Orthofix Reports Fourth Quarter and Full-Year 2025 Financial Results and Provides 2026 Financial Guidance

LEWISVILLE, Texas--( BUSINESS WIRE)--Orthofix Medical Inc. (NASDAQ:OFIX), a leading global medical technology company, today reported its financial results for the fourth quarter and full-year ended December 31, 2025, provided full-year 2026 financial guidance and updated its three-year financial targets. All pro forma measures contained within this release exclude the impact of the Company’s decision to discontinue its M6™ product lines.

Highlights

“The fourth quarter capped a year of meaningful operational progress for Orthofix,” said Massimo Calafiore, President and Chief Executive Officer. “Throughout 2025, BGT and U.S. Limb Reconstruction delivered strong performance, and the work we did to finalize our Spine commercial channel supported double-digit year‑over‑year constant currency net sales growth in our global Spine Fixation business. This momentum contributed to our eighth consecutive quarter of adjusted EBITDA growth and a standout quarter of free cash flow generation, clear evidence of the strength of our focused initiatives and margin-enhancement efforts.”

Mr. Calafiore added, “As we move into 2026, our priorities remain centered on expanding market penetration, accelerating adoption of enabling technologies, such as 7D FLASH™ Navigation, and advancing commercial execution. With full-year contributions from the TRUELOK™ Elevate System and the FITBONE™ Bone Transport and Trochanteric Lengthening Nails, the planned second-half full launch of VIRATA™, continued Spine commercial channel optimization, a renewed focus on advancing our Biologics portfolio, and sustained momentum across our Limb Reconstruction and BGT businesses, we believe the Company is well-positioned to deliver durable top-line growth, expanding margins, and strong free cash flow that supports long-term shareholder value.”

1 Spine Fixation is comprised of the Company’s Spinal Implants product category, excluding motion preservation product offerings

Financial Results Overview

Fourth Quarter 2025 Net Sales and Financial Results

The following table provides net sales by major product category and by reporting segment on a pro forma basis, removing the effects of the Company’s discontinued M6 product lines:

Three Months Ended December 31,

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

2025

2024

Change

Constant

Currency

Change

Bone Growth Therapies

68.3

63.9

7.0

Spinal Implants, Biologics and Enabling Technologies*

112.3

110.2

1.9

1.8

Global Spine*

180.6

174.1

3.7

Global Limb Reconstruction

38.0

35.8

6.2

(0.1

Pro forma net sales*

218.6

209.9

4.2

3.1

Impact from discontinuation of M6 product lines

1.3

5.8

(77.2

(77.5

Reported net sales

219.9

215.7

2.0

0.9

* Results above for each of Spinal Implants, Biologics, and Enabling Technologies; Global Spine; and pro forma net sales exclude the impact from discontinuation of the M6 product lines. Since 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.

For the fourth quarter 2025, net sales were $219.9 million, including sales from M6 artificial cervical and lumbar discs, and pro forma net sales were $218.6 million, excluding sales from M6 discs, representing an increase of 2.0% on a reported basis and 3.1% on a pro forma constant currency basis compared to fourth quarter 2024.

For the fourth quarter 2025, gross margins were 71.1% and were 71.4% on a non-GAAP pro forma adjusted basis.

Fourth quarter 2025 reported net loss was $(2.2) million, or $(0.06) per share compared to reported net loss of $(29.1) million, or $(0.75) per share in the prior year period. Non-GAAP pro forma adjusted EBITDA was $29.2 million, or 13.4% of pro forma net sales, in the fourth quarter of 2025, representing an increase of $5.3 million compared to reported non-GAAP adjusted EBITDA of $23.9 million, or 11.1% of reported net sales, in the fourth quarter of 2024.

Full-Year 2025 Net Sales and Financial Results

The following table provides net sales by major product category and by reporting segment on a pro forma basis, removing the effects of the Company’s discontinued M6 product lines:

Year Ended December 31,

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

2025

2024

Change

Constant

Currency

Change

Bone Growth Therapies

247.2

233.4

5.9

Spinal Implants, Biologics and Enabling Technologies*

430.0

418.5

2.8

Global Spine*

677.2

651.9

3.9

Global Limb Reconstruction

134.7

124.2

8.4

5.3

Pro forma net sales*

811.9

776.1

4.6

4.1

Impact from discontinuation of M6 product lines

10.4

23.4

(55.4

(55.5

Reported net sales

822.3

799.5

2.9

2.4

For the full-year 2025, net sales were $822.3 million, including sales from M6 artificial cervical and lumbar discs, and pro forma net sales were $811.9 million, excluding sales from M6 discs, representing an increase of 2.9% on a reported basis and 4.1% on a pro forma constant currency basis compared to full-year 2024.

For the full-year 2025, gross margins were 68.8% and were 71.6% on a non-GAAP pro forma adjusted basis.

Full-year 2025 net loss was $(92.2) million, or $(2.33) per share, compared to net loss of $(126.0) million, or $(3.30) per share in the prior year period. Full-year 2025 non-GAAP pro forma adjusted EBITDA was $85.9 million, or 10.6% of non-GAAP pro forma net sales for the same period, compared to non-GAAP adjusted EBITDA of $67.4 million, or 8.4% of reported net sales, in the prior year period.

Liquidity

Cash, cash equivalents, and restricted cash on December 31, 2025 totaled $85.1 million compared to $65.9 million on September 30, 2025.

Business Outlook

The Company is providing full-year 2026 guidance as follows:

Three-Year Financial Targets

The Company is updating its three-year financial targets and recalibrating the timeline by one year to fully capture the anticipated benefits of its Spine commercial channel optimization. This refreshed 2026-2028 outlook affirms the Company’s expectation of delivering above-market net sales growth, expanding its profitability profile, and generating sustained positive free cash flow:

An investor presentation for the Company’s fourth quarter and full-year 2025 financial results is available in the “Events & Presentations” section of the Orthofix Investor Relations Website at ir.orthofix.com.

Conference Call

Orthofix will host a conference call today at 8:30 AM Eastern time to discuss the Company’s financial results for the fourth quarter and full-year ended December 31, 2025. Interested parties may access the conference call by dialing (888) 596-4144 in the U.S., and (646) 968-2525 in all other locations, and referencing the conference ID 2236604. A webcast and replay of the conference call may be accessed in the “Events & Presentations” section of the Orthofix Investor Relations Website at ir.orthofix.com.

Internet Posting of Information

Orthofix regularly shares important updates in the “Investors” section of its website at www.orthofix.com. The Company encourages investors and potential investors to consult the Orthofix website regularly for important information about Orthofix.

About Orthofix

Orthofix is a global medical technology company headquartered in Lewisville, Texas. By providing medical technologies that heal musculoskeletal pathologies, Orthofix delivers exceptional experiences and life-changing solutions to patients around the world. Orthofix offers a comprehensive portfolio of spinal hardware, bone growth therapies, limb reconstruction solutions, biologics and enabling technologies, including the 7D FLASH Navigation System. Learn more about our surgical and therapeutic solutions at Orthofix.com and follow us on LinkedIn.

Forward-Looking Statements

This communication contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, relating to our business and financial outlook, which are based on our current beliefs, assumptions, intentions, plans, expectations, estimates, forecasts and projections. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “intends,” “predicts,” “potential,” “positioned,” “deliver,” or “continue” or other comparable terminology. Forward-looking statements in this communication include the Company’s expectations regarding net sales, adjusted EBITDA, and free cash flow for the year ended December 31, 2025. Forward-looking statements are not guarantees of our future performance, are based on our current expectations and assumptions regarding our business, the economy and other future conditions, and are subject to risks, uncertainties and changes in circumstances that are difficult to predict, including the risks described in Part I, Item 1A under the heading Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2025. Factors that could cause future results to differ from those expressed by forward-looking statements include, but are not limited to, (i) our ability to maintain operations to support our customers and patients in the near-term and to capitalize on future growth opportunities, (ii) risks associated with acceptance of surgical products and procedures by surgeons and hospitals, (iii) development and acceptance of new products or product enhancements, (iv) clinical and statistical verification of the benefits achieved via the use of our products, (v) our ability to adequately manage inventory, (vi) our ability to successfully optimize our commercial channels, (vii) our success in defending legal proceedings brought against us, and (viii) the other risks and uncertainties more fully described in our periodic filings with the Securities and Exchange Commission (the “SEC”). As a result of these various risks, our actual outcomes and results may differ materially from those expressed in these forward-looking statements.

Further, any forward-looking statement speaks only as of the date hereof, unless it is specifically otherwise stated to be made as of a different date. The Company undertakes no obligation to update, and expressly disclaims any duty to update, its forward-looking statements, whether as a result of circumstances or events that arise after the date hereof, new information, or otherwise, except as required by law.

The Company is unable to provide expectations of GAAP net income (loss), the closest comparable GAAP measures to adjusted EBITDA (which is a non-GAAP measure), on a forward-looking basis because the Company is unable to predict, without unreasonable efforts, the ultimate outcome of matters (including acquisition-related expenses, accounting fair value adjustments, and other such items) that will determine the quantitative amount of the items excluded in calculating adjusted EBITDA, which items are further described in the reconciliation tables and related descriptions below. These items are uncertain, depend on various factors, and could be material to the Company’s results computed in accordance with GAAP.

ORTHOFIX MEDICAL INC.

Condensed Consolidated Statements of Operations

Three Months Ended

Year Ended

December 31,

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

2025

2024

2025

2024

(Unaudited)

Net sales

219,911

215,657

822,312

799,491

Cost of sales

63,569

66,816

256,295

253,606

Gross profit

156,342

148,841

566,017

545,885

Sales, general, and administrative

136,752

136,479

554,329

532,525

Research and development

15,373

18,807

65,847

73,643

Acquisition-related amortization, impairment, and remeasurement

3,723

5,031

27,269

24,336

Operating income (loss)

494

(11,476

)

(81,428

)

(84,619

)

Interest expense, net

(4,351

)

(14,920

)

(17,488

)

(29,631

)

Other income (expense), net

1,665

(3,315

)

8,106

(9,625

)

Loss before income taxes

(2,192

)

(29,711

)

(90,810

)

(123,875

)

Income tax benefit (expense)

(30

)

564

(1,382

)

(2,122

)

Net loss

(2,222

)

(29,147

)

(92,192

)

(125,997

)

Net loss per common share:

Basic

(0.06

)

(0.75

)

(2.33

)

(3.30

)

Diluted

(0.06

)

(0.75

)

(2.33

)

(3.30

)

Weighted average number of common shares (in millions):

Basic

40.0

38.7

39.6

38.1

Diluted

40.0

38.7

39.6

38.1

ORTHOFIX MEDICAL INC.

Condensed Consolidated Balance Sheets

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

December 31, 2025

December 31, 2024

Assets

Current assets

Cash and cash equivalents

82,025

83,238

Restricted cash

3,090

2,500

Accounts receivable, net of allowances of $8,308 and $7,418, respectively

135,746

134,713

Inventories

172,319

189,452

Prepaid expenses and other current assets

23,667

23,382

Total current assets

416,847

433,285

Property, plant, and equipment, net

129,399

139,804

Intangible assets, net

72,765

98,803

Goodwill

194,934

Other long-term assets

36,702

26,468

Total assets

850,647

893,294

Liabilities and shareholders’ equity

Current liabilities

Accounts payable

58,392

48,803

Current portion of finance lease liability

837

755

Other current liabilities

111,253

119,070

Total current liabilities

170,482

168,628

Long-term debt

157,391

157,015

Long-term portion of finance lease liability

17,060

17,835

Other long-term liabilities

55,677

46,692

Total liabilities

400,610

390,170

Contingencies

Shareholders’ equity

Common shares $0.10 par value; 100,000 shares authorized;

39,834 and 38,486 issued and outstanding as of December 31,

2025 and 2024, respectively

3,983

3,849

Additional paid-in capital

813,769

779,718

Accumulated deficit

(368,333

)

(276,141

)

Accumulated other comprehensive income (loss)

618

(4,302

)

Total shareholders’ equity

450,037

503,124

Total liabilities and shareholders’ equity

850,647

893,294

ORTHOFIX MEDICAL INC.

Non-GAAP Financial Measures

The following tables present reconciliations of various financial measures calculated in accordance with U.S. generally accepted accounting principles (“GAAP”), to various non-GAAP financial measures that exclude (or in the case of free cash flow, include) items specified in the tables. The GAAP measures shown in the tables below represent the most comparable GAAP measure to the applicable non-GAAP measure(s) shown in the table. For further information regarding the nature of these exclusions, why the Company believes that these non-GAAP financial measures provide useful information to investors, the specific manner in which management uses these measures, and some of the limitations associated with the use of these measures, please refer to the Company’s Current Report on Form 8-K regarding this press release filed today with the SEC available on the SEC’s website at www.sec.gov and on the “Investors” page of the Company’s website at www.orthofix.com.

The Company’s non-GAAP financial measures for the three months and year ended December 31, 2025, and 2024, have been adjusted to eliminate the financial effects of the Company’s decision to discontinue its M6 product lines. Accordingly, previously reported figures for 2024 have been recast to reflect the financial impact of this decision.

Adjusted Gross Profit and Adjusted Gross Margin

Three Months Ended December 31,

Year Ended December 31,

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

2025

2024

2025

2024

Gross profit

156,342

148,841

566,017

545,885

Share-based compensation expense

398

462

1,695

2,053

SeaSpine merger-related costs

(392

)

675

4,111

6,254

Restructuring costs and impairments related to M6 product lines

(401

)

—

13,309

—

Strategic investments

192

Acquisition-related fair value adjustments

—

3,047

—

12,188

Amortization/depreciation of acquired long-lived assets

313

1,253

1,153

Adjusted gross profit

156,262

153,370

586,444

567,725

Adjusted gross margin as a percentage of reported net sales

71.1

71.3

71.0

Adjusted gross profit attributable to M6 product lines

(256

)

(3,316

)

(4,791

)

(11,556

)

Pro forma adjusted gross profit

156,006

150,054

581,653

556,169

Pro forma adjusted gross margin as a percentage of pro forma net sales

71.4

71.5

71.6

71.7

Adjusted EBITDA

Three Months Ended December 31,

Year Ended December 31,

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

2025

2024

2025

2024

Net loss

(2,222

)

(29,147

)

(92,192

)

(125,997

)

Income tax expense (benefit)

(564

)

1,382

2,122

Interest expense, net

4,351

14,920

17,488

29,631

Depreciation and amortization

13,078

15,994

77,321

60,061

Share-based compensation expense

7,214

7,165

28,688

32,455

Foreign exchange impact

314

3,132

(2,910

)

4,395

SeaSpine merger-related costs

(49

)

1,493

6,093

14,485

Restructuring costs and impairments related to M6 product lines

495

—

14,564

—

Strategic investments

821

440

4,915

910

Acquisition-related fair value adjustments

660

3,737

(1,140

)

19,088

Interest and (gain) loss on investments

)

—

(48

)

5,120

Litigation and investigation costs

5,169

5,452

33,788

15,770

Succession charges

—

1,315

—

9,376

Employee retention credit

(1,972

)

—

(4,826

)

—

Adjusted EBITDA

27,882

23,937

83,123

67,416

Adjusted EBITDA as a percentage of reported net sales

12.7

11.1

10.1

8.4

Operating losses attributable to M6 product lines

1,323

1,058

2,741

6,371

Pro forma adjusted EBITDA

29,205

24,995

85,864

73,787

Pro forma adjusted EBITDA as a percentage of pro forma net sales

13.4

11.9

10.6

9.5

Adjusted Net Income

Three Months Ended December 31,

Year Ended December 31,

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

2025

2024

2025

2024

Net loss

(2,222

)

(29,147

)

(92,192

)

(125,997

)

Share-based compensation expense

7,214

7,165

28,688

32,455

Foreign exchange impact

314

3,132

(2,910

)

4,395

SeaSpine merger-related costs

(449

)

4,430

8,962

17,864

Restructuring costs and impairments related to M6 product lines

496

—

35,495

—

Strategic investments

824

470

4,966

1,036

Acquisition-related fair value adjustments

660

3,737

(1,140

)

19,088

Amortization/depreciation of acquired long-lived assets

3,376

4,837

15,627

19,323

Litigation and investigation costs

5,169

5,452

33,788

15,770

Succession charges

—

1,315

—

9,376

Interest and (gain) loss on investments

)

—

(48

)

5,070

Employee retention credit

(2,197

)

—

(5,813

)

—

Long-term income tax rate adjustment

(3,668

)

(796

)

(6,123

)

1,981

Adjusted net income

9,510

595

19,300

361

Operating losses attributable to M6 product lines

1,336

1,533

2,282

8,261

Long-term income tax rate adjustment for M6 product lines

(374

)

(429

)

(639

)

(2,313

)

Pro forma adjusted net income

10,472

1,699

20,943

6,309

Cash Flow and Free Cash Flow

Year Ended December 31,

(U.S. Dollars, in thousands)

2025

2024

Net cash provided by operating activities

33,347

25,790

Net cash used in investing activities

(34,598

)

(27,580

)

Net cash provided by (used in) financing activities

(786

)

50,709

Effect of exchange rate changes on cash

1,414

(938

)

Net change in cash, cash equivalents, and restricted cash

(623

)

47,981

Year Ended December 31,

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

2025

2024

Net cash provided by operating activities

33,347

25,790

Capital expenditures

(34,626

)

(34,876

)

Free cash flow

(1,279

)

(9,086

)

Reconciliation of Non-GAAP Financial Measures to Reported Operating Expenses

Three Months Ended December 31,

Year Ended December 31,

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

2025

2024

2025

2024

Sales, general, and administrative

136,752

136,479

554,329

532,525

Reconciling items impacting sales, general, and administrative:

SeaSpine merger-related costs

(3,617

)

(4,614

)

(11,072

)

Restructuring costs and impairments related to M6 product lines

(898

)

—

(6,164

)

—

Strategic investments

(879

)

(456

)

(2,819

)

(602

)

Amortization/depreciation of acquired long-lived assets

)

(182

)

(61

)

(733

)

Litigation and investigation costs

(5,169

)

(5,452

)

(33,338

)

(15,770

)

Succession charges

—

(160

)

—

(8,221

)

Sales, general, and administrative expense, as adjusted

129,871

126,612

507,333

496,127

As a percentage of reported net sales

59.1

58.7

61.7

62.1

Sales, general, and administrative expense attributable to M6 product lines

(866

)

(3,667

)

(3,914

)

(14,108

)

Pro forma sales, general, and administrative expense, as adjusted

129,005

122,945

503,419

482,019

As a percentage of pro forma net sales

59.0

58.6

62.0

62.1

Three Months Ended December 31,

Year Ended December 31,

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

2025

2024

2025

2024

Research and development expense, as reported

15,373

18,807

65,847

73,643

Reconciling items impacting research and development:

SeaSpine merger-related costs

)

(154

)

(237

)

(538

)

Restructuring costs and impairments related to M6 product lines

—

(1,927

)

—

Strategic investments

(2,090

)

(242

)

Litigation and investigation costs

—

(450

)

—

Succession charges

—

(1,155

)

—

(1,155

)

Research and development expense, as adjusted

15,420

17,517

61,143

71,708

As a percentage of reported net sales

7.0

8.1

7.4

9.0

Research and development expense attributable to M6 product lines

(710

)

(2,501

)

(3,086

)

(9,364

)

Pro forma research and development expense, as adjusted

14,710

15,016

58,057

62,344

As a percentage of pro forma net sales

6.7

7.2

8.0

Reconciliations of Non-GAAP Financial Measures to Reported Non-Operating (Income) Expense

Three Months Ended December 31,

Year Ended December 31,

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

2025

2024

2025

2024

Non-operating expense

2,686

18,235

9,382

39,256

Reconciling items impacting non-operating expense:

Restructuring costs and impairments related to M6 product lines

—

Foreign exchange impact

(314

)

(3,132

)

2,910

(4,395

)

Interest and gain (loss) on investments

—

(5,070

)

Employee retention credit

2,198

—

5,814

—

Non-operating expense, as adjusted

4,577

15,103

18,157

29,791

As a percentage of reported net sales

2.1

7.0

2.2

3.7

Losses attributable to M6 product lines

(15

)

(56

)

(72

)

(144

)

Pro forma non-operating expense, as adjusted

4,562

15,047

18,085

29,647

As a percentage of pro forma net sales

2.1

7.2

2.2

3.8