false000088462400008846242025-05-062025-05-06

 

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): May 06, 2025

 

 

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 May 6, 2025, Orthofix Medical Inc. (the “Company”) issued a press release announcing, among other things, its financial results for the first quarter ended March 31, 2025. A copy of the press 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. Such 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 sections below under the header "Non-GAAP Adjustments."

Adjusted Operating Expenses

Adjusted operating expenses represents GAAP expenses, such as sales, general, and administrative expense, and research and development expense, with adjustments to exclude the impact of certain items recorded in such GAAP operating expenses. Potential adjustments are listed within the section below under the header "Non-GAAP Adjustments."

Adjusted Non-Operating Expenses

Adjusted non-operating expenses represents GAAP expenses, such as interest income (expense), net and other income (expense), net, with adjustments to exclude the impact of certain items recorded in such GAAP non-operating expenses. Potential adjustments are listed within the section below under the header "Non-GAAP Adjustments."

EBITDA

EBITDA is a non-GAAP financial measure, which the Company calculates by adding interest expense (income), net; income tax expense (benefit); and depreciation and amortization to net income (loss). EBITDA provides management with additional insight to the Company's results of operations. Adjusted EBITDA, which is the primary metric used by the Company's Chief Operating Decision Maker in managing the business, consists of EBITDA with adjustments to exclude certain items listed within the section below under the header "Non-GAAP Adjustments."

Non-GAAP Adjustments

The Company's non-GAAP financial measures provide management with additional insight to the Company's results of operations and reflect the exclusion of the following items:

Share-based compensation expense – Costs related to awards granted under the Company's share-based compensation plans, which include stock options, performance-based or market-based stock options, restricted stock units, performance-based or market-based restricted stock units, and stock issued under the Company's stock purchase plan; see the share-based compensation footnote in the Company's Form 10-Q for the quarter ended March 31, 2025, for an allocation of these costs by consolidated statement of operations line item. Management excludes this item when evaluating the Company's operating performance as it represents a non-cash expense.

Foreign exchange impact – Gains and losses related to foreign currency transactions, which are recorded as other income (expense), net. Management excludes this item when evaluating the Company's operating results as it is primarily a non-cash expense or benefit and is non-operating in nature.
SeaSpine merger-related costs – Costs related to the Company's merger with SeaSpine Holdings Corporation ("SeaSpine"), which was consummated in January 2023, including costs relating to integration efforts, severance and retention costs, product rationalization charges, contract termination penalties, and professional fees related to the merger. Management excludes this item when evaluating the Company's operating results as these costs associated with this event are of a temporary nature, are not related to the Company's core operating performance, and are not expected to recur at a similar frequency and magnitude in the future.
Strategic investments – Costs related to the Company's strategic investments, such as due diligence and integration costs (unrelated to the merger with SeaSpine), which are primarily recorded as sales, general, and administrative expenses. These costs are not factored into the evaluation of the Company's performance by management because they are of a temporary nature, not related to the Company's core operating performance, and because the frequency and amount of such costs vary significantly based on the timing and magnitude of the Company's strategic investments.
Acquisition-related fair value adjustments – Comprised of (i) gains and losses related to remeasurement of contingent consideration to fair value, which are recorded as operating expenses, (ii) recognized costs related to acquired in-process research and development ("IPR&D") assets, which are expensed immediately, and (iii) amortization of acquired inventory fair market value adjustments. Management excludes this item when evaluating the Company's operating results as the remeasurement of contingent consideration is primarily non-cash in nature, the frequency and amount of IPR&D charges can vary significantly based on the timing and magnitude of the Company's acquisition transactions, and inventory fair market value adjustments are of a temporary and non-cash nature.
Amortization/depreciation of acquired long-lived assets – Amortization of intangible assets acquired in business combinations or asset acquisitions, including items such as developed technologies, customer relationships, trade names, manufacturing agreements, and other intangible assets, and any impairment of acquired goodwill, which are recorded in cost of sales or operating expenses. This item also includes depreciation recognized on adjustments to the fair value of certain long-lived assets acquired in the merger with SeaSpine. Management excludes this item when evaluating the Company's operating performance as it represents a non-cash expense.
Interest and gain (loss) on investments – Interest income and net gains or losses recognized (realized or unrealized) within interest income (expense), net and other income (expense), net, respectively, relating to certain of the Company's investments. Management excludes these items when evaluating the Company's operating performance as it typically represents a non-cash gain or loss and is not related to the Company's core operating performance.
Litigation and investigation-related costs – Inclusive of (i) adverse or favorable legal judgments or negotiated legal settlements and certain related legal expenses and (ii) amounts incurred in relation to and as a result of the Board of Directors’ investigation conducted by independent outside legal counsel that resulted in the departure of three former executive officers and certain charges stemming from these actions. These charges are primarily recorded within sales, general, and administrative expenses. Management excludes these items when evaluating the Company's operating results as these costs and/or benefits can vary significantly based on the timing, frequency, and magnitude of litigation matters.
Succession charges – Costs related to the transition of certain executive officers, including any cessation and onboarding amounts, consulting services, and other related expenses, which are primarily recorded as sales, general, and administrative expenses. Management excludes this item when evaluating the Company's operating results as these costs associated with events that are not expected to recur at a similar frequency and magnitude in the future.
Long-term income tax rate adjustment – Reflects management’s expectation of a long-term normalized effective tax rate of 28% for 2024 and 2025 results, which is based on current tax law and current expected adjusted income; actual reported tax expense will ultimately be based on GAAP earnings and may differ from the expected long-term normalized effective tax rate due to a variety of factors, including the resolutions of issues arising from tax audits with various tax authorities, the ability to realize deferred tax assets, and the tax impact of certain reconciling items that are excluded in determining adjusted net income (loss).
Restructuring costs and impairments related to M6 product lines - Restructuring costs, including severance-related benefits, and impairment charges incurred as a result of the Company’s decision to discontinue its M6 artificial disc product lines. Management excludes this item when evaluating the Company's operating results as these costs associated with this event are one-time in nature and are not related to the Company's expected ongoing operations.

Usefulness and Limitations of Non-GAAP Financial Measures

Management uses non-GAAP measures to evaluate performance period-over-period, analyze the underlying trends in the Company's business, assess the Company's performance relative to its competitors, and establish operational goals and forecasts used in allocating resources. Management uses these non-GAAP measures as the basis for evaluating the ability of the Company's underlying operations


to generate cash, prior to required investments in working capital, and to further its understanding of the performance of the Company's business units.

Material Limitations Associated with the Use of Non-GAAP Financial Measures

The non-GAAP financial measures described above may have limitations as analytical tools, and should not be considered in isolation or as a replacement for GAAP financial measures. Some of the limitations associated with the use of these non-GAAP financial measures are that they exclude items that reflect an economic cost and can have a material effect on cash flows. Similarly, certain non-cash expenses, such as share-based compensation, do not directly impact cash flows, but are part of total compensation costs accounted for under GAAP.

Compensation for Limitations Associated with Use of Non-GAAP Financial Measures

The Company compensates for the limitations of its non-GAAP financial measures by relying upon GAAP results to gain a complete picture of the Company's performance. GAAP results provide management with the ability to understand the Company's performance based on a defined set of criteria. The Company provides reconciliations of the non-GAAP financial measures to the most directly comparable GAAP measures and encourages investors to review these reconciliations.

Usefulness of Non-GAAP Financial Measures to Investors

The Company believes that providing non-GAAP financial measures that exclude certain items provides investors with greater transparency to the information used by management in its financial and operational decision-making. Management believes it is important to provide investors with the same non-GAAP financial measures it uses to supplement information regarding the performance and underlying trends of the Company's business operations in order to facilitate comparisons to the Company's historical operating results and internally evaluate the effectiveness of the Company's operating strategies. The Company believes that these non-GAAP financial measures also facilitates comparisons of the Company's underlying operating performance with other companies in the industry that also supplement their GAAP results with non-GAAP financial measures.

Item 7.01 Regulation FD Disclosure.

The Company expects to use the corporate investor relations presentation furnished as Exhibit 99.2 to this report, in whole or in part, and possibly with modifications, in connection with presentations to investors, analysts, and others during the fiscal year ending December 31, 2025.

The information furnished in this Item 7.01, including the exhibit furnished herewith as Exhibit 99.2, will not be treated as “filed” for the purposes of Section 18 of 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, or into another filing under the Exchange Act, unless that filing expressly incorporates by reference this Item 7.01 of this report.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

 

99.1

Press release, dated May 6, 2025

99.2

Corporate Investor Relations Presentation, dated May 6, 2025

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

 


 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

Orthofix Medical Inc.

 

 

By:

 

 

/s/ JULIE ANDREWS

 

 

 

Julie Andrews

Chief Financial Officer

 

 

 

Date: May 6, 2025

 


 

Exhibit 99.1

img236010591_0.jpg

News Release

Orthofix Reports First Quarter 2025 Financial Results

LEWISVILLE, Texas — May 6, 2025 — Orthofix Medical Inc. (NASDAQ:OFIX), a leading global medical technology company, today reported its financial results for the first quarter ended March 31, 2025, updated its full-year 2025 net sales guidance, and reaffirmed its full-year 2025 non-GAAP adjusted EBITDA and positive free cash flow guidance. All pro forma measures contained within this release exclude the impact of the Company’s decision to discontinue its M6-C™ and M6-L™ artificial disc product lines.

Highlights

First quarter 2025 net sales of $193.6 million, including sales from its M6 artificial cervical and lumbar discs, and pro forma net sales of $189.2 million, excluding sales from its M6 discs, representing an increase of 3% on a reported basis and 4% on a pro forma constant currency basis compared to first quarter 2024
U.S. Spine Fixation1 net sales growth of 4% compared to first quarter 2024
Bone Growth Therapies ("BGT") net sales of $55.1 million, representing growth of 5%, with BGT Fracture net sales growth of 6% compared to first quarter 2024
Global Orthopedics net sales of $29.8 million, achieving constant currency growth of 11% and U.S. Orthopedics net sales growth of 10% compared to first quarter 2024
Received 510(k) clearance and CE Mark for 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
First quarter 2025 net loss of $(53.1) million on a reported basis; Non-GAAP pro forma adjusted EBITDA of $11.4 million, with pro forma adjusted EBITDA margin expanding approximately 200 basis points compared to reported non-GAAP adjusted EBITDA for the first quarter 2024

First quarter 2025 net sales were $193.6 million, including sales from M6 artificial cervical and lumbar discs, and pro forma net sales of $189.2 million, excluding sales from its M6 discs, representing an increase of 2.7% on a reported basis and 4.3% on a pro forma constant currency basis compared to first quarter 2024. Net loss was $(53.1) million, or $(1.35) per share, on a reported basis. Non-GAAP pro forma adjusted EBITDA was $11.4 million for the first quarter, an increase of $3.8 million compared to reported non-GAAP adjusted EBITDA for the first quarter of 2024, representing 49.1% growth over prior year.

“We are continuing to execute the priorities that we outlined in our three-year plan to transform our business and deliver on our commitment to drive disciplined, profitable growth,” said Massimo Calafiore, President and Chief Executive Officer. “While we made excellent progress in adjusted EBITDA in the first quarter, our ongoing efforts to optimize our commercial channel resulted in some incremental softness in Biologics and Spine Fixation. Once these optimization efforts are completed, we expect growth to return to historical levels.”

Mr. Calafiore continued, “We also are taking additional proactive steps to optimize our spine commercial channel and accelerate targeted distributor transitions in a few U.S. territories in order to maximize our growth opportunities and more closely align with our strategic focus. This transition won’t be completed until later this year and will require some time for the full effects to be realized, but it is expected to result in a stronger, more scalable commercial organization as we shift into our next phase of growth. We have adjusted our guidance accordingly to reflect the short-term impact from this targeted transition, which we believe will set us up for success and generate significant future returns.”

Mr. Calafiore concluded, “Looking ahead, we are focused on three strategic priorities to drive market share gains in our spine business and build a fast-growing orthopedics business specifically focused on limb reconstruction. First, further sharpening our commercial execution to drive deeper market penetration through our comprehensive portfolio offerings, including the adoption of our 7D FLASH™ Navigation System; second, implementing projects to improve our gross margin; and finally, focusing on disciplined capital allocation, adjusted EBITDA expansion, and positive free cash flow generation, ensuring we are well-positioned to create long-term value for our shareholders in 2025 and beyond.”

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

1


 

Financial Results Overview

First 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 March 31,

 

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

 

2025

 

 

2024

 

 

Change

 

 

Constant
Currency
Change

 

Bone Growth Therapies

 

$

55.1

 

 

$

52.5

 

 

 

4.9

%

 

 

4.9

%

Spinal Implants, Biologics and Enabling Technologies*

 

 

104.3

 

 

 

102.3

 

 

 

2.0

%

 

 

2.0

%

Global Spine*

 

 

159.4

 

 

 

154.8

 

 

 

3.0

%

 

 

3.0

%

Global Orthopedics

 

 

29.8

 

 

 

27.3

 

 

 

9.1

%

 

 

11.5

%

Pro forma net sales*

 

 

189.2

 

 

 

182.1

 

 

 

3.9

%

 

 

4.3

%

Impact from discontinuation of M6 product lines

 

 

4.4

 

 

 

6.5

 

 

 

(31.9

%)

 

 

(31.5

%)

Reported net sales

 

$

193.6

 

 

$

188.6

 

 

 

2.7

%

 

 

3.0

%

 

* 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.

Gross margins were 62.8% for the quarter and were 70.3% on a non-GAAP pro forma adjusted basis.

Net loss was $(53.1) million, or $(1.35) per share, on a reported basis, compared to net loss of $(36.0) million, or $(0.95) per share in the prior year period. Non-GAAP pro forma adjusted EBITDA was $11.4 million, or 6.0% of pro forma net sales, compared to reported non-GAAP adjusted EBITDA of $7.7 million, or 4.1% of reported net sales, in the prior year period.

Liquidity

Cash, cash equivalents, and restricted cash on March 31, 2025 totaled $60.5 million compared to $85.7 million on December 31, 2024. This decrease was primarily due to the payment of the 2024 annual bonuses, commissions for the fourth quarter of 2024, and cash severance payments, among other items. Excluding these items, uses of cash were in line with normal business operations.

Business Outlook

The Company is updating its full-year net sales guidance and reaffirming its full-year 2025 adjusted EBITDA and free cash flow guidance as follows:

Net sales now expected to range between $808 million to $816 million, excluding sales from the discontinued M6 product lines, representing implied constant currency growth of 5.0% year-over-year at the midpoint of the range. This compares to the previous full-year net sales guidance of $818 million to $826 million. The revised guidance range assumes a $5 million negative impact from U.S. funded non-governmental organization (NGO) business as compared to the full-year 2024. It is also based on current foreign currency exchange rates and does not take into account any additional potential exchange rate changes that may occur this year.
No change to non-GAAP adjusted EBITDA, which is expected to be $82 million to $86 million. This range includes the anticipated impact from the discontinuation of the M6 product lines that was previously announced in February 2025.
No change to free cash flow, which is expected to be positive for full-year 2025, excluding the impact of restructuring charges related to the discontinuation of the M6 product lines.

An investor presentation for the Company's first quarter 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 quarter ended March 31, 2025. Interested parties may access the conference call by dialing (888) 596-4144 in the U.S., and (646) 968-2525 in all

2


 

other locations, and referencing the conference ID 7524113. 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 routinely posts information that may be important to investors in the “Investor Relations” 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, we deliver 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. To learn more, visit Orthofix.com and follow 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,” 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, 2024, and in Part II, Item 1A under the heading Risk Factors in our Quarterly Report on Form 10-Q for the quarter ended March 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. 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, 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.

 

3


 

Company Contact

 

Investors and Media

Julie Dewey, IRC

Chief Investor Relations & Communications Officer

JulieDewey@Orthofix.com

209.613.6945

 

 

 

 

 

 

4


 

ORTHOFIX MEDICAL INC.

Condensed Consolidated Statements of Operations

 

 

 

Three Months Ended

 

 

 

March 31,

 

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

 

2025

 

 

2024

 

 

 

 

 

Net sales

 

$

193,646

 

 

$

188,608

 

Cost of sales

 

 

72,027

 

 

 

61,366

 

Gross profit

 

 

121,619

 

 

 

127,242

 

Sales, general, and administrative

 

 

132,981

 

 

 

131,691

 

Research and development

 

 

19,766

 

 

 

19,492

 

Acquisition-related amortization, impairment, and remeasurement

 

 

17,745

 

 

 

5,396

 

Operating loss

 

 

(48,873

)

 

 

(29,337

)

Interest expense, net

 

 

(4,506

)

 

 

(4,558

)

Other income (expense), net

 

 

1,246

 

 

 

(1,274

)

Loss before income taxes

 

 

(52,133

)

 

 

(35,169

)

Income tax expense

 

 

(961

)

 

 

(851

)

Net loss

 

$

(53,094

)

 

$

(36,020

)

 

 

 

 

 

 

 

Net loss per common share:

 

 

 

 

 

 

Basic

 

$

(1.35

)

 

$

(0.95

)

Diluted

 

 

(1.35

)

 

 

(0.95

)

Weighted average number of common shares (in millions):

 

 

 

 

 

 

Basic

 

 

39.2

 

 

 

37.7

 

Diluted

 

 

39.2

 

 

 

37.7

 

 

5


 

ORTHOFIX MEDICAL INC.

Condensed Consolidated Balance Sheets

 

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

 

March 31,
2025

 

 

December 31,
2024

 

 

 

(Unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

57,953

 

 

$

83,238

 

Restricted Cash

 

 

2,500

 

 

 

2,500

 

Accounts receivable, net of allowances of $8,602 and $7,418, respectively

 

 

131,865

 

 

 

134,713

 

Inventories

 

 

174,480

 

 

 

189,452

 

Prepaid expenses and other current assets

 

 

23,512

 

 

 

23,382

 

Total current assets

 

 

390,310

 

 

 

433,285

 

Property, plant, and equipment, net

 

 

130,693

 

 

 

139,804

 

Intangible assets, net

 

 

81,213

 

 

 

98,803

 

Goodwill

 

 

194,934

 

 

 

194,934

 

Other long-term assets

 

 

25,994

 

 

 

26,468

 

Total assets

 

$

823,144

 

 

$

893,294

 

Liabilities and shareholders’ equity

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

$

45,176

 

 

$

48,803

 

Current portion of finance lease liability

 

 

767

 

 

 

755

 

Other current liabilities

 

 

98,173

 

 

 

119,070

 

Total current liabilities

 

 

144,116

 

 

 

168,628

 

Long-term debt

 

 

156,885

 

 

 

157,015

 

Long-term portion of finance lease liability

 

 

17,636

 

 

 

17,835

 

Other long-term liabilities

 

 

46,213

 

 

 

46,692

 

Total liabilities

 

 

364,850

 

 

 

390,170

 

Contingencies

 

 

 

 

 

 

Shareholders’ equity

 

 

 

 

 

 

Common shares $0.10 par value; 100,000 shares authorized;
    39,096 and 38,486 issued and outstanding as of March 31,
    2025, and December 31, 2024, respectively

 

 

3,910

 

 

 

3,849

 

Additional paid-in capital

 

 

786,175

 

 

 

779,718

 

Accumulated deficit

 

 

(329,235

)

 

 

(276,141

)

Accumulated other comprehensive loss

 

 

(2,556

)

 

 

(4,302

)

Total shareholders’ equity

 

 

458,294

 

 

 

503,124

 

Total liabilities and shareholders’ equity

 

$

823,144

 

 

$

893,294

 

 

6


 

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 both the three months ended March 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 March 31,

 

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

 

2025

 

 

2024

 

Gross profit

 

$

121,619

 

 

$

127,242

 

Share-based compensation expense

 

 

462

 

 

 

537

 

SeaSpine merger-related costs

 

 

600

 

 

 

1,303

 

Restructuring costs and impairments related to M6 product lines

 

 

10,919

 

 

 

 

Strategic investments

 

 

13

 

 

 

65

 

Acquisition-related fair value adjustments

 

 

 

 

 

3,047

 

Amortization/depreciation of acquired long-lived assets

 

 

313

 

 

 

318

 

Adjusted gross profit

 

$

133,926

 

 

$

132,512

 

Adjusted gross margin as a percentage of reported net sales

 

 

69.2

%

 

 

70.3

%

Adjusted gross profit attributable to M6 product lines

 

 

(906

)

 

 

(2,895

)

Pro forma adjusted gross profit

 

$

133,020

 

 

$

129,617

 

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

 

 

70.3

%

 

 

71.2

%

Adjusted EBITDA

 

 

Three Months Ended March 31,

 

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

 

2025

 

 

2024

 

Net loss

 

$

(53,094

)

 

$

(36,020

)

Income tax expense

 

 

961

 

 

 

851

 

Interest expense, net

 

 

4,506

 

 

 

4,558

 

Depreciation and amortization

 

 

34,431

 

 

 

14,862

 

Share-based compensation expense

 

 

6,469

 

 

 

8,800

 

Foreign exchange impact

 

 

(1,044

)

 

 

1,588

 

SeaSpine merger-related costs

 

 

1,130

 

 

 

4,479

 

Restructuring costs and impairments related to M6 product lines

 

 

9,880

 

 

 

 

Strategic investments

 

 

3,514

 

 

 

120

 

Acquisition-related fair value adjustments

 

 

(610

)

 

 

4,217

 

Interest and loss on investments

 

 

 

 

 

(260

)

Litigation and investigation costs

 

 

3,042

 

 

 

2,260

 

Succession charges

 

 

 

 

 

2,210

 

Adjusted EBITDA

 

$

9,185

 

 

$

7,665

 

Adjusted EBITDA as a percentage of reported net sales

 

 

4.7

%

 

 

4.1

%

Operating losses attributable to M6 product lines

 

 

2,246

 

 

 

1,854

 

Pro forma adjusted EBITDA

 

$

11,431

 

 

$

9,519

 

Adjusted EBITDA as a percentage of pro forma net sales

 

 

6.0

%

 

 

5.2

%

 

7


 

Adjusted Net Income

 

 

Three Months Ended March 31,

 

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

 

2025

 

 

2024

 

Net loss

 

$

(53,094

)

 

$

(36,020

)

Share-based compensation expense

 

 

6,469

 

 

 

8,800

 

Foreign exchange impact

 

 

(1,044

)

 

 

1,588

 

SeaSpine merger-related costs

 

 

1,474

 

 

 

4,848

 

Restructuring costs and impairments related to M6 product lines

 

 

30,204

 

 

 

 

Strategic investments

 

 

3,543

 

 

 

126

 

Acquisition-related fair value adjustments

 

 

(610

)

 

 

4,217

 

Amortization/depreciation of acquired long-lived assets

 

 

4,632

 

 

 

4,792

 

Litigation and investigation costs

 

 

3,042

 

 

 

2,260

 

Succession charges

 

 

 

 

 

2,210

 

Interest and loss on investments

 

 

 

 

 

(260

)

Long-term income tax rate adjustment

 

 

2,200

 

 

 

2,696

 

Adjusted net loss

 

$

(3,184

)

 

$

(4,743

)

Operating losses attributable to M6 product lines

 

 

2,688

 

 

 

2,400

 

Long-term income tax rate adjustment for M6 product lines

 

 

(753

)

 

 

(672

)

Pro forma adjusted net loss

 

$

(1,249

)

 

$

(3,015

)

Cash Flow and Free Cash Flow

 

 

Three Months Ended March 31,

 

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

 

2025

 

 

2024

 

Net cash from operating activities

 

$

(18,391

)

 

$

(18,595

)

Net cash from investing activities

 

 

(6,736

)

 

 

(10,867

)

Net cash from financing activities

 

 

(651

)

 

 

21,453

 

Effect of exchange rate changes on cash

 

 

493

 

 

 

(284

)

Net change in cash and cash equivalents

 

$

(25,285

)

 

$

(8,293

)

 

 

 

Three Months Ended March 31,

 

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

 

2025

 

 

2024

 

Net cash from operating activities

 

$

(18,391

)

 

$

(18,595

)

Capital expenditures

 

 

(6,736

)

 

 

(10,817

)

Free cash flow

 

$

(25,127

)

 

$

(29,412

)

Reconciliation of Non-GAAP Financial Measures to Reported Operating Expenses

 

 

Three Months Ended March 31,

 

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

 

2025

 

 

2024

 

Sales, general, and administrative

 

$

132,981

 

 

$

131,691

 

Reconciling items impacting sales, general, and administrative:

 

 

 

 

 

 

Restructuring costs and impairments related to M6 product lines

 

 

(3,336

)

 

 

 

Strategic investments

 

 

(2,304

)

 

 

(3,431

)

Amortization/depreciation of acquired long-lived assets

 

 

(60

)

 

 

(248

)

Litigation and investigation costs

 

 

(3,042

)

 

 

(2,260

)

Succession charges

 

 

 

 

 

(2,210

)

Sales, general, and administrative expense, as adjusted

 

$

124,239

 

 

$

123,542

 

As a percentage of reported net sales

 

 

64.2

%

 

 

65.5

%

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

 

 

(2,388

)

 

 

(4,155

)

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

 

$

121,851

 

 

$

119,387

 

As a percentage of pro forma net sales

 

 

64.4

%

 

 

65.6

%

 

8


 

 

 

 

Three Months Ended March 31,

 

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

 

2025

 

 

2024

 

Research and development expense, as reported

 

$

19,766

 

 

$

19,492

 

Reconciling items impacting research and development:

 

 

 

 

 

 

Restructuring costs and impairments related to M6 product lines

 

 

(1,852

)

 

 

 

Strategic investments

 

 

(2,099

)

 

 

(237

)

Research and development expense, as adjusted

 

$

15,815

 

 

$

19,255

 

As a percentage of reported net sales

 

 

8.2

%

 

 

10.2

%

Research and development expense attributable to M6 product lines

 

 

(1,192

)

 

 

(2,236

)

Pro forma research and development expense, as adjusted

 

$

14,623

 

 

$

17,019

 

As a percentage of pro forma net sales

 

 

7.7

%

 

 

9.3

%

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

 

 

Three Months Ended March 31,

 

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

 

2025

 

 

2024

 

Non-operating expense

 

$

3,260

 

 

$

5,832

 

Reconciling items impacting non-operating expense:

 

 

 

 

 

 

Foreign exchange impact

 

 

1,044

 

 

 

(1,588

)

Interest and loss on investments

 

 

 

 

 

283

 

Non-operating expense, as adjusted

 

$

4,304

 

 

$

4,527

 

As a percentage of reported net sales

 

 

2.2

%

 

 

2.4

%

Losses attributable to M6 product lines

 

 

(15

)

 

 

(47

)

Pro forma non-operating expense, as adjusted

 

$

4,289

 

 

$

4,480

 

As a percentage of pro forma net sales

 

 

2.3

%

 

 

2.5

%

 

Source

Orthofix Medical Inc.

 

###

9


Slide 1

Clear Course for Profitable Growth 1Q 2025 Earnings Call May 6, 2025


Slide 2

Forward-Looking Statements This presentation 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,” or “continue” or other comparable terminology. Forward-looking statements in this presentation 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, 2024, and in Part II, Item 1A under the heading Risk Factors in our Quarterly Report on Form 10-Q for the quarter ended March 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. 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, 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.


Slide 3

Non-GAAP Financial Measures Management uses certain non-GAAP financial measures in this presentation, most specifically Adjusted EBITDA, Adjusted Gross Margin, Adjusted Net Income and Free Cash Flow, as a supplement to GAAP financial measures to further evaluate the Company’s operating performance period over period, analyze the underlying business trends, assess performance relative to competitors and establish operational objectives. ​ Management believes it is important to provide investors with the same non-GAAP metrics it uses to evaluate the performance and underlying trends of the Company’s business operations to facilitate comparisons to its historical operating results and evaluate the effectiveness of its operating strategies. Disclosure of these non-GAAP financial measures also facilitates comparisons of the Company’s underlying operating performance with other companies in the industry that also supplement their GAAP results with non-GAAP financial measures.​ Unless noted otherwise, full-year guidance is based on the current foreign currency exchange rates and does not take into account any additional potential exchange rate changes that may occur this year. These non-GAAP financial measures should not be considered in isolation from, or as replacements for, the most directly comparable GAAP financial measures, as these measures are not prepared in accordance with U.S. GAAP.​ Reconciliations between GAAP and non‐GAAP results are included at the end of this presentation and represent the most comparable GAAP measure(s) 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 its first quarter 2025 press release filed on May 6, 2025 with the SEC and 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 both the three months ended March 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. Amounts may not add due to rounding.​


Slide 4

TAKE OWNERSHIP INNOVATE BOLDLY WIN TOGETHER The unrivaled partner in Med Tech, delivering ​exceptional experiences and life-changing solutions. 4


Slide 5

Orthofix Today Healing Musculoskeletal Pathologies in Spine and Orthopedics with Specialized Solutions and Enabling Technologies Unrivaled Partner in Med Tech Delivering Exceptional Experiences and Life-Changing Solutions Key Stats TTM Net Sales2 by Business ~$783M Bone Growth Therapies Spinal Implants, Biologics, and Enabling Technologies Orthopedics ~16% Int’l HQ Lewisville, TX ~84% U.S. Founded 1980 Employees 1,600+ NASDAQ OFIX Office Manufacturing / Distribution 3rd-Party Logistics Global Presence TTM Net Sales2 by Geography ~$538M Market-Cap1 ~$75.7M TTM Adjusted EBITDA2 ~71.5% TTM Adjusted Gross Margin2 ~$60.5M Cash, Cash Equivalents, and Restricted Cash2 Note: TTM = Trailing 12 Months. 1 5/2/2025. 2 As of March 31, 2025; All figures exclude the impact of net sales related to the discontinuation of the M6 product lines.


Slide 6

We are focused on three strategic priorities to drive market share gains in our spine business and build a fast-growing orthopedics business specifically focused on limb reconstruction. First, further sharpening our commercial execution to drive deeper market penetration through our comprehensive portfolio offerings, including the adoption of our 7D FLASH™ Navigation System; second, implementing projects to improve our gross margin; and finally, focusing on disciplined capital allocation, adjusted EBITDA expansion, and positive free cash flow generation, ensuring we are well-positioned to create long-term value for our shareholders in 2025 and beyond. “ Massimo Calafiore President & Chief Executive Officer ” 6 1 The Company’s non-GAAP financial measures have been adjusted to eliminate the financial effects of the Company’s decision to discontinue its M6 product lines. 2 Constant Currency is calculated by applying foreign currency rates applicable to the comparable, prior-year period to present the current period net sales at comparable rates. Same sales day metrics normalize results for variations in the number of selling days between periods based upon average sales per day. 3 The reasons for and nature of non-GAAP disclosures by the Company, descriptions of the adjustments used to calculate those non-GAAP financial measures, and reconciliations of those non-GAAP financial measures to the most comparable GAAP financial measure, are provided in the Company’s press release issued and Quarterly Report on Form 10-Q filed on May 6, 2025..4 Spine Fixation is comprised of the Company's Spinal Implants product category, excluding motion preservation product offerings. Q1 2025 Financial Highlights $11.4M Non-GAAP Pro Forma Adjusted EBITDA1,3 $3.8M YoY increase and ~200 bps margin expansion $(25.1)M Free Cash Flow3 Continued positive YoY progress 4% U.S. Spine Fixation4 YoY Net Sales Growth 5% growth YoY on same sales day basis2 5% Bone Growth Therapies YoY Net Sales Growth 7% growth YoY on same sales day basis2 70.3% Non-GAAP Pro Forma Adjusted Gross Margin1,3 Compared to 70.3% reported for Q1 2024  $189.2M Pro Forma Net Sales1 6% growth YoY on same sales day constant currency basis1,2 10% U.S. Orthopedics YoY Net Sales Growth 12% growth YoY on same sales day basis2


Slide 7

7 Continuing to execute the priorities that we outlined in our long-term plan to transform our business and deliver on our commitment to drive disciplined, profitable growth 01 Pro forma adjusted EBITDA exceeded expectations – pro forma adjusted EBITDA margin expanded by ~200 bps compared to reported non-GAAP adjusted EBITDA for 1Q 2024 02 510(k) clearance and CE Mark for TrueLok™ Elevate Transverse Bone Transport (TBT) System – first FDA-cleared device for TBT to correct non-unions and bony or soft tissue deformities or defects 03 Taking proactive steps to optimize our spine commercial channel to maximize growth opportunities and more closely align with our strategic focus 04 Prudently deploying capital and prioritizing investment in profitable growth opportunities and increased penetration of our technology and product platforms in areas where we can win 05 Q1 2025 Key Messages


Slide 8

Q1 2025 Results Summary First Quarter 2025 Results Summary (in millions)           Q1 2025   Q1 2024   Constant Currency Change Bone Growth Therapies $ 55.1 $ 52.5 4.9% Spinal Implants, Biologics, and Enabling Technologies 104.3 102.3 2.0% Global Spine 159.4 154.8 3.0% Global Orthopedics 29.8 27.3 11.5% Pro forma net sales (excludes M6) $ 189.2 $ 182.1 4.3% Impact from discontinuation of M6 4.4 6.5 (31.5%) Reported net sales $ 193.6 $ 188.6 3.0% Non-GAAP Adjusted Gross Margins 70.3% 70.3% +5 bps Non-GAAP Adjusted EBITDA $ 11.4   $ 7.7   49.1% Q1 Total Pro Forma Net Sales: $189.2M 4.3% YoY pro forma constant currency growth Q1 Non-GAAP Pro Forma Adjusted EBITDA: $11.4M 6.0% of pro forma net sales vs $7.7M in 1Q24; 4.1% of reported net sales Q1 Non-GAAP Pro Forma Adjusted Gross Margin: 70.3% vs 70.3% as reported in 1Q24  Q1 Non-GAAP Pro Forma SG&A Expense: $121.9M 64.4% of pro forma net sales vs $123.5M in 1Q24; 65.5% of reported net sales Q1 Non-GAAP Pro Forma R&D Expense: $14.6M 7.7% of pro forma net sales vs $19.3M in 1Q24; 10.2% of reported net sales 8 Q1 2025 Total Pro Forma Net Sales $189.2M +4.3% YoY* Bone Growth Therapies $55.1M +4.9% Global Orthopedics $29.8M +11.5%* Global Spinal Implants, Biologics, & Enabling Technologies $104.3M +2.0%* International Spinal Implants, Biologics & Enabling Technologies  $10.8M (29.7%)* U.S. Spinal Implants, Biologics & Enabling Technologies  $93.6M -0.4% 90% 10% * YoY Growth on a pro forma constant currency basis compared to 1Q24


Slide 9

Q1 2025 Business Segment Highlights 9 TBT = Transverse Bone Transport * Net sales growth is on a same sales day, constant currency basis BONE GROWTH THERAPIES BGT net sales +7%* Successful cross-selling Continued focus on adding new surgeons and competitive surgeon conversions BGT Fracture with AccelStim™ bone growth therapy device continuing to outperform the market ORTHOPEDICS Global Orthopedics net sales +13%* U.S. Orthopedics net sales +12%* Growth led by combination of TrueLok™ and Fitbone™ products and growth in Galaxy™ fixation product family TrueLok™ Elevate TBT System – limited launch ongoing – full launch planned in Q3 2025 SPINE U.S. Spine Fixation net sales +5%* Continued to gain share in categories where we recently launched new products, including ALIF, MIS and Cervical Fusion portfolios, all of which significantly outperformed the market Ongoing limited market release of Reef™ L Lateral Lumbar Interbody and WaveForm™ A Interbody


Slide 10

Comprehensive Portfolio of Transformative Solutions Improved Clinical Efficiencies and Economic Value with 7D Enabling Technology Established Distribution Channels and Extensive Global Commercial Reach Large Addressable Markets with High- Growth Opportunities Across Continuum of Care World-Class, Visionary Leadership Team with Deep Sector Expertise Expanding and Deepening Customer Relationships 10 Capitalizing on Clear Competitive Advantages


Slide 11

Spinal Implants Executing Innovation and Taking Share Select Product Examples Market Overview Sales channel optimization for growth, cross-selling, and OPEX leverage Pull through from lateral, cervical, and 7D earnouts Best-in-class implants to improve patient outcomes Interbody Cervical Thoracolumbar Fixation NorthStar™ OCT Mariner™ Deformity WaveForm™ (3D Printed) Explorer™ (Expandable) Reef™ (IBDs) ~$10.1B TAM1 Thoracolumbar Fixation Significant share capture opportunity ~3% – 4% market growth rate (2025 – 2027) Interbody Significant share capture opportunity ~3% – 4% market growth rate (2025 – 2027) Cervical Significant share capture opportunity ~3% – 4% market growth rate (2025 – 2027) OFIX Growth Drivers Shoreline™ ACS Wayfinder™ Phoenix™ MIS Meridian™ 1 U.S. Total Addressable Market. Sources: iData Research Inc.; U.S. Market Report for Spinal Implants and VCF; SmartTrak US Spine Market Report; Internal OFIX estimates Supporting Clinicians and Patients through Continuous Innovation of Procedure Solutions Comprehensive, best-in-class spinal implants designed to work in concert with 7D Navigation and biologics to support improved clinical outcomes Focus on deformity correction and experts in cervical fixation and material science


Slide 12

AccelStim™ SpinalStim™ PhysioStim™ CervicalStim™ Complex Foot & Ankle Reconstruction and Fracture Management Bone Growth Therapies Maximizing #1 Market Position Growing Above Market through Innovation and Expansion Safe, effective, non-surgical alternative to aid in bone healing of fracture management and high-risk spine fusions Most comprehensive portfolio of bone growth stimulation devices Most indications on the market to aid in bone healing solutions Select Product Examples #1 prescribed bone growth stimulator First to offer free recycling for patients to properly dispose their devices PEMF technology approved since 1986 Prescribed devices 1,100,000+ Spine Fusion Therapy Market Overview Procedural selling focused on cross-selling with orthopedics and spine New market channels with established sales representatives AccelStim growth to penetrate Fracture market ~$0.6B TAM1 Spine #1 Position ~2% – 3% market growth rate (2025 – 2027) Fracture #2 Position ~2% – 3% market growth rate (2025 – 2027) OFIX Growth Drivers Note: PEMF = Pulsed Electromagnetic Field. 1 U.S. Total Addressable Market.


Slide 13

Biologics Growing from a Position of Strength Strategically Introducing New Products to Capture Additional Market Share Full spectrum of biologic solutions to enhance fusion process and promote bone repair and growth Provide industry leading, best-in-class products in each of the major bone grafting categories Select Product Examples Demineralized Bone Matrix OsteoSurge™ 300 OsteoStrand™ Plus Synthetic Procedure-Specific OsteoCove™ OsteoBallast™ Market Overview Opportunities in current portfolio and spine Product innovation with clinical research Disc regeneration, channel expansion options ~$2.1B TAM1 Synthetic Significant share capture opportunity ~2% – 3% market growth rate (2025 – 2027) Cellular Allograft #2 Position ~2% – 3% market growth rate (2025 – 2027) OFIX Growth Drivers Trinity Elite™ Cellular Allograft Growth Factors, Other Do not participate 1 Global Total Addressable Market, including Growth Factors. Demineralized Bone Matrix #2 Position ~2% – 3% market growth rate (2025 – 2027)


Slide 14

Orthopedics Redefining Limb Reconstruction Proven Leader with Room to Grow through Innovation of Hardware and Digital Solutions Enabling Technologies - OrthoNext™ 1 Global Total Addressable Market. TBT = Transverse Bone Transport Select Product Examples Unique portfolio of limb reconstruction solutions, addressing the most challenging orthopedic conditions in patients of all ages Galaxy Gemini™ Complex Fracture Management Fitbone™ Limb Lengthening TL-HEX™ Extremity Deformity Correction TrueLok Elevate™ TBT Market Overview Accelerating U.S. growth and expanding position Global sales channel optimization through execution and focused distribution New product platforms with next-gen digital capabilities OFIX Growth Drivers ~$1.7B TAM1 Complex Fracture Management Significant share capture opportunity ~3% – 4% market growth rate (2025 – 2027) Limb Lengthening Significant share capture opportunity ~7% – 8% market growth rate (2025 – 2027) Extremity Deformity Correction & Limb Restoration Significant share capture opportunity ~5% – 6% market growth rate (2025 – 2027) Limb Preservation


Slide 15

Complex Fracture Management Limb Lengthening Limb Preservation Extremity Deformity Correction LIMB RECON Industry leader with a unique portfolio of limb reconstruction solutions, addressing the most challenging conditions in patients of all ages ENABLING TECHNOLOGIES ENABLING TECHNOLOGIES 15 Orthopedics: Redefining the Category of Limb Reconstruction


Slide 16

Watch What Limb Reconstruction Looks Like For Justin REAL STORIES. REAL IMPACT. TL-HEX™ TrueLok Hexapod System Patient 16


Slide 17

Enabling Technologies Empowering Excellence with Real-Time, Integrated Smart Technologies Capturing Significant Opportunity to Leverage Technology and Expand Share in Spine FLASHTM Navigation with 7D Technology, world’s leading, zero-radiation1 spine image-guided surgery system Allows surgeons to perform fast, cost-effective, and radiation-free surgery Pacesetting leader for open spine procedures and deformity correction Open and Percutaneous Spine Modules2 Market Overview OFIX Growth Drivers 7D deployments through commercial financing structures and product pull through Product integration with spinal implant portfolio Digital ecosystem expansion (pre-op planning, intra-op navigation, and post-op care) ~$0.4B TAM3 Spinal Navigation Significant share capture opportunity ~10% – 12% market growth rate (2025 – 2027) FLASH™ Navigation with 7D Technology Product Example Significant Focus in Spine 1 Based on a pre-op CT or MRI, no intra-op radiation is required using Open Spine Module, eliminating exposure to surgeons, staff, and patients. Intra-op radiation is required for Percutaneous Module. 2 ~40% of U.S. installed base has cranial module. 3 Global Total Addressable Market.


Slide 18

Innovation Spotlight – FLASHTM Navigation with 7D Technology Technology Differentiates Portfolio While Enabling Service to Full Continuum of Surgical Care 97.8% reduction in intraoperative radiation during adult degenerative spinal fusions1* Revolutionizing Spinal Navigation Created Meaningful Advantages with FLASHTM Navigation with 7D Technology 61% reduction in intraoperative radiation during complex pediatric deformity spinal fusions2* 98.8% accurate with no pedicle breach1* 94% faster than intraoperative CT-based systems3* 63.6 minutes saved per case4* Flexible Selling Models to Meet Unique Needs of Facility First and only image-guided surgery system featuring 7D’s machine-vision technology, allowing surgeons to perform fast, cost-effective, radiation-free IGS Capital Purchase Lease “Earnout” through purchase of spine hardware and/or biologics; creating recurring revenue stream and stronger customer relationships Voyager Earnout Program *Not an Orthofix sponsored clinical study. 1 Malham GM, Munday NR. Comparison of novel machine vision spinal image guidance system with existing 3D fluoroscopy-based navigation system: a randomized prospective study. Spine J. 2022 Apr;22(4):561-569. doi: 10.1016/j.spinee.2021.10.002. Epub 2021 Oct 16. PMID: 34666179. 2 Comstock, Christopher P. MD; Wait, Eric MD. Novel Machine Vision Image Guidance System Significantly Reduces Procedural Time and Radiation Exposure Compared With 2-dimensional Fluoroscopy-based Guidance in Pediatric Deformity Surgery. Journal of Pediatric Orthopaedics ():10.1097/BPO.0000000000002377, March 6, 2023. | DOI: 10.1097/ BPO.0000000000002377 3 Jakubovic R, Guha D, Gupta S, et al. High speed, high density intraoperative 3D optical topographical imaging with efficient registration to MRI and CT for craniospinal surgical navigation. Sci Rep. 2018;8:14894. doi:10.1038/s41598-018-32424-z. 4 Lim KBL, Yeo ISX, Ng SWL, Pan WJ, Lee NKL. The machine-vision image guided surgery system reduces fluoroscopy time, ionizing radiation and intraoperative blood loss in posterior spinal fusion for scoliosis. Eur Spine J. 2023 Jul 10. doi: 10.1007/s00586-023-07848-5. Epub ahead of print. PMID: 37428212.Stewart G. Visible Light Navigation in Spine Surgery: My Experience With My First 150 Cases. Int J Spine Surg. 2022 Oct;16(S2):S28-S36. doi: 10.14444/8274. Epub 2022 Aug 5. PMID: 36456113; PMCID: PMC9808787.


Slide 19

Significant Cross-Portfolio Commercial Opportunities Bone Growth Therapies (BGT) Combined portfolio with Biologics to target Trauma surgeons Combine with select Orthopedics product lines Expanding domestically through legacy SeaSpine distribution and orthopedics Expand internationally via Orthopedics Channels Biologics Expand cross-selling with U.S. Orthopedics channels Spine Maximize procedural selling opportunity with Biologics, 7D, and BGT Orthopedics Maximize procedural selling opportunity with Biologics, BGT, and Enabling Technologies Enabling Technologies (ET) Focus on 7D equipment placements to drive recurring implant usage Leverage investment and drive synergistic approach across the portfolio


Slide 20

Looking Forward – Accelerating Our Profitable Growth Engine Advancing Toward Our Goals for Consistent Above-Market Growth, Improved Profitability, and Positive Free Cash Flow Invest in Differentiated Technologies in Areas Where We Can Win and Lead Innovation Capitalize on Multiple Access Points to Grow Business at Sustained, Above-Market Rates Operate with Discipline for Margin Expansion Improve Financial Strength and Drive Strong, Positive Cash Flow


Slide 21

Full-Year 2025 Guidance1 $808M – $816M Net Sales $82M – $86M Adjusted EBITDA Positive Free Cash Flow for 2025² 1 As of the Company’s Q1 2025 Earnings Call hosted on 5/6/2025. Inclusion of this information in this presentation is not a confirmation or an update of, and should not be construed or otherwise assumed to reflect any confirmation or update of, that guidance by Orthofix leadership as of any date other than 5/6/2025. Net sales range of $808 million to $816 million excludes sales from the discontinued M6 product lines and assumes a $5 million negative impact from U.S. funded non-governmental organization (NGO) business as compared to the full-year 2024. The Company’s expected net sales represent implied constant currency growth of 5.0% year-over-year at 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. 2 Excluding impact of restructuring charges related to the discontinuation of the M6 product lines


Slide 22

Investment Summary – Why Invest in Orthofix? 01 Strong fundamentals with profitable growth opportunity and compelling value proposition across diverse portfolio 02 More focused commercial strategy with robust innovation pipeline complemented by successful cross-selling 03 New leadership team well-positioned to implement strategic vision and achieve sustainable, profitable growth across portfolio 04 Improved operational execution to drive toward profitability objectives and positive free cash flow 05 Long-term financial targets reflect confidence in sustainable growth trends and commercial strategy and execution


Slide 23

For additional information, please contact: Julie Dewey, IRC Chief IR & Communications Officer juliedewey@orthofix.com 209-613-6945 www.Orthofix.com NASDAQ: OFIX


Slide 24

Financial and Non-GAAP Reconciliation Tables Appendix


Slide 25

Net Sales by Major Product Category by Reporting Segment * 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.     Three Months Ended March 31,   (Unaudited, U.S. Dollars, in millions)   2025     2024     Change     Constant Currency Change   Bone Growth Therapies   $ 55.1     $ 52.5       4.9 %     4.9 % Spinal Implants, Biologics and Enabling Technologies*     104.3       102.3       2.0 %     2.0 % Global Spine*     159.4       154.8       3.0 %     3.0 % Global Orthopedics     29.8       27.3       9.1 %     11.5 % Pro forma net sales*     189.2       182.1       3.9 %     4.3 % Impact from discontinuation of M6 product lines     4.4       6.5       (31.9 %)     (31.5 %) Reported net sales   $ 193.6     $ 188.6       2.7 %     3.0 %


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Condensed Consolidated Balance Sheets


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Condensed Consolidated Statements of Operations     Three Months Ended       March 31,   (Unaudited, U.S. Dollars, in thousands, except share and per share data)   2025     2024           Net sales   $ 193,646     $ 188,608   Cost of sales     72,027       61,366   Gross profit     121,619       127,242   Sales, general, and administrative     132,981       131,691   Research and development     19,766       19,492   Acquisition-related amortization, impairment, and remeasurement     17,745       5,396   Operating loss     (48,873 )     (29,337 ) Interest expense, net     (4,506 )     (4,558 ) Other income (expense), net     1,246       (1,274 ) Loss before income taxes     (52,133 )     (35,169 ) Income tax expense     (961 )     (851 ) Net loss   $ (53,094 )   $ (36,020 )               Net loss per common share:             Basic   $ (1.35 )   $ (0.95 ) Diluted     (1.35 )     (0.95 ) Weighted average number of common shares (in millions):             Basic     39.2       37.7   Diluted     39.2       37.7  


Slide 28

Adjusted Gross Profit and Adjusted Gross Margin     Three Months Ended March 31,   (Unaudited, U.S. Dollars, in thousands)   2025     2024   Gross profit   $ 121,619     $ 127,242   Share-based compensation expense     462       537   SeaSpine merger-related costs     600       1,303   Restructuring costs and impairments related to M6 product lines     10,919       —   Strategic investments     13       65   Acquisition-related fair value adjustments     —       3,047   Amortization/depreciation of acquired long-lived assets     313       318   Adjusted gross profit   $ 133,926     $ 132,512   Adjusted gross margin as a percentage of reported net sales     69.2 %     70.3 % Adjusted gross profit attributable to M6 product lines     (906 )     (2,895 ) Pro forma adjusted gross profit   $ 133,020     $ 129,617   Pro forma adjusted gross margin as a percentage of pro forma net sales     70.3 %     71.2 %


Slide 29

Adjusted EBITDA     Three Months Ended March 31,   (Unaudited, U.S. Dollars, in thousands)   2025     2024   Net loss   $ (53,094 )   $ (36,020 ) Income tax expense     961       851   Interest expense, net     4,506       4,558   Depreciation and amortization     34,431       14,862   Share-based compensation expense     6,469       8,800   Foreign exchange impact     (1,044 )     1,588   SeaSpine merger-related costs     1,130       4,479   Restructuring costs and impairments related to M6 product lines     9,880       —   Strategic investments     3,514       120   Acquisition-related fair value adjustments     (610 )     4,217   Interest and loss on investments     —       (260 ) Litigation and investigation costs     3,042       2,260   Succession charges     —       2,210   Adjusted EBITDA   $ 9,185     $ 7,665   Adjusted EBITDA as a percentage of reported net sales     4.7 %     4.1 % Operating losses attributable to M6 product lines     2,246       1,854   Pro forma adjusted EBITDA   $ 11,431     $ 9,519   Adjusted EBITDA as a percentage of pro forma net sales     6.0 %     5.2 %


Slide 30

Adjusted Net Income (Loss)     Three Months Ended March 31,   (Unaudited, U.S. Dollars, in thousands)   2025     2024   Net loss   $ (53,094 )   $ (36,020 ) Share-based compensation expense     6,469       8,800   Foreign exchange impact     (1,044 )     1,588   SeaSpine merger-related costs     1,474       4,848   Restructuring costs and impairments related to M6 product lines     30,204       —   Strategic investments     3,543       126   Acquisition-related fair value adjustments     (610 )     4,217   Amortization/depreciation of acquired long-lived assets     4,632       4,792   Litigation and investigation costs     3,042       2,260   Succession charges     —       2,210   Interest and loss on investments     —       (260 ) Long-term income tax rate adjustment     2,200       2,696   Adjusted net loss   $ (3,184 )   $ (4,743 ) Operating losses attributable to M6 product lines     2,688       2,400   Long-term income tax rate adjustment for M6 product lines     (753 )     (672 ) Pro forma adjusted net loss   $ (1,249 )   $ (3,015 )


Slide 31

Cash Flow and Free Cash Flow     Three Months Ended March 31,   (Unaudited, U.S. Dollars, in thousands)   2025     2024   Net cash from operating activities   $ (18,391 )   $ (18,595 ) Net cash from investing activities     (6,736 )     (10,867 ) Net cash from financing activities     (651 )     21,453   Effect of exchange rate changes on cash     493       (284 ) Net change in cash and cash equivalents   $ (25,285 )   $ (8,293 )     Three Months Ended March 31,   (Unaudited, U.S. Dollars, in thousands)   2025     2024   Net cash from operating activities   $ (18,391 )   $ (18,595 ) Capital expenditures     (6,736 )     (10,817 ) Free cash flow   $ (25,127 )   $ (29,412 )


Slide 32

Adjusted Sales, General and Administrative Expense     Three Months Ended March 31,   (Unaudited, U.S. Dollars, in thousands)   2025     2024   Sales, general, and administrative   $ 132,981     $ 131,691   Reconciling items impacting sales, general, and administrative:             Restructuring costs and impairments related to M6 product lines     (3,336 )     —   Strategic investments     (2,304 )     (3,431 ) Amortization/depreciation of acquired long-lived assets     (60 )     (248 ) Litigation and investigation costs     (3,042 )     (2,260 ) Succession charges     —       (2,210 ) Sales, general, and administrative expense, as adjusted   $ 124,239     $ 123,542   As a percentage of reported net sales     64.2 %     65.5 % Sales, general, and administrative expense attributable to M6 product lines     (2,388 )     (4,155 ) Pro forma sales, general, and administrative expense, as adjusted   $ 121,851     $ 119,387   As a percentage of pro forma net sales     64.4 %     65.6 %


Slide 33

Adjusted Research and Development Expense     Three Months Ended March 31,   (Unaudited, U.S. Dollars, in thousands)   2025     2024   Research and development expense, as reported   $ 19,766     $ 19,492   Reconciling items impacting research and development:             Restructuring costs and impairments related to M6 product lines     (1,852 )     —   Strategic investments     (2,099 )     (237 ) Research and development expense, as adjusted   $ 15,815     $ 19,255   As a percentage of reported net sales     8.2 %     10.2 % Research and development expense attributable to M6 product lines     (1,192 )     (2,236 ) Pro forma research and development expense, as adjusted   $ 14,623     $ 17,019   As a percentage of pro forma net sales     7.7 %     9.3 %


Slide 34

Adjusted Non-Operating Expense     Three Months Ended March 31,   (Unaudited, U.S. Dollars, in thousands)   2025     2024   Non-operating expense   $ 3,260     $ 5,832   Reconciling items impacting non-operating expense:             Foreign exchange impact     1,044       (1,588 ) Interest and loss on investments     —       283   Non-operating expense, as adjusted   $ 4,304     $ 4,527   As a percentage of reported net sales     2.2 %     2.4 % Losses attributable to M6 product lines     (15 )     (47 ) Pro forma non-operating expense, as adjusted   $ 4,289     $ 4,480   As a percentage of pro forma net sales     2.3 %     2.5 %


Slide 35

2024 Pro Forma Financial Statements – M6 Product Lines     Three Months Ended   Three Months Ended   Year Ended (Unaudited, U.S. Dollars, in thousands)   March 31, 2025   March 31, 2024   June 30, 2024   September 30, 2024   December 31, 2024   December 31, 2024 Net sales   $ 4,443   $ 6,520   $ 5,804   $ 5,328   $ 5,792   $ 23,444 Cost of sales   14,457   3,638   2,874   3,137   2,514   12,163 Gross profit   (10,014)   2,882   2,930   2,191   3,278   11,281 Sales, general, and administrative   5,723   3,283   2,883   2,547   2,792   11,505 Research and development   3,044   2,091   2,320   2,099   2,120   8,630 Acquisition-related amortization and remeasurement   14,097   980   980   980   980   3,920 Operating loss   (32,878)   (3,472)   (3,253)   (3,435)   (2,614)   (12,774) Interest expense, net   (5)   (5)   (5)   (5)   (5)   (20) Other income (expense), net   (10)   (42)   (13)   (18)   (51)   (124) Loss before income taxes   (32,893)   (3,519)   (3,271)   (3,458)   (2,670)   (12,918) Income tax expense   —   —   —   —   —   — Net loss   $ (32,893)   $ (3,519)   $ (3,271)   $ (3,458)   $ (2,670)   $ (12,918)


Slide 36

2024 Pro Forma Non-GAAP Adjusted EBITDA – M6 Product Lines     Three Months Ended   Three Months Ended   Year Ended (Unaudited, U.S. Dollars, in thousands)   March 31, 2025   March 31, 2024   June 30, 2024   September 30, 2024   December 31, 2024   December 31, 2024 Net loss   $ (32,893)   $ (3,519)   $ (3,271)   $ (3,458)   $ (2,670)   $ (12,918) Interest expense, net   5   5   5   5   5   20 Depreciation and amortization   20,762   1,521   1,426   1,393   1,432   5,772 Share-based compensation expense   —   111   95   88   79   373 Foreign exchange impact   —   11   —   4   42   57 SeaSpine merger-related costs   —   17   (49)   304   53   325 Restructuring costs and impairments related to M6 product lines   9,880   —   —   —   —   — Adjusted EBITDA   $ (2,246)   $ (1,854)   $ (1,794)   $ (1,664)   $ (1,059)   $ (6,371)


Slide 37

2024 Pro Forma Non-GAAP Adjusted Net Loss and Adjusted Gross Margin – M6 Product Lines     Three Months Ended   Three Months Ended   Year Ended (Unaudited, U.S. Dollars, in thousands)   March 31, 2025   March 31, 2024   June 30, 2024   September 30, 2024   December 31, 2024   December 31, 2024 Net loss   $ (32,893)   $ (3,519)   $ (3,271)   $ (3,458)   $ (2,670)   $ (12,918) Share-based compensation expense   —   111   95   88   79   373 Foreign exchange impact   —   11   —   4   42   57 SeaSpine merger-related costs   —   17   (49)   304   34   306 Amortization/depreciation of acquired long-lived assets   20,325   980   980   980   980   3,920 Restructuring costs and impairments related to M6 product lines   9,880   —   —   —   —   — Long-term income tax rate adjustment   753   672   629   583   429   2,313 Adjusted net loss   $ (1,935)   $ (1,728)   $ (1,616)   $ (1,499)   $ (1,106)   $ (5,949)     Three Months Ended   Three Months Ended   Year Ended (Unaudited, U.S. Dollars, in thousands)   March 31, 2025   March 31, 2024   June 30, 2024   September 30, 2024   December 31, 2024   December 31, 2024 Gross profit   $ (10,014)   $ 2,882   $ 2,930   $ 2,191   $ 3,278   $ 11,281 Share-Based Compensation Expense   —   13   13   12   9   47 SeaSpine Merger-Related Costs   —   —   —   198   29   227 Restructuring costs and impairments related to M6 product lines   10,920   —   —   —   —   — Adjusted gross profit   $ 906   $ 2,895   $ 2,943   $ 2,401   $ 3,316   $ 11,555 Adjusted gross margin as a percentage of net sales   20.4%   44.4%   50.7%   45.1%   57.3%   49.3%

v3.25.1
Document And Entity Information
May 06, 2025
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date May 06, 2025
Entity Registrant Name ORTHOFIX MEDICAL INC.
Entity Central Index Key 0000884624
Entity Emerging Growth Company false
Entity File Number 000-19961
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 98-1340767
Entity Address, Address Line One 3451 Plano Parkway
Entity Address, City or Town Lewisville
Entity Address, State or Province TX
Entity Address, Postal Zip Code 75056
City Area Code (214)
Local Phone Number 937-2000
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common stock, $0.10 par value per share
Trading Symbol OFIX
Security Exchange Name NASDAQ

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