ZIMMER BIOMET HOLDINGS, INC. The following discussion and analysis should be read in conjunction with the interim condensed consolidated financial statements and corresponding notes included elsewhere in this Form 10-Q. Certain percentages presented in this discussion and analysis are calculated from the underlying whole-dollar amounts and, therefore, may not recalculate from the rounded numbers used for disclosure purposes. OnMarch 1, 2022 , we completed the spinoff of our spine and dental businesses into ZimVie. The historical results of our spine and dental businesses have been reflected as discontinued operations in our condensed consolidated financial statements through the date of the spinoff and in the prior year period. In addition, as ofDecember 31, 2021 , the assets and liabilities associated with these businesses are classified as assets and liabilities of discontinued operations in our condensed consolidated balance sheet. See Note 2 to our interim condensed consolidated financial statements included in Part I, Item 1 of this report for additional information. The discussions in the following discussion and analysis are presented on a continuing operations basis.
Executive Level Overview
Impact of the COVID-19 Global Pandemic
Our results continue to be impacted by the COVID-19 global pandemic. The vast majority of our net sales are derived from products used in elective surgical procedures that have typically declined during surges of the virus as governments and healthcare systems take actions in an effort to prevent the spread and provide sufficient hospital beds and other resources for COVID-19 patients. Additionally, we believe that staffing shortages at hospitals have contributed, and continue to contribute, to the deferral of elective surgical procedures. In the three-month period endedMarch 31, 2022 , the Omicron variant resulted in fewer elective surgical procedures earlier in the quarter, but then procedures approached pre-pandemic levels as the surge began to subside later in the quarter.
Results for the Three-Month Period ended
Our net sales increased by 3.9 percent in the three-month period endedMarch 31, 2022 when compared to the same prior year period. We saw the return of elective surgical procedures across most markets when compared to the prior year period being negatively affected by a surge of the COVID-19 virus in early 2021 and before vaccines were widely available. Our net sales growth was tempered by a negative 2.9 percent effect from changes in foreign currency exchange rates on year-over-year sales. Our net earnings were$14.2 million in the three-month period endedMarch 31, 2022 , compared to$198.1 million in the same prior year period. The decline in net earnings in the three-month period endedMarch 31, 2022 was primarily due to losses from discontinued operations from costs related to the ZimVie spinoff, an unrealized investment loss due to a decline in the value of our investment in ZimVie, higher litigation-related charges, higher restructuring charges, and higher spending in research and development ("R&D"), travel, medical training and education and other areas as certain activities started to return to pre-pandemic levels.
2022 Outlook
We believe that COVID-19 and staffing shortages will continue to negatively affect net sales, but to a lesser degree than what we experienced in 2021. However, if foreign currency exchange rates stay at recent levels, we estimate net sales will be negatively affected by approximately 3.5%. For expenses, we expect that supply chain and inflation pressures will result in higher expenses. However, we anticipate these higher expenses will be partially offset by savings from our restructuring programs.
Results of Operations
We review sales by two geographies,the United States and International, and by the following product categories: Knees; Hips; S.E.T. (Sports Medicine, Extremities, Trauma, Craniomaxillofacial and Thoracic); and Other. This sales analysis differs from our reportable operating segments, which are based upon our senior management organizational structure and how we allocate resources toward achieving operating profit goals. We review sales by these geographies because the underlying market trends in any particular geography tend to be similar across product categories, because we primarily sell the same products in all geographies and many of our competitors publicly report in this manner. Our business is seasonal in nature to some extent, as many of our products are used in elective surgical procedures, which typically decline during the summer months and can increase at the end of the year once annual deductibles have been met on health insurance plans. This seasonal pattern was disrupted in 2020 and 2021 due to COVID-19 as our net sales were influenced by the infection levels and precautions taken to prevent the spread in a particular location. It is uncertain if this seasonal pattern will return in 2022. 27
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The following table presents our net sales by geography and the percentage changes (dollars in millions):
Three Months Ended
March 31,
2022 2021 % Inc
United States $ 941.2 $ 889.2 5.8 %
International 722.0 712.2 1.4
Total $ 1,663.2 $ 1,601.4 3.9
The following table presents our net sales by product category and the percentage changes (dollars in millions):
Three Months Ended
March 31,
2022 2021 % Inc / (Dec)
Knees $ 662.8 $ 614.3 7.9 %
Hips 451.0 447.0 0.9
S.E.T. 416.8 417.6 (0.2 )
Other 132.6 122.5 8.2
Total $ 1,663.2 $ 1,601.4 3.9
The following table presents our net sales by geography for our Knees and Hips product categories, which represent our most significant product categories (dollars in millions):
Three Months Ended March 31,
2022 2021 % Inc / (Dec)
Knees
United States $ 379.5 $ 339.6 11.7 %
International 283.3 274.7 3.1
Total $ 662.8 $ 614.3 7.9
Hips
United States $ 224.6 $ 217.4 3.3 %
International 226.4 229.6 (1.4 )
Total $ 451.0 $ 447.0 0.9
Demand (Volume and Mix) Trends
Changes in volume and mix of product sales had a positive effect of 8.4 percent on year-over-year sales during the three-month period endedMarch 31, 2022 . We saw recovery of elective surgical procedures, most notably in theU.S. andEurope , driving volume growth.Asia Pacific net sales volumes were negatively affected by preventative measures taken inChina to prevent the spread of COVID-19.
Pricing Trends
Global selling prices had a negative effect of 1.6 percent on year-over-year sales during the three-month period endedMarch 31, 2022 . The majority of countries in which we operate continue to experience pricing pressure from governmental healthcare cost containment efforts and from local hospitals and health systems. Additionally, pricing was negatively affected inChina by a nationwide volume-based procurement ("VBP") process being implemented.
Foreign Currency Exchange Rates
For the three-month period endedMarch 31, 2022 , changes in foreign currency exchange rates had a negative effect of 2.9 percent on year-over-year sales. If foreign currency exchange rates remain at levels consistent with recent rates, we estimate there will be a negative impact of approximately 3.5 percent on full-year 2022 sales. 28
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Geography
The 5.8 percent net sales growth in theU.S. was driven by recovery in surgical procedures as COVID-19 cases subsided, especially in knees. Internationally, net sales grew by 1.4 percent, despite a negative impact of 6.7 percent due to changes in foreign currency exchange rates. We experienced net sales growth in EMEA of 13.6 percent in the quarter due to our most significant markets in that region recovering from COVID-19 surges, but this was offset by a decline of 13.1 percent inAsia Pacific . The decline inAsia Pacific net sales was primarily due toChina experiencing lockdowns in the 2022 period due to COVID-19 as well as the negative effects of the VBP implementation.
Product Categories
Knees and Hips net sales grew 7.9 percent and 0.9 percent, respectively, when compared to the same prior year period due to the recovery in elective surgical procedures and new product introductions. Knees and Hips net sales were negatively affected 3.1 percent and 3.6 percent, respectively, by changes in foreign currency exchange rates. S.E.T. net sales declines were due to the negative effects of changes in foreign currency exchange rates and some declines in certain product subcategories.
Expenses as a Percentage of
Three Months Ended
March 31, % Inc /
2022 2021 (Dec)
Cost of products sold, excluding intangible
asset amortization 30.1 % 27.2 % 2.9 %
Intangible asset amortization 7.9 8.3 (0.4 )
Research and development 5.8 5.1 0.7
Selling, general and administrative 41.2 41.0 0.2
Restructuring and other cost reduction
initiatives 2.6 1.3 1.3
Quality remediation 0.4 0.6 (0.2 )
Acquisition, integration, divestiture and
related 0.1 0.2 (0.1 )
Operating profit 11.9 16.2 (4.3 )
The increase in cost of products sold as a percentage of net sales for the
three-month period ended March 31, 2022 compared to the same prior year period
was primarily due to higher excess and obsolete inventory charges, inflationary
cost pressures and lower average selling prices.
Intangible asset amortization expense was similar in both amount and as a
percentage of net sales in the three-month period ended
R&D expenses increased in both amount and as a percentage of net sales in the three-month period endedMarch 31, 2022 compared to the same prior year period. The increases in the three-month period endedMarch 31, 2022 were primarily due to reengaging in R&D projects in the current year period compared to early 2021 when COVID-19 caused delays in project spending. Selling, general and administrative ("SG&A") expenses increased in both amount and as a percentage of sales in the three-month period endedMarch 31, 2022 when compared to the same prior year period. The increase in the three-month period endedMarch 31, 2022 was primarily due to higher litigation-related charges of$33.2 million in the 2022 period compared to$10.7 million in the 2021 period, increased bad debt charges caused by theRussia /Ukraine conflict, and higher travel and medical training and education costs in the 2022 period as certain activities have resumed. As a result of the invasion ofUkraine byRussia , economic sanctions and export controls were imposed by much of the world on Russian financial institutions and businesses. Our operations inRussia consist primarily of local commercial activities, including sales and customer support. We do not have direct operations inUkraine . Our net sales inRussia andUkraine for the year endedDecember 31, 2021 and three-month period endedMarch 31, 2022 were less than 1 percent of our consolidated net sales. Therefore, the ongoing conflict and economic sanctions are not expected to have a significant effect on our results of operations or financial position. The bad debt charges for expected credit losses inRussia andUkraine resulted in a significant portion of our accounts receivable from customers in these countries being impaired. In addition to accounts receivable, we also have inventory and instruments that could require impairment if our business inRussia deteriorates more than our current expectations; however, any such amounts are not expected to be material. See Part II, Item 1A "Risk Factors" for additional risks related to this conflict. In December of 2021 and 2019, we initiated restructuring programs. TheDecember 2021 restructuring program is intended to reorganize our operations due to the spinoff of ZimVie with an objective of reducing costs. TheDecember 2019 restructuring program has an objective of reducing costs to allow us to invest in higher priority growth opportunities. We recognized expenses of 29 --------------------------------------------------------------------------------$43.9 million and$21.3 million in the three-month periods endedMarch 31, 2022 and 2021, respectively, primarily related to employee termination benefits, sales agent contract terminations, and consulting and project management expenses associated with these programs. The expenses were higher in the 2022 period due to additional expenses from theDecember 2021 restructuring program that had just been initiated. For more information regarding these charges, see Note 5 to our interim condensed consolidated financial statements included in Part I, Item 1 of this report.
We continue to incur quality remediation expenses to complete our remediation milestones that address inspectional observations on Form 483 and a Warning Letter issued by the FDA at our Warsaw North Campus facility, among other matters.
Acquisition, integration, divestiture and related expenses declined slightly in the three-month period endedMarch 31, 2022 when compared to the same prior year period.
Other (Expense) Income, Net, Interest Expense, Net, and Income Taxes
In the three-month period ended
Interest expense, net, decreased in the three-month period ended
In the three-month period endedMarch 31, 2022 , our effective tax rate ("ETR") was 27.8 percent compared to 9.8 percent in the three-month period endedMarch 31, 2021 . The 27.8 percent ETR in the three-month period endedMarch 31, 2022 was driven by the loss on our investment in ZimVie which is not deductible for tax purposes. The 9.8 percent ETR in the three-month period endedMarch 31, 2021 was the result of favorable discrete adjustments from the filing of Swiss tax returns and an excess tax benefit related to stock-based compensation. Absent discrete tax events, we expect our future ETR will be lower than theU.S. corporate income tax rate of 21.0 percent due to our mix of earnings betweenU.S. and foreign locations, which have lower corporate income tax rates. Our ETR in future periods could also potentially be impacted by: changes in our mix of pre-tax earnings; changes in tax rates, tax laws or their interpretation; the outcome of various federal, state and foreign audits; and the expiration of certain statutes of limitations. Currently, we cannot reasonably estimate the impact of these items on our financial results.
Segment Operating Profit
Operating Profit as a
Net Sales Operating Profit Percentage of Net Sales
Three Months Ended Three Months Ended Three Months Ended
March 31, March 31, March 31,
(dollars in millions) 2022 2021 2022 2021 2022 2021
Americas $ 1,004.3 $ 946.1 $ 389.1 $ 379.7 38.7 % 40.1 %
EMEA 379.9 334.4 78.3 75.3 20.6 22.5
Asia Pacific 279.0 320.9 82.9 114.6 29.7 35.7
All of our operating segments' operating profit as a percentage of net sales
declined in the three-month period ended March 31, 2022 , when compared to the
same prior year period. In the Americas , the decline was driven by higher excess
and obsolete inventory charges, investments in R&D and the resumption of various
activities. In our EMEA operating segment, the decline was primarily due to bad
debt expense as a result of the Russia /Ukraine conflict. In our Asia Pacific
operating segment, the decline was driven by lower net sales coupled with fixed
costs that do not decrease in proportion to net sales.
Liquidity and Capital Resources
As ofMarch 31, 2022 , we had$435.8 million in cash and cash equivalents. In addition, we had$1.0 billion available to borrow under our 2021 364-Day Credit Agreement that matures onAugust 19, 2022 , and$1.4 billion available under our 2021 Five-Year Revolving Facility that matures onAugust 20, 2026 . The terms of the 2021 364-Day Credit Agreement and the 2021 Five-Year Revolving Facility are described further in Note 8 to our interim condensed consolidated financial statements included in Part I, Item 1 of this report. We believe that cash flows from operations, our cash and cash equivalents on hand, and available borrowings under our revolving credit facilities will be sufficient to meet our ongoing liquidity requirements for at least the next twelve months. At this time, we do 30 -------------------------------------------------------------------------------- not anticipate needing to borrow further against our revolving credit facilities to fund our operations. However, due to the continued uncertainties related to the COVID-19 pandemic, it is possible our needs may change. Further, there can be no assurance that, if needed, we will be able to secure additional financing on terms favorable to us, if at all.
Sources of Liquidity
Cash flows provided by operating activities from continuing operations were$315.7 million in the three-month period endedMarch 31, 2022 , compared to$223.5 million in the same prior year period. The increase in cash flows provided by operating activities from continuing operations was primarily from terminating our accounts receivable purchase programs in theU.S. andJapan in the fourth quarter of 2020, which resulted in lower collections in the 2021 period cash flows. Additionally, investments in inventory were less in the 2022 period than in the 2021 period. Cash flows used in investing activities from continuing operations were$81.1 million in the three-month period endedMarch 31, 2022 , compared to$108.1 million in the same prior year period. Instrument and property, plant and equipment additions reflected ongoing investments in our product portfolio and optimization of our manufacturing and logistics networks. Cash flows used in financing activities from continuing operations were$122.4 million in the three-month period endedMarch 31, 2022 , compared to$195.8 million in the same prior year period. At the ZimVie spinoff date, we received$540.6 million as partial consideration for the contribution of assets in connection with the separation. We used these proceeds, together with$100.0 million of borrowings on our 2021 Five-Year Revolving Facility and cash on hand to redeem the full$750.0 million on senior notes that were dueApril 1, 2022 . In the 2021 period, we paid the remaining$200.0 million on our floating rate notes due 2021 which matured in the period. We place our cash and cash equivalents in highly-rated financial institutions and limit the amount of credit exposure to any one entity. We invest only in high-quality financial instruments in accordance with our internal investment policy. As ofMarch 31, 2022 ,$319.5 million of our cash and cash equivalents were held in jurisdictions outside of theU.S. Of this amount,$46.2 million is denominated inU.S. Dollars and, therefore, bears no foreign currency translation risk. The balance of these assets is denominated in currencies of the various countries where we operate. We intend to repatriate$5.0 to$6.0 billion of unremitted earnings in future years. Our concentrations of credit risks with respect to trade accounts receivable are limited due to the large number of customers and their dispersion across a number of geographic areas and by frequent monitoring of the creditworthiness of the customers to whom credit is granted in the normal course of business. Substantially all of our trade receivables are concentrated in the public and private hospital and healthcare industry in theU.S. and internationally or with distributors or dealers who operate in international markets and, accordingly, are exposed to their respective business, economic and country-specific variables. We have continued to collect on outstanding receivables throughout the pandemic. However, we are closely monitoring the financial stability of our customers and the country-specific risks, including those customers in markets with hospitals sponsored by the government.
Material Cash Requirements from Known Contractual and Other Obligations
AtMarch 31, 2022 , we had outstanding debt of$6,300.8 million , of which$1,014.5 million was classified as current debt. Of our current debt,$271.9 million of Japanese Yen denominated term loans mature onSeptember 27, 2022 ,$556.3 million of Euro denominated senior notes mature onDecember 13, 2022 ,$86.3 million of senior notes mature onMarch 19, 2023 and$100.0 million was outstanding on our 2021 Five-Year Revolving Facility that was borrowed on a short-term basis. We believe we can satisfy these debt obligations with cash generated from our operations, with cash received from selling a portion or all of our shares of ZimVie common stock, by issuing new debt, and/or by borrowing on our revolving credit facilities. For additional information on our debt, including types of debt, maturity dates, interest rates, debt covenants and available revolving credit facilities, see Note 8 to our interim condensed consolidated financial statements included in Part I, Item 1 of this report.
In
In
As discussed in Note 5 to our interim condensed consolidated financial
statements in Part I, Item 1 of this report, we have a 2021 Restructuring Plan
and a 2019 Restructuring Plan. The 2021 Restructuring Plan is expected to result
in total pre-tax restructuring
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charges of approximately $240 million , of which approximately $60 million was
incurred through March 31, 2022 . We expect to reduce gross annual pre-tax
operating expenses by approximately $210 million relative to the 2021 baseline
expenses by the end of 2024 as program benefits under the 2021 Restructuring
Plan are realized. The 2019 Restructuring Plan is expected to result in total
pre-tax restructuring charges of approximately $350 million to $400 million , of
which approximately $235 million was incurred through March 31, 2022 . We expect
to reduce gross annual pre-tax operating expenses by approximately $200 million
to $300 million relative to the 2019 baseline expenses by the end of 2023 as
program benefits under the 2019 Restructuring Plan are realized.
As discussed in Note 12 to our interim condensed consolidated financial
statements included in Part I, Item 1 of this report, the IRS has issued
proposed adjustments for years 2010 through 2012, as well as proposed
adjustments for years 2013 through 2015, reallocating profits between certain of
our U.S. and foreign subsidiaries. We have disputed these proposed adjustments
and intend to continue to vigorously defend our positions. Although the ultimate
timing for resolution of the disputed tax issues is uncertain, future payments
may be significant to our operating cash flows.
As discussed in Note 15 to our interim condensed consolidated financial
statements included in Part I, Item 1 of this report, we are involved in various
litigation matters. We estimate the total liabilities for all litigation matters
was $423.0 million as of March 31, 2022 . We expect to pay these liabilities over
the next few years. Additionally, we have entered into development, distribution
and other contractual arrangements that may result in future payments dependent
upon various events such as the achievement of certain product R&D milestones,
sales milestones, or, at our discretion, maintenance of exclusive rights to
distribute a product. Since there is uncertainty on the timing or whether such
payments will have to be made, they have not been recognized on our condensed
consolidated balance sheets. These estimated payments could range from $0 to
approximately $360 million .
Recent Accounting Pronouncements
Information pertaining to recent accounting pronouncements can be found in Note 3 to our interim condensed consolidated financial statements included in Part I, Item 1 of this report. Critical Accounting Estimates The preparation of our financial statements is affected by the selection and application of accounting policies and methods, and also requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Critical accounting estimates are those that involve a significant level of estimation uncertainty and have had or are reasonably likely to have a material impact on our financial condition and results of operations. There were no changes in the three-month period endedMarch 31, 2022 to our critical accounting estimates as described in our Annual Report on Form 10-K for the year endedDecember 31, 2021 .
Cautionary Note Regarding Forward-Looking Statements and Factors That May Affect Future Results
This quarterly report contains certain statements that are forward-looking statements within the meaning of federal securities laws. Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts. When used in this report, the words "may," "will," "can," "should," "would," "could," "anticipate," "expect," "plan," "seek," "believe," "are confident that," "look forward to," "predict," "estimate," "potential," "project," "target," "forecast," "see," "intend," "design," "strive," "strategy," "future," "opportunity," "assume," "guide," "position," "continue" and similar expressions are intended to identify forward-looking statements. Forward-looking statements are based on current beliefs, expectations and assumptions that are subject to significant risks, uncertainties and changes in circumstances that could cause actual results to differ materially from such forward-looking statements. These risks, uncertainties and changes in circumstances include, but are not limited to:
• the effects of the COVID-19 global pandemic and other adverse public
health developments on the global economy, our business and operations and
the business and operations of our suppliers and customers, including the
deferral of elective surgical procedures and our ability to collect
accounts receivable, the failure of vaccine rollouts and other strategies
to mitigate or reverse the impacts of the COVID-19 pandemic, and the
failure of elective surgical procedures to recover at the levels or on the
timeline anticipated;
• the risks and uncertainties related to our ability to successfully execute
our restructuring plans;
• our ability to attract, retain and develop the highly skilled employees we
need to support our business;
• the success of our quality and operational excellence initiatives,
including ongoing quality remediation efforts at our Warsaw North Campus
facility;
• the ability to remediate matters identified in inspectional observations
or warning letters issued by the FDA, while continuing to satisfy the
demand for our products;
• the risks and uncertainties associated with the spinoff of ZimVie Inc.,
including, without limitation, the tax-free nature of the transaction, the
tax-efficient nature of any subsequent disposal of any ZimVie Inc. common
stock we retain, possible disruptions in our relationships with customers,
suppliers and other business partners, and the possibility that the
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anticipated benefits and synergies of the transaction, strategic and
competitive advantages, and future growth and other opportunities will not
be realized within the expected time periods or at all;
• the impact of substantial indebtedness on our ability to service our debt
obligations and/or refinance amounts outstanding under our debt
obligations at maturity on terms favorable to us, or at all;
• the ability to retain the employees, independent agents and distributors
who market our products;
• dependence on a limited number of suppliers for key raw materials and
outsourced activities;
• the possibility that the anticipated synergies and other benefits from
mergers and acquisitions will not be realized, or will not be realized
within the expected time periods;
• the risks and uncertainties related to our ability to successfully
integrate the operations, products, employees and distributors of acquired
companies;
• the effect of the potential disruption of management's attention from
ongoing business operations due to integration matters related to mergers
and acquisitions;
• the effect of mergers and acquisitions on our relationships with
customers, suppliers and lenders and on our operating results and
businesses generally;
• challenges relating to changes in and compliance with governmental laws
and regulations affecting our
regulations of the FDA and foreign government regulators, such as more
stringent requirements for regulatory clearance of products;
• the outcome of government investigations;
• competition;
• pricing pressures;
• changes in customer demand for our products and services caused by
demographic changes or other factors;
• the impact of healthcare reform measures;
• reductions in reimbursement levels by third-party payors and costcontainment efforts sponsored by government agencies, legislative bodies,
the private sector and healthcare purchasing organizations, including the
volume-based procurement in
• dependence on new product development, technological advances and innovation;
• shifts in the product category or regional sales mix of our products and
services;
• supply and prices of raw materials and products;
• control of costs and expenses;
• the ability to obtain and maintain adequate intellectual property protection;
• breaches or failures of our information technology systems or products,
including by cyber-attack, unauthorized access or theft;
• the ability to form and implement alliances;
• changes in tax obligations arising from tax reform measures, including
• product liability, intellectual property and commercial litigation losses;
• changes in general industry and market conditions, including domestic and
international growth rates;
• changes in general domestic and international economic conditions,
including interest rate and currency exchange rate fluctuations;
• the domestic and international business impact of political, social and
economic instability, tariffs, trade embargoes, sanctions, wars, disputes
and other conflicts;
• the effects of inflation, including the effects of different rates of
inflation in different countries, on our costs, especially of titanium
used in our products, and the costs of our products;
• the effects of supply chain continuity disruptions;
• and the impact of the ongoing financial and political uncertainty on
countries in EMEA relating to the Russian-Ukrainian crisis and otherwise,
on the ability to collect accounts receivable in affected countries.
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Our Annual Report on Form 10-K for the year ended December 31, 2021 and this
Quarterly Report on Form 10-Q contain detailed discussions of these and other
important factors under the heading "Risk Factors." You should understand that
it is not possible to predict or identify all factors that could cause actual
results to differ materially from forward-looking statements. Consequently, you
should not consider any list or discussion of such factors to be a complete set
of all potential risks or uncertainties.
Forward-looking statements speak only as of the date they are made and we expressly disclaim any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Readers of this report are cautioned not to rely on these forward-looking statements since there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this report. Item 3. Quantitative and Qualitative Disclosures About Market Risk
There have been no material changes from the information provided in our Annual
Report on Form 10-K for the year ended
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