Zimmer Biomet Holdings (ZBH) 10-K risk factor changes: FY2022 vs FY2021
The 2022-12-31 10-K against the 2021-12-31 one, compared heading by heading and sentence by sentence.
Item 1A141 rewritten44 added210 removed118 unchanged
All filing items1,299 rewritten831 added1,157 removed1,043 unchanged
Summary
counted, not written
- Item 1A headings could not be compared: only 2 carried over between the two years, which usually means one filing was read wrongly, so none is reported as new or removed.
- Sentence by sentence, 831 added, 1,157 removed, 1,299 rewritten and 1,043 unchanged across 23 items that differ.
Sentences by item
23 items, with every count and a link to each item that changed
Underlined words on a shaded ground are new in FY2022; struck-through words were in FY2021. Sentences that are wholly new or wholly gone are labelled rather than marked.
Item 1A. Risk Factors
141 rewritten, 44 added, 210 removed, 118 unchanged
Read the full itemFY2022 item · filed February 24, 2023FY2021 item · filed February 25, 2022
[removed: We] [added: *We] operate in a rapidly changing economic and technological environment that presents numerous risks, many of which are driven by factors that we cannot control or predict.
You should carefully consider these risks and uncertainties before investing in our [removed: securities.][added: securities.*]
[removed: Risks] [added: Risks] Related to our Business, Operations and [removed: Strategy][added: Strategy]
[removed: The] [added: Business and economic conditions, including disruptions related to the] COVID-19 [removed: pandemic has] [added: pandemic, have] adversely impacted, and [removed: continues to pose risks to,] [added: may, either alone or in combination with other risks, in the future adversely impact,] our business, results of operations and financial condition, the nature and extent of which are [removed: highly] uncertain and [removed: remain unpredictable.][added: unpredictable.]
[removed: Our] [added: Our] restructuring [removed: program] [added: programs] may not be successful or we may not fully realize the expected cost savings and/or operating efficiencies from our restructuring [removed: initiatives.][added: initiatives.]
In December 2019, our Board of Directors approved, and we initiated, a global restructuring program (the “2019 Restructuring Plan”) with an objective of reducing costs to allow us to further invest in higher priority growth opportunities, which [removed: program] is ongoing.
In December 2021, our management also initiated a global restructuring program (the “2021 Restructuring Plan”) to [added: further reduce costs and to] reorganize our [added: global] operations in preparation for the [removed: planned] spinoff of [removed: ZimVie with an objective of reducing costs.][added: ZimVie.]
Restructuring initiatives present significant risks that may impair our ability to achieve anticipated operating enhancements and/or cost reductions, or otherwise harm our business, including higher than anticipated costs in implementing our restructuring [removed: program,] [added: programs,] as well as management distraction.
For more information on our restructuring [removed: program,] [added: programs,] see Note [removed: 4] [added: 5] to our consolidated financial statements.
[removed: Our] [added: Our] success largely depends on [removed: the strength of] our [removed: talent,] [added: ability to attract, retain, develop and motivate our human capital,] including our senior management, and [removed: ensuring we] [added: on our ability to] have meaningful succession plans in [removed: place.][added: place to prepare for foreseen and unforeseen changes.]
Our future performance depends, in large part, on the continued skills, experiences, competencies and services of our senior management and other key talent, including our ability to attract, retain, develop and motivate [removed: key talent.][added: our highly skilled employees, senior management, independent agents and distributors.]
Our ability to attract and retain key talent, in particular senior management, [removed: will be] [added: is] dependent on a number of factors, including prevailing market [removed: conditions and] [added: conditions,] our ability to offer competitive compensation [removed: packages.][added: packages and our ability to be perceived as a preferred place to work.]
[removed: Failure] [added: Effective succession planning is also important] to [added: our long-term success; failure to] ensure effective transfer of knowledge and orderly transitions involving key employees could hinder our [removed: strategic planning and execution.][added: business.]
[removed: We] [added: We] may not be able to effectively integrate acquired businesses into our operations or achieve expected cost savings or profitability from our [removed: acquisitions.][added: acquisitions.]
[removed: | | • |] unforeseen difficulties in integrating personnel and sales forces, operations, manufacturing, logistics, research and development, information technology, compliance, vendor management, communications, purchasing, accounting, marketing, administration and other systems and processes; [removed: |]
[removed: | | • |] difficulties harmonizing and optimizing quality systems and operations; [removed: |]
[removed: | | • |] diversion of financial and management resources from existing operations; [removed: |]
[removed: | | • |] unforeseen difficulties related to entering geographic regions [added: or markets] where we do not have prior experience; [removed: |]
[removed: | | • |] potential loss of key employees; [removed: |]
[removed: | | • |] unforeseen risks and liabilities associated with businesses acquired, including any unknown vulnerabilities in acquired technology or compromises of acquired data; [removed: and |][added: and/or]
[removed: | | • |] inability to generate sufficient revenue or realize sufficient cost savings to offset acquisition or investment costs. [removed: |]
[removed: The planned spinoff,] [added: The spinoff of ZimVie Inc.] and [removed: any subsequent] [added: the] divestiture of our retained interest in [removed: ZimVie,] [added: ZimVie Inc.] could result in substantial tax [removed: liability.][added: liability.]
We obtained [removed: an] Internal Revenue Service (“IRS”) [removed: ruling,] [added: rulings] and [removed: we intend to obtain] an opinion as to the tax-free nature of the spinoff under the U.S. Internal Revenue Code of 1986, as amended.
The IRS [removed: ruling is,] [added: rulings] and [removed: the] opinion [removed: will be,] [added: are] based, among other things, on various factual assumptions and representations we [removed: will make.][added: made.]
If any of these assumptions or representations are, or become, inaccurate or incomplete, reliance on the opinion and [removed: ruling] [added: rulings] may be jeopardized.
If the [removed: spinoff] [added: spinoff, or the subsequent divestiture of our retained interest in ZimVie,] does not qualify for tax-free treatment for U.S. federal income tax purposes, the resulting tax liability to us, to our stockholders and to ZimVie stockholders could be substantial.
[removed: Interruption] [added: Interruption] of manufacturing operations could adversely affect our business, financial condition and results of [removed: operations.][added: operations.]
In some instances, however, the manufacturing of certain of our product lines is concentrated in one or more [removed: plants.][added: plants, some of which plants are geographically concentrated.]
Damage to one or more facilities from weather or natural disaster-related events, vulnerabilities in technology, cyber-attacks against our information systems or the information systems of our business partners (such as ransomware attacks), or issues in manufacturing arising from failure to follow specific internal protocols and procedures, compliance concerns relating to the [removed: QSR] [added: Quality System Regulation (“QSR”)] and Good Manufacturing Practice requirements, equipment breakdown or malfunction, reductions in operations and/or worker [removed: absences due to the COVID-19 pandemic or other health epidemics (or local, state, or national reactions to such epidemics),] [added: absences, trade impediments] or other factors could adversely affect the ability to manufacture our products.
We have experienced such interruptions due to the COVID-19 pandemic, and we may experience such interruptions in the [removed: future.][added: future due to the pandemic or otherwise.]
[removed: Disruptions] [added: Disruptions] in the supply of the materials and components used in manufacturing our products or the sterilization of our products by third-party suppliers could adversely affect our business, financial condition and results of [removed: operations.][added: operations.]
We purchase many of the materials and components used in manufacturing our products from third-party [removed: suppliers] [added: suppliers,] and we outsource some key manufacturing activities.
In certain cases, we may not be able to establish additional or replacement suppliers for such materials or components or outsourced activities in a timely or cost effective manner, [removed: largely] [added: due to market constraints or] as a result of FDA and other worldwide regulations that require validation of materials and components prior to their use in our products and the complex nature of our and many of our suppliers' manufacturing processes and the need for clearance or approval of significant changes by worldwide regulatory bodies prior to implementation.
A reduction or interruption in the supply of materials or components used in manufacturing our products, such as due to one or more suppliers experiencing reductions in operations and/or worker absences due to [removed: the COVID-19] [added: a] pandemic or [removed: other health epidemics;] [added: otherwise;] an inability to timely develop and validate alternative sources if required; or a significant increase in the price of such materials or components could adversely affect our business, financial condition and results of operations.
In addition, many of our products require sterilization prior to [removed: sale] [added: sale,] and we utilize a mix of internal resources and contract sterilizers to perform this service.
To the extent we or our contract sterilizers are unable to sterilize our products, whether due to capacity, availability of materials for sterilization, regulatory or other constraints, including federal and state regulations on the use of ethylene oxide, or reductions in operations and/or worker absences due to the COVID-19 pandemic or [removed: other health epidemics,] [added: otherwise,] we may be unable to transition to other contract sterilizers, sterilizer locations or sterilization methods in a timely or cost effective manner or at all, which could have a material impact on our results of operations and financial condition.
In addition, we are incurring additional costs to comply with this rule, including costs related to determining the source of any relevant [removed: minerals and] [added: minerals,] metals [added: and other materials] used in our products.
We have a complex supply [removed: chain] [added: chain,] and we may not be able to sufficiently verify the origins of the minerals and metals used in our products through our due diligence procedures.
As a result of technology initiatives, expanding [added: and evolving] privacy and cybersecurity laws, changes in our system platforms and integration of new business acquisitions, we have been consolidating and integrating the number of systems we operate and have upgraded and expanded our information systems capabilities.
In addition, some of our products and services incorporate software or information technology that collects data regarding patients and patient therapy, and some [removed: products or] software [added: and other products] we provide to customers connect to our systems for maintenance and other purposes.
Our operations expose us to risks from business interruptions that may arise from a variety of sources, including public health crises and outbreaks of diseases, such as the COVID-19 pandemic and its variants, supply chain
disruptions, trade and tariff disputes and global conflicts, that can, singly or in combination with other factors, adversely affect our business and financial results.
We experienced a sustained decline in elective surgical procedures globally due to the COVID-19 pandemic and its associated effects, including deferrals of elective surgical procedures and staffing shortages at hospitals.
Surgical volumes generally recovered over the course of 2022, but may return to lower levels due to future COVID-19 variants and resurgences.
We continue to experience risks and uncertainty in several aspects of our business including relating to global, regional and national supply chain disruption; dynamic economic conditions; foreign exchange rate volatility; inflation; workforce availability changes; healthcare staffing challenges and changes in government spending.
We expect several of these factors to continue, and there can be no assurance that we will successfully manage these risks without adverse impacts to our business or financial results.
The COVID-19 pandemic has illustrated that the occurrence of one risk can have unpredictable effects on other risks, such as we experienced with supply chain disruptions connected to the COVID-19 pandemic.
The occurrence of any one or more risks described in these Risk Factors or otherwise may have unpredictable effects on other risks, our business, operations or financial results which may be comparable to, or more adverse than, those we experienced in connection with the COVID-19 pandemic.
Therefore, we are also at risk from business and other risks and uncertainties, either alone or in combination with other risk factors.
Competition for talent in our business is significant.
The global supply chain has been and continues to be negatively impacted by COVID-19 and a variety of other macro factors which has, in part, resulted in challenges to meet end market demand in some instances.
We expect similar challenges in 2023.
successful.
Competition is primarily on the basis of technology, innovation, quality, reputation, customer service and pricing.
Our competition may have greater financial, marketing and other resources than us; respond more quickly to new or emerging technologies; undertake more extensive marketing campaigns; operate more effective sales and distribution channels; adopt more aggressive pricing policies; or be more successful in attracting potential customers, employees and strategic partners.
Demand for our products may change, in certain cases, in ways we may not anticipate because of evolving customer needs, changing demographics, slowing industry growth rates, declines in the musculoskeletal implant market, the introduction of new products and technologies and evolving surgical philosophies and industry standards.
The success of our new product offerings will depend on several factors, including our ability to properly identify and anticipate customer needs; commercialize new products in a timely manner; manufacture and deliver instruments and products in sufficient volumes on time; differentiate our offerings from competitors’ offerings; achieve positive clinical outcomes for new products; satisfy the increased demands by healthcare payors, providers and patients for shorter hospital stays, faster post-operative recovery and lower-cost procedures; innovate and develop new materials, product designs and surgical techniques; and provide adequate medical education relating to new products.
In addition,
In cases where our product is not selected in VBP, sales of that product are substantially impacted.
At December 31, 2022, our total indebtedness was $5.7 billion.
In December 2022, the European Union Council established effective dates of January 1, 2024 and January 1, 2025 for different aspects of Pillar Two.
We are continuing to evaluate the potential impact on future periods of the Pillar Two, pending legislative adoption by additional individual countries, including those within the European Union.
We subsequently obtained supplemental IRS rulings as to the tax-free nature of our divestiture of retained shares of ZimVie common stock following the spinoff, which divestiture completed in February 2023.
the characterization of these relationships.
the effects of inflation, including the effects of different rates of inflation in different countries, on our costs and the costs of our products;
Wars and other conflicts may increase certain of these risks and may adversely affect our business and financial performance, including by limiting our ability to operate in, or export from, certain markets.
Losing access to such markets or exports may have a material adverse effect on our business in the affected market and may limit our ability to operate some of our businesses globally.
We anticipate that the effects of emerging, expanding and new conflicts, such as a possible expansion of the Russian-Ukrainian conflict or a conflict involving China and Taiwan, would not be limited to the specific markets involved.
For example, the U.S. and other countries have imposed sanctions on Russia, certain of its governmental bodies, certain businesses and certain individuals due to the invasion of Ukraine, and additional sanctions may continue to be imposed.
Similar sanctions could be expected to emerge from other conflicts.
Sanctions, and other civil, political and economic effects of such conflicts may have adverse impacts globally, including supply chain continuity disruption; inflationary pressures and increased costs of raw materials and inputs; manufacturing or shipping delays; increased shipping costs; inability to ship products to or from certain countries potentially resulting in an inability to sell certain products globally; and increased disruptions and delays on our ability to collect payment for our products and services in particular markets.
While Russia and Ukraine do not constitute material portions of our business, a significant escalation or expansion of economic disruption or of the conflict’s current scope, or the emergence of new conflicts involving other countries, could adversely affect our results of operations.
require corrective action, or other forms of enforcement.
If we fail to comply with data privacy and security laws and regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected.
We process personal and personal health data in our business, particularly through our ZBEdgeTM ecosystem, our suite of integrated digital and robotic technologies, incorporating data-powered insights across the continuum of care.
In addition, some of our products and services incorporate software or information technology that processes health data regarding patients and patient therapy for treatment, health care, maintenance and other purposes.
Further, we obtain and process personal data related to our employees, individual business partners (such as physicians and consultants), and website visitors located around the world.
These data and information-focused activities carry additional risk.
We, and certain of our affiliates and associates, are also subject to reporting requirements relating to certain data and other breaches.
In addition, new and more stringent multinational, national and state privacy legislation and regulations may be adopted in 2023 and beyond.
| --- | --- |
Our global operations expose us to risks associated with public health crises and outbreaks of epidemic, pandemic, or contagious diseases, such as COVID-19.
We continue to experience a decline in elective surgical procedures globally due to the COVID-19 pandemic.
In the third and fourth quarters of 2021, the highly transmissible Delta and Omicron variants resulted in further deferrals of elective surgical procedures, and we believe that staffing shortages at hospitals also contributed to the deferral of such procedures.
We expect these declines to continue for the duration of the pandemic, and they may be further impacted by COVID-19 variants and resurgences.
The COVID-19 global pandemic has had, and we expect it to continue to have, an adverse impact on our financial condition, results of operations and cash flows.
Our net sales have not returned to pre-pandemic levels.
It is not certain when our financial condition, results of operations, or cash flows will return to pre-pandemic levels.
Deferral of elective surgical procedures has caused us to experience certain of the following, and we may experience other of the following, among other potential negative outcomes:
| | • | lower revenues, profits and cash flows compared to historic trends; |
| --- | --- | --- |
| | • | additional charges from operating our manufacturing facilities at less than normal capacity; |
| --- | --- | --- |
| | • | goodwill impairment charges; |
| --- | --- | --- |
| | • | delays in certain strategic projects and investments, including our restructuring plans, which will delay or may eliminate the effectiveness of these strategic initiatives; |
| --- | --- | --- |
| | • | excess inventory we cannot sell; |
| --- | --- | --- |
| | • | failure to satisfy the covenants in our credit facilities, which may cause any outstanding amounts to be payable immediately and could affect our access to capital to fund our business; and |
| --- | --- | --- |
| | • | downgrades to our credit ratings, which could result in increased interest expense. |
| --- | --- | --- |
COVID-19 and the current financial, economic and capital markets environment, and future developments in these and other areas, present material uncertainty and risk with respect to our performance, financial condition, volume of business, results of operations and cash flows.
We may not be able to attract, retain and develop the highly skilled employees we need to support our business, which could harm our business.
Competition for talent in the various geographies and business segments in which we operate is significant.
There is no guarantee that we will have the continued service of key employees who we rely upon to execute our business strategy and identify and pursue strategic opportunities and initiatives.
The loss of the services of any of our senior management or other key talent, or our inability to attract highly qualified senior management and other key talent, could harm our business.
In particular, we may have to incur costs to replace senior officers or other key employees who leave, and our ability to execute our business strategy could be impaired if we are unable to replace such persons in a timely manner.
Effective succession planning is also important to our long-term success.
Further, changes in our management team may be disruptive to our business, and any failure to successfully integrate key new hires or promoted employees could adversely affect our business and results of operations.
| --- | --- | --- |
| --- | --- | --- |
| --- | --- | --- |
| --- | --- | --- |
| --- | --- | --- |
| --- | --- | --- |
| --- | --- | --- |
The planned spinoff of our Spine and Dental businesses may not be completed on the terms or timeline currently contemplated, if at all, and may not achieve the intended results.
As previously announced, we plan to spin off our Spine and Dental businesses to form ZimVie Inc., a new and independent, publicly traded company (“ZimVie”) through a tax-free distribution to our stockholders of publicly traded stock in ZimVie.
An excerpt. Shown here: 40 of 141 rewritten, 40 of 44 added and 40 of 210 removed. The counts are complete. For every sentence, read Item 1A. Risk Factors in the FY2022 filing and the FY2021 filing.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
100 rewritten, 139 added, 230 removed, 67 unchanged
Read the full itemFY2022 item · filed February 24, 2023FY2021 item · filed February 25, 2022
The following discussion, analysis and comparisons generally focus on the operating results for the years ended December 31, [removed: 2021] [added: 2022] and [removed: 2020.][added: 2021.]
Discussion, analysis and comparisons of the years ended December 31, [removed: 2020] [added: 2021] and [removed: 2019] [added: 2020] that are not included in this Form 10-K can be found in [removed: "Management's] [added: (i) “Management's] Discussion and Analysis of Financial Condition and Results of [removed: Operations"] [added: Operations”] in Part II, Item 7 of [removed: the Company's] [added: our] Annual Report on Form 10-K for the year ended December 31, [removed: 2020.][added: 2021 (the “2021 Form 10-K”) prior to the spinoff of ZimVie; and (ii) “Management's Discussion and Analysis of Financial Condition and Results of Operations” in Part II, Item 7 of Exhibit 99.1 filed with our Form 8-K on June 22, 2022, which Form 8-K was filed to recast certain items of the 2021 Form 10-K, including Part II, Item 7, to reflect the historical results of our spine and dental businesses as discontinued operations following the ZimVie spinoff.]
[removed: EXECUTIVE] [added: EXECUTIVE] LEVEL [removed: OVERVIEW][added: OVERVIEW]
[removed: Impact] [added: *Impact] of the COVID-19 Global [removed: Pandemic][added: Pandemic*]
Additionally, we believe that staffing shortages at hospitals [removed: are also contributing] [added: have contributed] to the deferral of elective surgical procedures.
[removed: 2021] [added: *2022] Financial [removed: Highlights][added: Highlights*]
Our net [removed: earnings] [added: earnings, including discontinued operations,] were [removed: $401.6] [added: $231.4] million in [removed: 2021] [added: 2022] compared to [removed: a net loss of $138.9] [added: $401.6] million in [removed: 2020.][added: 2021.]
These [removed: reduced expenses in 2021] [added: unfavorable factors to net earnings] were partially offset by [added: higher net sales, hedge gains recognized from our hedging program, the favorable effects of our restructuring programs, lower litigation-related expenses, and the fact the 2021 period included] a [added: $165.1 million] charge for the early extinguishment of [removed: debt, higher research] [added: debt] and [removed: development expenses, including] [added: $65.0 million of charges related to] certain agreements we entered into to gain access to or acquire third-party in-process [removed: R&D projects, higher consulting and professional service expenses related to the planned spinoff of our Spine and Dental businesses,] [added: research] and [removed: higher litigation-related charges.][added: development (“IPR&D”) projects.]
[removed: RESULTS] [added: RESULTS] OF [removed: OPERATIONS][added: OPERATIONS]
This sales analysis differs from our reportable operating segments, which are based upon our senior management organizational structure and how we allocate [added: resources toward achieving operating profit goals.]
We [removed: analyze] [added: review] sales by [removed: geography] [added: these geographies] because the underlying market trends in any particular geography tend to be similar across product [removed: categories and] [added: categories,] because we primarily sell the same products in all [removed: geographies.][added: geographies and many of our competitors publicly report in this manner.]
[removed: Net] [added: Net] Sales by [removed: Geography][added: Geography]
The following [removed: tables present] [added: table presents] net sales by geography and the [removed: components of the] percentage changes (dollars in millions):
| | | [removed: Year] [added: Year] Ended [removed: December 31, | | | |] [added: December 31,] | | | | | | | | [removed: Volume/] | | | | | | | | [removed: Foreign] | | | |
| | | [removed: Year] [added: Year] Ended December [removed: 31, | | | |] [added: 31,] | | | | | | | | [removed: Volume/] | | | | | | | | [removed: Foreign] | | | |
[removed: Net] [added: Net] Sales by Product [removed: Category][added: Category]
The following [removed: tables present] [added: table presents] net sales by product category and the [removed: components of the] percentage changes (dollars in millions):
| | | [removed: Year] [added: Year] Ended December [removed: 31, | | | |] [added: 31,] | | | | | | | | [removed: Volume/] | | | | | | | | [removed: Foreign] | | | |
| Knees | | $ | [removed: 2,647.9] [added: 2,778.3] | | | $ | [removed: 2,378.3 | | | | 11.3] [added: 2,647.9] | | [removed: %] | [added: $] | [removed: 12.4] [added: 2,378.3] | | [removed: %] | | [removed: (2.4] [added: 4.9] | [removed: )] | % | | [removed: 1.3] [added: 11.3] | | % |
| Hips | | | [removed: 1,856.1 | | | | 1,750.5] [added: 1,894.9] | | | | [removed: 6.0] [added: 1,856.1] | | | | [removed: 8.2] [added: 1,750.5] | | | | [removed: (3.3] [added: 2.1] | [removed: )] | | | [removed: 1.1] [added: 6.0] | | |
| S.E.T. | | | [removed: 1,727.8 | | | | 1,525.6] [added: 1,696.7] | | | | [removed: 13.3] [added: 1,727.8] | | | | [removed: 12.2] [added: 1,525.6] | | | | [removed: (0.3] [added: (1.8] | ) | | | [removed: 1.4] [added: 13.3] | | |
| | | [removed: Year] [added: Year] Ended December [removed: 31, | | | | | | | | | | | | Volume/ | |] [added: 31,] | | | | | | [removed: Foreign] | | | |
| | | [removed: Year] [added: Year] Ended December [removed: 31, | | | | | | | | | | | | |] [added: 31,] | | | | | | |
| | | [removed: 2021] [added: 2022] | | | | [removed: 2020] [added: 2021] | | | | [removed: 2019] [added: 2020] | | | | [removed: 2021] [added: 2022] vs. [removed: 2020] [added: 2021] % [removed: Inc/(Dec)] [added: Inc/(Dec)] | | | | [removed: 2020] [added: 2021] vs. [removed: 2019] [added: 2020] % [removed: Inc/(Dec)] [added: Inc] | | | |
| Total | | $ | [removed: 2,647.9] [added: 2,778.3] | | | $ | [removed: 2,378.3] [added: 2,647.9] | | | $ | [removed: 2,780.6] [added: 2,378.3] | | | | [removed: 11.3] [added: 4.9] | | | | [removed: (14.5] [added: 11.3] | [removed: )] | |
| Total | | $ | [removed: 1,856.1] [added: 1,894.9] | | | $ | [removed: 1,750.5] [added: 1,856.1] | | | $ | [removed: 1,931.5] [added: 1,750.5] | | | | [removed: 6.0] [added: 2.1] | | | | [removed: (9.4] [added: 6.0] | [removed: )] | |
[removed: Demand] [added: *Demand] (Volume/Mix) [removed: Trends][added: Trends*]
Changes in volume and mix of product sales had a positive effect of [removed: 12.1] [added: 7.6] percent [added: and 12.3 percent] on year-over-year sales during the [removed: year] [added: years] ended December 31, [removed: 2021.][added: 2022 and 2021, respectively.]
Based upon country dynamics, volume changes varied by region in [removed: 2021.][added: 2022.]
The volume increases in [removed: 2021] [added: 2022] were largely a product of how much the COVID-19 pandemic negatively affected the various regions in [removed: 2020.][added: 2021.]
The China VBP had a negative effect on volume due to inventory reductions by distributors and short-term deferral of procedures as patients waited to have a surgical procedure performed until after VBP pricing [removed: is effective.][added: was effective in 2022.]
[removed: Pricing Trends][added: *Pricing Trends*]
Global selling prices had [removed: a] negative [removed: effect] [added: effects] of [removed: 1.8] [added: 1.0] percent [added: and 2.1 percent] on year-over-year sales during [removed: 2021.][added: 2022 and 2021, respectively.]
[removed: Foreign] [added: *Foreign] Currency Exchange [removed: Rates][added: Rates*]
In [added: 2022 and] 2021, changes in foreign currency exchange rates had a [removed: positive] [added: negative] effect of [removed: 1.3] [added: 5.0] percent [added: and a positive effect of 1.2 percent, respectively,] on year-over-year sales.
[removed: Expenses] [added: Expenses] as a Percent of Net [removed: Sales][added: Sales]
| | | [removed: Year] [added: Year] Ended December [removed: 31,] [added: 31,] | | | | | | | | | | | | [added: Year Ended December 31,] | | | | | | | | [added: | | | | Year Ended December 31, | | | | | | | | | | | |]
| | | [removed: 2021] [added: 2022] | | | | [removed: 2020] [added: 2021] | | | | [removed: 2019] [added: 2020] | | | | [removed: 2021] [added: 2022] vs. [removed: 2020 Inc/(Dec)] [added: 2021 % Inc/(Dec)] | | | | [removed: 2020] [added: 2021] vs. [removed: 2019 Inc/(Dec)] [added: 2020 % Inc] | | | |
| Cost of products sold, excluding intangible asset amortization | | [removed: | 29.9 |] [added: 29.1] | % | [removed: | 30.3 |] [added: 28.7] | % | [removed: | 28.2 |] [added: 29.8] | % | [removed: | (0.4 | )] [added: 0.4] | % | [removed: | 2.1 |] [added: (1.1)] | % |
| Intangible asset amortization | | | [removed: 7.9 | | | | 8.5 | | | | 7.3 | | | | (0.6 | )] [added: 0.2] | | | [removed: 1.2] | [added: 0.6] | |
On March 1, 2022, we completed the spinoff of our spine and dental businesses into ZimVie.
The historical results of our spine and dental businesses have been reflected as discontinued operations in our consolidated financial statements in our 2022 results through the date of the spinoff and in the prior year periods.
In addition, as of December 31, 2021, the assets and liabilities associated with these businesses are classified as assets and liabilities of discontinued operations in our consolidated balance sheet.
See Note 3 to our consolidated financial statements for additional information.
The following discussion and analysis is presented on a continuing operations basis unless otherwise noted.
The vast majority of our net sales are derived from products used in elective surgical procedures that have typically declined during surges of the virus as governments and healthcare systems take actions in an effort to prevent the spread and provide sufficient hospital beds and other resources for COVID-19 patients.
In the year ended December 31, 2022, the Omicron variant resulted in fewer elective surgical procedures earlier in the year with recovery in procedures as the surge began to subside later in the first quarter and through the second quarter.
In the second half of 2022, procedural volumes continued to improve across most markets relative to the first half of the year.
However, in the fourth quarter we did experience more acute deferrals of elective surgical procedures in some markets, such as China, due to surges of the virus.
In 2022, our net sales increased by 1.6 percent compared to 2021.
Our net sales in 2022 were tempered by a negative 5.0 percent effect from changes in foreign currency exchange rates.
We continued to see the return of elective surgical procedures across most markets when compared to the prior year, which was negatively affected by a surge of the COVID-19 virus in early 2021 before vaccines were widely available and later in the year by the Delta variant.
In 2022, we recognized a goodwill impairment charge of $289.8 million, which was the primary driver for lower net earnings in 2022 when compared to 2021.
Other significant unfavorable items in 2022 when compared to 2021 include an unrealized investment loss of $116.6 million due to a decline in the value of our investment in ZimVie, higher restructuring-related costs as we continued to execute on our 2019 and 2021 Restructuring Plans, and higher spending on travel and other activities which started to return to pre-pandemic levels.
*2023 Outlook*
We expect revenue growth in 2023 to be driven by a combination of market growth, procedure volume recovery from COVID-19 and new product introductions.
We believe there will continue to be some deferrals of elective surgical procedures caused by COVID-19 surges and staffing shortages, but to a lesser extent in 2023 than in 2022.
In addition, based on foreign currency exchange rates at the end of 2022 we expect foreign currency to negatively affect net sales growth in 2023, but at a lower level than experienced in 2022.
We expect that supply chain and inflation pressures will continue into 2023, but with supply chain pressure easing in the second half of the year and with inflation stable to the level experienced at the end of 2022.
We estimate our operating expenses in 2023 will be impacted by the expected non-reoccurrence of goodwill impairment charges, lower quality remediation expenses due to the completion of our remediation milestones, and lower restructuring-related expenses related to our 2019 and 2021 Restructuring Plans.
We expect our interest expense, net, will increase primarily due to higher interest rates.
We also expect our non-operating other (expense) income, net, will decline in 2023 since the 2022 expense was primarily driven by an investment loss in the shares of ZimVie that we held following the spinoff, which shares we disposed of in February 2023.
We review sales by two geographies, the United States and International, and by the following product categories: Knees; Hips; S.E.T. (Sports Medicine, Extremities, Trauma, Craniomaxillofacial and Thoracic); and Other.
Our business is seasonal in nature to some extent, as many of our products are used in elective surgical procedures, which typically decline during the summer months and can increase at the end of the year once annual deductibles have been met on health insurance plans.
Additionally, with sales to customers where title to product passes upon shipment, these customers may purchase items in large quantities if incentives are offered or if there are new product offerings in a market, which could cause period-to-period differences in sales.
Due to the COVID-19 global pandemic, the typical seasonal patterns did not occur in 2020 or 2021, but started to return in 2022.
| | | | | | | | | | | | | | | | | | | | | | |
| United States | | $ | 4,012.4 | | | $ | 3,853.9 | | | $ | 3,507.7 | | | | 4.1 | | % | | 9.9 | | % |
| International | | | 2,927.5 | | | | 2,973.4 | | | | 2,619.8 | | | | (1.5 | ) | | | 13.5 | | |
| Total | | $ | 6,939.9 | | | $ | 6,827.3 | | | $ | 6,127.5 | | | | 1.6 | | | | 11.4 | | |
| | | | | | | | | | | | | | | | | | | | | | |
| Other | | | 570.0 | | | | 595.5 | | | | 473.1 | | | | (4.3 | ) | | | 25.9 | | |
| Total | | $ | 6,939.9 | | | $ | 6,827.3 | | | $ | 6,127.5 | | | | 1.6 | | | | 11.4 | | |
| | | | | | | | | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | 2022 | | | | 2021 | | | | 2020 | | | | 2022 vs. 2021 % Inc/(Dec) | | | | 2021 vs. 2020 % Inc | | | |
| United States | | $ | 1,615.0 | | | $ | 1,487.6 | | | $ | 1,382.5 | | | | 8.6 | | % | | 7.6 | | % |
| International | | | 1,163.3 | | | | 1,160.3 | | | | 995.8 | | | | 0.3 | | | | 16.5 | | |
| United States | | $ | 960.9 | | | $ | 921.5 | | | $ | 881.1 | | | | 4.3 | | % | | 4.6 | | % |
| International | | | 934.0 | | | | 934.6 | | | | 869.4 | | | | (0.1 | ) | | | 7.5 | | |
| --- | --- |
The following discussion and analysis should be read in conjunction with the consolidated financial statements and the corresponding notes included elsewhere in this Annual Report on Form 10-K.
On February 5, 2021, we announced our intention to pursue a plan to spin off our Spine and Dental businesses into a new public company.
The expected completion date of the spinoff of ZimVie is March 1, 2022.
The following discussion and analysis includes these businesses in our discussion of financial condition and results of operations.
The vast majority of our net sales are derived from products used in elective surgical procedures.
As COVID-19 rapidly started to spread throughout the world in early 2020, our net sales decreased dramatically as countries took precautions to prevent the spread of the virus with lockdowns and stay-at-home measures and as hospitals deferred elective surgical procedures.
The timing, level and sustainability of the recovery of elective surgical procedures has been difficult to predict, as a number of factors are involved, including which geographies are affected and the different measures governments and healthcare systems take in response to the virus in those areas.
In the second half of 2021, the highly transmissible Delta and Omicron variants resulted in further deferrals of elective surgical procedures.
In 2021, our net sales increased by 11.6 percent compared to 2020 primarily due to the significant deferral of elective surgical procedures at the onset of the COVID-19 pandemic in 2020.
In 2021, we returned to profitability compared to a net loss in 2020, primarily due to higher net sales combined with fixed operating costs that did not increase proportionally to the increase in net sales, and a reduction in operating expenses including goodwill and intangible asset impairment charges and certain fixed overhead and hourly production worker labor expenses.
In 2020, we recognized $645.0 million of goodwill and intangible asset impairment charges primarily due to the forecasted impact of COVID-19 on our operating results.
In the second quarter of 2020, we also temporarily suspended or limited production at certain manufacturing facilities, resulting in additional expense recognized in cost of products sold that related to certain fixed overhead costs and hourly production worker labor expenses that are included in the cost of inventory when these facilities are operating at normal capacity.
The additional expense for suspended and limited production continued throughout 2020 and while we did recognize similar charges in 2021, they were lower than the 2020 charges.
2022 Outlook
We believe the COVID-19 variant surges and continuing staffing shortages that occurred late in 2021 will continue to negatively impact our net sales in 2022.
As previously mentioned, we expect to spin off our Spine and Dental businesses on March 1, 2022.
We expect to apply discontinued operations accounting after the separation, which will require us to recast our prior period results to reflect both continuing and discontinued operations.
Accordingly, it is difficult to provide forward-looking information that is comparable to our historical results until the recasting of prior periods is complete.
We analyze sales by three geographies, the Americas, EMEA and Asia Pacific, and by the following product categories: Knees; Hips; S.E.T.; Spine & Dental; and Other.
resources towards achieving operating profit goals.
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | 2021 | | | | 2020 | | | | % Inc | | | | Mix | | | | Price | | | | Exchange | | | |
| Americas | | $ | 4,800.2 | | | $ | 4,335.4 | | | | 10.7 | | % | | 11.7 | | % | | (1.2 | ) | % | | 0.2 | | % |
| EMEA | | | 1,671.1 | | | | 1,391.3 | | | | 20.1 | | | | 16.7 | | | | (0.3 | ) | | | 3.7 | | |
| Asia Pacific | | | 1,364.9 | | | | 1,297.8 | | | | 5.2 | | | | 8.9 | | | | (5.5 | ) | | | 1.8 | | |
| Total | | $ | 7,836.2 | | | $ | 7,024.5 | | | | 11.6 | | | | 12.1 | | | | (1.8 | ) | | | 1.3 | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | 2020 | | | | 2019 | | | | % (Dec) | | | | Mix | | | | Price | | | | Exchange | | | |
| Americas | | $ | 4,335.4 | | | $ | 4,875.8 | | | | (11.1 | ) | % | | (7.9 | ) | % | | (3.1 | ) | % | | (0.1 | ) | % |
| EMEA | | | 1,391.3 | | | | 1,746.9 | | | | (20.4 | ) | | | (20.5 | ) | | | (0.8 | ) | | | 0.9 | | |
| Asia Pacific | | | 1,297.8 | | | | 1,359.5 | | | | (4.5 | ) | | | (4.5 | ) | | | (1.5 | ) | | | 1.5 | | |
| Total | | $ | 7,024.5 | | | $ | 7,982.2 | | | | (12.0 | ) | | | (10.0 | ) | | | (2.4 | ) | | | 0.4 | | |
“Foreign Exchange” used in the tables in this report represents the effect of changes in foreign currency exchange rates on sales.
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | 2021 | | | | 2020 | | | | % Inc | | | | Mix | | | | Price | | | | Exchange | | | |
| Spine & Dental | | | 1,008.8 | | | | 897.0 | | | | 12.5 | | | | 11.8 | | | | (0.3 | ) | | | 1.0 | | |
| Other | | | 595.6 | | | | 473.1 | | | | 25.9 | | | | 26.7 | | | | (1.7 | ) | | | 0.9 | | |
| Total | | $ | 7,836.2 | | | $ | 7,024.5 | | | | 11.6 | | | | 12.1 | | | | (1.8 | ) | | | 1.3 | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
An excerpt. Shown here: 40 of 100 rewritten, 40 of 139 added and 40 of 230 removed. The counts are complete. For every sentence, read Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations in the FY2022 filing and the FY2021 filing.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
8 rewritten, 1 added, 8 removed, 35 unchanged
Read the full itemFY2022 item · filed February 24, 2023FY2021 item · filed February 25, 2022
[removed: MARKET RISK][added: MARKET RISK]
[removed: FOREIGN] [added: FOREIGN] CURRENCY EXCHANGE [removed: RISK][added: RISK]
To reduce the [removed: uncertainty] [added: potential effects] of foreign currency exchange rate movements on [removed: transactions denominated in foreign currencies,] [added: net earnings,] we enter into derivative financial instruments in the form of foreign currency exchange forward contracts with major financial institutions.
A sensitivity analysis of changes in the fair value of foreign currency exchange forward contracts outstanding at December 31, [removed: 2021] [added: 2022] indicated that, if the U.S. Dollar uniformly strengthened or weakened in value by 10 percent relative to all currencies, with no change in the interest differentials, the fair value of those contracts would affect earnings in a range of a decrease of approximately [removed: $98] [added: $93] million to an increase of approximately [removed: $91] [added: $88] million before income taxes in periods through June [removed: 2024.][added: 2025.]
We had net assets, excluding goodwill and intangible assets, in legal entities with non-U.S. Dollar functional currencies of [removed: $1,442.8] [added: $1,771.5] million at December 31, [removed: 2021.][added: 2022.]
[removed: COMMODITY] [added: COMMODITY] PRICE [removed: RISK][added: RISK]
[removed: INTEREST] [added: INTEREST] RATE [removed: RISK][added: RISK]
Based upon our overall interest rate exposure as of December 31, [removed: 2021,] [added: 2022,] a change of 10 percent in interest rates, assuming the principal amount outstanding remains constant, would not have a material effect on interest expense, net.
See Note 15 to our consolidated financial statements for further details on our foreign currency exchange risk exposure and management.
| --- | --- |
We are primarily exposed to foreign currency exchange rate risk with respect to transactions and net assets denominated in Euros, Swiss Francs, Japanese Yen, British Pounds, Canadian Dollars, Australian Dollars, Korean Won, Swedish Krona, Czech Koruna, Thai Baht, Taiwan Dollars, South African Rand, Russian Rubles, Indian Rupees, Turkish Lira, Polish Zloty, Danish Krone, and Norwegian Krone.
We manage the foreign currency exposure centrally, on a combined basis, which allows us to net exposures and to take advantage of any natural offsets.
These forward contracts are designed to hedge anticipated foreign currency transactions, primarily intercompany sale and purchase transactions, for periods consistent with commitments.
Realized and unrealized gains and losses on these contracts that qualify as cash flow hedges are temporarily recorded in accumulated other comprehensive income, then recognized in cost of products sold when the hedged item affects net earnings.
For contracts outstanding at December 31, 2021, we had obligations to purchase U.S. Dollars and sell Euros, Japanese Yen, British Pounds, Canadian Dollars, Australian Dollars, Korean Won, Swedish Krona, Czech Koruna, Thai Baht, Taiwan Dollars, South African Rand, Russian Rubles, Indian Rupees, Turkish Lira, Polish Zloty, Danish Krone, and Norwegian Krone and purchase Swiss Francs and sell U.S. Dollars at set maturity dates ranging from January 2022 through June 2024.
The notional amounts of outstanding forward contracts entered into with third parties to purchase U.S. Dollars at December 31, 2021 were $1,295.2 million.
The notional amounts of outstanding forward contracts entered into with third parties to purchase Swiss Francs at December 31, 2021 were $347.0 million.
Item 1. Business
119 rewritten, 65 added, 135 removed, 158 unchanged
Read the full itemFY2022 item · filed February 24, 2023FY2021 item · filed February 25, 2022
[removed: Overview][added: Overview]
We design, manufacture and market orthopedic reconstructive products; sports medicine, biologics, extremities and trauma products; [removed: spine,] craniomaxillofacial and thoracic (“CMFT”) products; [removed: dental implants; and related] surgical [removed: products.][added: products; and a suite of integrated digital and robotic technologies that leverage data, data analytics and artificial intelligence.]
On [removed: February 5, 2021,] [added: March 1, 2022,] we [removed: announced our intention to pursue a plan to spin off] [added: completed the spinoff of] our [removed: Spine] [added: spine] and [removed: Dental] [added: dental] businesses into a new public [removed: company named] [added: company,] ZimVie Inc. (“ZimVie”).
The [removed: planned] transaction [removed: is] [added: was] intended to benefit our stockholders by enhancing the focus of both Zimmer Biomet and ZimVie to meet the needs of patients and customers and, therefore, achieve faster growth and deliver greater value for all stakeholders.
[removed: Customers,] [added: Customers,] Sales and [removed: Marketing][added: Marketing]
Our primary customers include orthopedic surgeons, neurosurgeons, [removed: oral surgeons,] and other specialists, [removed: dentists,] hospitals, stocking distributors, healthcare dealers and, in their capacity as agents, healthcare purchasing organizations or buying groups.
These customers range from large multinational enterprises to independent [removed: clinicians and dentists.][added: clinicians.]
We market and sell products through [removed: three] [added: two] principal channels: 1) direct to healthcare institutions, such as [removed: hospitals,] [added: hospitals and ambulatory surgery centers,] referred to as direct channel accounts; [added: and] 2) through stocking distributors and healthcare [removed: dealers; and 3) directly to dental practices and dental laboratories.][added: dealers.]
With sales to stocking distributors, some healthcare dealers and [added: some] hospitals, [removed: dental practices and dental laboratories,] title to product passes upon shipment.
Consignment sales represented approximately [removed: 80] [added: 85] percent of our net sales in [removed: 2021.][added: 2022.]
No individual customer accounted for more than 1 percent of our net sales for [removed: 2021.][added: 2022.]
[added: Additionally, we keep current with key surgical] developments and other issues related to orthopedic surgeons, neurosurgeons, other specialists, [removed: dentists] and [removed: oral surgeons and] the medical [removed: and dental] procedures they perform.
We allocate resources to achieve our operating profit goals through [removed: four] [added: three regional] operating segments.
Our operating segments are comprised of [removed: Americas Orthopedics;] [added: the Americas;] Europe, Middle East and Africa (“EMEA”); [removed: Asia Pacific;] and [removed: Americas Spine and Global Dental.][added: Asia Pacific.]
[added: *Americas.*] The Americas [removed: Orthopedics] operating segment is our largest operating segment.
This segment is comprised principally of the U.S. and includes other North, Central and South American [removed: markets for our orthopedic product categories.][added: markets.]
This segment also includes research, development engineering, medical [removed: education,] [added: education] and brand management for our [removed: orthopedic] product category headquarter locations.
[added: *EMEA.*] The EMEA operating segment is our second largest operating segment.
France, Germany, Italy, Spain and the United Kingdom [added: (the “UK”)] collectively account for approximately 55 percent of net sales in the region.
[added: *Asia Pacific.*] The Asia Pacific operating segment includes key markets such as Japan, China, Australia, New Zealand, Korea, Taiwan, India, Thailand, Singapore, Hong Kong and Malaysia.
Most notably, in 2021 the Chinese government began to implement a nationwide volume-based procurement (“VBP”) process across certain of our product categories that negatively affected our net sales due to distributor inventory reductions, ongoing pricing negotiations with distributor partners, revaluation of channel inventory and volume reductions as patients deferred procedures until after VBP pricing [removed: has become effective.][added: became effective in 2022.]
[removed: Seasonality][added: Seasonality]
Due to the COVID-19 global pandemic, [removed: the] typical seasonal patterns [removed: did not occur] [added: were disrupted] in 2020 [removed: or 2021.][added: and 2021, but started to return to normal in 2022.]
[removed: Products][added: Products]
Our products include orthopedic reconstructive products; sports medicine, biologics, extremities and trauma products; [removed: spine and] CMFT products; [removed: dental implants; and related] surgical [removed: products.][added: products; and a suite of integrated digital and robotic technologies.]
Our significant knee brands include the [removed: following:][added: Persona® Knee, NexGen® Knee Implants, Vanguard® Knee, and Oxford® Partial Knee.]
Our trauma products are used to stabilize damaged or broken [added: bones and their surrounding tissues to support the body’s natural healing process.]
Our CMFT product division includes face and skull reconstruction products as well as products that fixate and stabilize the bones of the chest in order to facilitate healing or reconstruction after open heart surgery, trauma or for deformities of the [removed: chest.][added: chest. Our significant S.E.T. brands include the JuggerKnot® Soft Anchor System, Gel-One® Cross-linked Hyaluronate, Comprehensive® Shoulder, Natural Nail® System, and SternaLock® System.]
[removed: Research] [added: Research] and [removed: Development][added: Development]
As of December 31, [removed: 2021,] [added: 2022,] we employed approximately [removed: 2,000] [added: 2,100] research and development employees worldwide.
[removed: | 1 | Registered] [added: Gel-One® is a registered] trademark of Seikagaku [removed: Corporation |][added: Corporation.]
[removed: Government] [added: Government] Regulation and [removed: Compliance][added: Compliance]
There is a global trend toward increased regulatory activity related to medical [removed: products.][added: products and medical devices.]
In the U.S., numerous laws and regulations govern [removed: all] the processes by which our products are brought to market.
These [removed: include, among others,] [added: include] the Federal Food, Drug and Cosmetic [removed: Act (“FDCA”)] [added: Act, as amended (“FDCA”),] and [removed: regulations issued or promulgated thereunder.][added: associated regulations.]
[removed: The] U.S. Food and Drug Administration (“FDA”) [removed: has enacted] regulations [removed: that] control all aspects of the development, [removed: manufacture,] [added: manufacturing,] advertising, [removed: promotion] [added: promotion, marketing, distribution] and postmarket surveillance of medical [removed: products, including] [added: products and] medical devices.
Most of our new products fall into [removed: an FDA medical device] [added: a] classification that requires the submission of a Premarket Notification (510(k)) to the [removed: FDA.][added: FDA before we can market the new device.]
[removed: The PMA process requires us to provide] [added: Other devices we develop and market require stringent FDA] clinical [added: investigation] and [added: Premarket Approval (“PMA”) requirements, including submission of clinical and] laboratory data that establishes that the new medical device is safe and effective.
All of our devices marketed in the U.S. have been cleared or approved by the FDA, [removed: with the exception of some devices which are classified by FDA regulation as] [added: except for those] exempt from [added: FDA] premarket clearance and approval [removed: or were] [added: and those] in commercial distribution prior to May 28, 1976.
[removed: The QSR requires that each manufacturer] [added: We are required to] establish a quality system by which [removed: the manufacturer monitors the] [added: we monitor our (and our third-party manufacturers')] manufacturing [removed: process] [added: processes] and [removed: maintains] [added: maintain] records that show compliance with FDA regulations and [removed: the manufacturer’s] [added: manufacturers'] written specifications and [removed: procedures relating to the devices.][added: procedures.]
Zimmer Biomet is a global medical technology leader with a comprehensive portfolio designed to maximize mobility and improve health.
Additionally, our ROSA® Robot utilizes robotic technologies to assist a surgeon with implant positioning in total knee arthroplasty or partial knee arthroplasty.
Our significant hip brands include the Taperloc® Hip System, Avenir Complete® Hip System, Arcos® Modular Hip System, and G7® Acetabular System.
Our global regulatory environment is increasingly stringent, unpredictable and complex.
*Medical Product and Medical Device Regulation*
The process of obtaining FDA clearance or approval to market a product is resource intensive, lengthy, and costly.
FDA review may involve substantial delays that adversely affect the marketing and sale of our products.
Additionally, certain of our new products incorporate innovations related to artificial intelligence, machine learning and software as a medical device, which are subject to emerging FDA oversight and regulation.
We are subject to FDA Quality System regulations governing design and manufacturing practices, testing, manufacturing quality assurance, labeling and record keeping and reporting requirements for our products, which apply both to our own and to our third-party manufacturers' operations.
In
The EU Medical Device Regulation (the “EU MDR”) took effect in May 2021, replacing the MDD.
The EU MDR imposes significant additional premarket and postmarket requirements.
Products currently certified per the existing MDD regulations must be certified to the new EU MDR regulation prior to the current MDD certificate expiry or May 2024, whichever comes first.
Industry members, EU Notified Bodies and individual EU country heath administrations have voiced concern over the lack of progress in the issuance of MDR certifications and the subsequent impact on product availability on the European market as the May 2024 deadline nears.
Subsequently the EU Commission recommended action to ensure medical device access to patients, which we expect to be detailed and forthcoming in 2023.
The UK additionally is in the process of creating a new medical device framework (the “UK MDR”) following its exit from the European Union.
The new regulation, initially scheduled to be implemented in 2023, is anticipated to be delayed until 2024.
The UK, in the meantime, continues to allow product meeting the current EU regulations to be marketed.
*Foreign Corrupt Practices Act and Related Laws*
*Environmental Laws*
*Data Privacy Laws*
health-related and other personal information, including laws and regulations that regulate and restrict cross-border data transfers.
Certain of these laws and regulations impose time-sensitive notification requirements to governmental authorities or consumers.
We are also subject to emerging guidance governing data security and cyber risk management for medical devices.
Information regarding the risks associated with data privacy and protection laws may be found in *Item 1A.
Risk Factors – If we fail to comply with data privacy and security laws and regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected.*
The Zimmer Biomet Foundation is an independent, non-profit organization established in 2018 to address the needs of our global community;
Cybersecurity
We have established a cybersecurity program intended to protect the confidentiality, integrity and availability of our systems, data and products in a manner consistent with industry best practices and the NIST Cybersecurity framework.
We are currently ISO 27001 certified for our surgery planning ecosystem and continue to maintain this industry certification while expanding its scope.
The Audit Committee of the Board of Directors receives cybersecurity updates at least quarterly.
The Audit Committee considers cybersecurity risk individually and within our overall risk management framework.
We obtain periodic assessments of our cybersecurity program from independent third-party experts, the results of which assessments are reported to our Audit Committee.
Our Chief Information Security Officer (“CISO”) leads our cybersecurity program through our global information security operations team.
Our CISO reports to our Chief Information Officer, who in turn reports to our Chairman, President and Chief Executive Officer.
Under our program, cybersecurity issues are analyzed by subject matter experts, including in IT, risk and compliance, for potential financial, operational, legal, reputational and other risks, based on, among other factors, the nature of the matter and the potential breadth of impact.
Matters involving potential data breaches are considered against applicable data breach notification requirements.
Matters determined to present potential material impacts to our financial results, operations, and/or reputation are required to be immediately reported to the Audit Committee, as appropriate, in accordance with our escalation framework.
In addition, we have established procedures providing that members of management responsible for overseeing the operation of our disclosure controls and procedures are informed in a timely manner of known cybersecurity risks and incidents that may materially impact our operations and that timely public disclosure is made, as appropriate.
Our cybersecurity program includes a variety of policies, procedures and attributes including training requirements, threat monitoring and detection, threat containment, risk assessments, third-party penetration testing and security requirements for third-party vendors.
| --- | --- |
Zimmer Biomet is a global leader in musculoskeletal healthcare.
The transaction is intended to qualify as a tax-free distribution, for U.S. federal income tax purposes, to U.S. stockholders of new publicly traded stock in ZimVie.
The expected completion date of the spinoff is March 1, 2022.
Additionally, we keep current with key surgical
Americas Orthopedics.
EMEA.
This operating segment includes all product categories in these markets, except for Dental.
We emphasize the advantages of our clinically proven, established designs and innovative solutions and new and enhanced materials and surfaces.
Asia Pacific.
This operating segment includes all product categories in these markets, except for Dental.
Americas Spine and Global Dental.
The Americas Spine and Global Dental operating segment constitutes a majority of the operations that will be spun off to ZimVie.
The U.S. accounts for approximately 75 percent of sales in this operating segment.
The Americas Spine market dynamics are similar to Americas Orthopedics.
However, the Spine business maintains a separate sales force of independent sales agents.
In our Dental products division, our sales force is primarily composed of employees who market our products to customers.
We sell directly to dental practices or dental laboratories, or to independent stocking distributors depending on the market.
A developing trend in knee replacement surgeries is the use of robotic technologies to assist a surgeon with implant positioning.
In 2019, we entered the robotic assistance market with our ROSA® Robot.
The ROSA® Robot can be used for total knee arthroplasty or partial knee arthroplasty.
| | • | Persona® Knee |
| --- | --- | --- |
| | • | NexGen® Knee Implants |
| --- | --- | --- |
| | • | Vanguard® Knee |
| --- | --- | --- |
| | • | Oxford® Partial Knee |
| --- | --- | --- |
Our significant hip brands include the following:
| | • | Taperloc® Hip System |
| --- | --- | --- |
| | • | Avenir Complete® Hip System |
| --- | --- | --- |
| | • | Arcos® Modular Hip System |
| --- | --- | --- |
| | • | G7® Acetabular System |
| --- | --- | --- |
bones and their surrounding tissues to support the body’s natural healing process.
Our significant S.E.T. brands include the following:
An excerpt. Shown here: 40 of 119 rewritten, 40 of 65 added and 40 of 135 removed. The counts are complete. For every sentence, read Item 1. Business in the FY2022 filing and the FY2021 filing.
Item 3. Legal Proceedings
0 rewritten, 0 added, 1 removed, 1 unchanged
Read the full itemFY2022 item · filed February 24, 2023FY2021 item · filed February 25, 2022
| --- | --- |
Cover and table of contents
56 rewritten, 8 added, 2 removed, 60 unchanged
Read the full itemFY2022 item · filed February 24, 2023FY2021 item · filed February 25, 2022
[added: UNITED STATES] SECURITIES AND EXCHANGE [removed: COMMISSION][added: COMMISSION]
[removed: Washington,] [added: Washington,] D.C. [removed: 20549][added: 20549]
[removed: FORM 10-K][added: FORM 10-K]
[removed: ANNUAL] [added: ANNUAL] REPORT PURSUANT TO SECTION 13 OR 15(d) OF [removed: THE][added: THE]
[removed: SECURITIES] [added: SECURITIES] EXCHANGE ACT OF [removed: 1934][added: 1934]
[removed: For] [added: For] year [removed: ended December 31, 2021][added: ended December 31, 2022]
[removed: Commission] [added: Commission] file [removed: number 001-16407][added: number 001-16407]
[removed: ZIMMER] [added: ZIMMER] BIOMET HOLDINGS, [removed: INC.][added: INC.]
[removed: (Exact] [added: (Exact] name of registrant as specified in its [removed: charter)][added: charter)]
| [removed: Delaware] [added: Delaware] | | [removed: 13-4151777] [added: 13-4151777] |
| [removed: (State] [added: (State] of [removed: Incorporation)] [added: Incorporation)] | | [removed: (IRS] [added: (IRS] Employer Identification [removed: No.)] [added: No.)] |
| [removed: 345] [added: 345] East Main [removed: Street Warsaw, Indiana] [added: Street Warsaw, Indiana] | | [removed: 46580] [added: 46580] |
| [removed: (Address] [added: (Address] of principal executive [removed: offices)] [added: offices)] | | [removed: (Zip Code)] [added: (Zip Code)] |
[removed: Registrant’s] [added: Registrant’s] telephone number, including area code: [removed: (574) 267-6131][added: (574) 373-3121]
[removed: Securities] [added: Securities] registered pursuant to Section 12(b) of the [removed: Act:][added: Act:]
| [removed: Title] [added: Title] of each [removed: class] [added: class] | [removed: Trading Symbol(s)] [added: Trading Symbol(s)] | [removed: Name] [added: Name] of each exchange on which [removed: registered] [added: registered] |
| [removed: Common] [added: Common] Stock, $0.01 par [removed: value] [added: value] | [removed: ZBH] [added: ZBH] | [removed: New] [added: New] York Stock [removed: Exchange] [added: Exchange] |
| [removed: 1.414%] [added: 2.425%] Notes due [removed: 2022] [added: 2026 1.164% Notes due 2027] | [removed: ZBH 22A] [added: ZBH 26 ZBH 27] | [removed: New] [added: New] York Stock [removed: Exchange] [added: Exchange New York Stock Exchange] |
[removed: Securities] [added: Securities] registered pursuant to Section 12(g) of the Act: [removed: None][added: None]
The aggregate market value of shares held by non-affiliates was [removed: $33,533,707,317] [added: $22,002,934,091] (based on the closing price of these shares on the New York Stock Exchange on June 30, [removed: 2021] [added: 2022] and assuming solely for the purpose of this calculation that all directors and executive officers of the registrant are “affiliates”).
As of February 7, [removed: 2022, 209,177,445] [added: 2023, 208,980,256] shares of the registrant’s $.01 par value common stock were outstanding.
[removed: Documents] [added: Documents] Incorporated by [removed: Reference][added: Reference]
| [removed: Document] [added: Document] | | [removed: Form 10-K] [added: Form 10-K] |
| Portions of the Proxy Statement with respect to the [removed: 2022] [added: 2023] Annual Meeting of Stockholders | | Part III |
[removed: ZIMMER] [added: ZIMMER] BIOMET HOLDINGS, [removed: INC.][added: INC.]
[removed: ANNUAL REPORT][added: ANNUAL REPORT]
[removed: Cautionary] [added: Cautionary] Note Regarding Forward-Looking [removed: Statements][added: Statements]
[removed: These risks, uncertainties and changes in circumstances include, but are not limited to: the effects of the COVID-19 global pandemic and other adverse public health developments on the global economy, our business and operations and the business and operations of our suppliers and customers, including the deferral of elective surgical procedures and our ability to collect accounts receivable; the failure of vaccine rollouts and other strategies to mitigate or reverse the impacts of the COVID-19 pandemic; the failure of elective surgical procedures to recover at the levels or on the timeline anticipated; the risks and uncertainties related to our ability to successfully execute our restructuring plans; our ability to attract, retain and develop the highly skilled employees we need to support our business; the risks and uncertainties associated with the planned spinoff of ZimVie Inc., including, without limitation, the significant expenses, time and efforts related to implementing such transaction, the ability to complete the transaction on our expected timeline or at all, the tax-free nature of the transaction, the tax-efficient nature of any subsequent distribution of any ZimVie Inc. common stock we retain, possible disruptions in our relationships with customers, suppliers and other business partners, and the possibility that the anticipated benefits and synergies of the transaction, strategic and competitive advantages of each company, and future growth and other opportunities will not be realized within the expected time periods or at all; the success of our quality and operational excellence initiatives, including ongoing quality remediation efforts at our Warsaw North Campus facility; the ability to remediate matters identified in inspectional observations or warning letters issued by the U.S. Food and Drug Administration (FDA), while continuing to satisfy the demand for our products; the impact of substantial indebtedness on our ability to service our debt obligations and/or refinance amounts outstanding under our debt obligations at maturity on terms favorable to us, or at all; the ability to retain the employees, independent agents and distributors who market our products; dependence on a limited number of suppliers for key raw materials and outsourced activities; the possibility that the anticipated synergies and other benefits from mergers and acquisitions will not be realized, or will not be realized within the expected time periods; the risks and uncertainties related to our ability to successfully integrate the operations, products, employees and distributors of acquired companies; the effect of the potential disruption of management’s attention from ongoing business operations due to integration matters related to mergers and acquisitions; the effect of mergers and acquisitions on our relationships with customers, suppliers and lenders and on our operating results and businesses generally; challenges relating to changes in and compliance with governmental laws and regulations affecting our U.S. and international businesses, including regulations of the FDA and foreign government regulators, such as more stringent requirements for regulatory clearance of products; the outcome of government investigations; competition; pricing pressures; changes in customer demand for our products and services caused by demographic changes or other factors; the impact of healthcare reform measures; reductions in reimbursement levels by third-party payors and cost containment efforts sponsored by government agencies, legislative bodies, the private sector and healthcare purchasing organizations, including the volume-based procurement process in China; dependence on new product development, technological advances and innovation; shifts in the product category or regional sales mix of our products and services; supply and prices of raw materials and products; control of costs and expenses; the ability to obtain and maintain adequate intellectual property protection; breaches or failures of our information technology systems or products, including by cyberattack, unauthorized access or theft; the ability to form and implement alliances; changes in tax obligations arising from tax reform measures, including European Union rules on state aid, or examinations by tax authorities; product liability, intellectual property and commercial litigation losses; changes in general industry and market conditions, including domestic and international growth rates; changes in general domestic and international economic conditions, including interest rate and currency exchange rate fluctuations; the domestic and international business impact of political, social and economic instability, tariffs, trade embargoes, sanctions, wars, disputes and other conflicts; and the impact of the ongoing financial and political uncertainty on countries in EMEA on the ability to collect accounts receivable in affected countries.][added: These risks, uncertainties and changes in circumstances include, but are not limited to: the effects of business disruptions such as the COVID-19 pandemic, either alone or in combination with other risks on our business and operations; the risks and uncertainties related to our ability to successfully execute our restructuring plans; control of costs and expenses; our ability to attract, retain and develop the highly skilled employees, senior management, independent agents and distributors we need to support our business; the possibility that the anticipated synergies and other benefits from mergers and acquisitions will not be realized, or will not be realized within the expected time periods; the risks and uncertainties related to our ability to successfully integrate the operations, products, employees and distributors of acquired companies; the effect of the potential disruption of management’s attention from ongoing business operations due to integration matters related to mergers and acquisitions; the effect of mergers and acquisitions on our relationships with customers, suppliers and lenders and on our operating results and businesses generally; the ability to form and implement alliances; dependence on a limited number of suppliers for key raw materials and other inputs and for outsourced activities; the risk of disruptions in the supply of materials and components used in manufacturing or sterilizing our products; supply and prices of raw materials and products; breaches or failures of our information technology systems or products, including by cyberattack, unauthorized access or theft; challenges relating to changes in and compliance with governmental laws and regulations affecting our U.S. and international businesses, including regulations of the U.S. Food and Drug Administration (“FDA”) and foreign government regulators, such as more stringent requirements for regulatory clearance of products; the outcome of government investigations; dependence on new product development, technological advances and innovation; shifts in the product category or regional sales mix of our products and services; competition; pricing pressures; changes in customer demand for our products and services caused by demographic changes or other factors; the impact of healthcare reform and cost containment measures, including efforts sponsored by government agencies, legislative bodies, the private sector and healthcare purchasing organizations, through reductions in reimbursement levels and otherwise; the impact of substantial indebtedness on our ability to service our debt obligations and/or refinance amounts outstanding under our debt obligations at maturity on terms favorable to us, or at all; changes in tax obligations arising from examinations by tax authorities and from changes in tax laws in jurisdictions where we do business, including those expected to occur as a result of the “base erosion and profit shifting” project undertaken by the Organisation for Economic Co-operation and Development and otherwise; challenges to the tax-free nature of the ZimVie Inc. (“ZimVie”) spinoff transaction and the subsequent liquidation of our retained interest in ZimVie; the risk of additional tax liability due to the recategorization of our independent agents and distributors to employees; the risk that material impairment of the carrying value of our intangible assets, including goodwill, could negatively affect our operating results; changes in general domestic and international economic conditions, including interest rate and currency exchange rate fluctuations; changes in general industry and market conditions, including domestic and international growth, inflation and currency exchange rates; the domestic and international business impact of political, social and economic instability, tariffs, trade restrictions and embargoes, sanctions, wars, disputes and other conflicts, including on our ability to operate in, export from or collect accounts receivable in affected countries; challenges relating to changes in and compliance with governmental laws and regulations affecting our U.S. and international businesses, including regulations of the FDA and foreign government regulators relating to medical products, healthcare fraud and abuse laws and data privacy and security laws; the success of our quality and operational excellence initiatives; the ability to remediate matters identified in inspectional observations or warning letters issued by the FDA and other regulators, while continuing to satisfy the demand for our products; product liability, intellectual property and commercial litigation losses; and the ability to obtain and maintain adequate intellectual property protection.]
See also the section titled “Risk Factors” (refer to Part I, Item 1A of this report) for further discussion of certain risks and uncertainties that could cause actual results and events to differ materially from the forward-looking [removed: statements.]
[removed: TABLE] [added: TABLE] OF [removed: CONTENTS][added: CONTENTS]
| | | | [removed: Page] [added: Page] |
| Item 1A. | [Risk [removed: Factors](#ITEM_1A_RISK_FACTORS)] [added: Factors](#item_1a_risk_factors)] | | [removed: 15] [added: 14] |
| Item 1B. | [Unresolved Staff [removed: Comments](#ITEM_1B_UNRESOLVED_STAFF_COMMENTS)] [added: Comments](#item_1b_unresolved_staff_comments)] | | [removed: 29] [added: 26] |
| Item 2. | [removed: [Properties](#ITEM_2_PROPERTIES)] [added: [Properties](#item_2_properties)] | | [removed: 29] [added: 26] |
| Item 3. | [Legal [removed: Proceedings](#ITEM_3_LEGAL_PROCEEDINGS)] [added: Proceedings](#item_3_legal_proceedings)] | | [removed: 29] [added: 26] |
| Item 4. | [Mine Safety [removed: Disclosures](#ITEM_4_MINE_SAFETY_DISCLOSURES)] [added: Disclosures](#item_4_mine_safety_disclosures)] | | [removed: 29] [added: 26] |
| [PART [removed: II](#PART_II)] [added: II](#part_ii)] | | | [removed: 30] [added: 27] |
| Item 5. | [Market for the Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities](#ITEM_5_MARKET_FOR_REGISTRANTS_COMMON_EQU)] [added: Securities](#item_5_market_for_registrants_common_equ)] | | [removed: 30] [added: 27] |
| Item 6. | [removed: [\[Reserved\]](#ITEM_6_RESERVED)] [added: [\[Reserved\]](#item_6_reserved)] | | [removed: 31] [added: 29] |
| Item 7. | [Management’s Discussion and Analysis of Financial Condition and Results of [removed: Operations](#ITEM_7_MANAGEMENTS_DISCUSSION_ANALYSIS_F)] [added: Operations](#item_7_managements_discussion_analysis_f)] | | [removed: 32] [added: 29] |
| | | |
| | | |
| | | | | |
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).
| | | |
statements.
| | | | |
UNITED STATES
| 2.425% Notes due 2026 1.164% Notes due 2027 | ZBH 26 ZBH 27 | New York Stock Exchange New York Stock Exchange |
An excerpt. Shown here: 40 of 56 rewritten, all 8 added and all 2 removed. The counts are complete. For every sentence, read Cover and table of contents in the FY2022 filing and the FY2021 filing.
Item 1B. Unresolved Staff Comments
0 rewritten, 0 added, 1 removed, 1 unchanged
Read the full itemFY2022 item · filed February 24, 2023FY2021 item · filed February 25, 2022
| --- | --- |
Item 2. Properties
2 rewritten, 0 added, 2 removed, 10 unchanged
Read the full itemFY2022 item · filed February 24, 2023FY2021 item · filed February 25, 2022
We own or lease approximately [removed: 340] [added: 280] different facilities around the world, of which approximately half are in the U.S. Our corporate headquarters is in Warsaw, Indiana.
We have approximately [removed: 35] [added: 25] manufacturing locations in the U.S. and internationally.
| --- | --- |
Our Spine, CMFT and Dental products divisions also have business unit headquarters located in the U.S. that are the primary facilities for these product divisions’ manufacturing, R&D and other business activities.
Item 4. Mine Safety Disclosures
1 rewritten, 0 added, 1 removed, 1 unchanged
Read the full itemFY2022 item · filed February 24, 2023FY2021 item · filed February 25, 2022
[removed: PART II][added: PART II]
| --- | --- |
Item 5. Market for the Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
1 rewritten, 24 added, 1 removed, 3 unchanged
Read the full itemFY2022 item · filed February 24, 2023FY2021 item · filed February 25, 2022
Our common stock is traded on the New York Stock Exchange and the SIX Swiss Exchange under the symbol “ZBH.” As of February [removed: 8, 2022,] [added: 7, 2023,] there were approximately [removed: 15,400] [added: 14,540] holders of record of our common stock.
*Market for the Registrant’s Common Equity and Related Stockholder Matters*
The graph below shows the cumulative total stockholder return on our common stock compared to the S&P 500 Stock Index, the S&P 500 Health Care Equipment Index and the common stock of a selected group of peer issuers (the “Peer Group”).
The chart assumes $100 was invested on December 31, 2017 in Zimmer Biomet common stock and each index and that dividends were reinvested.
Returns over the indicated period should not be considered indicative of future returns.
The Peer Group is a group of publicly traded companies, including other large healthcare equipment and services companies, life sciences services companies and companies with whom we compete for business and for executive talent, which companies we use as a market reference point for performance comparisons, executive compensation levels, equity usage and incentive plan design and industry trend analysis.
The Peer Group is selected by our Compensation and Management Development Committee from time to time, most recently in May 2022, and currently consists of the following issuers: Agilent Technologies, Inc.; Align Technology, Inc.; Baxter International Inc.; Becton Dickinson and Company; Boston Scientific Corporation; DexCom, Inc.; Edwards Lifesciences Corporation; Hologic, Inc.; Intuitive Surgical, Inc.; Laboratory Corporation of America Holdings; Quest Diagnostics Incorporated; Stryker Corporation; Teleflex Incorporated; and The Cooper Companies, Inc. We have selected the Peer Group to replace the S&P 500 Health Care Equipment Index because we believe it better reflects our relative market performance and to provide consistency in evaluating our relative executive compensation practices.

| | | | | | | | | | | | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Company/Index | | 2017 | | | | 2018 | | | | 2019 | | | | 2020 | | | | 2021 | | | | 2022 | | |
| Zimmer Biomet Holdings, Inc. | | $ | 100.00 | | | $ | 86.69 | | | $ | 126.03 | | | $ | 130.77 | | | $ | 108.51 | | | $ | 113.18 | |
| S&P 500 Stock Index | | | 100.00 | | | | 95.62 | | | | 125.72 | | | | 148.85 | | | | 191.58 | | | | 156.88 | |
| S&P 500 Health Care Equipment Index | | | 100.00 | | | | 116.24 | | | | 150.32 | | | | 176.83 | | | | 211.05 | | | | 171.25 | |
| Peer Group | | | 100.00 | | | | 112.39 | | | | 147.56 | | | | 171.63 | | | | 208.11 | | | | 165.99 | |
*Issuer Purchases of Equity Securities*
The following table summarizes repurchases of common stock settled during the three months ended December 31, 2022:
| | | | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Period | | Total Number of Shares Purchased | | | | Average Price Paid per Share | | | | Total Number of Shares Purchased as a Part of Publicly Announced Program(1) | | | | Maximum Approximate Dollar Value of Shares that may yet be Purchased Under the Program(1) | | |
| October 2022 | | | \- | | | $ | \- | | | | \- | | | $ | 1,000,000,000 | |
| November 2022 | | | \- | | | | \- | | | | \- | | | | 1,000,000,000 | |
| December 2022 | | | 1,185,064 | | | | 126.58 | | | | 1,185,064 | | | | 850,000,131 | |
| Total | | | 1,185,064 | | | $ | 126.58 | | | | 1,185,064 | | | $ | 850,000,131 | |
(1) In February 2016, our Board of Directors authorized a $1.0 billion share repurchase program effective March 1, 2016, with no expiration date.
| --- | --- |
Item 6. [Reserved]
0 rewritten, 0 added, 1 removed, 0 unchanged
Read the full itemFY2022 item · filed February 24, 2023FY2021 item · filed February 25, 2022
| --- | --- |
Item 8. Financial Statements and Supplementary Data
733 rewritten, 498 added, 499 removed, 547 unchanged
Read the full itemFY2022 item · filed February 24, 2023FY2021 item · filed February 25, 2022
| [removed: Financial Statements:] [added: Financial Statements:] | | [removed: Page] [added: Page] |
| [Report of Independent Registered Public Accounting [removed: Firm](#REPORT_INDEPENDENT_REGISTERED_PUBLIC_ACC)] [added: Firm](#report_independent_registered_public_acc)] (PCAOB ID: 238) | | [removed: 47] [added: 41] |
| [Consolidated Statements of Earnings for the Years Ended December 31, [removed: 2021, 2020] [added: 2022, 2021] and [removed: 2019](#CONSOLIDATED_STATEMENTS_EARNINGS)] [added: 2020](#consolidated_statements_earnings)] | | [removed: 50] [added: 44] |
| [Consolidated Statements of Comprehensive Income (Loss) for the Years Ended December 31, [removed: 2021, 2020] [added: 2022, 2021] and [removed: 2019](#CONSOLIDATED_STATEMENTS_COMPREHENSIVE_IN)] [added: 2020](#consolidated_statements_comprehensive_in)] | | [removed: 51] [added: 45] |
| [Consolidated Balance Sheets as of December 31, [removed: 2021] [added: 2022] and [removed: 2020](#CONSOLIDATED_BALANCE_SHEETS)] [added: 2021](#consolidated_balance_sheets)] | | [removed: 52] [added: 46] |
| [Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, [removed: 2021, 2020] [added: 2022, 2021] and [removed: 2019](#CONSOLIDATED_STATEMENTS_STOCKHOLDERS_EQU)] [added: 2020](#consolidated_statements_stockholders_equ)] | | [removed: 53] [added: 47] |
| [Consolidated Statements of Cash Flows for the Years Ended December 31, [removed: 2021, 2020] [added: 2022, 2021] and [removed: 2019](#CONSOLIDATED_STATEMENTS_CASH_FLOWS)] [added: 2020](#consolidated_statements_cash_flows)] | | [removed: 54] [added: 48] |
| [Notes to Consolidated Financial [removed: Statements](#NOTES_TO_CONSOLIDATED_FINANCIAL_STATEMEN)] [added: Statements](#notes_to_consolidated_financial_statemen)] | | [removed: 55] [added: 49] |
[removed: Report] [added: Report] of Independent [removed: Registered] [added: Registered] Public Accounting [removed: Firm][added: Firm]
[removed: Opinions] [added: Opinions] on the Financial Statements and Internal Control over Financial [removed: Reporting][added: Reporting]
[added: We have audited the accompanying consolidated balance sheets of Zimmer Biomet Holdings, Inc.] and its subsidiaries (the “Company”) as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] and the related consolidated statements of earnings, of comprehensive income (loss), of stockholders’ equity and of cash flows for each of the three years in the period ended December 31, [removed: 2021,] [added: 2022,] including the related notes and schedule of valuation and qualifying accounts for each of the three years in the period ended December 31, [removed: 2021] [added: 2022] appearing under Item 15(a)(2) (collectively referred to as the “consolidated financial statements”).
We also have audited the Company's internal control over financial reporting as of December 31, [removed: 2021,] [added: 2022,] based on criteria established in *Internal Control - Integrated Framework* (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2021] [added: 2022] in conformity with accounting principles generally accepted in the United States of America.
Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, [removed: 2021,] [added: 2022,] based on criteria established in *Internal Control [removed: –] [added: -] Integrated Framework* (2013) issued by the COSO.
[removed: Basis] [added: Basis] for [removed: Opinions][added: Opinions]
[removed: Definition] [added: Definition] and Limitations of Internal Control over Financial [removed: Reporting][added: Reporting]
A 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 [added: accordance with generally accepted accounting principles, 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]
[removed: accordance with generally accepted accounting principles, 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 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.
[removed: Critical] [added: Critical] Audit [removed: Matters][added: Matters]
[removed: Goodwill] [added: *Goodwill] Impairment Assessment - [removed: EMEA, Dental] [added: EMEA] and Americas CMFT Reporting [removed: Units][added: Units*]
As described in Notes 2 and 11 to the consolidated financial statements, the Company’s consolidated goodwill balance was [removed: $9,192.2] [added: $8,580.2] million as of December 31, [removed: 2021,] [added: 2022,] and the goodwill associated with the EMEA [removed: reporting unit, Dental reporting unit,] and Americas CMFT reporting [removed: unit, was $317.3 million, $267.8 million and $290.9 million, respectively.][added: units represents a portion of the consolidated goodwill balance.]
Management estimated the fair value of the [removed: EMEA, Dental] [added: EMEA] and Americas CMFT reporting units based on income and market approaches.
Fair value under the market approach utilized the guideline public company methodology, which uses valuation indicators from [removed: other businesses] [added: publicly-traded companies] that are similar to the [removed: EMEA, Dental] [added: EMEA] and Americas CMFT reporting units.
Significant assumptions are incorporated into the discounted cash flow analysis such as [added: forecasted net sales,] revenue growth rates, forecasted operating [removed: expenses,] [added: expenses] and risk-adjusted discount rates.
The principal considerations for our determination that performing procedures relating to the goodwill impairment assessment of the [removed: EMEA, Dental] [added: EMEA] and Americas CMFT reporting units is a critical audit matter are (i) the significant judgment by management [removed: related to the discounted cash flow analysis] when [removed: developing] [added: estimating] the fair value [removed: measurement] of the reporting units; (ii) a high degree of auditor judgment, subjectivity, and effort in performing procedures and [removed: in] evaluating management’s significant assumptions related to [added: forecasted net sales, forecasted operating expenses and risk-adjusted discount rate for the EMEA reporting unit and] revenue growth rates, forecasted operating expenses and risk-adjusted discount [removed: rates;] [added: rate for the Americas CMFT reporting unit;] and (iii) the audit effort involved the use of professionals with specialized skill and knowledge.
These procedures included testing the effectiveness of controls relating to management’s goodwill impairment assessment, including controls over the [removed: discounted cash flow analysis related to the] valuation of the Company’s reporting units.
These procedures also included, among [removed: others,] [added: others] (i) testing management’s process for developing the [added: estimated] fair value [removed: estimate;] [added: of the EMEA and Americas CMFT reporting units;] (ii) evaluating the appropriateness of [removed: management’s fair value approaches;] [added: the discounted cash flow analysis;] (iii) testing the completeness and accuracy of the underlying data used in the discounted cash flow [removed: analysis,] [added: analysis;] and (iv) evaluating the reasonableness of the significant assumptions used by management in the discounted cash flow analysis related to [added: forecasted net sales, forecasted operating expenses and risk-adjusted discount rate for] the [added: EMEA reporting unit and] revenue growth rates, forecasted operating [removed: expenses,] [added: expenses] and risk-adjusted discount [removed: rates.][added: rate for the Americas CMFT reporting unit.]
Evaluating management’s assumptions related to [added: forecasted net sales,] revenue growth rates and forecasted operating expenses involved evaluating whether the assumptions used by management were reasonable considering (i) the [added: current and] past performance of the [added: EMEA and Americas CMFT] reporting [removed: units;] [added: units, where applicable;] (ii) the consistency with external data from market and industry sources; and (iii) whether these assumptions were consistent with evidence obtained in other areas of the audit.
[removed: Professionals with specialized skill and knowledge were used to assist in the evaluation] [added: appropriateness] of the Company’s discounted cash flow analysis and the [added: reasonableness of the] risk-adjusted discount rate assumptions.
[removed: Tax] [added: *Tax] Liabilities for [added: Certain] Unrecognized Tax [removed: Benefits][added: Benefits*]
As described in Notes 2 and 17 to the consolidated financial statements, the Company has recorded tax liabilities for unrecognized tax benefits [added: with a consolidated balance] of [removed: $558.6] [added: $521.0] million as of December 31, [removed: 2021.][added: 2022.]
The calculation of [added: certain of] the Company’s estimated tax [removed: liabilities] [added: liabilities, representing a majority of the consolidated balance,] involves dealing with uncertainties in the application of complex tax laws and regulations in a multitude of jurisdictions across the Company’s global operations.
The Company’s income tax filings are regularly [added: under audit in multiple federal, state and foreign jurisdictions.]
[added: Our income tax filings are regularly] under audit in multiple federal, [removed: state] [added: state,] and foreign jurisdictions.
The principal considerations for our determination that performing procedures relating to tax liabilities for [added: certain] unrecognized tax benefits is a critical audit matter are [added: (i)] the significant judgment by management when determining the tax [removed: liabilities, related] [added: liabilities for certain unrecognized tax benefits due] to a high degree of estimation uncertainty [removed: relative] [added: related] to [removed: the numerous and] [added: management’s application of] complex tax laws and regulations, [removed: frequency] [added: the result] of income tax audits, and potential for significant adjustments as a result of such [removed: audits.][added: audits; (ii) a high degree of auditor judgment, subjectivity, and effort in performing procedures to evaluate the timely identification and accurate measurement of tax liabilities for certain unrecognized tax benefits and evaluating audit evidence available to support the estimates; and (iii) the audit effort involved the use of professionals with specialized skill and knowledge.]
These procedures included testing the effectiveness of controls relating to the [removed: identification, accurate measurement,] [added: identification] and [removed: recognition] [added: accurate measurement] of tax liabilities for unrecognized tax benefits, including controls addressing [added: the] completeness of the tax liabilities.
These procedures also included, among [removed: others,] [added: others] (i) [added: evaluating the accuracy of the measurement of tax liabilities for certain unrecognized tax benefits by] testing certain information used in the calculation of tax liabilities for [added: certain] unrecognized tax benefits by [removed: jurisdiction] [added: jurisdiction,] on a sample [removed: basis,] [added: basis;] (ii) assessing the completeness of the Company’s identification of tax liabilities for unrecognized tax benefits and possible outcomes for [removed: each] [added: certain] unrecognized tax [removed: benefit,] [added: benefits;] and (iii) evaluating the status and results of income tax audits [added: related to certain unrecognized tax benefits] with the relevant tax authorities.
Professionals with specialized skill and knowledge were used to assist in [removed: the evaluation of the Company’s interpretation and] [added: evaluating management’s] application of [removed: relevant] [added: complex] tax laws and regulations in various jurisdictions and assessing the reasonableness of [added: certain of] the Company’s tax positions.
[removed: ZIMMER] [added: ZIMMER] BIOMET HOLDINGS, INC. AND [removed: SUBSIDIARIES][added: SUBSIDIARIES]
[removed: CONSOLIDATED STATEMENTS] [added: CONSOLIDATED STATEMENTS] OF [removed: EARNINGS][added: EARNINGS]
| | | |
The annual goodwill impairment test resulted in an impairment charge of $289.8 million related to the EMEA reporting unit, which represented all of the remaining goodwill.
Professionals with specialized skill and knowledge were used to assist in evaluating the
February 24, 2023
| Net Sales | | $ | 6,939.9 | | | $ | 6,827.3 | | | $ | 6,127.5 | |
| Intangible asset amortization | | | 526.8 | | | | 529.5 | | | | 512.1 | |
| Research and development | | | 406.0 | | | | 435.8 | | | | 322.8 | |
| Operating expenses | | | 6,243.6 | | | | 5,967.0 | | | | 6,044.4 | |
| Operating Profit | | | 696.3 | | | | 860.3 | | | | 83.1 | |
| Earnings (loss) from continuing operations before income taxes | | | 403.5 | | | | 499.0 | | | | (105.2 | ) |
| Provision (benefit) for income taxes from continuing operations | | | 112.3 | | | | 53.5 | | | | (96.0 | ) |
| Net Earnings (Loss) from Continuing Operations | | | 291.2 | | | | 445.5 | | | | (9.2 | ) |
| Net Earnings (Loss) from Continuing Operations of Zimmer Biomet Holdings, Inc. | | | 290.2 | | | | 445.0 | | | | (10.7 | ) |
| Loss from Discontinued Operations, Net of Tax | | | (58.8 | ) | | | (43.4 | ) | | | (128.2 | ) |
| Basic Earnings (Loss) Per Common Share | | | | | | | | | | | | |
| Earnings (Loss) from Continuing Operations | | $ | 1.38 | | | $ | 2.14 | | | $ | (0.05 | ) |
| Loss from Discontinued Operations | | | (0.28 | ) | | | (0.21 | ) | | | (0.62 | ) |
| Diluted Earnings (Loss) Per Common Share | | | | | | | | | | | | |
| Earnings (Loss) from Continuing Operations | | $ | 1.38 | | | $ | 2.12 | | | $ | (0.05 | ) |
| Loss from Discontinued Operations | | | (0.28 | ) | | | (0.21 | ) | | | (0.62 | ) |
| | | | | | | | | | | | | |
| | | | | | | | | | | | | |
| Net Earnings (Loss) of Zimmer Biomet Holdings, Inc. | | $ | 231.4 | | | $ | 401.6 | | | $ | (138.9 | ) |
| | | | | | | | | |
| | | 2022 | | | | 2021 | | |
| Cash and cash equivalents | | $ | 375.7 | | | $ | 378.1 | |
| Accounts receivable, less allowance for credit losses | | | 1,381.5 | | | | 1,259.6 | |
| Inventories | | | 2,147.2 | | | | 2,148.0 | |
| Prepaid taxes | | | 198.4 | | | | 326.7 | |
| Prepaid expenses and other current assets | | | 324.5 | | | | 271.0 | |
| Current assets of discontinued operations | | | \- | | | | 501.6 | |
| Goodwill | | | 8,580.2 | | | | 8,919.4 | |
| Intangible assets, net | | | 5,063.8 | | | | 5,533.6 | |
| Other assets | | | 1,122.2 | | | | 1,005.0 | |
| Noncurrent assets of discontinued operations | | | \- | | | | 1,276.8 | |
| Accounts payable | | $ | 354.1 | | | $ | 306.5 | |
| Income taxes payable | | | 38.5 | | | | 62.0 | |
| Other current liabilities | | | 1,421.3 | | | | 1,317.1 | |
| Current liabilities of discontinued operations | | | \- | | | | 177.2 | |
| Deferred income taxes, net | | | 474.8 | | | | 558.5 | |
| --- | --- |
| --- | --- | --- |
We have audited the accompanying consolidated balance sheets of Zimmer Biomet Holdings, Inc.
This in turn led to a high degree of auditor judgment, subjectivity, and effort in performing procedures to evaluate the timely identification and accurate measurement of tax liabilities for unrecognized tax benefits.
Also, the evaluation of audit evidence available to support the estimates is complex and required significant auditor judgment as the nature of the evidence is often highly subjective, and the audit effort involved the use of professionals with specialized skill and knowledge.
February 25, 2022
| Net Sales | | $ | 7,836.2 | | | $ | 7,024.5 | | | $ | 7,982.2 | |
| Intangible asset amortization | | | 615.7 | | | | 597.6 | | | | 584.3 | |
| Operating expenses | | | 7,056.1 | | | | 7,112.3 | | | | 6,844.7 | |
| Operating Profit (Loss) | | | 780.1 | | | | (87.8 | ) | | | 1,137.5 | |
| Earnings (Loss) before income taxes | | | 418.4 | | | | (274.4 | ) | | | 905.8 | |
| Net Earnings (Loss) | | | 402.1 | | | | (137.4 | ) | | | 1,131.5 | |
| Net Earnings (Loss) | | $ | 402.1 | | | $ | (137.4 | ) | | $ | 1,131.5 | |
| Comprehensive Income (Loss) | | | 468.3 | | | | (193.3 | ) | | | 1,077.0 | |
| Comprehensive Income (Loss) Attributable to Noncontrolling Interest | | | 0.5 | | | | 1.5 | | | | (0.1 | ) |
| Inventories | | | 2,394.5 | | | | 2,450.7 | |
| Prepaid taxes | | | 329.5 | | | | 208.8 | |
| Goodwill | | | 9,192.2 | | | | 9,261.8 | |
| Balance January 1, 2019 | | | 307.9 | | | $ | 3.1 | | | $ | 8,686.1 | | | $ | 9,491.2 | | | $ | (187.4 | ) | | | (103.9 | ) | | $ | (6,721.7 | ) | | $ | 4.8 | | | $ | 11,276.1 | |
| Net earnings | | | \- | | | | \- | | | | \- | | | | 1,131.6 | | | | \- | | | | \- | | | | \- | | | | (0.1 | ) | | | 1,131.5 | |
| Stock compensation plans | | | 2.0 | | | | \- | | | | 234.0 | | | | 1.7 | | | | \- | | | | \- | | | | 1.2 | | | | \- | | | | 236.9 | |
| Net earnings (loss) | | $ | 402.1 | | | $ | (137.4 | ) | | $ | 1,131.5 | |
| Depreciation and amortization | | | 1,067.4 | | | | 1,032.7 | | | | 1,006.1 | |
| Receivables | | | (15.1 | ) | | | (70.0 | ) | | | (93.8 | ) |
| Inventories | | | 18.8 | | | | (40.8 | ) | | | (125.2 | ) |
| Additions to instruments | | | (301.8 | ) | | | (291.7 | ) | | | (315.9 | ) |
| Acquisition of intellectual property rights | | | (8.4 | ) | | | (0.4 | ) | | | (197.6 | ) |
| Investments in other assets | | | (23.3 | ) | | | (22.2 | ) | | | (19.7 | ) |
| Net payments on other debt | | | \- | | | | \- | | | | (5.3 | ) |
| Cash and cash equivalents, beginning of year | | | 802.1 | | | | 617.9 | | | | 542.8 | |
| Cash and cash equivalents, end of period | | $ | 478.5 | | | $ | 802.1 | | | $ | 617.9 | |
| --- | --- |
In 2015, we completed our merger with LVB Acquisition, Inc., the parent company of Biomet, Inc. (“Biomet”).
Planned Spinoff - On February 5, 2021, we announced our intention to pursue a plan to spin off our Spine and Dental businesses into a new public company named ZimVie Inc. (“ZimVie”).
The planned transaction is intended to benefit our stockholders by enhancing the focus of both Zimmer Biomet and ZimVie to meet the needs of patients and customers and, therefore, achieve faster growth and deliver greater value for all stakeholders.
The transaction is intended to qualify as a tax-free distribution, for U.S. federal income tax purposes, to U.S. stockholders of new publicly traded stock in ZimVie.
The expected completion date of the spinoff is March 1, 2022.
Our Board of Directors has declared a pro rata dividend of 80.3% of the outstanding common stock of ZimVie to our stockholders of record as of the close of business on February 15, 2022.
Immediately following the dividend, we will retain 19.7% of the outstanding shares of ZimVie common stock, which we intend to divest after the separation in a tax-efficient manner.
| --- | --- |
An excerpt. Shown here: 40 of 733 rewritten, 40 of 498 added and 40 of 499 removed. The counts are complete. For every sentence, read Item 8. Financial Statements and Supplementary Data in the FY2022 filing and the FY2021 filing.
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
0 rewritten, 0 added, 1 removed, 1 unchanged
Read the full itemFY2022 item · filed February 24, 2023FY2021 item · filed February 25, 2022
| --- | --- |
Item 9A. Controls and Procedures
11 rewritten, 0 added, 7 removed, 8 unchanged
Read the full itemFY2022 item · filed February 24, 2023FY2021 item · filed February 25, 2022
[removed: Evaluation] [added: *Evaluation] of Disclosure Controls and [removed: Procedures][added: Procedures*]
Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that as of December 31, [removed: 2021,] [added: 2022,] the end of the period covered by this report, our disclosure controls and procedures were effective at a reasonable assurance level.
[removed: Management’s] [added: *Management’s] Annual Report on Internal Control over Financial [removed: Reporting][added: Reporting*]
[removed: | | • |] Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the Company; [removed: |]
[removed: | | • |] Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the Company; and [removed: |]
[removed: | | • |] Provide reasonable assurance regarding 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. [removed: |]
The Company’s management assessed the effectiveness of the Company’s internal control over financial reporting as of December 31, [removed: 2021.][added: 2022.]
Based on their assessment, management has concluded that, as of December 31, [removed: 2021,] [added: 2022,] the Company’s internal control over financial reporting is effective based on those criteria.
[removed: The Company’s] [added: PricewaterhouseCoopers LLP, an] independent registered public accounting firm, [removed: PricewaterhouseCoopers LLP, has] audited the effectiveness of [removed: the Company’s] [added: our] internal control over financial reporting as of December 31, [removed: 2021,] [added: 2022 and issued an unqualified opinion thereon] as stated in [removed: its report] [added: their report,] which appears [removed: in] [added: under] Item 8 of this Annual Report on Form 10-K.
[removed: Changes] [added: *Changes] in Internal Control Over Financial [removed: Reporting][added: Reporting*]
There were no changes in our internal control over financial reporting that occurred during the quarter ended December 31, [removed: 2021] [added: 2022] that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
| --- | --- |
| --- | --- | --- |
| --- | --- | --- |
| --- | --- | --- |
During the quarter ended December 31, 2021, we continued to transition certain functions into our new Global Business Services (“GBS”) organization.
This is part of a multiyear plan to support our growth while simplifying and centralizing key global processes to harmonize and gain efficiencies in our processes and internal controls.
Although the underlying internal controls did not significantly change with this move, the responsibility to perform these internal controls has transferred to the new GBS centers as well as certain outsourced providers.
Item 9B. Other Information
1 rewritten, 8 added, 1 removed, 1 unchanged
Read the full itemFY2022 item · filed February 24, 2023FY2021 item · filed February 25, 2022
During the fourth quarter of [removed: 2021,] [added: 2022,] the Audit Committee of our Board of Directors approved the engagement of PricewaterhouseCoopers LLP, our independent registered public accounting firm, to perform certain non-audit services.
*Disclosure Pursuant to Section 13(r) of the Exchange Act*
Section 13(r) of the Exchange Act requires an issuer to disclose in its annual or quarterly reports if it or any of its affiliates knowingly engaged in certain activities, transactions or dealings relating to parties subject to sanctions administered by OFAC within the United States Department of the Treasury, whether or not such activities are prohibited or sanctionable under United States law.
On March 2, 2021, the United States government designated the Russian Federal Security Service (the “FSB”) as a blocked party under Executive Order 13382.
On the same day, OFAC updated General License No. 1B (the “OFAC General License”), which generally authorizes certain licensing, permitting, certification, notification and related transactions with the FSB as may be required pursuant to Russian encryption product import controls for the importation, distribution or use of certain information technology products and radio frequency technology products in the Russian Federation.
As required under Russian law and as permitted under the OFAC General License, one of our subsidiaries in Russia periodically files notifications with or applies for import licenses and permits from the FSB on our behalf in connection with the importation of our products into Russia.
These notification and licensing activities are free of charge, and none of our gross revenue or net profits are attributable to such activities.
We expect to continue to file notifications with and apply for import licenses and permits from the FSB to qualify our products for importation and distribution in the Russian Federation to the extent required under Russian law, but only so long as such notification and licensing activities are authorized by the OFAC General License, any successor general license or other authorization issued by OFAC.
During the fourth quarter of 2022, we filed one notification with the FSB as described above.
| --- | --- |
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
1 rewritten, 0 added, 1 removed, 1 unchanged
Read the full itemFY2022 item · filed February 24, 2023FY2021 item · filed February 25, 2022
[removed: PART III][added: PART III]
| --- | --- |
Item 10. Directors, Executive Officers and Corporate Governance
1 rewritten, 1 added, 1 removed, 3 unchanged
Read the full itemFY2022 item · filed February 24, 2023FY2021 item · filed February 25, 2022
Information required by this item is incorporated by reference from our definitive Proxy Statement for the annual meeting of stockholders to be held on May [removed: 13, 2022] [added: 12, 2023] (the [removed: “2022] [added: “2023] Proxy Statement”).
Information regarding our executive officers is included in Part I, Item 1 of this Annual Report on Form 10-K under the caption “Information About our Executive Officers.”
| --- | --- |
Item 11. Executive Compensation
1 rewritten, 0 added, 1 removed, 0 unchanged
Read the full itemFY2022 item · filed February 24, 2023FY2021 item · filed February 25, 2022
Information required by this item is incorporated by reference from our [removed: 2022] [added: 2023] Proxy Statement.
| --- | --- |
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
1 rewritten, 0 added, 1 removed, 0 unchanged
Read the full itemFY2022 item · filed February 24, 2023FY2021 item · filed February 25, 2022
Information required by this item is incorporated by reference from our [removed: 2022] [added: 2023] Proxy Statement.
| --- | --- |
Item 13. Certain Relationships and Related Transactions and Director Independence
1 rewritten, 0 added, 1 removed, 0 unchanged
Read the full itemFY2022 item · filed February 24, 2023FY2021 item · filed February 25, 2022
Information required by this item is incorporated by reference from our [removed: 2022] [added: 2023] Proxy Statement.
| --- | --- |
Item 14. Principal Accountant Fees and Services
2 rewritten, 0 added, 1 removed, 0 unchanged
Read the full itemFY2022 item · filed February 24, 2023FY2021 item · filed February 25, 2022
Information required by this item is incorporated by reference from our [removed: 2022] [added: 2023] Proxy Statement.
[removed: PART IV][added: PART IV]
| --- | --- |
Item 15. Exhibits and Financial Statement Schedules
91 rewritten, 23 added, 32 removed, 21 unchanged
Read the full itemFY2022 item · filed February 24, 2023FY2021 item · filed February 25, 2022
[removed: | | 2. |] [added: (2)] Financial Statement Schedule [removed: |]
| | | | | | | [removed: Additions] [added: Additions] | | | | | | | | | | | | | | |
| | | [removed: Balance at] [added: Balance at] | | | | [removed: Charged] [added: Charged] | | | | [removed: Deductions /] [added: Deductions /] | | | | [removed: Effects of] [added: Effects of] | | | | [removed: Balance at] [added: Balance at] | | |
| | | [removed: Beginning] [added: Beginning] | | | | [removed: (Credited)] [added: (Credited)] | | | | [removed: Other Additions] [added: Other Additions] | | | | [removed: Foreign] [added: Foreign] | | | | [removed: End of] [added: End of] | | |
| [removed: Description] [added: Description] | | [removed: of Period] [added: of Period] | | | | [removed: to Expense] [added: to Expense] | | | | [removed: to Reserve] [added: to Reserve] | | | | [removed: Currency] [added: Currency] | | | | [removed: Period] [added: Period] | | |
[removed: | | (1) |] Includes the [removed: $3.1] [added: $2.1] cumulative-effect adjustment related to the adoption of ASU 2016-13, Financial Instruments – Credit Losses (Topic 326). [removed: |]
[removed: | | (2) |] Primarily relate to amounts generated by tax rate changes or current year activity which have offsetting changes to the associated attribute and therefore there is no resulting impact on tax expense in the consolidated financial statements. [removed: |]
[removed: | | 3. | Exhibits |][added: INDEX TO EXHIBITS]
[removed: INDEX TO EXHIBITS][added: (3) Exhibits: See Index to Exhibits below]
| 3.1 | | [Restated Certificate of Incorporation of Zimmer Biomet Holdings, Inc., dated May 17, 2021 (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K filed May 20, [removed: 2021)](http://www.sec.gov/Archives/edgar/data/1136869/000119312521167789/d568447dex32.htm)] [added: 2021)](https://www.sec.gov/Archives/edgar/data/1136869/000119312521167789/d568447dex32.htm)] |
| [removed: 3.2] [added: 10.33*] | | [removed: [Restated Bylaws of Zimmer] [added: [Zimmer] Biomet Holdings, [removed: Inc., effective] [added: Inc. 2009 Stock Incentive Plan (As Amended on] May [removed: 17, 2021] [added: 14, 2021)] (incorporated by reference to Exhibit [removed: 3.3] [added: 10.1] to the Registrant’s Current Report on Form 8-K filed May 20, [removed: 2021)](http://www.sec.gov/Archives/edgar/data/1136869/000119312521167789/d568447dex33.htm)] [added: 2021)](https://www.sec.gov/Archives/edgar/data/1136869/000119312521167789/d568447dex101.htm)] |
| 4.1 | | [Description of Securities Registered under Section 12 of the Securities Exchange Act of [removed: 1934](https://www.sec.gov/Archives/edgar/data/1136869/000156459022007160/zbh-ex41_7.htm)] [added: 1934](https://www.sec.gov/Archives/edgar/data/1136869/000095017023004264/zbh-ex4_1.htm)] |
| 4.2 | | [Specimen Common Stock Certificate (incorporated by reference to Exhibit 4.1 to the Registrant’s Quarterly Report on Form 10-Q filed August 5, [removed: 2019)](http://www.sec.gov/Archives/edgar/data/1136869/000156459019028842/zbh-ex41_93.htm)] [added: 2019)](https://www.sec.gov/Archives/edgar/data/1136869/000156459019028842/zbh-ex41_93.htm)] |
| 4.3 | | [Indenture dated as of November 17, 2009 between Zimmer Holdings, Inc. (now known as Zimmer Biomet Holdings, Inc.) and Wells Fargo Bank, National Association, as Trustee (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed December 13, [removed: 2016)](http://www.sec.gov/Archives/edgar/data/1136869/000119312516791951/d298678dex41.htm)] [added: 2016)](https://www.sec.gov/Archives/edgar/data/1136869/000119312516791951/d298678dex41.htm)] |
| 4.4 | | [First Supplemental Indenture to the Indenture dated as of November 17, 2009 between Zimmer Holdings, Inc. and Wells Fargo Bank, National Association, as Trustee (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed November 17, [removed: 2009)](http://www.sec.gov/Archives/edgar/data/1136869/000095012309063461/c54692exv4w2.htm)] [added: 2009)](https://www.sec.gov/Archives/edgar/data/1136869/000095012309063461/c54692exv4w2.htm)] |
| 4.5 | | [Form of 5.750% Note due 2039 (incorporated by reference to Exhibit 4.4 [removed: above)](http://www.sec.gov/Archives/edgar/data/1136869/000095012309063461/c54692exv4w2.htm)] [added: above)](https://www.sec.gov/Archives/edgar/data/1136869/000095012309063461/c54692exv4w2.htm)] |
| 4.6 | | [Second Supplemental Indenture dated as of November 10, 2011, to the Indenture dated as of November 17, 2009 between Zimmer Holdings, Inc. and Wells Fargo Bank, National Association, as Trustee (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed November 10, [removed: 2011)](http://www.sec.gov/Archives/edgar/data/1136869/000119312511306336/d252786dex41.htm)] [added: 2011)](https://www.sec.gov/Archives/edgar/data/1136869/000119312511306336/d252786dex41.htm)] |
| 4.7 | | [Third Supplemental Indenture, dated as of March 19, 2015, to the Indenture dated as of November 17, 2009 between Zimmer Holdings, Inc. and Wells Fargo Bank, National Association, as Trustee (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed March 19, [removed: 2015)](http://www.sec.gov/Archives/edgar/data/1136869/000119312515098570/d894178dex41.htm)] [added: 2015)](https://www.sec.gov/Archives/edgar/data/1136869/000119312515098570/d894178dex41.htm)] |
| 4.8 | | [Form of [removed: 3.150%] [added: 3.550%] Notes due [removed: 2022] [added: 2025] (incorporated by reference to Exhibit 4.7 [removed: above)](http://www.sec.gov/Archives/edgar/data/1136869/000119312515098570/d894178dex41.htm)] [added: above)](https://www.sec.gov/Archives/edgar/data/1136869/000119312515098570/d894178dex41.htm)] |
| 4.9 | | [Form of [removed: 3.550%] [added: 4.250%] Notes due [removed: 2025] [added: 2035] (incorporated by reference to Exhibit 4.7 [removed: above)](http://www.sec.gov/Archives/edgar/data/1136869/000119312515098570/d894178dex41.htm)] [added: above)](https://www.sec.gov/Archives/edgar/data/1136869/000119312515098570/d894178dex41.htm)] |
| 4.10 | | [Form of [removed: 4.250%] [added: 4.450%] Notes due [removed: 2035] [added: 2045] (incorporated by reference to Exhibit 4.7 [removed: above)](http://www.sec.gov/Archives/edgar/data/1136869/000119312515098570/d894178dex41.htm)] [added: above)](https://www.sec.gov/Archives/edgar/data/1136869/000119312515098570/d894178dex41.htm)] |
| [removed: 4.11] [added: 4.12] | | [Form of [removed: 4.450%] [added: 2.425%] Notes due [removed: 2045] [added: 2026] (incorporated by reference to Exhibit [removed: 4.7 above)](http://www.sec.gov/Archives/edgar/data/1136869/000119312515098570/d894178dex41.htm)] [added: 4.11 above)](https://www.sec.gov/Archives/edgar/data/1136869/000119312516791951/d298678dex42.htm)] |
| [removed: 4.12] [added: 4.11] | | [Fourth Supplemental Indenture, dated as of December 13, 2016, between Zimmer Biomet Holdings, Inc. and Wells Fargo Bank, National Association, as Trustee (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed December 13, [removed: 2016)](http://www.sec.gov/Archives/edgar/data/1136869/000119312516791951/d298678dex42.htm)] [added: 2016)](https://www.sec.gov/Archives/edgar/data/1136869/000119312516791951/d298678dex42.htm)] |
| [removed: 4.13] [added: 4.16] | | [Form of [removed: 1.414%] [added: 3.700%] Notes due [removed: 2022] [added: 2023] (incorporated by reference to Exhibit [removed: 4.12 above)](http://www.sec.gov/Archives/edgar/data/1136869/000119312516791951/d298678dex42.htm)] [added: 4.15 above)](https://www.sec.gov/Archives/edgar/data/1136869/000119312518087778/d657056dex42.htm)] |
| [removed: 4.14] [added: 4.21] | | [Form of [removed: 2.425%] [added: 3.050%] Notes due 2026 (incorporated by reference to Exhibit [removed: 4.12 above)](http://www.sec.gov/Archives/edgar/data/1136869/000119312516791951/d298678dex42.htm)] [added: 4.20 above)](https://www.sec.gov/Archives/edgar/data/1136869/000119312520080651/d869142dex42.htm)] |
| [removed: 4.15] [added: 4.13] | | [Agency Agreement, dated as of December 13, 2016, by and among Zimmer Biomet Holdings, Inc., as issuer, Elavon Financial Services DAC, UK Branch, as paying agent, Elavon Financial Services DAC, as registrar and transfer agent, and Wells Fargo Bank, National Association, as Trustee (incorporated by reference to Exhibit 4.3 to the Registrant’s Current Report on Form 8-K filed December 13, [removed: 2016)](http://www.sec.gov/Archives/edgar/data/1136869/000119312516791951/d298678dex43.htm)] [added: 2016)](https://www.sec.gov/Archives/edgar/data/1136869/000119312516791951/d298678dex43.htm)] |
| [removed: 4.16] [added: 4.14] | | [Amendment No. 1, dated as of January 4, 2017, to the Agency Agreement dated as of December 13, 2016, by and among Zimmer Biomet Holdings, Inc., as issuer, Elavon Financial Services DAC, UK Branch, as paying agent, Elavon Financial Services DAC, as original registrar and original transfer agent, U.S. Bank National Association, as successor registrar and successor transfer agent, and Wells Fargo Bank, National Association, as Trustee (incorporated by reference to Exhibit 4.4 to the Registrant’s Registration Statement on Form 8-A filed January 4, [removed: 2017)](http://www.sec.gov/Archives/edgar/data/1136869/000119312517001314/d306834dex44.htm)] [added: 2017)](https://www.sec.gov/Archives/edgar/data/1136869/000119312517001314/d306834dex44.htm)] |
| [removed: 4.17] [added: 4.15] | | [Fifth Supplemental Indenture, dated as of March 19, 2018, between Zimmer Biomet Holdings, Inc. and Wells Fargo Bank, National Association, as Trustee (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed March 19, [removed: 2018)](http://www.sec.gov/Archives/edgar/data/1136869/000119312518087778/d657056dex42.htm)] [added: 2018)](https://www.sec.gov/Archives/edgar/data/1136869/000119312518087778/d657056dex42.htm)] |
| 4.18 | | [Form of [removed: 3.700%] [added: 1.164%] Notes due [removed: 2023] [added: 2027] (incorporated by reference to Exhibit 4.17 [removed: above)](http://www.sec.gov/Archives/edgar/data/1136869/000119312518087778/d657056dex42.htm)] [added: above)](https://www.sec.gov/Archives/edgar/data/1136869/000119312519293426/d796220dex42.htm)] |
| [removed: 4.19] [added: 4.17] | | [Sixth Supplemental Indenture, dated as of November 15, 2019, between Zimmer Biomet Holdings, Inc. and Wells Fargo Bank, National Association, as Trustee (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed November 15, [removed: 2019)](http://www.sec.gov/Archives/edgar/data/1136869/000119312519293426/d796220dex42.htm)] [added: 2019)](https://www.sec.gov/Archives/edgar/data/1136869/000119312519293426/d796220dex42.htm)] |
| [removed: 4.20] [added: 4.22] | | [Form of [removed: 1.164%] [added: 3.550%] Notes due [removed: 2027] [added: 2030] (incorporated by reference to Exhibit [removed: 4.19 above)](http://www.sec.gov/Archives/edgar/data/1136869/000119312519293426/d796220dex42.htm)] [added: 4.20 above)](https://www.sec.gov/Archives/edgar/data/1136869/000119312520080651/d869142dex42.htm)] |
| [removed: 4.21] [added: 4.19] | | [Agency Agreement, dated as of November 15, 2019, by and between Zimmer Biomet Holdings, Inc., as issuer, Elavon Financial Services DAC, UK Branch, as paying agent, U.S. Bank National Association, as transfer agent [removed: and registrar, and Wells Fargo Bank, National Association, as trustee (incorporated by reference to Exhibit 4.3 to the Registrant’s Current Report on Form 8-K filed on November 15, 2019)](http://www.sec.gov/Archives/edgar/data/1136869/000119312519293426/d796220dex43.htm)] [added: and](https://www.sec.gov/Archives/edgar/data/1136869/000119312519293426/d796220dex43.htm)] |
| [removed: 4.22] [added: 4.20] | | [Seventh Supplemental Indenture, dated as of March 20, 2020, between Zimmer Biomet Holdings, Inc. and Wells Fargo Bank, National Association, as trustee (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed March 20, [removed: 2020](http://www.sec.gov/Archives/edgar/data/1136869/000119312520080651/d869142dex42.htm))] [added: 2020](https://www.sec.gov/Archives/edgar/data/1136869/000119312520080651/d869142dex42.htm))] |
| [removed: 4.23] [added: 4.24] | | [Form of [removed: 3.050%] [added: 1.450%] Notes due [removed: 2026] [added: 2024] (incorporated by reference to Exhibit [removed: 4.22 above)](http://www.sec.gov/Archives/edgar/data/1136869/000119312520080651/d869142dex42.htm)] [added: 4.23 above)](https://www.sec.gov/Archives/edgar/data/1136869/000119312521340365/d226882dex42.htm)] |
| [removed: 4.24] [added: 4.25] | | [Form of [removed: 3.550%] [added: 2.600%] Notes due [removed: 2030] [added: 2031] (incorporated by reference to Exhibit [removed: 4.22 above)](http://www.sec.gov/Archives/edgar/data/1136869/000119312520080651/d869142dex42.htm)] [added: 4.23 above)](https://www.sec.gov/Archives/edgar/data/1136869/000119312521340365/d226882dex42.htm)] |
| [removed: 4.25] [added: 4.23] | | [Eighth Supplemental Indenture, dated as of November 24, 2021, between Zimmer Biomet Holdings, Inc. and Computershare Trust Company, N.A., as trustee (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed November 24, [removed: 2021)](http://www.sec.gov/Archives/edgar/data/1136869/000119312521340365/d226882dex42.htm)] [added: 2021)](https://www.sec.gov/Archives/edgar/data/1136869/000119312521340365/d226882dex42.htm)] |
| 10.1* | | [Zimmer Biomet Holdings, Inc. Executive Performance Incentive Plan, as amended May 7, 2013 and further amended as of June 24, 2015 (incorporated by reference to Exhibit 10.4 to the Registrant’s Quarterly Report on Form 10-Q filed November 9, [removed: 2015)](http://www.sec.gov/Archives/edgar/data/1136869/000119312515372121/d206828dex104.htm)] [added: 2015)](https://www.sec.gov/Archives/edgar/data/1136869/000119312515372121/d206828dex104.htm)] |
| 10.2* | | [Amendment to Zimmer Biomet Holdings, Inc. Executive Performance Incentive Plan (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed January 7, [removed: 2016)](http://www.sec.gov/Archives/edgar/data/1136869/000119312516423531/d116893dex101.htm)] [added: 2016)](https://www.sec.gov/Archives/edgar/data/1136869/000119312516423531/d116893dex101.htm)] |
| 10.3* | | [Amendment to Zimmer Biomet Holdings, Inc. Executive Performance Incentive Plan, Effective May 7, 2020 (incorporated by reference to Exhibit 10.7 to the Registrant’s Quarterly Report on Form 10-Q filed May 11, [removed: 2020)](http://www.sec.gov/Archives/edgar/data/1136869/000156459020024235/zbh-ex107_187.htm)] [added: 2020)](https://www.sec.gov/Archives/edgar/data/1136869/000156459020024235/zbh-ex107_187.htm)] |
| [removed: 10.4*] [added: 10.5*] | | [removed: [Zimmer] [added: [Restated Zimmer] Biomet [removed: Deferred Compensation] [added: Holdings, Inc. Long Term Disability Income] Plan [added: for Highly Compensated Employees] (incorporated by reference to Exhibit [removed: 10.3] [added: 10.4] to the Registrant’s Current Report on Form 8-K filed January 7, [removed: 2016)](http://www.sec.gov/Archives/edgar/data/1136869/000119312516423531/d116893dex103.htm)] [added: 2016)](https://www.sec.gov/Archives/edgar/data/1136869/000119312516423531/d116893dex104.htm)] |
(a) (1) Financial Statements: See the Consolidated Financial Statements under Item 8 of this Report.
| | | | | | | | | | | | | | | | | | | | | |
| Year Ended December 31, 2020 | | $ | 46.3 | | | $ | 19.1 | | | $ | (8.3 | ) | (1) | $ | 1.5 | | | $ | 58.6 | |
| Year Ended December 31, 2021 | | | 58.6 | | | | 12.4 | | | | (9.0 | ) | | | (1.9 | ) | | | 60.1 | |
| Year Ended December 31, 2022 | | | 60.1 | | | | 22.5 | | | | (7.6 | ) | | | 3.4 | | | | 78.4 | |
| Year Ended December 31, 2020 | | $ | 529.6 | | | $ | (2.0 | ) | | $ | (3.1 | ) | (2) | $ | 2.8 | | | $ | 527.3 | |
| Year Ended December 31, 2021 | | | 527.3 | | | | (2.6 | ) | | | (61.5 | ) | (2) | | (3.1 | ) | | | 460.1 | |
| Year Ended December 31, 2022 | | | 460.1 | | | | 3.0 | | | | 2.0 | | (2) | | (1.9 | ) | | | 463.2 | |
(1)
(2)
| | | |
| | | |
| 2.1 | | [Separation and Distribution Agreement, dated as of March 1, 2022, by and between Zimmer Biomet Holdings, Inc. and ZimVie Inc. (incorporated by reference to Exhibit 2.1 to the Registrant’s Current Report on Form 8-K filed March 1, 2022)](https://www.sec.gov/Archives/edgar/data/1136869/000119312522061356/d650132dex21.htm) |
| 3.2 | | [Restated Bylaws of Zimmer Biomet Holdings, Inc., effective December 14, 2022](https://www.sec.gov/Archives/edgar/data/1136869/000095017023004264/zbh-ex3_2.htm) |
| | | |
| | | [registrar, and Wells Fargo Bank, National Association, as trustee (incorporated by reference to Exhibit 4.3 to the Registrant’s Current Report on Form 8-K filed on November 15, 2019)](https://www.sec.gov/Archives/edgar/data/1136869/000119312519293426/d796220dex43.htm) |
| | | |
| | | |
| 10.49 | | [Transition Manufacturing and Supply Agreement, dated as of March 1, 2022, by and between Zimmer, Inc. and ZimVie Inc. (incorporated by reference to Exhibit 10.6 to the Registrant’s Current Report on Form 8-K filed March 1, 2022)](https://www.sec.gov/Archives/edgar/data/1136869/000119312522061356/d650132dex106.htm) |
| 10.50 | | [Reverse Transition Manufacturing and Supply Agreement, dated as of March 1, 2022, by and between Zimmer, Inc. and ZimVie Inc. (incorporated by reference to Exhibit 10.7 to the Registrant’s Current Report on Form 8-K filed March 1, 2022)](https://www.sec.gov/Archives/edgar/data/1136869/000119312522061356/d650132dex107.htm) |
| 10.51 | | [Transitional Trademark License Agreement, dated as of March 1, 2022, by and between Zimmer Biomet Holdings, Inc. and ZimVie Inc. (incorporated by reference to Exhibit 10.8 to the Registrant’s Current Report on Form 8-K filed March 1, 2022)](https://www.sec.gov/Archives/edgar/data/1136869/000119312522061356/d650132dex108.htm) |
| | | |
| | | |
| --- | --- |
| (a) 1. | Financial Statements |
| --- | --- |
The following consolidated financial statements of Zimmer Biomet Holdings, Inc. and its subsidiaries are set forth in Part II, Item 8.
Report of Independent Registered Public Accounting Firm
Consolidated Statements of Earnings for the Years Ended December 31, 2021, 2020 and 2019
Consolidated Statements of Comprehensive Income (Loss) for the Years Ended December 31, 2021, 2020 and 2019
Consolidated Balance Sheets as of December 31, 2021 and 2020
Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2021, 2020 and 2019
Consolidated Statements of Cash Flows for the Years Ended December 31, 2021, 2020 and 2019
Notes to Consolidated Financial Statements
| --- | --- | --- |
| Year Ended December 31, 2019 | | $ | 65.7 | | | $ | 5.5 | | | $ | (5.3 | ) | | $ | (0.9 | ) | | $ | 65.0 | |
| Year Ended December 31, 2020 | | | 65.0 | | | | 21.8 | | | | (12.7 | ) | (1) | | 1.7 | | | | 75.8 | |
| Year Ended December 31, 2021 | | | 75.8 | | | | 15.1 | | | | (14.2 | ) | | | (2.1 | ) | | | 74.6 | |
| Year Ended December 31, 2019 | | $ | 390.9 | | | $ | (6.6 | ) | | $ | 165.7 | | (2) | $ | (3.9 | ) | | $ | 546.1 | |
| Year Ended December 31, 2020 | | | 546.1 | | | | (3.8 | ) | | | (3.2 | ) | (2) | | 3.0 | | | | 542.1 | |
| Year Ended December 31, 2021 | | | 542.1 | | | | (4.4 | ) | | | (64.0 | ) | (2) | | (3.6 | ) | | | 470.1 | |
| --- | --- | --- |
| --- | --- | --- |
| --- | --- | --- |
| 4.26 | | [Form of 1.450% Notes due 2024 (incorporated by reference to Exhibit 4.25 above)](http://www.sec.gov/Archives/edgar/data/1136869/000119312521340365/d226882dex42.htm) |
| 4.27 | | [Form of 2.600% Notes due 2031 (incorporated by reference to Exhibit 4.25 above)](http://www.sec.gov/Archives/edgar/data/1136869/000119312521340365/d226882dex42.htm) |
| 10.40* | | [Form of Restricted Stock Unit Award Agreement (three-year vesting) under the Zimmer Biomet Holdings, Inc. 2009 Stock Incentive Plan](https://www.sec.gov/Archives/edgar/data/1136869/000156459022007160/zbh-ex1040_373.htm) |
| 10.41* | | [Form of Restricted Stock Unit Award Agreement (two-year cliff vesting) under the Zimmer Biomet Holdings, Inc. 2009 Stock Incentive Plan (incorporated by reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q filed August 6, 2018)](http://www.sec.gov/Archives/edgar/data/1136869/000156459018019495/zbh-ex102_108.htm) |
| 10.43* | | [Form of Performance-Based Restricted Stock Unit Award Agreement (Hanson one-time award) under the Zimmer Biomet Holdings, Inc. 2009 Stock Incentive Plan (incorporated by reference to Exhibit 10.5 to the Registrant’s Current Report on Form 8-K filed December 21, 2017)](http://www.sec.gov/Archives/edgar/data/1136869/000119312517376624/d520208dex105.htm) |
| 10.45* | | [Form of Performance-Based Restricted Stock Unit Award Agreement (Upadhyay one-time award) under the Zimmer Biomet Holdings, Inc. 2009 Stock Incentive Plan (incorporated by reference to Exhibit 10.43 to the Registrant’s Annual Report on Form 10-K filed February 21, 2020)](http://www.sec.gov/Archives/edgar/data/1136869/000156459020005657/zbh-ex1043_438.htm) |
| 10.49 | | [First Amendment and Limited Waiver, dated as of February 25, 2020, between Zimmer Biomet G.K. and Sumitomo Mitsui Banking Corporation, to the JP¥21,300,000,000 Term Loan Agreement dated as of September 22, 2017 (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q filed May 11, 2020)](http://www.sec.gov/Archives/edgar/data/1136869/000156459020024235/zbh-ex101_185.htm) |
| 10.52 | | [First Amendment, dated as of April 23, 2018, to the Amended and Restated Term Loan Agreement ¥11,700,000,000 dated as of September 22, 2017 between Zimmer Biomet G.K. and Sumitomo Mitsui Banking Corporation (incorporated by reference to Exhibit 10.49 to the Registrant’s Annual Report on Form 10-K filed February 21, 2020)](http://www.sec.gov/Archives/edgar/data/1136869/000156459020005657/zbh-ex1049_474.htm) |
| 10.53 | | [Second Amendment and Limited Waiver, dated as of February 25, 2020, between Zimmer Biomet G.K. and Sumitomo Mitsui Banking Corporation, to the JP¥11,700,000,000 Amended and Restated Term Loan Agreement dated as of September 22, 2017, as amended by the First Amendment dated as of April 23, 2018 (incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q filed May 11, 2020)](http://www.sec.gov/Archives/edgar/data/1136869/000156459020024235/zbh-ex102_186.htm) |
| 10.54 | | [Third Amendment, dated as of April 28, 2020, to the Amended and Restated Term Loan Agreement JP¥11,700,000,000 dated as of September 22, 2017, between Zimmer Biomet G.K. and Sumitomo Mitsui Banking Corporation (incorporated by reference to Exhibit 10.4 to the Registrant’s Current Report on Form 8-K filed April 29, 2020)](http://www.sec.gov/Archives/edgar/data/1136869/000119312520126216/d900112dex104.htm) |
| --- | --- |
An excerpt. Shown here: 40 of 91 rewritten, all 23 added and all 32 removed. The counts are complete. For every sentence, read Item 15. Exhibits and Financial Statement Schedules in the FY2022 filing and the FY2021 filing.
Item 16. Form 10-K Summary
28 rewritten, 20 added, 19 removed, 7 unchanged
Read the full itemFY2022 item · filed February 24, 2023FY2021 item · filed February 25, 2022
[removed: SIGNATURES][added: SIGNATURES]
| Dated: February [removed: 25, 2022] [added: 24, 2023] | | | | Bryan Hanson |
| | | | | [removed: Chairman,] [added: *Chairman,] President and Chief Executive [removed: Officer] [added: Officer*] |
| [removed: SIGNATURE |] [added: SIGNATURE] | [removed: TITLE] | [added: TITLE] | [removed: DATE] | [added: DATE] |
| /s/ Bryan Hanson | | Chairman, President and Chief Executive Officer | | February [removed: 25, 2022 |] [added: 24, 2023] |
| Bryan Hanson | | (Principal Executive Officer) | | | [removed: |]
| /s/ Suketu Upadhyay | | Executive Vice President and Chief Financial Officer | | February [removed: 25, 2022 |] [added: 24, 2023] |
| Suketu Upadhyay | | (Principal Financial Officer) | | | [removed: |]
| /s/ [removed: Derek Davis] [added: Paul Stellato] | | Vice President, [removed: Interim] Controller and Chief Accounting | | February [removed: 25, 2022 |] [added: 24, 2023] |
| [removed: Derek Davis] [added: Paul Stellato] | | Officer (Principal Accounting Officer) | | | [removed: |]
| /s/ Christopher Begley | | Director | | February [removed: 25, 2022 |] [added: 24, 2023] |
| Christopher Begley | | | | | [removed: |]
| /s/ Betsy Bernard | | Director | | February [removed: 25, 2022 |] [added: 24, 2023] |
| Betsy Bernard | | | | | [removed: |]
| /s/ Michael Farrell | | Director | | February [removed: 25, 2022 |] [added: 24, 2023] |
| Michael Farrell | | | | | [removed: |]
| /s/ Robert Hagemann | | Director | | February [removed: 25, 2022 |] [added: 24, 2023] |
| Robert Hagemann | | | | | [removed: |]
| /s/ Arthur Higgins | | Director | | February [removed: 25, 2022 |] [added: 24, 2023] |
| Arthur Higgins | | | | | [removed: |]
| /s/ Maria Teresa Hilado | | Director | | February [removed: 25, 2022 |] [added: 24, 2023] |
| Maria Teresa Hilado | | | | | [removed: |]
| /s/ Syed Jafry | | Director | | February [removed: 25, 2022 |] [added: 24, 2023] |
| Syed Jafry | | | | | [removed: |]
| /s/ Sreelakshmi Kolli | | Director | | February [removed: 25, 2022 |] [added: 24, 2023] |
| Sreelakshmi Kolli | | | | | [removed: |]
| /s/ Michael Michelson | | Director | | February [removed: 25, 2022 |] [added: 24, 2023] |
| Michael Michelson | | | | | [removed: |]
| | | | | |
| | | | | |
| --- | --- | --- | --- | --- |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| --- | --- |
| --- | --- | --- | --- | --- | --- |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |