Item 9A. Controls and Procedures
Item 9A. Controls and Procedures.
Limitations on Effectiveness of Controls and Procedures
In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our President and Chief Executive Officer and Chief Financial Officer, conducted an evaluation of the effectiveness of our disclosure controls and procedures as of the end of the period covered by this Annual Report on Form 10-K. Based on this evaluation, our President and Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of December 31, 2023.
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Management’s Report on Internal Control over Financial Reporting
The Company’s management is responsible for establishing and maintaining adequate internal control over financial reporting (as such term is defined in the Exchange Act Rule 13a-15(f)). The Company’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the Company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with U.S. GAAP, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the Company; and (iii) provide reasonable assurance regarding the prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the financial statements. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
In connection with the preparation and filing of this Annual Report, the Company’s management, including our President and Chief Executive Officer and our Chief Financial Officer, conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2023, based on the framework set forth in “Internal Control—Integrated Framework (2013)” issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”). Based on the Company’s evaluation, our President and Chief Executive Officer and Chief Financial Officer, concluded that, as of December 31, 2023, the Company’s internal controls over financial reporting were effective.
Material Weaknesses in Internal Control over Financial Reporting
A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected and corrected on a timely basis.
Changes in Control Environment
As previously reported, we identified a material weakness in internal control related to an ineffective risk assessment in 2022 to identify and assess changes in our business processes and internal control environment related to newly acquired companies and multiple information technology (“IT”) system implementations that occurred. Further, there was a lack of adequate personnel resources in accounting, IT, and other support functions to support simultaneous system implementations and business process integrations for acquired companies, implement appropriate controls for acquired companies and maintain focus on compliance with internal controls for legacy Bioventus processes.
In addition, during 2022, the Company saw an unprecedented level of turnover in roles that drive execution of internal control activities. This turnover, paired with business changes, including those related to acquisitions, resulted in a disruption to the effective completion of control activities across a number of business processes. Further, management identified a gap in control design related to sufficient tracking of control performance to ensure controls operated effectively.
In considering these breakdowns in the control environment, Bioventus determined the associated COSO principles requiring further control and action by management were:
(a) Control environment - Establishes structure, authority, and responsibility (COSO Principle 3);
(b) Risk assessment – Identifies and analyzes significant change (COSO Principle 9); and
(c) Monitoring – Conducts ongoing and /or separate evaluations (COSO Principle 16).
These ongoing control deficiencies resulted in certain immaterial restatements of the Company’s financial statements as discussed in our Quarterly Reports on Form 10-Q for the periods ended April 1, 2023, July 1, 2023 and September 30, 2023.
Remediation Measures
During 2023, management implemented our previously disclosed remediation plans including:
(a) Ensuring adequate personnel were in place, taking steps to decrease turnover and driving additional accountability, including: (i) hiring personnel and temporary resources to backfill positions vacated due to employee turnover and adding additional headcount in accounting, finance and IT to expand capacity; (ii) making organizational changes to ensure proper governance and oversight; (iii) implementing certain retention programs to retain key resources; (iv) driving additional accountability for control owners by tying a portion of their performance objectives to successful completion of internal controls;
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(b) Enhancing our risk assessment processes to (i) identify and assess changes for acquired companies and IT systems; (ii) prioritize key projects to ensure organizational capacity, with only essential IT projects occurring during 2023; (iii) update our internal control policy that further defines expectations for communication and approval of changes to financially relevant processes and internal controls.
(c) Enhancing tracking of control performance and reinforcing execution rigor by (i) establishing and monitoring monthly internal control metrics compared with target performance; (ii) establishing required quarterly internal control certifications; (iii) providing additional visibility of internal control performance to management and the Audit Committee; (iv) engaging third-party consultants to perform an Accounting Transformation & Integration Assessment (“Project Action”) that enhanced processes and use of existing systems for financially relevant processes which allow for more time for internal control execution; (vi) meeting weekly with leadership to discuss actions needed to successfully close internal control deficiencies identified; (v) updating and/or developing standard operating procedures to further document process and control performance for use in day-to-day execution and when training new employees.
During the fourth quarter of 2023, we completed our testing of the operating effectiveness of the implemented and remediated controls and found them to be effective. As a result, we have concluded the material weakness has been remediated as of December 31, 2023.
Rebates Accrual Material Weakness
As previously reported, we identified a material weakness related to the Company’s internal controls over financial reporting that were not performed at a sufficient level of precision to ensure that the third quarter 2022 rebates accrual was complete and accurate. The process undertaken to estimate the expected reduction in revenue from rebates was consistent with the Company’s historical practice. However, subsequent to the initial calculation of the third quarter 2022 rebates accrual, an unexpectedly large invoice was received and there were not processes in place to ensure it was reviewed timely in order to update the accrual.
The Company reassessed open rebates accruals and the approach for calculating the rebate accruals based on this invoice. The Company revised its estimation methodology resulting in a decrease of revenue of $8.4 million. This adjustment was recorded subsequent to the earnings release but prior to the filing of the Company’s Quarterly Report on Form 10-Q for the third quarter of 2022. Further, this change in revenue projection related to the rebates accrual adjustment for 2022 and cascading effect on future revenue projections materially impacted the Company’s evaluation of its ability to meet debt covenants in its Amended 2019 Credit Agreement, resulting in liquidity and going concern disclosures in the Company’s Quarterly Report on Form 10-Q for the third quarter of 2022.
Remediation Measures
We have designed and implemented new processes and enhanced controls to address the underlying causes of the material weakness related to the rebates accrual, including:
• Refining the estimation method for calculating the rebates accruals, including enhancing the precision of the controls;
• Implementing enhanced status tracking and introduced new controls to ensure that rebates invoices from third-party payers are received and reviewed timely; and
• Increasing rigor of documenting key conversations with payers.
The Company implemented and enhanced the precision of procedures to ensure the completeness and accuracy of key reports and information used in the rebates accrual and further enhanced supporting documentation for control performance.
During the fourth quarter of 2023, we completed our testing of the operating effectiveness of the enhanced controls and found them to be effective. As a result, we have concluded the material weakness has been remediated as of December 31, 2023.
We believe the implementations and continued operation of the actions described above with respect to our control environment and rebates accrual processes are sufficient to remediate our previously identified material weaknesses and strengthen our internal control over financial reporting.
When considered in the aggregate, the previously identified material weaknesses no longer create a reasonable possibility that a material misstatement to the consolidated financial statements would not be prevented or detected on a timely basis. Therefore, management concluded that the deficiencies no longer represent a material weakness in our internal control over financial reporting, and that disclosure controls and procedures were effective, at the reasonable assurance level, as of December 31, 2023.
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The President and Chief Executive Officer and Chief Financial Officer believe that the financial statements and related financial information included in this Annual Report on Form 10-K fairly present, in all material respects, our balance sheets, statements of operations and comprehensive (loss) income, statement of changes in stockholders’ equity and statements of cash flows as of and for the periods presented.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting that occurred during the fourth quarter of 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting except for changes to controls resulting from the material weaknesses described above.
Attestation Report of Independent Registered Public Accounting Firm
This Annual Report does not include an attestation report on our internal control over financial reporting of our registered public accounting firm due to an exemption established by the JOBS Act for emerging growth companies.
Item 9B. Other Information.
During the quarter ended December 31, 2023, none of our directors or officers (as defined in rule 16a-1(f) under the Exchange Act) adopted , modified or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement” (as such terms are defined in Item 408 of Regulation S-K).
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
Not Applicable.
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PART III
Item 10. Directors, Executive Officers and Corporate Governance.
The following table sets forth information regarding our directors as of March 1, 2024:
Name
Age
Position(s)
Robert E. Claypoole 52 President, Chief Executive Officer and Director
William A. Hawkins 70 Director, Chairperson
John A. Bartholdson 53 Director
Patrick J. Beyer 58 Director
Philip G. Cowdy 56 Director
Mary Kay Ladone 57 Director
Michelle McMurry-Heath 54 Director
Guido J. Neels 75 Director
Guy P. Nohra 63 Director
Martin P. Sutter 68 Director
Susan M. Stalnecker 71 Director
Robert Claypoole joined Bioventus as our President, Chief Executive Officer and a director in January 2024. Please see Mr. Claypoole’s biography set forth in Part I, Item 1. Business—Information about our Executive Officers of this Annual Report .
William A. Hawkins has served as a member of our Board since September 2020 and as Chairperson of our Board since September 2020. Mr. Hawkins is a Senior Advisor to EW Healthcare Partners, a leading private equity firm investing in life sciences. From October 2011 to July 2015, Mr. Hawkins served as President and Chief Executive Officer of Immucor, Inc., a leading provider of transfusion and transplantation diagnostic products worldwide. Prior to that, Mr. Hawkins served in positions of increasing responsibility at Medtronic, Inc., a prominent medical technology company, from January 2001 to June 2011, most recently serving as its Chief Executive Officer from November 2007 to June 2011. Mr. Hawkins served as President and Chief Executive Officer of Novoste Corporation, a global leader in the field of vascular brachytherapy, from 1988 to 2002 and has also held several senior leadership positions at American Home Products (now known as Wyeth, LLC), Johnson & Johnson, Guidant Corp. and Eli Lilly and Co. Mr. Hawkins served as a member of the board of managers of BV LLC from January 2016 until the time of our IPO. Mr. Hawkins also currently serves on the board of directors of Biogen Inc. and MiMedx Group Inc., each a public biopharmaceutical company; and Baebies, Inc., Cirtec Medical Corp., Enterra Medical and Virtue Labs, LLC, each a privately-held life science company. Mr. Hawkins serves on the compensation committee of Biogen and chairs the ethics and compliance committee of MiMedx. Mr. Hawkins previously served on the Board of Directors of Avanos Medical, Inc. from 2015 to April 2021 and Immunor, Inc. from 2015 to 2023. Mr. Hawkins served on the Duke University Board of Trustees from 2011 to 2023, where he held the position of Vice Chair, and was recently appointed Duke University Trustee Emeritus. Mr. Hawkins also previously served as the Chair of the Duke University Health System board of directors. He is currently a member of the board of directors of the North Carolina Biotechnology Center and the Focused Ultrasound Foundation Society. Mr. Hawkins holds a Master of Business Administration from the University of Virginia Darden School of Business and received a Bachelor of Science in electrical and biomedical engineering from Duke University. Mr. Hawkins was selected to serve on our Board because of his experience in and knowledge of the life science industry.
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John A. Bartholdson was appointed as a member of our Board in January 2023 and his appointment became effective January 8, 2023. Mr. Bartholdson is the co-founder and has been a Partner of Juniper Investment Company, a private investment management firm that invests in publicly traded and private companies through concentrated ownership positions since its inception in 2007. Mr. Bartholdson has 25 years of experience leading and overseeing private and public equity investments. His experience includes extensive management oversight, service on multiple public and private company boards, and deep transactional expertise. Mr. Bartholdson presently serves as the Chairman of the board of directors of Theragenics Corporation, a medical device company serving the surgical products and prostate cancer treatment markets. From 2019, he has been a member of the board of directors of Lincoln Educational Services Corporation, a public company and a leading provider of career education and training services, and presently serves on its Compensation, Audit and Nominating and Corporate Governance Committees. Previously, he served as a member of the board of directors of Obagi Medical Products, Inc., a public specialty pharmaceutical company, until its acquisition by Valeant Pharmaceuticals in 2013. In addition, Mr. Bartholdson has previously served on the board of directors of numerous private companies. Mr. Bartholdson was a Partner of Stonington Partners, where he worked from 1997 to 2011. Prior to that, he was an analyst at Merrill Lynch Capital Partners from 1992 to 1994. Mr. Bartholdson received his Bachelor of Arts from Duke University and his Master of Business Administration from Stanford Graduate School of Business. Mr. Bartholdson was selected to serve on our board because of his significant governance, finance, and transactional experience on multiple public and private company boards.
Patrick J. Beyer has served as a member of our Board since October 2021. Mr. Beyer is the President of International and Global Orthopedics for ConMed Corporation, a publicly held medical technology company, a position in which he has served since October 2020. He previously served as President of ConMed International from December 2014 to October 2020. Prior to joining ConMed, Mr. Beyer served as Chief Executive Officer of ICNet, a privately held infectious control software company from 2010 to 2014 when the company was sold. Prior to this, he spent 21 years at Stryker Corporation where he led Stryker Europe from 2005 to 2009; Stryker UK, South Africa and Ireland from 2002 to 2005 and Stryker Medical from 1999 to 2002. Mr. Beyer previously served on the board of directors of Misonix, Inc. from May 2021 to October 2021, where he was a member of its audit committee. Mr. Beyer graduated from Kalamazoo College with a Bachelor of Arts in Economics, Western Michigan University with a Master of Business Administration in Finance and Harvard Business School’s Advanced Management Program. Mr. Beyer was selected to serve on our Board because of his extensive healthcare and public company experience.
Philip G. Cowdy has served as a member of our Board since September 2020. Mr. Cowdy has served as the Chief Business Development and Corporate Affairs Officer for Smith & Nephew plc, a medical equipment manufacturing company, since 2018 Since joining Smith & Nephew plc in June 2008, he has also served as Executive Vice President of Business Development and Corporate Affairs, Head of Corporate Affairs and Strategic Planning, Group Director of Corporate Affairs and Director of Investor Relations. Prior to joining Smith & Nephew plc, Mr. Cowdy served as a Senior Director at Deutsche Bank for 13 years, providing corporate finance and equity capital markets advice to a variety of UK-based companies. Mr. Cowdy served as a member of the board of managers of BV LLC from January 2012 to October 2017 and again from July 2018 until the time of our IPO, and has served as a member of its Audit, Compliance and Quality Committee. Mr. Cowdy received his Bachelor of Science in Natural Sciences from Durham University (“UK”) and is a qualified chartered accountant. Mr. Cowdy was selected to serve on our Board because of his experience in the industry, his finance experience, and his knowledge of the Company.
Mary Kay Ladone has served as a member of our Board since July 2021. Ms. Ladone served as Senior Vice President, Corporate Development, Strategy and Investor Relations, of Hill-Rom Holdings, Inc. (“Hill-Rom”), a medical technology provider, from December 2018 to December 2021. Ms. Ladone previously served as Hill-Rom’s Vice President, Investor Relations, July 2016 to December 2018. Ms. Ladone served as Senior Vice President, Investor Relations, of Baxalta Inc. from 2015 to 2016 before joining Hill-Rom. Prior to Baxalta Inc., Ms. Ladone served in a variety of senior finance, business development and investor relations roles for Baxter International, Inc. Since March 2022, Ms. Ladone has also served on the board of directors of Inogen Inc., a publicly traded supplemental oxygen therapies provider, where she is a member of the audit and compensation committees. Ms. Ladone also serves on the board of directors of Kestra Medical Technologies, Inc., a privately held wearable medical device and digital healthcare company, where she has been the chair of the audit committee since September 2022. Ms. Ladone holds a Bachelor of Arts in Finance and Economics from the University of Notre Dame. Ms. Ladone was selected to serve on our Board due to her significant finance and investor relations experience at large healthcare companies.
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Michelle McMurry-Heath , MD, PhD, has served as a member of our Board since January 2022. Dr. McMurry-Heath served as President and Chief Operating Officer of the Biotechnology Innovation Organization, a membership and advocacy organization focused on improving biotech research and applying biotech innovations to major healthcare challenges, from 2020 to 2022. Dr. McMurry-Health was previously with Johnson & Johnson (“J&J”) from 2014 to 2020, where she served as Global Head of Evidence Generation for Medical Device Companies and then Vice President of Global External Innovation and Global Leader for Regulatory Sciences. Prior to her time at J&J, Dr. McMurry-Heath was a key science policy leader in government, conducting a comprehensive analysis of the National Science Foundation’s policies, programs and personnel. President Obama then named her associate science director of the FDA’s Center for Devices and Radiological Health where she served from 2010 to 2014. From 2005 to 2010, Dr. McMurry-Heath was Director of the Health, Biomedical Science and Society Policy Program at the Aspen Institute. Dr. McMurry-Heath began her career as a Senior Policy Advisor for Senator Joseph Lieberman for Health, Social, and Biomedical Innovation Policy from 2001 to 2004. She later served as a Robert Wood Johnson Health and Society Scholar at the University of California, San Francisco and Berkeley from 2004 to 2005 and a Mcarthur Fellow, Global Health for the Council on Foreign Relations from 2004 to 2006. Dr. McMurry-Heath also serves on the Board of Directors at publicly traded PerkinElmer, where she is a member of the audit committee. Dr. McMurray-Heath received her M.D./Ph.D. in Immunology from Duke University’s Medical Scientist Training Program, becoming the first African American to graduate from the prestigious program, and her AB in Biochemistry from Harvard University. Dr. McMurry-Heath was selected to serve on our Board due to her significant policy, regulatory, commercial health care and advocacy experience.
Guido J. Neels has served as a member of our Board since September 2020. Mr. Neels has been with EW Healthcare Partners (formerly Essex Woodlands), a healthcare growth equity and venture capital firm, since August 2006, where he is has served as Operating Partner since 2013. Prior to joining EW Healthcare Partners, Mr. Neels served in a variety of management positions at Guidant Corporation, a developer of cardiovascular medical products. From July 2004 until retiring in November 2005, Mr. Neels served as Guidant’s Chief Operating Officer, where he was responsible for the global operations of Guidant’s four operating units: Cardiac Rhythm Management, Vascular Intervention, Cardiac Surgery and Endovascular Solutions. From December 2002 to July 2004, Mr. Neels served as Guidant’s Group Chairman, Office of the President, responsible for worldwide sales operations, corporate communications, corporate marketing, investor relations and government relations. In January 2000, Mr. Neels was named Guidant’s President, Europe, Middle East, Africa and Canada. In addition, Mr. Neels served as Guidant’s Vice President, Global Marketing, Vascular Intervention, from 1996 to 2000 and as Guidant’s General Manager, Germany and Central Europe, from 1994 to 1996. Mr. Neels served as a member of the board of managers of BV LLC from May 2012 until the time of our IPO. Mr. Neels also currently serves on the board of directors of Axogen, Inc. and is a member of its compensation committee. Mr. Neels previously served on the board of directors of Endologix, Inc. from December 2010 to June 2019 and on the board of directors of Entellus Medical from November 2009 to February 2018, each of which is a public company. Mr. Neels holds a Master in Business Administration from the Stanford University Graduate School of Business and received his Business Engineering degree from the University of Leuven in Belgium. Mr. Neels was selected to serve on our Board because of his experience in the industry, familiarity with serving on the boards of public companies and his knowledge of our business.
Guy P. Nohra has served as a member of our Board since September 2020. In March 1996, Mr. Nohra co-founded Alta Partners, a life sciences venture capital firm, and he has since been involved in the funding and development of numerous medical technology and life sciences companies. Mr. Nohra served as a member of the board of managers of BV LLC, from May 2012 until the time of our IPO. Mr. Nohra currently serves as a member of the boards of directors of Spiral Therapeutics, Inc., a private life sciences company. He also previously served on the board of directors of various public companies, including ATS Medical, Inc., Cutera, Inc., AcelRx Pharmaceuticals, Inc., and ZS Pharma, as well as several private companies, including Bionure, Inc., Sanifit Therapeutics S.A., Carbylan Biosurgery, Inc., Cerenis Therapeutics, Coapt Systems, Paracor Medical, Inc. and PneumRx. Mr. Nohra holds a Master in Business Administration from the University of Chicago and received his Bachelor of Arts in History from Stanford University. Mr. Nohra was selected to serve on our Board because of his extensive experience in the life sciences industry, his investment and development experience, and his service as a director of other life sciences companies.
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Martin P. Sutter has served as a member of our Board since September 2020. Mr. Sutter is one of the two founding Managing Directors of EW Healthcare Partners (previously known as Essex Woodlands), one of the oldest and largest life sciences and healthcare focused growth equity and venture capital firms, which he formed in 1985. Mr. Sutter has more than 35 years of management experience in operations, marketing, finance and venture capital. Mr. Sutter served as a member of the board of managers of BV LLC from May 2012 until the time of our IPO. Mr. Sutter also currently serves on the board of directors of MiMedx Group, Inc., a publicly traded regenerative medicine life sciences company, and Prolacta Biosciences, Inc., a privately held life sciences company. Mr. Sutter has also previously served on the board of directors of Abiomed, Inc., Tissue Tech, Inc. and Suneva Medical, Inc. Mr. Sutter currently serves on the compensation and nominating and governance committees of MiMedx Group, Inc. and Prolacta Biosciences, Inc. and previously served on the compensation and nominating and governance committee of Abiomed, Inc. Mr. Sutter holds a Master of Business Administration from the University of Houston and received his Bachelor of Science from Louisiana State University. Mr. Sutter was selected to serve on our Board because of his extensive experience in the life sciences industry, his investment experience, and his service as a director of other life sciences companies.
Susan M. Stalnecker has served as a member of our Board since September 2020. Ms. Stalnecker has been a Senior Advisor at Boston Consulting Group, a global management consulting firm, since March 2016. Ms. Stalnecker served as Vice President of E.I. duPont de Nemours and Co. (now known as DuPont de Nemours, Inc., or DuPont), a diversified science and innovations public company and leader in the fields of healthcare, electronics and transportation, from December 1976 until she retired in 2016. During her nearly 40-year career at DuPont, Ms. Stalnecker served in several senior leadership roles including Vice President, Treasurer & M&A; Vice President, Risk Management; Vice President, Government and Consumer Markets; and Vice President, Productivity & Shared Services. Ms. Stalnecker served as a member of the board of managers of BV LLC from November 2018 until the time of our IPO. Ms. Stalnecker also currently serves on the board of directors of Leidos Holding, Inc. and Optimum Funds McQuairie. She also serves on the audit & finance committee of Leidos Inc. and the audit committee of Optimum Funds McQuairie. From 2009 to 2023, Ms. Stalnecker served on the Board of Trustees of the Duke Health System, where she was a member of the compliance, audit and finance committees. Ms. Stalnecker holds a Master of Business Administration from The Wharton School of the University of Pennsylvania and received her Bachelor of Arts from Duke University. Ms. Stalnecker was selected to serve on our Board because of her extensive experience as a financial expert, her investment experience, and her service as a director of other public companies.
Additional information required by this Item concerning our directors is incorporated by reference from the sections captioned “Election of Directors,” “Corporate Governance” and “Committees of the Board” contained in our definitive proxy statement for our 2024 Annual Meeting of Stockholders to be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2023.
The information required by this Item concerning our Audit and Risk Committee is incorporated by reference from the section captioned “Committees of the Board-Audit and Risk Committee” contained in our definitive proxy statement for our 2024 Annual Meeting of Stockholders to be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2023.
Code of compliance and ethics
We have adopted a written code of compliance and ethics that applies to our directors, officers and employees, including our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions. A current copy of the code is posted on our website, www.bioventus.com . In addition, we intend to post on our website all disclosures that are required by law or Nasdaq listing standards concerning any amendments to, or waivers from, any provision of the code.
The information required by this Item concerning our executive officers is set forth at the end of Part I of this Annual Report.
The information required by this Item, if any, concerning compliance with Section 16(a) of the Exchange Act will be incorporated by reference from the section captioned “Delinquent Section 16(a) Reports” contained in our definitive proxy statement for our 2024 Annual Meeting of Stockholders to be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2023.
Item 11. Executive Compensation.
The information required by this Item is incorporated by reference from the section captioned “Executive and Director Compensation” contained in our definitive proxy statement for our 2024 Annual Meeting of Stockholders to be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2023.
Item 12. Security Ownership of Certain Beneficial Owner and Management and Related Stockholder Matters.
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The information required by this Item is incorporated by reference from the section captioned “Equity Compensation Plan Information” and “Security Ownership of Certain Beneficial Owners and Management” contained in our definitive proxy statement for our 2024 Annual Meeting of Stockholders to be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2023.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
The information required by this Item is incorporated by reference from the section captioned “Certain Relationships and Related Party Transactions” contained in our definitive proxy statement for our 2024 Annual Meeting of Stockholders to be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2023.
Item 14. Principal Accounting Fees and Services.
The information required by this Item is incorporated by reference from the section captioned “Report of the Audit and Risk Committee of the Board of Directors” contained in our definitive proxy statement for our 2024 Annual Meeting of Stockholders to be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2023.
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PART IV
Item 15. Exhibits and Financial Statement Schedules.
(a) Financial Statements. See the table of contents under Part II, Item 8. Financial Statements and Supplementary Data of this Annual Report on Form 10-K above for the list of financial statements filed as part of this report.
(b) Exhibits. The following is a list of exhibits filed as part of this Annual Report on Form 10-K.
Exhibit no.
Description
Form File No. Exhibit Filing Date Filed / Furnished Herewith
2.1 Agreement and Plan of Merger, dated as of March 30, 2021, by and among Bioventus LLC, Bioness Inc., Perseus Intermediate, Inc., Perseus Merger Sub, Inc., Alfred E. Mann Living Trust and Mann Group, LLC.
8-K 001-37844 10.1 3/31/2021
2.2 Agreement and Plan of Merger, dated July 29, 2021, by and among Bioventus Inc., Oyster Merger Sub I, Inc., Oyster Merger Sub II, LLC and Misonix, Inc.
8-K 001-37844 2.1 7/29/2021
2.3 Asset Purchase Agreement, dated a s of May 10, 2023, by and among Misonix, LLC, Solsys Medical, LLC, Bioventus LLC and LifeNet Health.
8-K 001-37844 2.1 5/16/2023
3.1 Amended and Restated Certificate of Incorporation of Bioventus Inc.
8-K 001-37844 3.1 2/17/2021
3.2 Amended and Restated Bylaws of Bioventus Inc.
8-K 001-37844 3.2 2/17/2021
4.1 Specimen Stock Certificate evidencing the shares of Class A common stock .
S-1 333-252238 4.1 1/20/2021
4.2 Description of C apital Stock.
10-K 001-37844 4.2 3/26/2021
10.1 Tax Receivable Agreement, dated as of February 16, 2021, by and among Bioventus Inc., Bioventus LLC and its Members .
8-K 001-37844 10.2 2/17/2021
10.2 Registration Rights Agreement, dated February 16, 2021, by and among Bioventus Inc. and the Original LLC .
8-K 001-37844 10.3 2/17/2021
10.3 Second Amended and Restated Limited Liability Company Agreement of Bioventus LLC dated as of February 16, 2021.
8-K 001-37844 10.1 2/17/2021
10.4 Stockholders Agreement, dated February 16, 2021, by and among Bioventus Inc., Bioventus LLC and the Principal Stockholders .
8-K 001-37844 10.4 2/17/2021
10.5† Amended and Restated License Agreement, dated as of December 9, 2016, by and between Bioventus LLC, Q-Med AB and Nestlé Skin Health S.A.
S-1 333-252238 10.5 1/20/2021
10.6† Amended and Restated Supply Agreement, dated as of December 9, 2016, by and between Bioventus LLC and Q-Med AB .
S-1 333-252238 10.6 1/20/2021
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Exhibit no.
Description
Form File No. Exhibit Filing Date Filed / Furnished Herewith
10.7† Exclusive License, Supply and Distribution Agreement, dated as of February 9, 2016, by and between IBSA Institut Biochimique SA (Switzerland) and Bioventus LLC.
S-1 333-252238 10.7 1/20/2021
10.7(a)† Amendment No. 1 to Exclusive License, Supply and Distribution Agreement, dated as of December 31, 2018, by and between IBSA Institut Biochimique SA (Switzerland) and Bioventus LLC .
S-1 333-252238 10.7(a) 1/20/2021
10.7(b)† Amendment No. 2 to Exclusive License, Supply and Distribution Agreement, dated as of December 31, 2020, by and between IBSA Institut Biochimique SA (Switzerland) and Bioventus LLC .
S-1/A 333-252238 10.7(b) 2/4/2021
10.8 Credit and Guaranty Agreement, dated as of December 6, 2019, by and among Bioventus LLC, certain Guarantor Subsidiaries party thereto, Wells Fargo Bank, National Association, as administrative agent and collateral agent and the lenders and other financial institutions party thereto.
S-1 001-37844 10.11 1/20/2021
10.8(a) Amendment No. 1 to Credit and Guaranty Agreement, dated as of August 29, 2021, by and among Bioventus LLC, certain Guarantor Subsidiaries party thereto, Wells Fargo Bank, National Association, as administrative agent and the lenders and other financial institutions party thereto.
10-Q 001-37844 10.1 11/10/2021
10.8(b) Amendment No. 2 to Credit and Guaranty Agreement, dated as of October 29, 2021, by and among Bioventus LLC, Oyster Merger Sub I, LLC, Oyster Merger Sub II, LLC, Misonix, Inc., certain Guarantor Subsidiaries party thereto, Wells Fargo Bank, National Association, as administrative agent and the lenders and other financial institutions party thereto.
8-K 001-37844 10.1 10/29/2021
10.8(c) Amendment No. 3 to Credit and Guaranty Agreement between Bioventus LLC, Guarantor Subsidiaries party thereto, Wells Fargo Bank, National Association, as administrative agent, dated July 11, 2022 .
8-K 001-37844 10.1 7/12/2022
10.8(d) Amendment No. 4 to Credit and Guaranty Agreement between Bioventus LLC, Guarantor Subsidiaries party thereto, Wells Fargo Bank, National Association, as administrative agent, dated March 31, 2023.
10-K 001-37844 10.8(d) 3/31/2023
10.8(e) Amendment No. 5 to Credit and Guaranty Agreement between Bioventus LLC, Guarantor Subsidiaries party thereto, Wells Fargo Bank, National Association, as administrative agent and collateral agent, and the lenders and other financial institutions party thereto, dated January 18, 2024.
8-K 001-37844 10.1 1/19/2024
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Exhibit no.
Description
Form File No. Exhibit Filing Date Filed / Furnished Herewith
10.9^ Director Offer Letter, dated as of December 11, 2015, by and between Bioventus LLC and William A. Hawkins .
S-1 333-252238 10.33 1/20/2021
10.10^ Director Offer Letter, dated as of October 3, 2018, by and between Bioventus LLC and Susan M. Stalnecker.
S-1 333-252238 10.38 1/20/2021
10.11^ Phantom Profits Interest Plan Award Agreement, dated as of June 25, 2020, by and between Bioventus LLC and Kenneth M. Reali .
S-1 333-252238 10.42 1/20/2021
10.12^ Option Letter, dated as of July 30, 2020, by and between Bioventus LLC and Kenneth M. Reali .
S-1 333-252238 10.43 1/20/2021
10.13^ Bioventus Inc. 2021 Employee Stock Purchase Plan .
S-1/A 333-252238
10.44 2/4/2021
10.14^ Bioventus Inc. 2021 Equity Incentive Plan.
10-Q 001-37844 10.3 8/12/2022
10.15^ Form of Notice of Stock Option Grant and Stock Option Agreement .
S-1/A 333-252238
10.47 2/10/2021
10.16^ Form of Restricted Stock Unit Award Grant Notice and Restricted Stock Unit Agreement .
S-1/A 333-252238
10.48 2/10/2021
10.17^ Bioventus Inc. Non-Employee Director Compensation Policy .
S-1/A 333-252238
10.51 2/10/2021
10.18^ Employment Agreement, dated as of February 9, 2021, by and among Bioventus Inc., Bioventus LLC and Kenneth Reali .
S-1/A 333-252238
10.52 2/10/2021
10.19^ Employment Agreement, dated as of February 9, 2021, by and among Bioventus Inc., Bioventus LLC and Anthony D’Adamio .
S-1/A 333-252238
10.55 2/10/2021
10.20^ Form of Indemnification Agreement .
S-1/A 333-252238
10.46 2/4/2021
10.21 Lease Agreement, dated November 17, 2021, between Bioventus LLC and 7101 Goodlett Farms Parkway, LLC.
8-K 001-37844 10.1 11/22/2021
10.22^ Revised Employment Agreement, dated as of February 14, 2022, by and among Bioventus Inc., Bioventus LLC and Mark Singleton.
8-K 001-37844 10.1 2/28/2022
10.23^ Bioventus Inc. Restricted Stock Unit Award Grant Notice and Restricted Stock Unit Agreement Inducement Award .
S-8 333-264050 99.1 4/1/2022
10.24^ Bioventus Inc. Notice of Stock Option Grant Inducement Award .
S-8 333-264050 99.2 4/1/2022
10.25 Option and Equity Purchase Agreement, between Bioventus LLC, CartiHeal (2009) Ltd., Elron Electronic Industries Ltd., dated July 15, 2020.
S-1 333-252238 10.10 1/20/2021
10.25(a) Amendment to Option and Equity Purchase Agreement, between Bioventus LLC, CartiHeal (2009) Ltd., Elron Ventures Ltd. and dated June 17, 2022.
8-K 001-37844 10.1 6/22/2022
140
Table of Contents
Exhibit no.
Description
Form File No. Exhibit Filing Date Filed / Furnished Herewith
10.26^ Settlement Agreement by and among CartiHeal (2009) Ltd., Bioventus LLC, Elron Ventures Ltd., and certain other parties detailed therein, dated February 27, 2023 .
10-Q 001-37844 10.3 5/16/2023
10.27† Amended and Restated Exclusive Distribution Agreement No. 2, between Bioventus LLC and Seikagaku Corporation and dated as of December 22, 2020.
S-1 333-252238 10.9 1/20/2021
10.28^ Consulting Agreement between Alessandra Pavesio and Bioventus LLC, dated as of January 1, 2023.
10-Q 001-37844 10.1 5/16/2023
10.29^ Separation Agreement and Release between Kenneth Reali and Bioventus Inc., dated April 4, 2023.
8-K 001-37844 10.1 4/5/2023
10.30^ Employment Agreement between Anthony P. Bihl III and Bioventus Inc., dated as of April 5, 2023.
8-K/A 001-37844 10.1 4/11/2023
10.31^ Bioventus Inc. 2023 Retention Equity Award Plan .
8-K 001-37844 10.1 6/9/2023
10.32^ Form of Restricted Stock Unit Award Grant Notice and Restricted Stock Unit Agreement.
8-K 001-37844 10.2 6/9/2023
10.33^ Employment Agreement, between Robert E. Claypoole and Bioventus Inc. , dated as of December 19, 2023.
8-K 001-37844 10.1 12/21/2023
10.34^ Form of Bioventus Inc. Inducement Award - Restricted Stock Unit Agreement.
8-K 001-37844 10.2 12/21/2023
10.35^ Form of Bioventus Inc. Inducement Award - Option Agreement.
8-K 001-37844 10.3 12/21/2023
21.1 Listing of Subsidiaries
*
23.1
Consent of Grant Thornton LLP (Bioventus Inc.) .
*
31.1
Certification of President and Chief Executive Officer pursuant to Rules 13a-14(a)/15d-14(a) under the Securities Exchange Act of 1934, as amended .
*
31.2
Certification of President and Chief Financial Officer pursuant to Rules 13a-14(a)/15d-14(a) under the Securities Exchange Act of 1934, as amended .
*
32
Certification of President and Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 .
**
97.1 Bioventus Inc. Compensation Recovery Policy, dated September 7, 2023.
*
99.1
List of patents and pending patent applications directed to Bioventus Inc.’s material products .
*
141
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Exhibit no.
Description
Form File No. Exhibit Filing Date Filed / Furnished Herewith
101.INS Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document ***
101.SCH Inline XBRL Taxonomy Extension Schema Document ***
101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document ***
101.DEF Inline XBRL Extension Definition Linkbase Document ***
101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document ***
101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document ***
104 Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document contained in Exhibit 10 ***
* Filed herewith
** Furnished herewith
*** Submitted electronically herewith
† Certain portions of this exhibit have been omitted pursuant to Regulation S-K, Item (601)(b)(10).
^ Indicates management contract or compensatory plan.
(c) Financial Statement Schedules. Schedules for which provision is made in the applicable accounting regulation of the Securities and Exchange Commission have been omitted because they are not applicable, not required or the information required is given in the Consolidated Financial Statements and notes thereto set forth above under Part II, Item 8. Financial Statements and Supplemental Data .
Item 16. Form 10-K Summary.
None
142
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SIGNATURE
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
BIOVENTUS INC.
By: /s/ Robert E. Claypoole
Name: Robert E. Claypoole
Title: President, Chief Executive Officer and Director (Principal Executive Officer)
March 12, 2024
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Table of Contents
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Name
Date Title
/s/ Robert E. Claypoole March 12, 2024 President, Chief Executive Officer and Director
(Principal Executive Officer)
Robert E. Claypoole
/s/ Mark L. Singleton March 12, 2024 Senior Vice President and Chief Financial Officer
(Principal Financial Officer and Principal Accounting Officer)
Mark L. Singleton
/s/ William A. Hawkins III March 12, 2024 Chairman
William A. Hawkins III
/s/ John A. Bartholdson March 12, 2024 Director
John A. Bartholdson
/s/ Patrick J. Beyer
March 12, 2024 Director
Patrick J. Beyer
/s/ Philip G. Cowdy March 12, 2024 Director
Philip G. Cowdy
/s/ Mary Kay Ladone March 12, 2024 Director
Mary Kay Ladone
/s/ Michelle McMurry-Heath March 12, 2024 Director
Michelle McMurry-Heath
/s/ Guido J. Neels March 12, 2024 Director
Guido J. Neels
/s/ Guy P. Nohra March 12, 2024 Director
Guy P. Nohra
/s/ Susan M. Stalnecker March 12, 2024 Director
Susan M. Stalnecker
/s/ Martin P. Sutter March 12, 2024 Director
Martin P. Sutter
144