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Bioventus Inc.

In its 2026 annual report the company says: “We are a global medical device company focused on helping patients recover and live life to the fullest by relieving pain and addressing musculoskeletal challenges through a diverse portfolio of high-quality, innovative, and clinically-proven solutions. We manage our business through two reporting segments, U.S. and International, which accounted for 88% and 12%, respectively, of our total net sales during the fiscal year ended December 31, 2025.”5 It is headquartered in Durham, North Carolina.1 Its shares trade on Nasdaq under the symbol BVS.1

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Last updated Oct 21, 2026.

Overview

$568.1MRevenue, fiscal 20252
$22.7MNet income, fiscal 20252

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  • TickerBVS on Nasdaq1
  • IndustrySurgical & Medical Instruments & Apparatus1
  • HeadquartersDurham, North Carolina1
  • Incorporated inDE3
  • Business address4721 Emperor Boulevard, Suite 100, Durham, Nc 277033
  • Filer categoryAccelerated filer, Emerging growth company3

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We are a global medical device company focused on helping patients recover and live life to the fullest by relieving pain and addressing musculoskeletal challenges through a diverse portfolio of high-quality, innovative, and clinically-proven solutions. We manage our business through two reporting segments, U.S. and International, which accounted for 88% and 12%, respectively, of our total net sales during the fiscal year ended December 31, 2025.5 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

68.3%Gross margin2
9.5%Operating margin2
4.0%Net margin2
-0.9%Revenue growth, 20252
12.3%Return on equity2
1.52×Debt to equity2
$72.1MFree cash flow2

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue32¢$179.9M
  • Research and development2¢$12.1M
  • Selling, general and admin55¢$314.0M
  • Other costs7¢$37.7M
  • Income tax0¢$1.6M
  • Profit4¢$22.7M

Out of $568.1M in revenue.2

Where each dollar of operating cash went, fiscal 2025

  • Capital spending3¢$2.6M
  • Kept or used elsewhere97¢$72.1M

Out of $74.7M of cash from operations.2

Financial statements

Revenue67892$568.1M in 2025+67% since 2019
0$200.0M$400.0M$600.0M2019: $340.1M$340.1M20192020: $321.2M$321.2M2020−6%2021: $430.9M$430.9M2021+34%2022: $512.1M$512.1M2022+19%2023: $512.3M$512.3M2023+0%2024: $573.3M$573.3M2024+12%2025: $568.1M$568.1M2025−1%
Gross profit67892$388.2M in 2025+56% since 2019
0$100.0M$200.0M$300.0M$400.0M2019: $249.2M$249.2M20192020: $233.5M$233.5M2020−6%2021: $302.7M$302.7M2021+30%2022: $331.1M$331.1M2022+9%2023: $328.2M$328.2M2023−1%2024: $388.2M$388.2M2024+18%2025: $388.2M$388.2M2025−0%
Operating income67892$54.0M in 2025+73% since 2019
-$200.0M-$100.0M0$100.0M2019: $31.2M$31.2M20192020: $21.2M$21.2M2020−32%2021: $12.1M$12.1M2021−43%2022: -$167.2M-$167.2M20222023: -$81.7M-$81.7M2023−51%2024: -$15.2M-$15.2M2024−81%2025: $54.0M$54.0M2025
Net income67892$22.7M in 2025+232% since 2019
-$200.0M-$150.0M-$100.0M-$50.0M0$50.0M2019: $6.9M$6.9M20192020: $16.4M$16.4M2020+140%2021: $19.4M$19.4M2021+18%2022: -$158.7M-$158.7M20222023: -$156.2M-$156.2M2023−2%2024: -$36.1M-$36.1M2024−77%2025: $22.7M$22.7M2025
Fiscal year20182019202020212022202320242025
Revenue$340.1M6$321.2M7$430.9M8$512.1M9$512.3M2$573.3M2$568.1M2
Cost of revenue$90.9M6$87.6M7$128.2M8$181.0M9$184.2M2$185.1M2$179.9M2
Gross profit$249.2M6$233.5M7$302.7M8$331.1M9$328.2M2$388.2M2$388.2M2
Research and development$11.1M6$11.2M7$19.0M8$23.9M9$13.4M2$14.0M2$12.1M2
Selling, general and admin$198.5M6$193.1M7$254.3M8$332.1M9$303.9M2$343.8M2$314.0M2
Operating income$31.2M6$21.2M7$12.1M8-$167.2M9-$81.7M2-$15.2M2$54.0M2
Income before tax$9.5M8-$189.0M9-$121.1M2-$52.3M2$25.7M2
Income tax$1.6M6$1.2M7-$2.0M8-$44.4M9$85.0K2-$5.3M2-$1.6M2
Net income$6.9M6$16.4M7$19.4M8-$158.7M9-$156.2M2-$36.1M2$22.7M2
Earnings per share-$0.158-$2.599-$2.492-$0.562$0.342
Earnings per share (diluted)-$0.158-$2.599-$2.492-$0.562$0.332
Shares (weighted, basic)45.5M shares861.4M shares962.6M shares264.5M shares266.6M shares2
Shares (weighted, diluted)45.5M shares861.4M shares962.6M shares264.5M shares268.9M shares2

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Corporate structure

Bioventus Inc. sits at the top of its group. 11 entities, 5 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Bioventus Inc.

  • Bioventus Inc. Durham, North Carolina
    • Bioness Inc. Subsidiary · Delaware, United States
    • Bioventus Canada, Ulc Subsidiary · British Columbia, Canada
    • Bioventus Coöperatief U.A. Subsidiary · Netherlands
    • Bioventus Germany GmbH Subsidiary · Germany
    • Bioventus Holdings LLC Subsidiary · North Carolina, United States
    • Bioventus UK, Ltd Subsidiary · United Kingdom
    • Misonix LLC Subsidiary · Delaware, United States
    • Misonix OpCo, LLC Subsidiary · Delaware, United States
    • Perseus Intermediate, Inc. Subsidiary · Delaware, United States
    • Solsys Medical, LLC Subsidiary · Delaware, United States

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 Bioventus 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
Finance-lease assets$11.2M2 Dec 31, 2025$12.7M2 Dec 31, 2024−11.7%
Operating-lease assets (leased space)$5.1M2 Dec 31, 2025$6.5M2 Dec 31, 2024−21.3%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$51.2M2 Dec 31, 2025$41.6M2 Dec 31, 2024+23.2%
Long-term investments$2.3M2 Dec 31, 2025$1.9M2 Dec 31, 2024+21.2%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$7.5M2 Dec 31, 2025$7.5M2 Dec 31, 20240%
Intangible assets, net (excluding goodwill)$368.4M2 Dec 31, 2025$404.7M2 Dec 31, 2024−9.0%
Finite-lived intangibles, gross$706.8M2 Dec 31, 2025$764.5M2 Dec 31, 2024−7.5%
Accumulated amortization$338.0M2 Dec 31, 2025$358.3M2 Dec 31, 2024−5.7%
Finite-lived intangibles, net$368.4M2 Dec 31, 2025$404.7M2 Dec 31, 2024−9.0%

Inventory

ItemLatestA year beforeChange
Inventory, total$82.2M2 Dec 31, 2025$92.5M2 Dec 31, 2024−11.1%
Finished goods$61.0M2 Dec 31, 2025$70.4M2 Dec 31, 2024−13.3%

Properties, in its own words

Our principal executive offices are located on leased property in Durham, North Carolina. We also occupy leased office and manufacturing space in Cordova, Tennessee, Farmingdale, New York, and Valencia, California. In addition, our international operations occupy leased office spaces in Hoofddorp, Netherlands and Mississauga, Canada. We believe that our facilities are sufficient to meet our current needs and that suitable additional space will be available as and when needed on acceptable terms.

Item 2 of the 10-K filed Mar 5, 2026.5

Leadership

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

Chief executive

  1. Kenneth Michael Reali2021–2023
  2. Anthony P. Bihl Iii.2023
  3. Robert E. Claypoole2024–now

President

  1. Robert E. Claypoole2024–now

Chief financial officer

  1. Gregory O. Anglum2021–2022
  2. Mark Leonard Singleton2022–now
2025
Board members and other officers (22)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Bioness Inc. Delaware4
  • Bioventus Canada, Ulc British Columbia4
  • Bioventus Coöperatief U.A. The Netherlands4
  • Bioventus Germany GmbH Germany4
  • Bioventus Holdings LLC North Carolina4
  • Bioventus Inc. Delaware4
  • Bioventus LLC Delaware4
  • Bioventus UK, Ltd United Kingdom4
  • Misonix LLC Delaware4
  • Misonix OpCo, LLC Delaware4
  • Perseus Intermediate, Inc. Delaware4
  • Solsys Medical, LLC Delaware4

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

Timeline

  1. Aug 5, 20268-K Results of operations; Other events38
  2. Jun 4, 20268-K Shareholder vote39
  3. May 21, 20268-K Regulation FD disclosure40
  4. May 6, 20268-K Results of operations41
  5. Mar 5, 20268-K Results of operations42
  6. Nov 17, 20258-K Executive or director change43
  7. Nov 4, 20258-K Results of operations44
  8. Aug 6, 20258-K Results of operations45
  9. Aug 4, 20258-K Entered a material agreement; New debt or obligation46
  10. Jul 31, 20258-K Other events47
  11. Jun 4, 20258-K Shareholder vote48
  12. May 6, 20258-K Results of operations49
  13. Jan 12, 2024New chief executive Robert E. Claypoole becomes CEO14
  14. Apr 10, 2023New chief executive Anthony P. Bihl Iii. becomes CEO15
  15. Apr 5, 2021New chief executive Kenneth Michael Reali becomes CEO16

Calendar

Coming up

  1. Nov 3, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported $0.15 a share, on Nov 4, 2025.50

When it reported results

  1. Aug 5, 2026Reported quarterly or annual results38
  2. May 6, 2026Reported quarterly or annual results41
  3. Mar 5, 2026Reported quarterly or annual results42
  4. Nov 4, 2025Reported quarterly or annual results44
  5. Aug 6, 2025Reported quarterly or annual results45
  6. May 6, 2025Reported quarterly or annual results49
  7. Mar 11, 2025Reported quarterly or annual results51
  8. Nov 5, 2024Reported quarterly or annual results52

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

Filings

359 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 63 major events, 207 insider forms, 20 large holders, 49 other. The latest 20:

  1. Aug 5, 202610-Q EDGAR
  2. Aug 5, 20268-K EDGAR
  3. Jul 27, 2026SCHEDULE 13G EDGAR
  4. Jun 4, 20264 EDGAR
  5. Jun 4, 20264 EDGAR
  6. Jun 4, 20264 EDGAR
  7. Jun 4, 20268-K EDGAR
  8. Jun 4, 20264 EDGAR
  9. Jun 4, 20264 EDGAR
  10. Jun 4, 20264 EDGAR
  11. Jun 4, 20264 EDGAR
  12. Jun 4, 20264 EDGAR
  13. Jun 4, 20264 EDGAR
  14. Jun 4, 20264 EDGAR
  15. May 29, 2026SD EDGAR
  16. May 21, 20268-K EDGAR
  17. May 6, 202610-Q EDGAR
  18. May 6, 20268-K EDGAR
  19. Apr 22, 2026ARS EDGAR
  20. Apr 22, 2026DEFA14A EDGAR

The 359 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

68 open-market trades by officers, directors and large owners since October 2021: 18 buys and 50 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Mar 11, 2026McMurry-Heath MichelleDirectorSale12,000$8.79$105.5KForm 4
Dec 4, 2025NOHRA GUY PDirectorSale10,000$7.57$75.7KForm 4
Nov 7, 2025McMurry-Heath MichelleDirectorSale17,701$7.42$131.3KForm 4
Apr 11, 2025Singleton Mark LeonardSVP & CFOSale3,875$7.57$29.3KForm 4
Apr 11, 2025D'Adamio AnthonySVP & General CounselSale2,958$7.57$22.4KForm 4
Apr 11, 2025CHURCH KATRINA JSVP & Chief Compliance OfficerSale1,283$7.57$9.7KForm 4
Mar 24, 2025Singleton Mark LeonardSVP & CFOSale5,479$9.79$53.6KForm 4
Mar 17, 2025CHURCH KATRINA JSVP & Chief Compliance OfficerSale1,018$9.75$9.9KForm 4
Mar 17, 2025D'Adamio AnthonySVP & General CounselSale2,615$9.75$25.5KForm 4
Feb 18, 2025Singleton Mark LeonardSVP & CFOSale6,498$10.19$66.2KForm 4
Feb 18, 2025D'Adamio AnthonySVP & General CounselSale4,380$10.19$44.6KForm 4
Feb 18, 2025CHURCH KATRINA JSVP & Chief Compliance OfficerSale1,537$10.19$15.7KForm 4
Jan 13, 2025Claypoole Robert EPresident and CEOSale28,786$9.10$262.0KForm 4
Dec 23, 2024Singleton Mark LeonardSVP & CFOSale10,733$10.53$113.0KForm 4
Dec 23, 2024CHURCH KATRINA JSVP & Chief Compliance OfficerSale2,535$10.53$26.7KForm 4
Dec 23, 2024D'Adamio AnthonySVP & General CounselSale5,848$10.53$61.6KForm 4
Aug 19, 2024Bartholdson John A.DirectorBuy25,500$8.55$218.0KForm 4
Aug 16, 2024Bartholdson John A.DirectorBuy80,000$8.55$684.0KForm 4
Jun 21, 2024Singleton Mark LeonardSVP & CFOSale9,219$5.57$51.4KForm 4
Jun 21, 2024D'Adamio AnthonySVP & General CounselSale5,904$5.57$32.9KForm 4

All 68 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
2025Robert E. Claypoole54$824.1K$4.3M61
2025Mark Singleton57$499.9K$1.9M61
2025Anthony D'Adamio65$469.4K$1.4M61
2024President & ChiefExecutive Officer$780.3K$6.4M61
2024Senior Vice President &Chief Financial Officer$473.8K$2.1M61

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
Essex Woodlands Management, Inc.13,021,324$122.9M48.3%No change
Nantahala Capital Management, LLC12,000,558$113.3M3.4%+5,878,155
Juniper Investment Company, LLC6,939,357$65.5M17.4%No change
BlackRock, Inc.3,435,914$32.4M0.0%+302,373
Royce & Associates LP1,833,212$17.3M0.1%+291,930
Vanguard Capital Management LLC1,751,678$16.5M0.0%+36,971
Geode Capital Management, LLC1,365,716$12.9M0.0%+197,469
American Century Companies Inc1,353,415$12.8M0.0%+733,612
Dimensional Fund Advisors LP1,128,465$10.7M0.0%+255,327
State Street Corp1,104,878$10.4M0.0%+116,511
Vanguard Portfolio Management LLC1,042,796$9.8M0.0%+69,792
Hillsdale Investment Management Inc.907,739$8.6M0.2%+236,600
Engine Capital Management, LP900,558$8.5M0.8%+585,540
Wellington Management Group Llp748,358$7.1M0.0%+594,217
Renaissance Technologies LLC736,000$6.9M0.0%+246,540
Oberweis Asset Management Inc/709,714$6.7M0.1%+81,600
Goldman Sachs Group Inc652,367$6.2M0.0%+178,983
Kennedy Capital Management LLC466,563$4.4M0.1%−8,408
Fmr LLC452,850$4.3M0.0%+56,617
Northern Trust Corp443,824$4.2M0.0%+81,001
Prudential Financial Inc394,520$3.7M0.0%+200,720
Charles Schwab Investment Management Inc391,859$3.7M0.0%+17,917
Tocqueville Asset Management L.P.369,673$3.5M0.0%+24,673
Vanguard Fiduciary Trust Co327,838$3.1M0.0%+6,865
Aqr Capital Management LLC326,124$3.1M0.0%−13,914

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

SEC filer profile

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

  • Name on EDGARBioventus Inc.1
  • CIK0001665988
  • Employer ID (EIN)81-09808615
  • Filer statusAccelerated filer an emerging growth company; a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 311
  • Industry code (SIC)3841 Surgical & Medical Instruments & Apparatus1
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
  • Business address4721 Emperor Boulevard, Suite 100, Durham, NC 277031
  • Phone(919) 474-67001
  • Shares outstanding67,368,052 Common Class A shares; 15,786,737 Common Class B shares as of Feb 27, 20265
  • Public float$264.4M as of Jun 28, 20255
  • AuditorGRANT THORNTON LLP, Raleigh, North Carolina PCAOB ID 248; no auditor attestation of internal control over financial reporting5
  • On EDGAR sinceApr 19, 20161
  • Filings460 in all: 4 (218), 8-K (70), 3 (27), 10-Q (17), 144 (14), S-8 (10), SC 13G/A (7), 10-K (6)1
    All 43 form types

    CORRESP (6), DEFA14A (6), SC 13G (6), 4/A (5), 425 (5), DEF 14A (5), S-1/A (5), UPLOAD (5), 8-K/A (3), ARS (3), EFFECT (3), SC 13D/A (3), SCHEDULE 13G/A (3), SEC STAFF LETTER (3), 424B3 (2), 8-A12B (2), CERTNAS (2), DRS (2), DRS/A (2), DRSLTR (2), NT 10-Q (2), S-1 (2), SD (2), 3/A (1), 424B4 (1), CERT (1), NT 10-K (1), PRE 14A (1), RW (1), S-1MEF (1), S-3 (1), S-4 (1), S-4/A (1), SC 13D (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Mar 5, 2026
    Quarterly report (10-Q) Aug 5, 2026
    Proxy statement (DEF 14A) Apr 22, 2026
    Latest 8-K (8-K) Aug 5, 2026

Securities registered for trading

ClassSymbolExchange
Class A Common Stock, $0.001 par value per shareBVSThe Nasdaq Global Select Market

From the cover page of the 10-K filed Mar 5, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks Bioventus Inc. names in Item 1A of its 10-K filed Mar 5, 2026: 73 risks under these headings, as written.5

  • Risks Related to Our Financial Position
  • Our 2025 Credit Agreement contains financial and operating restrictions that could limit our access to credit. If we fail to comply with its financial or other covenants, we might be required to repay the indebtedness, which could harm our liquidity.
  • We might require additional capital to fund our financial and operating obligations and support business growth.
  • Failure to establish and maintain effective financial controls could cause us to have material weaknesses and financial misstatements due to error, which could adversely affect our business and stock price.
  • We maintain our cash and cash equivalents at financial institutions, in accounts where the balance exceeds federally insured limits (“FDIC”).
  • Risks Related to Our Business
  • We are currently subject to derivative shareholder lawsuits and have been defendants in securities class action litigation and may be subject to similar or other future litigation, which will require significant management time and attention, result in significant legal expenses and may result in unfavorable outcomes, any or all of which may have a material adverse effect on our business, operating results and financial condition, and negatively affect the price of our common stock.
  • We are highly dependent on a limited number of products for revenue generation and profitability.
  • Our long-term growth may be limited by our inability to develop, acquire and commercialize new products, line extensions or expanded indications.
  • If we fail to properly manage growth or scale our business processes, systems, and data management, our business could suffer.
  • Demand for our existing products and any new products, line extensions or expanded indications depends on the continued and future acceptance of our products by physicians, patients, third-party payers and others in the medical community.
  • The reserves we use to estimate the amount of variable consideration for items such as rebate payments due to third-party payers may be insufficient to cover our contractual payment obligations to them, which could adversely affect our business, results of operations and financial condition.
The other 63 risks
  • We rely on a limited number of third-party manufacturers to manufacture certain of our products and critical components.
  • Due to the implementation of processing and billing system changes by payers, we may experience unexpected increases in the volume of rebate claims we receive from payers with whom we contract, which could negatively impact our business and financial results.
  • If we are unable to achieve and maintain adequate levels of coverage and/or reimbursement for our products, the procedures using our products, or any future products we may seek to commercialize, the commercial success of these products may be severely hindered.
  • If our facilities are damaged or become inoperable, we will be unable to continue to research, develop and manufacture our products and, as a result, our business, results of operations and financial condition may be adversely affected until we are able to secure a new facility.
  • Our business may be adversely affected if consolidation in the healthcare industry leads to demand for price concessions or if a GPO, third-party payer or other similar entities exclude us from being a supplier.
  • We may be unable to complete proposed acquisitions or to successfully integrate proposed or recent acquisitions in a cost-effective and non-disruptive manner.
  • We may not realize the anticipated strategic or financial benefits from our business divestitures, which may adversely affect our results of operations and financial condition.
  • Pricing pressure from our competitors or hospitals may affect our ability to sell our products at prices necessary to support our current business strategies.
  • If we fail to successfully enter into purchasing contracts for our Surgical Solutions products or engage in contract bidding processes internationally, we may not be able to receive access to certain hospital facilities and our sales may decrease.
  • Governments outside the United States may not provide coverage or reimbursement of our products, which may adversely affect our international expansion plans and harm our business, results of operations and financial condition.
  • Our future growth depends on physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products.
  • The proposed down-classification of non-invasive bone growth stimulators, including EXOGEN, by the FDA could increase future competition for bone growth stimulators and otherwise adversely affect our sales of EXOGEN.
  • We compete and may compete in the future against other companies, some of which have longer operating histories, more established products or greater resources than we do, which may prevent us from achieving increased market penetration or improved operating results.
  • The reclassification of our HA products from medical devices to drugs in the United States by the FDA could negatively impact our ability to market these products and may require that we conduct costly additional clinical studies to support current or future indications for use of those products.
  • Our ability to maintain our competitive position and to execute our strategic plans depends on our ability to attract, retain and motivate our senior management team and other highly qualified personnel, and our failure to do so could adversely affect our business, results of operations and financial condition.
  • We may not be able to strengthen our brand and the brands associated with our products.
  • We face the risk of product liability claims that could be expensive, divert management’s attention and harm our reputation and business. We may not be able to maintain adequate product liability insurance.
  • Fluctuations in the demand for our products or our inability to forecast demand accurately may influence the ability of our suppliers to meet our delivery needs or result in excess product inventory.
  • We may face issues with respect to the supply of our products or their components, including increased costs, disruptions of supply, shortages, contamination or mislabeling.
  • If we fail to maintain our numerous contractual relationships, our business, results of operations and financial condition could be adversely affected.
  • Actual or attempted breaches of security, unauthorized access to or disclosure of information, cyberattacks, or other incidents or the perception that personal and/or other sensitive or confidential information in our possession or control or in the possession or control of our vendors or service providers is not secure, could result in a material loss of business, substantial legal liability or significant harm to our reputation.
  • Failure of a key information technology and communication system, process or site could adversely affect our business, results of operations and financial condition.
  • Our business subjects us to economic, political, regulatory and other risks associated with international sales and operations that could adversely affect our business, results of operations and financial condition.
  • We are exposed to foreign currency risks, which may adversely affect our business, results of operations and financial condition.
  • International tariffs, including tariffs applied to goods traded between the United States and other countries, and restrictions on goods imported from certain such regions may adversely affect our business, results of operations and financial condition.
  • Risks Related to Government Regulation
  • Our products and operations are subject to extensive governmental regulation, and our failure to comply with applicable requirements could cause our business to suffer.
  • We may be subject to enforcement action if we engage in improper claims submission practices and resulting audits or denials of our claims by government agencies could reduce our net sales or profits and could lead to significant civil or criminal penalties and other liability.
  • The FDA regulatory process is expensive, time-consuming and uncertain, and the failure to obtain and maintain required regulatory clearances and approvals could prevent us from commercializing our products.
  • Legislative or regulatory reforms, including those currently under consideration by FDA and the EU, could make it more difficult or costly for us to obtain regulatory clearance, approval or certification of any future products and to manufacture, market and distribute our products after clearance, approval or certification is obtained, which could adversely affect our competitive position and materially affect our business and financial results.
  • Our HCT/P products are subject to extensive government regulation and our failure to comply with these requirements could cause our business to suffer.
  • If clinical studies of our future products do not produce results necessary to support regulatory clearance, approval or certification in the United States or elsewhere, we will be unable to expand the indications for or commercialize these products.
  • Interim, “top-line” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • We may be subject to enforcement action if we engage in improper marketing or promotion of our products, and the misuse or off-label use of our products may harm our image in the marketplace, result in injuries that lead to product liability suits or result in costly investigations, fines and/or sanctions by regulatory bodies if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.
  • Our products may cause or contribute to adverse medical events that we are required to report to the FDA, and if we fail to do so, we would be subject to sanctions that could materially harm our business.
  • We and our third-party manufacturers and suppliers are subject to various governmental regulations related to the manufacturing of our products.
  • Various governmental reimbursement reform and other healthcare cost containment proposals may affect our ability to sell our products profitably and could adversely affect our business results and operations and financial conditions.
  • Our products may be subject to product recalls. A recall of our products, either voluntarily or at the direction of the FDA or another governmental authority, or the discovery of serious safety issues with our products, could adversely affect us.
  • As we conduct clinical studies designed to generate long-term data on some of our existing products, the data we generate may not be consistent with our existing data and may demonstrate less favorable safety or efficacy. Data we generate may ultimately not be favorable, or could even hurt the commercial prospects for our products.
  • We may rely on third parties to conduct our clinical studies and to assist us with preclinical development, and if they fail to perform as contractually required or expected, we may not be able to obtain regulatory clearance, approval or certification to commercialize our products.
  • Healthcare regulatory reform may affect our ability to sell our products profitably and could adversely affect our business, results of operations and financial condition.
  • We are subject to federal, state and foreign laws and regulations relating to our healthcare business, and could face substantial penalties if we are determined not to have fully complied with such laws, which would adversely affect our business, results of operations and financial condition.
  • We are subject to governmental regulation and other legal obligations, particularly related to privacy, data protection and information security, and we are subject to consumer protection laws that regulate our marketing practices and prohibit unfair or deceptive acts or practices. Our actual or perceived failure to comply with such obligations could harm our business.
  • Failure to comply with the FCPA and laws associated with our activities outside the United States could adversely affect our business, results of operations and financial condition.
  • If we fail to meet Medicare accreditation and surety bond requirements or DMEPOS supplier standards, it could adversely affect our business, results of operations and financial condition.
  • Our operations involve the use of hazardous and toxic materials, and we must comply with environmental, health and safety laws and regulations, which can be expensive, and could adversely affect our business, results of operations and financial condition.
  • Our employees, independent distributors, independent contractors, suppliers and other third parties may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could expose us to liability and hurt our reputation.
  • Regulatory reforms, such as the EU Medical Devices Regulation, could limit our ability to market and distribute our products after clearance, approval or certification is obtained and make it more difficult or costly for us to obtain regulatory clearance, approval or certification of any future products, which could adversely affect our competitive position and materially affect our business and financial results.
  • We may be subject to environmental, social and governance (“ESG”) regulations or stakeholder requirements which may negatively impact our business or adversely affect our relationship with customers.
  • Recent environmental regulatory actions regarding medical device sterilization facilities could result in disruptions in the supply of certain of our products and could adversely affect our business, results of operations and financial condition.
  • Risks Related to Intellectual Property Matters
  • Protection of our intellectual property rights may be difficult and costly, and our inability to protect our intellectual property could adversely affect our competitive position.
  • Trade Secrets and Know-How
  • We depend on certain technologies that are licensed to us. We do not control the intellectual property rights covering these technologies and any loss of our rights to these technologies or the rights licensed to us could prevent us from selling our products, which could adversely impact our business, results of operations and financial condition.
  • Our intellectual property agreements with third parties may be subject to disagreements over contract interpretation, which could narrow the scope of our rights to the relevant intellectual property or technology.
  • We may in the future be a party to patent and other intellectual property litigation and administrative proceedings that could be costly and could interfere with our ability to successfully market our products.
  • We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of our competitors or former employers or are in breach of non-competition or non-solicitation agreements with our competitors or former employers.
  • Any product candidates that we develop as biologics subject to the BLA pathway may be subject to competition sooner than anticipated.
  • Intellectual property rights do not necessarily address all potential threats to our business.
  • Risks Related to Our Organizational Structure and the Tax Receivable Agreement
  • Our principal asset is our interest in BV LLC, and, accordingly, we depend on distributions from BV LLC to pay our taxes and expenses, including payments under the Tax Receivable Agreement. BV LLC’s ability to make such distributions may be subject to various limitations and restrictions.
  • The TRA with the Continuing LLC Owner requires us to make cash payments to it in respect of certain tax benefits to which we are or may become entitled, and we expect that the payments we will be required to make could be significant.
  • In certain cases, payments under the TRA to the Continuing LLC Owner may be accelerated or significantly exceed the actual benefits we realize in respect of the tax attributes subject to the TRA.
  • We may make payments to the Continuing LLC Owner under the TRA that exceed the tax benefits actually realized by us in the event that any tax benefits are disallowed by a taxing authority.
  • Unanticipated changes in effective tax rates or adverse outcomes resulting from examination of our income or other tax returns could adversely affect our results of operations and financial condition.
  • If we were deemed to be an investment company under the Investment Company Act of 1940, as amended, or the 1940 Act, as a result of our ownership of BV LLC, applicable restrictions could make it impractical for us to continue our business as contemplated and could adversely affect our business, results of operations and financial condition.
  • Bioventus is controlled by the Original LLC Owners, whose interests may differ from those of our public stockholders.
  • Risks Related to Ownership of Our Class A Common Stock

Legal proceedings

Bioventus Shareholder Litigation

On January 12, 2023, the Company and certain of its current and former directors and officers were named as defendants in a putative class action lawsuit filed in the Middle District of North Carolina (the “Court”), Ciarciello v. Bioventus Inc., No. 1:23– cv – 00032-CCE-JEP (M.D.N.C.). The complaint asserted violations of Sections 10(b) and 20(a) of the Exchange Act and of Sections 11 and 15 of the Securities Act and generally alleges that the Company failed to disclose certain information regarding its rebate practices, its business and financial prospects, and the sufficiency of internal controls regarding financial reporting. The complaint sought damages in an unspecified amount. On April 12, 2023, the Court appointed Wayne County Employees’ Retirement System as lead plaintiff. The plaintiff’s amended consolidated complaint was filed with the Court on June 12, 2023. On July 17, 2023, the defendants filed a motion to dismiss the complaint raising a number of legal and factual deficiencies with the amended consolidated complaint. In response to the defendants’ motion to dismiss, the lead plaintiff filed a second amended complaint on July 31, 2023. The defendants moved to dismiss the second amended complaint on August 21, 2023, which the Court granted in part and denied in part on November 6, 2023. The Court dismissed the plaintiff’s Securities Act claims, but allowed the plaintiff’s Exchange Act claims to proceed into discovery.

The opening of Item 3, Legal Proceedings.5

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