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Orthofix cuts 2026 outlook after Medicare change

Orthofix Medical Inc. is updating its outlook after Medicare reimbursement changes for non-invasive bone growth stimulators.

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Orthofix Medical Inc. is updating its outlook after Medicare reimbursement changes for non-invasive bone growth stimulators. Following an FDA reclassification of these devices to Class II and related CMS billing updates effective May 18, 2026, the company expects average Medicare reimbursement for key HCPCS codes to decline by about 10%.

Orthofix now projects full-year 2026 net sales of $838–$848 million and non-GAAP adjusted EBITDA of $90–$93 million, and it does not expect positive free cash flow for 2026. The company has withdrawn its three-year financial targets and will continue assessing the long-term effects of current and future CMS actions.

Positive

  • None.

Negative

  • Medicare reimbursement pressure: Orthofix expects average Medicare reimbursement for key non-invasive bone growth stimulator codes to decline by about 10%, directly impacting revenue and margins.
  • Weaker 2026 outlook and cash flow: New guidance of $838–$848 million in 2026 net sales and $90–$93 million in non-GAAP adjusted EBITDA is paired with an expectation of no positive free cash flow for 2026.
  • Withdrawal of long-term targets: The company’s three-year financial targets are no longer applicable, signaling increased uncertainty around longer-term performance due to CMS reimbursement actions.

Insights

CMS reimbursement cuts drive a weaker 2026 outlook and withdrawn long-term targets.

Orthofix highlights a roughly 10% drop in average Medicare reimbursement for non-invasive bone growth stimulators, tied to FDA reclassification and CMS billing and fee schedule changes effective May 18, 2026. This directly pressures revenue and profitability in a key product area.

The company now guides to $838–$848M in 2026 net sales and $90–$93M in non-GAAP adjusted EBITDA, and no longer expects positive free cash flow for the year. Management has also withdrawn its three-year financial targets, underscoring uncertainty around the longer-term impact of reimbursement changes. Future CMS decisions and resulting claim volumes and payer behavior will be important for understanding sustained effects, based on upcoming company disclosures.

Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Medicare reimbursement change ≈10% decline Average Medicare reimbursement for HCPCS E0747, E0748, E0760
2026 net sales guidance $838–$848 million Full-year 2026 expected net sales
2026 non-GAAP adjusted EBITDA $90–$93 million Full-year 2026 non-GAAP adjusted EBITDA guidance
2026 free cash flow Not expected to be positive Full-year 2026 free cash flow outlook
FDA device reclassification Class III to Class II Non-invasive bone growth stimulators reclassified on April 16, 2026
Effective date for CMS changes May 18, 2026 Dates of service for updated billing and fee schedule
non-invasive bone growth stimulators medical
"reclassifying non-invasive bone growth stimulators from Class III to Class II devices"
HCPCS codes technical
"billed under HCPCS codes E0747, E0748 and E0760 for dates of service"
non-GAAP adjusted EBITDA financial
"expects net sales for full-year 2026 to be in the range of $838 million to $848 million and non-GAAP adjusted EBITDA"
Non-GAAP adjusted EBITDA is a measure of a company's profitability that shows earnings before interest, taxes, depreciation, and amortization, with certain adjustments made to exclude irregular or non-recurring expenses and income. It provides a clearer picture of ongoing operational performance by filtering out items that might distort the core business results. Investors use it to better compare how well different companies are performing without the noise of one-time events.
free cash flow financial
"At this time, the Company does not expect positive free cash flow for full-year 2026."
Free cash flow is the amount of money a company has left over after paying all its expenses and investing in its business, like buying equipment or updating facilities. It shows how much cash is available to reward shareholders, pay down debt, or save for future growth. This helps investors understand if a company is financially healthy and able to grow.
Regulation FD Disclosure regulatory
"Item 7.01 Regulation FD Disclosure."
Regulation FD disclosure requires public companies to share important, market-moving information with everyone at the same time instead of tipping off analysts or large investors first. Think of it as making sure all players on a field hear the same announcement simultaneously; that fairness helps investors trust that stock prices reflect the same information and reduces the risk of sudden, unfair trading advantages or regulatory penalties for selective leaks.
forward-looking statements regulatory
"This disclosure contains forward-looking statements within the meaning of Section 21E"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.

FAQ

How are CMS reimbursement changes affecting Orthofix Medical (OFIX)?
CMS billing and fee schedule updates for non-invasive bone growth stimulators are expected to reduce Orthofix’s average Medicare reimbursement by about 10%. This change pressures revenue and profitability in that product category beginning with dates of service on or after May 18, 2026.

What 2026 net sales guidance did Orthofix Medical (OFIX) provide?
Orthofix now expects 2026 net sales between $838 million and $848 million. This range reflects the anticipated impact of lower Medicare reimbursement for certain non-invasive bone growth stimulators following recent FDA reclassification and CMS billing and payment changes.

What is Orthofix Medical’s 2026 non-GAAP adjusted EBITDA outlook?
The company projects 2026 non-GAAP adjusted EBITDA of $90 million to $93 million. This guidance incorporates the expected reimbursement-driven revenue impact on its non-invasive bone growth stimulators and reflects current assumptions about operating costs and business performance.

Does Orthofix Medical (OFIX) expect positive free cash flow in 2026?
No. Orthofix explicitly states it does not expect positive free cash flow for full-year 2026. This outlook is tied to the financial impact of reduced Medicare reimbursement and the company’s current assumptions about operating performance and capital needs during the year.

What happened to Orthofix Medical’s three-year financial targets?
Orthofix states that its three-year financial targets are no longer applicable. This change reflects uncertainty around the longer-term impact of current and potential future CMS reimbursement actions on its non-invasive bone growth stimulator business and overall financial performance.

When do the new Medicare billing changes start affecting Orthofix Medical?
The billing and Medicare fee schedule changes for non-invasive bone growth stimulators apply to services billed under HCPCS codes E0747, E0748 and E0760 for dates of service on or after May 18, 2026. Orthofix’s updated 2026 outlook incorporates these effective dates.

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false000088462400008846242026-05-212026-05-21

 

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 21, 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 7.01 Regulation FD Disclosure.

On April 16, 2026, the U.S. Food and Drug Administration issued a final order reclassifying non-invasive bone growth stimulators from Class III to Class II devices. In connection with that reclassification, the Centers for Medicare & Medicaid Services (“CMS”) recently updated certain billing requirements and Medicare fee schedule treatment applicable to non-invasive bone growth stimulators billed under HCPCS codes E0747, E0748 and E0760 for dates of service on or after May 18, 2026.

Based on the revised billing and payment information currently available, Orthofix Medical Inc. (the “Company”) currently expects average Medicare reimbursement for these codes to decline by approximately 10% and, as a result, is updating its financial outlook. The Company now expects net sales for full-year 2026 to be in the range of $838 million to $848 million and non-GAAP adjusted EBITDA to be in the range of $90 million to $93 million. At this time, the Company does not expect positive free cash flow for full-year 2026. Further changes by CMS to Medicare reimbursement rates for non-invasive bone growth stimulators could require the Company to revise its financial outlook.

In light of these developments, the Company’s three-year financial targets are no longer applicable. The Company will continue to evaluate the long-term impact of current and future CMS action.

Forward-Looking Statements

This disclosure 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, including statements regarding the expected impact of the reimbursement changes on the Company’s business and financial outlook. These statements are based on our current beliefs, assumptions, intentions, plans, expectations, estimates, forecasts and projections. Actual results may differ materially from those indicated in these forward-looking statements as a result of various important factors, including the implementation of the revised reimbursement rules, changes in claim volumes or payer behavior, and other risks and uncertainties affecting the Company’s business. Forward-looking statements are not guarantees of our future performance, are based on our current expectations and assumptions regarding our business, the economy and other future conditions, and are subject to risks, uncertainties and changes in circumstances that are difficult to predict, including the risks described in Part I, Item 1A under the heading Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2025, 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, 2026. Any forward-looking statements speak only as of the date hereof, and the Company undertakes no obligation to update, and expressly disclaims any duty to update, its forward-looking statements, whether as a result of circumstances or events that arise after the date hereof, new information, or otherwise, except as required by law.

 

SIGNATURES

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.

 

 

 

 

Date:

May 21, 2026

By:

/s/ J. Andrés Cedrón

 

 

 

J. Andrés Cedrón
Chief Legal Officer

 

Source: View Original Filing on SEC EDGAR

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