OFIX

EX-99.1

2 ofix-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

News Release

Orthofix Reports First Quarter 2026 Results Highlighting Steady Execution Following Spine

Commercial Channel Actions; Reaffirms Full-Year 2026 Financial Guidance

LEWISVILLE, Texas — May 5, 2026 — Orthofix Medical Inc. (NASDAQ:OFIX), a leading global medical technology company, today reported its financial results for the first quarter ended March 31, 2026, reflecting steady execution following recent spine commercial channel actions. Based on first-quarter performance, the Company reaffirmed its full-year 2026 financial guidance. All pro forma measures contained within this release exclude the impact of the Company’s decision to discontinue its M6™ product lines.

Highlights

• First quarter 2026 reported net sales of $196.7 million, including sales from M6 artificial cervical and lumbar discs. Non-GAAP pro forma net sales of $196.4 million, excluding sales from M6 discs, increased 3% year over year on a constant currency basis, reflecting steady execution during the final stages of distributor transitions, with further improvement expected as productivity increases.

• Global Spine Fixation1 delivered reported net sales growth of 6% and constant currency growth of 6% compared to the prior year period, including U.S. Spine Fixation growth of 4%, driven by enhanced commercial focus, deeper procedural penetration, and continuing benefits from distributor transition initiatives.

• Therapeutic Solutions (formerly Bone Growth Therapies) achieved year-over-year net sales growth of 5%, supported by continued demand across the portfolio and effective commercial execution.

• Global Limb Reconstruction reported net sales growth of 10% and constant currency growth of 3% compared to the prior year period, reflecting continued demand for core fixation and reconstruction systems.

• First quarter 2026 reported net loss of $(20.9) million and non-GAAP pro forma adjusted EBITDA of $9.7 million, reflecting impacts from geography mix and commercial transitions.

“Our first-quarter results reflect steady execution as we complete key spine commercial channel actions and sharpen our strategic focus,” said Massimo Calafiore, President and Chief Executive Officer. “While the quarter continued to absorb the impact of these transitions, most notably in biologics, we saw improved commercial focus and operating discipline as the quarter progressed.”

Mr. Calafiore continued, “Importantly, distributor transitions are now largely behind us, providing greater visibility for the remainder of the year. As we move through 2026, our priorities are clear: driving more consistent commercial execution, advancing targeted innovation across our portfolio, and expanding margins through disciplined operational management. With recent spine leadership changes, a renewed focus on advancing our biologics portfolio, and planned product launches later this year, we believe Orthofix is positioned to deliver more consistent growth, expand margins, and generate strong free cash flow to support long-term shareholder value.”

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

1

Financial Results Overview

First Quarter 2026 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 March 31,

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

2026

2025

Change

Constant Currency Change

Therapeutic Solutions

$

57.8

$

55.1

4.9

%

4.9

%

Spinal Implants, Biologics and Enabling Technologies*

105.8

104.3

1.4

%

1.4

%

Global Spine*

163.6

159.4

2.6

%

2.6

%

Global Limb Reconstruction

32.8

29.8

10.2

%

3.0

%

Pro forma net sales*

196.4

189.2

3.8

%

2.7

%

Impact from discontinuation of M6 product lines

0.3

4.4

(94.2

%)

(94.5

%)

Reported net sales

$

196.7

$

193.6

1.6

%

0.4

%

* 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 first quarter of 2026, net sales were $196.7 million, including sales from M6 artificial cervical and lumbar discs, and non-GAAP pro forma net sales were $196.4 million, excluding sales from M6 discs, representing an increase of 1.6% on a reported basis and 2.7% on a non-GAAP pro forma constant currency basis compared to first quarter 2025.

For the first quarter of 2026, GAAP gross margins were 70.9% and were 70.7% on

EX-99.1

2 ofix-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

News Release

Orthofix Realigns Spine Leadership to Strengthen Focus and Execution

Company Reports Preliminary First Quarter 2026 Net Sales and Reaffirms 2026 Outlook

LEWISVILLE, Texas — April 9, 2026 — Orthofix Medical Inc. (NASDAQ:OFIX), a leading global medical technology company, today announced a strategic realignment of its Spine leadership team designed to accelerate profitable growth and sharpen execution across its commercial and innovation priorities. The Company also reported preliminary, unaudited net sales results for the first quarter ended March 31, 2026.

Spine Leadership Realignment

To accelerate decision-making, sharpen leadership accountability, and further advance commercialization of the 7D™ navigation platform, Orthofix has streamlined its Spine organization by eliminating the role of President, Global Spine Solutions. As a result, key Spine leaders will now report directly to Orthofix Chief Executive Officer, Massimo Calafiore.

• Shaeffer Bannigan, Senior Vice President Global Spinal Solutions, has assumed an expanded role as Leader, Spinal Solutions, with responsibility for overall Spine strategy, commercial operations, and portfolio innovation.

• Mark Sienkiewicz, Vice President U.S. Sales, will continue to lead spinal implant commercial execution, with priority focus on distributor expansion and onboarding.

• John Winge, Vice President Spine Commercial Strategy, will drive commercial strategies to accelerate adoption and growth of the 7D FLASH™ Navigation System.

In addition, Patrick Fisher, head of Limb Reconstruction, recently assumed leadership of the Company’s Biologics business. This expanded scope is intended to strengthen commercial focus in Biologics while leveraging operational and customer-facing synergies across complementary portfolio segments.

“These updates further clarify leadership alignment and ownership across our Spine portfolio while strengthening coordination across our commercial, strategic, and enabling technology teams,” said Massimo Calafiore, President and Chief Executive Officer. “By simplifying our structure and placing decision-making closer to execution, we believe we are better positioned to move faster, scale high-value opportunities, and deliver sustainable, profitable growth for our shareholders.”

Preliminary First Quarter 2026 Net Sales Results and 2026 Guidance

Orthofix today reported preliminary, unaudited first quarter 2026 net sales of approximately $196.7 million, including sales from M6 artificial cervical and lumbar discs, and non-GAAP pro forma net sales of approximately $196.4 million, excluding sales from M6 discs, representing an increase of 0.4% on a reported basis and 3% on a non-GAAP pro forma constant currency basis compared to Q1 2025.

The company also reaffirmed its full-year 2026 guidance as follows:

• Net sales expected to range between $850 million to $860 million. The Company’s expected net sales represent implied year-over-year pro forma constant currency growth of approximately 5.5% at the midpoint of the range. This guidance range is based on current foreign currency exchange rates and does not take into account any additional potential exchange rate changes that may occur this year.

• Non-GAAP adjusted EBITDA expected to be $95 million to $98 million. This represents 70 basis points of non-GAAP adjusted EBITDA margin expansion at the midpoint of the range compared to 2025.

• Free cash flow expected to be positive for full-year 2026, excluding the impact of any potential legal settlements.

Mr. Calafiore added, “Precise execution, faster decision-making and innovation is the focus for Orthofix in 2026. Our teams executed well to start the year, and we are proving our ability to create shareholder value. Our preliminary first quarter net sales reflect meaningful progress through recent distributor transitions as we gear up for new product launches later this year. With a clearer strategic focus, stronger leadership alignment, and an increased emphasis on high-value growth initiatives, we believe we are well positioned to scale our commercial engine, accelerate innovation, and deliver long-term value for our shareholders.”

Page 1

Preliminary First Quarter 2026 Net Sales Results

The following table provides preliminary net sales:

Three Months Ended March 31,

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

2026

2025

Change

Constant Currency Change

Pro forma net sales*

196.4

189.2

3.8

%

2.7

%

Impact from discontinuation of M6 product lines

0.3

4.4

(94.2

%)

(94.5

%)

Reported net sales

$

196.7

$

193.6

1.6

%

0.4

%

* 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 for

8-K

false000088462400008846242026-02-242026-02-24

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 24, 2026

ORTHOFIX MEDICAL INC.

(Exact name of Registrant as Specified in Its Charter)

Delaware

000-19961

98-1340767

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

3451 Plano Parkway

Lewisville, Texas

75056

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (214) 937-2000

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) 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

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). 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. ☐

Item 2.02. Results of Operations and Financial Condition. On February 24, 2026, Orthofix Medical Inc. (the “Company”) issued a news release announcing, among other things, its financial results for the fourth quarter and year ended December 31, 2025. A copy of the news release is furnished herewith as Exhibit 99.1 and attached hereto. The information furnished in this Item 2.02, including the exhibit furnished herewith as Exhibit 99.1, will not be treated as “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. This information will not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended (the “Securities Act”), or into another filing under the Exchange Act, unless that filing expressly incorporates by reference this Item 2.02 of this report. Discussion of Non-GAAP Financial Measures In addition to using standard measures of performance and liquidity that are recognized in accordance with accounting principles generally accepted in the United States of America ("GAAP"), the Company uses additional financial measures excluding certain GAAP items ("non-GAAP measures"), such as: Constant Currency Constant currency is a non-GAAP measure, which the Company calculates 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 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 a non-GAAP financial measure, which is calculated by subtracting capital expenditures from cash flow provided by or used in operating activities. Free cash flow is an important indicator of how much cash is generated or used by the Company's business operations, including capital expenditures. Management uses free cash flow to measure progress on its capital efficiency and cash flow initiatives. Adjusted Gross Profit and Adjusted Gross Margin Adjusted gross profit represents GAAP gross profit with adjustments to exclude the impact of the certain items recorded to cost of goods sold. Potential adjustments are listed within the section below under the header "Non-GAAP Adjustments." Adjusted gross margin represents adjusted gross profit as a percentage of GAAP net sales. Adjusted Net Income (Loss) Adjusted net income (loss) represents GAAP net loss with adjustments to exclude the impact of certain items recorded in such GAAP net loss. Potential adjustments are listed within the section below under the header "Non-GAAP Adjustments." Adjusted Operating Expenses Adjusted operating expenses represents GAAP operating expenses, such as sales, general, and administrative expense and research and development expense, with adjustments to exclude the impact of certain items recorded in