consolidated statements of operations as the employee’s cash compensation. The following tables present the detail of share-based compensation expense by line item in the consolidated statements of income as well as by award type, for the years ended December 31, 2024, 2023, and 2022:
| Year Ended December 31, | |||
|---|---|---|---|
| (U.S. Dollars, in thousands) | 2024 | 2023 | 2022 |
| Cost of sales | $2,053 | $1,901 | $826 |
| Sales, general, and administrative | 27,123 | 29,917 | 16,782 |
| Research and development | 3,279 | 3,889 | 835 |
| Total | $32,455 | $35,707 | $18,443 |
| Year Ended December 31, | |||
|---|---|---|---|
| (U.S. Dollars, in thousands) | 2024 | 2023 | 2022 |
| Stock options | $4,331 | $6,130 | $1,114 |
| Market-based stock options | 2,118 | — | — |
| Time-based restricted stock awards and stock units | 18,818 | 27,290 | 9,452 |
| Performance-based / Market-based restricted stock units | 4,941 | 227 | 6,425 |
| Stock purchase plan | 2,247 | 2,060 | 1,452 |
| Total | $32,455 | $35,707 | $18,443 |
The income tax benefit related to this expense was $5.8 million, $5.8 million, and $3.3 million for the years ended December 31, 2024, 2023, and 2022, respectively.
Stock Options
The fair value of time-based stock options is determined using the Black-Scholes valuation model, with such value recognized as expense over the service period, which is typically three to four years, net of actual forfeitures. A summary of the Company’s assumptions used in determining the fair value of the stock options granted during each of the years ended December 31, 2024, 2023, and 2022, is shown in the following table. The Company did not grant any time-based stock options in 2022.
| Year Ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| Assumptions: | |||
| Expected term (in years) | 4.5 | 6 | — |
| Expected volatility | 45.7% – 47.6% | 36.8% – 42.3% | — |
| Risk free interest rate | 3.47% – 4.65% | 3.38% – 4.61% | — |
| Dividend yield | — | — | — |
| Weighted average grant date fair value | $5.90 | $8.43 | $— |
The expected term of the options granted is estimated based on a number of factors, including the vesting and expiration terms of the award, historical employee exercise behavior for both options that are currently outstanding and options that have been exercised or are expired, and an employee’s average length of service. Expected volatility is based on the historical volatility of the Company’s common stock. The risk-free interest rate is determined based upon a constant U.S. Treasury security rate with a contractual life that approximates the expected term of the option.
Certain of the Company's outstanding stock options contain market-based vesting conditions. The fair value of market-based stock options is determined at the date of the grant using the Monte Carlo valuation methodology. The Monte Carlo methodology incorporates into the valuation the possibility that the market condition may not be satisfied. Such value is recognized over thethree-year service period, net of actual forfeitures.
Asummary of the status of the Company’s time-based stock option plans as of December 31, 2024, and 2023, and changes during the year ended December 31, 2024, is presented below:
| (In thousands) | Options | WeightedAverageExercisePrice | WeightedAverageRemainingContractualTerm (Years) |
|---|---|---|---|
| Outstanding at December 31, 2023 | 3,223 | $30.64 | |
| Granted | 773 | $13.54 | |
| Exercised | (12) | $14.69 | |
| Forfeited or expired | (787) | $32.31 | |
| Outstanding at December 31, 2024 | 3,197 | $26.15 | 4.52 |
| Vested and expected to vest at December 31, 2024 | 3,197 | $26.15 | 4.52 |
| Exercisable at December 31, 2024 | 2,119 | $30.84 | 3.32 |
A summary of the status of the Company’s market-based stock option plans as of December 31, 2024, and 2023, and changes during the year ended December 31, 2024, is presented below:
| (In thousands) | Options | WeightedAverageExercisePrice | WeightedAverageRemainingContractualTerm (Years) |
|---|---|---|---|
| Outstanding at December 31, 2023 | — | — | |
| Granted | 754 | $13.39 | |
| Exercised | — | — | |
| Forfeited or expired | — | — | |
| Outstanding at December 31, 2024 | 754 | $13.39 | 6.19 |
| Vested and expected to vest at December 31, 2024 | 754 | $13.39 | 6.19 |
| Exercisable at December 31, 2024 | — | — | — |
As of December 31, 2024, the unamortized compensation expense relating to options granted and expected to be recognized was $5.3 million. This amount is expected to be recognized through December 2027 over a weighted average period of approximately 1.1 years. The total intrinsic value of options exercised was less than $0.1 million, $0.0 million, and $0.0 million for the years ended December 31, 2024, 2023, and 2022, respectively. For the year ended December 31, 2024, the Company received $0.2 million cash from stock option exercises, and realized $0.1 million in tax benefit for the tax deductions from stock option exercises. The aggregate intrinsic value of options outstanding and options exercisable as of December 31, 2024, is calculated as the difference between the exercise price of the underlying options and the market price of the Company’s common stock for options that had exercise prices lower than $17.46, the closing price of the Company’s stock on December 31, 2024. The aggregate intrinsic value of options outstanding was $6.9 million as of December 31, 2024. The aggregate intrinsic value of options exercisable was $0.7 million as of that date.
Time-based Restricted Stock Awards and Stock Units
Compensation expense for time-based restricted stock awards and stock units, which represents the fair value of the stock measured at the market price at the date of grant, is recognized on a straight-line basis over the vesting period, which is typically three tofour years, net of actual forfeitures.
The aggregate fair value of time-based restricted stock awards and stock units that vested during the years ended December 31, 2024, 2023, and 2022, was $13.3 million, $17.2 million, and $5.2 million, respectively. Unamortized compensation expense related to time-based restricted stock awards and stock units amounted to $15.7 million at December 31, 2024. This amount is expected to berecognized through December 2027 over a weighted average period of approximately 1.6 years. The aggregate intrinsic value of time-based restricted stock awards and stock units outstanding was $35.2 million as of December 31, 2024.
Performance-based and Market-based Restricted Stock Units
Certain of the Company's outstanding restricted stock units contain performance-based vested conditions or market-based vesting conditions. As previously discussed, in January 2023 all then outstanding performance-based and market-based restricted stock units became time-based restricted stock units with the performance goals deemed achieved at the target level of 100% upon completion of the Merger based on the Board of Directors' determination to treat the transaction as a "Change in Control" under applicable agreements and equity plans.
The fair value of performance-based restricted stock units is calculated based upon the closing stock price at the date of grant. Such value is recognized as expense over the requisite service period beginning in the period in which they are deemed probable to vest, net of actual forfeitures. Vesting probability is assessed based upon forecasted financial metrics or applicable milestones associated with the applicable grant.
The fair value of market-based restricted stock units is determined at the date of the grant using the Monte Carlo valuation methodology, with any discounts for post-vesting restrictions estimated using the Chaffe Model. The Monte Carlo methodology incorporates into the valuation the possibility that the market condition may not be satisfied. Such value is recognized on a straight-line basis over the vesting period, net of actual forfeitures.
The fair value of performance-based and/or market-based restricted stock units that vested and settled during each of the years ended December 31, 2024, 2023, and 2022, totaled less than $0.1 million, respectively. Unamortized compensation expense for performance-based and/or market-based restricted stock units totaled $11.1 million at December 31, 2024, and is expected to be recognized over a weighted average period of approximately 2.0 years. The aggregate intrinsic value of performance-based restricted stock units outstanding was $16.8 million as of December 31, 2024.
A summary of the status of our time-based and performance-based and/or market-based restricted stock units as of December 31,2024, and 2023, and changes during the year ended December 31, 2024, is presented below:
| Time-based Restricted StockAwards and Stock Units | Performance-based and/or Market-basedRestricted Stock Units | |||
|---|---|---|---|---|
| (In thousands) | Shares | WeightedAverage GrantDate Fair Value | Shares | WeightedAverage GrantDate Fair Value |
| Outstanding at December 31, 2023 | 2,040 | $26.96 | 9 | $22.69 |
| Granted | 1,264 | $13.48 | 1,062 | $16.73 |
| Vested and settled | (1,089) | $28.41 | (6) | $16.78 |
| Cancelled | (200) | $16.77 | (105) | $16.60 |
| Outstanding at December 31, 2024 | 2,015 | $18.73 | 960 | $16.81 |
- Defined contribution plans and deferred compensation
Defined Contribution Plans
Orthofix sponsors a defined contribution plan (the "401(k) Plan") covering substantially all full-time U.S. employees. The 401(k) Plan allows participants to contribute up to 90% of their pre-tax compensation, subject to certain limitations, with the Company matching 100% of the first 4% of the employee's base compensation. During the years ended December 31,2024, 2023, and 2022, incurred expenses relating to the 401(k) Plan, including matching contributions, were approximately $5.9 million, $4.6 million, and $3.3 million, respectively.
The Company also operates defined contribution plans for its international employees meeting minimum service requirements. The Company’s expenses for such contributions during each of the years ended December 31, 2024, 2023, and 2022, were $1.2 million, $1.1 million, and $1.1 million, respectively.
Deferred Compensation Plans
Under Italian Law, our Italian subsidiary accrues deferred compensation on behalf of its employees, which is paid on termination of employment. The accrual for deferred compensation is based on a percentage of the employee’s current annual remuneration plus an annual charge. Deferred compensation is also accrued for the leaving indemnity payable to agents in case of dismissal, which is regulated by a national contract and is equal to approximately 4% of total commissions earned from the Company. The Company’s relations with its Italian employees, who represent 14% of total employees at December 31,2024, are governed by the provisions of a National Collective Labor Agreement setting forth mandatory minimum standards for labor relations in the metal mechanic workers industry. The Company is not a party to any other collective bargaining agreement. The liability is recorded within other long-term liabilities as of December 31, 2024, and 2023, and totaled $1.7 million and $1.7 million, respectively. This represents the amount that would be payable if all the employees and agents had terminated employment at that date.
- Income taxes
Income (loss) before provision for income taxes consisted of the following:
| Year Ended December 31, | |||
|---|---|---|---|
| (U.S. Dollars, in thousands) | 2024 | 2023 | 2022 |
| U.S. | $(113,197) | $(154,794) | $(22,318) |
| Non-U.S. | (10,678) | 6,115 | 4,612 |
| Loss before income taxes | $(123,875) | $(148,679) | $(17,706) |
The provision for income taxes consists of the following:
| Year Ended December 31, | |||
|---|---|---|---|
| (U.S. Dollars, in thousands) | 2024 | 2023 | 2022 |
| U.S. | |||
| Current | $(590) | $17 | $1,151 |
| Deferred | 1,572 | 1,160 | 67 |
| 982 | 1,177 | 1,218 | |
| Non-U.S. | |||
| Current | 829 | 2,120 | 578 |
| Deferred | 311 | (581) | 247 |
| 1,140 | 1,539 | 825 | |
| Income tax expense | $2,122 | $2,716 | $2,043 |
The differences between the income tax provision at the U.S. federal statutory tax rate and the Company’s effective tax rate for the years ended December 31,2024, 2023, and 2022, consist of the following:
| 2024 | 2023 | 2022 | ||||
|---|---|---|---|---|---|---|
| (U.S. Dollars, in thousands, except percentages) | Amount | Percent | Amount | Percent | Amount | Percent |
| Statutory U.S. federal income tax rate | $(26,013) | 21.0% | $(31,222) | 21.0% | $(3,718) | 21.0% |
| State taxes, net of U.S. federal benefit | (3,753) | 3.0 | (3,452) | 2.3 | (1,312) | 7.4 |
| Foreign rate differential, including withholding taxes | (1,304) | 1.1 | (738) | 0.5 | 475 | (2.7) |
| Valuation allowances, net | 30,491 | (24.6) | 28,322 | (19.0) | 7,638 | (43.1) |
| Foreign income inclusions, net | 320 | (0.3) | 2,333 | (1.6) | 1,018 | (5.7) |
| Research credits | (1,262) | 1.0 | (1,219) | 0.8 | (750) | 4.2 |
| Unrecognized tax benefits, net of settlements | (1,393) | 1.1 | 71 | — | (599) | 3.4 |
| Equity compensation | 2,781 | (2.2) | 4,210 | (2.8) | 1,441 | (8.1) |
| Executive compensation | 2,001 | (1.6) | 3,030 | (2.0) | 697 | (3.9) |
| Contingent consideration | — | — | — | — | (3,316) | 18.7 |
| Other, net | 254 | (0.2) | 1,381 | (0.9) | 469 | (2.6) |
| Income tax expense/effective rate | $2,122 | (1.7)% | $2,716 | (1.8)% | $2,043 | (11.5)% |
The Company paid (received or was refunded) cash relating to taxes totaling $1.3 million, $0.9 million, and ($0.9) million for the years ended December 31,2024, 2023, and 2022, respectively.
The Company’s deferred tax assets and liabilities are as follows:
| December 31, | ||
|---|---|---|
| (U.S. Dollars, in thousands) | 2024 | 2023 |
| Intangible assets and goodwill | $— | $— |
| Inventories and related reserves | 34,745 | 33,122 |
| Deferred revenue and cost of goods sold | 5,775 | 4,409 |
| Other accruals and reserves | 5,738 | 5,382 |
| Accrued compensation | 17,216 | 15,434 |
| Provision for expected credit losses | 1,797 | 1,821 |
| Accrued interest | 6,336 | 1,227 |
| Net operating loss and tax credit carryforwards | 132,524 | 123,210 |
| Research and development capitalization | 18,016 | 15,174 |
| Lease liabilities | 8,856 | 9,632 |
| Other, net | 8,456 | 4,856 |
| Total deferred tax assets | 239,459 | 214,267 |
| Valuation allowance | (228,724) | (200,192) |
| Deferred tax asset, net of valuation allowance | $10,735 | $14,075 |
| Intangible assets and goodwill | $(3,557) | $(1,662) |
| Withholding taxes | (10) | (10) |
| Property, plant, and equipment | (3,390) | (5,737) |
| Right-of-use lease assets | (7,875) | (8,755) |
| Deferred tax liability | $(14,832) | $(16,164) |
| Net deferred tax assets (liabilities) | $(4,097) | $(2,089) |
| Reported as: | ||
| Deferred income tax assets (classified within other long-term assets) | $1,542 | $2,081 |
| Deferred income tax liabilities (classified within other long-term liabilities) | (5,639) | (4,170) |
| Net deferred tax assets (liabilities) | $(4,097) | $(2,089) |
The Company historically presented deferred income tax assets as a separate and discrete line item on its consolidated balance sheet; however, as the significance of the asset has decreased as a result of the recognition of valuation allowances, the Company has reclassified this balance to be included within other long-term assets. Deferred income tax liabilities are included in Other Long Term Liabilities.
The Company accounts for income taxes using the asset and liability method, under which deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the financial reporting and income tax basis of assets and liabilities, and for operating losses and credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates in effect for the years in which those items are expected to be realized. Tax law and rate changes are recorded in the period such changes are enacted. The Company establishes a valuation allowance when it is more likely than not that certain deferred tax assets will not be realized in the foreseeable future. We recognize the tax impact of including certain foreign earnings in US taxable income as a period cost.
The valuation allowance is primarily attributable to net operating loss carryforwards and temporary differences in domestic and certain foreign jurisdictions. The net increase in the valuation allowance of $28.5 million during the year principally relates to recognizing a full valuation allowance against the net deferred tax asset within the Company’s U.S. and Italy operations. The Company considered many factors when assessing the likelihood of future realization of these deferred tax assets, including recent cumulative losses experienced by the subsidiary, expectations of future taxable income or loss, the carryforward periods available to the Company for tax reporting purposes, and other relevant factors. That increase was partially offset by a decrease of valuation allowances on net operating loss carryforwards in other foreign jurisdictions due to expiration, statutory rate changes, and changes regarding the realizability of net deferred tax assets. It is reasonably possible that the valuation allowance will increase in 2025 due to further losses in certain jurisdictions, offset by decreases related to the expiration of foreign net operating losses.
The Company has federal net operating loss carryforwards of $351.4 million and federal research and development credits of $5.9 million. These federal carryforwards are subject to limitation under the provisions of Internal Revenue Code Section 382 and will beginto expire in 2025. The Company has state net operating loss carryforwards of approximately $252.1 million, principally related to California, Colorado, Michigan, and New York. These carryforwards are subject to limitation under various provisions implemented by each specific state jurisdiction. Additionally, the Company has net operating loss carryforwards in various foreign jurisdictions of approximately $137.8 million, which mainly relate to the Company’s Netherlands, Brazil, Italy, and Canada operations. The majority of the foreign net operating losses do not expire. The Company also has research and development credits in Canada of $1.3 million which begin to expire in 2041.
Unremitted foreign earnings were $15.7 million as of December 31, 2024. The Company’s investment in foreign subsidiaries continues to be indefinite in nature; however, the Company may periodically repatriate a portion of these earnings to the extent that it does not incur significant additional tax liability. Quantification of the deferred tax liability, if any, associated with indefinitely reinvested earnings of foreign subsidiaries is not practicable.
The Company records a benefit for uncertain tax positions when the weight of available evidence indicates that it is more likely than not, based on an evaluation of the technical merits, that the tax position will be sustained on audit. The tax benefit is measured as the largest amount that is more than 50% likely to be realized upon settlement. The Company re-evaluates income tax positions periodically to consider changes in facts or circumstances such as changes in or interpretations of tax law, effectively settled issues under audit, and new audit activity. The Company includes interest and any applicable penalties related to income tax issues as part of income tax expense in its consolidated financial statements.
The Company’s unrecognized tax benefit was $1.7 million and $3.0 million for the years ended December 31, 2024, and 2023, respectively. The Company recorded net interest and penalties expense (benefit) on unrecognized tax benefits of $0.2 million, $0.2 million, and $0.1 million for the years ended December 31, 2024, 2023, and 2022, respectively, and had approximately $1.0 million and $1.1 million accrued for payment of interest and penalties as of December 31, 2024, and 2023, respectively. The entire amount of unrecognized tax benefits, including interest, would favorably impact the Company's effective tax rate if recognized. The Company believes it is reasonably possible that, in the next 12 months, no unrecognized tax benefits, exclusive of interest and penalties, will be resolved.
A reconciliation of the gross unrecognized tax benefits (excluding interest and penalties) for the years ended December 31,2024, and 2023, is shown below:
| (U.S. Dollars, in thousands) | 2024 | 2023 |
|---|---|---|
| Balance as of January 1, | $2,974 | $1,743 |
| Additions for current year tax positions | 40 | 416 |
| Increases for prior year tax positions | 42 | 815 |
| Settlements of prior year tax positions | — | — |
| Expiration of statutes | (1,333) | — |
| Balance as of December 31, | $1,723 | $2,974 |
The Company and its subsidiaries file income tax returns in the U.S. federal jurisdiction and in certain state and foreign jurisdictions, including Italy, as well as other jurisdictions where the Company maintains operations. The statute of limitations with respect to federal and state tax filings is closed for years prior to 2021. The statute of limitations with respect to the major foreign tax filing jurisdictions is closed for years prior to 2020. In October 2024, the Company was notified of an examination of its Italian subsidiary for 2020 and in December 2024, the examination was concluded with no change. The Company cannot reasonably determine if any state and local or foreign examinations will have a material impact on its financial statements and cannot predict the timing regarding the resolution of these tax examinations.
- Earnings per share (EPS)
The Company used the treasury stock method of computing basic and diluted EPS. Basic EPS is computed using the weighted average number of common shares outstanding during each of the respective years. Diluted EPS is computed using the weighted average number of common and common equivalent shares outstanding during each of the respective years using the more dilutive of either the treasury stock method or two-class method (if other participating securities were outstanding). The difference between basic and diluted shares, if any, largely results from common equivalent shares, which represents the dilutive effect of the assumed exercise of certain outstanding share options, the assumed vesting of restricted stock granted to employees and directors, or the satisfaction of certain necessary conditions for contingently issuable shares (see Note 18).
For each of the three years ended December 31, 2024, 2023, and 2022, no significant adjustments were made to net income for purposes of calculating basic and diluted EPS. The following is a reconciliation of the weighted average shares used in the diluted EPS computations:
| Year Ended December 31, | |||
|---|---|---|---|
| (In thousands) | 2024 | 2023 | 2022 |
| Weighted average common shares-basic | 38,134 | 36,729 | 20,054 |
| Effect of diluted securities: | |||
| Unexercised stock options and employee stock purchase plan | — | — | — |
| Unvested time-based restricted stock units | — | — | — |
| Weighted average common shares-diluted | 38,134 | 36,729 | 20,054 |
There were 7.2 million,6.5 million, and 2.3 million weighted average outstanding options, time-based restricted stock awards and stock units, performance-based stock units, and market-based stock units not included in the diluted earnings per share computation for the years ended December 31,2024, 2023, and 2022, respectively, because inclusion of these awards was anti-dilutive or, for performance-based stock units and market-based stock units, all necessary conditions had not been satisfied by the end of the respective period.
- Subsequent events
Consistent with Orthofix’s strategic focus on spinal fixation and deformity correction, the Company made an assessment and decided in January 2025 to discontinue its M6-C artificial cervical disc and M6-L artificial lumbar disc product lines (together, the “M6 artificial discs” or “M6 devices”) and will allocate associated resources and investment to more profitable growth opportunities in those focus areas on a prospective basis. Global net sales for the M6-C artificial cervical and M6-L artificial lumbar discs were $23.4 million in 2024. Manufacturing activities related to the M6 artificial discs are expected to cease before March 31, 2025. Orthofix intends to fulfill all requirements related to post-market surveillance activities and meet our obligations with respect to premarket approval (“PMA”) of M6 devices, including completion of the investigational device exemption (“IDE”) study in the United States.
Management has evaluated this decision within the context of ASC 855, Subsequent Events, and has determined this to be a nonrecognized subsequent event. Accordingly, the Company has not incorporated the financial impact of this decision within its consolidated balance sheet, statements of operations, or cash flows as of and for the period ending December 31, 2024. The related financial impact of this decision is currently being evaluated and cannot be reasonably estimated as of the date of these financial statements. However, this information will be reflected within the Company’s consolidated financial statements for the quarter ended March 31, 2025.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.