UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number:
(Exact Name of Registrant as Specified in its Charter)
( State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer |
(Address of principal executive offices) |
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Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
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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.
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).
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.
Large accelerated filer |
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Emerging growth company |
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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
The number of shares of the Registrant’s Common Stock outstanding as of April 28, 2023 was
ZIMVIE INC.
QUARTERLY REPORT
Cautionary Note Regarding Forward-Looking Statements
This Quarterly Report contains forward-looking statements within the meaning of federal securities laws, including, among others, any statements about our expectations, plans, intentions, strategies or prospects. We generally use the words “may,” “will,” “expects,” “believes,” “anticipates,” “plans,” “estimates,” “projects,” “assumes,” “guides,” “targets,” “forecasts,” “sees,” “seeks,” “should,” “could,” “would,” “predicts,” “potential,” “strategy,” “future,” “opportunity,” “work toward,” “intends,” “guidance,” “confidence,” “positioned,” “design,” “strive,” “continue,” “track,” “look forward to” and similar expressions to identify forward-looking statements. All statements other than statements of historical or current fact are, or may be deemed to be, forward-looking statements. Such statements are based upon the current beliefs, expectations and assumptions of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially from the 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 procedures and our ability to collect accounts receivable; 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; pricing pressures from competitors, customers, dental practices and insurance providers; changes in customer demand for our products and services caused by demographic changes or other factors; challenges relating to changes in and compliance with governmental laws and regulations affecting our United States (“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; competition; the impact of healthcare reform measures; reductions in reimbursement levels by third-party payors; cost containment efforts sponsored by government agencies, legislative bodies, the private sector and healthcare group purchasing organizations, including the volume-based procurement process in China; control of costs and expenses; dependence on a limited number of suppliers for key raw materials and outsourced activities; 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 retain the independent agents and distributors who market our products; our ability to attract, retain and develop the highly skilled employees we need to support our business; the effect of mergers and acquisitions on our relationships with customers, suppliers and lenders and on our operating results and businesses generally; a determination by the Internal Revenue Service that the distribution or certain related transactions should be treated as taxable transactions; financing transactions undertaken in connection with the separation and risks associated with additional indebtedness; the impact of the separation on our businesses and the risk that the separation and the results thereof may be more difficult, time consuming and/or costly than expected, which could impact our relationships with customers, suppliers, employees and other business counterparties; restrictions on activities following the distribution in order to preserve the tax-free treatment of the distribution; the ability to form and implement alliances; changes in tax obligations arising from tax reform measures, including European Union (“EU”) 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 inflation and interest rate and currency exchange rate fluctuations; and the impact of the ongoing financial and political uncertainty on countries in the Euro zone on the ability to collect accounts receivable in affected countries.
See also Part I, Item 1A, “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2022 for further discussion of certain risks and uncertainties that could cause actual results and events to differ materially from the forward-looking statements. 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. Forward-looking statements speak only as of the date they are made, and we expressly disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For additional information concerning factors that may cause actual results to vary materially from those stated in the forward-looking statements, see our reports on Form 10-K, 10-Q and 8-K filed with the U.S. Securities and Exchange Commission (the “SEC”) from time to time.
i
Table of Contents
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Page |
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PART I. |
3 |
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Item 1. |
3 |
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3 |
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Condensed Consolidated Statements of Comprehensive Income (Loss) |
3 |
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4 |
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5 |
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6 |
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Notes to Unaudited Condensed Consolidated Financial Statements |
7 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
18 |
Item 3. |
22 |
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Item 4. |
23 |
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PART II. |
24 |
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Item 1. |
24 |
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Item 1A. |
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Item 6. |
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ii
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements.
ZIMVIE INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
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For the Three Months Ended March 31, |
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2023 |
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2022 |
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Net Sales |
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Third party, net |
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$ |
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$ |
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Related party, net |
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Total Net Sales |
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Cost of products sold, excluding intangible asset amortization |
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Related party cost of products sold, excluding intangible asset amortization |
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Intangible asset amortization |
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Research and development |
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Selling, general and administrative |
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Restructuring and other cost reduction initiatives |
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Acquisition, integration, divestiture and related |
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Operating Expenses |
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Operating Loss |
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Other (expense) income, net |
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Interest expense, net |
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( |
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Loss Before Income Taxes |
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( |
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Income tax (expense) benefit |
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( |
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Net Loss |
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$ |
( |
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$ |
( |
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Net Loss Per Common Share - Basic |
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$ |
( |
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$ |
( |
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Net Loss Per Common Share - Diluted |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
ZIMVIE INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(in thousands)
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For the Three Months Ended March 31, |
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2023 |
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2022 |
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Net Loss |
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$ |
( |
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$ |
( |
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Other Comprehensive Income (Loss): |
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Foreign currency cumulative translation adjustments, net of tax |
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( |
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Total Other Comprehensive Income (Loss) |
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( |
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Comprehensive Loss |
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$ |
( |
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$ |
( |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
3
ZIMVIE INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except per share data)
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March 31, 2023 |
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December 31, 2022 |
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ASSETS |
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Current Assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Accounts receivable, net of allowance for credit losses of $ |
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Related party receivable |
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Inventories |
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Prepaid expenses and other current assets |
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Total Current Assets |
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Property, plant and equipment, net of accumulated depreciation of $ |
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Goodwill |
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Intangible assets, net |
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Other assets |
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Total Assets |
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$ |
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$ |
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LIABILITIES AND EQUITY |
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Current Liabilities: |
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Accounts payable |
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$ |
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$ |
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Related party payable |
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Income taxes payable |
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Other current liabilities |
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Total Current Liabilities |
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Deferred income taxes |
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Lease liability |
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Other long-term liabilities |
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Non-current portion of debt |
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Total Liabilities |
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Stockholders' Equity: |
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Common stock, $ |
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Preferred stock, $ |
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Additional paid in capital |
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Accumulated deficit |
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( |
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( |
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Accumulated other comprehensive loss |
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( |
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( |
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Total Stockholders' Equity |
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Total Liabilities and Stockholders' Equity |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
4
ZIMVIE INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands)
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Accumulated |
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Additional |
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Net Parent |
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Other |
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Common |
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Paid-In |
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Accumulated |
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Company |
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Comprehensive |
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Total |
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Stock |
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Capital |
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Deficit |
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Investment |
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(Loss) Income |
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Equity |
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Balance December 31, 2022 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
( |
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$ |
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Net loss |
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( |
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( |
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Stock activity under stock plans |
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( |
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( |
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Share-based compensation expense |
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Other comprehensive income |
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Balance March 31, 2023 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
( |
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$ |
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Accumulated |
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Additional |
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Net Parent |
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Other |
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Common |
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Paid-In |
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Accumulated |
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Company |
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Comprehensive |
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Total |
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Stock |
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Capital |
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Deficit |
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Investment |
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Loss |
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Equity |
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Balance December 31, 2021 |
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$ |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
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Net loss |
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( |
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( |
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( |
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Net transactions with Zimmer Biomet Holdings, Inc., including separation adjustments |
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( |
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( |
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Net consideration paid to Zimmer Biomet Holdings, Inc. in connection with distribution |
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( |
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( |
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Reclassification of net parent company investment to additional paid-in capital |
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( |
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Stock activity under stock plans |
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( |
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Share-based compensation expense |
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Other comprehensive loss |
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( |
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( |
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Balance March 31, 2022 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
( |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
5
ZIMVIE INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
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For the Three Months Ended March 31, |
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2023 |
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2022 |
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Cash flows used in operating activities: |
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Net loss |
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$ |
( |
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$ |
( |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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Share-based compensation |
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Deferred income tax provision |
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( |
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( |
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Other non-cash items |
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Changes in operating assets and liabilities |
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Income taxes |
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Accounts receivable |
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( |
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( |
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Related party receivable |
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( |
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Inventories |
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Prepaid expenses and other current assets |
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( |
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Accounts payable and accrued liabilities |
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( |
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( |
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Related party payable |
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( |
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Other assets and liabilities |
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( |
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( |
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Net cash used in operating activities |
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( |
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( |
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Cash flows used in investing activities: |
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Additions to instruments |
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( |
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( |
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Additions to other property, plant and equipment |
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( |
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( |
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Other investing activities |
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( |
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( |
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Net cash used in investing activities |
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( |
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( |
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Cash flows (used in) provided by financing activities: |
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Net transactions with Zimmer Biomet |
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Dividend paid to Zimmer Biomet |
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Proceeds from term loans |
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Payments on term loans |
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Debt issuance costs |
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( |
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Payments related to tax withholding for share-based compensation |
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( |
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( |
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Proceeds from stock option activity |
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Net cash (used in) provided by financing activities |
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( |
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Effect of exchange rates on cash and cash equivalents |
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( |
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(Decrease) increase in cash and cash equivalents |
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( |
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Cash and cash equivalents, beginning of year |
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Cash and cash equivalents, end of period |
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$ |
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$ |
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Supplemental cash flow information: |
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Income taxes paid, net |
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$ |
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$ |
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Interest paid |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
6
ZIMVIE INC.
Notes to Unaudited Condensed Consolidated Financial Statements
1. Background, Nature of Business and Basis of Presentation
Background
On March 1, 2022, ZimVie Inc. ("ZimVie," "we," "us" and "our") and Zimmer Biomet Holdings, Inc. ("Zimmer Biomet" or "Parent") entered into a Separation and Distribution Agreement (the "Separation Agreement"), pursuant to which Zimmer Biomet agreed to spin off its dental and spine businesses into ZimVie, a new, publicly traded company. Zimmer Biomet effected the separation through a pro rata distribution of
Nature of Business
ZimVie is a leading medical technology company dedicated to enhancing the quality of life for dental and spine patients worldwide. We develop, manufacture and market a comprehensive portfolio of products and solutions designed to support dental tooth replacement and restoration procedures and treat a wide range of spine pathologies. We are well-positioned in the growing global dental implant, biomaterials and digital dentistry market with a strong presence in the tooth replacement market with market leading positions in certain geographies. Our broad portfolio also addresses all areas of spine with market leadership in cervical disc replacement and vertebral body tethering to treat pediatric scoliosis. Our operations are principally managed on a products basis and include
In the dental products market, our core services include designing, manufacturing and distributing dental implant solutions. Dental reconstructive implants are for individuals who are totally without teeth or are missing one or more teeth, dental prosthetic products are aimed at providing a more natural restoration to resemble the original teeth, and dental regenerative products are for soft tissue and bone rehabilitation. Our key products include the T3® Implant, Tapered Screw-Vent Implant System, Trabecular Metal™ Dental Implant, BellaTek Encode Impression System, and Puros Allograft Particulate.
In the spine products market, our core services include designing, manufacturing and distributing medical devices and surgical instruments to deliver comprehensive solutions for individuals with back or neck pain caused by degenerative conditions, deformities or traumatic injury of the spine. We also provide devices that promote bone healing. Other differentiated products in our spine portfolio include Mobi-C® Cervical Disc, a motion-preserving alternative to fusion for patients with cervical disc disease, and The Tether™, a novel non-fusion device for treatment of pediatric scoliosis.
Basis of Presentation
Prior to March 1, 2022, we existed and functioned as part of the consolidated business of Zimmer Biomet. The accompanying condensed consolidated financial statements are prepared on a standalone basis and, for periods prior to March 1, 2022, were prepared on a carveout basis from Zimmer Biomet’s consolidated financial statements and accounting records, and, accordingly, may not be indicative of the financial position, results of operations or cash flows had we operated as a standalone company during those periods, or comparable to our financial position subsequent to March 1, 2022.
On March 1, 2022, ZimVie became a standalone publicly traded company, and our financial statements are now presented on a consolidated basis. The unaudited financial statements for all periods presented, including our historical results prior to March 1, 2022, are now referred to as "Condensed Consolidated Financial Statements," and have been prepared pursuant to the rules and regulations for reporting on Form 10-Q. Accordingly, certain information and disclosures required by U.S. generally accepted accounting principles ("GAAP") for complete consolidated financial statements are not included herein. In our opinion, all adjustments necessary for a fair statement of these interim statements have been included and are of a normal and recurring nature. These interim statements should be read in conjunction with the audited financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2022 ("Annual Report"). The results of operations of any interim period are not necessarily indicative of the results of operations for the full year.
7
Prior to the distribution, our equity balance in these condensed consolidated financial statements represented the excess of total assets over liabilities including the due to/from balances between us and Zimmer Biomet (referred to as "net parent investment" or "NPI") and accumulated other comprehensive income (loss). NPI was primarily impacted by contributions from Zimmer Biomet that were the result of treasury activities and net funding provided by or distributed to Zimmer Biomet.
Following the distribution, certain functions that Zimmer Biomet provided to us prior to the distribution either continue to be provided to us by Zimmer Biomet under a transition services agreement or are being performed using our own resources or third-party service providers. Additionally, under manufacturing and supply agreements, we manufacture certain products for Zimmer Biomet and Zimmer Biomet manufactures certain products for us. We have incurred, and expect to continue to incur, certain costs to establish ourselves as a standalone public company, as well as ongoing additional costs associated with operating as an independent, publicly traded company.
As of each of March 31, 2023 and December 31, 2022, we had $
Accounting Pronouncements Recently Issued
There are no recently issued accounting pronouncements that we have not yet adopted that are expected to have a material effect on our financial position, results of operations or cash flows.
2
The following table summarizes the changes in the carrying amount of goodwill by historical reportable segment (in thousands):
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Dental |
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Spine |
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Total |
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|||
Balance at December 31, 2022 |
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Goodwill, Gross |
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$ |
|
|
$ |
|
|
$ |
|
|||
Accumulated impairment losses |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Goodwill, Net |
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|||
Currency translation |
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Balance at March 31, 2023 |
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Goodwill, Gross |
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|
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|
|||
Accumulated impairment losses |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Goodwill, Net |
|
$ |
|
|
$ |
|
|
$ |
|
|||
The components of identifiable intangible assets were as follows (in thousands):
|
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Technology |
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Trademarks |
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Customer Relationships |
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Other |
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Total |
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As of December 31, 2022: |
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Intangible assets subject to amortization: |
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|||||
Gross carrying amount |
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$ |
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|
$ |
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|
$ |
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|
$ |
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$ |
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|||||
Accumulated amortization |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Total identifiable intangible assets |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
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|||||
As of March 31, 2023: |
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Intangible assets subject to amortization: |
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|||||
Gross carrying amount |
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$ |
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$ |
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$ |
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$ |
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$ |
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|||||
Accumulated amortization |
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|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Total identifiable intangible assets |
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$ |
|
|
$ |
|
|
$ |
|
|
$ |
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|
$ |
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8
Estimated annual amortization expense for the years ending December 31, 2023 through 2027 based on exchange rates in effect at December 31, 2022 is as follows (in millions):
For the Years Ending December 31, |
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2023 (remaining) |
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$ |
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2024 |
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2025 |
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2026 |
|
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2027 |
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Thereafter |
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Total |
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$ |
|
|
3. Share-Based Compensation
Conversion Awards
Zimmer Biomet has share-based compensation plans under which it granted stock options, restricted stock units ("RSUs") and performance-based RSUs. In connection with the distribution, ZimVie employees with outstanding Zimmer Biomet share-based awards received replacement share-based awards. The ratio used to convert the Zimmer Biomet share-based awards was designed to preserve the aggregate intrinsic value of the award immediately after the distribution when compared to the aggregate intrinsic value of the award immediately prior to the distribution. Outstanding RSUs and performance-based RSUs were converted into
ZimVie Awards
Effective March 1, 2022, ZimVie established the ZimVie Inc. 2022 Stock Incentive Plan (the "2022 Plan"). A total of
For periods prior to the distribution, we specifically identified employees who were associated with our historical operations and calculated expense based upon the awards received under the Zimmer Biomet plans, as well as expense related to corporate or shared employees allocated to us on a proportional cost allocation method, primarily based on revenue.
Share-based compensation expense was as follows (in thousands):
|
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For the Three Months Ended March 31, |
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2023 |
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2022 |
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Share-based compensation expense recognized in: |
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Cost of products sold, excluding intangible asset amortization |
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$ |
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$ |
|
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Research and development |
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Selling, general and administrative |
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Tax benefit related to awards |
|
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( |
) |
|
|
( |
) |
Total expense, net of tax |
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$ |
|
|
$ |
|
||
We use a Black-Scholes option-pricing model to determine the fair value of our stock options. For new awards granted after the distribution: expected volatility of
9
expected term of the stock options of
Stock option activity was as follows:
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Period Ended March 31, 2023 |
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Weighted |
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Weighted Average |
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Average |
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Remaining |
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Aggregate |
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Number of |
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Exercise |
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Contractual |
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Intrinsic |
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Stock Options |
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Price |
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Life (Years) |
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Value (in Millions) |
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Outstanding at December 31, 2022 |
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$ |
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Granted |
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Exercised |
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Forfeited |
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( |
) |
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Outstanding at March 31, 2023 |
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$ |
|
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$ |
|
||||
Exercisable at March 31, 2023 |
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$ |
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$ |
|
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Aggregate intrinsic value was negligible at March 31, 2023. At March 31, 2023, we had unrecognized share-based compensation cost related to unvested stock options of $
RSU activity was as follows:
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Period Ended March 31, 2023 |
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Weighted |
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Average |
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Number of |
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Grant Date |
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RSUs |
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Fair Value |
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Outstanding at December 31, 2022 |
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$ |
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Granted |
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Vested |
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( |
) |
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Forfeited |
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( |
) |
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Outstanding at March 31, 2023 |
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$ |
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At March 31, 2023, we had unrecognized share-based compensation cost related to unvested RSUs of $
4. Earnings Per Share
On March 1, 2022,
10
The calculation of weighted average shares for the basic and diluted net earnings (loss) per common share is as follows (in thousands, except per share data):
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For the Three Months Ended March 31, |
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2023 |
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2022 |
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Net loss |
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$ |
( |
) |
|
$ |
( |
) |
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Weighted Average shares outstanding for basic net loss per share |
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Effect of dilutive stock options and other equity awards (1) |
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Weighted Average shares outstanding for dilutive net loss per share |
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Basic and diluted net loss per common share |
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$ |
( |
) |
|
$ |
( |
) |
(1) Since we incurred a net loss in each of the three months ended March 31, 2023 and 2022, no dilutive stock options or other equity awards were included as diluted shares in either of those periods.
For the three months ended March 31, 2023 and 2022, a weighted average of
5. Balance Sheet Details
Inventories consisted of the following (in thousands):
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March 31, 2023 |
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|
December 31, 2022 |
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Finished goods |
|
$ |
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$ |
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Work-in-progress |
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Raw materials |
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Inventories |
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$ |
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$ |
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Amounts related to cost of products sold in the condensed consolidated statements of operations for excess and obsolete ("E&O") inventory, including certain product lines we intend to discontinue, were a benefit of $
Other current liabilities consisted of the following (in thousands):
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March 31, 2023 |
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December 31, 2022 |
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Other current liabilities: |
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|
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License and service agreements |
|
$ |
|
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$ |
|
||
Salaries, wages and benefits |
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Lease liabilities |
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Accrued liabilities |
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Total other current liabilities |
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$ |
|
|
$ |
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6. Fair Value Measurements of Assets and Liabilities
The fair value of foreign currency exchange forward contracts (see Note 8) are determined using Level 2 inputs. The carrying value of our debt (see Note 7) approximates fair value as it bears interest at floating rates. The carrying amounts of other financial instruments (i.e., cash and cash equivalents, restricted cash, bank time deposits, accounts receivable, net, and accounts payable) approximated their fair values at December 31, 2022 and March 31, 2023 due to their short-term nature.
The fair values of acquisition-related contingent payments are estimated using Level 3 inputs. Contingent payments related to acquisitions consist of sales-based payments, and are valued using discounted cash flow techniques. The fair value of sales-based payments is based upon probability-weighted future revenue estimates, and increases as revenue estimates increase. See Note 3 to our consolidated financial statements included in our Annual Report for additional information regarding contingent payments related to acquisitions.
11
The following table provides a reconciliation of the beginning and ending balances of items measured at fair value on a recurring basis that used significant unobservable inputs (Level 3) (in thousands):
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Level 3 - Liabilities |
|
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Contingent payments related to acquisitions |
|
|
|
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Balance December 31, 2022 |
|
$ |
|
|
Settlements |
|
|
( |
) |
Balance March 31, 2023 |
|
$ |
|
|
7. Debt
Our debt consisted of the following (in thousands):
|
|
March 31, 2023 |
|
|
December 31, 2022 |
|
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Term loan |
|
$ |
|
|
$ |
|
||
Debt issuance costs |
|
|
( |
) |
|
|
( |
) |
Total debt |
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|
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|
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|
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Less: current portion |
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|
|
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Total debt due after one year |
|
$ |
|
|
$ |
|
||
We entered into a Credit Agreement, dated as of December 17, 2021 (the “Credit Agreement”), with JP Morgan Chase Bank, N.A., as administrative agent and syndication agent, and the lenders and issuing banks named therein. The Credit Agreement provides for revolving loans of up to $
On March 31, 2023, we made a principal payment of $
Borrowings under the Credit Facility are collateralized by substantially all of our personal property, including intellectual property, and certain real property and we, along with our subsidiaries party to the Credit Facility, pledged our equity interests in our subsidiaries, subject to materiality thresholds and certain limitations with respect to foreign subsidiaries. The Credit Facility contains various covenants that restrict our ability to take certain actions, including incurrence of indebtedness, creation of liens, mergers or consolidations, dispositions of assets, making certain investments, prepayments or redemptions of subordinated debt, or making certain restricted payments. In addition, the Credit Facility contains financial covenants that require us to maintain a maximum consolidated total net leverage ratio of
See Note 10 to our consolidated financial statements included in our Annual Report for additional information on our Credit Agreement.
8
We enter into foreign currency exchange forward contracts with terms of to
of $
12
9. Income Taxes
Our effective tax rate (“ETR”) on loss before income taxes was (
During the three months ended March 31, 2022, income tax balances were adjusted to reflect the income tax positions after distribution, including those related to tax loss and credit carryforwards, other deferred tax assets and liabilities and valuation allowances. These separation-related adjustments resulted in a $
10. Segment Data
Net sales and operating profit (loss) by segment are as follows (in thousands):
|
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Net Sales |
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Operating Profit (Loss) |
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|
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Three Months Ended March 31, |
|
|
Three Months Ended March 31, |
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||||||||||
|
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2023 |
|
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2022 |
|
|
2023 |
|
|
2022 |
|
||||
Dental |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Spine |
|
|
|
|
|
|
|
|
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Segment Total |
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Related party transactions |
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( |
) |
|||
Expenses related to Parent products |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
Intangible asset amortization |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Restructuring and other cost reduction initiatives |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Acquisition, integration, divestiture and related |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Other |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Total |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
||
11. Commitments and Contingencies
We are subject to contingencies, such as various claims, legal proceedings and investigations regarding product liability, intellectual property, commercial and other matters that arise in the normal course of business. On a quarterly and annual basis, we review relevant information with respect to loss contingencies and update our accruals, disclosures and estimates of reasonably possible losses or ranges of loss based on such reviews. We record liabilities for loss contingencies when it is probable that a loss has been incurred and the amount can be reasonably estimated. For matters where a loss is believed to be reasonably possible, but not probable, no accrual has been made. Legal defense costs expected to be incurred in connection with a loss contingency are accrued when probable and reasonably estimable. The recorded accrual balance for loss contingencies was $
Subject to certain exceptions specified in the Separation Agreement, we assumed the liability for, and control of, all pending and threatened legal matters related to our business, including liabilities for any claims or legal proceedings related to products that had been part of our business, but were discontinued prior to the distribution, as well as assumed or retained liabilities, and will indemnify Zimmer Biomet for any liability arising out of or resulting from such assumed legal matters.
12. Related Party Transactions
Prior to the distribution, we did not operate as a standalone business and had various relationships with Zimmer Biomet whereby Zimmer Biomet provided services to us. Following the distribution, certain functions that Zimmer Biomet provided to us prior to the distribution either continue to be provided to us by Zimmer Biomet under a transition services agreement or are being performed using our own
13
resources or third-party service providers. The following disclosures summarize activities between us and Zimmer Biomet that are included in our condensed consolidated financial statements.
Prior to Distribution
Corporate Overhead and Other Allocations from Zimmer Biomet
Zimmer Biomet provided certain services, which included, but were not limited to, executive oversight, treasury, finance, legal, human resources, tax planning, internal audit, financial reporting, information technology and other corporate departments. The expenses related to these services have been allocated based on direct usage or benefit where specifically identifiable, with the remainder allocated on a proportional cost allocation method based primarily on net trade sales, as applicable. When specific identification is not practicable, a proportional cost method was used primarily based on sales.
Corporate allocations reflected in the condensed consolidated statements of operations are as follows (in thousands):
|
|
For the Three Months Ended March 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
Cost of products sold |
|
$ |
|
|
$ |
( |
) |
|
Selling, general & administrative |
|
|
|
|
|
|
||
Acquisition, integration, divestiture and related |
|
|
|
|
|
( |
) |
|
Management believes that the methods used to allocate expenses to ZimVie are a reasonable reflection of the utilization of services provided to, or the benefit derived by, ZimVie during the periods presented. However, the allocations may not necessarily reflect the condensed consolidated financial position, results of operations and cash flows in the future or what they would have been had ZimVie been a separate, standalone entity during the periods presented.
Share-Based Compensation
As discussed in Note 3, our employees participated in Zimmer Biomet’s share-based compensation plans, the costs of which were allocated and recorded in cost of products sold, R&D, and selling, general and administrative expenses in the condensed consolidated statements of operations. Share-based compensation benefit related to our employees prior to the distribution were $
In connection with the distribution, the awards held by employees were modified and resulted in incremental compensation expense as discussed in Note 3.
Centralized Cash Management
Zimmer Biomet used a centralized approach to cash management and financing of operations. The majority of our subsidiaries were party to Zimmer Biomet’s cash pooling arrangements with several financial institutions to maximize the availability of cash for general operating and investing purposes. Under these cash pooling arrangements, cash balances were swept regularly from our accounts. Cash transfers to and from Zimmer Biomet’s cash concentration accounts and the resulting balances at the end of each reporting period were reflected in NPI and net transactions with Zimmer Biomet in the condensed consolidated balance sheets and statements of cash flows, respectively.
Prior to the distribution, we borrowed $
14
Manufacturing Services to Zimmer Biomet
We have certain manufacturing facilities that also produce orthopedic products that continue to be sold by Zimmer Biomet after the separation.
|
|
For the Three Months Ended March 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
Related party net sales |
|
$ |
|
|
$ |
|
||
Related party cost of products sold, excluding intangible asset amortization |
|
|
|
|
|
|
||
We will continue to sell these products to Zimmer Biomet in future periods pursuant to a transition manufacturing and supply agreement as described below. As of February 1, 2023, Zimmer Biomet had sold all of its
Net Parent Company Investment
As discussed in Note 1, NPI is primarily impacted by contributions from Zimmer Biomet, which are the result of treasury activity and net funding provided by or distributed to Zimmer Biomet. For the three months ended March 31, 2023 and 2022, net transactions with Zimmer Biomet reflected in the cash flows pre-distribution were
For all periods prior to the distribution, transfers between ZimVie and Zimmer Biomet affiliates were recognized in Net transactions with Zimmer Biomet. In connection with the distribution, certain net assets of approximately $
After Distribution
In connection with the distribution, ZimVie entered into various agreements that govern activity between the parties, including, but not limited to, the Separation Agreement, the Transition Services Agreement, interim operating model ("IOM") agreements, the Tax Matters Agreement, the Employee Matters Agreement and transition manufacturing and supply agreements. As of February 1, 2023, Zimmer Biomet had sold all of its
The amounts due from and to Zimmer Biomet under the various agreements described below are included in related party receivable or payable, as applicable, in our condensed consolidated balance sheets as follows (in thousands):
|
|
March 31, 2023 |
|
|
December 31, 2022 |
|
||
Related party receivable |
|
$ |
|
|
$ |
|
||
Related party payable |
|
|
|
|
|
|
||
The Separation Agreement sets forth our agreements with Zimmer Biomet regarding the principal actions taken in connection with the separation and the distribution. It also sets forth other agreements that govern aspects of our relationship with Zimmer Biomet following the separation and the distribution. The Separation Agreement provides for, among other things, (i) the assets transferred, the liabilities assumed and the contracts assigned to each of us and Zimmer Biomet as part of the separation, (ii) cross-indemnities principally designed to place financial responsibility for the obligations and liabilities of the ZimVie businesses with us and financial responsibility for the obligations and liabilities of Zimmer Biomet’s remaining businesses with Zimmer Biomet, (iii) procedures with respect to claims subject to indemnification and related matters and governing our and Zimmer Biomet’s obligations and allocations of liabilities with respect to ongoing litigation matters and (iv) the allocation between us and Zimmer Biomet of rights and obligations under existing insurance policies with respect to occurrences prior to completion of the distribution.
The Separation Agreement also provides that, in order to obtain certain requisite governmental approvals, or for other business reasons, following the distribution date, Zimmer Biomet and certain of its affiliates will continue to operate certain activities relating to the ZimVie businesses in certain jurisdictions until the requisite approvals have been received or the occurrence of all other actions
15
permitting the legal transfer of such activities, and we will receive, to the greatest extent possible, all of the economic benefits and burdens of such activities.
The agreements that we entered into with Zimmer Biomet that govern aspects of ZimVie's relationship with Zimmer Biomet following the distribution include:
Transition Services Agreement - Pursuant to the Transition Services Agreement, we and Zimmer Biomet provide certain services to one another, on an interim, transitional basis following the separation and the distribution. The services provided include certain regulatory services, commercial services, operational services, tax services, clinical affairs services, information technology services, finance and accounting services and human resource and employee benefits services. The agreed-upon charges for such services are generally intended to allow the providing company to recover all costs and expenses of providing such services and are included in Selling, general and administrative expenses in our condensed consolidated statements of operations. The Transition Services Agreement terminates on the expiration of the term of the last service provided thereunder, which will generally be no later than March 31, 2025. Subject to certain exceptions in the case of willful misconduct or fraud, the liability of each of Zimmer Biomet and us under the Transition Services Agreement for the services it provides will be limited to the aggregate service fees paid to it in the immediately preceding one-year period.
Interim Operating Agreements - Zimmer Biomet and ZimVie entered into a series of IOM agreements pursuant to which Zimmer Biomet and certain of its affiliates that held licenses, permits and other rights in connection with marketing, import and/or distribution of ZimVie products in various jurisdictions prior to the distribution continue to market, import and distribute such products until such time as the relevant licenses and permits are transferred to ZimVie or its affiliates, while permitting ZimVie (or Zimmer Biomet, as applicable) to recognize revenue relating to the sale of its respective products, to the extent practicable. Under such IOM agreements and in accordance with the Separation Agreement, the relevant Zimmer Biomet entity will continue operations in the affected market on behalf of ZimVie, with ZimVie receiving all of the economic benefits and burdens of such activities. ZimVie began receiving these economic benefits as of March 1, 2022. Based on the terms of the IOM agreements, ZimVie determined it is the principal under this arrangement when: ZimVie holds all risks and rewards of ownership inclusive of risk of loss, market risk and benefits related to the inventory; ZimVie has latitude in pricing; ZimVie has the ability to direct Zimmer Biomet regarding decisions over inventory; and ZimVie is responsible for all credit and collections risks and losses associated with the related receivables. ZimVie is the principal in the majority of the IOM agreements and recognizes those sales on a gross basis. In limited jurisdictions, ZimVie is not the principal and recognizes revenue on a net basis. Upon exit of certain IOM agreements, we initially expected to pay approximately $
Tax Matters Agreement - The Tax Matters Agreement governs the respective rights, responsibilities and obligations of us and Zimmer Biomet after the distribution with respect to taxes (including taxes arising in the ordinary course of business and taxes, if any, incurred as a result of any failure of the distribution and certain related transactions to qualify as tax-free for U.S. federal income tax purposes), tax attributes, the preparation and filing of tax returns, tax elections, the control of audits and other tax proceedings and assistance and cooperation in respect of tax matters.
The Tax Matters Agreement also imposes certain restrictions on us and our subsidiaries (including, among others, restrictions on share issuances, business combinations, sales of assets and similar transactions) designed to preserve the tax-free status of the distribution and certain related transactions. The Tax Matters Agreement provides special rules that allocate tax liabilities in the event the distribution, together with certain related transactions, does not qualify as tax-free. In general, under the Tax Matters Agreement, each party is expected to be responsible for any taxes imposed on Zimmer Biomet or us, as the case may be, that arise from the failure of the distribution, together with certain related transactions, to qualify as a transaction that is generally tax-free under Sections 355 and 368(a)(1)(D) and certain other relevant provisions of the Internal Revenue Code of 1986, to the extent that the failure to so qualify is attributable to actions, events or transactions relating to such party’s respective stock, assets or business, or a breach of the relevant representations or covenants made by that party in the Tax Matters Agreement. However, if such failure was the result of any acquisition of our shares or assets, or of any of our representations, statements or undertakings being incorrect, incomplete or breached, we generally will be responsible for all taxes imposed as a result of such acquisition or breach.
Employee Matters Agreement - The Employee Matters Agreement allocates liabilities and responsibilities relating to employment matters, employee compensation and benefits plans and programs and other related matters. The Employee Matters Agreement governs certain compensation and employee benefits obligations with respect to the current and former employees and non-employee directors of each party. The Employee Matters Agreement provides that, except as otherwise specified, Zimmer Biomet is generally responsible for liabilities associated with employees who will remain employed by Zimmer Biomet and former employees whose last employment was with Zimmer Biomet’s businesses, and we are generally responsible for liabilities associated with employees who are or will be employed by us and former employees whose last employment was with the ZimVie businesses. The Employee Matters Agreement provided for the conversion of the outstanding awards granted under Zimmer Biomet’s equity compensation programs into adjusted awards relating to shares of Zimmer Biomet and/or ZimVie common stock in a manner intended to preserve the aggregate intrinsic value
16
of the original awards. The adjusted awards are subject to substantially similar terms, vesting conditions, post-termination exercise rules and other restrictions that applied to the original Zimmer Biomet awards immediately before the separation.
Transition Manufacturing and Supply Agreement and Reverse Transition Manufacturing and Supply Agreement - Pursuant to the Transition Manufacturing and Supply Agreement and the Reverse Transition Manufacturing and Supply Agreement, we or Zimmer, Inc., a wholly-owned subsidiary of Zimmer Biomet, as the case may be, will manufacture or cause to be manufactured certain products for the other party, on an interim, transitional basis. Pursuant to such agreements, we or Zimmer, Inc., as the case may be, will be required to purchase certain minimum amounts of products from the other party. The Transition Manufacturing and Supply Agreement and the Reverse Transition Manufacturing and Supply Agreement will terminate on the expiration of the term of the last product manufactured by us or Zimmer, Inc., as the case may be, pursuant to such agreements, which will generally be no later than March 1, 2027.
Other agreements include the Intellectual Property Matters Agreement and the Transitional Trademark License Agreement.
13. Restructuring and Other Cost Reduction Initiatives
In June 2022, we initiated a restructuring plan with the objective of reducing costs and optimizing our global footprint. In addition, the national volume-based procurement ("VBP") program for spine products in China took place in late September 2022, and we were not successful in our bid. After evaluating our alternatives, in the fourth quarter of 2022, we approved a plan to exit our spine products activities in China. During the three months ended March 31, 2023, we recorded pre-tax charges of $
In December 2019 and December 2021, Zimmer Biomet initiated restructuring plans (the "ZB Restructuring Plans") with an objective of reducing costs to allow further investment in higher priority growth opportunities. We incurred pre-tax charges related to the ZB Restructuring Plans of $
The following table summarizes the liabilities directly attributable to us that were recognized under the plans discussed above and excludes non-cash charges (in thousands):
|
|
Employee |
|
|
Other |
|
|
Total |
|
|||
Balance, December 31, 2022 |
|
$ |
|
|
$ |
|
|
$ |
|
|||
Additions |
|
|
|
|
|
|
|
|
|
|||
Cash payments |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Balance, March 31, 2023 |
|
$ |
|
|
$ |
|
|
$ |
|
|||
|
|
|
|
|
|
|
|
|
|
|||
Balance, December 31, 2021 |
|
$ |
|
|
$ |
|
|
$ |
|
|||
Additions |
|
|
|
|
|
|
|
|
|
|||
Cash payments |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Balance, March 31, 2022 |
|
$ |
|
|
$ |
|
|
$ |
|
|||
In April 2023, we initiated additional restructuring activities to better position our organization for future success based on the current business environment. These initiatives have the objective of reducing our global cost structure and streamlining our organizational infrastructure across all regions, functions and levels. We accrued charges of $
We do not include charges for restructuring and other cost reduction initiatives in the operating profit of our reportable segments.
17
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following information should be read in conjunction with the interim condensed consolidated financial statements and related 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. The following discussion may contain forward-looking statements that reflect our plans, estimates and beliefs. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to these differences include those factors discussed in this Form 10-Q and in our Annual Report, particularly in “Cautionary Note Regarding Forward-Looking Statements” and “Risk Factors.”
OVERVIEW
ZimVie Inc. (“ZimVie,” “we,” “us,” “our” or the “Company”) was incorporated in the State of Delaware on July 30, 2021 as a wholly owned subsidiary of Zimmer Biomet Holdings, Inc. (“Zimmer Biomet” or “Parent”). We were formed solely for the purpose of effecting the distribution of our outstanding shares of common stock on a pro rata basis to holders of Zimmer Biomet common stock and to hold directly or indirectly the assets and liabilities associated with the dental and spine businesses of Zimmer Biomet prior to the distribution. The distribution was completed on March 1, 2022, and resulted in ZimVie becoming a standalone, publicly traded company. Prior to March 1, 2022, ZimVie’s financial statements were prepared on a carve-out basis and were derived from Zimmer Biomet’s consolidated financial statements and accounting records.
Following the distribution, Zimmer Biomet initially retained 19.7% of the outstanding shares of ZimVie common stock, and all transactions between ZimVie and Zimmer Biomet from the distribution to February 1, 2023 were reported as related party transactions. As of February 1, 2023, Zimmer Biomet had sold all of its 19.7% ownership in ZimVie and is no longer considered a related party. As such, transactions with Zimmer Biomet subsequent to February 1, 2023 are reported as third party transactions.
ZimVie is a leading medical technology company dedicated to enhancing the quality of life for dental and spine patients worldwide. We develop, manufacture and market a comprehensive portfolio of products and solutions designed to support dental tooth replacement and restoration procedures and treat a wide range of spine pathologies. We are well-positioned in the growing global dental implant, biomaterials and digital dentistry market with a strong presence in the tooth replacement market with market leading positions in certain geographies. Our broad portfolio also addresses all areas of spine with market leadership in cervical disc replacement and vertebral body tethering to treat pediatric scoliosis. Our operations are principally managed on a products basis and include two operating segments, 1) the dental products segment, and 2) the spine products segment.
In the dental products market, our core services include designing, manufacturing and distributing a comprehensive portfolio of dental implant solutions, biomaterials and digital dentistry solutions. Dental reconstructive implants are for individuals who are totally without teeth or are missing one or more teeth, dental prosthetic products are aimed at providing aesthetic and functional restoration to resemble the original teeth, and dental regenerative products are for soft tissue and bone rehabilitation.
In the spine products market, our core services include designing, manufacturing and distributing a full suite of spinal surgery solutions to treat patients with back or neck pain caused by degenerative conditions, deformities, tumors or traumatic injury of the spine. We also provide devices that promote bone healing.
We have a broad geographic revenue base, with meaningful exposure to both established and emerging markets. We have six manufacturing site locations, and a global presence in approximately 25 countries.
RESTRUCTURING AND OTHER COST REDUCTION INITIATIVES
2022 Programs
In June 2022, we initiated a restructuring plan with the objective of reducing costs and optimizing our global footprint. In addition, the national volume-based procurement (“VBP”) program for spine products in China took place in late September 2022, and we were not successful in our bid. As a result, after evaluating our alternatives, in the fourth quarter of 2022 we approved a plan to exit our spine products activities in China. For the three months ended March 31, 2023, we recorded charges of $1.1 million related to accelerated
18
depreciation of fixed assets as we wind down our spine products operations in China. Annual 2022 spine product sales in China represented less than 1% of our consolidated annual sales.
During the three months ended March 31, 2023, we recorded pre-tax charges of $3.3 million related to these actions, and we have incurred pre-tax charges of $12.3 million from inception to date. We anticipate total charges related to these actions of approximately $14-15 million, including projects in process or under final evaluation. The restructuring charges incurred in the three months ended March 31, 2023 under this plan were primarily related to accelerated depreciation and impairment of assets. We anticipate incurring the remaining charges throughout 2023.
The national VBP program for dental products in China took place in January 2023, and we were not successful in our bid. We are evaluating the impact of this result on our dental products business in China and reviewing our strategic alternatives. Annual 2022 dental product sales in China represented less than 1% of our consolidated annual sales.
2023 Program
In April 2023, we initiated additional restructuring activities to better position our organization for future success based on the current business environment. These initiatives have the overall objective of reducing our global cost structure and streamlining our organizational infrastructure across all regions, functions, and levels. As a result of this initiative, we expect an approximate 5% reduction in our global workforce, in addition to reductions in discretionary spending.
We expect this restructuring initiative will complement our initiatives to improve operating margins and cash flow, as well as provide us with the financial flexibility to continue to prioritize investments in our product offerings and technologies. We estimate that this program will generate $17-20 million in annualized net savings by 2024. We accrued $1.6 million in March 2023 for professional fees to assist in the evaluation of our global organization and cost structure, and we anticipate total charges related to the program of approximately $15-16 million, to be incurred in 2023 and 2024.
RESULTS OF OPERATIONS
Three Months Ended March 31, 2023 and 2022
Net Sales by Product Category
The following tables present net sales by product category and the components of the percentage changes (dollars in thousands):
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
|
|
|
|
|
Foreign |
|
|||||||||
|
|
2023 |
|
|
2022 |
|
|
% Inc (Dec) |
|
|
Volume/Mix |
|
|
Price |
|
|
Exchange |
|
||||||
Dental |
|
$ |
120,170 |
|
|
$ |
120,569 |
|
|
|
(0.3 |
)% |
|
|
2.0 |
% |
|
|
(0.2 |
)% |
|
|
(2.1 |
)% |
Spine |
|
|
104,918 |
|
|
|
114,113 |
|
|
|
(8.1 |
) |
|
|
(6.9 |
) |
|
|
(0.9 |
) |
|
|
(0.3 |
) |
Third Party Sales |
|
|
225,088 |
|
|
|
234,682 |
|
|
|
(4.1 |
) |
|
|
(2.3 |
) |
|
|
(0.6 |
) |
|
|
(1.2 |
) |
Related Party |
|
|
339 |
|
|
|
919 |
|
|
|
(63.1 |
) |
|
N/A |
|
|
N/A |
|
|
N/A |
|
|||
Total |
|
$ |
225,427 |
|
|
$ |
235,601 |
|
|
|
(4.3 |
) |
|
N/A |
|
|
N/A |
|
|
N/A |
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Demand (Volume/Mix) Trends
Demand in the dental product category increased in the three months ended March 31, 2023 compared to the same 2022 period, primarily due to higher demand for tooth replacement procedures combined with a growing digital dentistry market. Demand in the spine product category was negatively impacted in the three months ended March 31, 2023 compared to the same prior year period by increased competition and lower sales due to our exit from our spine products activities in China. This decline was partially offset by net spine product sales retained by Zimmer Biomet in the same 2022 period in certain geographies where our separation and transition activities extended beyond the distribution date that did not recur in 2023 (for more information, see "After Distribution - Interim Operating Agreements" in Note 12 to our condensed consolidated financial statements). Both segments were favorably impacted by one more selling day in the first quarter of 2023.
Pricing Trends
The dental product category experienced price improvement in certain geographic regions, including North America and Europe; however, there was an overall price decline due to the timing of price changes year-over-year in certain European countries. The spine product category continued to experience governmental healthcare cost pricing pressure efforts and similar efforts at local hospitals and health systems.
19
Foreign Currency Exchange Rates
In countries where we have a subsidiary, we sell to customers in their local currencies. Accordingly, our net sales as reported in U.S. Dollars are affected by changes in foreign currency exchange rates. We are primarily exposed to foreign currency exchange rate risk with respect to net sales denominated in Euros, Chinese Renminbi, Israeli Shekel, New Zealand Dollar, Japanese Yen, Canadian Dollar and Swedish Krona. For the three months ended March 31, 2023, foreign exchange fluctuations had a negative effect on year-over-year sales, mainly due to the strengthening of the U.S. Dollar against the Euro.
Expenses as a Percent of Net Sales
|
|
Three Months Ended March 31, |
||||||||||||
|
|
2023 |
|
|
2022 |
|
|
|
2023 vs. |
|
|
|||
Cost of products sold, excluding intangible asset |
|
|
31.4 |
% |
|
|
36.1 |
% |
|
|
|
(4.7 |
)% |
|
Related party cost of products sold, excluding intangible |
|
|
0.1 |
|
|
|
0.3 |
|
|
|
|
(0.2 |
) |
|
Intangible asset amortization |
|
|
9.1 |
|
|
|
8.9 |
|
|
|
|
0.2 |
|
|
Research and development |
|
|
6.8 |
|
|
|
7.5 |
|
|
|
|
(0.7 |
) |
|
Selling, general and administrative |
|
|
56.8 |
|
|
|
56.9 |
|
|
|
|
(0.1 |
) |
|
Restructuring and other cost reduction initiatives |
|
|
2.2 |
|
|
|
0.3 |
|
|
|
|
1.9 |
|
|
Acquisition, integration, divestiture and related |
|
|
0.7 |
|
|
|
3.8 |
|
|
|
|
(3.1 |
) |
|
Operating Loss |
|
|
(7.2 |
) |
|
|
(13.8 |
) |
|
|
|
(6.6 |
) |
|
Cost of Products Sold and Intangible Asset Amortization
The decrease in cost of products sold in dollars and as a percentage of net sales in the three months ended March 31, 2023 compared to the three months ended March 31, 2022 was primarily due to a reduction in inventory charges in the spine product category, as well as expense of $1.6 million in share-based compensation due to converted Zimmer Biomet awards recorded in the prior year period that did not recur (for more information, see Note 3 to our condensed consolidated financial statements).
Intangible asset amortization decreased slightly in dollars and increased slightly as a percentage of net sales in the three months ended March 31, 2023 as compared to the three months ended March 31, 2022, due to the relatively fixed nature of amortization expense period over period.
Operating Expenses
Research and development ("R&D") expenses as a percentage of net sales decreased in the three months ended March 31, 2023 compared to the same 2022 period, primarily due to less spend in the dental segment due to timing of new product launch initiatives. R&D expenses also decreased as a result of a decrease of $1.8 million in share-based compensation due to converted Zimmer Biomet awards recorded in the prior year period that did not recur (for more information, see Note 3 to our condensed consolidated financial statements).
Selling, general and administrative ("SG&A") expenses decreased slightly as a percentage of net sales in the three months ended March 31, 2023 as compared to the three months ended March 31, 2022, primarily as a result of decreases in variable selling expenses resulting from decreased sales, and indemnification of certain legal costs by Zimmer Biomet in the three months ended March 31, 2023, stricter cost containment measures on discretionary spending, and a $7.0 million decrease in share-based compensation due to converted Zimmer Biomet awards recorded in the prior year period that did not recur (for more information, see Note 3 to our condensed consolidated financial statements). These decreases were partially offset by increased general and administrative costs due to us being a standalone public company for the entire three-month period ended March 31, 2023 compared to the one-month period ended March 31, 2022 as well as increased medical education events in the 2023 period compared to the 2022 period.
Expenses related to restructuring and other cost reduction initiatives relate to our exit of our spine products business in China, our restructuring plan initiated in June 2022, and Zimmer Biomet's restructuring plans initiated in the fourth quarters of 2019 and 2021, and the restructuring activities we initiated in April 2023. We recognized expenses of $5.0 million and $0.7 million in the three months ended March 31, 2023 and 2022, respectively. These expenses primarily related to consulting fees, employee termination benefits, accelerated depreciation, impairment of assets and for the three months ended March 31, 2023, included $1.6 million accrued for professional services related to the development of the April 2023 global restructuring program. For more information regarding these expenses, see Note 13 to our condensed consolidated financial statements.
20
Acquisition, integration, divestiture and related expenses decreased in the three months ended March 31, 2023 as compared to the three months ended March 31, 2022, due to less costs incurred in connection with building out capabilities necessary to becoming a standalone, public company.
Other Income (Expense), net, Interest Expense, net, and Income Taxes
Our non-operating other (expense) income, net, primarily relates to the remeasurement of monetary assets and liabilities that are denominated in a currency other than the subsidiary’s functional currency. Therefore, the income or expense varies based upon the volatility of foreign currency exchange rates.
Interest expense, net, in the three months ended March 31, 2023 increased compared to the same 2022 period, primarily due to higher average outstanding debt and increased interest rates.
Our effective tax rate (“ETR”) on loss before income taxes was (15.3%) and 22.4% for the three months ended March 31, 2023 and 2022, respectively. In the three months ended March 31, 2023, the income tax expense was lower than the 21% U.S. federal statutory rate due to additional expense for increasing valuation allowances. In the three months ended March 31, 2022 the additional income tax benefit compared to the statutory rate was driven by the impact of losses recorded prior to the distribution that were calculated on a “carve-out” basis, which applied the accounting guidance as if we filed income tax returns on a standalone, separate return basis and are not reflective of the tax results we expect to generate in the future. Additionally, for the three months ended March 31, 2023 and 2022, profit in inventory recorded prior to the distribution is non-taxable as the inventory is sold post-separation to third parties, resulting in a significant benefit to the foreign rate differential.
During the three months ended March 31, 2022, income tax balances were adjusted to reflect the income tax positions after distribution, including those related to tax loss and credit carryforwards, other deferred tax assets and liabilities and valuation allowances. These separation-related adjustments resulted in a $3.9 million increase to the net deferred tax liability, primarily due to inventory and intangible assets transferred in the separation, tax rate changes and changes to the permanent reinvestment assertion in the post-separation environment. The increase in the net deferred tax liability was offset by a corresponding decrease in net parent investment.
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
|
|
Net Sales |
|
|
Operating Profit |
|
|
Operating Profit as a |
|
|||||||||||||||
|
|
Three Months Ended March 31, |
|
|
Three Months Ended March 31, |
|
|
Three Months Ended March 31, |
|
|||||||||||||||
(dollars in thousands) |
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
||||||
Dental |
|
$ |
120,170 |
|
|
$ |
120,569 |
|
|
$ |
23,033 |
|
|
$ |
25,659 |
|
|
|
19.2 |
% |
|
|
21.3 |
% |
Spine |
|
|
104,918 |
|
|
|
114,113 |
|
|
|
10,235 |
|
|
|
5,099 |
|
|
|
9.8 |
|
|
|
4.5 |
|
Sales in our dental segment in the three months ended March 31, 2023 decreased from the same prior year period, primarily due to changes in foreign exchange rates, partially offset by an increase in demand for tooth replacement procedures combined with a growing digital dentistry market. Sales in our spine segment in the three months ended March 31, 2023 decreased from the same prior year period, primarily due to increased competition and lower sales as a result of our exit from our spine products activities in China, partially offset by net spine product sales retained by Zimmer Biomet in the 2022 period in certain geographies where our separation and transition activities extended beyond the distribution date that did not recur in 2023 (for more information, see "After Distribution - Interim Operating Agreements" in Note 12 to our condensed consolidated financial statements).
In our dental segment, operating profit decreased for the three months ended March 31, 2023 compared to the same prior year period, primarily due to timing of new product launch initiatives. In our spine segment, operating profit increased for the three months ended March 31, 2023 compared to the same prior year period, primarily due to E&O inventory charges in the 2022 period that did not recur.
LIQUIDITY AND CAPITAL RESOURCES
As of March 31, 2023 and December 31, 2022, we had $66.4 million and $89.6 million, respectively, in cash and cash equivalents.
21
Sources of Liquidity
Cash flows used in operating activities were $7.2 million and $9.9 million in the three months ended March 31, 2023 and March 31, 2022, respectively. An increase in cash used in working capital was primarily attributable to an increase in cash used for accounts payable, accrued liabilities and taxes and a decrease in cash provided by inventories, mostly offset by a decrease in cash used for prepayments and an increase in cash provided by accounts receivable.
Cash flows used in investing activities were $5.8 million in the three months ended March 31, 2023 compared to $8.1 million in the three months ended March 31, 2022. The decrease in cash used in investing activities was primarily related to the decrease in expenditures for instruments due to efforts to optimize our product portfolio and manufacturing and logistics network.
Cash flows used in financing activities were $10.9 million in the three months ended March 31, 2023 compared to cash flows provided by financing activities of $22.2 million in the three months ended March 31, 2022. In the current year period, we prepaid the debt repayments scheduled for the first half of 2024 (as discussed in Note 7 to our condensed consolidated financial statements). In the 2022 period, new borrowings under our Term Loan (as discussed in Note 7 to our condensed consolidated financial statements) were used primarily for a dividend paid to Zimmer Biomet at the time of the distribution.
Liquidity and Capital Resources
For additional information regarding our current debt arrangements, including the term loan amortization schedule, see Note 10 to our consolidated financial statements included in our Annual Report. In addition, for information regarding our other material estimated future cash requirements under our contractual obligations and certain other commitments, see “Material Cash Requirements” in Part II, Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report. There have been no material changes to such information except as set forth herein.
We believe that available cash and cash equivalents, cash flows generated through operations and cash available under our revolving credit facility will be sufficient to meet our liquidity needs, including capital expenditures, for at least the next 12 months.
CRITICAL ACCOUNTING ESTIMATES
Our financial results are affected by the selection and application of accounting policies and methods and require 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 March 31, 2023 to the application of our critical accounting estimates as described in our Annual Report.
ACCOUNTING DEVELOPMENTS
See Note 1 to our condensed consolidated financial statements for information on how recent accounting pronouncements have affected or may affect our financial position, results of operations or cash flows.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Market Risk
We are exposed to certain market risks as part of our ongoing business operations, including risks from changes in foreign currency exchange rates, interest rates and commodity prices that could affect our financial condition, results of operations and cash flows.
Foreign Currency Exchange Risk
We operate on a global basis and are exposed to the risk that our financial condition, results of operations and cash flows could be adversely affected by changes in foreign currency exchange rates. We are primarily exposed to foreign currency exchange rate risk with respect to transactions and net assets denominated in Euros, Chinese Renminbi, Israeli Shekel, New Zealand Dollar, Japanese Yen, Canadian Dollar and Swedish Krona. We manage our foreign currency exposure centrally, on a combined basis, which allows us to net exposures and to take advantage of any natural offsets. To reduce the uncertainty of foreign currency exchange rate movements on transactions denominated in foreign currencies, we enter into derivative financial instruments in the form of foreign currency exchange forward contracts with major financial institutions. These forward contracts are designed to reduce the foreign exchange impact monetary assets and liabilities in non-functional currencies have on our financial results. Realized and unrealized gains and losses on these contracts are recognized in other income (expense), net.
22
Commodity Price Risk
We purchase raw material commodities such as cobalt chrome, titanium, tantalum, polymer and sterile packaging. We enter into supply contracts generally with terms of 12 to 24 months, where available, on these commodities to alleviate the effect of market fluctuations in prices. As part of our risk management program, we perform sensitivity analyses related to potential commodity price changes. A 10% price change across all these commodities would not have a material effect on our condensed consolidated financial position, results of operations or cash flows.
Interest Rate Risk
Our interest expense and related risks as reported in our condensed consolidated statements of operations are growing due to the Credit Agreement. As of March 31, 2023 we had $525.9 million of floating rate debt potentially subject to the adjusted term secured overnight financing rate ("SOFR"). A hypothetical increase of 100 basis points in SOFR to our floating rate debt would, among other things, increase our annual pre-tax loss by $5.3 million.
Credit Risk
Financial instruments, which potentially subject us to concentrations of credit risk, are primarily cash and cash equivalents, derivative instruments and accounts receivable.
We place our cash and cash equivalents with highly rated financial institutions and limit the amount of credit exposure to any one entity. We believe we do not have any significant credit risk on our cash and cash equivalents.
Our concentrations of credit risks with respect to trade accounts receivable is 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 dental practices in the 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. Our ability to collect accounts receivable in some countries depends in part upon the financial stability of these hospital and healthcare sectors and the respective countries’ national economic and healthcare systems. Most notably, in Europe healthcare is typically sponsored by the government. Since we sell products to public hospitals in those countries, we are indirectly exposed to government budget constraints. To the extent the respective governments’ ability to fund their public hospital programs deteriorates, we may have to record significant bad debt expenses in the future.
While we are exposed to risks from the broader healthcare industry in Europe and around the world, there is no significant net exposure due to any individual customer. Exposure to credit risk is controlled through credit approvals, credit limits and monitoring procedures, and we believe that reserves for losses are adequate.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of our disclosure controls and procedures as defined under Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended ("Exchange Act"). Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of March 31, 2023 to provide reasonable assurance that information required to be disclosed in our reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC 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 disclosure.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting during the three months ended March 31, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
23
PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
We are subject to various claims, legal proceedings and investigations regarding product liability, intellectual property, commercial and other matters that arise in the normal course of business. We currently do not expect the outcome of these matters to have a material adverse impact on our results of operations, cash flows or financial position. However, the outcome of such matters is unpredictable, our assessment of them may change, and resolution of them could have a material adverse effect on our financial position, results of operations or cash flows.
For additional information related to our contingencies, see Note 11 to our condensed consolidated financial statements included in Part I, Item 1 of this report, which is incorporated herein by reference.
Item 1A. Risk Factors.
You should carefully consider the factors discussed in Part I, Item 1A, “Risk Factors” of our Annual Report, which could materially affect our business, financial condition and results of operations. There have been no material changes in those risk factors. The risks described in our Annual Report 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 Annual Report, any of which could materially affect our business, financial condition and results of operations.
Item 6. Exhibits.
Exhibit Index
Exhibit Number |
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Description |
3.1 |
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3.2 |
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21 |
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31.1 |
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31.2 |
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32.1 |
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32.2 |
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101.INS |
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Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document. |
101.SCH |
|
Inline XBRL Taxonomy Extension Schema Document |
101.CAL |
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
101.DEF |
|
Inline XBRL Taxonomy Extension Definition Linkbase Document |
101.LAB |
|
Inline XBRL Taxonomy Extension Label Linkbase Document |
101.PRE |
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
24
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.
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ZimVie Inc. |
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Date: May 3, 2023 |
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By: |
/s/ Richard Heppenstall |
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Richard Heppenstall |
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Executive Vice President, Chief Financial Officer and Treasurer (Principal Financial Officer) |
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25
Exhibit 21
Subsidiaries of ZimVie Inc.
As of March 31, 2023
Name of Subsidiary |
Jurisdiction of Formation |
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Domestic subsidiaries: |
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Biomet 3i, LLC |
Florida |
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dba Zimmer Biomet Dental |
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dba ZimVie Dental |
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EBI Holdings, LLC |
Delaware |
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EBI Medical Systems, LLC |
Delaware |
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EBI, LLC |
Indiana |
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dba Biomet Healing Technologies (Forced) |
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dba Biomet Spine (Forced) |
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dba Biomet Spine & Bone Healing Technologies, LLC (Forced) |
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dba Biomet Spine & Bone Healing Technologies, Biomet Bracing and Biomet Osteobiologics, LLC (Forced) |
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dba Biomet Trauma, Biomet Spine (Forced) |
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dba Biomet Trauma, Biomet Spine, Biomet Bracing and Biomet Osteobiologics, LLC (Forced) |
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dba EBI, LLC (IN) (Forced) |
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dba EBI, LLC of Indiana (Forced) |
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dba ZimVie |
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Electro-Biology, LLC |
Delaware |
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Implant Concierge, LLC |
Texas |
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Zimmer Biomet Spine, Inc. |
Delaware |
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dba Lanx |
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dba Zimmer Spine |
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dba ZimVie |
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dba ZimVie Spine |
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Zimmer Dental Inc. |
Delaware |
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dba ZimVie Dental |
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ZimVie Holdings US 1 LLC |
Delaware |
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ZimVie Holdings US 2 LLC |
Delaware |
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Foreign subsidiaries: |
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Biomet 3i Australia Pty. Ltd. |
Australia |
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ZimVie Austria GmbH |
Austria |
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Biomet 3i Belgium N.V. |
Belgium |
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ZimVie Brasil Comercio, Importacao e Exportacao de Produtos Medicos Ltda. |
Brazil |
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Zimmer Biomet Dental Canada Inc. |
Canada |
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Zimmer Dental Chile Spa |
Chile |
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Zimmer Dental (Shanghai) Medical Device Co. Ltd. |
China |
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IC Guided Surgery, SRL |
Costa Rica |
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LDR Médical S.A.S. |
France |
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Zimmer Dental SAS |
France |
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Zimmer Spine SAS |
France |
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Zfx GmbH |
Germany |
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Zimmer Dental GmbH |
Germany |
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ZB Dental India Private Limited |
India |
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Zimmer Dental Ltd. |
Israel |
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3DIEMME Srl |
Italy |
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Zfx Innovation GmbH |
Italy |
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Zimmer Dental Italy Srl |
Italy |
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ZimVie Japan G.K. |
Japan |
Name of Subsidiary |
Jurisdiction of Formation |
|
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ZimVie Korea Co Ltd. |
Korea |
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JERDS Luxembourg Holding S.ar.l |
Luxembourg |
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Biomet 3i Mexico S.A. de C.V. |
Mexico |
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Biomet 3i Netherlands B.V. |
Netherlands |
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ZimVie Netherlands Global Holding B.V. |
Netherlands |
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ZimVie Netherlands Holding B.V. |
Netherlands |
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Biomet 3i Portugal (Representaçoes de Produtos Dentarios Sociedade Unipessoal, Lda.) |
Portugal |
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EBI Patient Care, Inc. |
Puerto Rico |
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ZimVie Singapore Pte. Ltd. |
Singapore |
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Biomet 3i Dental Iberica SLU |
Spain |
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Biomet 3i Switzerland GmbH (Biomet 3i Schweiz GmbH) |
Switzerland |
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ZimVie Taiwan Co Ltd. |
Taiwan |
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Biomet 3i Turkey (Biomet 3i Diş Sağlığı Ürünleri Pazarlama, İthalat, İhracat ve Dış Ticaret Limited Şirketi) |
Turkey |
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Biomet 3i UK Ltd. |
United Kingdom |
Exhibit 31.1
CERTIFICATION PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Vafa Jamali, certify that:
Date: May 3, 2023 |
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By: |
/s/ Vafa Jamali |
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|
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Vafa Jamali |
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|
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Chief Executive Officer |
Exhibit 31.2
CERTIFICATION PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Richard Heppenstall, certify that:
Date: May 3, 2023 |
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By: |
/s/ Richard Heppenstall |
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|
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Richard Heppenstall |
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Chief Financial Officer |
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of ZimVie Inc. (the “Company”) on Form 10-Q for the period ended March 31, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:
Date: May 3, 2023 |
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By: |
/s/ Vafa Jamali |
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|
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Vafa Jamali |
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|
|
Chief Executive Officer |
Exhibit 32.2
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of ZimVie Inc. (the “Company”) on Form 10-Q for the period ended March 31, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:
Date: May 3, 2023 |
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By: |
/s/ Richard Heppenstall |
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|
|
Richard Heppenstall |
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|
|
Chief Financial Officer |