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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 10-Q

(Mark one)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended June 30, 2025

OR

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from to .

Commission File Number: 0-19961

 

img223559691_0.jpg

ORTHOFIX MEDICAL INC.

(Exact name of registrant as specified in its charter)

Delaware

 

98-1340767

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

 

 

3451 Plano Parkway,

Lewisville, Texas

 

75056

(Address of principal executive offices)

 

(Zip Code)

(214) 937-2000

(Registrant's telephone number, including area code)

 

Not applicable

(Former name, former address and former fiscal year, if changed since last report)

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company," and "emerging growth company" in Rule 12b-2 of the Exchange Act.

Large Accelerated filer

Accelerated filer

 

 

 

 

Non-Accelerated filer

Smaller Reporting Company

 

 

 

 

 

 

Emerging Growth Company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No

As of July 31, 2025, 39,494,265 shares of common stock were issued and outstanding.

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which registered

Common stock, $0.10 par value per share

 

OFIX

 

Nasdaq Global Select Market

 

 


 

Table of Contents

 

 

 

 

 

 

Page

PART I

 

FINANCIAL INFORMATION

 

 

 

 

 

 

 

Item 1.

 

Financial Statements

 

4

 

 

 

 

 

 

 

Condensed Consolidated Balance Sheets as of June 30, 2025, and December 31, 2024

 

4

 

 

 

 

 

 

 

Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2025, and 2024

 

5

 

 

 

 

 

 

 

Condensed Consolidated Statements of Changes in Shareholders' Equity for the three and six months ended June 30, 2025, and 2024

 

6

 

 

 

 

 

 

 

Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2025, and 2024

 

7

 

 

 

 

 

 

 

Notes to the Unaudited Condensed Consolidated Financial Statements

 

8

 

 

 

 

 

Item 2.

 

Management's Discussion and Analysis of Financial Condition and Results of Operations

 

23

 

 

 

 

 

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

31

 

 

 

 

 

Item 4.

 

Controls and Procedures

 

32

 

 

 

 

 

PART II

 

OTHER INFORMATION

 

 

 

 

 

 

 

Item 1.

 

Legal Proceedings

 

33

 

 

 

 

 

Item 1A.

 

Risk Factors

 

33

 

 

 

 

 

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

 

33

 

 

 

 

 

Item 3.

 

Defaults Upon Senior Securities

 

33

 

 

 

 

 

Item 4.

 

Mine Safety Disclosures

 

33

 

 

 

 

 

Item 5.

 

Other Information

 

33

 

 

 

 

 

Item 6.

 

Exhibits

 

33

 

 

 

 

 

SIGNATURES

 

34

 

2


 

Forward-Looking Statements

This Quarterly Report contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), relating to our business and financial outlook, which are based on our current beliefs, assumptions, expectations, estimates, forecasts, and projections. All statements, other than statements of historical fact, contained in this report, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "projects," "intends," "predicts," "potential," "positioned," "deliver," or "continue" or the negative version of those terms and other similar expressions. Forward-looking statements include, but are not limited to, statements about:

our intentions, beliefs, and expectations regarding our operations, sales, expenses, and future financial performance;
our operating results;
our intentions, beliefs, and expectations regarding the anticipated benefits of the merger with SeaSpine Holdings Corporation ("SeaSpine"), including the anticipated cross-selling opportunities from the merger;
our plans for future products and enhancements of existing products;
anticipated growth and trends in our business;
the timing of and our ability to maintain and obtain regulatory clearances or approvals;
our belief that our cash and cash equivalents, investments, and access to our credit facilities will be sufficient to satisfy our anticipated cash requirements;
our expectations regarding our revenues, customers, and distributors;
our expectations regarding our costs, suppliers, and manufacturing abilities;
our beliefs and expectations regarding our market penetration and expansion efforts;
our anticipated trends and challenges in the markets in which we operate; and
our expectations and beliefs regarding, and the impact of, investigations, claims, and litigation.

Forward-looking statements are not guarantees of future performance and involve risks, uncertainties, estimates, and assumptions. Any or all forward-looking statements that we make may turn out to be wrong (due to inaccurate assumptions that we make or otherwise), and our actual outcomes and results may differ materially from those expressed in forward-looking statements. Potential risks and uncertainties that could cause actual results to differ materially include, but are not limited to, those set forth in Part I, Item 1A under the heading Risk Factors of our Annual Report on Form 10-K for the year ended December 31, 2024 ("2024 10-K"); Part II, Item 7 Management's Discussion and Analysis of Financial Condition and Results of Operations of the 2024 10-K; and elsewhere throughout the 2024 10-K, and in our reports filed with the U.S. Securities and Exchange Commission (the "SEC") subsequent to the date we filed the 2024 10-K with the SEC. You should not place undue reliance on any forward-looking statements. Further, any forward-looking statement in this report speaks only as of the date hereof, unless it is specifically otherwise stated to be made as of a different date. Except as required by law, we undertake no obligation to update, and expressly disclaim any duty to update, our forward-looking statements, whether as a result of circumstances or events that arise after the date hereof, new information, or otherwise.

Trademarks

Solely for convenience, our trademarks and trade names in this report are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that we will not assert, to the fullest extent under applicable law, our rights thereto.

3


 

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

ORTHOFIX MEDICAL INC.

Condensed Consolidated Balance Sheets

(U.S. Dollars, in thousands, except par value data)

 

June 30,
2025

 

 

December 31,
2024

 

 

 

(Unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

65,606

 

 

$

83,238

 

Restricted cash

 

 

3,083

 

 

 

2,500

 

Accounts receivable, net of allowances of $8,909 and $7,418, respectively

 

 

129,556

 

 

 

134,713

 

Inventories

 

 

172,993

 

 

 

189,452

 

Prepaid expenses and other current assets

 

 

24,592

 

 

 

23,382

 

Total current assets

 

 

395,830

 

 

 

433,285

 

Property, plant, and equipment, net

 

 

129,200

 

 

 

139,804

 

Intangible assets, net

 

 

78,868

 

 

 

98,803

 

Goodwill

 

 

194,934

 

 

 

194,934

 

Other long-term assets

 

 

38,325

 

 

 

26,468

 

Total assets

 

$

837,157

 

 

$

893,294

 

 

 

 

 

 

 

 

Liabilities and shareholders’ equity

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

$

45,098

 

 

$

48,803

 

Current portion of finance lease liability

 

 

797

 

 

 

755

 

Other current liabilities

 

 

102,486

 

 

 

119,070

 

Total current liabilities

 

 

148,381

 

 

 

168,628

 

Long-term debt

 

 

157,047

 

 

 

157,015

 

Long-term portion of finance lease liability

 

 

17,448

 

 

 

17,835

 

Other long-term liabilities

 

 

55,934

 

 

 

46,692

 

Total liabilities

 

 

378,810

 

 

 

390,170

 

Contingencies (Note 7)

 

 

 

 

 

 

Shareholders’ equity

 

 

 

 

 

 

Common shares $0.10 par value; 100,000 shares authorized;
    
39,483 and 38,486 issued and outstanding as of June 30,
    2025, and December 31, 2024, respectively

 

 

3,948

 

 

 

3,849

 

Additional paid-in capital

 

 

796,807

 

 

 

779,718

 

Accumulated deficit

 

 

(343,316

)

 

 

(276,141

)

Accumulated other comprehensive income (loss)

 

 

908

 

 

 

(4,302

)

Total shareholders’ equity

 

 

458,347

 

 

 

503,124

 

Total liabilities and shareholders’ equity

 

$

837,157

 

 

$

893,294

 

The accompanying notes form an integral part of these condensed consolidated financial statements.

4


 

ORTHOFIX MEDICAL INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 30,

 

(Unaudited, U.S. Dollars, in thousands, except per share data)

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Net sales

 

$

203,121

 

 

$

198,620

 

 

$

396,767

 

 

$

387,228

 

Cost of sales

 

 

63,588

 

 

 

63,871

 

 

 

135,615

 

 

 

125,237

 

Gross profit

 

 

139,533

 

 

 

134,749

 

 

 

261,152

 

 

 

261,991

 

Sales, general, and administrative

 

 

136,493

 

 

 

134,218

 

 

 

269,474

 

 

 

265,909

 

Research and development

 

 

15,934

 

 

 

18,049

 

 

 

35,700

 

 

 

37,541

 

Acquisition-related amortization, impairment, and remeasurement (Note 11)

 

 

3,109

 

 

 

7,388

 

 

 

20,854

 

 

 

12,784

 

Operating loss

 

 

(16,003

)

 

 

(24,906

)

 

 

(64,876

)

 

 

(54,243

)

Interest expense, net

 

 

(3,950

)

 

 

(4,943

)

 

 

(8,456

)

 

 

(9,501

)

Other income (expense), net

 

 

5,730

 

 

 

(2,510

)

 

 

6,976

 

 

 

(3,784

)

Loss before income taxes

 

 

(14,223

)

 

 

(32,359

)

 

 

(66,356

)

 

 

(67,528

)

Income tax benefit (expense)

 

 

142

 

 

 

(1,084

)

 

 

(819

)

 

 

(1,935

)

Net loss

 

$

(14,081

)

 

$

(33,443

)

 

$

(67,175

)

 

$

(69,463

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per common share:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.36

)

 

$

(0.88

)

 

$

(1.71

)

 

$

(1.84

)

Diluted

 

 

(0.36

)

 

 

(0.88

)

 

 

(1.71

)

 

 

(1.84

)

Weighted average number of common shares:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

39,501

 

 

 

38,020

 

 

 

39,317

 

 

 

37,787

 

Diluted

 

 

39,501

 

 

 

38,020

 

 

 

39,317

 

 

 

37,787

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive income (loss), before tax

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain on debt securities

 

 

 

 

 

 

 

 

 

 

 

1,671

 

Reclassification adjustment for historical unrealized gain on debt security

 

 

 

 

 

(1,671

)

 

 

 

 

 

(1,671

)

Currency translation adjustment

 

 

3,464

 

 

 

(400

)

 

 

5,210

 

 

 

(1,438

)

Other comprehensive income (loss), before tax

 

 

3,464

 

 

 

(2,071

)

 

 

5,210

 

 

 

(1,438

)

Income tax expense related to other comprehensive income (loss)

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive income (loss), net of tax

 

 

3,464

 

 

 

(2,071

)

 

 

5,210

 

 

 

(1,438

)

Comprehensive loss

 

$

(10,617

)

 

$

(35,514

)

 

$

(61,965

)

 

$

(70,901

)

The accompanying notes form an integral part of these condensed consolidated financial statements.

5


 

ORTHOFIX MEDICAL INC.

Condensed Consolidated Statements of Changes in Shareholders' Equity

 

(Unaudited, U.S. Dollars, in thousands)

 

Number of
Common
Shares
Outstanding

 

 

Common
Shares

 

 

Additional
Paid-in
Capital

 

 

Accumulated Deficit

 

 

Accumulated
Other
Comprehensive Income (Loss)

 

 

Total
Shareholders’
Equity

 

At December 31, 2024

 

 

38,486

 

 

$

3,849

 

 

$

779,718

 

 

$

(276,141

)

 

$

(4,302

)

 

$

503,124

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(53,094

)

 

 

 

 

 

(53,094

)

Other comprehensive income, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,746

 

 

 

1,746

 

Share-based compensation expense

 

 

 

 

 

 

 

 

6,469

 

 

 

 

 

 

 

 

 

6,469

 

Common shares issued, net

 

 

610

 

 

 

61

 

 

 

(12

)

 

 

 

 

 

 

 

 

49

 

At March 31, 2025

 

 

39,096

 

 

$

3,910

 

 

$

786,175

 

 

$

(329,235

)

 

$

(2,556

)

 

$

458,294

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(14,081

)

 

 

 

 

 

(14,081

)

Other comprehensive income, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,464

 

 

 

3,464

 

Share-based compensation expense

 

 

 

 

 

 

 

 

7,824

 

 

 

 

 

 

 

 

 

7,824

 

Common shares issued, net

 

 

387

 

 

 

38

 

 

 

2,808

 

 

 

 

 

 

 

 

 

2,846

 

At June 30, 2025

 

 

39,483

 

 

$

3,948

 

 

$

796,807

 

 

$

(343,316

)

 

$

908

 

 

$

458,347

 

 

 

(Unaudited, U.S. Dollars, in thousands)

 

Number of
Common
Shares
Outstanding

 

 

Common
Shares

 

 

Additional
Paid-in
Capital

 

 

Accumulated Deficit

 

 

Accumulated
Other
Comprehensive Income
(Loss)

 

 

Total
Shareholders’
Equity

 

At December 31, 2023

 

 

37,165

 

 

$

3,717

 

 

$

746,450

 

 

$

(150,144

)

 

 

(1,293

)

 

$

598,730

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(36,020

)

 

 

 

 

 

(36,020

)

Other comprehensive income, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

633

 

 

 

633

 

Share-based compensation expense

 

 

 

 

 

 

 

 

8,800

 

 

 

 

 

 

 

 

 

8,800

 

Common shares issued, net

 

 

245

 

 

 

24

 

 

 

(1,852

)

 

 

 

 

 

 

 

 

(1,828

)

At March 31, 2024

 

 

37,410

 

 

$

3,741

 

 

$

753,398

 

 

$

(186,164

)

 

$

(660

)

 

$

570,315

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(33,443

)

 

 

 

 

 

(33,443

)

Other comprehensive loss, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(2,071

)

 

 

(2,071

)

Share-based compensation expense

 

 

 

 

 

 

 

 

9,959

 

 

 

 

 

 

 

 

 

9,959

 

Common shares issued, net

 

 

629

 

 

 

63

 

 

 

1,181

 

 

 

 

 

 

 

 

 

1,244

 

At June 30, 2024

 

 

38,039

 

 

$

3,804

 

 

$

764,538

 

 

$

(219,607

)

 

$

(2,731

)

 

$

546,004

 

The accompanying notes form an integral part of these condensed consolidated financial statements.

6


 

ORTHOFIX MEDICAL INC.

Condensed Consolidated Statements of Cash Flows

 

 

Six Months Ended
June 30,

 

(Unaudited, U.S. Dollars, in thousands)

 

2025

 

 

2024

 

Cash flows from operating activities

 

 

 

 

 

 

Net loss

 

$

(67,175

)

 

$

(69,463

)

Adjustments to reconcile net loss to net cash from operating activities

 

 

 

 

 

 

Depreciation, amortization, and impairment

 

 

51,302

 

 

 

28,894

 

Inventory reserve expenses

 

 

25,393

 

 

 

13,759

 

Amortization of inventory fair value step-up

 

 

 

 

 

6,094

 

Amortization of operating lease assets, debt costs, and other assets

 

 

2,377

 

 

 

2,986

 

Provision for expected credit losses

 

 

1,837

 

 

 

1,573

 

Deferred income taxes

 

 

12

 

 

 

1,180

 

Share-based compensation expense

 

 

14,293

 

 

 

18,759

 

Loss on disposal of fixed assets

 

 

581

 

 

 

2,566

 

Change in valuation of investment securities

 

 

(31

)

 

 

3,992

 

Change in fair value of contingent consideration

 

 

(1,373

)

 

 

4,240

 

Other

 

 

(1,188

)

 

 

2,297

 

Changes in operating assets and liabilities

 

 

 

 

 

 

Accounts receivable

 

 

5,089

 

 

 

710

 

Inventories

 

 

(5,890

)

 

 

(8,571

)

Prepaid expenses and other current assets

 

 

(394

)

 

 

2,717

 

Accounts payable

 

 

(9,138

)

 

 

(7,501

)

Other current liabilities

 

 

(21,763

)

 

 

(9,977

)

Other long-term assets and liabilities

 

 

(684

)

 

 

(3,866

)

Net cash used in operating activities

 

 

(6,752

)

 

 

(9,611

)

Cash flows from investing activities

 

 

 

 

 

 

Capital expenditures

 

 

(13,845

)

 

 

(20,533

)

Other investing activities

 

 

12

 

 

 

(50

)

Net cash used in investing activities

 

 

(13,833

)

 

 

(20,583

)

Cash flows from financing activities

 

 

 

 

 

 

Proceeds from issuance of common shares

 

 

3,054

 

 

 

3,191

 

Payments related to tax withholdings for share-based compensation

 

 

(159

)

 

 

(3,775

)

Payments related to finance lease obligation

 

 

(375

)

 

 

(346

)

Proceeds from credit facility

 

 

 

 

 

40,000

 

Repayment of borrowings from credit facility

 

 

 

 

 

(15,000

)

Payment of debt issuance costs and other financing activities

 

 

(531

)

 

 

(2,392

)

Net cash provided by financing activities

 

 

1,989

 

 

 

21,678

 

Effect of exchange rate changes on cash

 

 

1,547

 

 

 

(375

)

Net change in cash and cash equivalents

 

 

(17,049

)

 

 

(8,891

)

Cash, cash equivalents, and restricted cash at the beginning of period

 

 

85,738

 

 

 

37,757

 

Cash, cash equivalents, and restricted cash at the end of period

 

$

68,689

 

 

$

28,866

 

 

 

 

 

 

 

 

Components of cash, cash equivalents, and restricted cash at the end of period

 

 

 

 

 

 

Cash and cash equivalents

 

$

65,606

 

 

$

26,366

 

Restricted cash

 

 

3,083

 

 

 

2,500

 

Cash, cash equivalents, and restricted cash at the end of period

 

$

68,689

 

 

$

28,866

 

 

 

 

 

 

 

 

Noncash investing activities - Accrued purchases of capital expenditures

 

$

10,990

 

 

$

5,996

 

Noncash investing activities - Purchase of intangible assets

 

 

40

 

 

 

50

 

The accompanying notes form an integral part of these condensed consolidated financial statements.

7


 

ORTHOFIX MEDICAL INC.

Notes to the Unaudited Condensed Consolidated Financial Statements

1. 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 accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States ("U.S. GAAP") for interim financial information and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Pursuant to these rules and regulations, certain information and note disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. In the opinion of management, all adjustments (consisting of normal recurring items) considered necessary for a fair statement have been included. These condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and related notes contained in the Company's 2024 Form 10-K. Operating results for the three and six months ended June 30, 2025, are not necessarily indicative of the results that may be expected for other interim periods or the year ending December 31, 2025.

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, the Company evaluates its estimates, including those related to revenue recognition; contractual allowances; allowances for expected credit losses; inventories; valuation of intangible assets; goodwill; fair value measurements, including contingent consideration; litigation and contingent liabilities; tax matters; and share-based compensation. Actual results could differ from these estimates.

Changes in Presentation of Consolidated Financial Statements

Certain prior year balances have been reclassified in the condensed consolidated financial statements to conform to current period presentation.

2. Recently adopted accounting standards and recently issued accounting pronouncements

Adoption of Accounting Standards Update ("ASU") 2023-09 - Improvements to Income Tax Disclosures

In December 2023, the Financial Accounting Standards Board ("FASB") issued ASU 2023-09, which enhances the transparency and usefulness of income tax disclosures required pursuant to Topic 740, Income Taxes, to provide information to better assess how an entity's operations, tax risks and tax planning, and operational opportunities affect its tax rate and future cash flows. The Company adopted this standard effective January 1, 2025, on a modified retrospective basis. Adoption of this standard did not have a material impact on the Company's consolidated balance sheet, statements of operations, or cash flows.

8


 

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.

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 for reporting periods after the effective date or 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 condensed consolidated financial statements.

3. Inventories

Inventories were as follows:

(U.S. Dollars, in thousands)

 

June 30,
2025

 

 

December 31,
2024

 

 

 

(Unaudited)

 

 

 

 

Raw materials

 

$

26,588

 

 

$

27,180

 

Work-in-process

 

 

61,408

 

 

 

56,920

 

Finished products

 

 

84,997

 

 

 

105,352

 

Inventories

 

$

172,993

 

 

$

189,452

 

 

9


 

 

4. Leases

A summary of the Company's lease portfolio as of June 30, 2025, and December 31, 2024, is presented in the table below:

(U.S. Dollars, in thousands)

 

Classification

 

June 30,
2025

 

 

December 31,
2024

 

 

 

 

 

(Unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Operating leases

 

Other long-term assets

 

$

24,859

 

 

$

17,238

 

Finance leases

 

Property, plant, and equipment, net

 

 

14,908

 

 

 

15,386

 

Total lease assets

 

 

 

$

39,767

 

 

$

32,624

 

 

 

 

 

 

 

 

 

 

Liabilities

 

 

 

 

 

 

 

 

Current

 

 

 

 

 

 

 

 

Operating leases

 

Other current liabilities

 

$

3,048

 

 

$

4,023

 

Finance leases

 

Current portion of finance lease liability

 

 

797

 

 

 

755

 

Long-term

 

 

 

 

 

 

 

 

Operating leases

 

Other long-term liabilities

 

 

26,398

 

 

 

14,084

 

Finance leases

 

Long-term portion of finance lease liability

 

 

17,448

 

 

 

17,835

 

Total lease liabilities

 

 

 

$

47,691

 

 

$

36,697

 

Supplemental cash flow information related to leases was as follows:

(Unaudited, U.S. Dollars, in thousands)

 

Six Months Ended
June 30, 2025

 

 

Six Months Ended
June 30, 2024

 

Cash paid for amounts included in the measurement of lease liabilities

 

 

 

 

 

 

Operating cash flows from operating leases

 

$

4,407

 

 

$

4,311

 

Operating cash flows from finance leases

 

 

401

 

 

 

417

 

Financing cash flows from finance leases

 

 

375

 

 

 

346

 

ROU assets obtained in exchange for lease obligations

 

 

 

 

 

 

Operating leases

 

 

11,690

 

 

 

721

 

Finance leases

 

 

28

 

 

 

 

 

5. Long-term debt

The carrying values of the Company's outstanding debt obligations as of June 30, 2025, and December 31, 2024, were as follows:

(U.S. Dollars, in thousands)

 

June 30,
2025

 

 

December 31,
2024

 

 

 

(Unaudited)

 

 

 

 

Outstanding Term Loans

 

 

 

 

 

 

Principal amount

 

$

160,000

 

 

$

160,000

 

Unamortized original debt discount

 

 

(2,083

)

 

 

(2,327

)

Unamortized debt issuance costs and lenders fees

 

 

(870

)

 

 

(658

)

Total indebtedness from outstanding term loans

 

 

157,047

 

 

 

157,015

 

 

 

 

 

 

 

 

Revolving Credit Facilities

 

 

 

 

 

 

Principal amount outstanding

 

 

 

 

 

 

Total indebtedness outstanding

 

$

157,047

 

 

$

157,015

 

 

 

 

 

 

 

 

Current portion of long-term debt

 

$

 

 

$

 

Long-term debt

 

 

157,047

 

 

 

157,015

 

Total indebtedness outstanding

 

$

157,047

 

 

$

157,015

 

 

10


 

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. The Credit Agreement contains financial covenants requiring the Company to maintain (i) a minimum level of liquidity at all times and (ii) a maximum total debt-to-EBITDA leverage ratio (measured on a quarterly basis) during the term of the facility. As of June 30, 2025, the Company was in compliance with all required financial covenants.

As of June 30, 2025, the Company had no borrowings on its available lines of credit in Italy, which provide up to an aggregate amount of €5.5 million ($6.5 million).

6. Fair value measurements and investments

The fair value measurements of the Company's financial assets and liabilities measured on a recurring basis were as follows:

 

 

June 30,
2025

 

 

December 31,
2024

 

(U.S. Dollars, in thousands)

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

(Unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Neo Medical convertible loan agreement

 

$

 

 

$

 

 

$

 

 

$

 

 

$

 

Neo Medical preferred equity securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total

 

$

 

 

$

 

 

$

 

 

$

 

 

$

 

Liabilities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Lattus contingent consideration

 

$

 

 

$

 

 

$

(14,027

)

 

$

(14,027

)

 

$

(15,400

)

Deferred compensation plan

 

 

 

 

 

(1,695

)

 

 

 

 

 

(1,695

)

 

 

(1,703

)

Total

 

$

 

 

$

(1,695

)

 

$

(14,027

)

 

$

(15,722

)

 

$

(17,103

)

Neo Medical Convertible Loan Agreement 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. 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 table below presents a reconciliation of the beginning and ending balances of the Company's investment in Neo Medical preferred equity securities:

(Unaudited, U.S. Dollars, in thousands)

 

2025

 

 

2024

 

Fair value of Neo Medical preferred equity securities at January 1

 

$

 

 

$

4,951

 

Conversion of loan into preferred equity securities

 

 

 

 

 

8,224

 

Unrealized loss recognized in other expense, net

 

 

 

 

 

(2,233

)

Fair value of Neo Medical preferred equity securities at June 30

 

$

 

 

$

10,942

 

Cumulative unrealized loss on Neo Medical preferred equity securities

 

$

 

 

$

(2,953

)

 

11


 

The following table provides a reconciliation of the beginning and ending balances of the Convertible Loan, which was measured at fair value using significant unobservable inputs:

(Unaudited, U.S. Dollars, in thousands)

 

2025

 

 

2024

 

Fair value of Neo Medical Convertible Loan at January 1

 

$

 

 

$

6,760

 

Gain recognized in other comprehensive income

 

 

 

 

 

1,671

 

Interest recognized in interest income, net

 

 

 

 

 

162

 

Foreign currency remeasurement recognized in other expense, net

 

 

 

 

 

(602

)

Expected credit loss recognized in other income, net

 

 

 

 

 

260

 

Conversion into preferred equity securities

 

 

 

 

 

(8,224

)

Realized foreign currency loss recognized in other expense, net

 

 

 

 

 

(27

)

Fair value of Neo Medical Convertible Loan at June 30

 

$

 

 

$

 

 

 

 

 

 

 

 

Contractual value of Neo Medical Convertible Loan at June 30

 

$

 

 

$

 

Allowance for credit loss recognized in other income (expense), net

 

 

 

 

 

 

Amortized cost basis of Neo Medical Convertible Loan at June 30

 

$

 

 

$

 

Lattus Contingent Consideration

In connection with the merger with SeaSpine Holdings Corporation ("SeaSpine") in 2023 (the "SeaSpine 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 this agreement, the Company may be required to make installment payments to Lattus (the "Lattus Contingent Consideration") 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 launch dates for the Lateral Products, estimated future sales of the 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):

(Unaudited, U.S. Dollars, in thousands)

 

2025

 

 

2024

 

Lattus Contingent Consideration estimated fair value at January 1

 

$

15,400

 

 

$

8,500

 

Change in fair value recognized in acquisition-related amortization, impairment, and remeasurement

 

 

(1,373

)

 

 

4,240

 

Lattus Contingent Consideration estimated fair value at June 30

 

$

14,027

 

 

$

12,740

 

The estimated fair value of the Lattus Contingent Consideration as of June 30, 2025, was $14.0 million; however, the actual amount ultimately paid could be higher or lower this. As of June 30, 2025, the Company classified the remaining Lattus Contingent Consideration liability of $10.5 million and $3.5 million within other current liabilities and other long-term liabilities, respectively.

The following table provides quantitative information related to certain key assumptions utilized within the valuation as of June 30, 2025:

(Unaudited, U.S. Dollars, in thousands)

 

Fair Value as of
 June 30, 2025

 

 

Unobservable inputs

 

Estimate

Lattus Contingent Consideration

 

$

14,027

 

 

Counterparty discount rates

 

10.8% - 11.0%

 

 

 

 

 

Revenue risk-adjusted discount rates

 

6.4% - 6.8%

 

12


 

7. Commitments and Contingencies

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. The three 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 is vigorously defending 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 Exchange Act, 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 SeaSpine Merger, alleges through the complaint violations of Sections 11, 12 and 15 of the Securities Act, 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 SeaSpine 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 April 17, 2025, the plaintiffs filed an amended complaint in the consolidated action, captioned In re Orthofix Medical Inc. Securities Litigation, with substantially the same allegations contained in the Bernal Complaint and the O'Hara Complaint. The consolidated case is captioned In re Orthofix Medical Inc. Securities Litigation, Case No. 24-cv-00690 and is pending in the Eastern District of Texas. The Company and the individual defendants moved to dismiss the amended complaint on May 15, 2025.

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

13


 

derivative shareholder complaint was filed with the same allegations made in the first derivative shareholder complaint. On March 21, 2025, the two derivative shareholder complaints were consolidated into one case.

The Company disagrees with the legal claims asserted in these complaints and is vigorously defending them. 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 SeaSpine 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, provided that the distributor meets the required conditions of such purchase option. 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 June 30, 2025, 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 0.4 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, which is subject to the distributor satisfying certain conditions.

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 $0.3 million and $0.6 million for the three and six months ended June 30, 2025, respectively, and expenses of $0.3 million and $0.6 million for the three and six months ended June 30, 2024, respectively. As of June 30, 2025, the Company has accrued $10.0 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.

8. Accumulated other comprehensive income (loss)

The components of and changes in accumulated other comprehensive income (loss) were as follows:

(Unaudited, U.S. Dollars, in thousands)

 

Currency
Translation
Adjustments

 

 

Neo Medical Convertible Loan

 

 

Accumulated Other
Comprehensive Income (Loss)

 

Balance at December 31, 2024

 

$

(4,074

)

 

$

(228

)

 

$

(4,302

)

Other comprehensive income

 

 

5,210

 

 

 

 

 

 

5,210

 

Income taxes

 

 

 

 

 

 

 

 

 

Balance at June 30, 2025

 

$

1,136

 

 

$

(228

)

 

$

908

 

 

14


 

9. Revenue recognition and accounts receivable

Revenue Recognition

The Company has two reporting segments: Global Spine and Global Orthopedics. Within the Global Spine reporting segment, there are two product categories: (i) Bone Growth Therapies, and (ii) Spinal Implants, Biologics, and Enabling Technologies.

The tables below present net sales by product category by reporting segment:

 

 

Three Months Ended June 30,

 

(Unaudited, U.S. Dollars, in thousands)

 

2025

 

 

2024

 

 

Change

 

Bone Growth Therapies

 

$

62,573

 

 

$

59,135

 

 

 

5.8

%

Spinal Implants, Biologics, and Enabling Technologies

 

 

107,251

 

 

 

108,899

 

 

 

-1.5

%

Global Spine

 

 

169,824

 

 

 

168,034

 

 

 

1.1

%

Global Orthopedics

 

 

33,297

 

 

 

30,586

 

 

 

8.9

%

Net sales

 

$

203,121

 

 

$

198,620

 

 

 

2.3

%

 

 

 

Six Months Ended June 30,

 

(Unaudited, U.S. Dollars, in thousands)

 

2025

 

 

2024

 

 

Change

 

Bone Growth Therapies

 

$

117,623

 

 

$

111,612

 

 

 

5.4

%

Spinal Implants, Biologics, and Enabling Technologies

 

 

216,037

 

 

 

217,715

 

 

 

-0.8

%

Global Spine

 

 

333,660

 

 

 

329,327

 

 

 

1.3

%

Global Orthopedics

 

 

63,107

 

 

 

57,901

 

 

 

9.0

%

Net sales

 

$

396,767

 

 

$

387,228

 

 

 

2.5

%

Product Sales and Marketing Service Fees

The table below presents product sales and marketing service fees, which are both components of net sales:

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

(Unaudited, U.S. Dollars, in thousands)

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Product sales

 

$

191,395

 

 

$

185,417

 

 

$

373,028

 

 

$

361,248

 

Marketing service fees

 

 

11,726

 

 

 

13,203

 

 

 

23,739

 

 

 

25,980

 

Net sales

 

$

203,121

 

 

$

198,620

 

 

$

396,767

 

 

$

387,228

 

Product sales primarily consist of the sale of bone growth therapies devices, spinal implants, certain biologics, enabling technologies, and orthopedics products. Marketing service fees are received from MTF Biologics ("MTF") based on total sales of biologics tissues sourced from MTF and relate solely to the Global Spine reporting segment. The Company partners with MTF to provide certain allograft solutions for various spine, orthopedic and other bone repair needs, with this partnership allowing the Company to exclusively market certain biologic offerings.

Accounts receivable and related allowances

The following table provides a detail of changes in the Company's allowance for expected credit losses for the three and six months ended June 30, 2025 and 2024:

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

(Unaudited, U.S. Dollars, in thousands)

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Allowance for expected credit losses beginning balance

 

$

8,602

 

 

$

8,398

 

 

$

7,418

 

 

$

7,130

 

Current period provision for expected credit losses

 

 

779

 

 

 

197

 

 

 

1,837

 

 

 

1,573

 

Write-offs charged against the allowance and other

 

 

(747

)

 

 

(184

)

 

 

(758

)

 

 

(203

)

Effect of changes in foreign exchange rates

 

 

275

 

 

 

(43

)

 

 

412

 

 

 

(132

)

Allowance for expected credit losses ending balance

 

$

8,909

 

 

$

8,368

 

 

$

8,909

 

 

$

8,368

 

 

15


 

 

10. Business segment information

The Company's operations are managed through two 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 Chief Operating Decision Maker ("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, restructuring costs and impairments related to M6 product lines, acquisition-related fair value adjustments, gains and/or losses on investments, litigation and investigation charges, succession charges, and refunds associated with the employee retention credit established by the Coronavirus Aid, Relief, and Economic Security Act.

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.

Global Spine

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 bone growth stimulation devices that enhance bone fusion. 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-spinal, appendicular fractures, treating both fresh or nonunion fractures. These products are sold almost exclusively in the U.S., using distributors and direct sales representatives to provide our devices to healthcare providers and their patients.

Spinal Implants, Biologics, and Enabling Technologies comprises (i) a broad portfolio of spine fixation 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.

Global Orthopedics

The Global Orthopedics reporting segment offers products and solutions for the underserved limb reconstruction market that encompasses four pillars: deformity correction, limb lengthening, complex fracture management, and limb preservation. 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. The Company sells these products worldwide through a global network of distributors and sales representatives to hospitals, healthcare organizations, and healthcare providers.

 

16


 

The following table presents adjusted EBITDA, the primary metric used in managing the Company, by reporting segment:

 

 

Three Months Ended June 30, 2025

 

Six Months Ended June 30, 2025

 

(U.S. Dollars, in thousands)

 

Global Spine

 

 

Global Orthopedics

 

 

Total

 

Global Spine

 

 

Global Orthopedics

 

 

Total

 

Segment revenues

 

$

169,824

 

 

$

33,297

 

 

$

203,121

 

$

333,660

 

 

$

63,107

 

 

$

396,767

 

Less:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP Cost of sales

 

 

42,811

 

 

 

12,266

 

 

 

55,077

 

 

87,398

 

 

 

24,137

 

 

 

111,535

 

Non-GAAP Sales, general, and administrative

 

 

97,169

 

 

 

17,990

 

 

 

115,159

 

 

189,708

 

 

 

35,911

 

 

 

225,619

 

Non-GAAP Research and development

 

 

11,761

 

 

 

2,674

 

 

 

14,435

 

 

23,384

 

 

 

5,526

 

 

 

28,910

 

Other segment expenses (benefits)

 

 

2,464

 

 

 

6

 

 

 

2,470

 

 

6,907

 

 

 

(169

)

 

 

6,738

 

Add:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP Depreciation, amortization, and share-based compensation expense

 

 

10,814

 

 

 

2,124

 

 

 

12,938

 

 

19,686

 

 

 

4,756

 

 

 

24,442

 

Segment Adjusted EBITDA

 

$

26,433

 

 

$

2,485

 

 

$

28,918

 

$

45,949

 

 

$

2,458

 

 

$

48,407

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Reconciling items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Corporate operating expenses

 

 

 

 

 

 

 

 

8,273

 

 

 

 

 

 

 

 

16,331

 

Interest expense, net

 

 

 

 

 

 

 

 

3,950

 

 

 

 

 

 

 

 

8,456

 

Depreciation and amortization

 

 

 

 

 

 

 

 

16,871

 

 

 

 

 

 

 

 

51,302

 

Share-based compensation expense

 

 

 

 

 

 

 

 

7,824

 

 

 

 

 

 

 

 

14,293

 

Foreign exchange impact

 

 

 

 

 

 

 

 

(2,751

)

 

 

 

 

 

 

 

(3,795

)

SeaSpine merger-related costs

 

 

 

 

 

 

 

 

4,886

 

 

 

 

 

 

 

 

6,016

 

Restructuring costs and impairments related to M6 product lines

 

 

 

 

 

 

 

 

3,354

 

 

 

 

 

 

 

 

15,480

 

Strategic investments

 

 

 

 

 

 

 

 

353

 

 

 

 

 

 

 

 

3,867

 

Acquisition-related fair value adjustments

 

 

 

 

 

 

 

 

(763

)

 

 

 

 

 

 

 

(1,373

)

Interest and loss on investments

 

 

 

 

 

 

 

 

(31

)

 

 

 

 

 

 

 

(31

)

Litigation and investigation costs

 

 

 

 

 

 

 

 

4,029

 

 

 

 

 

 

 

 

7,071

 

Employee retention credit

 

 

 

 

 

 

 

 

(2,854

)

 

 

 

 

 

 

 

(2,854

)

Loss before income taxes

 

 

 

 

 

 

 

$

(14,223

)

 

 

 

 

 

 

$

(66,356

)

 

17


 

 

 

 

 

Three Months Ended June 30, 2024

 

Six Months Ended June 30, 2024

 

(U.S. Dollars, in thousands)

 

Global Spine

 

 

Global Orthopedics

 

 

Total

 

Global Spine

 

 

Global Orthopedics

 

 

Total

 

Segment Revenues

 

$

168,034

 

 

$

30,586

 

 

$

198,620

 

$

329,327

 

 

$

57,901

 

 

$

387,228

 

Less:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP Cost of sales

 

 

43,958

 

 

 

12,469

 

 

 

56,427

 

 

88,812

 

 

 

23,316

 

 

 

112,128

 

Non-GAAP Sales, general, and administrative

 

 

92,542

 

 

 

19,375

 

 

 

111,917

 

 

184,354

 

 

 

37,522

 

 

 

221,876

 

Non-GAAP Research and development

 

 

14,118

 

 

 

3,542

 

 

 

17,660

 

 

30,063

 

 

 

6,854

 

 

 

36,917

 

Other segment expenses (benefits)

 

 

(170

)

 

 

36

 

 

 

(134

)

 

(137

)

 

 

(72

)

 

 

(209

)

Add:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP Depreciation, amortization, and share-based compensation expense

 

 

10,102

 

 

 

5,015

 

 

 

15,117

 

 

21,343

 

 

 

8,406

 

 

 

29,749

 

Segment Adjusted EBITDA

 

$

27,688

 

 

$

179

 

 

$

27,867

 

$

47,578

 

 

$

(1,313

)

 

$

46,265

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Reconciling items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Corporate operating expenses

 

 

 

 

 

 

 

 

11,234

 

 

 

 

 

 

 

 

21,967

 

Interest expense, net

 

 

 

 

 

 

 

 

4,943

 

 

 

 

 

 

 

 

9,501

 

Depreciation and amortization

 

 

 

 

 

 

 

 

14,032

 

 

 

 

 

 

 

 

28,894

 

Share-based compensation expense

 

 

 

 

 

 

 

 

9,959

 

 

 

 

 

 

 

 

18,759

 

Foreign exchange impact

 

 

 

 

 

 

 

 

851

 

 

 

 

 

 

 

 

2,439

 

SeaSpine merger-related costs

 

 

 

 

 

 

 

 

5,897

 

 

 

 

 

 

 

 

10,376

 

Strategic investments

 

 

 

 

 

 

 

 

311

 

 

 

 

 

 

 

 

431

 

Acquisition-related fair value adjustments

 

 

 

 

 

 

 

 

6,117

 

 

 

 

 

 

 

 

10,334

 

Interest and loss on investments

 

 

 

 

 

 

 

 

1,813

 

 

 

 

 

 

 

 

1,553

 

Litigation and investigation costs

 

 

 

 

 

 

 

 

(277

)

 

 

 

 

 

 

 

1,983

 

Succession charges

 

 

 

 

 

 

 

 

5,346

 

 

 

 

 

 

 

 

7,556

 

Loss before income taxes

 

 

 

 

 

 

 

$

(32,359

)

 

 

 

 

 

 

$

(67,528

)

The following table presents depreciation and amortization by reporting segment:

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

(Unaudited, U.S. Dollars, in thousands)

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Global Spine

 

$

14,851

 

 

$

11,044

 

 

$

46,753

 

 

$

22,973

 

Global Orthopedics

 

 

1,419

 

 

 

2,191

 

 

 

3,355

 

 

 

4,398

 

Corporate

 

 

601

 

 

 

797

 

 

 

1,194

 

 

 

1,523

 

Total

 

$

16,871

 

 

$

14,032

 

 

$

51,302

 

 

$

28,894

 

 

18


 

Geographical information

The table below presents net sales by geographic destination for each reporting segment and for the consolidated Company:

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 30,

 

(Unaudited, U.S. Dollars, in thousands)

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Global Spine

 

 

 

 

 

 

 

 

 

 

 

 

U.S.

 

$

161,850

 

 

$

159,191

 

 

$

314,553

 

 

$

311,056

 

International

 

 

7,974

 

 

 

8,843

 

 

 

19,107

 

 

 

18,271

 

Total Global Spine

 

 

169,824

 

 

 

168,034

 

 

 

333,660

 

 

 

329,327

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Global Orthopedics

 

 

 

 

 

 

 

 

 

 

 

 

U.S.

 

 

9,888

 

 

 

7,742

 

 

 

18,866

 

 

 

15,896

 

International

 

 

23,409

 

 

 

22,844

 

 

 

44,241

 

 

 

42,005

 

Total Global Orthopedics

 

 

33,297

 

 

 

30,586

 

 

 

63,107

 

 

 

57,901

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Consolidated

 

 

 

 

 

 

 

 

 

 

 

 

U.S.

 

 

171,738

 

 

 

166,933

 

 

 

333,419

 

 

 

326,952

 

International

 

 

31,383

 

 

 

31,687

 

 

 

63,348

 

 

 

60,276

 

Net sales

 

$

203,121

 

 

$

198,620

 

 

$

396,767

 

 

$

387,228

 

The following data includes net sales by geographic area:

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 30,

 

(Unaudited, U.S. Dollars, in thousands)

 

2025

 

 

2024

 

 

2025

 

 

2024

 

U.S.

 

$

171,738

 

 

$

166,933

 

 

$

333,419

 

 

$

326,952

 

Italy

 

 

5,646

 

 

 

5,257

 

 

 

10,699

 

 

 

10,259

 

France

 

 

3,184

 

 

 

3,510

 

 

 

5,809

 

 

 

6,026

 

United Kingdom

 

 

3,118

 

 

 

2,623

 

 

 

6,155

 

 

 

5,254

 

Germany

 

 

2,265

 

 

 

2,393

 

 

 

4,473

 

 

 

4,498

 

Brazil

 

 

988

 

 

 

1,708

 

 

 

2,123

 

 

 

3,236

 

Others

 

 

16,182

 

 

 

16,196

 

 

 

34,089

 

 

 

31,003

 

Net Sales

 

$

203,121

 

 

$

198,620

 

 

$

396,767

 

 

$

387,228

 

The following data includes property, plant, and equipment by geographic area:

(U.S. Dollars, in thousands)

 

June 30,
2025

 

 

December 31,
2024

 

 

 

(Unaudited)

 

 

 

 

U.S.

 

$

114,012

 

 

$

125,541

 

Italy

 

 

10,085

 

 

 

9,472

 

Germany

 

 

1,794

 

 

 

1,904

 

Others

 

 

3,309

 

 

 

2,887

 

Total

 

$

129,200

 

 

$

139,804

 

 

19


 

11. Acquisition-related amortization, impairment, and remeasurement

Acquisition-related amortization, impairment, and remeasurement consists of (i) amortization and impairment related to intangible assets acquired through business combinations or asset acquisitions and (ii) remeasurement of any related contingent consideration arrangements. Components of acquisition-related amortization, impairment, and remeasurement are as follows:

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 30,

 

(Unaudited, U.S. Dollars, in thousands)

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Amortization and impairment of acquired intangibles

 

$

3,872

 

 

$

4,318

 

 

$

22,227

 

 

$

8,544

 

Changes in fair value of contingent consideration

 

 

(763

)

 

 

3,070

 

 

 

(1,373

)

 

 

4,240

 

Total

 

$

3,109

 

 

$

7,388

 

 

$

20,854

 

 

$

12,784

 

 

 

12. Share-based compensation

Components of share-based compensation expense are as follows:

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 30,

 

(Unaudited, U.S. Dollars, in thousands)

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Cost of sales

 

$

468

 

 

$

514

 

 

$

929

 

 

$

1,090

 

Sales, general, and administrative

 

 

6,915

 

 

 

8,883

 

 

 

12,564

 

 

 

16,098

 

Research and development

 

 

441

 

 

 

562

 

 

 

800

 

 

 

1,571

 

Total

 

$

7,824

 

 

$

9,959

 

 

$

14,293

 

 

$

18,759

 

 

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 30,

 

(Unaudited, U.S. Dollars, in thousands)

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Stock options

 

$

1,594

 

 

$

1,382

 

 

$

2,463

 

 

$

2,500

 

Market-based stock options

 

 

592

 

 

 

499

 

 

 

1,238

 

 

 

826

 

Time-based restricted stock awards and units

 

 

3,528

 

 

 

6,254

 

 

 

6,522

 

 

 

12,127

 

Market-based / performance-based restricted stock units

 

 

1,650

 

 

 

1,303

 

 

 

3,070

 

 

 

2,141

 

Stock purchase plan

 

 

460

 

 

 

521

 

 

 

1,000

 

 

 

1,165

 

Total

 

$

7,824

 

 

$

9,959

 

 

$

14,293

 

 

$

18,759

 

During the three months ended June 30, 2025, and 2024, the Company issued 0.4 million and 0.6 million shares, respectively, of common stock related to stock purchase plan issuances, stock option exercises, and the vesting of restricted stock awards and units. During the six months ended June 30, 2025, and 2024, the Company issued 1.0 million and 0.9 million shares, respectively, of common stock related to stock purchase plan issuances, stock option exercises, and the vesting of restricted stock awards and units.

 

13. Income taxes

Generally, income tax provisions for interim periods are based on an estimated annual income tax rate, adjusted for discrete tax items, with any changes affecting the estimated annual effective tax rate recorded in the interim period in which the change occurs. Due to the impact of losses not benefited by the Company's U.S., Canadian and Italian operations, the Company determined the estimated annual effective tax rate method would not provide a reliable estimate of the Company's overall annual effective tax rate. As such, the Company has calculated the tax provision using the actual effective rate for the three and six months ended June 30, 2025. Due to the impact of temporary differences on the U.S. current tax liability without any deferred tax benefit, the actual effective rate may vary in future quarters.

For the three months ended June 30, 2025, and 2024, the effective tax rate was 1.0% and (3.3%), respectively. For the six months ended June 30, 2025, and 2024, the effective tax rate was (1.2%) and (2.9%), respectively. The primary factors affecting the Company's effective tax rate for the three and six months ended June 30, 2025, were certain losses not benefited and tax amortization on certain acquired intangibles.

20


 

14. Earnings per share ("EPS")

For the three and six months ended June 30, 2025, no 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 diluted EPS computations.

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 30,

 

(Unaudited, In thousands)

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Weighted average common shares-basic

 

 

39,501

 

 

 

38,020

 

 

 

39,317

 

 

 

37,787

 

Effect of dilutive securities

 

 

 

 

 

 

 

 

 

 

 

 

Unexercised stock options and stock purchase plan

 

 

 

 

 

 

 

 

 

 

 

 

Unvested restricted stock units

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares-diluted

 

 

39,501

 

 

 

38,020

 

 

 

39,317

 

 

 

37,787

 

 

There were 8.7 million and 7.1 million weighted average outstanding options, time-based restricted stock awards and units, performance-based stock units, and market-based stock units not included in the diluted EPS computation for the three months ended June 30, 2025, and 2024, respectively, and 8.4 million and 6.9 million weighted average outstanding options, time-based restricted stock awards and units, performance-based stock units, and market-based stock units not included in the diluted EPS computation for the six months ended June 30, 2025, and 2024, 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.

15. Discontinuation of M6 product lines

In February 2025, the Company announced its plan to discontinue its M6-C artificial cervical disc and M6-L artificial lumbar disc product lines (together, the "M6 artificial discs" or "M6 product lines") in order to allocate associated resources and investment to more profitable growth opportunities. In accordance with ASC 205, Presentation of Financial Statements, the Company determined that the discontinuation of the M6 artificial disc does not represent a strategic shift that will have a major effect on its consolidated financial results. Therefore, any related financial results were not reported as discontinued operations. Although the M6 product lines did not meet the criteria to be considered a discontinued operation, these assets were determined to meet the criteria to be classified as held for sale as of March 31, 2025, as the Company expected to complete the sale of these assets before December 31, 2025.

During the second quarter of 2025, following several months of marketing and holding the M6 product lines for sale, the Company has determined that it is no longer probable that a sale of the M6 product lines will be completed within one year; therefore, the assets no longer qualify to be classified as held for sale. In accordance with this determination, all assets and liabilities associated with the M6 product lines have now been reclassified from held for sale to held and used. However, the Company has also fully impaired all assets associated with the M6 product lines as of June 30, 2025.

Financial results for the Company's M6 product lines continue to be presented within the Company's consolidated statements of operations and comprehensive loss. A summary of impairment charges recognized during the three and six months ended June 30, 2025, and the associated financial statement lines in which such costs are recognized is shown in the table below. All such changes are included within the Company's Global Spine reporting segment.

 

(Unaudited, U.S. Dollars, in thousands)

Financial Statement Line Item

Three Months Ended June 30, 2025

 

 

Six Months Ended June 30, 2025

 

Inventory reserve charges

Cost of sales

$

2,548

 

 

$

11,251

 

Impairment of property, plant, and equipment

Operating expenses

 

608

 

 

 

6,834

 

Impairment of developed technology intangible asset

Acquisition-related amortization, impairment, and remeasurement

 

 

 

 

14,097

 

Loss on M6 inventories and long-lived assets held for sale

$

3,156

 

 

$

32,182

 

 

21


 

16. Subsequent events

On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was signed into law, which includes a broad range of tax reform provisions affecting businesses. The OBBBA includes numerous changes to existing tax law including extending or making permanent certain business and international tax measures initially established under the 2017 Tax Cuts and Jobs Act, which were set to expire. Additionally, the OBBBA permanently eliminates the requirement to capitalize and amortize U.S. based research and experimental expenditures over five years, making these expenditures fully deductible in the period incurred and returns the interest limitation rules under Internal Revenue Code Section 163(j) to be calculated on tax basis EBITDA as opposed to earnings before interest and taxes (EBIT). The Company expects these provisions to impact deferred tax assets with a corresponding change in the U.S. valuation allowance. The Company will continue to analyze the OBBBA and its impact on its financial statements.

 

22


 

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis of Orthofix Medical Inc.'s (sometimes referred to as "we," "us" or "our") financial condition and results of operations should be read in conjunction with the discussion under the heading "Forward-Looking Statements" and our condensed consolidated financial statements and related notes thereto appearing elsewhere in this Form 10-Q.

Executive Summary

We are a global medical technology company headquartered in Lewisville, Texas. By providing medical technologies that heal musculoskeletal pathologies, we deliver exceptional experiences and life-changing solutions to patients around the world. We offer a comprehensive portfolio of spinal hardware, bone growth therapies, specialized orthopedic solutions, biologics, and enabling technologies, including the 7D FLASH navigation system. To learn more, visit Orthofix.com and follow on LinkedIn. Information included on our website is not incorporated into, or otherwise creates a part of, this report.

Notable financial metrics in the second quarter of 2025 and recent achievements include the following:

Second quarter 2025 net sales of $203.1 million, including sales from our M6 artificial cervical and lumbar discs, and pro forma net sales of $200.7 million, excluding sales from our M6 discs, representing an increase of 2% on a reported basis and 4% on a pro forma constant currency basis compared to second quarter 2024
U.S. Spine Fixation net sales growth of 5% and procedure volume growth of 7% compared to second quarter 2024
Bone Growth Therapies ("BGT") net sales of $62.6 million, representing growth of 6%, with BGT Fracture net sales growth of 7% compared to second quarter 2024
Global Orthopedics net sales of $33.3 million, achieving constant currency growth of 5%, and U.S. Orthopedics net sales growth of 28% compared to second quarter 2024
Initiated global commercial launch of the TrueLok Elevate Transverse Bone Transport ("TBT") System – the first FDA-cleared device for TBT to correct non-unions and bony or soft tissue deformities or defects
Announced U.S. commercial launch of the Reef L Interbody System – completes Reef interbody product family with a full-spectrum solution for lateral lumbar spinal fusion procedures
Second quarter 2025 net loss of $(14.1) million on a reported basis; Non-GAAP pro forma adjusted EBITDA of $20.6 million, with pro forma adjusted EBITDA margin expanding approximately 190 basis points compared to reported non-GAAP adjusted EBITDA for the second quarter 2024
Six consecutive quarters of adjusted EBITDA margin expansion; positive free cash flow of $4.5 million for second quarter 2025

 

Results of Operations

The following table provides certain items in our condensed consolidated statements of operations as a percent of net sales:

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 30,

 

(Unaudited)

 

2025
(%)

 

 

2024
(%)

 

 

2025
(%)

 

 

2024
(%)

 

Net sales

 

 

100.0

 

 

 

100.0

 

 

 

100.0

 

 

 

100.0

 

Cost of sales

 

 

31.3

 

 

 

32.2

 

 

 

34.2

 

 

 

32.3

 

Gross profit

 

 

68.7

 

 

 

67.8

 

 

 

65.8

 

 

 

67.7

 

Sales, general, and administrative

 

 

67.3

 

 

 

67.5

 

 

 

67.9

 

 

 

68.7

 

Research and development

 

 

7.8

 

 

 

9.1

 

 

 

9.0

 

 

 

9.7

 

Acquisition-related amortization, impairment, and remeasurement

 

 

1.5

 

 

 

3.7

 

 

 

5.3

 

 

 

3.3

 

Operating loss

 

 

(7.9

)

 

 

(12.5

)

 

 

(16.4

)

 

 

(14.0

)

Net loss

 

 

(6.9

)

 

 

(16.8

)

 

 

(16.9

)

 

 

(17.9

)

 

23


 

Net Sales by Product Category and Reporting Segment

Our operations are managed through two reporting segments: Global Spine and Global Orthopedics. The following table provides net sales by product category by reporting segment:

 

 

Three Months Ended June 30,

 

(Unaudited, U.S. Dollars, in millions)

 

2025

 

 

2024

 

 

Change

 

 

Constant
Currency
Change

 

Bone Growth Therapies

 

$

62.6

 

 

$

59.1

 

 

 

5.8

%

 

 

5.8

%

Spinal Implants, Biologics and Enabling Technologies*

 

 

104.8

 

 

 

103.1

 

 

 

1.6

%

 

 

1.6

%

Global Spine*

 

 

167.4

 

 

 

162.2

 

 

 

3.2

%

 

 

3.2

%

Global Orthopedics

 

 

33.3

 

 

 

30.6

 

 

 

8.9

%

 

 

5.3

%

Pro forma net sales*

 

 

200.7

 

 

 

192.8

 

 

 

4.1

%

 

 

3.5

%

Impact from discontinuation of M6 product lines

 

 

2.5

 

 

 

5.8

 

 

 

(57.5

%)

 

 

(57.8

%)

Reported net sales

 

$

203.1

 

 

$

198.6

 

 

 

2.3

%

 

 

1.7

%

 

 

 

Six Months Ended June 30,

 

(Unaudited, U.S. Dollars, in millions)

 

2025

 

 

2024

 

 

Change

 

 

Constant
Currency
Change

 

Bone Growth Therapies

 

$

117.6

 

 

$

111.6

 

 

 

5.4

%

 

 

5.4

%

Spinal Implants, Biologics and Enabling Technologies*

 

 

209.1

 

 

 

205.4

 

 

 

1.8

%

 

 

1.8

%

Global Spine*

 

 

326.7

 

 

 

317.0

 

 

 

3.1

%

 

 

3.1

%

Global Orthopedics

 

 

63.1

 

 

 

57.9

 

 

 

9.0

%

 

 

8.2

%

Pro forma net sales*

 

 

389.8

 

 

 

374.9

 

 

 

4.0

%

 

 

3.9

%

Impact from discontinuation of M6 product lines

 

 

6.9

 

 

 

12.3

 

 

 

(44.0

%)

 

 

(43.9

%)

Reported net sales

 

$

396.7

 

 

$

387.2

 

 

 

2.5

%

 

 

2.4

%

* Results above for each of Spinal Implants, Biologics, and Enabling Technologies; Global Spine; and pro forma net sales exclude the impact of the Company's discontinuation of its M6 product lines. As pro forma net sales represent a Non-GAAP measure, see the reconciliation above of the Company's pro forma net sales to its reported figures under U.S. GAAP. The Company's reported figures under U.S. GAAP represent each of the pro forma line items discussed above plus the impact from discontinuation of the M6 product lines shown above.

Global Spine

Global Spine offers the following product categories:

-
Bone Growth Therapies, which manufactures, distributes, sells, and provides support services for market-leading devices used adjunctively in high-risk spinal fusion procedures and treats both nonunion and acute fractures in the orthopedic space. Bone Growth Therapies uses distributors and a direct sales channel to sell its devices and provide associated support services to hospitals, healthcare providers, and patients in the U.S.
-
Spinal Implants, Biologics, and Enabling Technologies is comprised of a broad portfolio of spine fixation implant products used in surgical procedures of the spine, which includes one of the most comprehensive biologics portfolios in both the demineralized bone matrix and cellular allograft market segments and 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.

Three months ended June 30, 2025 compared to 2024

Net sales of $169.8 million, an increase of $1.8 million or 1.1%

Bone Growth Therapies net sales increased $3.4 million, or 5.8%, largely driven by (i) favorable changes in average sales prices, (ii) increase in gross order volumes from our continued investment in our direct sales channels for both the spine and fracture markets, and (iii) continued share growth of AccelStim

24


 

Spinal Implants, Biologics, and Enabling Technologies net sales, excluding sales from the M6 product lines, increased $1.7 million, or 1.6%, primarily due to increased sales growth from new and existing high-volume distribution partners, particularly within Spinal Implants, which saw growth in its cervical and thoracolumbar franchises; growth in these areas were partially offset by a decline in Biologics net sales
Net sales from the M6 product lines decreased $3.3 million, or 57.6%, as a result of the announcement and discontinuation of the product lines to focus resources and investment in more profitable growth opportunities

Six months ended June 30, 2025 compared to 2024

Net sales of $333.7 million, an increase of $4.3 million or 1.3%

Bone Growth Therapies net sales increased $6.0 million, or 5.4%, largely driven by (i) favorable changes in average sales prices, (ii) increase in gross order volumes from our continued investment in our direct sales channels for both the spine and fracture markets, and (iii) continued share growth of AccelStim
Spinal Implants, Biologics, and Enabling Technologies net sales, excluding sales from the M6 product lines, increased $3.7 million, or 1.8%, primarily due to increased sales growth from new and existing high-volume distribution partners, particularly within Spinal Implants, which saw growth in each of cervical, interbody, thoracolumbar, and spine fixation franchises; growth in these areas were partially offset by a decline in Biologics net sales
Net sales from the M6 product lines decreased $5.4 million, or 44.0%, as a result of the announcement and discontinuation of the product lines to focus resources and investment in more profitable growth opportunities

 

Global Orthopedics

Global Orthopedics offers products and solutions for the underserved limb reconstruction market that encompasses four pillars: deformity correction, limb lengthening, complex fracture management, and limb preservation. Global Orthopedics sells its products through a global network of distributors and sales representatives to hospitals, healthcare organizations, and healthcare providers.

Three months ended June 30, 2025 compared to 2024

Net sales of $33.3 million, an increase of $2.7 million or 8.9% on a reported basis and 5.3% on a constant currency basis

U.S. growth of $2.1 million, or 27.7%, largely due to investments made in recent product launches, commercial execution within our sales channel, and from growth within our TrueLok and Fitbone product lines
International sales decreased $0.5 million, or 2.2% on a constant currency basis, primarily driven by large orders made by non-governmental organizations in the prior year partially offset by growth within our TrueLok and Fitbone product lines in Europe
Increase of $1.1 million due to movement in foreign currency exchange rates, which had a favorable impact on net sales in the quarter

Six months ended June 30, 2025 compared to 2024

Net sales of $63.1 million, an increase of $5.2 million or 9.0% on a reported basis and 8.2% on a constant currency basis

U.S. growth of $3.0 million, or 18.7%, largely due to investments made in recent product launches, commercial execution within our sales channel, and from growth within our TrueLok, Fitbone, and OSCAR PRO product lines
International growth of $1.8 million, or 4.3% on a constant currency basis, primarily driven by recent product launches in Europe and timing of certain tender offers and stocking distributor orders
Increase of $0.4 million due to movement in foreign currency exchange rates, which had a favorable impact on net sales in the quarter

25


 

Gross Profit

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

(Unaudited, U.S. Dollars, in thousands)

 

2025

 

 

2024

 

 

% Change

 

 

2025

 

 

2024

 

 

% Change

 

Net sales

 

$

203,121

 

 

$

198,620

 

 

 

2.3

%

 

$

396,767

 

 

$

387,228

 

 

 

2.5

%

Cost of sales

 

 

63,588

 

 

 

63,871

 

 

 

(0.4

%)

 

 

135,615

 

 

 

125,237

 

 

 

8.3

%

Gross profit

 

$

139,533

 

 

$

134,749

 

 

 

3.6

%

 

$

261,152

 

 

$

261,991

 

 

 

(0.3

%)

Gross margin

 

 

68.7

%

 

 

67.8

%

 

 

0.9

%

 

 

65.8

%

 

 

67.7

%

 

 

-1.8

%

Three months ended June 30, 2025 compared to 2024

Gross profit increased $4.8 million

Increase in gross profit of $3.0 million driven by a reduction of amortization of the inventory fair value step-up recognized in the merger with SeaSpine Holdings Corporation (the "SeaSpine Merger"), which were amortized over the expected sales cycles of the acquired inventory and concluded in December 2024
Increase in gross profit also driven by net sales growth across all principal product categories and from reduced headcount and overhead costs as a result of our decision to discontinue the M6 product lines
Partially offset by an increase in inventory reserve expenses of $2.8 million, primarily driven by our decision to discontinue the M6 product lines in order to focus resources and investments on more profitable growth opportunities

Six months ended June 30, 2025 compared to 2024

Gross profit decreased $0.8 million

Decrease in gross profit of $11.6 million resulting from an increase in inventory reserve expenses, primarily driven by our decision to discontinue the M6 product lines in order to focus resources and investments on more profitable growth opportunities
Partially offset by increase in gross profit of $6.1 million driven by a reduction of amortization of the inventory fair value step-up recognized in the SeaSpine Merger, which were amortized over the expected sales cycles of the acquired inventory and concluded in December 2024
Further offset by an increase in gross profit driven by net sales growth across all principal product categories

Sales, General, and Administrative Expense

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

(Unaudited, U.S. Dollars, in thousands)

 

2025

 

 

2024

 

 

% Change

 

 

2025

 

 

2024

 

 

% Change

 

Sales, general, and administrative

 

$

136,493

 

 

$

134,218

 

 

 

1.7

%

 

$

269,474

 

 

$

265,909

 

 

 

1.3

%

As a percentage of net sales

 

 

67.2

%

 

 

67.6

%

 

 

(0.4

%)

 

 

67.9

%

 

 

68.7

%

 

 

(0.8

%)

Three months ended June 30, 2025 compared to 2024

Sales, general, and administrative expense increased $2.3 million

Increase of approximately $4.0 million in compensation related costs, including variable compensation, due to the increase in net sales and from increased headcount
Increase of $3.9 million associated with certain legal matters, including our ongoing arbitration claims with former executives and the related securities class action complaints
Partially offset by a decrease of $5.3 million in succession charges as a result of changes made in our executive leadership positions in the prior year

Six months ended June 30, 2025 compared to 2024

Sales, general, and administrative expense increased $3.6 million

Increase of $7.4 million related to impairments on certain assets and losses incurred as a result of our decision to discontinue the M6 product lines

26


 

Increase of $4.6 million associated with certain legal matters, including our ongoing arbitration claims with former executives and the related securities class action complaints
Partially offset by a decrease of $6.1 million in succession charges as a result of changes made in our executive leadership positions in the prior year
Partially offset by a decrease of $2.3 million in integration-related costs, mostly stemming from severance expenses and professional fees incurred in the prior year

Research and Development Expense

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

(Unaudited, U.S. Dollars, in thousands)

 

2025

 

 

2024

 

 

% Change

 

 

2025

 

 

2024

 

 

% Change

 

Research and development

 

$

15,934

 

 

$

18,049

 

 

 

(11.7

%)

 

$

35,700

 

 

$

37,541

 

 

 

(4.9

%)

As a percentage of net sales

 

 

7.8

%

 

 

9.1

%

 

 

(1.3

%)

 

 

9.0

%

 

 

9.7

%

 

 

(0.7

%)

Three months ended June 30, 2025 compared to 2024

Research and development expense decreased $2.1 million

Primarily due to synergies achieved of around $2.5 million in comparison to the second quarter of 2024 as a result of our recent restructuring activities, mostly related to headcount, professional fees, and reduced spend for clinical studies as a result of our decision to discontinue the M6 product lines
Partially offset by an increase in legal settlement expenses of $0.5 million

Six months ended June 30, 2025 compared to 2024

Research and development expense decreased $1.8 million

Primarily due to synergies achieved of around $6.0 million in comparison to 2024 as a result of our recent restructuring activities, mostly related to headcount, professional fees, and reduced spend for clinical studies as a result of our decision to discontinue the M6 product lines
Further driven by a reduction of $0.7 million in costs to comply with the European Union Medical Device Regulations
Partially offset by $3.7 million related to the impairments associated with our discontinuation of the M6 product lines and other organizational restructuring activities
Partially offset by an increase in legal settlement expenses of $0.5 million

Acquisition-related Amortization, Impairment, and Remeasurement

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

(Unaudited, U.S. Dollars, in thousands)

 

2025

 

 

2024

 

 

% Change

 

 

2025

 

 

2024

 

 

% Change

 

Acquisition-related amortization, impairment, and remeasurement

 

$

3,109

 

 

$

7,388

 

 

 

(57.9

%)

 

$

20,854

 

 

$

12,784

 

 

 

63.1

%

As a percentage of net sales

 

 

1.5

%

 

 

3.7

%

 

 

(2.2

%)

 

 

5.3

%

 

 

3.2

%

 

 

2.1

%

Acquisition-related amortization, impairment, and remeasurement consists of (i) amortization and impairment related to intangible assets acquired through business combinations or asset acquisitions and (ii) remeasurement of related contingent consideration arrangements, which are recognized immediately upon acquisition.

Three months ended June 30, 2025 compared to 2024

Acquisition-related amortization, impairment, and remeasurement decreased $4.3 million

Decrease of $3.8 million associated with the remeasurement of a contingent consideration obligation with Lattus Spine LLC assumed in the SeaSpine Merger
Decrease of $0.4 million in amortization expense of acquired intangibles, primarily as a result of our decision in the first quarter of 2025 to discontinue the M6 product lines and other product portfolio decisions

27


 

Six months ended June 30, 2025 compared to 2024

Acquisition-related amortization, impairment, and remeasurement increased $8.1 million

Increase of $13.7 million in amortization and impairment expense of acquired intangibles, primarily associated with the impairment of certain acquired intangible assets as a result of the discontinuation of the M6 product lines and other product portfolio decisions
Partially offset by a decrease of $5.6 million associated with the remeasurement of a contingent consideration obligation with Lattus Spine LLC assumed in the SeaSpine Merger

Non-operating Income and Expense

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

(Unaudited, U.S. Dollars, in thousands)

 

2025

 

 

2024

 

 

% Change

 

 

2025

 

 

2024

 

 

% Change

 

Interest expense, net

 

$

(3,950

)

 

$

(4,943

)

 

 

(20.1

%)

 

$

(8,456

)

 

$

(9,501

)

 

 

(11.0

%)

Other income/(expense), net

 

 

5,730

 

 

 

(2,510

)

 

 

(328.3

%)

 

 

6,976

 

 

 

(3,784

)

 

 

(284.4

%)

Three months ended June 30, 2025 compared to 2024

Interest expense, net decreased $1.0 million

Favorable change of $0.8 million associated with interest earned associated with certain Employee Retention Credit refunds received during the second quarter of 2025
Favorable change of $0.3 million attributable to a decrease in interest expense resulting from the amortization of debt issuance costs

Other income (expense), net increased $8.2 million

Favorable change of $3.6 million associated with foreign currency exchange rates, as we recorded a non-cash remeasurement gain of $2.7 million in the second quarter of 2025 compared to a loss of $0.9 million in the second quarter of 2024
Increase of $2.8 million associated with the receipt of Employee Retention Credit refunds received during the second quarter of 2025
Increase of $1.4 million associated with the impairment of certain investments measured at fair value in the prior year

Six months ended June 30, 2025 compared to 2024

Interest expense, net decreased $1.0 million

Favorable change of $0.8 million associated with interest earned associated with certain Employee Retention Credit refunds received during the second quarter of 2025
Favorable change of $0.7 million attributable to a decrease in interest expense resulting from the amortization of debt issuance costs
Partially offset by a decrease of $0.3 million of interest income as a result of the conversion of our former convertible loan with Neo Medical into preferred equity securities in the second quarter of 2024

Other income (expense), net increased $10.8 million

Favorable change of $6.2 million associated with foreign currency exchange rates, as we recorded a non-cash remeasurement gain of $3.8 million in 2025 compared to a loss of $2.4 million in 2024
Increase of $2.8 million associated with the receipt of Employee Retention Credit refunds received during the second quarter of 2025
Increase of $1.4 million associated with the impairment of certain investments measured at fair value in the prior year

28


 

Income Taxes

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

(Unaudited, U.S. Dollars, in thousands)

 

2025

 

 

2024

 

 

% Change

 

 

2025

 

 

2024

 

 

% Change

 

Income tax (benefit) expense

 

$

(142

)

 

$

1,084

 

 

 

(113.1

%)

 

$

819

 

 

$

1,935

 

 

 

(57.7

%)

Effective tax rate

 

 

1.0

%

 

 

(3.3

%)

 

 

4.3

%

 

 

(1.2

%)

 

 

(2.9

%)

 

 

1.7

%

Three months ended June 30, 2025 compared to 2024

The decrease in tax expense compared to the prior year period is primarily due to decreased tax on foreign operations and tax benefit related to certain long-lived intangible assets
The primary factor affecting our tax expense for the second quarter of 2025 compared to the prior year period was tax amortization on certain acquired intangibles and financial statement losses not benefitted

Six months ended June 30, 2025 compared to 2024

The decrease in tax expense compared to the prior year period is primarily due to decreased tax on foreign operations and tax benefit related to certain long-lived intangible assets
The primary factor affecting our tax expense for the second quarter of 2025 compared to the prior year period was tax amortization on certain acquired intangibles and financial statement losses not benefitted

Liquidity and Capital Resources

Cash, cash equivalents, and restricted cash at June 30, 2025, totaled $68.7 million compared to $85.7 million at December 31, 2024. The following table presents the net change in cash, cash equivalents, and restricted cash for the six months ended June 30, 2025, and 2024, respectively:

 

 

Six Months Ended June 30,

 

(Unaudited, U.S. Dollars, in thousands)

 

2025

 

 

2024

 

 

Change

 

Net cash used in operating activities

 

$

(6,752

)

 

$

(9,611

)

 

$

2,859

 

Net cash used in investing activities

 

 

(13,833

)

 

 

(20,583

)

 

 

6,750

 

Net cash provided by financing activities

 

 

1,989

 

 

 

21,678

 

 

 

(19,689

)

Effect of exchange rate changes on cash

 

 

1,547

 

 

 

(375

)

 

 

1,922

 

Net change in cash and cash equivalents

 

$

(17,049

)

 

$

(8,891

)

 

$

(8,158

)


The following table presents free cash flow, a non-GAAP financial measure, which is calculated by subtracting capital expenditures from net cash from operating activities:

 

 

Six Months Ended June 30,

 

(Unaudited, U.S. Dollars, in thousands)

 

2025

 

 

2024

 

 

Change

 

Net cash used in operating activities

 

$

(6,752

)

 

$

(9,611

)

 

$

2,859

 

Capital expenditures

 

 

(13,845

)

 

 

(20,533

)

 

 

6,688

 

Free cash flow

 

$

(20,597

)

 

$

(30,144

)

 

$

9,547

 

Operating Activities

Cash flows from operating activities increased $2.9 million

Favorable change in net loss of $2.3 million
Favorable change of $6.9 million associated with non-cash gains and losses, such as depreciation and amortization, inventory reserve expenses, the amortization of the inventory fair value step-up recognized in the SeaSpine Merger, remeasurement of contingent consideration obligations, and share-based compensation expense
Unfavorable change of $6.3 million relating to changes in working capital accounts, primarily attributable to changes in other current assets and accounts receivable

29


 

Two of our primary working capital accounts are accounts receivable and inventory. Days sales in receivables were 58 days at June 30, 2025, compared to 57 days at June 30, 2024 (calculated using second quarter net sales and ending accounts receivable). Inventory turns improved to 1.5 times as of June 30, 2025 compared to 1.2 times as of June 30, 2024 (calculated using trailing twelve-month cost of goods sold and ending net inventories).

Investing Activities

Cash flows used in investing activities decreased $6.8 million

Decrease in spend of $6.7 million in capital expenditures

Financing Activities

Cash flows from financing activities decreased $19.7 million

Decrease of $25.0 million associated with net borrowing activities related to our credit facilities
Partially offset by an increase of $3.5 million in net proceeds from the issuance of common shares
Further offset by a favorable change of $1.9 million in debt issuance costs associated with our credit facilities

Credit Facilities

On November 7, 2024, we 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 our 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 our option from January 1, 2025 through June 30, 2026, subject to, among other conditions, our continued 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 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 Agreement contains financial covenants requiring us to maintain a minimum level of liquidity at all times and to maintain a maximum total debt-to-EBITDA leverage ratio (measured on a quarterly basis) during the term of the facility. As of June 30, 2025, we were in compliance with all required financial covenants.

As of June 30, 2025, we had $160.0 million of outstanding borrowings under the Credit Agreement related to the Initial Term Loan. We have not made any borrowings under the Delayed Draw Term Loans as of June 30, 2025.

As of June 30, 2025, we had no borrowings on our available lines of credit in Italy, which provide up to an aggregate amount of €5.5 million ($6.5 million).

Other

For information regarding contingencies, see Note 7 to the Notes to the Unaudited Condensed Consolidated Financial Statements contained herein.

Lattus Spine LLC ("Lattus") Contingent Consideration

Under the terms of a contingent consideration obligation in a purchase agreement assumed in the SeaSpine Merger, we 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 contingent consideration arrangement as of June 30, 2025, was $14.0 million; however, the actual amount ultimately paid could be higher or lower than the estimated fair value of the contingent consideration. As of June 30, 2025, we classified the remaining contingent consideration liability of $10.5 million and $3.5 million within other current liabilities and

30


 

other long-term liabilities, respectively. For additional discussion of this matter, see Note 6 of the Notes to the Unaudited Condensed Consolidated Financial Statements.

Off-balance Sheet Arrangements

As of June 30, 2025, we did not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, cash flows, liquidity, capital expenditures or capital resources that are material to investors.

Contractual Obligations

There have been no material changes in any of our material contractual obligations as disclosed in our Form 10-K for the year ended December 31, 2024.

Critical Accounting Estimates

Our discussion of operating results is based upon the condensed consolidated financial statements and accompanying notes. The preparation of these statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amount of revenues and expenses during the reporting period. Our critical accounting estimates are described in Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2024. There have been no significant changes to our critical accounting estimates during the quarter covered by this report.

Recently Issued Accounting Pronouncements

See Note 2 of the Notes to the Unaudited Condensed Consolidated Financial Statements for detailed information regarding the status of recently issued or adopted accounting pronouncements.

Non-GAAP Financial Measures

We believe that providing non-GAAP financial measures that exclude certain items provides investors with greater transparency to the information used by senior management in its financial and operational decision-making. We believe it is important to provide investors with the same non-GAAP financial measures used to supplement information regarding the performance and underlying trends of our business operations to facilitate comparisons to historical operating results and internally evaluate the effectiveness of our operating strategies. Disclosure of these non-GAAP financial measures also facilitates comparisons of our underlying operating performance with other companies in the industry that also supplement their U.S. GAAP results with non-GAAP financial measures.

The non-GAAP financial measures used in this filing may have limitations as analytical tools and should not be considered in isolation or as a replacement for U.S. GAAP financial measures. Some limitations associated with the use of these non-GAAP financial measures are that they exclude items that reflect an economic cost that can have a material effect on cash flows.

Constant Currency

Constant currency is calculated by using foreign currency rates from the comparable, prior year period to present net sales at comparable rates. Constant currency can be presented for numerous U.S. GAAP measures but is most commonly used by management to analyze net sales without the impact of changes in foreign currency rates.

Free Cash Flow

Free cash flow is calculated by subtracting capital expenditures from net cash from operating activities. Management uses free cash flow as an important indicator of how much cash is generated or used by our normal business operations, including capital expenditures. Management uses free cash flow as a measure of progress on its capital efficiency and cash flow initiatives.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

There have been no material changes to our market risks as disclosed in our Form 10-K for the year ended December 31, 2024.

31


 

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures (as defined in Rule 13a-15(e) of the Exchange Act) designed to provide reasonable assurance that the information required to be disclosed in reports filed or submitted under the Exchange Act are recorded, processed, summarized, and reported within the time periods specified in the SEC's rules and forms. These include controls and procedures designed to ensure that this information is accumulated and communicated to management, including our Chief Executive Officer and our Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure. Management, with the participation of the Chief Executive Officer and the Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2025. Based on this evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of June 30, 2025.

Changes in Internal Control over Financial Reporting

There was no change in our internal control over financial reporting that occurred during the quarterly period covered by this report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

32


 

PART II. OTHER INFORMATION

For information regarding legal proceedings, see Note 7 to the Notes to the Unaudited Condensed Consolidated Financial Statements contained herein, which is incorporated by reference into this Part II, Item 1.

Item 1A. Risk Factors

There have been no material changes from the risk factors disclosed in "Part I, Item 1A. Risk Factors" in our Form 10-K for the year ended December 31, 2024.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

We have not made any repurchases of our common stock during the second quarter of 2025.

Item 3. Defaults Upon Senior Securities

Not applicable.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

During the last fiscal quarter, none of our directors or officers (as defined in Rule 16a-1(f) of the Exchange Act) adopted, modified or terminated any contract, instruction, or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) of the Exchange Act or any "non-Rule 10b5-1 trading arrangement."

Item 6. Exhibits

10.1*†

 

Lease Agreement between Armada Drive Carlsbad LLC and Orthofix Medical Inc dated April 1, 2025

 

 

 

  31.1*

 

Rule 13a-14(a)/15d-14(a) Certification of Chief Executive Officer.

 

 

 

  31.2*

 

Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer.

 

 

 

  32.1#

 

Section 1350 Certifications of each of the Chief Executive Officer and Chief Financial Officer.

 

 

 

  101.INS*

 

Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document).

 

 

 

  101.SCH*

 

Inline XBRL Taxonomy Extension Schema Document.

 

 

 

  101.CAL*

 

Inline XBRL Taxonomy Extension Calculation Linkbase Document.

 

 

 

  101.DEF*

 

Inline XBRL Taxonomy Extension Definition Linkbase Document.

 

 

 

  101.LAB*

 

Inline XBRL Taxonomy Extension Label Linkbase Document.

 

 

 

  101.PRE*

 

Inline XBRL Taxonomy Extension Presentation Linkbase Document.

 

 

 

  104*

 

Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101).

* Filed herewith.

† Certain private and confidential portions of this exhibit that are not material were omitted by means of redacting a portion of the text and replacing it with a bracketed asterisk.

# Furnished herewith.

33


 

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

ORTHOFIX MEDICAL INC.

 

 

Date: August 5, 2025

By:

 

/s/ MASSIMO CALAFIORE

Name:

 

Massimo Calafiore

Title:

 

President and Chief Executive Officer

 

 

 

 

Date: August 5, 2025

By:

 

/s/ JULIE ANDREWS

Name:

 

Julie Andrews

Title:

 

Chief Financial Officer

 

34



ATTACHMENTS / EXHIBITS

ATTACHMENTS / EXHIBITS

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EX-32.1

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