OFIX on Nasdaq

Orthofix Medical Inc.

Orthofix Medical Inc. is a global medical technology company headquartered in Lewisville.1

Price unavailable

Last updated Oct 21, 2026.

Overview

Compare with Alphatec Holdings, Inc., iRhythm Holdings, Inc. or Inspire Medical Systems (United States), or pick any stock.

  • TickerOFIX on Nasdaq1
  • IndustrySurgical & Medical Instruments & Apparatus1
  • HeadquartersLewisville, Texas1
  • Business address3451 Plano Parkway, Lewisville, Tx 750562
  • Filer categoryAccelerated filer2

Orthofix is a global medical technology company headquartered in Lewisville, Texas. By providing medical technologies that heal musculoskeletal pathologies, Orthofix delivers exceptional experiences and life-changing solutions to patients around the world. Orthofix offers a comprehensive portfolio of spinal hardware, bone growth therapies, limb reconstruction solutions, biologics and enabling technologies, including the 7D FLASH Navigation System.4 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

68.8%Gross margin5
-9.9%Operating margin5
-11.2%Net margin5
2.9%Revenue growth, 20255
-20.5%Return on equity5
0.35×Debt to equity5

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Business segments

Global Spine brought in 84% of the revenue Orthofix Medical Inc. broke down this way in fiscal 2025.

  1. Global Spine$687.7M584%up 2% from 2024
  2. Global Limb Reconstruction$134.7M516%up 8% from 2024
Business segments by year
Business segments202320242025
Global Spine$631.3M$675.3M$687.7M
Global Limb Reconstruction$115.3M$124.2M$134.7M

Regions

United States brought in 83% of the revenue Orthofix Medical Inc. broke down this way in fiscal 2025.

  1. United States$684.1M583%up 2% from 2024
  2. Other Countries$76.7M59%up 16% from 2024
  3. Italy$22.3M53%up 6% from 2024
  4. United Kingdom$13.3M52%up 19% from 2024
  5. France$12.0M51%down 11% from 2024
  6. Germany$9.1M51%up 1% from 2024
  7. Brazil$4.8M51%down 15% from 2024
Regions by year
Regions202320242025
United States$620.8M$672.8M$684.1M
Other Countries$65.8M$66.4M$76.7M
Italy$20.1M$21.0M$22.3M
United Kingdom$10.9M$11.2M$13.3M
France$11.1M$13.4M$12.0M
Germany$11.5M$9.0M$9.1M
Brazil$6.5M$5.7M$4.8M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue29¢$256.3M
  • Research and development8¢$65.8M
  • Selling, general and admin63¢$554.3M
  • Income tax0¢$1.4M

Out of $822.3M in revenue.5 The company lost money this year.

Where each dollar of operating cash went, fiscal 2025

  • Kept or used elsewhere100¢$33.3M

Out of $33.3M of cash from operations.5

Financial statements

Revenue67895$822.3M in 2025+79% since 2019
0$250.0M$500.0M$750.0M$1.0B2019: $460.0M$460.0M20192020: $406.6M$406.6M2020−12%2021: $464.5M$464.5M2021+14%2022: $460.7M$460.7M2022−1%2023: $746.6M$746.6M2023+62%2024: $799.5M$799.5M2024+7%2025: $822.3M$822.3M2025+3%
Gross profit67895$566.0M in 2025+58% since 2019
0$200.0M$400.0M$600.0M2019: $359.3M$359.3M20192020: $304.7M$304.7M2020−15%2021: $349.6M$349.6M2021+15%2022: $337.2M$337.2M2022−4%2023: $486.3M$486.3M2023+44%2024: $545.9M$545.9M2024+12%2025: $566.0M$566.0M2025+4%
Operating income67895-$81.4M in 2025+333% since 2019
-$150.0M-$100.0M-$50.0M02019: -$18.8M-$18.8M20192020: -$6.3M-$6.3M2020−67%2021: -$8.3M-$8.3M2021+33%2022: -$13.3M-$13.3M2022+60%2023: -$139.1M-$139.1M2023+948%2024: -$84.6M-$84.6M2024−39%2025: -$81.4M-$81.4M2025−4%
Net income67895-$92.2M in 2025+224% since 2019
-$200.0M-$150.0M-$100.0M-$50.0M0$50.0M2019: -$28.5M-$28.5M20192020: $2.5M$2.5M20202021: -$38.4M-$38.4M20212022: -$19.7M-$19.7M2022−49%2023: -$151.4M-$151.4M2023+667%2024: -$126.0M-$126.0M2024−17%2025: -$92.2M-$92.2M2025−27%

Every line of the income statement as filed: the last 3 fiscal years, latest first.5

Period ending2025-12-312024-12-312023-12-31
Net sales$822.3M$799.5M$746.6M
Cost of sales$256.3M$253.6M$260.4M
Gross profit$566.0M$545.9M$486.3M
Sales, general, and administrative$554.3M$532.5M$530.4M
Research and development$65.8M$73.6M$80.2M
Acquisition-related amortization, impairment, and remeasurement (Note 17)$27.3M$24.3M$14.8M
Operating loss-$81.4M-$84.6M-$139.1M
Interest expense, net-$17.5M-$29.6M-$8.6M
Other (expense) income, net$8.1M-$9.6M-$938.0K
Loss before income taxes-$90.8M-$123.9M-$148.7M
Income tax expense-$1.4M-$2.1M-$2.7M
Net loss-$92.2M-$126.0M-$151.4M
Basic-$2.33-$3.30-$4.12
Diluted-$2.33-$3.30-$4.12
Basic39.6M shares38.1M shares36.7M shares
Diluted39.6M shares38.1M shares36.7M shares
Unrealized loss on debt securities-$1.3M
Currency translation adjustment$4.9M-$3.0M$1.4M
Other comprehensive income (loss), before tax$4.9M-$3.0M$83.0K
Other comprehensive income (loss), net of tax$4.9M-$3.0M$83.0K
Comprehensive loss-$87.3M-$129.0M-$151.3M

Compare Orthofix Medical Inc. with another company

Corporate structure

Orthofix Medical Inc. sits at the top of its group. 11 entities, 9 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Orthofix Medical Inc.

  • Orthofix Medical Inc. Lewisville, Texas
    • 7D Surgical ULC Subsidiary · Canada
    • Implantes y Sistemas Medicos, Inc. Subsidiary · Puerto Rico, United States
    • IsoTis International SARL Subsidiary · Switzerland
    • Orthofix AG Subsidiary · Switzerland
    • Orthofix Australia Pty. Ltd. Subsidiary · Australia
    • Orthofix do Brasil Ltda. Subsidiary · Brazil
    • Orthofix France SAS Subsidiary · France
    • Orthofix Netherlands B.V. Subsidiary · Netherlands
    • Orthofix S.r.l. Subsidiary · Italy
    • Orthofix Spine GmbH Subsidiary · Germany

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Orthofix Medical Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$380.1M5 Dec 31, 2025$352.0M5 Dec 31, 2024+8.0%
Accumulated depreciation$250.7M5 Dec 31, 2025$212.2M5 Dec 31, 2024+18.1%
Property and equipment, net$129.4M5 Dec 31, 2025$139.8M5 Dec 31, 2024−7.4%
Finance-lease assets$14.4M5 Dec 31, 2025$15.4M5 Dec 31, 2024−6.1%
Operating-lease assets (leased space)$22.3M5 Dec 31, 2025$17.2M5 Dec 31, 2024+29.2%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$82.0M5 Dec 31, 2025$83.2M5 Dec 31, 2024−1.5%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$194.9M5 Dec 31, 2025$194.9M5 Dec 31, 20240%
Intangible assets, net (excluding goodwill)$72.8M5 Dec 31, 2025$98.8M5 Dec 31, 2024−26.4%
Indefinite-lived intangibles (excluding goodwill)$1.0M5 Dec 31, 2025$4.1M9 Dec 31, 2024−75.1%
Accumulated amortization$145.7M5 Dec 31, 2025$105.6M5 Dec 31, 2024+38.0%
Finite-lived intangibles, net$71.7M5 Dec 31, 2025$94.7M9 Dec 31, 2024−24.2%

Inventory

ItemLatestA year beforeChange
Inventory, total$172.3M5 Dec 31, 2025$189.5M5 Dec 31, 2024−9.0%
Raw materials$22.9M5 Dec 31, 2025$27.2M5 Dec 31, 2024−15.9%
Work in process$63.3M5 Dec 31, 2025$56.9M5 Dec 31, 2024+11.1%
Finished goods$86.2M5 Dec 31, 2025$105.4M5 Dec 31, 2024−18.2%

Properties, in its own words

We lease or own real property to support our business. The following lists those properties that we believe are material to our business. We believe that our facilities meet our current needs and that we will be able to renew any such leases when needed on acceptable terms or find alternative facilities.

Facility · Location · Approx.SquareFeet · Ownership

The rest of Item 2

Manufacturing, warehousing, distribution, research and development, location of a cadaveric training laboratory, and administrative facility for corporate functions and all reporting segments · Lewisville, TX · 140,000 · Leased

Design, development, marketing, and inspection for biologics and spinal implant products, distribution of certain Spinal Implant products, location of a cadaveric training laboratory, and administrative facility · Carlsbad, CA · 82,000 · Leased

Manufacturing and distribution for certain Biologics products · Irvine, CA · 70,000 · Leased

Manufacturing, warehousing, distribution, research and development, and administrative facility for Motion Preservation · Sunnyvale, CA · 25,000 · Leased

Design of Spinal Implants and location of a cadaveric training laboratory · Wayne, PA · 3,700 · Leased

Design, development, and marketing for Enabling Technologies products · Toronto, Canada · 9,200 · Leased

Research and development, component manufacturing, quality control and training facility for Limb Reconstruction products and sales management, distribution and administrative facility for Italy · Verona, Italy · 38,000 · Owned

International distribution center for Limb Reconstruction products · Verona, Italy · 18,000 · Leased

Mechanical workshop for Limb Reconstruction products · Verona, Italy · 9,000 · Leased

Sales management, distribution and administrative facility for United Kingdom · Maidenhead, England · 5,600 · Leased

Sales management, distribution and administrative facility for Brazil · São Paulo, Brazil · 26,300 · Leased

Sales management, distribution and administrative facility for France · Arcueil, France · 8,500 · Leased

Sales management, distribution and administrative facility for Germany · Munich, Germany · 2,300 · Leased

Our manufacturing facilities are registered with the FDA. Our facilities are subject to FDA inspection to ensure compliance with its QSRs. For further information regarding the status of FDA inspections, see Item 1, "Business", under the subheading "Government Regulation."

Item 2 of the 10-K filed Feb 24, 2026.4

Leadership

Who has led Orthofix Medical Inc., and when. Pick a name to see everywhere that person has worked.

Board members and other officers (47)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • 7D Surgical ULC Canada3
  • Implantes y Sistemas Medicos, Inc. Puerto Rico3
  • IsoTis International SARL Switzerland3
  • Orthofix AG Switzerland3
  • Orthofix Australia Pty. Ltd. Australia3
  • Orthofix France SAS France3
  • Orthofix GmbH Germany3
  • Orthofix Limited UK3
  • Orthofix Netherlands B.V. Netherlands3
  • Orthofix S.r.l. Italy3
  • Orthofix Spine GmbH Germany3
  • Orthofix do Brasil Ltda. Brazil3

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Former names

  • ORTHOFIX INTERNATIONAL N VSep 3, 1998 to Aug 1, 20182

Timeline

  1. Aug 5, 20268-K Results of operations; Regulation FD disclosure98
  2. Jul 2, 20268-K Regulation FD disclosure99
  3. Jun 11, 20268-K Executive or director change; Shareholder vote100
  4. May 21, 20268-K Regulation FD disclosure101
  5. May 5, 20268-K Results of operations; Regulation FD disclosure102
  6. Apr 9, 20268-K Results of operations; Executive or director change103
  7. Feb 24, 20268-K Results of operations; Regulation FD disclosure104
  8. Nov 4, 20258-K Results of operations; Regulation FD disclosure105
  9. Aug 5, 20258-K Results of operations; Regulation FD disclosure106
  10. Jun 20, 20258-K Shareholder vote107
  11. May 6, 20258-K Results of operations; Regulation FD disclosure108
  12. Apr 7, 20258-K Entered a material agreement; Ended a material agreement109
  13. Jan 10, 2024New chief executive Massimo Calafiore becomes CEO13
  14. Oct 17, 2023New chief executive Catherine M. Burzik becomes CEO15
  15. Jan 9, 2023New chief executive Keith Valentine becomes CEO14
  16. Nov 5, 2019New chief executive Jon Carl Serbousek becomes CEO16
  17. Feb 16, 2012New chief executive Robert S. Vaters becomes CEO17
  18. Apr 12, 2006New chief executive Alan Milinazzo becomes CEO19
  19. Mar 7, 2006New chief executive Charles Federico becomes CEO18

Calendar

Coming up

  1. Nov 3, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.57) a share, on Nov 4, 2025.110

When it reported results

  1. Aug 5, 2026Reported quarterly or annual results98
  2. May 5, 2026Reported quarterly or annual results102
  3. Apr 9, 2026Reported quarterly or annual results103
  4. Feb 24, 2026Reported quarterly or annual results104
  5. Nov 4, 2025Reported quarterly or annual results105
  6. Aug 5, 2025Reported quarterly or annual results106
  7. May 6, 2025Reported quarterly or annual results108
  8. Feb 25, 2025Reported quarterly or annual results111

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

401 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 59 major events, 217 insider forms, 38 large holders, 67 other. The latest 20:

  1. Oct 5, 20264 EDGAR
  2. Sep 23, 20264/A PRIMARY DOCUMENT EDGAR
  3. Sep 22, 20264 PRIMARY DOCUMENT EDGAR
  4. Sep 3, 20264 EDGAR
  5. Sep 1, 2026144 EDGAR
  6. Aug 20, 20264 EDGAR
  7. Aug 18, 20264 PRIMARY DOCUMENT EDGAR
  8. Aug 14, 2026SCHEDULE 13G/A EDGAR
  9. Aug 5, 2026S-8 EDGAR
  10. Aug 5, 202610-Q EDGAR
  11. Aug 5, 20268-K EDGAR
  12. Jul 2, 20268-K EDGAR
  13. Jun 22, 20264 EDGAR
  14. Jun 12, 20264 EDGAR
  15. Jun 12, 20264 EDGAR
  16. Jun 12, 20264 EDGAR
  17. Jun 12, 20264 EDGAR
  18. Jun 12, 20264 EDGAR
  19. Jun 12, 20264 EDGAR
  20. Jun 12, 20264 EDGAR

The 401 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

71 open-market trades by officers, directors and large owners since October 2021: 24 buys and 47 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 21, 2026Bartholdson John A.10% ownerBuy190,000$8.86$1.7MForm 4
Sep 21, 2026Juniper Investment Company, LLC10% ownerSale190,000$8.86$1.7MForm 4
Sep 18, 2026Bartholdson John A.10% ownerBuy120,000$8.74$1.0MForm 4
Sep 18, 2026Juniper Investment Company, LLC10% ownerSale120,000$8.74$1.0MForm 4
Sep 1, 2026Fisher PatrickPresident, Global Limb ReconSale150$9.39$1.4KForm 4
Aug 18, 2026Fisher PatrickPresident, Global Limb ReconSale1,295$10.09$13.1KForm 4
Aug 17, 2026MICHAS ALEXIS P10% ownerSale20,000$10.01$200.2KForm 4
Aug 14, 2026MICHAS ALEXIS P10% ownerSale19,500$10.38$202.4KForm 4
Jun 18, 2026McPherron AvivaPres, Global Ops & QualSale3,670$9.38$34.4KForm 4
May 22, 2026Juniper Investment Company, LLC10% ownerSale242,000$10.70$2.6MForm 4
May 7, 2026HENNEMAN JOHN B IIIDirectorBuy5,000$12.26$61.3KForm 4
May 7, 2026Engine Jet Capital, L.P.10% ownerBuy30,000$12.18$365.5KForm 4
May 6, 2026Engine Jet Capital, L.P.10% ownerBuy41,946$12.23$513.0KForm 4
May 5, 2026Engine Jet Capital, L.P.10% ownerBuy112,950$11.99$1.4MForm 4
Apr 16, 2026Cedron Jorge AndresCLOSale3,743$12.82$48.0KForm 4
Mar 17, 2026Vitale LucasCP&BOOSale4,269$11.92$50.9KForm 4
Mar 10, 2026CAPPS VICKIE LDirectorBuy2,500$12.45$31.1KForm 4
Mar 9, 2026CAPPS VICKIE LDirectorBuy2,500$12.48$31.2KForm 4
Mar 5, 2026Andrews JulieCFOSale2,363$12.55$29.7KForm 4
Mar 5, 2026Vitale LucasCP&BOOSale1,141$12.55$14.3KForm 4

All 71 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Massimo Calafiore - President and$848.3K$7.3M123
2025Julie Andrews - Chief Financial Officer$488.4K$3.0M123
2025J. Andrés Cedrón - Chief Legal Officer$483.3K$2.1M123
2025Aviva McPherron - PresidentGlobal Operations and Quality$447.3K$1.8M123
2025Patrick Fisher - PresidentGlobal Biologics and Limb Reconstruction$462.7K$1.8M123
2024Chief Executive Officer$793.3K$10.6M123
2024Julie Andrews - Chief Financial Officer$447.6K$3.2M123
2024J. Andrés Cedrón - Chief Legal Officer$325.4K$2.4M123

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Engine Capital Management, LP4,575,675$41.8M4.1%+184,896
Juniper Investment Company, LLC4,442,543$40.6M10.8%+465,584
Rubric Capital Management LP3,721,715$34.0M0.3%No change
BlackRock, Inc.3,326,560$30.4M0.0%+118,771
Paradigm Capital Management Inc/ny3,300,499$30.2M0.8%−4,400
Armistice Capital, LLC3,264,000$29.8M0.8%+564,000
Vanguard Capital Management LLC1,731,108$15.8M0.0%+75,659
Geode Capital Management, LLC1,048,081$9.6M0.0%+109,196
State Street Corp953,148$8.7M0.0%+45,716
Aqr Capital Management LLC887,282$8.1M0.0%+698,158
Millennium Management LLC862,030$7.9M0.0%−204,870
AYAL Capital Advisors Ltd775,421$7.1M3.6%−8,268
Dimensional Fund Advisors LP731,638$6.7M0.0%−109,883
Jacobs Levy Equity Management, Inc480,836$4.4M0.0%+101,721
Goldman Sachs Group Inc446,140$4.1M0.0%+121,715
Vanguard Portfolio Management LLC404,839$3.7M0.0%+8,271
Northern Trust Corp363,884$3.3M0.0%+26,546
Arrowstreet Capital, Limited Partnership344,205$3.1M0.0%+143,975
Charles Schwab Investment Management Inc334,617$3.1M0.0%+8,874
Morgan Stanley295,656$2.7M0.0%+98,310
Bank Of America Corp /de/291,827$2.7M0.0%+79,658
Tudor Investment Corp Et Al269,038$2.5M0.0%+6,064
Vanguard Fiduciary Trust Co267,309$2.4M0.0%+11,287
Fmr LLC265,477$2.4M0.0%+170,725
Russell Investments Group, Ltd.199,319$1.8M0.0%−12,415

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Orthofix Medical Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGAROrthofix Medical Inc.1
  • CIK0000884624
  • Employer ID (EIN)98-13407674
  • Filer statusAccelerated filer not an emerging growth company; not a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 231
  • Industry code (SIC)3841 Surgical & Medical Instruments & Apparatus1
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
  • Business address3451 Plano Parkway, Lewisville, TX 750561
  • Phone214-937-20001
  • Shares outstanding40,732,608 as of Jul 31, 202611
  • Public float$440.2M as of Jun 30, 20254
  • AuditorErnst & Young LLP, Dallas, Texas PCAOB ID 42; it also attests to the company’s internal control over financial reporting4
  • On EDGAR sinceJan 12, 19981
  • Filings1,745 in all: 4 (756), 8-K (330), SC 13G/A (98), 3 (90), 10-Q (71), S-8 (37), SC 13G (35), DEFA14A (32)1
    All 49 form types

    4/A (25), 10-K (24), DEF 14A (24), UPLOAD (23), 425 (19), CORRESP (17), DFAN14A (16), SD (13), PRE 14A (12), 8-K/A (10), 3/A (9), SCHEDULE 13G/A (9), 10-K/A (8), S-8 POS (7), SCHEDULE 13D/A (7), 144 (6), CT ORDER (6), 20-F (5), 5 (4), 6-K (4), DEFC14A (4), DEFR14A (4), NT 10-Q (4), PREC14A (4), EFFECT (3), PRER14A (3), PRRN14A (3), SC 13D/A (3), 10-Q/A (2), 424B3 (2), DFRN14A (2), NT 10-K (2), S-4 (2), S-4/A (2), SC 13D (2), ARS (1), NTN 10Q (1), POS AM (1), PREC14C (1), S-3ASR (1), SCHEDULE 13D (1)

  • Latest filingsAnnual report (10-K) Feb 24, 2026
    Quarterly report (10-Q) Aug 5, 2026
    Proxy statement (DEF 14A) Apr 29, 2026
    Latest 8-K (8-K) Aug 5, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.10 par valueOFIXNasdaq Global Select Market

From the cover page of the 10-K filed Feb 24, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Orthofix Medical Inc. names in Item 1A of its 10-K filed Feb 24, 2026: 52 risks under these headings, as written.4

  • Risks Related to our Business and Industry
  • We continue to integrate legacy businesses that operate in different market segments, and we may not be able to achieve all of our intended synergies between such legacy businesses.
  • Our business may be adversely affected if consolidation in the healthcare industry leads to demand for price concessions or if a GPO or similar entity excludes us from being a supplier.
  • The industry in which we operate is highly competitive. New developments by others could make our products or technologies non-competitive or obsolete.
  • The COVID-19 pandemic and related supply chain and raw material disruptions previously had material adverse impacts to our global operations and financial condition. Future pandemics, wars and armed conflicts, terrorist attacks, and other such global events could similarly have a material impact on our global operations and the operations of our supply chain, which could adversely impact our business results and financial condition.
  • Our ability to market products successfully depends, in part, upon the acceptance of the products not only by consumers, but also by independent third parties.
  • Clinical studies are expensive and subject to extensive regulation and their results may not support our product candidate claims or may result in the discovery of adverse effects.
  • If the third parties on which we rely to conduct our clinical studies and to assist us with pre-clinical development do not perform as contractually required or expected, we may not obtain regulatory clearance, approval, or a CE Certificate of Conformity for our products or be able to successfully commercialize our products.
  • Our allograft and cellular bone allografts could expose us to certain risks that could disrupt our business.
  • Unfavorable media reports or other negative publicity concerning both alleged improper methods of tissue recovery from donors and disease transmission from donated tissue could limit widespread acceptance of some of our products.
  • We may not be able to successfully introduce new products to the market and market opportunities that we expect to develop for our products may not be as large as we expect.
  • There is no guarantee that the FDA will grant 510(k) clearance or premarket approval, or that equivalent foreign regulatory authorities will grant the foreign equivalent, of our future products, and failure to obtain necessary clearances or approvals for our future products would adversely affect our ability to grow our business.
The other 41 risks
  • Growing our business requires that we properly educate and train physicians regarding the distinctive characteristics, benefits, safety, clinical efficacy, and cost-effectiveness of our products.
  • Sales of, or the price at which we sell, our products may be adversely affected unless the safety and efficacy of our products, alone and relative to competing products, is demonstrated in clinical studies.
  • We may be adversely affected by any disruption in our information technology systems, which could adversely affect our cash flows, operating results, and financial condition.
  • We may be adversely affected by a failure or compromise from a cyber-attack, data breach or ransomware attack, which could have an adverse effect on our business.
  • The physical effects of climate change or legal, regulatory, or market measures intended to address climate change could adversely affect our operations and operating results.
  • If any of our manufacturing, development, or research facilities are damaged and/or if our manufacturing processes are interrupted, we could experience supply disruptions and/or lost revenues and our business could be seriously harmed including as the result of natural disasters and other catastrophic events outside our control.
  • We depend on third-party manufacturers for many of our products.
  • We depend on a limited number of third-party suppliers for processing activities, components and raw materials and losing any of these suppliers, or their inability to provide us with an adequate supply of materials that meet our quality and other requirements, could harm our business.
  • If we are unable to maintain and expand our network of independent sales representatives and distributors, we may not maintain or grow our revenue.
  • In order to compete, we must attract, retain, and motivate executives and key employees, and our failure to do so could have an adverse effect on our results of operations.
  • Risks Related to our Legal and Regulatory Environment
  • If we fail to maintain an effective system of internal controls or discover material weaknesses in our internal control over financial reporting, we may not be able to report our financial results accurately or detect fraud, which could harm our business and the trading price of our common stock.
  • We are subject to the FCPA and other similar anti-bribery laws, and any violations of such laws could subject us to adverse consequences.
  • We are subject to various healthcare fraud, abuse, and anti-self-referral laws, and could face substantial penalties if we are determined not to have fully complied with such laws.
  • We continue to be affected by U.S. healthcare reform initiatives.
  • We are subject to differing customs and import/export rules in several jurisdictions in which we operate.
  • The sales and marketing practices of our industry have been the subject of increased scrutiny from federal and state government agencies.
  • Reimbursement policies of third parties, cost containment measures, and healthcare reform could adversely affect the demand for our products and limit our ability to sell our products.
  • We and certain of our suppliers may be subject to extensive government regulation that increases our costs and could limit our ability to market or sell our products.
  • Prohibitions on promotion of "off-label" uses of medical devices might affect the way we market our products and compete in the marketplace.
  • An FDA panel recommended that bone growth stimulator devices be reclassified by the FDA from Class III to Class II devices, which could increase future competition for us in this product category and negatively affect our future sales of such products.
  • We are subject to requirements relating to hazardous materials which may impose significant compliance or other costs on us.
  • Risks Related to our Intellectual Property
  • We depend on our ability to protect our intellectual property and proprietary rights, but we may not be able to maintain the confidentiality of these assets or assure their protection.
  • Third parties may claim that we infringe on their proprietary rights and may prevent us from manufacturing and selling certain of our products.
  • If we seek to protect or enforce our intellectual property rights through litigation or other proceedings, it could require us to spend significant time and money, the results of which are uncertain.
  • We may be subject to claims that we, our employees, or our independent sales agents or stocking distributors have wrongfully used or disclosed alleged trade secrets of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors.
  • Risks Related to Litigation and Product Liability Matters
  • We may be subject to product and other liability claims that may not be covered by insurance and could require us to pay substantial sums.
  • Ongoing litigation and arbitration matters could negatively affect our business operations.
  • Risks Related to Potential Acquisitions, Investments, and Divestitures
  • Our efforts to identify, pursue, and implement new business opportunities (including acquisitions) may be unsuccessful and may have an adverse effect on our business.
  • We may incur significant costs or retain liabilities associated with disposition activity.
  • Risks Related to Our Financial Results and Financing Needs
  • Our quarterly operating results may fluctuate.
  • We face risks related to foreign currency exchange rates.
  • Our global operations may expose us to tax risks.
  • Our goodwill, intangible assets, and fixed assets are subject to potential impairment; we have recorded significant goodwill impairment charges in the past and may be required to record additional charges to future earnings if our remaining goodwill or intangible assets become impaired.
  • We maintain a $275.0 million credit facility secured by a pledge of substantially all of our property.
  • We may need additional financing in the future to meet our capital needs or to make opportunistic acquisitions, and such financing may not be available on favorable terms, if at all.
  • We must maintain high levels of inventory, which could consume a significant amount of our resources and reduce our cash flows.
  • We hold our cash and cash equivalents that we use to meet our working capital and operating expense needs in deposit accounts that could be adversely affected if the financial institutions holding such funds fail.
  • General Risks
  • Our stock price has fluctuated and may continue to fluctuate, which may make future prices of our stock difficult to predict.
  • We expend substantial resources to comply with laws and regulations relating to public companies, and any failure to maintain compliance could subject us to regulatory scrutiny and cause investors to lose confidence in our company, which could harm our business and have a material adverse effect on our stock price.
  • Environmental, social, and corporate governance ("ESG") regulations, policies and provisions may make our supply chain more complex and may adversely affect our relationships with customers.
  • Our business could be negatively impacted by corporate citizenship and ESG matters and/or our reporting of such matters.

Legal proceedings

For a description of material pending legal proceedings, refer to Note 13 of the Notes to the Consolidated Financial Statements in Item 8 of this Annual Report.

The opening of Item 3, Legal Proceedings.4

Sources

The numbers on this page point here. Each one links to the record it came from.

  1. 1
  2. 2
  3. 3
  4. 4
  5. 5
  6. 6
  7. 7
  8. 8
  9. 9
  10. 10
  11. 11
  12. 12
  13. 13
  14. 14
  15. 15
  16. 16
  17. 17
  18. 18
  19. 19
  20. 20
  21. 21
  22. 22
  23. 23
  24. 24
  25. 25
  26. 26
  27. 27
  28. 28
  29. 29
  30. 30
  31. 31
  32. 32
  33. 33
  34. 34
  35. 35
  36. 36
  37. 37
  38. 38
  39. 39
  40. 40
  41. 41
  42. 42
  43. 43
  44. 44
  45. 45
  46. 46
  47. 47
  48. 48
  49. 49
  50. 50
  51. 51
  52. 52
  53. 53
  54. 54
  55. 55
  56. 56
  57. 57
  58. 58
  59. 59
  60. 60
  61. 61
  62. 62
  63. 63
  64. 64
  65. 65
  66. 66
  67. 67
  68. 68
  69. 69
  70. 70
  71. 71
  72. 72
  73. 73
  74. 74
  75. 75
  76. 76
  77. 77
  78. 78
  79. 79
  80. 80
  81. 81
  82. 82
  83. 83
  84. 84
  85. 85
  86. 86
  87. 87
  88. 88
  89. 89
  90. 90
  91. 91
  92. 92
  93. 93
  94. 94
  95. 95
  96. 96
  97. 97
  98. 98
  99. 99
  100. 100
  101. 101
  102. 102
  103. 103
  104. 104
  105. 105
  106. 106
  107. 107
  108. 108
  109. 109
  110. 110
  111. 111
  112. 112
  113. 113
  114. 114
  115. 115
  116. 116
  117. 117
  118. 118
  119. 119
  120. 120
  121. 121
  122. 122
  123. 123