Zimmer Biomet Holdings 10-Q 2022-06-30

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

FOR THE QUARTERLY PERIOD ENDED June 30, 2022

Commission File Number 001-16407

ZIMMER BIOMET HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

345 East Main Street**,** Warsaw**,** IN 46580

(Address of principal executive offices)

Telephone: (574) 267-6131

Securities registered pursuant to Section 12(b) of the Act:

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of July 27, 2022, 209,819,548 shares of the registrant’s $.01 par value common stock were outstanding.

ZIMMER BIOMET HOLDINGS, INC.

INDEX TO FORM 10-Q

June 30, 2022

Part I – Financ****ial Information

ZIMMER BIOMET HOLDINGS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF EARNINGS

(in millions, except per share amounts, unaudited)

The accompanying notes are an integral part of these condensed consolidated financial statements.

ZIMMER BIOMET HOLDINGS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEM****ENTS OF COMPREHENSIVE INCOME

(in millions, unaudited)

The accompanying notes are an integral part of these condensed consolidated financial statements.

ZIMMER BIOMET HOLDINGS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDA****TED BALANCE SHEETS

(in millions, except share amounts, unaudited)

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The following discussion and analysis should be read in conjunction with the interim condensed consolidated financial statements and corresponding notes included elsewhere in this Form 10-Q. Certain percentages presented in this discussion and analysis are calculated from the underlying whole-dollar amounts and, therefore, may not recalculate from the rounded numbers used for disclosure purposes.

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 condensed consolidated financial statements 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 condensed consolidated balance sheet. See Note 2 to our interim condensed consolidated financial statements included in Part I, Item 1 of this report for additional information. The discussions in the following discussion and analysis are presented on a continuing operations basis.

Executive Level Overview

Impact of the COVID-19 Global Pandemic

Our results continue to be impacted by the COVID-19 global pandemic. 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. Additionally, we believe that staffing shortages at hospitals have contributed, and continue to contribute, to the deferral of elective surgical procedures. In the six-month period ended June 30, 2022, the Omicron variant resulted in fewer elective surgical procedures earlier in the year, but then we saw recovery in procedures as the surge began to subside later in the first quarter and through the second quarter.

Results for the Three and Six-Month Periods ended June 30, 2022

Our net sales increased by 1.0 percent and 2.4 percent in the three and six-month periods ended June 30, 2022 when compared to the same prior year periods. We saw the return of elective surgical procedures across most markets when compared to the prior year periods being negatively affected by a surge of the COVID-19 virus in early 2021 and before vaccines were widely available. Our net sales growth in the three and six-month periods ended June 30, 2022 was tempered by a negative 5.0 percent and a negative 4.0 percent effect, respectively, from changes in foreign currency exchange rates on year-over-year sales. Our net earnings were $153.7 million and $167.9 million in the three and six-month periods ended June 30, 2022, respectively, compared to $141.9 million and $340.0 million in the same prior year periods, respectively. The increase in net earnings in the three-month period ended June 30, 2022 when compared to the same prior year period was driven by higher net sales in 2022 as well as by the fact that the 2021 period included $65.0 million of charges, or $50.4 million net of tax, related to certain agreements we entered into to gain access to or acquire third-party in-process research and development (“IPR&D”) projects. The decline in net earnings in the six-month period ended June 30, 2022 was primarily due to losses from discontinued operations from costs related to the ZimVie spinoff, an unrealized investment loss due to a decline in the value of our investment in ZimVie, higher litigation-related charges, higher restructuring charges, and higher spending in travel, medical training and education and other areas as certain activities started to return to pre-pandemic levels.

2022 Outlook

We believe that COVID-19 and staffing shortages will continue to negatively affect net sales, but to a lesser degree than what we experienced in 2021 and early 2022. However, if foreign currency exchange rates stay at recent levels, we estimate net sales will be negatively affected by approximately 5.0%. For expenses, we expect that supply chain and inflation pressures will result in higher expenses when compared to 2021. However, we anticipate these higher expenses will be partially offset by savings from our restructuring programs.

Results of Operations

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. This sales analysis differs from our reportable operating segments, which are based upon our senior management organizational structure and how we allocate resources toward achieving operating profit goals. We review sales by these geographies because the underlying market trends in any particular geography tend to be similar across product categories, because we primarily sell the same products in all geographies and many of our competitors publicly report in this manner. 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. This seasonal pattern was disrupted in 2020 and 2021 due to COVID-19 as our net sales were influenced by the infection levels and precautions taken to prevent the spread in a particular location. It is uncertain if this seasonal pattern will return in 2022.

Net Sales by Geography

The following tables present our net sales by geography and the percentage changes (dollars in millions):

Net Sales by Product Category

The following tables present our net sales by product category and the percentage changes (dollars in millions):

The following table presents our net sales by geography for our Knees and Hips product categories, which represent our most significant product categories (dollars in millions):

Demand (Volume and Mix) Trends

Changes in volume and mix of product sales had positive effects of 7.2 percent and 7.8 percent on year-over-year sales during the three and six-month periods ended June 30, 2022, respectively. We saw recovery of elective surgical procedures, most notably in international markets, driving volume growth.

Pricing Trends

Global selling prices had negative effects of 1.2 percent and 1.4 percent on year-over-year sales during the three and six-month periods ended June 30, 2022, respectively. The majority of countries in which we operate continue to experience pricing pressure from governmental healthcare cost containment efforts and from local hospitals and health systems. Additionally, pricing was negatively affected in China by a nationwide volume-based procurement (“VBP”) process being implemented.

Foreign Currency Exchange Rates

For the three and six-month periods ended June 30, 2022, changes in foreign currency exchange rates had negative effects of 5.0 percent and 4.0 percent, respectively, on year-over-year sales. If foreign currency exchange rates remain at levels consistent with recent rates, we estimate there will be a negative impact of approximately 5.0 percent on full-year 2022 sales.

Geography

The 1.3 percent and 3.5 percent net sales growth in the U.S. in the three and six-month periods ended June 30, 2022, respectively, was driven by recovery in surgical procedures as COVID-19 cases subsided, especially in the Knees and Hips categories. Internationally, net sales grew by 0.7 percent and 1.0 percent during the three and six-month periods ended June 30, 2022, respectively. This growth was despite the negative impacts on International sales of 11.5 percent and 9.2 percent in the three and six-month periods ended June 30, 2022, respectively, due to changes in foreign currency exchange rates. The International net sales growth was across most of our markets.

Product Categories

Knees and Hips net sales grew 5.9 percent and 2.7 percent, respectively, in the three-month period ended June 30, 2022, respectively, when compared to the same prior year period. In the six-month period ended June 30, 2022, Knees and Hips net sales grew 6.9 percent and 1.8 percent, respectively, when compared to the same prior year period. The net sales increases were due to the recovery in elective surgical procedures and new product introductions. Knees net sales were negatively affected by 5.3 percent and 4.2 percent in the three and six-month periods ended June 30, 2022, respectively, due to changes in foreign currency exchange rates. Hips net sales were negatively affected by 5.9 percent and 4.8 percent in the three and six-month periods ended June 30, 2022, respectively, due to changes in foreign currency exchange rates. S.E.T. net sales declines were due to the negative effects of changes in foreign currency exchange rates and some declines in certain product subcategories.

Expenses as a Percentage of Net Sales

The increase in cost of products sold as a percentage of net sales for the three-month period ended June 30, 2022 compared to the same prior year period was primarily due to inflationary cost pressures and lower average selling prices. These unfavorable items were partially offset by hedge gains recognized in the current year period as part of our hedging program compared to hedge losses in the prior year period.

The increase in cost of products sold as a percentage of net sales for the six-month period ended June 30, 2022 compared to the same prior year period was primarily due to higher excess and obsolete inventory charges, inflationary cost pressures and lower average selling prices. These unfavorable items were partially offset by hedge gains recognized in the current year period as part of our hedging program compared to hedge losses in the prior year period.

Intangible asset amortization expense was similar in both amount and as a percentage of net sales in the three and six-month periods ended June 30, 2022 when compared to the same prior year periods.

R&D expenses decreased in both amount and as a percentage of net sales in the three and six-month periods ended June 30, 2022 compared to the same prior year periods. In the prior year periods, we entered into certain agreements to gain access to or acquire third-party IPR&D projects that resulted in charges of $65.0 million. We did not enter into any similar agreements in the current year periods.

Selling, general and administrative (“SG&A”) expenses decreased slightly in the three-month period ended June 30, 2022 and increased in the six-month period ended June 30, 2022 when compared to the same prior year periods. The decline in the three-month period ended June 30, 2022 was a result of savings from our 2021 Restructuring Plan. The increase in the six-month period ended June 30, 2022 was primarily due to higher litigation-related charges of $35.7 million in the 2022 period compared to $10.7 million in

the 2021 period, increased bad debt charges primarily caused by the Russia/Ukraine conflict, and higher travel and medical training and education costs in the 2022 period as certain activities have resumed. These unfavorable expenses were partially offset by savings from our 2021 Restructuring Plan. SG&A expenses as a percentage of net sales declined in the three and six-month periods ended June 30, 2022 when compared to the same prior year periods due to controlled spending and fixed costs while net sales increased.

As a result of the invasion of Ukraine by Russia, economic sanctions and export controls were imposed by much of the world on Russian financial institutions and businesses. Our operations in Russia consist primarily of local commercial activities, including sales and customer support. We do not have direct operations in Ukraine. Our net sales in Russia and Ukraine for the year ended December 31, 2021 and three and six-month periods ended June 30, 2022 were less than 1 percent of our consolidated net sales. Therefore, the ongoing conflict and economic sanctions are not expected to have a significant effect on our results of operations or financial position. The bad debt charges for expected credit losses in Russia and Ukraine resulted in a significant portion of our accounts receivable from customers in these countries being impaired. In addition to accounts receivable, we also have inventory and instruments that could require impairment if our business in Russia deteriorates more than our current expectations; however, any such amounts are not expected to be material. See Part II, Item 1A “Risk Factors” for additional risks related to this conflict.

In December of 2021 and 2019, we initiated restructuring programs. The December 2021 restructuring program is intended to reorganize our operations due to the spinoff of ZimVie with an objective of reducing costs. The December 2019 restructuring program has an objective of reducing costs to allow us to invest in higher priority growth opportunities. We recognized expenses of $57.0 million and $18.8 million in the three-month periods ended June 30, 2022 and 2021, respectively, and $100.9 million and $40.1 million in the six-month periods ended June 30, 2022 and 2021, respectively, primarily related to employee termination benefits, sales agent contract terminations, and consulting and project management expenses associated with these programs. The expenses were higher in the 2022 period due to additional expenses from the December 2021 restructuring program that had just been initiated. For more information regarding these charges, see Note 5 to our interim condensed consolidated financial statements included in Part I, Item 1 of this report.

We continue to incur quality remediation expenses to complete our remediation milestones that address inspectional observations on Form 483 and a Warning Letter issued by the FDA at our Warsaw North Campus facility, among other matters.

Acquisition, integration, divestiture and related declined in the three and six-month periods ended June 30, 2022 when compared to the same prior year periods primarily due to a reduction in contingent consideration liabilities from previous acquisitions.

Other (Expense) Income, Net, Interest Expense, Net, and Income Taxes

In the three-month period ended June 30, 2022 we incurred a loss of $42.6 million in our other (expense) income, net financial statement line item compared to a gain of $8.0 million in the same prior year period. The loss was primarily due to a $33.3 million loss on our investment in ZimVie. In the six-month period ended June 30, 2022 we incurred a loss of $98.7 million in our other (expense) income, net financial statement line item compared to a gain of $15.7 million in the same prior year period. The loss was primarily due to a $84.3 million loss on our investment in ZimVie.

Interest expense, net, decreased in the three and six-month periods ended June 30, 2022 when compared to the same prior year periods. The declines were primarily from using debt that we issued in the fourth quarter of 2021, along with cash on hand, to repurchase portions of outstanding notes with higher interest rates. Additionally, interest expense, net was lower due to additional debt paydown.

In the three and six-month periods ended June 30, 2022, our effective tax rate (“ETR”) was 22.8 percent and 24.5 percent, respectively, compared to 18.7 percent and 13.9 percent in the three and six-month periods ended June 30, 2021, respectively. The 22.8 percent and 24.5 percent ETR in the three and six-month periods ended June 30, 2022, respectively, was primarily driven by the loss on our investment in ZimVie which is not deductible for tax purposes. The 18.7 percent ETR in the three-month period ended June 30, 2021, was primarily due to our mix of earnings between U.S. and foreign locations. The 13.9 percent ETR in the six-month period ended June 30, 2021, was the result of favorable discrete adjustments from the filing of Swiss tax returns and an excess tax benefit related to stock-based compensation. Absent discrete tax events, we expect our future ETR will be lower than the U.S. corporate income tax rate of 21.0 percent due to our mix of earnings between U.S. and foreign locations, which have lower corporate income tax rates. Our ETR in future periods could also potentially be impacted by: changes in our mix of pre-tax earnings; changes in tax rates, tax laws or their interpretation; the outcome of various federal, state and foreign audits; and the expiration of certain statutes of limitations. Currently, we cannot reasonably estimate the impact of these items on our financial results.

Segment Operating Profit

All of our operating segments’ operating profit as a percentage of net sales increased in the three and six-month periods ended June 30, 2022, when compared to the same prior year periods. In the Americas and EMEA, the increases to operating profit as a percentage of net sales were driven by higher net sales and savings from our restructuring programs. In Asia Pacific, despite declines in net sales we were able to increase our operating profit as a percentage of net sales as the net sales declines were driven by the negative effects of changes in foreign currency exchange rates. In EMEA and Asia Pacific, net sales were negatively affected by changes in foreign currency exchange rates, but due to our hedging program these segments recognized hedge gains, which minimized the negative effects on segment operating profit. In Asia Pacific, despite the increase in operating profit as a percentage of net sales in the six-month period ended June 30, 2022 when compared to the same prior year period, overall operating profit in the 2022 period declined. The Asia Pacific decline in operating profit in the six-month period ended June 30, 2022 was primarily driven by China experiencing lockdowns in the first quarter and from the China government implementing a nationwide volume-based procurement process.

Liquidity and Capital Resources

As of June 30, 2022, we had $386.4 million in cash and cash equivalents. In addition, we had $1.0 billion available to borrow under our 2021 364-Day Credit Agreement that matures on August 19, 2022, and $1.5 billion available under our 2021 Five-Year Revolving Facility that matures on August 20, 2026. The terms of the 2021 364-Day Credit Agreement and the 2021 Five-Year Revolving Facility are described further in Note 9 to our interim condensed consolidated financial statements included in Part I, Item 1 of this report. We intend to enter into a similar 364-day revolving facility in August 2022.

We believe that cash flows from operations, our cash and cash equivalents on hand, and available borrowings under our revolving credit facilities will be sufficient to meet our ongoing liquidity requirements for at least the next twelve months. At this time, we do not anticipate needing to borrow further against our revolving credit facilities to fund our operations. However, due to the continued uncertainties related to the COVID-19 pandemic, it is possible our needs may change. Further, there can be no assurance that, if needed, we will be able to secure additional financing on terms favorable to us, if at all.

Sources of Liquidity

Cash flows provided by operating activities from continuing operations were $661.2 million in the six-month period ended June 30, 2022, compared to $642.5 million in the same prior year period. The increase in the 2022 period was driven by lower investments in inventory when compared to the 2021 period as well as the 2021 period included payments related to certain IPR&D agreements. These favorable cash flows were partially offset by increased payments under our restructuring programs in the six-month period ended June 30, 2022 when compared to the same prior year period.

Cash flows used in investing activities from continuing operations were $324.3 million in the six-month period ended June 30, 2022, compared to $207.0 million in the same prior year period. Instrument and property, plant and equipment additions reflected ongoing investments in our product portfolio, optimization of our manufacturing and logistics networks and investments in enterprise resource planning software. The six-month period ended June 30, 2022 also reflects investments for an acquisition as well as other investments for acquiring intellectual property related to products that have been commercialized.

Cash flows used in financing activities from continuing operations were $268.4 million in the six-month period ended June 30, 2022, compared to $224.1 million in the same prior year period. At the ZimVie spinoff date, we received $540.6 million as partial consideration for the contribution of assets in connection with the separation. We used these proceeds, together with borrowings on our 2021 Five-Year Revolving Facility and cash on hand to redeem the full $750.0 million on senior notes that were due April 1, 2022. We subsequently repaid all borrowings under the 2021 Five-Year Revolving Facility. In the 2021 period, we paid the remaining $200.0 million on our floating rate notes due 2021 which matured in the period.

We place our cash and cash equivalents in highly-rated financial institutions and limit the amount of credit exposure to any one entity. We invest only in high-quality financial instruments in accordance with our internal investment policy.

As of June 30, 2022, $304.0 million of our cash and cash equivalents were held in jurisdictions outside of the U.S. Of this amount, $25.6 million is denominated in U.S. Dollars and, therefore, bears no foreign currency translation risk. The balance of these assets is denominated in currencies of the various countries where we operate. We intend to repatriate $5.0 to $6.0 billion of unremitted earnings in future years.

Our concentrations of credit risks with respect to trade accounts receivable are limited due to the large number of customers and their dispersion across a number of geographic areas and by frequent monitoring of the creditworthiness of the customers to whom credit is granted in the normal course of business. Substantially all of our trade receivables are concentrated in the public and private hospital and healthcare industry in the U.S. and internationally or with distributors or dealers who operate in international markets and, accordingly, are exposed to their respective business, economic and country-specific variables. We have continued to collect on outstanding receivables throughout the pandemic. However, we are closely monitoring the financial stability of our customers and the country-specific risks, including those customers in markets with hospitals sponsored by the government.

Material Cash Requirements from Known Contractual and Other Obligations

At June 30, 2022, we had outstanding debt of $6,023.9 million, of which $851.9 million was classified as current debt. Of our current debt, $242.9 million of Japanese Yen denominated term loans mature on September 27, 2022, $522.7 million of Euro denominated senior notes mature on December 13, 2022 and $86.3 million of senior notes mature on March 19, 2023. We believe we can satisfy these debt obligations with cash generated from our operations, with cash received from selling a portion or all of our shares of ZimVie common stock, by issuing new debt, and/or by borrowing on our revolving credit facilities.

For additional information on our debt, including types of debt, maturity dates, interest rates, debt covenants and available revolving credit facilities, see Note 9 to our interim condensed consolidated financial statements included in Part I, Item 1 of this report.

In February and May 2022, our Board of Directors declared a quarterly cash dividend of $0.24 per share. We expect to continue paying cash dividends on a quarterly basis; however, future dividends are subject to approval of the Board of Directors and may be adjusted as business needs or market conditions change.

In February 2016, our Board of Directors authorized a new $1.0 billion share repurchase program effective March 1, 2016, with no expiration date. As of June 30, 2022, all $1.0 billion remained authorized.

As discussed in Note 5 to our interim condensed consolidated financial statements in Part I, Item 1 of this report, we have a 2021 Restructuring Plan and a 2019 Restructuring Plan. The 2021 Restructuring Plan is expected to result in total pre-tax restructuring charges of approximately $230 million, of which approximately $100 million was incurred through June 30, 2022. We expect to reduce gross annual pre-tax operating expenses by approximately $210 million relative to the 2021 baseline expenses by the end of 2024 as program benefits under the 2021 Restructuring Plan are realized. The 2019 Restructuring Plan is expected to result in total pre-tax restructuring charges of approximately $335 million to $385 million, of which approximately $230 million was incurred through June 30, 2022. We expect to reduce gross annual pre-tax operating expenses by approximately $180 million to $280 million relative to the 2019 baseline expenses by the end of 2023 as program benefits under the 2019 Restructuring Plan are realized.

As discussed in Note 13 to our interim condensed consolidated financial statements included in Part I, Item 1 of this report, the IRS has issued proposed adjustments for years 2010 through 2012, as well as proposed adjustments for years 2013 through 2015, reallocating profits between certain of our U.S. and foreign subsidiaries. We have disputed these proposed adjustments and intend to continue to vigorously defend our positions. Although the ultimate timing for resolution of the disputed tax issues is uncertain, future payments may be significant to our operating cash flows.

As discussed in Note 16 to our interim condensed consolidated financial statements included in Part I, Item 1 of this report, we are involved in various litigation matters. We estimate the total liabilities for all litigation matters was $395.8 million as of June 30,

2022. However, litigation is inherently uncertain, and upon resolution of any of these uncertainties, we may incur charges in excess of these estimates, and may in the future incur other material judgments or enter into other material settlements of claims. We expect to pay these liabilities over the next few years. Additionally, we have entered into development, distribution and other contractual arrangements that may result in future payments dependent upon various events such as the achievement of certain product R&D milestones, sales milestones, or, at our discretion, maintenance of exclusive rights to distribute a product. Since there is uncertainty on the timing or whether such payments will have to be made, they have not been recognized on our condensed consolidated balance sheets. These estimated payments could range from $0 to approximately $370 million.

Recent Accounting Pronouncements

Information pertaining to recent accounting pronouncements can be found in Note 3 to our interim condensed consolidated financial statements included in Part I, Item 1 of this report.

Critical Accounting Estimates

The preparation of our financial statements is affected by the selection and application of accounting policies and methods, and also requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Critical accounting estimates are those that involve a significant level of estimation uncertainty and have had or are reasonably likely to have a material impact on our financial condition and results of operations. There were no changes in the three-month period ended June 30, 2022 to our critical accounting estimates as described in our Annual Report on Form 10-K for the year ended December 31, 2021.

Cautionary Note Regarding Forward-Looking Statements and Factors That May Affect Future Results

This quarterly report contains certain statements that are forward-looking statements within the meaning of federal securities laws. Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts. When used in this report, the words “may,” “will,” “can,” “should,” “would,” “could,” “anticipate,” “expect,” “plan,” “seek,” “believe,” “are confident that,” “look forward to,” “predict,” “estimate,” “potential,” “project,” “target,” “forecast,” “see,” “intend,” “design,” “strive,” “strategy,” “future,” “opportunity,” “assume,” “guide,” “position,” “continue” and similar expressions are intended to identify forward-looking statements. Forward-looking statements are based on current beliefs, expectations and assumptions that are subject to significant risks, uncertainties and changes in circumstances that could cause actual results to differ materially from such forward-looking statements. 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 emergence of new pandemic variants, and 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 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 FDA, while continuing to satisfy the demand for our products;

the risks and uncertainties associated with the spinoff of ZimVie Inc., including, without limitation, the tax-free nature of the transaction, the tax-efficient nature of any subsequent disposal 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, and future growth and other opportunities will not be realized within the expected time periods or at all;

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 and regulatory 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 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, especially of titanium used in our products, 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 cyber-attack, 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;

the effects of inflation, including the effects of different rates of inflation in different countries, on our costs and the costs of our products;

the effects of supply chain continuity disruptions;

and the impact of the ongoing financial and political uncertainty on countries in EMEA relating to the Russian-Ukrainian crisis and otherwise, on the ability to collect accounts receivable in affected countries.

Our Annual Report on Form 10-K for the year ended December 31, 2021 and this Quarterly Report on Form 10-Q contain detailed discussions of these and other important factors under the heading “Risk Factors.” You should understand that it is not possible to predict or identify all factors that could cause actual results to differ materially from forward-looking statements. Consequently, you should not consider any list or discussion of such factors to be a complete set of all potential risks or uncertainties.

Forward-looking statements speak only as of the date they are made and we expressly disclaim any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Readers of this report are cautioned not to rely on these forward-looking statements since there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this report.

There have been no material changes from the information provided in our Annual Report on Form 10-K for the year ended December 31, 2021.

Evaluation of Disclosure Controls and Procedures. We maintain disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (“Exchange Act”)) that are designed to provide reasonable assurance that information required to be disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosures. Because of inherent limitations, disclosure controls and procedures, no matter how well designed and operated, can provide only reasonable, and not absolute, assurance that the objectives of disclosure controls and procedures are met.

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this report. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of the end of the period covered by this report, our disclosure controls and procedures were effective at a reasonable assurance level.

Changes in Internal Control Over Financial Reporting. There were no changes in our internal control over financial reporting that occurred during the quarter ended June 30, 2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Part II – Oth****er Information

Item 1. Legal Proceedings

Information pertaining to legal proceedings can be found in Note 16 to our interim condensed consolidated financial statements included in Part I, Item 1 of this report and is incorporated herein by reference.

You should carefully consider the factors discussed in Part I, Item 1A “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2021 (“2021 Form 10-K”) and the factors discussed below, which could materially affect our business, financial condition and results of operations. Except as set forth below, there have been no material changes in those risk factors. The risks described in our 2021 Form 10-K and below are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition or results of operations. In addition, the COVID-19 pandemic could exacerbate or trigger other risks discussed in our 2021 Form 10-K and below, any of which could materially affect our business, financial condition and results of operations.

The risk factor in our 2021 Form 10-K entitled “We conduct a significant amount of our sales activity outside of the U.S., which subjects us to additional business risks and may cause our profitability to decline due to increased costs” is replaced in its entirety by the following:

We conduct a significant amount of our sales activity outside of the U.S., which subjects us to additional business risks and may cause our profitability to decline due to increased costs.

We sell our products in more than 100 countries and derived approximately 40 percent of our net sales in 2021 from outside the U.S. We intend to continue to pursue growth opportunities in sales internationally, including in emerging markets, which could expose us to additional risks associated with international sales and operations. Our international operations are, and will continue to be, subject to a number of risks and potential costs, including:

changes in foreign medical reimbursement policies and programs;

changes in foreign regulatory requirements, such as more stringent requirements for regulatory clearance of products;

differing local product preferences and product requirements;

fluctuations in foreign currency exchange rates;

the effects of inflation, including the effects of different rates of inflation in different countries, on our costs and the costs of our products;

diminished protection of intellectual property in some countries outside of the U.S.;

trade protection measures, import or export requirements, new or increased tariffs, trade embargoes and sanctions and other trade barriers, which may prevent us from shipping products to a particular market, restrict our access to certain sources of raw materials, increase our operating costs and disrupt our ability to collect payment for our products and services in particular markets;

foreign exchange controls that might prevent us from repatriating cash earned in countries outside the U.S.;

complex data privacy and cybersecurity requirements and labor relations laws;

extraterritorial effects of U.S. laws such as the FCPA;

effects of foreign anti-corruption laws, such as the UK Bribery Act;

difficulty in staffing and managing foreign operations;

labor force instability;

potentially negative consequences from changes in tax laws; and

political, social and economic instability and uncertainty, including wars, other conflict and sovereign debt issues.

Violations of foreign laws or regulations could result in fines, criminal sanctions against us, our officers or our employees, prohibitions on the conduct of our business and damage to our reputation.

Wars and other conflicts may increase certain of these risks and may adversely affect our business and financial performance. 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. Sanctions, and other civil, political and economic effects of the Russia-Ukraine crisis, may have adverse impacts globally, including supply chain continuity disruption; inflationary pressures and increased costs of raw materials and inputs, especially titanium used in our products; manufacturing or shipping delays; increased shipping costs; 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 the conflict’s current scope could adversely affect our result of operations.

Item 2. Unregistered Sales of Equi****ty Securities and Use of Proceeds

None

Item 3. Defaults Upo****n Senior Securities

None

Item 4. Mine Saf****ety Disclosures

Not applicable

During the three-month period ended June 30, 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. This disclosure is made pursuant to Section 10A(i)(2) of the Exchange Act, as added by Section 202 of the Sarbanes-Oxley Act of 2002.

The following exhibits are filed or furnished as part of this report:

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.